2015 25595 PDF

Vol.
80 Friday,
No. 200 October 16, 2015
Part III
Department of Health and Human Services

Centers for Medicare & Medicaid Services
42 CFR Parts 412 and 495
Medicare and Medicaid Programs; Electronic Health Record Incentive
Program—Stage 3 and Modifications to Meaningful Use in 2015 Through
2017; Final Rule
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62762 Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Rules and Regulations
DEPARTMENT OF HEALTH AND later than 5 p.m. EST on December 15, courier delivery may be delayed and
HUMAN SERVICES 2015. received after the comment period.
ADDRESSES: In commenting, please refer For information on viewing public
Centers for Medicare & Medicaid to file code CMS–3310 & 3311–FC. comments, we refer readers to the
Services Because of staff and resource beginning of the SUPPLEMENTARY
limitations, we cannot accept comments INFORMATION section.
42 CFR Parts 412 and 495 by facsimile (FAX) transmission. FOR FURTHER INFORMATION CONTACT:
You may submit comments in one of Elizabeth Holland, (410) 786–1309,
[CMS–3310–FC and CMS–3311–FC] four ways (no duplicates, please): Medicare EHR Incentive Program and
1. Electronically. You may (and we Medicare payment adjustment.
RINs 0938–AS26 and 0938–AS58
encourage you to) submit electronic Elisabeth Myers (CMS), (410) 786–4751,
Medicare and Medicaid Programs; comments on this regulation to http:// Medicare EHR Incentive Program.
Electronic Health Record Incentive www.regulations.gov. Follow the Thomas Romano (CMS), (410) 786–
Program—Stage 3 and Modifications to instructions under the ‘‘submit a 0465, Medicaid EHR Incentive
Meaningful Use in 2015 Through 2017 comment’’ tab. Program.
2. By regular mail. You may mail Ed Howard (CMS), (410) 786–6368,
AGENCY: Centers for Medicare & written comments to the following Medicare Advantage.
Medicaid Services (CMS), HHS. address ONLY: Centers for Medicare & Elise Sweeney Anthony (ONC), (202)
ACTION: Final rules with comment Medicaid Services, Department of 475–2485, Certification definition.
period. Health and Human Services, Attention: SUPPLEMENTARY INFORMATION:
CMS–3310 & 3311–FC, P.O. Box 8013,
SUMMARY: This final rule with comment Baltimore, MD 21244–1850. Electronic Access
period specifies the requirements that Please allow sufficient time for mailed Inspection of Public Comments: All
eligible professionals (EPs), eligible comments to be received before the public comments received before the
hospitals, and critical access hospitals close of the comment period. close of the comment period are
(CAHs) must meet in order to qualify for 3. By express or overnight mail. You available for viewing by the public,
Medicare and Medicaid electronic may send written comments via express including any personally identifiable or
health record (EHR) incentive payments or overnight mail to the following confidential business information that is
and avoid downward payment address ONLY: Centers for Medicare & included in a comment. We post all
adjustments under the Medicare EHR Medicaid Services, Department of public comments received before the
Incentive Program. In addition, it Health and Human Services, Attention: close of the comment period on the
changes the Medicare and Medicaid CMS–3310 &3311–FC, Mail Stop C4– following Web site as soon as possible
EHR Incentive Programs reporting 26–05, 7500 Security Boulevard, after they have been received: http://
period in 2015 to a 90-day period Baltimore, MD 21244–1850. www.regulations.gov. Follow the search
aligned with the calendar year. This 4. By hand or courier. If you prefer, instructions on that Web site to view
final rule with comment period also you may deliver (by hand or courier) public comments.
removes reporting requirements on your written comments before the close This Federal Register document is
measures that have become redundant, of the comment period to either of the also available from the Federal Register
duplicative, or topped out from the following addresses: online database through Federal Digital
Medicare and Medicaid EHR Incentive a. For delivery in Washington, DC— System (FDsys), a service of the U.S.
Programs. In addition, this final rule Centers for Medicare & Medicaid Government Printing Office. This
with comment period establishes the Services, Department of Health and database can be accessed via the
requirements for Stage 3 of the program Human Services, Room 445–G, Hubert Internet at: http://www.gpo.gov/fdsys.
as optional in 2017 and required for all H. Humphrey Building, 200
Independence Avenue SW., Acronyms
participants beginning in 2018. The
final rule with comment period Washington, DC 20201. API Application Programming Interface
continues to encourage the electronic (Because access to the interior of the ARRA American Recovery and
submission of clinical quality measure Hubert H. Humphrey Building is not Reinvestment Act of 2009
(CQM) data, establishes requirements to readily available to persons without ACO Accountable Care Organization
Federal Government identification, AIU Adopt, Implement, Upgrade (certified
transition the program to a single stage, EHR Technology)
and aligns reporting for providers in the commenters are encouraged to leave
their comments in the CMS drop slots CAH Critical Access Hospital
Medicare and Medicaid EHR Incentive CCD Continuity of Care Document
Programs. located in the main lobby of the
CCDA C–CDA, Consolidated Clinical
building. A stamp-in clock is available Document Architecture
DATES: Effective Date: These regulations for persons wishing to retain a proof of CCDS Common Clinical Data Set
are effective on December 15, 2015. filing by stamping in and retaining an CCN CMS Certification Number
Comment Date: To be assured extra copy of the comments being filed.) CDC Centers for Disease Control &
consideration, comments on sections b. For delivery in Baltimore, MD— Prevention
II.B.1.b.(3).(iii), II.B.1.b.(4).(a), II.B.2.b, Centers for Medicare & Medicaid CDR Clinical Data Registry
II.D.1.e, and II.G.2 of preamble to this Services, Department of Health and CDS Clinical Decision Support
final rule with comment period; Human Services, 7500 Security CEHRT Certified Electronic Health Record
paragraphs (1)(ii)(C)(3), (1)(iii), Boulevard, Baltimore, MD 21244–1850. Technology

(2)(ii)(C)(3) and 2(iii) of the definition of If you intend to deliver your CFR Code of Federal Regulations
an EHR reporting period at § 495.4; and CHIP Children’s Health Insurance Program
comments to the Baltimore address, CHIPRA Children’s Health Insurance
paragraphs (2)(ii)(C)(2) and (2)(iii) of the please call the telephone number (410) Program Reauthorization Act of 2009
definition of an EHR reporting period 786–9994 in advance to schedule your CMS Centers for Medicare & Medicaid
for a payment adjustment year at § 495.4 arrival with one of our staff members. Services
must be received at one of the addresses Comments mailed to the addresses CPCI Comprehensive Primary Care
provided in the ADDRESSES section no indicated as appropriate for hand or Initiative
Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Rules and Regulations 62763
CPOE Computerized Physician Order Entry b. Meaningful Use Requirements, 2. Meaningful Use Objectives and
CQM Clinical Quality Measure Objectives, and Measures for 2015 Measures
CY Calendar Year Through 2017 a. Meaningful Use Objectives and Measures
DEC Data Element Catalog (1) EHR Reporting Period for 2015, 2016, and 2017
eCQM Electronic Clinical Quality Measure (2) Objectives and Measures Objective 1: Protect Patient Health
EHR Electronic Health Record c. Meaningful Use Requirements, Information
ELR Electronic Reportable Lab Objectives, and Measures for Stage 3 in Objective 2: Clinical Decision Support
EP Eligible Professional 2017 and Subsequent Years Objective 3: Computerized Provider Order
ePHI Electronic Protected Health (1) EHR Reporting Period Entry
Information (2) Objectives and Measures Objective 4: Electronic Prescribing
eRx Electronic Prescribing d. Certified EHR Technology Requirements Objective 5: Health Information Exchange
FACA Federal Advisory Committee Act for the EHR Incentive Programs Objective 6: Patient Specific Education
FAQ Frequently asked question e. Clinical Quality Measurement Objective 7: Medication Reconciliation
FCC Federal Communications Commission f. Demonstration of Meaningful Use Objective 8: Patient Electronic Access
g. Payment Adjustments and Hardship Objective 9: Secure Electronic Messaging
FFP Federal Financial Participation
Exceptions EP Only
FFS Fee-for-Service
h. Modifications to the Medicaid EHR Objective 10: Public Health and Clinical
FQHC Federally Qualified Health Center Data Registry Reporting
FY Fiscal Year Incentive Program
3. Summary of Costs and Benefits b. Objectives and Measures for Stage 3 of
HEDIS Healthcare Effectiveness Data and the EHR Incentive Programs
Information Set B. Overview of the Regulatory History
II. Provisions of the Proposed Regulations Objective 1: Protect Patient Health
HHS Department of Health and Human Information
and Analysis of and Responses to Public
Services Objective 2: Electronic Prescribing
Comments
HIE Health Information Exchange Objective 3: Clinical Decision Support
A. Introduction
HIT Health Information Technology Objective 4: Computerized Provider Order
B. Meaningful Use Requirements,
HIPAA Health Insurance Portability and Entry
Objectives, and Measures
Accountability Act of 1996 Objective 5: Patient Electronic Access to
1. Definitions Across the Medicare Fee-for-
HITECH Health Information Technology for Health Information
Service, Medicare Advantage, and
Economic and Clinical Health Act Objective 6: Coordination of Care Through
Medicaid Programs
HMO Health Maintenance Organization Patient Engagement
a. Uniform Definitions
ICR Information Collection Requirement Objective 7: Health Information Exchange
b. Definitions for 2015 Through 2017 and
IFC Interim Final Rule with Comment Objective 8: Public Health and Clinical
Subsequent Years
Period Data Registry Reporting
(1) Stages of Meaningful Use
IPPS Inpatient Prospective Payment System 3. Certified EHR Technology (CEHRT)
(2) Meaningful EHR User
IQR Inpatient Quality Reporting Requirements
(3) EHR Reporting Period
IT Information Technology a. CEHRT Definition for the EHR Incentive
(i) Calendar Year Reporting Programs
MA Medicare Advantage (ii) EHR Reporting Period in 2015 Through
MACRA Medicare Access and CHIP b. Defining CEHRT for 2015 Through 2017
2017 c. Defining CEHRT for 2018 and
Reauthorization Act of 2015 (iii) EHR Reporting Period in 2017 and
MIPS Merit-Based Incentive Payment Subsequent Years
Subsequent Years d. Final Definition of CEHRT
System (4) Considerations in Defining Meaningful
MITA Medicaid Information Technology C. Clinical Quality Measurement
Use 1. Clinical Quality Measure (CQM)
Architecture (a) Considerations in Review and Analysis
NPI National Provider Identifier Requirements for Meaningful Use in
of the Objectives and Measures for 2015 and 2016
NPPES National Plan and Provider Meaningful Use
Enumeration System 2. Clinical Quality Measure (CQM)
(i) Topped Out Measures and Objectives Requirements for Meaningful Use in
NwHIN Nationwide Health Information (ii) Electronic Versus Paper-Based
Network 2017 and Subsequent Years
Objectives and Measures a. Clinical Quality Measure Reporting
NQF National Quality Forum (iii) Advanced EHR Functions Requirements for EPs
ONC Office of the National Coordinator for (b) Considerations in Defining the b. CQM Reporting Requirements for
Health Information Technology Objectives and Measures of Meaningful Eligible Hospitals and Critical Access
OTC Over the counter Use for 2015 Through 2017 Hospitals
PFS Physician Fee Schedule (i) Changes to Objectives and Measures for c. Quality Reporting Data Architecture
PHA Public Health Agency 2015 Through 2017 Category III (QRDA–III) Option for
PHSA Public Health Service Act (ii) Structural Requirements of Meaningful Eligible Hospitals and CAHs
POS Place of Service Use in 2015 Through 2017 3. CQM Reporting Period Beginning in
PQRS Physician Quality Reporting System (iii) Alternate Exclusions and 2017
PHI Protected Health Information Specifications for Stage 1 Providers for a. CQM Reporting Period for EPs
QA Quality Assurance Meaningful Use b. CQM Reporting Period for Eligible
QRDA Quality Reporting Data Architecture (iv) Changes to Patient Engagement Hospitals and CAHs
SMHP State Medicaid Health Information Requirements for 2015 Through 2017 c. Reporting Flexibility EPs, Eligible
Technology Plan (c) Considerations in Defining the Hospitals, CAHs 2017
SRA Security Risk Assessment Objectives and Measures of Meaningful 4. Reporting Methods for CQMs
ToC Transitions of Care Use Stage 3 5. CQM Specification and Changes to the
VDT View, Download, and Transmit (d) Flexibility Within Meaningful Use Annual Update
Objectives and Measures 6. Certified EHR Technology Requirements
Table of Contents
(e) EPs Practicing in Multiple Practices for CQMs
I. Executive Summary and Background Locations 7. Electronic Reporting of CQMs

A. Executive Summary (f) Denominators D. Demonstration of Meaningful Use and
1. Purpose of Regulatory Action (g) Patient Authorized Representatives Other Issues
a. Need for Regulatory Action (h) Discussion of the Relationship of the 1. Demonstration of Meaningful Use
b. Legal Authority for the Regulatory Requirements of the EHR Incentive a. Common Methods of Demonstration in
Action Programs to CEHRT Medicare and Medicaid
2. Summary of Major Provisions (i) Discussion of the Relationship Between b. Methods for Demonstration of the
a. Considerations in Defining Meaningful a Stage 3 Objective and the Associated Criteria for Meaningful Use in 2015
Use Measure Through 2017
c. Attestation Deadlines for the EHR 1. Overall Effects proposed EHR rule. Section 101(b)(1)(A)
Incentive Programs in 2015 Through a. EHR Technology Development and of MACRA amended section
2017 Certification Costs—Stage 3 1848(a)(7)(A) of the Act to sunset the
d. New Participant Attestation Deadlines b. Regulatory Flexibility Analysis and
meaningful use payment adjustment for
for Meaningful Use in 2015 and 2016 to Small Entities
Avoid a Payment Adjustment (1) Small Entities EPs at the end of CY 2018. Section
e. Methods for Demonstration of the Stage (2) Conclusion 101(c) of MACRA added section 1848(q)
3 Criteria of Meaningful Use for 2017 c. Small Rural Hospitals—Modifications of the Act requiring the establishment of
and Subsequent Years d. Unfunded Mandates Reform Act a Merit-Based Incentive Payment
(1) Meaningful Use Objectives and e. Federalism System (MIPS), which would
Measures in 2017 and CEHRT Flexibility 2. Effects on EPs, Eligible Hospitals, and incorporate meaningful use. In light of
in 2017 CAHs the passage of MACRA, this final rule
(2) Stage and CEHRT Flexibility in 2017 a. Background and Assumptions
with comment period also allows for a
(3) CQM Flexibility in 2017 (1) EHR Incentive Programs in 2015
2. Alternate Method of Demonstration for Through 2017 60-day public comment period on
Certain Medicaid Providers Beginning in (2) Stage 3 certain provisions noted in the
2015 b. Industry Costs and Adoption Rates SUPPLEMENTARY INFORMATION section
3. Data Collection for Online Posting, (1) Modifications above in part to support the transition
Program Coordination, and Accurate (a.) Medicare Eligible Professionals (EPs) to MIPS. The comments received during
Payments (b.) Medicare Eligible Hospitals and CAHs the comment period may be considered
4. Hospital-Based Eligible Professionals (c.) Medicaid Only EPs as we prepare for future rulemaking to
5. Interaction With Other Programs (d.) Medicaid Only Hospitals
implement MIPS, which in general is
E. Payment Adjustments and Hardship (2) Stage 3
Exceptions c. Costs of EHR Adoption for EPs expected to be more broadly focused on
1. Statutory Basis for Payment Adjustments d. Costs of EHR Adoption for Eligible quality and care delivery.
and Hardship Exceptions Hospitals The enactment of MACRA has altered
a. Statutory Basis for Payment Adjustments 3. Medicare and Medicaid Incentive the EHR Incentive Programs such that
and Hardship Exceptions for Eligible Program Costs for Stage 3 the existing Medicare payment
Professionals (EPs) a. Medicare Program Costs for Stage 3 adjustment for EPs under 1848(a)(7)(A)
b. Statutory Basis for Payment Adjustments (1) Medicare Eligible Professionals (EPs)
of the Act will end in CY 2018 and be
and Hardship Exceptions for Eligible (2). Medicare Eligible Hospitals and CAHs
b. Medicaid Incentive Program Costs for incorporated under MIPS beginning in
Hospitals
c. Statutory Basis for Payment Adjustments Stage 3 CY 2019. It is our intent to issue a notice
and Hardship Exceptions for CAHs (1). Medicaid EPs of proposed rulemaking for MIPS by
2. EHR Reporting Period for a Payment (2). Medicaid Hospitals mid-2016. This final rule with comment
Adjustment Year 4. Benefits for all EPs and all Eligible period synchronizes reporting under the
a. Changes to the EHR Reporting Period for Hospitals EHR Incentive Programs to end the
a Payment Adjustment Year for EPs 5. Benefits to Society separate stages of meaningful use,
b. Changes to the EHR Reporting Period for 6. Summary
which we believe will prepare Medicare
a Payment Adjustment Year for Eligible D. Alternatives Considered for Stage 3
E. Accounting Statement and Table EPs for the transition to MIPS.
Hospitals
c. Changes to the EHR Reporting Period for (1) EHR Incentive Programs in 2015 In the Stage 3 and the EHR Incentive
a Payment Adjustment Year for CAHs Through 2017 Program in 2015 through 2017 proposed
3. Hardship Exceptions (2) Stage 3 rules, and in this final rule with
4. Administrative Review Process of VI. Response to Comments comment period, we have responded to
Certain Electronic Health Record Regulations Text public input and comments by
Incentive Program Determinations I. Executive Summary and Background providing for flexibility that may assist
F. Medicare Advantage Organization EPs in preparing for the transition to
Incentive Payments A. Executive Summary MIPS. This final rule with comment
G. The Medicaid EHR Incentive Program
1. Purpose of Regulatory Action period establishes a number of key final
1. State Flexibility for Meaningful Use
2. EHR Reporting Period and EHR policies in response to these concerns:
a. Need for Regulatory Action A simplification of program
Reporting Period for a Payment
Adjustment Year for First Time This final rule with comment period requirements, an introduction of
Meaningful EHR Users in Medicaid addresses the proposals made in two flexibility within certain objectives, an
3. Reporting Requirements separate CMS notices of proposed option to participate in Stage 3 in 2017
a. State Reporting on Program Activities rulemaking (NPRM); the March 30, 2015 but not required until 2018, and an
b. State Reporting on Meaningful EHR ‘‘Medicare and Medicaid Programs; overall focus on interoperability. We
Users Electronic Health Record Incentive have focused on leveraging health IT to
4. Clinical Quality Measurement for the
Program Stage 3’’ NPRM (80 FR 16731 support providers and reduce
Medicaid Program
J Pages through 16804) (hereafter referred to as burdensome requirements within an
III. Collection of Information Requirements the ‘‘Stage 3 proposed rule’’) and the evolving environment. In light of public
A. ICR Regarding Demonstration of April 9, 2015 ‘‘Medicare and Medicaid interest and in recognition that this is an
Meaningful Use Criteria (§ 495.24) Programs; Electronic Health Record ongoing and continuous process, we are
B. ICR Regarding Demonstration of Incentive Program—Modifications to providing a 60-day public comment
Meaningful Use Criteria (§ 495.20 Meaningful Use in 2015 through 2017’’ period on the final policies for the Stage
Through § 495.60) NPRM (80 FR 20346 through 20399) 3 objectives and measures and the EHR
C. ICRs Regarding Qualifying MA (hereafter referred to as the ‘‘EHR reporting period for Stage 3 in 2017 and
Organizations (§ 495.210)
Incentive Programs in 2015 through subsequent years. Public comments
D. ICR Regarding State Reporting
Requirements (§ 495.316 and § 495.352) 2017 proposed rule’’). However, the received may be considered as we plan
V. Regulatory Impact Analysis Medicare Access and CHIP for the incorporation of meaningful use
A. Statement of Need Reauthorization Act of 2015 (MACRA) into MIPS, and any policies developed
B. Overall Impact (Pub. L. 114–10) was enacted on April would be addressed in future
C. Anticipated Effects 16, 2015, after publication of the rulemaking.
The Stage 3 proposed rule (80 FR We are also finalizing changes to the including providing patients with
16733 through 16735) described the EHR reporting period, timelines, and electronic copies of their health
final stage of the program, which would structure of the Medicare and Medicaid information. We outlined Stage 1
incorporate portions of the prior stages EHR Incentive Programs for 2015 meaningful use criteria and finalized
into Stage 3 requirements, while altering through 2017 to better align EHR core and menu objectives for EPs,
other requirements in response to CMS’s reporting periods for providers; support eligible hospitals, and CAHs. (For a full
progress toward policy goals, the a flexible, clear framework to reduce discussion of Stage 1 of meaningful use,
widespread adoption of technology and provider burden; and support future we refer readers to the Stage 1 final rule
clinical standards among providers, and sustainability of the Medicare and (75 FR 44313 through 44588).)
high performance on certain objectives Medicaid EHR Incentive Programs. In the September 4, 2012 Stage 2 final
among providers. These proposed Overall, the requirements of the rule (77 FR 53967 through 54162), we
changes included simplifying and program finalized in this rule for 2015 focused on the next goal: The exchange
reducing the number of measures, and through 2017 seek to support near-term of essential health data among health
focusing the Medicare and Medicaid goals for delivery system reform and lay care providers and patients to improve
EHR Incentive Programs on the a foundation for our broader efforts to care coordination. We also finalized a
advanced use of EHR technology. In pursue interoperability and quality set of clinical quality measures (CQMs)
addition, the proposals set a path for initiatives focused on improving patient that all providers participating in any
providers to move toward aligned outcomes. stage of the program are required to
reporting on a single set of report to CMS beginning in 2014. (For
b. Legal Authority for the Regulatory a full discussion of the meaningful use
requirements, with the goal of moving
Action objectives and measures, and the CQMs
all participants in the Medicare and
Medicaid EHR Incentive Programs to a The American Recovery and we finalized under Stage 2, we refer
single set of requirements in 2018. The Reinvestment Act of 2009 (ARRA) (Pub. readers to the Stage 2 final rule at 77 FR
incorporation of the requirements into L. 111–5) amended Titles XVIII and XIX 53967 through 54162.)
one stage for all providers is intended to of the Social Security Act (the Act) to In the March 30, 2015 Federal
respond to stakeholder concerns by authorize incentive payments to EPs, Register, we published a proposed rule
creating simplicity in the program by eligible hospitals, CAHs, and Medicare titled ‘‘Medicare and Medicaid
focusing on the success of certain Advantage (MA) organizations to Programs; Electronic Health Record
measures that are part of the meaningful promote the adoption and meaningful Incentive Program Stage 3’’ (80 FR
use program to date, and setting a long- use of CEHRT. Sections 1848(o), 1853(l) 16731 through 16804) hereafter referred
term, sustainable foundation based on and (m), 1886(n), and 1814(l) of the Act to as the ‘‘Stage 3 proposed rule’’. In the
provide the statutory basis for the April 15, 2015 Federal Register, we
key advanced use objectives for the
Medicare incentive payments made to published a proposed rule titled
Medicare and Medicaid EHR Incentive
meaningful EHR users. These statutory ‘‘Medicare and Medicaid Programs;
Programs.
provisions govern EPs, MA Electronic Health Record Incentive
In the EHR Incentive Programs for Program—Modifications to Meaningful
2015 through 2017 proposed rule (80 FR organizations (for certain qualifying EPs
and hospitals that meaningfully use Use in 2015 through 2017’’ (80 FR
20346 through 20399), we proposed to 20346 through 20399) hereafter referred
make similar modifications to Stage 1 CEHRT), subsection (d) hospitals and
CAHs, respectively. Sections 1848(a)(7), to as the ‘‘EHR Incentive Programs in
and Stage 2 of the Medicare and 2015 through 2017 proposed rule’’. In
Medicaid EHR Incentive Programs in 1853(l) and (m), 1886(b)(3)(B), and
1814(l) of the Act also establish this final rule, we are finalizing both the
order to reduce reporting burden, to Stage 3 proposed rule and the EHR
eliminate redundant and duplicative downward payment adjustments,
Incentive Programs in 2015 through
reporting, and to better align the beginning with calendar or fiscal year
2017 proposed rule to build on the
objectives and measures of meaningful (FY) 2015, for EPs, MA organizations,
groundwork established in Stage 1 and
use with the proposed Stage 3 subsection (d) hospitals, and CAHs that
Stage 2and continue our Stage 2 goal of
requirements, which would be optional are not meaningful users of CEHRT for
increasing interoperable health data
in 2017 and required beginning in 2018. certain associated reporting periods.
sharing among providers. In addition,
In this final rule with comment Sections 1903(a)(3)(F) and 1903(t) of the
this final rule also focuses on the
period, we are finalizing the Act provide the statutory basis for
advanced use of EHR technology to
requirements for the EHR Incentive Medicaid incentive payments. (There
promote improved patient outcomes
Programs for 2015 through 2017 and for are no payment adjustments under and health information exchange. We
2018 and subsequent years. We note Medicaid). (For a more detailed are also finalizing proposals to continue
that our intent in finalizing the Stage 3 explanation of the statutory basis for the improving program efficiency,
proposed rule along with the changes EHR incentive payments, see the July effectiveness, and flexibility by making
for 2015 through 2017 while continuing 28, 2010 Stage 1 final rule titled, changes to the Medicare and Medicaid
to solicit comments on certain ‘‘Medicare and Medicaid Programs; EHR Incentive Programs that simplify
provisions is multifold; we are creating Electronic Health Record Incentive reporting requirements and reduce
consistency in the policies for the Program; Final Rule’’ (75 FR 44316 program complexity.
current program in 2015 through 2017 through 44317).) One significant change we proposed
and for 2018 and subsequent years; and 2. Summary of Major Provisions in the Stage 3 proposed rule (80 FR
we have established a clear vision of 16734) included establishing a single set

how current participation will assist in a. Considerations in Defining of objectives and measures (tailored to
meeting our long-term delivery system Meaningful Use EPs or eligible hospitals/CAHs) to meet
reform goals. We believe this sustained The Stage 1 final rule established the the definition of meaningful use for
consistency in policy will support the foundation for the Medicare and Stage 3 in 2017 and subsequent years.
planning and development for MIPS Medicaid EHR Incentive Programs by In the EHR Incentive Program in 2015
and the future use of EHR across a establishing requirements for the through 2017 proposed rule (80 FR
multitude of healthcare providers. electronic capture of clinical data, 20351), we additionally proposed a
transitional period in 2015 through 2017 duplicative, or topped out, and therefore on the Stage 3 proposed rule (80 FR
that would help move providers along a will no longer be required for the 16739) and public comments received.
participation continuum toward the successful demonstration of meaningful We are finalizing the proposal for full
long term goals proposed under the use for Stage 3. For further discussion calendar year reporting for providers
Stage 3 proposed rule. In this final rule, of this approach, we refer readers to beginning in 2018 with a limited
we are adopting this transition toward a section II.B.1.b.(4).(a) of this final rule exception for Medicaid providers in
new, streamlined set of requirements, with comment period. their first year of demonstrating
including an optional year for any In this final rule, we are adopting the meaningful use. We are also finalizing
provider who chooses to attest to the proposed approach from the EHR an optional 90-day reporting period for
objectives and measures for Stage 3 for Incentive Program in 2015 through 2017 providers demonstrating the Stage 3
an EHR reporting period in 2017. We are proposed rule to use a similar method requirements for an EHR reporting
additionally finalizing the objectives to identify the objectives and measures period in 2017. For further discussion,
and measures that will be required for from Stages 1 and 2 of meaningful use we refer readers to section II.B.1.b.(3) of
all eligible providers—regardless of that we believe should no longer be this final rule.
prior participation in the Medicare and required for a provider to demonstrate
(2) Objectives and Measures
Medicaid EHR Incentive Programs—for meaningful use in 2015 through 2017
an EHR reporting period in 2018 and because these measures have been The methodology outlined in the
subsequent years. identified as redundant, duplicative, or Stage 3 proposed rule at 80 FR 16741 for
In the Stage 3 proposed rule (80 FR topped out. We are also finalizing the selection of objectives and measures
16741), we outlined our proposed changes to remove the menu and core for the Medicare and Medicaid EHR
approach and method for measure structure of Stage 1 and Stage 2 and Incentive Programs for Stage 3 in 2017
selection that removed topped out, reduce the overall number of objectives and subsequent years included the
redundant, and duplicative measures to which a provider must attest. In following:
from reporting requirements and addition, we are finalizing changes to • Review attestation data for Stages 1
focused on only those measures that individual objectives and measures for and 2 of meaningful use;
represent the most advanced use of the Stage 2 of meaningful use as follows: • Conduct listening sessions and
functions and standards supported by • Changing the threshold for two interviews with providers, EHR system
CEHRT. In the EHR Incentive Program measures requiring patient action (the developers, regional extension centers,
in 2015 through 2017 proposed rule (80 second measure for the Stage 2 and health care provider associations;
FR 20352), we proposed adopting this Objective for Patient Electronic Access and
approach as applicable to the current and the measure for the Stage 2 • Review recommendations from
objectives and measures in use for Stage Objective for Secure Electronic government agencies and advisory
1 and Stage 2 of the program and Messaging). committees focused on health care
aligning the current objectives and • Consolidating all public health improvement, such as the Health
measures with those identified for long- reporting objectives into one objective Information Technology (HIT) Policy
term use in the Stage 3 proposed rule. with measure options similar to the Committee, the National Quality Forum
In this final rule, we adopt the approach structure of the Stage 3 Public Health (NQF), and the Centers for Disease
for the Stage 3 objectives and measures, Reporting Objective (80 FR 16762 Control and Prevention (CDC).
through 16767). The information we gathered from
as well as the similar approach for the
• Changing the eligible hospital these sources focused on analyzing
objectives and measures of the EHR
electronic prescribing objective from a measure performance, implementing
Incentive Program in 2015 through
menu objective to a required objective discrete EHR functionalities and
2017.
with an exclusion available for eligible standards, and examining objectives and
b. Meaningful Use Requirements, hospitals and CAHs in 2015 and 2016. measures presenting the best
Objectives, and Measures for 2015 We are additionally finalizing the opportunity to improve patient
Through 2017 proposal to maintain the existing outcomes and enhance provider
(1) EHR Reporting Period definitions for the objectives and support.
measures, including the numerator and Based on this analysis and
In this final rule, we adopt changes to consideration of public comment
the EHR reporting period for the denominator calculations, the proposal
to maintain certain measure received, we are finalizing a set of 8
Medicare and Medicaid EHR Incentive objectives with associated measures
Programs in 2015, 2016, and 2017 and specifications for 2015, and the proposal
to allow exclusions for certain measures designed to meet the following policy
finalize the changes that align reporting goals:
in 2015 and 2016 in order to facilitate
periods to the calendar year. We also • Align with national health care
finalize the proposal to adopt a 90-day the transition for providers already
quality improvement efforts;
reporting period for all providers in engaged in the workflows, data capture, • Promote interoperability and health
2015 and new participants in 2016, and and measure calculation for meaningful information exchange; and
based on public comment we are use for an EHR reporting period in 2015 • Focus on the 3-part aim of reducing
finalizing a 90-day reporting period for and 2016.For further discussion of this cost, improving access, and improving
new participants in 2017. approach, we refer readers to section quality.
II.B.1.b.(4).(b).of this final rule. We intend for Stage 3 to be the final
(2) Objectives and Measures
c. Meaningful Use Requirements, stage of the meaningful use framework,

In the Stage 3 proposed rule (80 FR Objectives, and Measures for Stage 3 in which leverages the structure identified
16741), we outlined our method and 2017 and Subsequent Years in the Stage 1 and Stage 2 final rules,
approach for identifying the objectives while simultaneously establishing a
and measures retained for Stage 3 of (1) EHR Reporting Period single set of objectives and measures
meaningful use beginning in 2017. We In this final rule, we are adopting designed to promote best practices and
also identified those objectives and changes to the EHR reporting period for continued improvement in health
measures that are now redundant, 2017, 2018, and subsequent years based outcomes in a sustainable manner.
Measures in the Stage 1 and Stage 2 requirements of the Medicare and electronically report their CQM data
final rules that included paper-based Medicaid EHR Incentive Programs. We using the established methods for
workflows, chart abstraction, or other are committed to continuing to promote electronic reporting outlined in section
manual actions have been removed or the electronic capture, calculation, and II.C. of this final rule. In addition, we
transitioned to an electronic format reporting of key clinical data through are finalizing that for an EHR reporting
utilizing EHR functionality for Stage 3. the use of CEHRT. We are also focused period in 2018, all providers are
In addition, we are finalizing the on improving alignment of reporting required to submit CQM data for the
removal of topped out measures, or requirements for CMS programs that Medicare EHR Incentive Program using
measures that are no longer useful in leverage EHR technology for clinical these established methods for electronic
gauging performance, because these less quality reporting and quality reporting. We refer readers to section
advanced measures are now achieving measurement to streamline reporting II.C. of this final rule for further
widespread adoption. mechanisms for providers and increase information on clinical quality
quality data integrity.
d. Certified EHR Technology This final rule addresses quality measurement.
Requirements for the EHR Incentive reporting alignment on several fronts.
Programs f. Demonstration of Meaningful Use
Our long-term vision seeks to have
In the EHR Incentive Programs in hospitals, clinicians, and other health We are finalizing our proposal to
2015 through 2017 proposed rule (80 FR care providers report through a single, continue our common method for
20374), we proposed no changes to the aligned mechanism for multiple CMS meaningful use in both the Medicare
individual certification requirements for programs. In order to facilitate and Medicaid EHR Incentive Programs
the objectives and measures of continuous quality improvement, we of attestation as the method for
meaningful use for an EHR reporting noted in the Stage 3 proposed rule our demonstrating that an EP, eligible
period in 2015 through 2017 using EHR intent to implement changes to quality hospital, or CAH has met the
technology certified to the 2014 Edition reporting requirements in conjunction requirements of the Medicare and
certification criteria. In the Stage 3 with the quality reporting programs Medicaid EHR Incentive Programs. We
proposed rule (80 FR 16767), we through the annual Medicare payment are additionally finalizing changes to
proposed that providers use EHR rules, such as the Physician Fee the attestation deadlines to
technology certified to the 2015 Edition Schedule (PFS) and the Inpatient accommodate the change to reporting
certification criteria for an EHR Prospective Payment Systems (IPPS) based on the calendar year for eligible
reporting period in 2018. In this rule, rules. In the Stage 3 proposed rule, we hospitals and CAHs beginning with an
we are finalizing that providers may proposed to continue encouraging CQM EHR reporting period in 2015, as well as
continue to usher technology certified to data submission through electronic
the 2014 Edition until EHR technology the proposed change to a 90-day EHR
submission for Medicare participants in
certified to the 2015 Edition is required reporting period for all providers in
2017 and to require electronic
with an EHR reporting period beginning submission of CQMs where feasible 2015. We are also finalizing changes to
in 2018. In the Stage 3 proposed rule, beginning in 2018 for Medicare the attestation deadlines for new
we also noted our intent to allow providers demonstrating meaningful meaningful EHR users in 2015 and 2016
providers to upgrade to technology use. (We further discuss Medicaid CQM to avoid the Medicare payment
certified to the 2015 Edition as soon as submission in section II.F.3 of this final adjustments in 2016 and 2017. Finally,
such technology is available if they rule.) we are adopting the alternate attestation
determine that the EHR technology We did not propose changes to the method proposed in the EHR Incentive
certified to the 2015 Edition would CQM selection or reporting scheme (9 or Program in 2015 through 2017 proposed
support and meet the requirements of 16 CQMs across at least 3 domains) from rule for certain Medicaid providers to
the EHR Incentive Programs in 2015 the CQM requirements previously demonstrate meaningful use in 2015
through 2017. We are finalizing that established for all providers seeking to and subsequent years to avoid Medicare
providers may use EHR technology demonstrate meaningful use in the payment adjustments. For further
certified to the 2014 Edition for an EHR Medicare and Medicaid EHR Incentive discussion, we refer readers to section
reporting period in 2015; EHR Programs defined in earlier rulemaking II.D of this final rule.
technology certified to either the 2014 (see 77 FR 54049 through 54089). In the
Edition, the 2015 Edition, or a EHR Incentive Programs in 2015 g. Payment Adjustments and Hardship
combination of the two in 2016 and through 2017 proposed rule, for an EHR Exceptions
2017; and EHR technology certified to reporting period in 2015, and for The HITECH statute requires
the 2015 Edition for an EHR reporting providers demonstrating meaningful use Medicare payment adjustments
period in 2018 and subsequent years. for the first time in 2016 or 2017, we
beginning in 2015. In this final rule, we
We are also finalizing a definition of proposed that providers may—
• Attest to any continuous 90-day are maintaining the payment adjustment
CEHRT within 42 CFR 495.4 that
period of CQM data during the calendar policies for EPs, eligible hospitals, and
includes the functions and standards
outlined for the certification of health year through the Medicare EHR CAHs as finalized in the Stage 2 final
information technology to the 2014 and Incentive Program registration and rule (77 FR 54093 through 54113 and
2015 Edition certification criteria for use attestation site; or 54115 through 54119), except for a
in the Medicare and Medicaid EHR • Electronically report CQM data change to the relationship between the
Incentive Programs. For further using the established methods for EHR reporting period year, the payment
discussion of the definition and use of electronic reporting. adjustment year, and the attestation
CEHRT, we direct readers to section We are finalizing these reporting deadlines to avoid the payment
II.B.3 of this final rule. periods for CQM reporting for 2015 and adjustment. For the discussion of
2016. We are finalizing that for 2017, payment adjustments and hardship
e. Clinical Quality Measurement providers beyond their first year of exceptions, we refer readers to section
EPs, eligible hospitals, and CAHs meaningful use may attest to one full II.E of this final rule with comment
must report CQMs in order to meet the calendar year of CQM data or they may period.
h. Modifications to the Medicaid EHR Based on prior rulemaking, we expect B. Overview of the Regulatory History
Incentive Program spending under the EHR Incentive The American Recovery and
Sections 1903(a)(3)(F) and 1903(t) of Programs for transfer payments to Reinvestment Act of 2009 (Pub. L. 111–
the Act provide the statutory basis for Medicare and Medicaid providers 5) (ARRA) amended Titles XVIII and
the Medicaid EHR Incentive Program. In between 2015 and 2017 to be $14.2 XIX of the Act to authorize incentive
this final rule with comment period, we billion; however, the policies in this payments to EPs, eligible hospitals,
finalize the proposed changes to EHR final rule with comment period do not CAHs, and MA organizations to promote
reporting periods that would begin in change estimates over the current the adoption and meaningful use of
period. CEHRT. In the July 28, 2010 Federal
2017; Medicaid EPs and eligible
Our analysis of impacts for the
hospitals demonstrating meaningful use Register (75 FR 44313 through 44588),
policies in this final rule with comment
for the first time in the Medicaid EHR we published a final rule (‘‘Medicare
period relate to the reduction in cost
Incentive Program would be required to and Medicaid Programs; Electronic
associated with provider reporting
attest for an EHR reporting period of any Health Record Incentive Program’’, or
burden estimates for 2015 through 2017
continuous 90-day period in the ‘‘Stage 1 final rule’’) that specified the
as affected by the adopted changes to
calendar year for purposes of receiving Stage 1 criteria EPs, eligible hospitals,
the current program. The estimates also
an incentive, as well as avoiding the relate to the transfer payments for and CAHs must meet in order to qualify
payment adjustment under the Medicare incentives for Medicaid providers and for an incentive payment, calculation of
Program (80 FR 16779). reductions in payments for Medicare the incentive payment amounts, and
We will continue to allow states to set providers through payment adjustments other program participation
up a CQM submission process that for 2018 and subsequent years. For 2015 requirements. For a full explanation of
Medicaid EPs and eligible hospitals may through 2017, we estimate the reduction the amendments made by ARRA, see the
use to report on CQMs for 2017 and in the reporting burden for providers Stage 1 final rule at 75 FR 44316. In the
subsequent years. We are also finalizing demonstrating meaningful use in a Stage 1 final rule, we also detailed that
amendments to state reporting on calendar year as 1.45 to 1.9 hours per EP the Medicare and Medicaid EHR
providers who are participating in the respondent and 2.62 hours per eligible Incentive Programs would consist of
Medicaid EHR Incentive Program, as hospital or CAH respondent. We three different stages of meaningful use
well as state reporting on estimate the total annual cost savings requirements.
implementation and oversight activities. related to this reduction at $52,547,132 In the September 4, 2012 Federal
The provisions included in this final for a low estimate and $68,617,864 for Register (77 FR 53967 through 54162),
rule with comment period will apply for a high estimate. We expect spending we published a final rule (‘‘Medicare
the Medicaid EHR Incentive Program, under the EHR Incentive Programs for and Medicaid Programs; Electronic
including the changes to the EHR transfer payments to Medicare and Health Record Incentive Program–Stage
reporting period in 2015 and 2016, and Medicaid providers between 2017 and 2; Final Rule,’’ or ‘‘Stage 2 final rule’’)
the objectives and measures required to 2020 to be $3.7 billion (this estimate that specified the Stage 2 criteria that
demonstrate meaningful use in 2015 includes net payment adjustments in EPs, eligible hospitals, and CAHs would
through 2017. We will continue to allow the amount of $0.8 billion for Medicare have to meet in order to qualify for
states flexibility under the Medicaid providers who do not achieve incentive payments. In addition, the
EHR Incentive Program for the public meaningful use). Stage 2 final rule finalized payment
health reporting objective. Specifically, In this final rule with comment adjustments and other program
for meaningful use in 2015 through period, we do not estimate total costs participation requirements under
2017 and for Stage 3, we will continue and benefits to the provider industry, Medicare for covered professional and
the policy stated in the Stage 2 final rule but rather provide a possible per EP and hospital services provided by EPs,
(77 FR 53979) to allow states to specify per eligible hospital outlay for eligible hospitals, and CAHs failing to
the means of transmission of the data or implementation and maintenance. demonstrate meaningful use of CEHRT,
otherwise change the public health Nonetheless, we believe there are finalized the revision of certain Stage 1
measure (as long as it does not require substantial benefits that can be obtained criteria, and finalized criteria that
EHR functionality above and beyond by society (perhaps accruing to eligible applied regardless of stage.
that which is included in the hospitals and EPs), including cost In the December 7, 2012 Federal
certification requirements specified reductions related to improvements in Register (77 FR 72985), CMS and the
under the 2014 Edition certification patient safety and patient outcomes and Office of the National Coordinator for
criteria). We refer readers to section II.G cost savings benefits through Health Information Technology (ONC)
of this final rule with comment period maximizing efficiencies in clinical and jointly published an interim final rule
for further information on the Medicaid business processes facilitated by with comment period (IFC) titled
EHR Incentive Programs. certified HIT. ‘‘Health Information Technology:
Executive Orders 12866 and 13563 Revisions to the 2014 Edition Electronic
3. Summary of Costs and Benefits direct agencies to assess all costs and Health Record Certification Criteria; and
Upon finalization, the provisions in benefits of available regulatory Medicare and Medicaid Programs;
this final rule with comment period are alternatives and, if regulation is Revisions to the Electronic Health
anticipated to have an annual effect on necessary, to select regulatory Record Incentive Program’’ (December
the economy of $100 million or more, approaches that maximize net benefits 7, 2012 IFC). The Department of Health
making it an economically significant (including potential economic, and Human Services (HHS) issued the
rule under the Executive Order and a environmental, public health and safety IFC to replace the Data Element Catalog
major rule under the Congressional effects, distributive impacts, and (DEC) standard and the Quality
Review Act. Accordingly, we have equity). Accordingly, we have prepared Reporting Document Architecture
prepared a Regulatory Impact Analysis a regulatory impact analysis that to the (QRDA) Category III standard adopted in
that to the best of our ability presents best of our ability presents the costs and the final rule published on September 4,
the costs and benefits of the final rule benefits of the final rule with comment 2012 in the Federal Register with
with comment period. period. updated versions of those standards.
The December 7, 2012 IFC also revised Payment Policies Under the Physician Stage 2 of the Medicare and Medicaid
the Medicare and Medicaid EHR Fee Schedule, Clinical Laboratory Fee EHR Incentive Programs.
Incentive Programs by— Schedule, Access to Identifiable Data for For Stage 1 and Stage 2, CMS and
• Adding an alternative measure for the Center for Medicare and Medicaid ONC worked closely to ensure that the
the Stage 2 meaningful use objective for Innovation Models & Other Revisions to definition of meaningful use of CEHRT
hospitals to provide structured Part B for CY 2015; Final Rule’’ (79 FR and the standards and certification
electronic laboratory results to 67976 through 67978) (November 13, criteria for CEHRT were coordinated.
ambulatory providers; 2014 IFC). Under this November 13, Current ONC regulations may be found
• Correcting the regulation text for 2014 IFC, we recognized a hardship at 45 CFR parts 170. CMS and ONC have
the measures associated with the exception for EPs and eligible hospitals worked together to align the Stage 3
objective for hospitals to provide for 2014 under the established category proposed rule and the ONC 2015
patients the ability to view online, of extreme and uncontrollable Edition proposed rule (80 FR 16731
download, and transmit information circumstances in accordance with the through 16804 and 80 FR 16804 through
about a hospital admission; and Secretary’s discretionary authority. To 16921), and again are working together
• Making the case number threshold accommodate this hardship exception, to align the final rules.
exemption for CQM reporting applicable we further extended the hardship Readers may also visit: http://
for eligible hospitals and CAHs application deadline for EPs and eligible www.cms.hhs.gov/
beginning with FY 2013. hospitals to November 30 for 2014 only. EHRincentiveprograms and http://
The December 7, 2012 IFC also We also amended the regulations to www.healthit.gov for more information
provided notice of our intention to issue allow CMS to specify a later hardship on the efforts at the Department of
technical corrections to the electronic application deadline for certain Health and Human Services (HHS) to
specifications for CQMs released on hardship categories for EPs, eligible advance HIT initiatives.
October 25, 2012. hospitals, and CAHs.
In the September 4, 2014 Federal In the March 30, 2015 Federal II. Provisions of the Proposed
Register (79 FR 52910 through 52933), Register, we published a proposed rule Regulations and Analysis of and
CMS and ONC published a final rule titled ‘‘Medicare and Medicaid Responses to Public Comments
titled ‘‘Medicare and Medicaid Programs; Electronic Health Record A. Introduction
Programs; Modifications to the Medicare Incentive Program Stage 3’’ (80 FR
and Medicaid Electronic Health Record 16731 through 16804). In the Stage 3 When the Medicare and Medicaid
(EHR) Incentive Program for 2014 and proposed rule, we specified the EHR Incentive Programs began in 2011,
Other Changes to the EHR Incentive proposed meaningful use criteria that the requirements for the objectives and
Program; and Health Information EPs, eligible hospitals, and critical measures of meaningful use were
Technology: Revisions to the Certified access hospitals must meet in order to designed to begin a process of health
EHR Technology Definition and EHR demonstrate meaningful use of CEHRT care delivery system transformation
Certification Changes Related to for Stage 3 of the Medicare and aligning with foundational goals defined
Standards; Final Rule’’ (‘‘2014 CEHRT Medicaid EHR Incentive Programs. The in the Health Information Technology
Flexibility final rule’’). Due to issues proposed rule also specified the for Economic and Clinical Health Act
related to availability delays for EHR proposed requirements for electronic (HITECH) Act. The HITECH Act
technology certified to the 2014 Edition, submission of CQMs and created a requires the Secretary to seek to
the 2014 CEHRT Flexibility final rule single set of meaningful use improve the use of EHR and health care
included policies allowing EPs, eligible requirements for Stage 3 that would be quality over time by requiring more
hospitals, and CAHs that could not fully optional for providers in 2017 and stringent measures of meaningful use
implement EHR technology certified to required for all providers beginning in (see section 1848(o)(2)(A)(iii) of the
the 2014 Edition for an EHR reporting 2018. Finally, the Stage 3 proposed rule Act); requiring the use of EHR
period in 2014 to continue to use one would also change the EHR reporting technology, which defines both the
of the following options for reporting period so that all providers would functions that should be available
periods in CY 2014 and FY 2014, report under a calendar year timeline. within the EHR and the purpose to
respectively— In the April 15, 2015 Federal which those functions should be
• EHR technology certified to the Register, we published a proposed rule applied (see section 1848(o)(4) of the
2011 Edition; or titled ‘‘Medicare and Medicaid Act); and defining key foundational
• A combination of EHR technology Programs; Electronic Health Record principles of meaningful use to support
certified to the 2011 Edition and EHR Incentive Program—Modifications to the improvement of care and care
technology certified to the 2014 Edition Meaningful Use in 2015 through 2017’’ coordination, and the use of EHR
for the EHR reporting periods. (80 FR 20346 through 20399). In the technology to submit information on
Although the 2014 CEHRT flexibility proposed rule, we proposed to change clinical quality measures and other
final rule did not alter the attestation or the EHR reporting period in 2015 to a measures (see section 1848(o)(2)(A) of
hardship exception application 90-day period aligned with the calendar the Act).
deadlines for 2014, it did make changes year and to align the EHR reporting In 2015, we published two notices of
to the attestation process to support period in 2016 with the calendar year. proposed rulemaking in 2015 relating to
these flexible options for CEHRT. This In addition, in the proposed rule, we the EHR Incentive programs to address
2014 CEHRT Flexibility final rule also proposed to modify the patient action near term goals in 2015 through 2017
discussed the provisions of the measures in the Stage 2 objectives and long-term goals for Stage 3 in 2017
December 7, 2012 IFC and finalized related to patient engagement. Finally, and subsequent years.
policies relating to the provisions we proposed to streamline the program In the March 30, 2015 Stage 3
contained in the December 7, 2012 IFC. by removing reporting requirements on proposed rule (80 FR 16734), we
In the November 13, 2014 Federal measures that have become redundant, proposed the requirements for the
Register, we published an interim final duplicative, or topped out through Medicare and Medicaid EHR Incentive
rule with comment period titled advancements in EHR function and Programs for 2017 and subsequent years
‘‘Medicare Program; Revisions to provider performance for Stage 1 and to build a long-term sustainable program
focused on the advanced use of CEHRT correspondence, public forums, and reduced set of objectives and measures
to support clinical effectiveness, health listening sessions. Additionally, we are based on the existing Stage 1 and
information exchange, and quality proposed these changes through a notice Stage 2 objectives and measures already
improvement. We proposed a total of of proposed rulemaking and accepted required for the EHR Incentive
eight objectives that focus on supporting comments from the public during the Programs.
advanced clinical processes, promoting comment periods for both proposed Additionally, we proposed to remove
interoperability and health information rules. We believe that providers helped measures that we believe are redundant,
exchange, continuing progress in to shape the requirements for duplicative, or topped out based on
electronic public health reporting, and meaningful use in part through those provider performance.
expanding the scope and methods for processes. Comment: Many commenters on the
provider and patient engagement. Comment: A few commenters stated Stage 3 proposed rule supported the
In the April 15, 2015 EHR Incentive that the proposal for the EHR Incentive proposals in the Stage 3 proposed rule
Programs in 2015 through 2017 Programs in 2015 through 2017 to establish a single set of objectives and
proposed rule (80 FR 20347), we proposed rule imposes unreasonable measures, align the Medicare and
proposed modifications to Stage 1 and financial constraints and reporting Medicaid EHR Incentive Programs
Stage 2 to reflect this long-term vision burdens. Other commenters stated the timeline and requirements for clinical
and to be responsive to the changing EHR Incentive Program in 2015 through quality measure reporting with other
environment and stakeholder concern 2017 proposed rule moves the program CMS quality reporting programs that use
over program complexity and redundant backward instead of forward. Another CEHRT, and have optional Stage 3
reporting requirements. The proposed commenter stated that there are participation in 2017.
rule included a reduced set of objectives administrative burdens that providers Response: We appreciate the
and measures based on the Stage 2 face daily that distract from patient care supportive comments and reiterate that
objectives and measures that align with or force implementation of alternative our priority is to improve the efficiency,
the policies for Stage 3. The proposed workflows or processes that do not effectiveness, and flexibility of the EHR
rule also proposed removing measures relate to real-world care or improved Incentive Programs by simplifying the
that had become topped out, redundant quality and that the EHR Incentive reporting requirements and reducing the
or duplicative, and easing requirements Programs add to that burden. complexity of the program.
around measures requiring providers to Response: We understand cost and
Comment: Several commenters on the
be accountable for patient action. We burden are factors for health care
Stage 3 proposed rule believed that the
proposed the modifications to address providers. As previously noted in the
EHR Incentive Programs in 2015 proposals made in the Stage 3 proposed
stakeholder concerns and to continue to
through 2017 proposed rule (80 FR rule would be burdensome, more time-
support the overall goal of the
20386), the regulatory impact analysis consuming, and do little to improve
widespread adoption and meaningful
outlines the reduction in the reporting patient care. Some commenters
use of CEHRT in efforts to transform our
burden for providers demonstrating attributed the increased burden to
health care delivery system and improve
meaningful use in 2015 and estimates increased measure thresholds.
health care quality.
Comment: Many commenters the total annual cost savings. We believe Response: We recognize clinical
supported the policies proposed in the the modifications to Stage 1 and Stage workflows and maintaining
EHR Incentive Programs in 2015 2 in the EHR Incentive Programs in 2015 documentation may require
through 2017 proposed rule. A few through 2017 proposed rule represent modifications upon implementation of
commenters stated that the proposed forward progress for the program by the requirements for Stage 3. However,
rule was a more accurate reflection of better aligning reporting periods for the changes were proposed in response
what caregivers are able to provide to providers; supporting a flexible, clear to stakeholder concerns and designed to
patients and the tools they have framework to reduce provider burden; reduce burdens associated with the
available to do so. Additionally, they and ensuring future sustainability of the number of program requirements, the
stated that the proposals reflected what Medicare and Medicaid EHR Incentive multiple stages of program
patients are willing to provide to the Programs. We understand the competing participation, and the timing of EHR
caregivers. demands on a provider’s time. However, reporting periods.
A few commenters indicated that as we have stated previously in the Patient-focused care is very important
CMS should update the measures and Stage 3 proposed rule (80 FR 16735), we to us, and we have proposed to maintain
requirements to ensure they are believe the efficiencies to be gained by measures specific to patient engagement
appropriately aligned and would the HIT user will provide a long-term and that support a patient’s access to
improve a provider’s ability to benefit for providers and outweigh the their health information. The measures
successfully demonstrate meaningful short-term concern over revisions to promote increased communication
use. A commenter stated that we should workflows, staff training, and other between providers and their patients,
first receive provider input before administrative needs. while placing focus on a patient’s
adding or suggesting any changes to the Comment: A commenter on the EHR involvement in their care.
requirements. Incentive Programs in 2015 through As noted in the Stage 3 proposed rule,
Response: We appreciate the 2017 proposed rule stated that new (80 FR 16734), Stage 3 is intended to
supportive comments and reiterate that measures should not be added and align the timeline and requirements for
our goals include reducing the reporting changes should either eliminate clinical quality measure reporting in the
burden, eliminating redundant and measures or reduce the measurement Medicare and Medicaid EHR Incentive
duplicative reporting, and better thresholds. Programs with other CMS quality
aligning the objectives and measures of Response: We did not propose to add reporting programs that use CEHRT.
meaningful use for 2015 through 2017 new measures to the EHR Incentive This alignment is meant to reduce
with the Stage 3 requirements. Programs in 2015 through 2017. We provider burden associated with
We proposed revisions to the proposed to require that all providers reporting on multiple CMS programs
requirements according to provider and attest to a reduced set of objectives and and enhance CMS operational
stakeholder feedback received through measures beginning in 2015. The efficiency.
In addition, we understand that the requirements, reduce program Stage 3 requirements depend on
increase in thresholds proposed in the complexity, and focus on the advanced interoperability of EHR systems, which
Stage 3 rule may increase the work use of EHR technology to promote has not yet been realized except within
required to achieve an individual improved patient outcomes and health health systems sharing the same
measure. However, we noted that part of information exchange to minimize software. These limited networks
our decision making process in the burdens placed on providers. contribute to a decrease in patient
overall reduction of the number of The Stage 3 objectives and measures access to care, choice, and timely
objectives in the program was to reduce were designed to focus on the three-part availability of specialists, thus thwarting
the burden on providers for those aim of better health, better care, and many of the overall objectives intended
measures by allowing them to focus on lower costs. We believe that the costs by the Medicare and Medicaid EHR
advanced use objectives that support associated with EHR adoption and Incentive Programs and creating a
clinical effectiveness, patient safety, continued maintenance are outweighed challenge for providers. Some
patient engagement, and care by the long-term benefits a provider may commenters stated interoperability must
coordination. We believe providers experience from meaningfully using expand in order for Stage 3 of the EHR
should prioritize their efforts to strive to CEHRT, including practice efficiencies Incentive Programs to generate the
achieve high performance on these and improvements in medical significant quality, safety, efficiency,
important measures. In addition, as outcomes. For example, EHR supported coordination, and public health
noted in the proposed rule (80 FR processes such as drug-drug and drug- outcomes needed. Those commenters
16740), the statute specifically requires allergy interaction and clinical decision suggested that one approach to this
the Secretary to seek to improve the use support, as well as electronic challenge would be for CMS and ONC
of EHRs and health care quality over prescribing and computerized provider to establish an interoperability
time by requiring more stringent order entry for medication orders, can benchmark first, and then measure its
measures of meaningful use (see, for all work in tandem to support a progress.
example, section 1848(o)(2)(A)(iii) of the provider’s efforts to effectively and Response: We disagree that the
Act). Therefore, for these reasons, we safely prescribe and administer Medicare and Medicaid EHR Incentive
intend to continue to use measure medications and reduce costs and risks Programs do little to establish or
thresholds that may increase over time associated with adverse events. In promote interoperability. As stated in
and to incorporate advanced use addition, while there may be a cost the Stage 3 proposed rule (80 FR 16734),
functions of CEHRT into meaningful use associated with HIT supported patient the Stage 3 measures and objectives are
objectives and measures. engagement as compared to not designed to promote interoperability
Comment: A commenter on the EHR engaging with patients, the use of HIT with a focus on the advanced use of
Incentive Programs in 2015 through allows providers to leverage economies EHR technology, the use of electronic
2017 proposed rule suggested that with of scale and engage with a large number standards, and the interoperable
Stage 3 in place, the Physician Quality and wide range of patients in ways not exchange of health information between
Reporting System (PQRS) program and otherwise possible. Patient education systems. The program leverages the
the Hospital Inpatient Quality Reporting and patient engagement in many forms ONC HIT Certification Program and the
(IQR) Program should be eliminated in support improved care and reduced cost associated editions of certification
2018. of care as patients who are engaged with criteria to ensure that eligible providers
Response: We cannot eliminate the their health care have better outcomes possess health IT that conforms with
PQRS and Hospital IQR Programs and cost savings for their care.1 The use standards and the requirements for the
because they are required by statute (see of CEHRT, while representing a capital capture and exchange of certain data in
sections 1848(a)(8) and investment in procurement and a structured format. This improves
1886(b)(3)(B)(viii) of the Act, maintenance, can result in improved interoperability by ensuring that data
respectively). Furthermore, although care and long term cost reduction and within one system can be received and
PQRS payment adjustments sunset after we believe these investments provide a used by the recipient system. Various
2018 in accordance with section strong return on investment for both objectives within the Stage 3 proposed
101(b)(2)(A) of MACRA, certain providers and patients in our healthcare rule aim to increase interoperability
provisions and processes under PQRS system. through—
will continue to apply for purposes of Comment: A commenter on the Stage • Provider to provider exchange
MIPS. MIPS is also required by statute 3 proposed rule recommended that CMS through the transmission of an
(see section 1848(q) of the Act, as added eliminate measures that focus on data electronic summary of care document;
by section 101(c) of MACRA). One of entry in favor of measures that focus on • Provider to patient exchange
the focal points for Stage 3, however, is interoperability. Some commenters through the provision of electronic
alignment with other quality programs stated the Medicare and Medicaid EHR access to view, download, or transmit
such as the Hospital IQR Program and Incentive Programs do little to establish health information; and
PQRS, not replacement of them. • Provider to public health agency
or promote interoperability among
Comment: A few commenters relayed exchange through the public health
providers, between providers and
concerns regarding financial issues reporting objectives.
consumers, or among participants in the Research supports our belief that the
related to costs associated with Stage 3
health information ecosystem. Some policies established in the EHR
implementation, upgrading, installing,
commenters stated that many of the Incentive Programs, the ONC HIT
testing, and maintenance of EHRs that
are outside of normal operating 1 Recent research cites an 8 percent cost of care
Certification Program, and the related
practices. A commenter stated reduction in the first year and 20 percent in effort to support provider participation
maintenance of EHRs requires many subsequent years attributable to patient at a state and national level have had a
expenses that surpass what is engagement. significant impact on the development
considered reasonable. Hibbard, Judith H and Jessica Greene. ‘‘What The of health information exchange
Evidence Shows About Patient Activation: Better
Response: We understand cost is a Health Outcomes And Care Experiences; Fewer
infrastructure in the United States. For
factor for health care providers. Our goal Data On Costs’’ Health Affairs: February 2013 EHR reporting periods in 2014, more
with Stage 3 is to simplify reporting 32:207–214. than 3,700 eligible hospitals and CAHs
and more than 232,000 EPs received and the use of these standards in b. Definitions for 2015 Through 2017,
incentive payments under the EHR clinical settings will continue to support and 2017 and Subsequent Years
Incentive Programs for meaningful use and promote interoperability. In the Stage 3 proposed rule (80 FR
of CEHRT, which included exchanging Furthermore, we believe the expansion 16737), we sought to streamline the
health information electronically with of the requirements around data criteria for meaningful use. We intended
other providers and with their patients. transmission will continue to drive use to do this by—
In addition, research shows a significant and the ongoing development and • Creating a single stage of
shift since the program began in 2011. strengthening of an interoperable HIE meaningful use objectives and measures
Hospital electronic health information infrastructure. (herein called Stage 3) that would be
exchange (HIE) with other hospitals or We also received numerous comments optional for all providers in 2017 and
ambulatory care providers outside their on the EHR Incentive Programs in 2015 mandatory for all providers in 2018;
organization increased by 85 percent through 2017 and Stage 3 proposed • Allowing providers flexible options
from 2008 to 2014 and increased by 23 rules during the public comment for 2017;
percent since 2013.2 periods that were either unrelated to the • Changing the EHR reporting period
The Stage 3 proposed rule focuses less Medicare and Medicaid EHR Incentive to a full calendar year for all providers;
on data capture and entry and more on Programs or outside the scope of the and
interoperable health data sharing by proposed rules. These comments • Aligning with other CMS quality
including additional functions and included considerations for future reporting programs using CEHRT, such
requirements for the transmission and rulemaking activities, requests for new as PQRS and Hospital IQR, for clinical
consumption of standardized health incentives for various provider types quality measurement.
data through electronic exchange. The that are not currently eligible to In the EHR Incentive Program in 2015
proposed Stage 3 objectives can participate, requests to create a sliding through 2017 proposed rule (80 FR
essentially be broken into 2 categories: scale for payment adjustments, and 20352), we proposed changes to a
• Category 1 objectives that support support or recommendations for ONC’s number of definitions previously
clinical effectiveness and patient safety, 2015 Edition proposals. We thank all finalized for the EHR Incentive
and the commenters for their suggestions Programs in the Stage 1 and Stage 2
• Category 2 objectives that support and feedback on the Medicare and final rules in order to modify the
health information exchange. Medicaid EHR Incentive Programs. program in response to the changing
For Category 2, four of the eight However, comments unrelated to the HIT environment and related
proposed objectives are clearly focused proposals fall outside the scope of the stakeholder concerns. These changes
on the electronic exchange of health proposed rule and are not addressed in address the following:
information through interoperable this final rule with comment period. • An overall simplification of the
systems: Patient Electronic Access, program aligned to the overarching
B. Meaningful Use Requirements,
Coordination of Care through Patient goals of sustainability, as discussed in
Objectives, and Measures
Engagement, Health Information the Stage 3 proposed rule (80 FR 16737)
Exchange, and Public Health and 1. Definitions Across the Medicare Fee- and in section II.B.1.b.(1) and (4) of this
Clinical Data Registry Reporting. Each of for-Service, Medicare Advantage, and final rule with comment period, and a
these objectives involves the capture of Medicaid Programs related change to requirements
structured data using a standard and the a. Uniform Definitions necessary to accommodate these
transmission of that data in a changes, outlined in sections II.B.1.b.(2).
standardized format that can be sent, We proposed changes to the uniform and (3). of this final rule with comment
received, and incorporated definitions in part 495 subpart A of the period.
electronically. These objectives build on regulations, in both the Stage 3 • Moving all providers to an EHR
the transmission standards established proposed rule (80 FR 16736 through reporting period aligned with the
in prior rules by incorporating receipt 16737) and the EHR Incentive Programs calendar year, as outlined in section
standards and consumption in 2015 through 2017 proposed rule (80 II.B.1.b.(3).A. of this final rule with
requirements for HIE. We also proposed FR 20351 through 20352). We proposed comment period.
to expand the technology functions that to maintain these definitions, unless • Allowing flexibility for providers in
may be used for transmission including specifically stated otherwise in the 2015 to accommodate the proposed
a wider range of options, such as proposed rule. We proposed moving to changes, as outlined in section II.B.1.b.
application-program interface (API) a single set of criteria for meaningful of this final rule with comment period.
functionality. use, which we herein call Stage 3, in • Removing requirements for
In addition, two of the three order to eliminate the varying stages of objectives and measures that are
objectives that fall into the first category the Medicare and Medicaid EHR redundant or duplicative or that have
(for example, computerized provider Incentive Programs. We proposed that a ‘‘topped out,’’ as described in the Stage
order entry and electronic prescribing) modified version of Stage 1 and Stage 2 3 proposed rule (80 FR 16741 through
may also be categorized as objectives would be applicable for 2015 through 16742) and outlined in section
that support the interoperable exchange 2017. We proposed that the Stage 3 II.B.1.b.(4).(a). of this final rule with
of health information through the definition of meaningful use would be comment period.
process of creating and transmitting optional for providers in 2017 and • Restructuring the remaining
prescriptions, medication orders, mandatory for all providers beginning in measures and objectives to streamline
laboratory order, and diagnostic imaging 2018. To support these changes, we requirements for 2015 through 2017 and
orders using standards established by proposed revising the uniform to accommodate the changes for an EHR
CEHRT for that purpose. definitions under 42 CFR 495.4 for reporting period in 2015, as outlined in
We believe this continued emphasis ‘‘EHR reporting period’’ and ‘‘EHR section II.B.1.b.(2). and (3). and
on requiring standards in the technology reporting period for a payment II.B.1.b.(4).(b). of this final rule with
adjustment year,’’ as discussed in comment period.
2 http://www.healthit.gov/sites/default/files/data- sections II.B.1.b.(3) and section II.E.2.2 • Refocusing the existing program so
brief/ONC_DataBrief24_HIE_Final.pdf. of this final rule with comment period. that it is building toward advanced use
of EHR technology, aligned with the this change may occur after providers proposed rule supported the proposal to
Stage 3 proposed rule (80 FR 16741) have already begun their work toward move all providers to Stage 3 in 2018.
through maintaining the objectives and meeting meaningful use in 2015, we Response: We appreciate the number
measures outlined in section II.B.2 of proposed accommodations within of commenters who supported the
this final rule with comment period. individual objectives for providers in proposal for optional Stage 3
different stages of participation. These participation in 2017. We believe the
(1) Stages of Meaningful Use option to attest to Stage 3 in 2017 offers
accommodations include retaining the
In the phased approach to meaningful different specifications between Stage 1 flexibility for those providers ready to
use, we finalized the criteria for and Stage 2 and allowing special move forward to Stage 3 requirements,
meaningful use through incremental exclusions for certain objectives or while allowing additional time for
rulemaking that covered Stage 1 and measures for EPs previously scheduled providers who may need to update,
Stage 2 of the Medicare and Medicaid to participate in Stage 1 for an EHR implement, and optimize the technology
EHR Incentive Programs. (For further reporting period in 2015. certified to the 2015 Edition. We believe
explanation of the criteria we finalized We proposed all providers would be vendors, developers, and providers will
in Stage 1 and Stage 2, we refer readers required to attest to certain objectives have an appropriate amount of time
to 75 FR 44314 through 44588, 77 FR and measures finalized in the Stage 2 between the publication date of the final
53968 through 54162, and 79 FR 52910 final rule that would align with those rule with comment period and 2018 to
through 52933.) objectives and measures proposed for transition to Stage 3.
In the Stage 3 proposed rule (80 FR We thank commenters for their
Stage 3 of meaningful use. In effect, this
16737 through 16739), we proposed to support of the proposal to move all
would create a new progression using
set a new foundation for this evolving providers to Stage 3 in 2018. As noted
the existing objectives and measures
program by proposing a number of in the EHR Incentive Programs in 2015
where providers attest to a modified
changes to the Medicare and Medicaid through 2017 proposed rule, the
version of Stage 2 with accommodations
EHR Incentive Programs. First, we proposal was based in part on
for Stage 1 providers (equivalent to a
proposed a definition of meaningful use comments received in earlier
reduced version of Stage 3) in 2015; a
that would apply beginning in 2017. rulemaking that relayed confusion and
modified version of Stage 2 in 2016
This definition, although herein referred concerns regarding increased reporting
to as Stage 3, would be the only (equivalent to a reduced version of Stage
burden related to the number of
definition for the Medicare and 3); either a modified version of Stage 2
program requirements, the multiple
Medicaid EHR Incentive Programs and (equivalent to a reduced version of Stage
stages of program participation, and the
would incorporate certain requirements 3) or the full version of Stage 3 outlined
timing of EHR reporting periods.
and aspects of Stage 1 and Stage 2. in the Stage 3 proposed rule in 2017; Comment: We received multiple
Beginning with 2018, we proposed to and the full version of Stage 3 outlined comments on the Stage 3 proposed rule
require all EPs, eligible hospitals, and in the Stage 3 proposed rule beginning opposing the proposal to move all
CAHs, regardless of their prior in 2018 (80 FR 16738). providers to Stage 3 in 2018.
participation in the Medicare and We sought comment on whether or Commenters indicated this proposal
Medicaid EHR Incentive Programs, to not we should implement only the changes CMS’ prior plan to permit
satisfy the requirements, objectives, and modifications proposed in the rule from providers who had not spent 2 years in
measures of Stage 3. However, for 2017, 2015 through 2017 (80 FR 20351 either Stage 1 or Stage 2 to remain in
we proposed that Stage 3 would be through 20353) and begin Stage 3 in that stage for a second year before
optional for providers. This proposed 2018 without an option year in 2017, or transitioning to Stage 3. A commenter
option would allow a provider to meet if we should allow providers the option suggested that CMS consider extending
to Stage 3 in 2017 or to remain at Stage to demonstrate Stage 3 beginning in Stage 1 and Stage 2 requirements for
2 or Stage 1, depending on their prior 2017 as discussed in the Stage 3 2015 through 2017 to also include 2018.
participation. proposed rule (80 FR 16738). A few commenters stated providers
Furthermore, we proposed that Stage Comment: Several commenters should remain in each stage of
3 would adopt a simplified reporting supported the option of moving to Stage meaningful use for 3 years to allow
structure on a focused set of objectives 3 or remaining in Modified Stage 2 in sufficient time to update, implement,
and associated measures to replace all 2017 in the EHR Incentive Program in and optimize the new technology. Some
criteria under Stage 1 and Stage 2. 2015 through 2017 proposed rule. Many commenters requested that CMS delay
Specifically, we proposed criteria for commenters believed that having the Stage 3 to 2019 or later based on a lack
meaningful use for EPs, eligible option to attest to Stage 3 in 2017 would of data related to experience for Stage 2.
hospitals, and CAHs (optional in 2017 allow vendor development and Response: We appreciate the feedback
and mandatory beginning in 2018), upgrades to be spread over a longer from commenters. We recognize that our
regardless of a provider’s prior period of time. Other providers proposals would modify our earlier
participation in the Medicare and supported the option for providers to approach of allowing providers to
Medicaid EHR Incentive Programs. attest to either Stage 1, Stage 2, or Stage remain in Stage 1 and Stage 2 for 2 years
In the EHR Incentive Program in 2015 3 in calendar year 2017. prior to transitioning to Stage 3. In the
through 2017 proposed rule (80 FR Numerous commenters on the EHR EHR Incentive Program in 2015 through
20352), we proposed to further reduce Incentive Program in 2015 through 2017 2017 proposed rule (80 FR 20352), we
complexity in the program and to proposed rule supported the proposal to proposed to reduce the complexity of
realign the current program to work move all providers to Stage 3 in 2018. the program by proposing to require
toward this overall shift to a single set They stated it is very complicated to providers to attest to a single set of
of objectives and measures in Stage 3 in keep track of all providers and their objectives and measures starting in
2018. We proposed to require that all various programs, stages, and years, and 2015. We proposed alternate exclusions
providers attest to a single set of that the proposed approach would ease and specifications for 2015 to
objectives and measures beginning with the burden associated with reporting accommodate Stage 1 providers working
an EHR reporting period in 2015 instead different stages of meaningful use. toward demonstration of meaningful use
of waiting until Stage 3 in 2018. Because Numerous commenters on the Stage 3 in 2015. Therefore, the combination of
Stage 1 and Stage 2 objectives and program. For example, new participants not be required to meet Stage 3
measures into a single stage (Modified who would otherwise have been in requirements in 2017 if they were not
Stage 2) beginning in 2015 effectively Stage 1 will be able to take advantage of ready to do so. Finally, the meaningful
removes the ‘‘Stage’’ designation. Under the alternate exclusions and use objectives and measures proposed
our proposal, providers would have the specifications of these Modified Stage 2 for 2015 through 2017 align with the
option to meet the single set of requirements. We understand cost is a objectives and measures proposed for
objectives and measures for Modified factor for health care providers. Stage 3. Therefore, we believe many
Stage 2 for up to 3 years (2015 through However, as noted in prior rules, we providers may seek to work toward
2017) prior to moving to Stage 3. We are believe the benefits of EHR adoption meeting Stage 3 in 2017. If they find
therefore removing the requirement that outweigh the potential costs (for more they are unable to meet the Stage 3
providers remain in each Stage for a set information, see the Stage 2 final rule at requirements, they would be able to
number of years because we believe our 77 FR 53971). successfully attest to Modified Stage 2
proposal to streamline the objectives Comment: A commenter on the Stage in 2017. Additionally, there is no
and measures reduces the complexity of 3 proposed rule requested clarity on the requirement nor any technological
the program. expectations for the 90-day ‘‘gap’’ limitation on providers to only
We proposed to align the objectives hospitals will have from October 1 collaborate with other providers with
and measures of meaningful use for through December 31, 2016, and EHR technology certified to the same
2015 through 2017 with the Stage 3 whether hospitals need to demonstrate Edition of certification criteria. In fact,
objectives and measures in part because meaningful use during that timeframe. many of the certification criteria are
we believe this will provide a smoother Response: In the Stage 3 proposed similar between the 2014 Edition and
transition for providers to Stage 3. rule (80 FR 16739 through 16740), we the 2015 Edition. Therefore, we believe
Additionally, we believe that noted a possible reporting gap from the transition to Stage 3 will be less
interoperability and EHR functionalities October 1 through December 31, 2016 as complex and the program will be more
will continue to advance prior to 2018, a result of our proposal to align the EHR streamlined moving forward. We believe
when Stage 3 would be required of all reporting period for eligible hospitals offering the option of a transitional year
eligible providers, which should and CAHs with the calendar year in 2017 would enable providers to
increase providers’ success in meeting beginning in 2017. After the Stage 3 weigh the risks and benefits of moving
the program requirements. Multiple proposed rule was published, we to Stage 3 and decide for themselves
providers have expressed their support published the EHR Incentive Program in what is most appropriate based on their
for the option to attest to Stage 3 in 2015 through 2017 proposed rule, in individual circumstances.
2017, indicating confidence in the which we proposed this alignment with Comment: Regarding the EHR
transition. Therefore, we are the calendar year would begin earlier, in Incentive Program in 2015 through 2017
maintaining the timeframe for 2015, eliminating the potential for a gap proposed rule, other commenters stated
implementation of Stage 3. in the fourth quarter of CY 2016. that the timeline in the proposed rule
Comment: Some commenters believed Comment: Some commenters on the represents an aggressive deadline for
that Stage 3, like its predecessors, takes EHR Incentive Program in 2015 through health IT vendors and developers
a ‘‘one size fits all’’ approach with 2017 proposed rule opposed having an supporting customers who might choose
requirements that may not be applicable option to attest to Stage 3 in 2017, to begin Stage 3 in 2017. A few
to all eligible participants. stating that keeping providers at the commenters stated removal of the
Response: We disagree that Stage 3 is same stage allows performance to option to participate in Stage 3 in 2017
a ‘‘one size fits all’’ approach. We remain at the same level, thereby would give EHR vendors and developers
believe our proposal for Stage 3 allows making it easier to track and measure. an additional 12 months to deploy EHR
flexibility within the objectives to allow Additional commenters stated the Technology certified to the 2015
providers to focus on implementations option does not support CMS efforts to Edition.
that support their practice. For example, streamline the EHR Incentive Programs. Response: We recognize stakeholder
we proposed to incorporate flexibility A few commenters were concerned concerns and the potential burden that
for the Stage 3 objectives of that many providers will have difficulty these changes may have on vendor
Coordination of Care through Patient attesting to Stage 3 in 2017 if other upgrades in relation to timing for system
Engagement, Health Information collaborating partners are not operating changes. We believe that some vendors,
Exchange, and Public Health Reporting with the same CEHRT. developers, and providers will be able
so that providers can choose the A few commenters indicated that a to make the necessary system changes in
measures most relevant to their unique provider electing to attest to a later stage time to implement Stage 3 in 2017. We
practice setting. was a rarity in previous years when encourage discussion between vendors,
Comment: A few commenters on the given an option. developers, and providers on the
EHR Incentive Program in 2015 through Response: We thank commenters for feasibility to upgrade to EHR technology
2017 proposed rule expressed concern their feedback. First, we note that certified to the 2015 Edition and attest
that providers entering the program in providers have not been given an option to Stage 3 in 2017. However, we remind
2015 or 2016 and those experiencing to move forward in their Stage commenters that this upgrade is
financial constraints would have progression in the past, and that CMS optional in 2017 and for those providers
difficulty moving to Stage 3 in 2018. has in fact received multiple requests to who choose to attest to Modified Stage
Response: As previously noted, we allow providers to do so in past years. 2 and not to Stage 3, EHR technology
proposed to align the objectives and Second, we understand the challenges certified to the 2015 Edition would not
measures of meaningful use for 2015 faced by providers who are not ready or be required until 2018. In addition,
through 2017 with the Stage 3 objectives able to move to Stage 3 in 2017. providers may also choose to upgrade
and measures. We believe that the However, as other comments have some modules as early as 2016 if the
modified Stage 2 we proposed for 2015 shown, several stakeholders are CEHRT is available.
through 2017 will provide a smoother supportive of the option for 2017 and, Comment: The majority of
transition for providers to Stage 3, because it is an option and not a commenters on the Stage 3 proposed
including new participants in the requirement for 2017, providers would rule supported the option of
participating in Stage 3 in 2017 and of proposed Stage 3 timetable will not 24 months between the date of the
using technology certified to either the allow for a full 18-month timeline publication of this final rule with
2014 or 2015 Edition in 2017 and before the beginning of Stage 3 as an comment period and 2018, when
believed this would provide relief to the option in 2017. providers must begin using EHR
industry. Some commented they would Some commenters on the EHR technology certified to the 2015 Edition.
support this flexibility in all future Incentive Program in 2015 through 2017
Because of this more than 24 month
years where changes to CEHRT will be proposed rule indicated that in case of
lead time for development, we do not
required and noted transitioning to unanticipated challenges or delays with
anticipate significant challenges or
technology certified to a new Edition the adoption and implementation of the
delays in the adoption and
can be complex and can require more technology certified to the 2015 Edition,
implementation of the 2015 Edition
resources and time than anticipated. CMS should proactively detail
CEHRT. We will continue to monitor
Other commenters suggested that alternative scenarios to avoid future rule
changes. and assess providers’ progress towards
providing an optional year to transition
Response: We appreciate the adoption and implementation as EHR
to technology certified to a new Edition
commenters’ feedback and seek to technology certified to the 2015 Edition
allows the time necessary to help ensure
explain a few points related to the becomes available.
a safe transition for patients and a
smoother transition for providers. Other proposed option for providers to Comment: Some commenters on the
commenters were also appreciative of participate in Stage 3 in 2017. First we Stage 3 proposed rule noted the
CMS’ response to their concerns as note that providers may upgrade to EHR previous transitional difficulties for
reflected in the Stage 3 proposed rule. technology certified to the 2015 Edition Stage 2 and recommended removing the
Some commenters on the EHR when it becomes available. We note that option to demonstrate Stage 3 in 2017
Incentive Program in 2015 through 2017 CMS will allow a provider to and only require the Modified Stage 2
proposed rule indicated that in the case successfully attest in 2015, 2016, or in 2017. These commenters suggested
of unanticipated challenges or delays 2017 with technology certified to either keeping the required start of Stage 3 at
with the adoption and implementation the 2014 Edition, the 2015 Edition, or a 2018, but allowing a 90-day or calendar
of the technology certified to the 2015 combination of the two as long, as the year quarter EHR reporting period for
Edition, CMS should preemptively technology possessed can support the the first year of Stage 3in 2018.
detail alternative scenarios to avoid objectives and measures to which they Response: We disagree with the
future rule changes. plan to attest. Therefore, providers may recommendation to remove the option
However, other commenters stated adopt technology certified to the 2015 of demonstrating Stage 3 in 2017.
that 2017 is not a realistic start date for Edition prior to 2017, either in a Although recognizing that not all
Stage 3 due to the expected timing of modular approach or in total, and may providers will have the necessary
the final rule; necessary upgrades to still choose to attest to Modified Stage technology to move to Stage 3 in 2017,
technology; transitional processes after 2 and wait to begin Stage 3 until 2018. many commenters supported allowing
deployment such as training, workflow, Providers who are seeking to
this option for those providers who are
and validation of reporting; and full demonstrate Stage 3 in 2017 cannot do
able to do so and we wish to maintain
year reporting requirements. A so without the support of certain
this proposed flexibility for providers.
commenter suggested there would be functions that are only available for
We address the suggestion for a 90-day
only 12–15 months from the publication certification as part of the 2015 Edition
EHR reporting period for Stage 3 in
date of the final rule (assuming certification criteria. This means that for
further detail in section II.B.1.b.(3).(iii)
publication in late 2015) until 2017 a provider must have at least a
technology certified to the2015 Edition of this final rule with comment period.
combination of EHR technology
would need to be available from certified to the 2014 Edition and the After consideration of the public
vendors and developers and 2015 Edition in order to support comments received, we are finalizing
implemented by organizations with participation in Stage 3. However, as our approach to the timing of the stages
necessary staff training completed for Stage 3 is optional, providers are not of meaningful use as proposed in the
new workflows. Some commenters required to upgrade to technology EHR Incentive Program in 2015 through
indicated EHR vendors and developers certified to the 2015 Edition until 2018. 2017 proposed rule and the Stage 3
need on average 18 months to develop, As discussed further in section II.B.3 proposed rule. We are finalizing that all
test, market, and implement new of this final rule with comment period, EPs, eligible hospitals, and CAHs must
functionality, while providers need lead this means providers have flexibility to attest to the Modified version of Stage
time to re-work their processes and use EHR technology certified to either 2 beginning with an EHR reporting
systems to new or revised requirements. the 2014 or 2015 Edition (or a period in 2015, with alternate
Other commenters indicated concern combination of CEHRT modules exclusions and specifications for certain
about the timeline of transitioning to certified to different Editions). We providers, as discussed further in
Stage 3 in 2017 and 2018, stating that 18 proposed the flexibility to allow section II.B.1.b.(4).(b).(iii). of this final
months is the minimum length of time providers to move forward with rule with comment period. We finalize
needed between the final rules and the upgrading their EHR technology at their as proposed the option for all EPs,
start of any stage of the EHR Incentive own speed and to optionally attest to eligible hospitals, and CAHs to attest to
Program. Furthermore, as the change Stage 3 in 2017 if they are able to do so. Stage 3 for an EHR reporting period in
requires a technology upgrade, and In total, these proposals allow for a 2017 and the requirement for all
given the likely timing for the staggered upgrade timeline for providers to attest to Stage 3 beginning
publication of the final rules, the developers and providers of more than with an EHR reporting period in 2018.
TABLE 1—STAGE OF MEANINGFUL USE CRITERIA BY FIRST YEAR

Stage of meaningful use
First year demonstrating
meaningful use 2019 and
2015 2016 2017 2018 future years
2011 .................................. Modified Stage 2 .............. Modified Stage 2 .............. Modified Stage 2 or Stage Stage 3 ....... Stage 3.
3.
3.
3.
3.
3.
2016 .................................. NA .................................... Modified Stage 2 .............. Modified Stage 2 or Stage Stage 3 ....... Stage 3.
3.
2017 .................................. NA .................................... NA .................................... Modified Stage 2 or Stage Stage 3 ....... Stage 3.
3.
2018 .................................. NA .................................... NA .................................... NA .................................... Stage 3 ....... Stage 3.
2019 and future years ....... NA .................................... NA .................................... NA .................................... NA ............... Stage 3.
We are adopting these provisions (2) Meaningful EHR User 20353), we additionally proposed to
under the definition of a ‘‘Meaningful In the Stage 3 proposed rule (80 FR redesignate some of the numbering of
EHR user’’ at § 495.4 as noted in section 16737), we proposed to modify the the regulation text under part 495 to
II.B.1.b.(2) of this final rule with definition of ‘‘Meaningful EHR user’’ more clearly identify which sections of
comment period and as noted in further under 42 CFR 495.4 to include the Stage the regulation apply to specific years of
detail in section II.B.2.a. and II.B.2.bof 3 objectives and measures defined at the program. The redesignated
this final rule with comment period. § 495.7. numerical references for the regulation
In the EHR Incentive Program in 2015 text are as follows:
through 2017proposed rule (80 FR
Current section designation Proposed section redesignation
§ 495.6—Objectives and Measures .......................................................... § 495.20—Objectives and Measures Prior to 2015.

§ 495.22—Objectives and Measures Beginning in 2015.
§ 495.7 *—Stage 3 Objectives and Measures .......................................... § 495.24—Stage 3 Objectives and Measures.
§ 495. 8—Demonstration of Meaningful Use ........................................... § 495.40—Demonstration of Meaningful Use.
§ 495.10—Participation Requirements ..................................................... § 495.60—Participation Requirements.
* Indicates a new section that was proposed in the Stage 3 proposed rule. We indicated that all proposed changes in part 495 would be rec-
onciled through this final rule with comment period.
We received no comments specific to In the EHR Incentive Programs in We proposed all providers (EPs, eligible
these proposals, and therefore, are 2015 through 2017 proposed rule (80 FR hospitals, and CAHs) would be required
finalizing them without modification. 20353), we proposed changes to the to complete an EHR reporting period
uniform definition of an ‘‘EHR reporting within January 1 and December 31 of
(3) EHR Reporting Period
period’’ in § 495.4 beginning in 2015. the calendar year in order to fulfill the
In both the EHR Incentive Program in We proposed similar changes to the requirements of the EHR Incentive
2015 through 2017 and Stage 3 definition of an ‘‘EHR reporting period Programs. We proposed that for 2015
proposed rules (80 FR 16739 and 80 FR for a payment adjustment year’’ in only, eligible hospitals and CAHs may
20353), we proposed changes to the § 495.4 beginning in 2015, as discussed begin an EHR reporting period as early
EHR reporting period in order to in section II.E.2of this final rule with as October 1, 2014 and must end by
accomplish the following: comment period. We proposed changes December 31, 2015. Beginning with
• Simplify reporting for providers, to the attestation deadlines for purposes 2016, the EHR reporting period must be
especially groups and diverse systems. of the incentive payments and payment completed within January 1 and
adjustments as discussed in section II.D December 31 of a calendar year.
• Support further alignment with For the payment adjustments under
of this final rule with comment period.
CMS quality reporting programs using Medicare, we proposed changes to the
certified health IT such as Hospital IQR (i) Calendar Year Reporting EHR reporting periods applicable for
and PQRS. In the EHR Incentive Program 2015 payment adjustment years in the EHR
• Simplify HHS system requirements through 2017 proposed rule (80 FR Incentive Program 2015 through 2017
for data capture. 20354), beginning in 2015, we proposed proposed rule at 80 FR 20379.
• Provide for greater flexibility in to change the definition of ‘‘EHR Comment: The majority of
developing, implementing, stress reporting period’’ at § 495.4 for EPs, commenters for the EHR Incentive
testing, and conducting Quality eligible hospitals, and CAHs such that Program in 2015 through 2017 proposed
Assurance (QA) of systems before the EHR reporting period would begin rule supported the move to calendar
deployment. and end in relation to a calendar year. year reporting for all providers and
believed this would simplify the EHR technology requirements with planning for the CMS systems in 2015
reporting, monitoring, and attestation minimal changes. Finally, the hospital was that the majority of providers
for hospitals. Other commenters stated attestation period is currently October 1 would be attesting during this time, as
aligning the reporting period would ease through the end of November of a given most would have been required to attest
provider reporting burden for larger year, while the new attestation period for a full year EHR reporting period. The
organizations that will not have to track was proposed as January 1 through the addition of fewer than 5,000 attestations
their providers through different stages. end of February. The attestation by eligible hospitals and CAHs during
Another commenter stated that this not window would still be the same amount this time will not significantly impact
only allows those health IT vendors and of time, and with the single period the load on the system. We do
developers who service both outpatient providers (especially those recommend that providers try to attest
and inpatient clients to be better aligned organizations that support both EPs and in January and not wait until the end of
in their deployment and support, but hospitals) can plan for testing and data February to allow adequate time to
also permits them to better harmonize validation for all settings in advance of address any issues that may arise, such
technology implementation and the required deadline for attestation. as issues related to the accuracy of their
program reporting. Other commenters Comment: A few commenters on the attestation or their contact and banking
stated that calendar year reporting, EHR Incentive Program in 2015 through information. CMS will also monitor
combined with the new ‘‘Active 2017 proposed rule stated that hospitals readiness and attestation progress
Engagement’’ options for public health should be able to choose whether to throughout the period and work to
and clinical data registry reporting (see report on a fiscal or calendar year basis mitigate any risk that should arise.
section II.B.2.a.x of this final rule with in 2015 and 2016. Some commenters After consideration of the public
comment period), will permit them to indicated that the proposed change to comments received, we are finalizing
onboard, test, and deploy participants in calendar year reporting would delay the proposal in the EHR Incentive
a timely manner based upon the ability incentive payments for at least 3 months Programs in 2015 through 2017
to meet their own internal resource and cause financial and budgeting proposed rule (80 FR 20348) to align the
constraints, while ensuring all challenges. Additionally, some of the
EHR reporting period for eligible
participants can meet their meaningful commenters stated hospitals have
hospitals and CAHs with the calendar
use objectives. already made reporting plans and fiscal
year beginning in 2015. For 2015 only,
Response: We thank the commenters projections for these years.
Response: We disagree with the eligible hospitals and CAHs may begin
for support of this proposal. As we
commenters’ recommendation to allow an EHR reporting period as early as
stated in the EHR Incentive Program in
hospitals to choose a fiscal or calendar October 1, 2014 and must end by
2015 through 2017 proposed rule (80 FR
year EHR reporting period in 2015 and December 31, 2015. Beginning with
20353), the movement of all providers to
2016. Allowing hospitals this option 2016, the EHR reporting period must be
calendar year reporting supports
would be inconsistent with the goal of completed within January 1 and
program alignment and simplifies
reporting requirements among provider program simplification and alignment. December 31 of the calendar year. We
types. We agree that for most eligible hospitals made corresponding revisions to the
Comment: A commenter stated the and CAHs, this change would shift the definition of an ‘‘EHR Reporting Period’’
move to reporting on the calendar year incentive payment by one quarter at § 495.4. For the payment adjustments
would eliminate the 3-month gap that within the same federal fiscal year. under Medicare, we discuss the
currently exists between the end of the However, these are incentive payments duration and timing of the EHR
hospital EHR reporting period and the and not reimbursements and, as noted reporting period in relation to the
end of the EPEHR reporting period. This in the EHR Incentive Program in 2015 payment adjustment year in section
could cause issues, especially among through 2017 proposed rule (80 FR II.E.2 of this final rule with comment
organizations that share resources to 20376), we believe the potential period.
support build, testing, and report negative impact of this change would be (ii) EHR Reporting Period in 2015
validation for eligible hospitals, CAHs, minimal and outweighed by the Through 2017
and EPs. Other commenters stated opportunity to capitalize on efficiencies
aligning all providers to a calendar year created by aligning the EHR reporting In the EHR Incentive Program in 2015
would diminish their time to periods across EPs, eligible hospitals, through 2017 proposed rule (80 FR
troubleshoot unexpected issues with and CAHs. 20354), we proposed to allow a 90-day
final reports and validate the accuracy Comment: A commenter stated this EHR reporting period in 2015 for all
of data or lead to an increased risk in alignment would further stress the CMS providers to accommodate
data entry errors in order to meet the reporting system because the systems implementation of the other changes
February deadline for attestation for currently struggle to handle the surge of proposed in that rule. For 2015 only, we
both EPs, eligible hospitals, and CAHs. activity that occurs with the staggered proposed to change the definition of
Response: We understand the reporting periods. The commenter ‘‘EHR reporting period’’ at § 495.4 for
concerns stated by stakeholders over the suggested we improve the capacity of EPs, eligible hospitals, and CAHs such
changes proposed for the EHR reporting the attestation systems to ease the that the EHR reporting period in 2015
periods. Because this final rule with burden of the reporting process. would be any continuous 90-day period
comment period maintains the existing Response: We understand the within the calendar year. We proposed
definitions for the objectives and commenter’s concerns. However, that for an EHR reporting period in
measures, including the numerator and historical evidence has shown that the 2015, EPs may select an EHR reporting
denominator calculations and measure vast majority of the more than 200,000 period of any continuous 90-day period
thresholds for 2015, we believe vendors, EPs have attested during the open from January 1, 2015 through December
developers, and providers will have attestation window from the beginning 31, 2015; eligible hospitals and CAHs
minimal issues in the upgrades and of January through the end of February may select an EHR reporting period of
testing for 2015. Likewise, the and have done so successfully each any continuous 90-day period from
requirements for 2015 through 2017 use year. In addition, consistent with past October 1, 2014 through December 31,
the existing measure specifications and experience, the expectation and 2015.
We proposed that in 2016, for EPs, she believes the modification to the EHR EPs are now familiar with reporting
eligible hospitals, and CAHs that have reporting period would present a real quarters and can plan accordingly.
not successfully demonstrated and material risk to patients and that Another commenter requested the
meaningful use in a prior year, the EHR patients should have the benefit of a full option to choose either a 90-day
reporting period would be any year EHR reporting period. However, consecutive reporting period or a
continuous 90-day period between some commenters stated that if a calendar quarter. Another commenter
January 1, 2016 and December 31, 2016. provider can demonstrate meaningful suggested a 60-day reporting period for
However, for all returning participants use for 90 days, that provider must have 2015.
that have successfully demonstrated the technology and workflows in place Response: We understand that some
meaningful use in a prior year, the EHR for meaningful use and therefore should commenters may favor quarterly
reporting period would be a full not be required to submit a full year of reporting due to the ease of planning
calendar year from January 1, 2016 data to confirm they are in compliance. based on a calendar quarter and to the
through December 31, 2016. Response: We agree that a full year prior requirement finalized in the Stage
For the payment adjustments under EHR reporting period is the most 2 final rule for EHR reporting periods in
Medicare, we proposed changes to the effective way to ensure that all actions 2014 (77 FR 53974). However, an EHR
EHR reporting periods applicable for related to patient safety that leverage reporting period of any continuous 90
payment adjustment years in the EHR CEHRT are fully enabled for the days would still allow for providers to
Incentive Programs in 2015 through duration of the year. This is one of the select and report on a quarter in the
2017 proposed rule at (80 FR 20379). primary considerations of our continued calendar year if they so choose. We
Comment: All comments received on push for full year reporting whenever disagree with the appropriateness of a
the EHR Incentive Program in 2015 feasible, in addition to promoting 60-day EHR reporting period, and
through 2017 proposed rule greater alignment with other CMS further note that a shorter EHR reporting
overwhelmingly supported the 90-day quality reporting programs. However, period is not easier to meet than a
EHR reporting period in 2015. Many we stated in the EHR Incentive longer period if the provider is fully
commenters stated the 90-day EHR Programs in 2015 through 2017 engaged in the workflows and has the
reporting period would be beneficial for proposed rule (80 FR 20348) that a 90- functions fully enabled. Statistically, a
small and rural providers and provide day EHR reporting period would allow larger number of patient encounters
the time needed to implement the providers additional time to address any allow providers a wider margin to meet
required changes for the next stage of remaining issues related to the overall threshold. As the majority of
meaningful use. Other commenters implementation of technology certified providers would already have been
stated that this is essential due to to the 2014 Edition. A 90-day EHR meaningfully using their CEHRT and
vendors and developers struggling to reporting period is necessary in order to then attesting based on a full year EHR
keep their systems up-to-date with all accommodate the proposed changes to reporting period, or for a minimum of a
the changes and new requirements. the program that reduce the overall 90-day EHR reporting period, these
We also received numerous comments burden on providers to allow greater workflows should be implemented and
on the Stage 3 proposed rule strongly focus on the objectives and measures functioning for at least that length of
supporting the proposal for a 90-day that promote patient safety, support time. Therefore, the necessity for a
EHR reporting period for all providers clinical effectiveness, and drive toward shorter EHR reporting period as dictated
in 2015. Some commenters noted that advanced use of health IT. Despite the by the need to accommodate the
the reduction to a 90-day EHR reporting allowance for a 90-day EHR reporting changes in this final rule with comment
period would assist providers period, we believe it is essential to period is limited in scope to 90 days.
transitioning from Stage 1 to Stage 2 maintain the processes and the Comment: A commenter stated that
without compromising patient care. workflows supporting and promoting their group practice has already
Another commenter stated changing to patient safety enabled and fully gathered data for some EPs for quarters
any continuous 90 days (as opposed to implemented throughout the year. The 1 and 2 and have new EPs for whom
calendar quarters) allows for needed EHR reporting period alone should not they would like to be able to report for
flexibility in the event of unforeseen dictate a provider’s commitment to quarter 4. The commenter requested
circumstances that could otherwise patient safety. organizations be allowed to use a
impede reporting within the originally In response to commenters who different EHR reporting period for each
planned timeframe. suggest that, in the future, EP.
Response: As stated in the EHR demonstrating meaningful use for a 90- Response: Each EP is required to
Incentive Program in 2015 through 2017 day period should serve as confirmation individually meet the requirements of
proposed rule (80 FR 20348), this 90- of a full year of compliance with meaningful use regardless of their
day EHR reporting period in 2015 program requirements, we note that if a affiliation with a group practice.
would allow providers additional time provider does have the necessary Therefore, each EP may use a separate
to address any remaining issues with workflows and processes in place for a EHR reporting period to demonstrate
the implementation of EHR technology full year there is no valid reason that meaningful use and in 2015, that EHR
certified to the 2014 Edition and to provider should not demonstrate reporting period may be any continuous
accommodate the proposed changes to meaningful use for a full year. If extreme 90-day period in the calendar year
the objectives and measures of circumstances outside of the provider’s selected by each individual EP.
meaningful use for 2015. We also control prohibit a full year of Comment: A few commenters from
proposed an EHR reporting period of meaningful use, the provider may file the EHR Incentive Programs in 2015
any continuous 90 days not tied to a for a hardship exception from the through 2017 proposed rule stated CMS
specific calendar quarter in 2015. Medicare payment adjustments. previously requiring a full year of
Comment: A commenter on the EHR Comment: A commenter in the EHR reporting and then subsequently
Incentive Program in 2015 through 2017 Incentive Programs in 2015 through removing that requirement dilutes the
proposed rule suggested that the 90-day 2017 proposed rule requested quarterly message to providers and sets an
EHR reporting period was too short. reporting, stating that it is far more expectation that goals do not need to be
Another commenter stated that he or efficient and that eligible hospitals and met.
Response: We note that this commenter suggested this would allow measurement and quality improvement
perception is of concern and is not a provider to create a monthly report initiatives like Accountable Care
reflective of our policy goals for the within their EHR system using their Organizations (ACOs) and the
program. As we stated in the EHR dashboard, regardless of the number of Comprehensive Primary Care Initiative
Incentive Programs in 2015 through days in any given month, as long as they (CPCI) as well as the value based
2017 proposed rule (80 FR 20348), the capture at least 90 days or 3 calendar purchasing programs that require full
90-day EHR reporting period is intended months. As an example, the commenter year reporting for the efficacy of data on
only to accommodate the changes to the suggested that an EP or administrator clinical processes and patient outcomes.
EHR Incentive Programs in 2015 can run a report for October through Thus, our policy has been to allow a 90-
through 2017, which are in turn December that would provide 92 days of day reporting period only in
intended to drive toward the long-term data, or February through April that circumstances where a shorter reporting
goals outlined in the Stage 3 proposed would provide 89 days of data. period is warranted to allow providers
rule. Response: We thank the commenter to implement program changes or to
Comment: A commenter requested for their suggestion and respectfully begin participation in the program.
CMS acknowledge the challenges disagree. The EHR reporting period Comment: Several commenters
associated with reporting on a full must be at least 90 continuous days in recommended the reporting period
calendar year for EPs newly employed order to ensure that all providers are should be 90 days for 2016 and
by a health system during the course of meeting at least the same minimum subsequent years, as this would greatly
a program year, switching EHRs, system requirement. While a provider may reduce the reporting burden. A few
downtime, cyber-attacks, and office choose a period longer than 90 days, commenters stated that a full year of
relocation. they may not choose a period that is reporting in 2016 is unreasonable.
A few commenters strongly less, so the use of the designated months Multiple commenters stated that a full
recommended in the EHR Incentive is not adequate. Furthermore, a 90-day year reporting period for all participants
Program in 2015 through 2017 proposed period need not be tied to the beginning in 2016 does not adequately account for
rule that CMS retain the 90-day or end of a month. Therefore, the use of a number of real life scenarios that
attestation option for providers who 90 days is the most appropriate for this could cause issues with meeting the
change employers during the year. policy as it allows flexibility for requirements, such as environmental
Furthermore, the commenters further providers to choose any continuous setbacks, infrastructure problems,
stated they do not believe an 90-day period, or any 3-monthperiod of vendor-related difficulties, and human
organization can sufficiently rely upon at least 90 days, or any calendar year resource issues. Some commenters
the actions of a previous employer to quarter of at least 90 days, without strongly recommended CMS retain the
complete the necessary validation, adding additional complexity. As 90-day EHR reporting period for first-
analysis, and implementation of an EHR proposed in the EHR Incentive Programs time attesters in the program in future
that would satisfy CMS audit in 2015 through 2017 proposed rule (80 years.
requirements. If a previous employer’s FR 20348), the EHR reporting period Response: We decline to extend the
data is found to be faulty, the current would be any continuous 90 days for all 90-day EHR reporting period to 2016 for
organization is put at risk for the data providers in 2015. This change allows all returning participants because we
reported. for greater flexibility in the reporting disagree that full year reporting is
Response: We understand the requirements. unreasonable. In 2012 and 2013,
commenters’ concerns and note that EPs Comment: A few commenters stated thousands of returning providers
may consider applying for a hardship they believed the statute does not successfully attested to program
exception from the reduction to obligate CMS to require a year for requirements for an EHR reporting
Medicare PFS payments based on reporting and believed the full year period of one full year. In addition, as
extreme and uncontrollable reporting requirement will discourage noted previously, hardship exceptions
circumstances. Specifically, in the case EPs from participation and increases may be available for providers
of issues related to CEHRT, situations risk of non-success. experiencing extreme and
involving technology upgrades, Response: We agree that the statute uncontrollable circumstances. However,
switching products during the year, or allows discretion to specify the EHR as proposed in the EHR Incentive
the decertification of a product may be reporting period and does not require a Programs in 2015 through 2017
reason for a provider to apply for a full year. As mentioned in our Stage 2 proposed rule (80 FR 20348), all
hardship. final rule (77 FR 53974), the more robust providers demonstrating meaningful use
EPs who are switching employment or data set provided by a full year EHR for the first time may use an EHR
practicing in multiple locations during reporting period offers more reporting period of any continuous 90
an EHR reporting period may apply for opportunity for alignment of programs, days in 2016, which has been the policy
a hardship exception that would be such as PQRS, than the data set in past years, to support these providers
reviewed on a case-by-case basis. provided by a shorter EHR reporting beginning implementation of the
However, we disagree that CMS should period, especially when compared program.
take into account the business practices across several years. We believe the full After consideration of the public
of individual EPs in establishing the reporting year will yield data necessary comments received, we are finalizing a
requirements for the entirety of the to sustain and further progress the 90-day EHR reporting period in 2015 for
program. It is incumbent on the program. Furthermore, we believe, as all providers as proposed. Eligible
individual EP to establish their own previously noted, that the actions and professionals may select an EHR
contractual or business arrangements for workflows that support the reporting period of any continuous 90-
the purposes of attesting for the requirements of the EHR Incentive day period from January 1, 2015 through
Medicare and Medicaid EHR Incentive Programs are intended to be in effect December 31, 2015; eligible hospitals
Programs. continuously, not enabled and and CAHs may select an EHR reporting
Comment: A commenter suggested the implemented for only 90 days. Finally, period of any continuous 90-day period
EHR reporting period should be at least we believe in the importance of from October 1, 2014 through December
90 days or 3 calendar months. The alignment with and support of quality 31, 2015. We are finalizing a 90-day
EHR reporting period in CY 2016 for to other CMS quality programs. Other maintaining drug interaction and drug
EPs, eligible hospitals, and CAHs that commenters stated that longer reporting allergy clinical decision supports for the
have not successfully demonstrated periods would facilitate public health duration of the EHR reporting period, no
meaningful use in a prior year. For all reporting, as Public Health Agencies measure has a threshold of 100 percent.
providers who have successfully (PHAs) have more time to work with We believe that system downtime could
demonstrated meaningful use in a prior providers and their EHR vendors and be expected in some cases for software
year, we are finalizing an EHR reporting developers to submit data to meet their or system maintenance, but providers
period of the full CY 2016. We have public health measures. A few may still meet meaningful use if they
made corresponding revisions to the commenters indicated annual reporting meet the threshold for each measure and
definition of ‘‘EHR reporting period’’ has the benefit of yielding valuable data are using the required CEHRT Edition
under § 495.4. For the payment that may not necessarily be captured for the EHR reporting period. Third, as
adjustments under Medicare, we discuss with a short 90-day reporting period. noted previously, if a provider is fully
the duration and timing of the EHR Response: We appreciate the support implementing the requirements of the
reporting period in relation to the of these comments. We believe full year program, the workflows and
payment adjustment year in section reporting will allow for the collection of implementation of the technology
II.E.2 of this final rule with comment more comparable data and increase would not be limited to only 90 days,
period. alignment across quality reporting and thus a longer EHR reporting period
programs, where measure data is should be feasible.
(iii) EHR Reporting Period in 2017 and Comment: A commenter
Subsequent Years typically collected over a calendar year
period. The more robust data set recommended shortening the reporting
In the Stage 3 proposed rule (80 FR provided by a full year EHR reporting period from 12 months to 3 months and
16739), we proposed that beginning in period offers more opportunity for that CMS should consider an
2017, and for all EPs, eligible hospitals, alignment than the data set provided by ‘‘incentive’’ for providers who report on
and CAHs, the EHR reporting period a shorter EHR reporting period, a 6-month period or even a 12-month
would be one full calendar year. We especially when compared across period. Another commenter similarly
proposed to eliminate the 90-day EHR several years. suggested reopening incentive payments
reporting period for new meaningful Comment: We received many for the program including providing
EHR users beginning in 2017, with a comments opposing the full year additional monies for new participants
limited exception for Medicaid EPs and reporting period, indicating that it is successfully demonstrating meaningful
eligible hospitals demonstrating very challenging and may add use for a full year under the Stage 3
meaningful use for the first time. For administrative burdens. Commenters requirements.
that exception, we proposed to maintain also indicated the following areas of Response: While we appreciate the
the 90-day EHR reporting period for a concerns that could impact the ability to commenter’s suggestion of additional
provider’s first payment year based on demonstrate a full year of meaningful incentives for providers, we do not have
meaningful use for EPs and eligible use: discretion to alter the timing and
hospitals participating in the Medicaid • EPs change in place of service duration of the incentive payments
EHR Incentive Program. We noted that (POS). under Medicare and Medicaid that are
the EHR incentive payments under • EPs joining a practice in the middle established by statute.
Medicare fee-for-service (FFS) and of the year. Comment: Some commenters also
MA(sections1848(o), 1886(n), 1814(l)(3), • Ongoing software updates (for stated that the yearly reporting period
1853(l) and(m) of the Act) will end example, ICD–10). also introduces problems for quality
before 2017. We stated that under these • Difficulty in getting data from reporting and that vendors and
proposals, EPs and eligible hospitals previous places of employment. developers have insufficient time to
that seek to qualify for an incentive • Not enough time for the vendors update and test the products, especially
payment under Medicaid would have a and developers to make software for new quality measures that will not
full calendar year EHR reporting period updates. be finalized under the Medicare PFS
if they are not demonstrating • Timing of the data submission. until November 1 of the previous year.
meaningful use for the first time. Other commenters stated full year Other commenters stated that vendors
These proposals would allow for a reporting does not allow sufficient time and developers are unlikely to be able
single EHR reporting period of a full for these practices to identify to implement the changes made in the
calendar year for all providers across all shortcomings in their adherence to Medicare PFS final rule in time to
settings. We proposed corresponding meaningful use and implement deliver updated products prior to the
revisions to the definition of ‘‘EHR corrective actions before the next January 1, 2018 Stage 3 deadline, and
reporting period’’ under § 495.4. For the reporting period. these conflicting deadlines will
payment adjustments under Medicare, Response: First, we understand the continue to be a problem that will
we proposed changes to the EHR commenters’ concerns and note that impact future program years.
reporting periods applicable for providers may consider applying for a Response: We note that CMS quality
payment adjustment years in the Stage hardship exception from the Medicare reporting programs for EPs (for example,
3 proposed rule (80 FR 16774 through payment adjustments based on extreme PQRS and Value-Based Payment
16777). circumstances outside the provider’s Modifier) have a full year reporting or
Comment: Several commenters control that contribute to their inability performance period and that the CQMs
supported the proposal to eliminate the to meet the requirements of the EHR used for those programs require a full
90-day EHR reporting period for new Incentive Programs. Second, we note year of data. CMS quality reporting
meaningful EHR users beginning in that the thresholds of the measures programs are working in partnership
2017, with a limited exception for themselves are designed to provide with the EHR developer and vendor
Medicaid EPs and eligible hospitals leeway for providers to adjust community to streamline the annual
demonstrating meaningful use for the workflows and implementation as update process to ensure the integrity of
first time. A commenter appreciated the necessary during the EHR reporting data and the effectiveness of eCQM
effort to standardize reporting timelines period. With the exception of specifications. (For further information,
we refer readers to section II.C of this to meet Stage 3 in 2017, the EHR • Providers are performing higher
final rule with comment period.) reporting period is any continuous 90- than the thresholds for some of the
Comment: A number of commenters day period within CY 2017. For all other meaningful use measures using some
requested a 90-day reporting period for providers, the EHR reporting period is EHR functionalities that—prior to the
providers in the first year of Stage 3 the full CY 2017. Beginning in CY 2018, Stage 1 and Stage 2 final rules—were
especially for any providers seeking to for all EPs, eligible hospitals, and CAHs not common place (such as the
demonstrate the Stage 3 objectives and (including those attesting to Stage 3 for maintenance of problem lists).
measures in the optional year in 2017. the first time), the EHR reporting period • Providers in different specialties
Some of these commenters indicated is the full CY. and settings implemented CEHRT and
that they agree with the need for full We finalize our proposal to maintain met objectives in different ways.
year reporting, but believe that it is the 90-day EHR reporting period for a • Providers express support for
appropriate to allow a 90-day EHR provider’s first payment year based on reducing the reporting burden on
reporting period when providers move meaningful use for EPs and eligible measures that have ‘‘topped out.’’
to a new stage in order to mitigate issues hospitals participating in the Medicaid • Providers expressed support for
with workflows, ensure the effective EHR Incentive Program for 2017 and advanced functionality that would offer
implementation of new technologies, subsequent years. value to providers and patients.
and integrate new processes into We revised the definition of ‘‘EHR • Providers expressed support for
clinical operations. reporting period’’ under § 495.4 to flexibility regarding how objectives are
Response: We disagree that a 90-day reflect these final policies. As we noted implemented in their practice settings.
EHR reporting period is appropriate for previously and in the Stage 3 proposed • Providers in health systems and
all providers moving to Stage 3, as we rule (80 FR 16739), the incentive large group practices expressed
believe the lead time required for payments under FFS and MA frustration about the reporting burden of
participation in 2018 is sufficient. In (sections1848(o), 1886(n), 1814(l)(3), having to compile multiple reports
addition, the optional year in 2017 1853(l) and (m) of the Act) will end spanning multiple stages and objectives.
allows providers to work toward the before 2017. Thus the final policies for Since the beginning of the Medicare
Stage 3 measures and test workflows the EHR reporting period we adopt here and Medicaid EHR Incentive Programs
prior to their required implementation would apply only for EPs and eligible in 2011, stakeholder associations and
in 2018. However, we agree that the hospitals that seek to qualify for an providers have requested that we
allowance of a 90-day EHR reporting incentive payment under Medicaid. For consider changes to the number of
period may be appropriate for providers the payment adjustments under objectives and measures required to
attesting to the objectives and measures Medicare, we discuss the duration and
of Stage 3 in 2017. A 90-day EHR meet the program requirements,
timing of the EHR reporting period for including the recommendation to allow
reporting period in this case would a payment adjustment year in section
recognize the shorter time period from a provider to fail any two objectives,
II.E.2 of this final rule with comment thus making all objectives ‘‘menu’’
development of the technology to period.
implementation for use in 2017 and a objectives. We noted in the Stage 3
shorter time period for the necessary (4) Considerations in Defining proposed rule (80 FR 16740) that we
testing and implementation of Meaningful Use decline to follow these
workflows and new technologies. A 90- recommendations for several reasons.
(a) Considerations in Review and First, the statute specifically requires
day EHR reporting period in 2017 Analysis of the Objectives and Measures
would allow for further flexibility in the the Secretary to seek to improve the use
for Meaningful Use of EHR and health care quality over time
installation and implementation of the
overall upgrade to technology certified In the Stage 3 proposed rule (80 FR by requiring more stringent measures of
to the 2015 Edition by spreading out the 16740), we noted that for the Stage 1 meaningful use (see, for example,
demand over a greater period of time. In and Stage 2 final rules, the requirements section 1848(o)(2)(A)(iii) of the Act).
addition, a 90-day EHR reporting period of the EHR Incentive Programs included Second, there are certain objectives and
in 2017 for Stage 3 providers would the concept of a core and a menu set of measures that capture policies
provide a benefit by easing the objectives that a provider needed to specifically required by the statute as
transition for those providers who meet as part of demonstrating core goals of meaningful use of CEHRT,
choose to move to Stage 3 early and will meaningful use of CEHRT. In Stage 2, such as electronic prescribing for EPs,
potentially make that choice more we also combined some of the objectives HIE, and clinical quality measurement
accessible for a greater number of of Stage 1 and incorporated them into (see sections 1848(o)(2)(A) and
providers. Therefore, we agree that objectives for Stage 2. In the Stage 2 1886(n)(3)(A) of the Act). Furthermore,
allowing a 90-day EHR reporting period final rule (77 FR 53973), we signaled the statute requires that the CEHRT
for Stage 3 providers in 2017 would that the Stage 2 core and menu providers must be a ‘‘qualified EHR’’ as
support the transition to a new objectives would all be included in the defined in section 3000(13) of the Public
technology, the adoption of technology Stage 3 proposal. Health Service Act as an electronic
and clinical workflows, and the overall However, since the Stage 2 final rule record of health-related information on
progress toward program goals. publication, we have reviewed program an individual that includes patient
After consideration of the public performance from both a qualitative and demographic and clinical health
comments received, we are finalizing quantitative perspective including information, such as medical history
our proposal to require a full CY EHR analyzing performance rates; reviewing and problem lists; and has the capacity
reporting period for all providers (with the adoption and use of CEHRT; and to—
a limited exception for new meaningful considering information gained by • Provide clinical decision support;
EHR users under Medicaid) beginning engaging with providers through • Support physician order entry;
in CY 2017, with a modification for listening sessions, correspondence, and • Capture and query information
providers attesting to Stage 3 of open forums like the HIT Policy relevant to health care quality; and
meaningful use in 2017. For EPs, Committee. The data supported the • Exchange electronic health
eligible hospitals, and CAHs that choose following key points for consideration: information with, and integrate such
information from, other sources (see compliance. Some commenters wrote we believe that the active use of the data
section 1848(o)(4) of the Act). that this would greatly reduce the elements is more beneficial for both
We analyzed the objectives and reporting burden for EPs and eligible provider and patient than the continued
measures in Stage 1 and Stage 2 of the hospitals. requirement to measure the capture of
program to determine where measures Response: We thank the commenters these elements.
are redundant, duplicative, or have for their support of this proposal. As we For further information on the
topped out. ‘‘Topped out’’ is the term stated in the Stage 3 proposed rule (80 performance rates for new participants,
used to describe measures that have FR 16741), the removal of topped out as well as quartile performance rates for
achieved widespread adoption at a high measures is intended in part to focus on individual measures, we direct readers
rate of performance and no longer reduction of the reporting burden on to the CMS EHR Incentive Program Web
represent a basis upon which provider providers for measures already site data and reports page.
performance may be differentiated. We achieving widespread adoption. Comment: A commenter cautioned
considered redundant objectives and Comment: A few commenters stated against removing measures that may
measures to include those where a they do not believe that performance appear to be topped out but are
viable health IT-based solution may rates alone provide a valid reason to clinically significant or focused on
replace paper-based actions, such as the consider a measure topped out. High patient safety. Another commenter
Stage 2 Clinical Summary objective (77 performance rates on some measures suggested that CMS consider both the
FR 54001 through 54002). We among reporting EPs may be partly pediatric population, as well as the
considered duplicative objectives and attributable to intensified improvement adult population before they determine
measures to include those where some efforts motivated by the reporting that a measure is topped out.
aspect is also captured in the course of opportunities. Furthermore, classifying Response: As we stated in the Stage
meeting another objective or measure, any given measure as having a high 3 proposed rule (80 FR 16741) and in
such as recording vital signs. performance rate when the Stage 2 the previous responses to comments, we
We proposed (as discussed in sections reporting rate is less than 10 percent of believe it is appropriate to remove some
II.B.1.b.(3) and II.C of this final rule all EPs is premature. measures which have reached
with comment period) to reduce Response: Performance rates are only widespread adoption. However, we
provider burden and simplify the one factor considered in the decision to agree that the analysis of these measures
program by aligning EHR reporting discontinue use of a measure in the and their identification as topped out
periods and CQM reporting. Our Medicare and Medicare EHR Incentive should take into account other factors
proposals for Stage 3 would continue Programs. Similarly, measure such as clinical significance and patient
the precedent of focusing on the performance among hospitals (whether safety. In the proposed rule we
advanced use of CEHRT and reduce the a measure is ‘‘topped out’’) is one of specifically discussed reviewing the
reporting burden; eliminate measures several criteria considered when provider performance on measures
that are now redundant, duplicative, determining whether to remove Hospital identified as redundant and duplicative
and topped out; create a single set of IQR Program measures (79 FR 50203). measures, as this impacts the statistical
objectives for all providers with limited Multiple factors beyond performance likelihood that the functions of
variation between EPs, eligible are included in the determination of measures and the processes behind
hospitals, and CAHs as necessary; and whether a measure should be them would continue even without a
provide flexibility within the objectives considered for removal from reporting requirement to report the results (80 FR
to allow providers to focus on requirements. 16742). For example, electronic
implementations that support their For the 2014 EHR reporting period, prescribing for EPs may be considered
practice. more than 1,800 eligible hospitals and topped out if only the performance
CAHs and 60,000 EPs attested for their percentiles are considered. However, we
(i) Topped Out Measures and Objectives performance on the Stage 2 objectives proposed to maintain this measure
In the Stage 3 proposed rule (80 FR and measures. However, we did not because it relates to clinical
16741 through 16742), we proposed to limit our analysis to only Stage 2 effectiveness and patient safety and is
adopt an approach to evaluate whether providers. Instead, we looked at foundational to the program (80 FR
objectives and measures have become performance rates across the longevity 16747).
topped out and, if so, whether a of the program for providers in all levels For the commenter mentioning
particular objective or measure should of participation. Most of the measures pediatric versus adult populations, the
be considered for removal from identified are at exceptionally high EHR Incentive Programs do not include
reporting requirements. We proposed to performance among first time a separate set of meaningful use
apply the following two criteria, which participants in Stage 1 as well, with objectives and measures for adult
are similar to the criteria used in the little or no variation as compared to populations versus pediatric
Hospital Inpatient Quality Reporting providers in 3 or more years of populations. Nor does CMS collect
(IQR) and Hospital Value Based participation. For the Medicare and individual patient data through the EHR
Purchasing (HVBP) Programs (79 FR Medicaid EHR Incentive Programs, we Incentive Programs. While certain
50203): (1) Statistically additionally looked at measures that measures may include specifications
indistinguishable performance at the represent static data capture measures related to age, CMS only collects
75th and 99th percentile, and (2) and measures for which the action is summary-level data in the form of
performance distribution curves at the now automated by the EHR technology, numerators and denominators.
25th, 50th, and 75th percentiles as as opposed to active measures that use Therefore we are not able to compare
compared to the required measure the structure data to inform a clinical performance on these measures for
threshold. decision, provide patient specific different patient populations. However,
Comment: A large number of education, or are used in care we would note that the measures we
commenters on the Stage 3 proposed coordination. Once the performance on proposed to remove had significantly
rule are in support of the removal of a static measure exceeds the point at high performance, with providers in all
reporting requirements for measures which reasonable differentiation can be specialties performing well above the
that have achieved high rates of made among providers using CEHRT, required thresholds.
Comment: Another commenter is reporting requirements and complexity goal is to focus on advanced use of
concerned that by suddenly eliminating within the program. EHRs. While we do not in any way seek
measures, CMS may be creating After consideration of the public to limit the methods by which a
uncertainty and inadvertently sending comments received, we are finalizing as provider may engage with a patient or
the message that sustained performance proposed our approach for evaluating share information, we do not believe
is no longer necessary. The commenter whether objectives and measures are that requiring providers to measure
believes it is important that EPs be given ‘‘topped out,’’ and if so, whether a paper-based actions is consistent with
proper notice of the agency’s plans for particular objective or measure should the long-term goals of the program. We
eliminating measures. be considered for removal from the EHR believe that the requirements and focus
Some commenters stated removing Incentive Programs. of the program should be exclusively on
the measures may lead to EHR vendors (ii) Electronic Versus Paper-Based leveraging HIT to support clinical
and developers not providing metrics on Objectives and Measures effectiveness and patient safety, HIE,
the measures in reports that are used for and quality improvement.
benchmarking and internal quality In Stage 1 and Stage 2, we require or Comment: Many commenters
improvement work. These commenters allow providers the option to include requested that we keep paper-based
recommended that providers should paper-based formats for certain measures in place, stating that CMS
continue to be required to report on all objectives and measures, including the should not encourage electronic
provision of a non-electronic summary processes exclusively until consumers
topped out measures without a
of care document for a transition or are ready to accept them.
threshold, where the measure would be
referral, at § 495.6(j)(14)(i) for EPs and Response: As noted in the Stage 3
to attest that the provider is recording
for eligible hospitals and CAHs proposed rule (80 FR 16742), our policy
the information.
at§ 495.6(l)(11)(i), and the provision of to no longer require or allow providers
Response: We notified the public of
paper-based patient education materials, to record and report paper-based actions
our intent to remove measures from the at § 495.6(j)(12)(i) for EPs and does not imply that we do not support
program through notice of proposed § 495.6(l)(9)(i) for eligible hospitals and the continued use of paper-based
rulemaking and requested public CAHs. For these objectives and materials in a practice setting. Some
comment on these changes in both the measures, providers would print, fax, patients may prefer to receive a paper
Stage 3 proposed rule and the EHR mail, or otherwise produce a paper version of their clinical summary or
Incentive Programs in 2015 through document and manually count these may want to receive education items or
2017 proposed rule. In addition, as actions to include in the measure reminders on paper or some other
noted in the Stage 3 proposed rule (80 calculation. We proposed to discontinue method that is not electronic. Our
FR 16741), evaluation of measures and this policy for Stage 3; paper-based proposal would simply no longer
performance is common practice for formats would not be required or require or allow providers to manually
CMS programs to ensure ongoing allowed for the purposes of the count and report on these paper-based
program effectiveness. objectives and measures for Stage 3 of exchanges.
We disagree that threshold measures meaningful use. Comment: Another commenter stated
should be replaced with ‘‘check box’’ This does not imply that we do not this proposal to eliminate paper-based
measures for each of the topped out support the continued use of paper- formats will cause extreme hardship for
measures as this would provide no based materials in a practice setting. We providers who serve geriatric
value for measurement and is counter to strongly recommend that providers populations and will negatively impact
the effort to reduce the reporting burden continue to provide patients with visit the quality of care their elderly patients
on providers. Providers who wish to summaries, patient health information, will receive. Many geriatric patients and
independently measure the capture of a and preventative care recommendations their caretakers do not have access to
particular data element should work in the format that is most relevant for internet or computers and do not have
with their EHR developer and vendor to each individual patient and easiest for any other means of receiving electronic
ensure they are receiving the most that patient to access. health information.
appropriate analytics for their practice Comment: Many commenters on the Response: We strongly recommend
and patient population—just as they Stage 3 proposed rule stated they that providers continue to provide
would with any data element they enthusiastically support this patients with visit summaries, patient
wished to track that was not already requirement. Requiring or even allowing health information, and preventative
required by the Medicare and Medicaid paper-based methods, such as faxing of care recommendations in the format that
EHR Incentive Programs. summaries of care at transitions or is most relevant for each individual
Comment: A few commenters stated referrals, may be hindering some patient and easiest for that patient to
the impact of reducing the reporting providers from adopting digital access. In some cases, this may include
burden for meaningful use is minimal technologies (for example, direct the continued use of non-IT based
and that the burden of meeting the addresses) that support the overarching resources. However, we proposed this
requirements of the EHR Incentive goal of meaningful use, which is to use method would no longer be required or
Programs lies in bridging clinical technology to improve patient allowed for manual measurement in
workflow and best practices, patient outcomes. order to meet the requirements of the
safety, technology, and program Response: We appreciate your Medicare and Medicaid EHR Incentive
understanding. feedback in support of eliminating Programs.
Response: While we agree that the paper-based methods of reporting in Comment: A commenter stated there
objectives and measures required in the order to be a meaningful user in Stage must be a focus on standards to ensure
program are directly correlated with 3 and we agree that limiting the focus that EHRs are collecting the appropriate
clinical workflows, technology, program of the program to only health IT and relevant clinical data. If printed, the
understanding, and patient safety, we solutions may encourage adoption as electronic versions of visit summaries
are responding to concerns stated by a well as spurring further innovation should be presented in a clinically
wide range and significant number of among IT developers. As stated in the relevant manner. In addition, because
stakeholders, including the burden of Stage 3 proposed rule (80 FR 16742) our the commercial payer community is not
impacted by the requirements of the patient demographic information is capture of structured data elements;
EHR Incentive Programs, many included in an electronic summary of however, we believe it is appropriate to
providers continue to prefer a paper- care document called a consolidated no longer require reporting to CMS on
based information format, with clinical document architecture (C–CDA) these redundant or duplicative
electronic formats limited to practice provided during a transition of care in measures. We believe this will allow
management software. A commenter the Stage 2 Summary of Care objective providers to focus on the use of the
also stated that if the EHR systems do and measures (77 FR 54013 through technology and the use of the data to
not adequately populate necessary 54021), which represents a more support care coordination and quality
information, paper-based formats are advanced use of the EHR function than improvement rather than monitoring the
necessary to track actions and measure in the Stage 1 and 2 objective to record simple capture of that data for a
calculations. patient demographic information (77 FR measure which has already reached
Response: We respectfully disagree. 53991 through 53993). high capture rates.
Paper-based formats are not necessary to We received the following comments We note that family health history is
populate information that CEHRT on this proposal and our response still a required data field within the
systems capture. CEHRT stores data in follows. definition of CEHRT at § 495.4. This
a structured format that allows patient Comment: Many commenters means it will still be part of CEHRT
information to be easily retrieved and applauded this proposal noting that it available for provider use. This measure
transferred. The removal of paper-based made no sense to require providers to in particular was identified as having
actions is intended to support the track the capture of data when providers high performance, but also representing
discontinuation of manual paper-based were also tracking the use of that exact a significant burden for counting and
calculation and chart abstraction. If a same data in other objectives and measurement purposes. According to
provider’s EHR is not accurately measures. Providers specifically noted provider recommendations, family
capturing and allowing for the retrieval that items such as vital signs and health history should not be recorded in
and transfer of data, the provider should smoking status were not only used in an EHR in episodic fashion but should
work with their EHR developer to multiple other objectives (for example, allow for linear capture as structured
correct the error. The provider should they must be included in a summary of data that can be leveraged by more
also ensure that all staff entering care document), but that they are also advanced functions, such as the Patient
information into the EHR have the included in CQMs which allow Specific Education measure under the
necessary training to input patient data, providers more insight into the clinical Patient Electronic Access objective.
just as staff were previously trained to relevance of the data. Electronic notes are similar use cases
input data correctly into a paper record Some commenters objected to within the CEHRT, as are the standards
or administrative or billing system. We removing duplicative data capture from for advance directives and smoking
believe this will also eliminate the program—specifically citing the status. In addition, the requirements for
redundancy for providers in clinical and measures for patient demographics, the fields within an electronic summary
administrative processes. As noted in structured lab results, vital signs, of care document, the C–CDA, include
the Stage 3 proposed rule, we consider advance directives, and smoking structured data elements such as
redundant objectives and measures to status—because they believe the demographics, medication list,
include those where a viable health IT- measures should continue to be medication allergy list, vital signs, and
based solution may replace paper-based independently captured. One structure lab results, among others,
actions (80 FR 16741). commenter requested clarification on which are required as part of the
After consideration of the public how Stage 2 measures like family health electronic summary of care document
comments, we are finalizing our history and electronic progress reports C–CDA a provider must send in
proposal that paper-based formats will are incorporated into Stage 3. A conjunction with a transition of care or
not be required or allowed for the commenter suggested that there needs to referral in support of effective care
purposes of the objectives and measures be more clarity with respect to how coordination. For further information,
for Stage 3 of meaningful use. those measures which are duplicative of we refer readers to the ONC 2015
more advanced processes are still Edition Certification Criteria final rule
(iii) Advanced EHR Functions required for use and potentially tracked published elsewhere in this Federal
In the Stage 3 proposed rule (80 FR through other means, such as in the Register.
16742), we proposed to simplify common clinical data set (CCDS). Comment: A commenter on the Stage
requirements for meaningful use Response: As stated previously in this 3 proposed rule stated that although it
through an analysis of existing final rule with comment period, we note is implied, it does not appear to be
objectives and measures for Stages 1 and that we sought to identify the objectives clearly stated that vocabularies and
2 to determine if they are redundant, and measures which measure only the standards associated with the topped
duplicative, or ‘‘topped out’’. We noted capture data in a structured format out, redundant, or duplicative measures
that some of the objectives and without any additional requirement on are still required for use.
measures which meet these criteria the use of that data within the measure. Response: We did not propose to
involve EHR functions that are required We also note that this was an important remove the required use of standards
by the statutory definition of ‘‘certified factor in reviewing those measures associated with structured data capture
EHR technology’’ (see section 1848(o)(4) which were identified as potentially within the CEHRT. CEHRT must still
of the Act, which references the topped out (section II.B.2.b.(4)(a)(i)). In include the functions and capabilities
definition of ‘‘qualified EHR’’ in section other words, most measures selected for that are part of the overall definition of
3000(13) of the Public Health Service removal were both topped out and also requirements for CEHRT for the
Act) which a provider must use to redundant or paper-based (as discussed Medicare and Medicaid EHR Incentive
demonstrate meaningful use. We stated previously in section II.B.2.b.(4)(a)(ii)), Programs, including LOINC standards,
that it was our intent that the objectives or duplicative of more advanced use HL7 standards, and SNOMED standards,
and measures proposed for Stage 3 objectives. We understand some among others, as established in the ONC
would include uses of these functions in providers may still find value in certification criteria for CEHRT. These
a more advanced form. For example, independently setting goals for data structured data elements must also be
part of the C–CDA in an electronic 20354), we stated that we analyzed the quartile performance rates for topped
exchange and the information provided existing objectives and measures of out measures.
to a patient through the view, meaningful use to consider if they Our analysis of the objectives and
download, and transmit functions of should be modified for the program measures of meaningful use Stage 1 and
CEHRT. For further information, we beginning in 2015. Using the approach Stage 2 identified a number of measures
refer readers to the ONC 2015 Edition outlined in the Stage 3 proposed rule, that met the criteria as either redundant,
Certification Criteria final rule we looked at the set of potential
published elsewhere in this Federal duplicative, or topped out, with new
objectives and measures for inclusion in participants consistently performing at a
Register. the program for 2017 and subsequent
After consideration of the public statistically comparable rate to returning
years and sought to determine if they participants. Table 2 identifies the
comments received, we are finalizing
our proposed approach for analyzing the were redundant, duplicative, or had current objectives and measures that
objectives and measures to identify and reached a performance level considered met the criteria. Therefore, we proposed
maintain and promote the advanced use to be topped out. We also considered (80 FR 20355) to no longer require
of health IT for Stage 3 of meaningful the functions and standards included providers to attest to these objectives
use. the technology certified to the 2014 and measures as currently codified in
Edition when determining if a measure the CFR under § 495.6 in order to meet
(b) Considerations in Defining the is redundant or duplicative and adding
Objectives and Measures of Meaningful program requirements beginning in
a review of isolated performance rates 2015.
Use for 2015 Through 2017 for providers in the first year of
In the EHR Incentive Programs in meaningful use in addition to reviewing
2015 through 2017 proposed rule (80 FR
TABLE 2—OBJECTIVES AND MEASURES IDENTIFIED BY PROVIDER TYPE

THAT ARE REDUNDANT, DUPLICATIVE, OR TOPPED OUT
Provider type Objectives and measures
Eligible Professional ........................ Record Demographics ........................................................................... 42 CFR 495.6(j)(3)(i) and (ii).
Record Vital Signs ................................................................................. 42 CFR 495.6(j)(4)(i) and (ii).
Record Smoking Status ......................................................................... 42 CFR 495.6(j)(5)(i) and (ii).
Clinical Summaries ................................................................................ 42 CFR 495.6(j)(11)(i) and (ii).
Structured Lab Results .......................................................................... 42 CFR 495.6(j)(7)(i) and (ii).
Patient List ............................................................................................. 42 CFR 495.6(j)(8)(i) and (ii).
Patient Reminders ................................................................................. 42 CFR 495.6(j)(9)(i) and (ii).
Summary of Care: ................................................................................. 42 CFR 495.6(j)(14)(i) and (ii).
Measure 1—Any Method
Measure 3—Test
Electronic Notes ..................................................................................... 42 CFR 495.6(j)(9)(i) and (ii).
Imaging Results ..................................................................................... 42 CFR 495.6(k)(6)(i) and (ii).
Family Health History ............................................................................ 42 CFR 495.6(k)(2)(i) and (ii).
Eligible Hospital/CAH ...................... Record Demographics ........................................................................... 42 CFR 495.6(l)(2)(i) and (ii).
Record Vital Signs ................................................................................. 42 CFR 495.6(l)(3)(i) and (ii).
Record Smoking Status ......................................................................... 42 CFR 495.6(l)(4)(i) and (ii).
Structured Lab Results .......................................................................... 42 CFR 495.6(l)(6)(i) and (ii).
Patient List ............................................................................................. 42 CFR 495.6(l)(7)(i) and (ii).
Summary of Care: ................................................................................. 42 CFR 495.6(l)(11)(i) and (ii).
Measure 1—Any Method
Measure 3—Test
eMAR ..................................................................................................... 42 CFR 495.6(l)(16)(i) and (ii).
Advanced Directives .............................................................................. 42 CFR 495.6(m)(1)(i) and (ii).
Electronic Notes ..................................................................................... 42 CFR 495.6(m)(2)(i) and (ii).
Imaging Results ..................................................................................... 42 CFR 495.6(m)(2)(i) and (ii).
Family Health History ............................................................................ 42 CFR 495.6(m)(3)(i) and (ii).
Structure Labs to Ambulatory Providers ............................................... 42 CFR 495.6(m)(6)(i) and (ii).
We noted that many of these own quality improvement goals. smoking status, structured lab results,
objectives and measures include actions Instead, we would no longer require patient lists, imaging results, family
that may be valuable to providers and providers to calculate and attest to the health history, and demographics. Some
patients, such as providing a clinical results of these measures in order to commenters stated they agree that many
summary to a patient after an office demonstrate meaningful use beginning of the measures no longer provided
visit. We encouraged providers to in 2015. enough value to remain part of the
continue to conduct these activities as Comment: The majority of program. Limiting the number of
best suits their practice and the commenters for the EHR Incentive objectives to those that can truly impact
preferences of their patient population. Programs in 2015 through 2017 the biggest issues facing healthcare
The removal of these measures is in no proposed rule were in support of technology is an appropriate and much
way intended as a withdrawal of an removing the objectives and measures needed direction.
endorsement for these best practices or that are considered redundant, Other commenters stated they believe
to discourage providers from conducting duplicative, or ‘‘topped out,’’ including this will have the effect of simplifying
and tracking these activities for their patient reminders, recording vital signs, the EHR Incentive Programs and easing
the administrative burdens associated the removal of the family history criteria to determine topped out
with the attestation process. Other measure because this data can be a measures: (1) Statistically
commenters support the idea of strong indicator for preventative indistinguishable performance at the
encouraging providers to continue to services. A few commenters are 75th and 99th percentile, and (2)
conduct these activities if it suits their concerned with the removal of the performance distribution curves at the
practice and the preferences of their record demographics measure and 25th, 50th, and 75th percentiles as
patient population—but not be required stated, if removed, adherence may drop compared to the required measure
to attest to these measures in order to and reporting will be less useful. threshold. We then compared the
meet the requirements of the program. Response: We agree that functions identified measures to other meaningful
Response: As we stated in the EHR and standards related to measures that use objectives that use the data in a
Incentive Programs in 2015 through are no longer required for the EHR more advanced function. We also
2017 proposed rule (80 FR 16741), we Incentive Programs could still hold proposed to remove measures that are
proposed the removal of these measures, value for some providers and paper-based for the reasons stated
or measures that are no longer useful in organizations. As stated in the EHR previously. We encourage commenters
gauging performance, in order to reduce Incentive Programs in 2015 through to review the performance data on our
the reporting burden on providers for 2017 proposed rule (80 FR 20355), we Web site under EHR Incentive Programs
measures already achieving widespread encourage providers to continue to use Objective and Measure Performance
adoption. the information as best suits their Report for additional information.3
Comment: Some commenters on the practice and the preferences of their After consideration of the public
EHR Incentive Programs in 2015 patient population. The removal of comments received, we are finalizing, as
through 2017 proposed rule indicated these measures from the EHR Incentive proposed, the list of objectives and
some objectives still require some of the Programs is not intended as a measures in Table 2 identified as
same structured data elements withdrawal of an endorsement of the redundant, duplicative, or topped out
scheduled to be retired and some may use of the standards, the capture of the and will no longer require these
still be of value to an organization in data, the implementation of best objectives and measures for meaningful
meeting other initiatives or regulatory practices, or to discourage providers use beginning with an EHR reporting
requirements and are, therefore, worth from conducting and tracking the period in 2015. The removal of these
retaining. A commenter disagreed with information for their own quality measures is reflected in the final
removal of the vital signs measure, as improvement goals. Additionally, the objectives and measures adopted in the
other measures may not fully capture data standards and functions will regulation text at § 495.22.
vital sign information on all patients remain part of CEHRT for provider use.
and keeping the measure incentivizes As part of our effort to reduce (i) Changes to Objectives and Measures
providers not only to collect these complexity, reduce reporting burden, for 2015 Through 2017
important data points but also to ensure and streamline the EHR Incentive In the EHR Incentive Programs in
that vital signs data is input into the Programs, we proposed to remove the 2015 through 2017 proposed rule, we
EHR. Another commenter stated that not core and menu structure established in noted that in order to implement the
providing clinical summaries could previous rules. We do not believe the proposed changes to the program to
have the adverse effect of decreasing continuation of an optional menu align with long-term goals; there are a
patient engagement, especially if objective for simple data capture number of changes that must be made
patients are not using patient portals. provides better support for the standard to other requirements of meaningful use
Some commenters indicated exempting than the support provided by requiring (80 FR 20355). These changes fall into
laboratory data is especially damaging the inclusion of the standard in CEHRT the following two major categories—
to the creation of EHRs because and the use of that data within a more • Changes to streamline the structure
structured laboratory data provides the advanced objective. in 2015 through 2017 to align with the
best opportunity to load results As noted previously, we support the proposed structure for Stage 3 of
automatically into an EHR, given the continued use of structured data within meaningful use in 2017 and subsequent
degree of coding and structure, and a certified EHR to support advanced years; and
prevents duplicate ordering. Other clinical processes, care coordination, • Changes to accommodate this shift
commenters are concerned that an EHR and quality improvement. The capture to allow providers to demonstrate
will not allow providers to create their of this data in a structured format allows meaningful use for an EHR reporting
own patient lists so they can assess the provider to use the data for these period in 2015.
which of their patients may require processes and supports the efficacy of We recognized and considered the
additional clinical attention. Another quality measurement and quality stakeholder and provider
commenter was opposed to the removal improvement. The removal of the representatives’ concerns in
of electronic notes, stating when requirement to count simple data implementing the patient engagement
providers must continually find the capture allows providers to shift the objectives requiring patient action (see
paper chart in order to know what is focus of their use of technology to the Stage 2 final rule at 77 FR 54046
going on with the patient, it slows them support effective use of the data. under the Health Outcomes Policy
down and they do not get optimal value Comment: A commenter on the EHR Priority ‘‘Engage patients and families in
out of an EHR. Incentive Programs in 2015 through their care’’), which include barriers to
Some commenters opposed the 2017 proposed rule requested CMS successful implementation of the
removal of specific objectives or clarify further the reasons why required health IT or CEHRT functions
measures, such as the imaging results objectives and measures were removed. necessary to support the measures. We
measure, stating it should be retained as Response: As we noted in the Stage 3 proposed changes to these objectives to
a menu set choice or as an alternate proposed rule (80 FR 16741 through allow providers to focus on
choice to implementing reporting for a 16742), we reviewed performance data improvements without jeopardizing
second public health measure in submitted by providers through
addition to immunization reporting. attestation to determine topped out 3 CMS EHR Incentive Programs Data and Reports
Other commenters are concerned with measures. We applied the following at www.CMS.gov/EHR Incentive Programs.
their ability to successfully fulfill the proposed to establish alternate options. If a provider is scheduled to
requirements of the EHR Incentive exclusions and specifications to mitigate attest to Stage 1 of meaningful use in
Programs. any additional burden on providers for 2015, we proposed to allow EPs to
an EHR reporting period in 2015 (80 FR report on only one of the five available
(ii) Structural Requirements of
20356). options outlined and the eligible
Meaningful Use in 2015 Through 2017
For the public health reporting hospitals or CAHs to report on any
In the EHR Incentive Programs in objectives and measures, we proposed combination of two of the six available
2015 through 2017 proposed rule, we to consolidate the different Stage 2 core options for an EHR reporting period in
proposed to eliminate the distinction and menu objectives into a single 2015 (80 FR 20366).
between core and menu objectives and objective with multiple measure Therefore, we proposed that the
purported that all retained objectives options. We proposed this approach for structure of meaningful use for 2015
would be required for the program. We the Stage 3 public health reporting through 2017 would be nine required
note that for Stage 1 providers, this objective because we believe it allows objectives for EPs using the Stage 2
means three current menu objectives for greater flexibility for providers and objectives for EPs, with alternate
would now be required; and for Stage 2 supports continued efforts to engage exclusions and specifications for Stage 1
eligible hospitals and CAHs, one current providers and public health agencies in providers in 2015. We proposed that the
menu objective would now be a the essential data capture and structure of meaningful use for 2015
required objective (80 FR 20356). These information exchange that supports through 2017 would be eight required
objectives are as follows: quality improvement, emergency objectives for eligible hospitals and
• Stage 1 Menu: Perform Medication response, and population health CAHs, with alternate exclusions and
Reconciliation management initiatives. For further specifications for Stage 1 providers and
• Stage 1 Menu: Patient Specific discussion of the rationale for the Stage some stage 2 providers in 2015. In
Educational Resources 3 objective, we direct readers to 80 FR addition, EPs would be required to
• Stage 1 Menu: Public Health 16731 through 16804. For the report on a total of two measures from
Reporting Objectives (multiple consolidated public health reporting the public health reporting objective or
options) objective in the EHR Incentive Programs meet the criteria for exclusion from up
• Stage 2 Menu: Eligible Hospitals and in 2015 through 2017 proposed rule (80 to five measures; eligible hospitals and
CAHs Only: Electronic Prescribing FR 20366), we proposed that EPs report CAHs would be required to report on a
Furthermore, we stated that the on any combination of two of the five total of three measures from the public
objectives and measures retained in available options, while eligible health reporting objective or meet the
each case for all providers would be the hospitals and CAHs report on any criteria for exclusion from up to six
Stage 2 objectives and measures and combination of three of the six available measures.
TABLE 3—CURRENT STAGE STRUCTURE, RETAINED OBJECTIVES, AND PROPOSED STRUCTURE

Current Stage 1 structure Retained objectives Proposed structure
EP .......................... 13 core objectives ................................. 6 core objectives ................................... 9 core objectives.

5 of 9 menu objectives including 1 3 menu objectives ................................. 1 public health objective (2 measure
public health objective. 2 public health objectives options).
EH/CAH ................. 11 core objectives ................................. 5 core objectives ................................... 8 core objectives.
5 of 10 menu objectives including 1 3 menu objectives ................................. 1 public health objective (3 measure
public health objective. 3 public health objectives options).
Current Stage 2 structure Retained objectives Proposed structure
EP .......................... 17 core objectives including public 9 core objectives ................................... 9 core objectives.
health objectives. 0 menu objectives ................................. 1 public health objective (2 measure
3 of 6 menu objectives ......................... 4 public health objectives options).
EH/CAH ................. 16 core objectives including public 7 core objectives ................................... 8 core objectives.
health objectives. 1 menu objective .................................. 1 public health objective (3 measure
3 of 6 menu objectives ......................... 3 public health objectives options).
We received public comment on this a single stage of meaningful use would rule with comment period, we are
proposal and our response follows. drastically reduce the administrative making changes to the requirements for
Comment: Many commenters on the burden, provide simplicity that will Stage 1 and Stage 2 for 2015 through
EHR Incentive Programs in 2015 benefit EHR developers and users, and 2017 to align with the approach for
through 2017 proposed rule relayed facilitate meeting interoperability goals. Stage 3 in 2018 and subsequent years.
their support of program consolidation Other commenters stated that by This includes a simplified structure and
with transition to a single stage, as well reducing the amount of effort that a focus on objectives and measures with
as the removal of core and menu participant has to exert—especially for sustainable growth potential aligned to
objectives and measures. measures that are already a matter of the programs’ foundational goals prior
Other commenters believe that such clinical routine—participants will have to the full implementation of Stage 3 in
changes will make it much easier for all an experience that is significantly less 2018.
providers to attest, for providers to intrusive. Comment: Some commenters on the
know what Stage they are in, and for Response: We appreciate the EHR Incentive Programs in 2015
CMS to track providers who are in commenters’ feedback and support for through 2017 proposed rule stated that
different reporting years. Some our proposal to transition to a single eliminating the core and menu structure
commenters stated that the transition to stage of meaningful use. In this final does not mean that choice should be
eliminated from the structure of to demonstrate meaningful use, despite to ease the transition to a single stage of
reporting. Other commenters requested the proposals to use only the Stage 2 meaningful use. We proposed to
that the original core and menu objectives and measures identified for accommodate eligible providers
structure be kept in the program. meaningful use in 2015 through 2017. previously scheduled to demonstrate
Response: The proposed removal of These provisions fall into the following Stage 1 in 2015 by allowing alternate
the core and menu structure is part of two major categories: exclusions and specifications for certain
our focus to simplify the reporting • Maintaining the specifications for objectives or measures. Providers
requirements and decrease complexity objectives and measures that have a scheduled to be in Stage 1 may opt to
in response to stakeholder feedback. We lower threshold or other measure use the alternate exclusions and
proposed this change to refocus program differences between Stage 1 and Stage 2; specifications, but they are not required
requirements on those objectives and • Establishing exclusion for Stage 2 to use them. The Medicare and
measures that represent advanced use of measures that do not have an equivalent Medicaid EHR Incentive Programs
CEHRT. Stage 1 measure associated with any registration and attestation system will
We disagree that the commenters’ Stage 1 objective, or where the provider automatically identify those providers
suggestion to retain a core and menu did not plan to attest to the menu who are eligible for alternate exclusions
structure offers value to supporting objective that would now be otherwise and specifications. Upon attestation,
program goals or to promoting flexibility required. these providers will be offered the
in a meaningful way. Retaining a menu For the first category, we proposed option to attest to the Stage 2 objective
of objectives that includes topped out, that for an EHR reporting period in and measure and the option to attest to
redundant, or duplicative measures for 2015, providers scheduled to the alternate specification or claim the
the sole purpose of allowing providers demonstrate Stage 1 of meaningful use alternate exclusion if available. The
to continue to choose among them is may attest based on the specifications provider may independently select the
counter-productive to efforts to reduce associated with the Stage 1 measure. We option available to them for each
program complexity and ease the noted that for an EHR reporting period measure for which an alternate
reporting burden on providers. It also beginning in 2016, we proposed that all specification or exclusion may apply.
offers no benefit to CMS to continue to providers must attest to the Comment: A commenter requested
require reporting on measures that no specifications (including the measure clarification on how providers should
longer represent a statistical value for thresholds) associated with the Stage 2 document that they did not intend to
measurement or a means of measure. For the second category, we attest to a menu objective or
differentiating provider performance. proposed the alternate exclusions clarification that this is not something
The only other method by which a outlined for providers would only apply that will be/should be audited.
menu could be implemented would be for an EHR reporting period in 2015. For Response: We understand that intent
to make formerly required objectives an EHR reporting period in 2016, we or lack thereof may be difficult for a
optional. As stated in the EHR Incentive proposed that all providers, including provider to document and will not
Programs in 2015 through 2017 those who would otherwise be require documentation that a provider
proposed rule (80 FR 20386), we do not scheduled for Stage 1 in 2016, would be did not plan to attest to a menu
believe that approach supports program required to meet the Stage 2 objective for the provider to claim the
goals or meets our statutory duty to specifications with no alternate alternate exclusion.
require more stringent measures of exclusions. Comment: A number of commenters
meaningful use over time. The proposed alternate exclusions strongly recommended that CMS keep
Furthermore, we believe the and specifications for certain objectives the alternate specifications and
objectives that we proposed to retain and measures of meaningful use for an exclusions proposed for 2015 available
represent the functions that any EHR reporting period in 2015 are for providers meant to be in Stage 1 in
provider should apply to leverage HIT defined for each objective and measure 2016 and 2017 to allow more recent
in support of improved outcomes for in the description of each objective and participants the same progression
their patients. We believe that the measure in the EHR Incentive Programs through the stages of the EHR Incentive
existing exclusions for each measure are in 2015 through 2017 proposed rule(80 Programs as those who entered the
adequate to allow flexibility for FR 20358 through 20374). program earlier. Other commenters
providers. Additionally, we have Comment: Many commenters were suggested that while the Stage 2
proposed to include alternate exclusions supportive of allowing alternate objectives are achievable with prior
and specifications for Stage 1 providers exclusions for Stage 1 providers in planning by 2017, retaining the alternate
in 2015 to allow them to continue the 2015.Some stated that if the proposal to exclusions alternate in 2016 would
workflows they have already established shift to a single set of measures for 2015 allow providers to obtain and effectively
for 2015 and give them time to move were adopted, providers who were implement any necessary software
forward with the more advanced planning to attest to Stage 1 in 2015 in required to meet certain Stage 2
measures. accordance with the current policies measures that they may not currently
After consideration of public would certainly require have in place. These commenters noted
comments received, we are finalizing accommodations. Other commenters that for some objectives and measures,
the changes to the structure as stated that these exclusions should also the need to obtain and implement
proposed. be considered optional for Stage 1 CEHRT that they do not already possess
providers who want to move to Stage 2 would require time to ensure privacy
(iii) Alternate Exclusions and immediately. Many commenters stated and security protocols and patient safety
Specifications for Stage 1 Providers for that it would benefit the provider if they measures are effectively implemented.
Meaningful Use were able to indicate the Stage that they Commenters noted this is especially
We proposed (80 FR 20357) several were scheduled to demonstrate for 2015 true with the functions, clinical
alternate exclusions and specifications in the attestation system. workflows, and staff training that would
for providers scheduled to demonstrate Response: We thank you for your be required to effectively implement
Stage 1 of meaningful use in 2015 that support of our proposal to establish electronic prescribing and computerized
would allow these providers to continue alternate exclusions and specifications provider order entry, which may present
a significant risk to patient safety if the CEHRT functions and standards. We significant barriers exist that heavily
technology is implemented incorrectly direct readers to each objective in impact a provider’s ability to meet the
in order to meet an expedited timeline. section II.B.2.a of this final rule with patient action measures. Therefore, we
Response: We understand the comment period for a full discussion of proposed to remove the thresholds for
commenters’ concerns that meeting the the details pertaining to the these two measures in order to allow for
Modified Stage 2 requirements may be requirements for the alternate further maturity of the technology,
challenging for some providers for those exclusions and specifications for the greater saturation in the market, and
objectives and measures that would applicable objectives and measures. increased awareness among patient
require the implementation of After consideration of the public population. We believe this allows for
additional CEHRT modules they did not comments, we finalize the structure of the necessary time for providers to work
previously possess because they were the objectives and measures for the EHR toward patient education and the
not scheduled to be in Stage 2 or Incentive Programs in 2015 through availability of these resources, as well as
because they did not intend to attest to 2017 as proposed. In addition, we are allowing the industry as a whole time to
the menu objective. In general, the finalizing as proposed the proposal for develop a stronger infrastructure
timing to implement these new alternate exclusions and specifications supporting patient engagement.
technologies would not necessary be for certain providers in 2015. We There are two objectives for EPs and
prohibitive for a provider to finalize that providers that were one objective for eligible hospitals and
successfully participate in 2016; scheduled to demonstrate Stage 1 in CAHs that specifically contain measures
2015 or2016 (for certain exclusions requiring a provider to track patient
however, as some commenters
only) may choose the alternate action. We proposed to modify these
mentioned there are patient safety risks
exclusions and specifications where measures as follows:
associated with the effective
applicable or may attest to the modified
implementation of the technology and
Stage 2 objectives and measures. We • Patient Action to View, Download,
the supportive workflows which are of or Transmit (VDT) Health Information
finalize that EPs, eligible hospitals and
concern for certain objectives. To ++ Remove the 5 percent threshold
CAHs that were scheduled to be in Stage
accommodate these concerns, we will for Measure 2 from the EP Stage 2
1 in 2016 may claim an alternate
allow providers who would otherwise Patient Electronic Access (VDT)
exclusion for an EHR reporting period
be scheduled for Stage 1 in 2016 to objective. Instead require that at least 1
in 2016 for the Computerized Provider
claim the alternate exclusions for the Order Entry Objective Measures 2 and 3 patient seen by the provider during the
Modified Stage 2 objectives and (lab and radiology orders) or choose the EHR reporting period views, downloads,
measures that would require the modified Stage 2 objective and or transmits his or her health
effective implementation of CEHRT measures. We finalize that eligible information to a third party.
modules for an EHR reporting period in hospitals and CAHs that were scheduled ++ Remove the 5 percent threshold
2016 that the provider does not to be in Stage 1 in 2016 may claim an for Measure 2 from the eligible hospital
currently possess. Specifically, we alternate exclusion for an EHR reporting and CAH Stage 2 Patient Electronic
believe this includes measures 2 and 3 period in 2016 for the Electronic Access (VDT) objective. Instead require
(lab and radiology orders) of the Prescribing Objective or choose the that at least 1 patient discharged from
Computerized Provider Order Entry modified Stage 2 Objective. For further the hospital during the EHR reporting
Objective for EPs, eligible hospitals, and detail, we direct readers to the period views, downloads, or transmits
CAHs, as well as the Electronic individual objectives and measures for his or her health information to a third
Prescribing Objective for eligible the EHR Incentive Programs in 2015 party.
hospitals and CAHs. However, we do through 2017 in section II.B.2.a of this
not believe this extension should • Secure Electronic Messaging Using
final rule with comment period. We CEHRT
include the Health Information refer readers to Table 1 in the EHR
Exchange Objective for a number of ++ Convert the measure for the Stage
Incentive Programs in 2015 through
reasons. First, we have already proposed 2 EP Secure Electronic Messaging
2017 proposed rule (80 FR 20352) for an
additional flexibility for that objective illustration of our policy on the prior objective from the 5 percent threshold to
in 2015 through 2017 regarding the progression of stages and whether a a yes/no attestation to the statement:
CEHRT requirement for the provider is scheduled to be in Stage 1 ‘‘The capability for patients to send and
transmission of an electronic summary in 2015 or 2016. receive a secure electronic message was
of care document. Second, we believe enabled during the EHR reporting
the threshold of 10 percent associated (iv) Changes to Patient Engagement period’’.
with the Health Information Exchange Requirements for 2015 Through 2017 These changes are reflected in the
Objective and measure is achievable As discussed in the EHR Incentive discussion of these objectives in section
within a calendar year. Finally, we Program for 2015 through 2017 II.B.2.a of this final rule with comment
believe that the ability of all providers proposed rule (80 FR 20357), we period. We note that these changes are
to successfully exchange health proposed to make changes to two intended to allow providers to work
information electronically is enhanced objectives that have measures related to toward meaningful patient engagement
by greater participation among patient engagement. We proposed to through HIT using the methods best
providers as a whole. We also do not remove the threshold requirement for suited to their practice and their patient
believe that providers who otherwise these two measures that count patient population. Furthermore, we note that
would be scheduled for Stage 1 in 2016 action in order for the provider to meet beginning in 2018 (and optionally in
should be allowed to use for an EHR the measure. While we support patient 2017); providers are required to meet an
reporting period in 2016 the alternate engagement and believe that providers objective exclusively focused on patient
specifications that we proposed for have a role in influencing patient engagement that has an expanded set of
2015, as these are only applicable for behavior and supporting improved measures and increased thresholds. (For
measures that already have both a Stage health literacy among their patients, further information on that proposed
1 and Stage 2 equivalent and are data analysis on the measures supports objective, we direct readers to 80 FR
supported by measures using the same concerns expressed by providers that 16755 through 16758.)
(c) Considerations in Defining the HIT Policy Committee and the goals and overall national health care
Objectives and Measures of Meaningful foundational goals and requirements improvement goals, such as those found
Use Stage 3 under the HITECH Act, we identified in in the CMS National Quality Strategy.4
After analysis of the existing Stage 1 the Stage 3 proposed rule (80 FR 16743) These eight policy areas provide the
and Stage 2 objectives and measures as eight key policy areas that represent the basis for the proposed objectives and
described in section II.B.1.b.(4)(a) and advanced use of EHR technology and measures for Stage 3. They are included
review of the recommendations of the align with the program’s foundational in Table 4 as follows:
TABLE 4—OBJECTIVES AND MEASURES FOR MEANINGFUL USE IN 2017 AND SUBSEQUENT YEARS
Program goal/objective Delivery system reform goal alignment
Protect Patient Health Information ........................................... Foundational to the EHR Incentive Program and Certified EHR Technology.*
Recommended by HIT Policy Committee.
Electronic Prescribing (eRx) ..................................................... Foundational to the EHR Incentive Program National Quality Strategy Alignment.
Clinical Decision Support (CDS) .............................................. Foundational to Certified EHR Technology.
Recommended by HIT Policy Committee National Quality Strategy Alignment.
Computerized Provider Order Entry (CPOE) ........................... Foundational to Certified EHR Technology National Quality Strategy Alignment.
Patient Electronic Access to Health Information ...................... Recommended by HIT Policy Committee National Quality Strategy Alignment.
Coordination of Care through Patient Engagement ................. Recommended by HIT Policy Committee National Quality Strategy Alignment.
Health Information Exchange (HIE) ......................................... Foundational to the EHR Incentive Program and Certified EHR Technology.
Recommended by HIT Policy Committee National Quality Strategy Alignment.
Public Health and Clinical Data Registry Reporting ................ Recommended by HIT Policy Committee National Quality Strategy Alignment.
* See, for example, sections 1848(o)(2) and (4) of the Act.
In the Stage 3 proposed rule (80 FR populations. Commenters also In response to commenters who
16743), we proposed that providers submitted comments on specific specifically cited a need to focus on
must successfully attest to these eight objectives or noted that across the board outcomes and quality improvement
objectives and the associated measures the measures associated with these based on outcomes measurement, we
(or meet the exclusion criteria for the objectives are not measuring agree with this assessment. We note that
applicable measure) to meet the improvements in patient outcomes. the goal of the EHR Incentive Program
requirements of Stage 3 in the Medicare Several commenters appreciated the is largely to spur the development and
and Medicaid EHR Incentive Programs. removal of the core and menu structure adoption of health HIT solutions that
These objectives and measures include of the objectives, while establishing a support these broader goals. We believe
advanced EHR functions, use a wide single set of objectives and measures in that technology itself cannot improve
range of structured standards in CEHRT, Stage 3, and believed it would reduce care coordination or patient outcomes,
employ increased thresholds over the program’s complexity. but the use of that technology can be a
similar Stage 1 and Stage 2 measures, Response: We thank the commenters tool for providers to work toward these
support more complex clinical and care for their input both on our selection key policy areas. HIT can provide
coordination processes, and require process and on the eight key policy efficiencies in administrative processes
enhanced care coordination through areas we identified as well as on the which support clinical effectiveness,
patient engagement through a flexibility structure of Stage 3. We agree with leveraging automated patient safety
structure of active engagement commenters who note that a wide range checks, supporting clinical decision
measures. of high priority health conditions, as making, enabling wider access to health
Comment: Many commenters well as specific specialties and information for patients, and allowing
supported the approach for identifying characteristics of unique patient for dynamic communication between
the key priorities for the EHR Incentive populations, are not explicitly providers. That is why we proposed a
Programs over the long term. recognized in our proposals or set of priorities for Stage 3 that focus on
Commenters’ opinions on the top identified in the eight key policy areas. these concepts. However, it is also the
priorities varied, with some supporting We note that we sought to establish a reason behind our efforts to align the
greater patient engagement, some broad spectrum of key policy areas, EHR Incentive Program with the
supporting a stronger shift towards which may include many varied National Quality Strategy and with CMS
outcomes-based quality measurement projects, initiatives, and outcomes-based quality measurement and quality
and quality improvement, and others impact goals within their scope. The improvement programs like PQRS,
encouraging continued support of eight key policy areas here identified are CPCI, Pioneer ACOs and Hospital IQR
interoperability and health information intentionally broad in scope because, as and HVBP programs. We welcome
exchange infrastructure. Several noted in the proposed rule, we are continued input from providers and
commenters agreed with the specific seeking to align with overarching stakeholder groups as we continue our
selection of high priority goals national health care improvement and efforts to support and promote patient-
identified by CMS. Other commenters delivery system reform goals and centered delivery system reform.
noted that the priority goals are too establish methods by which HIT can be We note that public comments
broad and not specific enough to leveraged by individual providers to received on specific objectives and
outcomes and chronic disease support their efforts toward these key responses to comments for these
management or that many may not be policy goals in their unique objectives are included in the
universally relevant across all patient implementation. discussion of each objective and its
4 The National Quality Strategy: ‘‘HHS National
Strategy for Quality Improvement in Health Care’’

http://www.ahrq.gov/workingforquality/about.htm.
associated measures in section II.B.2.b Entry (CPOE) and CDS in order to stated that this can be accomplished in
of this final rule with comment period. accommodate specialties who may have the following three ways:
After consideration of the comments low numbers of orders or who have • CEHRT could be permanently
received, we are finalizing our approach limited applicable CQMs to pair with a installed at the practice/location.
for setting the eight key policy areas for CDS. We also received • The EP could bring CEHRT to the
Stage 3 as proposed. We address the recommendations to change our practice/location on a portable
individual objectives and measures in approach toward flexibility including computing device.
section II.B.2.b of this final rule with allowing providers to attest to only 2 of • The EP could access CEHRT
comment period. the 3 measures for which they meet the remotely using computing devices at the
threshold to meet the objective, practice/location.
(d) Flexibility Within Meaningful Use We proposed to maintain these
Objectives and Measures allowing providers to attest to all 3
measures and meet only 1 threshold to definitions for Stage 3.
We proposed to incorporate flexibility meet the objective, and variations on Comment: We received a number of
within certain objectives for Stage 3 for those concepts. comments requesting clarification for
providers to choose the measures most Response: We thank the commenters providers practicing in certain settings
relevant to their unique practice setting. and note that we did not propose as to how they should calculate the
As a result, as part of successfully flexibility for other objectives such as percentage of their patient encounters
demonstrating meaningful use, CPOE and CDS because we believe there occurring in a location equipped with
providers would be required to attest to are already accommodations within CEHRT. Specifically, a commenter
the results for the numerators and these objectives for specialists. For requested guidance on how to calculate
denominators of all measures associated CPOE these are in the form of the percentage for providers who
with an objective. However, a provider exclusions and for CDS providers may practice in a long-term care facility but
would only need to meet the thresholds elect to focus their selection on high for whom these patient encounters
for two of the three associated measures. priority health conditions within their represent less than 50 percent of their
The proposed Stage 3 objectives specialty if they do not believe they total. Another commenter requested
including flexible measure options are have adequate CQM pairings to clarification on how the calculation
as follows: implement. We thank those commenters works with regards to a hardship
• Coordination of Care through who provided recommendations on the exception from a payment adjustment.
Patient Engagement—Providers must number of measures required for Response: Our policy is the same
attest to the numerators and attestation and for the thresholds. We across practice settings: To be a
denominators of all three measures, but note that our intent to require attestation meaningful EHR user, an EP must have
must only meet the thresholds for two to all three is to ensure that the 50 percent or more of his or her
of three measures. functions for all measures are available outpatient encounters during the EHR
• Health Information Exchange— for provider use and to provide CMS reporting period at a practice/location or
Providers must attest to the numerators with valuable data on performance from practices/locations equipped with
and denominators of all three measures, all providers on these measures. CEHRT. Thus, EPs who practice in long-
but must only meet the thresholds for After consideration of the public term care settings must track their
two of three measures. comments received, we are finalizing outpatient encounters across their
• Public Health Reporting—EPs must our proposal to provide flexibility practice settings during the EHR
report on three measures and eligible within certain measures as proposed. reporting period and meet the 50
hospitals and CAHs must report on four percent threshold. EPs who practice in
measures. (e) EPs Practicing in Multiple Practices/
Locations multiple locations and lack control over
For the objectives that allow providers the availability of CEHRT may consider
to meet the thresholds for two of three For Stage 3, we proposed to maintain applying for a hardship exception.
measures (for example, the Coordination the policy from the Stage 2 final rule (77 After consideration of the public
of Care through Patient Engagement FR 53981) that states that to be a comments received, we are finalizing
objective and the Health Information meaningful user, an EP must have 50 our proposal to maintain this policy as
Exchange objective), we proposed that if percent or more of his or her outpatient finalized in the Stage 2 final rule at (77
a provider claims an exclusion for a encounters during the EHR reporting FR 53981).
measure the provider must meet the period at a practice/location or
thresholds of the remaining two practices/locations equipped with (f) Denominators
measures to meet the objective. If a CEHRT. An EP who does not conduct at In the Stage 3 proposed rule (80 FR
provider meets the exclusion criteria for least 50 percent of their patient 16744), we note that the objectives for
two measures for such an objective, the encounters in any one practice/location Stage 3 include percentage-based
provider may exclude those measures would have to meet the 50 percent measures wherever possible. In the
and must meet the threshold of the threshold through a combination of Stage 2 final rule, we included a
remaining measure to meet the practices/locations equipped with discussion of the denominators used for
objective. If a provider meets the CEHRT. In the Stage 2 final rule at (77 the program that included the use of one
exclusion criteria for all three measures FR 53981), we defined patient of four denominators for each of the
for such an objective, the provider may encounter as any encounter where a measures associated with the
exclude those measures and would still medical treatment is provided or meaningful use objectives outlined in
meet the objective. evaluation and management services are the Stage 2 final rule (77 FR 53982 for
Comment: We received comments provided. EPs and 77 FR 53983 for eligible
supporting the flexibility proposed In addition, in the Stage 2 final rule hospitals and CAHs).
within certain objectives for Stage 3. at (77 FR 53981) we defined a practice/ For EPs, the references used to define
Several commenters requested also location as equipped with CEHRT if the the scope of the potential denominators
allowing flexibility within other record of the patient encounter that for measures include the following:
objectives not included in our proposal occurs at that practice/location is • Unique patients seen by the EP
such as Computerized Provider Order created and maintained in CEHRT. We during the EHR reporting period.
• Office visits. department method), as described for if they occurred prior to the beginning
• All medication, laboratory, and Stage 2 at 77 FR 53984. We stated that of the year or after the end of the year.
diagnostic imaging orders created all discharges from an inpatient setting Commenters noted that prior
during the reporting period. are considered a transition of care. We interpretation used by many developers
• Transitions of care and referrals also proposed for transitions from an contradicted this guidance and
including: emergency department, that eligible interpreted the lack of a time distinction
++ When the EP is the recipient of hospitals and CAHs must count any in the numerator to mean that the action
the transition or referral, first discharge where follow-up care is could occur at any point and was not
encounters with a new patient and ordered by an authorized provider constrained to the EHR reporting period
encounters with existing patients where regardless of the completeness of or even the calendar or fiscal year.
a summary of care record (of any type) information available to the receiving Commenters requested that CMS allow
is provided to the receiving EP. provider. a continuation of the prior
++ When the EP is the initiator of the Comment: We received a few interpretation until 2015 Edition
transition or referral, transitions and comments noting that we inadvertently technology is required in order to not
referrals ordered by the EP. left out the hospital denominator termed force developers to change systems to a
For the purposes of distinguishing ‘‘inpatient bed days,’’ which was different calculation.
settings of care in determining the discussed in the Stage 2 final rule. Response: We note that we do not
movement of a patient, we proposed Response: We thank the commenters agree with an interpretation of the
that a transition or referral may take for their assistance and note that this unique patient denominator that allows
place when a patient is transitioned or was not an oversight but a deliberate for an action in previous reporting years
referred between providers with omission. In the Stage 2 final rule, we to count in the numerator for a measure
different billing identities, such as a stated that while inpatient bed days was (such as the patient specific education
different National Provider Identifier a potential useful inclusion in defining objective and measure) in perpetuity.
(NPI) or hospital CMS Certification discharge calculations, it was not in use We believe that this not only skews the
Number (CCN). We also proposed that for any objective or measure (77 FR accuracy of the measure, it also is
in the cases where a provider has a 53984). As the denominators are counter to the intention of establishing
patient who seeks out and receives care specific to the language used in the a benchmark of performance in each
from another provider without a prior objectives and measures, we did not reporting period. We require these
referral, the first provider may include include inpatient bed days in our actions because we believe they should
that transition as a referral if the patient proposal. be regularly performed as part of a
subsequently identifies the other Comment: Multiple commenters provider’s meaningful use of CEHRT. In
provider of care. requested clarification on when patients addition, this method of measurement
For eligible hospitals and CAHs, the whose records are not maintained in suggested would cause drastic
references used to define the scope of CEHRT may be excluded from the variations between providers over time
the potential denominators for measures denominator for a measure. based on their specialty, patient
include the following: Response: Each objective includes a population, and frequency of repeat
• Unique patients admitted to the specific designation regarding whether visits. We do, however, understand the
eligible hospital’s or CAH’s inpatient or the denominator or denominators for desire to minimize the need for
emergency department during the EHR the associated measures may be limited developers to change EHR technology
reporting period. to only those records maintain in the already certified to the 2014 Edition or
• All medication, laboratory, and CEHRT. We direct readers to the to require recertification. We address
diagnostic imaging orders created definition of each objective in § 495.22 the issue of specification on timing
during the reporting period. for 2015 through 2017 and § 495.24 for directly in the applicable objectives in
• Transitions of care and referrals section II.B.2.a of this final rule with
Stage 3, respectively.
including: comment period.
Comment: Several commenters
++ When the hospital is the recipient Comment: One commenter requested
offered suggestions on an approach for
of a transition or referral, all admissions the removal of the qualifying language
calculation for the numerators related to
to the inpatient and emergency regarding encounters with a new patient
any measure or objective using the
departments. for the denominator for transitions and
++ When the hospital is the initiator ‘‘unique patient’’ denominator (for
referrals for an EP. The commenter
of the transition or referral, all example, patient specific education).
expressed concern that it was
discharges from the inpatient These commenters requested
burdensome to include all new patients
department, and after admissions to the clarification for measures which are
as a referral and that in many cases
emergency department when follow-up based on actions for unique patients and
there was no referring provider
care is ordered by authorized providers if they may occur before, during, or after
initiating the first encounter with the
of the hospital. the reporting period. Some commenters
patient.
We proposed that the explanation of specifically mentioned FAQ 8231 5 Response: We appreciate the
the terms ‘‘unique patients,’’ which specified the timing required to commenter’s concern, but note that
‘‘transitions of care,’’ and ‘‘referrals’’ measure actions for the numerator for these denominators and definitions are
stated previously for EPs would also measures which do not explicitly state for the purposes of defining the
apply for eligible hospitals and CAHs, the timing in the numerator. The FAQ objectives and measures for the
and we refer readers to the discussion stated these actions may occur before, Medicare and Medicaid EHR Incentive
of those terms in the hospital context in during or after the EHR reporting period Programs and that for the objectives
the Stage 2 final rule (77 FR 53983 and if the EHR reporting period is less than where this language is included, we
53984). We proposed for Stage 3 to one full year, but could not be counted believe it is appropriate to include all
maintain the policy that admissions 5 FAQ #8231 https://www.cms.gov/Regulations-
new patients. Specifically, this
may be calculated using one of two and-Guidance/Legislation/EHRIncentivePrograms/
denominator is used in objectives that
methods (the observation services FAQ.html Frequently Asked Questions: EHR relate to reconciling important patient
method and the all emergency Incentive Programs. health information including
medications the patient may be taking caring for parents of young children and 2. Meaningful Use Objectives and
and any medication allergies the patient working to engage the parent using Measures
may have. We believe that it is essential these tools in relation to the child who a. Meaningful Use Objectives and
that a provider include all new patient is their patient. Measures for 2015, 2016, and 2017
encounters (even those where there is Response: We thank the commenters
no referring provider) in these important In the EHR Incentive Programs in
for their support and insight into how 2015 through 2017 proposed rule (80 FR
objectives that impact patient safety. this policy supports the overall goals to
Furthermore, we note that these 20358), we proposed the following
expand the concept of patient objectives and measures for EPs, eligible
definitions in the Stage 3 proposed rule engagement and support the
at 80 FR 16744 are continuations of the hospitals, and CAHs to demonstrate
communication continuum between meaningful use for an EHR reporting
Stage 2 definitions previously finalized provider and patient with the clear
for the Medicare and Medicaid EHR period in 2015 through 2017. We noted
focus on patient-centered care. that there are nine proposed objectives
Incentive Programs in the Stage 2 final
rule at 77 FR 53984. After consideration of the public for EPs plus one consolidated public
After consideration of the public comments received, we are finalizing health reporting objective, and eight
comments received, we are finalizing this policy as proposed. We direct proposed objectives for eligible
these denominators and the related readers to the individual objectives and hospitals and CAHs plus one
explanations of terms as proposed. measures outlined in section II.B.2.b of consolidated public health reporting
this final rule with comment period for objective. We proposed these objectives
(g) Patient Authorized Representatives further discussion of this provision would be mandatory for all providers
In the Stage 3 proposed rule at 80 FR within the applicable objectives and for an EHR reporting period beginning
16745 we proposed the inclusion of measures. in 2016 and proposed to allow alternate
patient-authorized representatives in the (h) Discussion of the Relationship of the exclusions and specifications for some
numerators of the Coordination of Care Requirements of the EHR Incentive providers in 2015 depending on their
through Patient Engagement objective prior participation.
Programs to CEHRT
and the Patient Electronic Access
objective as equivalent to the inclusion Objective 1: Protect Patient Health
We proposed to continue our policy
of the patient. We expect that patient- Information
of linking each objective to the CEHRT
authorized representatives with access definition and to ONC-established In the EHR Incentive Programs in
to such health information will always certification criteria. As with Stage 1 2015 through 2017 proposed rule, we
act on the patient’s behalf and in the and Stage 2, EPs, eligible hospitals, and proposed at 80 FR 20358 to retain, with
patient’s best interests and will remain CAHs must use technology certified to certain modifications, the Stage 2
free from any potential or actual conflict the certification criteria in the ONC HIT objective and measure for Protect
of interest with the patient. Certification Program to meet the Electronic Health Information for
Furthermore, we expect that the patient- objectives and associated measures for meaningful use in 2015 through 2017. In
authorized representatives would have Stage 3. the Stage 2 final rule (77 FR 54002
the patient’s best interests at heart and We received no comments specific to through 54003), we discussed the
will act in a manner protective of the this proposal and are finalizing as benefits of safeguarding ePHI, as doing
patient. so is essential to all other aspects of
proposed. We direct readers to the
Comment: Commenters were meaningful use. Unintended and/or
individual objectives and measures
supportive of the inclusion of a patient- unlawful disclosures of ePHI could
authorized representative in the Stage 3 outline in section II.B.2.b of this final
rule with comment period for further diminish consumers’ confidence in
objectives and measures related to EHRs and health information exchange.
patient electronic access and patient discussion of this provision within the
applicable objectives and measures and Ensuring that ePHI is adequately
engagement. A commenter expressed protected and secured would assist in
approval of our proposal to include the to section II.B.3 of this final rule with
comment period for discussion of the addressing the unique risks and
patient-authorized representative in the challenges that EHRs may present.
meaningful use numerators as definition of CEHRT for the Medicare
We note that we were inconsistent
equivalent to the patient, believing this and Medicaid EHR Incentive Programs.
with our naming of this objective calling
will encourage physicians to treat the (i) Discussion of the Relationship it ‘‘protect patient health information’’
authorized representative in the same Between a Stage 3 Objective and the and alternately ‘‘protect electronic
fashion as the patient. The commenter Associated Measure health information’’. The former
noted that this is particularly important matches the Stage 3 Objective (section
for providers serving patient We proposed to continue our Stage 1 II.B.2.b.i) while the latter is what we
populations where a large percent have and Stage 2 policy that regardless of any called it in our Stage 2 final rule.
cognitive limitations or dementia and actual or perceived gaps between the Proposed Objective: Protect electronic
the role of the caregiver or authorized measure of an objective and full health information created or
representative is critical. Another compliance with the objective, meeting maintained by the CEHRT through the
commenter noted that many patients the criteria of the measure means that implementation of appropriate technical
trust and rely on their representatives to the provider has met the objective in capabilities.
help them navigate the health care Stage 3. Proposed Measure: Conduct or review
system, coordinate their care, and We received no comments specific to a security risk analysis in accordance
comply with treatment plans. Inclusion this proposal and are finalizing as with the requirements in 45 CFR
of patient-authorized representatives proposed. We direct readers to the 164.308(a)(1), including addressing the
recognizes the importance of these individual objectives and measures security (to include encryption) of ePHI
individuals in the care and treatment of outlined in section II.B.2.b of this final created or maintained in CEHRT in
many patients. A number of with comment period rule for further accordance with requirements under 45
commenters also noted that this would discussion of this provision within the CFR 164.312(a)(2)(iv) and 45 CFR
prove a substantial benefit to providers applicable objectives and measures. 164.306(d)(3), and implement security
updates as necessary and correct believe it is of utmost importance for all reporting period is less than one full
identified security deficiencies as part providers to protect ePHI. year. However, the analysis or review
of the EP, eligible hospital, or CAH’s We maintain that a focus on must be conducted within the same
risk management process. protection of electronic personal health calendar year as the EHR reporting
A review must be conducted for each information is necessary for all period, and if the provider attests prior
EHR reporting period and any security providers due to the number of breaches to the end of the calendar year, it must
updates and deficiencies that are reported to HHS involving lost or stolen be conducted prior to the date of
identified should be included in the devices. attestation. An organization may
provider’s risk management process and Comment: A commenter believes that conduct one security risk analysis or
implemented or corrected as dictated by these requirements are actually review which is applicable to all EPs
that process. redundant with existing expectations for within the organization, provided it is
The HHS Office for Civil Rights (OCR) security risk assessment under HIPAA within the same calendar year and prior
has issued guidance on conducting a Security Rule compliance. The current to any EP attestation for that calendar
security risk analysis in accordance HIPAA Security Rule requirement to year. However, each EP is individually
with the Health Insurance Portability conduct or review a security risk responsible for their own attestation and
and Accountability Act of 1996 (HIPAA) assessment is comprehensive and for independently meeting the objective.
Security Rule (http://www.hhs.gov/ocr/ clearly requires providers to comply Therefore, it is incumbent on each
privacy/hipaa/administrative/ with all of its provisions. Thus, it seems individual EP to ensure that any
securityrule/rafinalguidancepdf.pdf). unnecessary and overly burdensome to security risk analysis or review
Other free tools and resources available require attestation under the Medicare conducted for the group is relevant to
to assist providers include a Security and Medicaid EHR Incentive Programs. and fully inclusive of any unique
Response: As we have stated implementation or use of CEHRT
Risk Assessment (SRA) Tool developed
previously, this objective and measure relevant to their individual practice.
by ONC and OCR http://
are only relevant for meaningful use and We intend to update our FAQs to
www.healthit.gov/providers-
this program, and are not intended to reflect policy changes and clarifications
professionals/security-risk-assessment-
supersede what is separately required that flow from this final rule with
tool.
under HIPAA and other rulemaking. We comment period. Prior versions of FAQs
The scope of the security risk analysis do believe it is crucial that all EPs,
for purposes of this meaningful use and those related to past program years
eligible hospitals, and CAHs evaluate will be archived and maintained for
measure applies to ePHI created or the impact CEHRT has on their
maintained in CEHRT. However, we public access on our Web site at
compliance with HIPAA and the www.cms.gov/EHRIncentivePrograms.
noted that other ePHI may be subject to protection of health information in
the HIPAA rules, and we refer providers Comment: A commenter stated that
general. the scope of the risk assessment in the
to those rules for additional security Comment: A commenter requested
requirements. proposed rule appears to be limited to
clarification that only one risk ePHI created or maintained via CEHRT.
Comment: The vast majority of assessment is required by their
commenters expressed support for the The commenter questioned whether this
organization per year. The commenters scope is more limited than in prior
inclusion of this objective. These noted that their organization has
commenters recognized the importance meaningful use requirements.
multiple groups of EPs with multiple Response: The scope of the security
of protecting patient health information 90-day reporting periods in a year. risk analysis for the Medicare and
and agreed that this protection should Several commenters suggested that we Medicaid EHR Incentive Programs
consist of administrative, technical, and incorporate the language from one of relates to ePHI created or maintained
physical safeguards. A commenter our frequently asked questions (FAQs) using CEHRT. We did not propose to
stated that the measure is onerous for into the final rule—that the security risk change the scope of this objective and
small practices because the elements of assessment ‘‘may be completed outside measure from the Stage 2 requirements.
what constitutes a risk analysis are not of the EHR reporting period timeframe Comment: Several commenters
necessarily clear. A commenter but must take place no earlier than the requested a national educational
suggested an exclusion for small start of the EHR reporting year and no campaign sponsored by the federal
practices. later than the provider attestation date.’’ government to help physicians ensure
Another commenter noted that larger Many commenters suggested that we that they are adequately equipped to
healthcare networks have a dedicated IT update our frequently asked questions protect electronic patient information.
staff; small practices do not, making it that relate to security risk assessments. Response: We will continue to work
difficult and costly to meet the Response: As noted in the Stage 3 with OCR and ONC on educational
standards of an annual security risk proposed rule (80 FR 16746) (in which efforts related to protecting electronic
analysis and implementing security we proposed to maintain this Stage 2 health information. We agree that this
changes. objective even into Stage 3 with will require ongoing education and
Response: We appreciate the clarification on the timing for the outreach.
commenters’ support for the continued requirements),the existing policy is that After consideration of public
inclusion of this objective and measure. an analysis or review must be comments received, we are finalizing
We disagree that the elements of what conducted annually for each EHR this objective and measure as proposed
constitutes a security risk analysis are reporting period. We note that the with a minor modification to adopt the
not clear. In the proposed rule, we security risk assessment is not an title ‘‘Protect Patient Health
identified the specific requirements in ‘‘episodic’’ item related only to a Information’’ for EPs, eligible hospitals
the CFR and provided links to free tools snapshot in time, but should cover the and CAHs as follows:
and resources available to assist entirety of the year for which the
providers, including an SRA Tool analysis or review is conducted. Objective 1: Protect Patient Health
developed by ONC and OCR. We Therefore, it is acceptable for the Information
decline to consider exclusions, security risk analysis to be conducted Objective: Protect electronic health
including for small practices, as we outside the EHR reporting period if the information created or maintained by
the CEHRT through the implementation at a relevant point in patient care for the expressed that the use of CDS will have
of appropriate technical capabilities. entire EHR reporting period. Absent a positive impact on the quality, safety,
Measure: Conduct or review a security four clinical quality measures related to and efficiency of care. They also
risk analysis in accordance with the an EP, eligible hospital, or CAH’s scope supported the proposed objective and
requirements in 45 CFR 164.308(a)(1), of practice or patient population, the measures to use CDS to improve
including addressing the security (to clinical decision support interventions performance on high-priority health
include encryption) of ePHI created or must be related to high-priority health conditions.
maintained by CEHRT in accordance conditions. Response: We greatly appreciate and
with requirements under 45 CFR • Measure 2: The EP, eligible hospital thank commenters’ support for this
164.312(a)(2)(iv) and 45 CFR or CAH has enabled and implemented objective.
164.306(d)(3), and implement security the functionality for drug-drug and drug Comment: A few commenters
updates as necessary and correct allergy interaction checks for the entire expressed concern about the work and
identified security deficiencies as part EHR reporting period. strain and the substantial cost involved
of the EP, eligible hospital, or CAH’s For the first measure, we suggested in implementing, training, maintenance,
risk management process. that one of the five clinical decision and updating of the tools to meet the
We are adopting Objective 1: Protect support interventions be related to clinical decision support requirements.
Patient Health Information at improving healthcare efficiency. A commenter expressed concerned
§ 495.22(e)(1)(i) for EPs and Exclusion: For the second measure, that the requirement for every EP to
§ 495.22(e)(1)(ii) for eligible hospitals any EP who writes fewer than 100 have five CDS elements pertaining to his
and CAHs. We further specify that in medication orders during the EHR or her scope of work may be overly
order to meet this objective and reporting period. burdensome for large organizations with
measure, an EP, eligible hospital, or highly specialized EPs where there may
Proposed Alternate Exclusions and be circumstances necessary to build
CAH must use the capabilities and Specifications for Stage 1 Providers for
standards of as defined for as defined CDS tools that would only be useful for
Meaningful Use in 2015 a few individuals.
CEHRT at § 495.4. We direct readers to
section II.B.3 of this final rule with For an EHR reporting period in 2015 Additionally, a commenter stated
comment period for a discussion of the only, we proposed that an EP, eligible there is a struggle to interpret whether
definition of CEHRT and a table hospital or CAH who is scheduled to or not each of our implemented features
referencing the capabilities and participate in Stage 1 in 2015 may meet ONC’s referential link and source
standards that must be used for each satisfy the following Stage 1 measure attribute requirements.
measure. instead of the Stage 2 measure 1 as Response: We recognize commenters’
follows: concerns regarding implementation of
Objective 2: Clinical Decision Support • Proposed Alternate Objective and the necessary tools to meet the CDS
In the EHR Incentive Programs in Measure (For Measure 1): Objective: requirements. The companion ONC
2015 through 2017 proposed rule (80 FR Implement one clinical decision support standards and certification criteria final
20358), we proposed to retain the Stage rule relevant to specialty or high clinical rule for the 2014 Edition certification
2 objective and measures for Clinical priority, or high priority hospital (77 FR 54163 through 54292) as well as
Decision Support (CDS) for meaningful condition, along with the ability to track the 2015 Edition certification criteria in
use in 2015 through 2017 such that CDS compliance with that rule. Measure: the 2015 Edition final rule published
would be used to improve performance Implement one clinical decision support elsewhere in this Federal Register,
on high-priority health conditions. This rule. provide further information regarding
is a consolidated objective, which Comment: Many commenters the standards for CDS within CEHRT.
incorporates the Stage 1 objective to expressed support of the Clinical With each incremental phase of
implement drug-drug and drug-allergy Decision Support Objective in its meaningful use, CDS systems progress
interaction checks. It would be left to entirety. Several noted that the in their level of sophistication and
the provider’s clinical discretion to inclusion of this objective in the EHR ability to support patient care. It is our
select the most appropriate CDS Incentive Program in 2015 through 2017 expectation that, at a minimum,
interventions for his or her patient requirements ensures the continued providers will select CDS interventions
population. implementation of these important to drive improvements in the delivery of
Proposed Objective: Use clinical supports for providers. In addition, care for the high-priority health
decision support to improve commenters agree that it is best for CDS conditions relevant to their patient
performance on high-priority health interventions to be implemented at the population. Continuous quality
conditions. point in patient care that best enhances improvement requires an iterative
We proposed that CDS interventions clinical decision making before taking process in the implementation and
selected should be related to four or an action on behalf of a patient. Some evaluation of selected CDS interventions
more of the CQMs on which providers noted appreciation for the continued that will allow for ongoing learning and
would be expected to report. The goal requirement for drug-drug and drug- development. In this final rule with
of the proposed CDS objective is for allergy interaction checking. They also comment period, we will consider a
providers to implement improvements believe that it is a significant benefit to broad range of CDS interventions that
in clinical performance for high-priority patient care. improve both clinical performance and
health conditions that would result in A commenter was supportive of the the efficient use of healthcare resources,
improved patient outcomes. flexibility provided by CMS and ONC in and as noted in the Stage 2 final rule (77
Proposed Measure: In order for EPs, the use of homegrown alerts and for FR 53995 through 53996), we believe
eligible hospitals, and CAHs to meet the nurturing a supportive environment for sufficient CDS options exist to support
objective they must satisfy both of the those providers developing their own providers’ implementation of five total.
following measures: homegrown alerts and not deterring this Given the wide range of CDS
• Measure 1: Implement five clinical type of innovation with overly onerous interventions currently available and
decision support interventions related measure definitions or certification the continuing development of new
to four or more clinical quality measures requirements. Many commenters technologies, we do not believe that any
EP, eligible hospital, or CAH would be CDS and recommended that we allow up alerts. However, these alerts are not
unable to identify and implement five them to retain the freedom to use the only method of providing CDS. CDS
CDS interventions, as previously whatever forms of CDS make sense for should not be viewed as simply an
described. Therefore, we did not their practice including the timing of interruptive alert, notification, or
establish an exclusion for the first the interventions. A commenter stated explicit care suggestion. Well-designed
measure of this objective based on that tracking compliance puts increased CDS encompasses a variety of workflow
specialty in the Stage 2 final rule and emphasis on pop-up type support over optimized information tools, which can
we did not propose to change that other types where tracking compliance be presented to providers, clinical and
policy. does not necessarily happen easily and support staff, patients, and other
Comment: A commenter suggested we noted that provider responses to some caregivers at various points in time. We
eliminate the drug-drug and drug- types of CDS (like creating order sets for believe that the examples outlined in
allergy interaction checks as a topped different conditions and providing the Stage 3 proposed rule and further
out measure. health maintenance suggestions) are not discussed in the Stage 3 objective in
Other commenters requested the easily tracked, and not within their section II.B.2.b.iii of this final rule with
removal of the language requiring certified system. comment period are applicable for CDS
participants to have CDS enabled for Some commenters requested that CDS in general and would apply for the EHR
‘‘the entire reporting period,’’ as it is should be enabled to address conditions Incentive Programs in 2015 through
challenging for participants to meet. A relevant to the EP’s scope of practice. 2017. We refer readers to the CDS
commenter suggested that we change Others stated that children’s hospitals or objective description in the Stage 3
the requirement to provide that CDS be specialty providers should have the proposed rule for further information
enabled within the first 45 days of the same level of choice that is available to (80 FR 16749 through 16750).
reporting period and remain enabled adult hospitals and general After consideration of the public
throughout the reporting period. practitioners, while others requested the comments received, we are finalizing
Another commenter believes that the removal of the link to CQMs completed. the objective, measures, exclusions, and
level of interaction checks should be Still others requested that the five CDS alternate objective and measure as
determined by the organizational interventions be related either to CQMs proposed for EPs, eligible hospitals, and
directives, as well as the discretion of or to other metrics included in a CAHs as follows:
the clinical team. nationally recognized quality
Response: We noted our belief that improvement registry or a qualified Objective 2: Clinical Decision Support
automated drug-drug and drug-allergy clinical database registry. Objective: Use clinical decision
checks provide important information to One commenter on the EHR Incentive support to improve performance on
advise the provider’s decisions in Programs for 2015 through 2017 high-priority health conditions.
prescribing drugs to a patient. Because proposed rule specifically requested Measure 1: Implement five clinical
this functionality provides important clarification whether an example used decision support interventions related
CDS that focuses on patient health and in the Stage 3 proposed rule (for to four or more clinical quality measures
safety, we proposed to continue to example, the appropriate use criteria for at a relevant point in patient care for the
include the use of this functionality imaging services example at 80 FR entire EHR reporting period. Absent
within CEHRT as part of the objective 16750) could also be used to satisfy the four clinical quality measures related to
for using CDS and maintain our belief CDS objective for the EHR Incentive an EP, eligible hospital, or CAH’s scope
that this function should be enabled, as Programs in 2015 through 2017. of practice or patient population, the
previously finalized, for the duration of Response: We appreciate the clinical decision support interventions
the EHR reporting period. We note that comments and note that in Stage 1, we must be related to high-priority health
the provider has discretion to allowed providers significant leeway in conditions.
implement the CDS for drug-drug and determining the CDS interventions most Measure 2: The EP, eligible hospital
drug-allergy checks in a manner that is relevant to their scope of practice. In or CAH has enabled and implemented
most appropriate for their organization Stage 2 and later, we are continuing to the functionality for drug-drug and drug
and clinical needs. provide the flexibility for providers to allergy interaction checks for the entire
Comment: A commenter requested identify high-priority health conditions EHR reporting period.
clarification on the exclusion and for that are most appropriate for CDS. We Exclusions: For the second measure,
similar exclusions that include the expect that providers will implement any EP who writes fewer than 100
language ‘‘fewer than 100 (medication many CDS interventions, and providers medication orders during the EHR
orders, office visits, etc.).’’ Commenters are free to choose interventions in any reporting period.
requested further clarification that the domain that is a priority to the EP, Alternate Objective and Measure: For
100 would be over the course of the full eligible hospital, or CAH. an EHR reporting period in 2015 only,
year and requested confirmation that We also agree with the commenter an EP, eligible hospital or CAH who is
providers using a shorter reporting that providers should be allowed the scheduled to participate in Stage 1 in
period should pro-rate this total for that flexibility to determine the most 2015 may satisfy the following in place
reporting period. appropriate CDS intervention and of Measure 1:
Response: The policy is fewer than timing of the CDS. The CDS measure for • Objective: Implement one clinical
100 during the EHR reporting period EPs, eligible hospitals, and CAHs allows decision support rule relevant to
and this language is used consistently in this flexibility by allowing the specialty or high clinical priority, or
both Stage 1 and Stage 2 objectives and implementation at a relevant point in high priority hospital condition, along
measures that include a similar patient care that refers to a relevant with the ability to track compliance
exclusion. There is no distinction based point in clinical workflows when the with that rule.
on the length of the EHR reporting intervention can influence clinical • Measure: Implement one clinical
period and no option to pro-rate. decision making before diagnostic or decision support rule.
Comment: Commenters additionally treatment action is taken in response to We are adopting Objective 2: Clinical
expressed concern about the the intervention. Further, many Decision Support at § 495.22(e)(2)(i) for
requirement to track compliance with providers may associate CDS with pop- EPs and § 495.22(e)(2)(ii) for eligible
hospitals and CAHs. We further specify recorded using computerized provider Threshold: The resulting percentage
that in order to meet this objective and order entry. must be more than 30 percent in order
measures, an EP, eligible hospital, or • Measure 3: More than 30 percent of for an EP, eligible hospital or CAH to
CAH must use the capabilities and radiology orders created by the EP or by meet this measure.
standards of as defined for as defined authorized providers of the eligible Exclusion: Any EP who writes fewer
CEHRT at § 495.4. We direct readers to hospital’s or CAH’s inpatient or than 100 radiology orders during the
section II.B.3 of this final rule with emergency department (POS 21 or 23) EHR reporting period.
comment period for a discussion of the during the EHR reporting period are An EP, through a combination of
definition of CEHRT and a table recorded using computerized provider meeting the thresholds and exclusions
referencing the capabilities and order entry. (or both), must satisfy all three measures
standards that must be used for each We proposed to retain the three for this objective. A hospital must meet
measure. distinct measures of the Stage 2 the thresholds for all three measures.
objective to calculate a separate
Objective 3: Computerized Provider percentage threshold for all three types Proposed Alternate Exclusions and
Order Entry of orders: Medication, laboratory, and Specifications for Stage 1 Providers for
In the EHR Incentive Programs in radiology. We proposed to retain Meaningful Use in 2015
2015 through 2017 proposed rule (80 FR exclusionary criteria for those providers We proposed alternate exclusions and
20359),we proposed to retain the Stage who so infrequently issue an order type alternate specifications for this objective
2 objective and measures for CPOE for that it is not practical to implement and measures for Stage 1 providers in
meaningful use in 2015 through 2017, CPOE for that order type. To calculate 2015.
with modifications proposed for the percentage, CMS and ONC have Proposed Alternate Measure 1: More
alternate exclusions and specifications worked together to define the following than 30 percent of all unique patients
for Stage 1 providers for an EHR for this objective: with at least one medication in their
reporting period in 2015. • Proposed Measure 1: Medication medication list seen by the EP or
Proposed Objective: Use Orders admitted to the eligible hospital’s or
computerized provider order entry for Denominator: Number of medication CAH’s inpatient or emergency
medication, laboratory, and radiology orders created by the EP or authorized department (POS 21 or 23) during the
orders directly entered by any licensed providers in the eligible hospital’s or EHR reporting period have at least one
healthcare professional that can enter CAH’s inpatient or emergency medication order entered using CPOE;
orders into the medical record per state, department (POS 21 or 23) during the or more than 30 percent of medication
local, and professional guidelines. EHR reporting period. orders created by the EP during the EHR
We define CPOE as entailing the Numerator: The number of orders in reporting period, or created by the
provider’s use of computer assistance to the denominator recorded using CPOE. authorized providers of the eligible
directly enter medical orders (for Threshold: The resulting percentage hospital or CAH for patients admitted to
example, medications, consultations must be more than 60 percent in order their inpatient or emergency
with other providers, laboratory for an EP, eligible hospital or CAH to departments (POS 21 or 23) during the
services, imaging studies, and other meet this measure. EHR reporting period, are recorded
auxiliary services) from a computer or Exclusion: Any EP who writes fewer using computerized provider order
mobile device. The order is then than 100 medication orders during the entry.
documented or captured in a digital, EHR reporting period. Proposed Alternate Exclusion for
structured, and computable format for Measure 2: Provider may claim an
• Proposed Measure 2: Laboratory
use in improving the safety and exclusion for measure 2 (laboratory
Orders
efficiency of the ordering process. CPOE orders) of the Stage 2 CPOE objective for
improves quality and safety by allowing Denominator: Number of laboratory an EHR reporting period in 2015.
clinical decision support at the point of orders created by the EP or authorized Proposed Alternate Exclusion for
the order, and therefore, influences the providers in the eligible hospital’s or Measure 3: Provider may claim an
initial order decision. CPOE improves CAH’s inpatient or emergency exclusion for measure 3 (radiology
safety and efficiency by automating department (POS 21 or 23) during the orders) of the Stage 2 CPOE objective for
aspects of the ordering process to reduce EHR reporting period. an EHR reporting period in 2015.
the possibility of communication and Numerator: The number of orders in
Comment: A number of commenters
other errors. the denominator recorded using CPOE.
supported the inclusion of the objective
Threshold: The resulting percentage
Proposed Measures: In Stage 2 of into the proposed rule; some supported
must be more than 30 percent in order
meaningful use, we adopted three the thresholds and agreed with the
for an EP, eligible hospital or CAH to
measures for this objective: alternative specifications and
meet this measure.
• Measure 1: More than 60 percent of Exclusion: Any EP who writes fewer exclusions. A few commenters stated
medication orders created by the EP or than 100 laboratory orders during the the thresholds for all three measures are
by authorized providers of the eligible EHR reporting period. realistically achievable if scribes and
hospital’s or CAH’s inpatient or clinical staff with proper orders are
emergency department (POS 21 or 23) • Proposed Measure 3: Radiology allowed to perform CPOE. A few
during the EHR reporting period are Orders commenters appreciated the
recorded using computerized provider Denominator: Number of radiology clarification around who may enter
order entry. orders created by the EP or authorized orders using CPOE for purposes of this
• Measure 2: More than 30 percent of providers in the eligible hospital’s or objective. Another commenter believed
laboratory orders created by the EP or by CAH’s inpatient or emergency that the use of CPOE in conjunction
authorized providers of the eligible department (POS 21 or 23) during the with the Clinical Decision Support for
hospital’s or CAH’s inpatient or EHR reporting period. interaction checking greatly benefits
emergency department (POS 21 or 23) Numerator: The number of orders in patient safety initiatives and reduces
during the EHR reporting period are the denominator recorded using CPOE. medication errors.
Response: We appreciate the many interns, and certified medical assistants They stated that many specialists
comments of overall support for the in the numerator of the measure. practice in private office settings and
CPOE objective, thresholds and A commenter requested clarification many do not share the same EHR system
alternate specifications and exclusions. as to whether CEHRT entries completed as hospitals, laboratories, and imaging
We believe our explanation in the by scribes are eligible for CPOE. facilities.
proposed rule at 80 FR 20359 of which Another commenter inquired as to Response: We respectfully disagree
staff may enter orders using CPOE for whether orders entered by non- with the commenter’s feedback. As
purposes of this objective will alleviate physician staff through the means of noted in the proposed rule, we believe
some of the burden associated with standing orders are eligible as CPOE. A CPOE improves quality and safety. For
providers’ confusion. This explanation commenter requested clarification on example, a CPOE for medications may
was in response to feedback from whether phone orders from physicians trigger a clinical decision support
stakeholders requesting further can be considered CPOE if they are checking for potential medication
information. entered at the time of the call by a allergies or drug interactions at the
Comment: A commenter opposed the licensed healthcare professional that is point of the order and therefore,
objective indicating although there are authorized to enter orders based on the influences the appropriateness of initial
exclusions for providers who write less state regulations. order decision. In addition, we maintain
than 100 orders per EHR reporting Response: In the Stage 2 final rule (77 our position that CPOE improves safety
period for any of the measures, it still FR 53986) and in subsequent guidance and efficiency by automating aspects of
may be a high bar for providers new to in FAQ 9058,6 we explained for Stage 2 the ordering process to reduce the
the program or who have just completed that a licensed health care provider or possibility of communication and other
their first year. Other commenters a medical staff person who is a errors. However, we note that the
believe that Stage 1 participants would credentialed medical assistant or is inclusion of the order into the patient’s
have difficulty meeting the objective. credentialed to and performs the duties electronic record allows for the
Another commenter requested lower equivalent to a credentialed medical exchange of that information
thresholds related to CEHRT issues. assistant may enter orders. We maintain electronically, while paper-based order
Response: Under our proposals for our position that medical staff must entry systems do not.
2015, new participants in the program have at least a certain level of medical Comment: A commenter requested
or those scheduled to demonstrate Stage training in order to execute the related clarification on the definition of
1 in 2015 may attest to an alternate CDS for a CPOE order entry. We defer ‘‘exclusionary criteria.’’
measure 1, which is the equivalent of to the provider to determine the proper Response: Exclusionary criteria are
the current Stage 1 measure. credentialing, training, and duties of the merely the exclusions listed for each of
Additionally, we proposed alternate medical staff entering the orders as long the measures. We specifically stated that
exclusions for these providers for the as they fit within the guidelines we have we proposed to retain exclusionary
measures for laboratory and radiology proscribed. We believe that interns who criteria for those providers who so
orders (measures 2 and 3) under CPOE. have completed their medical training infrequently issue an order type that it
We believe the alternate specifications and are working toward appropriate is not practical to implement CPOE for
and exclusions provide ample flexibility licensure would fit within this that order type.
for meeting the requirements in 2015. Comment: A commenter requested a
definition. We maintain our position
Comment: A few commenters stated combined measure for CPOE rather than
that, in general, scribes are not included
that the definition of credentialed user the requirement that the measures be
as medical staff that may enter orders
is difficult to isolate and varies from broken down by lab, meds, and imaging
for purposes of the CPOE objective.
state to state. Another commenter stated and stated that a 60 percent overall
However, we note that this policy is not
the physician using an EHR should be threshold for all orders, regardless of
specific to a job title but to the
able to dictate who enters orders on type, would be less burdensome to
appropriate medical training,
their behalf. report.
knowledge, and experience. Response: We respectfully disagree.
Other commenters stated they Further, we note that we did not
disagreed with the requirement that As stated in the Stage 2 final rule (77 FR
propose to change our prior policy on
only credentialed staff may enter orders 53987), we believe providers implement
allowing providers to exclude standing
for CPOE, as not all medical assistants CPOE for packages of order types which
orders as finalized in the Stage 2 final
are required to be credentialed to are handled similarly and so we do not
rule at 77 FR 53986.
practice. They further suggested that if Finally, we believe that a believe it is appropriate to measure
a standard for medical assistant CPOE is circumstance involving tele-health or CPOE universally for all order types in
required, then the standard should be remote communication may be included one process. We also expressed
that the medical assistant must be in the numerator as long as the order concerns in the Stage 2 proposed rule
appropriately trained for CEHRT use entry otherwise meets the requirements about the possibility that an EP, eligible
(including CPOE) by the employer or of the objective and measures. hospital, or CAH could create a test
CEHRT vendor in order to be counted. Comment: A commenter stated that environment to issue the one order and
Other commenters recommended that CPOE does not help ensure patient not roll out the capability widely or at
we allow medical assistants who were safety or encourage continuity of care, all. For these reasons, we finalized
hired and handling the paper-based which is the premise of the program. percentage thresholds for all three types
equivalent of CPOE prior to the Stage 2 They stated ‘‘reputable labs’’ are not of order medications, laboratory, and
final rules (September 2012), and still equipped to accept online orders. The radiology, rather than one consolidated
with the same employing organization commenter also indicated that measure.
(as of September 2012), to be referred to Comment: A commenter
interoperability issues are also a
as ‘‘Veteran Medical Assistants’’ and be recommended that we clarify in the
concern with meeting this measure.
permitted to enter CPOE. preamble of the final rule that EPs can
Another commenter proposed that the 6 CMS.gov Frequently Asked Questions #9058 exclude ‘‘protocol’’ or ‘‘standing orders’’
rule be revised to allow orders placed by [EHR Incentive Programs] https:// from the denominators of the measures
licensed healthcare providers, medical questions.cms.gov/faq.php?id=5005&faqId=9058. under the CPOE objective, as this
explanation was provided in the of the order into the patient’s EHR that After consideration of public
preamble of the proposed rule for Stage uses a specific function of CEHRT. comments received, we are finalizing
3, but not in the 2015 through 2017 CPOE does not otherwise specify how the alternate exclusions and
proposed rule. the order is filled or otherwise carried specifications with the following
Response: We did not propose out. Therefore, whether the ordering of modifications based on the final policy
changes to our policy on ‘‘protocol’’ or laboratory or radiology services using we adopted in section II.B.1.b.(4)(b)(iii)
‘‘standing orders’’ from Stage 2. We CPOE in fact results in the order being of this final rule with comment period.
reiterate from the Stage 2 final rule that transmitted electronically to the We note that providers who would
we agree that this category of orders laboratory or radiology center otherwise have been scheduled for Stage
warrant different considerations than conducting the test does not affect a 1 in 2016 may be required to implement
orders that are due to a specific clinical provider’s performance on the CPOE technology functions for certain Stage 2
determination by the ordering provider measures. CPOE is a step in a process measures if they do not already have
for a specific patient. Therefore, we that takes place in both hospital and these functions in place because there is
allow providers to exclude orders that ambulatory settings, and we continue to no Stage 1 equivalent to the Stage 2
are predetermined for a given set of believe it is relevant to both settings. measure. In certain cases, the improper
patient characteristics or for a given Additionally, we note that when we implementation of these functions could
procedure from the calculation of CPOE analyzed attestation data from 2011 represent a patient safety issue and
numerators and denominators. Note this through 2013, provider performance on therefore we are finalizing an alternate
does not require providers to exclude the CPOE measures is high, but high exclusion in 2016 in order to allow
this category of orders from their performance is not the only sufficient time for implementation in
numerator and denominator (77 FR consideration in determining whether to these circumstances. The Stage 2 CPOE
53986). retain an objective or measure in the objective measure for lab orders and the
Comment: A commenter requested program. We also review provider measure for radiology orders both
clarification defining what constitutes performance across varying levels of require functions that a provider who
an ‘‘order’’ (for example, whether an participation, the variance between was expecting to be in Stage 1 in 2016
order is equivalent to a single provider types at different quartiles, may not be able to safely implement in
transaction or if each order code in the stakeholder feedback on the potential time for an EHR reporting period in
single transaction represents an value add of the objective and measure, 2016. Therefore a provider may elect to
individual) order. The commenter also and other similar considerations. Based exclude from these two measures for an
inquired whether a laboratory panel/ on these factors, we believe the CPOE EHR reporting period in 2016 if they
profile test is counted as one order. objective should be maintained in the were previously scheduled to be in
Response: Each order that is program as it promotes patient safety Stage 1 in 2016.
associated with a specific code would and clinical efficiency. In addition, we
count as one order. Multiple tests believe there is room for significant We are finalizing the objective,
ordered at the same time count improvement on measure performance. measures, exclusions and alternate
individually if they fall under a Comment: A commenter suggested specifications and exclusions for EPs,
different order code. For example, a replacing ‘‘radiology orders’’ with eligible hospitals, and CAHs as follows:
laboratory panel, which consists of one ‘‘imaging orders’’ to better align with the Objective 3: Computerized Provider
order code but multiple tests, would Stage 3 objective. Order Entry
only count as one order for the purposes Response: We appreciate the feedback
of CPOE. If those tests were ordered and suggestion. In the proposed rule, we Objective: Use computerized provider
individually with each having its own sought to make changes to the order entry for medication, laboratory,
order code, each test would count as an requirements for Stage 1 and Stage 2 of and radiology orders directly entered by
order. meaningful use for 2015 through 2017 to any licensed healthcare professional
Comment: Several commenters align with the approach for Stage 3. that can enter orders into the medical
requested that for CPOE measure 2 lab However, as stated in the proposed rule, record per state, local, and professional
orders, we modify the exclusion criteria we also sought to avoid proposing new guidelines.
to include circumstances where there requirements that would require Measure 1: More than 60 percent of
are no receiving centers for electronic changes to the existing technology medication orders created by the EP or
radiology orders or lab orders in case certified to the 2014 Edition by authorized providers of the eligible
there are no local or regional imaging certification criteria, and therefore, hospital’s or CAH’s inpatient or
centers that are set up to receive or retained the three measures of the emergency department (POS 21 or 23)
transmit CPOE. Another commenter current Stage 2 objective (medication, during the EHR reporting period are
believed there should be an additional laboratory, and radiology) as finalized in recorded using computerized provider
exclusion for measure 2 to address Stage 2 (77 FR 53987) order entry.
instances in which the lab does not Comment: A commenter specifically
• Denominator: Number of
want to connect electronically due to requested an exclusion for providers
medication orders created by the EP or
the low number of lab orders submitted who are using a 90-day reporting period
authorized providers in the eligible
by the physician. One commenter stated of less than 25 medication orders for the
hospital’s or CAH’s inpatient or
CPOE measures are not relevant or 90-day reporting period.
Response: We decline to change the emergency department (POS 21 or 23)
valuable for physician office or during the EHR reporting period.
outpatient settings and should be exclusion criteria. The policy is fewer

limited only to inpatient settings such than 100 orders during the EHR • Numerator: The number of orders
as hospitals. reporting period and this language is in the denominator recorded using
Some commenters stated that the used consistently in both Stage 1 and CPOE.
CPOE objective should be considered Stage 2 objectives and measures that • Threshold: The resulting percentage
topped out. include a similar exclusion. There is not must be more than 60 percent in order
Response: We respectfully disagree a distinction based on the length of the for an EP, eligible hospital or CAH to
with the commenters. CPOE is the entry EHR reporting period. meet this measure.
• Exclusion: Any EP who writes EHR reporting period, are recorded the form of adverse interactions and
fewer than 100 medication orders using computerized provider order other treatment possibilities; efficiency
during the EHR reporting period. entry. of the health care system by alerting the
Measure 2: More than 30 percent of Alternate Exclusion for Measure 2: EP to generic alternatives or to
laboratory orders created by the EP or by Providers scheduled to be in Stage 1 in alternatives favored by the patient’s
authorized providers of the eligible 2015 may claim an exclusion for insurance plan that are equally effective;
hospital’s or CAH’s inpatient or measure 2 (laboratory orders) of the reduction of communication errors; and
emergency department (POS 21 or 23) Stage 2 CPOE objective for an EHR automatic comparisons of the
during the EHR reporting period are reporting period in 2015; and, providers medication order to others the
recorded using computerized provider scheduled to be in Stage 1 in 2016 may pharmacy or third parties have received
order entry. claim an exclusion for measure 2 for the patient. We proposed to maintain
• Denominator: Number of laboratory (laboratory orders) of the Stage 2 CPOE these policies in the EHR Incentive
orders created by the EP or authorized objective for an EHR reporting period in Programs in 2015 through 2017
providers in the eligible hospital’s or 2016. proposed rule (80 FR 20361).
CAH’s inpatient or emergency Alternate Exclusion for Measure 3: Proposed EP Measure: More than 50
department (POS 21 or 23) during the Providers scheduled to be in Stage 1 in percent of all permissible prescriptions,
EHR reporting period. 2015may claim an exclusion for or all prescriptions, written by the EP
• Numerator: The number of orders measure 3 (radiology orders) of the are queried for a drug formulary and
in the denominator recorded using Stage 2 CPOE objective for an EHR transmitted electronically using CEHRT.
CPOE. reporting period in 2015; and, providers We proposed to retain the exclusion
• Threshold: The resulting percentage scheduled to be in Stage 1 in 2016 may introduced for Stage 2 that would allow
must be more than 30 percent in order claim an exclusion for measure 3 EPs to exclude this objective if no
for an EP, eligible hospital or CAH to (radiology orders) of the Stage 2 CPOE pharmacies within 10 miles of an EP’s
meet this measure. objective for an EHR reporting period in practice location at the start of his/her
• Exclusion: Any EP who writes 2016. EHR reporting period accept electronic
fewer than 100 laboratory orders during We are adopting the Objective 3: prescriptions.
the EHR reporting period. Computerized Provider Order Entry at We also proposed to retain the
Measure 3: More than 30 percent of § 495.22(e)(3)(i) for EPs and exclusion for EPs who write fewer than
radiology orders created by the EP or by § 495.22(e)(3)(ii) for eligible hospitals 100 permissible prescriptions during the
authorized providers of the eligible and CAHs. We further specify that in EHR reporting period.
hospital’s or CAH’s inpatient or order to meet this objective and To calculate the percentage, CMS and
emergency department (POS 21 or 23) measures, an EP, eligible hospital, or ONC have worked together to define the
during the EHR reporting period are CAH must use the capabilities and following for this objective:
recorded using computerized provider standards of as defined for as defined Denominator: Number of
order entry. CEHRT at § 495.4. We direct readers to prescriptions written for drugs requiring
• Denominator: Number of radiology section II.B.3 of this final rule with a prescription in order to be dispensed
orders created by the EP or authorized comment period for a discussion of the other than controlled substances during
providers in the eligible hospital’s or definition of CEHRT and a table the EHR reporting period; or Number of
CAH’s inpatient or emergency referencing the capabilities and prescriptions written for drugs requiring
department (POS 21 or 23) during the standards that must be used for each a prescription in order to be dispensed
EHR reporting period. measure. during the EHR reporting period.
• Numerator: The number of orders Numerator: The number of
in the denominator recorded using Objective 4: Electronic Prescribing
prescriptions in the denominator
CPOE. In the EHR Incentive Programs in generated, queried for a drug formulary,
• Threshold: The resulting percentage 2015 through 2017 proposed rule (80 FR and transmitted electronically using
must be more than 30 percent in order 20360),we proposed to retain the Stage CEHRT.
for an EP, eligible hospital or CAH to 2 objective and measure for Electronic Threshold: The resulting percentage
meet this measure. Prescribing (eRx) for EPs, as well as for must be more than 50 percent in order
• Exclusion: Any EP who writes eligible hospitals and CAHs, for for an EP to meet this measure.
fewer than 100 radiology orders during meaningful use in 2015 through 2017. Exclusions: Any EP who:
the EHR reporting period. We note that the Stage 2 objective for • Writes fewer than 100 permissible
eligible hospitals and CAHs is currently prescriptions during the EHR reporting
Alternate Exclusions and Specifications
a menu objective, but we proposed the period; or
• Alternate Measure 1: For Stage 1 objective would be required for 2015 • Does not have a pharmacy within
providers in 2015, more than 30 percent through 2017, with an exception for his or her organization and there are no
of all unique patients with at least one Stage 1 eligible hospitals and CAHs for pharmacies that accept electronic
medication in their medication list seen an EHR reporting period in 2015. prescriptions within 10 miles of the EP’s
by the EP or admitted to the eligible (A) Proposed EP Objective: Generate practice location at the start of his or her
hospital’s or CAH’s inpatient or and transmit permissible prescriptions EHR reporting period.
emergency department (POS 21 or 23) electronically (eRx).
during the EHR reporting period have at As noted in the Stage 2 final rule at Proposed Alternate Exclusions and
Specifications for Stage 1 Providers for
least one medication order entered 77 FR 54035, the use of electronic

using CPOE; or more than 30 percent of prescribing has several advantages over Meaningful Use in 2015
medication orders created by the EP having the patient carry the prescription We proposed that for an EHR
during the EHR reporting period, or or the provider directly faxing reporting period in 2015, EPs scheduled
created by the authorized providers of handwritten or typewritten to demonstrate Stage 1 of meaningful
the eligible hospital or CAH for patients prescriptions to the pharmacy. These use may attest to the specifications and
admitted to their inpatient or emergency advantages include: Providing decision threshold associated with the Stage 1
departments (POS 21 or 23) during the support to promote safety and quality in measure. We note that for an EHR
reporting period beginning in 2016, all long as the inclusion of these processing in order to comply with the
EPs must meet the specifications and prescriptions are permissible under in requirement that each prescription must
threshold for the retained Stage 2 accordance with state law. complete a query in order to count in
measure in order to successfully Response: We appreciate the feedback the numerator. Some providers noted a
demonstrate meaningful use. on the inclusion of controlled gap in the CEHRT function for this
Proposed Alternate EP Measure: More substances and agree that at present this measure.
than 40 percent of all permissible should remain an option for providers,
prescriptions written by the EP are but not be required. As the commenters Response: If no formulary is available
transmitted electronically using CEHRT. note, many states have varying policies for a prescription, the provider may still
We proposed no alternate exclusions regarding controlled substances and count the patient in the numerator for
for this EP objective. may address different schedules, the measure. However, we understand
Comment: We received a number of dosages, or types of prescriptions that the formulary query may prove
comments in support of this objective differently. Given these developments burdensome in some instances,
including commenters who stated that with states easing some of the prior especially when it requires additional
clinicians support electronic prescribing restrictions on electronically prescribing action beyond the automated function
if it is efficient and does not interfere controlled substances, we believe it is in CEHRT. We believe that the query of
with workflows. Of those who no longer necessary to categorically a formulary can provide a benefit, and
supported the objective, most believe exclude controlled substances from the our long-term vision is the progress
that electronic prescribing has clear term ‘‘permissible prescriptions.’’ toward fully automated queries using
patient and provider benefits, Therefore the continued inclusion of the universal standards in real time. In
specifically with helping to reduce term ‘‘controlled substances’’ in the order to balance the potential benefit of
prescription errors. Some commenters denominator may no longer be an this function with the current burden on
also supported the proposal to continue accurate description to allow for providers, we provide the following
to exclude over-the-counter medications providers seeking to include these guidance on how providers may count
from the definition of prescription for prescriptions in the circumstances the query of a formulary. Providers may
the purposes of the electronic where they may be included. We will count a patient in the numerator where
prescribing objective. Commenters define a permissible prescription as all no formulary exists to conduct a query,
specifically stated support, noting that drugs meeting our current Stage 2 providers may also limit their effort to
the use of electronic prescribing will definition of a prescription (77 FR query a formulary to simply using the
reduce the number of prescription drug 53989) with a modification to allow the function available to them in their
related adverse events, deter the inclusion of controlled substances CEHRT with no further action required.
creation of fraudulent prescriptions, and where feasible and allowed by law as This means that if a query using the
decrease the opportunity for proposed in Stage 3 (80 FR 16747) in the function of their CEHRT is not possible
prescription drug misuse and abuse. denominator of the measure. We will no or shows no result, a provider is not
Finally, a commenter noted that the longer distinguishing between required to conduct any further manual
inclusion of the drug formulary query prescriptions for controlled substances or paper-based action in order to
will support CMS’ efforts to reduce the and all other prescriptions, and instead
financial burden to the patient. complete the query, and the provider
will refer only to permissible may count the prescription in the
Response: We thank the commenters prescriptions (consistent with the
for their insight and support of this numerator.
definition for Stage 3 at Section
objective. II.B.2.b.ii). Therefore, we are changing After consideration of the public
Comment: One topic of concern the measure for this objective to remove comments received, we are finalizing
expressed by commenters was how the term controlled substances from the changes to the language to continue to
controlled substances would be denominator and instead changing the allow providers the option to include or
addressed in this final rule with denominator to read ‘‘permissible exclude controlled substances in the
comment period given that there are prescriptions’’. We note this is only a denominator where such medications
certain state restrictions on how change in wording and does not change can be electronically prescribed. We are
providers can prescribe controlled the substance of our current policy for finalizing that these prescriptions may
substances. Commenters stated that in Stage 2—which providers have the be included in the definition of
the past, previous mandates stated that option, but are not required, to include ‘‘permissible prescriptions’’ at the
prescriptions for controlled substances prescriptions for controlled substances providers discretion where allowable by
were required have to be written, not in the measure—which we will law. We are modifying the measure
electronically prescribed. Many maintain for 2015 through 2017. For the language to maintain ‘‘permissible
commenters indicated they believe the purposes of this objective, we are prescriptions’’ and remove the ‘‘or all
inclusion of controlled substances adopting that prescriptions for prescriptions’’ language and changing
should remain optional and depend on controlled substances may be included the denominator to read ‘‘Number of
whether or not the state allows the in the definition of permissible permissible prescriptions written for
electronic prescription submission of prescriptions where the electronic drugs requiring a prescription in order
these types of drugs. However, other prescription of a specific medication or to be dispensed during the EHR
commenters noted that many states now schedule of medications is permissible reporting period’’ in accordance with
allow controlled substances to be under state and federal law. this change. We are finalizing the
electronically prescribed either for all Comment: A number of providers

prescriptions or for certain alternate specifications for providers
commented on the inclusion of the
circumstances and types of drugs. These query for the drug formulary, noting that scheduled to demonstrate Stage 1 of
commenters noted that controlled this process takes time, interrupts meaningful for an EHR reporting period
substances should be included where provider workflows, is burdensome for in 2015 as proposed.
feasible, as the inclusion would reduce providers to conduct for patients who We are finalizing the objective,
the paper-based prescription process are uninsured, and often requires measure, exclusions and alternate
often used for such prescriptions, as additional paperwork or manual specifications for EPs as follows:
Objective 4: Electronic Prescribing alerting the EP to generic alternatives or reporting period in 2015 that were not
EP Objective: Generate and transmit to alternatives favored by the patient’s intending to attest to the eRx menu
permissible prescriptions electronically insurance plan that are equally effective; objective and measure may also claim
(eRx). and reducing communication errors by an exclusion.
allows the pharmacy or a third party to Proposed Alternate Eligible Hospital/
Measure: More than 50 percent of
automatically compare the medication CAH Exclusion: Provider may claim an
permissible prescriptions written by the
order to others they have received for exclusion for the eRx objective and
EP are queried for a drug formulary and
the patient. This allows for many of the measure for an EHR reporting period in
transmitted electronically using CEHRT.
same decision support functions 2015 if they were either scheduled to
• Denominator: Number of
enabled at the generation of the demonstrate Stage 1, which does not
permissible prescriptions written during
prescription, but with access to have an equivalent measure, or if they
the EHR reporting period for drugs
potentially greater information. For this are scheduled to demonstrate Stage 2
requiring a prescription in order to be
reason, we continue to support the use but did not intend to select the Stage 2
dispensed. eRx menu objective for an EHR
• Numerator: The number of of electronic prescribing for discharge
prescriptions in a hospital setting (80 FR reporting period in 2015.
prescriptions in the denominator We proposed no alternate
generated, queried for a drug formulary, 20361).
Proposed Eligible Hospital/CAH specifications for this eligible hospital
and transmitted electronically using and CAH objective.
CEHRT. Measure: More than 10 percent of
hospital discharge medication orders for Comment: Commenters were divided
• Threshold: The resulting percentage in terms of opposition to or support of
must be more than 50 percent in order permissible prescriptions (for new,
changed, and refilled prescriptions) are the proposed objective for eligible
for an EP to meet this measure. hospitals and CAHs. Those in support
• Exclusions: Any EP who: queried for a drug formulary and
transmitted electronically using CEHRT. expressed agreement with the concept
Æ Writes fewer than 100 permissible of the requirement that discharge
We proposed to retain the exclusion
prescriptions during the EHR reporting prescriptions be transmitted
that would allow a hospital to exclude
period; or electronically, citing improvements in
Æ Does not have a pharmacy within this objective if there is no internal
pharmacy that can accept electronic patient safety and reducing medication
his or her organization and there are no errors. Those in opposition
pharmacies that accept electronic prescriptions and is not located within
10 miles of any pharmacy that accepts predominantly cited concern over their
prescriptions within 10 miles of the EP’s ability to adopt the necessary
practice location at the start of his or her electronic prescriptions at the start of
their EHR reporting period. technology by 2016.
EHR reporting period A commenter noted that electronic
To calculate the percentage, CMS and
Alternate Specifications: Alternate EP prescribing would cause medication
ONC have worked together to define the
Measure: For Stage 1 providers in 2015, errors because the hospital often makes
following for this objective:
more than 40 percent of all permissible Denominator: Number of new, numerous changes to a patient’s
prescriptions written by the EP are changed, or refill prescriptions written prescription at the time of discharge,
transmitted electronically using CEHRT. for drugs requiring a prescription in and incorrect prescriptions (with the
We are adopting Objective 4: order to be dispensed other than wrong medication or dosage) written on
Electronic Prescribing at § 495.22(e)(4)(i) controlled substances for patients paper can simply be torn up rather than
for EPs. We further specify that in order discharged during the EHR reporting requiring a new prescription to be sent
to meet this objective and measure, an period. and causing confusion for the patient.
EPm must use the capabilities and Numerator: The number of Other commenters also stated similar
standards of as defined for as defined prescriptions in the denominator scenarios related to current workflows,
CEHRT at § 495.4. We direct readers to generated, queried for a drug formulary, which would need to be changed in
section II.B.3 of this final rule with and transmitted electronically. order to comply with electronic
comment period for a discussion of the Threshold: The resulting percentage prescribing requirements.
definition of CEHRT and a table must be more than 10 percent in order Response: We thank the commenters
referencing the capabilities and for an eligible hospital or CAH to meet for their input and consideration of this
standards that must be used for each this measure. proposal. We agree that the successful
measure. Exclusion: Any eligible hospital or implementation of electronic
(B) Proposed Eligible Hospital/CAH CAH that does not have an internal prescribing for eligible hospitals and
Objective: Generate and transmit pharmacy that can accept electronic CAHs would require changes to
permissible discharge prescriptions prescriptions and is not located within technology implementation and
electronically (eRx). 10 miles of any pharmacy that accepts workflows. However, we believe the
In the Stage 2 final rule at 77 FR electronic prescriptions at the start of opportunity for efficiencies and
54035, we describe how the use of their EHR reporting period. improvements in patient safety
electronic prescribing has several outweigh these concerns. We will
advantages over having the patient carry Proposed Alternate Exclusions and finalize the proposed objective and
the prescription to the pharmacy or Specifications for Stage 1 Providers for measure for eligible hospitals and
directly faxing a handwritten or Meaningful Use in 2015 CAHs. However, we will maintain the
typewritten prescription to the We proposed that eligible hospitals alternate exclusion through 2016 in
pharmacy. When the hospital generates and CAHs scheduled to report on Stage order to allow adequate time to update
the prescription electronically, CEHRT 1 objectives for an EHR reporting period systems and workflows to support
can provide support for a number of in 2015 may claim an exclusion for the successful and safe implementation.
purposes, such as: Promoting safety and Stage 2 eRx measure as there is not an Comment: A number of commenters
quality in the form of decision support equivalent Stage 1 measure defined at on the hospital measure also noted
around adverse interactions and other 42 CFR 495.6. We further proposed that concerns over the formulary and
treatment possibilities; increasing the eligible hospitals and CAHs scheduled controlled substances. As commenters
efficiency of the health care system by to report Stage 2 objectives for an EHR on the EP objective noted, there are
currently challenges involved in other prescription types. We agree with 1 or Stage 2 in 2016. We believe this
effectively completing a query of a drug the rationale stated by commenters; change will provide the time necessary
formulary universally which may cause however we note that many EHRs may to safely implement the technology for
an additional burden on providers. be programmed to automatically include eligible hospitals and CAHs. Therefore,
Commenters also noted that the ability these prescriptions and a change in the we are finalizing the alternate exclusion
to include or exclude controlled definition could cause unintended for providers scheduled to demonstrate
substances should be continued but negative consequences for EHR system meaningful for an EHR reporting period
made more flexible to reflect the developers and providers if the change in 2015with an extension of the
changes regarding the allowance and required significant modifications to the exclusion into 2016.
feasibility of electronic prescribing for software. Therefore we will modify the We are finalizing the objective,
these medications. Some commenters measure language to remove the measure, exclusions, and alternate
noted this would be especially requirement for refill prescriptions, but exclusion for eligible hospitals and
important for eligible hospitals and we will allow providers discretion over CAHs as follows:
CAHs serving patients in a wide including or excluding these
geographic region which may overlap prescriptions rather than requiring Objective 4: Electronic Prescribing
multiple jurisdictions. These providers to exclude them. Eligible Hospital/CAH Objective:
commenters noted that a change around After consideration of the public Generate and transmit permissible
the language to make it more flexible comments received, we are modifying discharge prescriptions electronically
would allow them to include our proposal and finalizing changes to (eRx).
prescriptions for controlled substance the language to continue to allow Measure: More than 10 percent of
based on an organizational policy that providers the option to include or hospital discharge medication orders for
addressed any potential discrepancies. exclude controlled substances in the permissible prescriptions (for new and
Other commenters requested denominator where such medications changed prescriptions) are queried for a
clarification on the approach for can be electronically prescribed. We are drug formulary and transmitted
internal pharmacies and drugs finalizing that these prescriptions may electronically using CEHRT.
dispensed on site. be included in the definition of • Denominator: Number of new or
Finally, other commenters provided ‘‘permissible prescriptions’’ at the changed permissible prescriptions
feedback on the request for comment providers discretion where allowable by written for drugs requiring a
regarding refill prescriptions and law. We are modifying the denominator prescription in order to be dispensed for
continued medications and whether the to read ‘‘Number of permissible new, patients discharged during the EHR
measure language should be modified to changed, or refill prescriptions written reporting period.
only mention ‘‘new prescriptions’’ or for drugs requiring a prescription in • Numerator: The number of
‘‘new or changed prescriptions’’ rather order to be dispensed for patients prescriptions in the denominator
than the proposed continuation of discharged during the EHR reporting generated, queried for a drug formulary,
including new, changed, and refilled period’’ in accordance with this change. and transmitted electronically.
prescriptions. The vast majority of Finally, we proposed that some of the • Threshold: The resulting percentage
commenters did not support including Stage 2 objectives and measures do not must be more than 10 percent in order
refilled prescriptions noting that these have an equivalent Stage 1 measure and for an eligible hospital or CAH to meet
prescriptions should be included and so for 2015 we proposed to allow this measure.
monitored by the original prescriber. providers to exclude from these • Exclusions: Any eligible hospital or
Commenters were divided on whether measures. However, the eligible hospital CAH that does not have an internal
to include or exclude changed electronic prescribing objective was pharmacy that can accept electronic
prescriptions. Some noting, again, that included in this policy for both Stage 1 prescriptions and is not located within
changed prescriptions should be providers and Stage 2 providers in 2015 10 miles of any pharmacy that accepts
monitored by the original prescriber because it was previously a menu electronic prescriptions at the start of
while others noted that the change measure so many Stage 2 providers may their EHR reporting period.
constitutes accountability for the not be able to meet the measure in 2015 Alternate Exclusion: Alternate
prescription by the eligible hospital. if they had not prepared to do so. As Eligible Hospital/CAH Exclusion: The
Response: We agree these concerns noted in section II.B.1.b.(4)(c)(iii), based eligible hospital or CAH may claim an
are applicable for both the EP and the on public comment we determined to exclusion for the eRx objective and
eligible hospital/CAH measures. The also allow alternate exclusions in 2016 measure if for an EHR reporting period
guidance we provided above regarding for certain measures. We determined in 2015 if they were either scheduled to
how providers may count the query of this to be necessary because, for certain demonstrate Stage 1, which does not
a formulary for the EP measure is also measures providers may not have the have an equivalent measure, or if they
applicable for the eligible hospital/CAH specific CEHRT function required to are scheduled to demonstrate Stage 2
measure. For controlled substances, support the measure if they were not but did not intend to select the Stage 2
based on public comment received we prepared to attest to that measure in eRx objective for an EHR reporting
are finalizing similar changes to the 2015. These providers may not be able period in 2015; and, the eligible hospital
denominator for the eligible hospital to successfully obtain and fully and or CAH may claim an exclusion for the
objective as were adopted for the EP safely implement the technology in time eRx objective and measure for an EHR
objective to allow for the inclusion or to succeed at the measure for an EHR reporting period in 2016 if they were
exclusion of these prescriptions at reporting period in 2016. In the case of either scheduled to demonstrate Stage 1
provider discretion where allowable by electronic prescribing, accelerating the in 2016 or if they are scheduled to
law. We further note that prescriptions implementation of the technology in a demonstrate Stage 2 but did not intend
from internal pharmacies and drugs short time frame could present a patient to select the Stage 2 eRx objective for an
dispensed on site may be excluded from safety risk, and so therefore for the EHR reporting period in 2016.
the denominator. Finally, we thank the eligible hospital objective we are We are adopting the Objective 4:
commenters for their insight and will finalizing an alternate exclusion in 2016 Electronic Prescribing at
exclude refill prescriptions but maintain for eligible hospitals scheduled for Stage § 495.22(e)(4)(ii) for eligible hospitals
and CAHs. We further specify that in for providers while continuing to drive Comment: Many commenters
order to meet this objective and interoperability across care settings and supported our efforts towards
measure, an eligible hospital or CAH encouraging further innovation. interoperability and continuity of care.
must use the capabilities and standards Previously, the measure specified the Commenters’ general opposition to our
of as defined for as defined CEHRT at manner in which the summary of care original Stage 2 efforts included
§ 495.4. We direct readers to section must be electronically transmitted concerns about building the direct tool
II.B.3 of this final rule with comment stating: Providers must either—(1) into existing systems being difficult and
period for a discussion of the definition Electronically transmit the summary of expensive, as well as the lack of
of CEHRT and a table referencing the care using CEHRT to a recipient; or (2) receiving facilities capable of direct
capabilities and standards that must be where the recipient receives the exchange. Commenters provided a
used for each measure. summary of care record via exchange number of general recommendations,
facilitated by an organization that is a including suggestions for keeping data
Objective 5: Health Information
Nationwide Health Information Network private, allowing providers more
Exchange
(NwHIN) Exchange participant or in a freedom regarding which information is
For Objective 5: Summary of Care manner that is consistent with the included in the summary of care
(here retitled to Health Information governance mechanism ONC establishes documents, and permitting more
Exchange), we proposed to retain only for the nationwide health information alternative technologies to meet the
the second measure of the existing Stage network. We proposed to update this measure. In addition, many commenters
2 Summary of Care objective for measure to state simply that a provider expressed the need for a more
meaningful use in 2015 through 2017 would be required to create the coordinated effort towards data
(80 FR 20361) and directed readers to summary of care record using CEHRT integration on a national scale, such as
the full description in the Stage 2 final and transmit the summary of care record a centralized data registry and national
rule at 77 FR 54013 through 54021. electronically. standards for interaction and interfacing
Proposed Objective: The EP, eligible To calculate the percentage of the with data through CEHRT.
hospital or CAH who transitions their measure, CMS and ONC have worked Response: We appreciate the
patient to another setting of care or together to define the following for this comments provided and the wide range
provider of care or refers their patient to objective: of subjects raised in the comments. We
another provider of care provides a Denominator: Number of transitions agree with the general sentiment that a
summary care record for each transition of care and referrals during the EHR continued push for improved
of care or referral. reporting period for which the EP’s or infrastructure, flexibility, and
Proposed Measure: The EP, eligible eligible hospital’s or CAH’s inpatient or interoperability among data systems is
hospital or CAH that transitions or emergency department (POS 21 or 23) necessary and appreciate the continued
refers their patient to another setting of was the transferring or referring efforts of providers to play a role in this
care or provider of care that—(1) Uses provider. ongoing effort to modernize health care
CEHRT to create a summary of care Numerator: The number of transitions information systems and promote better
record; and (2) electronically transmits of care and referrals in the denominator care coordination through electronic
such summary to a receiving provider where a summary of care record was health information exchange.
for more than 10 percent of transitions created using CEHRT and exchanged Comment: Some commenters
of care and referrals. electronically. expressed a general confusion that there
We proposed to retain an updated Threshold: The percentage must be was not a list of the required data
version of the second measure of the more than 10 percent in order for an EP, elements for the
Stage 2 Summary of Care objective with eligible hospital or CAH to meet this C–CDA in the proposed rule. Some
modifications based on guidance measure. commenters expressed an assumption
provided through CMS responses to Exclusion: Any EP who transfers a that because we did not restate the
frequently asked questions we have patient to another setting or refers a previously finalized list, we are
received since the publication of the patient to another provider less than 100 allowing providers to determine the
Stage 2 final rule. We proposed to retain times during the EHR reporting period. data and information to include in the
this measure for electronic transmittal summary of care document. Other
because we believe that the electronic Proposed Alternate Exclusions and commenters noted that in the numerator
exchange of health information between Specifications for Stage 1 Providers for discussion for the summary of care, the
providers would encourage the sharing Meaningful Use in 2015 problem list, medication list and
of the patient care summary from one We proposed that providers medication allergy list requirement is
provider to another and important scheduled to demonstrate Stage 1 of not reflected, but in subsequent text in
information that the patient may not meaningful use for an EHR reporting the proposed rule the required inclusion
have been able to provide. This can period in 2015 may claim an exclusion of these data elements is clearly
significantly improve the quality and for Measure 2 of the Stage 2 Summary identified. These commenters suggest
safety of referral care and reduce of Care core objective because there is clarification of this point.
unnecessary and redundant testing. Use not an equivalent Stage 1 measure. Finally, some commenters asked if the
of common standards in creating the Proposed Alternate Exclusion: omission was intentional and if we
summary of care record can Provider may claim an exclusion for the intended that the data elements would
significantly reduce the cost and measure of the Stage 2 Summary of Care still be available for providers to use
complexity of interfaces between objective, which requires the electronic discretion on a case-by-case basis. Other
different systems and promote transmission of a summary of care commenters did not express confusion
widespread exchange and document if, for an EHR reporting about the requirement, but did not that
interoperability. period in 2015, they were scheduled to some flexibility would be welcome as
The proposed updates to this measure demonstrate Stage 1, which does not their trading partners are often
reflect stakeholder input regarding have an equivalent measure. overwhelmed by the amount of
operational challenges in meeting this We proposed no alternate unnecessary information they receive,
measure, and seek to increase flexibility specifications for this objective. especially in relation to extensive
laboratory test results. The commenters to record (for example, laboratory tests), objective in this final rule with
suggested that allowing individual the EP, eligible hospital, or CAH may comment period we direct readers to
providers some flexibility to determine leave the field(s) blank and still meet section II.B.2.b.vii.
what is important and relevant to send the objective and its associated measure. Comment: Many commenters
to the next provider in care would allow In addition, all summary of care supported the modified objective
receiving providers to process and use documents used to meet this objective removing the 50 percent measure for
the information more effectively. must include the following in order to providing a summary of care record by
Response: First, we note that we did be considered a summary of care any means, as well as the measure’s
not intend to cause this confusion. As document for this objective: widening of the pathways acceptable for
stated in the EHR Incentive Program in • Current problem list (providers may transmitting Summary of Care records.
2015 through 2017 proposed rule at (80 also include historical problems at their These commenters noted that the
FR 20361) we proposed to maintain the discretion), relaxation of requirements for manual
second measure of the Stage 2 Summary • Current medication list, and transmission will allow them to better
of Care Objective with certain • Current medication allergy list. tailor the contents of the summary of
modifications. For efficiency and to An EP or hospital must verify these care document to the transport
reduce the overall length of the three fields for current problem list, mechanism and will, in fact, encourage
current medication list, and current the electronic adoption because of the
proposed rule, we focused our
medication allergy list are not blank and ease of obtaining a full range of
discussion on the proposed
include the most recent information information on a patient as compared to
modifications and referenced the full
known by the EP or hospital as of the non-electronic transport mechanisms.
description of the measure in the Stage
time of generating the summary of care Response: As noted previously, the
2 final rule at 77 FR 54013 through
document.’’ general movement away from requiring
54021. The only modifications that we We intend to maintain this policy of
intended to make were those that we reporting on paper-based measures is
the required data elements for the C– intended to allow providers to focus
expressly discussed, and unless we CDA as previously finalized. However,
indicated otherwise, our intention was efforts on the use of CEHRT to support
we do understand provider concern health information exchange. We agree
to maintain the existing Stage 2 policies over the ability to exercise some
for the measure. This includes that limiting the EHR Incentive Program
discretion over the amount of data objectives and measures exclusively to
maintaining the requirements for the transmitted, and as noted in the Stage 3
data elements included in the summary electronic transmissions while
proposed rule (80 FR 16760) we simultaneously expanding the options
of care document at 77 FR 54016 as recognize there may be reasons to apply
follows: by which such exchange may occur will
a policy of determining clinical allow developers, providers, and the
‘‘All summary of care documents used relevance for the amount of data in the
to meet this objective must include the industry as a whole to focus on the
lab results field and clinical notes field support of HIE infrastructure while
following information if the provider which should be included in the
knows it: supporting innovation in interoperable
summary of care document. health IT development.
• Patient name. Specifically, it may be beneficial for a
• Referring or transitioning provider’s Comment: Many commenters
provider to limit the lab results expressed opposition to the objective
name and office contact information (EP transmitted in the record of an extended
only). noting a lack of participation by EPs to
hospital stay to those which best whom the referrals are made. A large
• Procedures.
represent the patient status upon number of commenters believe that they
• Encounter diagnosis
admission, any outliers or abnormal should not be penalized for other EPs
• Immunizations.
• Laboratory test results. results, and the patient status upon inability to receive electronic delivery,
• Vital signs (height, weight, blood discharge. Further, we note that this is something over which they state they
pressure, BMI). only one example and other definitions have no control. In addition, some
• Smoking status. of clinical relevance for lab results may primary care doctors believe they are
• Functional status, including apply in other clinical settings and for unfairly being held responsible for
activities of daily living, cognitive and other situations. We are therefore communicating with specialists who
disability status. adopting a similar policy for this can claim an exclusion for referring less
• Demographic information measure as the one outlined for Stage 3; than 100 times. Many commenters
(preferred language, sex, race, ethnicity, however, we are limiting this policy to requested that we reduce the threshold
date of birth). lab results. We are therefore requiring or change the measure to a yes/no
• Care plan field, including goals and that a provider must have the ability to attestation due to the lack of control
instructions. send all laboratory test results in the over other EPs and eligible hospitals/
• Care team including the primary summary of care document, but that a CAHs without receiving capabilities.
care provider of record and any provider may work with their system Many recommendations about the
additional known care team members developer to establish clinically relevant denominator varied, with some
beyond the referring or transitioning parameters based on their specialty, suggesting that the denominator
provider and the receiving provider. patient population, or for certain referrals should exclude providers who
• Discharge instructions (Hospital transitions and referrals which allow for are not EPs, eligible hospitals, or CAHs
Only) clinical relevance to determine the most under the EHR Incentive Programs or
• Reason for referral (EP only) appropriate results for given transition should exclude patients who do not
In circumstances where there is no or referral. We further note that a choose a specific provider for their
information available to populate one or provider who limits the results in a recommended referral service.
more of the fields listed previously, summary of care document must send Commenters also requested various
either because the EP, eligible hospital, the full results upon the request of the exclusions, including exclusions for
or CAH can be excluded from recording receiving provider or upon the request transitions to pediatric providers,
such information (for example, vital by the patient. For discussion of this referrals to therapists, and for those in
signs) or because there is no information proposal in relation to the Stage 3 areas where there are not enough EPs
participating in Stage 2. Commenters within the industry. We believe that While we encourage the use of query-
requested clarifications on the measure requiring all participating providers to based exchange for many use cases, we
regarding what constitutes ‘‘transfer of exchange health information note that to count in the numerator the
care’’ and what defines electronic electronically when transitioning or sending provider must reasonable
transmissions. referring a patient to a new setting of certainty of receipt of the summary of
Response: We appreciate the care, but maintaining the reasonably care document. This means that a
commenters’ concern about a lack of low threshold at 10 percent, represents ‘‘push’’ to an HIE which might be
participation by EPs to whom the a reasonable balance between promoting queried by the recipient is insufficient.
referrals are made and note that this is participation and setting an achievable Instead, r the referring provider must
one reason behind the relatively low 10 goal for providers. confirmation that a query was made to
percent threshold for this measure. We We acknowledge that in some cases count the action toward the measure.
also note that in the proposed rule, we we have decided to extend the alternate We further specify that the exchange
expressed a concern that a key factor exclusion for 2015 into 2016 where a must comply with the privacy and
influencing successful HIE is the active provider may not have the appropriate security protocols for ePHI under
participation of a large number of CEHRT functions in place for a measure. HIPAA.
providers in the process. We note that However, we have limited those We thank the commenters for the
those providers who did participate in instances to those cases where rushed suggestion around the concept of an
electronic exchange through Stage 2 in implementation of the function could information exchange address
2014 performed reasonably well on the present a risk to patient safety. We do repository. We agree that a potential
measure, but through letters and public not believe this objective and measure model which might allow for easier
comment expressed a need for wider pose such a risk, and further maintain access to health information exchange
participation among providers to ensure our assertion from the Stage 3 proposed contact information could be a positive
a significant number of trading partners rule (80 FR 16739) that overall success step toward supporting interoperability
are available for electronic exchange. on in health information exchange is and an improved care continuum. We
This is a driving influence behind our enhanced by increased participation. refer readers to section II.D.3 of this
continued support of this measure and Comment: Many commenters final rule with comment period for
the move to require all providers to supported the modified objective and further discussion of the collection of
participate in this objective and measure the flexibility proposed around the direct addresses or health information
beginning in 2016.The definition of a pathways acceptable for transmitting exchange information for potential
transition of care for this objective was inclusion in a nationwide healthcare
Summary of Care records. Some
finalized in the Stage 2 final rule where provider directory. After consideration
commenters noted this change will
we outline the denominators for the of public comments received, we are
facilitate queried exchange and
various objectives and measures (77 FR finalizing this objective, measure,
encourage providers to push
53984). We subsequently further exclusion, and alternate exclusion as
information to an HIE. Another
defined (80 FR 16759) a transition of proposed for EPs, eligible hospitals, and
commenter believes that this update
care for electronic exchange as one CAHs as follows:
will enhance the growth and utilization
where the referring provider is under a
of the electronic exchange of Objective 5: Health Information
different billing identity within the
information while upholding the same Exchange
Medicare and Medicaid EHR Incentive
Programs than the receiving provider security standards as DIRECT or Objective: The EP, eligible hospital or
and where the providers do not share NwHIN. CAH who transitions their patient to
access to the EHR. In cases where the Some commenters requested that we another setting of care or provider of
providers do share access to the EHR, a initiate the mandatory reporting of care or refers their patient to another
transition or referral may still count direct address directories to a central provider of care provides a summary
toward the measure if the referring repository so that established standards care record for each transition of care or
providers creates the summary of care will help providers meet future referral.
document using CEHRT and sends the requirements in Stage 3. Measure: The EP, eligible hospital or
summary of care document Response: The intent behind the CAH that transitions or refers their
electronically. If a provider chooses to expansion of the potential transport patient to another setting of care or
include such transitions to providers mechanism proposed is to drive provider of care must—(1) Use CEHRT
where access to the EHR is shared, they interoperability across care settings and to create a summary of care record; and
must do so universally for all patient encourage further innovation in (2) electronically transmit such
and all transitions or referrals. electronic health information exchange summary to a receiving provider for
Comment: Some commenters and care coordination. We agree that the more than 10 percent of transitions of
requested an extension of the alternate retention of the document standards for care and referrals.
exclusion for Stage 1 providers into health information exchange will help Denominator: Number of transitions
2016 rather than only making this to support interoperability, while of care and referrals during the EHR
allowance for 2015. allowing providers a wider range of reporting period for which the EP or
Response: We do not believe that options for the electronic transport eligible hospital’s or CAH’s inpatient or
extending the alternate exclusion into mechanism. This will also mitigate emergency department (POS 21 or 23)
2016 serves the goals of the program to difficulties for providers whose most was the transferring or referring
promote interoperability, an expanded common referrals may be to other provider.

HIT infrastructure, and the use of HIT caregivers who are not using a Direct Numerator: The number of transitions
to support care coordination. As noted transport mechanism. We note that of care and referrals in the denominator
previously, one of the biggest concerns CEHRT is required to be able to receive where a summary of care record was
expressed by providers seeking to a C–CDA, but that the potential to use created using CEHRT and exchanged
engage in HIE is the need to increase a wider range of transport mechanisms electronically.
overall participation to ensure an will allow for greater diversity of Threshold: The percentage must be
adequate pool of trading partners exists information exchange. more than 10 percent in order for an EP,
eligible hospital or CAH to meet this the patient-specific educational Threshold: The resulting percentage
measure. resources. The EP or eligible hospital must be more than 10 percent in order
Exclusion: Any EP who transfers a may use these elements or additional for an eligible hospital or CAH to meet
patient to another setting or refers a elements within CEHRT to identify this measure.
patient to another provider less than 100 educational resources specific to
times during the EHR reporting period. Proposed Alternate Exclusions and
patients’ needs. The EP or hospital can Specifications for Stage 1 Providers for
Alternate Exclusion: then provide these educational
Alternate Exclusion: Provider may Meaningful Use in 2015
resources to patients in a useful format
claim an exclusion for the Stage 2 for the patient (such as electronic copy, While the Patient-Specific Education
measure that requires the electronic printed copy, electronic link to source objective is designated as an optional
transmission of a summary of care materials, through a patient portal or menu objective in Stage 1, the same
document if for an EHR reporting period PHR). objective is a mandatory core objective
in 2015, they were scheduled to Proposed EP Measure: Patient-specific in Stage 2. We expect that not all Stage
demonstrate Stage 1, which does not education resources identified by 1 scheduled providers were planning to
have an equivalent measure. CEHRT are provided to patients for choose this menu objective when
We are adopting Objective 5: Health more than 10 percent of all unique attesting in an EHR reporting period in
Information Exchange at § 495.22(e)(5)(i) 2015. Therefore, we proposed that any
patients with office visits seen by the EP
for EPs and § 495.22(e)(5)(ii) for eligible provider scheduled to demonstrate
during the EHR reporting period.
hospitals and CAHs. We further specify Stage 1 of meaningful use for an EHR
We proposed to retain the exclusion
that in order to meet this objective and reporting period in 2015 who was not
for EPs who have no office visits in
measures, an EP, eligible hospital, or intending to attest to the Stage 1 Patient-
order to accommodate such EPs.
CAH must use the capabilities and Specific Education menu objective, may
The resources would have to be those
standards of as defined for as defined claim an exclusion to the measure. We
identified by CEHRT. If resources are
CEHRT at § 495.4. We direct readers to note that for an EHR reporting period
not identified by CEHRT and provided
section II.B.3 of this final rule with beginning in 2016, all providers must
to the patient, then it would not be
comment period for a discussion of the attest to the objective and measure and
counted in the numerator. We do not
definition of CEHRT and a table meet the Stage 2 specifications and
intend through this requirement to limit
referencing the capabilities and threshold in order to successfully
the education resources provided to
standards that must be used for each demonstrate meaningful use.
patients to only those identified by
measure. Proposed Alternate Exclusion:
CEHRT. The education resources would
Providers may claim an exclusion for
Objective 6: Patient-Specific Education need to be provided prior to the
the measure of the Stage 2 Patient-
In the EHR Incentive Programs in calculation and subsequent attestation
Specific Education objective if for an
2015 through 2017 proposed rule (80 FR to meaningful use.
EHR reporting period in 2015 they were
20362), we proposed to retain the Stage To calculate the percentage for EPs,
scheduled to demonstrate Stage 1 but
2 objective and measure for Patient- CMS, and ONC have worked together to
did not intend to select the Stage 1
Specific Education for meaningful use define the following for this objective:
Patient Specific Education menu
for 2015 through 2017. Denominator: Number of unique
objective.
Proposed Objective: Use clinically patients with office visits seen by the EP We proposed no alternate
relevant information from CEHRT to during the EHR reporting period. specifications for this objective.
identify patient-specific education Numerator: Number of patients in the Comment: The vast majority of
resources and provide those resources to denominator who were provided commenters expressed support for the
the patient. patient-specific education resources inclusion of the Patient-Specific
In the Stage 2 proposed rule (77 FR identified by the CEHRT. Education objective in the EHR
54011), we explained that providing Threshold: The resulting percentage Incentive Programs for 2015 through
clinically relevant education resources must be more than 10 percent in order 2017 proposed rule. They recognized
to patients is a priority for the for an EP to meet this measure. the importance of supplying patients
meaningful use of CEHRT. While Exclusion: Any EP who has no office with materials about their conditions
CEHRT must be used to identify patient- visits during the EHR reporting period. and summaries about their visits.
specific education resources, these Proposed Eligible Hospital/CAH Response: We thank the commenters
resources or materials do not have to be Measure: More than 10 percent of all for their support of this objective.
maintained within or generated by the unique patients admitted to the eligible Comment: Those who opposed the
CEHRT. We are aware that there are hospital’s or CAH’s inpatient or objective believe that the inclusion of
many electronic resources available for emergency department (POS 21 or 23) the objective in the EHR Incentive
patient education materials, such as are provided patient-specific education Programs for 2015 through 2017
through the National Library of resources identified by CEHRT. proposed rule increased administrative
Medicine’s MedlinePlus (http:// To calculate the percentage for burden on providers. Some commenters
www.nlm.nih.gov/medlineplus), that hospitals, CMS and ONC have worked opposed to the objective believe that
can be queried via CEHRT (that is, together to define the following for this physicians should have flexibility
specific patient characteristics are objective: regarding the sources and types of
linked to specific consumer health Denominator: Number of unique materials they can provide to their
content). The EP or hospital should use patients admitted to the eligible hospital patients, rather than being limited to
CEHRT in a manner in which the or CAH inpatient or emergency those identified by CEHRT.
technology suggests patient-specific departments (POS 21 or 23) during the Response: We appreciate the insight
educational resources based on the EHR reporting period. from providers and note that the intent
information created or maintained in Numerator: Number of patients in the of the objective is to promote wider
the CEHRT. CEHRT is certified to use denominator who are subsequently availability of patient-specific education
the patient’s problem list, medication provided patient-specific education leveraging the function of CEHRT, as
list, or laboratory test results to identify resources identified by CEHRT. noted in the similar, electronic-only
Stage 3 proposed measure. We note that hospital stay. For EPs the measure states hospital, and consistent with FAQ 8231,
this should in no way limit the only that the patient had an office visit no later than the date of attestation. As
provider’s selection of patient-specific during the EHR reporting period and noted in section II.B.1.b.(4)(b), some
education materials or provision of was provided patient-specific EHRs may have previously been
paper-based education materials for education. This could refer to materials designed and certified to calculate this
patients if the provider deems such an provided during an office visit or at measure based on a prior assumption,
action beneficial and of use to the another point in time. and for that reason we will not require
patient. We are simply not requiring However, we disagree with the this method of calculation until the EHR
providers to count and report any such recommendation to allow any action to reporting period in 2017 in order to
provision that falls outside the count in perpetuity. We note that this allow sufficient time for the calculation
definition for the EHR Incentive measure refers to a single action for each to be updated in systems.
Programs for 2015 through 2017 as unique patient seen during the EHR Comment: Other commenters were
described in this objective and measure. reporting period. This means that if a concerned that the exclusion for
Comment: Multiple commenters provider meets the minimum action, providers who were scheduled for Stage
requested clarification of the timeframe even for those patients who have 1 but ‘‘did not intend to select the Stage
in which the information should be multiple office visits within an EHR 1 Patient Education menu objective’’ is
shared with the patient. Commenters reporting period, the provider would be vague and will lead to audit problems.
specifically requested additional clarity providing educational information a Response: We refer readers to the
on FAQ 8231 7 released by CMS, stating single time each year for only just over discussion of intent in section
the actions taken would need to fall 10 percent of their patients. We strongly II.B.1.b.(4).(b)(iii) of this final rule with
within the reporting year, even if they disagree that this represents an comment period where we acknowledge
fall outside of the reporting period. For unreasonable burden or that this action that it may be difficult for a provider to
the patient education measure of this should not be required to continue on document intent and will not require
objective, some commenters believe an annual basis. We disagree with the such documentation.
requiring the action to occur during the commenter’s suggestion that patient Comment: Multiple commenters
reporting period promotes wasted specific education is not useful or recommended that we add the Patient-
resources and functions from the relevant for a patient for each year in Specific Education objective to the list
provider. Specialty providers who are which they receive medical care. We of topped-out measures. Another group
providing long-term care for a patient further disagree with the examples of commenters recommended that we
would need to send out patient provided for specialists or other provide an alternate measure for eligible
education for what would amount to the providers providing long-term care or hospitals/CAHs/EPs that were
same problem each year. This education working with a patient to manage a scheduled to be in Stage 1 in 2015 and
could have been provided in a previous chronic disease that a single provision desired to select patient education as a
year to the patient, and the FAQ is of patient specific education should be menu objective utilizing the current
stating the patient be provided the counted for the numerator in perpetuity. Stage 1 measure definition. Others
education again in order to count for the Research shows that continued patient recommended we require that providers
numerator in the current reporting year. engagement and education positively have multi-lingual and low-literacy
Commenters further noted that many impacts patient outcomes, especially for patient portals.
specialist EPs provide education at the patients with a chronic disease and Response: We respectfully disagree
beginning of an engagement with a patients who may experience health that the measure is topped out and
patient appropriate to their condition disparities.8 In addition, as a patient believe there is value in continued
with the intent that it be applicable to ages, or as their health condition measurement especially in light of the
the entire duration of the treatment of changes, their needs for education about inclusion of the similar electronic
the patient’s condition. Commenters their care may also change. measure within Stage 3. We also
expressed concern that the policy would Therefore, as indicated in FAQ 8231, disagree with the recommendation to
we believe that while the patient- include an alternate specification for the
require the provider to either provide
specific education resources may be measure in addition to the alternate
repetitive education or identify
provided outside of the EHR reporting exclusion. While the policy would
additional educational opportunities in
period, this action must occur no earlier allow some providers to attest, it adds
order to count the action in the
than the start of the same year as the an additional level of complexity and
numerator. The commenters state that
EHR reporting period if the EHR makes no accommodation for those
allowing for any prior action to count
reporting period is less than one full providers in 2015 who have not been
would reduce the unnecessary burden
calendar year and no later than the date engaged in the measure at all, as they
placed on physicians, and the waste of
of attestation. For the eligible hospital did not intend to attest to that menu
resources to provide the patient with
and CAH measure, the numerator selection. Finally, we appreciate the
repetitive information.
Response: As discussed in section includes the qualifier ‘‘subsequently’’ recommendation on the inclusion of
II.B.1.b.(4), some measures in the Stage which indicates the patient-specific multi-lingual and low-literacy patient
2 final rule did not include a education resources must be provided portals to provide and support patient
specification on the timing when an after the patient’s admission to the education for a wider range of patients.
action must occur for inclusion in the We note that it is a priority of CMS and
numerator. The Stage 2 patient-specific
8 ‘‘Patient Education and Empowerment Can ONC to continue to foster
Improve Health Outcomes for Diabetes’’ NY interoperability between assistive

education objective did not contain Presbyterian DSME study August 2014: http://
language stating that the provision of www.nyp.org/news/hospital/2014-education-
technologies, portals such as those
patient-specific education must occur diabetes.html. recommended by the commenters,
within the office visit or during the Keolling,Todd M., MD; Monica L. Johnson, RN; applications leveraging multi-media
Robert J. Cody, MD; Keith D. Aaronson, MD, MS: supports, and other accessible tools and
‘‘Discharge Education Improves Clinical Outcomes
7 FAQ #8231: CMS Frequently Asked Questions: in Patients with Chronic Heart Failure’’ Heart
CEHRT. Unfortunately, while we
EHR Incentive Programs https://questions.cms.gov/ Failure: AHA Journals: http://circ.ahajournals.org/ strongly encourage adoption of these
faq.php?faqId=8231. content/111/2/179.full. resources and support the development
of standards and testing, we believe the consequences which may result from to select the Stage 1 Patient Specific
requirement of these tools for all changing the specifications for this Education menu objective.
providers in the Medicare and Medicaid measure for providers who are currently We are adopting Objective 6: Patient-
EHR Incentive Programs is premature using paper-based methods. For Specific Education at § 495.22(e)(6)(i)
based on the current availability of such information on the fully electronic for EPs and § 495.22(e)(6)(ii) for eligible
interoperable resources in the EHR Patient-specific Education measure hospitals and CAHs. We further specify
marketplace. included in the Stage 3 proposed rule, that in order to meet this objective and
Comment: Some commenters we direct readers to section II.B.2.b.vi of measures, an EP, eligible hospital, or
requested clarification if the transitive this final rule with comment period. CAH must use the capabilities and
effect described in FAQ 7735 and FAQ After consideration of public standards of as defined for as defined
9686 applies for the patient-specific comments received, we are finalizing CEHRT at § 495.4. We direct readers to
education objective as well. These the objective, measures, exclusions, and section II.B.3 of this final rule with
commenters note that if patient-specific alternate exclusion as proposed for EPs, comment period for a discussion of the
education is provided via a patient eligible hospitals and CAHs. definition of CEHRT and a table
portal, it is very difficult to measure as The final objective is as follows: referencing the capabilities and
attributable to a specific provider within standards that must be used for each
a group practice or even across settings Objective 6: Patient-Specific Education measure.
if providers are sharing an EHR. Objective: Use clinically relevant
Response: FAQ7735 and FAQ 9686 Objective 7: Medication Reconciliation
information from CEHRT to identify
refer to the Patient Electronic Access patient-specific education resources and In the EHR Incentive Programs for
Objective measures 2 and the Secure provide those resources to the patient. 2015 through 2017 proposed rule (80 FR
Electronic Messaging Objective 20363), we proposed to retain the Stage
EP Measure: Patient-specific
respectively,9 and allow for a single 2 objective and measure for Medication
education resources identified by
action by a patient to count in the Reconciliation for meaningful use in
CEHRT are provided to patients for
numerator for multiple providers under 2015 through 2017. Medication
more than 10 percent of all unique
certain circumstances if each of the reconciliation allows providers to
providers has the patient in their confirm that the information they have
denominator for that EHR reporting on the patient’s medication is accurate.
• Denominator: Number of unique
period. In each case, this policy is This not only assists the provider in his
patients with office visits seen by the EP or her direct patient care, it also
intended to facilitate calculation in during the EHR reporting period.
circumstances where accurate improves the accuracy of information
• Numerator: Number of patients in they provide to others through health
calculation and attribution of the action
the denominator who were provided information exchange.
to a single provider may be impossible.
patient-specific education resources Proposed Objective: The EP, eligible
This is not inherently the case with the
identified by the CEHRT. hospital, or CAH who receives a patient
patient-specific education objective
• Threshold: The resulting percentage from another setting of care or provider
which is why this objective is not
included in either FAQ. The Stage 2 must be more than 10 percent in order of care or believes an encounter is
Patient-specific Education Objective (80 for an EP to meet this measure. relevant should perform medication
FR 20362) does not limit the measure to • Exclusion: Any EP who has no reconciliation.
education provided via a patient portal office visits during the EHR reporting In the Stage 2 proposed rule at 77 FR
and therefore a universal policy period. 54012 through 54013, we noted that
allowing the ‘‘transitive effect’’ would Eligible Hospital/CAH Measure: More when conducting medication
not be appropriate. For example, if a than 10 percent of all unique patients reconciliation during a transition of
provider gives a patient a paper-based admitted to the eligible hospital’s or care, the EP, eligible hospital, or CAH
educational resource during their office CAH’s inpatient or emergency that receives the patient into their care
visit, that instance is only attributable to department (POS 21 or 23) during the should conduct the medication
that provider and should not be counted EHR reporting period are provided reconciliation. We reiterated that the
in the numerator for other providers patient-specific education resources measure of this objective does not
within the group practice. However, if identified by CEHRT. dictate what information must be
the resource is provided electronically • Denominator: Number of unique included in medication reconciliation,
and such attribution is impossible, it patients admitted to the eligible hospital as information included in the process
may be counted in the numerator for or CAH inpatient or emergency is appropriately determined by the
any provider within the group sharing departments (POS 21 or 23) during the provider and patient. We defined
the CEHRT who has contributed EHR reporting period. medication reconciliation as the process
information to the patient’s record, if • Numerator: Number of patients in of identifying the most accurate list of
that provider also has the patient in the denominator who are subsequently all medications that the patient is
their denominator for the EHR reporting provided patient-specific education taking, including name, dosage,
period. We recognize that this may resources identified by CEHRT. frequency, and route, by comparing the
result in a process of manual calculation • Threshold: The resulting percentage medical record to an external list of
if both electronic and paper-based must be more than 10 percent in order medications obtained from a patient,
resources are used. While we are for an eligible hospital or CAH to meet hospital or other provider. In the EHR
seeking to avoid manual calculation and this measure. Incentive Programs in 2015 through
paper-based actions, we must also Alternate Exclusion: 2017 proposed rule (80 FR 20363), we
balance avoiding unintended negative Alternate Exclusion: Providers may proposed to maintain these definitions
claim an exclusion for the measure of without modification.
9 CMS.gov Frequently Asked Questions: EHR
the Stage 2 Patient-Specific Education Proposed Measure: The EP, eligible
Incentive Programs FAQ 7735: https:// objective if for an EHR reporting period hospital or CAH performs medication
questions.cms.gov/faq.php?id=5005&faqId=7735
and FAQ 9686: https://questions.cms.gov/ in 2015 they were scheduled to reconciliation for more than 50 percent
faq.php?id=5005&faqId=9686. demonstrate Stage 1 but did not intend of transitions of care in which the
patient is transitioned into the care of reconciliation is out of scope for his In addition, robust health information
the EP or admitted to the eligible practice while others requested exchange is of great assistance to
hospital’s or CAH’s inpatient or excluding referrals for reading certain medication reconciliation, but an
emergency department (POS 21 or 23). tests or imaging services. Commenters electronic summary of care document is
To calculate the percentage, CMS and also requested that we revise the not required for medication
ONC have worked together to define the measure to allow an exclusion for reconciliation. Nor is electronic HIE the
following for this objective: providers with fewer than 100 only way EHRs can assist with
Denominator: Number of transitions transitions or referral received medication reconciliation. Medication
of care during the EHR reporting period electronically or to limit the reconciliation may take many forms,
for which the EP or eligible hospital’s or denominator to only those transitions or from automated inclusion of ePHI to
CAH’s inpatient or emergency referrals where an electronic summary review of paper records, to discussion
department (POS 21 or 23) was the of care document was received. with the patient upon intake or during
receiving party of the transition. Finally, one commenter stated a belief consultation with the provider. Going
Numerator: The number of transitions that the requirements for medication back to Stage 1 we have noted that
of care in the denominator where reconciliation objective depend upon medication reconciliation may become
medication reconciliation was the interoperability of EHR systems and more automated as technology
performed. may pose a significant burden to progresses, but may never reach a point
Threshold: The resulting percentage providers. of full automation as these other
must be more than 50 percent in order Response: We reiterate that in the methods continue to offer value—
for an EP, eligible hospital or CAH to EHR Incentive Program for 2015 through especially conversation with the patient
meet this measure. 2017 (80 FR 20363), we proposed to which may remain an important part of
Exclusion: Any EP who was not the maintain the denominators finalized that process (75 FR 44362).
recipient of any transitions of care through rulemaking in the Stage 2 final Furthermore, while the measure does
during the EHR reporting period. rule (77 FR 54012 through 54013 and involve health information exchange,
Proposed Alternate Exclusions and 53982 through 53984), including the we see no value in limiting the
Specifications for Stage 1 Providers for current definition of a transition of care medication reconciliation measure to
Meaningful Use in 2015 for inclusion in the denominator of this only those patients for whom a record
measure. We note that the denominator is received electronically. We believe
We proposed that any provider that it is appropriate and important to
scheduled to demonstrate Stage 1 of includes when the provider is the
recipient of the transition or referral, conduct medication reconciliation for
meaningful use for an EHR reporting each patient regardless of the method
period in 2015 who was not intending first encounters with a new patient and
encounters with existing patients where that reconciliation may require.
to attest to the Stage 1 Medication Therefore, while we believe that
Reconciliation menu objective, may a summary of care record (of any type)
is provided to the receiving provider (77 medication reconciliation will become
claim an exclusion to the measure. easier as health information exchange
Proposed Alternate Exclusion: FR 53984).
capability increases and that robust
Provider may claim an exclusion for the In addition, for those EPs who note
health information exchange supports
measure of the Stage 2 Medication that they have no office visits, or face-
medication reconciliation, it is not a
Reconciliation objective if for an EHR to-face encounters, and therefore should
prerequisite to performing medication
reporting period in 2015 they were not have to include patient encounters
reconciliation. Further, we believe the
scheduled to demonstrate Stage 1 but for these services (such as only reading continued inclusion of a broad
did not intend to select the Stage 1 an EKG); we refer readers to the requirement for medication
Medication Reconciliation menu description in the Stage 2 final rule (77 reconciliation will encourage
objective. FR 53982) which notes that a provider developers and providers to continue to
We proposed no alternate may choose to include these encounters focus on how HIT can be designed and
specifications for this objective. in the denominator or to exclude them. leveraged to better support provider
Comment: One commenter requested However, if the provider chooses to medication reconciliation workflows
clarification of whether CMS intends to include or exclude these encounters through innovative new tools and
limit the denominator of this proposed they must apply the policy universally resources.
measure to transitions of care, or if across all such encounters and across all Comment: A commenter
certain referrals would also continue to applicable measures. A provider should recommended that we require
be included as was the case prior to this consider how the policy will affect their medication reconciliation when a
rulemaking. Another commenter stated ability to meet all applicable measures, provider receives a Summary of Care
that they believe their CEHRT and then work with their EHR vendor to that is not a duplicate document and
incorrectly includes encounters in the ensure that the calculation of only reconcile if there are changes to the
denominator where no actual transition denominators and numerators matches medication list. Another commenter
of care is occurring or where the the provider’s decision. requested that automated results should
encounter is not a face-to-face encounter In terms of additional or expanded only be counted if there are medications
with the patient. exclusions or concerns over scope of in the queried document so it is possible
Many commenters provided practice, we note that we did not to ‘‘compare the medical record to an
recommendations for additional propose any such changes and disagree external list of medications obtained
exclusions for the objective including that any such changes are necessary or from a patient, hospital, or other
exclusions for providers who do not beneficial. We believe medication provider.’’
have office visits; and providers who reconciliation is an important part of Response: We note that we discuss
have fewer than 10 or 100 transitions of maintaining a patient’s record, that it is the denominator for a transition of care
care rather than limiting the exclusion integral to patient safety, and that in section II.B.1.b.(4)(f) of this final rule
to providers who not the recipient of maintaining an accurate list of with comment period and that in the
any transition or referral. Another medications may be relevant to any EHR Incentive Programs in 2015
commenter believes that medication provider’s plan of care for a patient. through 2017 proposed rule at (80 FR
20363) we proposed to maintain the the provider has never before in the denominator. We see no reason
definition for this objective from the encountered the patient’’ as specified in that patients referred from a provider
Stage 2 final rule when the EP is the the Stage 3 proposal) or only those new billing under a POS 22 should not be
recipient of the transition or referral, patients that are accompanied by a included in the definition of a transition
first encounters with a new patient and summary of care record. or referral.
encounters with existing patients where Response: For providers who are on After considerations of public
a summary of care record (of any type) the receiving end of a transition of care comments received, we are finalizing as
is provided to the receiving EP (77 FR or referral, the denominator includes proposed the objective, measure,
53984). We note that the reconciliation first encounters with a new patient and exclusion and alternate exclusions for
occurs with the transition or referral, encounters with existing patients where EPs, eligible hospitals, and CAHs as
not with the receipt of the summary of a summary of care record (of any type) follows:
care document. Therefore, if a provider is provided to the receiving provider.
receives duplicate summaries for a Comment: A commenter requested Objective 7: Medication Reconciliation
single referral such an action must only clarification of whether CMS intends to Objective: The EP, eligible hospital or
be counted once. In addition, the action limit the denominator of this proposed CAH that receives a patient from
of reviewing the medication list to measure to transitions of care, or if another setting of care or provider of
determine if there are changes or certain referrals would also continue to care or believes an encounter is relevant
confirm that there are no changes would be included as was the case prior to this performs medication reconciliation.
meet the requirements of the objective rulemaking. Measure: The EP, eligible hospital or
to count as an action in the numerator. Response: For the purposes of this CAH performs medication
Comment: Commenters requested that measure, we continue to maintain the reconciliation for more than 50 percent
CMS define what a ‘‘new’’ patient is for definition of a transition of care as the of transitions of care in which the
the purposes of the definition of a movement of a patient from one setting patient is transitioned into the care of
transition or referral. For example, one of care (for example, a hospital, the EP or admitted to the eligible
commenter noted that in their billing ambulatory primary care practice, hospital’s or CAH’s inpatient or
practices they define a patient as ‘‘new’’ ambulatory specialty care practice, long- emergency department (POS 21 or 23).
if they have not been seen in 2 years. term care, home health, rehabilitation
• Denominator: Number of transitions
The commenter noted that using this facility) to another. Referrals are cases
of care during the EHR reporting period
definition in the denominator would where one provider refers a patient to
for which the EP or eligible hospital’s or
include a greater number of relevant another, but the referring provider
CAH’s inpatient or emergency
patient encounters than our current maintains his or her care of the patient
department (POS 21 or 23) was the
definition which uses patients who as well. Thus, the denominator includes
receiving party of the transition.
were never before seen by the provider. both transitions of care and referrals in
• Numerator: The number of
The commenter suggested this which the provider was the transferring
transitions of care in the denominator
definition would ensure that these or referring provider.
Comment: The proposal to allow where medication reconciliation was
patients records were also updated
exclusion for this measure if a provider performed.
which would be a significant benefit.
Response: In the EHR Incentive was scheduled for Stage 1 but ‘‘did not • Threshold: The resulting percentage
Programs in 2015 through 2017 intend to select the Stage 1 Medication must be more than 50 percent in order
proposed rule (80 FR 20363) as in the Reconciliation menu objective’’ is vague for an EP, eligible hospital or CAH to
Stage 2 final rule (77 FR 54013), we and will lead to audit problems. It meet this measure.
consider a patient to be a new patient should just be clearly stated that this is • Exclusion: Any EP who was not the
if he or she has never before been seen exclusion for Stage 1 EPs. recipient of any transitions of care
by the provider. We agree that the Response: As explained in section during the EHR reporting period.
commenter’s definition of ‘‘new II.B.1.b.(4)(b)(iii) of this final rule with Alternate Exclusion:
patient’’ may capture a wider range of comment period where we acknowledge Alternate Exclusion: Provider may
patients for whom medication that it may be difficult for a provider to claim an exclusion for the measure of
reconciliation would be relevant and document intent and will not require the Stage 2 Medication Reconciliation
beneficial. While we will not change the such documentation. objective if for an EHR reporting period
denominator for this existing objective, Comment: While the commenter in 2015 they were scheduled to
a provider may use an expanded agrees that medication reconciliation is demonstrate Stage 1 but did not intend
definition which includes a greater a critical patient care requirement when to select the Stage 1 Medication
number of patients for whom the action patients move from one setting of care Reconciliation menu objective.
may be relevant within their practice. to another, they encourage us to specify We are adopting Objective 7:
We intend that our description of a new that transitions from physicians who Medication Reconciliation at
patient is a baseline that a provider furnish services in POS 22 code should § 495.22(e)(7)(i) for EPs and
must meet; however, if that requirement not be considered ‘‘transitions of care’’ § 495.22(e)(7)(ii) for eligible hospitals
is met the provider may include further for purposes of this objective and and CAHs. We further specify that in
actions or addition encounters relevant measure. order to meet this objective and
to their practice and patient population, Response: We note that we make no measures, an EP, eligible hospital, or
so long as the approach is applied distinction between settings nor do we CAH must use the capabilities and
universally across all such encounters, reference any POS code for the party standards of as defined for as defined
all settings and for the duration of the transitioning the patient. We consider a CEHRT at § 495.4. We direct readers to
EHR reporting period. transition as the movement of a patient section II.B.3 of this final rule with
Comment: A commenter requested from one care setting to another. We comment period for a discussion of the
clarification of whether the denominator reference POS in this objective only definition of CEHRT and a table
of medication reconciliation includes with regard to the inclusion of patients referencing the capabilities and
first encounters with all new patients admitted to either the Inpatient or standards that must be used for each
(in other words, ‘‘encounters in which Emergency Department (POS 21 and 23) measure.
Objective 8: Patient Electronic Access suggest covered providers reference the online access to their health
We proposed to retain the Stage 2 Department of Justice’s Effective information.
objective for Patient Electronic Access Communications guidance at http:// Threshold: The resulting percentage
for meaningful use in 2015 through www.ada.gov/effective-comm.htm. must be more than 50 percent in order
2017. We proposed to retain the first Proposed EP Measures: for an EP to meet this measure.
• EP Measure 1: More than 50 percent • Proposed EP Measure 2: At least
measure of the Stage 2 objective without
of all unique patients seen by the EP one patient seen by the EP during the
modification. We proposed to retain the
during the EHR reporting period are EHR reporting period (or his or her
second measure for the Stage 2 objective
provided timely (within 4 business days authorized representatives) views,
with modification to the measure
after the information is available to the downloads, or transmits his or her
threshold.
EP) online access to their health health information to a third party.
Proposed EP Objective: Provide • Proposed Exclusions: Any EP
patients the ability to view online, information subject to the EP’s
discretion to withhold certain who—
download, and transmit their health (a) Neither orders nor creates any of
information within 4 business days of information.
the information being available to the • EP Measure 2: At least one patient the information listed for inclusion as
seen by the EP during the EHR reporting part of the measures; or
EP. (b) Conducts 50 percent or more of his
Proposed Eligible Hospital/CAH period (or their authorized
representatives) views, downloads, or or her patient encounters in a county
Objective: Provide patients the ability to that does not have 50 percent or more
view online, download, and transmit transmits his or her health information
to a third party. of its housing units with 4Mbps
their health information within 36 hours broadband availability according to the
of hospital discharge. In order to meet this objective, the
following information must be made latest information available from the
In the Stage 2 proposed rule, we FCC on the first day of the EHR
stated that the goal of this objective was available to patients electronically
within 4 business days of the reporting period.
to allow patients easy access to their Proposed Eligible Hospital/CAH
health information as soon as possible, information being made available to the
EP: Measures:
so that they can make informed
++ Patient name. • Eligible Hospital/CAH Measure 1:
decisions regarding their care or share More than 50 percent of all patients who
++ Provider’s name and office contact
their most recent clinical information are discharged from the inpatient or
information.
with other health care providers and emergency department (POS 21 or 23) of
++ Current and past problem list.
personal caregivers as they see fit. ++ Procedures. an eligible hospital or CAH have their
The ability to have this information ++ Laboratory test results. information available online within 36
online means it is always retrievable by ++ Current medication list and hours of discharge.
the patient, while the download medication history. • Eligible Hospital/CAH Measure 2:
function ensures that the patient can ++ Current medication allergy list and At least 1 patient who is discharged
take the information with them when medication allergy history. from the inpatient or emergency
secure internet access is not available. ++ Vital signs (height, weight, blood department (POS 21 or 23) of an eligible
The patient must be able to access this pressure, BMI, growth charts). hospital or CAH (or his or her
information on demand, such as ++ Smoking status. authorized representative) views,
through a patient portal or PHR. We ++ Demographic information downloads or transmits to a third party
note that while a covered entity may be (preferred language, sex, race, ethnicity, his or her information during the EHR
able to fully satisfy a patient’s request date of birth). reporting period.
for information through VDT, the ++ Care plan field(s), including goals The following information must be
measure does not replace the covered and instructions. available to satisfy the objective and
entity’s responsibilities to meet the ++ Any known care team members measure:
broader requirements under HIPAA to including the primary care provider ++ Patient name.
provide an individual, upon request, (PCP) of record. ++ Admit and discharge date and
with access to PHI in a designated To calculate the percentage of the first location.
record set. Providers should also be measure for providing patient with ++ Reason for hospitalization.
aware that while meaningful use is timely online access to health ++ Care team including the attending
limited to the capabilities of CEHRT to information, CMS and ONC have of record as well as other providers of
provide online access there may be worked together to define the following care.
patients who cannot access their EHRs for this objective: ++ Procedures performed during
electronically because of their disability, • Proposed EP Measure 1: More than admission.
or who require assistive technology to ++ Current and past problem list.
50 percent of all unique patients seen by ++ Vital signs at discharge.
do so. Additionally, other health the EP during the EHR reporting period ++ Laboratory test results (available at
information may not be accessible. are provided timely (within 4 business time of discharge).
Finally, we noted that providers who days after the information is available to ++ Summary of care record for
are covered by civil rights laws, the EP) online access to their health transitions of care or referrals to another
including the Americans with information subject to the EP’s provider.
Disabilities Act, Section 504 of the discretion to withhold certain ++ Care plan field(s), including goals
Rehabilitation Act of 1973, or Section information. and instructions.

1577 of the Affordable Care Act, must Denominator: Number of unique ++ Discharge instructions for patient.
provide individuals with disabilities patients seen by the EP during the EHR ++ Demographics maintained by
equal access to information and reporting period. hospital (sex, race, ethnicity, date of
appropriate auxiliary aids and services Numerator: The number of patients in birth, preferred language).
as provided in the applicable statutes the denominator who have timely ++ Smoking status.
and regulations. For a useful reference (within 4 business days after the To calculate the percentage of the first
of how to meet these obligations, we information is available to the EP) measure for providing patients timely
access to discharge information, CMS become more comfortable accessing and the EHR reporting period have access to
and ONC have worked together to using patient portals, and will not view, download, and transmit their
define the following for this objective: penalize providers for failing to meet health information. In the proposed
• Proposed Eligible Hospital/CAH thresholds based on patient actions they rule, we proposed only to modify the
Measure 1: More than 50 percent of all cannot control. second measure (which measures the
patients who are discharged from the Response: We thank the commenters patient’s action, not the provider) from
inpatient or emergency department for their feedback concerning this a threshold of 5 percent to at least one
(POS 21 or 23) of an eligible hospital or proposed change in the EHR Incentive patient.
CAH have their information available Programs in 2015 through 2017. Comment: While some commenters
online within 36 hours of discharge. Comment: A number of commenters supported EP Measure 1 as proposed,
Denominator: Number of unique opposed our proposal to modify the many more were concerned with
patients discharged from an eligible second measure requiring that patients patients’ general ability to access their
hospital’s or CAH’s inpatient or taking action to view, download, or health information. A portion of
emergency department (POS 21 or 23) transmit their health information. These respondents in disagreement with
during the EHR reporting period. commenters stated concern that the Measure 1 were concerned the 50
Numerator: The number of patients in change will have a negative effect on percent threshold will be unattainable
the denominator whose information is patients access to their health record because their patient population is
available online within 36 hours of because it will allow providers to stop elderly, ill, low-income, and/or located
discharge. investing in the workflows, training, in remote, rural areas. These patients do
Threshold: The resulting percentage and patient education needed to support not have access to computers, Internet
must be more than 50 percent in order patient access. and/or email and are concerned with
for an eligible hospital or CAH to meet Other commenters urged CMS to having their health information online.
this measure. ‘‘preserve the existing thresholds for Several others believe Measure 1 is
• Proposed Eligible Hospital/CAH patient online access and secure, unnecessary, as patients must use the
Measure 2: At least 1 patient who is messaging’’ stating that requiring that access provided in order for an EP,
discharged from the inpatient or only one patient has access is not eligible hospital or CAH to meet
emergency department (POS 21 or 23) of meaningful enough. These commenters Measure 2 of this objective. A number
an eligible hospital or CAH (or his or included statements advocating for of commenters also disagreed with the
her authorized representative) views, patients to have the ability to access requirement for the provision of new
downloads or transmits to a third party their EHR and that we should not information within 36 hours for eligible
his or her information during the EHR reduce the threshold to let providers off hospitals and CAHs (four business days
reporting period. the hook. for EPs) stating that it was either too
• Proposed Exclusion: Any eligible Response: We appreciate the long a time for patients to wait or too
hospital or CAH that is located in a commenters’ advocacy for patients and short a time for providers to respond.
county that does not have 50 percent or agree that patient electronic access to Response: We have proposed no
more of its housing units with 4Mbps health information is essential to changes to the first measure and
broadband availability according to the improving the quality of care. However, reiterate our intent to maintain the first
latest information available from the we disagree that reducing the patient measure as previously finalized in the
FCC on the first day of the EHR action measure will negatively impact Stage 2 final rule. We note that
reporting period. the workflows, training, and patient providing access to patients to view,
education for patient access because the download, and transmit their
Proposed Alternate Exclusions and patient access measure is still fully in information is a top priority for patient
Specifications for Stage 1 Providers for place: That is, measure 1 which requires engagement, patient-centered care, and
Meaningful Use in 2015 providers to ensure that more than 50 care coordination. We note that in the
We proposed that providers percent of patients are provided access EHR Incentive Programs, the
scheduled to demonstrate Stage 1 of to their health information. This specifications for the measure allow the
meaningful use for an EHR reporting measure requires that providers ensure provision of access to take many forms
period in 2015 may additionally claim that patients have all the information and do not require a provider to obtain
an exclusion for the second measure of they need to access their record, even an email address from the patient. We
the Stage 2 Patient Electronic Access for patients who may choose to opt out, understand that many CEHRT products
objective because there is not an so a provider cannot stop doing the may be designed in that fashion, but it
equivalent Stage 1 measure defined at workflows, training, and patient is not by the program.
42 CFR 495.6. education for patient access and still If a provider’s CEHRT does require a
Proposed Alternate Exclusion meet the requirements of meaningful patient email address, but the patient
Measure 2: Providers may claim an use for measure one of this objective. does not have or refuses to provide an
exclusion for the second measure if for For the commenters who state that email address or elects to ‘‘opt out’’ of
an EHR reporting period in 2015 they one patient having access is not participation, that is not prohibited by
were scheduled to demonstrate Stage 1, meaningful enough, we believe these the EHR Incentive Program
which does not have an equivalent commenters may have misunderstood requirements nor does it allow the
measure. which measure we proposed to modify. provider to exclude that patient from
We proposed no alternate As noted, we proposed no changes to the denominator. Instead, the provider
specifications for this objective. the first measure under the Patient may still meet the measure by providing
Comment: Many commenters Electronic Access objective which is that patient all of the necessary
appreciate the proposed modifications required for all providers in Stage 1 and information required for the patient to
to the objective’s measures that rely on Stage 2, in Medicare and Medicaid, and subsequently access their information,
patient’s actions. Many respondents for both EPs, eligible hospitals, and obtain access through a patient-
believe the flexibility provided in the CAHs. For this measure, each provider authorized representative, or otherwise
modifications will provide more time must demonstrate that more than 50 opt-back-in without further follow up
for both providers and patients to percent of their unique patients during action required by the provider. We note
that we have proposed no changes to the For example, if a provider’s CEHRT providers to use an alternate calculation
timeframe for provision of new uses an enrollment process to issue a for an EHR reporting period in 2015 and
information and maintain that 36 hours user ID to the patient, a provider does 2016 if that calculation is a part of their
(for eligible hospitals and CAHs) and 4 not need to create a new user ID for a CEHRT to allow sufficient time to
business days (for EPs) is a reasonable patient each time the patient has an upgrade the calculation prior to
time limit because it allows for office visit. That initial enrollment can providers attesting to data for an EHR
immediate access (if feasible) and a occur any time as it is not governed by reporting period in 2017.
reasonable amount of time for providers the measure. What the measure Comment: Those commenters in
to review any information necessary addresses is the health information that support of the changes to measure 2 of
before it is made available to the patient. results from care (e.g. from an office this objective supported our
Comment: A commenter noted that visit or a hospital admission). The incorporation of stakeholder and
the patient access measure 1 needs measure timeline for making any health participant feedback into the
clarification as to when it must occur in information available resets to 36 hours modifications of this measure.
relation to the EHR reporting period. for an eligible hospital or CAH and 4 Supporting commenters agreed with the
The commenter further stated that once business days for an EP each time new proposed patient engagement threshold
a patient has been provided access there information is available to which the reduction, stating that it is currently
is no need to provide additional access patient should be provided access. unattainable for their practice due to a
unless the patient originally opted out Therefore, although a provider does not patient population that is elderly, ill,
of receiving electronic access. The need to enroll a unique patient a second low-income, and/or located in remote,
commenter further noted that active, time if the patient has a second office rural areas. For these sites, commenters
ongoing access that preceded the EHR visit during the EHR reporting period, believe lowering the threshold will
reporting period should always count in the provider must continue to update permit them flexibility in working with
the numerator for a patient seen during the information accessible to the patient their vendors and developing new
the EHR reporting period. The each time new information is available. approaches to increase their patient
commenter also states that when a In addition, if the provider fails to engagement.
patient opts out of electronic access, as provide access to a patient upon an Response: We thank the commenters
long as the patient was properly initial visit during the EHR reporting for their contribution. We believe that
educated on the portal and how to gain period, but provides access on a continued efforts to raise awareness and
access, there should be no need to count subsequent visit, the patient cannot be provide access through a wider range of
access again. counted in the numerator because the electronic means (such as the inclusion
Further commenters referenced EHR patient did not have timely online of APIs in the Stage 3 measure) will
Incentive Programs FAQ 8231 10 and help to expand the adoption of this
access to health information related to
recommended that we clarify measure technology over time.
the first visit. Similarly, the patient
one and measure 2, and suggested that Comment: The majority of
cannot be included in the numerator if commenters concerned about the
all measure with a denominator access is provided on the first visit, but
referencing unique patient should allow modifications of Measure 2 believe
the provider fails to update the lowering the patient engagement
a provider to count actions from any information within the time period
time period before the reporting period threshold is counter-productive for
required after the second visit. In short, improving patient outcomes and moving
or reporting year to count in the a patient who has multiple encounters
numerator. the meaningful use program forward.
during the EHR reporting period, or Commenters worry the new threshold is
Response: We believe the confusion even in subsequent EHR reporting
on this issue for the first measure may much too low to incentivize providers
periods in future years, needs to have to encourage patient access to the
relate to the ways in which different access to the information related to their
EHRs are set up to initiate access for a electronic health records that are central
care for each encounter where they are to the overarching goal of meaningful
patient the first time. The measure does seen by the EP or discharged from the
not address the enrollment process or use.
eligible hospital or CAH’s inpatient or Some commenters disagreed with the
how the initiation process to ‘‘turn on’’ emergency department.
access for a patient within an EHR modifications to Measure 2 and are
In relation to the suggestion that the concerned with the large jump to meet
system should function. The measure is
second measure should be allowed to be the proposed Stage 3 meaningful use
addressing the health information itself.
calculated including any action in any VDT requirement in 2018. Several
To count in the numerator, this health
time period before the EHR reporting commenters believe that the reduction
information needs to be made available
period to count in the numerator, we of the patient engagement threshold will
to each patient for view, download, and
strongly disagree. We do not believe a slow momentum of this measure leaving
transmit within 4 business days of its
single instance of a patient accessing providers ill-prepared for the future of
availability to the provider for each and
their record should be counted in meaningful use. Many commenters
every time that information is generated
perpetuity for the measure. The believed that lowering the requirement
whether the patient has been ‘‘enrolled’’
calculation may include actions taken to only one patient viewing,
for three months or for three years. We
before, during, or after the EHR downloading, or transmitting their
note that a patient needs to be seen by
reporting period if the period is less health information is counterproductive
the EP during the EHR reporting period
than one full year; however, consistent to improving patient outcomes
or be discharged from the hospital
with FAQ 8231, these actions must be nationally. Engaging patients by using
inpatient or emergency department
taken no earlier than the start of the technology is a critical path to move the
during the EHR reporting period in
same year as the EHR reporting period healthcare system forward and
order to be included in the
and no later than the date of attestation. demonstrate the core value of
denominator.
We understand, as discussed in section meaningful use. Several commenters
10 FAQ 8231. www.cms.gov/ehrincentiveprograms II.B.1.b.(4), that some certified EHRs recommended a phased approach for
CMS Frequently Asked Questions: EHR Incentive may not calculate the numerator in this the threshold for the measure,
Programs (archived). fashion and therefore we will allow increasing over time to the proposed
Stage 3 level. They recommended a commenters who noted that it provides EP Measure 2: For an EHR reporting
phased approach that recognizes the additional time for the adoption of period in 2015 and 2016, at least one
challenges that some providers are technology by patients, but also patient seen by the EP during the EHR
encountering as they try to get their maintains the importance of the reporting period (or patient-authorized
patient population more engaged with measure. We believe this approach will representative) views, downloads or
viewing, downloading or transmitting allow providers to set a progressive goal transmits to a third party his or her
their information to a third party. They with incremental increases in health information during the EHR
believe that a higher measure threshold performance through 2018. We believe reporting period.
will be easier to achieve as the this approach is in line with our policy • Denominator: Number of unique
technology becomes even more user- to build from basic to advanced use and patients seen by the EP during the EHR
friendly and patients begin to see the to increase measure thresholds over reporting period.
value in becoming more involved in time and that it will also maintain the • Numerator: The number of patients
their own care and taking these actions. incentive for providers to focus on in the denominator (or patient-
Overall, they believe a phased-in methods and approaches to increase authorized representative) who view,
approach for the patient electronic patient engagement. Therefore, we are download, or transmit to a third party
access objective would be an finalizing a change from our proposal their health information.
appropriate and balanced step forward. for 2015 through 2017 to build toward • Threshold: The numerator and
Response: We agree that providers the Stage 3 measure threshold required denominator must be reported, and the
have a role in promoting behavioral in 2018. We are setting the measure numerator must be equal to or greater
change among patients in regard to threshold at 1 patient for 2015 and 2016 than 1.
engaging with their health information and 5 percent in 2017 to work toward • Exclusions: Any EP who—
and increasing health literacy and that the increased threshold for Stage 3 in Æ Neither orders nor creates any of
provider influence may be a factor. 2018 (see also section II.B.2.b.(vi) for the the information listed for inclusion as
However, as noted in the EHR Incentive Stage 3 objective). part of the measures; or
Programs in 2015 through 2017 After consideration of public Æ Conducts 50 percent or more of his
proposed rule (80 FR 20357), statistical comment received, we are finalizing the or her patient encounters in a county
analysis of measure performance shows objective and the alternate exclusion to that does not have 50 percent or more
a wide variance, and further analysis in Measure 2 as proposed for EPs, eligible of its housing units with 4Mbps
comparison to the first measure does not hospitals and CAHs. broadband availability according to the
show a correlation between provider We are finalizing Measure 1 with latest information available from the
action and patient response.11 Through modifications to improve the clarity of FCC on the first day of the EHR
our analysis we found that neither high the measure language based on reporting period.
nor low performance on the first stakeholder feedback and Measure 2 For an EHR reporting period in 2017,
measure nor an overall increase or with modifications to the thresholds more than 5 percent of unique patients
decrease in the number of patients who and to specify the timing of the action seen by the EP during the EHR reporting
have access to their data, had a strong for EPs to match the eligible hospital period (or his or her authorized
or moderate correlation to performance and CAH measure. We are maintaining representatives) view, download or
on patient action either for high our prior policy for the information that transmit to a third party their health
performers or low performers. This must be provided to the patient for the information during the EHR reporting
suggests that other external factors objective as proposed. period.
currently impact performance on the We are adopting the objective as • Denominator: Number of unique
objective. This may include a lag in the follows: patients seen by the EP during the EHR
adoption of technologies by patients, reporting period.
Objective 8: Patient Electronic Access • Numerator: The number of patients
patient self-selection, or other unknown
factors related to the IT environment EP Objective: Provide patients the in the denominator who view,
and the patients themselves. We believe ability to view online, download, and download, or transmit to a third party
that continued efforts to raise awareness transmit their health information within their health information.
and provide access through a wider 4 business days of the information being • Threshold: The resulting percentage
range of electronic means (such as the available to the EP. must be greater than 5 percent.
inclusion of APIs in the Stage 3 EP Measure 1: More than 50 percent • Exclusions: Any EP who—
measure) will help to expand the of all unique patients seen by the EP Æ Neither orders nor creates any of
adoption of this technology over time, during the EHR reporting period are the information listed for inclusion as
and we maintain that providers should provided timely access to view online, part of the measures; or
be supported in that effort rather than download, and transmit to a third party Æ Conducts 50 percent or more of his
having additional burden added for their health information subject to the or her patient encounters in a county
factors outside their control. EP’s discretion to withhold certain that does not have 50 percent or more
We wish to reiterate that we information. of its housing units with 4Mbps
understand the concerns voiced by • Denominator: Number of unique broadband availability according to the
providers regarding patient populations patients seen by the EP during the EHR latest information available from the
that are unable to engage in their health reporting period. FCC on the first day of the EHR
care information electronically due to • Numerator: The number of patients reporting period.
various factors, which include income, in the denominator who have access to Eligible Hospital/CAH Objective:
age, technological capabilities, or view online, download and transmit Provide patients the ability to view
comprehension. We agree with the their health information within 4 online, download, and transmit their
phased approach recommended by the business days after the information is health information within 36 hours of
available to the EP. hospital discharge.
11 EHR Incentive Programs Performance Data: • Threshold: The resulting percentage Eligible Hospital/CAH Measure 1:
Program Data and Reports: www.cms.gov/EHR must be more than 50 percent in order More than 50 percent of all unique
Incentive Programs. for an EP to meet this measure. patients who are discharged from the
inpatient or emergency department or transmit to a third party their health Proposed Alternate Exclusions and
(POS 21 or 23) of an eligible hospital or information. Specifications for Stage 1 Providers for
CAH are provided timely access to view • Threshold: The resulting percentage Meaningful Use in 2015
online, download and transmit to a must be greater than 5 percent. We proposed that an EP scheduled to
third party their health information. • Exclusion: Any eligible hospital or demonstrate Stage 1 of meaningful use
• Denominator: Number of unique CAH that is located in a county that for an EHR reporting period in 2015
patients discharged from an eligible does not have 50 percent or more of its may claim an exclusion for the secure
hospital’s or CAH’s inpatient or housing units with 4Mbps broadband electronic messaging objective measure
emergency department (POS 21 or 23) availability according to the latest as there is not an equivalent Stage 1
during the EHR reporting period. information available from the FCC on objective or measure defined at 42 CFR
• Numerator: The number of patients the first day of the EHR reporting 495.6.
in the denominator who are have access period. • Alternate Exclusion: An EP may
to view, download, and transmit their Alternate Exclusion: Providers may claim an exclusion for the measure if for
health information within 36 hours after claim an exclusion for the second an EHR reporting period in 2015 they
the information is available to the measure if for an EHR reporting period were scheduled to demonstrate Stage 1,
eligible hospital or CAH. in 2015 they were scheduled to
• Threshold: The resulting percentage which does not have an equivalent
demonstrate Stage 1, which does not measure.
must be more than 50 percent in order have an equivalent measure. We proposed no alternate
for an eligible hospital or CAH to meet We are adopting Objective 8: Patient specifications for this objective and
this measure. Electronic Access at § 495.22(e)(8)(i) for
Eligible Hospital/CAH Measure 2: For there is no equivalent objective for
EPs and § 495.22(e)(8)(ii) for eligible eligible hospitals and CAHs in the Stage
an EHR reporting period in 2015 and
hospitals and CAHs. We further specify 2 objectives and measures for
2016, at least 1 patient who is
that in order to meet this objective and meaningful use.
discharged from the inpatient or
measures, an EP, eligible hospital, or Comment: Some commenters
emergency department (POS 21 or 23) of
CAH must use the capabilities and expressed their general support for
an eligible hospital or CAH (or patient-
standards of as defined for as defined secure messaging, stating their
authorized representative) views,
CEHRT at § 495.4. We direct readers to appreciation for the convenience and
downloads or transmits to a third party
section II.B.3 of this final rule with ease with messaging their EPs
his or her health information during the
comment period for a discussion of the electronically. Numerous commenters
EHR reporting period.
definition of CEHRT and a table also agreed with exclusions for EPs with
• Denominator: Number of unique
referencing the capabilities and no office visits during the EHR reporting
patients discharged from the inpatient
standards that must be used for each period and recommended a higher
or emergency department (POS 21 or 23)
measure. number than zero. A commenter
of the eligible hospital or CAH during
the EHR reporting period. Objective 9: Secure Electronic expressed support for the alternate
• Numerator: The number of patients Messaging (EP Only) exclusion and requested the extension
(or patient-authorized representative) in of this exclusion beyond 2015.
We proposed to retain the EP Stage 2 Commenters expressing general
the denominator who view, download,
objective for secure electronic opposition to secure messaging cited
or transmit to a third party their health
messaging with modifications to the their patients’ reluctance to sign up for
information.
• Threshold: The numerator and measure for meaningful use in 2015 the portal due to data breach fears, lack
denominator must be reported and the through 2017. of internet familiarity, and overall lack
numerator must be equal to or greater Proposed Objective: Use secure of access. Other commenters also
than 1. electronic messaging to communicate recommended continuing the reduced
• Exclusion: Any eligible hospital or with patients on relevant health requirement in the future.
CAH that is located in a county that information. Response: We thank the commenters
does not have 50 percent or more of its Proposed Measure: The capability for for their insight. We believe that given
housing units with 4Mbps broadband patients to send and receive a secure the proposed changes to the measure,
availability according to the latest electronic message with the provider the current exclusions are adequate and
information available from the FCC on was fully enabled during the EHR that the proposed alternate exclusion
the first day of the EHR reporting reporting period. does not need to be extended beyond
period. We proposed to retain the exclusion 2015.
For an EHR reporting period in 2017, for EPs who have no office visits and for Comment: Many commenters
more than 5 percent of unique patients those EPs who lack the infrastructure disagreed with the proposal to lower the
discharged from the inpatient or required for secure electronic messaging threshold, with some believing that it
emergency department (POS 21 or 23) of due to being located in areas with takes momentum away from patient
an eligible hospital or CAH (or patient- limited broadband availability as engagement. Some commenters
authorized representative) view, identified by the Federal conflated the proposals and stated the
download or transmit to a third party Communications Commission (FCC). same concerned opposition for secure
their health information during the EHR Exclusion: Any EP who has no office messaging as for the patient action
reporting period. visits during the EHR reporting period, measure discussed in section
• Denominator: Number of unique or any EP who conducts 50 percent or II.B.2.a.(viii) stating that ‘‘one patient’’
patients discharged from the inpatient more of his or her patient encounters in for secure messaging is not meaningful
or emergency department (POS 21 or 23) a county that does not have 50 percent enough.
of the eligible hospital or CAH during or more of its housing units with 4Mbps Response: We appreciate the
the EHR reporting period. broadband availability according to the commenters’ advocacy for patients and
• Numerator: The number of patients latest information available from the applaud their efforts to promote patient
(or patient-authorized representative) in FCC on the first day of the EHR engagement and raise awareness about
the denominator who view, download, reporting period. the need for accessibility of health
information. We agree with the intent We believe that the measure should commenters’ recommendations for a
behind the policy and support the be modified to better serve as a phased in approach over the period of
policy goal of promoting enhanced foundation for a more dynamic use of 2015 through 2017 to the Stage 3
patient and provider engagement, and HIT for patient engagement. For this threshold in 2018, as it will allow
leveraging HIT solutions to enhance reason, we proposed to continue providers to work incrementally toward
patient and provider communications. support of the function and to adopt a a high goal and is consistent with our
We direct readers to the proposed more dynamic measure for Stage 3 that past policy in the program to establish
measure we included for the Stage 3 will help drive adoption and innovation incremental change from basic to
Objective for Coordination of Care to support the long-term goals of advanced use and increased thresholds
through Patient Engagement in section leveraging HIT for patient engagement. over time. We will therefore finalize
II.B.2.b.vi of this final rule with Comment: General recommendations ‘‘fully enabled’’ for 2015, at least one
comment period. We would like to from commenters included encouraging patient for 2016, and a threshold of 5
highlight some key differences between greater definition around secure percent for 2017 to build toward the
the Stage 3 proposed objective and the messaging, allowing for texting/ Stage 3 threshold addressed in section
current objective, which are the result of voicemail/other options, adding more II.B.2.b.6 of this final rule with
lessons learned through feedback over exclusions, and taking into comment period.
the past few years from providers about consideration patients’ preferences for We cannot fully adopt the Stage 3
their efforts to implement the communication with their EPs. Some specifications as the commenters
requirements of the EHR Incentive commenters requested clarification on recommend because some parts, such as
Program. We believe this will help to what we consider ‘‘fully enabled’’ when communications among care team
illustrate why we proposed to reduce it comes to secure messaging. members, would not be supported by
the threshold for this Secure Messaging In addition, some commenters EHR technology certified to the 2014
objective and how we are seeking to opposed lowering the threshold believe Edition certification criteria. However,
maintain the policy of moving patient that removing the current thresholds we agree that it makes sense to focus the
engagement forward. will not help or encourage providers to measure on provider action rather than
prepare for upcoming Stage 3 on patient action and to allow provider
As noted in the Stage 3 proposed rule thresholds. These commenters initiated actions to be included in the
(80 FR 16756) and for the Stage 3 recommended that we consider an numerator. As noted previously, we
objective in section II.B.2.b.vi of this incrementally phased-in approach believe that a measure that more
final rule with comment period, we towards measure thresholds to balance accurately reflects the policy goal for
included proposals for bi-directional the challenges providers face in delivery system reform should include
communication and communications promoting patient engagement. These these provider initiated actions and we
among and between the patient and commenters suggested beginning with also agree with the inclusion of
multiple providers in a care team. We simple enabled functions as proposed interactions involving a patient-
also expanded the potential role of and increasing the threshold authorized representative as this is an
patient-authorized representatives, and incrementally year over year to work important factor for many patients in
we sought to adopt a wider range of toward the proposed Stage 3 threshold coordinating care. We will therefore
communications methods that could of 35 percent rather than having a static modify the current objective to include
support and promote patient-centered low threshold and a sudden jump to a provider initiated communications and
care coordination. We proposed this higher level in Stage 3. communications with a patient-
objective because we believe that Still other commenters requested authorized representative in the
leveraging health IT to support care expanding the definition of secure numerator. We note that this change
team communications in which a messaging in the current objective to also means that a patient-initiated
patient is actively engaged can lead to reflect the options and methods message would only count toward the
better care coordination and better proposed for the Stage 3 objective. numerator if the provider responded to
outcomes for the patient. However, the These commenters requested that the patient as that is part of measuring
current Stage 2 secure messaging provider initiated messaging should be the provider action rather than the
objective as finalized in the 2012 Stage the action that counts toward the patient action for this measure. As this
2 final rule (77 FR 54031) does not numerator for the current objective and measurement would not be required
include this flexibility of form, method that communications with a patient- until 2016 and then at a level of only 1
and participation. It includes only authorized representative on the patient, we believe it is reasonable to
patient-initiated communication rather patient’s behalf should also count make this change in the counting
than provider driven engagement, and it toward the measure. methodology in the current objective.
does not promote a wide range of use Response: Fully enabled means the Comment: Some commenters stated a
cases. Comments received indicate that function is fully installed, any security belief that the unique patient measures,
this is a significant shortfall in the measures are fully enabled, and the including secure messaging, should be
language of the current measure function is readily available for patient able to pull data from any time period
supporting the identified health care use. We note that we have proposed no before the reporting period and
delivery system reform goal. In addition, changes to the definition of secure reporting year in order to qualify in the
commenters note that these factors and messaging for this measure or to any of numerator. These commenters noted
other environmental or patient related the exclusions apart from the proposed that this clarification would reduce the
factors create a significant burden on alternate exclusion for Stage 1 providers unnecessary burden placed on
providers and negatively impact a in 2015. We proposed to remove the physicians, and the waste of resources
provider’s ability to meet the measure. Stage 2 threshold of 5 percent and to provide the patient with the same
This means that providers are investing instead require that the capability for information they have already been
a large amount of resources to achieve patients to send and receive a secure provided.
a measure that is flawed, does not electronic message is fully enabled Response: We do not believe a single
adequately meet the intended health during the EHR reporting period (80 FR instance of a patient sending a secure
goal, and provides only a limited value. 20365). However, we agree with message should be counted in
perpetuity for the measure. The patient-authorized representative), or in where prohibited and in accordance
calculation may include actions taken response to a secure message sent by the with applicable law and practice.
before, during, or after the EHR patient (or the patient-authorized In the EHR Incentive Programs for
reporting period if the period is less representative) during the EHR 2015 through 2017 proposed rule 80 FR
than one full year; however, consistent reporting period. 20366, we highlighted our intention to
with FAQ 8231, these actions must be • Denominator: Number of unique align with the Stage 3 proposed rule and
taken no earlier than the start of the patients seen by the EP during the EHR remove the prior ongoing submission
same year as the EHR reporting period reporting period. requirement and replace it with an
and no later than the date of attestation. • Numerator: The number of patients ‘‘active engagement’’ requirement. We
We understand, as discussed in section in the denominator for whom a secure reiterated our definition of ‘‘active
II.B.1.b.(4)(f), that some certified EHRs electronic message is sent to the patient engagement’’ as defined in the Stage 3
may not calculate the numerator in this (or patient-authorized representative), or proposed rule at (80 FR 16739 and
fashion; however, as we are also in response to a secure message sent by 16740) and noted our proposal to adopt
changing the threshold for the measure the patient (or patient-authorized the same definition for the Modified
so that significant measurement will not representative). Stage 2 objective proposed for 2015
be required until 2016 and then at a • Threshold: The resulting percentage through 2017 as we believe this change
required level of only 1 patient, we must be more than 5 percent in order for is more aligned with the process
believe that changing this calculation an EP, eligible hospital, or CAH to meet providers undertake to report to a
will not drastically impact EHR this measure. clinical registry or public health agency.
developers and providers. Exclusion: Any EP who has no office At (80 FR 20366), we proposed that
After consideration of the comments visits during the EHR reporting period, ‘‘active engagement’’ may be
received, we are finalizing as proposed or any EP who conducts 50 percent or demonstrated by any of the following
the objective, exclusion, and alternate more of his or her patient encounters in options:
exclusion as proposed. We are finalizing a county that does not have 50 percent Proposed Active Engagement Option
the measure with the modifications to or more of its housing units with 4Mbps 1—Completed Registration to Submit
the thresholds. We are adopting the broadband availability according to the Data: The EP, eligible hospital or CAH
objective as follows: latest information available from the registered to submit data with the PHA
Objective 9: Secure Electronic FCC on the first day of the EHR or, where applicable, the CDR to which
Messaging (EP Only) reporting period. the information is being submitted;
Alternate Exclusion: registration was completed within 60
EP Objective: Use secure electronic days after the start of the EHR reporting
Alternate Exclusion: An EP may claim
messaging to communicate with period; and the EP, eligible hospital, or
an exclusion for the measure if for an
patients on relevant health information. CAH is awaiting an invitation from the
EP Measure: For an EHR reporting EHR reporting period in 2015 they were
scheduled to demonstrate Stage 1, PHA or CDR to begin testing and
period in 2015, the capability for
which does not have an equivalent validation. This option allows providers
patients to send and receive a secure
measure. to meet the measure when the PHA or
electronic message with the EP was
We are adopting Objective 9: Secure the CDR has limited resources to initiate
fully enabled during the EHR reporting
Electronic Messaging at § 495.22(e)(9)(i) the testing and validation process.
period.
For an EHR reporting period in 2016, for EPs. We further specify that in order Providers that have registered in
for at least 1 patient seen by the EP to meet this objective and measures, an previous years do not need to submit an
during the EHR reporting period, a EP must use the capabilities and additional registration to meet this
secure message was sent using the standards of as defined for as defined requirement for each EHR reporting
electronic messaging function of CEHRT CEHRT at § 495.4. We direct readers to period.
to the patient (or the patient-authorized section II.B.3 of this final rule with Proposed Active Engagement Option
representative), or in response to a comment period for a discussion of the 2—Testing and Validation: The EP,
secure message sent by the patient (or definition of CEHRT and a table eligible hospital, or CAH is in the
the patient-authorized representative) referencing the capabilities and process of testing and validation of the
during the EHR reporting period. standards that must be used for each electronic submission of data. Providers
• Denominator: Number of unique measure. must respond to requests from the PHA
patients seen by the EP during the EHR or, where applicable, the CDR within 30
Objective 10: Public Health and Clinical days; failure to respond twice within an
reporting period. Data Registry Reporting
• Numerator: The number of patients EHR reporting period would result in
in the denominator for whom a secure In the EHR Incentive Programs in that provider not meeting the measure.
electronic message is sent to the patient 2015 through 2017 proposed rule 80 FR Proposed Active Engagement Option
(or patient-authorized representative), or 20366,we proposed to adopt a modified 3—Production: The EP, eligible
in response to a secure message sent by version of the consolidated Public hospital, or CAH has completed testing
the patient (or patient-authorized Health and Clinical Data Registry and validation of the electronic
representative). Reporting objective proposed in the submission and is electronically
• Threshold: The numerator and Stage 3 proposed rule for all providers submitting production data to the PHA
denominator must be reported, and the to demonstrate meaningful use for an or CDR.
numerator must be equal to or greater EHR reporting period in 2015 through We noted that the change in
than 1. 2017. definition is intended to better capture
For an EHR reporting period in 2017, Proposed Objective: The EP, eligible the activities a provider may conduct in
for more than 5 percent of unique hospital or CAH is in active engagement order to engage with a PHA or CDR, and
patients seen by the EP during the EHR with a Public Health Agency (PHA) or that any prior action taken to meet the
reporting period, a secure message was clinical data registry (CDR) to submit non-consolidated public health
sent using the electronic messaging electronic public health data in a reporting objectives of meaningful use
function of CEHRT to the patient (or the meaningful way using CEHRT, except Stages 1 and 2 would count toward
meeting the active engagement proposed rule includes the exact same Comment: Commenters also requested
requirement of this objective. requirement under ‘‘Active Engagement clarification regarding whether a
Comment: Many commenters Option 1: Completed Registration to provider can successfully attest to
expressed concern regarding whether Submit Data.’’ meaningful use using proof of active
provider and developers would have We also believe that the flexibility engagement collected by their
adequate time to implement a new within the active engagement options organization, or whether a provider
active engagement requirement in place enables a provider additional time to must demonstrate that they
of the ongoing submission requirement determine the option that is best suited independently engaged with the PHA or
in time to successfully attest for an EHR to their practice. For example, in Active CDR.
reporting period in 2015. Engagement Option 1, we also proposed Response: Providers can demonstrate
Response: We note that while the that a provider would be required to meaningful use by using
active engagement options included in register to submit data to the PHA communications and information
the EHR Incentive Program for 2015 to within 60 days of the beginning of the provided by a PHA or CDR to the
2017 replace the ‘‘ongoing submission’’ EHR reporting period and not on the provider directly. A provider also may
requirement included in the Stage 2 first day of the EHR reporting period. demonstrate meaningful use by using
final rule, they should not be considered We believe that this 60-day timeframe communications and information
mutually exclusive. We note that for will benefit providers who seek to provided by a PHA or CDR to the
providers who have already planned for determine whether Option 1 best practice or organization of the provider
and/or acted toward meeting any of the captures their reporting status, or as long as the provider shares the same
Stage 1 or Stage 2 public health whether Option 2 or Option 3 are more CEHRT as the practice or organization.
reporting objectives, those actions appropriate. We further note that this Comment: Some comments requested
would count toward meeting the active requirement would allow a provider to clarification of the definition of
engagement options. begin their registration prior to the start production under Active Engagement
For clarification on the rationale
of their EHR reporting period if such Option 3.
behind this change, we note that over
were necessary, so long as the action Response: To meet any of the
the past few years, we have received
was completed within 60 days of the measures using Active Engagement—
feedback on the Stage 1 and Stage 2
start of the EHR reporting period. Option 3 (production), we proposed that
public health reporting objectives
through letters, public forums, and Comment: Commenters requested a provider only may successfully attest
individual inquiries from both clarification on whether a provider to meaningful use when the receiving
providers/provider representatives and needed to register each year under the PHA or CDR moves the provider into a
from public health agencies. The active engagement option 1. production phase. We recognize that
common trend in these communications Commenters noted that requiring live data may be sent during the Testing
is that the difference between the Stage registration each year would result in and Validation phase of Active
1 and Stage 2 requirements and the duplicative registrations. Commenters Engagement: Option 2, but-in such a
‘‘ongoing submission’’ structure for the also requested clarity on whether case the data received in Option 2 is
Stage 2 objectives created confusion registration is required for each insufficient for purposes of meeting
around both the actions required and measure. A commenter noted that they Option 3 unless the PHA and CDR is
the timing of those actions for providers. recommend that clarity be provided actively accepting the production data
The active engagement requirement regarding whether registration is from the provider for purpose of
clarifies what is expected of a provider required for measures that the provider reporting.
who seeks to meet the measures within has not registered for previously (for Proposed Measures: We proposed a
this objective and more accurately example, measures not included in total of six possible measures for this
describes the actions necessary to meet Stage 2). objective. For meaningful use in 2015
each option within the structure. This Response: As we have noted through 2017, EPs would be required to
does not mean that actions a provider elsewhere in this final rule with choose from Measures 1 through 5, and
has already taken in an attempt to meet comment period, under the proposed would be required to successfully attest
the ‘‘ongoing submission’’ requirement active engagement requirement, to any combination of two measures.
would not be acceptable under the new providers would only need to register For meaningful use in 2015 through
objective. Any action which would be once with a public health agency or a 2017, eligible hospitals, and CAHs
acceptable under the Stage 1 and Stage clinical data registry and could register would be required to choose from
2 public health reporting objectives before the reporting period begins. In Measures 1 through 6, and would be
would fit within the definition of the addition, we note that previous required to successfully attest to any
‘‘active engagement’’ options. In registrations with a public health agency combination of three measures. In 2015
addition, because of the similarity or clinical data registry that occurred in only for providers scheduled to be in
between the substantive requirements of a previous stages of meaningful use Stage 1, EPs would be required to
the ‘‘ongoing submission’’ requirement could count toward Active Engagement choose from Measures 1 through 5, but
and the ‘‘active engagement’’ Option 1 for any of the EHR reporting would be permitted to successfully
requirement options included in this periods in 2015, 2016, or 2017. We attest to one measure; and eligible
final rule with comment period, we do clarify that providers must register with hospitals and CAHs would be required
not believe that significant time will be a PHA or CDR for each measure they to choose from Measures 1 through 6,
needed to implement the updated intend to use to meet meaningful use. but would be permitted to successfully
requirement. Further, we also clarify that to meet attest to any combination of two
For example, in Stage 2 a provider Active Engagement Option 1, measures. The proposed measures are as
could register their intent to submit data registration with the applicable PHA or shown in Table 5. We proposed that
to successfully meet a measure in one of CDR is required where a provider seeks measures 4 and 5 for Public Health
the public health reporting objectives. to meet meaningful use using a measure Registry Reporting and Clinical Data
Our proposal in the EHR Incentive they have not successfully attested to in Registry Reporting may be counted more
Programs for 2015 through 2017 a previous EHR reporting period. than once if more than one Public
Health Registry or Clinical Data Registry

is available.
TABLE 5—MEASURES FOR OBJECTIVE 8: PUBLIC HEALTH AND CLINICAL DATA REGISTRY REPORTING OBJECTIVE
Maximum times
Maximum times measure can
measure can count towards
Measure count towards objective for
objective for EP eligible hospital
or CAH
Measure 1—Immunization Registry Reporting ................................................................................ 1 1

Measure 2—Syndromic Surveillance Reporting .............................................................................. 1 1
Measure 3—Case Reporting ........................................................................................................... 1 1
Measure 4—Public Health Registry Reporting * .............................................................................. 2 3
Measure 5—Clinical Data Registry Reporting ** ............................................................................. 2 3
Measure 6—Electronic Reportable Laboratory Results .................................................................. N/A 1
* EPs, eligible hospitals, and CAHs may choose to report to more than one public health registry to meet the number of measures required to
meet the objective.
** EPs, eligible hospitals, and CAHs may choose to report to more than one clinical data registry to meet the number of measures required to
meet the objective.
For EPs, we proposed that an available measures. Available measures to submit immunization data and
exclusion for a measure does not count include ones for which the eligible receive immunization forecasts and
toward the total of two measures. hospital or CAH does not qualify for an histories from the public health
Instead, in order to meet this objective exclusion. immunization registry/immunization
an EP would need to meet two of the We note that we proposed to allow information system (IIS).
total number of measures available to EPs, eligible hospitals, and CAHs to We proposed that to successfully meet
them. If the EP qualifies for multiple choose to report to more than one public the requirements of this measure, bi-
exclusions and the remaining number of health registry to meet the number of directional data exchange between the
measures available to the EP is less than measures required to meet the objective. provider’s CEHRT system and the
two, the EP can meet the objective by We also proposed to allow EPs, eligible immunization registry/IIS is required.
meeting the one remaining measure hospitals, and CAHs to choose to report Exclusion: Any EP, eligible hospital,
available to them and claiming the to more than one clinical data registry or CAH meeting one or more of the
applicable exclusions. If no measures to meet the number of measures following criteria may be excluded from
remain available, the EP can meet the required to meet the objective. the immunization registry reporting
objective by claiming applicable Comment: Commenters requested measure if the EP, eligible hospital, or
exclusions for all measures. An EP who clarification regarding the number of CAH—
is scheduled to be in Stage 1 in 2015 measures that a provider would be ++ Does not administer any
must report at least one measure unless required to meet for the EHR reporting immunizations to any of the
they can exclude from all available periods covered by the EHR Incentive populations for which data is collected
measures. Available measures include Program in 2015 through 2017 by its jurisdiction’s immunization
ones for which the EP does not qualify requirements. registry or immunization information
for an exclusion. Response: In the EHR Incentive system during the EHR reporting period;
For eligible hospitals and CAHs, we Program for 2015 through 2017 ++ Operates in a jurisdiction for
proposed that an exclusion for a proposed rule (80 FR 20356), we which no immunization registry or
measure does not count toward the total proposed that for providers scheduled immunization information system is
of three measures. Instead, in order to to attest to Stage 1 in 2015, EPs would capable of accepting the specific
meet this objective, an eligible hospital be required to successfully attest to one standards required to meet the CEHRT
or CAH would need to meet three of the measure and eligible hospitals and definition at the start of the EHR
total number of measures available to CAHs would be required to successfully reporting period; or
them. If the eligible hospital or CAH attest to any combination of two ++ Operates in a jurisdiction where
qualifies for multiple exclusions and the measures. We also proposed that for no immunization registry or
total number of remaining measures providers scheduled to attest to Stage 2 immunization information system has
available to the eligible hospital or CAH in 2015 and for all providers in 2016 declared readiness to receive
is less than three, the eligible hospital, and 2017, EPs would be required to immunization data from the EP, eligible
or CAH can meet the objective by successfully attest to any combination of hospital, or CAH at the start of the EHR
meeting all of the remaining measures two measures and eligible hospitals and reporting period.
available to them and claiming the CAHs would be required to successfully Comment: For Measure 1—
applicable exclusions. If no measures attest to any combination of three Immunization Registry Reporting, the
remain available, the eligible hospital or measures. Finally, we proposed that EPs vast majority of commenters noted that
CAH can meet the objective by claiming may select from measures 1 through 5 the addition of bi-directionality during
applicable exclusions for all measures. while eligible hospitals and CAHs may the EHR Incentive Program 2015
An eligible hospital or CAH that is select from measures 1 through 6. through 2017 period would be
scheduled to be in Stage 1 in 2015 must To calculate the measures: burdensome to accomplish. A
report at least two measures unless they • Proposed Measure 1— commenter noted that bi-directional
can—either;—(1) Exclude from all but Immunization Registry Reporting: The capability is newly proposed for Stage 3
one available measure and report that EP, eligible hospital, or CAH is in active and as part of the 2015 Edition proposed
one measure; or (2) can exclude from all engagement with a public health agency rule, and is not currently part of the
Stage 2 or 2014 Edition rule ++ Operates in a jurisdiction where CAH is in active engagement with a
requirements. The commenter noted no public health agency has declared public health agency to submit case
that adding in this requirement would readiness to receive syndromic reporting of reportable conditions.
require significant development and surveillance data from eligible hospitals Proposed Exclusions: Any EP, eligible
implementation effort and that most or CAHs at the start of the EHR hospital, or CAH meeting one or more
states are not yet able to engage in this reporting period. of the following criteria may be
functionality. Comment: For Measure 2—Syndromic excluded from the case reporting
Response: We appreciate commenters’ Surveillance Reporting, many measure if the EP, eligible hospital, or
concerns regarding the addition of a bi- commenters noted that jurisdictions are CAH—
directionality requirement for the EHR not able to receive ambulatory ++ Does not treat or diagnose any
reporting periods covered by the syndromic surveillance data and that, reportable diseases for which data is
modified Stage 2 requirements. We the standards for ambulatory syndromic collected by their jurisdiction’s
agree with commenters that additional surveillance in 2014 CEHRT for reportable disease system during the
time may be needed for both public reporting are vague. A comment noted EHR reporting period;
health agencies and providers to adopt that few PHAs appear to be able to ++ Operates in a jurisdiction for
the necessary technology to support bi- accept non-emergency or non-urgent which no public health agency is
directional functionality. Therefore, we care ambulatory syndromic surveillance capable of receiving electronic case
are not finalizing the bi-directionality data electronically. These commenters reporting data in the specific standards
proposal in the EHR Incentive Programs recommended that the syndromic required to meet the CEHRT definition
for 2015 through 2017. surveillance measure should be at the start of the EHR reporting period;
• Proposed Measure 2—Syndromic removed from the objective. or
Surveillance Reporting: The EP, eligible Response: We disagree with ++ Operates in a jurisdiction where
hospital or CAH is in active engagement commenters who suggest that the no public health agency has declared
with a public health agency to submit syndromic surveillance measure should readiness to receive electronic case
syndromic surveillance data from a non- be removed from the EHR Incentive reporting data at the start of the EHR
urgent care ambulatory setting where Programs for 2015 through 2017. While reporting period.
the jurisdiction accepts syndromic data some jurisdictions are not currently Comment: Some commenters noted
from such settings and the standards are accepting syndromic surveillance data that case reporting is not mature enough
clearly defined for EPs, or an emergency from ambulatory care providers, there to be included in meaningful use for
or urgent care department for eligible are other providers who have been able 2015, 2016, or 2017. A commenter noted
hospitals and CAHs (POS 23). to report in their jurisdictions and who that the majority of eligible providers
Exclusion for EPs: Any EP meeting have successfully attested to this operate in jurisdictions where PHAs are
one or more of the following criteria measure. We believe that removing the not able to receive electronic case
may be excluded from the syndromic syndromic surveillance measure as an reporting data and have not developed
surveillance reporting measure if the option would negatively impact such the infrastructure to support such
EP— providers. We also believe that reporting. The commenters noted that
++ Does not treat or diagnose or maintaining this measure for 2015 the 2015 Edition proposed rule does not
directly treat any disease or condition through 2017 allows additional include certification criteria on case
associated with a syndromic providers to choose this measure in the reporting. These commenters
surveillance system in his or her future. We remind commenters that recommended removing this measure
jurisdiction; syndromic surveillance reporting is one from the objective for 2015 through
++ Operates in a jurisdiction for option available to providers. If this 2017.
which no public health agency is option is not suitable for the provider, Response: We appreciate commenter
capable of receiving electronic additional options are available and concerns regarding the readiness of
syndromic surveillance data from EPs in exclusions for this measure are also standards and functionality for case
the specific standards required to meet available. We are modifying the reporting and believe that technology
the CEHRT definition at the start of the proposed EP exclusion which states may not yet be sufficiently mature.
EHR reporting period; or ‘‘does not treat or diagnose or directly Based on public comment received, it is
++ Operates in a jurisdiction where treat any disease or condition associated clear that many public health
no public health agency has declared with a syndromic surveillance system in jurisdictions have not yet built the
readiness to receive syndromic his or her jurisdiction’’ to better indicate infrastructure to receive electronic case
surveillance data from EPs at the start of that the registry may or may not allow reports, and while a few public health
the EHR reporting period. the EP to report based on their category jurisdictions have infrastructure to
Exclusion for eligible hospitals/CAHs: rather than on whether they treat or accept case reports, many of these are
Any eligible hospital or CAH meeting diagnose specific diseases or condition not able to accept case reports in a
one or more of the following criteria for syndromic surveillance reporting. standard format. Building new
may be excluded from the syndromic For eligible hospitals and CAHs, almost infrastructure to support electronic case
surveillance reporting measure if the all jurisdictions currently accept reporting across multiple public health
eligible hospital or CAH— syndromic surveillance data. Finally, jurisdictions and to support certification
++ Does not have an emergency or we note that some eligible professionals may not be feasible for EHR Incentive
urgent care department; are already submitting syndromic Program reporting periods in 2015,
++ Operates in a jurisdiction for surveillance data which is allowable 2016, and 2017. We continue to believe
which no public health agency is under Stage 2. Therefore, we are that case reporting is a core component
capable of receiving electronic adopting a modification that allows all of public health reporting and to health
syndromic surveillance data from eligible professionals to submit improvement around the country and,
eligible hospitals or CAHs in the syndromic surveillance data for an EHR as noted elsewhere, are maintaining this
specific standards required to meet the reporting period in 2015 through 2017. measure for Stage 3. However, for
CEHRT definition at the start of the EHR • Proposed Measure 3—Case purposes of the EHR Incentive Program
reporting period; or Reporting: The EP, eligible hospital, or for 2015 through 2017, we believe
additional time is needed across the HIT 20367), we reiterated that any EP, seeking to attest to meaningful use in
landscape to develop the technology eligible hospital, or CAH may report to 2015, 2016, or 2017. Commenters
and infrastructure to support case more than one public health registry to specifically noted that the certification
reporting and we are not finalizing this meet the total number of required requirements for public health registries
measure as proposed. measures for the objective. For example, are not identified in the 2014 Edition
If a provider chooses to participate in if a provider meets this measure through rule and that the technology and
Stage 3 in 2017, they must meet the reporting to both the National Hospital infrastructure to support such registries
requirements defined for the Stage 3 Care Survey and the National is not yet mature.
Public Health and Clinical Data Registry Healthcare Safety Network registry, the Many commenters recommended
Reporting objective which may include provider could get credit for meeting changing this measure and the clinical
the case reporting measure defined for two measures. data registry reporting measure back to
the Stage 3 objectives discussed in We further noted that ONC adopted the prior Stage 2 requirements for the
section II.B.2.b.viii of this final rule standards for ambulatory cancer case specialized registry reporting objective
with comment period. reporting in its 2014 Edition final rule for 2015 through 2017 instead of
• Proposed Measure 4—Public Health (see § 170.314(f)(6)) and CMS provided splitting that objective into two
Registry Reporting: The EP, eligible EPs the option to select the cancer case measures as proposed. Commenters
hospital, or CAH is in active reporting menu objective in the Stage 2 noted that if the language in the Stage
engagement with a public health agency final rule (77 FR 54029 through 54030). 2 specialized registry reporting objective
to submit data to public health We included cancer registry reporting as were changed to include the ‘‘Active
registries. a separate objective from specialized engagement’’ definition, it would
As noted in the EHR Incentive registry reporting because it was more provide a wide range of options which
Programs in 2015 through 2017 mature in its development than other offers a value for providers and
proposed rule (80 FR 20368), in the registry types, not because other especially for certain EP specialties who
Stage 2 final rule, we were purposefully reporting was intended to be excluded may otherwise be excluding from all
general in our use of the term from meaningful use. In the EHR available measures. In addition,
‘‘specialized registry’’ (other than a Incentive Program in 2015 through 2017 commenters note that maintaining the
cancer registry) for the Stage 2 proposed rule (80 FR 20369), we existing specialized registry reporting
Specialized Registry Reporting proposed that EPs would have the objective would provide continuity for
Objective to encompass both registry option of counting cancer case reporting providers and not inadvertently
reporting to public health agencies and under the public health registry penalize providers who had selected to
clinical data registries in order to reporting measure, but that cancer case report to a registry under the specialized
prevent inadvertent exclusion of certain reporting is not an option for eligible registry reporting objective which may
registries through an attempt to be more hospitals and CAHs, because hospitals not qualify under the definition of a
specific (77 FR 54030). In response to have traditionally diagnosed and treated public health registry or a clinical data
insight gained from the industry cancers (or both) and have the registry from the proposed rule.
through listening sessions, public infrastructure needed to report cancer Response: We appreciate commenters
forums, and responses to a Federal cases. concerns regarding the public health
Register notice soliciting public Proposed Exclusions: Any EP, eligible registry reporting measure proposed. We
comments on the proposed information hospital, or CAH meeting at least one of agree that the standards for public
collections to develop a centralized the following criteria may be excluded health registry reporting are part of the
repository on public health readiness to from the public health registry reporting 2015 Edition rule and are not currently
support meaningful use (79 FR 7461); measure if the EP, eligible hospital, or part of 2014 Edition Rule that providers
we proposed to carry forward the CAH— are required to use in 2015 and may use
concept behind this broad category from ++ Does not diagnose or directly treat in 2016 and 2017. We understand
Stage 2, but also proposed to split any disease or condition associated with commenter concerns that requiring
public health registry reporting from a public health registry in their public health registry reporting could
clinical data registry reporting into two jurisdiction during the EHR reporting present a challenge for developers and
separate measures which better define period; for public health jurisdictions seeking to
the potential types of registries available ++ Operates in a jurisdiction for support such reporting. Furthermore,
for reporting in the EHR Incentive which no public health agency is we agree that our proposal to split the
Programs in 2015 through 2017 capable of accepting electronic registry Specialized Registry Reporting objective
proposed rule (80 FR 20367). We transactions in the specific standards into two measures may inadvertently
proposed to define a ‘‘public health required to meet the CEHRT definition cause some providers to no longer use
registry’’ as a registry that is at the start of the EHR reporting period; their current reporting option to meet
administered by, or on behalf of, a local, or the measure. We are therefore not
state, territorial, or national PHA and ++ Operates in a jurisdiction where finalizing our proposal to split
which collects data for public health no public health registry for which the specialized registry reporting into two
purposes. While immunization EP, eligible hospital, or CAH is eligible measures as proposed.
registries are a type of public health has declared readiness to receive Instead, we will maintain for 2015
registry, we proposed to keep electronic registry transactions at the through 2017 a unified specialized
immunization registry reporting beginning of the EHR reporting period. registry reporting measure which adopts
separate from the public health registry Comment: Some commenters noted the change from ‘‘ongoing submission’’
reporting measure to retain continuity that for Measure 4—Public Health to ‘‘active engagement’’. We believe that
from Stage 1 and 2 policy in which Registry Reporting, public health this will allow providers flexibility to
immunization registry reporting was a registries that would fall within this continue in the direction they may have
distinct and separate objective (77 FR measure would need additional time to already planned for reporting while still
54023). implement the applicable standards allowing for a wide range of reporting
In the EHR Incentive Programs in identified in the 2015 Edition rule, options in the future. We further note
2015 through 2017 proposed rule (80 FR which would be applicable to providers that we have previously supported the
inclusion of a variety of registries under National Quality Registry Network registries will need additional time to
the specialized registry measure, defines clinical data registries as those implement the applicable standards in
including Prescription Drug Monitoring that record information about the health the 2015 Edition rule. Other
Program reporting and electronic case status of patients and the health care commenters disagreed with our
reporting. We agree that a variety of they receive over varying periods of proposal to split the Specialized
registries may be considered specialized time [1]. We proposed to further Registry Reporting Objective into two
registries, which allows providers the differentiate between clinical data measures for reporting in 2015 through
flexibility to report using a registry that registries and public health registries as 2017 citing unintended negative
is most helpful to their patients. follows: For the purposes of meaningful consequences on providers who have
Therefore, we will continue to allow use, ‘‘public health registries’’ are those planned for and acted toward meeting
these registries to be considered administered by, or on behalf of, a local, the prior requirements, especially on the
specialized registries for purposes of state, territorial, or national public short term in 2015 and 2016. These
reporting the EHR Reporting period in health agencies; and, ‘‘clinical data commenters recommended retaining the
2015, 2016, and 2017. However, we will registries’’ are administered by, or on prior specifications for the objective
modify the exclusion not only to reflect behalf of, other non-public health instead of adopting two new measures.
the change from public health registry to agency entities. We believe that clinical Response: We agree that the standards
specialized registry but also to allow an data registries are important for for clinical data registry reporting are
exclusion if the provider does not providing information that can inform not currently part of the 2014 CEHRT
collect the data relevant to a specialized patients and their providers on the best definition requirements and understand
registry within their jurisdiction. course of treatment and for care commenter concerns that without
We are also finalizing our proposed improvements, and can support clarity on the functionality needed to
policy to incorporate cancer case specialty reporting by developing support this measure, it would be
reporting into the measure for EPs only. reporting for areas not usually covered difficult for providers to implement. As
Therefore, EPs who were previously by PHAs but that are important to a noted in relation to the proposed public
planning to attest to the cancer case specialist’s provision of care. Clinical health reporting measure, we also agree
reporting objective, may count that data registries can also be used to with commenters who state that there
action toward the Specialized Registry monitor health care quality and resource would potentially be unintended
Reporting measure. We believe this use. negative consequences for providers in
change is necessary to support We proposed that any EP, eligible 2015 and 2016 especially if we adopt
continued provider reporting to cancer hospital, or CAH may report to more the proposal to split the Specialized
case registries. However, we note that than 1 clinical data registry to meet the Registry Reporting Objective into two
EPs who did not intend to attest to the total number of required measures for separate measures As noted previously,
cancer case reporting menu objective are this objective. ONC would consider the we are not adopting this policy for the
not required to engage in or exclude adoption of standards and public health reporting measure, and we
from cancer case reporting in order to implementation guides in future are also therefore not adopting the
meet the specialized registry reporting rulemaking. Should these subsequently policy for a separate clinical data
measure. We further note that providers be finalized, they may then be adopted registry reporting measure. We are
may use electronic submission methods as part of the CEHRT definition as it therefore not adopting this measure as
beyond the functions of CEHRT to meet relates to meeting the clinical data proposed.
the requirements for the Specialized registry reporting measure through As noted previously, we are not
Registry Reporting measure. Finally, we future rulemaking for the EHR Incentive finalizing our proposal to split the
are adopting our proposal that providers Programs. measure from the Stage 2 Specialized
may count the measure more than one Exclusion: Any EP, eligible hospital, Registry Reporting Objective (77 FR
time if they report to multiple or CAH meeting at least one of the 54030) into two measures. Therefore, we
specialized registries as proposed. For following criteria may be excluded from are not finalizing the clinical data
the Stage 3 public health registry the clinical data registry reporting registry reporting measure for 2015,
reporting measure within the Public measure if the EP, eligible hospital, or 2016, and for 2017 for those providers
Health and Clinical Data Registry CAH— who are not demonstrating Stage 3. If a
Reporting Objective, we direct readers ++ Does not diagnose or directly treat provider chooses to participate in Stage
to section II.B.2.b.viii of this final rule any disease or condition associated with 3 in 2017, they must meet the
with comment period. a clinical data registry in their requirements defined for the Stage 3
• Proposed Measure 5—Clinical Data jurisdiction during the EHR reporting Public Health and Clinical Data Registry
Registry Reporting: The EP, eligible period; Reporting objective as discussed in
hospital, or CAH is in active ++ Operates in a jurisdiction for section II.B.2.b.viii of this final rule
engagement to submit data to a clinical which no clinical data registry is with comment period.
data registry. capable of accepting electronic registry • Proposed Measure 6—Electronic
As discussed in the Public Health transactions in the specific standards Reportable Laboratory Result Reporting:
Registry Reporting measure, we required to meet the CEHRT definition The eligible hospital or CAH is in active
proposed to split specialized registry at the start of the EHR reporting period; engagement with a public health agency
reporting into two separate, clearly or to submit electronic reportable
defined measures: Public health registry ++ Operates in a jurisdiction where laboratory (ELR) results. We proposed
reporting and clinical data registry no clinical data registry for which the this measure for eligible hospitals and
reporting. In Stage 2 for EPs, reporting EP, eligible hospital, or CAH is eligible CAHs only.
to specialized registries is a menu has declared readiness to receive Exclusion: Any eligible hospital or
objective and this menu objective electronic registry transactions at the CAH meeting one or more of the
includes reporting to clinical data beginning of the EHR reporting period. following criteria may be excluded from
registries. For Stage 3, we proposed to Comment: Some commenters noted the electronic reportable laboratory
include clinical data registry reporting that for Measure 5—Clinical Data result reporting measure if the eligible
as an independent measure. The Registry Reporting, the potential hospital or CAH—
++ Does not perform or order reporting which adopts the change from available to them and claiming the
laboratory tests that are reportable in ‘‘ongoing submission’’ to ‘‘active applicable exclusions. If no measures
their jurisdiction during the EHR engagement’’ and includes reporting for remain available, the eligible hospital or
reporting period; eligible hospitals and CAHs for 2015 CAH can meet the objective by claiming
++ Operates in a jurisdiction for through 2017. We include cancer case applicable exclusions for all measures.
which no public health agency is reporting as an option for EPs only An eligible hospital or CAH that is
capable of accepting the specific ELR under the adopted specialized registry scheduled to be in Stage 1 in 2015 must
standards required to meet the CEHRT reporting measure. We are redesignating report at least two measures unless they
definition at the start of the EHR this measure as ‘‘Measure 3’’. For can either—(1) Exclude from all but one
reporting period; or Measure 5, we are not finalizing the available measure and report that one
++ Operates in a jurisdiction where proposed clinical data registry reporting measure; or (2) can exclude from all
no public health agency has declared measure. For Measure 6, we are available measures. Available measures
readiness to receive electronic finalizing the measure language as include ones for which the eligible
reportable laboratory results from proposed and redesignating the measure hospital or CAH does not qualify for an
eligible hospitals or CAHs at the start of as ‘‘Measure 4’’. exclusion.
the EHR reporting period. For the explanation of terms, we are Finally, we note that a provider may
Comment: For Measure 6—ELR, finalizing the definition of active report to more than one specialized
commenters agreed with the engagement with the additional registry and may count specialized
continuation of this measure but clarification provided through response registry reporting more than once to
requested that it also be included as an to public comment. We are finalizing meet the required number of measures
option for EPs that maintain in-house that EPs must meet at least 2 measures for the objective.
laboratories. with a modification to reference the
Response: We thank commenters for We are adopting the final objective,
selection from measures 1 through 3 measures, exclusions, and alternate
their support of this measure. However, (rather than 1 through 5). Similarly, we
we do not agree that this measure specification as follows:
are finalizing that eligible hospitals and
should be extended to EPs. We note that CAHs must meet at least 3 measures Objective 10: Public Health Reporting
in-house laboratories of EPs do not from measures 1 through 4 (rather than
perform the types of tests that are Objective: The EP, eligible hospital or
1 through 6). We are also finalizing the CAH is in active engagement with a
reportable to public health jurisdictions. alternate specification that in 2015 Stage
For example, many in-house public health agency to submit
1 EPs may meet one measure to meet the electronic public health data from
laboratories focus on tests such as rapid threshold and Stage 1 eligible hospitals
strep tests that test for strep throat. The CEHRT except where prohibited and in
and CAHs may meet two measures to accordance with applicable law and
rapid strep tests are not reportable to meet the threshold.
public health agencies. practice.
For EPs, we are finalizing that an
After consideration of public Measure 1—Immunization Registry
exclusion for a measure does not count
comments received, for EHR reporting Reporting: The EP, eligible hospital, or
toward the total of two measures.
periods in 2015 through 2017, we are CAH is in active engagement with a
Instead, in order to meet this objective
finalizing the objective with a an EP would need to meet two of the public health agency to submit
modification to the name to state Public total number of measures available to immunization data.
Health Reporting Objective and to them. If the EP qualifies for multiple Exclusion: Any EP, eligible hospital,
remove the reference to clinical data exclusions and the remaining number of or CAH meeting one or more of the
registries. We are finalizing the measures available to the EP is less than following criteria may be excluded from
measures with modifications. For two, the EP can meet the objective by the immunization registry reporting
Measure 1, we remove the requirement meeting the one remaining measure measure if the EP, eligible hospital, or
for bi-directional data exchange and available to them and claiming the CAH—
note that providers will not be required applicable exclusions. If no measures • Does not administer any
to receive a full immunization history remain available, the EP can meet the immunizations to any of the
and will not be required to display an objective by claiming applicable populations for which data is collected
immunization forecast from an exclusions for all measures. An EP who by its jurisdiction’s immunization
Immunization Information System (IIS) is scheduled to be in Stage 1 in 2015 registry or immunization information
to meet the measure. Providers will only must report at least one measure unless system during the EHR reporting period;
need to electronically submit they can exclude from all available • Operates in a jurisdiction for which
immunization data to the appropriate measures. Available measures include no immunization registry or
public health jurisdiction’s IIS. For ones for which the EP does not qualify immunization information system is
Measure 2, we are adopting a for an exclusion. capable of accepting the specific
modification to the final policy to allow For eligible hospitals and CAHs, we standards required to meet the CEHRT
all EPs to submit syndromic are finalizing that an exclusion for a definition at the start of the EHR
surveillance data and to modify the measure does not count toward the total reporting period; or
exclusions to reflect that different of three measures. Instead, in order to • Operates in a jurisdiction where no
categories of providers may or may not meet this objective an eligible hospital immunization registry or immunization
be able to report based on the or CAH would need to meet three of the information system has declared
requirements of the registry. For total number of measures available to readiness to receive immunization data
Measure 3, we are not finalizing the them. If the eligible hospital or CAH from the EP, eligible hospital, or CAH at
proposed case reporting measure. For qualifies for multiple exclusions and the the start of the EHR reporting period.
Measure 4, we are not finalizing our total number of remaining measures Measure 2—Syndromic Surveillance
proposal to split specialized registry available to the eligible hospital or CAH Reporting: The EP, eligible hospital, or
reporting into two distinct measures. is less than three, the eligible hospital CAH is in active engagement with a
Instead, we will maintain a unified or CAH can meet the objective by public health agency to submit
specification for specialized registry meeting all of the remaining measures syndromic surveillance data.
Exclusion for EPs: Any EP meeting at the start of the EHR reporting period; registry transactions at the beginning of
one or more of the following criteria or the EHR reporting period.
may be excluded from the syndromic • Operates in a jurisdiction where no Measure 4—Electronic Reportable
surveillance reporting measure if the public health agency has declared Laboratory Result Reporting: The
EP— readiness to receive syndromic eligible hospital or CAH is in active
• Is not in a category of providers surveillance data from eligible hospitals engagement with a public health agency
from which ambulatory syndromic or CAHs at the start of the EHR to submit electronic reportable
surveillance data is collected by their reporting period. laboratory (ELR) results.
jurisdiction’s syndromic surveillance Measure 3—Specialized Registry Exclusion: Any eligible hospital or
system; Reporting—The EP, eligible hospital, or CAH meeting one or more of the
• Operates in a jurisdiction for which CAH is in active engagement to submit following criteria may be excluded from
no public health agency is capable of data to a specialized registry. the electronic reportable laboratory
receiving electronic syndromic Exclusions: Any EP, eligible hospital, result reporting measure if the eligible
surveillance data from EPs in the or CAH meeting at least one of the hospital or CAH—
specific standards required to meet the
following criteria may be excluded from • Does not perform or order
CEHRT definition at the start of the EHR
the specialized registry reporting laboratory tests that are reportable in
reporting period; or
• Operates in a jurisdiction where no measure if the EP, eligible hospital, or their jurisdiction during the EHR
public health agency has declared CAH— reporting period;
readiness to receive syndromic • Does not diagnose or treat any • Operates in a jurisdiction for which
surveillance data from EPs at the start of disease or condition associated with or no public health agency is capable of
the EHR reporting period. collect relevant data that is required by accepting the specific ELR standards
Exclusion for eligible hospitals/CAHs: a specialized registry in their required to meet the CEHRT definition
Any eligible hospital or CAH meeting jurisdiction during the EHR reporting at the start of the EHR reporting period;
one or more of the following criteria period; or
may be excluded from the syndromic • Operates in a jurisdiction for which • Operates in a jurisdiction where no
surveillance reporting measure if the no specialized registry is capable of public health agency has declared
eligible hospital or CAH— accepting electronic registry readiness to receive electronic
• Does not have an emergency or transactions in the specific standards reportable laboratory results from
urgent care department; required to meet the CEHRT definition eligible hospitals or CAHs at the start of
• Operates in a jurisdiction for which at the start of the EHR reporting period; the EHR reporting period.
no public health agency is capable of or Alternate Specification: An EP
receiving electronic syndromic • Operates in a jurisdiction where no scheduled to be in Stage 1 in 2015 may
surveillance data from eligible hospitals specialized registry for which the EP, meet 1 measure and an eligible hospital
or CAHs in the specific standards eligible hospital, or CAH is eligible has or CAH scheduled to be in Stage 1 in
required to meet the CEHRT definition declared readiness to receive electronic 2015 may meet two measures.
TABLE 6—PUBLIC HEALTH REPORTING OBJECTIVE MEASURES FOR EPS, ELIGIBLE HOSPITALS, AND CAHS IN 2015
THROUGH 2017
Maximum times measure can
Measure number and name Measure specification count towards the objective
Measure 1—Immunization Registry The EP, eligible hospital, or CAH is in active engagement with a pub- 1.
Reporting. lic health agency to submit immunization data.
Measure 2—Syndromic Surveil- The EP, eligible hospital or CAH is in active engagement with a pub- 1.
lance Reporting. lic health agency to submit syndromic surveillance data.
Measure 3—Specialized Registry The EP, eligible hospital, or CAH is in active engagement with a pub- 2 for EP, 3 for eligible hospital/
Reporting. lic health agency to submit data to a specialized registry. CAH.
Measure 4—Electronic Reportable The eligible hospital or CAH is in active engagement with a public N/A.
Laboratory Results Reporting. health agency to submit ELR results.
We are adopting Objective 10: Public § 495.4 where applicable; however, as period for a discussion of the definition
Health Reporting at § 495.22(e)(10)(i) for noted for measure 3, providers may use of CEHRT and a table referencing the
EPs and § 495.22(e)(10)(ii) for eligible functions beyond those established in capabilities and standards that must be
hospitals and CAHs. We further specify CEHRT in accordance with state and used for each measure.
that providers must use the functions local law. We direct readers to section
and standards as defined for CEHRT at II.B.3. of this final rule with comment
TABLE 7—ELIGIBLE PROFESSIONAL (EP) OBJECTIVES AND MEASURES FOR 2015 THROUGH 2017
Objectives for 2015, 2016 Alternate exclusions and/or specifications for certain
Measures for providers in 2015, 2016 and 2017
and 2017 providers
Objective 1: Protect Patient Measure: Conduct or review a security risk analysis in NONE.
Health Information. accordance with the requirements in 45 CFR
164.308(a)(1), including addressing the security (to
include encryption) of ePHI created or maintained by
Certified EHR Technology in accordance with re-
quirements in 45 CFR 164.312(a)(2)(iv) and 45 CFR
164.306(d)(3), and implement security updates as
necessary and correct identified security deficiencies
as part of the EP’s risk management process.
Objective 2: Clinical Deci- • Measure 1: Implement five clinical decision support If for an EHR reporting period in 2015, the provider is
sion Support. interventions related to four or more clinical quality scheduled to demonstrate Stage 1:
measures at a relevant point in patient care for the Alternate Objective and Measure 1:
entire EHR reporting period. Absent four clinical qual- Objective: Implement one clinical decision support rule
ity measures related to an EPs scope of practice or relevant to specialty or high clinical priority, along
patient population, the clinical decision support inter- with the ability to track compliance with that rule.
ventions must be related to high-priority health condi- Measure: Implement one clinical decision support rule.
tions.
• Measure 2: The EP has enabled and implemented
the functionality for drug-drug and drug-allergy inter-
action checks for the entire EHR reporting period.
Objective 3: Computerized • Measure 1: More than 60 percent of medication or- • Alternate Measure 1: For Stage 1 providers in 2015
Provider Order Entry ders created by the EP during the EHR reporting pe- only, more than 30 percent of all unique patients with
CPOE. riod are recorded using computerized provider order at least one medication in their medication list seen
entry. by the EP during the EHR reporting period have at
• Measure 2: More than 30 percent of laboratory or- least one medication order entered using CPOE; or
ders created by the EP during the EHR reporting pe- more than 30 percent of medication orders created
riod are recorded using computerized provider order by the EP during the EHR reporting period during the
entry. EHR reporting period, are recorded using computer-
• Measure 3: More than 30 percent of radiology orders ized provider order entry.
created by the EP during the EHR reporting period • Alternate Exclusion for Measure 2: Providers sched-
are recorded using computerized provider order entry. uled to be in Stage 1 in 2015 may claim an exclusion
for measure 2 (laboratory orders) of the Stage 2
CPOE objective for an EHR reporting period in 2015;
and, providers scheduled to be in Stage 1 in 2016
may claim an exclusion for measure 2 (laboratory or-
ders) of the Stage 2 CPOE objective for an EHR re-
porting period in 2016.
• Alternate Exclusion for Measure 3: Providers sched-
uled to be in Stage 1 in 2015 may claim an exclusion
for measure 3 (radiology orders) of the Stage 2
may claim an exclusion for measure 3 (radiology or-
Objective 4: Electronic Pre- EP Measure: More than 50 percent of all permissible Alternate EP Measure: For Stage 1 providers in 2015
scribing. prescriptions written by the EP are queried for a drug only, More than 40 percent of all permissible pre-
formulary and transmitted electronically using CEHRT. scriptions written by the EP are transmitted electroni-
cally using CEHRT.
Objective 5: Health Informa- Measure: The EP that transitions or refers their patient Alternate Exclusion: Provider may claim an exclusion
tion Exchange. to another setting of care or provider of care (1) uses for the measure of the Stage 2 Summary of Care ob-
CEHRT to create a summary of care record; and (2) jective, which requires the electronic transmission of
electronically transmits such summary to a receiving a summary of care document if for an EHR reporting
provider for more than 10 percent of transitions of period in 2015 they were scheduled to demonstrate
care and referrals. Stage 1, which does not have an equivalent meas-
ure.
Objective 6: Patient-Specific EP Measure: Patient-specific education resources iden- Alternate Exclusion: Provider may claim an exclusion
Education. tified by CEHRT are provided to patients for more for the measure of the Stage 2 Patient-Specific Edu-
than 10 percent of all unique patients with office vis- cation objective if for an EHR reporting period in
its seen by the EP during the EHR reporting period. 2015 they were scheduled to demonstrate Stage 1
but did not intend to select the Stage 1 Patient-Spe-
cific Education menu objective.

Objective 7: Medication Rec- Measure: The EP, performs medication reconciliation Alternate Exclusion: Provider may claim an exclusion
onciliation. for more than 50 percent of transitions of care in for the measure of the Stage 2 Medication Reconcili-
which the patient is transitioned into the care of the ation objective if for an EHR reporting period in 2015
EP. they were scheduled to demonstrate Stage 1 but did
not intend to select the Stage 1 Medication Reconcili-
ation menu objective.
TABLE 7—ELIGIBLE PROFESSIONAL (EP) OBJECTIVES AND MEASURES FOR 2015 THROUGH 2017—Continued
and 2017 providers
Objective 8: Patient Elec- • EP Measure 1: More than 50 percent of all unique Alternate Exclusion Measure 2: Providers may claim an
tronic Access (VDT). patients seen by the EP during the EHR reporting exclusion for the second measure if for an EHR re-
period are provided timely access to view online, porting period in 2015 they were scheduled to dem-
download, and transmit to a third party their health onstrate Stage 1, which does not have an equivalent
information subject to the EP’s discretion to withhold measure.
certain information.
• EP Measure 2: For 2015 and 2016: At least 1 patient
seen by the EP during the EHR reporting period (or
patient-authorized representative) views, downloads
or transmits his or her health information to a third
party during the EHR reporting period.
For 2017: More than 5 percent of unique patients seen
by the EP during the EHR reporting period (or pa-
tient-authorized representative) views, downloads or
transmits their health information to a third party dur-
ing the EHR reporting period.
Objective 9: Secure Mes- Measure: For 2015: For an EHR reporting period in Alternate Exclusion: An EP may claim an exclusion for
saging. 2015, the capability for patients to send and receive the measure if for an EHR reporting period in 2015
a secure electronic message with the EP was fully they were scheduled to demonstrate Stage 1, which
enabled. does not have an equivalent measure.
For 2016: For at least 1 patient seen by the EP during
the EHR reporting period, a secure message was
sent using the electronic messaging function of
CEHRT to the patient (or patient-authorized rep-
resentative), or in response to a secure message
sent by the patient (or patient-authorized representa-
tive) during the EHR reporting period.
For 2017: For more than 5 percent of unique patients
seen by the EP during the EHR reporting period, a
secure message was sent using the electronic mes-
saging function of CEHRT to the patient (or the pa-
tient-authorized representative), or in response to a
secure message sent by the patient (or the patient-
authorized representative) during the EHR reporting
period.
Objective 10: Public Health • Measure 1—Immunization Registry Reporting: The Stage 1 EPs in 2015 must meet at least 1 measure in
EP is in active engagement with a public health 2015, Stage 2 EPs must meet at least 2 measures in
agency to submit immunization data. 2015, and all EPs must meet at least 2 measures in
• Measure 2—Syndromic Surveillance Reporting: The 2016 and 2017.
EP is in active engagement with a public health
agency to submit syndromic surveillance data.
Measure 3—Specialized Registry Reporting: The EP is
in active engagement to submit data to a specialized
registry.
TABLE 8—ELIGIBLE HOSPITAL AND CAH OBJECTIVES AND MEASURES FOR 2015 THROUGH 2017
and 2017 providers
Objective 1: Protect Patient Measure: Conduct or review a security risk analysis in NONE.
Health Information. accordance with the requirements in 45 CFR
164.308(a)(1), including addressing the security (to
include encryption) of ePHI created or maintained in
CEHRT in accordance with requirements in 45 CFR
164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and im-
plement security updates as necessary and correct
identified security deficiencies as part of the eligible
hospital or CAHs risk management process.
TABLE 8—ELIGIBLE HOSPITAL AND CAH OBJECTIVES AND MEASURES FOR 2015 THROUGH 2017—Continued
and 2017 providers
Objective 2: Clinical Deci- • Measure 1: Implement five clinical decision support If for an EHR reporting period in 2015, the provider is
sion Support. interventions related to four or more clinical quality scheduled to demonstrate Stage 1:
measures at a relevant point in patient care for the Alternate Objective and Measure 1:
entire EHR reporting period. Absent four clinical qual- Objective: Implement one clinical decision support rule
ity measures related to an eligible hospital or CAH’s relevant to specialty or high clinical priority, along
scope of practice or patient population, the clinical with the ability to track compliance with that rule.
decision support interventions must be related to Measure: Implement one clinical decision support rule.
high-priority health conditions.
• Measure 2: The eligible hospital or CAH has enabled
and implemented the functionality for drug-drug and
drug-allergy interaction checks for the entire EHR re-
porting period.
Objective 3: Computerized • Measure 1: More than 60 percent of medication or- • Alternate Measure 1: For Stage 1 providers in 2015
Provider Order Entry ders created by authorized providers of the eligible only, more than 30 percent of all unique patients with
CPOE. hospital’s or CAH’s inpatient or emergency depart- at least one medication in their medication list seen
ment (POS 21 or 23) during the EHR reporting pe- by the EP during the EHR reporting period have at
riod are recorded using computerized provider order least one medication order entered using CPOE; or
entry. more than 30 percent of medication orders created
• Measure 2: More than 30 percent of laboratory or- by the EP during the EHR reporting period during the
ders created by authorized providers of the eligible EHR reporting period, are recorded using computer-
hospital’s or CAH’s inpatient or emergency depart- ized provider order entry.
ment (POS 21 or 23) during the EHR reporting pe- • Alternate Exclusion for Measure 2: Providers sched-
riod are recorded using computerized provider order uled to be in Stage 1 in 2015 may claim an exclusion
entry. for measure 2 (laboratory orders) of the Stage 2
• Measure 3: More than 30 percent of radiology orders CPOE objective for an EHR reporting period in 2015;
created by authorized providers of the eligible hos- and, providers scheduled to be in Stage 1 in 2016
pital’s or CAH’s inpatient or emergency department may claim an exclusion for measure 2 (laboratory or-
(POS 21 or 23) during the EHR reporting period are ders) of the Stage 2 CPOE objective for an EHR re-
recorded using computerized provider order entry. porting period in 2016.
• Alternate Exclusion for Measure 3: Providers sched-
uled to be in Stage 1 in 2015may claim an exclusion
for measure 3 (radiology orders) of the Stage 2
may claim an exclusion for measure 3 (radiology or-
Objective 4: Electronic Pre- Eligible Hospital/CAH Measure: More than 10 percent Alternate EH Exclusion: The eligible hospital or CAH
scribing. of hospital discharge medication orders for permis- may claim an exclusion for the eRx objective and
sible prescriptions (for new and changed prescrip- measure if for an EHR reporting period in 2015 if
tions) are queried for a drug formulary and trans- they were either scheduled to demonstrate Stage 1,
mitted electronically using CEHRT. which does not have an equivalent measure, or if
they are scheduled to demonstrate Stage 2 but did
not intend to select the Stage 2 eRx objective for an
EHR reporting period in 2015; and, the eligible hos-
pital or CAH may claim an exclusion for the eRx ob-
jective and measure if for an EHR reporting period in
2016 if they were either scheduled to demonstrate
Stage 1 in 2015 or 2016, or if they are scheduled to
demonstrate Stage 2 but did not intend to select the
Stage 2 eRx objective for an EHR reporting period in
2015.
Objective 5: Health Informa- Measure: The eligible hospital or CAH that transitions Alternate Exclusion: Provider may claim an exclusion
tion Exchange. or refers their patient to another setting of care or for the measure of the Stage 2 Summary of Care ob-
provider of care (1) uses CEHRT to create a sum- jective, which requires the electronic transmission of
mary of care record; and (2) electronically transmits a summary of care document if for an EHR reporting
such summary to a receiving provider for more than period in 2015 they were scheduled to demonstrate
10 percent of transitions of care and referrals. Stage 1, which does not have an equivalent meas-
ure.
Objective 6: Patient-Specific Eligible Hospital/CAH Measure: More than 10 percent Alternate Exclusion: Provider may claim an exclusion
Education. of all unique patients admitted to the eligible hos- for the measure of the Stage 2 Patient-Specific Edu-
pital’s or CAH’s inpatient or emergency department cation objective if for an EHR reporting period in
(POS 21 or 23) are provided patient-specific edu- 2015 they were scheduled to demonstrate Stage 1
cation resources identified by CEHRT. but did not intend to select the Stage 1 Patient-Spe-
cific Education menu objective.
TABLE 8—ELIGIBLE HOSPITAL AND CAH OBJECTIVES AND MEASURES FOR 2015 THROUGH 2017—Continued
and 2017 providers
Objective 7: Medication Rec- Measure: The eligible hospital or CAH performs medi- Alternate Exclusion: Provider may claim an exclusion
onciliation. cation reconciliation for more than 50 percent of tran- for the measure of the Stage 2 Medication Reconcili-
sitions of care in which the patient is admitted to the ation objective if for an EHR reporting period in 2015
eligible hospital’s or CAH’s inpatient or emergency they were scheduled to demonstrate Stage 1 but did
department (POS 21 or 23). not intend to select the Stage 1 Medication Reconcili-
ation menu objective.
Objective 8: Patient Elec- • Eligible Hospital/CAH Measure 1: More than 50 per- Alternate Exclusion Measure 2: Provider may claim an
tronic Access (VDT). cent of all unique patients who are discharged from exclusion for the second measure if for an EHR re-
the inpatient or emergency department (POS 21 or porting period in 2015 they were scheduled to dem-
23) of an eligible hospital or CAH are provided timely onstrate Stage 1, which does not have an equivalent
access to view online, download and transmit their measure.
health information to a third party their health infor-
mation.
• Eligible Hospital/CAH Measure 2: For 2015 and
2016: At least 1 patient who is discharged from the
inpatient or emergency department (POS 21 or 23) of
an eligible hospital or CAH (or patient-authorized rep-
resentative) views, downloads, or transmits to a third
party his or her health information during the EHR re-
porting period.
For 2017: More than 5 percent of unique patients dis-
charged from the inpatient or emergency department
(POS 21 or 23) of an eligible hospital or CAH (or pa-
tient-authorized representative) view, download, or
transmit to a third party their health information dur-
Objective 9: Secure Mes- Not applicable for eligible hospitals and CAHs .............. Not applicable for eligible hospitals and CAHs.
saging.
Objective 10: Public Health • Measure 1—Immunization Registry Reporting: The Stage 1 eligible hospitals and CAHs must meet at least
eligible hospital or CAH is in active engagement with 2 measures in 2015, Stage 2 eligible hospitals and
a public health agency to submit immunization data. CAHs must meet at least 3 measures in 2015, all eli-
• Measure 2—Syndromic Surveillance Reporting: The gible hospitals and CAHs must meet at least 3 meas-
eligible hospital or CAH is in active engagement with ures in 2016 and 2017.
a public health agency to submit syndromic surveil-
lance data.
• Measure 3—Specialized Registry Reporting: The eli-
gible hospital, or CAH is in active engagement to
submit data to a specialized registry.
• Measure 4—Electronic Reportable Laboratory Result
Reporting: The eligible hospital or CAH is in active
engagement with a public health agency to submit
ELR results.
b. Objectives and Measures for Stage 3 information. Most recently, we finalized final rules (77 FR 13716 through 13717
of the EHR Incentive Programs at (77 FR 54002 and 54003), a Stage 2 and 77 FR 54002).
Objective 1: Protect Patient Health meaningful use core objective requiring In the Stage 3 proposed rule, we noted
Information providers to ‘‘protect ePHI created or that public comments on the Stage 2
maintained by the certified EHR final rule and subsequent comments
In the Stage 3 proposed rule at 80 FR technology through the implementation received through public forums, suggest
16745 through 16747, we noted that, of appropriate technical capabilities.’’ some confusion remains among
consistent with HIPAA and its The measure for this objective requires providers between the requirements of
implementing regulations and both the providers to conduct or review a this meaningful use objective and the
Stage 1 and Stage 2 final rules (75 FR security risk analysis in accordance requirements established under 45 CFR
44368 through 44369 and 77 FR 54002 with the requirements under 45 CFR 164.308(a)(1), 45 CFR 164.312(a)(2)(iv)
through 54003), protecting electronic 164.308(a)(1), including addressing the and 45 CFR 164.306(d)(3) of the HIPAA
protected health information (ePHI) security (to include encryption) of data Security Rule. Although we stressed
remains essential to all aspects of stored in CEHRT in accordance with that the objective and measure finalized
meaningful use under the EHR Incentive requirements under 45 CFR 164.312 relating to ePHI are specific to the EHR
Programs. We remain cognizant that (a)(2)(iv) and 45 CFR 164.306(d)(3), Incentive Programs, and further added
unintended or unlawful disclosures of implementing security updates as that compliance with the requirements
ePHI could diminish consumer necessary, and correcting identified in the HIPAA Security Rule falls outside
confidence in EHRs and the overall security deficiencies as part of the the scope of this rulemaking, we
exchange of ePHI. Therefore, in both the provider’s risk management process. For nonetheless continued to receive
Stage 1 and 2 final rules, we created a further detail on this objective, we refer inquiries about the relationship between
meaningful use core objective aimed at readers to the Stage 2 proposed and our objective and the HIPAA Rules.
protecting patients’ health care Therefore, for Stage 3, in order to
alleviate provider confusion and Response: We appreciate the support the security risk analysis to satisfy this
simplify the EHR Incentive Program, we for this measure. As we stated in our proposed measure must be as follows:
proposed maintaining the previously proposal, we included administrative • EPs, eligible hospitals, and CAHs
finalized Stage 2 objective on protecting and physical safeguards because an must conduct the security risk analysis
ePHI. However, we proposed further entity would require them in addition to upon installation of CEHRT or upon
explanation of the security risk analysis technical safeguards to implement upgrade to a new Edition. The initial
timing and review requirements for security measures to reduce the risks security risk analysis and testing may
purposes of meeting this objective and and vulnerabilities identified. Technical occur prior to the beginning of the first
associated measure for Stage 3. safeguards alone are not enough to EHR reporting period using that Edition
Proposed Objective: Protect electronic ensure the confidentiality, integrity, and of CEHRT.
protected health information (ePHI) availability of ePHI. • In subsequent years, a provider
created or maintained by the CEHRT Proposed Measure: Conduct or review must review the security risk analysis of
through the implementation of a security risk analysis in accordance the CEHRT and the administrative,
appropriate technical, administrative, with the requirements under 45 CFR physical, and technical safeguards
and physical safeguards. 164.308(a)(1), including addressing the implemented, and make updates to its
For the proposed Stage 3 objective, we security (including encryption) of data analysis as necessary, but at least once
added language to the security stored in CEHRT in accordance with per EHR reporting period.
requirements for the implementation of requirements under 45 CFR Comment: A commenter suggested
appropriate technical, administrative, 164.312(a)(2)(iv) and 45 CFR that ‘‘mandatory consequential
and physical safeguards. We proposed 164.306(d)(3), implement security insurance’’ be required of all parties
to include administrative and physical updates as necessary, and correct involved in data handling, storage, and
safeguards because an entity would identified security deficiencies as part dissemination.
require technical, administrative, and of the provider’s risk management Response: We thank the commenter
physical safeguards to enable it to process. for their suggestion and we will share
implement risk management security
As noted in the proposed rule, a risk the suggestion with other programs and
measures to reduce the risks and
analysis must assess the risks and agencies, which deal directly with the
vulnerabilities identified. Technical
vulnerabilities to ePHI created or business requirements established
safeguards alone are not enough to
maintained by the CEHRT and must be under the HIPAA security rules.
ensure the confidentiality, integrity, and
conducted or reviewed for each EHR Comment: Several commenters stated
availability of ePHI. Administrative
reporting period, and any security that inclusion of this objective was
safeguards (for example, risk analysis,
updates and deficiencies identified superfluous and redundant, as it is
risk management, training, and
contingency plans) and physical should be included in the provider’s already required by HIPAA. Another
safeguards (for example, facility access risk management process and suggested that we accept compliance
controls, workstation security) are also implemented or corrected as dictated by with the HIPAA Security Rule as
required to protect against threats and that process. fulfillment of this objective. A
impermissible uses or disclosures to To address inquiries about the commenter noted that it is confusing
ePHI created or maintained by CEHRT. relationship between this measure and when there are requirements from more
Comment: Most commenters the HIPAA Security Rule, we explained than one oversight agency. They noted
supported the inclusion of this objective that the requirement of the proposed that protecting patient health
and many appreciate the addition of measure is narrower than what is information is in the purview of the
‘‘administrative and physical required to satisfy the security risk OCR.
safeguards’’ to the objective because it analysis requirement under 45 CFR Response: We disagree. In fact, in our
aligns with HIPAA. Most commenters 164.308(a)(1). The requirement of the audits of providers who attested to the
appreciated our clarification of the proposed measure is limited to annually requirements of the EHR Incentive
timing and content of the security risk conducting or reviewing a security risk Program, this objective and measure are
assessments. Several commenters analysis to assess whether the technical, failed more frequently than any other
appreciated the clarification that the administrative, and physical safeguards requirement. We have included this
requirements of this measure are and risk management strategies are objective in all Stages because of the
narrower than what is required by sufficient to reduce the potential risks importance of protecting patients’ ePHI.
HIPAA. and vulnerabilities to the Although OCR does oversee the
Some commenters noted in their confidentiality, availability, and implementation of the HIPAA Security
support of the objective that it is integrity of ePHI created by or Rule and the protection of patient health
essential for privacy protection and maintained in CEHRT. In contrast, the information, we believe it is important
consumer confidence in EHRs as security risk analysis requirement under and necessary for a provider to attest to
electronic personal health information 45 CFR 164.308(a)(1) must assess the the specific actions required to protect
is vulnerable to unauthorized access, potential risks and vulnerabilities to the ePHI created or maintained by CEHRT
theft, tampering, and corruption. confidentiality, availability, and in order to meet the EHR Incentive
Several commenters noted the rise in integrity of all ePHI that an organization Program requirements.
data breaches and the importance of this creates, receives, maintains, or Comment: Several commenters stated
objective in keeping health information transmits. This includes ePHI in all that the proposed measure is ‘‘too
well secured. forms of electronic media, such as hard comprehensive’’ and would be very
A commenter suggested triggers to drives, floppy disks, CDs, DVDs, smart difficult, time consuming, and
remind providers to conduct the cards or other storage devices, personal expensive.
security risk assessment. Many digital assistants, transmission media, or Many commenters requested
commenters supported the requirement portable electronic media. clarification about the requirement to
that providers conduct a security risk In the Stage 3 proposed rule at 80 FR perform a security risk analysis when
analysis upon installation or upgrade of 16746 through 16747, we further CEHRT is upgraded or patched. Others
CEHRT. proposed that the timing or review of noted that requiring a security risk
analysis whenever software is updated We note that for the proposed Comment: Commenters questioned if
is particularly burdensome. objective and measure, the measure the SRA Tool is only for providers and
A commenter recommended changing must be completed in the same calendar professionals in small and medium
the requirement of ‘‘conduct or review year as the EHR reporting period. If the sized practices asking for further
a security risk analysis’’ to ‘‘conduct EHR reporting period is 90 days, it must information on the definitions of small,
and review a security risk analysis,’’ to be completed in the same calendar year. medium, and large practices. Another
ensure both the behavior and the review This may occur either before or during commenter requested the identification
of a security risk analysis will be the EHR reporting period; or, if it occurs of additional guidance for solo or small
completed. Several commenters after the EHR reporting period, it must group practices.
requested further clarification of the occur before the provider attests or Several commenters recommended
timing for completion of the security before the end of the calendar year, that CMS collaborate with the OCR to
risk assessment. whichever date comes first. Again, we develop more robust guidance on
Response: We disagree with the reiterate that the security risk analysis conducting security risk assessments
concept that the objective as proposed is and review should not be an episodic and understanding and implementing
too comprehensive. We believe that the ‘‘snap-shot’’ in time, but rather include encryption. A commenter suggested a
proposed addition of administrative and an analysis and review of the protection national education campaign to help
technical safeguards to this measure of ePHI for the full year no matter at ensure that they are adequately
enables providers to implement risk what point in time that analysis or equipped to protect ePHI.
management security measures to review are conducted within the year. In Response: We decline to define
reduce the risks and vulnerabilities short, the analysis should cover practice size in this final rule with
identified. Administrative safeguards retrospectively from the beginning of comment period. Instructions for the
the year to the point of the analysis and SRA tool notes its usefulness to small
(for example, risk analysis, risk
prospectively from the point of the and medium practices because it was
management, training, and contingency
analysis to the end of the year. intended to provide support to
plans) and physical safeguards (for
Comment: A commenter noted that organizations, which often have more
example, facility access controls,
the measure only addresses compliance limited staff and organizational
workstation security) are also required
and risk and should also address knowledge on ePHI than larger
to protect against threats and
usability. They suggested that the organizations. However, the SRA Tool
impermissible uses or disclosures to
analysis of security should look at how information is applicable to and may be
ePHI created or maintained by CEHRT.
the data is used and if patients can useful for organizations of any size.
The proposed requirement is to In the Stage 3 proposed rule (80 FR
readily access the data.
perform the security risk analysis upon Response: We note that other 16747), we did note that OCR provides
installation of CEHRT or upon upgrade objectives in the EHR Incentive broad scale guidance on security risk
to a new Edition. Thus, it would be Program, as well as other certification analysis requirements and that other
required when a provider upgraded requirements around the technology, tools and resources are available to
from EHR technology certified to the include functions related to patient assist providers in the process. In
2014 Edition to EHR technology access to health data as well as the addition, CMS and ONC will continue
certified to the 2015 Edition as sharing of health data with patients and to work to provide tools and resources,
established by ONC. We note that the other providers. Inherent in these tip sheets, and to respond to FAQs from
second part of the requirement states a objectives is the requirement to use providers and developers on the privacy
review must be conducted at least on an certification criteria in the action or and security requirements.
annual basis, and additional review may process of information sharing. Comment: A commenter requested
be required if additional Therefore, these actions and functions clarification of the term ‘‘correcting
implementation changes are are part of the CEHRT and ePHI identified security deficiencies’’ as not
subsequently made that were not protections, which should be included all risks can be corrected. Commenters
included and planned for in the initial in the provider’s security risk analysis requested information on identity
review. and review. We note that providers proofing, authentication, and
We note that a security risk analysis should employ a security risk analysis authorization. Another commenter
is not a discrete item in time, but a that is most appropriate to their own requested more than a passing mention
comprehensive analysis covering the organization, which may include several of encryption.
full period of time for which it is resources for strategies and methods for Response: At minimum, providers
applicable; and the annual review of securing ePHI. Completing a security should be able to show a plan for
such an analysis is similarly risk analysis requires a time investment, correcting or mitigating deficiencies and
comprehensive. In other words, the and may necessitate the involvement of that steps are being taken to implement
analysis and review are not merely security, HIT, or system IT staff or that plan. Our discussion of this
episodic but should cover a span of the support teams at your facility. The OCR measure as it relates to 45 CFR
entire year, including a review planning provides broad scale guidance on 164.308(a)(1) is only relevant for
for future system changes within the security risk analysis requirements at: purposes of the EHR Incentive Program
year or a review of prior system changes http://www.hhs.gov/ocr/privacy/hipaa/ requirements and is not intended to
within the year. Therefore, we believe administrative/securityrule/ supersede or satisfy the broader,
the commenters’ concerns may be a rafinalguidancepdf.pdf. separate requirements under the HIPAA
semantic misunderstanding of the In addition, other tools and resources Security Rule and other rulemaking. For
nature of an analysis and annual review. are available to assist providers in the information on identity proofing,
We proposed to maintain the previously process. For example, the ONC provides authentication, authorization, and
finalized Stage 2 objective on protecting guidance and an SRA tool created in encryption, we refer readers to the OCR
ePHI, which includes the statement conjunction with OCR on its Web site Web site, www.hhs.gov/ocr.
‘‘conduct or review’’ for both the EHR at: http://www.healthit.gov/providers- As noted in the Stage 1 final rule (75
Incentive Programs in 2015 through professionals/security-risk-assessment- FR 44314 at 44368), while this objective
2017 and for Stage 3. tool. is intended to support compliance with
the HIPAA Privacy and Security Rules, finalized in the Stage 2 final rule (77 FR functions reliably. In all cases under
we maintain that meaningful use is not 53989 through 53990) for electronic this objective, the provider needs to use
the appropriate regulatory tool to ensure prescribing for EPs, with minor changes. CEHRT as the sole means of creating the
compliance with the HIPAA Privacy We also proposed to maintain the prescription, and when transmitting to
and Security Rules. In addition, as previous Stage 2 menu objective for an external pharmacy that is
noted in the Stage 2 final rule, the scope eligible hospitals and CAHs as a independent of the provider’s
of the security risk analysis for purposes required objective for Stage 3 with an organization, such transmission must be
of this meaningful use measure applies increased threshold. pursuant to ONC HIT Certification
only to data created or maintained by Proposed Objective: EPs must Program criteria.
CEHRT and does not apply to data generate and transmit permissible Comment: Some commenters
centers that are not part of CEHRT (77 prescriptions electronically, and eligible recommended that OTC medications
FR 53968 at 54003). hospitals and CAHs must generate and should be excluded in the definition of
After consideration of the comments transmit permissible discharge prescription, as they are not typically
received on this objective and measure, prescriptions electronically (eRx). prescribed electronically.
we are finalizing the objective as We proposed to continue to define Response: We thank commenters for
proposed and finalizing the measure ‘‘prescription’’ as the authorization by a their input and agree that OTC
with a modification to replace the word provider to dispense a drug that would medications should continue to be
‘‘stored’’ with the phrase ‘‘created or not be dispensed without such excluded from the definition.
maintained.’’ We are adopting this authorization. This includes Proposed EP Measure: More than 80
change to correct a discrepancy between authorization for refills of previously percent of all permissible prescriptions
the text of the objective and the measure authorized drugs. We proposed to written by the EP are queried for a drug
as well as between the measure (the continue to generally define a formulary and transmitted electronically
objective reads ‘‘created and ‘‘permissible prescription’’ as all drugs using CEHRT.
maintained’’) and to better reflect the meeting the definition of prescription We proposed to maintain for Stage 3
HIPAA security rules. We are finalizing not listed as a controlled substance in the exclusion from Stage 2 for EPs who
the objective and measure as follows: Schedules II–V (DEA Web site at http:// write fewer than 100 permissible
www.deadiversion.usdoj.gov/schedules/ prescriptions during the EHR reporting
Objective 1: Protect Patient Health index.html) (77 FR 53989), with a slight period. We also proposed to maintain
Information modification to allow for inclusion of for Stage 3 the exclusion from Stage 2
Objective: Protect electronic protected scheduled drugs where such drugs are if no pharmacies within a 10-mile
health information (ePHI) created or permitted to be electronically radius of an EP’s practice location at the
maintained by the CEHRT through the prescribed. We proposed that providers start of his or her EHR reporting period
implementation of appropriate who practice in a state where controlled accept electronic prescriptions (77 FR
technical, administrative, and physical substances may be electronically 53990). This is 10 miles in any straight
safeguards. prescribed who wish to include these line from the practice location
Measure: Conduct or review a security prescriptions in the numerator and independent of the travel route from the
risk analysis in accordance with the denominator may do so under the practice location to the pharmacy. For
requirements under 45 CFR definition of ‘‘permissible EPs practicing at multiple locations,
164.308(a)(1), including addressing the prescriptions’’ for their practice. If a they are eligible for the exclusion if any
security (including encryption) of data provider chooses to include such of their practice locations equipped
created or maintained by CEHRT in prescriptions, they must do so with CEHRT meet this criterion. An EP
accordance with requirements under 45 uniformly across all patients and across would not be eligible for this exclusion
CFR 164.312(a)(2)(iv) and 45 CFR all allowable schedules for the duration if he or she is part of an organization
164.306(d)(3), implement security of the EHR reporting period. We that owns or operates its own pharmacy
updates as necessary, and correct proposed to continue to exclude over- within the 10-mile radius regardless of
identified security deficiencies as part the-counter (OTC) medicines from the whether that pharmacy can accept
of the provider’s risk management definition of a prescription, although we electronic prescriptions from EPs
process. encouraged public comments on outside of the organization.
We are adopting Objective 1: Protect whether OTC medicines should be To calculate the percentage, CMS and
Patient Health Information at included in this objective for Stage 3. ONC have worked together to define the
§ 495.24(d)(1)(i) for EPs and In the Stage 2 final rule at (77 FR following for this objective:
§ 495.24(d)(1)(ii) for eligible hospitals 53989), we discussed several different Denominator: Number of
and CAHs. We further specify that in workflow scenarios that are possible prescriptions written for drugs requiring
order to meet this objective and when an EP prescribes a drug for a a prescription in order to be dispensed
measures, an EP, eligible hospital, or patient and that these differences in other than controlled substances during
CAH must use the capabilities and transmissions create differences in the the EHR reporting period; or number of
standards of as defined for as defined need for standards. For Stage 3, we prescriptions written for drugs requiring
CEHRT at § 495.4. We direct readers to proposed to maintain this policy for a prescription in order to be dispensed
section II.B.3 of this final rule with Stage 3 for EPs and extend it to eligible during the EHR reporting period.
comment period for a discussion of the hospitals and CAHs so that only a Numerator: The number of
definition of CEHRT and a table scenario in which a provider (1) prescriptions in the denominator
referencing the capabilities and Prescribes the drug; (2) transmits it to a generated, queried for a drug formulary,
standards that must be used for each pharmacy independent of the provider’s and transmitted electronically using
measure. organization; and (3) The patient obtains CEHRT.
the drug from that pharmacy requires Threshold: The resulting percentage
Objective 2: Electronic Prescribing the use of standards to ensure that the must be more than 80 percent in order
In the Stage 3 proposed rule (80 FR transmission meets the goals of for an EP to meet this measure.
16747 through16749), we proposed to electronic prescribing. In that situation, Exclusions: Any EP who: (1) Writes
maintain the objective and measure standards can ensure the whole process fewer than 100 permissible
prescriptions during the EHR reporting electronically promotes efficiency and denominator for the measure is based
period; or (2) does not have a pharmacy patient safety through reduced not on office visits but on permissible
within their organization and there are communication errors. prescriptions.
no pharmacies that accept electronic Comment: Many commenters Comment: Several commenters stated
prescriptions within 10 miles of the EP’s expressed concerns about requiring e- that the threshold of over 80 percent for
practice location at the start of his or her prescribing for hospitals where the EPs is too high. Commenters cited this
EHR reporting period. objective was previously a menu option. high threshold as a potential patient
Proposed Eligible Hospital/CAH Some noted that the shift from optional safety risk for providers switching
Measure: More than 25 percent of to required, combined with an increased products, since systems issues could
hospital discharge medication orders for threshold for Stage 3, makes the occur from inappropriately expediting
permissible prescriptions (for new and objective difficult to achieve for eligible implementation in order to meet the
changed prescriptions) are queried for a hospitals and CAHs. high threshold.
drug formulary and transmitted Response: We thank the commenters Some of these commenters expressed
electronically using CEHRT. for sharing their concerns. However, we that if the provider is required to query
We proposed to limit this measure for believe the potential benefits of a drug formulary, the provider cannot be
Stage 3 to only new and changed electronic prescribing are substantial. expected to meet the 80 percent
prescriptions and invited public As discussed in the Stage 2 final rule threshold. Further commenters
comment on whether a hospital would (77 FR 53989), transmitting the discussed the disconnect between the
issue refills upon discharge for prescription electronically promotes various options for formulary queries
medications the patient was taking efficiency and patient safety through and discussed the ongoing evolution of
when they arrived at the hospital and, reduced communication errors. It also standards specifically referencing the
if so, whether distinguishing those refill allows the pharmacy or a third party to following issues:
prescriptions from new or altered automatically compare the medication • Formulary queries where no
prescriptions is unnecessarily order to others they have received for formulary exists may generate errors on
burdensome for the hospital. the patient, which works in conjunction some systems;
To calculate the percentage, CMS and with clinical decision support • Formulary queries of formularies
ONC have worked together to define the interventions enabled at the generation with access restrictions, either
following for this objective: of the prescription. In addition, we note technological restrictions or proprietary
Denominator: The number of new or that, as required by the HITECH Act, e- restrictions limit the ability to query
changed prescriptions written for drugs prescribing has been a required part of even where such a formulary is
requiring a prescription in order to be the EHR Incentive Programs for EPs available;
dispensed other than controlled since 2011. As noted in the Stage 3 • Static formularies are often not fully
substances for patients discharged proposed rule, eligible hospital and electronic, are not a format that can be
during the EHR reporting period. CAH performance on electronic queried, or are updated infrequently so
Numerator: The number of prescribing in 2014 was well over the they provide limited benefit;
prescriptions in the denominator threshold. We believe that the • Real time formulary query
generated, queried for a drug formulary continued expansion of the standards are split with as many as
and transmitted electronically. infrastructure and 3 years to transition three primary options available in the
Threshold: The resulting percentage toward incremental increases via the industry.
must be more than 25 percent in order objective in place for 2015 through 2017 Despite these concerns, many
for an eligible hospital or CAH to meet will support hospitals in succeeding on commenters noted that they agree with
this measure. this measure. the concept of an automated, real-time
Exclusion: Any eligible hospital or Comment: Some commenters formulary query. Commenters stated
CAH that does not have an internal requested exclusions for eRx because that they believe it provides a value for
pharmacy that can accept electronic they have less than 100 office visits (in patients when the query is feasible and
prescriptions and there are no concurrence with previous successful.
pharmacies that accept electronic requirements) or have an average low Response: As we noted in the
prescriptions within 10 miles at the start census. Others simply stated that they proposed rule (80 FR 16747), our
of their EHR reporting period. could not meet the measure. analysis of the attestation data indicates
In the proposed rule, we recognized Response: We note that we proposed the majority of EPs have already been
that not every patient will have a to maintain for Stage 3 the exclusion exceeding this threshold; however, we
formulary that is relevant to him or her. from Stage 2 for EPs who write fewer note that each year a small but
If a relevant formulary is available, then than 100 permissible prescriptions significant portion of EPs may struggle
the information can be provided. If there during the EHR reporting period. We to meet this measure if they are engaged
is no formulary for a given patient, the also proposed to maintain for Stage 3 in a transition from one EHR product to
comparison could return a result of the exclusion from Stage 2 if no another or in a full upgrade of CEHRT
formulary unavailable for that patient pharmacies within a 10-mile radius of to a new Edition. For many functions,
and medication combination, and the an EP’s practice location at the start of the potential risk to patient safety
provider may count the prescription in his or her EHR reporting period accept during these transitions may be easily
the numerator if they generate and electronic prescriptions. For eligible mitigated; however, because the
transmit the prescription electronically hospitals and CAHs in Stage 3, there is appropriate management of prescribed
as required by the measure. an exclusion if they do not have an medications can be critical for both
Comment: A few commenters were in internal pharmacy that can accept acute and chronic patient care, the risk
support of the e-prescribing objective electronic prescriptions and there are no for electronic prescribing during
because it is an important priority in pharmacies that accept electronic transitions may be significant. We are
quality reporting efforts. prescriptions within 10 miles at the start therefore finalizing a threshold of 60
Response: We appreciate the support of their EHR reporting period. We do percent rather than the 80 percent
and note as we have previously stated, not agree with setting an exclusion proposed. We agree with the provider
transmitting the prescription based on office visits, as the commenter concerns regarding the drug
formulary query and reiterate that the V 12 (77 FR 53989) with a modification can be electronically prescribed. We are
long-term goal is to move toward real- to allow for inclusion of scheduled finalizing that these prescriptions may
time automated queries using a unified drugs where such drugs are permissible be included in the definition of
standard. For the short term, as noted to be electronically prescribed. ‘‘permissible prescriptions’’ at the
for the electronic prescribing objective Therefore the continued inclusion of the provider’s discretion where allowable
and measure for 2015 through 2017 in term ‘‘controlled substances’’ in the by law.
section II.B.2.a(iv), we believe that the denominator may no longer be an We will not include OTC medicines
query function should be maintained. accurate description to allow for in the definition of a prescription for
However, providers are only required to providers seeking to include these this objective. We are maintaining the
meet this part of the measure to the prescriptions in the circumstances different workflow scenarios that are
extent that such a query is automated by where they may be included. We are possible as discussed in the Stage 2 final
their CEHRT and to the extent that a modifying the denominator to remove rule at (77 FR 53989). We are
query is available and can be this language. Again, we note this is maintaining this policy for Stage 3 for
automatically queried by the provider. only a change in wording and does not EPs and extending it to eligible
This means that if a query using the change the substance of our current hospitals and CAHs.
function of their CEHRT is not possible policy that providers have the option, For EPs, eligible hospitals and CAHs
or shows no result, a provider is not but are not required, to include we are finalizing the objective as
required to conduct any further manual prescriptions for controlled substances follows:
or paper-based action in order to in the measure for Stage 3. For the EHR
Objective 2: Electronic Prescribing
complete the query, and the provider Incentive Programs in 2015 through
2017, we note that the inclusion of Objective: EPs must generate and
may count the prescription in the
controlled substances under permissible transmit permissible prescriptions
numerator.
prescriptions is optional under the electronically, and eligible hospitals and
Comment: Commenters noted that Electronic Prescribing Objective (see CAHs must generate and transmit
controlled substances should be section II.B.2.a.iv). For Stage 3, while permissible discharge prescriptions
included where feasible, as the we intended to maintain this option, electronically (eRx).
inclusion would reduce the paper based based on public comment received and EP Measure: More than 60 percent of
prescription process often used for such the progress of states toward acceptance all permissible prescriptions written by
prescriptions, as long as the inclusion of of electronic prescribing of controlled the EP are queried for a drug formulary
these prescriptions were permissible in substances we are modifying this policy and transmitted electronically using
accordance with state law. Commenters that the inclusion of controlled CEHRT.
noted that the ability to electronically substances should be required where it • Denominator: Number of
prescribe controlled substances is feasible to electronically prescribe the prescriptions written for drugs requiring
provides prescribers with a way to drug and where allowable by law. We a prescription in order to be dispensed
manage treatments for patients with believe the reduced threshold of 60 other than controlled substances during
pain electronically and also deters percent will help to mitigate the the EHR reporting period; or number of
creation of fraudulent prescriptions, additional effort to meet this prescriptions written for drugs requiring
which is a major concern in combating requirement and that the benefit a prescription in order to be dispensed
opioid misuse and abuse. outweighs this increased burden. during the EHR reporting period.
Therefore, we are changing the • Numerator: The number of
Response: We agree with commenters
measure for this objective to remove the prescriptions in the denominator
that the eventual progression toward
language regarding controlled generated, queried for a drug formulary,
universal inclusion of controlled
substances. Instead, we are adopting and transmitted electronically using
substances in electronic prescribing is a
that under ‘‘permissible prescriptions’’ CEHRT.
desired goal. However, as stated • Threshold: The resulting percentage
for the Stage 3 objective providers must
previously we believe that at present must be more than 60 percent in order
may include electronic prescriptions of
this should remain an option for for an EP to meet this measure.
controlled substances in the measure
providers, but not be required. As many • Exclusions: Any EP who: (1) writes
where creation of an electronic
states have now have eased some of the fewer than 100 permissible
prescription for the medication is
prior restrictions on electronically prescriptions during the EHR reporting
feasible using CEHRT and where
prescribing controlled substances, we period; or (2) does not have a pharmacy
allowed by law for the duration of the
believe it is no longer necessary to within their organization and there are
categorically exclude controlled no pharmacies that accept electronic
After consideration of the comments
substances from the term ‘‘permissible prescriptions within 10 miles of the EP’s
received, we are adopting the objective
prescriptions.’’ Therefore we will define practice location at the start of his or her
and exclusion for electronic prescribing
a permissible prescription as all drugs EHR reporting period.
as proposed. We will continue to define
meeting our current definition of a Eligible Hospital/CAH Measure: More
‘‘prescription’’ as the authorization by a
prescription as the authorization by a than 25 percent of hospital discharge
provider to dispense a drug that would
provider to dispense a drug that would medication orders for permissible
not be dispensed without such
not be dispensed without such prescriptions (for new and changed
authorization. This includes
authorization and we will no longer prescriptions) are queried for a drug
authorization for refills of previously
distinguishing between prescriptions for formulary and transmitted electronically

authorized drugs. We are finalizing
controlled substances and all other using CEHRT.
changes to the language to continue to
prescriptions. Instead will refer only to
allow providers the option to include or • Denominator: The number of new
permissible prescriptions consistent or changed prescriptions written for
exclude controlled substances in the
with the proposed definition for Stage 3 drugs requiring a prescription in order
denominator where such medications
(80 FR 16747) as all drugs meeting the to be dispensed other than controlled
definition of prescription not listed as a 12 (DEA Web site at http:// substances for patients discharged
controlled substance in Schedules II– www.deadiversion.usdoj.gov/schedules/index.html. during the EHR reporting period.
• Numerator: The number of for providers and patients; information suggest that this measure is ‘‘topped
prescriptions in the denominator displays or links; context-aware out’’ because most participants in the
generated, queried for a drug formulary knowledge retrieval specifications Medicare and Medicaid EHR Incentive
and transmitted electronically. which provide a standard mechanism to Program have many more than 5 CDS
• Threshold: The resulting percentage incorporate information from online implemented in their EHRs, but they
must be more than 25 percent in order resources (commonly referred to as believed that CDS is a statutory
for an eligible hospital or CAH to meet InfoButtons); clinical guidelines; requirement.
this measure. condition-specific order sets; focused Response: We appreciate the support
• Exclusion: Any eligible hospital or patient data reports and summaries; for this objective. As we stated in the
CAH that does not have an internal documentation templates; diagnostic proposed rule, clinical decision support
pharmacy that can accept electronic support; and contextually relevant at the relevant point of care is an area
prescriptions and there are no reference information. These of health IT in which significant
pharmacies that accept electronic functionalities may be deployed on a evidence exists for substantial positive
prescriptions within 10 miles at the start variety of platforms (that is, mobile, impact on the quality, safety, and
of their EHR reporting period. cloud-based, installed).13 We continue efficiency of care delivery. We believe
We are adopting Objective 2: to encourage innovative efforts to use these factors outweigh the potential
Electronic Prescribing at CDS to improve care quality, efficiency, reporting burden in place for providers
§ 495.24(d)(2)(i) for EPs and and outcomes. Health IT functionality who have significantly more than 5 CDS
§ 495.24(d)(2)(ii) for eligible hospitals that builds upon the foundation of an interventions in place for whom the
and CAHs. We further specify that in EHR to provide persons involved in care measurement may no longer be
order to meet this objective and processes with general and person- required.
measures, an EP, eligible hospital, or specific information, intelligently Proposed Measures: EPs, eligible
CAH must use the capabilities and filtered and organized, at appropriate hospitals, and CAHs must satisfy both
standards of as defined for as defined times, to enhance health and health measures in order to meet the objective:
CEHRT at § 495.4. We direct readers to care. CDS is not intended to replace Measure 1: Implement 5 clinical
section II.B.3 of this final rule with clinician judgment, but rather is a tool decision support interventions related
comment period for a discussion of the to assist care team members in making to four or more CQMs at a relevant point
definition of CEHRT and a table timely, informed, and higher quality in patient care for the entire EHR
referencing the capabilities and decisions. reporting period. Absent 4 CQMs related
standards that must be used for each Proposed Objective: Implement to an EP, eligible hospital, or CAH’s
measure. clinical decision support (CDS) scope of practice or patient population,
interventions focused on improving the clinical decision support
Objective 3: Clinical Decision Support
performance on high-priority health interventions must be related to high-
Clinical decision support at the conditions. priority health conditions.
relevant point of care is an area of HIT We proposed to retain both measures Measure 2: The EP, eligible hospital,
in which significant evidence exists for of the Stage 2 objective for Stage 3 and or CAH has enabled and implemented
substantial positive impact on the that these additional options stated the functionality for drug-drug and
quality, safety, and efficiency of care previously on the actions, functions, drug-allergy interaction checks for the
delivery. For Stage 3 of the EHR and interventions may constitute CDS entire EHR reporting period.
Incentive Programs, we proposed to for purposes of the EHR Incentive Exclusion: For the second measure,
maintain the Stage 2 objective with Programs and would meet the measure any EP who writes fewer than 100
slight modifications and further requirements outlined in the proposed medication orders during the EHR
explanation of the relevant point of care, measures. reporting period.
the types of CDS allowed, and the Comment: Most commenters agreed Where possible, we recommend
selection of a CDS applicable to a that clinical decision support should be providers implement CDS interventions
provider’s scope of practice and patient included as an objective in Stage 3, and that relate to care quality improvement
population. many expressed appreciation for the goals and a related outcome measure
First, we offered further explanation consistency between the existing Stage CQM. However, for specialty hospitals
of the concept of the relevant point of 2 objective and Stage 3. Some and certain EPs, if there are no CQMs
care and note that providers should commended CMS’ emphasis on clinical that are outcome measures related to
implement the CDS intervention at a decision support tools in the proposed their scope of practice, the provider
relevant point in clinical workflows rule. Others were also pleased that CMS should implement a CDS intervention
when the intervention can influence is aligning this objective with the HHS related to a CQM process measure; or if
clinical decision making before National Quality Strategy goals by none of the available CQMs apply, the
diagnostic or treatment action is taken emphasizing preventive care, chronic provider should apply an intervention
in response to the intervention. Second, condition management, and heart that he or she believes will be effective
many providers may associate CDS with disease and hypertension as areas of in improving the quality, safety, or
pop-up alerts. However, these alerts are focus for quality improvement. A efficiency of patient care.
not the only method of providing CDS. commenter acknowledged the value of Comment: Many commenters
CDS should not be viewed as simply an CDS available in EHR technology in supported Measure 1period), with a
interruptive alert, notification, or improving patient safety and care significant number supporting CMS for
explicit care suggestion. Well-designed quality, and believes that this acknowledgement of the wide variety of
CDS encompasses a variety of workflow- requirement has become obsolete as an innovative clinical decision tools that
optimized information tools, which can attestation measure. Others similarly can be used. Some acknowledged
be presented to providers, clinical and ‘‘alarm fatigue’’ and the subsequent
support staff, patients, and other 13 FDASIA Health IT report available on the FDA
ignoring of alerts, so they appreciated
caregivers at various points in time. Web site at: http://www.fda.gov/downloads/ the alternatives to pop-up alerts. As an
AboutFDA/CentersOffices/
These may include but are not limited OfficeofMedicalProductsandTobacco/CDRH/ alternative to alerts, one provider
to: computerized alerts and reminders CDRHReports/UCM391521.pdf. suggested that information display as
links for condition-specific order sets, tailored to best meet the provider’s choose to report and we note that we
diagnostic support, and contextually needs. However, please note that in this have a recommended set of CQMs for
relevant reference information, which example, the use of the InfoButton EPs, which includes both a set for adult
seem to be more user-friendly support would not count as a separate or population and for pediatric
tools. A commenter stated that the additional CDS intervention, but rather populations, which may serve as a
multiple tools available to meet the would be a supporting part of the one guide.14 As we stated when we finalized
requirements of CDS may be difficult CDS of which it is a part. this measure for Stage 2 of the EHR
and there could be substantial costs Comment: For Measure 1, many Incentive Programs (77 FR 53996), it is
associated with the tools. commenters appreciated the our expectation that, at a minimum,
Other commenters requested strengthened connection of CQMs to providers will select CDS interventions
clarification of the types of resources CDS. However, some commenters to drive improvements in the delivery of
that will count towards meeting the recommended removing the care for the high-priority health
requirements of the EHR Incentive requirement to link CDS to CQMs in conditions relevant to their patient
Programs related to CDS. Specifically, favor of high-priority safety and quality population. CQMs may be changed on
commenters asked about the InfoButton improvement objectives. A commenter an annual basis through the PFS or IPPS
standard, and the requirement that clarified that eliminating the link would rulemaking. As CQMs are still required
RCERHT enable users to review the enable them to meet their system quality as part of a provider’s demonstration of
attributes of CDS resources. improvement goals and would remove meaningful use, providers should
Response: Our examples are intended the measurement burden of tracking modify their CDS selections if CQMs
to illustrate that CDS encompasses a links between CDS and CQMs. Some change over time.
variety of workflow-optimized commenters noted a lack of CQMs for Providers who are not able to identify
information tools. The examples are some provider types and referenced CQMs that apply to their scope of
meant to be illustrative and not a pediatricians. Another stated that if the practice or patient population may
requirement to utilize all of the options. EHR developer limits the number of implement CDS interventions that they
We proposed to embrace a broad CQMs that are included in the CEHRT, believe are related to high-priority
definition of CDS, including (but not it may limit a providers’ ability to health conditions relevant to their
limited to) resources such as: implement CDS. A commenter inquired patient population and will be effective
Computerized alerts and reminders for about changes to CQMs that could relate in improving the quality, safety or
providers and patients, clinical to selected CDS. Another recommended efficiency of patient care. These high
guidelines, condition-specific order sets, that CDS interventions be grandfathered priority conditions must be determined
documentation templates, focused in for a year after a CQM change. prior to the start of the EHR reporting
patient data reports and summaries, and Many commenters requested period in order to implement the
contextually relevant reference clarification of ‘‘high-priority health appropriate CDS to allow for improved
information. We posted a tip sheet and conditions.’’ A commenter suggested performance. We proposed to require a
guidance on the CMS Web site, that ‘‘high-priority health conditions’’ minimum number of CDS interventions,
www.cms.hhs.gov/ehrincentive, which be replaced with ‘‘conditions relevant to and providers must determine whether
includes several examples of CDS and the EP’s scope of practice’’. Another a greater number of CDS interventions
information on the general intent of this suggested that the CDS be related to 4 are appropriate for their patient
requirement, and referencing best or more CQMS or high-priority health populations.
practices for using CDS to improve care. conditions. Yet another commenter Comment: A commenter
The guidance also clarifies that CDS stated that the high priority health recommended an exclusion for
need not necessarily be presented conditions are not related to many of the physicians who face challenges
during a patient encounter, or be limited specialties, including surgery, implementing 5 CDS interventions.
to interventions targeted at physicians, pediatrics, or medical subspecialties. Another requested that only 3 CDS
and is not limited to interruptive alerts They recommended that we allow interventions be required. A commenter
or reminders. CDS is often an integrated providers to link to clinical guidelines recommended an exclusion for highly
part of the provider’s EHR system, but relevant to their practice or a clinical specialized EPs and a reduction in the
may also present in a variety of other registry that can provide real-time number of interventions required for
mechanisms, including but not limited specialty-specific data on their scope of each individual EP.
to: pharmacy systems, patients’ personal practice if there are not four relevant Response: We believe that CDS at the
health records (PHRs), or Patient portals CQMs. A commenter urged us to point of care is an area of health IT in
provided by the practice. include immunization forecasting as a which significant evidence exists for its
The InfoButton standard can be used measure of CDS. Another commenter substantial positive impact on the
to provide hyperlinks to information, requested that we consider behavioral quality, safety, and efficiency of care
such as clinical guidelines or patient health as an additional priority area. A delivery. Therefore, we did not propose
data summaries, at the relevant point in commenter does not believe CDS exclusion for this measure. In addition,
the care continuum and therefore interventions are applicable to providers we proposed to offer considerable
represents one type of CDS that EPs, servicing elderly patient populations, flexibility in the selection of the CDS
eligible hospitals, and CAHs may use to specifically those in nursing homes with interventions.
meet the EHR Incentive Programs CDS cognitive deficit since their mental Comment: A commenter questioned if
requirements. There are also likely to be functions are limited and life all the CDS tools suggested are required.
cases where it makes sense for a CDS expectancy short. Another commenter recommended that
resource to display certain attributes at Response: For providers linking CDS HHS support research that would help
the time of presentation, or for a to CQM selections, we proposed that
resource to include an InfoButton providers are allowed the flexibility to 14 EHR Incentive Programs Recommended Core
linking to additional information with implement CDS interventions that are Set Adult and Pediatric Clinical Quality Measure
Tables available at: https://www.cms.gov/
CDS attributes. The potential workflows related to any of the CQMs that are Regulations-and-Guidance/Legislation/
and implementations of these resources finalized for the EHR Incentive Program. EHRIncentivePrograms/2014_
within a CDS is varied and should be They are not limited to the CQMs they ClinicalQualityMeasures.html.
providers identify the most valuable them to meet the CDS Objective objective as an organizational or group
CDS interventions and the most requirements without limiting the objective rather than a specific eligible
effective placement of such potential use and innovation of a wide professional objective and allow the
interventions in provider workflows. range of options for providers. organization’s efforts to meet the
Response: We offered a list of Comment: Several commenters requirements for each provider
workflow optimized information tools recommended removing the ‘‘entire practicing in that organization.
to illustrate some examples in the Stage EHR reporting period’’ from the measure Response: We disagree with the
3 proposed rule (80 FR 16749). It is not specifications to limit unnecessary suggestion to allow CDS attestations at
meant to be list of required tools, nor is measurement burden. Another a group level. While certain CDS may
it an exhaustive list of all the options commenter was concerned that the support providers in a wide range of
available. Also in the Stage 3 proposed requirement for CDS interventions to be specialties, others may be designed for
rule (80 FR 16750), CMS and ONC have in place for the entire reporting year particular patient populations or
provided examples of CDS interventions would make it impossible for EPs, specialties and the selection of CQMs
as well as program models such as eligible hospitals, and CAHs to change may also be related to the priorities for
Million Hearts, which may offer CEHRT mid-year and remain eligible. an individual provider. For example,
suggestions to providers and raise Response: We disagree. We believe the Million Hearts campaign may
awareness of the possibilities available. that having providers implement provide CDS models for many
CMS and ONC will consider providing improvements in clinical performance providers, but may not be relevant for
further guidance as to CDS options, CDS for high-priority health conditions will certain specialties. Providers should be
and CQM pairings, and industry result in improved patient outcomes selecting and implementing CDS within
research on various CDS and believe CDS should be in place for their practice based on their priorities to
implementations. the entire EHR reporting period. We promote quality improvement and
Comment: A commenter requested a note that we understand reasonable positive outcomes for patients, not to
clarification on the relationship between downtime as may be expected with any avoid a potential audit failure.
the functions that are included in the health IT systems to ensure security or Furthermore, we note that we will
definition of CEHRT and the actions fix any issues which arise is acceptable. provide guidance to the auditors to
that are required for the EHR Incentives We intend for the implementation of 5 support their understanding of the wide
Programs. Some commenters expressed five CDS interventions to be a scope of CDS interventions available to
concern that EPs and eligible hospitals minimum. We do not intend to limit the providers.
and CAHs might be limited only to CDS number of interventions that may be Comment: Most commenters
that ONC had certified. Several implemented if an organization chooses supported the second measure related to
commenters also expressed concern that to implement more than 5 five. The drug-drug and drug-allergy interaction
the CDS requirements for the EHR same interventions do not have to be checks. A commenter suggested
Incentive Program objectives do not implemented for the entire EHR clarifying that the use of the word
match the standards for certification and reporting period as long as the threshold ‘‘enabled’’ signifies that the provider is
question if the certification of 5 is maintained for the duration of the actively using the functionality as
requirements for health IT would limit EHR reporting period. For example, if a opposed to just having the functionality
the types or utility of CDS a provider provider identifies quality improvement available. Another appreciated the
might use to meet the Clinical Decision goals that change the quality inclusion of this measure because it is
Support Objective. improvement and CDS implementation a huge benefit to patient care.
Response: CMS does not certify CDS plan over the course of the year, they However, a commenter recommended
functions or resources, but instead may make these changes as long as the that we allow exclusions from the drug-
defines that a provider must use CDS total number of CDS interventions drug and drug-allergy interaction checks
resources and that those resources must implemented at any given time during if the EP is a low-volume prescriber.
meet the ONC certification criteria to the EHR reporting period is 5 or more. Response: We appreciate the support
meet the definition of CEHRT. The EHR In fact, we expect that EPs, eligible for this measure. We meant by
Incentive Programs do not otherwise hospitals, and CAHs will regularly ‘‘enabled’’ that the provider should be
restrict a provider’s ability to choose update and adjust their portfolios of actively using the function for the
any CDS option or resource to meet CDS interventions—fine-tuning them to duration of the EHR reporting period at
their unique needs. For the certification evolving patient population needs and the relevant point in care. For the
criteria for CDS, the ONC 2015 Edition in response to each intervention’s second measure, we did propose an
proposed rule (80 FR 16804 through observed impact on the related CQM(s). exclusion for any EP who writes fewer
16921) proposed the functionalities that Comment: Many commenters were than 100 medication orders during the
health IT developers would build into concerned about the documentation EHR reporting period.
their ‘‘CDS module’’ to meet the required for audit to demonstrate that a Comment: Several commenters stated
certification criteria. These ‘‘CDS specific CDS is implemented for the that for the second measure they believe
modules’’ are what meet the CEHRT duration of the reporting period. it is burdensome to require eligible
definition for the EHR Incentive Another commenter suggested reducing hospitals, CAHs, and EPs to enable and
Programs. However, while the the audit burden while several implement the functionality for drug-
certification rule specifies that the ‘‘CDS commenters suggested a clarification be drug and drug-allergy interaction checks
module’’ that is certified to the CDS added to reduce the audit burden by for the entire EHR reporting period.
standard must have certain capabilities only requiring documentation showing Response: We believe that this
to provide or enable CDS for provider the CEHRT has the functionality. measure is an important component of
use, it does not certify the supports or Several commenters requested the EHR Incentive Programs and offers
resources themselves. This means that clarification in the area of audit the opportunity for positive impact on
the ONC health IT certification criteria readiness and guidance related to quality, efficiency of care delivery, and
are designed to ensure that the ‘‘CDS expectations for the use of specific CDS especially patient safety. We believe
module’’ implemented by EPs and at the individual level. They requested that the functionality for drug-drug and
eligible hospitals and CAHs will enable that we to consider identifying this drug-allergy interaction checks should
be enabled and implemented for the orders as an objective of meaningful use these staff are credentialed to perform
duration of the EHR reporting period for Stage 3. the equivalent duties of a credentialed
with the exception of limited Proposed Objective: Use medical assistant by a credentialing
unavoidable downtime if a system issue computerized provider order entry body other than their employer and
should arise. (CPOE) for medication, laboratory, and perform such duties as part of their
After consideration of the public diagnostic imaging orders directly organizational or job title. We deferred
comments received, we are finalizing entered by any licensed healthcare to the provider’s discretion to determine
the objective, measures and exclusion as professional, credentialed medical the appropriateness of the credentialing
proposed for EPs, eligible hospitals and assistant, or a medical staff member of staff to ensure that any staff entering
CAHs as follows: credentialed to and performing the orders have the clinical training and
equivalent duties of a credentialed knowledge required to enter orders for
Objective 3: Clinical Decision Support medical assistant; who can enter orders CPOE. This determination must be
Objective: Implement clinical into the medical record per state, local, made by the EP or representative of the
decision support (CDS) interventions and professional guidelines. eligible hospital or CAH based on—
focused on improving performance on We proposed to continue our policy • Organizational workflows;
high-priority health conditions. from the Stage 2 final rule that the • Appropriate credentialing of the
Measure 1: Implement five clinical orders to be included in this objective staff member by an organization other
decision support interventions related are medication, laboratory, and than the employing organization;
to four or more CQMs at a relevant point radiology orders. However, we proposed • Analysis of duties performed by the
in patient care for the entire EHR to expand the third measure of the staff member in question; and
objective to include diagnostic imaging.
reporting period. Absent four CQMs • Compliance with all applicable
related to an EP, eligible hospital, or This change was intended to address the
federal, state, and local laws and
CAH’s scope of practice or patient needs of specialists and allow for a
professional guidelines.
wider variety of clinical orders relevant
population, the clinical decision However, as stated in the Stage 2 final
to particular specialists to be included
support interventions must be related to rule at 77 FR 53986, it is apparent that
for purposes of measurement.
high-priority health conditions. For Stage 3, we proposed to continue the prevalent time when CDS
Measure 2: The EP, eligible hospital, our policy from the Stage 2 final rule interventions are presented is when the
or CAH has enabled and implemented that the orders to be included in this order is entered into CEHRT, and that
the functionality for drug-drug and objective are medication, laboratory, not all EHRs also present CDS when the
drug-allergy interaction checks for the and radiology orders as such orders are order is authorized (assuming such a
entire EHR reporting period. commonly included in CPOE multiple step ordering process is in
Exclusion: For the second measure, implementation and offer opportunity to place). This means that the person
any EP who writes fewer than 100 maximize efficiencies for providers. entering the order would be required to
medication orders during the EHR However, for Stage 3, we proposed to enter the order correctly, evaluate a CDS
reporting period. expand the objective to include intervention either using their own
We are adopting Objective 3:Clinical diagnostic imaging, which is a broader judgment or through accurate relay of
Decision Support at § 495.24(d)(3)(i) for category including other imaging tests the information to the ordering
EPs and § 495.24(d)(3)(ii) for eligible such as ultrasound, magnetic resonance, provider, and then either make a change
hospitals and CAHs. We further specify and computed tomography in addition to the order based on the information
that in order to meet this objective and to traditional radiology. This change provided by the CDS intervention or
measures, an EP, eligible hospital, or addressed the needs of specialists and bypass the intervention. The execution
CAH must use the capabilities and allowed for a wider variety of clinical of this role represents a significant
standards of as defined for as defined orders relevant to particular specialists impact on patient safety; therefore, we
CEHRT at § 495.4. We direct readers to to be included for purposes of continued to maintain for Stage 3 that
section II.B.3 of this final rule with measurement. a layperson is not qualified to perform
comment period for a discussion of the We further proposed to continue the these tasks. We believe that the order
definition of CEHRT and a table policy from the Stage 2 final rule at 77 must be entered by a qualified
referencing the capabilities and FR 53986 that orders entered by any individual. We further proposed that if
standards that must be used for each licensed healthcare professional or the individual entering the orders is not
measure. credentialed medical assistant would the licensed healthcare professional, the
count toward this objective. A order must be entered with the direct
Objective 4: Computerized Provider credentialed medical assistant may supervision or active engagement of a
Order Entry enter orders if they are credentialed to licensed healthcare professional.
In the Stage 2 final rule, we expanded perform the duties of a medical assistant We proposed to maintain for Stage 3
the use of computerized provider order by a credentialing body other than the our existing policy for Stages 1 and 2
entry (CPOE) from the Stage 1 objective employer. If a staff member of the that the CPOE function should be used
requiring only medication orders to be eligible provider is appropriately the first time the order becomes part of
entered using CPOE to include credentialed and performs assistive the patient’s medical record and before
laboratory orders and radiology orders. services similar to a medical assistant, any action can be taken on the order.
For a full discussion of this expansion, but carries a more specific title due to The numerator of this objective also
we direct readers to (77 FR 53985 either specialization of their duties or to includes orders entered using CPOE
through 53989). We maintain CPOE the specialty of the medical professional initially when the patient record became
continues to represent an opportunity they assist, orders entered by that staff part of the CEHRT, but does not include
for providers to leverage technology to member would be included in this paper orders entered initially into the
capture these orders to reduce error and objective. We further noted that medical patient record or orders entered into
maximize efficiencies within their staff whose organizational or job title, or technology not compliant with the
practice, therefore we proposed to the title of their credential, is other than CEHRT definition and then transferred
maintain the use of CPOE for these medical assistant may enter orders if into the CEHRT at a later time.
In addition, we proposed to maintain engagement’’ was not meant to capture the EP or authorized providers of the
for Stage 3 that ‘‘protocol’’ or ‘‘standing’’ a hierarchical organizational or eligible hospital or CAH inpatient or
orders may but are not required to be contractual arrangement, but rather to emergency department (POS 21 or 23)
excluded from this objective. signify that any required assistance and during the EHR reporting period are
We proposed to maintain the Stage 2 direction to assess and act upon a CDS recorded using computerized provider
description of ‘‘laboratory services’’ as and ensure the order is accurately order entry;
any service provided by a laboratory entered should be provided in real time. Proposed Measure 2: More than 60
that could not be provided by a non- Comment: A commenter disagreed percent of laboratory orders created by
laboratory for the CPOE objective for that only ‘‘certified’’ medical assistants the EP or authorized providers of the
Stage 3 (77 FR 53984). We also proposed are capable of entering orders and eligible hospital or CAH inpatient or
to maintain for Stage 3 the Stage 2 requested clarification on the specific emergency department (POS 21 or 23)
description of ‘‘radiologic services’’ as certification required. Another during the EHR reporting period are
any imaging service that uses electronic commenter stated that in Massachusetts, recorded using computerized provider
product radiation (77 FR 53986). Even medical assistants are not required to be order entry; and
though we proposed to expand the credentialed in order to practice and Proposed Measure 3: More than 60
CPOE objective from radiology orders to there is no local credentialing body for percent of diagnostic imaging orders
all diagnostic imaging orders, this medical assistants. The commenter created by the EP or authorized
description would still apply for suggested that if a standard for medical providers of the eligible hospital or CAH
radiology services within the expanded assistant CPOE is required, then the inpatient or emergency department
objective. standard should be that the medical (POS 21 or 23) during the EHR reporting
We received public comment on our assistant must be appropriately trained period are recorded using computerized
proposals and our response follows. for CEHRT use (including CPOE) by the provider order entry.
Comment: The majority of employer or CEHRT vendor in order to We proposed to continue a separate
commenters supported the inclusion of be counted. percentage threshold for all three types
this objective. Some of the commenters Response: We thank the commenter of orders: Medication, laboratory, and
appreciated the consistency with the for their feedback and suggestion. We diagnostic imaging. We continue to
previous Stage 2 objective. A believe there may be some confusion believe that an aggregate denominator
commenter requested that we clarify related to the term ‘‘Certified Medical, cannot best capture differentiated
that there are no changes to the Assistant’’ which is not used by CMS in performance on the individual order
objective or to the definition of terms our proposed rules or guidance with types within the objective, and therefore
except for ‘‘diagnostic imaging.’’ reference to the credentialed medical maintain a separate denominator for
Response: We appreciate the support assistant or the credentialed medical each order type. We proposed to retain
for the objective. We proposed to staff equivalent of a medical assistant. exclusionary criteria from Stage 2 for
maintain the Stage 2 CPOE policies We reiterate that CMS does not require those EPs who so infrequently issue an
except that the third measure would be any specific or general ‘‘certification’’ order type specified by the measures
expanded from radiology orders to and note that credentialing may take (write fewer than 100 of the type of
diagnostic imaging orders and the many forms including, but not limited order), that it is not practical to
thresholds for the measures would be to, the appropriate degree from a health implement CPOE for that order type.
increased. training and education program from We proposed to retain exclusionary
Comment: Commenters requested which the medical staff matriculated. criteria from Stage 2 for those EPs who
clarification of ‘‘medical staff member We note that a simple search online so infrequently issue an order type
credentialed to perform the equivalent returns dozens of medical assistant specified by the measures (write fewer
duties of a credentialed medical training and credentialing programs as than 100 of the type of order), that it is
assistant’’ and requested clarification on well as local industry associations for not practical to implement CPOE for
a number of potential roles including an Medical Assistants offering resources on that order type.
in-house phlebotomist, an training in the Commonwealth of Finally, we sought public comment
ophthalmological assistant, a medical Massachusetts. We note that any such on whether to continue to allow, but not
student in residency, and other health program which met a provider’s require, providers to limit the measure
care professionals. Other commenters requirements for their practice would of this objective to those patients whose
requested clarification on the phrase also be an example of an acceptable records are maintained using CEHRT.
‘‘under the direct supervision or active credentialing for the purposes of this Comment: A few commenters
engagement of a licensed healthcare objective. supported not requiring providers to
professional.’’ We disagree that the training on the limit the measure of this objective to
Response: As noted in the Stage 3 use of CEHRT is adequate for the patients whose records are maintained
proposed rule (80 FR 16751), we require purposes of entering an order under using CEHRT.
that the person entering the orders be a CPOE and executing any relevant action Response: We believe that the
licensed health care professional or related to a CDS. We believe CPOE and majority of providers will store their
credentialed medical assistant (or staff CDS duties should be considered patient records in CEHRT by the
member credentialed to the equivalency clinical in nature, not clerical. beginning of Stage 3. However, as noted
and performing the duties equivalent to Therefore, CPOE and CDS duties, as previously, a certain percentage of
a medical assistant). We defer to the noted, should be viewed in the same charts may still be maintained outside
provider’s discretion to determine the category as any other clinical task, of CEHRT (such as workers
appropriateness of the credentialing of which may only be performed by a compensation or other special
staff to ensure that any staff entering qualified medical or clinical staff. contracts).
orders have the clinical training and Proposed Measures: An EP, eligible After consideration of public
knowledge required to enter orders for hospital or CAH must meet all three comments received, we maintain the
CPOE. measures. distinction between measures that
However, the descriptive phrase Proposed Measure 1: More than 80 include only those patients whose
‘‘direct supervision or active percent of medication orders created by records are maintained using CEHRT
and measures that include all patients. warrant an additional exclusion for an We appreciate the support for the
Providers may continue to limit the EP, such as a situation representing a inclusion of diagnostic imaging for
denominator to those patients whose barrier to successfully implementing the measure 3. We proposed the expansion
records are maintained using CEHRT for technology required to meet the for diagnostic imaging to include other
measures with a denominator other than objective. We also sought comment on imaging tests such as ultrasound,
unique patients seen by the EP during if there are circumstances where an magnetic resonance, and computed
the EHR reporting period or unique eligible hospital or CAH, which focuses tomography in addition to traditional
patients admitted to the eligible hospital on a particular patient population or radiology orders which were the limit of
or CAH inpatient or emergency specialty, may have an EHR reporting the scope of the Stage 2 objective at 80
department during the EHR reporting period where the calculation results in FR 16750. We believe this change
period. a zero denominator for one of the addresses the needs of specialists and
Proposed Measure 1: To calculate the measures, how often such allows for a wider variety of clinical
percentage, CMS and ONC have worked circumstances might occur, and whether orders relevant to particular specialists
together to define the following for this an exclusion would be appropriate. to be included for purposes of
measure: Comment: A few commenters noted measurement, benchmarking, and
Denominator: Number of medication potential barriers for cost of a system if process improvement initiatives within
orders created by the EP or authorized the provider conducts very few orders of healthcare organizations.
providers in the eligible hospital or a specific type. Many providers noted Finally, we thank those commenters
CAH inpatient or emergency department they believe that CPOE saves money and who supported the increased thresholds
(POS 21 or 23) during the EHR reporting delivers process improvement benefits for Stage 3. We have reconsidered the
period. in a relatively short and easily increase for the medication orders
Numerator: The number of orders in measure and are in agreement with
measureable cycle and so saw a strong
the denominator recorded using CPOE. commenters who suggested this
Threshold: The resulting percentage benefit from the objective.
Many commenters noted that the potential measure should not be raised
must be more than 80 percent in order to this level in order to avoid
for an EP, eligible hospital, or CAH to change from radiology orders to
diagnostic imaging orders increases inadvertently encouraging rushed
meet this measure. implementation if a provider is
Exclusion: Any EP who writes fewer relevance for specialty hospitals. A few
commenters requested clarification switching between products or
than 100 medication orders during the implementing an upgrade to the
EHR reporting period. around the inclusion of diagnostic
technology. As we explained in our
Proposed Measure 2: To calculate the imaging and how this is different from
discussion regarding the threshold of
percentage, CMS and ONC have worked Stage 2.
the Electronic Prescribing Objective for
together to define the following for this Some commenters stated that the
Stage 3, we believe the appropriate
measure: increase in thresholds, especially for management of medications can be
Denominator: Number of laboratory laboratory and radiology orders, were critical for both acute and chronic
orders created by the EP or authorized appropriate and they would be able to patient care, and therefore the risk
providers in the eligible hospital or meet them. Some commenters associated with CPOE for medication
CAH inpatient or emergency department supported the increased thresholds orders during transitions may be
(POS 21 or 23) during the EHR reporting noting that our inclusion of this significant. Therefore we will maintain
period. objective provided additional pressure the Stage 2 threshold for that measure
Numerator: The number of orders in on their organization to work toward a only which also aligns the three
the denominator recorded using CPOE. higher goal and maximize the potential
Threshold: The resulting percentage measures at the same level.
benefits CPOE offers. However, some After consideration of the public
must be more than 60 percent in order commenters noted that the 80 percent comments received, at we are finalizing
for an EP, eligible hospital, or CAH to threshold could present a problem for
meet this measure. the objective and the measures for CPOE
providers who are transitioning between for laboratory orders and CPOE for
Exclusion: Any EP who writes fewer certified EHR technologies within a
than 100 laboratory orders during the diagnostic imaging orders and the
reporting period. These commenters exclusions for all measures as proposed.
EHR reporting period. noted that for CPOE medication orders,
Proposed Measure 3: To calculate the We are finalizing the measure for CPOE
and the related CDS interventions for for medication orders with a modified
percentage, CMS and ONC have worked drug-drug and medication-allergies, it is
together to define the following for this threshold. We are adopting the objective
extremely important to allow adequate for EPs, eligible hospitals and CAHs as
measure: time for product and process
Denominator: Number of diagnostic follows:
implementation to ensure patient safety
imaging orders created by the EP or Objective 4: Computerized Provider
and minimize the risk of serious adverse
authorized providers in the eligible Order Entry
events.
hospital or CAH inpatient or emergency
department (POS 21 or 23) during the Response: In relation to the potential Objective: Use computerized provider
EHR reporting period. costs associated, we believe the order entry (CPOE) for medication,
Numerator: The number of orders in proposed exclusions would allow laboratory, and diagnostic imaging
the denominator recorded using CPOE. providers with significantly low orders directly entered by any licensed
Threshold: The resulting percentage numbers of a certain type or types of healthcare professional, credentialed
must be more than 60 percent in order orders to exclude the related measure medical assistant, or a medical staff
for an EP, eligible hospital, or CAH to and therefore avoid any unnecessary member credentialed to and performing
meet this measure. expenditure. We believe CPOE the equivalent duties of a credentialed
Exclusion: Any EP who writes fewer continues to represent an opportunity medical assistant, who can enter orders
than 100 diagnostic imaging orders for providers to leverage technology to into the medical record per state, local,
during the EHR reporting period. capture these orders to reduce error and and professional guidelines.
We further sought public comment on maximize efficiencies within their Measure 1: More than 60 percent of
if there are circumstances which might practice. medication orders created by the EP or
authorized providers of the eligible We are adopting Objective 4: the options through which providers
hospital or CAH inpatient or emergency Computerized Provider Order Entry at may engage with patients under the
department (POS 21 or 23) during the § 495.24(d)(4)(i) for EPs and EHR Incentive Programs. Specifically,
EHR reporting period are recorded using § 495.24(d)(4)(ii) for eligible hospitals we proposed an additional
computerized provider order entry; and CAHs. We further specify that in functionality, known as application
• Denominator: Number of order to meet this objective and programming interfaces (APIs), which
medication orders created by the EP or measures, an EP, eligible hospital, or would allow providers to enable new
authorized providers in the eligible CAH must use the capabilities and functionalities to support data access
hospital or CAH inpatient or emergency standards of as defined for as defined and patient exchange.
department (POS 21 or 23) during the CEHRT at § 495.4. We direct readers to We sought comment on what
EHR reporting period. section II.B.3 of this final rule with additional requirements might be
• Numerator: The number of orders comment period for a discussion of the needed to ensure that for the API— (1)
in the denominator recorded using definition of CEHRT and a table the functionality supports a patient’s
CPOE. referencing the capabilities and right to have his or her protected health
• Threshold: The resulting percentage standards that must be used for each information sent directly to a third party
must be more than 60 percent in order measure. designated by the patient; and (2)
for an EP, eligible hospital, or CAH to Objective 5: Patient Electronic Access to patients have at least the same access to
meet this measure. Health Information and use of their health information that
• Exclusion: Any EP who writes they have under the view, download,
fewer than 100 medication orders In the Stage 3 proposed rule (80 FR and transmit option.
16752), we identified two related policy Proposed Objective: The EP, eligible
goals within the overall larger goal of
Measure 2: More than 60 percent of hospital, or CAH provides access for
improved patient access to health
laboratory orders created by the EP or patients to view online, download, and
information and patient-centered
authorized providers of the eligible transmit their health information, or
communication. The first is to ensure
hospital or CAH inpatient or emergency retrieve their health information
patients have timely access to their full
department (POS 21 or 23) during the through an API, within 24 hours of its
health record and related important
EHR reporting period are recorded using availability.
health information; and that the second
computerized provider order entry; and is to engage in patient-centered We continue to believe that patient
• Denominator: Number of laboratory communication for care planning and access to their electronic health
orders created by the EP or authorized care coordination. While these two goals information, and to important
providers in the eligible hospital or are intricately linked, we noted that we information about their care, is a high
CAH inpatient or emergency department see them as two distinct priorities priority for the EHR Incentive Programs.
(POS 21 or 23) during the EHR reporting requiring different foci and measures of We noted that for this objective, the
period. success. For the first goal, we proposed provider is only required to provide
• Numerator: The number of orders to incorporate the Stage 2 objectives access to the information through these
in the denominator recorded using related to providing patients with access means; the patient is not required to
CPOE. to health information, including the take action in order for the provider to
• Threshold: The resulting percentage objective for providing access for meet this objective. We also stated that
must be more than 60 percent in order patients (or their authorized to ‘‘provide access’’ means that the
for an EP, eligible hospital, or CAH to representatives) to view online, patient has all the tools and information
meet this measure. download, and transmit their health they need to gain access to their health
• Exclusion: Any EP who writes information and the objective for information including, but not limited
fewer than 100 laboratory orders during patient-specific education resources, to, any necessary instructions, user
the EHR reporting period. into a new Stage 3 objective entitled, identification information, or the steps
Measure 3: More than 60 percent of ‘‘Patient Electronic Access’’ (Objective required to access their information if
diagnostic imaging orders created by the 5), focused on using CEHRT to support they have previously elected to ‘‘opt-
EP or authorized providers of the increasing patient access to important out’’ of electronic access. If this
eligible hospital or CAH inpatient or health information. For the second goal, information is provided to the patient in
emergency department (POS 21 or 23) we proposed an objective entitled a clear and actionable manner, the
during the EHR reporting period are Coordination of Care through Patient provider may count the patient for this
recorded using computerized provider Engagement (Objective 6) incorporating objective. We further stated that
order entry. the policy goals of the Stage 2 objectives providers may withhold from online
• Denominator: Number of diagnostic related to secure messaging, patient disclosure any information either
imaging orders created by the EP or reminders, and the ability for patients prohibited by federal, state, or local
authorized providers in the eligible (or their authorized representatives) to laws or if such information provided
hospital or CAH inpatient or emergency view online, download, and transmit through online means may result in
department (POS 21 or 23) during the their health information using the significant harm.
EHR reporting period. functionality of the CEHRT. Further, we noted that this objective
• Numerator: The number of orders In the Stage 3 Patient Electronic is a requirement for meaningful use and
in the denominator recorded using Access Objective, we proposed to it does not affect an individual’s right
CPOE. incorporate certain measures and under HIPAA to access his or her health
• Threshold: The resulting percentage objectives from Stage 2 into a single information. Providers must continue to
must be more than 60 percent in order objective focused on providing patients comply with all applicable requirements
for an EP, eligible hospital, or CAH to with timely access to information under the HIPAA Privacy Rule,
meet this measure. related to their care. We also proposed including the access provisions of 45
• Exclusion: Any EP who writes to no longer require or allow paper- CFR 164.524.
fewer than 100 diagnostic imaging based methods to be included in the We received the following comments
orders during the EHR reporting period. measures (80 FR 16753) and to expand and our response follows:
Comment: We received a number of two patient portals. Instead, this Response: For the provider to
comments requesting further proposed objective is supporting four implement an API under our proposal,
clarification of the proposal to basic actions that a patient should be the provider would need to fully enable
incorporate API functionality into an able to take: the API functionality such that any
objective for patient electronic access. • View their health information; application chosen by a patient would
We received comments requesting • Download their health information; enable the patient to gain access to their
clarification around how we envision • Transmit their health information to individual health information provided
the relationship between an API and the a third party; and that the application is configured to
existing view, download, and transmit • Access their health information meet the technical specifications of the
functionalities as well how a patient or through an API. API. Providers may not prohibit patients
provider might leverage an enabled API We also believe that these actions may from using any application, including
over multiple use cases. Commenters be supported by a wide range of system third-party applications, which meet the
also requested clarification on if the API solutions, which may overlap in terms technical specifications of the API,
would replace their patient portal or be of the software function used to do an including the security requirements of
a part of it or an additional Web site. action or multiple actions. This intent to the API. Providers are expected to
Some commenters expressed concern allow for innovation and change within provide patients with detailed
about supporting a second patient the scope of health IT development is instructions on how to authenticate
portal. part of a broader goal to lay the their access through the API and
Response: We thank the commenters foundation for health care systems to provide the patient with supplemental
and offer the following explanation of support the patient and provider. information on available applications
our intent for the use of an API within An API is a set of programming that leverage the API. We believe there
the patient electronic access objective as protocols established for multiple are multiple paths by which a provider
one of the potential functions through purposes. APIs may be enabled by a organization may provide this
which a patient may obtain access to provider or provider organization to information to the patient, just as the
their health information. provide the patient with access to their current information for access is
First, we do not consider the API to health information through a third-party provided through a variety of means
be a ‘‘second’’ patient portal and that application with more flexibility than is depending on the circumstances.
the current trend to use a patient portal often found in many current ‘‘patient Additionally, similar to how
to meet the view, download and portals.’’ providers support patient access to VDT
transmit functions, while prevalent and From the provider perspective, an API capabilities, we expect that providers
acceptable, is not the only way a could complement a specific provider will continue to have identity
provider might meet the current ‘‘branded’’ patient portal or could also verification processes to ensure that a
objective. We recognize the value in potentially make one unnecessary if patient using an application, which is
these systems and support the patients were able to use software leveraging the API, is provided access to
implementation of patient portals to applications designed to interact with their health information.
allow patients to engage with their an API that could support their ability We proposed for the Patient
health care providers for both clinical to view, download, and transmit their Electronic Access objective to allow
and administrative information. health information to a third party. providers to enable API functionality in
However, at a basic level, the EHR From the patient perspective, an API accordance with the proposed ONC
Incentive Program currently requires enabled by a provider will empower the requirements in the 2015 Edition
only that providers give their patients patient to receive information from their proposed rule. The certification criteria
access to their health information to be provider in the manner that is most proposed by ONC would establish API
able to do three activities: View their valuable to the patient. Patients could criteria, which would allow patients,
information, download their collect their health information from through an application of their choice
information, and transmit their multiple providers and potentially (including third-party applications), to
information. This is a nuanced but incorporate all of their health pull certain components of their unique
important distinction between the information into a single portal, health data directly from the provider’s
existing Stage 2 requirement and the application, program, or other software. CEHRT. This could also potentially
current systems, which are used to meet Such a solution may be offered on a allow a patient to pull such information
it. This distinction is important, as not state, local, or regional basis, for from multiple providers engaged in
only do we not require a ‘‘patient instance, through a health information their care. For further discussion on the
portal’’ format for VDT, we also do not exchange, or through another technical requirements for APIs, we
advocate such a limit on innovation in commercial vendor. In addition, we direct readers to the 2015 Edition
software or systems designed to allow recognize that a large number of patients proposed rule (80 FR 16840 through
patients to access and engage with their consult with and rely on trusted family 16850).
health information. We believe that the members and other caregivers to help Comment: A number of commenters
efficacy of the health IT environment coordinate care, understand health expressed concern over the privacy and
now and the potential for future information, and make decisions. For security of patient information through
innovation, relies on the establishment this reason, we proposed the inclusion the use of an API. Commenters noted a
of clear standards and functionality of patient-authorized representatives number of issues including—(1) How
requirements paired with the flexibility within the measures. the application would or would not be
to develop differentiated technical Comment: Commenters requested governed by HIPAA; (2) what
specifications, functions, and user clarification on the function of the API verification mechanisms would be
interface design that meet those itself, the standards in place, the required to be included by the provider,
requirements. potential process for determining the the EHR system, and the patient in order
This proposed Stage 3 objective for possible applications, which may to allow the enabled API to function
Patient Electronic Access is not a leverage the API, and how to with the patient selected application; (3)
‘‘patient portal’’ versus ‘‘API’’ successfully provide patients access to what standards would be required for
requirement or a requirement to support their information through an API. the API, the application, and any
provider verification process for recommended keeping the VDT further believe that it prevents any
enrolling patients; and (4) general threshold to Stage 2 levels. negative unintended consequences of
concern over the security of having an Several comments also included assumptions which may be placed on
enabled API for an EHR. concerns about patients not using or patients to use or not use various
Response: It is recognized that APIs accessing patient portals, which make it technologies. We believe that no patient
and VDT provide access to sensitive difficult for providers and hospitals to should be excluded from access to their
health care material and security and meet patient electronic access health care information for any reason,
privacy of patients’ ePHI is of utmost requirements. Eligible providers and especially reasons which would allow
importance. As has been seen in other hospitals do not want to be penalized if for a blanket exclusion of any patient
industries where system interoperability patients choose not to use the patient based on a demographic factor. We note
has enabled considerable benefits for portal or send them secure messages. A that we proposed to maintain our
the consumer, security technology is commenter recommended that current policy, which applies to the
constantly evolving to meet the compliance with access occur when the Stage 2 Patient Electronic Access
changing environment. Thus, detailed patient has been given documentation Objective, which requires that access be
monitoring, penetration testing, audits, on how to sign up for the patient portal, provided, even for those who choose to
and key management are all necessities. and that a patient’s decision to opt-out opt-out via providing them the
In addition, this changing environment be counted as compliance. The same information and resources they would
requires similarly nimble guidelines and commenter also recommended that the need to opt back in. We further thank
standards for privacy and security denominator for compliance with the those commenters for their support of
protocols. The EHR Incentive Program portal usage measure be counted as the the expansion of the concept of access
includes an Objective to Protect Patient total number of patients in the portal, for patient-authorized representatives
Health Information (see also section not the total number of qualified and note that this inclusion is designed
II.B.2.b.1 of this final rule with patients discharged in that period. to recognize the existing relationships
Many commenters supported the and expand the access to information
comment period). This objective
inclusion of patient-authorized for family members and other caregivers
includes a measure requiring providers
representatives within this objective who may serve as patient-authorized
to conduct or review a security risk
noting that this change is essential for representatives. Patient-authorized
analysis in accordance with HIPAA
patient care and provides greater representatives encompass both
requirements to ensure the protection of
flexibility for providers. These ‘‘personal representatives’’ as defined by
patient ePHI created or maintained by
commenters noted specific patient HIPAA, as well as those authorized or
CEHRT. This requirement to conduct
populations, such as disabled persons, designated by an individual.
and review a security risk analysis elderly patients, and newborn patients Proposed Measures: EPs, eligible
would include the certified API enabled or young children where the more hospitals, and CAHs must satisfy both
as a part of the provider’s CEHRT. This comprehensive inclusion of non- measures in order to meet the objective:
analysis must also be done in physician caregivers, family members, Proposed Measure 1: For more than
compliance with HIPAA Security Rules, and other patient-authorized 80 percent of all unique patients seen by
which would likewise be applicable to representatives within the measure the EP or discharged from the eligible
the provider actions related to the more accurately captures the hospital or CAH inpatient or emergency
provision of access to the patient’s inclusiveness of these interactions and department (POS 21 or 23):
health information. Beyond this the role that health IT can provide in (1) The patient (or patient-authorized
baseline, we believe that evidence in supporting communications with representative) is provided access to
similar technological transitions patients and their caregivers. view online, download, and transmit
illustrates the need for a balanced and Response: We note that this proposed their health information within 24 hours
responsive approach to privacy and objective is entirely focused on the of its availability to the provider; or
security. As noted previously, we provision of access to patients or their (2) The patient (or patient-authorized
encourage providers to innovate around authorized representatives and does not representative) is provided access to an
enrollment structures for patients to require the provider to be accountable ONC-certified API that can be used by
provide accountability for privacy and for the patient using that access. third-party applications or devices to
security standards; we encourage Additionally, the numerator is provide patients (or patient-authorized
developers to incorporate security best calculated based on the provision of representatives) access to their health
practices in their design; and we access by the provider, not based on information, within 24 hours of its
encourage patients to employ sound whether a patient possesses or can availability to the provider.
practices just as they would with their obtain technology for their own use. The We proposed that for measure 1, the
online banking or other online activities provision of access by the provider is patient must be able to access this
regarding personal information. the entirety of the measurement and any information on demand, such as
Comment: Many commenters subsequent barriers to access which are through a patient portal, personal health
expressed concerns about successfully outside the providers control do not record (PHR), or API and have
meeting the objective because their affect the numerator calculation. In everything necessary to access the
patient population is elderly, ill, low- other words, for this measure the information even if they opt out. We
income, and/or located in remote, rural provider must ensure the patient has proposed that all three functionalities
areas. These patients do not have access been provided the information they (view, download, and transmit) or an
to computers, Internet and/or email and would need to gain access whether or API must be present and accessible to
are concerned with having their health not the patient has the technology they meet the measure. We further proposed
information online. A commenter need to gain access. that the functionality must support a
specifically requested that clinics with We believe that the overall focus of patient’s right to have his or her
high elderly populations, especially this objective on the provision of access protected health information sent
those in rural areas, be exempt from allows providers the flexibility to work directly to a third party designated by
meeting these patient electronic access with patients with a wide range of the patient consistent with the provision
requirements. Another commenter backgrounds and IT adoption. We of access requirements at 45 CFR
164.524(c) of the HIPAA Privacy Rule. eligible hospital or CAH inpatient or and security of API technology for
However, we proposed that if the emergency department (POS 21 or 23) patient electronic access, and noted that
provider can demonstrate that at least during the EHR reporting period. the ONC API certification process is not
one application that leverages the API is Numerator: The number of patients in fully functional yet. In response to our
available (preferably at no cost to the the denominator who were provided request for comment regarding
patient) and that more than 80 percent electronic access to patient-specific expansion of the patient engagement
of all unique patients have been educational resources using clinically measures to include the use of
provided instructions on how to access relevant information identified from application programming interfaces
the information; the provider need not CEHRT. (APIs) in addition to, or in place of, a
create, purchase, or implement Threshold: The resulting percentage patient portal, one commenter
redundant software to enable view, must be more than 35 percent in order referenced the JASON report and the
download, and transmit capability for a provider to meet this measure. Argonaut Project 15 and expressed
independently of the API. Exclusions: An EP may exclude from strong support the use of APIs to
the measure if they have no office visits enhance interoperability, increase
To calculate the percentage, CMS and
during the EHR reporting period. patient engagement, and ease the
ONC worked together to define the Any EP that conducts 50 percent or
following for the proposed measure: burden of EHR end users with respect
more of his or her patient encounters in to programming, updating, and
Denominator: The number of unique a county that does not have 50 percent
patients seen by the EP or the number maintenance. Some commenters
or more of its housing units with 4Mbps expressed concern about the potential
of unique patients discharged from an broadband availability according to the
eligible hospital or CAH inpatient or cost associated with API
latest information available from the implementation.
emergency department (POS 21 or 23) FCC on the first day of the EHR
during the EHR reporting period. Response: As noted, referencing the
reporting period may exclude the JASON report and Argonaut Project, the
Numerator: The number of patients in measure.
the denominator who are provided use of APIs in the health care industry
Any eligible hospital or CAH will be represents an opportunity for both
access to information within 24 hours of excluded from the measure if it is
its availability to the EP or eligible patients and providers to leverage
located in a county that does not have technology to support the free flow of
hospital/CAH. 50 percent or more of their housing
Threshold: The resulting percentage information in a dynamic and secure
units with 4Mbps broadband manner. This technology is already in
must be more than 80 percent in order availability according to the latest
for a provider to meet this measure. widespread use in other industries with
information available from the FCC at similar implementation challenges, such
Exclusions: An EP may exclude from the start of the EHR reporting period.
the measure if they have no office visits as finance, and the social IT
We proposed that both measures for
during the EHR reporting period. environment includes the use of APIs in
this objective must be met using
Any EP that conducts 50 percent or simple every day interactions. Some
CEHRT.
more of his or her patient encounters in Comment: A number of commenters low-cost and even free API functions
a county that does not have 50 percent expressed concern about the timeframe already exist in the health IT industry,
or more of its housing units with 4Mbps of 24 hours for the availability, stating and we expect third-party application
broadband availability according to the that it was either too long for patients developers to continue to create low-
latest information available from the to wait or too short a time for providers cost solutions that leverage APIs as part
FCC on the first day of the EHR to adequately review the information of their business models.
reporting period may exclude the provided for accuracy and compliance Further, we encourage health IT
measure. with any concerns over disclosure of system developers to leverage the
Any eligible hospital or CAH will be information, such as sensitive test existing API platforms and applications
excluded from the measure if it is results, mental health issues, or as this would allow developers to
located in a county that does not have information which must be withheld in immediately begin offering providers
50 percent or more of their housing order to comply with state or local law. no-cost, or low-cost solutions to
units with 4Mbps broadband Response: We appreciate this implement and enable an API as part of
availability according to the latest assessment and recognize that such a their current systems even prior to the
information available from the FCC at review may be required in certain cases implementation of Stage 3 in 2018.
the start of the EHR reporting period. where the disclosure or non-disclosure In terms of cost, as we have stated in
Proposed Measure 2: The EP, eligible cannot simply be automated. We the past with the view, download, and
hospital or CAH must use clinically recognize that provider’s workflows, transmit functions, we do not believe it
relevant information from CEHRT to especially for EPs in small practices, would be appropriate for EPs and
identify patient-specific educational may be impacted in these instances hospitals or CAHs to charge patients a
resources and provide electronic access where such a need arises. Therefore, we fee for accessing their information using
to those materials to more than 35 are instead finalizing that information an API or VDT. We believe the
percent of unique patients seen by the must be included for access within 48 economies of scale provided by enabling
EP or discharged from the eligible hours for EPs and are retaining the an API render the cost of use by an
hospital or CAH inpatient or emergency current 36 hours for eligible hospitals individual patient minimal and we do
department (POS 21 or 23) during the and CAHs. We note that this would not believe that providing free access to
EHR reporting period. allow for immediate availability for patients represents a burden to the
Proposed Measure 2: To calculate the most patients where the provision of provider.
percentage, CMS and ONC worked information can be automated and will However, we recognize that the
together to define the following for this provide adequate time for review potential usage of APIs extends beyond
measure: processes for sensitive information by 15 JASON Report: http://www.healthit.gov/sites/
Denominator: The number of unique providers as necessary. default/files/ptp13-700hhs_white.pdfArgonaut
patients seen by the EP or the number Comment: A number of commenters Project: http://hl7.org/implement/standards/fhir/
of unique patients discharged from an expressed skepticism about the maturity 2015Jan/argonauts.html.
the individual patient to other provider the provider is less than a full calendar CAH inpatient or emergency department
organizations, non-physician care year. We note that the action must occur (POS 21 or 23):
settings, home health care, and many prior to the provider submitting their (1) The patient (or patient-authorized
other uses. We recognize that under attestation if they attest prior to the end representative) is provided access to
very high usage, it may be expensive to of the calendar year. For measure 1, we view online, download, and transmit
support APIs, and in those refer readers to the discussion on the their health information within 24 hours
circumstances, providers may want to Alternate Proposals for the measure of its availability to the provider; and
consider the feasibility of cost sharing immediately following. the patient (or patient-authorized
arrangements with outside organizations Alternate Proposals: representative) is provided access to an
or businesses, which frequently leverage For measure 1, we sought comment ONC-certified API that can be used by
the enabled API to support care on the following set of alternate third-party applications or devices to
coordination. proposals for providers to meet the provide patients (or patient-authorized
Comment: A few comments focused measure using the functions of CEHRT representatives) access to their health
on Measure 2, the requirement to outlined previously in this section. information within 24 hours of its
provide CEHRT-generated patient These alternate proposals involve the availability to the provider; or,
educational materials to patients. A requirements to use a view, download, (2) The patient (or patient-authorized
commenter discussed how low patient and transmit function or an API to representatives) is provided access to an
adoption of portals/APIs makes it provide patients access to their health ONC-certified API that can be used by
difficult to provide more than 35 information. Measure 1 as proposed third-party applications or devices to
percent of patients with electronic would allow providers the option either provide patients (or patient-authorized
educational materials. Another to give patients access to the view, representatives) access to their health
commenter requested that—(1) the download, and transmit functionality, information within 24 hours of its
denominator be patients who have or to give patients access to an API. availability to the provider.
office visits rather than patients who are Specifically, we sought comment on Alternate C: For more than 80 percent
seen by an EP; and (2) providers who whether the API option should be of all unique patients seen by the EP or
have less than 100 office visits during required rather than optional for discharged from the eligible hospital or
the EHR reporting period be excluded. providers, and if so, should providers CAH inpatient or emergency department
Lastly, a commenter opposed only using also be required to offer the view, (POS 21 or 23), the patient (or patient-
CEHRT-generated patient educational download, and transmit function. authorized representative) is provided
materials and thought additional Proposed Measure 1: For more than access to an ONC-certified API that can
materials printed in-office by providers 80 percent of all unique patients seen by be used by third-party applications or
should be acceptable. the EP or discharged from the eligible devices to provide patients (or patient-
Response: We disagree that this hospital or CAH inpatient or emergency authorized representatives) access to
measure threshold should be reduced or department (POS 21 or 23): their health information, within 24
limited to office visits or that providers (1) The patient (or patient-authorized hours of its availability to the provider.
should be required or allowed to representative) is provided access to We welcomed public comment on
continue to count paper-based actions view online, download, and transmit these proposals. We received the
toward this measure. We believe that their health information within 24 hours following comments and our response
the provision of access to patient- of its availability to the provider; or follows:
specific education following a similar (2) The patient (or the patient- Comment: The majority of
model as the provision of access to a authorized representative) is provided commenters who discussed APIs
patient’s record will allow providers the access to an ONC-certified API that can recommended that the use of APIs be
opportunity to leverage a wide range of be used by third-party applications or optional (for example, no requirement
resources for patients and include this devices to provide patients (or patient- for both APIs and patient portals); most
information in concert with the patient’s authorized representatives) access to opposed making APIs mandatory. A few
electronic health record. We believe that their health information, within 24 comments specifically noted that
as the technology continues to evolve hours of its availability to the provider. patient portals are already in place and
providers will perform well beyond the Alternate A: For more than 80 percent it would be counterproductive and
threshold and expect that innovative of all unique patients seen by the EP or financially wasteful to force investment
options will progress apace with this discharged from the eligible hospital or in APIs. Others also expressed
progress. We by no means intend to CAH inpatient or emergency department skepticism about the maturity and
discourage providers from also using (POS 21 or 23): security of API technology for patient
paper-based or other methods of (1) The patient (or the patient- electronic access, and noted that the
providing patients with education about authorized representative) is provided ONC API certification process is not
their health and their care. We are access to view online, download, and fully functional yet. Commenters noted
simply no longer requiring or allowing transmit his or her health information that EPs, eligible hospitals, and CAHs
paper-based actions to be counted within 24 hours of its availability to the have worked very hard to establish
because the EHR Incentive Programs provider; and patient portals, and have encouraged
focuses on leveraging health IT to (2) The patient (or patient-authorized patients to use them and that this effort
support patient engagement. representatives) is provided access to an has required an extraordinary effort in
We are therefore finalizing Measure 2 ONC-certified API that can be used by time and financial commitment. The
as proposed for the method of delivery third-party applications or devices to commenters further stated that it would
and with a modification to specify that provide patients (or patient-authorized not make financial, strategic, or
for the numerator of for measure 2 for representatives) access to their health technical sense to abandon patient
each year, the action must occur within information within 24 hours of its portals. They also stated that many
the same calendar year as the EHR availability to the provider. patients who have begun to engage with
reporting period, but may occur before, Alternate B: For more than 80 percent their health record would not be willing
during, or after the EHR reporting of all unique patients seen by the EP or to change their approach to obtaining
period if the EHR reporting period for discharged from the eligible hospital or their patient data, and while they may
eventually eagerly accept and use the objective with a modification based information from CEHRT to identify
alternatives, it will take time to on the change to the 24 hour patient-specific educational resources
transition them. Commenters requested requirement proposed as well as to and provide electronic access to those
maximum flexibility for this measure, better represent the functions of CEHRT materials to more than 35 percent of
noting that the stated goal of providing use. For Measure 1 we are finalizing unique patients seen by the EP or
such flexibility means that the best Alternate A which includes the discharged from the eligible hospital or
alternative is to allow providers to requirement that providers offer all four CAH inpatient or emergency department
choose whether to have a portal or an functionalities (view, download, (POS 21 or 23) during the EHR reporting
API, or both, but not to require both. transmit, and access through API) to period.
Requiring APIs as a substitute for their patients. We further specify that • Denominator: The number of
patient portals represents an overhaul of any patient health information must be unique patients seen by the EP or the
existing, expensive, and time- made available to the patient within 48 number of unique patients discharged
consuming technology. CMS should not hours of its availability to the provider from an eligible hospital or CAH
require such an overhaul. for an EP and 36 hours of its availability inpatient or emergency department
Response: As noted previously, we to the provider for an eligible hospital (POS 21 or 23) during the EHR reporting
disagree that the API functionality or CAH. For measure two, we are period.
cannot be implemented successfully by finalizing measure a modification to the • Numerator: The number of patients
2018 as the technology is already in numerator to specify the timing of the in the denominator who were provided
widespread use in other industries and action in relation to the EHR reporting electronic access to patient-specific
API functions already exist in the health period. educational resources using clinically
IT industry. Within the Objective for relevant information identified from
Patient Electronic Access, we see the Objective 5: Patient Electronic Access to CEHRT during the EHR reporting
potential and need for multiple use Health Information period.
cases, which leverage a wide range of Objective: The EP, eligible hospital or • Threshold: The resulting percentage
systems design, from the traditional CAH provides patients (or patient- must be more than 35 percent in order
patient portal to leveraged APIs, which authorized representative) with timely for a provider to meet this measure.
allow providers and patients to expand electronic access to their health Exclusions: A provider may exclude
information sharing among systems. information and patient-specific the measures if one of the following
Examples of these use cases could education. apply:
include a patient with a chronic Measure 1: For more than 80 percent • An EP may exclude from the
condition seeking to combine records of all unique patients seen by the EP or measure if they have no office visits
from multiple providers, home health discharged from the eligible hospital or during the EHR reporting period.
care providers accessing records from CAH inpatient or emergency department • Any EP that conducts 50 percent or
multiple patients in real time, patients (POS 21 or 23): more of his or her patient encounters in
accessing a wide range of health (1) The patient (or the patient- a county that does not have 50 percent
information and scheduling authorized representative) is provided or more of its housing units with 4Mbps
appointments with or requesting refills timely access to view online, download, broadband availability according to the
from a single provider on a dedicated and transmit his or her health latest information available from the
site, and many more. While we information; and FCC on the first day of the EHR
understand the commenters’ concern (2) The provider ensures the patient’s reporting period may exclude the
about adding new technology in light of health information is available for the measure.
the investment already made in existing patient (or patient-authorized • Any eligible hospital or CAH will
technology, we believe that patient representative) to access using any be excluded from the measure if it is
access should not be limited to a single application of their choice that is located in a county that does not have
function, action or use case when configured to meet the technical 50 percent or more of their housing
multiple viable options are available to specifications of the API in the units with 4Mbps broadband
support a wider range of potential use. provider’s CEHRT. availability according to the latest
We believe that the investments that • Denominator: The number of information available from the FCC at
have been made in existing patient unique patients seen by the EP or the the start of the EHR reporting period.
portals—serve a positive and necessary number of unique patients discharged We are adopting Objective 5: Patient
function, and those who invested in from an eligible hospital or CAH Electronic Access at § 495.24(d)(5)(i) for
such portals should not abandon that inpatient or emergency department EPs and § 495.24(d)(5)(ii) for eligible
investment. In addition, as noted (POS 21 or 23) during the EHR reporting hospitals and CAHs. We further specify
previously, we believe that there are period. that in order to meet this objective and
existing API options that can be • Numerator: The number of patients measures, an EP, eligible hospital, or
leveraged to provide low-cost health IT in the denominator (or patient- CAH must use the capabilities and
solutions that diversify the technology authorized representative) who are standards of as defined for as defined
pathways and expand the capacity of provided timely access to health CEHRT at § 495.4. We direct readers to
providers and patients to share health information to view online, download, section II.B.3 of this final rule with
information. We believe these functions and transmit to a third party and to comment period for a discussion of the
are compatible and complementary of access using an application of their definition of CEHRT and a table
each other and that the appropriate choice that is configured meet the referencing the capabilities and
requirement is the inclusion of both technical specifications of the API in the standards that must be used for each
concepts by supporting, all four possible provider’s CEHRT. measure.
actions for patients access (that is, view, • Threshold: The resulting percentage
download, transmit, and access data must be more than 80 percent in order Objective 6: Coordination of Care
through an API). for a provider to meet this measure. Through Patient Engagement
After consideration of public Measure 2: The EP, eligible hospital For Stage 3, as previously noted, we
comments received, we are finalizing or CAH must use clinically relevant proposed to incorporate the Stage 2
objectives related to providing patients commenters supported the changes we communications are in any way more
with access to health information into a proposed to expand the technologies significant that the existing challenges
new Stage 3 objective entitled, ‘‘Patient and methods by which providers and to communication posed by the current
Electronic Access’’ (see section patients can leverage technology to limited channels available. Nor do we
II.B.2.b.v). For this objective 6 entitled support communication and care note a causal relationship or correlation
‘‘Coordination of Care through Patient coordination. Commenters also between communications challenges
Engagement,’’ we proposed to commended us for the provision and a diminished need or interest in
incorporate the policy goals of the Stage allowing providers to attest to all three communicating with one’s provider.
2 objectives related to secure messaging, measures but only meet the threshold Therefore, we are aiming to support a
patient reminders, and the measure of for 2 of the 3 in order to pass the wide range of communication channels,
patient engagement requiring patients measure. Comments stated that this technologies, and approaches to support
(or their authorized representatives) to would allow us to collect meaningful many use cases.
view, download, and transmit their data but not penalize providers for Proposed Measure 1: During the EHR
health information using the variation in their patient populations or reporting period, more than 25 percent
functionality of the CEHRT. other factors that might impact their of all unique patients seen by the EP or
Proposed Objective: Use performance. discharged from the eligible hospital or
communications functions of CEHRT to Response: We thank the commenters CAH inpatient or emergency department
engage with patients or their authorized for their support of the objective and our (POS 21 or 23) actively engage with the
representatives about the patient’s care. approach to provide flexibility while electronic health record made accessible
The Stage 3 proposed rule focused on continuing to encourage a wide range of by the provider. An EP, eligible hospital
encouraging the use of EHR use cases for patient engagement. We or CAH may meet the measure by either:
functionality for secure dialogue and agree that the open communication (1) More than 25 percent of all unique
efficient communication between between provider and patient is a patients (or patient-authorized
providers, care team members, and fundamental factor in patient-centered representatives) seen by the EP or
patients about their care and health care and effective care coordination. discharged from the eligible hospital or
status, as well as important health This was a driver behind our proposal CAH inpatient or emergency department
information such as preventative and for this objective to improve and (POS 21 or 23) during the EHR reporting
coordinated care planning. Similar to enhance the channels of communication period view, download or transmit to a
the Patient Electronic Access Objective, through supporting health IT solutions. third party their health information; or
we also proposed to expand the options Comment: Some commenters (2) More than 25 percent of all unique
through which providers may engage disagreed with our approach and stated patients (or patient-authorized
with patients under the Medicare and that we should not enforce provider and representatives) seen by the EP or
Medicaid EHR Incentive Programs patient communication through the use discharged from the eligible hospital or
including the use of APIs. An API can of health IT. Commenters claimed that CAH inpatient or emergency department
enable a patient—through a third-party elderly populations, economically (POS 21 or 23) during the EHR reporting
application—to access and retrieve their disadvantaged populations, patients period access their health information
health information from a care provider living in rural areas, and patients with through the use of an ONC-certified API
in a way that is most valuable to that disabilities may not want to use that can be used by third-party
patient. We proposed the Coordination technology to engage with their provider applications or devices.
of Care through Patient Engagement and this makes the requirement unfair Proposed Option 1: View, Download,
Objective for Stage 3 to support this to providers serving these patient or Transmit to a Third Party
provider and patient engagement populations. Denominator: Number of unique
continuum based on the foundation Response: First, we disagree that any patients seen by the EP, or the number
already created within the EHR universal demographic factor would of unique patients discharged from an
Incentive Programs but using new prohibit a patient from using or eligible hospital or CAH inpatient or
methods and expanded options to leveraging technology to communicate emergency department (POS 21 or 23)
advance meaningful patient engagement with a provider. ONC’s research found during the EHR reporting period.
and patient-centered care. We also that there were no significant Numerator: The number of unique
proposed that for purposes of this differences in use of online medical patients (or their authorized
objective, patient engagement may records by age, race/ethnicity, education representatives) in the denominator who
include patient-centered or setting.16 We note that assistive have viewed online, downloaded, or
communication between and among technologies, telemedicine technologies, transmitted to a third party the patient’s
providers facilitated by authorized and affordable mobile technologies health information.
representatives of the patient and of the already exist in the marketplace to serve Threshold: The resulting percentage
EP, eligible hospital, or CAH. a wide range of individuals coming from must be more than 25 percent in order
We proposed three measures for this a wide range of backgrounds and we for an EP, eligible hospital, or CAH to
objective, which are discussed below. believe that health IT communications meet this measure.
We proposed that providers must attest technologies will find similar Proposed Option 2: API
to the numerator and denominator for utilization. Second, we recognize that Denominator: The number of unique
all three measures, but would only be technology supported communication patients seen by the EP or the number
required to successfully meet the may not be adopted by each patient, of unique patients discharged from an
threshold for two of the three proposed which is why we did not propose eligible hospital or CAH inpatient or
measures to meet the Coordination of requiring that a provider ensure all emergency department (POS 21 or 23)
Care through Patient Engagement patients actually take action and engage during the EHR reporting period.
Objective. in this manner. However, we note that Numerator: The number of unique
Comment: Commenters supported the we do not believe that potential patients (or their authorized
concept of patient engagement and challenges to online or electronic representatives) in the denominator who
promoting communication among have accessed their health information
provider and patients. Also, 16 ONC Data Brief June 2015 healthit.gov. through the use of an ONC-certified API.
Threshold: The resulting percentage should not be required to meet separate section II.B.1.b.(4)(b)(iv) of this final
must be more than 25 percent in order thresholds for patient use of the rule with comment period, we adopted
for an EP, eligible hospital, or CAH to different functions. They stated that the a phased approach for the two measures
meet this measure. use of APIs is currently self-selective related to patient action for reporting in
Exclusions: Applicable for either among patient populations, which skew 2015 through 2017 (Objective 8—Patient
option discussed previously, the the provider’s ability to push their use Electronic Access measure 2 and the
following providers may exclude from universally. Additionally, they noted Objective 9—Secure Electronic
the measure: issues related to independently Messaging.) This phased approach
• Any EP who has no office visits counting the usage of a function. For includes a 5 percent threshold in 2017,
during the EHR reporting period may example, an API may not be designed to and we believe it is appropriate to adopt
exclude from the measure. recognize individual instances of use a 5 percent threshold for measures 1 of
• Any EP that conducts 50 percent or separately over time; it may not this objective also (Objective 6—
more of his or her patient encounters in independently recognize an action Coordination of Care through Patient
a county that does not have 50 percent which might also meet the view, Engagement) for an EHR reporting
or more of its housing units with 4Mbps download, or transmit actions; or it may period in 2017. We believe that the
broadband availability according to the prohibit providers who wish to switch primary barrier to performance on the
latest information available from the to an API assisted VDT system from measure is the lag in the adoption of
FCC 17 on the first day of the EHR being able to also meet a separate VDT technology by patients as well as the
reporting period may exclude from the threshold. However, both commenters influence of self-selective participation.
measure. in support of the measure and opposed We further believe that these influences
• Any eligible hospital or CAH to the measure suggested a lower can be mitigated by providing
operating in a location that does not threshold in order to ensure that additional time for the technologies to
have 50 percent or more of its housing providers can meet the requirements by mature as noted in our rationale for
units with 4Mbps broadband 2018. Some commenters suggested an adoption of the phased approach.
availability according to the latest approach where the threshold increases Therefore, it is appropriate for the 5
information available from the FCC on over time to allow providers to work percent threshold in 2017 to apply for
the first day of the EHR reporting period toward incrementally increased levels. all applicable measures based on the
may exclude from the measure. Commenters noted that this would
For measure 1, for the API option, we timeline established.
allow providers more time to innovate We believe that 10 percent is a
proposed that providers must attest that workflows and methods to overcome
they have enabled an ONC-certified API reasonable threshold for providers
barriers to patient engagement. participating in 2018 as compared to the
and that at least one application, which Response: As noted previously, we
leverages the API, is available to proposed 25 percent threshold, and
disagree that providers have no role in should be attainable by providers. In
patients (or the patient-authorized influencing patient engagement. In this
representatives) to retrieve health addition, we will continue to monitor
new measure for Stage 3, we are seeking performance on the measure to
information from the provider’s CEHRT. to enhance a provider’s ability to
We also stated that we recognize that determine if any further adjustment is
influence patient engagement by needed prior to 2018 and to potentially
there may be inherent challenges in providing a wider range of technologies
measuring patient access to CEHRT set another incremental increase toward
and methods for a patient’s use. We the proposed 25 percent threshold in a
through third-party applications that agree with the commenters’
utilize an ONC-certified API, and we subsequent year.
recommendation against independent Proposed Measure 2: For more than
solicited comment on the nature of thresholds for the functions within the
those challenges and what solutions can 35 percent of all unique patients seen by
objective and reiterate our view that the EP or discharged from the eligible
be put in place to overcome them. We there are four actions a patient might
also solicited comment on suggested hospital or CAH inpatient or emergency
take: department (POS 21 or 23) during the
alternate proposals for measuring 1. View their information.
patient access to CEHRT through third- 2. Download their information. EHR reporting period, a secure message
party applications that utilize an API, 3. Transmit their information to a was sent using the electronic messaging
including the pros and cons of third party. function of CEHRT to the patient (or the
measuring a minimum number of 4. Access their information through patient’s authorized representatives), or
patients (one or more) who must access an API. in response to a secure message sent by
their health information through the use We further agree that these actions the patient (or the patient’s authorized
of an API in order to meet the measure may overlap and that a provider should representative).
of this objective. be able to count any and all actions in Denominator: Number of unique
Comment: Similar to the objective in the single numerator. Therefore, we patients seen by the EP or the number
general, a large number of commenters believe it is a reasonable modification to of unique patients discharged from an
opposed this measure stating providers change the first measure to state that a eligible hospital or CAH inpatient or
should not be held accountable for provider may meet a combined emergency department (POS 21 or 23)
patient action. However, those threshold of for VDT and API actions or during the EHR reporting period.
commenters in support of the measure if their technology functions overlap Numerator: The number of patients in
concept recommended that it be then any and view, download, transmit, the denominator for whom a secure
measured as a combination of use cases or API actions taken by the patient using electronic message is sent to the patient,
rather than independently for each CEHRT would count toward the the patient’s authorized representatives,
function. These commenters approved threshold. or in response to a secure message sent
the inclusion of the API function noting We do agree that the threshold should by the patient.
that it offers greater flexibility for represent a goal, but that we should seek Threshold: The resulting percentage
patients, but stated that providers to set a goal that will be attainable for must be more than 35 percent in order
providers who make the effort to for an EP, eligible hospital, or CAH to
17 www.broadbandmap.gov. achieve this measure. As noted in meet this measure.
Exclusion: Any EP who has no office resulting from the initial action should communications, provider-to-provider
visits during the EHR reporting period be excluded from patient disclosure to communications if the patient is
may exclude from the measure. prevent harm. We noted that if such a included, and allows the provider to
Any EP that conducts 50 percent or message is excluded, all subsequent count any patient-initiated
more of his or her patient encounters in actions related to that message would communication if the provider responds
a county that does not have 50 percent not count toward the numerator. to the patient (80 FR 16757). We
or more of its housing units with 4Mbps Comment: Commenters disagree that the provider should not be
broadband availability according to the overwhelmingly supported our required to respond to the patient in
latest information available from the approach to the redesigned secure order to meet the measure, the goal of
FCC on the first day of the EHR electronic messaging objective for Stage the measure is to promote provider-
reporting period may exclude from the 3. Specifically, commenters noted that patient communication where the action
measure. this more dynamic, multi-directional driving the communication rests with
Any eligible hospital or CAH objective is a better approach for provider initiated communication. We
operating in a location that does not meeting the underlying goal of effective note that this does not require the
have 50 percent or more of its housing provider-patient communication than provider to respond to every message
units with 4Mbps broadband our prior Stage 2 objective. received if no response is necessary. In
availability according to the latest Specifically, commenters also addition, the denominator is not based
information available from the FCC on supported the ability for providers to on the number of messages received
the first day of the EHR reporting period select to focus on this measure rather from the patient nor are patient-initiated
may exclude from the measure. than on measure 1 as for some messages required to meet the measure.
For measure 2, we proposed that specialists, the ability to quickly and Therefore we believe that it is
‘‘communicate’’ means when a provider effectively communicate with a patient reasonable to only allow providers to
sends a message to a patient (or the and other care team members is count messages in the numerator when
patient’s authorized representatives) or paramount. These commenters noted the provider participates in the
when a patient (or the patient’s that for their patients, the information communication, in this case by
authorized representatives) sends a they provide through VDT is often responding to the patient.
message to the provider. In patient-to- duplicative of that provided by the
provider communication, the provider patient’s primary care provider. Again, we do agree that the threshold
must respond to the patient (or the However, they note they often receive should represent a goal, but that we
patient’s authorized representatives) for request for clarification around specific should seek to set a goal that will be
purposes of this measure. We further results or recommendations so the attainable for providers who make the
proposed to include in the measure ability to provide that support through effort to achieve this measure. As
numerator situations where providers secure messaging with the patient and discussed for Measure 1, we adopted a
communicate with other care team other care team members is a significant phased approach for the two measures
members using the secure messaging benefit. related to patient action for reporting in
function of CEHRT, and the patient is Some commenters opposed the 2015 through 2017 (Objective 8—Patient
engaged in the message and has the measure in general, again highlighting Electronic Access measure 2 and the
ability to be an active participant in the that providers should not be held Objective 9—Secure Electronic
conversation between care providers. accountable for patient action. Still Messaging.) This phased approach
However, we sought comment on how others disagreed with the requirement includes a 5 percent threshold in 2017
this action could be counted in the that a provider must respond to a and we believe it is appropriate to adopt
numerator, and the extent to which that patient-initiated communication in a 5 percent threshold for measures 2 of
interaction could or should be counted order for such an action to count in the this objective (Stage 3 Objective 6—
for eligible providers engaged in the numerator. Coordination of Care through Patient
communication. In addition, we sought Again, commenters both opposed to Engagement) for an EHR reporting
comment on what should be considered and in support of the measure suggested period in 2017. In this case, it is not the
a contribution to the patient-centered a lower threshold to ensure the measure barrier of patient action which is a
communication; for example, a is attainable for providers who make the potential risk factor, as the measure
contribution must be active effort to engage in this action. Finally, itself has been changed, but instead the
participation or response, a contribution some commenters requested clarity adoption of new CEHRT and
may be viewing the communication, or about what the content of the message implementing the related workflows
a contribution may be simple inclusion needs to be to count toward the which would be required for providers
in the communication. numerator. participating in Stage 3 in 2017. We also
We specified that the secure messages Response: We appreciate the support believe a 25 percent threshold would be
sent should contain relevant health and agree with the commenters’ an attainable goal for providers in 2018
information specific to the patient in assessment that the Stage 2 objective did because the measure focuses on
order to meet the measure of this not fully meet the intended goal of provider-initiated action and offers
objective. We believe the provider is the secure messaging. We agree that this multiple paths for success; while the
best judge of what health information proposed objective supports a wider reduction from 35 percent reduces the
should be considered relevant in this range of use and a more effective risk of failure for those providers who
context. We noted that messages with method of communication for providers may require additional time to
content exclusively relating to billing and patients. implement the functions and workflows
questions, appointment scheduling, or We disagree that this proposed within their practice. As stated in the
other administrative subjects should not measure holds providers accountable for Stage 3 proposed rule (80 FR 16757), the
be included in the numerator. For care patient action, as the Stage 3 proposed types of communications which cannot
team secure messaging with the patient measure specifically puts the control count toward the measure are
included in the conversation, we also over communications in the hands of communications dealing exclusively
believe the provider may exercise the provider. For this measure, we with billing, appointment scheduling, or
discretion if further communications proposed to include provider-initiated other administrative processes.
Proposed Measure 3: Patient- monitoring of their health (such as efficacy of data originating from a
generated health data or data from a recording vital signs, activity and source other than a clinician, stated that
non-clinical setting is incorporated into exercise, medication intake, and patient generated data is not relevant to
the CEHRT for more than 15 percent of nutrition), either on their own, or at the their practice, or stated that all data is
all unique patients seen by the EP or direction of a member of the care team. patient generated so the measure is
discharged by the eligible hospital or We sought comment on how the useless.
CAH inpatient or emergency department information for measure 3 could be Most commenters requested further
(POS 21 or 23) during the EHR reporting captured, standardized, and information on what types of data
period. incorporated into an EHR. For the would count toward the measure. Some
Denominator: Number of unique purposes of this measure, the types of commenters asked if provider
patients seen by the EP or the number data that would satisfy the measure is questionnaires sent via secure message
of unique patients discharged from an broad. It may include, but is not limited might count while others asked if
eligible hospital or CAH inpatient or to, social service data, data generated by patient self-assessment screenings done
emergency department (POS 21 or 23) a patient or a patient’s authorized in the physician’s office may count.
during the EHR reporting period. representative, advance directives, Some commenters questioned whether a
Numerator: The number of patients in medical device data, home health patient that provided information on
the denominator for whom data from monitoring data, and fitness monitor family health history may count toward
non-clinical settings, which may data. the measure if the information were
include patient-generated health data, is We also sought comment on whether provided outside an office visit via an
captured through the CEHRT into the this proposed measure should have a electronic means. Finally, commenters
patient record. denominator limited to patients with requested an episodic designation for
Threshold: The resulting percentage whom the provider has multiple the measure to identify when the
must be more than 15 percent in order encounters, such as unique patients inclusion of such information must
for an EP, eligible hospital, or CAH to seen by the provider two or more times occur and if the inclusion must be
meet this measure. during the EHR reporting period. We repetitive for each EHR reporting
Exclusion: Any EP who has no office also sought comment on whether this period.
visits during the EHR reporting period measure should be divided into two Response: We thank the commenters
may exclude from the measure. distinct measures—for example, (1) for their input. We agree with the
Any EP that conducts 50 percent or patient-generated health data, or data recommendation to maintain a single
more of his or her patient encounters in generated predominantly through measure as we believe this best
a county that does not have 50 percent patient self-monitoring rather than by a represents the goal of the policy to
or more of its housing units with 4Mbps provider; and (2) all other data from a support the use of CEHRT to incorporate
broadband availability according to the non-clinical setting. This would result many kinds of data into a
latest information available from the in the objective including four comprehensive record for each patient.
FCC on the first day of the EHR measures, with providers having an We are declining the recommended
reporting period may exclude from the option of which two measures to focus changes to limit the denominator as we
measure. on for the EHR reporting period. believe a wider range is more suitable.
Any eligible hospital or CAH We also sought comment on whether However, we agree with the
operating in a location that does not the third measure should be proposed recommendation to reduce the required
have 50 percent or more of its housing for eligible hospitals and CAHs, or threshold for this new measure and
units with 4Mbps broadband remain an option only for eligible function to promote adoption with an
availability according to the latest professionals. For those commenters attainable goal. We are therefore
information available from the FCC on who believe it should not be applicable reducing the threshold to 5 percent for
the first day of the EHR reporting period for eligible hospitals and CAHs, we the measure. For the purposes of this
may exclude from the measure. sought further comment on whether measure, we note our intent as stated in
For measure 3, we noted that the use eligible hospitals and CAHs should then the Stage 3 proposed rule (80 FR 16757)
of the term ‘‘clinical’’ means different choose one of the remaining two that the types of data that would satisfy
things in relation to place of service for measures or be required to attest to both. the measure are broad. It may include,
billing for Medicare and Medicaid We received the following comments but is not limited to, social service data,
services. However, for purposes of this and our response follows: data generated by a patient or a patient’s
measure only, we proposed that a non- Comment: Commenters were authorized representative, advance
clinical setting be defined as a setting supportive of the concept of the directives, medical device data, home
with any provider who is not an EP, measure with a specific emphasis on the health monitoring data, and fitness
eligible hospital or CAH as defined for ability to incorporate this type of data monitor data. In addition, the sources of
the Medicare and Medicaid EHR into a patient record. Commenters felt data vary and may include mobile
Incentive Programs and where the care this measure specifically supports applications for tracking health and
provider does not have shared access to chronic disease management and care nutrition, home health devices with
the EP, eligible hospital, or CAH’s coordination. Commenters tracking capabilities such as scales and
CEHRT. This may include, but is not recommended that the denominator be blood pressure monitors, wearable
limited to, health and care-related data limited to two or more visits in a year, devices such as activity trackers or heart
from care providers such as which would make the measure more monitors, patient-reported outcome
nutritionists, physical therapists, relevant for hospitals and CAHs as well data, and other methods of input for
occupational therapists, psychologists, as some types of specialists. patient and non-clinical setting
and home health care providers, as well Commenters recommended against generated health data. We emphasized
as data obtained from patients splitting the measure into two parts and that these represent several examples of
themselves. We specifically noted this noted that the threshold proposed is too the data types that could be covered
last item and referred to this sub- high for a measure that is entirely new. under this measure. We note that
category as patient-generated health A number of commenters opposed the providers in non-clinical settings may
data, which may result from patient self- measure, expressed concern over the include, but are not limited to, care
providers such as nutritionists, physical their first visit during the EHR reporting Measure 2: For more than 25 percent
therapists, occupational therapists, period, the provider may count the of all unique patients seen by the EP or
psychologists, and home health care patient in the numerator even if no discharged from the eligible hospital or
providers. Other key providers in the further information is provided after a CAH inpatient or emergency department
care team such as behavioral health care subsequent visit. (POS 21 or 23) during the EHR reporting
providers, may also be included, and we After consideration of public period, a secure message was sent using
encourage providers to consider ways in comments received, we are finalizing the electronic messaging function of
which this measure can incorporate this the objective with a modification to CEHRT to the patient (or the patient-
essential information from the broader remove the reference to authorized representative), or in
care team. We also note, as stated in the communications functions due to the response to a secure message sent by the
Stage 3 proposed rule, while the scope adoption of the use of an API (which is patient or their authorized
of data covered by this proposed broader than a communication representative. For an EHR reporting
measure is broad, it may not include function). We are finalizing the period in 2017, the threshold for this
data related to billing, payment, or other exclusions as proposed and the measure is 5 percent rather than 25
insurance information (80 FR 16757). measures with the modifications for the percent.
We also disagree with the suggestion threshold as previously discussed. We • Denominator: Number of unique
that the data may be information the are finalizing that providers must attest patients seen by the EP or the number
patient provides to the EP, eligible to all three measures and must meet the of unique patients discharged from an
hospital or CAH on location during the thresholds for at least two measures to eligible hospital or CAH inpatient or
office visit or hospital stay as such data meet the objective. We are adopting emergency department (POS 21 or 23)
does not meet the intent of the measure finalizing the objective and measures as during the EHR reporting period.
to support care coordination and patient follows: • Numerator: The number of patients
engagement in a wide range of settings in the denominator for whom a secure
outside the provider’s immediate scope Objective 6: Coordination of Care electronic message is sent to the patient
of practice. However, we agree that if a Through Patient Engagement (or patient-authorized representative) or
patient separately provides clinical Objective: Use CEHRT to engage with in response to a secure message sent by
information including family health patients or their authorized the patient (or patient-authorized
history and the information noted representatives about the patient’s care. representative), during the EHR
previously through other means, that Measure 1: During the EHR reporting reporting period.
such information may count toward the period, more than 10 percent of all • Threshold in 2017: The resulting
numerator if it is incorporated into the unique patients (or their authorized percentage must be more than 5 percent
patient record using the adopted representatives) seen by the EP or in order for an EP, eligible hospital, or
specifications for CEHRT for the discharged from the eligible hospital or CAH to meet this measure
measure. CAH inpatient or emergency department • Threshold in 2018 and Subsequent
With regard to the efficacy of the data, Years: The resulting percentage must be
(POS 21 or 23) actively engage with the
we do not specify the manner in which more than 25 percent in order for an EP,
electronic health record made accessible
providers are required to incorporate the eligible hospital, or CAH to meet this
by the provider and either:
data. Providers may work with their measure.
(1) View, download or transmit to a
EHR developers to establish the Measure 3: Patient generated health
third party their health information; or
methods and processes which work best data or data from a nonclinical setting
for their practice and needs. We note (2) access their health information
is incorporated into the CEHRT for more
that in cases where the data provided through the use of an API that can be
than 5 percent of all unique patients
can be easily incorporated in a used by applications chosen by the
seen by the EP or discharged from the
structured format or into an existing patient and configured to the API in the
eligible hospital or CAH inpatient or
field within the EHR (such as a C–CDA provider’s CEHRT; or
emergency department (POS 21 or 23)
or care team member reported vital (3) a combination of (1) and (2).
signs or patient reported family health • Denominator: Number of unique • Denominator: Number of unique
history and demographic information) patients seen by the EP, or the number patients seen by the EP or the number
the provider may elect to do so. of unique patients discharged from an of unique patients discharged from an
Alternately, a provider may maintain an eligible hospital or CAH inpatient or eligible hospital or CAH inpatient or
isolation between the data and the emergency department (POS 21 or 23) emergency department (POS 21 or 23)
patient record and instead include the during the EHR reporting period. during the EHR reporting period.
data by other means such as • Numerator: The number of unique • Numerator: The number of patients
attachments, links, and text references patients (or their authorized in the denominator for whom data from
again as best meets their needs. We representatives) in the denominator who non-clinical settings, which may
believe there may be a wide range of have viewed online, downloaded, or include patient-generated health data, is
potential methods by which a provider transmitted to a third party the patient’s captured through the CEHRT into the
may ensure the data is relevant for their health information during the EHR patient record during the EHR reporting
needs and that provenance and purpose reporting period and the number of period.
are identified. unique patients (or their authorized • Threshold: The resulting percentage
Finally, we note that measure 3 representatives) in the denominator who must be more than 5 percent in order for
includes longitudinal measurement have accessed their health information an EP, eligible hospital, or CAH to meet
within the EHR reporting period, rather through the use of an API during the this measure.
than purely episodic measurement. This EHR reporting period. Exclusions: A provider may exclude
means that for more than 5 percent of • Threshold for 2017: The resulting the measures if one of the following
unique patients during the EHR percentage must be more than 5 percent. apply:
reporting period, this information must • Threshold for 2018 and Subsequent • An EP may exclude from the
be included. If information is obtained Years: The resulting percentage must be measure if they have no office visits
and incorporated for a patient following more than 10 percent. during the EHR reporting period.
• Any EP that conducts 50 percent or providers into their EHR using the We stated in the Stage 2 final rule at
more of his or her patient encounters in functions of CEHRT. 77 FR 13723 that if the receiving
a county that does not have 50 percent In the Stage 2 final rule at 77 FR provider has access to the medical
or more of its housing units with 4Mbps 53983, we described transitions of care record maintained by the provider
broadband availability according to the as the movement of a patient from one initiating the transition or referral, then
latest information available from the setting of care (hospital, ambulatory the summary of care record would not
FCC on the first day of the EHR primary care practice, ambulatory need to be provided and that patient
reporting period may exclude the specialty care practice, long-term care, may be excluded from the denominators
measure. home health, rehabilitation facility) to of the measures for the objective. We
• Any eligible hospital or CAH will another. For additional information, see further noted that this access may vary
be excluded from the measure if it is section II.B.1.b.(4).(f) of this final rule from read-only access of a specific
located in a county that does not have with comment period. Referrals are record, to full access with authoring
50 percent or more of their housing cases where one provider refers a capabilities, depending on provider
units with 4Mbps broadband patient to another provider, but the agreements and system implementation
availability according to the latest referring provider also continues to among practice settings. In many cases,
information available from the FCC at provide care to the patient. We also a clinical care summary for transfers
the start of the EHR reporting period. recognized there may be circumstances within organizations sharing access to
We are adopting Objective 6: when a patient refers himself or herself an EHR may not be necessary, such as
Coordination of Care Through Patient to a setting of care without a provider’s a hospital sharing their CEHRT with
Engagement at § 495.24(d)(6)(i) for EPs prior knowledge or intervention. These affiliated providers in ambulatory
and § 495.24(d)(6)(ii) for eligible referrals may be included as a subset of settings who have full access to the
hospitals and CAHs. We further specify the existing referral framework and they patient information. However, public
are an important part of the care comments received and questions
that in order to meet this objective and
coordination loop for which summary of submitted by the public on the Stage 2
measures, an EP, eligible hospital, or
care record exchange is integral. Summary of Care Objective reveal that
CAH must use the capabilities and
Therefore, a provider should include there may be benefits to the provision of
standards of as defined for as defined
these instances in their denominator for a summary of care document following
CEHRT at § 495.4. We direct readers to
the measures if the patient subsequently a transition or referral of a patient, even
section II.B.3 of this final rule with
identifies the provider from whom they when access to medical records is
comment period for a discussion of the
received care. In addition, the provider already available. For example, a
definition of CEHRT and a table
may count such a referral in the summary of care document would
referencing the capabilities and
numerator for each measure if they notify the receiving provider of relevant
standards that must be used for each undertake the action required to meet information about the latest patient
measure. the measure upon disclosure and encounter as well as highlight the most
Objective 7: Health Information identification of the provider from up-to-date information. In addition, the
Exchange whom the patient received care. ‘‘push’’ of a summary of care document
In the Stage 2 final rule, we indicated may function as an alert to the recipient
In the Stage 3 proposed rule 80 FR that a transition or referral within a provider of the transition that a patient
16758, we stated that improved single setting of care does not qualify as has received care elsewhere and would
communication between providers a transition of care (77 FR 53983). We encourage the provider to review a
caring for the same patient can help received public comments and patient’s medical record for follow-up
providers make more informed care questions requesting clearer care or reconciliation of clinical
decisions and coordinate the care they characterization of when a setting of information.
provide. Electronic health records and care can be considered distinct from Therefore, we proposed to revise this
the electronic exchange of health another setting of care. For example, objective for Stage 3 to allow the
information, either directly or through questions arose whether EPs who work inclusion of transitions of care and
health information exchanges, can within the same provider practice are referrals in which the recipient provider
reduce the burden of such considered the same or two distinct may already have access to the medical
communication. We noted that the settings of care. Similarly, questions record maintained in the referring
purpose of the proposed objective is to arose whether an EP who practices in an provider’s CEHRT, as long as the
ensure a summary of care record is outpatient setting that is affiliated with providers have different billing
transmitted or captured electronically an inpatient facility is considered a identities within the EHR Incentive
and incorporated into the EHR for separate entity. Therefore, in the Stage Program. We noted that for a transition
patients seeking care among different 3 proposed rule at 80 FR 16759 for the or referral to be included in the
providers in the care continuum, and to purposes of distinguishing settings of numerator, if the receiving provider
encourage reconciliation of health care in determining the movement of a already has access to the CEHRT of the
information for the patient. We further patient, we explained that for a initiating provider of the transition or
stated that the proposed objective transition or referral, it must take place referral, simply accessing the patient’s
promotes interoperable systems and between providers which have, at health information does not count
supports the use of CEHRT to share minimum, different billing identities toward meeting this objective. However,
information among care teams. within the EHR Incentive Programs, if the initiating provider also creates and
Proposed Objective: The EP, eligible such as different National Provider sends a summary of care document, this
hospital, or CAH provides a summary of Identifiers (NPI) or hospital CMS transition can be included in the
care record when transitioning or Certification Numbers (CCN) to count denominator and the numerator, as long
referring their patient to another setting toward this objective. as this transition is counted consistently
of care, retrieves a summary of care Please note that a ‘‘referral’’ as across the organization.
record upon the first patient encounter defined here only applies to the EHR Proposed Measures: We proposed that
with a new patient, and incorporates Incentive Programs and is not providers must attest to the numerator
summary of care information from other applicable to other federal regulations. and denominator for all three measures,
but would only be required to • Functional status, including or CAH can be excluded from recording
successfully meet the threshold for two activities of daily living, cognitive and such information (for example, vital
of the three proposed measures to meet disability status. signs) or because there is no information
the Health Information Exchange • Demographic information to record (for example, laboratory tests)
Objective. (preferred language, sex, race, ethnicity, the EP, eligible hospital, or CAH may
Proposed Measure 1: For more than date of birth). leave the field blank and still meet the
50 percent of transitions of care and • Care plan field, including goals and requirements for the measure.
referrals, the EP, eligible hospital or instructions. However, all summary of care
CAH that transitions or refers their • Care team including the primary documents used to meet this objective
patient to another setting of care or care provider of record and any must be populated with the following
provider of care: (1) Creates a summary additional known care team members information using the CCDS
of care record using CEHRT; and (2) beyond the referring or transitioning certification standards for those fields:
electronically exchanges the summary provider and the receiving provider. • Current problem list (Providers may
of care record. • Discharge instructions (Eligible also include historical problems at their
hospitals and CAHs Only). discretion).
Proposed Measure 2: For more than
• Reason for referral (EP only). • Current medication list.
40 percent of transitions or referrals For the 2015 Edition proposed rule, • Current medication allergy list.
received and patient encounters in ONC proposed a set of criteria called the We defined allergy in the proposed
which the provider has never before Common Clinical Data Set that include rule as an exaggerated immune response
encountered the patient, the EP, eligible the required elements for the summary or reaction to substances that are
hospital or CAH incorporates into the of care document, the standards generally not harmful (80 FR 16760).
patient’s EHR an electronic summary of required for structured data capture of Information on problems, medications,
care document from a source other than each, and further definition of related and medication allergies could be
the provider’s EHR system. terminology and use. Therefore, for obtained from previous records, transfer
Proposed Measure 3: For more than Stage 3 of meaningful use we proposed of information from other providers
80 percent of transitions or referrals that summary of care documents used to (directly or indirectly), diagnoses made
received and patient encounters in meet the Stage 3 Health Information by the EP or hospital, new medications
which the provider has never before Exchange objective must include the ordered by the EP or in the hospital, or
encountered the patient, the EP, eligible requirements and specifications through querying the patient.
hospital, or CAH performs a clinical included in the CCDS specified by ONC We proposed to maintain that all
information reconciliation. The provider for certification to the 2015 Edition summary of care documents contain the
must implement clinical information proposed rule. most recent and up-to-date information
reconciliation for the following three In the Stage 3 proposed rule (80 FR on all elements. In the event that there
clinical information sets: 16760), we stated that the CCDS may are no current diagnoses for a patient,
• Medication. Review of the patient’s include additional fields beyond those the patient is not currently taking any
medication, including the name, dosage, initially required for Stage 2 of medications, or the patient has no
frequency, and route of each meaningful use as new standards are known medication allergies; the EP,
medication. developed to accurately capture vital eligible hospital, or CAH must record or
• Medication allergy. Review of the information on patient health. For document within the required fields
patient’s known medication allergies. example, the 2015 Edition proposed that there are no problems, no
• Current Problem list. Review of the rule includes a criterion and standard medications, or no medication allergies
patient’s current and active diagnoses. for capturing the unique device recorded for the patient to satisfy the
For the first measure, we maintained identifier (UDI) for implantable medical measure of this objective. The EP or
the requirements established in the devices. As we noted in the Stage 3 hospital must verify that the fields for
Stage 2 final rule to capture structured proposed rule at 80 FR 16760, we problem list, medication list, and
data within the certified EHR and to believe the inclusion of the UDI in the medication allergy list are not blank and
generate a summary of care document CCDS reflects the understanding that include the most recent information
using CEHRT for purposes of this UDIs are an important part of patient known by the EP, eligible hospital, or
measure (77 FR 54014). For purposes of information that should be exchanged CAH as of the time of generating the
this measure, we required that the and available to providers who care for summary of care document.
summary of care document created by patients with implanted medical In the Stage 3 proposed rule 80 FR
CEHRT be sent electronically to the devices. The documentation of UDIs in 176760, we encouraged providers to
receiving provider. a patient medical record and the send a list of items that he or she
In the Stage 2 final rule at 77 FR inclusion of that data field within the believes to be pertinent and relevant to
54016, we specified all summary of care CCDS requirements for the summary of the patient’s care, rather than a list of all
documents must include the following care documents is a key step toward problems, whether active or resolved,
information in order to meet the improving the quality of care and that have ever populated the problem
objective, if the provider knows it: ensuring patient safety. This example list. While a current problem list must
• Patient name. highlights the importance of capturing always be included, the provider can
• Referring or transitioning provider’s health data in a structured format using use his or her judgment in deciding
name and office contact information (EP specified, transferable standards. For which items historically present on the
only). further information on the CCDS problem list, medical history list (if it
• Procedures. standards, please see ONC’s 2015 exists in CEHRT), or surgical history list
• Encounter diagnosis. Edition final rule, published elsewhere are relevant given the clinical
• Immunizations. in this issue of the Federal Register. In circumstances.
• Laboratory test results. circumstances where there is no Similarly, we noted comments from
• Vital signs (height, weight, blood information available to populate one or stakeholders and through public forums
pressure, BMI). more of the fields included in the CCDS, and correspondence on the potential of
• Smoking status. either because the EP, eligible hospital, allowing only clinically relevant
laboratory test results and clinical notes is referred to them or otherwise create a summary of care record using
(rather than all laboratory tests results transferred into their care. This proposal CEHRT for purposes of Measure 1
and clinical notes) in the summary of was designed to complete the electronic should be permitted to send the created
care document for purposes of meeting transmission loop and support summary of care record either—(1)
the objective. We stated our belief that providers in using CEHRT to support Through any electronic means; or (2) in
while there may be a benefit and the multiple roles a provider plays in a manner that is consistent with the
efficiency to be gained in the potential meaningful health information governance mechanism ONC establishes
to limit laboratory test results or clinical exchange. for the nationwide health information
notes to those most relevant for a For the purposes of defining the cases network. We additionally sought
patient’s care; a single definition of in the denominator, we proposed that comment on whether providers who are
clinical relevance may not be what constitutes ‘‘unavailable’’ and, receiving a summary of care record
appropriate for all providers, all therefore, may be excluded from the using CEHRT for the purposes of
settings, or all individual patient denominator, will be that a provider— Measure 2 should have a similar
diagnosis. Furthermore, we noted that • Requested an electronic summary of requirement for the transport of
should a reasonable limitation around a care record to be sent and did not summary of care documents requested
concept of ‘‘clinical relevance’’ be receive an electronic summary of care from a transitioning provider. Finally,
added, a provider must still have the document; and we sought comment on how a
CEHRT functionality to include and • Queried at least one external source governance mechanism established by
send all labs or clinical notes. Therefore, via HIE functionality and did not locate ONC at a later date could be
we proposed to defer to provider a summary of care for the patient, or the incorporated into the EHR Incentive
discretion on the circumstances and provider does not have access to HIE Programs for purposes of encouraging
cases in which a limitation around functionality to support such a query. interoperable exchange that benefits
We sought comment on whether patients and providers, including how
clinical relevance may be beneficial and
electronic alerts received by EPs from the governance mechanism should be
note that such a limitation would be
hospitals when a patient is admitted, captured in the numerator,
incumbent on the provider to define and
seen in the emergency room or denominator, and thresholds for both
develop in partnership with their health
discharged from the hospital—so called the first (send) and second (receive)
IT developer as best fits their ‘‘utilization alerts’’—should be included
organizational needs and patient measures of this HIE objective.
in measure 2two, or as a separate For the third measure, we proposed a
population. In the Stage 3 proposed rule measure. Use of this form of health
80 FR 16760 we further specified our measure of clinical information
information exchange is increasingly reconciliation, which incorporates the
proposal that while the provider has the rapidly, driven by hospital and EP
discretion to define the relevant clinical Stage 2 objective for medication
efforts to improve care transitions and reconciliation and expands the options
notes or relevant laboratory results to reduce readmissions. We also sought
send as part of the summary of care to allow for the reconciliation of other
comment on which information from a clinical information. Clinical
record, to state that providers must be utilization alert would typically be
able to provide all clinical notes or information such as medication allergies
incorporated into a patient’s record and and problems will allow providers
laboratory results through an electronic how this is done today.
transmission of a summary of care additional flexibility in meeting the
For both the first and second measure in a way that is relevant to
document if that level of detail is measures, we proposed that a provider their scope of practice. In the Stage 2
subsequently requested by a provider may use a wide range of health IT final rule, we outlined the benefits of
receiving a transition of care or referral systems for health information exchange medication reconciliation, which
or the patient is transitioning to another to receive or send an electronic enables providers to validate that the
setting of care. We noted that this summary of care document, but must patient’s list of active medications is
proposal would apply for lab results, use their certified EHR technology to accurate (77 FR 54011 through 54012).
clinical notes, problem lists, and the create the summary of care document This activity improves patient safety,
care plan within the summary of care sent or to incorporate the summary of improves care quality, and improves the
document. care document received into the patient validity of information that the provider
For the second measure, we proposed record. We also proposed that the shares with others through health
to address the other end of the transition receipt of the summary of care information exchange. We believe that
of care continuum. In the Stage 2 final document may be passive (provider is reconciliation of medication allergies
rule, we limited the action required by sent the C–CDA and incorporates it) or and problems affords similar benefits.
providers to sending an electronic active (provider requests a direct For this proposed measure, we
transmission of a summary of care transfer of the C–CDA or provider specified that the EP, eligible hospital,
document (77 FR 54017 through 54018). queries an HIE for the C–CDA). In the or CAH that receives the patient into
We did not have a related requirement Stage 2 proposed rule, we noted the their care should conduct the clinical
for the recipient of that transmission. benefits of requiring standards for the information reconciliation. It is for the
We did not adopt a certification transport mechanism for health receiving provider that up-to-date
requirement for the receiving end of a information exchange consistently information will be most crucial to
transition or referral or for the measure nationwide (77 FR 13723). In the Stage make informed clinical judgments for
related to sending the summary, as that 2 final rule, a governance mechanism patient care. We reiterated that this
is a factor outside the sending provider’s option was included in the second measure does not dictate what subset of
immediate control. However, in Stage 3 measure for the summary of care information must be included in
of meaningful use, we proposed a objective at 77 FR 54020. In the Stage reconciliation. Information included in
measure for the provider as the recipient 3 proposed rule 80 FR 16762,we again the process is determined by the
of a transition or referral requiring him sought comment on a health provider’s clinical judgment of what is
or her to actively seek to incorporate an information exchange governance most relevant to patient care.
electronic summary of care document mechanism. Specifically we sought For this measure, we proposed to
into the patient record when a patient comment on whether providers who define clinical information
reconciliation as the process of creating data sets, or if we should potentially reporting period may exclude the
the most accurate patient-specific require providers to choose 2 of 3 measures.
information in one or more of the information reconciliation data sets Any eligible hospital or CAH will be
specified categories using the clinical relevant to their specialty or patient excluded from the measure if it is
information reconciliation capability of population. We explained that we located in a county that does not have
certified EHR technology, which will expect that most providers would find 50 percent or more of their housing
compare the ‘‘local’’ information to that conducting clinical information units with 4Mbps broadband
external/incoming information that is reconciliation for medications, availability according to the latest
being incorporated into the certified medication allergies, and problem lists information available from the FCC at
EHR technology from any external is relevant for every patient the start of the EHR reporting period.
source. We referred providers to the encountered. We solicited examples Measure 2: To calculate the
standards and certification criteria for describing challenges and burdens that percentage of the second measure, CMS
clinical information reconciliation providers who deliver specialist care or and ONC worked together to define the
proposed in ONC’s 2015 Edition employ unique clinical workflow following for this measure:
proposed rule at 80 FR 16831 through practices may experience in completing Denominator: Number of patient
16833. clinical information reconciliation for encounters during the EHR reporting
As with medication reconciliation, we all three data sets and whether an period for which an EP, eligible
believe that an electronic exchange of exclusion should be considered for hospital, or CAH was the receiving party
information following the transition of providers for whom such reconciliation of a transition or referral or has never
care of a patient is the most efficient may not be relevant to their scope of before encountered the patient and for
method of performing clinical practice or patient population. which an electronic summary of care
information reconciliation. Additionally, we solicited comments record is available.
We recognized that workflows to around the necessity to conduct Numerator: Number of patient
reconcile clinical information vary different types of clinical information encounters in the denominator where an
widely across providers and settings of reconciliation of data for each electronic summary of care record
care, and we requested comment on the individual patient. For example, it is received is incorporated by the provider
challenges that this objective might possible that the data for certain into the certified EHR technology.
present for providers, and how such patients should always be reviewed for Threshold: The percentage must be
challenges might be mitigated, while medication allergy reconciliation, when more than 40 percent in order for an EP,
preserving the policy intent of the it may not be as relevant to other patient eligible hospital, or CAH to meet this
measure. In particular, we solicited populations. measure.
comment on the following: We proposed that to meet this
• Automation and Manual Exclusion: Any EP, eligible hospital or
objective, a provider must attest to the CAH for whom the total of transitions or
Reconciliation. The Stage 2 measure
numerator and denominator for all three referrals received and patient
does not specify whether reconciliation
measures but would only be required to encounters in which the provider has
must be automated or manual. Some
successfully meet the threshold for two never before encountered the patient, is
providers have expressed concern over
of the three proposed measures. fewer than 100 during the EHR
the automatic inclusion of data in the
Measure 1: To calculate the reporting period is excluded from this
patient record from referring providers,
percentage of the first measure, CMS measure.
while others have indicated that
and ONC worked together to define the Any EP that conducts 50 percent or
requiring manual reconciliation imposes
following for this measure: more of his or her patient encounters in
significant workflow burden. We also
sought comment on whether the use and Denominator: Number of transitions a county that does not have 50 percent
display of meta-tagged data could of care and referrals during the EHR or more of its housing units with 4Mbps
address concerns related to the origin of reporting period for which the EP or broadband availability according to the
data and thereby permit more eligible hospital or CAH inpatient or latest information available from the
automated reconciliation of these data emergency department (POS 21 or 23) FCC on the first day of the EHR
elements. was the transferring or referring reporting period may exclude the
• Review of Reconciled Information. provider. measures.
Depending on clinical setting, this Numerator: The number of transitions Any eligible hospital or CAH will be
measure could be accomplished through of care and referrals in the denominator excluded from the measure if it is
manual reconciliation or through where a summary of care record was located in a county that does not have
automated functionality. In either created using certified EHR technology 50 percent or more of their housing
scenario, should the reconciliation or and exchanged electronically. units with 4Mbps broadband
review of automated functionality be Threshold: The percentage must be availability according to the latest
performed only by the same staff more than 50 percent in order for an EP, information available from the FCC at
allowed under the Stage 3 requirements eligible hospital, or CAH to meet this the start of the EHR reporting period.
for the CPOE objective? measure. Measure 3: To calculate the
• What impact would the Exclusion: An EP neither transfers a percentage, CMS and ONC worked
requirement of clinical information patient to another setting nor refers a together to define the following for this
reconciliation have on workflow for patient to another provider during the measure:
specialists? Are there particular EHR reporting period. Denominator: Number of transitions
specialties where this measure would be Any EP that conducts 50 percent or of care or referrals during the EHR
difficult to meet? more of his or her patient encounters in reporting period for which the EP or
• What additional exclusions, if any, a county that does not have 50 percent eligible hospital or CAH inpatient or
should be considered for this measure? or more of its housing units with 4Mbps emergency department (POS 21 or 23)
We also encouraged comment on the broadband availability according to the was the recipient of the transition or
proposal to require reconciliation of all latest information available from the referral or has never before encountered
three clinical information reconciliation FCC on the first day of the EHR the patient.
Numerator: The number of transitions providers, an essential function that required to engage eligible professionals
of care or referrals in the denominator EHRs can provide. and eligible hospitals who are also
where the following three clinical Still others expressed conceptual working toward meeting the
information reconciliations were support for the proposed objective as requirements of the EHR Incentive
performed: Medication list, medication the measures rationally seeks to Programs, and that there should be
allergy list, and current problem list. organize the care of the patient on the exclusions based on the capabilities of
Threshold: The resulting percentage care continuum and takes the next step surrounding practices or a lack of
must be more than 80 percent in order in closing the transitions of care loop by trading partners. Other commenters
for an EP, eligible hospital, or CAH to incorporating outside medical indicated statewide and regional health
meet this measure. information and promoting the information exchanges are at varying
Exclusion: Any EP, eligible hospital or reconciliation of medical data from levels of development and vary widely
CAH for whom the total of transitions or transitioning patients. These in their capabilities and sophistication.
referrals received and patient commenters expressed a belief that the Other commenters stated the HIE
encounters in which the provider has efforts to improve communication technology and interoperability
never before encountered the patient, is between providers for the same patient capabilities are not mature enough to
fewer than 100 during the EHR promotes better care decisions and care meet these HIE requirements and will
reporting period is excluded from this coordination. The ability to lead to provider failure or providers
measure. communicate information electronically being held responsible for criteria they
Any EP that conducts 50 percent or decreases the chance of errors, missing cannot control and standards they
more of his or her patient encounters in information, or misunderstandings due cannot meet.
a county that does not have 50 percent to lack of standardization. Finally many
commenters noted that the ability to Another commenter stated there are
or more of its housing units with 4Mbps no national or regional data repositories
broadband availability according to the send and receive data from other
providers throughout the care in place for direct email addresses to be
latest information available from the shared which has made it extremely
FCC on the first day of the EHR continuum is imperative to transforming
healthcare and improving patient care. challenging for providers to comply
reporting period may exclude the with this objective and measure, even if
Response: We thank the commenters
measure. the provider has the capability to
for their support and agree that this
Any eligible hospital or CAH will be generate and transmit a C–CDA.
objective should be a top priority for
excluded from the measure if it is delivery system reform to promote the
located in a county that does not have Response: We disagree and believe
real-time interoperable exchange of that this threshold is a reasonable and
50 percent or more of their housing health information and facilitate care
units with 4Mbps broadband achievable goal for providers for an EHR
coordination. We also appreciate the reporting period in 2018. We
availability according to the latest insight on how electronic exchange can
information available from the FCC at understand the challenges providers
support care management through and other stakeholders describe and
the start of the EHR reporting period. reducing errors and duplicate testing. recognize that the transition to
We received the following comments We believe the benefits of effective interoperable health information
and our response follows: health information exchange are exchange requires a paradigm shift
Comment: Many commenters extensive for both providers and across the health care industry. We
supported our proposal for the HIE patients and for this reason we have believe the work providers are already
Objective applauding the focus on maintained health information exchange engaged in and the HIE objectives and
interoperability stating the move toward as a key goal of the EHR Incentive measures from Stage 2 are helping to
a true ability to share all patient health Programs. actualize this change. As described in
records in real time, regardless of EHR Comment: The majority of the Stage 3 proposed rule (80 FR 16739),
system in use, is much needed and very commenters believe the thresholds for we believe that electronic exchange is
valuable to both providers and patients. health information exchange (HIE) are more likely to succeed as a higher
This would almost certainly allow better too high for EPs. They pointed to volume of providers are actively
management of care, less duplication of various interoperability challenges, engaged in the sending and receiving of
tests and reduction of other waste which make it difficult to meet the electronic health information. Further,
elements in the system, thus reducing requirements and generally state that we we note that we have proposed more
costs. Other commenters noted support are holding providers accountable for flexibility in the transport mechanism in
of the use of CEHRT to transmit a industry or national issues surrounding order to support the exchange of a
summary of care record during interoperability that are beyond their standardized file in a wide range of
transitions of care and acknowledges the control. transactions. Therefore, we believe that
value of incorporating a patient’s Many commenters stated that there
the requirement of this objective is a
summary of care record received from are not enough providers and practices
challenging goal, but a challenge that
another provider to facilitate clinical that can electronically receive transition
can and should be achieved.
information reconciliation and care of care documents because many
delivery. (especially those in rural areas) do not We disagree that there should be
Some commenters specifically have the capabilities needed to meet the additional exclusions for this objective.
mentioned that people with cancer often HIE requirements (for example, Direct As stated previously, we believe that the
receive fragmented and uncoordinated technologies, HIE access). Other increased participation in the EHR
care because their treatments frequently commenters stated a lack of trading Incentive Programs will help to support
require multiple clinicians including partners, including health care the overall ability for providers to
surgeons, oncologists, primary care providers who are not subject to these electronically exchange health
physicians, and other specialists. These regulations) as one of the main obstacles information. Further, we note that
commenters noted that providing to meeting the Stage 3 HIE performance for providers in rural areas
coordinated care requires access to all of requirements. Several commenters on the Stage 2 objective does not differ
a patient’s data by all of his or her requested that providers only be from the overall performance on the
measure.18 We also note that, as stated Commenters further went on to included under the referring EPs
in the proposed rule, we define a express support for the option to supervision. Some examples which
transition of care or referral as a include providers with a shared EHR would be excluded under the policy are
transition or referral to another provider and support for the ability to include an EP in one setting referring a patient
of care that is recognized as a different patient-self referrals as an option, and to another setting for a different service
billing entity for the EHR Incentive asked specific questions relating to how but where the same EP is the provider,
Programs (NPI, CCN). The inclusion or these items impact any variation in the an eligible hospital referring a patient
exclusion of additional provider types denominators between the measures. from one clinical setting within the
and transitions or referrals is at the Response: We refer commenters to the hospital to another (where they attest
discretion of the provider as best meets Stage 2 final rule at 77 FR 53982 with the same CCN), and an EP sending
their practice needs as long as the through 53983 as well as section to a non-EP practitioner who is under
inclusion or exclusion policy is applied II.B.1.b.(4).(f) of this final rule with direct supervision and whose patient
universally for the duration of the EHR comment period for further explanation encounters may be included in the EPs
reporting period. of the definition of transitions of care attestation.
We intend to support policies that and the definition of transition or We note that in the Stage 3 proposed
mitigate the impact that a lack of trading referral, which has not been modified rule (80 FR 16759) we stated that we
partners or a lack of transport from Stage 2. believe a provider should count a
mechanisms have on providers. As we For our policy regarding transitions or
referral in the denominator in the case
note throughout this final rule with referrals among providers with a shared
of patient-self referrals if the patient
comment period, we are seeking to EHR, in the Stage 3 proposed rule, we
subsequently identifies the provider
increase participation among EHR proposed that providers may count a
from whom they received care. We
Incentive Program participants and transition of care or referral as long as
the receiving provider would at least be further stated that the provider may
expand the methods by which providers count such a referral in the numerator
may exchange information. These considered a different provider if
attesting for the EHR Incentive Programs for each measure if they undertake the
policies are aimed at ensuring that a action required to meet the measure
lack of trading partners will not (individual NPI or CCN level) in the
denominator if they do so universally upon disclosure and identification of
continue to be a significant hurdle for the provider from whom the patient
providers as the widespread adoption of across all settings. They may also count
these transitions with providers who received care. However, we have
certified EHRs continues and new reconsidered this requirement based on
share a certified EHR if they do so
flexible innovations for transport are feedback from commenters who note
universally across all settings and for all
supported. that variations in timing and provider
such transitions. However, for any
In addition, CMS and ONC share a specialty might impact the feasibility
action to count in the numerator of a
mutual understanding of the issue and value proposition for a provider to
measure within this objective, the
relating to importance of provider count patient self-referrals in this
provider may not simply deem the
access to health information exchange manner. For example, if a primary care
shared access to the record sufficient,
contact information and agree that a provider is notified of a self-referral to
they would instead need to complete
method to facilitate this access would the required action associated with each a specialist months after the resulting
support interoperable health measure. We maintain that this option visit with the specialist has occurred,
information exchange. We are to include or not include such the receipt and incorporation (Measure
committed to exploring potential transitions is entirely at the provider’s 2) and reconciliation (Measure 3) of the
models and opportunities to enable discretion, but the policy must be summary of care record by the primary
providers to more readily share their applied universally for all transitions or care provider from the specialist is
own electronic exchange contact referrals related to the denominator for important for the patient’s continued
information and access the contact Measure 1 and Measure 2. We believe care by the primary care provider. In
information of potential trading that these transitions and referrals this scenario, it may not make sense for
partners. It is our intent to populate the should not be excluded from Measure 3, Measure 1 to be required. Under
National Plan and Provider as clinical information reconciliation measure 1 as proposed, the primary care
Enumeration System (NPPES) with may include actions beyond the provider would be required to send a
direct addresses and/or electronic electronic exchange of a patient record. summary of care record to the specialist.
service endpoints of EHR Incentive We further clarify that the use of the If the specialist has already seen the
Program participants as a means of reference to a billing identity within the patient and no follow-up or continued
creating a health care provider directory program is intended to establish the treatment is needed, we believe the
resource. For more information, we baseline that if a provider chooses to referring provider is best suited to
direct readers to section II.D.3 of this included exchanges with providers with determine whether the summary of care
final rule with comment period. a shared EHR they may do so as long as record should still be sent. We note that
Comment: Many commenters the recipient would be considered a there are further examples of such
requested a clearer definitions for the different provider in the EHR Incentive instances which provide further
denominators relating to the measures Programs (e.g., by the EPs NPI or the complications for feasibility of this
including: eligible hospital or CAH CCN). Some requirement as proposed. We are,
• Transitions of care for providers examples which would be included therefore, modifying our initial proposal
with a shared EHR under this policy would be one EP so that patient self-referrals may be
• Patient-reported referrals and sending to another EP in the same group included, but are not required, for
patient self-referrals practice, an eligible hospital sending to measure 1. The provider should
• New patients and patient an EP in an ambulatory setting which determine in what cases they would
encounters in which the provider has shares the hospital EHR, or a provider include or not include patient-self
never before encountered the patient sending to a non-EP practitioner who referrals and apply that policy across all
may have shared access to the EHR but such referrals for the duration of the
18 ONC Data Brief June 2015 healthit.gov. whose patient encounters are not reporting period. We note that providers
should seek to receive or retrieve a proposed Stage 3 CCDS would involve Comment: Some commenters noted
summary of care document from the significant effort to implement and the importance of the availability of
other provider of care and should seek transition the data elements necessary to certain information in care delivery,
to reconcile clinical information once support the standard summary of care including sexual orientation & gender
the provider is identified in the same record. identity, disparities, behavior health,
manner they would for any other Other commenters noted agreement and UDI data. Some commenters
transition or referral for measures 2 and with the expansion of captured data specifically highlighted the importance
3. elements and recommended we of capturing UDI data for improved care
For the definition of new patient and maintain capture of this information in and better reporting of adverse events as
never before seen by the provider, we a format supported by the C–CDA data well as allowing for the ability to
stated that we use the same definition structure, but that they should not be provide more effective corrective and
of ‘‘new patient’’ as described in mandatory to be populated on the C– preventative action in response to
Objective 7 Medication Reconciliation CDA in order to meet the numerator of device recalls and alerts.
for the EHR Incentive Programs in 2015 sending an electronic summary of care. Response: We thank commenters for
through 2017 in section II.B.2.a.v of this These commenters supported their comments and for their support of
final rule with comment period. continuing to require that the current UDI within the program. We note that
Comment: Some commenters opposed problem list, medication list, and ONC’s 2015 Edition final rule,
the option to allow providers to only medication allergy must be populated published elsewhere in this issue of the
meet the threshold for 2 of 3 objectives, within the C–CDA. Federal Register, includes UDIs for a
suggesting this would result in slower Response: We thank the commenters patient’s implantable devices in the
adoption of true interoperability and note that our proposal to allow for CCDS and the corresponding
between providers as they pursue provider discretion over clinical implantable device list certification
different goals of the EHR Incentive relevance stemmed largely from the
criterion in the Base EHR definition. We
Programs. These commenters stated that input from providers on how best to
believe that incorporating UDIs,
providers need to align on common address issues with this measure. We
beginning with UDIs for implantable
goals to successfully reach also agree that it is essential to maintain
devices, in certified EHR technology
interoperability. Other commenters the ability to send a full set of all
will be integral to patient care, as this
praised this flexibility stating that it available lab results and clinical notes.
information can help those within a
would allow them to set internal goals We reiterate that while the provider
patient’s care team to accurately identify
and a continuous improvement process generally has the discretion to define
the patient’s devices (and associated
and still be able to meet program the relevant clinical notes or relevant
clinically relevant information, such as
requirements if they sought to make laboratory results, providers must be
adjustments to workflows. able to provide all clinical notes and/or a device’s latex content or MRI safety)
Response: We appreciate the insights laboratory results through an electronic and thus be better informed and better
from the commenters and agree that the transmission of a summary of care able to care for the needs of the patient.
allowance to meet two of three document. Furthermore, providers must We refer readers to the 2015 Edition
thresholds represents a more flexible send all clinical notes and/or all final rule for further discussion of this
option for providers. We believe that laboratory results if that level of detail criteria.
rather than hinder participation, this is subsequently requested by a provider Certain other types of information,
flexibility will allow providers to receiving a transition of care or referral, while not required within the CCDS,
innovate and expand their uses of HIE or if that level of detail is requested by have associated standards and
as best meets their organizational needs. the patient who is transitioning to capabilities for data capture that are
Comment: Many commenters another setting of care. included in certification criteria that
supported our proposal allowing We disagree with the suggestion that compose the Base EHR definition. As
providers to limit the transmission of the C–CDA not be required and that any such, while these types of information
certain data elements based on clinical electronic transmission of patient health are not required within the CCDS, the
relevance. Others commended the information may be accepted for ability to capture this information is
approach of requiring the ability to send attestation. Furthermore, we disagree required under the definition of CEHRT.
all data elements while allowing with suggestions that the C–CDA should This distinction means the provider
flexibility for providers to make the not include all required elements of the would have the data element available
determination of relevance as best fits ONC defined CCDS for purposes of for use within their certified EHR and
their practice and patient population. CEHRT. We note that both the CCDS would have the ability to capture the
Some commenters further suggested and C–CDA support the interoperable data in a structured format as
that providers be able to limit the C– exchange of data elements for provider appropriate for their individual practice
CDA itself or not be required to send the use. Without standards, the data from and patient population. For example,
full C–CDS on all transitions of care. one system cannot readily be translated the Base EHR definition included in the
Many commenters addressed the C–CDS into usable data in another system. 2015 Edition final rule provides for the
itself stating that they support renaming However, we clarify that not all capture of demographic data within
the clinical data sets from ‘‘Common elements of the CCDS are required to certified EHR technology, including the
MU Data Set’’ to a new term, as the data include data if no such data is available capture of more granular data on race
sets are relevant beyond the EHR or known to the provider. The only and ethnicity and of data that extends
Incentive Programs. Some noted that three fields which must include data are beyond a more limited understanding of
CCDS is close to C–CDA however the current problem list, medication list, clinical care data—such as the
commenters were split on if that was a and medication allergy list, which must collection of social, psychological, and
problem or a benefit. at least include a reference that no such behavioral health information. The
Some commenters opposed the data is known or available. This is an ability to capture this information in
changes to the required data set in the important patient safety element CEHRT supports provider efforts to
CCDS stating that the additional data finalized in the Stage 2 final rule which provide improved, patient-centered care
fields that are incorporated into the we maintain for Stage 3. and reduce health disparities.
The 2015 Edition proposed rule also Response: We reiterate that CMS and care document) is to promote and
included a criterion to record a patient’s ONC are committed to working with the facilitate a wide range of options and
sexual orientation and gender identity industry to support and promote an also to specifically facilitate the receipt
(SO/GI) in a structured way with expanded HIE infrastructure to facilitate of a summary of care document
standardized data. Where the patient health IT facilitated care coordination. electronically. In the past, in response to
chooses to disclose this information, the We believe expanding the flexibility for inquiries by providers we developed an
inclusion of this information can help the use of a wide variety of transport FAQ which stated that an electronic
those within the patient’s care team to mechanisms, encouraging wider summary of care document may be
have more information on the patient provider participation and continuing to converted from a C–CDA to another
that can aid in identifying interventions support the use of standards for format (e.g. SOAP, secure email,
and treatments most helpful to the structured data in certified EHR electronic fax, and etc.) by a third party
particular patient. Additionally, sexual technology will help to mitigate these intermediary, and that such a transition
orientation and gender identity can be concerns. We do not believe the may still be counted in the numerator if
relevant to individual treatment threshold is too high given the past the third party can confirm for the
decisions; for example, transgender men performance, the expansion of options, sending provider that the summary of
who were assigned female at birth and the expressed need for higher care was ultimately received by the next
should be offered a cervical exam, as overall participation. We do however provider of care.19 However, for Stage 3
appropriate. In the final rule, ONC is note that the change to the exclusion we do not intend to continue to allow
requiring that Health IT modules enable may be problematic for providers with this policy, as it does not drive toward
a user to record, change, and access SO/ very few transitions in an EHR reporting the overall goal of the HIE Objective that
GI to be certified to the 2015 Edition period and are therefore maintaining the providers send, receive or retrieve, and
‘‘demographics’’ certification criterion. exclusion at 100 transitions and incorporate an electronic summary of
By doing so, SO/GI is now included in referrals as finalized in the Stage 2 final care document for each transition or
the 2015 Edition Base EHR definition, rule for an electronic summary of care referral. This means the initiating
which is a part of the definition of and consistent with measures 2 and 3. provider must send a C–CDA document
CEHRT (see section II.B.3). We note that Comment: Some commenters that the receiving provider would be
certification does not require that a requested clarification if any electronic capable of electronically incorporating
provider collect this information; it means could include transmission via as a C–CDA on the receiving end. In
requires only that their CEHRT enable pdf or electronic fax, or the conversion other words, if a provider sends a C–
the provider to do so. CMS and ONC of a C–CDA document into one of these CDA and the receiving provider
believe including SO/GI in the formats. Commenters also suggested that converts the C–CDA into a pdf or a fax
‘‘demographics’’ criterion represents a any electronic means is not a rigorous or some other format, the sending
crucial step forward to improving care enough definition to ensure the security provider may still count the transition
for LGBT communities. of patient information in transmission. or referral in the numerator. If the
Many commenters strongly supported
We also note that we received sending provider converts the file to a
the expansion of the available methods
comments specific to the composition of format the receiving provider could not
by which secure electronic exchange
the CCDS and addressing the C–CDA, electronically receive and incorporate as
could occur. Some strongly encouraged
which are out of scope for this rule. We a C–CDA, the initiating provider may
us to continue to require summary of
refer readers to the 2015 Edition final not count the transition in their
care record exchange in a manner that
rule included elsewhere in this Federal numerator. We further note that for
is consistent with a governance
Register for further information on the mechanism ONC establishes for the measure 1, a provider must have
CCDS and the C–CDA, as well as for nationwide health information network. confirmation of receipt or that a query
further information on provisions These commenters noted that of the summary of care record has
related to data collection, including the transmission of a summary of care occurred in order to count the action in
collection of sexual orientation and record could be accomplished in the numerator.
gender identity data and behavioral, We further note that the security of
various ways and requested that CMS
social, and psychological data. the transmission is of paramount
and ONC should provide resources
Comment: For Measure 1, many importance to CMS. We, therefore,
outside the regulations to support and
commenters expressed similar concerns clarify these requirements for remind providers and emphasize that
with the first measure as with HIE as a developers and providers. any transmission method chosen by a
whole citing interoperability barriers Other commenters specifically provider must comply with the privacy
and the lack of providers and other supported the requirement for the and security protocols for ePHI outlined
trading partners available to transmission of electronic summary of in HIPAA.
electronically exchange data. care document in a manner that is We requested comment from
Commenters also considered the consistent with the governance providers on how the governance
threshold of 50% to be too high and too mechanism ONC establishes for the mechanism could be considered for
far a leap from the 10% requirement in nationwide health information network purposes of the objectives and measures
Stage 2. Additionally, commenters and believe that allowing any other in Stage 3 and we thank commenters for
opposed removing the exclusion transmission method will increase the their comments. We will continue to
qualifier which allowed providers to cost and complexity of receiving and consider these comments as we work
exclude the measure if they conduct incorporating data into the EHR. with ONC to address governance as it
fewer than 100 referrals or transitions of Response: We note that the intent for relates to health information exchange,
care during the EHR reporting period. A flexibility around sending via any and look forward to continuing to work
few commenters believe measure 1 is electronic means (so long as the with stakeholders in this area.
valuable driver of interoperability provider is using the standards 19 FAQ #10660 https://www.cms.gov/Regulations-
within health care, but acknowledged established for certified health IT under and-Guidance/Legislation/EHRIncentivePrograms/
that refinements/adjustments need to be the ONC certification program for the FAQ.html Frequently Asked Questions: EHR
made. creation of the electronic summary of Incentive Programs.
Comment: For Measure 2, some instead allow a provider to query for a • The provider requested an
commenters acknowledged the potential document and receive that document electronic summary of care record to be
benefit of this measure with the via direct transport from the HIE. sent and did not receive an electronic
understanding that various challenges Response: We disagree with the summary of care document; and
would need to be overcome first. commenters that it is unreasonable to • The provider either:
Commenters felt the 40 percent include new patients and note that the 1. Queried at least one external source
threshold was too high, particularly for example provided about the ability of a via HIE functionality and did not locate
a new measure. They also expressed hospital to find information on a patient a summary of care for the patient, or
concerns with the administrative presenting at the emergency department 2. Confirmed that HIE functionality
burden, workflow and time management is exactly the type of process that is supporting query for summary of care
challenges, and technological barriers supported by health IT rather than documents was not operational in the
involved in reviewing and incorporating hindered by it. provider’s geographic region and not
data from other providers. We also decline to add the qualifier to available within the provider’s EHR
Response: We respectfully disagree the measure to specify only counting network as of the start of the EHR
that the threshold for the measure is too existing electronic transitions or reporting period.
high, as the ability to retrieve, receive Comment: Finally, commenters
referrals in the requirement to receive,
and incorporate an electronic summary requested information on what the term
request or query for an electronic
of care document for transitions or ‘‘incorporated’’ means in the numerator.
summary of care record. If we were to
referrals as defined by the measure is Some expressed concerns over the
change the measure to read ‘‘received integrity of the information if they are
entirely within the provider’s control. electronically’’ it eliminates any further
For example, in our proposal we allow forced to incorporate it into their EHR.
follow up to request or query for an Response: We do not define
providers to exclude a patient from the electronic record when an electronic
denominator where a reasonable due incorporate, as it may vary among
record was not already received with recipient providers based on the
diligence reveals that no electronic the transition or referral. This change
record is available for the patient. This providers HIE workflows, their patient
would fundamentally alter the measure population, and based on the referring
reduces the burden on providers to and render it meaningless.
incorporate the record for only those provider. The record may be included as
The proposed measure denominator an attachment, as a link within the EHR,
patients for whom an electronic record already allows providers to exclude
is available after their effort to receive, as imported structured data, or the
patients for whom no electronic provider may conduct a reconciliation
request, or query for an electronic
document is available after a reasonable of the clinical information within the
summary of care is successful. We
effort is made, such as a request to the record to incorporate this information
believe there may be many variations in
referring provider and a query of any into the patient record within their EHR.
how providers accomplish this measure
HIE or service. As stated in the We note that a record cannot be
and believe those workflows and
proposed rule, for the purposes of considered to be incorporated if it is
processes are best left to provider
defining the cases in the denominator, discarded without the reconciliation of
discretion.
Comment: Some commenters we proposed that what constitutes clinical information or if it is stored in
expressed that it would be unreasonable ‘‘unavailable’’ and, therefore, may be a manner that is not accessible for
to include patients never before seen by excluded from the denominator, will be provider use within the EHR.
the provider. These commenters noted that a provider— Comment: Many commenters
that, for example, emergency • Requested an electronic summary of supported Measure 3 and clinical
department workflows are simply care record to be sent and did not information reconciliation with some
incompatible with requirements to try to receive an electronic summary of care stating that the measure should be
identify outside sources of summary of document; and required rather than an option within
care records for walk-in patients. They • Queried at least one external source the objective. Others stated that all three
further noted that the infrastructure for via HIE functionality and did not locate types of information should be required
doing this does not exist in most areas a summary of care for the patient, or the for all care transitions because
and is not likely to exist for several provider does not have access to HIE reconciliation of medications,
years to come. functionality to support such a query. medication allergies, and current
Other commenters requested we add However, we do agree with problems is consistent with the
the word ‘‘electronically’’ to the commenters and are adopting a change requirement to provide the safest care.
measure language so that the measure to state that the reference to HIE Many commenters also agreed with the
reads ‘‘For 40 percent of transitions or functionality within the denominator threshold for the measure of more than
referrals received electronically’’. Other calculation should be revised to reflect 80 percent, with some stating that we
commenters noted that a provider may whether or not there is an HIE from should simply require all patients for
have the capacity to query an HIE in which the provider is able to query and this measure instead.
their CEHRT, but is unable to do so receive a C–CDA using their CEHRT. We Some commenters discussed the
because there is no HIE in their area or are therefore adding an additional administrative burden, various
their organization is still in the process qualifier to the statement to include that workflow challenges involved in
of on-boarding with a potential HIE the HIE functionality supporting a query reviewing, and incorporating data from
network. These commenters expressed for a summary of care document is not other providers including the amount of
concern that the denominator currently operational in the provider’s time required to review inbound
calculation would not allow them to geographic region or EHR network. summary of care reports. Other
exclude patients for whom they were Therefore, for the purposes of defining commenters discussed how the CCDS
unable to query in this instance. Others the cases in the denominator, we are are not helpful because they contain too
expressed a similar concern over the modifying our proposal to state that much unnecessary and redundant
understanding of an HIE noting that what constitutes, ‘‘unavailable’’ and information as well as the risk
many do not require the provider to therefore may be excluded from the associated with receiving summary of
possess additional functionality, but denominator,—is as follows: care information that has not been
reviewed by a provider in a timely necessary, the process of reconciliation standard for potential inclusion in the
manner. may consist of simply verifying that fact future.
Other commenters stated that not all or reviewing a record received on After consideration of public
new patient referrals require referral and determining that such comments received, we are finalizing
comprehensive data reconciliation. For information is merely duplicative of the objective with a minor modification
example a dermatologist evaluating a existing information in the patient to the language to clarify receiving or
simple skin lesion or an orthopedist record. Both such examples would retrieving a summary of care through
evaluating a painful joint may not need count toward the measure if the query as discussed for measure 2. We
to perform in depth reconciliation to provider established their reconciliation are finalizing the measures and
provide quality care. process to include such verification. exclusions as proposed for EPs, eligible
In addition, many commenters Comment: Commenters requested hospitals and CAHs. We are finalizing
discussed the means of measurement for clarification on whether data can be that providers must attest to all three
medications, problems, and allergies reconciled by non-credentialed staff or measures and must meet the thresholds
such as if duplicate records needed to by credentialed staff only. Commenters for at least two measures to meet the
be reconciled or if data that is verified were split on their opinions of whether objective. The final objective and
as requiring no further update would reconciliation should be conducted by measures are as follows:
also count toward the measure. Several only credentialed medical staff like
commenters requested clarification on CPOE or by any staff trained to work Objective 7: Health Information
whether the reconciliation should be with the EHR and enter patient Exchange
automated or manual. Some requested information. Some recommended Objective: The EP, eligible hospital, or
we offer both options to allow providers allowing auto reconciliation of data as CAH provides a summary of care record
to choose the means that best fits their long as it is reviewed by credentialed when transitioning or referring their
practice, and many commenters had staff or provider. Other commenters patient to another setting of care,
concerns about the liability associated stated that non-credentialed staff should receives or retrieves a summary of care
with automated reconciliation. be able to reconcile the data, then have record upon the receipt of a transition
Response: We appreciate the support it reviewed by credentialed staff. or referral or upon the first patient
for the measure; however, we did not Response: We require the person encounter with a new patient, and
propose that this measure should be entering the order in CPOE to be incorporates summary of care
required for the objective but rather that credentialed medical staff because of the information from other providers into
providers must meet the threshold for need to review, assess, and potentially their EHR using the functions of
two of three measures based on the act on a CDS based on the order entered. CEHRT.
needs of their practice. We believe that For further discussion, we direct readers Measure 1: For more than 50 percent
many providers may conduct some form to the CPOE objective in section II.B.2.a. of transitions of care and referrals, the
of reconciliation in conjunction with of this final rule with comment period. EP, eligible hospital or CAH that
measure 2, or that providers in certain In most cases, clinical information transitions or refers their patient to
specialties may elect to conduct reconciliation may not require the same another setting of care or provider of
reconciliation of clinical information level of medical training and knowledge care: (1) Creates a summary of care
even beyond our requirement at all and a non-clinical staff person trained to record using CEHRT; and (2)
patient encounters. We understand from accurately and completely enter patient electronically exchanges the summary
previous listening sessions and feedback information may be fully qualified to of care record.
from stakeholders that the summary of conduct this task. However, in some • Denominator: Number of transitions
care documents sometimes contain an instances, further medical knowledge of care and referrals during the EHR
overwhelming amount of information. and training may be required, such as if reporting period for which the EP or
For this reason, we allow provider a medication reconciliation triggers a eligible hospital or CAH inpatient or
discretion to define the relevant clinical CDS drug-drug intervention. We emergency department (POS 21 or 23)
notes and/or laboratory results to send therefore agree with commenters that was the transferring or referring
in the summary of care document, non-medical staff may conduct provider.
although we maintain that providers reconciliation under the direction of the • Numerator: The number of
must still have the CEHRT functionality provider so long as the provider or other transitions of care and referrals in the
to include and send all labs or clinical credentialed medical staff is responsible denominator where a summary of care
notes. We believe this will provide the and accountable for review of the record was created using certified EHR
efficiency sought by stakeholders in information and for the assessment of technology and exchanged
their feedback. and action on any relevant CDS. electronically.
We note that this measure builds on Comment: A few commenters • Threshold: The percentage must be
the existing Medication Reconciliation supported the inclusion of electronic more than 50 percent in order for an EP,
Objective for the EHR Incentive alerts to the EP, when their patient is eligible hospital, or CAH to meet this
Programs in 2015 through 2017 (see seen in the emergency department or measure.
section II.B.2.a.v). We agree that this admitted and/or discharged from the • Exclusion: A provider may exclude
process may include both automated hospital. Other commenters stated that from the measure if any of the following
and manual reconciliation to allow the the standard is too vague and the apply:
receiving provider to work with both the technology too immature for required Æ Any EP who transfers a patient to
electronic data provided with any use at this time and that CMS should another setting or refers a patient to
necessary review, and to work directly allow providers to choose if they wish another provider less than 100 times
with the patient to reconcile their health to participate in this action for the near during the EHR reporting period.
information. We further note that the future. Æ Any EP that conducts 50 percent or
point of reconciliation is to assist in Response: We decline to finalize an more of his or her patient encounters in
maintaining the most relevant, inclusion of electronic alerts at this a county that does not have 50 percent
complete, and up to date information for time. We will continue to review the or more of its housing units with 4Mbps
a given patient. If no update is development of the technology and broadband availability according to the
latest information available from the the patient, the EP, eligible hospital, or flexibility in the options that an eligible
FCC on the first day of the EHR CAH performs a clinical information provider has to successfully report.
reporting period may exclude the reconciliation. The provider must We further noted that this objective
measures. implement clinical information places increased focus on the
Æ Any eligible hospital or CAH will reconciliation for the following three importance of the ongoing lines of
be excluded from the measure if it is clinical information sets: communication that should exist
located in a county that does not have (1) Medication. Review of the between providers and public health
50 percent or more of their housing patient’s medication, including the agencies or as further discussed later in
units with 4Mbps broadband name, dosage, frequency, and route of this section, between providers and
availability according to the latest each medication. clinical data registries. Providers’ use of
information available from the FCC at (2) Medication allergy. Review of the certified EHR technology can increase
the start of the EHR reporting period. patient’s known medication allergies. the flow of secure health information
Measure 2: For more than 40 percent (3) Current Problem list. Review of the and reduce the burden that otherwise
of transitions or referrals received and patient’s current and active diagnoses. could attach to these important
patient encounters in which the • Denominator: Number of transitions communications. The purpose of this
provider has never before encountered of care or referrals during the EHR Stage 3 objective is to further advance
the patient, the EP, eligible hospital or reporting period for which the EP or communication between providers and
CAH incorporates into the patient’s EHR eligible hospital or CAH inpatient or public health agencies and clinical data
an electronic summary of care emergency department (POS 21 or 23) registries, as well as strengthen the
document. was the recipient of the transition or capture and transmission of such health
• Denominator: Number of patient referral or has never before encountered information within the care continuum.
encounters during the EHR reporting the patient. For Stage 3, we proposed changes to
period for which an EP, eligible • Numerator: The number of the Stage 1 and Stage 2 public health
hospital, or CAH was the receiving party transitions of care or referrals in the and specialty registry objectives to
of a transition or referral or has never denominator where the following three consolidate the prior objectives and
before encountered the patient and for clinical information reconciliations measures into a single objective in
which an electronic summary of care were performed: Medication list, alignment with efforts to streamline the
record is available. medication allergy list, and current program and support flexibility for
• Numerator: Number of patient problem list. providers. We proposed to include a
encounters in the denominator where an • Threshold: The resulting percentage new measure for electronic case
electronic summary of care record must be more than 80 percent in order reporting to reflect the diverse ways that
received is incorporated by the provider for an EP, eligible hospital, or CAH to providers can electronically exchange
into the certified EHR technology. meet this measure. data with public health agencies. In
• Threshold: The percentage must be • Exclusion: Any EP, eligible hospital addition, we used new terms such as
more than 40 percent in order for an EP, or CAH for whom the total of transitions public health registries and clinical data
eligible hospital, or CAH to meet this or referrals received and patient registries to incorporate the Stage 2
measure. encounters in which the provider has designations for cancer registries and
• Exclusion: A provider may exclude never before encountered the patient, is specialized registries under these
from the measure if any of the following fewer than 100 during the EHR categories which are known in the
apply: reporting period is excluded from this health care industry to designate a
Æ Any EP, eligible hospital or CAH measure. broader range of registry types. We
for whom the total of transitions or We are adopting Objective 7: Health further explained the use of these terms
referrals received and patient Information Exchange at within the specifications outlined for
encounters in which the provider has § 495.24(d)(7)(i) for EPs and each applicable measure.
never before encountered the patient, is § 495.24(d)(7)(ii) for eligible hospitals Proposed Objective: The EP, eligible
fewer than 100 during the EHR and CAHs. We further specify that in hospital, or CAH is in active
reporting period is excluded from this order to meet this objective and engagement with a public health agency
measure. measures, an EP, eligible hospital, or or clinical data registry to submit
Æ Any EP that conducts 50 percent or CAH must use the capabilities and electronic public health data in a
more of his or her patient encounters in standards of as defined for as defined meaningful way using certified EHR
a county that does not have 50 percent CEHRT at § 495.4. We direct readers to technology, except where prohibited,
or more of its housing units with 4Mbps section II.B.3 of this final rule with and in accordance with applicable law
broadband availability according to the comment period for a discussion of the and practice.
latest information available from the definition of CEHRT and a table For Stage 3, we proposed to remove
FCC on the first day of the EHR referencing the capabilities and the prior ‘‘ongoing submission’’
reporting period may exclude the standards that must be used for each requirement and replace it with an
measures. measure. ‘‘active engagement’’ requirement.
Æ Any eligible hospital or CAH will Depending on the measure, the ongoing
be excluded from the measure if it is Objective 8: Public Health and Clinical submission requirement from the Stage
located in a county that does not have Data Registry Reporting 1 and Stage 2 final rules required the
50 percent or more of their housing In the Stage 3 proposed rule (80 FR successful ongoing submission of
units with 4Mbps broadband 16763) we proposed this objective to applicable data from certified EHR
availability according to the latest build on the requirements set forth in technology to a public health agency or
information available from the FCC at the Stage 2 final rule (77 FR 54021 clinical data registry for the entire EHR
the start of the EHR reporting period. through 54026). We proposed this reporting period. As part of the Stage 2
Measure 3: For more than 80 percent objective to include improvements to final rule, we provided examples
of transitions or referrals received and the Stage 2 measures, support demonstrating how ongoing submission
patient encounters in which the innovation that has occurred since the could satisfy the measure (77 FR 54021).
provider has never before encountered Stage 2 final rule was released, and add However, stakeholders noted that the
ongoing submission requirement does Active Engagement Option 3— to ‘‘active engagement.’’ We received
not accurately capture the nature of Production: The EP, eligible hospital, or feedback from a variety of stakeholders
communication between providers and CAH has completed testing and that the ‘‘ongoing submission’’ structure
a public health agency or clinical data validation of the electronic submission created confusion. This feedback
registry, and does not consider the many and is electronically submitting highlighted that providers are unsure of
steps necessary to arrange for registry production data to the public health how ongoing submission could be
submission to a public health agency or agency or clinical data registry. achieved and whether periodic,
clinical data registry. Given this We also proposed to provide support continuous, or episodic reporting was
feedback, we believe that ‘‘active to providers seeking to meet the generally required. We found that the
engagement’’ as defined later in this requirements of this objective by wide variation among potential provider
section is more aligned with the process creating a centralized repository of reporting scenarios and submission
providers undertake to report to a national, state, and local public health processes contributed to the difficulty in
clinical data registry or to a public agency and clinical data registry defining ‘‘ongoing submission’’ in a fair
health agency. readiness. In the Stage 2 final rule (77 and universally applicable manner.
For purposes of meeting this new FR 54021), we noted the benefits of Therefore our change to ‘‘active
objective, EPs, eligible hospitals and developing a centralized repository engagement’’ is intended to more clearly
CAHs would be required to demonstrate where a public health agency could post identify the progression of the
that ‘‘active engagement’’ with a public readiness updates regarding their ability requirement as well as providing a basis
health agency or clinical data registry to accept electronic data using for defining the actions required by the
has occurred. Active engagement means specifications prescribed by ONC for the provider in each step of the process. In
that the provider is in the process of public health objectives. In accordance a sense, the active engagement options
moving towards sending ‘‘production with the Paperwork Reduction Act of are a clarification of the more basic
data’’ to a public health agency or 1995, we also published a notice in the concept of reporting which is that the
clinical data registry, or is sending Federal Register on February 7, 2014 provider is taking action and in
production data to a public health soliciting public comment on the communication with a public health
agency or clinical data registry. We proposed information collection agency in order to register, test and
noted that the term ‘‘production data’’ required to develop the centralized submit data in a progression which
refers to data generated through clinical repository on public health readiness results in the provider successfully
processes involving patient care and it (79 FR 7461). We considered the reporting relevant data to the public
is used to distinguish between this data comments and we proposed moving health agency.
and ‘‘test, data’’ which may be forward with the development of the The active engagement requirement
submitted for the purposes of enrolling centralized repository. The centralized clarifies what is expected of a provider
in and testing electronic data transfers. repository is integral to meaningful use who seeks to meet the measures within
We proposed that ‘‘active engagement’’ and is expected to be available by the this objective and renames the
may be demonstrated by any of the start of CY 2017. We expect that the requirement to better describe the
following options: centralized repository will include provider’s role in meeting each option
Active Engagement Option 1— readiness updates for public health within the structure. There is an
Completed Registration to Submit Data: agencies and clinical data registries at intentional similarity between some of
The EP, eligible hospital, or CAH the state, local, and national level. We the broad descriptions of the Stage 2
registered to submit data with the public received the following comments and ‘‘ongoing reporting’’ and the
health agency or, where applicable, the our responses follow: requirements for the ‘‘active
clinical data registry to which the Comment: Some commenters engagement’’ options. This is both to
information is being submitted; expressed concern regarding the active provide continuity and to define a more
registration was completed within 60 engagement requirement included in the comprehensive progression for
days after the start of the EHR reporting proposed rule. Commenters noted that providers in meeting the measure. For
period; and the EP, eligible hospital, or the description of active engagement is example, in the Stage 2 rule (77 FR
CAH is awaiting an invitation from the vague. Commenters also noted that 54021), we generally stated that a
public health agency or clinical data additional time, beyond the 2018 provider could register their intent to
registry to begin testing and validation. requirement year, would be needed to submit data to successfully meet a
This option allows providers to meet the ensure that providers could change their measure in the public health objective.
measure when the public health agency current framework to meet the new This concept is defined with additional
or the clinical data registry has limited active engagement requirement. Other guidance in the Stage 3 proposed rule as
resources to initiate the testing and commenters requested clarification on Active Engagement Option 1:
validation process. Providers that have the definition of production in Option 3. Completed Registration to Submit Data.
registered in previous years do not need Other commenters noted that during the For the commenters discussing the
to submit an additional registration to production phase, issues may arise that submission of production data as
meet this requirement for each EHR need resolution and that, similar to the defined in Action Engagement Option 3:
reporting period. testing and validation phases, processes Production, we note that under this
Active Engagement Option 2—Testing are needed to ensure proper resolution. option a provider only may successfully
and Validation: The EP, eligible A commenter proposed adding a 30-day attest to meaningful use when the
hospital, or CAH is in the process of allowance to the active engagement receiving public health agency or
testing and validation of the electronic option 3 (production) to align with the clinical data registry moves the provider
submission of data. Providers must 30-day allowance included in active into a production phase. We recognize
respond to requests from the public engagement option 2 (testing and that live data may be sent during the
health agency or, where applicable, the validation). Testing and Validation phase of Option
clinical data registry within 30 days; Response: We thank the commenters 2, but the data received in Option 2 is
failure to respond twice within an EHR for their input and note the following not sufficient for purposes of meeting
reporting period would result in that clarifications of intent and purpose for Option 3 unless the public health
provider not meeting the measure. the change from ‘‘ongoing submission’’ agency and clinical data registry is
actively accepting the production data engagement collected by their need advance readiness notification
from the provider for purpose of organization, or whether a provider from public health agencies and clinical
reporting. We agree with commenters must demonstrate that he or she data registries to prepare and plan
who noted that issues may arise that independently engaged with the public before the EHR reporting period begins,
require provider action. In such a case, health agency or clinical data registry. we are broadening the exclusions that
we require providers to respond to Response: The EHR Incentive could apply to providers seeking to
issues in the same manner as described Programs are based on individual meet the objective. The exclusion will
in Option 2. For example, a provider in providers meeting the objectives and allow providers more time to prepare
the production phase would not be able measures of meaningful use. Therefore their processes to align with what data
to successfully attest to Option 3 if there an individual provider can only meet an public health jurisdictions are ready to
were issues in production where the objective or measure if they are engaged accept. Specifically, we will not finalize
provider fails to respond to an issue in the activity which is used to meet the the proposed requirement that public
within 30 days on two occasions. measure. This means a provider can
health agency and clinical data
Comment: Some commenters sought demonstrate meaningful use by using
registries declare readiness on the first
clarification on whether a provider who communications and information
day of the EHR reporting period. We are
has already registered with a public provided by a public health agency or
health agency or clinical data registry clinical data registry to the provider instead finalizing a modified exclusion
during a previous reporting period directly for individual reporting. Or, a that if public health agencies have not
would have to register again in order to provider also may demonstrate declared 6 months before the start of the
meet the active engagement meaningful use by using EHR reporting period whether the
requirement. Commenters noted that a communications and information registry they are offering will be ready
registration requirement in such provided by a public health agency or on January 1 of the upcoming year for
circumstances would be duplicative. clinical data registry to the practice or use by providers seeking to meet EHR
Response: As we have noted in the organization of the provider if the reporting periods in that upcoming year,
proposed rule, under the active organization reports at the group level a provider can claim an exclusion. We
engagement requirement, providers as long as the provider is contributing believe that modifying the exclusion to
would only need to register once with to the data reported by the group. If the request public health agency or clinical
a public health agency or a clinical data provider does not contribute to the data, data registry to declare their readiness 6
registry and could register before the they must claim the exclusion if months ahead of the first day of the EHR
reporting period begins. In addition, we applicable and/or meet another public reporting period would allow providers
note that previous registrations with a health reporting measure. For example, adequate notice of public health agency
public health agency or clinical data a provider who does not administer and clinical data registry plans to accept
registry that occurred in a previous stage immunizations should claim the data at the beginning of an EHR
of meaningful use could count toward exclusion even if their organization reporting period.
option 1 of the active engagement submits immunization reporting at the Proposed Measures: We proposed a
requirement for purposes of attesting to group level. total of six possible measures for this
Stage 3. We clarify that providers must Comment: Commenters also
objective. EPs would be required to
register with a public health agency or expressed support for the proposed
clinical data registry for each measure centralized repository of public health choose from measures 1 through 5, and
they intend to use to meet meaningful agencies and clinical data registry would be required to successfully attest
use. Further, we also clarify that to meet readiness. Commenters noted that the to any combination of three measures.
option 1 of the active engagement repository would help developers and Eligible hospitals and CAHs would be
requirement, registration with the providers consider available registry required to choose from measures one
applicable public health agency or options and provide advance notice of through six, and would be required to
clinical data registry is required where the status of registries. Though the successfully attest to any combination of
a provider seeks to meet meaningful use repository received many positive four measures. The proposed measures
using a measure they have not comments, some commenters noted that are as shown in Table 9. As noted, we
successfully attested to in a previous variability in the readiness of public proposed that measures four and five for
EHR reporting period. health agencies presented an additional Public Health Registry Reporting and
Comment: Commenters requested challenge for providers who seek to Clinical Data Registry Reporting may be
clarification regarding whether a prepare for and meet the measures. counted more than once if more than
provider can successfully attest to Response: In response to comments one Public Health Registry or Clinical
meaningful use using proof of active received and the concern that providers Data Registry is available.
Maximum
Maximum times measure
times measure can count to-
Measure can count towards objec-
wards objective for eligible
tive for EP hospital or
CAH
Measure 1—Immunization Registry Reporting ........................................................................................................ 1 1

Measure 2—Syndromic Surveillance Reporting ...................................................................................................... 1 1
Measure 3—Case Reporting ................................................................................................................................... 1 1
Measure 4—Public Health Registry Reporting * ...................................................................................................... 3 4
Measure 5—Clinical Data Registry Reporting ** ..................................................................................................... 3 4
TABLE 9—MEASURES FOR OBJECTIVE 8: PUBLIC HEALTH AND CLINICAL DATA REGISTRY REPORTING OBJECTIVE—
Continued
Maximum
times measure can count to-
Measure can count towards objec-
wards objective for eligible
tive for EP hospital or
CAH
Measure 6—Electronic Reportable Laboratory Results .......................................................................................... N/A 1

meet the objective.
meet the objective.
For EPs, we proposed that an engagement with a public health agency health community would benefit from
exclusion for a measure does not count to submit immunization data and technology that can accommodate bi-
toward the total of three measures. receive immunization forecasts and directional immunization data
Instead, in order to meet this objective, histories from the public health exchange. We welcomed comment on
an EP would need to meet three of the immunization registry/immunization this proposal.
total number of measures available to information system (IIS). Proposed Exclusion for Measure 1:
them. If the EP qualifies for multiple In the Stage 3 proposed rule (80 FR Any EP, eligible hospital, or CAH
exclusions and the remaining number of 16764), we noted that the immunization meeting one or more of the following
measures available to the EP is less than registry reporting measure remains a criteria may be excluded from the
three, the EP can meet the objective by priority because the exchange of immunization registry reporting
meeting all of the remaining measures information between certified EHR measure if the EP, eligible hospital, or
available to them and claiming the technology and immunization registries CAH: (1) Does not administer any
applicable exclusions. Available allows a provider to use the most immunizations to any of the
measures include ones for which the EP complete immunization history populations for which data is collected
does not qualify for an exclusion. available to inform decisions about the by their jurisdiction’s immunization
For eligible hospitals and CAHs, we vaccines a patient may need. Public registry or immunization information
proposed that an exclusion for a health agencies and providers also use system during the EHR reporting period;
measure does not count toward the total immunization information for (2) operates in a jurisdiction for which
of four measures. Instead, in order to emergency preparedness and to estimate no immunization registry or
meet this objective an eligible hospital population immunization coverage immunization information system is
or CAH would need to meet four of the levels of certain vaccines. capable of accepting the specific
total number of measures available to We proposed that to successfully meet standards required to meet the CEHRT
them. If the eligible hospital or CAH the requirements of this measure, bi- definition at the start of the EHR
qualifies for multiple exclusions and the directional data exchange between the reporting period; or (3) operates in a
total number of remaining measures provider’s certified EHR technology and jurisdiction where no immunization
available to the eligible hospital or CAH the immunization registry/IIS is registry or immunization information
is less than four, the eligible hospital or required. We understand that many system has declared readiness to receive
CAH can meet the objective by meeting states and local public health immunization data at the start of the
all of the remaining measures available jurisdictions are exchanging EHR reporting period.
to them and claiming the applicable immunization data bi-directionally with Comment: Many comments supported
exclusions. Available measures include providers, and that the number of states the concept of bi-directional messaging,
ones for which the eligible hospital or and localities able to support bi- but some commenters requested
CAH does not qualify for an exclusion. directional exchange continues to additional background on what bi-
We also proposed to allow EPs, increase. In the 2015 Edition proposed directionality means for purpose of the
eligible hospitals, and CAHs to choose rule, ONC proposed to adopt a bi- measure. Many commenters expressed
to report to more than one public health directional exchange standard for concern about elements of the bi-
registry to meet the number of measures reporting to immunization registries/IIS. directional components of
required to meet the objective. We also We believe this functionality is immunization registry reporting, and
proposed allowing EPs, eligible important for patient safety and around jurisdictional variation and the
hospitals, and CAHs to choose to report improved care because it allows the lack of public health readiness to
to more than one clinical data registry provider to use the most complete implement bi-directional data exchange.
to meet the number of measures immunization record possible to make Many commenters expressed concern
required to meet the objective. We decisions on whether a patient needs a about public health readiness for bi-
explained that we believe that this vaccine. Immunization registries and directional data exchange, especially
flexibility allows for EPs, eligible health IT systems also are able to during the EHR Incentive Program
hospitals, and CAHs to choose reporting provide immunization forecasting reporting periods of 2015 through 2017.
options that align with their practice functions which can inform discussions A commenter expressed concern that
and that will aid the provider’s ability between providers and patients on what immunization registries are not fully
to care for their patients. vaccines they may need in the future prepared to support bi-directional
Proposed Measure 1—Immunization and the timeline for the receipt of such interfaces. Many commenters also
Registry Reporting: The EP, eligible immunizations. Therefore, we believe expressed concern around accepting the
hospital, or CAH is in active that patients, providers, and the public immunization history and forecast from
an IIS when the EHR may already outbreaks, as well as monitoring disease value to the industry. Another
perform that functionality and may have and condition trends. We distinguished commenter noted that for the few
better information to perform the between EPs and eligible hospitals or jurisdictions accepting syndromic
forecasting algorithm. A commenter CAHs reporting locations because, as surveillance data from ambulatory
expressed concern that the forecast info discussed in the Stage 2 final rule, few practices, the data that these
interface could conflict with their public health agencies appeared to have jurisdictions are accepting are not data
system’s existing health maintenance the ability to accept non-emergency or that is commonly considered syndromic
functionality. non-urgent care ambulatory syndromic surveillance data. A commenter noted
Response: Bi-directionality, as noted surveillance data electronically (77 FR that if data is being requested or
in the applicable implementation guide 53979). We continued to observe collected for use cases beyond the
Version 2.5.1: Implementation Guide for differences in the infrastructure and standard syndromic surveillance
Immunization Messaging, Release 1.5 current environments for supporting definition, the requested or collected
(October 2014) (‘‘Release 1.5’’), provides electronic syndromic surveillance data data should be used to report to
that certified health IT must be able to submission to public health agencies proposed Measure 4: Public Health
receive and display a consolidated between eligible hospitals or CAHs and Reporting, not this measure.
immunization history and forecast in EPs. Because eligible hospitals and Response: We agree that few
addition to sending the immunization CAHs send syndromic surveillance data jurisdictions accept syndromic
record. Some comments noted that using different methods as compared to surveillance from non-urgent care
certified EHR technology may already EPs, we defined slightly different eligible professionals and that at times
perform the forecast and may have exclusions for each setting as described the data that is collected may not be
better information to perform the later in this section. considered traditional syndromic
forecasting algorithm. For clarification, Proposed Exclusion for EPs for surveillance data. For the EHR Incentive
we note that the provider’s technology Measure 2: Any EP meeting one or more Programs in 2015 through 2017, we
certified in accordance with the ONC of the following criteria may be continue to offer syndromic surveillance
Health IT Certification Program may excluded from the syndromic as an option for ambulatory care
layer additional information and surveillance reporting measure if the EP: providers as a few jurisdictions are
recommendations on top of the forecast (1) Does not treat or diagnose or directly already accepting such data. Because
received from the immunization treat any disease or condition associated syndromic surveillance reporting is
registry. The requirements of CEHRT with a syndromic surveillance system in more appropriate for urgent care settings
serve only as a baseline upon which their jurisdiction; (2) operates in a and eligible hospitals/CAHs, we remove
additional capabilities may be built. jurisdiction for which no public health this measure for eligible professionals
Regarding the bi-directionality agency is capable of receiving electronic for Stage 3 with the exception of
requirement, we note that we have syndromic surveillance data from EPs in providers who are practicing in urgent
modified the requirements of bi- the specific standards required to meet care settings. For CAHs and eligible
directionality for the EHR Incentive the CEHRT definition at the start of the hospitals, we adopt this measure as
Program for 2015 through 2017 (see EHR reporting period; or (3) operates in proposed. We further note that as any
section II.B.2.a.x). However, for Stage 3, a jurisdiction where no public health provider for whom reporting is not
we believe that the bi-directionality agency has declared readiness to receive possible, an exclusion is already
requirement should remain. We believe syndromic surveillance data from EPs at available; therefore, the additional
that by the time Stage 3 begins, the bi- the start of the EHR reporting period. setting restriction within the measure
directional components of Proposed Exclusion for eligible language is duplicative and may cause
immunization registry reporting will be hospitals/CAHs for Measure 2: Any confusion for providers who practice in
ready. At the time of publication of this eligible hospital or CAH meeting one or multiple settings where the measure
final rule with comment period, more more of the following criteria may be may have different relevance. We are
than half of public health jurisdictions excluded from the syndromic therefore modifying the measure
can support bi-directional messaging surveillance reporting measure if the language and the exclusion to help
and the remaining public health eligible hospital or CAH: (1) Does not clarify the measure for those reporting
jurisdictions are on their way to have an emergency or urgent care on the measure and the exclusion
supporting the bi-directional capability. department; (2) operates in a options for those who are not reporting
Therefore, we are finalizing this jurisdiction for which no public health on the measure.
measure, with the modification that a agency is capable of receiving electronic Proposed Measure 3—Case Reporting:
provider’s health IT system may layer syndromic surveillance data from The EP, eligible hospital, or CAH is in
additional information on the eligible hospitals or CAHs in the active engagement with a public health
immunization history, forecast, and still specific standards required to meet the agency to submit case reporting of
successfully meet this measure. CEHRT definition at the start of the EHR reportable conditions.
Proposed Measure 2—Syndromic reporting period; or (3) operates in a This proposed new reporting option
Surveillance Reporting: The EP, eligible jurisdiction where no public health was not part of Stage 2. The collection
hospital, or CAH is in active agency has declared readiness to receive of electronic case reporting data greatly
engagement with a public health agency syndromic surveillance data from improves reporting efficiencies between
to submit syndromic surveillance data eligible hospitals or CAHs at the start of providers and the public health agency.
from a non-urgent care ambulatory the EHR reporting period. Public health agencies collect
setting for EPs, or an emergency or Comment: Many commenters noted ‘‘reportable, conditions’’, as defined by
urgent care department for eligible that many jurisdictions are not able to the state, territorial, and local public
hospitals and CAHs (POS 23). receive ambulatory syndromic health agencies, to monitor disease
In the Stage 3 proposed rule (80 FR surveillance data and that the standards trends and support the management of
16764), we noted that this measure for reporting are vague. A commenter outbreaks. In many circumstances, there
remains a policy priority because expressed concern that requiring a has been low reporting compliance
electronic syndromic surveillance is provider’s system to be certified to the because providers do not know when,
valuable for early detection of ambulatory standard does not provide where, or how to report. In some cases,
the time burden to report can also count under the specialized registry reporting to both the National Hospital
contribute to low reporting compliance. measure. For Stage 3, we do believe that Care Survey and the National
However, electronic case reporting case reporting should remain. However, Healthcare Safety Network registry, the
presents a core benefit to public health to allow EPs, EHR vendors, and other provider could get credit for meeting
improvement and a variety of entities adequate time to prepare for this two measures. ONC will consider the
stakeholders identified electronic case new measure in Stage 3, this measure adoption of standards and
reporting as a high value element of will not begin requiring electronic case implementation guides in future
patient and continuity of care. Further, reporting until 2018. By the 2018 year rulemaking. Should these subsequently
we believe that electronic case reporting of Stage 3, we believe that the standards be finalized, they may then be adopted
reduces burdensome paper-based and will be mature and that jurisdictions as part of the certified EHR technology
labor-intensive case reporting. will be able to accept these types of definition as it relates to meeting the
Electronic reporting will support more data. Therefore, we finalize this measure public health registry reporting measure
rapid exchange of case reporting as proposed to begin in 2018. through future rulemaking for the EHR
information between public health Proposed Measure 4—Public Health Incentive Programs.
agencies and providers and can include Registry Reporting: The EP, eligible We further noted that ONC adopted
structured questions or data fields to hospital, or CAH is in active standards for ambulatory cancer case
prompt the provider to supply engagement with a public health agency reporting in its final rule ‘‘2014 Edition,
additional required or care-relevant to submit data to public health Release 2 EHR Certification Criteria and
information. registries. the ONC HIT Certification Program;
Proposed Exclusion for Measure 3: In the Stage 2 final rule, we were Regulatory Flexibilities, Improvements,
Any EP, eligible hospital, or CAH purposefully general in our use of the and Enhanced Health Information
meeting one or more of the following term ‘‘specialized registry’’ (other than a Exchange’’ (79 FR 54468) and we
criteria may be excluded from the case cancer registry) to encompass both provided EPs the option to select the
reporting measure if the EP, eligible registry reporting to public health cancer case reporting menu objective in
hospital, or CAH: (1) Does not treat or agencies and clinical data registries in the Stage 2 final rule (77 FR 54029
diagnose any reportable diseases for order to prevent inadvertent exclusion through 54030). We included cancer
which data is collected by their of certain registries through an attempt registry reporting as a separate objective
jurisdiction’s reportable disease system to be more specific (77 FR 54030). In from specialized registry reporting
during the EHR reporting period; (2) response to insight gained from the because it was more mature in its
operates in a jurisdiction for which no industry through listening sessions, development than other registry types,
public health agency is capable of public forums, and responses to the not because other reporting was
receiving electronic case reporting data February 2014 Public Health Reporting intended to be excluded from
in the specific standards required to Request for Information, we proposed to meaningful use. For the Stage 3 public
meet the CEHRT definition at the start carry forward the concept behind this health registry reporting measure, given
of the EHR reporting period; or (3) broad category from Stage 2, but also the desire to provide more flexible
operates in a jurisdiction where no proposed to split public health registry options for providers to report to the
public health agency has declared reporting from clinical data registry registries most applicable for their scope
readiness to receive electronic case reporting into two separate measures of practice, we proposed that EPs would
reporting data at the start of the EHR which better define the potential types have the option of counting cancer case
reporting period. of registries available for reporting. We reporting under the public health
Comment: For Measure 3, proposed to define a ‘‘public health registry reporting measure. We noted
commenters overwhelmingly supported registry’’ as a registry that is that cancer case reporting is not an
the need for electronic case reporting. administered by, or on behalf of, a local, option for eligible hospitals and CAHs
Many comments expressed concern state, territorial, or national public under this measure because hospitals
with the standards referenced and the health agency and which collects data have traditionally diagnosed or treated
immaturity to perform these functions, for public health purposes. While cancers and have the infrastructure
especially the ability of public health immunization registries are a type of needed to report cancer cases.
jurisdictions to accept data during the public health registry, we proposed to Proposed Exclusions for Measure 4:
EHR Incentive program for 2015 through keep immunization registry reporting Any EP, eligible hospital, or CAH
2017. Some commenters noted their separate from the public health registry meeting at least one of the following
support for case reporting, including its reporting measure to retain continuity criteria may be excluded from the
potential impact on patient outcomes from Stage 1 and 2 policy in which public health registry reporting measure
and the use of data elements for immunization registry reporting was a if the EP, eligible hospital, or CAH: (1)
reporting. Another commenter distinct and separate objective (77 FR Does not diagnose or directly treat any
supported the measure, but noted the 54023). We believe it is important to disease or condition associated with a
importance of ensuring high quality retain the public health registry public health registry in their
data and sufficient funding for public reporting option for Stage 3 because jurisdiction during the EHR reporting
health agencies to accept data these registries allow the public health period; (2) operates in a jurisdiction for
transmissions. community to monitor health and which no public health agency is
Response: We note that we did not disease trends, and inform the capable of accepting electronic registry
finalize the case reporting option for the development of programs and policy for transactions in the specific standards
EHR Incentive Program in 2015 through population and community health required to meet the CEHRT definition
2017 to allow additional time for the improvement. at the start of the EHR reporting period;
development of the technology and We reiterated that any EP, eligible or (3) operates in a jurisdiction where
infrastructure to support the measure. hospital, or CAH may report to more no public health registry for which the
We also, as described elsewhere in this than one public health registry to meet EP, eligible hospital, or CAH is eligible
final rule with comment period and as the total number of required measures has declared readiness to receive
noted in the Stage 2 final rule, we did for the objective. For example, if a electronic registry transactions at the
allow case reporting to continue to provider meets this measure through beginning of the EHR reporting period.
Comment: Many commenters noted states that already designated • Example 2, EPs would not receive
their support for public health registries. specialized registries in Stage 2. credit for case reporting under the
Commenters appreciated the flexibility Another commenter expressed concern Specialized Registry measure in Stage 3
and additional means to meet the that without a special provision in place for production data submission that
measure, which they noted, aids in Stage 3, some of the existing started in Modified Stage 2; rather the
specialists. Nearly all commenters specialized registries would not meet EPs would need to be in active
expressed specific support for the the requirements for Stage 3. engagement with the public health
Centralized Readiness Repository noting Response: We understand the agency under the Case Reporting
that it is essential for providers to concerns raised by these providers. The Measure using the standards mandated
determine if they can attest to the specialized registry provision included in the 2015 Edition Certification
measure if they should take an in the Stage 2 final rule was developed Criteria.
exclusion. Commenters also noted the to provide additional flexibility to In future years, as standards are
specific content that should be available providers to choose a registry best developed and referenced in future ONC
within the Centralized Readiness suited for their practice. Many public regulations, CMS may require further
Repository. health jurisdictions began to accept specialized registries to meet these
Response: We appreciate the overall electronic case reporting and future requirements under the ONC
support for this measure. We agree that prescription drug monitoring during Health IT Certification Program.
this measure offers flexibility for previous stages of meaningful use and Proposed Measure 5—Clinical Data
specialists and as other public health these reporting options were considered Registry Reporting: The EP, eligible
registry standards mature, additional specialized registries. We want to hospital, or CAH is in active
options will be available. We also continue to encourage those providers engagement to submit data to a clinical
appreciate the support for the who have already started down the path data registry.
Centralized Readiness Repository and As discussed in the Public Health
of reporting to a specialized registry as
will make note of the specific Registry Reporting measure, in the Stage
part of their participation in Stage 2.
requirements made by commenters, 3 proposed rule (80 FR 16766) we
Therefore, we will allow such
including the requirement for national proposed to split specialized registry
specialized registries to be counted for
as well as local and state public health reporting into two separate, clearly
purposes of reporting to this objective in
registries. defined measures: Public health registry
Stage 3 under the public health registry
Comment: Some commenters noted reporting and clinical data registry
reporting measure for Stage 3 in 2017,
that there were no public health reporting. In Stage 2 for EPs, reporting
2018 and subsequent years in the
registries available for their specialty or to specialized registries is a menu
following manner: A provider may
that their state may not be ready to objective and this menu objective
count a specialized registry if the
receive data for the registries includes reporting to clinical data
provider achieved the phase of active
appropriate for them. Commenters were registries. For Stage 3, we proposed to
engagement defined under Active
concerned that they would not be able include clinical data registry reporting
Engagement Option 3: Production,
to meet this measure because of a lack as an independent measure. The
including production data submission
of public health registries available to National Quality Registry Network
with the specialized registry in a prior
them. defines clinical data registries as those
Response: We appreciate the year under the applicable requirements
that record information about the health
comments. We note that providers may of the EHR Incentive Programs in 2015
status of patients and the health care
exclude from the public health registry through 2017. We do note that reporting
they receive over varying periods of
as noted in the exclusions if there are no to specialized registries does not require
time.20 We proposed to further
public health registries available. certification under the ONC Health IT
differentiate between clinical data
Providers can still meet the overall Certification Program or adherence to
registries and public health registries as
objective by choosing other measures or specific implementation guides for
follows: For the purposes of meaningful
excluding out of other measures. reporting in 2015 through 2017, and we
use, ‘‘public health registries’’ are those
Comment: Many commenters noted direct readers to section aII.B.2.b.x for
administered by, or on behalf of, a local,
that public health would not be further information on the Specialized
state, territorial, or national public
providing data back as part of the public Registry Reporting measure for 2015
health agencies; and ‘‘clinical data
health registries. through 2017.
registries’’ are administered by, or on
Response: We appreciate the However we note that providers behalf of, other non-public health
comments on the bi-directional would not be able to count production agency entities. We believe that clinical
component of public health registries. reporting to a specialized registry under data registries are important for
We encourage associations to work with the Public Health Reporting Objective providing information that can inform
their public health colleagues to for 2015 through 2017, if there are patients and their providers on the best
maximize the use of data flowing into, standards and requirements referenced course of treatment and for care
and out of, public health registries. in the ONC 2015 Edition regulations for improvements, and can support
Comment: Many commenters Public Health and Clinical Data Registry specialty reporting by developing
expressed concern that under the Stage 3 Measures: reporting for areas not usually covered
proposal, specialized registries included • Example 1, EPs would not receive by public health agencies but that are
in the Stage 2 final rule would not be credit for cancer reporting under the important to a specialist’s provision of
available as a measure option for Specialized Registry measure in Stage 3; care. Clinical data registries can also be
eligible providers seeking to attest to rather the EPs would need to be in used to monitor health care quality and
Stage 3. A commenter noted that the active engagement with the public resource use.
addition of specific standards for health agency under the Public Health In the Stage 3 proposed rule, we
reporting to public health registries and Registry Measure to submit cancer case reiterated that any EP, eligible hospital,
clinical data registries is a change from data to the PHA using the standards
the specialized registry objective in mandated in the 2015 Edition 20 https://download.ama-assn.org/resources/doc/
Stage 2 and may pose a problem for Certification Criteria. cqi/x-pub/nqrn-what-is-clinical-data-registry.pdf.
or CAH may report to more than one Response: Our definition of works for them. For example, the public
clinical data registry to meet the total jurisdiction here is general, and the health agency and clinical data registry
number of required measures for this scope may be local, state, regional or at measure does not limit the provider to
objective. We further noted that ONC the national level. The definition will be a predetermined list of reporting
will consider the adoption of standards dependent on the type of registry to options. Rather, these two measures
and implementation guides in future which the provider is reporting. A allow a provider to consider a broad
rulemaking and should these be registry that is ‘‘borderless’’ would be array of reporting options available from
finalized, they may then be adopted as considered a registry at the national public health agencies and clinical data
part of the certified EHR technology level and would be included for registries and allows for reporting
definition as it relates to meeting the purposes of this measure. options developed in the future to be
clinical data registry reporting measure Comment: Some commenters noted used to meet this measure. Considering
through future rulemaking for the EHR that there were no clinical data the multiple ways and the flexibility
Incentive Programs. registries available for the specialty or included in this objective, we do not
Proposed Exclusions for Measure 5: that their state may not be ready to believe that additional exclusions are
Any EP, eligible hospital, or CAH receive data for the registries necessary. We believe that the
meeting at least one of the following appropriate for them. Commenters were requirements for exclusions under this
criteria may be excluded from the concerned that they would not be able objective strike the right balance to
clinical data registry reporting measure to meet this measure because of a lack ensure that a provider seeking to
if the EP, eligible hospital, or CAH: (1) of clinical data registries available to exclude from a measure is unable to
Does not diagnose or directly treat any them. meet the requirements of the measure.
disease or condition associated with a Response: We appreciate the Proposed Measure 6—Electronic
clinical data registry in their jurisdiction comments. We note that providers may Reportable Laboratory Result Reporting:
during the EHR reporting period; (2) exclude from the clinical data registry as The eligible hospital or CAH is in active
operates in a jurisdiction for which no noted in the exclusions; if there are no engagement with a public health agency
clinical data registry is capable of clinical data registries available, to submit electronic reportable
accepting electronic registry providers can exclude from this laboratory results. This measure is
transactions in the specific standards measure. Providers can still meet the available to eligible hospitals and CAHs
required to meet the CEHRT definition overall objective by choosing other only. Electronic reportable laboratory
at the start of the EHR reporting period; measures or excluding out of other result reporting to public health
or (3) operates in a jurisdiction where measures. agencies is required for eligible
no clinical data registry for which the Comment: Many comments noted that hospitals and CAHs in Stage 2 (77 FR
EP, eligible hospital, or CAH is eligible organizations hosting clinical data 54021). We proposed to retain this
has declared readiness to receive registries would not be providing data measure for Stage 3 to promote the
electronic registry transactions at the back as part of the measure. exchange of laboratory results between
beginning of the EHR reporting period. Response: We appreciate the eligible hospitals/CAHs and public
Comment: Many commenters noted comments on the bi-directional health agencies for improved timeliness,
their support for clinical data registries. component of clinical data registries. reduction of manual data entry errors,
Commenters appreciated the flexibility We encourage all stakeholders to work and more complete information.
and additional means to meet the with their clinical data registry Proposed Exclusion for Measure 6:
measure, which they noted aids colleagues to maximize the use of data Any eligible hospital or CAH meeting
specialists. Nearly all commenters flowing into, and out of, clinical data one or more of the following criteria
expressed specific support for the registries. may be excluded from the electronic
Centralized Readiness Repository noting Comment: Many commenters noted reportable laboratory result reporting
that it is essential for providers to that better exclusion criteria should measure if the eligible hospital or CAH:
determine if they can attest to the exist for providers in jurisdictions with (1) Does not perform or order laboratory
measure of if they should take an limited options for reporting and in tests that are reportable in their
exclusion. Commenters also noted the cases where registries are not able to jurisdiction during the EHR reporting
specific content that should be available receive data. A commenter suggested period; (2) operates in a jurisdiction for
within the Centralized Readiness that CMS consider allowing exclusions which no public health agency is
Repository. for providers in states where electronic capable of accepting the specific ELR
Response: We appreciate the overall reporting is not possible. Other standards required to meet the CEHRT
support for this measure. We agree that commenters noted that specialists and definition at the start of the EHR
this measure offers flexibility for other providers who do not perform reporting period; or (3) operates in a
specialists and as other clinical data specific types of reporting should have jurisdiction where no public health
registry standards mature, additional better ways to exclude out of the agency has declared readiness to receive
options will be available. We also applicable measures. Another electronic reportable laboratory results
appreciate the support for the commenter noted that for orthopedic from an eligible hospital or CAH at the
Centralized Readiness Repository and surgeons, there are few clinical data start of the EHR reporting period.
will make note of the specific registry reporting options. Comment: For Measure 6, Electronic
requirements made by commenters, Response: We believe that the Reportable Laboratory Result Reporting,
including the requirement for national measure and associated exclusions that commenters agreed with the
as well as local and state public health we have proposed provide a variety of continuation of this measure, but
registries. options for providers to successfully requested that it also be included as an
Comment: A commenter noted that attest or as appropriate be excluded option for EPs with in-house
since an increasing number of clinical from the measure. We note that the laboratories.
data registries are national in scope and measure framework allows for multiple Response: We thank commenters for
are essentially ‘‘borderless,’’ it is unclear ways to achieve successful attestation their support of this measure. However,
how CMS would define a provider’s under this objective, and allow for a we do not agree that this measure
‘‘jurisdiction.’’ provider to find a reporting option that should be extended to EPs. We note that
in-house laboratories of EPs do not for use in 2015 through 2017 and for reporting period; or (3) operates in a
typically perform the types of tests that Stage 3 in 2017, 2018 and subsequent jurisdiction where no immunization
are reportable to public health years. registry or immunization information
jurisdictions. For example, many in- After consideration of public system has declared readiness to receive
house laboratories focus on tests such as comment received, we are finalizing the immunization data as of 6 months prior
rapid strep tests that test for strep throat. objectives, measures, and exclusions as to the start of the EHR reporting period.
The rapid strep tests are not reportable proposed except for the items Measure 2—Syndromic Surveillance
to public health agencies. previously discussed in this section. Reporting: The EP, eligible hospital, or
Specifically we are adopting CAH is in active engagement with a
Use of CEHRT for Public Health and modifications to include the 6 month public health agency to submit
Clinical Data Registry Reporting lead time for the declaration of syndromic surveillance data from an
Objective readiness for all exclusions for all 6 urgent care setting.
As proposed previously, the Public measures, to clarify the setting Exclusion for EPs for Measure 2: Any
Health and Clinical Data Registry specificity for syndromic surveillance EP meeting one or more of the following
Reporting objective requires active reporting, and to specify electronic case criteria may be excluded from the
engagement with a public health agency reporting, We are finalizing a total of 6 syndromic surveillance reporting
to submit electronic public health data measures for this objective, and EPs measure if the EP: (1) Is not in a
from certified EHR technology. ONC would be required to choose from category of providers from which
defined the standards and certification measures 1 through 5, and would be ambulatory syndromic surveillance data
criteria to meet the definition of CEHRT required to successfully attest to any is collected by their jurisdiction’s
in its 2011, 2014, and 2014 Release 2 combination of two measures. Eligible syndromic surveillance system; (2)
Edition EHR certification criteria rules hospitals and CAHs would be required operates in a jurisdiction for which no
(see section II.B. of the ‘‘2014 Edition, to choose from measures one through public health agency is capable of
Release 2 EHR Certification Criteria and six, and would be required to receiving electronic syndromic
the ONC HIT Certification Program; successfully attest to any combination of surveillance data from EPs in the
Regulatory Flexibilities, Improvements, four measures. We are finalizing that specific standards required to meet the
and Enhanced Health Information providers may attest to measure 4 and CEHRT definition at the start of the EHR
Exchange’’ for a full description of measure 5 more than once, and that an reporting period; or (3) operates in a
ONC’s regulatory history (79 FR 54434)). exclusion to a measure does not count jurisdiction where no public health
For example, ONC adopted standards toward the total in the manner agency has declared readiness to receive
for immunization reporting (see proposed. The final objective and syndromic surveillance data from EPs as
§ 170.314(f)(1) and (f)(2)), inpatient measures are as follows: of 6 months prior to the start of the EHR
syndromic surveillance (see reporting period.
§ 170.314(f)(3) and (f)(7)), ELR (see Objective 8: Public Health and Clinical Exclusion for eligible hospitals/CAHs
§ 170.314(f)(4)), and cancer case Data Registry Reporting for Measure 2: Any eligible hospital or
reporting (see § 170.314(f)(5) and (f)(6)) Objective: The EP, eligible hospital, or CAH meeting one or more of the
in its 2014 Edition final rule. CAH is in active engagement with a following criteria may be excluded from
We support ONC’s intent to promote public health agency or clinical data the syndromic surveillance reporting
standardized and interoperable registry to submit electronic public measure if the eligible hospital or CAH:
exchange of public health data across health data in a meaningful way using (1) Does not have an emergency or
the country. Therefore, to meet all of the certified EHR technology, except where urgent care department; (2) operates in
measures within this public health prohibited, and in accordance with a jurisdiction for which no public health
objective EPs, eligible hospitals, and applicable law and practice. agency is capable of receiving electronic
CAHs must use CEHRT as we proposed Measure 1—Immunization Registry syndromic surveillance data from
to define it under § 495.4 in the Reporting: The EP, eligible hospital, or eligible hospitals or CAHs in the
proposed rule and use the standards CAH is in active engagement with a specific standards required to meet the
included in the 2015 Edition proposed public health agency to submit CEHRT definition at the start of the EHR
rule. We anticipate that as new public immunization data and receive reporting period; or (3) operates in a
health registries and clinical data immunization forecasts and histories jurisdiction where no public health
registries are created, ONC and CMS from the public health immunization agency has declared readiness to receive
will work with the public health registry/immunization information syndromic surveillance data from
community and clinical specialty system (IIS). eligible hospitals or CAHs as of 6
societies to develop ONC-certified Exclusion for Measure 1: Any EP, months prior to the start of the EHR
electronic reporting standards for those eligible hospital, or CAH meeting one or reporting period.
registries so that providers have the more of the following criteria may be Measure 3—Electronic Case
option to count participation in those excluded from the immunization Reporting: The EP, eligible hospital, or
registries under the measures of this registry reporting measure if the EP, CAH is in active engagement with a
objective. ONC will look to adopt such eligible hospital, or CAH: (1) Does not public health agency to submit case
standards, as appropriate, in future administer any immunizations to any of reporting of reportable conditions.
rulemaking. the populations for which data is Exclusion for Measure 3: Any EP,
Comment: Many commenters collected by their jurisdiction’s eligible hospital, or CAH meeting one or
requested clarification of the CEHRT immunization registry or immunization more of the following criteria may be
specifications for each measure. information system during the EHR excluded from the case reporting
Response: We thank the commenters reporting period; (2) operates in a measure if the EP, eligible hospital, or
for these comments and refer readers to jurisdiction for which no immunization CAH: (1) Does not treat or diagnose any
section II.B.3 for a discussion of the registry or immunization information reportable diseases for which data is
definition of CEHRT and a table system is capable of accepting the collected by their jurisdiction’s
referencing the certification criteria specific standards required to meet the reportable disease system during the
required for each objective and measure CEHRT definition at the start of the EHR EHR reporting period; (2) operates in a
jurisdiction for which no public health electronic registry transactions as of 6 Exclusion for Measure 6: Any eligible
agency is capable of receiving electronic months prior to the start of the EHR hospital or CAH meeting one or more of
case reporting data in the specific reporting period. the following criteria may be excluded
standards required to meet the CEHRT Measure 5—Clinical Data Registry from the electronic reportable laboratory
definition at the start of the EHR Reporting: The EP, eligible hospital, or result reporting measure if the eligible
reporting period; or (3) operates in a CAH is in active engagement to submit hospital or CAH: (1) Does not perform
jurisdiction where no public health data to a clinical data registry. or order laboratory tests that are
agency has declared readiness to receive Proposed Exclusions for Measure 5: reportable in their jurisdiction during
electronic case reporting data as of 6 Any EP, eligible hospital, or CAH the EHR reporting period; (2) operates in
months prior to the start of the EHR meeting at least one of the following a jurisdiction for which no public health
reporting period. criteria may be excluded from the agency is capable of accepting the
Measure 4—Public Health Registry clinical data registry reporting measure specific ELR standards required to meet
Reporting: The EP, eligible hospital, or if the EP, eligible hospital, or CAH: (1) the CEHRT definition at the start of the
CAH is in active engagement with a Does not diagnose or directly treat any EHR reporting period; or (3) operates in
public health agency to submit data to disease or condition associated with a a jurisdiction where no public health
public health registries. clinical data registry in their jurisdiction agency has declared readiness to receive
Exclusions for Measure 4: Any EP, during the EHR reporting period; (2) electronic reportable laboratory results
eligible hospital, or CAH meeting at operates in a jurisdiction for which no from an eligible hospital or CAH as of
least one of the following criteria may clinical data registry is capable of 6 months prior to the start of the EHR
be excluded from the public health accepting electronic registry reporting period.
registry reporting measure if the EP, transactions in the specific standards We are adopting Objective 8: Public
eligible hospital, or CAH: (1) Does not required to meet the CEHRT definition Health and Clinical Data Registry
diagnose or directly treat any disease or at the start of the EHR reporting period; Reporting at § 495.24(d)(8)(i) for EPs and
condition associated with a public or (3) operates in a jurisdiction where § 495.24(d)(8)(ii) for eligible hospitals
health registry in their jurisdiction no clinical data registry for which the and CAHs. We further specify that in
during the EHR reporting period; (2) EP, eligible hospital, or CAH is eligible order to meet this objective and
operates in a jurisdiction for which no has declared readiness to receive measures, an EP, eligible hospital, or
public health agency is capable of electronic registry transactions as of 6 CAH must use the capabilities and
accepting electronic registry months prior to the start of the EHR standards of as defined for as defined
transactions in the specific standards reporting period. CEHRT at § 495.4. We direct readers to
required to meet the CEHRT definition Measure 6—Electronic Reportable section II.B.3 of this final rule with
at the start of the EHR reporting period; Laboratory Result Reporting: The comment period for a discussion of the
or (3) operates in a jurisdiction where eligible hospital or CAH is in active definition of CEHRT and a table
no public health registry for which the engagement with a public health agency referencing the capabilities and
EP, eligible hospital, or CAH is eligible to submit electronic reportable standards that must be used for each
has declared readiness to receive laboratory results. measure.
Maximum
times measure can count
can count towards
Measure towards objective
objective for eligible
for EP hospital or
CAH
Measure 1—Immunization Registry Reporting ........................................................................................................ 1 1

Measure 2—Syndromic Surveillance Reporting ...................................................................................................... 1 1
Measure 3—Case Reporting ................................................................................................................................... 1 1
Measure 4—Public Health Registry Reporting* ...................................................................................................... 2 4
Measure 5—Clinical Data Registry Reporting** ...................................................................................................... 2 4
Measure 6—Electronic Reportable Laboratory Results .......................................................................................... N/A 1
meet the objective. A specialized registry to which the EP, eligible hospital or CAH reported using Active Engagement Option 3: Production in a
prior year under the EHR Incentive Programs in 2015 through 2017 public health reporting objective may also count toward the measure in 2017,
2018 and subsequent years.
meet the objective.
3. Certified EHR Technology (CEHRT) measures. The Stage 2 final rule requires with 45 CFR 170.314(c)(1) and
Requirements that CEHRT must be used by EPs, ‘‘electronic submission’’ in accordance
a. CEHRT Definition for the EHR eligible hospitals, and CAHs to satisfy with 45 CFR 170.314(c)(3) (77 FR
Incentive Programs their CQM reporting requirements in the 54053). Certified EHR technology is
Medicare and Medicaid EHR Incentive defined for the Medicare and Medicaid
The definition of CEHRT establishes Programs. In addition, the CQM data EHR Incentive Programs at 42 CFR 495.4
the requirements for EHR technology reported to CMS must originate from and previously referenced ONC’s
that must be used by providers to meet EHR technology that is certified to definition of CEHRT in 45 CFR 170.102.
the meaningful use objectives and ‘‘capture and export’’ in accordance
In the Stage 3 proposed rule 80 FR multiple options for HIE transport, and increase confusion. A commenter noted
16767, rather than establishing a in this final rule with comment period, that the Stage 3 proposed rule reference
specific CEHRT definition for the EHR we have further expanded the to ‘‘certified EHR technology’’ conflicts
Incentive Programs in the ONC 2015 mechanisms by which a provider can with use of the term ‘‘health information
Edition proposed rule, we instead send and receive a C–CDA. We maintain technology’’ in the 2015 Edition
proposed to define the term ‘‘Certified that the C–CDA standard is required, proposed rule.
EHR Technology’’ at § 495.4. This and that a single C–CDA standard serves Several commenters addressed
proposed change is designed to simplify to support the interoperable exchange of proposals specific to the Health IT
the overall regulatory relationship health information. Certification Program, the scope and
between ONC and CMS rules for Comment: Many commenters focus of the certification criteria and
stakeholders and to ensure that relevant supported the proposal to allow standards for health IT under
CMS policy for the Medicare and providers to upgrade to the 2015 Edition consideration by the ONC, testing of
Medicaid EHR Incentive Programs is at their own pace with an allowance for health IT systems presented for
clearly defined in CMS regulations. early upgrades in 2016 and 2017. certification to ONC, and the specifics
We also proposed that providers must Commenters noted that with the on how the newly created
use EHR technology certified at least to modular certification process, providers interoperability standards apply to the
the 2014 Edition in 2016 and 2017. We may be able to update parts of systems certification process.
further proposed that providers may beginning in late 2016 so the allowance Response: CMS, in consultation with
adopt EHR technology certified to the for technology certified to a ONC, believes that placing the CEHRT
2015 Edition prior to the beginning of combination of Editions is necessary. definition in the Stage 3 rule increases
Stage 3 in 2017 or 2018, and that Most commenters noted that, given the the simplicity of the rule. We do not
technology could be used to satisfy the timing, it is unlikely that technology believe that moving the CEHRT
definition of CEHRT under § 495.4 to certified to the 2015 Edition will be definition will lead to program
demonstrate meaningful use (80 FR widely available in time to participate confusion. Rather, by placing the
16767 through 16768). in Stage 3 in 2017 and expressed requirements of the CEHRT definition
Comment: Some commenters support of the flexibility to select a stage
within the rule that it impacts—the
suggested potential changes to the in 2017. Other commenters expressed
Stage 3 rule—we avoid confusion
certification program. Some commenters concern citing the same reasons and
suggested the current EHR incentive regarding the scope of the CEHRT
noted that the time between publication
programs mandate the use of certified definition (which is limited to EHR
and implementation of the requirements
EHRs that incorporate draft standards to Incentive Program participants) and the
of the Stage 3 final rule is too short to
support program requirements, broader scope of the ONC Health IT
require 2015 Edition and Stage 3 in
including the exchange of health Certification Program (which applies to
2017. Some commenters suggested that
information among clinicians and the EHR Incentive Program participants and
18 months is required for the transition
format of the content exchanged. others, and may be used by other HHS
and suggested making Stage 3 optional
Inconsistency in the implementation of in 2018 or further delaying Stage 3 to programs). We believe that placing the
the standards by vendors has led to support the upgrade timing. CEHRT definition within the Stage 3
confusion and limited provider success Response: We thank the commenters rule is appropriate and CMS will
in meeting regulatory requirements for for their input and agree that the shift continue to work closely with ONC on
information exchange. For example, should allow for greater flexibility in the the certification requirements that
Stage 2 of meaningful use established a upgrade process for developers and would be needed to support the
reliance on the ‘‘direct protocol,’’ a new providers. We note that we have objectives and measures of the EHR
standard to support the sharing of changed the EHR reporting period in Incentive Programs. In addition, we are
information. As a result of inconsistent 2017 to 90 days for providers who committed to releasing educational
implementation among EHR vendors, choose to participate in Stage 3, which materials that will ease the transition
the ability to use the direct protocol allows a longer time frame between the related to the move of the CEHRT
standard to enable information publication of the final rules and definition and, as requested by many
exchange varies. For example, providers implementation of systems capable of commenters, have included a chart that
are required to use the C–CDA standard supporting the Stage 3 objectives and outlines the certification criteria that
to send patient care summaries in a measures. We also note that many of the will support providers who intend to
structured template. However, the C– standards required for Stage 3 are attest to Stage 3 of meaningful use.
CDA has proved difficult to use and has similar or the same in 2014 and 2015 Regarding references in to ‘‘health
not met clinical needs to share pertinent Edition certification criteria. Finally, we IT,’’ we do not agree that the use of the
information to support care. Finally, one reiterate the requirement that providers term ‘‘health IT’’ and the use of the term
commenter stated that given the use the 2015 Edition in 2018 to meet the ‘‘certified EHR technology’’ is evidence
complexity of the objectives proposed requirements for Stage 3 for an EHR of a disconnect between the Stage 3 and
under Stage 3, we believe meaningful reporting period in 2018 and note that the ONC Health IT Certification
use of EHRs can only be achieved if and this timing also allows more than 24 Program. Rather, certified EHR
when data captured in various EHRs months to the requirement to use technology is one type of health IT and
and other data systems are technology certified to the 2015 Edition is mandated required by the HITECH
interoperable. for an EHR reporting period in 2018. Act as part of for purposes of meeting
Response: We refer commenters to the Comment: Some commenters attestation requirements and becoming a
ONC 2015 Edition certification criteria expressed support for our decision to meaningful user. The ONC Health IT
final rule published elsewhere in this move the CEHRT definition from the Certification Program and the associated
Federal Register for the established ONC certification criteria rules to the 2015 Edition final rule provides
standards for certified health IT (see EHR Incentive Programs rule. Other certification criteria and standards
also the 2015 Edition proposed rule at commenters expressed concern integral to the CEHRT definition for
80 FR 16813 through 16872). We note regarding whether moving the CEHRT Stage 3, but also is designed to address
that in the Stage 2 rule we adopted definition to the Stage 3 rule would the needs of a broader set of settings that
use health IT functionality beyond the upgrade to the 2015 Edition prior to technology certified by the ONC Health
requirements of the CEHRT definition. 2018 to meet the required certified EHR IT Certification Program to meet
Finally, comments related to the technology definition for the EHR requirements of CMS’ chronic care
specific certification criteria proposed reporting periods in 2015, 2016, or management program would not need
in the 2015 Edition proposed rule are 2017, or they may use a combination of the automated numerator recording and
outside the scope of this rulemaking. 2014 and 2015 Editions prior to 2018 if measure calculation. ONC has sought to
We direct commenters to the 2015 they have modules from both Editions avoid requiring non-EHR Incentive
Edition proposed rule published on which that meet the requirements for Program participants to possess
March 30, 2015. (80 FR 16804 through the objectives and measures or if they technology with the criteria previously
16921) and the 2015 Edition final rule fully upgrade during an EHR reporting stated in this final rule with comment
published elsewhere in this Federal period. period. Therefore, the 2015 Edition
Register. Additionally, because ONC proposed, proposed and final rule includes the
After consideration of public for the 2015 Edition, to no longer criteria for developers who intend to
comments received, we are finalizing require certification of Health IT certify their products for use by EHR
the provision to include a full EHR Modules to capabilities that support Incentive Program providers, but it does
Incentive Programs specific definition of meaningful use objectives with not make such criteria requirements for
CEHRT at 495.4 as proposed. percentage-based measures, we all technology certified under the ONC
b. Defining CEHRT for 2015 Through proposed to include these capabilities Health IT Certification Program.
2017 (45 CFR 170.314(g)(1) or (2) or 45 CFR Comment: Some commenters
170.315(g)(1) or (2)), as applicable, in requested clarification on whether 2014
In adopting a CEHRT definition the CEHRT definition for 2015 through Edition or 2015 Edition (or both) could
specific for the EHR Incentive Programs, 2017, so that providers have technology be used to attest to meaningful use in
we proposed in the EHR Incentive that can appropriately record and 2015 through 2017.
Programs in the Stage 3 proposed rule calculate meaningful use measures. In Response: We clarify as follows:
80 FR 16767 to include, as currently for the EHR Incentive Program in the Stage For EHR reporting periods in 2017:
the ONC CEHRT definition under 45 3 proposed rule, we noted that there are • A provider who has technology
CFR 170.102, the relevant Base EHR many combinations of 2014 and 2015 certified to the 2015 Edition may attest
definitions adopted by ONC in 45 CFR Edition certified technologies that could to Stage 3 or to the modified Stage 2
170.102 and other ONC certification be used to successfully meet the requirements identified elsewhere in
criteria relevant to the EHR Incentive transitions of care requirements this rule.
Programs. We referred readers to ONC’s included in the 2014 and 2015 Edition • A provider who has technology
2015 Edition proposed rule for the Base EHR definitions for the purposes of certified to a combination of 2015
proposed 2015 Edition Base EHR meeting meaningful use objectives and Edition and 2014 Edition may attest to:
definition and a discussion of the 2014 measures. We explained that we believe (1) The modified Stage 2 requirements;
Edition Base EHR definition. We we have identified all combinations in or (2) potentially to the Stage 3
included the Base EHR definition(s) the proposed regulation text under requirements if the mix of certified
because, as ONC explained in the 2014 § 495.4 that could be used to meet the technologies would not prohibit them
Edition certification final rule (77 FR CEHRT definition through 2017 and be from meeting the Stage 3 measures.
54443 through 54444), the ‘‘Base EHR’’ used for the purposes of meeting • A provider who has technology
essentially serves as a substitute for the meaningful use objectives and certified to the 2014 Edition only may
term ‘‘Qualified EHR’’ in the definition measures. We sought comments on the attest to the modified Stage 2
of CEHRT. The term ‘‘Qualified EHR’’ is accuracy of the identified available requirements and may not attest to Stage
defined in section 3000(13) of the Public options. We received the following 3.
Health Service Act (PHSA), to include comments and our responses follow: For EHR reporting periods in 2018:
certain capabilities listed in that section, Comment: Some commenters • All providers must use technology
and is included in the statutory expressed concern that there is a certified to the 2015 Edition to meet
definition of ‘‘certified EHR technology’’ misalignment between the requirements Stage 3 requirements.
for the EHR Incentive Programs (for of the ONC Health IT Certification Comment: Commenters expressed
example, see section 1848(o)(4) of the Program and the objectives and concern that it is unclear whether
Act). The Base EHR definition(s) also measures of Stage 3. Specifically, the technology that is certified only to the
includes additional capabilities as commenter noted that though the Base EHR definition is adequate for
proposed by ONC that we agreed all automated numerator recording and purposes of attesting to meaningful use.
providers should have that are measure calculation are not required for Another commenter suggested that the
participating in the EHR Incentive a module to be certified to the 2015 ‘‘Base certified EHRs’’ should be fully
Programs to support their attempts to Edition, it is required for Stage 3. capable of meeting the needs of an EHR
meet meaningful use objectives and Response: The automated numerator Incentive Program participant, without
measures, as well as to support recording and measure calculation are having to—for example—purchase add-
interoperable health information not requirements of modules seeking ons, interfaces, or pay for reporting.
exchange. certification under the 2015 Edition Some commenters noted that requiring
We also proposed to define the final rule. However, this does not providers to attest to meaningful use
editions of certification criteria that may represent a misalignment between the using technology certified to the 2015
be used for years 2015 through 2017 to ONC Health IT Certification Program Edition Base EHR definition will result
meet the CEHRT definition. At a and the EHR Incentive Programs. in providers having to possess software
minimum, EPs, eligible hospitals, and Rather, the two criteria are required for that is not necessary to that provider
CAHs would be required to use EHR purposes of meeting meaningful use, but achieving meaningful use.
technology certified to the 2014 Edition may not be necessary for other users of Response: Technology that is certified
certification criteria for their respective the ONC’s Health IT Certification only to the Base EHR definition would
EHR reporting periods in 2015 through Program. For example, a non-EHR not be adequate for purposes of attesting
2017. We stated that a provider may also Incentive Program provider using to meaningful use in any EHR reporting
period. We agree that the components of all privacy and security criteria important capabilities that include the
the Base EHR definition proposed in the included in the 2014 Edition Base EHR capabilities to:
2015 Edition proposed rule are integral definition, expect the ‘‘integrity’’ • Record or create and incorporate
to attesting to meaningful use and criterion. family health history;
include a variety of criteria including, Our proposal did not, however, • Capture patient health information
among others, criteria related to account for the unlikely, but plausible, such as advance directives;
demographics, CPOE, medication scenario where a new entrant to the • Record numerators and
allergy lists and data portability. EHR Incentive Programs in 2016 or 2017 denominators for meaningful use
However, the Base EHR definition does was able to meet the CEHRT definition objectives with percentage-based
not include criteria related to items such for a federal fiscal year or calendar year measures and calculate the percentages;
as public health reporting, electronic before 2018 with EHR technology only • Calculate and report clinical quality
prescribing, and drug-drug/drug-allergy, measures; and
or mostly certified to the 2014 Edition
checks—which also are integral to attest • Any other capabilities needed to be
that did not include the requisite
to meaningful use. a Meaningful EHR User.
privacy and security capabilities which For information on 2015 Edition
The Base EHR definition is designed are part of the 2014 Base EHR
to include specific criteria that would certification criteria that include these
definition. Therefore, we have capabilities and are associated with
apply to a broad cross section of specifically included privacy and
developers seeking to support provider proposed Meaningful Use objectives for
security certification criteria in the Stage 3, we referred readers to the 2015
needs. The Base EHR definition is not definition to guard against this
designed solely for the use of the EHR Edition proposed rule. We noted that we
possibility. expect that the certification criteria with
Incentive Programs. For this reason, a We note that we encourage providers
product that a provider seeks to use to capabilities that support CQM
to work closely with their developers to calculation and reporting would be
attest to meaningful use must be determine what compilation of
certified to the Base EHR definition and jointly proposed with CQM reporting
technology certified under the ONC requirements in a separate rulemaking.
additional criteria that is determined by Health IT Certification Program would
(a) the requirements of this CEHRT Comment: We received a variety of
allow the provider to successfully attest comments on these proposals. Some
definition and (b) the specific objectives to meaningful use in an EHR reporting
and measures the provider intends to commenters agreed that technology
period covered under this rule. We also certified to the 2015 Edition would be
use to meet meaningful use. Therefore,
have provided a chart of the technology developed and could be implemented
we do not believe it is appropriate to
that would be required for a provider by providers by 2018. Other
limit the CEHRT definition to the
seeking to attest to an objective or commenters expressed their concern
criteria included in ONC’s Base EHR
measure (See Table 2, 80 FR 16810 that requiring providers to attest to
definition.
In this final rule with comment through 16811). In addition, we Stage 3 using 2015 Edition technology
period, we have specifically identified encourage providers to review the Web in 2018 was not realistic, and did not
the privacy and security certification site of the ONC Health IT Certification account for the new technology that
criteria that EHR technology must be Program and the Certified Health IT needed to be developed to support the
certified to meet the CEHRT definition Products List (CHPL), which include objectives and measures in Stage 3.
for any federal fiscal year or calendar real time information on what products Some commenters requested that
year before 2018, when an EP, eligible are certified for what functionalities (see providers in 2018 be allowed to use
hospital, or CAH is using EHR certified www.healthit.gov). technology certified to the 2014 Edition
to both the 2014 Edition and 2015 We note that some commenters and the 2015 Edition to meet Stage 3
Edition to meet the definition. expressed concern regarding fraudulent requirements. A commenter expressed a
We proposed provisions in the statements and claims regarding the concern that requiring use of 2015
CEHRT definition for any federal fiscal technology offered to meet meaningful Edition in 2018 may be problematic for
year or calendar year before 2018 that use. We encourage providers to use the certain providers that need radiation
would permit the use of a mix of EHR CHPL as a resource for identifying oncology EHR products. The commenter
technology certified to 2014 and 2015 whether a product is certified and to requested that the 2018 year be a flex
editions. This was designed to account contact ONC if fraudulent activity is year as well as 2017. Another
for providers upgrading from EHR suspected. commenter suggested that making the
technology certified to the 2014 Edition After consideration of public 2015 Edition optional in 2017 could
to the 2015 Edition to meet the comments received, we are finalizing create confusion and that we should
requirements of the CEHRT definition and adopting this provision without simply adopt a single edition.
for 2018 and subsequent years (i.e., the modification at § 495.4. Response: We note that 2017 provides
use of EHR technology only certified to a flex year for providers to fully
c. Defining CEHRT for 2018 and
the 2015 Edition). In most instances, implement their CEHRT. Extending the
Subsequent Years
providers will have certified privacy flex year beyond 2017 would slow
and security capabilities because these In the Stage 3 proposed rule at 80 FR provider progression to updated
capabilities are part of the 2014 Edition 16767, we proposed that starting with technology that better enables
Base EHR definition. The proposal also 2018, all EPs, eligible hospitals, and interoperability, care coordination, and
took into account that the adoption of CAHs would be required to use health information exchange. We
EHR technology certified to the 2015 technology certified to the 2015 Edition appreciate commenters concerns
Edition would likely include most, if to meet the CEHRT definition and to regarding whether technology certified
not, all relevant privacy and security demonstrate meaningful use for an EHR to the 2015 Edition would be ready in
capabilities. For example, EHR reporting period in 2018 and subsequent 2018. Developers have noted that
technology certified only to the 2015 years. The CEHRT definition would between 18 or 24 months is the
Edition CPOE-order medications include, for the reasons discussed necessary to develop and implement
criterion will also be required to be previously, meeting the 2015 Edition health IT technology. With the
certified to the 2015 Edition versions of Base EHR definition and having other finalization of this final rule with
comment period, developers and or Stage 3 Public Health measure using family health history or other patient
providers will have more than 24 reporting options other than syndromic information (such as advanced
months to develop and implement 2015 surveillance reporting. In such a case, directives) is a foundational element of
Edition technology required by this final the provider would not need to possess health IT that we will continue to
rule with comment period. technology certified to ONC’s support. For this reason, we decline to
Further, we note that many of the ‘‘Transmission to Public Health remove family health history or the
requirements of Stage 3 are similar to Agencies—Syndromic Surveillance requirement to capture patient health
those of Stage 2 and would use the same Criterion’’. In contrast, in Stage 3, some information from the CEHRT definition.
certification criteria with slight updates objectives require a provider to attest to Comment: A commenter
to vocabulary standards. For those all three measures but only successfully recommended that the ability to
criteria that are new to meaningful use meet the thresholds of two of the three
automatically query an HIE and retrieve
in Stage 3 or for which significant measures. For such objectives, a
a summary of care document be part of
updates are required, we agree with provider would need to possess certified
developers who confirm that 18 to 24 the definition of CERT. Many current
technology for all three measures for
months provide enough time to develop systems rely on an EP to download a
purposes of attesting. We further note
and implement certified technology for summary of care document from an
that in the case of a provider that meets
purposes of meaningful use. We refer external portal and then manually
the exclusions of a measure, the
readers to section III.A. Table 2 of the upload it into their EHR.
provider is not required to possess
ONC 2015 Edition Certification Criteria technology to meet that measure. Response: This was not a separate
final rule published elsewhere in this We caution providers to carefully functionality that we proposed to be
Federal Register for further information make determinations regarding the part of the CEHRT definition, and we do
on the differences between 2014 Edition technology they will need to attest to not intend to adopt this suggestion as
and 2015 Edition criteria. meaningful use and encourage providers part of the CEHRT definition. However,
We further note that 2018 is the to work closely with their developers to we did propose that to meet the CEHRT
required year for the use of 2015 Edition ensure that the technology they possess definition a provider must have
and for attesting to Stage 3. We will meet their attestation needs. Please technology certified to the ‘‘Transitions
proposed and are finalizing in this rule refer to Tables 11 through 16, which we of Care’’ certification criterion (45 CFR
a 2017 flex year that allows providers have developed in conjunction with 170.315(b)(1)). The criterion requires
options in the edition of CEHRT used ONC of the technology requirements that technology be capable of sending
and the stage of meaningful use to that support the CEHRT definition and and receiving a C–CDA. We believe this
which the provider attests. This each measure in section II.B.3.(d). of will support a provider’s ability to
flexibility is in place in recognition of this final rule with comment period. electronically exchange interoperable
the implementation needed for We also note that the CEHRT health information.
technology. However, by 2018, all definition provides a baseline of
After consideration of public
providers will be required to attest to functionality, but a provider may choose
comments received, we are finalizing
Stage 3 using 2015 Edition technology. to possess technology that goes beyond
Comment: Some commenters and adopting this provision as proposed
the requirements of this CEHRT
requested clarification on if a provider at § 495.4.
definition. We encourage providers to
would be required to be certified to review products available to meet their d. Final Definition of CEHRT
technology needed for measures the needs and to review the Certified Health
provider does not intend to use for IT Products List that is available online To facilitate readers identifying the
attestation or if there is a specific at www.healthit.gov. requirements of CEHRT for each
certification requirement for certain Comment: Some commenters objective and measure defined in
specialties. suggested that providers should not be sections II.B.2.a and II.B.2.b of this final
Response: ONC certifies products not required to possess technology that is rule with comment period, ONC and
by specialty, but by each specific certified to record or create and CMS have developed a set of tables
functionality. In some cases, intended incorporate family health history. providing the appropriate certification
impatient or ambulatory use may be a Response: We do not agree. Family criteria reference under the 2014 Edition
factor in the product a provider chooses health history is an integral component and 2015 Edition certification criteria
to possess. Beyond this distinction, the in the provision of care and the criterion for the objectives and measures of
definition of CEHRT includes the supports the intake of such data into a meaningful use. These tables are
requirements specific to each measure provider’s health IT system. As a result, provided for references purposes and
which may be independently certified care coordination between providers reflect the definition of CEHRT adopted
and a provider may not be required to and between providers and patients is at § 495.4 for each year. We note that
obtain and use functions for which they improved and accessible. The CEHRT providers must also have the
do not intend to attest. We recognize definition includes the baseline of capabilities defined at § 495.4 for
that there are multiple permutations functionality that we believe is clinical quality measures (1)(ii)(B) or
that could lead to a successful necessary to provide better care, (2)(ii)(B), privacy and security (1)(ii)(C)
attestation under the EHR Incentive advance care coordination, and support or (2), and the certification criteria that
Programs. For example, a provider may interoperability. Requiring a provider to are necessary to be a Meaningful EHR
decide to attest to the modified Stage 2 have a system that is able to capture User (1)(ii)(D) or (2)(ii)(A).
TABLE 11—EP OBJECTIVES, MEASURES, AND CERTIFICATION CRITERIA FOR 2015 THROUGH 2017
Objective Measure(s) 2014 edition 2015 edition Additional considerations
Objective 1: Protect Measure: Conduct or review a security risk The requirements are in- The requirements are a The requirements are a part of
Patient Health Infor- analysis in accordance with the require- cluded in the Base EHR part of CEHRT specific CEHRT specific to each certifi-
mation. ments in 45 CFR 164.308(a)(1), including Definition. to each certification cri- cation criterion.
addressing the security (to include terion.
encryption) of ePHI created or maintained
in Certified EHR Technology in accord-
ance with requirements in 45 CFR
164.312(a)(2)(iv) and 45 CFR
164.306(d)(3), and implement security up-
dates as necessary and correct identified
security deficiencies as part of the EP’s
risk management process.
Objective 2: Clinical Measure 1: Implement five clinical decision § 170.314(a)(8) (Clinical § 170.315(a)(9) (Clinical N/A.
Decision Support. support interventions related to four or Decision Support). Decision Support).
more clinical quality measures at a rel-
evant point in patient care for the entire
Measure 2: The EP has enabled and imple- § 170.314(a)(2) (Drug- § 170.315(a)(4) (Drug- N/A.
mented the functionality for drug-drug and drug, Drug-Allergy Inter- drug, Drug-Allergy Inter-
drug-allergy interaction checks for the en- action Checks). action Checks for
tire EHR reporting period. CPOE).
Objective 3: Comput- Measure 1: More than 60% of medication or- § 170.314(a)(1) (Computer- § 170.315(a)(1) (Computer- N/A.
erized Provider ders created by the EP during the EHR re- ized Provider Order ized Provider Order
Order Entry CPOE. porting period are recorded using CPOE. Entry) or Entry—Medications).
§ 170.314(a)(18) (Op-
tional—Computerized
Provider Order Entry—
Medications).
Measure 2: More than 30% of laboratory or- § 170.314(a)(1) (Computer- § 170.315(a)(2) (Computer- N/A.
ders created by the EP during the EHR re- ized Provider Order ized Provider Order
porting period are recorded using CPOE. Entry) or Entry—Laboratory).
§ 170.314(a)(19) (Op-
Laboratory).
Measure 3: More than 30% of radiology or- § 170.314(a)(1) (Computer- § 170.315(a)(3) (Computer- N/A.
ders created by the EP during the EHR re- ized Provider Order ized Provider Order
porting period are recorded using CPOE. Entry) or Entry—Diagnostic Imag-
§ 170.314(a)(20) (Op- ing).
Diagnostic Imaging).
Objective 4: Electronic Measure: More than 50% of all permissible § 170.314(b)(3) (Electronic § 170.315(b)(3) (Electronic EPs may use a combination of
Prescribing. prescriptions written by the EP are queried Prescribing). Prescribing). technologies certified to either
for a drug formulary and transmitted elec- § 170.314(a)(10) (Drug- § 170.315(a)(10) (Drug- the 2014 Edition or 2015 Edi-
tronically using CEHRT. Formulary and Preferred Formulary and Preferred tion.
Drug List Checks). Drug List Checks).
Objective 5: Health In- Measure: The EP that transitions or refers § 170.314(b)(2) (Transi- § 170.315(b)(1) (Transi- N/A.
formation Exchange. their patient to another setting of care or tions of Care-Create and tions of Care).
provider of care (1) uses CEHRT to create Transmit Transition of
a summary of care record; and (2) elec- Care/Referral Sum-
tronically transmits such summary to a re- maries) or
ceiving provider for more than 10% of tran- § 170.314(b)(8) (Optional—
sitions of care and referrals. Transitions of care).
Objective 6: Patient- Measure: Patient-specific education re- § 170.314(a)(15) (Patient- § 170.315(a)(13) (Patient- N/A.
Specific Education. sources identified by CEHRT are provided Specific Education Re- Specific Education Re-
to patients for more than 10% of all unique sources). sources).
Objective 7: Medica- Measure: The EP performs medication rec- § 170.314(b)(4) (Clinical In- § 170.315(b)(2) (Clinical In- N/A.
tion Reconciliation. onciliation for more than 50% of transitions formation Reconciliation) formation Reconciliation
of care in which the patient is transitioned or and Incorporation).
into the care of the EP. § 170.314(b)(9) (Optional—
Clinical Information Rec-
onciliation and Incorpo-
ration).
Objective 8: Patient Measure 1: More than 50%of all unique pa- § 170.314(e)(1) (View, § 170.315(e)(1) (View, N/A.
Electronic Access tients seen by the EP during the EHR re- Download, and Transmit Download, and Transmit
(VDT). porting period are provided timely access to 3rd Party). to 3rd Party).
to view online, download, and transmit to a
third party their health information subject

to the EP’s discretion to withhold certain
information.
TABLE 11—EP OBJECTIVES, MEASURES, AND CERTIFICATION CRITERIA FOR 2015 THROUGH 2017—Continued
Objective Measure(s) 2014 edition 2015 edition Additional considerations
Measure 2: For 2015 and 2016: At least one § 170.314(e)(1) (View, § 170.315(e)(1) (View, N/A.
patient seen by the EP during the EHR re- Download, and Transmit Download, and Transmit
porting period (or his or her authorized to 3rd Party). to 3rd Party).
representatives) views, downloads, or
transmits his or her health information to a
third party, during the EHR reporting pe-
riod.
For 2017: More than 5 percent of unique pa-
tients seen by the EP during the EHR re-
porting period (or their authorized rep-
resentatives) views, downloads, or trans-
mits their health information to a third
party, during the EHR reporting period.
Objective 9: Secure Measure: For 2015: During the EHR report- § 170.314(e)(3) (Secure § 170.315(e)(2) (Secure N/A.
Messaging. ing period the capability for patients to Messaging). Messaging).
send and receive a secure electronic mes-
sage with the EP was fully enabled.
For 2016: For at least 1 patient seen by the
EP during the EHR reporting period, a se-
cure message was sent using the elec-
tronic messaging function of CEHRT to the
patient (or the patient-authorized rep-
resentative), or in response to a secure
message sent by the patient (or the pa-
tient-authorized representative) during the
For 2017: For more than 5 percent of unique
patients seen by the EP during the EHR
reporting period, a secure message was
sent using the electronic messaging func-
tion of CEHRT to the patient (or the pa-
tient-authorized representative), or in re-
sponse to a secure message sent by the
resentative) during the EHR reporting pe-
riod.
Objective 10: Public Measure 1—Immunization Registry Report- § 170.314(f)(1) (Immuniza- N/A .................................... N/A.
Health Reporting. ing. tion Information) and
§ 170.314(f)(2) (Trans-
mission to Immunization
Registries).
Measure 2—Syndromic Surveillance Report- § 170.314(f)(3) (Trans- § 170.315(f)(2) (Trans- N/A.
ing. mission to Public Health mission to Public Health
Agencies—Syndromic Agencies—Syndromic
Surveillance) or Surveillance) Urgent
§ 170.314(f)(7) (Optional— Care Settings Only.
Ambulatory Setting
Only—Transmission to
Public Health Agen-
cies—Syndromic Sur-
veillance).
Measure 3—Specialized Registry Reporting § 170.314(f)(5) (Optional— EPs may choose one or Certified EHR technology is not
Ambulatory Setting more of the following: required for specialized registry
Only—Cancer Case In- § 170.315(f)(5) (Trans- reporting for 2015–2017, but
formation) and mission to Public Health EHR technology certified to the
§ 170.314(f)(6) (Optional— Agencies—Electronic 2014 Edition or 2015 Edition
Ambulatory Setting Case Reporting). may be used.
Only—Transmission to § 170.315(f)(7) Trans- Other non-named specialized reg-
Cancer Registries). mission to Public Health istries unsupported by certifi-
Agencies—Health Care cation requirements may also
Surveys. be chosen.
§ 170.315(f)(4) Trans-
mission to Cancer Reg-
istries.
TABLE 12—ELIGIBLE HOSPITAL AND CAH OBJECTIVES, MEASURES, AND CERTIFICATION CRITERIA FOR 2015 THROUGH
2017
Objective Measure(s) 2014 Edition 2015 Edition Additional considerations
Objective 1: Protect Patient Measure: Conduct or review a security The requirements are in- The requirements are a part The requirements are a part
Health Information. risk analysis in accordance with the re- cluded in the Base EHR of CEHRT specific to of CEHRT specific to
quirements in 45 CFR 164.308(a)(1), in- Definition. each certification criterion. each certification criterion.
cluding addressing the security (to in-
clude encryption) of data stored in
CEHRT in accordance with require-
ments in 45 CFR 164.312(a)(2)(iv) and
45 CFR 164.306(d)(3), and implement
security updates as necessary and cor-
rect identified security deficiencies as
part of the eligible hospital or CAH’s risk
management process.
Objective 2: Clinical Deci- Measure 1: Implement five clinical deci- § 170.314(a)(8) (Clinical De- § 170.315(a)(9) (Clinical De- N/A.
sion Support. sion support interventions related to four cision Support). cision Support).
or more clinical quality measures at a
relevant point in patient care for the en-
tire EHR reporting period.
Measure 2: The eligible hospital or CAH § 170.314(a)(2) (Drug-drug, § 170.315(a)(4) (Drug-drug, N/A.
has enabled and implemented the Drug-Allergy Interaction Drug-Allergy Interaction
functionality for drug-drug and drug-al- Checks). Checks for CPOE).
lergy interaction checks for the entire
Objective 3: Computerized Measure 1: More than 60% of medication § 170.314(a)(1) (Computer- § 170.315(a)(1) (Computer- N/A.
Provider Order Entry orders created by authorized providers ized Provider Order Entry) ized Provider Order
CPOE. of the eligible hospital’s or CAH’s inpa- or Entry—Medications).
tient or emergency department (POS 21 § 170.314(a)(18) (Optional—
or 23) during the EHR reporting period Computerized Provider
are recorded using CPOE. Order Entry—Medica-
tions).
Measure 2: More than 30% of laboratory § 170.314(a)(1) (Computer- § 170.315(a)(2) (Computer- N/A.
orders created by authorized providers ized Provider Order Entry) ized Provider Order
of the eligible hospital’s or CAH’s inpa- or Entry—Laboratory).
tient or emergency department (POS 21 § 170.314(a)(19) (Optional—
are recorded using CPOE. Order Entry—Laboratory).
Measure 3: More than 30% of radiology § 170.314(a)(1) (Computer- § 170.315(a)(3) (Computer- N/A.
orders created by authorized providers ized Provider Order Entry) ized Provider Order
of the eligible hospital’s or CAH’s inpa- or Entry—Diagnostic Imag-
tient or emergency department (POS 21 § 170.314(a)(20) (Optional— ing).
are recorded using CPOE. Order Entry—Diagnostic
Imaging).
Objective 4: Electronic Pre- Measure: More than 10% of hospital dis- § 170.314(b)(3) (Electronic § 170.315(b)(3) (Electronic Eligible hospitals and CAHs
scribing. charge medication orders for permis- Prescribing). Prescribing). may use a combination of
sible prescriptions (for new or changed § 170.314(a)(10) (Drug-For- § 170.315(a)(10) (Drug-For- technologies certified to
prescriptions) are queried for a drug formulary and Preferred mulary and Preferred either the 2014 Edition or
mulary and transmitted electronically Drug List Checks). Drug List Checks). 2015 Edition.
using CEHRT.
Objective 5: Health Informa- Measure: The eligible hospital or CAH that § 170.314(b)(2) (Transitions § 170.315(b)(1) (Transitions N/A.
tion Exchange. transitions or refers their patient to an- of Care-Create and of Care).
other setting of care or provider of care Transmit Transition of
(1) uses CEHRT to create a summary Care/Referral Summaries)
of care record; and (2) electronically or
transmits such summary to a receiving § 170.314(b)(8) (Optional—
provider for more than 10% of transi- Transitions of care).
tions of care and referrals.
Objective 6: Patient-Specific Measure: More than 10% of all unique pa- § 170.314(a)(15) (Patient- § 170.315(a)(13) (Patient- N/A.
Education. tients admitted to the eligible hospital’s Specific Education Re- Specific Education Re-
or CAH’s inpatient or emergency de- sources). sources).
partment (POS 21 or 23) are provided
patient specific education resources
identified by CEHRT.
Objective 7: Medication Measure: The eligible hospital or CAH § 170.314(b)(4) (Clinical In- § 170.315(b)(2) (Clinical In- N/A.
Reconciliation. performs medication reconciliation for formation Reconciliation) formation Reconciliation
more than 50% of transitions of care in or and Incorporation).
which the patient is admitted to the eli- § 170.314(b)(9) (Optional—
gible hospital’s or CAH’s inpatient or Clinical Information Rec-
emergency department (POS 21 or 23). onciliation and Incorpora-
tion).
Objective 8: Patient Elec- Measure 1: More than 50 percent of all § 170.314(e)(1) (View, § 170.315(e)(1) (View, N/A.
tronic Access (VDT). unique patients who are discharged Download, and Transmit Download, and Transmit
from the inpatient or emergency depart- to 3rd Party). to 3rd Party).
ment (POS 21 or 23) of an eligible hos-
pital or CAH are provided timely access
to view online, download and transmit
their health information to a third party
their health information.
TABLE 12—ELIGIBLE HOSPITAL AND CAH OBJECTIVES, MEASURES, AND CERTIFICATION CRITERIA FOR 2015 THROUGH
2017—Continued
Objective Measure(s) 2014 Edition 2015 Edition Additional considerations
Measure 2: For 2015 and 2016: At least 1 § 170.314(e)(1) (View, § 170.315(e)(1) (View, N/A.
patient who is discharged from the inpa- Download, and Transmit Download, and Transmit
tient or emergency department (POS 21 to 3rd Party). to 3rd Party).
or 23) of an eligible hospital or CAH (or
his or her authorized representative)
views, downloads, or transmits to a third
party his or her information during the
For 2017: More than 5 percent of unique
patients discharged from the inpatient or
emergency department (POS 21 or 23)
of an eligible hospital or CAH (or his or
her authorized representative) view,
download, or transmit to a third party
their information during the EHR report-
ing period.
Objective 9: Secure Mes- N/A ............................................................. N/A ...................................... N/A ...................................... N/A.
saging.
Objective 10: Public Health Measure 1—Immunization Registry Re- § 170.314(f)(1) (Immuniza- N/A ...................................... N/A.
Reporting. porting. tion Information) and
§ 170.314(f)(2) (Trans-
mission to Immunization
Registries).
Measure 2—Syndromic Surveillance Re- § 170.314(f)(3) (Trans- § 170.315(f)(2) (Trans- N/A.
porting. mission to Public Health mission to Public Health
Surveillance). Surveillance).
Measure 3—Specialized Registry Report- N/A ...................................... Eligible Hospitals/CAHs may Certified EHR technology is
ing. choose one or more of not required for special-
the following: ized registry reporting for
§ 170.315(f)(5) (Trans- 2015–2017, but EHR
mission to Public Health technology certified to the
Agencies—Electronic 2014 Edition or 2015 Edi-
Case Reporting ). tion may be used.
§ 170.315(f)(6) Transmission Other non-named special-
to Public Health Agen- ized registries unsup-
cies—Antimicrobial Use ported by certification re-
and Resistance Reporting. quirements may also be
§ 170.315(f)(7) Transmission chosen.
to Public Health Agen-
cies—Health Care Sur-
veys.
Measure 4—Electronic Reportable Lab- § 170.314(f)(4) (Inpatient § 170.315(f)(3) (Trans- N/A.
oratory Result Reporting. Setting Only—Trans- mission to Public Health
mission of Reportable Agencies—Reportable
Laboratory Tests and Val- Laboratory Tests and Val-
ues/Results. ues/Results).
TABLE 13—EP OBJECTIVES, MEASURES, AND CERTIFICATION CRITERIA FOR STAGE 3 IN 2017
Objective Measure(s) 2014 Edition 2015 Edition Combinations
Objective 1: Protect Elec- Measure: Conduct or review a security The requirements are in- The requirements are a part The requirements are a part
tronic Health Information. risk analysis in accordance with the re- cluded in the Base EHR of CEHRT specific to of CEHRT specific to
quirements in 45 CFR 164.308(a)(1), in- Definition. each certification criterion. each certification criterion.
cluding addressing the security (to in-
clude encryption) of ePHI data created
or maintained by CEHRT in accordance
with requirements in 45 CFR
164.312(a)(2)(iv) and 45 CFR
164.306(d)(3), and implement security
updates as necessary and correct iden-
tified security deficiencies as part of the
provider’s risk management process.
Objective 2: Electronic Pre- Measure: More than 60% of all permis- § 170.314(b)(3) (Electronic § 170.315(b)(3) (Electronic EPs may use a combination
scribing. sible prescriptions written by the EP are Prescribing) Prescribing). of technologies certified to
queried for a drug formulary and trans- § 170.314(a)(10) (Drug-For- § 170.315(a)(10) (Drug-For- either the 2014 Edition or
mitted electronically using CEHRT. mulary and Preferred mulary and Preferred 2015 Edition.
Drug List Checks). Drug List checks).
Objective 3: Clinical Deci- Measure 1: The EP must implement five § 170.314(a)(8) (Clinical De- § 170.315(a)(9) (Clinical De- N/A.
sion Support. clinical decision support interventions cision Support). cision Support).
related to four or more CQMs at a rel-
evant point in patient care for the entire
TABLE 13—EP OBJECTIVES, MEASURES, AND CERTIFICATION CRITERIA FOR STAGE 3 IN 2017—Continued
Measure 2: The EP has enabled and im- § 170.314(a)(2) (Drug-Drug, § 170.315(a)(4) (Drug-Drug, N/A.
plemented the functionality for drug— Drug-Allergy Interaction Drug-Allergy Interaction
drug and drug—allergy interaction Checks). Checks for CPOE).
checks for the entire EHR reporting pe-
riod.
Objective 4: Computerized Measure 1: More than 60% of medication § 170.314(a)(1) (Computer- § 170.315(a)(1) (Computer- N/A.
Provider Order Entry orders created by the EP during the ized Provider Order Entry) ized Provider Order
(CPOE). EHR reporting period are recorded or Entry–Medications).
using CPOE. § 170.314(a)(18) (Optional—
Computerized Provider
Order Entry–Medications).
Measure 2: More than 60% of laboratory § 170.314(a)(1) (Computer- § 170.315(a)(2) (Computer- N/A.
orders created by the EP during the ized Provider Order Entry) ized Provider Order
EHR reporting period are recorded or Entry–Laboratory).
using CPOE. § 170.314(a)(19) (Optional–
Order Entry–Laboratory).
Measure 3: More than 60% of diagnostic § 170.314(a)(1) (Computer- § 170.315(a)(3) (Computer- N/A.
imaging orders created by the EP dur- ized Provider Order Entry) ized Provider Order
ing the EHR reporting period are re- or Entry–Diagnostic Imaging).
corded using CPOE. § 170.314(a)(20) (Optional–
Order Entry–Diagnostic
Imaging).
Objective 5: Patient Elec- Measure 1: For more than 80% of all § 170.314(e)(1) (View, § 170.315(e)(1) (View, EPs may use technologies
tronic Access. unique patients seen by the EP: Download, and Transmit Download, and Transmit certified to either the 2014
(1) The patient (or the patient authorized to 3rd Party). to 3rd Party). Edition or 2015 Edition
representative) is provided timely ac- § 170.315(g)(7) (Application VDT certification criteria
cess to view online, download, and Access—Patient Selec- (i.e., § 170.314(e)(1)
transmit his or her health information; tion) *. or § 170.315(e)(1)) in 2017).
and § 170.315(g)(8) (Application The 2014 Edition does not
(2) The EP ensures the patient’s health in- Access—Data Category offer ‘‘API’’ certification
formation is available for the patient (or Request) *. criteria. Therefore, EPs
patient—authorized representative) to § 170.315(g)(9) (Application choosing to attest to the
access using any application of their Access—All Data Re- Stage 3 measures in
choice that is configured to meet the quest) *. 2017 would need to pos-
technical specifications of the API in the * The three criteria com- sess technology certified
provider’s CEHRT. bined are the ‘‘API’’ cer- to § 170.315(g)(7),
tification criteria. § 170.315(g)(8), and
§ 170.315(g)(9).
Measure 2: The EP must use clinically rel- § 170.314(a)(15) (Patient- § 170.315(a)(13) (Patient- N/A.
evant information from CEHRT to iden- Specific Education Re- specific Education Re-
tify patient-specific educational resources). sources).
sources and provide electronic access
to those materials to more than 35% of
unique patients seen by the EP.
Objective 6: Coordination of Measure 1: For 2017, during the EHR re- § 170.314(e)(1) (View, § 170.315(e)(1) (View, EPs may use a combination
Care through Patient En- porting period, more than 5% of all Download, and Transmit Download, and Transmit of technologies certified to
gagement. unique patients(or patient-authorized to 3rd Party). to 3rd Party). either the 2014 Edition or
representative)seen by the EP actively § 170.315(g)(7) (Application 2015 Edition VDT certifi-
engage with the EHR made accessible Access—Patient Selec- cation criteria (i.e.,
by the provider. An EP may meet the tion) *. § 170.314(e)(1) or
measure by either— § 170.315(g)(8) (Application § 170.315(e)(1)) in 2017).
(1) view, download or transmit to a third Access—Data Category The 2014 Edition does not
party their health information; or. Request) *. offer API certification cri-
(2) access their health information through § 170.315(g)(9) (Application teria. Therefore, EPs
the use of an API that can be used by Access—All Data Re- choosing to attest to the
applications chosen by the patient and quest) *. Stage 3 measures in
configured to the API in the provider’s * The three criteria com- 2017 would need to pos-
CEHRT; or (3) a combination of (1) and bined are the ‘‘API’’ cer- sess technology certified
(2). tification criteria. to § 170.315(g)(7),
§ 170.315(g)(8), and
§ 170.315(g)(9).
Measure 2: For 2017, more than 5% of all § 170.314(e)(3) (Secure § 170.315(e)(2) (Secure N/A.
unique patients seen by the EP during Messaging). Messaging).
the EHR reporting period, a secure
message was sent using the electronic
messaging function of CEHRT to the
resentative), or in response to a secure
message sent by the patient (or the pa-
tient-authorized representative.
TABLE 13—EP OBJECTIVES, MEASURES, AND CERTIFICATION CRITERIA FOR STAGE 3 IN 2017—Continued
Measure 3: Patient—generated health N/A ...................................... § 170.315(e)(3) (Patient

data or data from a non-clinical setting Health Information Cap-
is incorporated into the CEHRT for ture) *.
more than 5 of all unique patients seen * Supports meeting the
by the EP during the EHR reporting pe- measure, but is NOT re-
riod. quired to be used to meet
the measure. The certifi-
cation criterion is part of
the CEHRT definition be-
ginning in 2018.
Objective 7: Health Informa- Measure 1: For more than 50% of transi- § 170.314(b)(2) (Transitions § 170.315(b)(1) (Transitions N/A.
tion Exchange. tions of care and referrals, the EP that of Care—Create and of Care).
transitions or refers their patient to an- Transmit Transition of
other setting of care or provider of Care/Referral Summaries)
care—(1) creates a summary of care or
record using CEHRT; and (2) electroni- § 170.314(b)(8) (Optional—
cally exchanges the summary of care Transitions of Care).
record.
Measure 2: For more than 40% of transi- § 170.314(b)(1) (Transitions § 170.315(b)(1) (Transitions N/A.
tions or referrals received and patient of Care-Receive, Display of Care).
encounters in which the EP has never and Incorporate Transition
before encountered the patient, the EP of Care/Referral Sum-
receives or retrieves and incorporates maries) or
into the patient’s record an electronic § 170.314(b)(8) (Optional—
summary of care document. Transitions of Care).
Measure 3: For more than 80% of transi- § 170.314(b)(4) (Clinical In- § 170.315(b)(2) (Clinical In- N/A.
tions or referrals received and patient formation Reconciliation) formation Reconciliation
encounters in which the EP has never or and Incorporation).
before encountered the patient, the EP § 170.314(b)(9) (Optional—
performs clinical information reconcili- Clinical Information Rec-
ation. onciliation and Incorpora-
tion).
Objective 8: Public Health Measure 1: Immunization Registry Report- N/A ...................................... § 170.315(f)(1) (Trans- N/A.
and Clinical Data Registry ing. mission to Immunization
Reporting. Registries).
Data Registry Reporting ...... Measure 2: Syndromic Surveillance Re- § 170.314(f)(3) (Trans- § 170.315(f)(2) (Trans- N/A.
porting. mission to Public Health mission to Public Health
Surveillance) or Surveillance) Urgent Care
§ 170.314(f)(7) (Optional– Setting Only.
Ambulatory Setting Only–
Transmission to Public
Health Agencies—
Syndromic Surveillance).
Measure 3: Electronic Case Reporting ...... N/A ...................................... § 170.315(f)(5) (Trans- N/A.
mission to Public Health
Agencies—Electronic
Case Reporting).
Measure 4: Public Health Registry Report- § 170.314(f)(5) (Optional EPs may choose one or EPs may choose to use
ing. —Ambulatory Setting more of the following: technologies certified to
Only—Cancer Case Infor- § 170.315(f)(4) (Trans- either the 2014 Edition or
mation) and mission to Cancer Reg- 2015 Edition certification
§ 170.314(f)(6) (Optional— istries). criteria in 2017.
Ambulatory Setting Only– § 170.315(f)(7) .....................
Transmission to Cancer (Transmission to Public
Registries). Health Agencies—Health
Care Surveys).
Measure 5: Clinical Data Registry Report- N/A ...................................... No 2015 Edition health IT N/A.
ing. certification criteria at this
time.
TABLE 14—ELIGIBLE HOSPITAL/CAH OBJECTIVES, MEASURES, AND CERTIFICATION CRITERIA FOR STAGE 3 IN 2017
Objective 1: Protect Measure: Conduct or review a secu- The requirements are The requirements are a The requirements are a
Electronic Health Infor- rity risk analysis in accordance included in the Base part of CEHRT spe- part of CEHRT spe-
mation. with the requirements in 45 CFR EHR Definition. cific to each certifi- cific to each certifi-
164.308(a)(1), including address- cation criterion. cation criterion.
ing the security (to include
encryption) of ePHI data created
or maintained by CEHRT in ac-
cordance with requirements in 45
CFR 164.312(a)(2)(iv) and 45
CFR 164.306(d)(3), and imple-
ment security updates as nec-
essary and correct identified secu-
rity deficiencies as part of the pro-
vider’s risk management process.
Objective 2: Electronic Measure: More than 25% of hospital § 170.314(b)(3) (Elec- § 170.315(b)(3) (Elec- Eligible Hospitals/CAHs
Prescribing. discharge medication orders for tronic Prescribing). tronic Prescribing).. may use a combina-
permissible prescriptions (for new § 170.314(a)(10) (Drug- § 170.315(a)(10) (Drug- tion of technologies
and changed prescriptions) are Formulary and Pre- Formulary and Pre- certified to either the
queried for a drug formulary and ferred Drug List ferred Drug List 2014 Edition or 2015
transmitted electronically using Checks). Checks). Edition.
CEHRT.
Objective 3: Clinical De- Measure 1: The eligible hospital or § 170.314(a)(8) (Clinical § 170.315(a)(9) (Clinical N/A.
cision Support. CAH must implement five clinical Decision Support). Decision Support).
decision support interventions re-
lated to four or more CQMs at a
relevant point in patient care for
the entire EHR reporting period.
Measure 2: The eligible hospital or § 170.314(a)(2) (Drug- § 170.315(a)(4) (Drug- N/A.
CAH has enabled and imple- Drug, Drug-Allergy Drug, Drug-Allergy
mented the functionality for Interaction Checks). Interaction Checks for
drug-drug and drug-allergy inter- CPOE).
action checks for the entire EHR
reporting period.
Objective 4: Computer- Measure 1: More than 60% of medi- § 170.314(a)(1) (Com- § 170.315(a)(1) (Com- N/A
ized Provider Order cation orders created by the au- puterized Provider puterized Provider
Entry (CPOE). thorized providers of the eligible Order Entry) or Order Entry—Medica-
hospital’s or CAH’s inpatient or § 170.314(a)(18) (Op- tions).
emergency department (POS 21 tional—Computerized
or 23) during the EHR reporting Provider Order
period are recorded using CPOE. Entry—Medications).
Measure 2: More than 60% of lab- § 170.314(a)(1) (Com- § 170.315(a)(2) (Com- N/A.
oratory orders created by the au- puterized Provider puterized Provider
thorized providers of the eligible Order Entry) or Order Entry—Labora-
hospital’s or CAH’s inpatient or § 170.314(a)(19) (Op- tory).
emergency department (POS 21 tional—Computerized
or 23) during the EHR reporting Provider Order
period are recorded using CPOE. Entry—Laboratory).
Measure 3: More than 60% of diag- § 170.314(a)(1) (Com- § 170.315(a)(3) (Com- N/A.
nostic imaging orders created by puterized Provider puterized Provider
the authorized providers of the eli- Order Entry) or Order Entry—Diag-
gible hospital’s or CAH’s inpatient § 170.314(a)(20) (Op- nostic Imaging).
or emergency department (POS tional—Computerized
21 or 23) during the EHR report- Provider Order
ing period are recorded using Entry—Diagnostic Im-
CPOE. aging).
TABLE 14—ELIGIBLE HOSPITAL/CAH OBJECTIVES, MEASURES, AND CERTIFICATION CRITERIA FOR STAGE 3 IN 2017—
Continued
Objective 5: Patient Measure 1: For more than 80% of § 170.314(e)(1) (View, § 170.315(e)(1) (View, Eligible Hospitals/CAHs
Electronic Access. all unique patients discharged Download, and Trans- Download, and Trans- may use technologies
from the eligible hospital or CAH mit to 3rd Party). mit to 3rd Party). certified to either the
inpatient or emergency depart- § 170.315(g)(7)* (Appli- 2014 Edition or 2015
ment (POS 21 or 23): cation Access—Pa- Edition VDT certifi-
(1) The patient (or the patient au- tient Selection). cation criteria (i.e.,
thorized representative) is pro- § 170.315(g)(8)* (Appli- § 170.314(e)(1) or
vided timely access to view online, cation Access—Data § 170.315(e)(1))in
download, and transmit his or her Category Request)*. 2017).
health information.; and § 170.315(g)(9) (Applica- The 2014 Edition does
(2) The provider ensures the pa- tion Access—All Data not offer ‘‘API’’ certifi-
tient’s health information is avail- Request)* cation criteria.
able for the patient (or pa- * The three criteria com- Therefore, Eligible Hos-
tient-authorized representative) to bined are the ‘‘API’’ pitals/CAHs choosing
access using any application of certification criteria. to attest to the Stage
their choice that is configured to 3 measures in 2017
meet the technical specifications would need to pos-
of the API in the provider’s sess technology cer-
CEHRT. tified to
§ 170.315(g)(7),
§ 170.315(g)(8), and
§ 170.315(g)(9).
Measure 2: The eligible hospital or § 170.314(a)(15) (Pa- § 170.315(a)(13) (Pa- N/A.
CAH must use clinically relevant tient-Specific Edu- tient-Specific Edu-
information from CEHRT to iden- cation Resources). cation Resources).
tify patient-specific educational re-
sources and provide electronic ac-
cess to those materials to more
than 35% of unique patients dis-
charged from the eligible hospital
or CAH inpatient or emergency
department (POS 21 or 23) during
the EHR reporting period.
Objective 6: .................... Measure 1: During the EHR report- § 170.314(e)(1) (View, § 170.315(e)(1) (View, Eligible Hospitals/CAHs
Coordination of Care ing period, more than 10 percent Download, and Trans- Download, and Trans- may use technologies
through Patient En- of all unique patients (or their au- mit to 3rd Party). mit to 3rd Party). certified to either the
gagement. thorized representatives) dis- § 170.315(g)(7) (Applica- 2014 Edition or 2015
charged from the eligible hospital tion Access—Patient Edition VDT certifi-
or CAH inpatient or emergency Selection)*. cation criteria (i.e.,
department (POS 21 or 23) ac- § 170.315(g)(8) (Applica- § 170.314(e)(1) or
tively engage with the EHR made tion Access—Data § 170.315(e)(1)) in
accessible by the provider and ei- Category Request)*. 2017.
ther: § 170.315(g)(9) (Applica- The 2014 Edition does
(1) view, download or transmit to a tion Access—All Data not offer ‘‘API’’ certifi-
third party their health information; Request)*. cation criteria. There-
or * The three criteria com- fore, Eligible Hos-
(2) access their health information bined are the ‘‘API’’ pitals/CAHs choosing
through the use of an API that can certification criteria. to attest to the Stage
be used by applications chosen by 3 measures in 2017
the patient and configured to the would need to pos-
API in the provider’s CEHRT; or sess technology cer-
(3) a combination of (1) and (2). ...... tified to
§ 170.315(g)(7),
§ 170.315(g)(8), and
§ 170.315(g)(9).
Measure 2: For more than 25% of § 170.314(e)(3) (Secure § 170.315(e)(2) (Secure N/A.
all unique patients discharged Messaging). Messaging).
from the eligible hospital or CAH
inpatient or emergency depart-
ment (POS 21 or 23) during the
EHR reporting period, a secure
message was sent using the elec-

tronic messaging function of
CEHRT to the patient (or the pa-
tient-authorized representative), or
in response to a secure message
sent by the patient (or the patient-
authorized representative) during
Continued
Measure 3: Patient-generated health N/A ................................ § 170.315(e)(3) (Patient N/A.

data or data from a non-clinical Health Information
setting is incorporated into the Capture)*..
CEHRT for more than 5% of all *Supports meeting the
unique patients discharged from measure, but is NOT
the eligible hospital or CAH (POS required to be used to
21 and 23) during the EHR report- meet the measure.
ing period. The certification cri-
terion is part of the
CEHRT definition be-
ginning in 2018.
Objective 7: Health Infor- Measure 1: For more than 50% of § 170.314(b)(2) (Transi- § 170.315(b)(1) (Transi- N/A.
mation Exchange. transitions of care and referrals, tions of Care—Create tions of Care).
the eligible hospital or CAH that and Transmit Transi-
transitions or refers their patient to tion of Care/Referral
another setting of care or provider Summaries) or
of care—(1) creates a summary of § 170.314(b)(8) (Op-
care record using CEHRT; and (2) tional—Transitions of
electronically exchanges the sum- Care).
mary of care record
Measure 2: For more than 40% of § 170.314(b)(1) (Transi- § 170.315(b)(1) (Transi- N/A.
transitions or referrals received tions of Care—Re- tions of Care).
and patient encounters in which ceive, Display and In-
the provider has never before en- corporate Transition
countered the patient, the eligible of Care/Referral Sum-
hospital or CAH receives or re- maries) or
trieves and incorporates into the § 170.314(b)(8) (Op-
patient’s record in their EHR an tional—Transitions of
electronic summary of care docu- Care).
ment.
Measure 3: For more than 80%of § 170.314(b)(4) (Clinical § 170.315(b)(2) (Clinical N/A.
transitions or referrals received Information Reconcili- Information Reconcili-
and patient encounters in which ation) or ation and Incorpora-
the provider has never before en- § 170.314(b)(9) (Op- tion).
countered the patient, the eligible tional—Clinical Infor-
hospital or CAH performs clinical mation Reconciliation
information reconciliation. and Incorporation).
Objective 8: Public Measure 1: Immunization Registry N/A ................................ § 170.315(f)(1) (Trans- N/A.
Health and Clinical Reporting. mission to Immuniza-
Data Registry Report- tion Registries).
ing.
Measure 2: Syndromic Surveillance § 170.314(f)(3) (Trans- § 170.315(f)(2) (Trans- N/A.
Reporting. mission to Public mission to Public
Health Agencies— Health Agencies—
Syndromic Surveil- Syndromic Surveil-
lance). lance).
Measure 3: Electronic Case Report- N/A ................................ § 170.315(f)(5) (Trans- N/A.
ing. mission to Public
Health Agencies—
Electronic Case Re-
porting).
Measure 4: Public Health Registry N/A ................................ Eligible Hospitals/CAHs EPs may choose to use
Reporting. may choose one or technologies certified
more of the following:. to either the 2014 Edi-
§ 170.315(f)(6) (Trans- tion or 2015 Edition
mission to Public certification criteria in
Health Agencies— 2017.
Antimicrobial Use and
Resistance)..
§ 170.315(f)(7) (Trans-
mission to Public
Health Agencies—
Health Care Surveys).
Measure 5: Clinical Data Registry ....................................... No 2015 Edition health N/A.
Reporting. IT certification criteria
at this time.
Continued
Measure 6: Electronic Reportable § 170.314(f)(4) (Inpatient § 170.315(f)(3) (Trans- N/A.

Laboratory Result Reporting. Setting Only—Trans- mission to Public
mission of Reportable Health Agencies—Re-
Laboratory Tests and portable Laboratory
Values/Results). Tests and Values/Re-
sults).
TABLE 15—EP OBJECTIVES, MEASURES, AND CERTIFICATION CRITERIA FOR STAGE 3 IN 2018 AND SUBSEQUENT YEARS
Objective Measure(s) 2015 Edition
Objective 1: Protect Electronic Measure: Conduct or review a security risk analysis in accordance The requirements are a part of
Health Information. with the requirements in 45 CFR 164.308(a)(1), including address- CEHRT specific to each certifi-
ing the security (to include encryption) of ePHI data created or cation criterion.
maintained by CEHRT in accordance with requirements in 45 CFR
164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement secu-
rity updates as necessary and correct identified security defi-
ciencies as part of the provider’s risk management process.
Objective 2: Electronic Prescribing Measure: More than 60% of all permissible prescriptions written by § 170.315(b)(3) (Electronic Pre-
the EP are queried for a drug formulary and transmitted electroni- scribing)
cally using CEHRT. § 170.315(a)(10) (Drug-Formulary
and Preferred Drug List checks).
Objective 3: Clinical Decision Sup- Measure 1: The EP must implement five clinical decision support § 170.315(a)(9) (Clinical Decision
port. interventions related to four or more CQMs at a relevant point in Support).
patient care for the entire EHR reporting period.
Measure 2: The EP has enabled and implemented the functionality § 170.315(a)(4) (Drug-Drug, Drug-
for drug-drug and drug-allergy interaction checks for the entire Allergy Interaction Checks for
EHR reporting period. CPOE).
Objective 4: Computerized Provider Measure 1: More than 60% of medication orders created by the EP § 170.315(a)(1)
Order Entry (CPOE). during the EHR reporting period are recorded using CPOE. (Computerized Provider Order
Entry—Medications).
Measure 2: More than 60% of laboratory orders created by the EP § 170.315(a)(2)
during the EHR reporting period are recorded using CPOE. (Computerized Provider Order
Entry—Laboratory).
Measure 3: More than 60% of diagnostic imaging orders created by § 170.315(a)(3)
the EP during the EHR reporting period are recorded using CPOE. (Computerized Provider Order
Entry—Diagnostic Imaging).
Objective 5: Patient Electronic Ac- Measure 1: For more than 80% of all unique patients seen by the § 170.315(e)(1) (View, Download,
cess. EP: and Transmit to 3rd Party)
(1) The patient (or the patient authorized representative) is provided § 170.315(g)(7)
timely access to view online, download, and transmit his or her (Application Access—Patient Se-
health information; and lection)*
(2) The EP ensures the patient’s health information is available for § 170.315(g)(8) (Application Ac-
the patient (or patient-authorized representative) to access using cess—Data Category Request)*
any application of their choice that is configured to meet the tech- § 170.315(g)(9) (Application Ac-
nical specifications of the API in the provider’s CEHRT. cess—All Data Request)*
*The three criteria combined are
the ‘‘API’’ certification criteria.
Measure 2: The EP must use clinically relevant information from § 170.315(a)(13) (Patient-specific
CEHRT to identify patient-specific educational resources and pro- Education Resources).
vide electronic access to those materials to more than 35% of
unique patients seen by the EP.
Objective 6: Coordination of Care Measure 1: For 2017, during the EHR reporting period, more than § 170.315(e)(1) (View, Download,
through Patient Engagement. 10% of all unique patients(or patient-authorized representative) and Transmit to 3rd Party)
seen by the EP actively engage with the EHR made accessible by § 170.315(g)(7)
the provider. An EP may meet the measure by either— (Application Access—Patient Se-
(1) view, download or transmit to a third party their health informa- lection)*
tion; or § 170.315(g)(8) (Application Ac-
(2) access their health information through the use of an API that can cess—Data Category Request)*
be used by applications chosen by the patient and configured to § 170.315(g)(9) (Application Ac-
the API in the provider’s CEHRT; or (3) a combination of (1) and cess—All Data Request)*
(2). *The three criteria combined are
the ‘‘API’’ certification criteria.
Measure 2: For 2017, more than 25% of all unique patients seen by § 170.315(e)(2) (Secure Mes-
the EP during the EHR reporting period, a secure message was saging).
sent using the electronic messaging function of CEHRT to the pa-
tient (or the patient-authorized representative), or in response to a
secure message sent by the patient (or the patient-authorized rep-
resentative.
TABLE 15—EP OBJECTIVES, MEASURES, AND CERTIFICATION CRITERIA FOR STAGE 3 IN 2018 AND SUBSEQUENT
YEARS—Continued
Measure 3: Patient-generated health data or data from a non-clinical § 170.315(e)(3) (Patient Health In-
setting is incorporated into the CEHRT for more than 5 of all formation Capture)*
unique patients seen by the EP during the EHR reporting period. *Supports meeting the measure,
but is NOT required to be used
to meet the measure. The cer-
tification criterion is part of the
CEHRT definition beginning in
2018.
Objective 7: Health Information Ex- Measure 1: For more than 50% of transitions of care and referrals, § 170.315(b)(1) (Transitions of
change. the EP that transitions or refers their patient to another setting of Care).
care or provider of care—(1) creates a summary of care record
using CEHRT; and (2) electronically exchanges the summary of
care record.
Measure 2: For more than 40% of transitions or referrals received § 170.315(b)(1) (Transitions of
and patient encounters in which the EP has never before encoun- Care).
tered the patient, the EP receives or retrieves and incorporates into
the patient’s record an electronic summary of care document.
Measure 3: For more than 80% of transitions or referrals received § 170.315(b)(2) (Clinical Informa-
and patient encounters in which the EP has never before encoun- tion Reconciliation and Incorpo-
tered the patient, the EP performs clinical information reconciliation. ration).
Public Health and Clinical Data Measure 1: Immunization Registry Reporting ....................................... § 170.315(f)(1) (Transmission to
Registry Reporting. Immunization Registries).
Measure 2: Syndromic Surveillance Reporting ..................................... § 170.315(f)(2) (Transmission to
Public Health Agencies—
Syndromic Surveillance)
Urgent Care Setting Only.
Measure 3: Electronic Case Reporting ................................................. § 170.315(f)(5) (Transmission to
Public Health Agencies—Elec-
tronic Case Reporting ).
Measure 4: Public Health Registry Reporting ....................................... EPs may choose one or more of
the following:
§ 170.315(f)(4) (Transmission to
Cancer Registries)
§ 170.315(f)(7)
(Transmission to Public Health
Agencies—Health Care Sur-
veys).
Measure 5: Clinical Data Registry Reporting ........................................ No 2015 Edition health IT certifi-
cation criteria at this time.
TABLE 16—ELIGIBLE HOSPITAL/CAH OBJECTIVES, MEASURES, AND CERTIFICATION CRITERIA FOR STAGE 3 IN 2018 AND
SUBSEQUENT YEARS
Objective 1: Protect Electronic Measure: Conduct or review a security risk analysis in accordance The requirements are a part of
Health Information. with the requirements in 45 CFR 164.308(a)(1), including address- CEHRT specific to each certifi-
ing the security (to include encryption) of ePHI data created or cation criterion.
maintained by CEHRT in accordance with requirements in 45 CFR
164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement secu-
rity updates as necessary and correct identified security defi-
ciencies as part of the provider’s risk management process.
Objective 2: Electronic Prescribing Measure: More than 25% of hospital discharge medication orders for § 170.315(b)(3) (Electronic Pre-
permissible prescriptions (for new and changed prescriptions) are scribing).
queried for a drug formulary and transmitted electronically using § 170.315(a)(10) (Drug-Formulary
CEHRT. and Preferred Drug List
Checks).
Objective 3: Clinical Decision Sup- Measure 1: The eligible hospital or CAH must implement five clinical § 170.315(a)(9) (Clinical Decision
port. decision support interventions related to four or more CQMs at a Support).
relevant point in patient care for the entire EHR reporting period.
Measure 2: The eligible hospital or CAH has enabled and imple- § 170.315(a)(4) (Drug-Drug, Drug-
mented the functionality for drug-drug and drug-allergy interaction Allergy Interaction Checks for
checks for the entire EHR reporting period. CPOE).
Objective 4: Computerized Provider Measure 1: More than 60% of medication orders created by the au- § 170.315(a)(1) (Computerized
Order Entry (CPOE). thorized providers of the eligible hospital’s or CAH’s inpatient or Provider Order
emergency department (POS 21 or 23) during the EHR reporting Entry—Medications).
period are recorded using CPOE.
SUBSEQUENT YEARS—Continued
Measure 2: More than 60% of laboratory orders created by the au- § 170.315(a)(2) (Computerized
thorized providers of the eligible hospital’s or CAH’s inpatient or Provider Order Entry—Laboratory).
emergency department (POS 21 or 23) during the EHR reporting
period are recorded using CPOE.
Measure 3: More than 60% of diagnostic imaging orders created by § 170.315(a)(3) (Computerized
the authorized providers of the eligible hospital’s or CAH’s inpatient Provider Order Entry—Diag-
or emergency department (POS 21 or 23) during the EHR report- nostic Imaging).
ing period are recorded using CPOE.
Objective 5: Patient Electronic Ac- Measure 1: For more than 80% of all unique patients discharged § 170.315(e)(1) (View, Download,
cess. from the eligible hospital or CAH inpatient or emergency depart- and Transmit to 3rd Party)
ment (POS 21 or 23): § 170.315(g)(7)* (Application Ac-
(1) The patient (or the patient authorized representative) is provided cess—Patient Selection).
timely access to view online, download, and transmit his or her § 170.315(g)(8)* (Application Ac-
health information.; and cess—Data Category Request)*.
(2) The provider ensures the patient’s health information is available § 170.315(g)(9) (Application Ac-
for the patient (or patient-authorized representative) to access cess—All Data Request)*
using any application of their choice that is configured to meet the *The three criteria combined are
technical specifications of the API in the provider’s CEHRT. the ‘‘API’’ certification criteria.
Measure 2: The eligible hospital or CAH must use clinically relevant § 170.315(a)(13) (Patient-Specific
information from CEHRT to identify patient-specific educational re- Education Resources).
sources and provide electronic access to those materials to more
than 35% of unique patients discharged from the eligible hospital
or CAH inpatient or emergency department (POS 21 or 23) during
Objective 6: Coordination of Care Measure 1: During the EHR reporting period, more than 10 percent § 170.315(e)(1) (View, Download,
through Patient Engagement. of all unique patients (or their authorized representatives) dis- and Transmit to 3rd Party)
charged from the eligible hospital or CAH inpatient or emergency § 170.315(g)(7)
department (POS 21 or 23) actively engage with the EHR made (Application Access—Patient Se-
accessible by the provider and either: lection)*.
(1) view, download or transmit to a third party their health informa- § 170.315(g)(8) (Application Ac-
tion; or cess—Data Category Request)*.
(2) access their health information through the use of an API that can § 170.315(g)(9) (Application Ac-
be used by applications chosen by the patient and configured to cess—All Data Request)*
the API in the provider’s CEHRT; or *The three criteria combined are
(3) a combination of (1) and (2) ............................................................ the ‘‘API’’ certification criteria.
Measure 2: For more than 25% of all unique patients discharged § 170.315(e)(2) (Secure Mes-
from the eligible hospital or CAH inpatient or emergency depart- saging).
ment (POS 21 or 23) during the EHR reporting period, a secure
message was sent using the electronic messaging function of
CEHRT to the patient (or the patient-authorized representative), or
in response to a secure message sent by the patient (or the pa-
tient-authorized representative) during the EHR reporting period.
Measure 3: Patient-generated health data or data from a non-clinical § 170.315(e)(3) (Patient Health In-
setting is incorporated into the CEHRT for more than 5% of all formation Capture)*.
unique patients discharged from the eligible hospital or CAH (POS *Supports meeting the measure,
21 and 23) during the EHR reporting period. but is NOT required to be used
to meet the measure. The cer-
tification criterion is part of the
CEHRT definition beginning in
2018.
Objective 7: Health Information Ex- Measure 1: For more than 50% of transitions of care and referrals, § 170.315(b)(1) (Transitions of
change. the eligible hospital or CAH that transitions or refers their patient to Care).
another setting of care or provider of care— (1) creates a summary
of care record using CEHRT; and (2) electronically exchanges the
summary of care record.
Measure 2: For more than 40% of transitions or referrals received § 170.315(b)(1) (Transitions of
and patient encounters in which the provider has never before en- Care).
countered the patient, the eligible hospital or CAH receives or re-
trieves and incorporates into the patient’s record in their EHR an
electronic summary of care document.
Measure 3: For more than 80% of transitions or referrals received § 170.315(b)(2) (Clinical Informa-
and patient encounters in which the provider has never before en- tion Reconciliation and Incorpo-
countered the patient, the eligible hospital or CAH performs clinical ration).
information reconciliation.
Objective 8: Public Health and Clin- Measure 1: Immunization Registry Reporting ....................................... § 170.315(f)(1) (Transmission to
ical Data Registry Reporting. Immunization Registries).
Measure 2: Syndromic Surveillance Reporting ..................................... § 170.315(f)(2) (Transmission to
Public Health Agencies—
Syndromic Surveillance).
SUBSEQUENT YEARS—Continued
Measure 3: Electronic Case Reporting ................................................. § 170.315(f)(5) (Transmission to

Public Health Agencies—Elec-
tronic Case Reporting).
Measure 4: Public Health Registry Reporting ....................................... Eligible Hospitals/CAHs may
choose one or more of the fol-
lowing:
Public Health Agencies—Anti-
microbial Use and Resistance).
Public Health Agencies—Health
Care Surveys).
Measure 5: Clinical Data Registry Reporting ........................................ No 2015 Edition health IT certifi-
cation criteria at this time.
Measure 6: Electronic Reportable Laboratory Result Reporting .......... § 170.315(f)(3) (Transmission to
Public Health Agencies—Re-
portable Laboratory Tests and
Values/Results).
C. Clinical Quality Measurement using QRDA, or via the GPRO Web 2015 and for all methods of reporting,
Interface. eligible hospitals and CAHs would be
1. Clinical Quality Measure (CQM)
• Eligible hospital and CAH Options required to complete a reporting period
Requirements for Meaningful Use in
for Medicare EHR Incentive Program for clinical quality measures aligned
2015 and 2016
Participation (single program with the calendar year in order to
Under sections 1848(o)(2)(A), participation—EHR Incentive Program demonstrate meaningful use.
1886(n)(3)(A), and 1814(l)(3)(A) of the only) For 2015 only, we proposed to change
Act and 42 CFR 495.4, EPs, eligible ++ Option 1: Attest to CQMs through the EHR reporting period for all EPs,
hospitals, and CAHs must report on the EHR Registration & Attestation eligible hospitals, and CAHs to any
CQMs selected by CMS using certified System continuous 90-day period within the
EHR technology, as part of being a ++ Option 2: Electronically report calendar year. In connection with this
meaningful EHR user under the CQMs through QualityNet Portal proposal, we proposed a 90-day
Medicare and Medicaid EHR Incentive • Eligible hospital and CAH Options reporting period in 2015 for clinical
Programs. for Electronic Reporting for Multiple quality measures for all EPs, eligible
In the EHR Incentive Programs in Programs (for example: EHR Incentive hospitals, and CAHs that report clinical
2015 through 2017 proposed rule (80 FR Program plus IQR participation) quality measures by attestation. We
20375 through 20376), we proposed to ++ Electronically report through proposed that EPs may select any
maintain the existing requirements QualityNet Portal continuous 90-day period from January
established in earlier rulemaking for the For the Medicaid EHR Incentive 1, 2015 through December 31, 2015,
reporting of CQMs. We summarized the Program, we stated that states would while eligible hospitals and CAHs may
options for CQM submission for continue to be responsible for select any continuous 90-day period
providers in the Medicare EHR determining whether and how from October 1, 2014 through December
Incentive Program as follows: electronic reporting of CQMs would 31, 2015, to report CQMs via attestation
• EP Options for Medicare EHR occur, or if they wish to allow reporting using the EHR Incentive Program
Incentive Program Participation (single through attestation. Any changes that registration and attestation system. We
program Participation—EHR Incentive states make to their CQM reporting proposed that a provider may choose to
Program only) methods must be submitted through the attest to a CQM reporting period of
State Medicaid Health IT Plan (SMHP) greater than 90 days up to and including
++ Option 1: Attest to CQMs through
process for our review and approval 1 full calendar year of data.
the EHR Registration & Attestation
prior to being implemented. We further proposed to continue our
System
We proposed to maintain the existing existing policy that providers in any
++ Option 2: Electronically report CQM reporting requirements of nine year of participation for the EHR
CQMs through Physician Quality CQMs covering at least three NQS Incentive Programs for 2015 through
Reporting System (PQRS) Portal domains for EPs and 16 CQMs covering 2017 may instead electronically report
• EP Options for Electronic Reporting at least three NQS domains for eligible CQM data using the options previously
for Multiple Programs (for example: hospitals and CAHs (77 FR 54058 for outlined for electronic reporting either
EHR Incentive Program plus PQRS EPs and 77 FR 54056 for eligible for single program participation in the
participation) hospitals and CAHs). Medicare EHR Incentive Programs, or

++ Option 1: Report individual EP’s Beginning in 2015, we proposed to for participation in multiple programs if
CQMs through PQRS Portal change the definition of ‘‘EHR reporting the requirements of the aligned quality
++ Option 2: Report group’s CQMs period’’ in § 495.4 for eligible hospitals program are also met. We noted that EPs
through PQRS Portal and CAHs such that the EHR reporting seeking to participate in multiple
We note that under option 2, this may period would begin and end in relation programs with a single electronic
include an EP reporting using the group to a calendar year. In connection with submission would be required to submit
reporting option, either electronically this proposal, we also proposed that in a full calendar year of CQM data using
the 2014 electronic specifications for the Response: The QCDR reporting this option should be extended to every
CQMs (which are also known as mechanism was introduced for the year of the EHR Incentive Programs.
eCQMs) for a reporting period in 2015. Physician Quality Reporting System Some commenters noted that alignment
We also noted that eligible hospitals and (PQRS) beginning in 2014. For 2015, a with other quality programs such as
CAHs seeking to participate in multiple QCDR is a CMS-approved entity that PQRS requires full-year reporting even
programs with a single electronic collects medical and clinical data, or in 2015, and therefore this policy does
submission for a reporting period in both, for the purpose of patient and not align with those quality programs.
2015 would be required to submit one disease tracking to foster improvement Commenters also suggested that there be
calendar quarter of data for 2015 from in the quality of care provided to a 90-day reporting period for PQRS.
either Q1 (January 1, 2015–March 31, patients. A QCDR is different from a Response: We appreciate the
2015), Q2 (April 1, 2015–June 30, 2015), PQRS qualified registry in that it is not comments in support of our proposal.
or Q3 (July 1, 2015–September 30, 2015) limited to reporting data on measures We note that our proposal was for 2015
and would require of the use of the within the PQRS measure set or the EHR only, and that we are not extending it
April 2014 release of the eCQMs. For Incentive Program. We appreciate the to 2016 or subsequent years. We also
further information on the requirements commenters’ suggestion to allow CQM acknowledge that this 90-day reporting
for eligible hospitals and CAHs reporting for the EHR Incentive period does not fully align with other
electronically submitting CQMs for a Programs through the PQRS QCDR CMS quality programs such as PQRS,
reporting period in 2015 for the option and will consider broadening our and that each quality program has its
Medicare EHR Incentive Program, we policy to accept all QCDR submissions own reporting requirements. While we
referred readers to the FY 2015 IPPS in future policy and rulemaking. seek to align the CMS quality programs
final rule (79 FR 50319 through 50323). Currently, EPs can report on CQMs wherever possible and as appropriate,
We noted that an EHR certified for through a QCDR and satisfy some of the we acknowledge that this is one area
CQMs under the 2014 Edition requirements for the Medicare EHR where a provider seeking to satisfy the
certification criteria does not need to be Incentive Program, as well as PQRS various requirements of multiple
recertified each time it is updated to a requirements, if they submit CQMs programs would need to report data
more recent version of the eCQMs. using certified EHR technology and the separately to each program, or choose to
Comment: We received many approved QRDA–I or QRDA–III format instead report through one of our
comments in support of maintaining the (78 FR 74754 through 74755). We note aligned options.
existing CQM reporting requirements for the Medicare EHR Incentive After consideration of the public
and aligning CQM requirements with Program, the only CQMs that may be comments, we are finalizing all of the
other quality programs where possible, reported through a QCDR are those proposals discussed previously as
including support of our proposal to finalized in the Stage 2 final rule (77 FR proposed. We note that after these
align reporting for eligible hospitals and 54069 through 54075), and this does not proposals were published, we published
CAHs to the calendar year. Some include the non-PQRS measures the August 17, 2015 FY 2016 IPPS final
commenters expressed concerns over submitted via QCDR. rule (80 FR 49756 through 49761),
their ability to report CQMs, and some Comment: Some commenters which includes additional final policies
commenters requested that CMS expand suggested that reporting on CQMs could for eligible hospitals and CAHs
the number of CQMs available to be removed as a requirement from the reporting CQMs in 2016 for the
specialists. EHR Incentive Program. Medicare EHR Incentive Program.
Response: We appreciate the Response: As we noted in the Stage 2
comments in support of our proposals final rule (77 FR 54056 through 54078), 2. Clinical Quality Measure (CQM)
and understand the concerns raised by CQM reporting is a statutory Requirements for Meaningful Use in
others. CMS continues to evaluate the requirement for providers seeking to be 2017 and Subsequent Years
available CQMs for inclusion in the EHR meaningful users of certified EHR a. Clinical Quality Measure Reporting
Incentive Programs and will consider technology. In addition, as noted in the Requirements for EPs
adding CQMs to the program as they are EHR Incentive Programs in 2015
developed and found to be appropriate through 2017 proposed rule (80 FR In the Stage 3 proposed rule (80 FR
for inclusion. In the meantime, we 20351) and in the Stage 3 proposed rule 16768), we noted that to further our
understand that there are situations in (80 FR 16740 through 16741), the use of goals of alignment and avoiding
which an EP, eligible hospital or CAH EHR technology to submit information redundant or duplicative reporting
does not have data to report on for a on clinical quality measures is defined across the various CMS quality
particular CQM, and its EHR is not in the HITECH Act as a key reporting programs, we intend to
certified to additional CQMs or does not foundational principle and policy of address CQM reporting requirements for
have additional CQMs available to meaningful use (see sections the Medicare and Medicaid EHR
report on. In these instances, we believe 1848(o)(2)(A) and 1886(n)(3)(A) of the Incentive Program for EPs for 2017 and
that our policy on allowing zero Act). Additionally, we believe CQM subsequent years in the Medicare
denominators to be reported allow these reporting is key to the continued efforts Physician Fee Schedule (PFS)
providers and specialists to meet the to improve the quality of care in a rulemaking, which also establishes the
CQM reporting requirements of the EHR patient centered delivery system reform requirements for PQRS and other
Incentive Programs (see the Stage 2 final model. We maintain our commitment to quality programs affecting EPs. We
rule 77 FR 54059 and 54079 and FY CQM reporting as part of meaningful noted that the form and manner of
2015 IPPS final rule 79 FR 50323). use of certified EHR technology. reporting of CQMs for Medicare EPs
Comment: A few commenters Comment: Many commenters would also be included in the PFS,
suggested that we further align the supported our proposal to allow a 90- while for Medicaid we would continue
Medicare EHR Incentive Program with day reporting period for clinical quality to allow the states to determine form
PQRS and allow EPs reporting through measures for all EPs, eligible hospitals, and method requirements subject to
a Qualified Clinical Data Registry and CAHs that report clinical quality CMS approval.
(QCDR) to satisfy the CQM reporting measures by attestation. Some We proposed to continue the policy of
requirements for meaningful use. commenters additionally suggested that establishing certain CQM requirements
that apply for both the Medicare and are generally updated annually, and Medicare and Medicaid EHR Incentive
Medicaid EHR Incentive Programs, certain updates are posted in advance of Programs for EPs in the PFS rulemaking.
including a common set of CQMs and the final rule. We also note that re- We intend to continue to allow the
the reporting periods for CQMs in the certification of EHR technology is not states to determine form and manner of
EHR Incentive Programs. required for the CQM annual update. reporting CQMs for their respective state
Comment: Commenters supported the Additionally, we have taken steps to Medicaid EHR Incentive Programs
alignment efforts between the Medicare align certain aspects of the various CMS subject to CMS approval.
EHR Incentive Program and PQRS or quality reporting programs that include
other quality programs affecting EPs. b. CQM Reporting Requirements for
the submission of CQMs.
Most commenters stated that alignment Comment: Other commenters Eligible Hospitals and Critical Access
would reduce burden on EPs and expressed concern about the number of Hospitals
streamline the quality reporting process. stakeholders involved in these aligned In the Stage 3 proposed rule (80 FR
Some commenters also appreciated the programs, and stated that it would be 16769), similar to our intentions for EPs
link between the annual rulemaking challenging for EPs to get answers to discussed previously, we noted that to
cycle and updates to the CQMs stating questions or responses from CMS due to further our alignment goal among CMS
that aligning CQM requirements for the the number of stakeholders involved in quality reporting programs for eligible
EHR Incentive Programs with other CQM submissions. hospitals and CAHs, and avoid
quality programs in annual rulemaking Response: We understand this redundant or duplicative reporting
would require measure developers to concern, and we note that we also among hospital programs, we intend to
revise their CQM specifications more continue to align CMS help desks, address CQM reporting requirements for
frequently, helping to ensure CQMs feedback processes, and other resources the Medicare and Medicaid EHR
reflect the latest clinical evidence. to avoid delays in answering questions. Incentive Program for eligible hospitals
Response: We appreciate the We believe that alignment of the CQM and CAHs for 2016, 2017, and future
commenters’ support of our proposal, requirements along with this years, in the Inpatient Prospective
and agree that aligning the Medicare coordination effort will greatly reduce Payment System (IPPS) rulemaking. We
EHR Incentive Program and PQRS or burden on EPs. stated that we intend to include all
other quality programs affecting EPs Comment: While commenters Medicare EHR Incentive Program
would reduce burden on EPs. We also acknowledged the alignment effort to requirements related to CQM reporting
agree that annual rulemaking will allow address CQM policies in the PFS rule, in the IPPS rulemaking including, but
CMS to ensure that CQMs used in some also requested further clarification not limited to, new program
quality reporting programs are updated in regard to how CQM alignment among requirements, reporting requirements,
regularly. the programs would work. Specifically, reporting and submission periods,
Comment: A few commenters they questioned whether EPs who reporting methods, and information
suggested that since CQMs are a choose to attest in 2017 would still be regarding the CQMs.
requirement of multiple EP quality required to report to other quality As with EPs, for the Medicaid EHR
programs, they could be removed from programs, or whether attestation could Incentive Program we would continue
the EHR Incentive Program count for multiple programs. to allow the states to determine form
requirements because this CQM Response: We appreciate the question and method requirements subject to
reporting is redundant. and opportunity to further explain this CMS approval. We proposed to continue
Response: We appreciate the policy, which is a current policy not a the policy of establishing certain CQM
commenters’ suggestion. However, as new policy. Reporting CQMs by requirements that apply for both the
noted previously, CQM reporting for the attestation under the EHR Incentive Medicare and Medicaid EHR Incentive
EHR Incentive Programs is required by Programs is not an acceptable method of Programs including a common set of
section 1848(o)(2)(A)(iii) of the Act and submission for other CMS quality CQMs and the reporting periods for
an integral part of the National Quality reporting programs because, unlike the CQMs in the EHR Incentive Programs.
Strategy for CMS and HHS as a whole. EHR Incentive Programs, these other Comment: Commenters supported the
We further note that in the EHR programs have not adopted attestation alignment efforts between the Medicare
Incentive Programs in 2015 through as a reporting mechanism and also have EHR Incentive Program and Hospital
2017 proposed rule (80 FR 20375) we additional requirements that relate to IQR Program. Most commenters stated
stated our intent to maintain these CQM the results of the CQM calculation. that alignment would reduce burden on
policies as previously finalized. We Therefore, reporting CQMs by eligible hospitals and CAHs. Some
further believe that by aligning the CQM attestation for the EHR Incentive commenters also appreciated the link
requirements of the different quality Programs would not count toward CQM between the annual rulemaking cycle
reporting programs, we are reducing reporting for other quality programs. and updates to the CQMs stating that
burden and removing the redundancy of EPs who choose to report CQMs for the aligning CQM requirements for the EHR
CQM reporting by allowing EPs to EHR Incentive Programs by attestation Incentive Program with other quality
report once for multiple programs. in 2017 would need to separately report programs in annual rulemaking would
Comment: Some commenters to other quality programs via one of the require measure developers to revise
expressed concerns regarding the approved reporting mechanisms for the their CQM specifications more
amount of time between the publication particular program. frequently helping to ensure that CQMs
of the PFS final rule and when the After consideration of the public reflect the latest clinical evidence.
CQMs and policies would go into effect. comments we received, we intend to Response: We appreciate the
Many expressed concern over whether continue our policy of establishing commenters’ support of our proposal,
their EHR vendor would have time to certain CQM requirements that apply for and agree that aligning the Medicare
certify and update their system to the both the Medicare and Medicaid EHR EHR Incentive Program and the Hospital
most recent version of the CQMs. Incentive Programs, including a IQR Program or other quality programs
Response: We understand the common set of CQMs and the reporting affecting eligible hospitals and CAHs
commenters’ concerns and note that periods for CQMs. We intend to address would reduce burdens. We also agree
CQMs referenced in the PFS rulemaking CQM reporting requirements for the that annual rulemaking will allow CMS
to ensure that CQMs used in quality After consideration of the public reporting period of one full calendar
reporting programs are updated comments we received, we intend to year for meaningful use for providers
regularly. continue our policy of establishing participating in the Medicare EHR
Comment: Some commenters certain CQM requirements that apply for Incentive Program, with a limited
expressed concerns regarding the both the Medicare and Medicaid EHR exception for Medicaid providers
amount of time between the publication Incentive Programs, including a demonstrating meaningful use for the
of the IPPS final rule and when the common set of CQMs and the reporting first time (80 FR 16779). We proposed
CQMs and policies would go into effect. periods for CQMs. We intend to address to require the same length for the CQM
Many expressed concern over whether CQM reporting requirements for the reporting period for EPs, eligible
their EHR vendor would have time to Medicare and Medicaid EHR Incentive hospitals, and CAHs beginning in 2017.
certify and update their system to the Programs for eligible hospitals and We proposed a limited exception for
most recent version of the CQMs, and a CAHs in the IPPS rulemaking. We Medicaid providers demonstrating
few went on to request that changes to intend to continue to allow the states to meaningful use for the first time who
CQMs and submission requirements not determine form and manner of reporting would have a CQM reporting period of
change from one quarter reporting CQMs for their respective state any continuous 90 days that is the same
period to the next. Medicaid EHR Incentive Programs 90-day period as their EHR reporting
Response: We understand the subject to CMS approval. period.
commenters’ concerns and note that c. Quality Reporting Data Architecture a. CQM Reporting Period for EPs
CQMs referenced in the IPPS Category III (QRDA–III) Option for We proposed to require a CQM
rulemaking are generally updated Eligible Hospitals and CAHs reporting period of one full calendar
annually, and certain updates are posted
In the Stage 3 proposed rule (80 FR year for all EPs participating in the
in advance of the final rule. The 2016
16771), we proposed to remove the Medicare and Medicaid EHR Incentive
IPPS final rule provides flexibility to
QRDA–III option for eligible hospitals Program, with a limited exception for
eligible hospitals and CAHs needing to
and CAHs, as we believe the CQM Medicaid providers demonstrating
update their EHR systems only for the
calculations, per the QRDA–III, are not meaningful use for the first time who
most recent version of the CQMs. No
advantageous to quality improvement in would have a CQM reporting period of
changes to 2014 CEHRT criteria or
a hospital setting. We noted that as the any continuous 90 days that is the same
timelines are being finalized in this final
EHR Incentive Programs further aligns 90-day period as their EHR reporting
rule with comment period. period. We proposed these reporting
with the Hospital IQR Program, we
Comment: Some commenters intend to continue utilizing the periods would apply beginning in CY
expressed concerns related to CMS’ electronic reporting standard of QRDA– 2017 for all EPs participating in the EHR
ability to accept electronically I patient level data that we finalized in Incentive Program.
submitted CQMs. the FY 2015 IPPS rule (79 FR 50322), Comment: Most commenters
Response: We understand the which will allow the same level of CQM supported one full calendar year of
commenters’ concerns. CMS has worked reporting, and use and analysis of these reporting for EPs participating in the
to continually develop and improve its data for quality improvement initiatives. EHR Incentive Programs. Some
CQM receiving system for the purposes We also proposed that states would commenters stated that they believed
of collecting CQMs electronically. continue to have the option, subject to this would result in more complete and
Comment: Some commenters noted our prior approval, to allow or require accurate data. A few commenters stated
that the Hospital IQR Program is not QRDA–III for CQM reporting. that no exception should be granted for
required for CAHs and requested We received comments regarding Medicaid providers demonstrating
clarification on how the alignment of these proposals in response to the Stage meaningful use for the first time because
the Medicare EHR Incentive Program 3 proposed rule, as well as comments this exception would cause confusion.
and Hospital IQR Program would regarding the QRDA–III option in A commenter recommended that under
impact CAHs seeking to electronically response to the FY 2016 IPPS/LTCH this exception, we allow the 90-day
submit their CQM data. PPS proposed rule. We considered these reporting period for CQMs to be
Response: We agree that the Hospital comments and responded to them in the different than the 90-day EHR reporting
IQR Program is not required for CAHs. FY 2016 IPPS/LTCH PPS final rule, and period.
Only subsection (d) hospitals are subject we finalized our proposal to remove the Response: We appreciate the
to the requirements and payment QRDA–III as an option for reporting comments in support of our proposal,
reductions of the Hospital IQR Program. under the Medicare EHR Incentive and we agree that a full year of reporting
For the EHR Incentive Programs, CAHs Program. We stated that for 2016 and would lead to more complete data.
may continue to report their CQM data future years, we are requiring QRDA–I However, we believe that a 90-day CQM
by attestation in CY 2016. However, we for CQM electronic submissions for the reporting period is appropriate for the
encourage CAHs to submit their CQMs Medicare EHR Incentive Program. We Medicaid EHR Incentive Program when
electronically through the QualityNet also noted that states would continue to the EP is attesting to meaningful use for
portal. We believe electronic submission have the option, subject to our prior the first time. A 90-day CQM reporting
of CQMs is an important next step in the approval, to allow or require QRDA–III period would allow Medicaid EPs
meaningful use of certified EHR for CQM reporting. For more additional time and flexibility within
technology, and encourage CAHs to information, we refer readers to the their first year of demonstrating
begin submitting CQMs electronically in discussion in the FY 2016 IPPS/LTCH meaningful use to implement certified
2016. We further note that in section PPS final rule (80 FR 49759 through EHR technology and otherwise integrate
II.C.4 of this final rule with comment 49760). the meaningful use objectives into their
period, we finalize our policy to require practices. We also believe that it would
the electronic submission of CQMs 3. CQM Reporting Period Beginning in reduce the burden on states to
starting in 2018 and thus encourage 2017 implement significant policy and
CAHs to begin electronically reporting In the Stage 3 proposed rule (80 FR system changes in preparation for Stage
CQMs as soon as feasible. 16773), we proposed to require an EHR 3, as the 90-day period for the first year
of meaningful use is consistent with our day reporting period for CQMs for 2017. the proposal stating that there is
previous policies and meaningful use The shorter reporting period for Stage 3 additional work that needs to be done
timelines. We agree with the participants is intended to ease the to assess the feasibility, accuracy, and
commenter’s recommendation that we transition to the new Stage 3 objectives reliability of electronically submitted
not require the reporting period for and measures and higher thresholds. data. Some commenters opposed the
CQMs to be the same 90-day period as There is no such difference between the proposal stating that it creates
the EHR reporting period under the CQM requirements for Stage 3 additional burden on eligible hospitals
exception proposed for Medicaid. We participation in 2017 versus and CAHs to collect the data, and some
believe it is appropriate for the CQM participation meeting the objectives and went on to suggest that CMS continue
reporting period to be any continuous measures outline for use in 2015 the validation pilot instead of requiring
90-day period in the calendar year for through 2017 in section II.B.2.a of this one full year of electronically submitted
providers demonstrating meaningful use final rule with comment period. data in 2018. A few commenters
for the first time under the Medicaid Note that there is also a 90-day EHR suggested a 90-day reporting period for
EHR Incentive Program. This will give reporting period permitted in 2017 for all eligible hospitals and CAHs in 2018
providers flexibility with attesting and EPs participating for the first time in when electronic reporting is required. A
would not require states to make system either the Medicare or Medicaid EHR commenter recommended that under
changes as there are 90-day reporting Incentive Programs. Consistent with the limited exemption for Medicaid
periods under the current policy. prior program years, we are permitting eligible hospitals and CAHs, we should
Comment: Some commenters opposed EPs participating for the first time in allow the 90-day reporting period for
the proposal stating that there is 2017 to use a 90-day reporting period CQMs to be different than the 90-day
additional work that needs to be done for CQMs. EHR reporting period.
to assess the feasibility, accuracy, and After considering the public Response: We appreciate the
reliability of electronically reported comments we received, we are comments we received in support of our
data, while others stated that requiring finalizing our proposal to require a CQM proposal, and agree that accepting one
one calendar year of electronically reporting period of one full calendar full year of data will result in more
submitted data creates additional year for EPs participating in the
complete and accurate data. We
burden on EPs to collect that data. A Medicare and Medicaid EHR Incentive
understand the concerns stated by
few commenters suggested a 90-day Programs starting in 2017. We are
commenters regarding the additional
reporting period for all EPs in 2018 finalizing with modification our
burden and efforts associated with
when electronic reporting is required. proposal of a limited exception for EPs
collecting this data, but we note that
Response: We understand the demonstrating meaningful use for the
providers would be able to submit one
commenters’ concerns and note that first time under the Medicaid EHR
full year of data for both the EHR
CMS continues to assess electronically Incentive Program. For these EPs, the
Incentive Program and the Hospital IQR
reported data for accuracy and reporting period for CQMs would be any
Program, thereby reducing provider
reliability. If data is determined to be continuous 90-day period within the
flawed, such data will be identified by CY, with the modification that it could burden. We further note that CMS
CMS in order to preserve the integrity be a different 90-day period than their continues to assess electronically
of data used for differentiating EHR reporting period for the incentive submitted data for accuracy and
performance. Additionally we note that payment under Medicaid. reliability. If data is determined to be
one calendar year of data is required for flawed, such data will be identified by
b. CQM Reporting Period for Eligible CMS in order to preserve the integrity
PQRS and other quality reporting
Hospitals and CAHs of data used for differentiating
programs with which we seek to align
the EHR Incentive Program; this For eligible hospitals and CAHs in performance.
alignment reduces provider burden by 2017 and subsequent years, in the Stage While we are allowing a 90-day EHR
allowing EPs to report once for multiple 3 proposed rule (80 FR 16770)we reporting period for eligible hospitals
programs. We believe full year reporting proposed to require a reporting period and CAHs who demonstrate Stage 3 in
is necessary for the efficacy of quality of one full calendar year which consists 2017, we do not believe it is necessary
measurement and quality improvement of 4 quarterly data reporting periods for to similarly allow returning participants
planning, and, in fact, most CQMs are providers participating in the Medicare who are participating in Stage 3 to also
designed to be collected over a 12- and Medicaid EHR Incentive Program, use a 90-day reporting period for CQMs
month period, including multiple with a limited exception for Medicaid for 2017. The shorter reporting period
variables to track change over time. As providers demonstrating meaningful use for Stage 3 participants is intended to
mentioned in the Stage 3 proposed rule, for the first time who would have a ease the transition to the new Stage 3
we believe full year CQM reporting will CQM reporting period of any objectives and measures and higher
allow for the collection of more continuous 90 days that is the same 90- thresholds. There is no such difference
comparable data across CMS quality day period as their EHR reporting between the CQM requirements for
programs, increase alignment across period. We stated that more details of Stage 3 participation in 2017 versus
those programs, and reduce the the form and manner will be provided participation meeting the objectives and
complexity of reporting requirements in the IPPS rulemaking cycle. measures outlined for use in 2015
for the Medicare EHR Incentive Program Comment: Most commenters through 2017 in section II.B.2.a. of this
by streamlining the reporting timeline supported one full calendar year of final rule with comment period.
for providers for CQMs and meaningful reporting for eligible hospitals and Note that there is also a 90-day EHR
use objectives and measures (79 FR CAHs participating in the EHR Incentive reporting period permitted in 2017 for
16769). While we are allowing a 90-day Programs. Some commenters stated that eligible hospitals and CAHs
EHR reporting period for EPs who they believed this would result in more participating for the first time in either
demonstrate Stage 3 in 2017, we do not complete and accurate data, and others the Medicare or Medicaid EHR
believe it is necessary to similarly allow expressed support for a consistent Incentive Programs. Consistent with
returning participants who are reporting period across reporting prior program years, we are permitting
participating in Stage 3 to also use a 90- programs. Some commenters opposed eligible hospitals and CAHs
participating for the first time in 2017 to attest also using the most recent (2016 II.C.1.b. of the Stage 3 proposed rule (80
use a 90-day reporting period for CQMs. version) eCQM electronic specifications. FR 16770), we would allow attestation
After consideration of the public Comment: Commenters supported our for CQMs in 2017.
comments that we received, we are proposal to allow more flexibility in For 2018 and subsequent years, we
finalizing our proposal to require a 2017 reporting. Most commenters proposed that providers participating in
reporting period of one full calendar supported a move toward electronic the Medicare EHR Incentive program
year which consists of 4 quarterly data reporting, and also agreed that must electronically report where
reporting periods starting in 2017 for attestation should remain an option for feasible and that attestation to CQMs
eligible hospitals and CAHs 2017 to provide options to, and reduce would no longer be an option except in
participating in the Medicare and burden on EPs, eligible hospitals, and certain circumstances where electronic
Medicaid EHR Incentive Program. We CAHs. Some commenters supported our reporting is not feasible. This would
are finalizing with modification our proposal but urged CMS to make include providers facing circumstances
proposal of a limited exception for electronic reporting mandatory in 2018 which render them unable to
or move up the timeline to require electronically report (such as a data
eligible hospitals and CAHs
mandatory electronic reporting as soon submission system failure, natural
demonstrating meaningful use for the
as possible. disaster, or certification issue outside
first time under the Medicaid EHR
Response: We appreciate the the control of the provider) who may
Incentive Program. For these eligible
comments in support of our proposal, attest to CQMs if they also attest that
hospitals and CAHs, the reporting
and agree with commenters’ statements electronically reporting was not feasible
period for CQMs would be any
that flexibility reduces burden on EPs, for their demonstration of meaningful
continuous 90-day period within the
eligible hospitals, and CAHs. We also use for a given year. We noted that we
CY, with the modification that it could
appreciate commenters’ support of a intend to address the form and manner
be a different 90-day period than their
move toward electronic reporting, and of electronic reporting in future
EHR reporting period for the incentive
requiring electronic reporting in 2018 or Medicare payment rules.
payment under Medicaid. More details For the Medicaid EHR Incentive
moving up the timeline for mandatory
of the form and manner will be Program, as in the Stage 2 rulemaking
electronic reporting. We believe
provided in the IPPS rulemaking cycle. (77 FR 54089), we proposed that states
electronic reporting is an important step
c. Reporting Flexibility for EPs, Eligible in demonstrating meaningful use of would continue in Stage 3 to be
Hospitals, and CAHs in 2017 certified EHR technology and note that responsible for determining whether
in section II.C.4 of this final rule with and how electronic reporting of CQMs
We proposed that EPs, eligible comment period, we are finalizing our would occur, or whether they wish to
hospitals, and CAHs would be able to proposal to require electronic reporting continue to allow reporting through
have more flexibility to report CQMs in in 2018 where feasible. attestation. If a state does require such
one of two ways in 2017—via electronic After consideration of these public electronic reporting, the state is
reporting or attestation (80 FR 16770). comments, we are finalizing this policy responsible for sharing the details of the
First EPs, eligible hospitals, and CAHs as proposed. process with its provider community.
may choose to report eCQMs We proposed for Stage 3 that the states
electronically using the CQMs finalized 4. Reporting Methods for CQMs would establish the method and
for use in 2017 using the most recent In the Stage 3 proposed rule (80 FR requirements, subject to our prior
version of the eCQMs (electronic 16770), starting in 2017, we proposed to approval, for the electronic capture and
specifications), which would be the continue to encourage electronic reporting of CQMs from CEHRT. We
electronic specifications of the CQMs submission of CQM data for all EPs, have included Table 17 in this final rule
published by CMS in 2016. Alternately, eligible hospitals, and CAHs where with comment period as a summary of
a provider may choose to continue to feasible. However, as outlined in section our proposals (80 FR 16770).
TABLE 17—PROPOSED ECQM REPORTING TIMELINES FOR MEDICARE AND MEDICAID EHR INCENTIVE PROGRAM
2018 and Subsequent 2018 and Subsequent
Year 2017 Only 2017 Only years years
Reporting method available Attestation ......................... Electronic Reporting .......... Attestation ......................... Electronic Reporting
Provider Type who May All Medicare providers ...... All Medicare Providers ...... Medicare Providers with All Medicare Providers
Use Method. Medicaid providers must Medicaid providers must circumstances rendering Medicaid providers must
refer to state require- refer to state require- them unable to eReport. refer to state require-
ments for reporting. ments for reporting. Medicaid providers must ments for reporting.
refer to state require-
ments for reporting.
CQM Reporting Period ...... 1 CY for Medicare ............. 1 CY for Medicare ............. 1 CY for Medicare ............. 1 CY for Medicare
1 CY for returning Med- 1 CY for returning Med- 1 CY for returning Med- 1 CY for returning Med-
icaid. icaid. icaid. icaid
90 days for first time 90 days for first time 90 days for first time 90 days for first time
meaningful user Med- meaningful user Med- meaningful user Med- meaningful user Med-
icaid. icaid. icaid. icaid.

eCQM Version Required ... 2016 Annual Update ......... 2016 Annual Update ......... 2016 Annual Update or 2017 Annual Update.
(CQM electronic specifica- more recent version.
tions update).
CEHRT Edition Required .. 2014 Edition Or 2015 Edi- 2014 Edition Or 2015 Edi- 2015 Edition ...................... 2015 Edition
tion. tion.
Comment: Most commenters Comment: A few commenters we require the most recent version of
supported the move to electronic suggested that CMS should direct states the CQM specifications to be used for
reporting; however, they did so with on reporting method to prevent too electronic reporting methods, we
caution. Commenters expressed their much variation among the state and understand that EHR vendors must
support, as well as concerns, related to federal programs. make CQM updates on an annual basis
the feasibility of the move to electronic Response: While we appreciate the and providers must regularly implement
reporting of CQMs citing issues with commenters’ suggestion, we believe those updates to stay current with the
data submission and the reliability of that, consistent with our policy in most recent CQM version.
CQMs. Some commenters expressed previous years for the EHR Incentive In the Stage 3 proposed rule (80 FR
concerns about committing to a timeline Programs, the reporting method for 16771), we proposed no changes to our
for implementing electronic reporting of CQMs in the Medicaid EHR Incentive policy on updating CQM specifications.
CQMs stating that they had concerns Program is an operational question that However, we stated that we will
about future updates to CQMs and the is best left to state discretion subject to continue to evaluate the CQM update
difficulties eligible hospitals face in our approval. Allowing states flexibility timeline and look for ways to provide
implementing CQMs currently. with respect to the reporting method for CQM updates timely, so that vendors
Response: We appreciate the CQMs permits states to continue using can develop, test, and deploy these
comments in support of our move to attestation or to pursue other options updates and providers can implement
electronic reporting, and understand such as electronic reporting. We believe those updates as necessary.
some of the concerns that come along this is appropriate given the varying We received many comments in
with that move. CMS continues to capabilities and policies among states response to our request for comments.
evaluate the accuracy and reliability of regarding CQM submission. However, we note that we did not make
CQM data received from providers. We We are finalizing our policy as any specific proposal in regard to the
believe that it is important to set a proposed, that in 2017 all providers annual update process for CQMs.
timeline for requiring electronic have two options to report CQM data, Comment: Many commenters
reporting and to give EPs, eligible either through attestation or through use expressed concerns regarding the timing
hospitals, CAHs and their EHR vendors of established methods for electronic and frequency of annual updates.
time to prepare for this requirement. reporting where feasible. Starting in Several stated that EHR vendors need
Comment: A few commenters 2018, providers participating in the more time to update the CQMs in their
requested clarification as to which CQM Medicare EHR Incentive Program must EHRs and suggested updates should be
version would be accepted via electronically report where feasible and minimal, or that the new specifications
attestation. that attestation to CQMs would no for CQMs should be released well in
Response: We appreciate the longer be an option except in certain advance of their implementation. A few
comments and the opportunity to clarify circumstances where electronic commenters suggested that the CQM
our policy. For 2017 reporting, we will reporting is not feasible. We are also updates should be more frequent, such
accept the 2016 version of the CQM finalizing our proposal that for the as monthly, to address changes in
specifications for both attested and Medicaid EHR Incentive Program states clinical guidance and to keep the CQMs
electronically reported CQMs. For 2018 would continue to be responsible for relevant.
reporting, we will accept the 2017 determining whether and how Response: We appreciate both
version of the CQM specifications for electronic reporting of CQMs would perspectives on this subject and note
both attested and electronically reported occur, or whether they wish to continue that the CQM specifications are posted
CQMs. For 2018, we will additionally to allow reporting through attestation. at least 6 months prior to the reporting
accept the 2016 version of the CQM We note that if a state does require such period. We believe it is important to
specifications for attestation. We note electronic reporting, the state is reflect the most recent clinical guidance
that attestation in 2018 will be allowed responsible for sharing the details of the in CQMs, and therefore seek to find an
for providers facing circumstances process with its provider community. appropriate balance between the timing
which render them unable to We also note that the states would of the posting of CQM specifications
electronically report (such as a data establish the method and requirements, and the reporting period for those
submission system failure, natural subject to our prior approval, for the CQMs.
disaster, or certification issue outside electronic capture and reporting of Comment: Some commenters
the control of the provider) who may CQMs from CEHRT. suggested that recertification should be
attest to CQMs if they also attest that required with each update to the CQMs.
5. CQM Specification and Changes to
electronically reporting was not feasible, Response: At this time, we do not
the Annual Update
and we are therefore allowing either the require recertification with the annual
2016 or 2017 version of the CQM In the Stage 3 proposed rule (80 FR update, but instead strongly recommend
specifications due to this exception. 16771), we recognized that it may be and encourage EHR vendors to test their
Comment: A few commenters stated necessary to update CQM specifications products against CMS verification tools
that since attestation to core objectives after they have been published to ensure and receiving systems.
is a manual process, CQM submission their continued clinical relevance, Comment: Some commenters
should also remain a manual process accuracy, and validity. CQM suggested that CMS have some
and the two should not be split. specification updates may include flexibility in when a CQM can be
Response: We believe that electronic administrative changes, such as adding updated in order to address those
reporting is a valuable step in the NQF endorsement number to a situations where a CQM required an
demonstrating meaningful use and CQM, correcting faulty logic, adding or update mid-year. For example, these
helps us to reach our goal of alignment deleting codes as well as providing commenters suggested that CMS be able
with other quality reporting programs. additional implementation guidance for to update or suspend the use of that
In addition, we note that the data a CQM. These changes are described CQM at any point during the year.
received via electronic reporting is through the annual updates to the Response: We appreciate all
valuable and necessary for quality electronic specifications for EHR comments received in regard to the
improvement. submission published by CMS. Because annual update process, and will take
them into consideration for future eligible hospitals and CAHs; in plan to certify to all CQMs, even in a
rulemaking and policy development. subsequent years of the plan, we would phased approach, because they were
We note that we did not make any increase the number of required CQMs unclear about the number and quality of
specific proposals in the Stage 3 for EPs until the EHR is certified to all the CQMs to be included in future years
proposed rule, and thus are not applicable CQMs for EPs, eligible of the EHR Incentive Program. Lastly,
finalizing any change to our policy at hospitals, and CAHs. some commenters expressed concern
this time. We have also considered alternate about the burden this plan could place
plans that would require EHRs to be on EPs, eligible hospitals, and CAHs
6. Certified EHR Technology certified to more than the minimum because of the added effort it would take
Requirements for CQMs number of CQMs required for reporting, to implement these measures in their
In the 2014 Edition EHR Certification but would not require the EHR to be provider setting.
Criteria Final Rule, ONC finalized certified to all available CQMs. For Response: We appreciate all of the
certain certification criteria to support example, we might require that EHRs be comments we received in regard to the
the meaningful use objectives and certified to a certain core set of CQMs plans we outline in the proposed rule(s).
CQMs set forth by CMS. In that rule, plus an additional 9 CQMs for EPs, and We note that we did not make any
ONC also specified that in order for an a certain core set of CQMs plus an proposals to implement these plans, and
EP, eligible hospital, or CAH to have additional 16 CQMs for eligible we will not be finalizing any policy
EHR technology that meets the Base hospitals and CAHs, which the EHR regarding a requirement to have EHRs
EHR definition, the EHR technology vendor could choose from the list of certify to a certain number of CQMs. We
must be certified to a minimum of nine available CQMs. agree with the majority of commenters
CQMs for EPs or 16 CQMs for eligible We note that the specifics of this plan that EHRs should be required to certify
hospitals and CAHs (77 FR 54264 would be outlined in separate notice- to more than the minimum number of
through 54265; see also 45 CFR and-comment rulemaking such as the CQMs for reporting. However, we are
170.102). This is the same number PFS or IPPS rules. In the Stage 3 still determining what that number
required for quality reporting to the proposed rule (80 FR 16771 through should be, and will take these
Medicare and Medicaid EHR Incentive 16772), we sought comment on a plan comments into consideration as we
Programs, the PQRS EHR reporting and, to increase the number of CQMs to continue to develop that policy.
beginning in 2015, the electronic which an EHR is certified.
reporting option under the Hospital IQR Comment: We received many 7. Electronic Reporting of CQMs
Program. comments in support of a plan to As previously stated in the Medicare
As stated in the Stage 3 proposed rule require EHR vendors to certify to more and Medicaid EHR Incentive Programs
(80 FR 16771 through 16772), we than the minimum required CQMs, and Stage 2 final rule (77 FR 54051 through
believe EHRs should be certified to several comments in support of a plan 54053) and restated in the Stage 3
more than the minimum number of to have EHR vendors certify to all proposed rule (80 FR 16772), CQM data
CQMs required by one or more CMS CQMs. Most commenters stated that submitted by EPs, eligible hospitals, and
quality reporting programs so that EPs, either approach would reduce burden CAHs are required to be captured,
eligible hospitals, and CAHs have a on EPs, eligible hospitals, and CAHs by calculated, and reported using certified
choice of which CQMs to report, and allowing them to choose which EHR technology. We do not consider the
could therefore choose to report on measures to report instead of being manual abstraction of data from a
CQMs most applicable to their patient forced to report on only those CQMs to patient’s chart to be capturing the data
population or scope of practice. which their EHR is certified. using certified EHR technology. We
We realize that requiring EHRs to be Commenters also stated that having believe that electronic information
certified to more than the minimum more CQMs to choose from would interfaced or electronically transmitted
number of CQMs required by the reduce the number of zero denominators from non-certified EHR technology,
Medicare and Medicaid EHR Incentive that are reported to CMS because EPs, such as lab information systems,
Programs may increase the burden on eligible hospitals, and CAHs would automated blood pressure cuffs, and
EHR vendors. However, in the interest have better access to CQMs for which electronic scales, into the certified EHR,
of EPs, eligible hospitals, and CAHs they have patient data. Some would satisfy the ‘‘capture’’
being able to choose to report eCQMs commenters also proposed alternative requirement, as long as that data is
that represent their patient populations, plans such as a requirement to have visible to providers in the EHR.
we would like to see EP vendors certify EHRs certify to ‘‘capture and export’’ all Comment: We received several
to all eCQMs that are in the EP selection CQMs, but not necessarily to ‘‘calculate comments regarding the manual
list, or eligible hospital/CAH vendors and report’’ those CQMs, or to have all extraction of data from a patient’s chart.
certify to all eCQMs in the selection list consumers of CQM data, including Specifically, a few commenters objected
for those stakeholders. states, private payers, etc., agree on one to the loss of opportunity to manually
We are also considering a phased set of CQMs to be reported. extract data from a patient’s chart, and
approach such that the number of CQMs A few commenters opposed any plan a few stated their need to continue
required for the vendors to have to require a certain number of CQMs to extracting data from a patient’s chart.
certified would increase each year until which EHRs must be certified stating Response: We did not make any
EHR products are required to certify all that EHR vendors should be allowed to proposals on this subject in the Stage 3
CQMs required for reporting by EPs, choose CQMs based on their provider proposed rule, but noted that we do not
eligible hospitals, and CAHs. For population or specialty product. Some consider the manual abstraction of data
example, in year one of this phased commenters opposed the plan to certify from the EHR to be capturing the data
plan, we might require that EHRs be to all CQMs because of the burden it using certified EHR technology (80 FR
certified to at least 18 of 64 available would place on EHR vendors, and 16772). Explanation of our goal to
CQMs for EPs and 22 of 29 available because it would force EHRs to be transition from manual abstraction of
CQMs for eligible hospitals and CAHs; certified to CQMs that are not relevant data to electronic reporting for hospital
in year two, we might require at least 36 to the EHR’s provider population. Other reporting can be found in the Medicare
CQMs for EPs and all 29 CQMs for commenters expressed concern about a and Medicaid EHR Incentive Programs
Stage 2 final rule (77 FR 54078 through Response: We understand the need to concerns if hospital attestations are
54079). provide information for providers as added to that total. Finally, a number of
quickly as possible and will work to commenters requested that systems be
D. Demonstration of Meaningful Use
create educational guides, FAQs, tip opened early to allow eligible hospitals
and Other Issues
sheets, and other tools to support that are attesting for the first time to
1. Demonstration of Meaningful Use providers seeking to meet the earn an incentive payment as quickly as
a. Common Methods of Demonstration requirements of the EHR Incentive possible.
Program for an EHR reporting period in Response: First, we note that under
in Medicare and Medicaid
2015. the Administrative Procedure Act, we
In the EHR Incentive Programs for After consideration of the comments could not accept attestations for 2015
2015 through 2017 and the Stage 3 received, we are finalizing our proposal that are based solely on proposals made
proposed rules, we proposed to to maintain attestation as the in a notice of proposed rulemaking.
continue our common method for demonstration method for EHR Second, as we stated in the EHR
demonstrating meaningful use in both reporting periods in 2015 through 2017 Incentive Program in 2015 through 2017
the Medicare and Medicaid EHR and the corresponding regulation text at proposed rule (80 FR 20376), the
Incentive Programs (80 FR 20376 and 80 § 495.40. majority of eligible professionals would
FR 16772). The demonstration methods have been attesting for an EHR reporting
we adopt for Medicare will c. Attestation Deadlines for the EHR
period in 2015 of one full year at the
automatically be available to the states Incentive Programs in 2015 through
close of CY 2015. This means that the
for use in their Medicaid programs. 2017
high volume of attestations in January
In the EHR Incentive Program in 2015 and February of 2015 has already been
b. Methods for Demonstration of the
through 2017 proposed rule (80 FR anticipated and preparations for that
Criteria for Meaningful Use in 2015
20376), we proposed changes to the time have been made. Therefore, we do
through 2017
attestation deadlines for eligible not expect the proposed changes to the
As mentioned previously in section hospitals and CAHs in connection with attestation deadlines would
II.B.1.b.(2). of this final rule with the proposal that these providers must significantly increase the load on CMS
comment period, we are redesignating complete an EHR reporting period systems, and even with full
the numbering of certain sections of the between October 1, 2014 and the end of participation among eligible hospitals
regulation text under part 495. In prior the calendar year (CY) on December 31, and CAHs, only an additional 4,000
rules, we defined the criteria for the 2015, and complete an EHR reporting attestations would be received at the
demonstration of meaningful use at period for 2016 between January 1, 2016 close of the calendar year with the shift
§ 495.8, which is redesignated as and December 31, 2016. Specifically, we from fiscal year to calendar year
§ 495.40. We defined the criteria for the proposed changes to the attestation reporting for these providers.
demonstration of meaningful use at deadlines as follows: Comment: A number of commenters
§ 495.40, including references to the • For an EHR reporting period in requested an extension of the attestation
objectives and measures as well as the 2015, an eligible hospital or CAH must period following the close of the year for
requirement to report CQMs. In order to attest by February 29, 2016. EHR reporting periods in 2015. Some of
demonstrate meaningful use in 2015 • For an EHR reporting period in these commenters recommended that
through 2017, we proposed (80 FR 2016, an eligible hospital or CAH must data submission be allowed for 3
20374) that the requirements at § 495.40 attest by February 28, 2017. months or for 6 months following the
include a reference to the objectives and In addition, we noted that providers close of the calendar year. Other
measures for 2015 through 2017 would not be able to attest for an EHR commenters stated that large
outlined at § 495.22 which the provider reporting period in 2015 prior to organizations need more time to
must satisfy (80 FR 20376). January 1, 2016 in order to allow complete attestations. A number of
We proposed to continue the use of adequate time to make the system commenters requested that CMS allow
attestation as the method for changes necessary to accept attestations. greater flexibility in prolonging an
demonstrating that an EP, eligible This change would not delay incentive attestation period for 2015 only. Still
hospital, or CAH has met the objectives payments for Medicare EPs because other commenters noted that there may
and measures of meaningful use. Instead 2015 cannot be an EP’s first payment be a lag after the end of the reporting
of individual Medicare EP attestation year under section 1848(o)(1)(B)(v) of period before all data can be collected
through the CMS Registration and the Act. Thus, all EPs who qualify for and validated. These commenters
Attestation System, we also proposed to an incentive payment for 2015 would be suggested that we allow for a longer
continue the existing optional batch file returning participants in the program period of time in which to attest after
process for attestation. Further, we and would have had the full CY 2015 as the reporting period, which would
proposed changes to the deadlines for their EHR reporting period under our allow for accurate collection, validation,
EPs, eligible hospitals, and CAHs to current policy. We received the documentation, and attesting to the
demonstrate meaningful use in 2015 following comments and our response data. Other commenters noted the
and 2016; as well as specific changes to follows: volume of attestations and requested
the deadlines for providers to Comment: A number of commenters additional time, as the volume of
demonstrate meaningful use for the first requested that CMS allow providers to providers that will be completing their
time in 2015 and 2016 in order to avoid attest to an EHR reporting period for attestations during that time period may
a payment adjustment in the subsequent 2015 prior to the finalization of the tax the system and cause extensive
year. proposals contained in the EHR delays while entering the data.
Comment: A number of commenters Incentive Programs in 2015 through Response: We believe that an
requested additional support for 2017 proposed rule for various reasons, attestation period of 2 months following
providers seeking to attest for an EHR including concerns about the load on the close of the calendar year (February
reporting period in 2015 given the CMS systems in the attestation period if 29, 2016 for an EHR reporting period in
proposed changes for the program in all providers attest at the same time. 2015) is appropriate because it is
2015. Others commenters expressed similar consistent with our current policy of
requiring attestation within the 2 and Medicaid EHR Incentive Programs. on large groups of individuals (77 FR
months after the close of the fiscal year We further note that while this final rule 54089).
for returning eligible hospitals and with comment period makes additional We stated that we would continue to
CAHs or calendar year for returning EPs. changes to the program, we believe leave open the possibility for CMS and
We further note that this attestation these changes will help to settle the the states to test options for
period also aligns with the submission program into a more regular and demonstrating meaningful use that
period for CQM reporting for PQRS. We predictable schedule for all participants. utilize existing and emerging HIT
understand the concern over a high After consideration of the comments products and infrastructure capabilities.
volume of attestations. However, as received, we are finalizing the These options could involve the use of
noted previously, we do not anticipate attestation deadlines for meaningful use registries or the direct electronic
that the proposed changes to the in 2015 and 2016 as proposed. We note reporting of measures associated with
attestation deadlines would that any EP, eligible hospital or CAH the objectives. We would not require
significantly increase the volume over that attested to meaningful use for the any EP, eligible hospital, or CAH to
what was expected for 2015. In first time under Medicare or Medicaid participate in this testing in order to
addition, as we have done in past years, for an EHR reporting period in 2015 receive an incentive payment or avoid
we will monitor progress, attestation prior to the effective date of this final the payment adjustment.
volume, and provider readiness in real rule with comment period will not be For 2017 only, we proposed changes
time as the attestation period progresses. required to submit a new attestation. to the attestation process for the
Comment: A commenter requested meaningful use objectives and
that we clarify how the requirements of d. New Participant Attestation measures, which would allow flexibility
the program prior to the final rule relate Deadlines for Meaningful Use in 2015 for providers during this transitional
to those after the effective date of the and 2016 To Avoid a Payment year (80 FR 16772).
final rule in terms of the attestation Adjustment
Comment: A few commenters
windows and selection of an EHR suggested that EHR Incentive Program
In § 495.4, the definition of an EHR
reporting period. The commenter attestation be automated. EPs, eligible
reporting period for a payment
requested that new participants be able hospitals, or CAHs should be able to use
adjustment year establishes special
to attest to the current Stage 1 objectives their certified EHR technology to
deadlines for attestation for EPs and
and measures even after the effective
eligible hospitals that are demonstrating directly share EHR Incentive Program
date of this final rule with comment
meaningful use for the first time in the performance data with CMS,
period for an EHR reporting period in
year immediately preceding a payment eliminating the need for the manual
2015. The commenter also requested
adjustment year. In the EHR Incentive input of data into the agency’s
guidance on whether states will be
Programs in 2015 through 2017 attestation portal. Allowing automated
required to take an approach consistent
proposed rule (80 FR 20376), we noted EHR Incentive Program attestation will
with CMS on this issue.
Response: Any attestations accepted that we are proposing a later deadline improve participation in the program,
by a state for the Medicaid EHR for attestation for 2015 only to allow cut down on possible manual input
Incentive Program prior to the effective enough time for all providers to errors, and be more in line with the
date of this final rule with comment complete a 90-day EHR reporting period intent of supporting interoperability and
period must meet the requirements in after the anticipated effective date of the the seamless transfer of electronic
effect at that time for the Medicaid EHR final rule. We proposed changes to the health care performance data.
Incentive Program. In addition, the attestation deadlines for purposes of the Response: We note that in the Stage
objectives and measures of meaningful payment adjustment years for EPs, 2 proposed rule we requested input on
use apply to both the Medicare and eligible hospitals, and CAHs in the EHR the potential of developing an
Medicaid EHR Incentive Programs, and Incentive Programs in 2015 through automated electronic reporting system
the demonstration methods we adopt for 2017 proposed rule at 80 FR 20380 and for the objectives and measures of the
Medicare would automatically be 20381. We address those proposals and EHR Incentive Programs (77 FR 13764).
available to the states for use in their respond to the comments received in We decided not to develop such a
Medicaid programs. section II.E.2. of this final rule with submission method at that time as the
We refer the commenter to sections comment period. system update required could prove
II.B.1.b.(4).(a). and II.E. of this final rule burdensome for providers, especially
e. Methods for Demonstration of the
with comment period for an explanation small practices and those operating
Stage 3 Criteria of Meaningful Use for
of when in 2015 the 90-day EHR proprietary systems, and we instead
2017 and Subsequent Years
reporting period and EHR reporting adopted the batch reporting option
period for a payment adjustment year We proposed to continue the use of which does allow for a more automated
may occur. We further note that CMS attestation as the method for process for large groups to submit their
will not be accepting attestations for an demonstrating that an EP, eligible data to CMS (77 FR 54089). As noted in
EHR reporting period in 2015 and hospital, or CAH has met the Stage 3 the Stage 2 final rule, we will continue
subsequent years for any objective or objectives and measures. We proposed to review and analyze the possibility of
measure which has been removed in to continue the existing optional batch an electronic system to replace the
this final rule with comment period in file process for attestation in lieu of current manual attestation as CMS
section II.B.1.b.(4).(b). individual Medicare EP attestation continues to work toward program
Comment: A commenter stated that through our registration and attestation alignment with quality reporting
providers believe that the management system. This batch reporting process programs, which support electronic
of attestation deadlines and payment ensures that the objectives and measures submission of CQM data using CEHRT.
adjustments is very complicated and of the program and the use of certified After consideration of the comments
difficult to follow. EHR technology continues to be received, we are finalizing our proposal
Response: We note that this is part of measured at the individual level, while to maintain attestation as the method of
the motive behind some of the changes promoting efficiencies for group demonstration of meaningful use for the
to reporting periods for the Medicare practices that must submit attestations EHR Incentive Programs for 2017 and
subsequent years and the corresponding therefore the proposal to change the for the EHR reporting period in 2018.
regulation text at § 495.40. stage designations at 80 FR 20352 We also reiterated that providers may
through 20353 had not yet been made. elect to attest to Stage 3 of the program
(1) Meaningful Use Objectives and
In section II.B.2.a. of this final rule with using EHR technology certified to the
Measures in 2017 and CEHRT
comment period, we finalized a set of 2015 Edition beginning in 2017. Finally,
Flexibility in 2017
objectives and measures that all EPs, in the Stage 3 proposed rule we stressed
In the Stage 3 proposed rule (80 FR eligible hospitals, and CAHs must meet that the use of 2011 CEHRT, although an
16772), in order to allow all providers for an EHR reporting period in 2015, option under the 2014 CEHRT
to successfully transition to Stage 3 of 2016, and 2017, unless a provider Flexibility final rule (79 FR 52913
the EHR Incentive Programs for a full chooses to meet the Stage 3 objectives through 52914), is not an option under
year-long EHR reporting period in 2018, in 2017. Thus, we will not allow this proposal (80 FR 16773).
we proposed to allow flexibility for the attestation to Stage 1 objectives and We sought comment on this flexibility
EHR Incentive Programs in 2017. We measures in 2017 regardless of prior option including alternate flexibility
stated that this transition period would program participation. As stated options and received the following
allow providers to establish and test previously, CMS will not be accepting comments on these proposals and our
their processes and workflows for Stage attestations for an EHR reporting period response follows:
3 of the EHR Incentive Programs prior in 2015 and subsequent years for any Comment: While some commenters
to 2018. Specifically, for 2017, we objective or measure which has been expressed skepticism that providers
proposed that providers may either removed in this final rule with comment would be ready to attest to Stage 3 in
repeat a year at their current stage or period in section II.B.1.b.(4).(b). 2017, the majority of commenters were
move up stage levels. We also proposed After consideration of public in support of the flexible options for
that for 2017, a provider may not move comment received, we are finalizing our Stage 3 in 2017, especially allowing for
backward in their progression and that proposal with modifications to allow the timeline required to fully update to
providers who participated in Stage 1 in providers to attest to the Stage 3 EHR technology certified to the 2015
2016 may choose to attest to the Stage objectives and measures defined at Edition. While commenters generally
1 objective and measures, or they may § 495.24 for an EHR reporting period in expressed concern that most providers
move on to Stage 2 or Stage 3 objectives 2017 instead of the objectives and may not be ready to progress to Stage 3
and measures for an EHR reporting measures for 2015 through 2017 defined in 2017, they supported the proposal to
period in 2017. Providers who at § 495.22 if they so choose. allow providers to select the option for
participated in Stage 2 in 2016 may themselves in 2017, which would allow
choose to attest to the Stage 2 objectives (2) Stage and CEHRT Flexibility in 2017 them to work toward that goal but to
and measures or move on to Stage 3 In the Stage 3 proposed rule (80 FR still successfully meet the requirements
objectives and measures for an EHR 16772 through 16773), we also proposed of the program in 2017, even if they do
reporting period in 2017. However, to allow providers flexible CEHRT not meet the Stage 3 requirements.
under no circumstances may providers options for an EHR reporting period in Additionally, some commenters noted
return to Stage 1. 2017 and noted that these options may that they would not support an alternate
Finally, we proposed that in 2018, all impact the selection of objectives and option or policy which required the
providers, regardless of their prior measures to which a provider can attest. selection of the Stage 3 objectives and
participation or the stage level chosen in Specifically, under the CEHRT options measures in 2017 if the provider has
2017, would be required to attest to for 2017, we proposed that providers fully implemented EHR technology, but
Stage 3 objectives and measures for an would have the option to continue to that they agreed that the flexibility to
EHR reporting period in 2018. use EHR technology certified to the select or not select Stage 3 is a benefit
Comment: Many commenters 2014 Edition, in whole or in part, for an for providers. A number of commenters
supported allowing providers to choose EHR reporting period in 2017. We noted requested that this flexibility also be
or not choose Stage 3 in 2017. that providers who use only EHR extended into 2018 and noted that
Commenters noted that the inability to technology certified to the 2014 Edition technology certified to the 2015 Edition
select the stage of participation in prior for an EHR reporting period in 2017 may not be ready in time for a reporting
years was a significant frustration for may not choose to attest to the Stage 3 period in 2018.
providers and that allowing choice and objectives and measures as those Response: We are committed to
flexibility offers providers to the chance objectives and measures require the working toward the goals outlined for
to review their performance and attest to support of EHR technology certified to Stage 3 of the EHR Incentive Programs,
the highest level they were able to the 2015 Edition. We further explained but we also recognize the need for
achieve. However, many commenters this proposal at 80 FR 16773 stating that balance and support of providers in
were confused by this proposal and how providers using only EHR technology making this transition. We agree that the
this proposal related to the proposals in certified in whole or in relevant part to option of participating in Stage 3 in
the EHR Incentive Programs in 2015 the 2014 Edition certification criteria 2017 should be encouraged but not
through 2017 proposed rule which may attest to the Stage 1 or Stage 2 required. Therefore, we will finalize our
would remove the Stage 1 objectives objectives and measures; and, providers proposal to allow providers to choose
and measures from the program. using EHR technology certified in whole Stage 3 participation in 2017, and will
Response: We thank the commenters or in relevant part to the 2015 Edition not require Stage 3 participation if the
for their insight and reiterate that our certification criteria may elect to attest provider has fully implemented EHR
intent in the selection of stage for the to the Stage 1 or Stage 2 objectives and technology certified to the 2015 Edition
demonstration of meaningful use is measures or to the Stage 3 objectives in 2017.
intended to offer greater flexibility for and measures if they have all the 2015 However, we do reiterate that a
providers. We note that the proposal Edition functionality required to meet provider must have the necessary
which includes references to Stage 1 all Stage 3 objectives. functions certified to the 2015 Edition
was published prior to the publication We noted that all providers would be in order to successfully demonstrate
of the EHR Incentive Programs in 2015 required to fully upgrade to EHR Stage 3 if they so choose. As discussed
through 2017 proposed rule and technology certified to the 2015 Edition in section II.B.3. of this final rule with
comment period, EHR technology measure which has been removed in objectives and measures in 2017 and use
certified to the 2015 Edition can support this final rule with comment period in EHR technology certified to the 2014
the Stage 2 objectives and measures, but section II.B.1.b.(4).(b). Further we Edition for their CQM reporting for an
EHR technology certified to the 2014 reiterate that certification to the 2011 EHR reporting period in 2017.
Edition on its own cannot support all of Edition is no longer valid for use in the For an EHR reporting period in 2017,
the Stage 3 objectives and measures. So EHR Incentive Programs and a provider we proposed that EPs, eligible hospitals,
even though EHR technology certified to may not attest to a system with that and CAHs may choose to report eCQMs
the 2015 Edition is not required until certification in any year after 2014. electronically using the CQMs finalized
2018, a provider must at least have the Finally, we note that providers using for use in 2017 using the most recent
functions of CEHRT certified to the 2015 only EHR technology certified to the version of the eCQMs (electronic
Edition which are required to support 2014 Edition may not attest to the Stage specifications), which would be the
the unique Stage 3 measures in order to 3 objectives and measures for an EHR electronic specifications of the CQMs
participate in Stage 3 in 2017. For Stage reporting period in 2017. Therefore, we published by CMS in 2016, or a
3 there are certain EHR technology reiterate the following options for provider may choose to continue to
functions which are not available within providers for Stage and CEHRT attest to the CQMs established for use in
the 2014 Edition certification criteria, flexibility for an EHR reporting period 2017 also using the most recent (2016
and if a provider chooses to attest to in 2017: version) eCQM electronic specifications.
Stage 3 in 2017 they must use EHR Providers using only EHR technology Similar to our rationale under the
technology modules certified to the certified in whole or in relevant part to 2014 CEHRT Flexibility final rule (79
2015 Edition for those functions. These the2014 Edition certification criteria FR 52910 through 52933), we stated that
modules and module certified to the may attest to the objectives and we believe the proposals outlined for
2014 Edition can be used together in measures of meaningful use defined at attestation in 2017 would allow
many combinations to make up the § 495.22. providers the flexibility to choose the
whole EHR system and meet the Providers using EHR technology option which applies to their particular
definition of CEHRT required for the certified in relevant parts to the2014 circumstances and use of CEHRT (80 FR
program. We direct readers to section Edition certification criteria and EHR 16773). We proposed that upon
II.B.3. of this final rule with comment technology certified in relevant parts to attestation, providers may select one of
period for further information on the the 2015 Edition certification criteria the proposed options available for their
CEHRT definition at § 495.4. See Tables may elect to: participation year and EHR Edition, and
14, 15, and 16 in section II.B.3. for more • Attest to the objectives and the EHR Incentive Program Registration
information about which modules measures at § 495.22. and Attestation System would then
support specific Stage 3 objectives and • Attest to the Stage 3 objectives and prompt the provider to attest to meeting
measures. measures at § 495.24 if they have the the objectives, measures, and CQMs
We believe providing flexibility in 2015 Edition functionality required to applicable under that option. We further
2017 will allow for an easier transition meet the Stage 3 objectives and proposed that auditors would be
and full scale upgrade to EHR measures. (See Tables 14, 15, and 16 in provided guidance related to reviewing
technology certified to the 2015 Edition section II.B.3. for more information attestations associated with the options
for participation in 2018. We did not about which modules support specific for using CEHRT in 2017, as was done
propose an extension of this flexibility Stage 3 objectives and measures.) for 2014.
into 2018 as we are committed to Providers using only EHR technology We received comments related to the
moving toward a single streamlined certified in whole or in relevant parts to reporting requirements for CQMs, which
program to support long term the 2015 Edition certification criteria are addressed in section II.C. of this
sustainability and reduce the overall may elect to: final rule with comment period. We also
complexity for providers participating • Attest to the objectives and received a number of questions and
in the EHR Incentive Programs. We note measures at § 495.22. comments on reporting clinical quality
that, as mentioned in section II.B.1.b.(3). • Attest to the Stage 3 objectives and measures for the Medicaid program,
of this final rule with comment period, measures at § 495.24. which are addressed in section II.C. and
we are finalizing a 90-day EHR reporting We are adopting these policies at II.G. of this final rule with comment
period for providers demonstrating § 495.40 with references to the period. We received no comments
Stage 3 in 2017 to further support objectives and measures outlined in specific to the demonstration of these
providers seeking to move to Stage 3 in § 495.22 and § 495.24 for the applicable requirements beyond those previously
2017. years. addressed in section II.D.1.(e).(1). and
After consideration of the comments (2) of this final rule with comment
(3) CQM Flexibility in 2017 period in relation to the selection of
received, we are finalizing a
modification to our proposal to allow In the Stage 3 proposed rule (80 FR stage, the selection of certified EHR
providers using EHR technology 16773), we proposed to allow greater technology, and the overall
certified to the 2015 Edition, in whole flexibility by proposing to split the use demonstration of meaningful use in
or in part, the option to attest to Stage of CEHRT for CQM reporting from the 2017 and subsequent years via
3 objectives and measures if they have use of CEHRT for the objectives and attestation.
the relevant CEHRT modules certified to measures for 2017. This means that We are finalizing as proposed the
the 2015 Edition certification criteria providers would be able to separately policy to allow providers the flexibility
necessary to support Stage 3. (See report CQMs using EHR technology to electronically report CQMs or to
Tables 14, 15, 16 in section II.B.3. for certified to the 2015 Edition even if they attest to CQMs using either EHR
more information about which modules use EHR technology certified to the technology certified to the 2014 Edition
support specific Stage 3 objectives and 2014 Edition for the meaningful use or EHR technology certified to the 2015
measures.) We further note that CMS objectives and measures for an EHR Edition, independently of the Edition
will not be accepting attestations for an reporting period in 2017. Providers may they use for their objectives and
EHR reporting period in 2015 and also use EHR technology certified to the measures for an EHR reporting period in
subsequent years for any objective or 2015 Edition for their meaningful use 2017. For further discussion of this final
policy, we direct readers to section II.C. Incentive Program attestation 2015 or 2016 and also wish to attest to
of this final rule with comment period. information for a number of purposes, avoid the Medicare payment
such as informing other state programs adjustment.
2. Alternate Method of Demonstration Response: We did not propose this
and making policy decisions. However,
for Certain Medicaid Providers option for 2015. However, we
we will not send information from those
Beginning in 2015 understand there may be new
attestations to states, consistent with
In the EHR Incentive Programs in preceding practice. participants, and especially newly
2015 through 2017 proposed rule (80 FR Comment: A commenter requested practicing EPs or new hospitals, for
20377), we proposed that certain clarification regarding the reporting whom this option might be relevant and
Medicaid EPs would have the option of period for EPs who are in the Medicaid beneficial. We have considered a
attesting through the EHR Incentive EHR Incentive Program and use the number of scenarios that are consistent
Program Registration and Attestation alternate method of attestation through with our proposed policy which is to
system for the purpose of avoiding the the CMS registration and attestation allow providers who are working
Medicare payment adjustment. This system. toward achieving meaningful use in the
alternate method would allow EPs who Response: We proposed that EPs Medicaid EHR Incentive Program to
have previously received an incentive using this alternate method would be attest under Medicare to avoid the
payment under the Medicaid EHR required to demonstrate meaningful use payment adjustment without switching
Incentive Program (for either AIU or for the applicable EHR reporting period if they are unable to attest under
meaningful use) to demonstrate that established for the Medicare EHR Medicaid for a given year. The option
they are meaningful EHR users in Incentive Program, which would will be available for 2015 under the
situations where they fail to meet the depend on the year as well as the EP’s following scenarios:
eligibility criteria for the Medicaid EHR prior participation in the program and • For an EHR reporting period 2015,
Incentive Program in a subsequent year. stage of meaningful use. For example, if an EP who has not successfully attested
Comment: Many commenters agreed the EP is in their first year of to AIU or meaningful use in either the
with our proposal to establish an demonstrating meaningful use, and the Medicare or Medicaid program may use
alternate method of demonstrating Medicare EHR Incentive Program has a the alternate attestation option under
meaningful use to allow Medicaid EPs 90-day EHR reporting period for EPs the Medicare EHR Incentive Program to
to attest using the CMS registration and demonstrating meaningful use for the avoid a payment adjustment in 2016
attestation system so they can avoid the first time in that year, then the EP and 2017. This EP cannot qualify for an
Medicare payment adjustment. Some would use a 90-day EHR reporting incentive payment under Medicare for
commenters questioned whether this period. 2015 because 2014 is the last first year
would be available prior to February 28, We reiterate that an EP’s attestation that an EP may begin receiving
2016, to allow EPs to attest in cases using this alternate method would not Medicare incentive payments under
where the state’s attestation system was constitute a switch from the Medicaid section 1848(o) of the Act. The EP may
not ready by the deadline. Some EHR Incentive Program to the Medicare attest to meaningful use in the Medicaid
commenters questioned whether EHR Incentive Program. For the program for an EHR reporting period in
attestation information submitted to purposes of the Medicaid EHR Incentive 2016 if they meet the eligibility and
CMS would be shared with the states. Program, an EP’s use of this alternate other requirements for the Medicaid
Response: We intend for this alternate method would be treated the same as if EHR Incentive Program.
method of demonstrating meaningful the EP had not attested to meaningful • A provider may not use the
use to be available beginning January 1, use for that year. For an EP who uses alternate attestation option to attest to
2016 for EPs attesting for their EHR this alternate method, their EHR meaningful use in Medicare to avoid a
reporting period in 2015. However, we reporting period in a subsequent year payment adjustment in conjunction
proposed this method only for Medicaid for the Medicaid EHR Incentive Program with an attestation for an incentive
EPs who did not meet the eligibility would be determined without regard to payment for AIU in the Medicaid
criteria and thus would not be able to any previous attestations using this program in the same year.
attest to the Medicaid EHR Incentive alternate method. For example, an EP Comment: A number of commenters
Program for the same year and receive could still have a 90-day EHR reporting requested clarification from a systems
an incentive payment. period for the Medicaid EHR Incentive perspective on how CMS will offer the
We note that Medicaid EPs can avoid Program for their first year of alternate attestation option and
the Medicare payment adjustment by demonstrating meaningful use even coordinate with states on
successfully demonstrating meaningful though they had demonstrated implementation. Some commenters
use to the state Medicaid agency under meaningful use through this alternate questioned if CMS is considering an
the Medicaid EHR Incentive Program, method in a previous year. option to allow the states flexibility to
even if it occurs after the Medicare Comment: Commenters also asked if develop a no-payment attestation
attestation period closes, as long as the CMS would allow this policy for pathway as another option for the
attestation is accepted by the state. It providers who had not yet attested in providers who are unable to switch but
would then be the state’s responsibility Medicare or Medicaid as of 2015, given do not meet the thresholds for patient
to include that EP in the quarterly report that Medicaid still allows incentive volume required to qualify for a
on meaningful users, which we discuss payments for new participants until Medicaid incentive payment. Another
in section II.G. of this final rule with 2016. A number of commenters commenter requested that we describe
comment period. requested clarification on what any operational and technical changes
Attestations from Medicaid EPs that scenarios would providers be allowed to states may need to make to their EHR
come through the CMS registration and use the alternate attestation and where Incentive Program.
attestation system will be treated the would it be prohibited, if this did apply Response: We reiterate that the
same as other provider attestations that for 2015. Specifically, these commenters alternate attestation option for the
are submitted to that system for inquired whether this alternate purpose of avoiding a Medicare
purposes of data sharing. We recognize attestation option is available for payment adjustment will be
that states collect, analyze, and use EHR providers who are attesting to AIU in implemented within the Medicare
registration and attestation system only. ++ Such as DIRECT address required may be one step in the process to
As mentioned previously, Medicaid EPs (if available). facilitate health information exchange
seeking to exercise this option must ++ If DIRECT address is not available, among providers across a wide range of
attest in the Medicare system and in Electronic Service Information is settings.
accordance with the requirements for required. After consideration of the public
the Medicare EHR Incentive Program in ++ If DIRECT address is available, comments received, we are finalizing
order to successfully demonstrate Electronic Service Information is these proposals as proposed.
meaningful use and avoid the Medicare optional in addition to DIRECT address.
We did not propose any changes to 4. Hospital-Based Eligible Professionals
payment adjustment. The only
requirement for state support of this the registration for the Medicare and As noted in the EHR Incentive
proposal is to notify EPs of their Medicaid EHR Incentive Programs. Programs in 2015 through 2017
eligibility to exercise this alternate We received the following comments proposed rule (80 FR 20378), several
option in partnership with CMS and our response follows: hospital associations, individual
provider education and outreach efforts. Comment: We received a number of providers, and other stakeholders have
comments requesting a wider range of raised concerns with our current
We will not require additional reporting
publically available data on the definition of a hospital-based EP.
from states, nor require states to process
Medicare and Medicaid EHR Incentive Specifically, these stakeholders asserted
additional systems changes. We will
Programs including cross-referencing that the limitation of hospital-based
work with the states to coordinate any
Medicaid participation and performance POS codes 21 and 23, covering inpatient
necessary information sharing and to
data. and emergency room settings only, does
monitor real-time use of the alternate Response: We thank the commenters
attestation option once implemented. not adequately capture all settings
for their suggestions and will continue where services might be furnished by a
After consideration of the comments
to work to promote data transparency hospital-based EP. They stated that POS
received, we are finalizing the proposal
and provide data across both programs 22, which covers an outpatient hospital
for this alternate method of
on provider participation and place of service, is also billed by
demonstrating meaningful use for
performance. We refer readers to section hospital-based EPs, especially in
certain Medicaid EPs to avoid the
II.G.4. of this final rule with comment relation to certain CPT codes. These
Medicare payment adjustment with a
period for further information on the stakeholders expressed the belief that
modification allowing the alternate
types of information, CMS is requesting our current definition of hospital-based
attestation for new participants in 2015
from states to support these efforts and EP in the regulations is too narrow and
as described previously.
note that we will continue to post data will unfairly subject many EPs who are
3. Data Collection for Online Posting, files for public use on the CMS Web site not hospital-based under our definition,
Program Coordination, and Accurate at: www.cms.gov/EHRIncentivePrograms but whom stakeholders would consider
Payments on the data and reports section. to be hospital-based, to the downward
We proposed to continue posting Comment: Some commenters noted payment adjustment under Medicare in
Stage 1 and Stage 2 aggregate and the inclusion of the health information 2015. Accordingly, these stakeholders
individual performance and exchange information in the providers’ recommended that we consider adding
participation data resulting from the record within the NPPES system. A additional place of service codes or
EHR Incentive Programs online commenter opposed the inclusion, settings to the regulatory definition of
regularly for public use. We further stating that not all providers have a hospital-based EP. We noted that we
noted our intent to potentially publish direct address. However, the majority appreciate this feedback from
the performance and participation data support the proposed enhancements to stakeholders and requested public
on Stage 3 objectives and measures of NPPES as a step in the right direction. comment on our current definition of a
meaningful use in alignment with Some commenters requested CMS take hospital-based EP under § 495.4 for the
quality programs, which utilize publicly additional steps to develop some form EHR Incentive Programs. We sought
available performance data such as of ‘‘centralized national healthcare public comment on whether additional
Physician Compare. provider directory’’ to support health place of service codes or settings should
In addition to the data already being information exchange and care be included in our definition of a
collected under our regulations, as coordination. Some commenters made hospital-based EP. In addition, we
outlined in the Stage 3 proposed rule further suggestions as to how such a sought comments on whether and how
(80 FR 16774), we proposed to collect directory should be organized as well as the inclusion of additional POS codes or
the following information from the full extent of exchange information settings in our definition of hospital-
providers to ensure providers keep their it should contain for each provider. based EP might affect the eligibility of
information up-to-date through the Response: We note that CMS and EPs for the EHR incentive payments
system of record for their NPI in the ONC are committed to exploring under Medicare or Medicaid.
NPPES: potential models and opportunities to We received the following comments
• Primary Practice Address (address, support improved access to the relevant and our response follows:
city, state zip, country code, etc.). contact information to facilitate health Comment: A number of commenters
• Primary Business/Billing Address information exchange among providers. on the EHR Incentive Program in 2015
(address, city, state, zip, country code, We understand that not all providers through 2017 proposed rule requested
etc.). may have a direct address. Therefore, the addition of place of service code
• Primary License information (for we proposed to include other exchange (POS 22) to the definition of hospital-
example, provide medical license in at information in the system of record as based EP. Some of these comments
least one state (or territory)). noted in the Stage 3 proposed rule (80 stated that providers may practice
• Contact Information (phone FR 16774). We also understand that not across multiple settings and their
number, fax number, and contact email all providers who might participate in organizational base may be the hospital
address). health information exchange are outpatient setting, and as a result, they
• Health Information Exchange participating in the EHR Incentive face significant challenges in meeting
Information: Programs. However, we believe that this the requirements of the program. Some
commenters stated that certain observation period, and should not be CMS included POS 22 services in the
physician specialties, such as penalized. hospital-based provider definition, CMS
pathologists, radiologists, and even Many commenters opposed any would need to revisit whether the
some hospitalists, have reported change in the hospital-based inclusion of these services affects the
challenges with the existing definition designation. Some commenters stated hospital payment calculation and
and that a change in the definition of that this proposal could compromise the collection of EHR Incentive Program
hospital-based would provide more purpose of the program. A commenter encounters for hospitals. Another
clarity for these physicians. A stated that changing the definition of commenter expressed a similar concern
commenter stated that the definition of hospital-based eligible professional at that changing the hospital-based
a hospital-based provider is this time in the program could designation may have unintended
fundamentally flawed and suggested to encourage fraud. If an EP who was consequences on the hospital payment
define a hospital-based provider as a previously eligible for the incentive calculation, necessitating adjustments to
provider who performs 90 percent or would now be ineligible for payment all payments made to date if CMS
more of their services in place of service adjustments due to the change, this chooses to make a change to the
21, 22, and/or 23 (Inpatient Hospital, would be unfair. Some commenters definition of hospital based.
Outpatient Hospital, and Emergency stated that redefining EP by once again Other commenters stated this is a very
Room Hospital). A commenter offered including POS 22 in the ‘‘hospital’’ complex issue and sought further
an example stating that a cardiac definition would not be reasonable so clarification on the impact of a potential
interventionist might not quality as long as provider-based billing exists. change, noting organizations that have
hospital-based because 90 percent of The commenter suggested considering many subspecialists who see patients in
their services were not billed POS 21 or some combination of place of service the hospital outpatient setting using an
POS 23 even though they spend 100 and NPPES classification which does office or ambulatory workflow and that
percent of their time in the hospital not exclude the large base of ambulatory these providers may be required to bill
setting. The commenter indicated that providers who bill provider based. with POS 22 due to the physical
the interventionist treats many patients Another commenter stated that location of their offices. The commenter
who are admitted as outpatients, reads including POS 22 in the definition of a stated that the majority of these EPs are
echocardiograms for the hospital, and hospital-based EP could have major currently meeting the requirements of
has no patient encounters, which are implications for the eligible hospital the program and will continue to
not included in the hospital EHR; but numerators and denominators. practice medicine in the same manner
the provider also cannot independently Additionally, the design and going forward. However, the commenter
meet the requirements of the program. implementation of the various parts of also noted that there are EPs who are
a hospital’s EHR system would have to truly ‘‘hospital-based,’’ such as
Some commenters additionally
be redesigned in order to change the hospitalists, who are currently being
requested that CMS include POS 51
status in addition to changing work held to the same standard as ambulatory
(Inpatient Psychiatric Facility) in
flows and training to match that change, providers, even though their workflow
addition to POS 22 Observation Services
which would drastically impact the is not conducive to easily meeting such
Patients in the hospital-based
hospital’s ability to meet the measures standards. The commenter then
determination.
as well as their overall IT expenditures. recommended that CMS allow providers
On the hospital side, a commenter Some commenters stated that adding who see both inpatient and ambulatory
expressed support for a change in the POS 22 or another change to the patients with a significant volume to
hospital-based designation because they designation may undermine the current choose whether they want to be
are currently struggling with the understanding of the program and excluded from the program or continue
hospital-based designation for the would require additional education and to participate as an individual eligible
inclusion of services provided in guidance to ambulatory providers who professional.
hospital settings by providers who are have already successfully attested. A Other recommendations from
designated EPs and that the hospital commenter stated that they do not commenters included a mention of
performance on the measures would be support re-classifying services provided hardship exceptions for POS 22-related
higher if these patient encounters were in an outpatient hospital (POS 22) issues, a suggestion to allow EPs the
included. The provider recommended setting as hospital-based because of a right, in an expedited fashion, to
that all POS codes should be revisited concern that expanding the hospital- petition for a change in their hospital-
and the requirements for hospital-based based definition to reduce the number based status when there is a material
eligibility could be expanded to include of EPs for EHR Incentives may inhibit change in their organizational affiliation
all hospital-based POS codes that are continuous hospital investments in (that is, a physician leaving a hospital-
rendered in the hospital settings ambulatory EHRs. The commenter noted based practice to join an outpatient
including rehabilitation hospitals and that the ambulatory EHR space is an physician practice), excluding patient
hospital observations, which are important component to the overall HIT encounters in POS 21 and POS 23 for
otherwise not included in the ecosystem and that CMS should an EP, and excluding the POS 21 and
numerators of their percentages. encourage investment in this area by POS 23 encounters from Medicare
Commenters in support of a change excluding outpatient services from the payment adjustment.
were split on when such a change hospital-based calculation. The Response: The scenarios and
should be implemented. A commenter commenter stated that the current examples described by the commenters
recommended that CMS change its definition of a hospital-based provider are consistent with those we have heard
definition beginning with 2017. Other is consistent with the hospital’s from providers previously. However, we
commenters believe that CMS should payment calculation, which is based on are concerned that there does not seem
retroactively make this correction, and inpatient discharges and emergency to be an identifiable factor that has
refund physicians who were penalized department services, and is consistent changed since the program began and
because of this issue stating physicians with the collection of EHR Incentive caused EPs who were previously
who use POS 22 typically are using the Program information for hospitals. The designated hospital-based to be
hospital-based EHR during the patient commenter continued by stating that if designated otherwise. In addition, the
comments both in support of and EHR reporting period for the year, then 44447 through 44448 and 77 FR 54093
opposing a revision to the hospital- the Medicare physician fee schedule through 54102) for more information.
based EP definition show the wide (PFS) amount for covered professional
b. Statutory Basis for Payment
diversity of providers who may have services furnished by the EP during the
Adjustments and Hardship Exceptions
services billed under a different POS year (including the fee schedule amount
for Eligible Hospitals
who fall on both sides of the argument for purposes of determining a payment
for and against an amendment of the based on the fee schedule amount) is Section 1886(b)(3)(B)(ix)(I) of the Act,
definition. We see no method to modify adjusted to equal the ‘‘applicable as amended by section 4102(b)(1) of the
the current definition to clearly identify percent’’ of the fee schedule amount HITECH Act, provides for an adjustment
EPs for whom inclusion in the that would otherwise apply. to the applicable percentage increase to
definition might be reasonable and The Medicare Access and CHIP the IPPS payment rate for those eligible
those for whom inclusion in the Reauthorization Act of 2015 (MACRA) hospitals that are not meaningful EHR
definition might be inappropriate. (Pub. L. 114–10) was enacted on April users for the associated EHR reporting
Further, we are concerned that any 16, 2015, after the publication of the period for a payment adjustment year,
blanket redesignation of EPs in certain Stage 3 proposed rule and the EHR beginning in FY 2015. Specifically,
settings would result in the exclusion of Incentive Program in 2015 through 2017 section 1886(b)(3)(B)(ix)(I) of the Act
patient encounters in those settings proposed rule. Section 101(b)(1)(A) of provides that, for FY 2015 and each
being captured in an EHR. Without a MACRA amended section 1848(a)(7)(A) subsequent fiscal year, an eligible
clear rationale for a change, and without of the Act to sunset the meaningful use hospital that is not ‘‘a meaningful EHR
a clear definition to change to, we payment adjustment for EPs at the end user . . . for an EHR reporting period’’
cannot proceed to change the definition of CY 2018. Section 101(c) of MACRA will receive a reduced update to the
of hospital-based EP at this time. added section 1848(q) of the Act IPPS standardized amount. This
Therefore, we are not finalizing requiring the establishment of a MIPS, reduction applies to ‘‘three-quarters of
changes to the definition of hospital- which would incorporate certain the percentage increase otherwise
based EP at this time. We will continue existing provisions and processes applicable’’ prior to the application of
to consider this issue in the future as we related to meaningful use. The term statutory adjustments under sections
explore program requirements for the ‘‘applicable percent’’ is defined in 1886(b)(3)(B)(viii), 1886(b)(3)(B)(xi), and
MIPS. section 1848(a)(7)(A)(ii) of the Act, as 1886(b)(3)(B)(xii) of the Act, or three-
5. Interaction With Other Programs amended by section 101(b)(1)(A) of quarters of the applicable market basket
We proposed no changes to the ability MACRA, as: (I) for 2015, 99 percent (or, update. The reduction to three-quarters
of providers to participate in the in the case of an EP who was subject to of the applicable update for an eligible
Medicare and Medicaid EHR Incentive the application of the payment hospital that is not a meaningful EHR
Programs and other CMS programs. We adjustment [if the EP was not a user will be ‘‘33B percent for FY 2015,
continue to work on aligning the data successful electronic prescriber] under 66o percent for FY 2016, and 100
collection and reporting of the various section 1848(a)(5) of the Act for 2014, 98 percent for FY 2017 and each
CMS programs, especially in the area of percent); (II) for 2016, 98 percent; and subsequent FY.’’ In other words, for
clinical quality measurement. See (III) for 2017 and 2018, 97 percent. eligible hospitals that are not
sections II.C. of this final rule with In addition, section 1848(a)(7)(A)(iii) meaningful EHR users, the Secretary
comment period for the policies and of the Act, as amended by section must reduce the applicable percentage
requirements for CQM reporting. 101(b)(1)(A) of MACRA, provides that if, increase (prior to the application of
for CY 2018, the Secretary finds the other statutory adjustments) by 25
E. Payment Adjustments and Hardship proportion of EPs who are meaningful percent (33B of 75 percent) in FY 2015,
Exceptions EHR users is less than 75 percent, the 50 percent (66o percent of 75 percent) in
Sections 4101(b) and 4102(b) of the applicable percent shall be decreased by FY 2016, and 75 percent (100 percent of
HITECH Act, amending sections 1848, 1 percentage point for EPs who are not 75 percent) in FY 2017 and subsequent
1853, and 1886 of the Act, require meaningful EHR users from the years. Section 4102(b)(1)(B) of the
reductions in payments to EPs, eligible applicable percent in the preceding HITECH Act also provides that the
hospitals, and CAHs that are not year. reduction shall apply only with respect
meaningful users of certified EHR Section 1848(a)(7)(B) of the Act to the fiscal year involved and the
technology, beginning in CY 2015 for provides that the Secretary may, on a Secretary shall not take into account
EPs, FY 2015 for eligible hospitals, and case-by-case basis, exempt an EP who is such reduction in computing the
in cost EHR reporting periods beginning not a meaningful EHR user for the EHR applicable percentage increase for a
in FY 2015 for CAHs. reporting period for the year from the subsequent fiscal year.
1. Statutory Basis for Payment application of the payment adjustment Section 1886(b)(3)(B)(ix)(II) of the Act,
Adjustments and Hardship Exceptions if the Secretary determines that as amended by section 4102(b)(1) of the
compliance with the requirements for HITECH Act, provides that the Secretary
a. Statutory Basis for Payment being a meaningful EHR user would may, on a case-by-case basis, exempt a
Adjustments and Hardship Exceptions result in a significant hardship, such as hospital from the application of the
for Eligible Professionals (EPs) in the case of an EP who practices in a applicable percentage increase
Section 1848(a)(7) of the Act provides rural area without sufficient internet adjustment for a fiscal year if the
for payment adjustments, effective for access. The exception is subject to Secretary determines that requiring such
CY 2015 and subsequent years, for EPs annual renewal, but in no case may an hospital to be a meaningful EHR user
as defined in § 495.100, who are not EP be granted an exception for more will result in a significant hardship,
meaningful EHR users during the than 5 years. such as in the case of a hospital in a
relevant EHR reporting period for the We established regulations rural area without sufficient internet
year. Section 1848(a)(7) of the Act implementing these statutory provisions access. This section also provided that
provides that beginning in 2015, if an under § 495.102. We refer readers to the such determinations are subject to
EP is not a meaningful EHR user for the final rules for Stages 1 and 2 (75 FR annual renewal and that in no case may
a hospital be granted an exception for several changes to the definition of the for new participants who attest under
more than 5 years. EHR reporting period for a payment Medicare beginning in 2017. We agree
Section 412.64(d) sets forth the adjustment year for EPs, eligible that a full year EHR reporting period
adjustment to the percentage increase in hospitals, and CAHs at § 495.4, in could be a barrier for new entrants and
the market basket index for those connection with other proposals made could deter participation in the program
eligible hospitals that are not in those rules. For an explanation of especially as new entrants need time to
meaningful EHR users for the EHR these proposals, we refer readers to 80 install and learn to use technology
reporting period for a payment year, FR 16774 through 16779 and 80 FR before beginning their first EHR
beginning in FY 2015. 20378 through 20381. reporting period. However, we maintain
We established regulations that it is important to move all providers
implementing these statutory provisions a. Changes to the EHR Reporting Period
to the same EHR reporting period to
under § 412.64. We refer readers to the for a Payment Adjustment Year for EPs
simplify the program. So in 2018 all
final rules for Stages 1 and 2 (75 FR As follows is a summary of the providers will attest to the Stage 3
44460 and 77 FR 54102 through 54109) comments received on the proposals for definition of meaningful use for an EHR
for more information. the EHR reporting period for a payment reporting period of the entire calendar
adjustment year for EPs (80 FR 16774 year, with a limited exception for
c. Statutory Basis for Payment
through 16779 and 80 FR 20378 through Medicaid providers who demonstrated
Adjustments and Hardship Exceptions
20381): AIU prior to 2017 and are demonstrating
for CAHs Comment: We received a few meaningful use for the first time. For
Section 4102(b)(2) of the HITECH Act comments supporting the proposed these reasons, we will adopt a final
amended section 1814(l) of the Act to deadline of February 29, 2016 for new policy that for EPs demonstrating
include an adjustment to a CAH’s participants to attest in order to avoid a meaningful use for the first time in 2017
Medicare reimbursement for inpatient payment adjustment in CY 2016 in light under Medicare or Medicaid, the EHR
services if the CAH is not a meaningful of the other program changes proposed reporting period for a payment
EHR user for an EHR reporting period. in the rule. Many commenters expressed adjustment year is any continuous 90-
The adjustment will be made for cost concern with our proposal to remove day period in CY 2017 and applies for
EHR reporting periods that begin in FY the 90-day EHR reporting period for purposes of the payment adjustments in
2015, FY 2016, FY 2017, and each new participants. They noted that this CY 2018. To avoid the payment
subsequent FY thereafter. Specifically, will create an enormous barrier for new adjustment in CY 2018, the 90-day
sections 1814(l)(4)(A) and (B) of the Act entrants and will likely deter period must occur within the first three
provide that, if a CAH does not participation in the program and others quarters of CY 2017 and the EP must
demonstrate meaningful use of CEHRT stated that new entrants need time to attest by October 1, 2017.
for an applicable EHR reporting period, install and learn to use technology Comment: Some commenters noted
then for a cost EHR reporting period before beginning their first EHR that new participants in 2018 would be
beginning in FY 2015, the CAH’s reporting period. Commenters also moving to Stage 3 and should have a 90
reimbursement shall be reduced from requested an extended deadline ranging day EHR reporting period for that
101 percent of its reasonable costs to from 2 months to 6 months additional purpose, not just in Medicaid but also
100.66 percent of reasonable costs. For time in 2016 for attestations for EHR in Medicare. Other commenters stated
a cost EHR reporting period beginning reporting periods in 2015. Additionally that any provider in their first year, and
in FY 2016, its reimbursement would be some commenters requested all providers in the first year of a new
reduced to 100.33 percent of its clarification of the early attestation stage, should have a 90-day reporting
reasonable costs. For a cost EHR deadlines for new participant EPs in period.
reporting period beginning in FY 2017 2016 and 2017. Response: We do not believe a 90-day
and each subsequent fiscal year, its Response: We thank you for your EHR reporting period is necessary for
reimbursement would be reduced to 100 comments and support. For discussion new participants in 2018 as discussed in
percent of reasonable costs. We of the attestation deadlines for EPs we section II.B.1.b.(3).(a). of this final rule
established regulations implementing direct readers to section II.D. of this with comment period. However, we
these statutory provisions under final rule with comment period. note that we are offering additional
§ 413.70. We refer readers to the final Regarding the comments on the flexibility for any provider, new or
rules for Stages 1 and 2 (75 FR 44464 attestation deadlines, we proposed that returning, who elects to participate in
and 77 FR 54110 through 54111) for for EPs demonstrating meaningful use Stage 3 in 2017 which we believe is a
more information. for the first time in 2016, the EHR fair solution to support these providers’
However, as provided for eligible reporting period for a payment efforts to move forward in the program.
hospitals, a CAH may, on a case-by-case adjustment year is any continuous 90- As noted in section II.E.2. of this final
basis, be granted an exception from this day period in CY 2016 and applies for rule with comment period, we are
adjustment if CMS or its Medicare purposes of the payment adjustments in adopting a policy for EPs in the
contractor determines, on an annual CYs 2017 and 2018. To avoid the Medicaid program, and for eligible
basis, that a significant hardship exists, payment adjustment in CY 2017, the 90- hospitals and CAHs who demonstrate
such as in the case of a CAH in a rural day period must occur within the first Stage 3 in 2017, allowing a 90-day EHR
area without sufficient internet access. three quarters of CY 2016 and the EP reporting period. We are adopting this
However, in no case may a CAH be must attest by October 1, 2016. We refer policy based on public comment
granted this exception for more than 5 readers to 80 FR 20380 through 20381 received (as discussed in section
years. of the EHR Incentive Programs in 2015 II.B.1.b.(3)(c) of this final rule with
through 2017 proposed rule for comment period) in relation to the EHR
2. EHR Reporting Period for a Payment additional information. reporting period for 2017 in order to
Adjustment Year We agree with the concerns expressed allow these providers adequate time to
In the EHR Incentive Programs in by commenters regarding our proposal upgrade to the required 2015 Edition
2015 through 2017 proposed rule and to discontinue the 90-day EHR reporting technology and to encourage providers
the Stage 3 proposed rule, we proposed period for a payment adjustment year to select the option to participate in the
Stage 3 objectives and measures which finalizing these proposals is because CY who have successfully demonstrated
support our long term goals. For 2018 will be the last payment meaningful use in a prior year
Medicaid EPs, and for new participants adjustment year for EPs under section (‘‘returning participants’’) is any
in Medicaid and Medicare, this 90-day 1848(a)(7)(A) of the Act, as amended by continuous 90-day period in CY 2015.
EHR reporting period for Stage 3 would section 101(b)(1)(A) of MACRA. As An EP who successfully demonstrates
also apply for the purposes of avoiding noted previously, section 1848(q) of the meaningful use for this period and
the payment adjustment in 2019 for Act, as added by section 101(c) of satisfies all other program requirements
returning participants and for the MACRA, requires the establishment of will avoid the payment adjustment in
payment adjustment in 2018 for new MIPS, which would incorporate certain CY 2017 if the EP successfully attests by
participants who attest to Stage 3 prior existing provisions and processes February 29, 2016.
to October 1, 2017. related to meaningful use. We intend to In CY 2016, the EHR reporting period
For Medicare EPs, we note that the implement MIPS through future for a payment adjustment year for EPs
EHR reporting period for a payment rulemaking, which among other things who are new participants is any
adjustment year for returning would address the effect on Medicare continuous 90-day period in CY 2016.
participants in 2017 and for all Physician Fee Schedule payments in CY An EP who successfully demonstrates
Medicare EPs in 2018 and subsequent 2019 and subsequent years for certain meaningful use for this period and
years will be established through future EPs who are not meaningful EHR users satisfies all other program requirements
rulemaking in association with the MIPs for an applicable performance period. will avoid the payment adjustment in
program discussed further in the We encourage readers to review and CY 2017 if the EP successfully attests by
comments and responses immediately respond to our request for information October 1, 2016, and will avoid the
following. titled ‘‘Request for Information payment adjustment in CY 2018 if the
Comment: We received a number of Regarding Implementation of the Merit- EP successfully attests by February 28,
comments requesting clarification of based Incentive Payment System, 2017.
how the policies proposed in the EHR Promotion of Alternative Payment
Incentive Program in 2015 through 2017 In CY 2016, the EHR reporting period
Models, and Incentive Payments for
and Stage 3 proposed rules are affected for a payment adjustment year for EPs
Participation in Eligible Alternative
by recent legislation modifying the who are returning participants is the full
Payment Models’’ published in the
HITECH Act provisions for payment CY 2016. An EP who successfully
October 1, 2015 Federal Register (80 FR
adjustments for eligible professionals. demonstrates meaningful use for this
59102).
Response: As noted previously, After consideration of the public period and satisfies all other program
section 101(b)(1)(A) of MACRA comments, we are finalizing the requirements will avoid the payment
amended section 1848(a)(7)(A) of the following changes to the EHR reporting adjustment in CY 2018 if the EP
Act to sunset the EHR Incentive period for a payment adjustment year successfully attests by February 28,
Program payment adjustment for EPs at for EPs as proposed, with a modification 2017.
the end of CY 2018. Thus, we are not for 2017. In CY 2015, the EHR reporting In CY 2017, the EHR reporting period
finalizing the proposal (80 FR 16775) period for a payment adjustment year for a payment adjustment year for EPs
that for all EPs beginning with the CY for EPs who have not successfully who are new participants is any
2019 payment adjustment year, the EHR demonstrated meaningful use in a prior continuous 90-day period in CY 2017.
reporting period for a payment year (‘‘new participants’’) is any An EP who successfully demonstrates
adjustment year would be the full continuous 90-day period in CY 2015. meaningful use for this period and
calendar year that is 2 years before the An EP who successfully demonstrates satisfies all other program requirements
payment adjustment year (for example, meaningful use for this period and will avoid the payment adjustment in
CY 2017 as the EHR reporting period for satisfies all other program requirements CY 2018 if the EP successfully attests by
the CY 2019 payment adjustment year). will avoid the payment adjustments in October 1, 2017.
We are also not finalizing the proposed CYs 2016 and 2017 if the EP We have revised the definition of
limited exception for EPs demonstrating successfully attests by February 29, ‘‘EHR reporting period for a payment
meaningful use under the Medicaid 2016. adjustment year’’ under § 495.4 to
EHR Incentive Program for the first time In CY 2015, the EHR reporting period reflect these final policies. Table 18
(80 FR 16775). The reason we are not for a payment adjustment year for EPs contains a summary of the final policies.
TABLE 18—EHR REPORTING PERIODS AND RELATED PAYMENT ADJUSTMENT YEARS FOR EPS
2015
EHR reporting period for a Applies to avoid a payment Applies to avoid a payment
payment adjustment year adjustment in CY 2016 adjustment in CY 2017
EPs who have not successfully Any continuous 90-day period in Yes, if EP successfully attests by Yes, if EP successfully attests by
demonstrated meaningful use in CY 2015. February 29, 2016. February 29, 2016.
a prior year (new participants).
EPs who have successfully dem- Any continuous 90-day period in No ................................................. Yes, if EP successfully attests by
onstrated meaningful use in a CY 2015. February 29, 2016.
prior year (returning participants).
2016
payment adjustment year adjustment in CY 2017 adjustment in CY 2018.
EP new participants ....................... Any continuous 90-day period in Yes, if EP successfully attests by Yes, if EP successfully attests by
CY 2016. October 1, 2016. February 28, 2017.
EP returning participants ............... CY 2016 ........................................ No ................................................. Yes, if successfully attest by Feb-
ruary 28, 2017.
2017
payment adjustment year adjustment in CY 2018 adjustment in CY 2019
EP new participants ....................... Any continuous 90-day period in Yes, if EP successfully attests by N/A.
CY 2017. October 1, 2017.
EP returning participants ............... N/A ................................................ N/A ................................................ N/A.
Medicaid EP returning participants Any continuous 90-day period in No ................................................. Yes, if successfully attest by Feb-
demonstrating Stage 3. CY 2017. ruary 28, 2018.
b. Changes to the EHR Reporting Period participants to attest to avoid the Response: We recognize the
for a Payment Adjustment Year for payment adjustments in 2017. commenters’ concerns, and for the
Eligible Hospitals Response: We appreciate the reasons stated in section II.E.2.a with
commenters’ feedback and support. We regard to new participant EPs in 2017,
As follows is a summary of the
strongly believe this will simplify the we will adopt a final policy that for
comments received on the proposals for
EHR Incentive Program and further our eligible hospitals demonstrating
the EHR reporting period for a payment meaningful use for the first time in 2017
adjustment year for eligible hospitals goal to align reporting requirements
under the EHR Incentive Program and under Medicare or Medicaid, the EHR
(80 FR 16776 through 16778 and 80 FR reporting period for a payment
20380 through 20381): the reporting requirements for various
CMS quality reporting programs, to adjustment year is any continuous 90-
Comment: We received a number of day period in CY 2017 and applies for
comments stating that new participant respond to stakeholders who cited
difficulty with following varying purposes of the payment adjustments in
eligible hospitals should be allowed to FY 2018. To avoid the payment
attest prior to January 1, 2016 in order reporting requirements, and to simplify
HHS system requirements for data adjustment in FY 2018, the 90-day EHR
to earn an incentive payment and avoid reporting period must occur within the
the Medicare payment adjustment for capture.
first three quarters of CY 2017 and the
2016. We received comments in support Comment: Some commenters eligible hospital must attest by October
of the proposed changes to the EHR expressed concerns about our proposal 1, 2017.
reporting period for a payment to require first-time participants to However, we will adopt a final policy
adjustment year to allow for greater fulfill an EHR reporting period 2 years beginning in 2018 to require eligible
flexibility and more time for eligible in advance of the payment adjustment hospitals (new participants and
hospitals to work toward successful year. They believe that this policy returning participants) that attest to
demonstration of meaningful use. change is unnecessarily confusing and meaningful use under Medicare to
Response: We thank the commenters unfairly penalizes first-time complete a full CY EHR reporting period
and note that the attestation period will participants. They recommended that that is 2-years before the payment
be open for all providers in January of CMS retain its current policy to allow adjustment year. We are adopting a
2016 to attest for an EHR reporting first-time participants to avoid a penalty limited exception of a 90-day EHR
period in 2015. in the subsequent year. reporting period the year that is 2 years
Comment: Some commenters agreed Some commenters noted that new before the payment adjustment year for
with the proposal as described to align participants in 2018 would be moving to Medicaid participants demonstrating
EHR reporting periods for the purpose Stage 3 and should have a 90 day EHR meaningful use for the first time that
of future payment adjustments and reporting period for that purpose. Other previously demonstrated AIU prior to
endorsed the proposal to continue with commenters stated that any provider in 2017 to allow these providers to earn an
the current structure for these their first year, and all providers in the incentive payment in the Medicaid
components. Some comments also first year of a new stage, should have a program for 2018 without receiving an
supported a single deadline for new 90 day reporting period. penalty in the Medicare program.
We disagree that the change to a full- meaningful use for this period and participants and are not demonstrating
year EHR reporting period unfairly satisfies all other program requirements Stage 3, is the full CY 2017. An eligible
impacts new participant. We note that will avoid the payment adjustment in hospital that successfully demonstrates
the prior exception to allow a 90-day FY 2017 if the eligible hospital meaningful use for this period and
EHR reporting period favors new successfully attests by February 29, satisfies all other program requirements
participants over returning participants 2016. will avoid the payment adjustment in
who have no such opportunity to avoid In CY 2016, the EHR reporting period FY 2019 if the eligible hospital
a payment adjustment in the subsequent for a payment adjustment year for successfully attests by February 28,
year. We further note that new eligible hospitals that are new 2018.
participants could have chosen to begin participants is any continuous 90-day Beginning in CY 2018, the EHR
the program at any time since 2011 period in CY 2016. An eligible hospital reporting period for a payment
unless they are newly practicing that successfully demonstrates adjustment year for eligible hospitals is
providers who are already afforded a meaningful use for this period and the entire calendar year that is two years
hardship exception from the penalty. satisfies all other program requirements before the payment adjustment year. For
After consideration of the public will avoid the payment adjustment in example, CY 2018 is the EHR reporting
comments, we are finalizing the FY 2017 if the eligible hospital period for the FY 2020 payment
following changes to the EHR reporting successfully attests by October 1, 2016, adjustment year. The exception to this
period for a payment adjustment year and will avoid the payment adjustment general rule is for eligible hospitals that
for eligible hospitals as proposed, with in FY 2018 if the eligible hospital successfully demonstrated AIU under
a modification for the EHR reporting successfully attests by February 28, the Medicaid EHR Incentive Program for
period in 2017. For the reasons stated in 2017. a payment year prior to 2017 and are
section II.E.2.a. of this final rule with In CY 2016, the EHR reporting period
demonstrating meaningful use for the
comment period for Medicaid EPs for a payment adjustment year for
first time under the Medicaid EHR
participating in Stage 3 in 2017, we are eligible hospitals that are returning
Incentive Program in the calendar year
finalizing a similar policy for eligible participants is the full CY 2016. An
that is two years before the payment
hospitals to establish a 90-day EHR eligible hospital that successfully
adjustment year. For those eligible
reporting for Stage 3 participants in demonstrates meaningful use for this
hospitals, the same 90-day EHR
2017 for the purposes of avoiding the period and satisfies all other program
reporting period used for the Medicaid
payment adjustment in 2019 for requirements will avoid the payment
incentive payment will also apply for
returning participants and for the adjustment in FY 2018 if the eligible
purposes of the Medicare payment
payment adjustment in 2018 for new hospital successfully attests by February
adjustment year 2 years after the
participants who attest to Stage 3 prior 28, 2017.
calendar year in which the eligible
to October 1, 2017. For further In CY 2017, the EHR reporting period
hospital demonstrates meaningful use.
discussion of the policy related to the for a payment adjustment year for
For example, if an eligible hospital has
EHR reporting period in 2017 we direct eligible hospitals that are new
never successfully demonstrated
readers to section II.B.1.b.(3).iii. of this participants is any continuous 90-day
meaningful use in a prior year and
final rule with comment period. period in CY 2017. An eligible hospital
In CY 2015, the EHR reporting period demonstrates under the Medicaid EHR
that successfully demonstrates
for a payment adjustment year for Incentive Program that it is a
meaningful use for this period and
eligible hospitals that have not meaningful EHR user for the first time
satisfies all other program requirements
successfully demonstrated meaningful in CY 2018, the EHR reporting period
will avoid the payment adjustment in
use in a prior year (new participants) is for the Medicaid incentive payments
FY 2018 if the eligible hospital
any continuous 90-day period beginning any continuous 90-day period within
successfully attests by October 1, 2017
on October 1, 2014 and ending on CY 2018, and the same 90-day period
and will avoid the payment adjustment
December 31, 2015. An eligible hospital also serves as the EHR reporting period
in FY 2019 if the eligible hospital
that successfully demonstrates for the FY 2020 payment adjustment
successfully attests by February 28,
meaningful use for this period and year under Medicare. An eligible
2018.
satisfies all other program requirements In CY 2017, the EHR reporting period hospital that successfully demonstrates
will avoid the payment adjustment in for a payment adjustment year for meaningful use for the relevant period
FYs 2016 and 2017 if the eligible eligible hospitals that are demonstrating and satisfies all other program
hospital successfully attests by February Stage 3 is any continuous 90-day period requirements will avoid the payment
29, 2016. in CY 2017. An eligible hospital that adjustment in the relevant year if the
In CY 2015, the EHR reporting period successfully demonstrates meaningful eligible hospital successfully attests by
for a payment adjustment year for use for this period and satisfies all other the date specified by CMS.
eligible hospitals that have successfully program requirements will avoid the We have revised the definition of
demonstrated meaningful use in a prior payment adjustment in FY 2019 if the ‘‘EHR reporting period for a payment
year (returning participants) is any eligible hospital successfully attests by adjustment year’’ under § 495.4 to
continuous 90-day period beginning on February 28, 2018. reflect these final policies. Table 19
October 1, 2014 and ending on In CY 2017, the EHR reporting period contains a summary of the final policies,
December 31, 2015. An eligible hospital for a payment adjustment year for although it does not include years
that successfully demonstrates eligible hospitals that are returning beyond 2018.
TABLE 19—EHR REPORTING PERIODS AND RELATED PAYMENT ADJUSTMENT YEARS FOR ELIGIBLE HOSPITALS
2015
EHR reporting period for a pay- Applies to avoid a payment ad- Applies to avoid a payment ad-
ment adjustment year justment in FY 2016 justment in FY 2017
Eligible hospitals that have not Any continuous 90-day period Yes, if eligible hospital success- Yes, if eligible hospital success-
successfully demonstrated from October 1, 2014 through fully attests by February 29, fully attests by February 29,
meaningful use in a prior year December 31, 2015. 2016. 2016.
(new participants).
Eligible hospitals that have suc- Any continuous 90-day period No ................................................. Yes, if eligible hospital success-
cessfully demonstrated meaning- from October 1, 2014 through fully attests by February 29,
ful use in a prior year (returning December 31, 2015. 2016.
participants).
2016
payment adjustment year adjustment in FY 2017 adjustment in FY 2018
Eligible hospital new participants ... Any continuous 90-day period in Yes, if eligible hospital success- Yes, if eligible hospital success-
CY 2016. fully attests by October 1, 2016. fully attests by February 28,
2017.
Eligible hospital returning partici- CY 2016 ........................................ No ................................................. Yes, if eligible hospital success-
pants. fully attests by February 28,
2017.
2017
Eligible hospital new participants ... Any continuous 90-day period in Yes, if eligible hospital success- Yes, if eligible hospital success-
CY 2017. fully attests by October 1, 2017. fully attests by February 28,
2018.
Eligible hospital Stage 3 partici- Any continuous 90-day period in No for returning participants ......... Yes, if eligible hospital success-
pants. CY 2017. fully attests by February 28,
2018.
2018.
2018
Eligible hospital new participants ... CY 2018 ........................................ No ................................................. Yes, if eligible hospital success-
fully attests by February 28,
2019.
Eligible hospital Medicaid excep- The continuous 90-day EHR re- No ................................................. Yes, if eligible hospital success-
tion. porting period for the Medicaid fully attests by February 28,
incentive payment in CY 2018. 2019.
2019.
c. Changes to the EHR Reporting Period requests for clarification of whether the reasonable costs incurred if the CAH
for a Payment Adjustment Year for early attestation deadlines apply for does not successfully demonstrate
CAHs CAHs in order to avoid future payment meaningful use for the applicable EHR
As follows is a summary of the adjustments as first time participants. reporting period. Furthermore, for the
comments received on the proposals for Response: As noted in section II.D. of reasons stated in section II.E.2.a. of this
the EHR reporting period for a payment this final rule with comment period, final rule with comment period with
adjustment year for CAHs (80 FR 16777 some new participant CAHs have regard to new participant EPs in 2017,
through 16779 and 80 FR 20381): already attested to meaningful use for an we will adopt a final policy that for
Comment: We received a number of EHR reporting period in 2015. The early CAHs demonstrating meaningful use for
comments stating that CAHs should be attestation deadlines do not apply to the first time in 2017 under Medicare or
allowed to attest in 2015 if they are CAHs because of the alignment of the Medicaid, the EHR reporting period for
demonstrating meaningful use for the EHR reporting period with the payment a payment adjustment year is any
first time in order to earn an incentive adjustment year and the use of the cost continuous 90-day period in CY 2017
payment and avoid the 2015 payment report reconciliation process to reduce a and applies for purposes of the payment
adjustment. We further received CAH’s Medicare reimbursement for adjustments in FY 2017.
We will also adopt a final policy December 31, 2015. A CAH that successfully attests by February 28,
beginning in 2018 to require CAH (new successfully demonstrates meaningful 2018.
participants and returning participants) use for this period and satisfies all other Beginning in CY 2018, the EHR
that attest to meaningful use under program requirements will avoid the reporting period for a payment
Medicare to complete a full CY EHR payment adjustment in FY 2015 if the adjustment year for CAHs is the
reporting period that is the payment CAH successfully attests by February calendar year that begins on the first day
adjustment year. We are adopting a 29, 2016. of the second quarter of the federal
limited exception of a 90-day EHR In CY 2016, the EHR reporting period fiscal year that is the payment
reporting period within the calendar for a payment adjustment year for CAHs adjustment year. For example, in order
year that is the payment adjustment year that are new participants is any for a CAH to avoid application of the
for Medicaid CAH participants continuous 90-day period in CY 2016. A adjustment to its reasonable costs
demonstrating meaningful use for the CAH that successfully demonstrates incurred in a cost reporting period that
first time that previously demonstrated meaningful use for this period and begins in FY 2018, the CAH must
AIU prior to 2017 to allow these satisfies all other program requirements demonstrate it is a meaningful EHR user
providers to earn an incentive payment will avoid the payment adjustment in for an EHR reporting period of the full
in the Medicaid program for 2018 FY 2016 if the CAH successfully attests CY 2018. The exception to this general
without receiving an penalty in the by February 28, 2017. rule is for CAHs that successfully
Medicare program. In CY 2016, the EHR reporting period demonstrated AIU under the Medicaid
After consideration of the public for a payment adjustment year for CAHs EHR Incentive Program for a payment
comments, we are finalizing the that are returning participants is the full year prior to 2017 and are
following changes to the EHR reporting CY 2016. A CAH that successfully demonstrating meaningful use for the
period for a payment adjustment year demonstrates meaningful use for this first time under the Medicaid EHR
for CAHs as proposed, with a period and satisfies all other program Incentive Program in the calendar year
modification for the EHR reporting requirements will avoid the payment that begins on the first day of the second
period in 2017. For the reasons stated in adjustment in FY 2016 if the CAH quarter of the federal fiscal year that is
section II.E.2.a. of this final rule with
successfully attests by February 28, the payment adjustment year. For those
comment period for Medicaid EPs for
2017. CAHs, the same 90-day EHR reporting
Stage 3 in 2017, we are finalizing a
In CY 2017, the EHR reporting period period used for the Medicaid incentive
similar policy for CAHs to establish a
for a payment adjustment year for CAHs payment will also apply for purposes of
90-day EHR reporting for Stage 3
that are new participants is any the Medicare payment adjustment year.
participants in 2017 for the purposes of
continuous 90-day period in CY 2017. A For example, if a CAH has never
avoiding the payment adjustment for FY
2017. For further discussion of the CAH that successfully demonstrates successfully demonstrated meaningful
policy related to the EHR reporting meaningful use for this period and use in a prior year and demonstrates
period in 2017 we direct readers to satisfies all other program requirements under the Medicaid EHR Incentive
section II.B.1.b.(3).iii. of this final rule will avoid the payment adjustment in Program that it is a meaningful EHR
with comment period. FY 2017 if the CAH successfully attests user for the first time in CY 2018, the
In CY 2015, the EHR reporting period by February 28, 2018. EHR reporting period for the Medicaid
for a payment adjustment year for CAHs In CY 2017, the EHR reporting period incentive payment is any continuous
that have not successfully demonstrated for a payment adjustment year for CAHs 90-day period within CY 2018, and the
meaningful use in a prior year (new that are demonstrating Stage 3 is any same 90-day period also serves as the
participants) is any continuous 90-day continuous 90-day period in CY 2017. A EHR reporting period for the FY
period beginning on October 1, 2014 CAH that successfully demonstrates 2018payment adjustment year under
and ending on December 31, 2015. A meaningful use for this period and Medicare. A CAH that successfully
CAH that successfully demonstrates satisfies all other program requirements demonstrates meaningful use for the
meaningful use for this period and will avoid the payment adjustment in relevant period and satisfies all other
satisfies all other program requirements FY 2017 if the CAH successfully attests program requirements will avoid the
will avoid the payment adjustment in by February 28, 2018. payment adjustment in the relevant year
FY 2015 if the CAH successfully attests In CY 2017, the EHR reporting period if the CAH successfully attests by the
by February 29, 2016. for a payment adjustment year for CAHs date specified by CMS.
In CY 2015, the EHR reporting period that are returning participants and are We have revised the definition of
for a payment adjustment year for CAHs not demonstrating Stage 3, is the full CY ‘‘EHR reporting period for a payment
that have successfully demonstrated 2017. A CAH that successfully adjustment year’’ under § 495.4 to
meaningful use in a prior year demonstrates meaningful use for this reflect these final policies. Table 20
(returning participants) is any period and satisfies all other program contains a summary of the final policies,
continuous 90-day period beginning on requirements will avoid the payment although it does not include years
October 1, 2014 and ending on adjustment in FY 2017 if the CAH beyond 2018.
TABLE 20—EHR REPORTING PERIODS AND RELATED PAYMENT ADJUSTMENT YEARS FOR CAHS
2015
EHR reporting period for a payment Applies to avoid a payment adjustment

adjustment year in FY 2015
CAHs that have not successfully demonstrated Any continuous 90-day period from October 1, Yes, if CAH successfully attests by February
meaningful use in a prior year (new partici- 2014 through December 31, 2015 29, 2016.
pants).
CAHs that have successfully demonstrated Any continuous 90-day period from October 1,
meaningful use in a prior year (returning par- 2014 through December 31, 2015
ticipants).
2016
EHR reporting period for a payment Applies to avoid a payment adjustment in FY

adjustment year 2016
CAH new participants ........................................ Any continuous 90-day period in CY 2016 Yes, if CAH successfully attests by February
28, 2017.
CAH returning participants ................................. CY 2016.
2017

28, 2018.
CAH Stage 3 participants .................................. Any continuous 90-day period in CY 2017
2018

28, 2018.
3. Hardship Exceptions 80 FR 16777 and 80 FR 16779), nor did significant cost which should be
we propose any new types of exceptions avoided where feasible. Furthermore, if
As stated previously, sections
for 2017 and subsequent years. the applicable EHR reporting period for
1848(a)(7)(B) and 1886(b)(3)(B)(ix)(II) of
Accordingly, we proposed that the a payment adjustment year occurs 2
the Act provide the Secretary with
exceptions continue as previously years before the payment adjustment
discretionary authority to exempt, on a
finalized. As follows is a summary of year, providers that fail to demonstrate
case by case basis, a provider from the
the comments received for hardship meaningful use for that period will be
application of the Medicare payment exceptions:
adjustment if the Secretary determines aware of their status well in advance of
Comment: We received a number of the deadline for applying for a hardship
that compliance with the requirements comments requesting an extension of
for being a meaningful EHR user would exception, and thus no such extension
the hardship exception application is necessary. New participants in the
result in a significant hardship. We have deadline from July 1 to December 31 of
established various types of hardship program who are uncertain of their
the year proceeding the payment ability to meet the requirements of the
exceptions for which providers may adjustment year. A commenter noted
apply as well as deadlines for program in a given year may apply for
that CMS allowed for providers to apply a hardship exception even if they later
application. For more information, we for a hardship exception in November of
refer readers to the Stage 2 final rule at find they are able to successfully attest
the year proceeding the payment in the program. The provider is not
77 FR 54093 through 54113. adjustment year in 2014 and that such
In the EHR Incentive Programs in required to withdraw the hardship
a provision should be possible in every
2015 through 2017 proposed rule (80 FR exception application, and the
year.
20381), we proposed no changes to the Response: We thank the commenters application does not affect their
types of hardship exceptions available for their suggestions but disagree with subsequent attestation for meaningful
use. Therefore, we do not believe a
to EPs, eligible hospitals, and CAHs. their assessment. The extension of the
Further, we proposed no changes to the hardship exception application deadline general extension of the hardship
existing hardship exception process and to later in the year is both unnecessary exception application deadline is
timelines under our regulations. and a significant burden for the program necessary, although we may consider
In the Stage 3 proposed rule we and for those providers whose claims extensions in exceptional
proposed no changes to the types of may need to be reprocessed. We note circumstances.
exceptions previously finalized for EPs, that the expedited processing and Comment: A large number of
eligible hospitals or CAHs (80 FR 16775, reprocessing of claims represents a commenters requested that CMS add
new hardship exception categories for exemptions are not granted once and considered eligible for this hardship
the EHR Incentive Programs. applicable for a full five-year period. exception.
Commenters believed that there should Under 495.102(d)(4)(iv)(C), an EP may Response: We appreciate the
be additional exception categories, receive a hardship exception if he or she commenter’s suggestion about an
especially for providers experiencing has a primary specialty listed in PECOS indicator to identify a newly practicing
issues with certified EHR technology as anesthesiology, radiology or EP in the registration system and will
and EHR vendors; providers who are pathology 6 months prior to the first day consider analysis to determine
unable to achieve meaningful use due to of the payment adjustments that would feasibility.
the all-or-nothing approach; providers otherwise apply. The following five Comment: Commenters supported the
practicing in multiple locations or who specialty codes correspond to those existing hardship exception structure
have transitioned between locations; primary specialties in PECOS: and categories for the Medicare payment
providers who are beyond retirement Diagnostic Radiology (30), Nuclear adjustment in the EHR Incentive
age; specialty providers; providers who Medicine (36), Interventional, Radiology Programs. Some commenters requested
are new to the EHR Incentive Program (94), Anesthesiology (05), or Pathology a change the hardship exception
and have not yet achieved meaningful (22). application date for eligible hospitals to
use; providers who see observation Comment: A commenter expressed reflect the realignment to the calendar
patients; and fellows. Commenters concern regarding the requirement that year.
believe providers who fall into any of the hardship exception is subject to Response: We appreciate the support
these categories have significant reasons annual renewal, but in no case may an expressed by commenters of our current
to be included in the list of those who EP be granted an exception for more process for hardship exceptions for
qualify for hardship exceptions and than 5 years. Specifically, the eligible hospitals. We agree with the
should not receive payment commenter stated that a large recommendation to modify the hardship
adjustments. percentage of these EPs practice in areas exception application deadline for
Response: We note that providers may that do not have availability of CEHRT eligible hospitals to allow for adequate
already apply for a hardship exception for demonstration of meaningful use. time between the close of the calendar
under the extreme and uncontrollable Because these providers lack control year and the submission requirements
circumstances category if they over availability of CEHRT for more for hardship applications. We will align
experience issues with a vendor product than 50 percent of patient encounters, the eligible hospital deadline with the
including issues related to upgrades and they cannot demonstrate meaningful EP deadline so that applications will be
transitions from one product to another. use. The commenter anticipates these due on July 1 of the year preceding the
In addition, we note that new providers to continue practicing at payment adjustment year.
participants have the same ability to multiple locations beyond the 5 years We are finalizing no changes to the
apply for a hardship exception as any allowed for hardship exceptions. Some types of hardship exceptions already
other provider. We also established commenters suggested a hardship available to EPs, eligible hospitals, and
hardship exception categories for newly exemption should be available for EPs CAHs, nor do we finalize any new types
practicing EPs, new eligible hospitals, working in long term post-acute care of hardship exceptions. We are
and new CAHs. We do not believe there (LTPAC) which should continue beyond finalizing one procedural change to the
are acceptable standards to establish a the 5-year time limit; while other hardship exception application deadline
category based on age or potential commenters questioned what if there is for eligible hospitals to July 1 of the year
retirement status given the wide not sufficient broadband access in the preceding the payment adjustment year
variation among providers and potential region and 5 years may not be enough to align the application period with EPs
influencing factors. Finally, we believe time for some remote areas to be in light of the change to align hospitals
that the existing categories are broad ‘‘connected’’. A commenter with the calendar year for the EHR
and comprehensive enough to cover recommended simply eliminating the 5- reporting period for a payment
many different circumstances where year maximum for providers claiming adjustment year and the changed
meeting the program requirements this hardship exception. attestation deadlines as finalized in
would be a significant hardship due to Response: We are sympathetic to the section II.E.2.b and II.D of this final rule
circumstances outside the control of the challenges identified by the commenters with comment period. This change is
provider and related to their particular and believe that barriers to achieving reflected in § 412.64(d)(4).
practice or organization. meaningful use should be minimized
Comment: Some commenters over time. As noted earlier, the 5-year 4. Administrative Review Process of
requested clarification around whether limitation on hardship exceptions is a Certain Electronic Health Record
the 5-year limitation for hardship statutory requirement under section Incentive Program Determinations
exceptions will be applicable to 1848(a)(7)(B) of the Act, and we do not In the Stage 2 final rule (77 FR 54112
providers with PECOS specialties of have discretion to alter this through 54113), we discussed an
diagnostic radiology (30), nuclear requirement. administrative appeals process for both
medicine (36), interventional radiology Comment: We received a suggestion Stages 1 and 2 of meaningful use. We
(94), anesthesiology (05), and pathology from a commenter for an indication in believe this appeals process is primarily
(22). Commenters believed these the registration system that would procedural and does not need to be
providers might retain the same PECOS identify the new EPs, which may be specified in regulation. We developed
specialty code for more than 5 years. helpful to assist with program guidance on the appeals process, which
Response: Under section 1848(a)(7)(B) management. The commenter indicated is available on our Web site at
of the Act, the Secretary has discretion, for a large group practice, it is very www.cms.gov/EHRIncentivePrograms.
on a case-by-case basis, to exempt an EP difficult to determine if an EP is We proposed no changes to this process
from the Medicare payment adjustment considered ‘‘new’’ by CMS standards and intend to continue to specify the
if the Secretary determines, subject to and therefore may qualify for a hardship appeals process in guidance available
annual renewal, that requiring the EP to exception for newly practicing EPs. on our Web site.
be a meaningful EHR user would result Some EPs have moonlighted during Comments: We received a number of
in a significant hardship. Such residency or fellowship and may be comments with references to specific
instances of audits or appeals Comment: A commenter requested would be permitted. One commenter
submitted. In addition, we received a clarification that CMS is not changing requested clarification on whether
wide range of recommendations for the quality reporting requirements for immunization registries would be
changes the auditors should make and MA organizations in this proposed rule included, whether states could continue
for the requirements for the audit so that MA providers may still meet the to specify transport options, and
program. Finally, we received a number quality reporting requirements by way whether states could decide not to
of comments expressing frustration with of their Healthcare Effectiveness Data declare readiness to accept submissions
failed audits due to lack of response and Information Set (HEDIS) to clinical data registries for meaningful
from the provider or the provider not submission. Another commenter use purposes.
receiving notification. requested that hardship exceptions be Response: We note that the state
Response: We thank the commenters granted to MA providers under the same flexibility to propose a revised
for sharing their experiences and insight provisions available for non-MA definition of meaningful use with
with us. While we will not respond to providers. respect to particular public health
each individual circumstance in this Response: We are confirming that we measures continues as allowed in Stage
final rule with comment period, as this will continue to allow MA organizations 1 and Stage 2 at § 495.316(d)(2) and
is not the appropriate vehicle to address to report HEDIS measures in lieu of § 495.332(f)(2). We note that the final
these individual concerns, we note that CQMs for purposes of meaningful use rule has altered the structure of
providers may contact us directly and for qualifying MA–EPs and MA- meaningful use under Stage 2 with
we will work with them to understand affiliated eligible hospitals. respect to the public health and clinical
their audit or appeal status, review any We did not propose any changes to data registry reporting measures, such
determinations and provide information the hardship exemption policy for MA that there is a single objective with a list
related to the programs. We also providers in the proposed regulation. of measures that providers may choose
appreciate those who provided Therefore, the comment is outside the from. However, we would still permit
suggestions for additional guidance scope of the proposed rule and is not states to exercise flexibility with respect
which might assist the auditors to make addressed in this final rule with to each of the Stage 2 items listed at
determinations on certain requirements comment period. § 495.316(d)(2)(ii) that still apply in
for the program. We have reviewed this 2015 through 2017 under this final rule.
G. The Medicaid EHR Incentive Program We will also take the following
information and will update our
1. State Flexibility for Meaningful Use considerations into account when, as
guidance in response to
part of ’our review and approval of the
recommendations received. Finally, we Consistent with our approach under state’s Medicaid HIT plan, we review
note that it is incumbent on providers both Stage 1 and 2, for Stage 3 we state requests for flexibility with respect
to maintain the appropriate contact proposed to continue to offer states to the public health reporting objective
information in the system of record and flexibility under the Medicaid EHR (Objective 8) for Stage 3 (see section
regularly verify that their contact Incentive Program in Stage 3 by adding II.B.2.b.(viii). of this final rule with
information is correct. It is this contact a new provision at § 495.316(d)(2)(iii) comment period. We want to balance
information provided by the EP, eligible subject to the same conditions and states’ flexibility to customize the public
hospital, or CAH which we use to notify standards as the Stage 2 flexibility health and clinical data registry
the provider of any status update or policy. We proposed at that under Stage requirements for meaningful use against
audit request for the EHR Incentive 3 (80 FR 16779), state flexibility would ensuring providers have options to
Programs. Once notification has been apply only with respect to the public submit to registries that are most
sent, it is also this contact information health and clinical data registry relevant to their practices. Therefore, we
which is used by the auditors to reporting objective. We proposed that expect that for Stage 3 we would be
communicate with the provider on states could continue to specify the more likely to approve requests under
status, documentation requests, and any means of transmission of data and which a state would require an EPs,
other necessary items in order to otherwise change the public health eligible hospitals and CAHs to submit to
expedite the audit process and ensure agency reporting objective as long as the a specific registry meeting the
the use of verified and authorized state does not require functionality specification of measures 1 through 4 or
contact information for the EP, eligible greater than what is required for Stage 6 rather than establishing specific
hospital or CAH. 3 and included in the 2015 Edition requirements for measure 5.
We are finalizing our proposal to proposed rule. The flexibility to specify transmission
maintain this policy as previously Similarly, in the preamble to the EHR standards remains unchanged from the
adopted. Incentive Programs in 2015 through Stage 2 Rule. In the Stage 2 final rule (77
2017 proposed rule (80 FR 20349), we FR 53979), we explained that a state
F. Medicare Advantage Organization
proposed to continue to offer states could not require a different standard
Incentive Payments
flexibility for the public health reporting than the one included in 2014 ONC EHR
We did not propose any changes to objective as modified under Stage 2 for certification criteria, but in cases where
the existing policies and regulations for 2015 through 2017. We would continue the 2014 ONC EHR certification criteria
MA organizations. Our existing policies the policy stated in the Stage 2 final rule are silent, such as the means of
and regulations include provisions (77 FR 53979) to allow states to specify transmission for a given public health
concerning the EHR incentive payments the means of transmission of the data or objective, the state may propose changes
to qualifying MA organizations and the otherwise change the public health to public health measures. We maintain
payment adjustments for 2015 and measure as long as it does not require this distinction for Stage 3 in relation to
subsequent MA payment adjustment EHR functionality that supersedes that the 2015 ONC certification criteria for
years. (For more information on MA which is included in the certification health IT.
organization incentive payments, we requirements specified under the 2014 Comment: Most commenters
refer readers to the final rules for Stages Edition certification criteria. supported the new provision to provide
1 and 2 (75 FR 44468 through 44482 and Comment: Commenters requested states with flexibility regarding the
77 FR 54113 through 54119).) clarification on the state flexibility that Stage 3 public health and clinical data
registry reporting objective. One period for a payment adjustment year’’ and eligible hospitals participating in
commenter questioned whether a state in § 495.4 that would apply to providers the Medicaid EHR Incentive Program.
could opt to not declare readiness to attesting in the Medicaid EHR Incentive We proposed that this exception would
accept clinical data registries for Program. While many of the proposed apply both for purposes of receiving an
meaningful use purposes, expressing amendments would apply to providers incentive payment in the Medicaid
concern that providers may prioritize attesting in either the Medicare or program and for purposes of avoiding
reporting to federal clinical data Medicaid EHR Incentive Program, we the payment adjustment under the
registries over the public health also proposed a limited exception for Medicare program for the payment
reporting objectives. Another new meaningful EHR users in the adjustment year that is two years after
commenter expressed concern that that Medicaid program beginning in 2017. the calendar year in which the provider
this flexibility would lead to differing In the EHR Incentive Programs in first demonstrates meaningful use for an
objectives and measures among the 2015 through 2017 proposed rule (80 FR EHR reporting period. As the last year
states instead of a consistent, standard 20353 and 20354), we proposed that all that an eligible professional can begin
approach. providers (EPs, eligible hospitals, and participation in the Medicaid EHR
Response: We proposed to continue to CAHs) would be required to complete Incentive Program is 2016, this limited
offer states flexibility under the an EHR reporting period within January exception would apply only to
Medicaid EHR Incentive Program in 1 and December 31 of the calendar year providers who received an incentive
Stage 3, but subject to the same in order to fulfill the requirements of the payment for adopt, implement, or
considerations discussed previously in EHR Incentive Programs beginning in upgrade of CEHRT in 2011 through
Stage 2 (77 FR 53979). For Stage 3 of calendar year 2015 (except for eligible 2016, but did not receive an incentive
meaningful use, we would continue to hospitals and CAHs in 2015, which may payment for demonstration of
allow states to specify the means of begin an EHR reporting period as early meaningful use until 2017 or after. In
transmission of the data and otherwise as October 1, 2014 and must end by this section, we address comments
change the public health agency December 31, 2015). We also proposed received on this limited exception for
reporting objective as long as they do that for an EHR reporting period in new meaningful EHR users in the
not require functionality greater than 2015, eligible professionals may select Medicaid program.
what is required for Stage 3 and an EHR reporting period of any Comment: Several commenters
included in the 2015 Edition final rule. continuous 90-day period from January supported the proposal to allow
States may change the definition of 1, 2015 through December 31, 2015; Medicaid providers to have a 90-day
meaningful use with respect to the eligible hospitals and CAHs may select EHR reporting period for their first year
public health registry and clinical data an EHR reporting period of any of demonstrating meaningful use under
registry reporting objective as discussed continuous 90-day period from October the Medicaid EHR Incentive Program.
in our earlier response. While this 1, 2014 through December 31, 2015. Response: We refer readers to sections
policy may lead to variations in the These proposed amendments and the II.B.1.b.(3). and II.E.2. of this final rule
definition of meaningful use with final policies adopted are discussed in with comment period with comment
respect to this objective among the sections II.B.1.b.(3).(i). and (ii). of this period for a discussion of our final
states, we believe that it is important to final rule with comment period. policies for Medicaid providers for the
allow states to better shape their public In the Stage 3 proposed rule (80 FR EHR reporting period and the EHR
health policies and encourage providers 16739), we proposed that beginning in reporting period for a payment
to submit data to particular public 2017 and for all EPs, eligible hospitals, adjustment year.
health registries. and CAHs, the EHR reporting period We believe that these changes will
States generally do not have would be one full calendar year. This allow flexibility for providers who have
discretion to categorically deny proposed amendment is discussed in not demonstrated meaningful use in a
providers from using clinical data section II.B.1.b.(3).(iii). of this final rule previous year and will encourage
registries to meet the public health and with comment period, and is finalized providers to participate in the program.
clinical data registry reporting objective, with a modification to begin for all Comment: Some commenters opposed
so long as the clinical data repositories providers in 2018 and multiple the proposed 90-day EHR reporting
fall within federal rules and guidance. modifications to the EHR reporting period for certain Medicaid providers
To address concerns that providers may period in 2017. For EPs, eligible because they believed it would cause
be discouraged from attesting to public hospitals, and CAHs that choose to meet confusion as it conflicts with the
health registries, we reiterate that states Stage 3 in 2017, the EHR reporting proposed Medicare policy. In addition,
can submit for CMS approval revisions period is any continuous 90-day period these commenters were concerned that
to their SMHPs that would require that within CY 2017. For new participants, providers attesting to the 90-day EHR
providers meet certain measures. the EHR reporting period is any reporting period for Medicaid would
We are finalizing the Stage 3 state continuous 90-day reporting period still be subject to the Medicare payment
flexibility provision generally as within CY 2017. These modifications adjustment.
proposed, with only a minor change to regarding providers attesting to Stage 3 Response: We recognize the
update a cross-reference to the public of meaningful use in 2017 applies to possibility of provider confusion
health and clinical data registry providers attesting to the Medicaid EHR regarding EHR reporting periods
objective. Incentive Program as well. between the Medicare and Medicaid
In the Stage 3 proposed rule (80 FR EHR Incentive Programs under the final
2. EHR Reporting Period and EHR 16739), we also proposed a limited rule, but we believe that there are
Reporting Period for a Payment exception for Medicaid providers benefits that outweigh this potential
Adjustment Year for First Time demonstrating meaningful use for the concern. A 90-day EHR reporting period
Meaningful EHR Users in Medicaid first time in 2017 and subsequent years. would allow Medicaid providers
In the Stage 3 proposed rule (80 FR For that exception, we proposed to additional time and flexibility within
16779), we proposed several maintain the 90-day EHR reporting their first year of demonstrating
amendments to the definitions of ‘‘EHR period for a provider’s first payment meaningful use to implement certified
Reporting Period’’ and ‘‘EHR reporting year based on meaningful use for EPs EHR technology and otherwise integrate
the meaningful use objectives into their process of how states report to us proposed that states would report on the
practices. We believe that this will annually on the providers that have following activities: State system
encourage participation in the program attested to adopt, implement, or upgrade implementation dates; provider
and move a greater number of providers (AIU), or that have attested to outreach; auditing; state-specific SMHP
towards meaningful use. It also would meaningful use. Under this proposal, tasks; state staffing levels and changes;
reduce the burden on states to states would follow a structured the number and type of providers that
implement significant policy and submission process, in the manner qualified for an incentive payment on
system changes in preparation for Stage prescribed by CMS, which would the basis of demonstrating that they are
3, as the 90-day period for the first year include a new annual reporting meaningful EHR users of CEHRT and
of meaningful use is consistent with our deadline. We proposed to require states the amounts of incentive payments; and
previous policies and meaningful use to submit annual reports to CMS within the number and type of providers that
timelines. With regard to the question 45 days of the end of the second quarter qualified for an incentive payment on
raised by commenters if providers of each federal fiscal year. the basis of having adopted,
attesting to the 90-day EHR reporting We proposed to regularize the timing implemented, or upgraded CEHRT and
period for Medicaid may still be subject of the annual reporting process the amounts of incentive payments.
to the Medicare payment adjustment, described in § 495.316 to ensure more We proposed these changes to the
we refer to our discussion of the EHR timely annual reports and allow for quarterly reporting process described in
reporting period for the payment clearer communication to states on § 495.352 so that CMS and states can
adjustment year in section II.E.2. of this when the reports should be submitted to better track state implementation and
final rule with comment period. CMS. In addition, CMS and states oversight activity progress in a way that
Comment: Some commenters would be able to more effectively track would permit CMS and the states to
requested that CMS allow states to give the progress of states’ incentive program compare overall programmatic and
providers the option to attest to ‘‘at least implementation and oversight as well as provider progress. We also expect that
90 days or 3 calendar months,’’ rather provider progress in achieving streamlined and enhanced quarterly
than 90 days within the calendar year, meaningful use. Predictable deadlines progress reporting would lead to an
because it is more convenient for for annual reporting would permit CMS improvement in overall data quality that
providers to run reports out of their and the states to more quickly compare would help inform future meaningful
CEHRT by month. and assess overall program impact each use activity across states.
Response: We believe that it is year. Finally, we proposed to include a
important to maintain a consistent EHR In the Stage 3 proposed rule (80 FR deadline for states’ quarterly reporting
reporting period for providers in their 16779), we also noted our intent to under the proposed amendments to
first year of meaningful use and consider changes to the data that the § 495.352, and requested public
changing the EHR period at this point annual reporting requirements outlined comment on a deadline of 30 days after
also risks provider confusion. Allowing in § 495.316(d) require states to include the end of each federal fiscal year
3 calendar months would open the in their annual reports. Specifically, we quarter.
explained we were considering whether Comment: Commenters supported
possibility of a reporting period that is
to remove the requirement that states formalizing the process of how states
shorter than 90 days, and we believe
report information about practice report annually on the providers that
that 90 days is already a short period as have attested to AIU, or that have
location for providers that qualify for
compared to the entire year. attested to meaningful use, but
incentive payments on the basis of
Furthermore, a 90-day period need not requested to submit annual reports
having adopted, implemented, or
be tied to the beginning or end of a within 60 days of the end of the second
upgraded CEHRT or on the basis of
month and permits flexibility for quarter of each federal fiscal year rather
demonstrating they are meaningful
providers. than the 45 days proposed in the rule.
users of CEHRT. We stated our belief
Comment: A commenter requested A commenter stated that this will
that this data is useful to both CMS and
that CMS provide outreach and alleviate systems and programming
the states for program implementation
education to assure understanding of changes typically faced by states at the
purposes, but that the benefits of
the 90-day EHR reporting period for including it in state reports might be end of the calendar year, while another
Medicaid providers demonstrating outweighed by the burdens to states of commenter expressed that states would
meaningful use for the first time. reporting it and requested more need more time to produce current
Response: We will provide outreach information on state burdens and costs program year data to be included in the
and education around this policy. associated with complying with this annual report.
Because the exception for new requirement. We solicited comments Response: We agree with the
meaningful EHR users in the Medicaid both on the burdens associated with the commenter’s statements regarding the
program who had successfully attested requirement to report practice location implications of year-end program
to AIU prior to 2016 to allow a 90-day information for providers that receive changes and the need for additional
EHR reporting period in 2018 and incentive payments through the time to produce related data. Therefore,
subsequent years is consistent with Medicaid EHR Incentive Program, and we are finalizing these provisions to
existing policy with respect to Medicaid on the benefits of including this require that annual reports be submitted
provider EHR reporting periods, we do information in state reports. to CMS within 60 days of the end of the
not anticipate significant additional We proposed to amend § 495.352 to second quarter of each federal fiscal
confusion. formalize the process of how states year rather than 45 days, as was
3. Reporting Requirements submit quarterly progress reports on proposed. States should have ample
implementation and oversight activities time to prepare to submit the annual
a. State Reporting on Program Activities and to specify the elements that should reports to CMS, and we are not adding
In the Stage 3 proposed rule (80 FR be included in the quarterly reports. additional data elements for states to
16779), we also proposed to amend Under this proposal, states would report; therefore, the first report under
§ 495.316(c), as well as add a new follow a structured submission process, this amendment will be due within 60
paragraph § 495.316(f), to formalize the in the manner prescribed by CMS. We days of the end of the second quarter of
the federal fiscal year in which the final collected through state reporting payment through the Medicare EHR
rule takes effect. activities with the designated public Incentive Program. If the state is
Comment: Commenters supported our health agency, but also recognize that reporting a disqualification, then the
proposal to remove practice location the mechanism and interface between state would leave the state qualification
from the annual report. A commenter the reporting organization and the field blank. If applicable, in the cases of
noted that their state already reports public health agency must be live, EPs or eligible hospitals previously
practice location, but does not find this operational, and capable of interfacing identified as meaningful EHR users, the
data point to be beneficial and is in with all parties involved. Additionally, state would be required to specify the
favor of removing this requirement. our state reporting provisions are meant state disqualification and state
Another commenter finds this to cover reporting from state Medicaid disqualification date (that is, the
requirement to be burdensome because agencies to CMS. We decline to add a beginning date of the EHR reporting
it requires manual review of attestations requirement that state Medicaid period during which an EP or eligible
in order to identify accurate data on agencies report this data to other hospital was found not to meet the
practice locations, and fears this will entities, including public health definition of a meaningful EHR user).
lead to inaccurate data. agencies. We also proposed that states would
Response: We appreciate the submit this information beginning with
commenters’ feedback on this topic. b. State Reporting on Meaningful EHR payment year 2013 data. The reports
While we believe that there is a benefit Users would cover back to the 2013 payment
to having states report this information In the Stage 3 proposed rule at (80 FR year because that would be the EHR
in the annual reports, we believe that 16780), we noted that CMS must have reporting period for the 2015 Medicare
this benefit is outweighed by the burden accurate and timely data from states payment adjustment year under § 495.4.
of states having to collect and report this regarding both EPs and eligible Providers that successfully attested to
information on providers. Moreover, hospitals that have successfully meaningful use for 2013 would be
there is also a risk that inaccurate demonstrated meaningful use for each exempt from the Medicare payment
practice location data may be reported payment year to ensure that meaningful adjustment in 2015.
due to manual data collection processes. EHR users in the Medicaid EHR We also proposed that states would
We believe that we can effectively Incentive Program are appropriately not be required to report on those EPs
oversee the program without states exempted from the Medicare payment who are eligible for the Medicaid EHR
reporting this particular information. adjustment for the applicable payment Incentive Program on the basis of being
Therefore, we intend to remove the adjustment year. Accordingly, we a nurse practitioner, certified nurse-
requirement at § 495.316(d)(1)(i) and proposed to add new paragraphs (g) and midwife, or physician assistant.
(iii) that states report information about (h) to § 495.316 to require that states Comment: Most comments favored
practice location for providers that submit reports on a quarterly basis that and expressed no concern with the
qualify for incentive payments on the identify certain providers that attested associated requirements, nor anticipated
basis of having adopted, implemented, to meaningful use through the Medicaid burden. A commenter shared that he or
or upgraded CEHRT or on the basis of EHR Incentive Program for each she found the state reporting on
demonstrating they are meaningful payment year. Under this proposal, Meaningful EHR Users to be time
users of CEHRT. We encourage states to states would submit quarterly reports, in consuming and suggested that we use
collect and use practice location the manner prescribed by CMS, for the National Level Repository (NLR)
information, as it could prove useful Medicaid EPs and eligible hospitals that transactions to determine meaningful
and may differ from the business successfully attest to meaningful use for users and remove this burden from the
address information that is used for each payment year. states. In this commenter’s view, the
program administration purposes. We proposed that states would report payment adjustment is a Medicare
Comment: Commenters supported the quarterly information on each provider function; therefore states should be
proposed requirement for states to that successfully attests to meaningful removed from the process. Another
submit quarterly progress reports to use, regardless of whether the provider commenter requested that we further
CMS within 30 days after the end of has been paid yet. The report would be clarify who is exempt from the state
each federal fiscal year quarter and do required to specify the Medicaid state reporting.
not anticipate that this requirement and payment year. For each EP or Response: We intend to finalize these
would create any burden. eligible hospital listed in the report, the provisions as proposed for the reasons
Response: Based on the positive state would also specify the payment provided in the preamble to the Stage 3
feedback we are finalizing the proposal year number, the NPI for EPs and the proposed rule. As outlined in the Stage
with a modification to require the CCN for eligible hospitals, the 3 proposed rule (80 FR 16780), we must
deadline of 30 days after the end of each attestation submission date, the state have accurate and timely data from
federal fiscal year quarter that was qualification (as either meaningful use states regarding both EPs and eligible
discussed in the proposed rule. In order or blank), and the state qualification hospitals to ensure that meaningful
to give states sufficient time to prepare date (the beginning date of the reporting users in the Medicaid EHR Incentive
to submit the quarterly reports, the first period in which successful meaningful Program are appropriately exempted
report under the amendments to use attestation was achieved by the EP from the Medicare payment adjustment
§ 495.352 will be due in the second or eligible hospital). The EP’s or eligible for the applicable payment adjustment
quarter following the one in which the hospital’s ‘‘payment year number’’ year. This additional reporting is
final rule takes effect. refers to the number of years that the necessary because the electronic data
Comment: A commenter provider has been paid in the EHR currently contained in the NLR are
recommended that all public health Incentive Program; so, for example, this insufficient to determine which
measures collected or tracked through would be ‘‘2’’ for the 2014 payment year Medicaid providers should be exempted
the state reporting activities be reported if the provider received payments for from the Medicare payment adjustments
to the public health agency. 2013 and 2014. States would have this in an accurate and timely manner.
Response: We support the notion of data, even for providers that have Regarding the exemption with respect to
sharing public health measures previously received an incentive reports on certain providers, we are not
requiring states to report on nurse providers attempting to meaningfully actual burden would remain constant
practitioners, certified nurse-midwives, use EHR in areas with large numbers of for 2015 through 2017 as EPs, eligible
or physician assistants because these uninsured populations. They also hospitals, and CAHs would only need to
provider types are not subject to the recommended that CMS continue to attest that they have successfully
Medicare payment adjustments. The encourage state Medicaid programs to demonstrated meaningful use in 2015
first report under this requirement will collaborate with public health agencies, through 2017. The only variable from
be due in the quarter following the one and to assist in reducing barriers to the year to year will be the number of
in which the rule takes effect. use of Federal funding to build public respondents, as noted in the impact
health information infrastructure. A analysis assumptions.
4. Clinical Quality Measurement for the We solicited public comment on each
commenter recommended changes to
Medicaid Program of these issues for the following sections
the Medicaid patient-volume rules.
In the Stage 3 proposed rule (80 FR Response: We will consider these of this document that contain
16780), we noted that states are recommendations as we develop future information collection requirements
responsible for determining whether planning for long-term delivery system (ICRs).
and how electronic reporting of CQMs reform and related policies. We note
would occur, or whether they wish to A. ICR Regarding Demonstration of
that some of these comments were
allow reporting through attestation. If a Meaningful Use Criteria (§ 495.24)
outside of the scope of the proposed
state does require electronic reporting, rules. This final rule with comment period
the state is responsible for sharing the specifies applicable criteria for
details on the process with its provider III. Collection of Information demonstrating meaningful use of
community. States that wish to establish Requirements CEHRT for EHR reporting periods in
the method and requirements for Under the Paperwork Reduction Act 2015 through 2017 and for Stage 3 in
electronically reporting would continue of 1995, we are required to provide 60- 2017 and subsequent years. The
to be required to do so through the day notice in the Federal Register and applicable criteria for demonstrating
SMHP submission, subject to our prior solicit public comment before a meaningful use for an EHR reporting
approval. collection of information requirement is period in 2015 through 2017 are based
To further our goals of alignment and submitted to the Office of Management on modifications to the criteria
avoiding duplicative reporting across and Budget (OMB) for review and previously set out in Stage 1 and 2 of
quality reporting programs, we would approval. In order to evaluate fairly the EHR Incentive Programs. These
recommend that states include a whether an information collection changes in the overall burden for
narrative in their SMHP for CY 2017 should be approved by OMB, section providers reporting in 2015 through
describing how their proposed 3506(c)(2)(A) of the Paperwork 2017 are discussed in further detail in
meaningful use CQM data submission Reduction Act of 1995 requires that we the ICR analysis for 2015 through 2017
strategy aligns with their State Medicaid solicit comment on the following issues: outlined in section III.B of this final rule
Quality Strategy and report which • The need for the information with comment period. The ICRs in this
CEHRT requirements they mandate for collection and its usefulness in carrying section (that is, section III.A. of this
eCQM reporting. out the proper functions of our agency. final rule with comment period) reflect
For more information on requirements • The accuracy of our estimate of the the provider burden associated with
around the State Medicaid Quality information collection burden. complying with and reporting of Stage
Strategy, see http://medicaid.gov/ • The quality, utility, and clarity of 3 requirements beginning in 2017 and
Federal-Policy-Guidance/Downloads/ the information to be collected. each subsequent year.
SHO-13-007.pdf. • Recommendations to minimize the In § 495.24 (redesignated from
Comment: A commenter supported information collection burden on the § 495.7) we proposed that to
the proposal to continue allowing states affected public, including automated successfully demonstrate meaningful
to be responsible for determining how collection techniques. use of CEHRT for Stage 3, an EP, eligible
providers will report CQMs because not The following is a discussion of the hospital, or CAH (collectively referred
all states are at the same readiness level requirements contained in the proposed to as ‘‘provider’’ in this section) must
to accept eCQMs, and states must regulations that we believed were attest, through a secure mechanism in a
implement system changes to subject to PRA and collection of specified manner, to the following
accommodate policy change. information requirements (ICRs) as a during the EHR reporting period:
Response: We appreciate this result of this final rule with comment • The provider used CEHRT and
comment, and we are finalizing this period. This analysis finalizes our specified the technology was used.
policy as proposed. projections which were proposed in the • The provider satisfied each of the
Comment: A number of commenters March 30, 2015 Federal Register (80 FR applicable objectives and associated
provided feedback regarding Medicaid 16781 through 16787) and the April 15, measures in § 495.26.
quality improvement initiatives and 2015 Federal Register (80 FR 20381 In § 495.40 (redesignated from
recommendations on how to best through 20386). The projected numbers § 495.8), we stipulated that providers
conduct outreach and engagement to of EPs, eligible hospitals, CAHs, MA must also successfully report the
providers and patients in various organizations, MA EPs, and MA- clinical quality measures selected by
clinical settings. Commenters also affiliated hospitals were based on the CMS to CMS or the states, as applicable.
recommended ways to publicize EP numbers used in the impact analysis We estimated that the CEHRT adopted
accomplishments in providing essential assumptions, as well as estimated by the provider captures many of the
health services to patients benefiting federal costs and savings in the sections objectives and associated measures and
from the Medicaid EHR Incentive of the proposed rules. The actual burden generate automated numerator and
Program. In addition, commenters would remain constant for all of Stage denominator information where
encouraged CMS to continue its 3 as EPs, eligible hospitals, and CAHs required, or generate automated
conversations with state Medicaid would only need to attest that they have summary reports. We noted that we also
agencies and health groups in an effort successfully demonstrated meaningful expect that the provider would enable
to explore the issues faced by eligible use in 2017 and annually thereafter. The the functionality required to complete
the objectives and associated measures the total annual cost burden for all EPs providers attesting in their first year of
that require the provider to attest that to attest to EHR technology, meaningful the program.
they have done so. use objectives and associated measures, Additionally, providers will be
We proposed that there would be five and electronically submit the clinical required to report they have completed
objectives and ten measures that would quality measures would be objectives and associated measures that
require an EP to enter numerators and $385,834,395 (609,100 EPs × 6 hours 52 require a ‘‘yes’’ or ‘‘no’’ response during
denominators during attestation. minutes × $92.25 (mean hourly rate for attestation. For EPs, there are three
Eligible hospitals and CAHs would have physicians based on May 2013 BLS) objectives that require a ‘‘yes’’ or ‘‘no’’
to attest they have met five objectives data). response during attestation. As
and ten measures that would require Comment: One commenter noted that discussed previously, the associated
numerators and denominators. For the time to attest is likely accurate; measures are that EPs are required to
objectives and associated measures however, they stated that the estimate conduct a security risk analysis, report
requiring a numerator and denominator does not reflect the dollars and to three registries to fulfill the public
in the proposed rule, we limited our resources spent on software upgrades, health objective, and must implement at
estimates to actions taken in the implementation costs, continuous least five clinical decision support
presence of certified EHR technology. auditing, and the gathering of data for interventions. For eligible hospitals and
We did not anticipate a provider would calculation. CAHs, there are three objectives that
maintain two recordkeeping systems Response: We appreciate the public require a ‘‘yes’’ or ‘‘no’’ response during
when CEHRT is present. Therefore, we comments on this burden analysis. attestation. The associated measures for
assumed that all patient records that However, this analysis specifically eligible hospitals and CAHs require the
would be counted in the denominator reflects the amount of time we estimate provider to conduct a security risk
would be kept using certified EHR providers will take to prepare and report analysis, report to four registries to
technology. We expected it would take their meaningful use data through the fulfill the public health objective and
an individual provider or designee Medicare and Medicaid EHR Incentive must implement at least five clinical
approximately 10 minutes to attest to Programs Registration and Attestation decision support interventions. We
each meaningful use objective and System. We cannot account for other estimate each of these measures would
associated measure that requires a costs related to participation in these take 1 minute to report.
numerator and denominator to be programs or for variation in how an
Providers will also be required to
generated. The security risk assessment individual provider may collect,
attest that they are protecting electronic
and its associated measure would not calculate or document actions related to
health information. We estimate
require a numerator and denominator their unique business practices and
completion of the analysis required to
and we would expect it would take an systems workflows.
meet successfully the associated
individual provider or designee After consideration of the public
measure for this objective will take
approximately 6 hours to complete. The comments received, we are finalizing
approximately 6 hours, which is
clinical decision support and active these burden estimates as proposed but
identical to our estimate for the Stage 1
engagement with a public health agency have updated them to reflect policy
and Stage 2 requirements. This burden
measures would take an eligible changes implemented through this final
estimate assumes that covered entities
professional, eligible hospital or critical rule with comment period.
In this final rule with comment are already conducting and reviewing
access hospital 1 minute each to report these risk analyses under current
each CDS intervention or registry. period, there were five objectives that
will require an EP to enter numerators HIPAA regulations. Therefore, we do
We proposed that EPs would be not account for the additional burden
required to report on a total of 8 and denominators during attestation.
Eligible hospitals and CAHs will have to associated with the conduct or review of
objectives and 16 associated measures. such analyses.
For the purpose of the proposed attest that they have met five objectives
that require numerators and Table 21 lists the Stage 3 objectives
collection of information, we assumed
denominators. For objectives and and associated measures for EPs and
that all eligible providers would comply
associated measures requiring a eligible hospitals and CAHs. We
with the requirements of meaningful use
numerator and denominator, we limit estimate the objectives and associated
Stage 3. We proposed that eligible
our estimates to actions taken in the measures will take an EP 6 hours 52
hospitals and CAHs would be required
presence of certified EHR technology. minutes to complete, and will take an
to report on a total of 8 objectives and
We do not anticipate a provider will eligible hospital or CAH 6 hours 52
17 associated measures. We estimated
maintain two recordkeeping systems minutes to complete.
the total annual cost burden for all
when CEHRT is present. Therefore, we We believe that EPs, eligible
eligible hospitals and CAHs to attest to
assume that all patient records that will hospitals, and CAHs have virtually
EHR technology, meaningful use
be counted in the denominator will be identical burdens. Eligible hospitals and
objectives and associated measures, and
kept using certified EHR technology. We CAHs are required to report to one
electronically submit the clinical quality
expect it will take an individual additional registry than EPs are required
measures would be $2,135,204 (4,900
provider or designee approximately 10 to report. Consequently, we did not
eligible hospitals and CAHs × 6 hours
minutes to attest to each meaningful use prepare lowest and highest burdens.
52 minutes × $63.46 21). We estimated
objective and associated measure that Rather, we computed a burden for EPs
requires a numerator and denominator and a burden for eligible hospitals and
21 Mean hourly rate for lawyers based on May
2013 Business and Labor Statistics (BLS) data. to be generated, as well as each CQM for CAHs.
TABLE 21—BURDEN ESTIMATES STAGE 3—§ 495.24

Objectives—Eligible Objectives—Eligible Burden estimate per Burden estimate per
Measures
professionals hospitals/CAHs respondent (EPs) respondent (hospitals)
Protect electronic pro- Protect electronic pro- Conduct or review a security risk 6 hours .......................... 6 hours.
tected health informa- tected health informa- analysis in accordance with the
tion (ePHI) created or tion (ePHI) created or requirements under 45 CFR
maintained by the maintained by the 164.308(a)(1), including address-
CEHRT through the CEHRT through the ing the security (to include
implementation of ap- implementation of ap- encryption) of data created or
propriate technical, ad- propriate technical, maintained by CEHRT in accord-
ministrative and phys- administrative and ance with requirements under 45
ical safeguards. physical safeguards. CFR 164.312(a)(2)(iv) and 45
CFR 164.306(d)(3), implement se-
curity updates as necessary, and
correct identified security defi-
ciencies as part of the provider’s
Generate and transmit Generate and transmit 1. EP Measure: More than 60% of 10 minutes .................... 10 minutes.
permissible prescrip- permissible discharge all permissible prescriptions writ-
tions electronically prescriptions elec- ten by the EP are queried for a
(eRx.). tronically (eRx). drug formulary and transmitted
electronically using CEHRT.
2. Eligible Hospital/CAH Measure:
More than 25% of hospital dis-
charge medication orders for per-
missible prescriptions (for new
and changed prescriptions) are
queried for a drug formulary and
transmitted electronically using
CEHRT.
Implement clinical deci- Implement clinical deci- Measure 1. The EP, eligible hospital 1 minute ........................ 1 minute.
sion support (CDS) sion support (CDS) and CAH must implement five
interventions focused interventions focused clinical decision support interven-
on improving perform- on improving perform- tions related to four or more
ance on high-priority ance on high-priority CQMs at a relevant point in pa-
health conditions. health conditions. tient care for the entire EHR re-
porting period. Absent four CQMs
related to an EP, eligible hospital,
or CAH’s scope of practice or pa-
tient population, the clinical deci-
sion support interventions must be
related to high-priority health con-
ditions.
Measure 2: The EP, eligible hospital,
or CAH has enabled and imple-
mented the functionality for
drug-drug and drug-allergy inter-
action checks for the entire EHR
reporting period.
Use CPOE for medica- Use CPOE for medica- Measure 1. More than 60 percent of 10 minutes .................... 10 minutes.
tion, laboratory, and tion, laboratory, and medication orders created by the
diagnostic imaging or- diagnostic imaging or- EP or authorized providers of the
ders directly entered ders directly entered eligible hospital’s or CAH’s inpa-
by any licensed by any licensed tient or emergency department
healthcare profes- healthcare profes- (POS 21 or 23) during the EHR
sional, credentialed sional, credentialed reporting period are recorded
medical assistant, or a medical assistant, or using CPOE.
medical staff member a medical staff mem- Measure 2: More than 60 percent of
credentialed to and ber credentialed to laboratory orders created by the
performing the equiva- and performing the EP or authorized providers of the
lent duties of a equivalent duties of a eligible hospital’s or CAH’s inpa-
credentialed medical credentialed medical tient or emergency department
assistant; who can assistant; who can (POS 21 or 23) during the EHR
enter orders into the enter orders into the reporting period are recorded
medical record per medical record per using CPOE.

state, local, and pro- state, local, and pro- Measure 3: More than 60 percent of
fessional guidelines. fessional guidelines. diagnostic imaging orders created
by the EP or authorized providers
of the eligible hospital’s or CAH’s
ment (POS 21 or 23) during the
EHR reporting period are recorded
using CPOE.
TABLE 21—BURDEN ESTIMATES STAGE 3—§ 495.24—Continued

Measures
The EP provides pa- The eligible hospital or Measure 1: For more than 80 per- 10 minutes .................... 10 minutes.
tients or their author- CAH provides patients cent of all unique patients seen by
ized representatives or their authorized the EP or discharged from the eli-
electronic access to representatives elec- gible hospital or CAH inpatient or
their health information tronic access to their emergency department (POS 21
and patient-specific health information and or 23):
education. patient-specific edu- (1) The patient (or the pa-
cation. tient-authorized representative) is
provided access to view online,
download, and transmit his or her
health information; and
(2) The provider ensures the pa-
tient’s health information is avail-
able for the patient (or pa-
tient-authorized representative) to
access using any application of
their choice that is configured to
meet the technical specifications
of the API in the provider’s
CEHRT.
Measure 2: The EP, eligible hospital
or CAH must use clinically rel-
evant information from CEHRT to
identify patient-specific edu-
cational resources and provide
electronic access to those mate-
rials to more than 35 percent of
unique patients seen by the EP or
discharged from the eligible hos-
pital or CAH inpatient or emer-
gency department (POS 21 or 23)
Use CEHRT to engage Use CEHRT to engage Measure 1: During the EHR report- 10 minutes .................... 10 minutes.
with patients or their with patients or their ing period, more than 10 percent
authorized representa- authorized represent- of all unique patients (or their au-
tives about the pa- atives about the pa- thorized representatives) seen by
tient’s care. tient’s care. the EP or discharged from the eli-
gible hospital or CAH inpatient or
emergency department (POS 21
or 23) actively engage with the
EHR made accessible by the pro-
vider and either:
(1) view, download or transmit to a
third party their health information;
or
(2) access their health information
through the use of an API that can
be used by applications chosen by
the patient and configured to the
API in the provider’s CEHRT; or
(3) a combination of (1) and (2).
Measure 2: For more than 25 per-
cent of all unique patients seen by
the EP or discharged from the eli-
gible hospital or CAH inpatient or
emergency department (POS 21
or 23) during the EHR reporting
period, a secure message was
sent using the electronic mes-
saging function of CEHRT to the
patient (or the patient-authorized
representative), or in response to
a secure message sent by the pa-

tient (or the patient-authorized
representative).

Measures
Measure 3: Patient-generated health

data or data from a non-clinical
setting is incorporated into the
CEHRT for more than 5 percent of
all unique patients seen by the EP
or discharged by the eligible hos-
pital or CAH (POS 21 or 23) dur-
The EP provides a sum- The eligible hospital or Measure 1: For more than 50 per- 10 minutes .................... 10 minutes.
mary of care record CAH provides a sum- cent of transitions of care and re-
when transitioning or mary of care record ferrals, the EP, eligible hospital or
referring their patient when transitioning or CAH that transitions or refers their
to another setting of referring their patient patient to another setting of care
care, retrieves a sum- to another setting of or provider of care—(1) creates a
mary of care record care, retrieves a sum- summary of care record using
upon the first patient mary of care record CEHRT; and (2) electronically ex-
encounter with a new upon the first patient changes the summary of care
patient, and incor- encounter with a new record.
porates summary of patient, and incor- Measure 2: For more than 40 per-
care information from porates summary of cent of transitions or referrals re-
other providers into care information from ceived and patient encounters in
their EHR using the other providers into which the provider has never be-
functions of CEHRT. their EHR using the fore encountered the patient, the
functions of CEHRT. EP, eligible hospital or CAH incor-
porates into the patient’s record
an electronic summary of care
document from a source other
than the provider’s EHR system.
Measure 3: For more than 80 per-
cent of transitions or referrals re-
ceived and patient encounters in
which the provider has never be-
fore encountered the patient, the
EP, eligible hospital, or CAH per-
forms a clinical information rec-
onciliation. The provider must im-
plement clinical information rec-
onciliation for the following three
clinical information sets:
Medication. Review of the patient’s
medication, including the name,
dosage, frequency, and route of
each medication.
Medication allergy. Review of the
patient’s known medication aller-
gies.
Current Problem list. Review of the
patient’s current and active diag-
noses.
The EP is in active en- ....................................... Measure 1—Immunization Registry 1 minute ........................ 1 minute.
gagement with a PHA Reporting: The EP, eligible hos-
or CDR to submit pital, or CAH is in active engage-
electronic public health ment with a public health agency
data in a meaningful to submit immunization data and
way using CEHRT, ex- receive immunization forecasts
cept where prohibited, and histories from the public
and in accordance health immunization registry/im-
with applicable law munization information system
and practice. (IIS).
Measure 2—Syndromic Surveillance
Reporting: The EP, eligible hos-
pital, or CAH is in active engage-

ment with a public health agency
to submit syndromic surveillance
data from an urgent care setting
(urgent care ambulatory for EP,
emergency or urgent care depart-
ment for eligible hospitals and
CAHs).

Measures
Measure 3—Electronic Case Report-

ing: The EP, eligible hospital, or
CAH is in active engagement with
a public health agency to submit
case reporting of reportable condi-
tions.
Measure 4—Public Health Registry
to submit data to public health
registries.
Measure 5—Clinical Data Registry
ment to submit data to a clinical
data registry.
EPs must meet 2 measures and
may choose to report to more
than one public health registry or
clinical data registry to meet the
objective.
The eligible hospital or Measure 1—Immunization Registry 1 minute ........................ 1 minute.
CAH is in active en- Reporting: The EP, eligible hos-
gagement with a PHA pital, or CAH is in active engage-
or CDR to submit ment with a public health agency
electronic public to submit immunization data and
health data in a receive immunization forecasts
meaningful way using and histories from the public
CEHRT, except where health immunization registry/im-
prohibited, and in ac- munization information system
cordance with applica- (IIS).
ble law and practice. Measure 2—Syndromic Surveillance
data from an urgent care setting
(urgent care ambulatory for EP,
emergency or urgent care depart-
ment for eligible hospitals and
CAHs).
Measure 3—Electronic Case Report-
ing: The EP, eligible hospital, or
case reporting of reportable condi-
tions.
Measure 4—Public Health Registry
to submit data to public health
registries.
Measure 5—Clinical Data Registry
ment to submit data to a clinical
data registry.
Measure 6—Electronic Reportable
Laboratory Result Reporting: The
eligible hospital or CAH is in ac-

tive engagement with a public
health agency to submit ELR re-
sults.

Measures
Eligible Hospitals and CAHs must

meet 4 measures and may
choose to report to more than one
public health registry and/or clin-
ical data registry to meet the ob-
jective.
Criteria Burden ............... ....................................... ........................................................... 6 hours 52 minutes ....... 6 hours 52 minutes
Time to Attest and Re-
port Clinical Quality
Measures.
Total—Criteria Bur- ....................................... ........................................................... 6 hours 52 minutes ....... 6 hours 52 minutes
den.
In this final rule with comment CAHs × $63.46 (6 hours 52 minutes × technology. We do not anticipate a
period, we estimate that it will take no $63.46 (mean hourly rate for lawyers provider would maintain two
longer than 6 hours and 52 minutes for based on May 2013 BLS) data)). recordkeeping systems when CEHRT is
an EP to report on each of the applicable present. Therefore, we assumed that all
B. ICR Regarding Demonstration of
objectives and associated measures. The patient records that would be counted
Meaningful Use Criteria (§ 495.20
total burden hours for an EP to attest to in the denominator would be kept using
through § 495.60)
the criteria previously specified will be certified EHR technology. We expect it
6 hours 52 minutes. We estimate that In § 495.40 we proposed that to will take an individual provider or
there could be approximately 609,100 successfully demonstrate meaningful designee approximately 10 minutes to
non-hospital-based Medicare and use of CEHRT for meaningful use in attest to each meaningful use objective
Medicaid EPs in 2017. 2015 through 2017, an EP, eligible and associated measure that requires a
We estimate the burden for the hospital, or CAH (collectively referred numerator and denominator to be
approximately 13,635 MA EPs in the to as ‘‘provider’’ in this section) must generated, as well as approximately 1
MAO burden section. We estimate the attest, through a secure mechanism in a hour 30 minutes to attest to CQM
total burden associated with these specified manner, to the following requirements.
requirements for an EP will be 6 hours during the EHR reporting period: (1) Additionally, providers would be
52 minutes. The total estimate annual The provider used CEHRT and specified required to report they have completed
cost burden for all EPs to attest to EHR the technology was used; and (2) the objectives and associated measures that
technology and meaningful use provider satisfied each of the applicable require a ‘‘yes’’ or ‘‘no’’ response during
objectives will be $385,834,395 (506,400 objectives and associated measures in attestation. For EPs, there are three
× 6 hours 52 minutes × $92.25 (mean § 495.22. In § 495.40, we stipulated that objectives that would require a ‘‘yes’’ or
hourly rate for physicians based on May providers must also successfully report ‘‘no’’ response during attestation. For
2013 BLS data)). the clinical quality measures selected by eligible hospitals and CAHs, there are 2
Similarly, eligible hospitals and CAHs CMS to CMS or the states, as applicable. objectives and that would require a
will attest that they have met the core We estimated that the CEHRT adopted ‘‘yes’’ or ‘‘no’’ response during
meaningful use objectives and by the provider captures many of the attestation. We expect that it would take
associated measures, and will objectives and associated measures and a provider or their designee 1 minute to
electronically submit the clinical quality generate automated numerator and attest to each objective that requires a
measures. We estimate that it will take denominator information where ‘‘yes’’ or ‘‘no’’ response.
no longer, than 6 hours and 52 minutes required, or generate automated Providers would also be required to
to attest that during the EHR reporting summary reports. We also expected that attest that they are protecting ePHI. We
period, they used the certified EHR the provider would enable the estimate completion of the analysis
technology, specified the EHR functionality required to complete the required to meet successfully the
technology used, and satisfied each of objectives and associated measures for associated measure for this objective
the applicable objectives and associated which they are required to attest. would take approximately 6 hours,
measures. We estimate that there are We proposed that EPs would be which is identical to our estimate for the
about 4,900 eligible hospitals and CAHs required to report on a total of ten Stage 1 and Stage 2 requirements. This
(3,397 acute care hospitals, 1,395 CAHs, objectives and associated measures and burden estimate assumes that covered
97 children’s hospitals, and 11 cancer eligible hospitals and CAHs would entities are already conducting and
hospitals) that may attest to the report on a total of nine objectives and reviewing these risk analyses under
aforementioned criteria in FY 2017. We associated measures. There are six current HIPAA regulations. Therefore,
estimate the total burden associated objectives that will require an EP to we have not accounted for the
with these requirements for an eligible enter numerators and denominators additional burden associated with the
hospital and CAH would be 6 hours 52 during attestation. Eligible hospitals and conduct or review of such analyses.
minutes. The total estimated annual cost CAHs will have to attest that they have We estimate the objectives and
burden for all eligible hospitals and met six objectives that require associated measures would take an EP 6
CAHs to attest to EHR technology, numerators and denominators. For hours 49 minutes to complete, and
meaningful use core set and menu set objectives and associated measures would take an eligible hospital or CAH
criteria, and electronically submit the requiring a numerator and denominator, 6 hours 48 minutes to complete.
clinical quality measures will be we limit our estimates to actions taken Comment: Some stated that CMS
$2,135,204 (4,908 eligible hospitals and in the presence of certified EHR should account for the amount of time
required to prepare for attestation. They Programs Registration and Attestation hospitals and CAHs. EPs, eligible
also stated that CMS should more System. hospitals, and CAHs have nearly
carefully consider the multiple factors After consideration of the public identical reporting burdens. Eligible
that contribute to the burden of comments received, we are finalizing hospitals and CAHs are required to
physician reporting. these burden estimates as proposed but report to one additional registry than
have updated them to reflect policy EPs are required to report. However, EPs
Response: We appreciate the public
changes implemented through this final have an additional objective, Secure
comments on this burden analysis.
rule with comment period. In this final Electronic Messaging, which requires a
However, this analysis specifically rule with comment period, there are 10 ‘‘yes’’ or ‘‘no’’ response. Consequently,
reflects the amount of time we estimate objectives for EPs and 9 objectives for we have not prepared lowest and
providers will take to prepare and report eligible hospitals and CAHs. highest burdens. Rather, we have
their meaningful use data through the Table 22 lists those objectives and computed a burden for EPs and a
Medicare and Medicaid EHR Incentive associated measures for EPs and eligible burden for eligible hospitals and CAHs.
TABLE 22—BURDEN ESTIMATES—§ 495.22
Eligible hospitals and Burden estimate per Burden estimate per
Eligible professionals Measures
CAHs respondent (EPs) respondent (Hospitals)
Objectives and Measures
Protect ePHI created or Protect ePHI created or Conduct or review a security risk 6 hours .......................... 6 hours.
maintained by the maintained by the analysis in accordance with the
CEHRT through the CEHRT through the requirements under 45 CFR
implementation of ap- implementation of ap- 164.308(a)(1), including address-
propriate technical ca- propriate technical ca- ing the security (to include
pabilities. pabilities. encryption) of data stored in
CEHRT in accordance with re-
quirements under 45 CFR
164.312(a)(2)(iv) and 45 CFR
164.306(d)(3), and implement se-
curity updates as necessary and
correct identified security defi-
ciencies as part of the provider’s
Use clinical decision Use clinical decision 1. Implement five clinical decision 1 minute ........................ 1 minute.
support to improve support to improve support interventions related to
performance on performance on four or more clinical quality meas-
high-priority health high-priority health ures at a relevant point in patient
conditions. conditions. care for the entire EHR reporting
period. Absent four clinical quality
measures related to an EP, eligi-
ble hospital or CAH’s scope of
practice or patient population, the
clinical decision support interven-
tions must be related to high-pri-
ority health conditions.
2. The EP, eligible hospital or CAH
has enabled and implemented the
functionality for drug-drug and
drug-allergy interaction checks for
the entire EHR reporting period.
Use CPOE for medica- Use CPOE for medica- More than 60% of medication, 30% 10 minutes .................... 10 minutes.
tion, laboratory and ration, laboratory and of laboratory, and 30% of radi-
diology orders directly radiology orders diology orders created by the EP or
entered by any li- rectly entered by any authorized providers of the eligible
censed healthcare licensed healthcare hospital’s or CAH’s inpatient or
professional who can professional who can emergency department (POS 21
enter orders into the enter orders into the or 23) during the EHR reporting
medical record per medical record per period are recorded using CPOE.
state, local and profes- state, local and pro-
sional guidelines. fessional guidelines.
Generate and transmit ....................................... More than 50% of all permissible 10 minutes
permissible prescrip- prescriptions written by the EP are
tions electronically queried for a drug formulary and
(eRx). transmitted electronically using

CEHRT.
Generate and transmit More than 10% of hospital discharge ....................................... 10 minutes.
permissible discharge medication orders for permissible
prescriptions elec- prescriptions (for new or changed
tronically (eRx). prescriptions) are queried for a
drug formulary and transmitted
electronically using CEHRT.
TABLE 22—BURDEN ESTIMATES—§ 495.22—Continued

The EP who transitions The eligible hospital or 1. The EP, eligible hospital or CAH 10 minutes .................... 10 minutes.
their patient to another CAH who transitions that transitions or refers their pa-
setting of care or pro- their patient to an- tient to another setting of care or
vider of care or refers other setting of care provider of care (1) uses CEHRT
their patient to another or provider of care or to create a summary of care
provider of care pro- refers their patient to record; and (2) electronically
vides a summary care another provider of transmits such summary to a re-
record for each transi- care provides a sum- ceiving provider for more than 10
tion of care or referral. mary care record for percent of transitions of care and
each transition of care referrals.
or referral.
Use clinically relevant in- ....................................... Patient-specific education resources 10 minutes.
formation from CEHRT identified by CEHRT are provided
to identify pa- to patients for more than 10% of
tient-specific education all unique patients with office visits
resources and provide seen by the EP during the EHR
those resources to the reporting period.
patient.
Use clinically relevant More than 10% of all unique patients ....................................... 10 minutes.
information from admitted to the eligible hospital’s
CEHRT to identify pa- or CAH’s inpatient or emergency
tient-specific edu- departments (POS 21 or 23) are
cation resources and provided patient- specific edu-
provide those re- cation resources identified by
sources to the patient. CEHRT.
The EP who receives a The eligible hospital or The EP, eligible hospital or CAH 10 minutes .................... 10 minutes.
patient from another CAH who receives a performs medication reconciliation
setting of care or pro- patient from another for more than 50% of transitions
vider of care or be- setting of care or proof care in which the patient is
lieves an encounter is vider of care or be- transitioned into the care of the
relevant should per- lieves an encounter is EP or admitted to the eligible hos-
form medication rec- relevant should per- pital’s or CAH’s inpatient or emer-
onciliation. form medication rec- gency department (POS 21 or 23).
onciliation.
Provide patients the abil- ....................................... 1. More than 50 percent of all 10 minutes.
ity to view online, unique patients seen by the EP
download, and trans- during the EHR reporting period
mit their health infor- are provided timely online access
mation within 4 busi- to view online, download, and
ness days of the infor- transmit to a third party their
mation being available health information subject to the
to the EP. EP’s discretion to withhold certain
information.
2. For 2015 and 2016: At least 1 pa-
tient seen by the EP during the
EHR reporting period (or his or
her authorized representative)
views, downloads or transmits his
or her health information to a third
party during the EHR reporting pe-
riod. For 2017: More than 5 per-
cent of unique patients seen by
the EP during the EHR reporting
period (or their authorized rep-
resentatives) views, downloads or
transmits their health information
to a third party during the EHR re-
porting period.

Provide patients the 1. More than 50 percent of all ....................................... 10 minutes.

ability to view online, unique patients who are dis-
download, and trans- charged from the inpatient or
mit their health infor- emergency department (POS 21
mation within 36 or 23) of an eligible hospital or
hours of hospital dis- CAH are provided timely access
charge. to view online, download and
transmit their health information to
a third party their health informa-
tion.
2. For 2015 and 2016: At least 1 pa-
tient who is discharged from the
ment (POS 21 or 23) of an eligible
hospital or CAH (or his or her au-
thorized representative) views,
downloads, or transmits to a third
party his or her health information
For 2017: More than 5 percent of
unique patients discharged from
the inpatient or emergency depart-
ment (POS 21 or 23) of an eligible
hospital or CAH (or his or her au-
thorized representative) view,
download, or transmit to a third
party their health information dur-
Use secure electronic ....................................... For 2015: For an EHR reporting pe- 10 minutes.
messaging to commu- riod in 2015, the capability for pa-
nicate with patients on tients to send and receive a se-
relevant health infor- cure electronic message with the
mation. EP was fully enabled. For 2016:
For at least 1 patient seen by the
EP during the EHR reporting pe-
riod, a secure message was sent
using the electronic messaging
function of CEHRT to the patient
(or the patient-authorized rep-
resentative), or in response to a
secure message sent by the pa-
tient (or the patient-authorized
representative) during the EHR re-
porting period. For 2017: For more
than 5 percent of unique patients
seen by the EP during the EHR
reporting period, a secure mes-
sage was sent using the electronic
messaging function of CEHRT to
the patient (or the patient-author-
ized representative), or in re-
sponse to a secure message sent
by the patient (or the pa-
tient-authorized representative)

The EP is in active en- ....................................... Stage 1 EPs in 2015 must meet at

gagement with a pub- least 1 measure in 2015, Stage 2
lic health agency to EPs must meet at least 2 meas-
submit electronic pub- ures in 2015, and all EPs must
lic health data from meet at least 2 measures in 2016
CEHRT except where and 2017.
prohibited and in ac- Measure 1—Immunization Registry
cordance with applica- Reporting: The EP is in active en-
ble law and practice. gagement with a public health
agency to submit immunization
data.
Measure 2—Syndromic Surveillance
Reporting: The EP is in active en-
gagement with a public health
agency to submit syndromic sur-
veillance data.
Measure 3—Specialized Registry
Reporting.
—The EP is in active engagement
with a public health agency to
submit data to a specialized reg-
istry.
The eligible hospital or Stage 1 eligible hospitals and CAHs 1 minute ........................ 1 minute.
CAH is in active en- must meet at least 2 measures in
gagement with a pub- 2015, Stage 2 eligible hospitals
lic health agency to and CAHs must meet at least 3
submit electronic pub- measures in 2015, all eligible hos-
lic health data from pitals and CAHs must meet at
CEHRT except where least 3 measures in 2016 and
prohibited and in ac- 2017.
cordance with applica- • Measure 1—Immunization Reg-
ble law and practice. istry Reporting: The eligible hos-
pital or CAH is in active engage-
to submit immunization data.
• Measure 2—Syndromic Surveil-
lance Reporting: The eligible hos-
pital or CAH is in active engage-
data.
• Measure 3—Specialized Registry
Reporting: The eligible hospital or
data to a specialized registry.
• Measure 4—Electronic Reportable
Laboratory Result Reporting: The
eligible hospital or CAH is in ac-
tive engagement with a public
health agency to submit ELR re-
sults.
Time to Attest to Objec- ....................................... ........................................................... 6 hours 49 minutes ....... 6 hours 48 minutes.
tives and Measures.
Time to Attest and Re- ....................................... ........................................................... 1 hour 30 minutes ......... 1 hour 30 minutes.
port Clinical Quality
Measures.
Total—Objectives ....................................... ........................................................... 8 hours 19 minutes ....... 8 hours 18 minutes.
+CQM Reporting.
We estimate that it will take no longer there could be approximately 595,100 EPs, or approximately 51 percent of the
than 6 hours 49 minutes for an EP to non-hospital-based Medicare EPs in Medicaid-only EPs, will successfully
attest to each of the applicable 2015. Based on the historical data, we demonstrate meaningful use in 2015.
objectives and associated measures. The anticipate approximately 60 percent The total estimated annual cost burden
total burden hours for an EP to attest to (357,060) of these EPs may attest to the for all EPs to attest to meaningful use
the meaningful use objectives and objectives and measures of meaningful would be $297,076,291 (387,060 × 8
measures and to report CQMs will be 8 use. In addition, we believe hours 19 minutes × $92.25 (mean hourly
hours 19 minutes. We estimate that approximately 30,000 Medicaid only rate for physicians based on May 2013
BLS data)). Similarly, eligible hospitals estimated annual cost burden for all previously defined if the policies
and CAHs will attest that they have met eligible hospitals and CAHs to attest to proposed in this rule were not finalized.
the meaningful use objectives and meaningful use would be $2,451,872 Therefore, we estimate that the policies
associated measures, and would submit (4,655 eligible hospitals and CAHs × contained herein will result in an
the clinical quality measures. We $63.46 (8 hours 18 minutes × $63.46 overall reduction in the reporting
estimate that it will take no longer than (mean hourly rate for lawyers based on burden for providers of 1.45 hours to 1.9
6 hours 48 minutes to attest to each of May 2013 BLS) data)). hours for EPs and 2.62 hours for eligible
the applicable objectives and associated We provide the estimate of the burden hospitals and CAHs per respondent.
measures. Therefore, the total burden for the approximately 13,635 MA Eps in While batch reporting for objectives and
hours for an eligible hospital or CAH to the MA organization burden section. measures and group reporting for CQMs
attest to the meaningful use objectives The total annual burden estimates for are available for EPs in the current
and measures and to report CQMs, will meaningful use for modifications for program; the program is based upon
be 8 hours 18 minutes. We estimate that 2015 through 2017 are shown in Table successful individual provider
there are about 4,900 eligible hospitals 23. demonstration of meaningful use and so
and CAHs that may attest to the For the purpose of this collection of individual totals are used to identify the
aforementioned criteria in FY 2015 of information, we assumed that all estimated reduction in provider
which 95 percent are expected to eligible providers will comply with the reporting burden. This reduction of
demonstrate meaningful use. The total requirements of Meaningful Use as burden is outlined in Table 23.
TABLE 23—REDUCTION IN REPORTING BURDEN HOURS

Estimated burden per
Burden under current program and Estimated burden per respondent eligible
proposed modifications respondent EPs hospitals and CAHs
Total Under Current Stage 2 Requirements at 42 CFR 495.6 9 hours 46 minutes ................................ NA.
Core Set (including CQMs) + Least Burdensome Menu Set
Criteria.
Total Under Current Stage 2 Requirements at 42 CFR 495.6 10 hours 13 minutes .............................. 10 hours 55 minutes.
Core Set (including CQMs) + Most Burdensome Menu Set
Criteria.
Total Under Proposed Modifications at 495.22 ...................... 8 hours 19 minutes ................................ 8 hours 18 minutes.
All Objectives and Measures + CQMs ....................................
Reduction from Least Burdensome Estimate ......................... 1 hour 27 minutes ................................. NA.
Reduction from Most Burdensome Estimate .......................... 1 hour 54 minutes ................................. 2 hour 37 minutes.
Using the hourly costs associated with per response savings of $133.76 to estimated at $48,534,332 at the lowest
the reporting burden as mentioned $175.28 for EPs and $166.27 for eligible and $63,359,464 at the highest. These
previously, this reduction of 1.45 hours hospitals and CAHs. The total cost estimates are further outlined in Table
to 1.9 hours for EPs and 2.62 hours for reduction in cost for providers 24.
eligible hospitals and CAHs represents a demonstrating meaningful use is
TABLE 24—REDUCTION IN BURDEN COST SAVINGS

Burden reduction Reduction per
Number of responses Hourly cost Total cost reduction
hours respondent
387,060 ................................................................ 1.45 $92.25 $133.76 $51,773,146

387,060 ................................................................ 1.9 92.25 175.28 67,843,877
4,655 .................................................................... 2.62 63.46 166.27 773,987
Total Least ........................................................... .............................. .............................. .............................. 52,547,132
Total Most ............................................................ .............................. .............................. .............................. 68,617,864
C. ICRs Regarding Qualifying MA used CEHRT. In other words, qualifying has met the meaningful use objectives
Organizations (§ 495.210) MA organizations can make the and measures, and 15 minutes for an
determination in masse if the CEHRT is individual to make the attestation for
We estimate that the burden will be
required to be used at its facilities, each MA EP. Furthermore, the
significantly less for qualifying MA
whereas under FFS, each EP likely must individuals performing the assessment
organizations attesting to the
make the determination on an and attesting will not likely be the
meaningful use of their MA EPs,
because qualifying MA EPs use the EHR individual basis. We further note that eligible professional, but non-clinical
these differences also mean the total staff. We believe that the individual
technology in place at a given location

or system, so if CEHRT is in place and reduction in burden for MA gathering the information could be
the qualifying MA organization requires organizations resulting from the equivalent to a GS 11, step 1 (2015
its qualifying MA EPs to use the modifications in this rule will be unadjusted for locality rate), with an
technology, qualifying MA negligible. We estimate that, on average, hourly rate of approximately $25.00/
organizations will be able to determine it will take an individual 45 minutes to hour, and the person attesting (and who
at a faster rate than individual FFS EPs, collect information necessary to may bind the qualifying MA
that its qualifying MA EPs meaningfully determine if a given qualifying MA EP organization based on the attestation)
could be equivalent to a GS 15, step 1 requirements will increase the burden who are meaningful EHR users in the
(2015 unadjusted for locality rate), or on states beyond what was previously Medicaid EHR Incentive Program are
approximately $50.00/hour. Therefore, finalized under OMB control number appropriately exempted from the
for the estimated 13,635 potentially 0938–1158 following the Stage 2 final Medicare payment adjustment. We
qualifying MA EPs with assumed 100 rule. The deadlines will be consistent cannot accurately exempt these
percent successfully demonstrating with our past practice, and the changes providers using the current data
meaningful use, we believe it will cost to the data elements to be reported on received from states. We expect that it
the participating qualifying MA are either reduced or similar in burden. will take a state 20 hours each year to
organizations approximately $426,050 Similarly, we do not expect that the submit this report on a quarterly basis.
annually to collect the required amendments regarding the 90-day EHR We believe that the state employee
information and make the attestations reporting period for first time reporting the information could be
([10,226 hours × $25.00]+[3,408 hours × meaningful users will impose a burden equivalent to a GS 12, step 1 (2015
$50.00]). on states because those amendments unadjusted for locality rate), with an
would generally maintain the current hourly rate of approximately $30.00/
D. ICR Regarding State Reporting
policy. hour. This amount is then reduced by
Requirements (§ 495.316 and § 495.352)
However, we are also amending the 90 percent federal contribution for
We are revising 42 CFR 495 regarding § 495.316 to include a new quarterly administrative services for Medicaid
state reporting requirements to CMS. reporting requirement. States will report under the EHR Incentive Programs; this
With respect to the annual reporting quarterly to CMS regarding the EPs and equates to approximately $3.00/hour.
requirements in § 495.316 and the Medicaid eligible hospitals that have Therefore, for all state Medicaid
quarterly reporting requirements in successfully demonstrated meaningful agencies to report 4 times per year at 20
§ 495.352, we do not believe that the use for each payment year. We need this hours per report the estimated cost is
amendments to these reporting information to ensure that those EPs $13,460 (4560 hours × $3.00/hour).
TABLE 25—ESTIMATED ANNUAL INFORMATION COLLECTION BURDEN

Hourly labor
Burden per Total annual
OMB control Number of Number of cost of Total cost
Reg section response burden
No. respondents responses reporting ($)
(hours) (hours) ($)
§ 495.x—Objectives/
Measures (EPs) ........ 0938–1158 609,100 609,100 6.86 4,178,426 92.25 385,834,395
§ 495.6—Objectives/
Measures (hospitals/
CAHs) ....................... 0938–1158 4,900 4,900 6.86 33,614 63.46 2,135,204
§ 495.210—Gather in-
formation for attesta-
tion (MA EPs) ........... 0938–1158 13,635 13,635 0.75 10,226 25.00 255,650
§ 495.210—Attestation
on behalf of MA EPs 0938–1158 13,635 13,635 0.25 3408.75 50.00 170,400
§ 495.316—Quarterly
Reporting .................. 0938–1158 56 224 20 4480 3.00 13,440
Totals .................... ........................ 627,635 627,635 ........................ 4,225,674 ........................ 388,408,189

Notes: 1. All non-whole numbers in this table are rounded to 2 decimal places.
2. There are no capital/maintenance costs associated with the information collection requirements contained in this rule. Therefore, we re-
moved the associated column from Table 22.
V. Regulatory Impact Analysis B. Overall Impact alternatives and, if regulation is

necessary, to select regulatory
A. Statement of Need We have examined the impacts of this approaches that maximize net benefits
final rule with comment period as (including potential economic,
This final rule with comment period required by Executive Order 12866 on
will implement the provisions of the environmental, public health and safety
Regulatory Planning and Review effects, distributive impacts, and
American Recovery and Reinvestment (September 30, 1993), Executive Order equity). A regulatory impact analysis
Act (ARRA) of 2009 that provide 13563 on Improving Regulation and (RIA) must be prepared for major rules
incentive payments to EPs, eligible Regulatory Review (January 18, 2011), with economically significant effects
hospitals, and CAHs participating in the Regulatory Flexibility Act (RFA) ($100 million or more in any 1 year).
Medicare and Medicaid programs that (September 19, 1980, Pub. L. 96–354), This final rule with comment period is
adopt and meaningfully use CEHRT. section 1102(b) of the Social Security anticipated to have an annual effect on
This final rule with comment period Act, section 202 of the Unfunded the economy of $100 million or more,
specifies applicable criteria for Mandates Reform Act of 1995 (March making it an economically significant
demonstrating the Stage 3 requirements 22, 1995; Pub. L. 104–4), Executive rule under the Executive Order and a
for the EHR Incentive Programs. This Order 13132 on Federalism (August 4, major rule under the Congressional
final rule with comment period also 1999) and the Congressional Review Act Review Act. Accordingly, we have
specifies the applicable criteria for an (5 U.S.C. 804(2)). prepared a Regulatory Impact Analysis
EHR reporting period in 2015 through Executive Orders 12866 and 13563 (RIA) that presents the estimated costs
2017. direct agencies to assess all costs and and benefits of this final rule with
benefits of available regulatory comment period.
The portion of the final rule related to includes net payment adjustments for benefits, including practice efficiencies
Stage 3 is one of two coordinated rules Medicare providers who do not achieve and improvements in medical
related to the EHR Incentive Programs. meaningful use in the amount of $0.8 outcomes. Although both cost and
The other is ONC’s 2015 Edition Health billion). benefit estimates are highly uncertain,
Information Technology (Health IT) We stated in the Stage 2 final rule (77 the RIA that we have prepared presents
Certification Criteria, 2015 Edition Base FR 54135 through 54136) that the the estimated costs and benefits of this
Electronic Health Record (EHR) statute provides Medicare and Medicaid final rule with comment period.
Definition, and ONC Health IT incentive payments for the meaningful In addition, we include the impact of
Certification Program Modifications. use of CEHRT. Additionally, the the EHR Incentive Programs in 2015
Thus, there is an analysis that focuses Medicaid program also provides through 2017. In relation to the existing
on the impact associated with Stage 3 incentives for the adoption, program requirements outlined in the
requirements for the EHR Incentive implementation, and upgrade of Stage 2 final rule (77 FR 53967 through
Program, the changes in quality certified EHR technology. Beginning in 54162), we do not expect this final rule
measures that would take effect 2015, payment adjustments are with comment period to result in more
beginning in 2017, and other changes incorporated into the Medicare EHR incentives paid or in more providers
being for the Medicare and Medicaid Incentive Program for providers unable failing meaningful use and being
EHR Incentive Programs. to demonstrate meaningful use. The assessed a payment adjustment. This is
As we discussed in the Stage 2 final absolute and relative strength of these is due to the nature of the modifications
rule (77 FR 54163 through 54291), a unclear. For example, a provider with being implemented by this rule, which,
number of factors would affect the relatively small Medicare billings will
while they reduce the reporting burden
adoption of EHR systems and be less affected by payment adjustments
on providers, do not affect the clinical
demonstration of meaningful use. In this than one with relatively large Medicare
processes and IT functions required to
final rule with comment period, we billings. Another uncertainty arises
meet the objectives and measures of the
continue to believe that a number of because there are likely to be
EHR Incentive Programs. The provisions
factors would affect the adoption of EHR ‘‘bandwagon’’ effects as the number of
of the modifications portion in this final
systems and demonstration of providers using EHRs rises, thereby
rule with comment period do not
meaningful use. Readers should inducing more participation in the
fundamentally change the technology
understand that these forecasts are also program, as well as greater adoption by
required to support participation in the
subject to substantial uncertainty since entities (for example, clinical
meeting the requirements of the laboratories) that are not eligible for Medicare and Medicaid EHR Incentive
program will depend not only on the incentives or subject to payment Programs. Under the current program,
standards and requirements for 2017 adjustments, but do business with EHR the requirement to report data on the
and for eligible hospitals and EPs, but adopters. It is impossible to predict measures and objectives which have
on future rules issued by the exactly if and when such effects may now been identified as redundant to
Department of Health and Human take hold. other more advanced measures being
Services (DHHS). All of these factors taken together retained, or are duplicative of other
Based on the Stage 2 final rule, we make it impossible in this final rule measures using the same CEHRT
expect spending under the EHR with comment period to predict with function, is essentially requiring
Incentive Programs for transfer precision the timing or rates of adoption providers to report on the same action
payments to Medicare and Medicaid and successful participation in the or process twice. Therefore, it is not the
providers between 2015 and 2017 to be program. However, new data is occurrence of the action or process
$14.2 billion. However, the policies in currently available regarding rates of which is reduced by the provisions in
this final rule with comment period adoption or costs of implementation this final rule with comment period, but
which are applicable for the EHR since the publication of our Stage 1 and the burden associated with the
Incentive Programs in 2015 through Stage 2 final rules. We have included duplicative and redundant reporting. In
2017 do not change these estimates over the new data in our estimates, although addition, the objectives and measures,
the current period as the proposals in even these forecasts are still uncertain. which are considered topped out, have
the EHR Incentive Programs in 2015 We have also estimated ‘‘per entity’’ reached high performance and the
through 2017 proposed rule applied no costs for EPs, eligible hospitals, and statistical evidence demonstrates that
changes to the payment of incentives or CAHs for implementation/maintenance the expected result of any provider
the application of payment adjustments and reporting requirement costs, not all attesting to the EHR Incentive Programs
for 2015 through 2017. costs. We believe many adopting would be a score near the maximum.
Our analysis of impacts for the entities may achieve dollar savings at However, the analysis of these measures
policies in this final rule with comment least equal to their total costs, and that and their identification as topped out
period relate to the reduction in cost there may be additional benefits to also takes into account the statistical
associated with provider reporting society. We also believe that likelihood that the functions of
burden estimates for 2015 through 2017 implementation costs are significant for measures and the processes behind
as affected by the adopted changes to each participating entity because them would continue even without a
the current program and to the transfer providers who were likely to qualify as requirement to report the results.
payments for incentives for Medicaid meaningful users of EHRs were likely to Therefore, while the provisions result in
providers and reductions in payments purchase CEHRT. However, we believe a reduction in reporting requirements,
for Medicare providers through payment that providers who have already this does not correlate to a change in the
adjustments for 2018 and subsequent purchased CEHRT and participated in overall achievement of the measures
years. In the Stage 3 proposed rule, we Stage 1 or Stage 2 of the EHR Incentive and objective as compared to the current
noted our expectation that spending Program will experience significantly program. Finally, when compared
under the EHR Incentive Program for lower costs for participation in the against historical data, the shortened
transfer payments to Medicare and program. We continue to believe that EHR reporting period in 2015 is
Medicaid providers between 2017 and the short-term costs of the program may expected to have a minimal impact on
2020 to be $3.7 billion (this estimate be outweighed by the long-term successful demonstration of meaningful
use. This expectation of minimal impact economically significant rule under the the healthcare sector, Small Business
is based on a number of factors: Executive Order and a major rule under Administration (SBA) size standards
• The shortened EHR reporting the Congressional Review Act is still define a small entity as one with
period is for 2015 only and not for 2016 applicable. The burden estimate and between $7.5 to $38.5 million in annual
or 2017. analysis of the impact of the policies revenues. For the purposes of the RFA,
• Historical data on attestations implemented by the modifications of essentially all non-profit organizations
shows no strong correlation between a this final rule with comment period are are considered small entities, regardless
shorter EHR reporting period and the outlined further in section III. of this of size. Individuals and states are not
ability of providers to attest for a second final rule with comment period. included in the definition of a small
year, no correlation for providers entity. Since the vast majority of
C. Anticipated Effects
returning to attest to a third or fourth Medicare providers (well over 90
year of meaningful use, and providers The objective of the remainder of this percent) are small entities within the
who would otherwise be in their first final RIA is to summarize the costs and RFA’s definitions, it is the normal
year of meaningful use would already benefits of the HITECH Act incentive practice of HHS simply to assume that
have a 90-day EHR reporting period.22 program for the Medicare FFS, all affected providers are ‘‘small’’ under
• Performance data shows Medicaid, and MA programs. We also the RFA. In this case, most EPs, eligible
statistically negligible disparity among provide assumptions and a narrative hospitals, and CAHs are either nonprofit
providers attesting for a 90-day EHR addressing the potential costs to the or meet the SBA’s size standard for
reporting period and those attesting for health care industry for implementation small business. We also believe that the
a full year EHR reporting period on the of this technology. effects of the incentives program on
measures which have been identified as 1. Overall Effects many and probably most of these
redundant, duplicative, and topped affected entities would be economically
a. EHR Technology Development and significant. Accordingly, this RIA
out.23
Certification Costs—Stage 3 section, in conjunction with the
For these reasons, we do not believe
the modification provisions in this final We note that the costs incurred by IT remainder of the preamble, constitutes
rule with comment period will impact developers for EHR technology the required Final Regulatory Flexibility
the overall estimates for incentive development and certification to the Analysis (IFRFA). We believe that the
payments, payment adjustments, and 2015 Edition certification criteria for adoption and meaningful use of EHRs
the net transfer costs associated with the health IT are also in part attributable to will have an impact on virtually every
program. However, these provisions do the requirements for the use of CEHRT EP and eligible hospital, as well as
affect the costs associated with the established in this final rule with CAHs and some EPs and hospitals
reporting burden on providers. The comment period for Stage 3 of the EHR affiliated with MA organizations. While
impacts directly attributable with the Incentive Programs. Therefore, to the the program is voluntary, in the first 5
provisions in this final rule with extent that providers’ implementation years it carries substantial positive
comment period relate to both an hourly and adoption costs are attributable to incentives that make it attractive to
reduction per response and an overall this final rule with comment period, virtually all eligible entities.
reduction in the cost associated with health IT developers’ preparation and Furthermore, entities that do not
provider reporting. The burden analysis development costs would also be demonstrate meaningful use of EHR
for modifications in this final rule with attributable as these categories of technology for an applicable EHR
comment period, as compared to the activities may be directly or indirectly reporting period will be subject to
Stage 2 estimates, reduces the reporting incentivized by the requirements to significant Medicare payment
burden for attestation for providers by participate in the EHR Incentive reductions beginning in 2015. These
approximately 1.45 hours to 1.9 hours Programs. However, other CMS Medicare payment adjustments are
for EPs and 2.62 hours for eligible programs (for example PQRS and IQR) expected to motivate EPs, eligible
hospitals and CAHs per respondent. do require or promote certification to hospitals, and CAHs to adopt and
This burden estimate and analysis of the ONC’s criteria–or a professional meaningfully use certified EHR
organization or other such entity could technology.
impact of the policies result in a total
require or promote certification to For some EPs, CAHs, and eligible
cost reduction estimated at $48,534,332
ONC’s criteria.24 As noted previously, hospitals, the EHR technology currently
at the lowest and $63,359,464 at the implemented could be upgraded to meet
highest. However, we believe the this analysis focuses on the impact
associated with Stage 3 requirements for the criteria for CEHRT as defined for
modifications portion of this final rule this program. These costs may be
with comment period will have providers, while the development and
certification costs are addressed in the minimal, involving no more than a
additional impacts—most notably, cost software upgrade. ‘‘Home-grown’’ EHR
savings for hospitals and providers that 2015 Edition final rule.
systems that might exist may also
would have additional time to meet the b. Regulatory Flexibility Analysis and require an upgrade to meet the
requirements of the program—which Small Entities certification requirements. We believe
cannot be adequately estimated because many currently used non-certified EHR
of the wide variation among provider The Regulatory Flexibility Act (RFA)
requires agencies to prepare an Initial systems will require significant changes
types, and therefore a designation as an to achieve certification and that EPs,
Regulatory Flexibility Analysis to
describe and analyze the impact of the CAHs, and eligible hospitals will have
22 CMS Data and Reports: Quarterly Public Use
Files for participation, Monthly Reports for final rule on small entities unless the to make process changes to achieve
performance rates: http://www.cms.gov/ Secretary can certify that the regulation meaningful use.
Regulations-and-Guidance/Legislation/
will not have a significant impact on a Data available suggests that more
EHRIncentivePrograms/DataAndReports.html
substantial number of small entities. In providers have adopted EHR technology
23 CMS Data and Reports: Quarterly Public Use
since the publication of the Stage 1 final
Files for participation, Monthly Reports for
performance rates: http://www.cms.gov/ 24 In this case, the provider implementation and rule. An ONC data brief (No. 16, May
Regulations-and-Guidance/Legislation/ adoption costs discussed in this CMS RIA would 2014) noted that hospital adoption of
EHRIncentivePrograms/DataAndReports.html instead be attributable to ONC’s rulemaking. EHR systems has increased 5 fold since
2008. Nine in 10 acute care hospitals the EHR Incentive Programs. The There is no identifiable disparity
possessed CEHRT in 2013, increasing 29 potential costs savings in modifications among this group and the overall
percent since 2011. As of January 1, to the EHR Incentive Programs portion success rates for eligible hospitals and
2015, more than 95 percent of eligible of this final rule with comment period CAHs in meeting the requirements of
hospitals had successfully demonstrated will benefit these providers as a the program; furthermore, 95 percent of
meaningful use. In January 2014, a CDC reduction in the overall cost of program eligible hospitals and CAHs have
data brief entitled, ‘‘Use and participation. successfully participated as of January
Characteristics of Electronic Health 1, 2015. Finally, on the whole we
Record Systems Among Office-based (2) Conclusion anticipate an estimated reduction in the
Physician Practices: United States, 2001 As discussed later in this analysis, we reporting burden on eligible hospitals as
through 2013,’’ found that 78 percent of believe that there are many positive a group to be less than $1 million.
office-based EPs used any type of EHR effects of adopting EHR on health care Therefore, we do not believe that the
systems, up from 18 percent in 2001. providers. We believe that the net effect modifications portion of this final rule
The majority of EPs have already on some individual providers may be with comment period will have a
purchased CEHRT, implemented this positive. Furthermore, we believe that significant impact on a substantial
new technology, and trained their staff the provisions in this EHR Incentive number of small entities.
on its use with over 60 percent earning Programs in 2015 through 2017 portion d. Unfunded Mandates Reform Act
an incentive payment for participation of this final rule with comment period
in the program prior to 2015. The costs will result in an overall reduction in the Section 202 of the Unfunded
for implementation and complying with reporting burden for providers of all Mandates Reform Act of 1995 (UMRA)
the criteria of EHR Incentive Programs types. Accordingly, we believe that the requires that agencies assess anticipated
could lead to higher operational object of the RFA to minimize burden costs and benefits before issuing any
expenses. However, we believe that the on small entities is met by this final rule rule whose mandates will require
combination of payment incentives and with comment period. spending in any 1 year $100 million in
long-term overall gains in efficiency 1995 dollars, updated annually for
may compensate for some of the initial c. Small Rural Hospitals—Modifications inflation. In 2014, that threshold is
expenditures. Furthermore, the cost approximately $144 million. UMRA
Section 1102(b) of the Act requires us
reductions provided by the EHR does not address the total cost of a rule.
to prepare a regulatory impact analysis
Incentive Programs in 2015 through Rather, it focuses on certain categories
(RIA) if a rule will have a significant
2017 offer a benefit to these providers. of cost, mainly those ‘‘federal mandate’’
impact on the operations of a substantial
costs resulting from—(1) imposing
(1) Small Entities number of small rural hospitals. This enforceable duties on state, local, or
We estimate that EPs would spend analysis must conform to the provisions tribal governments, or on the private
approximately $54,000 to purchase and of section 604 of the RFA. For purposes sector; or (2) increasing the stringency of
implement a certified EHR and $10,000 of section 1102(b) of the Act, we define conditions in, or decreasing the funding
annually for ongoing maintenance a small rural hospital as a hospital that of, state, local, or tribal governments
according to the Congressional Budget is located outside of a metropolitan under entitlement programs.
Office (CBO) (75 FR 44546). statistical area and has fewer than 100 This final rule with comment period
In the paper, Evidence on the Costs beds. imposes no substantial mandates on
and Benefits of Health Information The Stage 3 portion of this final rule states. This program is voluntary for
Technology, May 2008, in attempting to with comment period will affect the states and states offer the incentives at
estimate the total cost of implementing operations of a substantial number of their option. The state role in the
health IT systems in office-based small rural hospitals because they may incentive program is essentially to
medical practices, the CBO recognized be subject to adjusted Medicare administer the Medicaid EHR Incentive
the complicating factors of EHR types, payments in 2015 if they fail to adopt Program. While this entails certain
available features and differences in CEHRT by the applicable EHR reporting procedural responsibilities, these do not
characteristics of the practices that are period. As stated previously, we have involve substantial state expense. In
adopting them. The CBO estimated a determined that this final rule with general, each state Medicaid Agency
cost range of $25,000 to $45,000 per comment period will create a significant that participates in the incentive
physician. Annual operating and impact on a substantial number of small program would be required to invest in
maintenance amount was estimated at entities, and have prepared a Regulatory systems and technology to comply.
12 to 20 percent of initial costs (that is, Flexibility Analysis as required by the States would have to identify and
$3,000 to $9,000) per physician. For all RFA and, for small rural hospitals, educate providers, evaluate their
eligible hospitals, the range is from $1 section 1102(b) of the Act. Furthermore, attestations and pay the incentive.
million to $100 million. Though reports any impacts that would arise from the However, the federal government would
vary widely, we anticipate that the implementation of CEHRT in a rural fund 90 percent of the state’s related
average will be $5 million for eligible eligible hospital would be positive, with administrative costs, providing controls
hospitals to achieve meaningful use. We respect to the streamlining of care and on the total state outlay. In addition, the
estimate $1 million for maintenance, the ease of sharing information with changes being made by the
upgrades, and training each year per other EPs to avoid delays, duplication, modifications portion of this final rule
eligible hospital. However, as stated or errors. However, the Secretary retains with comment period have very little
earlier, many providers have already the discretionary statutory authority to impact on any state functions.
purchased systems with expenditures make case-by-case exceptions for The investments needed to meet the
focused on maintenance and upgrades. significant hardships, and has already requirements of the program and obtain
We believe that future retrospective established certain categories where incentive funding are voluntary, and
studies on the costs to implement and case-by-case applications may be made hence not ‘‘mandates’’ within the
EHR and the return on investment (ROI) such as barriers to Internet connectivity meaning of the statute. However, the
will demonstrate the actual costs that impact health information potential reductions in Medicare
incurred by providers participating in exchange. reimbursement beginning with FY 2015
would have a negative impact on December 31, 2014 which were ensue if they fail to do so. The estimates
providers that fail to meaningfully use identified through the process of for the provisions affecting Medicare
CEHRT for the applicable EHR reporting implementing payment adjustments for and Medicaid EPs, eligible hospitals,
period. We note that we have no 2015, we estimated the numbers of EPs and CAHs are uncertain for the
discretion as to the amount of those and eligible hospitals, including CAHs following reasons:
potential payment reductions. Private under Medicare, Medicaid, and MA for
• The program is voluntary although
sector EPs that voluntarily choose not to 2015 through 2017 and used the
participate in the program may payment adjustments will be imposed
updated estimates throughout the
anticipate potential costs in the analysis. These total potential eligible on Medicare providers beginning in
aggregate that may exceed $141 million. providers are as follows: 2015 if they are unable to demonstrate
However, because EPs may choose for • About 660,000 Medicare FFS EPs meaningful use for the applicable EHR
various reasons not to participate in the (some of whom will also be Medicaid reporting period.
program, we do not have firm data for EPs). • The criteria for the demonstration
the percentage of participation within About 595,100 non-hospital based of meaningful use of CEHRT has been
the private sector. This RIA, taken Medicare EPs. finalized for Stage 1 and Stage 2 and is
together with the remainder of the • About 58,300 non-Medicare eligible being finalized for Stage 3, but may
preamble, constitutes the analysis EPs (such as dentists, pediatricians, and change over time.
required by UMRA. eligible non-physicians such as certified
nurse-midwives, nurse practitioners, • The impact of the financial
e. Federalism incentives and payment adjustments on
and physicians assistants).
Executive Order 13132 establishes • 4,900 eligible hospitals comprising the rate of adoption of CEHRT by EPs,
certain requirements that an agency the following: eligible hospitals, and CAHs is difficult
must meet when it promulgates a final ++ 3,397 acute care hospitals. to predict based on the information we
rule that imposes substantial direct ++ 1,395 CAHs. have currently collected.
requirement costs on state and local ++ 97 children’s hospitals (Medicaid
governments, preempts state law, or b. Industry Costs and Adoption Rates
only).
otherwise has federalism implications. ++ 11 cancer hospitals (Medicaid (1) Modifications
This final rule with comment period only).
will not have a substantial direct effect • 16 MA organizations and 13,635 In the EHR Incentive Programs in
on state or local governments, preempt MA EPs 2015 through 2017 proposed rule, we
state law, or otherwise have a federalism proposed no new policies which would
implication. Importantly, state Medicaid (1) EHR Incentive Programs in 2015 require changes to the development,
agencies are receiving 100 percent Through 2017
certification, and implementation of
match from the federal government for There are no new costs associated CEHRT or to adoption rates as compared
incentives paid and a 90 percent match with the modifications portion of this to the policies in the existing program
for expenses associated with final rule with comment period. outlined in the Stage 2 final rule (77 FR
administering the program. As Furthermore, the estimates for the 54136 through 54146).
previously stated, we believe that state provisions affecting Medicare and
administrative costs are minimal. Medicaid EPs, eligible hospitals, and As noted at the beginning of this
We note that the Stage 3 portion of CAHs are somewhat uncertain for the analysis, it is difficult to predict the
this final rule with comment period following reasons: actual impacts of the policies in this
does add a new business requirement • The program is voluntary although proposed rule with certainty. We
for states, because of the existing payment adjustments will be imposed believe the assumptions and methods
systems that would need to be modified on Medicare providers if they are unable described herein are reasonable for
to track and report on the new to meet the requirements of the program estimating the financial impact of the
requirements of the program for for the applicable EHR reporting period. provisions on providers participating in
provider attestations. We are providing • The potential reduction in burden the Medicare and Medicaid programs,
90 percent Federal Financial for EPs relate to assumptions of what but acknowledge the wide range of
Participation (FFP) to states for options for meeting the requirements of possible outcomes.
modifying their existing EHR Incentive the program they would otherwise attest
Program systems. We believe the federal to should the policies in this final rule (a) Medicare Eligible Professionals (EPs)
share of the 90 percent match will with comment period not be adopted. In brief, the estimates of Medicare EP
protect the states from burdensome • The net costs and savings for any
financial outlays and, as noted burden reduction are based on current
individual provider may not directly
previously, states offer the Medicaid participation as of January 1, 2015. We
correlate to the total for the organization
EHR incentive program at their option. estimate that significant cost reductions
as larger organizations may employ
The modifications portion of this final economies of scale in EHR attestations. for Medicare EPs participating in the
rule with comment period will not have EHR Incentive Program will result from
a substantial direct effect on state or (2) Stage 3 the policies in this final rule with
local governments, preempt state law, or The principal costs of the Stage 3 comment period when compared to the
otherwise have a Federalism portion of final rule are the additional previous requirements for 2015. Our
implication. expenditures that will be undertaken by estimates of the reduction in burden

2. Effects on EPs, Eligible Hospitals, and eligible entities in order to obtain the cost savings are presented in Table 27.
CAHs Medicaid incentive payments to adopt, They reflect our assumptions about the
implement or upgrade and demonstrate proportion of EPs who will demonstrate
a. Background and Assumptions (or both) meaningful use of certified meaningful use of CEHRT outlined in
Based on the actual count of EHR technology, and to avoid the Table 26 based on historical data.
provider’s eligible for the program as of Medicare payment adjustments that will
TABLE 26—MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF CEHRT

Calendar Year
2015 2016 2017
Medicare EPs who have claims with Medicare (in thousands) ...................................... 660.0 667.8 675.5
Nonhospital-based Medicare EPs (in thousands) ........................................................... 595.1 602.1 609.1
Percent of EPs who are Meaningful Users ..................................................................... 60 65 70
Meaningful Users (in thousands) ..................................................................................... 357.1 391.4 426.4
TABLE 27—ESTIMATED COST REDUCTION FOR MEDICARE EPS

Calendar Year
2015 2016 2017
Meaningful Users (in thousands) ..................................................................................... 357.1 391.4 426.4

Lowest Estimated Cost Savings ...................................................................................... $47,760,345.60 $52,353,664.00 $57,035,264.00
Highest Estimated Cost Savings ..................................................................................... $62,585,476.80 $68,604,592.00 $74,739,392.00
(b) Medicare Eligible Hospitals and for Medicare eligible hospitals and presented in Table 29. They reflect our
CAHs CAHs participating in the EHR Incentive assumptions about the proportion of
Program will result from the policies in eligible hospitals and CAHs that will
In brief, the estimates of hospital this final rule with comment period demonstrate meaningful use of CEHRT
burden reduction are based on current when compared to the previous outlined in Table 28 based on historical
participation as of January 1, 2015. We requirements for 2015. Our estimates of data.
estimate that significant cost reductions the reduction in burden cost savings are
TABLE 28—MEDICARE ELIGIBLE HOSPITALS AND CAHS DEMONSTRATING MEANINGFUL USE OF CEHRT
Calendar Year
2015 2016 2017
Eligible Hospitals ............................................................................................................. 3397 3397 3397

CAHs ................................................................................................................................ 1395 1395 1395
Percent Demonstrating Meaningful Use .......................................................................... 95 97 99
Meaningful Users ............................................................................................................. 4552 4648 4744
TABLE 29—ESTIMATED COST REDUCTION FOR MEDICARE ELIGIBLE HOSPITALS AND CAHS
Calendar Year
2015 2016 2017

Estimated Cost Savings .................................................................................................. $756,861.04 $772,822.96 $788,784.88
(c) Medicaid Only EPs this final rule with comment period assumptions about the proportion of
We estimate that significant cost when compared to the previous Medicaid only EPs who will
reductions for Medicaid only EPs requirements for 2015. Our estimates of demonstrate meaningful use of CEHRT
participating in the EHR Incentive the reduction in burden cost savings are outlined in Table 30 based on historical
Program will result from the policies in presented in Table 31. They reflect our data.
TABLE 30—MEDICAID ONLY EPS DEMONSTRATING MEANINGFUL USE

Calendar Year
2015 2016 2017

Medicaid only EPs ........................................................................................................... 58.3 59.4 60.6

Percent of EPs who are Meaningful Users ..................................................................... 51 53 55
Meaningful Users (in thousands) ..................................................................................... 30 31.48 33.33
TABLE 31—ESTIMATED COST REDUCTION FOR MEDICAID ONLY EPS

Calendar Year
2015 2016 2017
Meaningful Users (in thousands) ..................................................................................... 30,000 31,480 33,330

Lowest Estimated Cost Savings ...................................................................................... $4,012,800.00 $4,210,764.80 $4,458,220.80
Highest Estimated Cost Savings ..................................................................................... $5,258,400.00 $5,517,814.40 $5,842,082.40
It should be noted that since the on the total current volume of Medicare participating in the EHR Incentive
Medicaid EHR Incentive Program EPs who have demonstrated meaningful Program will result from the policies in
provides that a Medicaid EP can receive use in either Medicare or Medicaid as of this final rule with comment period
an incentive payment in their first year January 1, 2015. when compared to the previous
because he or she has demonstrated requirements for 2015. Our estimates of
(d) Medicaid Only Hospitals
meaningful use or because he or she has the reduction in burden cost savings are
adopted, implemented, or upgraded The burden reduction for Medicaid presented in Table 33. They reflect our
CEHRT, these participation rates only eligible hospitals assumes a similar assumptions about the proportion of
include only those Medicaid providers participation rate for the demonstration Medicaid only eligible hospitals that
who are expected to demonstrate of meaningful use as is applicable for
will demonstrate meaningful use of
meaningful use. Providers who are dual- Medicare eligible hospitals. We estimate
CEHRT outlined in Table 32 based on
eligible have been included in the that significant cost reductions for
historical data.
Medicare EP program estimates based Medicaid only eligible hospitals
TABLE 32—MEDICAID ONLY ELIGIBLE HOSPITALS DEMONSTRATING MEANINGFUL USE OF CEHRT

Calendar year
2015 2016 2017
Eligible Hospitals ............................................................................................................. 108 108 108

Percent Demonstrating Meaningful Use .......................................................................... 95 97 99
TABLE 33—ESTIMATED COST REDUCTION FOR MEDICARE ELIGIBLE HOSPITALS AND CAHS
Calendar year
2015 2016 2017

Estimated Cost Savings .................................................................................................. $17,125.81 $17,458.35 $17,790.89
(2) Stage 3 EPs that the average adopt/implement/ are affected by the final rule; the
upgrade cost is $54,000 per physician variability includes, but is not limited
In the Stage 2 final rule (77 FR 54136 FTE, while annual maintenance costs to, the size of the hospital, extent of use
through 54146), we estimated the average $10,000 per physician FTE. of electronic systems, type of system
impact on healthcare providers using For all eligible hospitals, we continue used, number of staff using the EHR
information from four studies. In the to estimate the range is from $1 million system and the cost for maintaining and
absence of any more recent estimates to $100 million. Although reports vary upgrading systems or both.
that we are aware of, in this final rule widely, we continue to anticipate that
with comment period, we continue to Industry costs are important, in part,
the average will be $5 million to achieve
use the same estimates cited in the Stage meaningful use, because providers who because EHR adoption rates will be a
2 final rule. We continue to believe that will likely qualify as meaningful users function of these industry costs and the
these estimates are reasonably reflective of EHRs will need to purchase certified extent to which the costs of ‘‘certified
of EHR costs. However, we note, we are EHRs. We further acknowledge EHRs’’ are higher than the total value of
unable to delineate all costs due to the ‘‘certified EHRs’’ may differ in many EHR incentive payments available to
great variability in characteristics among important respects from the EHRs EPs and eligible hospitals (as well as
the entities that are affected by the final currently in use and may differ in the adjustments, in the case of the Medicare
rule; the variability includes, but is not functionalities they contain. We EHR incentive program) and any
limited to, the size of the practice, continue to estimate $1 million for perceived benefits including societal
extent of use of electronic systems, type maintenance, upgrades, and training benefits. Because of the uncertainties
of system used, number of staff using each year. Both of these estimates are surrounding industry cost estimates, we
the EHR system and the cost for based on average figures provided in the have made various assumptions about
maintaining and upgrading systems or 2008 CBO report. However, as noted adoption rates in the following analysis
both. Based on these studies and current previously, we are unable to delineate in order to estimate the budgetary
average costs for available CEHRT all costs due to the great variability in impact on the Medicare and Medicaid
products, we continue to estimate for characteristics among the entities that programs.
c. Costs of EHR Adoption for EPs Medicare or Medicaid programs. • About 16 MA organizations
Since the publication of the Stage 1 However, as noted previously, we are
unable to delineate all costs due to the a. Medicare Program Costs for Stage 3
final rule, there has been little data
published regarding the cost of EHR great variability that are affected by but The estimates for the HITECH Act
adoption and implementation. A 2011 not limited to the size of the eligible provisions are based on the economic
study (http://content.healthaffairs.org/ hospital, extent of use of electronic assumptions underlying the President’s
content/30/3/481.abstract) estimated systems, type of system used, number of FY 2016 Budget. Under the statute,
costs of implementation for a five- staff using the EHR system, and the cost Medicare incentive payments for
physician practice to be $162,000, with for maintaining and upgrading systems CEHRT are excluded from the
$85,500 in maintenance expenses in the or both. determination of MA capitation
first year. In the absence of additional 3. Medicare and Medicaid Incentive benchmarks. We continue to expect a
data regarding the cost of adoption and Program Costs for Stage 3 negligible impact on benefit payments
implementation costs for certified EHR to hospitals and EPs from Medicare and
Based on input from a number of
technology, we proposed to continue to Medicaid because of the
internal and external sources, we
estimate for EPs that the average adopt/ estimated the numbers of EPs and implementation of EHR technology.
implement/upgrade cost is $54,000 per eligible hospitals, including CAHs As noted at the beginning of this
physician FTE, while annual under Medicare, Medicaid, and MA analysis, it is difficult to predict the
maintenance costs average $10,000 per expected to be eligible for the program actual impacts of the HITECH Act with
physician FTE, based on the cost in 2017 and used these estimates for the great certainty. We believe the
estimate of the Stage 1 final rule. following analysis of Stage 3 program assumptions and methods described
However, as noted previously, we are costs. herein are reasonable for estimating the
unable to delineate all costs due to the • About 675,500 Medicare FFS EPs in financial impact of the provisions on the
great variability that are affected by but 2017 (some of whom will also be Medicare and Medicaid programs, but
not limited to the size of the practice, Medicaid EPs). acknowledge the wide range of possible
extent of use of electronic systems, type • About 60,600 non-Medicare eligible outcomes.
of system used, number of staff using EPs (such as dentists, pediatricians, and
the EHR system, and the cost for eligible non-physicians such as certified (1) Medicare Eligible Professionals (EPs)
maintaining and upgrading systems or nurse-midwives, nurse practitioners,
both. We began making EHR Incentive
and physician assistants) could be
payments in 2011. Medicare payments
d. Costs of EHR Adoption for Eligible eligible to receive the Medicaid
are to be paid for the successful
Hospitals incentive payments in 2017.
• 4,900 eligible hospitals comprising demonstration on meaningful use
According to the American Hospital the following: through CY 2016. Due to the payment
Association 2008 Survey, the range in ++ 3,397 acute care hospitals lag, some payments may be issued in CY
yearly information technology spending ++ 1,395 CAHs 2017. To avoid the Medicare payment
among hospitals ranged from $36,000 to ++ 97 children’s hospitals (Medicaid adjustment beginning in 2015, EPs need
over $32 million. EHR system costs only) to successfully demonstrate meaningful
specifically were reported by other ++ 11 cancer hospitals (Medicaid use regardless of whether they earn an
experts to run as high as $20 million to only) incentive payment. We estimated the
$100 million (77 FR 54139). We note • All eligible hospitals, except for percentage of the remaining EPs who
that recently about 96 percent of eligible children’s and cancer hospitals, may would be meaningful users each
hospitals have received at least one qualify and apply for both Medicare and calendar year. Table 34 shows the
incentive payment under either the Medicaid incentive payments. results of these calculations.
TABLE 34—MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF CEHRT

Calendar year
2017 2018 2019 2020
Medicare EPs who have claims with Medicare (thousands) ........................................... 675.5 683.3 691.1 698.8
Non-Hospital-based Medicare EPs (thousands) ............................................................. 609.1 616.1 623.1 630.1
Percent of EPs who are Meaningful Users ..................................................................... 70 73 75 78
Meaningful Users (thousands) ......................................................................................... 426.4 446.7 467.3 488.3
Our estimates of the incentive CEHRT. Estimated costs are expected to represent the estimated amount of
payment costs and payment adjustment decrease in 2017 through 2020 due to a money collected due to the payment
savings are presented in Table 35. They smaller number of new EPs that would adjustments for those not achieving
reflect actual historical data and our achieve meaningful use and the meaningful use. Estimated net costs for
assumptions about the proportion of EPs cessation of the incentive payment the Medicare EP portion of the HITECH
who will demonstrate meaningful use of program. Payment adjustment receipts Act are also shown in Table 35.
TABLE 35—ESTIMATED COSTS (+) AND SAVINGS (¥) FOR MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF CEHRT
[in billions]
Payment
Incentive Benefit
Fiscal year adjustment Net total
payments payments
receipts
2017 ................................................................................................................. $0.6 ¥$0.2 ........................ $0.3

2018 ................................................................................................................. ........................ ¥0.2 ........................ ¥0.2
2019 ................................................................................................................. ........................ ¥0.2 ........................ ¥0.2
2020 ................................................................................................................. ........................ ¥0.1 ........................ ¥0.1
(2) Medicare Eligible Hospitals and eligible hospitals would achieve payment incentives available to
CAHs meaningful use by 2018. No new hospitals under the Medicare and
incentive payments would be paid after Medicaid EHR Incentive Programs are
In brief, the estimates of hospital
2016. However, some incentive included in our regulations at 42 CFR
adoption were developed by calculating
payments originating in 2016 would be part 495. We further estimate that there
projected incentive payments and then paid in 2017.
making assumptions about how rapidly are 16 MA organizations that might be
The average incentive payment for eligible to participate in the incentive
hospitals would adopt meaningful use. each eligible hospital was $1.5 million program. Those plans have 32 eligible
Specifically, the first step in preparing in the first year. In later years, the
estimates of Medicare program costs for hospitals. The costs for the MA program
amount of the incentive payments drops have been included in the overall
eligible hospitals was to determine how according to the schedule allowed in
many eligible hospitals already received Medicare estimates.
law. The average incentive payment for
payments under the EHR Incentive CAHs received in the first year was The estimated payments to eligible
program and for what years those about $950,000. The average incentive hospitals were calculated based on the
payments were received. In order to do payment received in the second year hospitals’ qualifying status and
this, we used the most recent available was about $332,500. The average individual incentive amounts under the
data that listed the recipients of incentive payment received in the third statutory formula. Similarly, the
incentive payments, and the year and year was about $475,000. These average estimated payment adjustments for non-
payment amount. This information amounts were used for these incentive qualifying hospitals were based on the
pertained to eligible hospitals receiving payments in the future. The third year market basket reductions and Medicare
payments through September 2014. average was also used for the fourth revenues. The estimated savings in
We assume that all eligible hospitals year. These assumptions about the Medicare eligible hospital benefit
that receive a payment in the first year number of hospitals achieving expenditures resulting from the use of
will receive payments in future years. meaningful use in a particular year and hospital certified EHR systems were
We also assume the eligible hospitals the average amount of an incentive discussed earlier in this section. We
that have not yet received any incentive payment allows us to calculate the total assumed no future growth in the total
payments will eventually achieve amount of incentive payments to be number of hospitals in the U.S. because
meaningful use (either to receive made and the amount of payment growth in acute care hospitals has been
incentive payments or to avoid payment adjustments for those hospitals who minimal in recent years. The results are
adjustments). We assume that all have not achieved meaningful use. The shown in Table 36.
TABLE 36—ESTIMATED COSTS (+) AND SAVINGS (¥) FOR MEDICARE ELIGIBLE HOSPITALS DEMONSTRATING MEANINGFUL
USE OF CEHRT
[in billions]
Payment
Incentive Benefit
Fiscal year adjustment Net total
payments payments
receipts
2017 ................................................................................................................. $1.6 (1) (1 ) $1.6

2018 ................................................................................................................. 0.0 (1) (1 ) (1 )
2019 ................................................................................................................. 0.0 0.0 (1) ( 1)
2020 ................................................................................................................. 0.0 0.0 (1) ( 1)
1 Savings of less than $50 million. All numbers are projections.
b. Medicaid Incentive Program Costs for the writing of this rule, all states already providers who can demonstrate
Stage 3 participate. The payment incentives meaningful use of EHR technology were
available to EPs and eligible hospitals estimated similarly to the estimates for
Under section, 4201 of the HITECH under the Medicaid EHR Incentive Medicare eligible hospitals and EPs.
Act, states and territories can Program are included in our regulations Table 37 shows our estimates for the net
voluntarily participate in the Medicaid at 42 CFR part 495. The federal costs for Medicaid costs for eligible hospitals and
EHR Incentive Program. However, as of Medicaid incentive payments to EPs.
TABLE 37—ESTIMATED FEDERAL COSTS (+) AND SAVINGS (¥) UNDER MEDICAID
[in billions]
Incentive payments
Benefit
Fiscal year Net total
Eligible payments
Hospitals professionals
2017 ................................................................................................................. 0.4 0.8 (1) 1.2

2018 ................................................................................................................. 0.1 0.5 (1) 0.6
2019 ................................................................................................................. 0 0.3 (1) 0.3
2020 ................................................................................................................. 0.0 0.2 (1) 0.2
1 Savings of less than $50 million.
(1) Medicaid EPs
TABLE 38—ASSUMED NUMBER OF NONHOSPITAL BASED MEDICAID EPS WHO WOULD BE MEANINGFUL USERS OF
CEHRT
[Population figures in thousands]
Calendar year
2017 2018 2019 2020
A .................. EPs who meet the Medicaid patient volume threshold ......... 101.3 102.3 103.3 104.4
B .................. Medicaid only Eps ................................................................. 60.6 61.7 62.9 64.0
Total Medicaid EPs (A+B) ..................................................... 161.8 164.0 166.2 168.4
Percent of EPs receiving incentive payment during year ..... 44.7 30.9 20.7 14.3
Number of EPs receiving incentive payment during year ..... 72.4 50.7 34.5 24.0
Percent of EPs who have ever received incentive payment 67.9 74.7 78.0 81.1
Number of EPs who have ever received incentive payment 109.9 122.5 129.6 136.6
It should be noted that since the TABLE 39—ESTIMATED PERCENTAGE 4. Benefits for All EPs and All Eligible
Medicaid EHR Incentive Program OF HOSPITALS THAT COULD BE PAID Hospitals
provides that a Medicaid EP can receive FOR MEANINGFUL USE AND ESTI-
an incentive payment in his or her first In this final rule with comment
MATED PERCENTAGE PAYABLE BY period, we did not quantify the overall
year because he or she has demonstrated FISCAL YEAR
a meaningful use or because he or she benefits to the industry, nor to eligible
has adopted, implemented, or upgraded hospitals or EPs in the Medicare,
Percent of
CEHRT, these participation rates hospitals Percent of Medicaid, or MA programs. Although
include not only meaningful users but Fiscal year who are hospitals being information on the costs and benefits of
eligible providers implementing CEHRT
meaningful paid adopting systems that specifically meet
users the requirements for the EHR Incentive
as well.
Programs (for example, CEHRT) has not
2017 .......... 100.0 13.5
(2) Medicaid Hospitals yet been collected, and although some
2018 .......... 100.0 5.2
Medicaid incentive payments to most 2019 .......... 100.0 1.5 studies question the benefits of health
eligible hospitals were estimated using 2020 .......... 100.0 0.0 information technology, a 2011 study
completed by ONC 25 found that 92
the same methodology as described percent of articles published from July
previously for Medicare eligible As stated previously, the estimated
2007 up to February 2010 reached
hospitals and shown in Table 39. Many eligible hospital incentive payments
conclusions that showed the overall
eligible hospitals may qualify to receive were calculated based on the eligible
positive effects of health information
both the Medicare and Medicaid hospitals’ qualifying status and
technology. Among the positive results
incentive payment. We assume that all individual incentive amounts payable
highlighted in these articles were
eligible hospitals would achieve under the statutory formula. The
decreases in patient mortality,
meaningful use by 2016. However, average Medicaid incentive payment in
reductions in staffing needs, correlation
many of these eligible hospitals would the first year was $1 million. The
of clinical decision support to reduced
have already received the maximum estimated savings in Medicaid benefit
transfusion and costs, reduction in
amount of incentive payments. Table 40 expenditures resulting from the use of
complications for patients in hospitals
shows our assumptions about the CEHRT are discussed in section V.C.4 of
with more advanced health IT, and a
remaining incentive payments to be this final rule with comment period.

Since we use Medicare data and little reduction in costs for hospitals with less
paid.
data existed for children’s hospitals, we advanced health IT. A subsequent 2013
estimated the Medicaid incentives study completed by the RAND
payable to children’s hospitals as an
25 Buntin et al. 2011 ‘‘The Benefits of Health
add-on to the base estimate, using data
Information Technology: A Review of the Recent
on the number of children’s hospitals Literature Shows Predominantly Positive Results’’
compared to non-children’s hospitals. Health Affairs.
Corporation for ONC 26 found 77 ability to exchange information more time for the provider to spend in patient
percent of articles published between efficiently. However, it is important to care.
January 2010 to August 2013 that note that the CBO identifies the highest In the Stage 2 final rule at 77 FR
evaluated the effects of health IT on gains accruing to large provider systems 54144, we discussed research
healthcare quality, safety, and efficiency and groups and claims that office-based documenting the association of EHRs
reported findings that were at least physicians may not realize similar with improved outcomes among
partially positive. Another study, at one benefits from purchasing health IT diabetics 30 and trauma patients,31
hospital emergency room in Delaware, products. At this time, there is limited enhanced efficiencies in ambulatory
showed the ability to download and data regarding the efficacy of health IT care settings,32 and improved outcomes
create a file with a patient’s medical for smaller practices and groups, and and lower costs in hospitals.33 The 2013
history saved the ER $545 per use, the CBO report notes that this is a ONC report cited previously reported
mostly in reduced waiting times. A pilot potential area of research and analysis findings from their literature review on
study of ambulatory practices found a that remains unexamined. The benefits health IT and safety of care, health IT
positive return on investment within 16 resulting specifically from this final rule and quality of care, health IT and safety
months and annual savings thereafter.27 with comment period are even harder to of care, and health IT and efficiency of
Another study compared the quantify because they represent, in care in ambulatory and non-ambulatory
productivity of 75 providers within a many cases, adding functionality to care settings. The report indicated that
large urban primary care practice over a existing systems and reaping the a majority of studies that evaluated the
4-year period showed increases in network externalities created by larger effects of health IT on healthcare
productivity of 1.7 percent per month numbers of providers participating in quality, safety, and efficiency reported
per provider after EHR adoption.28 As information exchange. In many cases, findings that were at least partially
participation and adoption increases, they represent the reduction in the time positive. The report concluded that their
there will be more opportunities to spent per each individual respondent to findings ‘‘suggested that health IT,
capture and report on cost savings and particularly those functionalities
attest to the EHR Incentive Program
benefits. included in the Meaningful Use, can
objectives and measures. While this
5. Benefits to Society time may represent a reduced burden improve healthcare quality and safety.
According to a CBO study, when used and the opportunity to reallocate However, data relating specifically to
effectively, EHRs can enable providers recourses, there is no viable way to the EHR Incentive Programs is limited at
to deliver health care more efficiently.29 estimate that benefit over a wide range this time.
For example, the study states that EHRs of provider types, practice sizes and 6. Summary
can reduce the duplication of diagnostic other potential variables. For example,
tests, prompt providers to prescribe the reduction of about 2 hours per In this final rule with comment
cost-effective generic medications, respondent for a small practice might be period, the burden estimate and analysis
remind patients about preventive care, insignificant; however, for a practice of of the impact of the policies result in a
reduce unnecessary office visits, and 1,000 providers it may represent as total cost reduction estimated at
assist in managing complex care. This is many as 2,000 man hours, which could $48,534,332 at the lowest and
consistent with the findings in the ONC be reallocated, to making other $63,359,464 at the highest for an EHR
study cited previously. Further, the CBO improvements in clinical processes and reporting period on an annual basis for
report claims that there is a potential to patient outcomes. Conversely, a large 2015 through 2017. For further
gain both internal and external savings practice may instead leverage the batch information on prior estimates of
from widespread adoption of health IT, reporting option and only see an overall program costs we direct readers to the
noting that internal savings will likely reduction of 20 man hours as an Stage 2 final rule (77 FR 54145).
be in the reductions in the cost of organization while a small practice may The total cost to the Medicare and
providing care, and that external savings find an even greater reduction than the Medicaid programs between 2017 and
could accrue to the health insurance estimate, which may amount to a 2020 is estimated to be $3.7 billion in
plan or even the patient, such as the significantly increased benefit and more transfers.
TABLE 40—ESTIMATED EHR INCENTIVE PAYMENTS AND BENEFITS IMPACTS ON THE MEDICARE AND MEDICAID PROGRAMS
OF THE HITECH EHR INCENTIVE PROGRAM (FISCAL YEAR)
[in billions]
Medicare eligible Medicaid eligible

Fiscal year Total
Profes- Profes-
Hospitals Hospitals
sionals sionals
2017 ......................................................................................................... $1.6 $0.3 $0.4 $0.8 $3.1
26 Shekelle et al. 2013 ‘‘Health Information 29 Congressional Budget Office: ‘‘Evidence on the 31 Deckelbaum, D. et al. (2009) ‘‘Electronic
Technology: An Updated Systemic Review with a Costs and Benefits of Health Information medical records and mortality in trauma patients
Focus on Meaningful Use Functionalities. Technology’’ http://www.cbo.gov//ftpdocs/91xx/ ‘‘The Journal of Trauma: Injury, Infection, and
27 Greiger et al. 2007, A Pilot Study to Document doc9168/05-20-HealthIT.pdf. Critical Care 67(3): 634–636.
30 (Hunt, JS et al. (2009) ‘‘The impact of a 32 Chen, C et al. (2009) ‘‘The Kaiser Permanente
the Return on Investment for Implementing an
physician-directed health information technology Electronic Health Record: Transforming and
Ambulatory Electronic Health Record at an
system on diabetes outcomes in primary care: a pre- Streamlining Modalities Of Care. ‘‘Health Affairs’’
Academic Medical Center http:// 28(2):323–333.
and post-implementation study’’ Informatics in
www.journalacs.org/article/S1072- Primary Care 17(3):165–74; Pollard, C et al. (2009) 33 Amarasingham, R. et al. (2009) ‘‘Clinical
7515%2807%2900390-0/abstract-article-footnote-1. ‘‘Electronic patient registries improve diabetes care information technologies and inpatient outcomes: a
28 DeLeon et al. 2010, ‘‘The business end of health
and clinical outcomes in rural community health multiple hospital study’’ Archives of Internal
information technology’’. centers’’ Journal of Rural Health 25(1):77–84). Medicine 169(2):108–14.
TABLE 40—ESTIMATED EHR INCENTIVE PAYMENTS AND BENEFITS IMPACTS ON THE MEDICARE AND MEDICAID PROGRAMS
OF THE HITECH EHR INCENTIVE PROGRAM (FISCAL YEAR)—Continued
[in billions]
Medicare eligible Medicaid eligible

Fiscal year Total
Profes- Profes-
Hospitals Hospitals
sionals sionals
2018 ......................................................................................................... 0.0 ¥0.2 0.1 0.5 0.4

2019 ......................................................................................................... 0.0 ¥0.2 0.0 0.3 0.1
2020 ......................................................................................................... 0.0 ¥0.1 0.0 0.2 0.1
Total .................................................................................................. 1.6 ¥0.2 0.5 1.8 3.7
D. Alternatives Considered for Stage 3 technology to obtain and meaningfully Monetary annualized benefits and non-
use CEHRT. We recognize that there budgetary costs are presented as
As stated in the Stage 1 final rule (75 may be additional costs that result from discounted flows using 3 percent and 7
FR 44546), HHS has no discretion to various discretionary policy choices by percent factors in the following tables.
change the incentive payments or providers. However, those costs cannot We are not able to explicitly define the
payment adjustment reductions be estimated as the potential for universe of those additional costs, nor
specified in the statute for providers variance by provider type, organization specify what the high or low range
that adopt or fail to adopt CEHRT and size, place of service, geographic might be to implement EHR technology
demonstrate meaningful use of CEHRT. location, patient population, and the in this final rule with comment period.
However, we have discretion around impact of state and local laws is We note that federal annualized
how best to meet the HITECH Act extensive and such variations are not monetized transfers represent the net
requirements for meaningful use for FY captured in this analysis. total of annual incentive payments in
2017 and subsequent years, which we the Medicare and Medicaid EHR
have exercised in this final rule with E. Accounting Statement and Table
Incentive programs less the reductions
comment period. Additionally, we have When a rule is considered a in Medicare payments to providers
used our discretion to propose the significant rule under Executive Order failing to demonstrate meaningful use as
timing of registration, attestation, and 12866, we are required to develop an a result of the related Medicare payment
payment requirements to allow EPs and accounting statement indicating the adjustments.
eligible organizations as much time as classification of the expenditures
possible in coordination with the associated with the provisions of this (1) EHR Incentive Programs in 2015
anticipated certification of EHR final rule with comment period. Through 2017
TABLE 41—ACCOUNTING STATEMENT FOR MODIFICATIONS: CLASSIFICATION OF ESTIMATED COST REDUCTIONS AND
BENEFITS CYS 2015 THROUGH 2017
[in millions]
Category
Benefits
Annualized Monetized Cost Reductions to Private Industry Associated with

Reporting Requirements ................................................................................ Low High
estimate estimate
2015 $52.8 $68.9 7% CYs 2015–2017.

$52.8 $68.9 3%
Qualitative—Other private industry and societal benefits associated with the

reduction in provider reporting burden and with having additional time to
meet the requirements of the program.
In this final rule with comment (2) Stage 3 Payments for 2017 through 2020 based
period, there is no estimated increase in Expected qualitative benefits include on the policies in this final rule with
costs associated with incentive improved quality of care, better health comment period and the estimated
payments or payment adjustments for outcomes, reduced errors and the like. reduction in Medicare payments
the Medicare and Medicaid EHR Private industry costs would include the through the application of payment
Programs attributable to the impact of EHR activities such as adjustments for the same period. We
modifications to the program proposed temporary reduced staff productivity note that this estimate relates only to the
in the EHR Incentive Programs in 2015 related to learning how to use the EHR, policies in this final rule with comment
through 2017 proposed rule. the need for additional staff to work period and does not address subsequent
with HIT issues, and administrative changes pertaining to the MIPS program
costs related to reporting. Transfers as established by MACRA which will be
related to the payment of EHR Incentive further defined in future rulemaking.
TABLE 42—STAGE 3—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES CYS 2017 THROUGH
2020
[in millions]
Category
Benefits
Qualitative .......................................................................................................... Expected qualitative benefits include improved quality of care,

better health outcomes, reduced errors and the like.
Costs
Year Estimates Unit Period covered.

dollar (in millions) discount
rate
Primary estimate
Annualized Monetized Costs to Private Industry Associated with Reporting 2017 $478.1 7% CY 2017.
Requirements. $478.4 3%
Qualitative—Other private industry costs associated with the adoption of EHR These costs would include the impact of EHR activities such as
technology. reduced staff productivity related to learning how to use the
EHR technology, the need for additional staff to work with HIT
issues, and administrative costs related to reporting.
Transfers
Year Estimates Unit Period covered

dollar (in millions) discount
rate
Federal Annualized Monetized .......................................................................... 2017 $1,000.4 7% CYs 2017–2020.

$954.8 3%
From Whom To Whom? .................................................................................... Federal Government to Medicare- and Medicaid-eligible

professionals and hospitals.
VI. Response to Comments Medicaid Services amends 42 CFR PART 495—STANDARDS FOR THE
Because of the large number of public Chapter IV as set forth below: ELECTRONIC HEALTH RECORD
comments we normally receive on TECHNOLOGY INCENTIVE PROGRAM
Federal Register documents, we are not PART 412—PROSPECTIVE PAYMENT
able to acknowledge or respond to them SYSTEMS FOR INPATIENT HOSPITAL ■ 3. The authority citation for part 495
individually. We will consider all SERVICES continues to read as follows:
comments we receive by the date and Authority: Secs. 1102 and 1871 of the
time specified in the DATES section of ■ 1. The authority citation for Part 412 Social Security Act (42 U.S.C. 1302 and
this final rule with comment period, continues to read as follows: 1395hh).
and, if we proceed with a subsequent Authority: Secs. 1102 and 1871 of the ■ 4. Section 495.4 is amended as
document, we will respond to the Social Security Act (42 U.S.C. 1302 and follows:
comments in the preamble to that 1395hh), sec. 124 of Pub. L. 106–113 (113 ■ A. Adding the definition of ‘‘API’’ in
document. Stat. 1501A–332), sec. 1206 of Pub. L. 113– alphabetical order.
List of Subjects 67, and sec. 112 of Pub. L. 113–93. ■ B. Revising the definition of ‘‘Certified
electronic health record technology’’.
42 CFR Part 412 § 412.64 [Amended] ■ C. Amending the definition of ‘‘EHR
Administrative practice and ■ 2. Section 412.64 is amended by— reporting period’’ by—
procedure, Health facilities, Medicare, ■ i. Redesignating paragraphs (1)(i),
Puerto Rico, Reporting and ■ A. In paragraph (d)(4)(ii)(A) by (1)(ii), (1)(iii) introductory text,
recordkeeping requirements. removing the phrase ‘‘April 1’’ wherever (1)(iii)(A), (1)(iii)(B), (1)(iii)(C),
it appears and adding the phrase ‘‘July (1)(iii)(D), and (1)(iv) as paragraphs
42 CFR Part 495 1’’ in its place. (1)(i)(A), (1)(i)(B), (1)(i)(C) introductory
Administrative practice and ■ B. In paragraph (d)(4)(ii)(B)(1) by text, (1)(i)(C)(1), (1)(i)(C)(2), (1)(i)(C)(3),
procedure, Electronic health records, removing the phrase ‘‘April 1’’ and (1)(i)(C)(4), and (1)(i)(D), respectively.
Health facilities, Health professions, adding the phrase ‘‘July 1’’ in its place. ■ ii. Adding new paragraph (1)(i)
Health maintenance organizations introductory text.
(HMO), Medicaid, Medicare, Penalties, ■ C. In paragraph (d)(4)(ii)(B)(2) by
■ iii. Adding new paragraphs (1)(ii) and
Privacy, Reporting and recordkeeping removing the phrase ‘‘April 1’’ and (iii).
requirements. adding the phrase ‘‘July 1’’ in its place. ■ iv. Redesignating paragraphs (2)(i),
For the reasons stated in the (2)(ii), (2)(iii) introductory text,
preamble, the Centers for Medicare & (2)(iii)(A), (2)(iii)(B), (2)(iii)(C), and
(2)(iii)(D), as paragraphs (2)(i)(A), in its place the reference ‘‘under (x) 45 CFR 170.314(b)(8), (h)(1), and
(2)(i)(B), (2)(i)(C) introductory text and §§ 495.20, 495.22, and 495.24’’. 170.315(h)(2).
(2)(i)(C)(1), (2)(i)(C)(2), (2)(i)(C)(3), and The additions and revision read as (xi) 45 CFR 170.314(b)(1), (b)(2), and
(2)(i)(C)(4), respectively. follows: 170.315(b)(1).
■ v. Adding new paragraphs (2)(i) (xii) 45 CFR 170.314(b)(1), (b)(2),
§ 495.4 Definitions. (h)(1), and 170.315(b)(1).
introductory text.
■ vi. Adding new paragraphs (2)(ii) and * * * * * (xiii) 45 CFR 170.314(b)(1), (b)(2),
(iii). API stands for application (b)(8), and 170.315(b)(1).
■ D. Amending the definition of ‘‘EHR programming interface. (xiv) 45 CFR 170.314(b)(1), (b)(2),
reporting period for a payment Certified electronic health record (b)(8), (h)(1), and 170.315(b)(1).
adjustment year’’ by: technology (CEHRT) means the (xv) 45 CFR 170.314(b)(8), (h)(1), and
■ i. Redesignating paragraphs (1)(i)(A), following: 170.315(b)(1).
(1)(i)(B), (1)(ii), (1)(iii)(A), and (1)(iii)(B) (1) For any Federal fiscal year or (xvi) 45 CFR 170.314(b)(1), (b)(2),
as paragraphs (1)(i)(A)(1), (1)(i)(A)(2), calendar year before 2018, EHR (b)(8), (h)(1), 170.315(b)(1), and
(1)(i)(B), (1)(i)(C)(1) and (1)(i)(C)(2), technology (which could include 170.315(h)(1).
respectively. multiple technologies) certified under (xvii) 45 CFR 170.314(b)(1), (b)(2),
■ ii. In newly redesignated paragraph the ONC Health IT Certification Program (b)(8), (h)(1), 170.315(b)(1), and
(1)(i)(A)(1), by removing the cross- that meets one of the following: 170.315(h)(2).
reference ‘‘paragraphs (1)(i)(B), (ii), and (i) The 2014 Edition Base EHR (xviii) 45 CFR 170.314(h)(1) and
(iii)’’ and adding in its place the cross- definition (as defined at 45 CFR 170.315(b)(1).
reference ‘‘paragraphs (1)(i)(A)(2), 170.102) and has been certified to the (xix) 45 CFR 170.315(b)(1) and (h)(1).
certification criteria that are necessary (xx) 45 CFR 170.315(b)(1) and (h)(2).
(1)(i)(B), and (1)(i)(C)’’. (xxi) 45 CFR 170.315(b)(1), (h)(1), and
■ iii. In newly redesignated paragraph to be a Meaningful EHR User (as defined
in this section), including the applicable (h)(2); and
(1)(i)(A)(2), by removing the cross- (B) Clinical quality measures at—
reference ‘‘paragraphs (1)(iii) or (1)(iv)’’ measure calculation certification
criterion at 45 CFR 170.314(g)(1) or (2) (1) 45 CFR 170.314(c)(1) or
and adding in its place the cross- 170.315(c)(1);
reference ‘‘paragraph (1)(i)(C)’’. for all certification criteria that support
(2) 45 CFR 170.314(c)(2) or
■ iv. Adding new paragraph (1)(i) a meaningful use objective with a
170.315(c)(2);
introductory text. percentage-based measure. (3) 45 CFR 170.314(c)(3) or
■ v. Adding new paragraph. (1)(ii)). (ii) Certification to—
(A) The following certification 170.315(c)(3); and
■ vi. Redesignating paragraphs (2)(i)(A), (C) Privacy and security at—
(2)(i)(B), (2)(ii), (2)(iii)(A), and (2)(iii)(B) criteria: (1) 45 CFR 170.314(d)(1) or
as paragraphs (2)(i)(A)(1), (2)(i)(A)(2), (1) CPOE at—
170.315(d)(1);
(2)(i)(B), (2)(i)(C)(1), and (2)(i)(C)(2), (i) 45 CFR 170.314(a)(1), (18), (19) or
(2) 45 CFR 170.314(d)(2) or
respectively. (20); or
170.315(d)(2);
■ vii. In newly redesignated paragraph
(ii) 45 CFR 170.315(a)(1), (2) or (3).
(3) 45 CFR 170.314(d)(3) or
(2)(i) Record demographics at 45 CFR
(2)(i)(A)(1), by removing the cross- 170.315(d)(3);
170.314(a)(3); or
reference ‘‘paragraphs (2)(i)(B), (ii), and (4) 45 CFR 170.314(d)(4) or
(ii) 45 CFR 170.315(a)(5).
(iii)’’ and adding in its place the cross- (3)(i) Problem list at 45 CFR 170.315(d)(4);
reference ‘‘paragraphs (2)(i)(A)(2), (5) 45 CFR 170.314(d)(5) or
170.314(a)(5); or
(2)(i)(B), and (2)(i)(C)’’. (ii) 45 CFR 170.315(a)(6). 170.315(d)(5);
■ viii. In newly redesignated paragraph (6) 45 CFR 170.314(d)(6) or
(4)(i) Medication list at 45 CFR
(2)(i)(A)(2), by removing the cross- 170.315(d)(6);
170.314(a)(6); or
reference ‘‘paragraph (2)(iii)’’ and (7) 45 CFR 170.314(d)(7) or
(ii) 45 CFR 170.315(a)(7).
adding in its place the cross-reference (5)(i) Medication allergy list 45 CFR 170.315(d)(7);
‘‘paragraph (2)(i)(C)’’. (8) 45 CFR 170.314(d)(8) or
170.314(a)(7); or
■ ix. Adding new paragraph (2)(i) (ii) 45 CFR 170.315(a)(8). 170.315(d)(8); and
introductory text. (6)(i) Clinical decision support at 45 (D) The certification criteria that are
■ x. Adding new paragraphs (2)(ii) and CFR 170.314(a)(8); or necessary to be a Meaningful EHR User
(iii). (ii) 45 CFR 170.315(a)(9). (as defined in this section), including
■ xi. Redesignating paragraphs (3)(i) and (7) Health information exchange at the applicable measure calculation
(3)(ii) as paragraphs (3)(i)(A) and transitions of care at one of the certification criterion at 45 CFR
(3)(i)(B). following: 170.314(g)(1) or (2) or 45 CFR
■ xii. In newly redesignated paragraph (i) 45 CFR 170.314(b)(1) and (2). 170.315(g)(1) or (2) for all certification
(3)(i)(A), by removing the cross- (ii) 45 CFR 170.314(b)(1), (b)(2), and criteria that support a meaningful use
reference ‘‘paragraph (3)(ii)’’ and adding (h)(1). objective with a percentage-based
in its place the cross-reference (iii) 45 CFR 170.314(b)(1), (b)(2), and measure.
‘‘paragraph (3)(i)(B)’’. (b)(8). (iii) The definition for 2018
■ xiii. Adding new paragraph (3)(i) (iv) 45 CFR 170.314(b)(1), (b)(2), subsequent years specified in paragraph
introductory text. (b)(8), and (h)(1). (2) of this definition.
■ xiv. Adding new paragraphs (3)(ii) (v) 45 CFR 170.314(b)(8) and (h)(1). (2) For 2018 and subsequent years,
and (iii). (vi) 45 CFR 170.314(b)(1), (b)(2), and EHR technology (which could include
■ e. Amend the definition of 170.315(h)(2). multiple technologies) certified under
‘‘Meaningful EHR user’’ by: (vii) 45 CFR 170.314(b)(1), (b)(2), the ONC Health IT Certification Program
■ i. In paragraph (1), by removing the (h)(1), and 170.315(h)(2). that meets the 2015 Edition Base EHR
reference ‘‘§ 495.8’’ and adding in its (viii) 45 CFR 170.314(b)(1), (b)(2), definition (as defined at 45 CFR
place the reference ‘‘§ 495.40’’. (b)(8), and 170.315(h)(2). 170.102) and has been certified to the
■ ii. In paragraph (1), by removing the (ix) 45 CFR 170.314(b)(1), (b)(2), 2015 Edition health IT certification
reference ‘‘under § 495.6 ’’ and adding (b)(8), (h)(1), and 170.315(h)(2). criteria—
(i) At 45 CFR 170.315(a)(12) (family (ii) The following are applicable for (B) In 2016 as follows:
health history) and 45 CFR 170.315(e)(3) 2015, 2016, and 2017: (1) If an EP has not successfully
(patient health information capture); (A) For the FY 2015 payment year, demonstrated he or she is a meaningful
and any continuous 90-day period within EHR user in a prior year, the EHR
(ii) Necessary to be a Meaningful EHR the period beginning on October 1, 2014 reporting period is any continuous 90-
User (as defined in this section), and ending on December 31, 2015. day period within CY 2016 and applies
including the following: (B) For the FY 2016 payment year as for the CY 2017 and 2018 payment
(A) The applicable measure follows: adjustment years. For the CY 2017
calculation certification criterion at 45 (1) For the eligible hospital or CAH payment adjustment year, the EHR
CFR 170.315(g)(1) or (2) for all first demonstrating it is a meaningful reporting period must end before and
certification criteria that support a EHR user, any continuous 90-day period the EP must successfully register for and
meaningful use objective with a within CY 2016. attest to meaningful use no later than
percentage-based measure. (2) For the eligible hospital or CAH October 1, 2016.
(B) Clinical quality measure that has successfully demonstrated it is (2) If in a prior year an EP has
certification criteria that support the a meaningful EHR user in any prior successfully demonstrated he or she is
calculation and reporting of clinical year, the CY 2016. a meaningful EHR user, the EHR
quality measures at 45 CFR (C) For the FY 2017 payment year reporting period is CY 2016 and applies
170.315(c)(2) and (3). under the Medicaid EHR Incentive for the CY 2018 payment adjustment
* * * * * Program: year.
(1) For the eligible hospital or CAH (C) In 2017 as follows:
EHR reporting period. * * *
first demonstrating it is a meaningful (1) If an EP has not successfully
(1) * * *
(i) The following are applicable before EHR user, any continuous 90-day period demonstrated he or she is a meaningful
2015: within CY 2017. EHR user in a prior year, the EHR
(2) For the eligible hospital or CAH reporting period is any continuous 90-
* * * * * that has successfully demonstrated it is
(ii) The following are applicable for day period within CY 2017 and applies
a meaningful EHR user in any prior for the CY 2018 payment adjustment
2015, 2016, and 2017: year, the CY 2017.
(A) For the CY 2015 payment year, year. For the CY 2018 payment
(3) For the eligible hospital or CAH
any continuous 90-day period within adjustment year, the EHR reporting
demonstrating the Stage 3 objectives
CY 2015. period must end before and the EP must
and measures at § 495.24, any
(B) For the CY 2016 payment year: successfully register for and attest to
continuous 90-day period within CY
(1) For the EP first demonstrating he meaningful use no later than October 1,
2017.
or she is a meaningful EHR user, any 2017.
(iii) The following are applicable
continuous 90-day period within CY (2) If an EP is demonstrating Stage 3
beginning with the FY 2018 payment
2016. of meaningful use in 2017 under
year under the Medicaid EHR Incentive
(2) For the EP who has successfully § 495.24 in the Medicaid program, the
Program:
demonstrated he or she is a meaningful (A) For the payment year in which the EHR reporting period is any continuous
EHR user in any prior year, the CY 2016. eligible hospital or CAH is first 90-day period within CY 2017 and
(C) For the CY 2017 payment year demonstrating it is a meaningful EHR applies for the FY 2019 payment
under the Medicaid EHR Incentive user, any continuous 90-day period adjustment year.
Program: within the calendar year. (2) * * *
(1) For the EP first demonstrating he (B) For the subsequent payment years (i) The following are applicable before
or she is a meaningful EHR user, any following the payment year in which 2015:
continuous 90-day period within CY the eligible hospital or CAH first * * * * *
2017. successfully demonstrates it is a (ii) The following are applicable for
(2) For the EP who has successfully meaningful EHR user, the calendar year. 2015, 2016, and 2017:
demonstrated he or she is a meaningful EHR reporting period for a payment (A) In 2015 as follows:
EHR user in any prior year, the CY 2017. adjustment year. * * * (1) If an eligible hospital has not
(3) For the EP demonstrating the Stage (1) * * * successfully demonstrated it is a
3 objectives and measures at § 495.24, (i) The following are applicable before meaningful EHR user in a prior year, the
any continuous 90-day period within 2015: EHR reporting period is any continuous
CY 2017. * * * * * 90-day period within the period
(iii) The following are applicable (ii) The following are applicable for beginning on October 1, 2014 and
beginning with the CY 2018 payment 2015, 2016, and 2017: ending on December 31, 2015 and
year under the Medicaid EHR Incentive (A) In 2015 as follows: applies for the FY 2016 and 2017
Program: (1) If an EP has not successfully payment adjustment years.
(A) For the payment year in which the demonstrated he or she is a meaningful (2) If in a prior year an eligible
EP is first demonstrating he or she is a EHR user in a prior year, the EHR hospital has successfully demonstrated
meaningful EHR user, any continuous reporting period is any continuous 90- it is a meaningful EHR user, the EHR
90-day period within the calendar year. day period within CY 2015 and applies reporting period is any continuous 90-
(B) For the subsequent payment years for the CY 2016 and 2017 payment day period within the period beginning
following the payment year in which adjustment years. on October 1, 2014 and ending on
the EP first successfully demonstrates (2) If in a prior year an EP has December 31, 2015 and applies for the
he or she is a meaningful EHR user, the successfully demonstrated he or she is FY 2017 payment adjustment year.
calendar year. a meaningful EHR user, the EHR (B) In 2016 as follows:
(2) * * * reporting period is any continuous 90- (1) If an eligible hospital has not
(i) The following are applicable before day period within CY 2015 and applies successfully demonstrated it is a
2015: for the CY 2017 payment adjustment meaningful EHR user in a prior year, the
* * * * * year. EHR reporting period is any continuous
90-day period within CY 2016 and 2017 period beginning on October 1, 2014 § 495.10 [Redesignated as § 495.60]
applies for the FY 2017 and 2018 and ending on December 31, 2015 and ■ 7. Redesignate § 495.10 as § 495.60.
payment adjustment years. For the FY applies for the FY 2015 payment ■ 8. Newly redesignated § 495.20 is
2017 payment adjustment year, the EHR adjustment year. amended by revising the section
reporting period must end before and (B) In 2016 as follows: heading and adding new introductory
the eligible hospital must successfully (1) If a CAH has not successfully text to read as follows.
register for and attest to meaningful use demonstrated it is a meaningful EHR
no later than October 1, 2016. user in a prior year, the EHR reporting § 495.20 Meaningful use objectives and
(2) If in a prior year an eligible period is any continuous 90-day period measures for EPs, eligible hospitals, and
hospital has successfully demonstrated CAHs before 2015.
within CY 2016 and applies for the FY
it is a meaningful EHR user, the EHR 2016 payment adjustment year. The following criteria are applicable
reporting period is CY 2016 and applies (2) If in a prior year a CAH has before 2015:
for the FY 2018 payment adjustment successfully demonstrated it is a * * * * *
year. meaningful EHR user, the EHR reporting ■ 9. Section § 495.22 is added to read as
(C) In 2017 as follows: period is CY 2016 and applies for the follows:
(1) If an eligible hospital has not FY 2016 payment adjustment year.
successfully demonstrated it is a (C) In 2017 as follows: § 495.22 Meaningful use objectives and
meaningful EHR user in a prior year, the (1) If the CAH has not successfully
measures for EPs, eligible hospitals, and
EHR reporting period is any continuous CAHs for 2015 through 2017.
demonstrated meaningful EHR use in a
90-day period within CY 2017 and prior year the EHR reporting period is (a) General rules. (1) The criteria
applies for the FY 2018 and 2019 any continuous 90-day period within specified in this section are applicable
payment adjustment years. For the FY CY 2017 and applies for the FY 2017 for all EPs, eligible hospitals, and CAHs
2018 payment adjustment year, the EHR payment adjustment year. for 2015 through 2017.
reporting period must end before and (2) For 2017 only, EPs, eligible
(2) If a CAH is demonstrating Stage 3
the eligible hospital must successfully hospitals, and CAHs have the option to
of meaningful use under § 495.24, the
register for and attest to meaningful use use the criteria specified for 2018 (as
EHR reporting period is any continuous
no later than October 1, 2017. outlined at § 495.24) instead of the
90-day period within CY 2017 and
(2) If an eligible hospital is criteria specified in this section.
applies for that begins on the first day
demonstrating Stage 3 of meaningful use (b) Criteria for EPs for 2015 through
of second quarter of the FY 2017
under § 495.24, the EHR reporting 2017—(1) General rule regarding criteria
payment adjustment year.
period is any continuous 90-day period for meaningful use for 2015 through
within CY 2017 and applies for the FY (3) If in a prior year a CAH has
2017 for EPs. Except as specified in
2019 payment adjustment year. successfully demonstrated it is a
paragraph (b)(2) of this section, EPs
(3) If in a prior year an eligible meaningful EHR user, the EHR reporting
must meet all objectives and associated
hospital has successfully demonstrated period is CY 2017 and applies for the
measures of the meaningful use criteria
it is a meaningful EHR user, the EHR FY 2017 payment adjustment year.
specified under paragraph (e) of this
reporting period is CY 2017 and applies (iii) The following are applicable section to meet the definition of a
for the FY 2019 payment adjustment beginning in 2018: meaningful EHR user.
year. (A) Except as provided in paragraph (2) Exclusion for non-applicable
(iii) The following are applicable (3)(iii)(B) of this definition, the EHR objectives. (i) An EP may exclude a
beginning in 2018: reporting period is the calendar year particular objective contained in
(A) Except as provided in paragraph that begins on the first day of second paragraph (e) of this section, if the EP
(2)(iii)(B) of this definition, the EHR quarter of the Federal fiscal year that is meets all of the following requirements:
reporting period is the calendar year the payment adjustment year. (A) Must ensure that the objective in
that is 2 years before the payment (B) If a CAH is demonstrating under paragraph (e) of this section includes an
adjustment year. the Medicaid EHR Incentive Program option for the EP to attest that the
(B) If an eligible hospital is that it is a meaningful EHR user for the objective is not applicable.
demonstrating under the Medicaid EHR first time in the calendar year that (B) Meets the criteria in the applicable
Incentive Program that it is a begins on the first day of the second objective that would permit the
meaningful EHR user for the first time quarter of the Federal fiscal year that is attestation to the exclusion.
in the calendar year that is 2 years the payment adjustment year, then any (C) Attests.
before the payment adjustment year, the continuous 90-day period within such (ii) An exclusion will reduce (by the
EHR reporting period for that payment calendar year. The EHR reporting period number of exclusions applicable) the
adjustment year is the same continuous for that payment adjustment year is the number of objectives that would
90-day period that is the EHR reporting same continuous 90-day period that is otherwise apply in paragraph (e) of this
period for the Medicaid incentive the EHR reporting period for the section.
payment within the calendar year that is Medicaid incentive payment within the (c) Criteria for eligible hospitals and
2 years before that payment adjustment calendar year that that begins on the CAHs for 2015 through 2017—(1)
year. first day of the second quarter of the General rule regarding criteria for
(3) * * * Federal fiscal year that is the payment meaningful use for 2015 through 2017
adjustment year.
(i) The following are applicable before for eligible hospitals and CAHs. Except
2015: * * * * * as specified in paragraph (c)(2) of this
* * * * * § 495.6 [Redesignated as § 495.20]
section, eligible hospitals and CAHs
(ii) The following are applicable for must meet all objectives and associated
2015, 2016, and 2017: ■ 5. Redesignate § 495.6 as § 495.20. measures of the meaningful use criteria
(A) In 2015 as follows: specified under paragraph (e) of this
§ 495.8 [Redesignated as § 495.40]
(1) The EHR reporting period is any section to meet the definition of a
continuous 90-day period within the ■ 6. Redesignate § 495.8 as § 495.40. meaningful EHR user.
(2) Exclusion for non-applicable accordance with requirements under 45 allergy interaction checks for the entire
objectives. (i) An eligible hospital or CFR 164.312(a)(2)(iv) and 45 CFR EHR reporting period.
CAH may exclude a particular objective 164.306(d)(3), and implement security (B) Alternate specifications. An
contained in paragraph (e) of this updates as necessary, and correct eligible hospital or CAH previously
section, if the eligible hospital or CAH identified security deficiencies as part scheduled to be in Stage 1 in 2015 may
meets all of the following requirements: of the eligible hospital’s or CAH’s risk meet an alternate measure described in
(A) Must ensure that the objective in management process. paragraph (e)(2)(iii)(B)(2) of this section
paragraph (e) of this section includes an (2) Clinical decision support— (i) in place of the measure described in
option for the eligible hospital or CAH Objective. Use clinical decision support paragraph (e)(2)(iii)(A)(1) of this section
to attest that the objective is not to improve performance on high-priority for an EHR reporting period in 2015.
applicable. health conditions. (1) Alternate objective. Implement one
(B) Meets the criteria in the applicable (ii) EP measures—(A) Measure. In clinical decision support rule relevant
objective that would permit the order for EPs to meet the objective they to a high priority hospital condition
attestation to the exclusion. must satisfy both of the following along with the ability to track
(C) Attests. measures: compliance with that rule.
(ii) An exclusion will reduce (by the (1) Implement five clinical decision (2) Alternate measure. Implement one
number of exclusions applicable) the support interventions related to four or clinical decision support rule.
number of objectives that would more clinical quality measures at a (3) Computerized provider order
otherwise apply in paragraph (e) of this relevant point in patient care for the entry. (i) Objective. Use computerized
section. entire EHR reporting period. Absent provider order entry for medication,
(d) Many of the objectives and four clinical quality measures related to laboratory, and radiology orders directly
associated measures in paragraph (e) of an EP’s scope of practice or patient entered by any licensed healthcare
this section rely on measures that count population, the clinical decision professional who can enter orders into
unique patients or actions. (1) If a support interventions must be related to the medical record per state, local, and
measure (or associated objective) in high-priority health conditions. professional guidelines.
paragraph (e) of this section references (2) Enabled and implemented the (ii) EP measures. (A) Measures. An EP
paragraph (d) of this section, then the functionality for drug-drug and drug- must meet the following 3 measures,
measure may be calculated by reviewing allergy interaction checks for the entire subject to paragraph (d) of this section:
only the actions for patients whose EHR reporting period. (1) More than 60 percent of
records are maintained using CEHRT. A (B) Exclusion in accordance with medication orders created by the EP
patient’s record is maintained using paragraph (b)(2) of this section. An EP during the EHR reporting period are
CEHRT if sufficient data was entered in who writes fewer than 100 medication recorded using computerized provider
the CEHRT to allow the record to be orders during the EHR reporting period order entry.
saved, and not rejected due to may be excluded from the measure (2) More than 30 percent of laboratory
incomplete data. under paragraph (e)(2)(i)(A)(2) of this orders created by the EP during the EHR
(2) If the objective and associated section. reporting period are recorded using
measure does not reference this (C) Alternate specifications. An EP computerized provider order entry.
paragraph (d) of this section, then the previously scheduled to be in Stage 1 in (3) More than 30 percent of radiology
measure must be calculated by 2015 may meet an alternate objective orders created by the EP during the EHR
reviewing all patient records, not just and measure specified in paragraph reporting period are recorded using
those maintained using CEHRT. (e)(2)(ii)(C)(1) and (2) in place of the computerized provider order entry.
(e) Meaningful use objectives and measure outlined under paragraph (B) Exclusion in accordance with
measures for 2015 through 2017—(1) (e)(2)(ii)(A)(1) of this section for an EHR paragraph (b)(2) of this section. (1) For
Protect patient health information— (i) reporting period in 2015 only. the measure specified in paragraph
Objective. Protect electronic protected (1) Alternate objective. Implement one (e)(3)(ii)(A)(1) of this section, any EP
health information created or clinical decision support rule relevant who writes fewer than 100 medication
maintained by the CEHRT through the to specialty or high clinical priority orders during the EHR reporting period.
implementation of appropriate technical along with the ability to track (2) For the measure specified in
capabilities. compliance with that rule. paragraph (e)(3)(ii)(A)(2) of this section,
(ii) Measures—(A) EP measure. (2) Alternate measure. Implement one any EP who writes fewer than 100
Conduct or review a security risk clinical decision support rule. laboratory orders during the EHR
analysis in accordance with the (iii) Eligible hospital and CAH reporting period.
requirements in 45 CFR 164.308(a)(1), measures—(A) Measure. In order for (3) For the measure specified in
including addressing the security (to eligible hospitals and CAHs to meet the paragraph (e)(3)(ii)(A)(3) of this section,
include encryption) of ePHI created or objective they must satisfy both of the any EP who writes fewer than 100
maintained by CEHRT in accordance following measures: radiology orders during the EHR
with requirements under 45 CFR (1) Implement five clinical decision reporting period.
164.312(a)(2)(iv) and 45 CFR support interventions related to four or (C) Alternate exclusions and
164.306(d)(3), and implement security more clinical quality measures at a specifications. An EP previously
updates as necessary and correct relevant point in patient care for the scheduled to be in Stage 1 in 2015 may
identified security deficiencies as part entire EHR reporting period. Absent meet an alternate measure (e)(3)(ii)(C)(1)
of the EP’s risk management process. four clinical quality measures related to in place of the measure outlined under
(B) Eligible hospital or CAH measure. an eligible hospital or CAH’s scope of paragraph (e)(3)(ii)(A)(1) of this section,
Conduct or review a security risk practice or patient population, the and may exclude the measures outlined
analysis in accordance with the clinical decision support interventions under paragraphs (e)(3)(ii)(A)(2) and (3)
requirements under 45 CFR must be related to high-priority health of this section for an EHR reporting
164.308(a)(1), including Addressing the conditions. period in 2015. An EP previously
security (to include encryption) of ePHI (2) Enabled and implemented the scheduled to be in Stage 1 in 2016 may
created or maintained in CEHRT in functionality for drug-drug and drug- exclude the measures outlined under
paragraphs (e)(3)(ii)(A)(2) and (3) of this this section for an EHR reporting period (iii) Eligible hospital and CAH
section for an EHR reporting period in in 2016. measure—(A) Measure. Subject to
2016. (2) Alternate measure 1 in 2015. paragraph (d) of this section, more than
(1) Alternate measure 1 in 2015. Subject to paragraph (d) of this 10 percent of hospital discharge
Subject to paragraph (d) of this section— medication orders for permissible
section— (i) More than 30 percent of all unique prescriptions are queried for a drug
(i) More than 30 percent of all unique patients with at least one medication in formulary and transmitted electronically
patients with at least one medication in their medication list admitted to the using CEHRT.
their medication list seen by the EP eligible hospital’s or CAH’s inpatient or (B) Exclusion in accordance with
during the EHR reporting period have at emergency department (POS 21 or 23) paragraph (c)(2) of this section. Any
least one medication order entered have at least one medication order eligible hospital or CAH that does not
using CPOE; or entered using CPOE; or have an internal pharmacy that can
(ii) More than 30 percent of (ii) More than 30 percent of accept electronic prescriptions and is
medication orders created by the EP medication orders created by the not located within 10 miles of any
during the EHR reporting period are authorized providers of the eligible pharmacy that accepts electronic
recorded using computerized provider hospital or CAH for patients admitted to prescriptions at the start of their EHR
order entry. their inpatient or emergency reporting period.
(2) Alternate exclusions in 2015. An departments (POS 21 or 23) during the (C) Alternate exclusions. (1) An
EP scheduled to be in Stage 1 in 2015 EHR reporting period are recorded using eligible hospital or CAH previously
may exclude the measures specified in computerized provider order entry. scheduled to be in—
paragraphs (e)(3)(ii)(A)(2) and (3) Alternate exclusions in 2015 and (i) Stage 1 in 2015 may exclude the
(e)(3)(ii)(A)(3) of this section in 2015. 2016. An eligible hospital or CAH measure specified in paragraph
(3) Alternate exclusions in 2016. An scheduled to be in Stage 1 in 2015 may (e)(4)(iii)(A) of this section for an EHR
EP scheduled to be in Stage 1 in 2016 exclude the following measures in 2015 reporting period in 2015; or
may exclude the measure specified in and eligible hospital or CAH scheduled (ii) Stage 2 in 2015 may exclude the
paragraph (e)(3)(ii)(A)(3) of this section to be in Stage 1 in 2016 may exclude the measure specified in paragraph
in 2016. following measures in 2016: (e)(4)(iii)(A) of this section for an EHR
(iii) Eligible hospital and CAH (i) The measure specified in reporting period in 2015.
measures. (A) An eligible hospital or paragraph (e)(3)(iii)(A)(2) of this section.
CAH must meet the following 3 (2) An eligible hospital or CAH
(ii) The measure specified in
measures, subject to paragraph (d) of previously scheduled to be in—
paragraph (e)(3)(iii)(A)(3) of this section.
this section: (i) Stage 1 in 2016, may exclude the
(4) Electronic prescribing—(i)
(1) More than 60 percent of measure specified in paragraph
Objective. For EPs, generate and
medication orders created by authorized (e)(4)(iii)(A) of this section for an EHR
transmit permissible prescriptions
providers of the eligible hospital’s or reporting period in 2016; or
electronically (eRx); and, for eligible
CAH’s inpatient or emergency hospitals and CAHs, generate, and (ii) Stage 2 in 2016, may exclude the
department (POS 21 or 23) during the transmit permissible discharge measure specified in paragraph
EHR reporting period are recorded using prescriptions electronically (eRx). (e)(4)(iii)(A) of this section for an EHR
computerized provider order entry. (ii) EP measure—(A) Measure. Subject reporting period in 2016.
(2) More than 30 percent of laboratory to paragraph (d) of this section, more (5) Health Information Exchange—(i)
orders created by authorized providers than 50 percent of all permissible Objective. The EP, eligible hospital or
of the eligible hospital’s or CAH’s prescriptions written by the EP are CAH who transitions a patient to
inpatient or emergency department queried for a drug formulary and another setting of care or provider of
(POS 21 or 23) during the EHR reporting transmitted electronically using CEHRT. care or refers a patient to another
period are recorded using computerized (B) Exclusion in accordance with provider of care provides a summary
provider order entry. paragraph (b)(2) of this section. Any EP care record for each transition of care or
(3) More than 30 percent of radiology who— referral.
orders created by authorized providers (1) Writes fewer than 100 permissible (ii) EP measure. (A) Measure. Subject
of the eligible hospital’s or CAH’s prescriptions during the EHR reporting to paragraph (d) of this section, the EP
inpatient or emergency department period; or who transitions or refers his or her
(POS 21 or 23) during the EHR reporting (2) Does not have a pharmacy within patient to another setting of care or
period are recorded using computerized his or her organization and there are no provider of care must do the following:
provider order entry. pharmacies that accept electronic (1) Use CEHRT to create a summary
(B) Alternate exclusions and prescriptions within 10 miles of the EP’s of care record.
specifications. (1) An eligible hospital or practice location at the start of his or her (2) Electronically transmit such
CAH previously scheduled to be in EHR reporting period. summary to a receiving provider for
Stage 1 in 2015 may meet an alternate (C) Alternate specification. In 2015 an more than 10 percent of transitions of
measure specified in paragraph EP— care and referrals.
(e)(3)(iii)(B)(2) of this section in place of (1) Previously scheduled to be in (B) Exclusion in accordance with
the measure outlined under paragraph Stage 1 in 2015 may meet an alternate paragraph (b)(2) of this section. Any EP
(e)(3)(iii)(A)(1) of this section, and may measure under paragraph (e)(4)(ii)(C)(2) who transfers a patient to another
exclude the measures outlined under of this section in place of the measure setting or refers a patient to another
paragraphs (e)(3)(iii)(A)(2) and outlined under paragraph(e)(4)(ii)(A) of provider less than 100 times during the
(e)(3)(iii)(A)(3) of this section for an this section; and EHR reporting period.
EHR reporting period in 2015. An (2) Subject to paragraph (d) of this (C) Alternate exclusion. An EP
eligible hospital or CAH previously section, more than 40 percent of all previously scheduled to be in Stage 1 in
scheduled to be in Stage 1 in 2016 may permissible prescriptions written by the 2015 may exclude the measure specified
exclude the measures outlined under EP are transmitted electronically using in paragraph (e)(5)(ii)(A) of this section
paragraphs (e)(3)(iii)(A)(2) and (3) of CEHRT. for an EHR reporting period in 2015.
(iii) Eligible hospital and CAH transitions of care during the EHR (2) Any EP who conducts 50 percent
measure—(A) Measure. Subject to reporting period. or more of his or her patient encounters
paragraph (d) of this section, the eligible (C) Alternate exclusion. An EP in a county that does not have 50
hospital or CAH that transitions or previously scheduled to be in Stage 1 in percent or more of its housing units
refers its patient to another setting of 2015 may exclude the measure specified with 4Mbps broadband availability
care or provider of care must do the in paragraph (e)(7)(ii)(A) of this section according to the latest information
following: for an EHR reporting period in 2015. available from the Federal
(1) Use CEHRT to create a summary (iii) Eligible hospital or CAH measure. Communications Commission on the
of care record. An eligible hospital or CAH must meet first day of the EHR reporting period is
(2) Electronically transmit such the following measure, subject to excluded from paragraph (e)(8)(ii)(A)(2)
summary to a receiving provider for paragraph (d) of this section: of this section.
more than 10 percent of transitions of (A) Measure. Subject to paragraph (d) (C) Alternate exclusion. An EP
care and referrals. of this section, the eligible hospital or previously scheduled to be in Stage 1 in
(B) Alternate exclusion. An eligible CAH performs medication 2015 may exclude the measure specified
hospital or CAH previously scheduled reconciliation for more than 50 percent in paragraph (e)(8)(ii)(A)(2) of this
to be in Stage 1 in 2015 may exclude the of transitions of care in which the section for an EHR reporting period in
measure specified in paragraph patient is admitted to the eligible 2015.
(e)(5)(iii)(A) of this section for an EHR hospital’s or CAH’s inpatient or (ii) Eligible hospital and CAH
reporting period in 2015. emergency department (POS 21 or 23). objective. Provide patients the ability to
(6) Patient specific education—(i) (B) Alternate exclusion. An eligible view online, download, and transmit
Objective. Use clinically relevant hospital or CAH previously scheduled information within 36 hours of hospital
information from CEHRT to identify to be in Stage 1 in 2015 may exclude the discharge.
patient-specific education resources and measure specified in paragraph (A) Eligible hospital and CAH
provide those resources to the patient. (e)(7)(iii)(A) of this section for an EHR measures. An eligible hospital or CAH
(ii) EP measure—(A) Measure. reporting period in 2015. must meet the following 2 measures:
Patient-specific education resources (1) Measure 1. More than 50 percent
(8) Patient electronic access—(i) EP
identified by CEHRT are provided to of all unique patients who are
objective. Provide patients the ability to
patients for more than 10 percent of all discharged from the inpatient or
view online, download, and transmit
unique patients with office visits seen emergency department (POS 21 or 23) of
their health information within 4
by the EP during the EHR reporting an eligible hospital or CAH have timely
business days of the information being
period. access to view online, download and
available to the EP.
(B) Exclusion in accordance with transmit to a third party their health
(A) EP measures. An EP must meet
paragraph (b)(2) of this section. Any EP information.
the following 2 measures: (2) Measure 2. For an EHR reporting
who has no office visits during the EHR
(1) Measure 1: More than 50 percent period—
reporting period.
(C) Alternate exclusion. An EP of all unique patients seen by the EP (i) In 2015 or 2016, at least 1 patient
previously scheduled to be in Stage 1 in during the EHR reporting period are (or patient-authorized representative)
2015 may exclude the measure specified provided timely access to view online, who is discharged from the inpatient or
in paragraph (e)(6)(ii)(A) of this section download and transmit to a third party emergency department (POS 21 or 23) of
for an EHR reporting period in 2015. their health information subject to the an eligible hospital or CAH during the
(iii) Eligible hospital and CAH EP’s discretion to withhold certain EHR reporting period views, downloads
measure—(A) Measure. More than 10 information. or transmits to a third party his or her
percent of all unique patients admitted (2) Measure 2: For an EHR reporting information during the EHR reporting
to the eligible hospital’s or CAH’s period— period; and
inpatient or emergency department (i) In 2015 and 2016, at least 1 patient (ii) In 2017, more than 5 percent of
(POS 21 or 23) are provided patient- seen by the EP during the EHR reporting unique patients (or patient-authorized
specific education resources identified period (or patient-authorized representatives) discharged from the
by CEHRT. representative) views, downloads or inpatient or emergency department
(B) Alternate exclusion. An eligible transmits his or her health information (POS 21 or POS 23) of an eligible
hospital or CAH previously scheduled to a third party during the EHR hospital or CAH during the EHR
to be in Stage 1 in 2015 may exclude the reporting period. reporting period view, download or
measure specified in paragraph (ii) In 2017, more than 5 percent of transmit to a third party their health
(e)(6)(iii)(A) of this section for an EHR unique patients seen by the EP during information during the EHR reporting
reporting period in 2015. the EHR reporting period (or their period.
(7) Medication reconciliation—(i) authorized representatives) views, (B) Exclusion applicable under
Objective. The EP, eligible hospital or downloads or transmits their health paragraph (c)(2) of this section. Any
CAH that receives a patient from information to a third party during the eligible hospital or CAH that is located
another setting of care or provider of EHR reporting period. in a county that does not have 50
care or believes an encounter is relevant (B) Exclusion in accordance with percent or more of its housing units
performs medication reconciliation. paragraph (b)(2) of this section—(1) Any with 4Mbps broadband availability
(ii) EP measure—(A) Measure. Subject EP who neither orders nor creates any according to the latest information
to paragraph (d) of this section, the EP of the information listed for inclusion as available from the FCC on the first day
performs medication reconciliation for part of the measure in paragraph of the EHR reporting period is excluded
more than 50 percent of transitions of (e)(8)(ii)(A)(1) or (2) of this section, from paragraph (e)(8)(iii)(A)(2) of this
care in which the patient is transitioned except for ‘‘Patient name’’ and section.
into the care of the EP. ‘‘Provider’s name and office contact (C) Alternate exclusion. An eligible
(B) Exclusion in accordance with information,’’ is excluded from hospital or CAH previously scheduled
paragraph (b)(2) of this section. Any EP paragraphs (e)(8)(ii)(A)(1) and (2) of this to be in Stage 1 in 2015 may exclude the
who was not the recipient of any section. measure specified in paragraph
(e)(8)(iii)(A)(2) of this section for an (e)(10)(i)(B)(3) of this section more than (i) Does not diagnose or treat any
EHR reporting period in 2015. one time. These measures may be met disease or condition associated with or
(9) Secure messaging—(i) EP by any combination in accordance with collect relevant data that is required by
objective. Use secure electronic applicable law and practice. a specialized registry in their
messaging to communicate with (1) Immunization registry reporting. jurisdiction during the EHR reporting
patients on relevant health information. The EP is in active engagement with a period;
(ii) EP measure—(A) Measure. For an public health agency to submit (ii) Operates in a jurisdiction for
EHR reporting period— immunization data. which no specialized registry is capable
(1) In 2015, the capability for patients (2) Syndromic surveillance reporting. of accepting electronic registry
to send and receive a secure electronic The EP is in active engagement with a transactions in the specific standards
message with the EP was fully enabled public health agency to submit required to meet the CEHRT definition
during the EHR reporting period; syndromic surveillance data. at the start of the EHR reporting period;
(2) In 2016, for at least 1 patient seen (3) Specialized registry reporting. The or
by the EP during the EHR reporting EP is in active engagement to submit (iii) Operates in a jurisdiction where
period, a secure message was sent using data to specialized registry. no specialized registry for which the EP
the electronic messaging function of (C) Exclusions in accordance with is eligible has declared readiness to
CEHRT to the patient (or the patient- paragraph (b)(2) of this section. (1) Any receive electronic registry transactions
authorized representative), or in EP meeting one or more of the following at the beginning of the EHR reporting
response to a secure message sent by the criteria may be excluded from the period.
patient (or the patient-authorized immunization registry reporting (D) Alternate specifications. An EP
representative) during the EHR measure in paragraph (e)(10)(i)(B)(1) of previously scheduled to be in Stage 1 in
reporting period; and this section if the EP: 2015 may choose from measures 1
(3) In 2017, for more than 5 percent (i) Does not administer any through 3 (as specified in paragraphs
of unique patients seen by the EP during immunizations to any of the (e)(10)(i)(B)(1) through (3) of this
the EHR reporting period, a secure populations for which data is collected section) and must successfully attest to
message was sent using the electronic by his or her jurisdiction’s any one measure in accordance with
messaging function of CEHRT to the immunization registry or immunization applicable law and practice for an EHR
patient (or the patient-authorized information system during the EHR reporting period in 2015.
representative), or in response to a reporting period. (ii) Eligible hospital and CAH Public
secure message sent by the patient (or (ii) Operates in a jurisdiction for
Health and Clinical Data Registry
the patient-authorized representative) which no immunization registry or
reporting objective. (A) Objective. The
during the EHR reporting period. immunization information system is
eligible hospital or CAH is in active
(B) Exclusion in accordance with capable of accepting the specific
engagement with a public health agency
paragraph (b)(2) of this section. An EP standards required to meet the CEHRT
to submit electronic public health data
may exclude from the measure if he or definition at the start of his or her EHR
from CEHRT, except where prohibited,
she— reporting period.
(1) Has no office visits during the EHR (iii) Operates in a jurisdiction in and in accordance with applicable law
reporting period; or which no immunization registry or and practice.
(2) Conducts 50 percent or more of his immunization information system has (B) Measures. In order to meet the
or her patient encounters in a county declared readiness to receive objective under paragraph (e)(10)(ii)(A)
that does not have 50 percent or more immunization data from the EP at the of this section, an eligible hospital or
of its housing units with 4Mbps start of the EHR reporting period. CAH must choose from measures 1
broadband availability according to the (2) Any EP meeting one or more of the through 4 (as described in paragraphs
latest information available from the following criteria may be excluded from (e)(10)(ii)(B)(1) through (4) of this
Federal Communications Commission the syndromic surveillance reporting section) and must successfully attest to
on the first day of the EP’s EHR measure described in paragraph any combination of three measures.
reporting period. (e)(10)(i)(B)(2) of the section if the EP: These measures may be met by any
(C) Alternate specification. An EP (i) Is not in a category of providers combination, including meeting the
previously scheduled to be in Stage 1 in from which ambulatory syndromic measure specified in paragraph
2015 may exclude the measure specified surveillance data is collected by their (e)(10)(ii)(B)(3) of this section multiple
in paragraph (e)(9)(ii)(A) of this section jurisdiction’s syndromic surveillance times, in accordance with applicable
for an EHR reporting period in 2015. system; law and practice:
(10) Public Health Reporting—(i) EP (ii) Operates in a jurisdiction for (1) Immunization registry reporting.
Public Health Reporting—(A) Objective. which no public health agency is The eligible hospital or CAH is in active
The EP is in active engagement with a capable of receiving electronic engagement with a public health agency
public health agency to submit syndromic surveillance data from EPs in to submit immunization.
electronic public health data from the specific standards required to meet (2) Syndromic surveillance reporting.
CEHRT, except where prohibited, and in the CEHRT definition at the start of the The eligible hospital or CAH is in active
accordance with applicable law and EHR reporting period. engagement with a public health agency
practice. (iii) Operates in a jurisdiction where to submit syndromic surveillance data
(B) Measures. In order to meet the no public health agency has declared (3) Specialized registry reporting. The
objective under paragraph (e)(10)(i)(A) readiness to receive syndromic eligible hospital or CAH is in active
of this section, an EP must choose from surveillance data from EPs at the start of engagement to submit data to a
measures 1 through 3 (as specified in the EHR reporting period. specialized registry.
paragraphs (e)(10)(i)(B)(1) through (3) of (3) Any EP who meets one or more of (4) Electronic reportable laboratory
this section) and must successfully the following criteria may be excluded result reporting. The eligible hospital or
attest to any combination of two from the specialized registry reporting CAH is in active engagement with a
measures. The EP may attest to measure measure described in paragraph public health agency to submit
3 (as specified in paragraph (e)(10)(i)(B)(3) of this section if the EP: electronic reportable laboratory results.
(C) Exclusions in accordance with at the start of the EHR reporting period; 2 out of the 3 measures associated with
paragraph (c)(2) of this section. (1) Any or an objective, rather than meeting the
eligible hospital or CAH meeting one or (iii) Operates in a jurisdiction where criteria for all 3 of the measures, if the
more of the following criteria may be no specialized registry for which the EP meets all of the following
excluded from the immunization eligible hospital or CAH is eligible has requirements:
registry reporting measure specified in declared readiness to receive electronic (i) Must ensure that the objective in
paragraph (e)(10)(ii)(B)(1) of this section registry transactions at the beginning of paragraph (d) of this section includes an
if the eligible hospital or CAH: the EHR reporting period. option to meet 2 out of the 3 associated
(i) Does not administer any (4) Any eligible hospital or CAH measures.
immunizations to any of the meeting one or more of the following (ii) Meets the threshold for 2 out of
populations for which data is collected criteria may be excluded from the the 3 measures for that objective.
by its jurisdiction’s immunization electronic reportable laboratory result (iii) Attests to all 3 of the measures for
registry or immunization information reporting measure specified in that objective
system during the EHR reporting period. paragraph (d)(10)(ii)(B)(4) of this section (3) Exclusion for non-applicable
(ii) Operates in a jurisdiction for if the eligible hospital or CAH: objectives and measures. (i) An EP may
which no immunization registry or (i) Does not perform or order exclude a particular objective that
immunization information system is laboratory tests that are reportable in the includes an option for exclusion
capable of accepting the specific eligible hospital’s or CAH’s jurisdiction contained in paragraph (d) of this
standards required to meet the CEHRT during the EHR reporting period section, if the EP meets all of the
definition at the start of the EHR (ii) Operates in a jurisdiction for following requirements:
reporting period. which no public health agency that is (A) Meets the criteria in the
(iii) Operates in a jurisdiction where capable of accepting the specific ELR applicable objective that would permit
no immunization registry or standards required to meet the CEHRT the exclusion.
immunization information system has definition at the start of the EHR (B) Attests to the exclusion.
reporting period. (ii) An EP may exclude a measure
declared readiness to receive
(iii) Operates in a jurisdiction where within an objective which allows for a
immunization data from the eligible
no public health agency has declared provider to meet the threshold for 2 of
hospital or CAH at the start of the EHR
readiness to receive electronic the 3 measures, as outlined in paragraph
reporting period.
reportable laboratory results from (a)(2) of this section, in the following
(2) Any eligible hospital or CAH
eligible hospitals or CAHs at the start of manner:
meeting one or more of the following (A)(1) Meets the criteria in the
criteria may be excluded from the the EHR reporting period.
(D) Alternate specification. An applicable measure or measures that
syndromic surveillance reporting would permit the exclusion; and
measure specified in paragraph eligible hospital or CAH previously
scheduled to be in Stage 1 in 2015 may (2) Attests to the exclusion or
(e)(10)(ii)(B)(2) of this section if the exclusions.
eligible hospital or CAH: choose from measures 1 through 4 (as
specified in paragraphs (e)(10)(ii)(B)(1) (B)(1) Meets the threshold; and
(i) Does not have an emergency or (2) Attests to any remaining measure
urgent care department. through (4) of this section) and must
successfully attest to any 2 measures. or measures.
(ii) Operates in a jurisdiction for (4) Exception for Medicaid EPs who
which no public health agency is These measures may be met by any
combination, including meeting the adopt, implement or upgrade in their
capable of receiving electronic first payment year. For Medicaid EPs
syndromic surveillance data from measures specified in paragraph
(e)(10)(ii)(B)(3) of this section multiple who adopt, implement or upgrade its
eligible hospitals or CAHs in the CEHRT in their first payment year, the
specific standards required to meet the times, in accordance with applicable
law and practice. meaningful use objectives and
CEHRT definition at the start of the EHR associated measures of the Stage 3
reporting period. ■ 10. Section 495.24 is added to read as
criteria specified in paragraph (d) of this
(iii) Operates in a jurisdiction where follows: section apply beginning with the second
no public health agency has declared § 495.24 Stage 3 meaningful use payment year, and do not apply to the
readiness to receive syndromic objectives and measures for EPs, eligible first payment year.
surveillance data from eligible hospitals hospitals, and CAHs for 2018 and (b) Stage 3 criteria for eligible
or CAHs at the start of the EHR subsequent years. hospitals and CAHs—(1) General rule
reporting period. The following criteria are optional for regarding Stage 3 criteria for meaningful
(3) Any eligible hospital or CAH EPs, eligible hospitals, and CAHs in use for eligible hospitals or CAHs.
meeting one or more of the following 2017 as outlined at § 495.40(a)(2)(i)(E)(3) Except as specified in paragraphs (b)(2)
criteria may be excluded from the and (b)(2)(E)(3) and applicable for all and (3) of this section, eligible hospitals
specialized registry reporting measure EPs, eligible hospitals, and CAHs for and CAHs must meet all objectives and
described in paragraph (e)(10)(i)(B)(3) of 2018 and subsequent years: associated measures of the Stage 3
this section if the EP: (a) Stage 3 criteria for EPs—(1) criteria specified in paragraph (d) of this
(i) Does not diagnose or directly treat General rule regarding Stage 3 criteria section to meet the definition of a
any disease associated with or collect for meaningful use for EPs. Except as meaningful EHR user.
relevant data is required by a specified in paragraphs (a)(2) through (2) Selection of measures for specified
specialized registry for which the (a)(3) of this section, EPs must meet all objectives in paragraph (d) of this
eligible hospital or CAH is eligible in objectives and associated measures of section. An eligible hospital or CAH
their jurisdiction. the Stage 3 criteria specified in may meet the criteria for 2 out of the 3
(ii) Operates in a jurisdiction for paragraph (d) of this section to meet the measures associated with an objective,
which no specialized registry is capable definition of a meaningful EHR user. rather than meeting the criteria for all 3
of accepting electronic registry (2) Selection of measures for specified of the measures, if the eligible hospital
transactions in the specific standards objectives in paragraph (d) of this or CAH meets all of the following
required to meet the CEHRT definition section. An EP may meet the criteria for requirements:
(i) Must ensure that the objective in (d) Stage 3 objectives and measures (B) Measure. Subject to paragraph (c)
paragraph (d) of this section includes an for EPs, eligible hospitals, and CAHs— of this section, more than 25 percent of
option to meet 2 out of the 3 associated (1) Protect patient health information— hospital discharge medication orders for
measures. (i) EP protect patient health permissible prescriptions (for new and
(ii) Meets the threshold for 2 out of information. (A) Objective. Protect changed prescriptions) are queried for a
the 3 measures for that objective. electronic protected health information drug formulary and transmitted
(iii) Attests to all 3 of the measures for (ePHI) created or maintained by the electronically using CEHRT.
that objective. CEHRT through the implementation of (C) Exclusions in accordance with
(3) Exclusion for non-applicable appropriate technical, administrative, paragraph (b)(3) of this section. Any
objectives and measures. (i) An eligible and physical safeguards. eligible hospital or CAH that does not
hospital or CAH may exclude a (B) Measure. Conduct or review a have an internal pharmacy that can
particular objective that includes an security risk analysis in accordance accept electronic prescriptions and
option for exclusion contained in with the requirements under 45 CFR there are no pharmacies that accept
paragraph (d) of this section, if the 164.308(a)(1), including addressing the electronic prescriptions within 10 miles
eligible hospital or CAH meets all of the security (including encryption) of data at the start of the eligible hospital or
following requirements: created or maintained by CEHRT in CAH’s EHR reporting period.
(A) Meets the criteria in the accordance with requirements under 45 (3) Clinical decision support—(i) EP
applicable objective that would permit CFR 164.312(a)(2)(iv) and 45 CFR clinical decision support—(A) Objective.
the exclusion. 164.306(d)(3), implement security Implement clinical decision support
(B) Attests to the exclusion. updates as necessary, and correct (CDS) interventions focused on
(ii) An eligible hospital or CAH may identified security deficiencies as part improving performance on high-priority
exclude a measure within an objective of the provider’s risk management health conditions.
process. (B) Measures. (1) Implement five
which allows for a provider to meet the
(ii) Eligible hospital/CAH protect clinical decision support interventions
threshold for 2 of the 3 measures, as
patient health information—(A) related to four or more clinical quality
outlined in paragraph (b)(2) of this
Objective. Protect electronic protected measures at a relevant point in patient
section, in the following manner:
health information (ePHI) created or care for the entire EHR reporting period.
(A)(1) Meets the criteria in the
maintained by the CEHRT through the Absent four clinical quality measures
applicable measure or measures that
implementation of appropriate related to an EP’s scope of practice or
would permit the exclusion; and
technical, administrative, and physical patient population, the clinical decision
(2) Attests to the exclusion or safeguards. support interventions must be related to
exclusions. (B) Measure. Conduct or review a high-priority health conditions; and
(B)(1) Meets the threshold; and security risk analysis in accordance (2) The EP has enabled and
(2) Attests to any remaining measure with the requirements under 45 CFR implemented the functionality for drug-
or measures. 164.308(a)(1), including addressing the drug and drug-allergy interaction checks
(4) Exception for Medicaid eligible security (including encryption) of data for the entire EHR reporting period.
hospitals or CAHs that adopt, created or maintained by CEHRT in (C) Exclusion in accordance with
implement or upgrade in their first accordance with requirements under 45 paragraph (a)(3) of this section for
payment year. For Medicaid eligible CFR 164.312(a)(2)(iv) and 45 CFR paragraph (d)(3)(i)(B)(2) of this section.
hospitals or CAHs who adopt, 164.306(d)(3), implement security An EP who writes fewer than 100
implement or upgrade CEHRT in their updates as necessary, and correct medication orders during the EHR
first payment year, the meaningful use identified security deficiencies as part reporting period.
objectives and associated measures of of the provider’s risk management (ii) Eligible hospital/CAH clinical
the Stage 3 criteria specified in process. (2) Electronic prescribing—(i) decision support—(A) Objective.
paragraph (d) of this section apply EP electronic prescribing—(A) Implement clinical decision support
beginning with the second payment Objective. Generate and transmit (CDS) interventions focused on
year, and do not apply to the first permissible prescriptions electronically improving performance on high-priority
payment year. (eRx). health conditions.
(c) Objectives and associated (B) Measure. Subject to paragraph (c) (B) Measures. (1) Implement five
measures in paragraph (d) of this of this section, more than 60 percent of clinical decision support interventions
section that rely on measures that count all permissible prescriptions written by related to four or more clinical quality
unique patients or actions. (1) If a the EP are queried for a drug formulary measures at a relevant point in patient
measure (or associated objective) in and transmitted electronically using care for the entire EHR reporting period.
paragraph (d) of this section references CEHRT. Absent four clinical quality measures
paragraph (c) of this section, then the (C) Exclusions in accordance with related to an eligible hospital or CAH’s
measure may be calculated by reviewing paragraph (a)(3) of this section. (1) Any patient population, the clinical decision
only the actions for patients whose EP who writes fewer than 100 support interventions must be related to
records are maintained using CEHRT. A permissible prescriptions during the high-priority health conditions; and
patient’s record is maintained using EHR reporting period; or (2) The eligible hospital or CAH has
CEHRT if sufficient data was entered in (2) Any EP who does not have a enabled and implemented the
the CEHRT to allow the record to be pharmacy within its organization and functionality for drug-drug and drug-
saved, and not rejected due to there are no pharmacies that accept allergy interaction checks for the entire
incomplete data. electronic prescriptions within 10 miles EHR reporting period.
(2) If the objective and associated of the EP’s practice location at the start (4) Computerized provider order entry
measure does not reference this of his/her EHR reporting period. (CPOE).—(i) EP CPOE—(A) Objective.
paragraph (c) of this section, then the (ii) Eligible hospital/CAH electronic Use computerized provider order entry
measure must be calculated by prescribing—(A) Objective. Generate (CPOE) for medication, laboratory, and
reviewing all patient records, not just and transmit permissible discharge diagnostic imaging orders directly
those maintained using CEHRT. prescriptions electronically (eRx). entered by any licensed healthcare
professional, credentialed medical (3) More than 60 percent of diagnostic discharged from the eligible hospital or
assistant, or a medical staff member imaging orders created by authorized CAH inpatient or emergency department
credentialed to and performing the providers of the eligible hospital’s or (POS 21 or 23):
equivalent duties of a credentialed CAH’s inpatient or emergency (i) The patient (or patient-authorized
medical assistant, who can enter orders department (POS 21 or 23) during the representative) is provided timely
into the medical record per state, local, EHR reporting period are recorded using access to view online, download, and
and professional guidelines. computerized provider order entry. transmit his or her health information;
(B) Measures. Subject to paragraph (c) (5) Patient electronic access to health and
of this section— information—(i) EP patient electronic (ii) The provider ensures the patient’s
(1) More than 60 percent of access to health information—(A) health information is available for the
medication orders created by the EP Objective. The EP provides patients (or patient (or patient-authorized
during the EHR reporting period are patient-authorized representative) with representative) to access using any
recorded using computerized provider timely electronic access to their health application of their choice that is
order entry; information and patient-specific configured to meet the technical
(2) More than 60 percent of laboratory education. specifications of the API in the
orders created by the EP during the EHR (B) Measures. EPs must meet the provider’s CEHRT.
reporting period are recorded using following two measures: (2) The eligible hospital or CAH must
computerized provider order entry; and (1) For more than 80 percent of all use clinically relevant information from
(3) More than 60 percent of diagnostic unique patients seen by the EP— CEHRT to identify patient-specific
imaging orders created by the EP during (i) The patient (or the patient- educational resources and provide
the EHR reporting period are recorded authorized representative) is provided electronic access to those materials to
using computerized provider order timely access to view online, download, more than 35 percent of unique patients
entry. and transmit his or her health discharged from the eligible hospital or
(C) Exclusions in accordance with information; and CAH inpatient or emergency department
(ii) The provider ensures the patient’s (POS 21 or 23) during the EHR reporting
paragraph (a)(3) of this section. (1) For
health information is available for the period.
the measure specified in paragraph
patient (or patient-authorized (C) Exclusion in accordance with
(d)(4)(i)(B)(1) of this section, any EP
representative) to access using any paragraph (b)(3) of this section. Any
who writes fewer than 100 medication
application of their choice that is eligible hospital or CAH that is located
orders during the EHR reporting period.
configured to meet the technical in a county that does not have 50
(2) For the measure specified in
specifications of the API in the percent or more of its housing units
paragraph (d)(4)(i)(B)(2) of this section,
provider’s CEHRT. with 4Mbps broadband availability
any EP who writes fewer than 100 (2) The EP must use clinically according to the latest information
laboratory orders during the EHR relevant information from CEHRT to available from the FCC on the first day
reporting period. identify patient-specific educational of the EHR reporting period is excluded
(3) For the measure specified in resources and provide electronic access from the measures specified in
paragraph (d)(4)(i)(B)(3) of this section, to those materials to more than 35 paragraphs (d)(5)(ii)(B)(1) and (2) of this
any EP who writes fewer than 100 percent of unique patients seen by the section.
diagnostic imaging orders during the EP during the EHR reporting period. (6) Coordination of care through
EHR reporting period. (C) Exclusions in accordance with patient engagement—(i) EP
(ii) Eligible hospital and CAH CPOE— paragraph (a)(3) of this section. (1) Any coordination of care through patient
(A) Objective. Use computerized EP who has no office visits during the engagement—(A) Objective. Use CEHRT
provider order entry (CPOE) for reporting period may exclude from the to engage with patients or their
medication, laboratory, and diagnostic measures specified in paragraphs authorized representatives about the
imaging orders directly entered by any (d)(5)(i)(B)(1) and (B)(2) of this section. patient’s care.
licensed healthcare professional, (2) Any EP that conducts 50 percent (B) Measures. In accordance with
credentialed medical assistant, or a or more of his or her patient encounters paragraph (a)(2) of this section, an EP
medical staff member credentialed to in a county that does not have 50 must satisfy 2 out of the 3 following
and performing the equivalent duties of percent or more of its housing units measures in paragraphs (d)(6)(i)(B)(1),
a credentialed medical assistant; who with 4Mbps broadband availability (2), and (3) of this section except those
can enter orders into the medical record according to the latest information measures for which an EP qualifies for
per state, local, and professional available from the FCC on the first day an exclusion under paragraph (a)(3) of
guidelines. of the EHR reporting period may this section.
(B) Measures. Subject to paragraph (c) exclude from the measures specified in (1) During the EHR reporting period,
of this section— paragraphs (d)(5)(i)(B)(1) and (2) of this more than 10 percent of all unique
(1) More than 60 percent of section. patients (or their authorized
medication orders created by authorized (ii) Eligible hospital and CAH patient representatives) seen by the EP actively
providers of the eligible hospital’s or electronic access to health engage with the electronic health record
CAH’s inpatient or emergency information—(A) Objective. The eligible made accessible by the provider and
department (POS 21 or 23) during the hospital or CAH provides patients (or either of the following:
EHR reporting period are recorded using patient-authorized representative) with (i) View, download or transmit to a
computerized provider order entry; timely electronic access to their health third party their health information;
(2) More than 60 percent of laboratory information and patient-specific (ii) Access their health information
orders created by authorized providers education. through the use of an API that can be
of the eligible hospital’s or CAH’s (B) Measures. Eligible hospitals and used by applications chosen by the
inpatient or emergency department CAHs must meet the following two patient and configured to the API in the
(POS 21 or 23) during the EHR reporting measures: provider’s CEHRT; or
period are recorded using computerized (1) For more than 80 percent of all (iii) A combination of paragraphs
provider order entry; and unique patients seen by the EP or (d)(6)(i)(B)(1)(i) and (ii).
(iv) For an EHR reporting period in health record made accessible by the and incorporates summary of care
2017 only, an EP may meet a threshold provider and one of the following: information from other providers into
of 5 percent instead of 10 percent for the (i) View, download or transmit to a their EHR using the functions of
measure at paragraph (d)(6)(i)(B)(1) of third party their health information. CEHRT.
this section. (ii) Access their health information (B) Measures. In accordance with
(2) During the EHR reporting period— through the use of an API that can be paragraph (a)(2) of this section, an EP
(i) For an EHR reporting period in used by applications chosen by the must attest to all 3 measures, but must
2017 only, for more than 5 percent of all patient and configured to the API in the meet the threshold for 2 of the 3
unique patients seen by the EP during provider’s CEHRT. measures in paragraph (d)(7)(i)(B)(1),
the EHR reporting period, a secure (iii) A combination of paragraphs (2), and (3), in order to meet the
message was sent using the electronic (d)(6)(ii)(B)(1)(i) and (ii). objective. Subject to paragraph (c) of
messaging function of CEHRT to the (iv) For an EHR reporting period in this section—
patient (or their authorized 2017, an eligible hospital or CAH may (1) Measure 1. For more than 50
representatives), or in response to a meet a threshold of 5 percent instead of percent of transitions of care and
secure message sent by the patient; or 10 percent for the measure at paragraph referrals, the EP that transitions or refers
(ii) For an EHR reporting period other (d)(6)(ii)(B)(1) of this section. their patient to another setting of care or
than 2017, for more than 25 percent of (2) During the EHR reporting period— provider of care—
all unique patients seen by the EP (i) For an EHR reporting period in (i) Creates a summary of care record
during the EHR reporting period, a 2017 only, for more than 5 percent of all using CEHRT; and
secure message was sent using the unique patients discharged from the (ii) Electronically exchanges the
electronic messaging function of CEHRT eligible hospital or CAH inpatient or summary of care record.
to the patient (or their authorized emergency department (POS 21 or 23) (2) Measure 2. For more than 40
representatives), or in response to a during the EHR reporting period, a percent of transitions or referrals
secure message sent by the patient. secure message was sent using the received and patient encounters in
(3) Patient generated health data or electronic messaging function of CEHRT which the provider has never before
data from a nonclinical setting is to the patient (or their authorized encountered the patient, the EP
incorporated into the CEHRT for more representatives), or in response to a incorporates into the patient’s EHR an
than 5 percent of all unique patients secure message sent by the patient (or electronic summary of care document.
seen by the EP during the EHR reporting their authorized representatives). (3) Measure 3. For more than 80
period. (ii) For an EHR reporting period other percent of transitions or referrals
(C) Exclusions in accordance with than 2017, for more than 25 percent of received and patient encounters in
paragraph (a)(3) of this section. (1) Any all unique patients discharged from the which the provider has never before
EP who has no office visits during the eligible hospital or CAH inpatient or encountered the patient, the EP
reporting period may exclude from the emergency department (POS 21 or 23) performs clinical information
measures specified in paragraphs during the EHR reporting period, a reconciliation. The EP must implement
(d)(6)(i)(B)(1), (2), and (3) of this section. secure message was sent using the clinical information reconciliation for
(2) Any EP that conducts 50 percent electronic messaging function of CEHRT two of the following three clinical
or more of his or her patient encounters to the patient (or their authorized information sets:
in a county that does not have 50 representatives), or in response to a (i) Medication. Review of the patient’s
percent or more of its housing units secure message sent by the patient (or medication, including the name, dosage,
with 4Mbps broadband availability their authorized representatives). frequency, and route of each
according to the latest information (3) Patient generated health data or medication.
available from the FCC on the first day data from a non-clinical setting is (ii) Medication allergy. Review of the
of the EHR reporting period may incorporated into the CEHRT for more patient’s known allergic medications.
exclude from the measures specified in than 5 percent of unique patients (iii) Current problem list. Review of
paragraphs (d)(6)(i)(B)(1), (2), and (3) of discharged from the eligible hospital or the patient’s current and active
this section. CAH inpatient or emergency department diagnoses.
(ii) Eligible hospital and CAH (POS 21 or 23) during the EHR reporting (C) Exclusions in accordance with
coordination of care through patient period. paragraph (a)(3) of this section. An EP
engagement—(A) Objective. Use CEHRT (C) Exclusions under paragraph (b)(3) must be excluded when any of the
to engage with patients or their of this section. Any eligible hospital or following occur:
authorized representatives about the CAH operating in a location that does (1) Any EP who transfers a patient to
patient’s care. not have 50 percent or more of its another setting or refers a patient to
(B) Measures. In accordance with housing units with 4Mbps broadband another provider less than 100 times
paragraph (b)(2) of this section, an availability according to the latest during the EHR reporting period must
eligible hospital or CAH must satisfy 2 information available from the FCC on be excluded from paragraph
of the 3 following measures in the first day of the EHR reporting period (d)(7)(i)(B)(1) of this section.
paragraph (d)(6)(ii)(B)(1), (2), and (3) of may exclude from the measures (2) Any EP for whom the total of
this section, except those measures for specified in paragraphs (d)(6)(ii)(B)(1), transitions or referrals received and
which an eligible hospital or CAH (B)(2), and (B)(3) of this section. patient encounters in which the
qualifies for an exclusion under (7) Health information exchange—(i) provider has never before encountered
paragraph (b)(3) of this section. EP health information exchange—(A) the patient, is fewer than 100 during the
(1) During the EHR reporting period, Objective. The EP provides a summary EHR reporting period may be excluded
more than 10 percent of all unique of care record when transitioning or from paragraphs (d)(7)(i)(B)(2) and
patients (or their authorized referring their patient to another setting (d)(7)(i)(B)(3) of this section.
representatives) discharged from the of care, receives or retrieves a summary (3) Any EP that conducts 50 percent
eligible hospital or CAH inpatient or of care record upon the receipt of a or more of his or her patient encounters
emergency department (POS 21 or 23) transition or referral or upon the first in a county that does not have 50
actively engage with the electronic patient encounter with a new patient, percent or more of its housing units
with 4Mbps broadband availability and patient encounters in which the measure in paragraph (d)(8)(i)(B)(1) of
according to the latest information provider has never before encountered this section if the EP:
available from the FCC on the first day the patient, is fewer than 100 during the (i) Does not administer any
of the EHR reporting period may EHR reporting period may be excluded immunizations to any of the
exclude from the measures specified in from paragraphs (d)(7)(i)(B)(2) and (3) of populations for which data is collected
paragraphs (d)(7)(i)(B)(1) and (2) of this this section. by their jurisdiction’s immunization
section. (2) Any eligible hospital or CAH registry or immunization information
(ii) Eligible hospitals and CAHs health operating in a location that does not system during the EHR reporting period.
information exchange—(A) Objective. have 50 percent or more of its housing (ii) Operates in a jurisdiction for
The eligible hospital or CAH provides a units with 4Mbps broadband which no immunization registry or
summary of care record when availability according to the latest immunization information system is
transitioning or referring their patient to information available from the FCC on capable of accepting the specific
another setting of care, receives or the first day of the EHR reporting period standards required to meet the CEHRT
retrieves a summary of care record upon may exclude from the measures definition at the start of its EHR
the receipt of a transition or referral or specified in paragraphs (d)(7)(ii)(B)(1), reporting period.
upon the first patient encounter with a and (2) of this section. (iii) Operates in a jurisdiction where
new patient, and incorporates summary (8) Public Health and Clinical Data no immunization registry or
of care information from other providers Registry Reporting—(i) EP Public Health immunization information system has
into their EHR using the functions of and Clinical Data Registry: Reporting declared readiness to receive
CEHRT. objective—(A) Objective. The EP is in immunization data as of 6 months prior
(B) Measures. In accordance with active engagement with a public health to the start of the EHR reporting period.
paragraph (b)(2) of this section, an agency or clinical data registry to submit (2) Any EP meeting one or more of the
eligible hospital or CAH must attest to electronic public health data in a following criteria may be excluded from
all three measures, but must meet the meaningful way using CEHRT, except the syndromic surveillance reporting
threshold for 2 of the 3 measures in where prohibited, and in accordance measure described in paragraph
paragraph (d)(7)(ii)(B)(1), (2), and (3). with applicable law and practice. (d)(8)(i)(B)(2) of the section if the EP:
Subject to paragraph (c) of this section— (B) Measures. In order to meet the (i) Is not in a category of providers
(1) Measure 1. For more than 50 objective under paragraph (d)(8)(i)(A) of from which ambulatory syndromic
percent of transitions of care and this section, an EP must choose from surveillance data is collected by their
referrals, the eligible hospital or CAH measures 1 through 5 (paragraphs jurisdiction’s syndromic surveillance
that transitions or refers its patient to (d)(8)(i)(B)(1) through (d)(8)(i)(B)(5) of system.
another setting of care or provider of (ii) Operates in a jurisdiction for
this section) and must successfully
care— which no public health agency is
attest to any combination of two
(i) Creates a summary of care record capable of receiving electronic
measures. These measures may be met
using CEHRT; and syndromic surveillance data in the
by any combination, including meeting
(ii) Electronically exchanges the specific standards required to meet the
measure specified in paragraph
summary of care record. CEHRT definition at the start of the EHR
(d)(8)(i)(B)(4) or (5) of this section
(2) Measure 2. For more than 40 reporting period.
multiple times, in accordance with (iii) Operates in a jurisdiction where
percent of transitions or referrals
applicable law and practice: no public health agency has declared
received and patient encounters in
(1) Immunization registry reporting: readiness to receive syndromic
which the provider has never before
The EP is in active engagement with a surveillance data from EPs as of 6
encountered the patient, the eligible
public health agency to submit months prior to the start of the EHR
hospital or CAH incorporates into the
immunization data and receive reporting period.
patient’s EHR an electronic summary of
immunization forecasts and histories (3) Any EP meeting one or more of the
care document from a source other than
from the public health immunization following criteria may be excluded from
the provider’s EHR system.
(3) Measure 3. For more than 80 registry/immunization information the case reporting measure at paragraph
percent of transitions or referrals system (IIS). (d)(8)(i)(B)(3) of this section if the EP:
received and patient encounters in (2) Syndromic surveillance reporting. (i) Does not treat or diagnose any
which the provider has never before The EP is in active engagement with a reportable diseases for which data is
encountered the patient, the eligible public health agency to submit collected by their jurisdiction’s
hospital or CAH performs a clinical syndromic surveillance data from an reportable disease system during the
information reconciliation. The provider urgent care setting EHR reporting period.
must implement clinical information (3) Electronic case reporting. The EP (ii) Operates in a jurisdiction for
reconciliation for two of the following is in active engagement with a public which no public health agency is
three clinical information sets: health agency to submit case reporting capable of receiving electronic case
(i) Medication. Review of the patient’s of reportable conditions. reporting data in the specific standards
medication, including the name, dosage, (4) Public health registry reporting. required to meet the CEHRT definition
frequency, and route of each The EP is in active engagement with a at the start of the EHR reporting period.
medication. public health agency to submit data to (iii) Operates in a jurisdiction where
(ii) Medication allergy. Review of the public health registries. no public health agency has declared
patient’s known allergic medications. (5) Clinical data registry reporting. readiness to receive electronic case
(iii) Current problem list. Review of The EP is in active engagement to reporting data as of 6 months prior to
the patient’s current and active submit data to a clinical data registry. the start of the EHR reporting period.
diagnoses. (C) Exclusions in accordance with (4) Any EP meeting at least one of the
(C) Exclusions in accordance with paragraph (a)(3) of this section. following criteria may be excluded from
paragraph (b)(3) of this section. (1) Any (1) Any EP meeting one or more of the the public health registry reporting
eligible hospital or CAH for whom the following criteria may be excluded from measure specified in paragraph
total of transitions or referrals received the immunization registry reporting (d)(8)(i)(B)(4) of this section if the EP:
(i) Does not diagnose or directly treat receive immunization forecasts and CEHRT definition at the start of the EHR
any disease or condition associated with histories from the public health reporting period.
a public health registry in the EP’s immunization registry/immunization (iii) Operates in a jurisdiction where
jurisdiction during the EHR reporting information system (IIS). no public health agency has declared
period. (2) Syndromic surveillance reporting. readiness to receive syndromic
(ii) Operates in a jurisdiction for The eligible hospital or CAH is in active surveillance data from eligible hospitals
which no public health agency is engagement with a public health agency or CAHs as of 6 months prior to the start
capable of accepting electronic registry to submit syndromic surveillance data of the EHR reporting period.
transactions in the specific standards from an urgent care setting. (3) Any eligible hospital or CAH
required to meet the CEHRT definition (3) Case reporting. The eligible meeting one or more of the following
at the start of the EHR reporting period. hospital or CAH is in active engagement criteria may be excluded from the case
(iii) Operates in a jurisdiction where with a public health agency to submit reporting measure specified in
no public health registry for which the case reporting of reportable conditions. paragraph (d)(8)(ii)(B)(3) of this section
EP, eligible hospital, or CAH is eligible (4) Public health registry reporting. if the eligible hospital or CAH:
has declared readiness to receive The eligible hospital or CAH is in active (i) Does not treat or diagnose any
electronic registry transactions as of 6 engagement with a public health agency reportable diseases for which data is
months prior to the start of the EHR to submit data to public health collected by their jurisdiction’s
reporting period. registries. reportable disease system during the
(5) Any EP meeting at least one of the (5) Clinical data registry reporting. EHR reporting period.
following criteria may be excluded from The eligible hospital or CAH is in active (ii) Operates in a jurisdiction for
the clinical data registry reporting engagement to submit data to a clinical which no public health agency is
measure specified in paragraph data registry. capable of receiving electronic case
(d)(8)(i)(B)(5) of this section if the EP: (6) Electronic reportable laboratory reporting data in the specific standards
(i) Does not diagnose or directly treat
result reporting. The eligible hospital or required to meet the CEHRT definition
any disease or condition associated with
CAH is in active engagement with a at the start of their EHR reporting
a clinical data registry in their
public health agency to submit period.
jurisdiction during the EHR reporting
electronic reportable laboratory results. (iii) Operates in a jurisdiction where
period.
(ii) Operates in a jurisdiction for (C) Exclusions in accordance with no public health agency has declared
which no clinical data registry is paragraph (b)(3) of this section. (1) Any readiness to receive electronic case
capable of accepting electronic registry eligible hospital or CAH meeting one or reporting data as of 6 months prior to
transactions in the specific standards more of the following criteria may be the start of the EHR reporting period.
required to meet the CEHRT definition excluded from to the immunization (4) Any eligible hospital or CAH
at the start of the EHR reporting period. registry reporting measure specified in meeting at least one of the following
(iii) Operates in a jurisdiction where paragraph (d)(8)(ii)(B)(1) of this section criteria may be excluded from the
no clinical data registry for which the if the eligible hospital or CAH: public health registry reporting measure
EP, eligible hospital, or CAH is eligible (i) Does not administer any specified in paragraph (d)(8)(ii)(B)(4) of
has declared readiness to receive immunizations to any of the this section if the eligible hospital or
electronic registry transactions as of 6 populations for which data is collected CAH:
months prior to the start of the EHR by its jurisdiction’s immunization (i) Does not diagnose or directly treat
reporting period. registry or immunization information any disease or condition associated with
(ii) Eligible hospital and CAH Public system during the EHR reporting period. a public health registry in its
Health and Clinical Data Registry: (ii) Operates in a jurisdiction for jurisdiction during the EHR reporting
Reporting objective—(A) Objective. The which no immunization registry or period.
eligible hospital or CAH is in active immunization information system is (ii) Operates in a jurisdiction for
engagement with a public health agency capable of accepting the specific which no public health agency is
(PHA) or clinical data registry (CDR) to standards required to meet the CEHRT capable of accepting electronic registry
submit electronic public health data in definition at the start of the EHR transactions in the specific standards
a meaningful way using CEHRT, except reporting period. required to meet the CEHRT definition
where prohibited, and in accordance (iii) Operates in a jurisdiction where at the start of the EHR reporting period.
with applicable law and practice. no immunization registry or (iii) Operates in a jurisdiction where
(B) Measures. In order to meet the immunization information system has no public health registry for which the
objective under paragraph (d)(8)(ii)(A) declared readiness to receive EP, eligible hospital, or CAH is eligible
of this section, an eligible hospital or immunization data as of 6 months prior has declared readiness to receive
CAH must choose from measures 1 to the start of the EHR reporting period. electronic registry transactions as of 6
through 6 (as described in paragraphs (2) Any eligible hospital or CAH months prior to the start of the EHR
(d)(8)(ii)(B)(1) through (6) of this meeting one or more of the following reporting period.
section) and must successfully attest to criteria may be excluded from the (5) Any eligible hospital or CAH
any combination of four measures. syndromic surveillance reporting meeting at least one of the following
These measures may be met by any measure specified in paragraph criteria may be excluded from the
combination, including meeting the (d)(8)(ii)(B)(2) of this section if the clinical data registry reporting measure
measure specified in paragraph eligible hospital or CAH: specified in paragraph (d)(8)(ii)(B)(5) of

(d)(8)(ii)(B)(4) or (5) of this section (i) Does not have an emergency or this section if the eligible hospital or
multiple times, in accordance with urgent care department. CAH:
applicable law and practice: (ii) Operates in a jurisdiction for (i) Does not diagnose or directly treat
(1) Immunization registry reporting. which no public health agency is any disease or condition associated with
The eligible hospital or CAH is in active capable of receiving electronic a clinical data registry in their
engagement with a public health agency syndromic surveillance data in the jurisdiction during the EHR reporting
to submit immunization data and specific standards required to meet the period.
(ii) Operates in a jurisdiction for § 495.6(f) and § 495.6(g)’’ and adding in § 495.310 [Amended]
which no clinical data registry is its place the cross-reference ‘‘under ■ 12. Section 495.310(d) is amended by
capable of accepting electronic registry § 495.20 or § 495.24’’. removing the reference ‘‘§ 495.10 of this
transactions in the specific standards ■ i. Redesignating paragraph (b)(1)(iv) as
part’’ and adding in its place the
required to meet the CEHRT definition paragraph (b)(1)(iii). reference ‘‘§ 495.60’’.
at the start of the EHR reporting period. j. In newly redesignated paragraph
■ 13. Section 495.316 is amended by:
(iii) Operates in a jurisdiction where (b)(1)(iii), by removing the cross-
■ a. Revising paragraph (c) introductory
no clinical data registry for which the reference ‘‘in § 495.6 and § 495.8 of this
text.
EP, eligible hospital, or CAH is eligible subpart’’ and adding in its place the
■ b. In paragraphs (d)(1)(i) and (iii)
has declared readiness to receive cross-reference ‘‘in § 495.20 or § 495.24
removing the phrase ‘‘The number, type,
electronic registry transactions as of 6 and § 495.40’’.
■ k. Revising paragraph (b)(2)(i)(B).
and practice location(s) of providers’’
months prior to the start of the EHR and adding in its place ‘‘The number
reporting period. ■ l. In paragraph (b)(2)(i)(D) by
removing the cross-reference ‘‘under and type of providers’’.
(6) Any eligible hospital or CAH ■ c. Adding paragraphs (d)(2)(iii), (f),
meeting one or more of the following § 495.6(b)(4) or (i)(3)’’ and adding in its
place the cross-reference ‘‘in (g), and (h) to read as follows:
criteria may be excluded from the
electronic reportable laboratory result § 495.20(b)(4) or (h)(3)’’. § 495.316 State monitoring and reporting
■ m. Adding paragraphs (b)(2)(i)(E), (F),
reporting measure specified in regarding activities required to receive an
paragraph (d)(8)(ii)(B)(6) of this section and (G). incentive payment.
if the eligible hospital or CAH: The revisions and additions read as
* * * * *
(i) Does not perform or order follows:
(c) Subject to § 495.332 and § 495.352,
laboratory tests that are reportable in its § 495.40 Demonstration of meaningful use the State is required to submit to CMS
jurisdiction during the EHR reporting criteria. annual reports, in the manner
period. (a) * * * prescribed by CMS, on the following:
(ii) Operates in a jurisdiction for (2) * * * * * * * *
which no public health agency that is (i) * * * (d) * * *
capable of accepting the specific ELR (B) For calendar years before 2015, (2) * * *
standards required to meet the CEHRT satisfied the required objectives and (iii) Subject to § 495.332, the State
definition at the start of the EHR associated measures under § 495.20 for may propose a revised definition for
reporting period. the EP’s stage of meaningful use. Stage 3 of meaningful use of CEHRT,
(iii) Operates in a jurisdiction where * * * * * subject to CMS prior approval, but only
no public health agency has declared (E) For CYs 2015 through 2017, with respect to the public health and
readiness to receive electronic satisfied the required objectives and clinical data registry reporting objective
reportable laboratory results from an associated measures under § 495.22(e) described in § 495.24(d)(8).
eligible hospital or CAH as of 6 months for meaningful use.
prior to the start of the EHR reporting * * * * *
(F) For CY 2017 only, an EP may
period. (f) Each State must submit to CMS the
satisfy either of the following objectives
annual report described in paragraph (c)
■ 11. Newly redesignated § 495.40 is and measures for meaningful use:
(1) Objectives and measures specified of this section within 60 days of the end
amended by: of the second quarter of the Federal
■ a. In paragraph (a) introductory text, in § 495.22 (e); or
(2) Objectives and measures specified fiscal year.
by removing the cross-reference ‘‘under
in § 495.24 (d). (g) The State must, on a quarterly
§ 495.6 of this subpart’’ and adding in
basis and in the manner prescribed by
its place the cross-reference ‘‘under * * * * *
(b) * * * CMS, submit a report(s) on the
§ 495.20 or § 495.24’’.
■ b. In paragraph (a)(1)(i)(B), by (2) * * * following:
removing the cross-reference ‘‘under (i) * * * (1) The State and payment year to
§ 495.6(d) and § 495.6(e) of this subpart’’ (B) For fiscal years before 2015, which the quarterly report pertains.
and adding in its place the cross- satisfied the required objectives and (2) Subject to paragraph (h)(2) of this
reference ‘‘under § 495.20 or § 495.24’’. associated measures under § 495.20 for section, provider-level attestation data
■ c. In paragraph (a)(1)(iii), by removing the eligible hospital or CAH’s stage of for each EP and eligible hospital that
the cross-reference ‘‘in § 495.6 and meaningful use. attests to demonstrating meaningful use
§ 495.8 of this subpart’’ and adding in * * * * * for each payment year beginning with
its place the cross-reference ‘‘in § 495.20 (E) For CYs 2015 through 2017, 2013.
or § 495.24 and § 495.40’’. satisfied the required objectives and (h)(1) Subject to paragraph (h)(2) of
■ d. Revising paragraph (a)(2)(i)(B). associated measures under § 495.22(e) this section, the quarterly report
■ e. In paragraph (a)(2)(i)(D) by for meaningful use. described in paragraph (g) of this
removing the cross-reference ‘‘under (F) For CY 2017 only, an eligible section must include the following for
§ 495.6(a)(4) or (h)(3)’’ and adding in its hospital or CAH may satisfy either of each EP and eligible hospital:
place the cross-reference ‘‘in the following objectives and measures (i) The payment year number.
§ 495.20(a)(4) or (h)(3)’’. for meaningful use: (ii) The provider’s National Provider
■ f. Adding paragraphs (a)(2)(i)(E) and (1) Objectives and measures specified Identifier or CCN, as appropriate.
(F). at § 495.22(e); or (iii) Attestation submission date.

■ g. In paragraph (a)(2)(iv), by removing (2) Objectives and measures specified (iv) The state qualification.
the cross-reference ‘‘in § 495.6 and at § 495.24(d). (v) The state qualification date, which
§ 495.8 of this subpart’’ and adding in (G) For CY 2018 and subsequent is the beginning date of the provider’s
its place the cross-reference ‘‘in § 495.20 years, satisfied the required objectives EHR reporting period for which it
or § 495.24 and § 495.40’’. and associated measures under demonstrated meaningful use.
■ h. In paragraph (b)(1)(i)(B), by § 495.24(d) for meaningful use. (vi) The State disqualification, if
removing the cross-reference ’’ under * * * * * applicable.
(vii) The State disqualification date, progress report, in the manner (7) The number and type of providers
which is the beginning date of the prescribed by HHS, documenting that qualified for an incentive payment
provider’s EHR reporting period to specific implementation and oversight on the basis of having demonstrated that
which the provider attested but for activities performed during the quarter, they are meaningful users of CEHRT and
which it did not demonstrate including progress in implementing the the amounts of incentive payments.
meaningful use, if applicable. State’s approved Medicaid HIT plan. (c) States must submit the quarterly
(2) The quarterly report described in (b) The quarterly progress reports progress reports described in this
paragraph (g) of this section is not must include, but need not be limited to
section within 30 days after the end of
required to include information on EPs providing, updates on the following:
each federal fiscal year quarter.
who are eligible for the Medicaid EHR (1) State system implementation
dates. Dated: September 23, 2015.
incentive program on the basis of being
(2) Provider outreach. Andrew M. Slavitt,
a nurse practitioner, certified nurse- (3) Auditing.
midwife or physician assistant. Acting Administrator, Centers for Medicare
(4) State-specific State Medicaid HIT & Medicaid Services.
14. Section 495.352 is revised to read Plan tasks.
Dated: September 25, 2015.
as follows: (5) State staffing levels and changes.
(6) The number and type of providers Sylvia M. Burwell,
§ 495.352 Reporting requirements. that qualified for an incentive payment Secretary, Department of Health and Human
(a) Beginning with the first quarter of on the basis of having adopted, Services.
calendar year 2016, each State must implemented or upgraded CEHRT and [FR Doc. 2015–25595 Filed 10–6–15; 4:15 pm]
submit to HHS on a quarterly basis a the amounts of incentive payments. BILLING CODE 4120–01–P

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Department of Health and Human Services

paragraphs (1)(ii)(C)(3), (1)(iii), Boulevard, Baltimore, MD 21244–1850. Technology

I. Executive Summary and Background Locations 7. Electronic Reporting of CQMs

we have established a clear vision of 16734) included establishing a single set

c. Meaningful Use Requirements, stage of the meaningful use framework,

TABLE 1—STAGE OF MEANINGFUL USE CRITERIA BY FIRST YEAR

Current section designation Proposed section redesignation

§ 495.6—Objectives and Measures .......................................................... § 495.20—Objectives and Measures Prior to 2015.

TABLE 2—OBJECTIVES AND MEASURES IDENTIFIED BY PROVIDER TYPE

Provider type Objectives and measures

TABLE 3—CURRENT STAGE STRUCTURE, RETAINED OBJECTIVES, AND PROPOSED STRUCTURE

EP .......................... 13 core objectives ................................. 6 core objectives ................................... 9 core objectives.

Current Stage 2 structure Retained objectives Proposed structure

4 The National Quality Strategy: ‘‘HHS National

Strategy for Quality Improvement in Health Care’’

outpatient settings and should be exclusion criteria. The policy is fewer

least one medication order entered 77 FR 54035, the use of electronic

electronically prescribed either for all Comment: A number of providers

promote interoperability, an expanded common referrals may be to other provider.

Improve Health Outcomes for Diabetes’’ NY interoperability between assistive

Rehabilitation Act of 1973, or Section information. and instructions.

Health Registry or Clinical Data Registry

Measure 1—Immunization Registry Reporting ................................................................................ 1 1

cific Education menu objective.

distinguishing between prescriptions for formulary and transmitted electronically

Measure 1—Immunization Registry Reporting ........................................................................................................ 1 1

Measure 6—Electronic Reportable Laboratory Results .......................................................................................... N/A 1

Stage 2 and may pose a problem for Certification Criteria. cqi/x-pub/nqrn-what-is-clinical-data-registry.pdf.

Measure 1—Immunization Registry Reporting ........................................................................................................ 1 1

third party their health information subject

Measure 3: Patient—generated health N/A ...................................... § 170.315(e)(3) (Patient

message was sent using the elec-

Measure 3: Patient-generated health N/A ................................ § 170.315(e)(3) (Patient N/A.

Measure 6: Electronic Reportable § 170.314(f)(4) (Inpatient § 170.315(f)(3) (Trans- N/A.

Measure 3: Electronic Case Reporting ................................................. § 170.315(f)(5) (Transmission to

participation) hospitals and CAHs). Medicare EHR Incentive Programs, or

icaid. icaid. icaid. icaid.

EHR reporting period for a payment Applies to avoid a payment adjustment

EHR reporting period for a payment Applies to avoid a payment adjustment in FY

EHR reporting period for a payment Applies to avoid a payment adjustment in FY

EHR reporting period for a payment Applies to avoid a payment adjustment in FY

21 Mean hourly rate for lawyers based on May

TABLE 21—BURDEN ESTIMATES STAGE 3—§ 495.24

medical record per medical record per using CPOE.

TABLE 21—BURDEN ESTIMATES STAGE 3—§ 495.24—Continued

a secure message sent by the pa-

TABLE 21—BURDEN ESTIMATES STAGE 3—§ 495.24—Continued

Measure 3: Patient-generated health

pital, or CAH is in active engage-

TABLE 21—BURDEN ESTIMATES STAGE 3—§ 495.24—Continued

Measure 3—Electronic Case Report-

eligible hospital or CAH is in ac-

TABLE 21—BURDEN ESTIMATES STAGE 3—§ 495.24—Continued

Eligible Hospitals and CAHs must

Objectives and Measures

(eRx). transmitted electronically using

TABLE 22—BURDEN ESTIMATES—§ 495.22—Continued

TABLE 22—BURDEN ESTIMATES—§ 495.22—Continued

Provide patients the 1. More than 50 percent of all ....................................... 10 minutes.

TABLE 22—BURDEN ESTIMATES—§ 495.22—Continued

The EP is in active en- ....................................... Stage 1 EPs in 2015 must meet at

TABLE 23—REDUCTION IN REPORTING BURDEN HOURS