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Wednesday,

July 28, 2010

Part II

Department of
Health and Human
Services
Centers for Medicare & Medicaid Services

42 CFR Parts 412, 413, 422 et al.


Medicare and Medicaid Programs;
Electronic Health Record Incentive
Program; Final Rule
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44314 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

DEPARTMENT OF HEALTH AND Acronyms PIHP Prepaid Inpatient Health Plan


HUMAN SERVICES POS Place of Service
ARRA American Recovery and PPO Preferred Provider Organization
Reinvestment Act of 2009 PQRI Physician Quality Reporting Initiative
Centers for Medicare & Medicaid AAC Average Allowable Cost (of certified PSO Provider Sponsored Organization
Services EHR technology) RHC Rural Health Clinic
AIU Adopt, Implement, Upgrade (certified RHQDAPU Reporting Hospital Quality Data
42 CFR Parts 412, 413, 422, and 495 EHR technology) for Annual Payment Update
CAH Critical Access Hospital RPPO Regional Preferred Provider
[CMS–0033–F] CAHPS Consumer Assessment of Organization
Healthcare Providers and Systems SMHP State Medicaid Health Information
RIN 0938–AP78 CCN CMS Certification Number Technology Plan
CFR Code of Federal Regulations TIN Tax Identification Number
Medicare and Medicaid Programs; CHIP Children’s Health Insurance Program
Electronic Health Record Incentive CHIPRA Children’s Health Insurance Table of Contents
Program Program Reauthorization Act of 2009
CMS Centers for Medicare & Medicaid I. Background
AGENCY: Centers for Medicare & Services A. Overview of the HITECH Programs
CPOE Computerized Physician Order Entry Created by the American Recovery and
Medicaid Services (CMS), HHS.
CY Calendar Year Reinvestment Act of 2009
ACTION: Final rule. B. Statutory Basis for the Medicare &
EHR Electronic Health Record
EP Eligible Professional Medicaid EHR Incentive Programs
SUMMARY: This final rule implements II. Provisions of the Proposed Regulations
EPO Exclusive Provider Organization
the provisions of the American FACA Federal Advisory Committee Act and Response and Analysis of Comments
Recovery and Reinvestment Act of 2009 FFP Federal Financial Participation A. Definitions Across the Medicare FFS,
(ARRA) (Pub. L. 111–5) that provide FFY Federal Fiscal Year Medicare Advantage, and Medicaid
incentive payments to eligible FFS Fee-For-Service Programs
professionals (EPs), eligible hospitals FQHC Federally Qualified Health Center 1. Definitions
FTE Full-Time Equivalent a. Certified Electronic Health Record (EHR)
and critical access hospitals (CAHs) Technology
participating in Medicare and Medicaid FY Fiscal Year
HEDIS Healthcare Effectiveness Data and b. Qualified Electronic Health Record
programs that adopt and successfully c. Payment Year
Information Set
demonstrate meaningful use of certified HHS Department of Health and Human d. First, Second, Third, Fourth, Fifth and
electronic health record (EHR) Services Sixth Payment Year
technology. This final rule specifies— HIE Health Information Exchange e. EHR Reporting Period
the initial criteria EPs, eligible hospitals, HIT Health Information Technology f. Meaningful EHR User
and CAHs must meet in order to qualify HIPAA Health Insurance Portability and 2. Definition of Meaningful Use
Accountability Act of 1996 a. Considerations in Defining Meaningful
for an incentive payment; calculation of Use
the incentive payment amounts; HITECH Health Information Technology for
Economic and Clinical Health Act b. Common Definition of Meaningful Use
payment adjustments under Medicare Under Medicare and Medicaid
HMO Health Maintenance Organization
for covered professional services and HOS Health Outcomes Survey c. Stage 1 Criteria for Meaningful Use
inpatient hospital services provided by HPSA Health Professional Shortage Area 3. Sections 4101(a) and 4102(a)(1) of
EPs, eligible hospitals and CAHs failing HRSA Health Resource and Services HITECH Act: Reporting on Clinical
to demonstrate meaningful use of Administration Quality Measures Using EHR by EPs,
certified EHR technology; and other IAPD Implementation Advance Planning Eligible Hospitals and CAHs
Document a. General
program participation requirements.
ICR Information Collection Requirement b. Requirements for the Submission of
Also, the Office of the National Clinical Quality Measures by EPs,
Coordinator for Health Information IHS Indian Health Service
IPA Independent Practice Association Eligible Hospitals and CAHs
Technology (ONC) will be issuing a IT Information Technology c. Statutory Requirements and Other
closely related final rule that specifies MA Medicare Advantage Considerations for the Selection of
the Secretary’s adoption of an initial set MAC Medicare Administrative Contractor Clinical Quality Measures for Electronic
of standards, implementation, MAO Medicare Advantage Organization Submission by EPs, Eligible Hospitals
specifications, and certification criteria MCO Managed Care Organization and CAHs
for electronic health records. ONC has MITA Medicaid Information Technology (1) Statutory Requirements for the
Architecture Selection of Clinical Quality Measures
also issued a separate final rule on the
MMIS Medicaid Management Information for Electronic Submission by EPs,
establishment of certification programs Eligible Hospitals and CAHs
Systems
for health information technology. (2) Other Considerations for the Selection
MSA Medical Savings Account
DATES: Effective Date: These regulations NAAC Net Average Allowable Cost (of of Clinical Quality Measures for
are effective on September 27, 2010. certified EHR technology) Electronic Submission by EPs, Eligible
NCQA National Committee for Quality Hospitals and CAHs
FOR FURTHER INFORMATION CONTACT:
Assurance d. Clinical Quality Measures for EPs
Elizabeth Holland, (410) 786–1309, EHR e. Clinical Quality Measures Reporting
NCVHS National Committee on Vital and
incentive program issues. Health Statistics Criteria for EPs
Edward Gendron, (410) 786–1064, NPI National Provider Identifier f. Clinical Quality Measures for Electronic
Medicaid incentive payment issues. NPRM Notice of Proposed Rulemaking Submission by Eligible Hospitals
Jim Hart, (410) 786–9520, Medicare fee ONC Office of the National Coordinator for g. Potential Measures for EPs, Eligible
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for service payment issues. Health Information Technology Hospitals and CAHs in Stage 2 and
Bob Kuhl or Susan Burris, (410) 786– PAHP Prepaid Ambulatory Health Plan Subsequent Years
5594, Medicare CAH payment and PAPD Planning Advance Planning h. Reporting Method for Clinical Quality
Document Measures for 2011 and Beginning With
charity care issues.
PFFS Private Fee-For-Service the 2012 Payment Years
Frank Szeflinski, (303) 844–7119, PHO Physician Hospital Organization (1) Reporting Method for 2011 Payment
Medicare Advantage issues. PHS Public Health Service Year
SUPPLEMENTARY INFORMATION: PHSA Public Health Service Act (2) Reporting Method Beginning in 2012

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Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations 44315

i. Alternative Reporting Methods for 4. Timeframe for Payment 9. Financial Oversight, Program Integrity
Clinical Quality Measures 5. Avoiding Duplicate Payment and Provider Appeals
j. Reporting Period for Reporting Clinical 6. Meaningful User Attestation III. Collection of Information Requirements
Quality Measures 7. Posting Information on the CMS Web A. ICRs Regarding Demonstration of
4. Demonstration of Meaningful Use site Meaningful Use Criteria (§ 495.8)
a. Common Methods of Demonstration in 8. Limitation on Review B. ICRs Regarding Participation
Medicare and Medicaid 9. Conforming Changes Requirements for EPs, Eligible Hospitals,
b. Methods for Demonstration of the Stage 10. Payment Adjustment and Future and Qualifying CAHs (§ 495.10)
1 Criteria of Meaningful Use Rulemaking C. ICRs Regarding Identification of
5. Data Collection for Online Posting, D. Medicaid Incentives Qualifying MA Organizations, MA–EPs
Program Coordination, and Accurate 1. Overview of Health Information and MA-Affiliated Eligible Hospitals
Payments Technology in Medicaid (§ 495.202)
a. Online Posting 2. General Medicaid Provisions D. ICRs Regarding Incentive Payments to
b. Program Election Between Medicare 3. Identification of Qualifying Medicaid Qualifying MA Organizations for MA–
FFS/MA and Medicaid for EPs EPs and Eligible Hospitals EPs and Hospitals (§ 495.204)
c. Data To Be Collected a. Overview E. ICRs Regarding Meaningful User
6. Hospital-Based Eligible Professionals b. Program Participation Attestation (§ 495.210)
7. Interaction With Other Programs 1. Acute Care Hospitals F. ICRs Regarding Incentive Payments to
B. Medicare Fee-for-Service Incentives 2. Children’s Hospitals Qualifying MA Organizations for MA-
1. Incentive Payments for Eligible c. Medicaid Professionals Program Eligible Professionals and Hospitals
Professionals Eligibility (§ 495.220)
a. Definitions d. Calculating Patient Volume G. ICRs Regarding Process for Payments
b. Incentive Payment Limits Requirements (§ 495.312)
c. Increase in Incentive Payment for EPs e. Entities Promoting the Adoption of H. ICRs Regarding Activities Required To
Who Predominantly Furnish Services in Certified EHR Technology Receive an Incentive Payment
a Geographic Health Professional 4. Computation of Amount Payable to (§ 495.314)
Shortage Area Qualifying Medicaid EPs and Eligible I. ICRs Regarding State Monitoring and
d. Form and Timing of Payment Hospitals Reporting Regarding Activities Required
e. Payment Adjustment Effective in CY a. Payment Methodology for EPs To Receive an Incentive Payment
2015 and Subsequent Years for EPs Who (1) General Overview (§ 495.316)
Are Not Meaningful Users of Certified (2) Average Allowable Costs J. ICRs Regarding State Responsibilities for
(3) Net Average Allowable Costs Receiving FFP (§ 495.318)
EHR Technology
(4) Payments for Medicaid Eligible K. ICRs Regarding Prior Approval
2. Incentive Payments for Hospitals
Professionals Conditions (§ 495.324)
a. Definition of Eligible Hospital for
(5) Basis for Medicaid EHR Incentive L. ICRs Regarding Termination of Federal
Medicare
Program First Payment Year and Financial Participation (FFP) for Failure
b. Incentive Payment Calculation for Subsequent Payment Years
Eligible Hospitals To Provide Access to Information
(i) Medicaid EP Who Begins Adopting, (§ 495.330)
c. Medicare Share Implementing or Upgrading Certified
d. Charity Care M. ICRs Regarding State Medicaid Agency
EHR Technology in the First Year and Medicaid EP and Hospital Activities
e. Transition Factor (ii) Medicaid EP Who Has Already
f. Duration and Timing of Incentive (§ 495.332 Through § 495.338)
Adopted, Implemented or Upgraded N. ICRs Regarding Access to Systems and
Payments Certified EHR Technology and
g. Incentive Payment Adjustment Effective Records (§ 495.342)
Meaningfully Uses EHR Technology O. ICRs Regarding Procurement Standards
in Federal FY 2015 and Subsequent b. Payment Methodology for Eligible
Years for Eligible Hospitals Who Are Not (§ 495.344)
Hospitals P. ICRs Regarding State Medicaid Agency
Meaningful EHR Users c. Alternative and Optional Early State
3. Incentive Payments for Critical Access Attestations (§ 495.346)
Implementation To Make Incentive Q. ICRs Regarding Reporting Requirements
Hospitals Payments for Adopting, Implementing or
a. Definition of CAHs for Medicare (§ 495.348)
Upgrading Certified EHR Technology
b. Current Medicare Payment of R. ICRs Regarding Retroactive Approval of
d. Process for Making and Receiving
Reasonable Cost for CAHs FFP With an Effective Date of February
Medicaid Incentive Payments
c. Changes Made by the HITECH Act 18, 2009 (§ 495.358)
e. Avoiding Duplicate Payment
d. Incentive Payment Calculation for CAHs S. ICRs Regarding Financial Oversight and
f. Flexibility To Alternate Between
e. Reduction of Reasonable Cost Payment Monitoring Expenditures (§ 495.362)
Medicare and Medicaid EHR Incentive
in FY 2015 and Subsequent Years for T. ICRs Regarding Appeals Process for a
Programs One Time
CAHs That Are Not Meaningful EHR Medicaid Provider Receiving Electronic
g. One State Selection
Users 5. Single Provider Election Repository and Health Record Incentive Payments
4. Process for Making Incentive Payments State Data Collection (§ 495.366)
Under the Medicare FFS Program 6. Collection of Information Related to the IV. Regulatory Impact Analysis
a. Incentive Payments to EPs Eligible Professional’s National Provider A. Overall Impact
b. Incentive Payments to Eligible Hospitals Identifier (NPI) and the Tax B. Regulatory Flexibility Analysis
c. Incentive Payments to CAHs Identification Number (TIN) C. Small Rural Hospitals
d. Payment Accounting Under Medicare 7. Activities Required To Receive Incentive D. Unfunded Mandates Reform Act
C. Medicare Advantage Organization Payments E. Federalism
Incentive Payments a. General Overview F. Anticipated Effects
1. Definitions b. Definitions Related to Certified EHR G. HITECH Impact Analysis
a. Qualifying MA Organization Technology and Adopting, Implementing H. Accounting Statement
b. Qualifying MA Eligible Professional or Upgrading Such Technology I. Background
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c. Qualifying MA-Affiliated Eligible (1) Certified EHR Technology


Hospital (2) Adopting, Implementing or Upgrading A. Overview of the HITECH Programs
2. Identification of Qualifying MA c. Other General Terminology Created by the American Recovery and
Organizations, MA EPs, and MA- d. Quality Measures Reinvestment Act of 2009
Affiliated Eligible Hospitals 8. Overview of Conditions for States To
3. Computation of Incentives to Qualifying Receive Federal Financial Participation The American Recovery and
MA Organizations for MA EPs and (FFP) for Incentive Payments and Reinvestment Act of 2009 (ARRA) (Pub.
Hospitals Implementation Funding L. 111–5) was enacted on February 17,

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2009. Title IV of Division B of ARRA specifications, and certification criteria of 99 percent for 2015 (or, in the case
amends Titles XVIII and XIX of the elsewhere in this issue of the Federal of an eligible professional who was
Social Security Act (the Act) by Register. subject to the application of the
establishing incentive payments to In a related proposed rule published payment adjustment under section
eligible professionals (EPs), eligible on March 10, 2010, (75 FR 11328) 1848(a)(5) of the Act, 98 percent for
hospitals, and critical access hospitals entitled ‘‘Proposed Establishment of 2014), 98 percent for 2016, and 97
(CAHs), and Medicare Advantage Certification Programs for Health percent for 2017 and each subsequent
Organizations to promote the adoption Information Technology’’ ONC proposed year. Section 4101(c) of the HITECH Act
and meaningful use of interoperable the establishment of two certification adds a new subsection (l) to section
health information technology (HIT) and programs for purpose of testing and 1853 of the Act to provide incentive
qualified electronic health records certifying health information payments to certain Medicare
(EHRs). These provisions, together with technology. In the June 24, 2010 Federal Advantage (MA) organizations for their
Title XIII of Division A of ARRA, may Register (75 FR 36157), ONC published affiliated EPs who meaningfully use
be cited as the ‘‘Health Information a final rule to establish a temporary certified EHR technology and meet
Technology for Economic and Clinical certification program whereby the certain other requirements, and requires
Health Act’’ or the ‘‘HITECH Act.’’ These National Coordinator would authorize a downward adjustment to Medicare
incentive payments are part of a broader organizations to test and certify payments to certain MA organizations
effort under the HITECH Act to complete EHRs and EHR Modules, and for professional services provided by
accelerate the adoption of HIT and plans to issue a separate final rule to any of their affiliated EPs who are not
utilization of qualified EHRs. establish a permanent certification meaningful users of certified EHR
On January 13, 2010 we published a program to replace the temporary technology, beginning in 2015. Section
proposed rule (75 FR 1844), entitled certification program. Specifically, this 1853(l) of the Act also requires us to
‘‘Medicare and Medicaid Programs; final rule will ensure that the definition establish a process that ensures that
Electronic Health Record Incentive of meaningful use of certified EHR there are no duplicate payments made
Program’’ to implement the provisions of technology does not require EPs, eligible to MA organizations under section
ARRA that provide incentive payments hospitals, and CAHs to perform 1853(l) of the Act and to their affiliated
to EPs, eligible hospitals, and CAHs functions for which standards have not EPs under the FFS EHR incentive
participating in Medicare and Medicaid been recognized or established. program established under section
programs that adopt and successfully Similarly, the functionality of certified 1848(o)(1)(A) of the Act.
demonstrate meaningful use of ‘‘certified EHR technology should enable and
EHR technology,’’ and incentive advance the definition of meaningful Section 4102(a) of the HITECH Act
payments to certain Medicare use. adds a new subsection (n) to section
Advantage Organizations for their We urge those interested in this final 1886 of the Act. Section 1886(n) of the
affiliated EPs and eligible hospitals that rule to also review the ONC interim Act establishes incentives payments for
meaningfully use certified EHR final rule on standards and demonstration of meaningful use of
technology. Through this final rule, we implementation specifications for certified EHR technology by subsection
are developing the incentive programs certified EHR technology and the related (d) hospitals, as defined under section
which are outlined in Division B, Title final rule as well as the final rule on the 1886(d)(1)(B) of the Act, participating in
IV of the HITECH Act. This final rule establishment of a temporary the Medicare FFS program beginning in
sets forth the definition of ‘‘meaningful certification program. Readers may also Federal fiscal year (FFY) 2011. Section
use of certified EHR technology.’’ visit http://healthit.hhs.gov and http:// 4102(b)(1) of the HITECH Act amends
Section 13101 of the HITECH Act www.cms.hhs.gov/Recovery/11_ section 1886(b)(3)(B) of the Act to
adds a new section 3000 to the Public HealthIT.asp#TopOfPage for more provide that, beginning in FY 2015,
Health Service Act (PHSA), which information on the efforts at the subsection (d) hospitals that are not
defines ‘‘certified EHR technology’’ as a Department of Health and Human meaningful users of certified EHR
qualified EHR that has been properly Services (HHS) to advance HIT technology will receive a reduced
certified as meeting standards adopted initiatives. annual payment update for their
under section 3004 of the PHSA. CMS inpatient hospital services. Section
B. Statutory Basis for the Medicare & 4102(a)(2) of the HITECH Act amends
and ONC have been working closely to
Medicaid EHR Incentive Programs section 1814(l) of the Act to provide an
ensure that the definition of meaningful
use of certified EHR technology and the Section 4101(a) of the HITECH Act incentive payment to critical access
standards for certified EHR technology adds a new subsection (o) to section hospitals (CAHs) who meaningfully use
are coordinated. In the interim final rule 1848 of the Act. Section 1848(o) of the certified EHR technology based on the
published on January 13, 2010 (75 FR Act establishes incentive payments for hospitals’ reasonable costs for the
2014) entitled ‘‘Health Information demonstration of meaningful use of purchase of certified EHR technology
Technology: Initial Set of Standards, certified EHR technology by EPs beginning in FY 2011. In addition,
Implementation Specifications, and participating in the original Medicare section 4102(b)(2) of the HITECH Act
Certification Criteria for Electronic program (hereinafter referred to as the amends section 1814(l) of the Act to
Health Record Technology,’’ ONC Medicare Fee-for-Service (FFS) provide for a downward payment
defined the term ‘‘certified EHR program) beginning in calendar year adjustment for hospital services
technology,’’ identified the initial set of (CY) 2011. Section 4101(b) of the provided by CAHs that are not
standards and implementation HITECH Act also adds a new paragraph meaningful users of certified EHR
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specifications that such EHR technology (7) to section 1848(a) of the Act. Section technology for cost reporting periods
would need to support the achievement 1848(a)(7) of the Act provides that beginning in FY 2015. Section 4102(c)
of the proposed meaningful use Stage 1, beginning in CY 2015, EPs who do not of the HITECH Act adds a new
as well as the certification criteria that demonstrate that they are meaningful subsection (m) to section 1853 of the
will be used to certify EHR technology. users of certified EHR technology will Act to provide incentive payments to
ONC is also issuing a final rule on the receive an adjustment to their fee qualifying MA organizations for certain
standards, implementation schedule for their professional services affiliated hospitals that meaningfully

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use certified EHR technology to make a provisions of the HITECH Act encourage The incentive payments are available
downward adjustment to payments to avoiding duplication of payments, to EPs which are non-hospital-based
certain MA organizations for inpatient reporting, and other requirements, physicians, as defined in section 1861(r)
hospital services provided by its particularly in the area of demonstration of the Act, who either receive
affiliated hospitals that are not of meaningful use of certified EHR reimbursement for services under the
meaningful users of certified EHR technology. Eligible hospitals and CAHs Medicare FFS program or have an
technology beginning in FY 2015. may participate in both the Medicare employment or contractual relationship
Section 1853(m) of the Act also requires program and the Medicaid program, with a qualifying MA organization
us to establish a process that ensures assuming they meet each program’s meeting the criteria under section
that there are no duplicate payments eligibility requirements, which vary 1853(l)(2) of the Act; or healthcare
made to MA organizations under section across the two programs. In certain professionals meeting the definition of
1853(m) of the Act and to their affiliated cases, the HITECH Act has used nearly ‘‘eligible professional’’ under section
hospitals under the FFS EHR incentive identical or identical language in 1903(t)(3)(B) of the Act as well as the
program established under section defining terms that are used in the patient-volume and non-hospital-based
1886(n) of the Act. Medicare FFS, MA, and Medicaid criteria of section 1903(t)(2)(A) of the
Section 4103 of the HITECH Act programs, including such terms as Act and eligible hospitals which are
provides for implementation funding for ‘‘hospital-based EPs’’ and ‘‘certified EHR subsection (d) hospitals as defined
the EHR incentives program under technology.’’ For these reasons, we seek under subsection 1886(d)(1)(B) of the
Medicare. to create as much commonality between Act that either receive reimbursement
Section 4201 of the HITECH Act the three programs as possible and have for services under the Medicare FFS
amends section 1903 of the Act to structured this final rule, as we did the program or are affiliated with a
provide 100 percent Federal financial proposed rule, based on the premise by qualifying MA organization as described
participation (FFP) to States for beginning with those provisions that cut in section 1853(m)(2) of the Act; critical
incentive payments to certain eligible across the three programs before moving access hospitals (CAHs); or acute care or
providers participating in the Medicaid on to discuss the provisions specific to children’s hospitals described under
program to purchase, implement, Medicare FFS, MA and Medicaid. section 1903(t)(2)(B) of the Act.
operate (including support services and
training for staff) and meaningfully use A. Definitions Across the Medicare FFS, a. Certified Electronic Health Record
certified EHR technology and 90 percent MA, and Medicaid Programs (EHR) Technology
FFP for State administrative expenses Under all three EHR incentive
Title IV, Division B of ARRA programs, EPs, eligible hospitals, and
related to the program outlined in
establishes incentive payments under CAHs must utilize ‘‘certified EHR
1903(t) of the Act. Section 4201(a)(2) of
the HITECH Act adds a new subsection the Medicare and Medicaid programs technology’’ if they are to be considered
(t) to section 1903 of the Act to establish for certain professionals and hospitals eligible for the incentive payments. In
a program with input from the States to that meaningfully use certified EHR the Medicare FFS EHR incentive
provide incentives for the adoption and technology, and for certain MA program this requirement for EPs is
subsequent meaningful use of certified organizations whose affiliated EPs and found in section 1848(o)(2)(A)(i) of the
EHR technology for providers hospitals meaningfully use certified Act, and for eligible hospitals and CAHs
participating in the Medicaid program. EHR technology. We refer to the in section 1886(n)(3)(A)(i) of the Act. In
incentive payments made under the the MA EHR incentive program this
II. Provisions of the Proposed Rule and original Medicare program to EPs, requirement for EPs is found in section
Analysis of and Responses to Public eligible hospitals, and CAHs as the 1853(l)(1) of the Act, and for eligible
Comments Medicare FFS EHR incentive program, hospitals and CAHs, in section
We proposed to add a new part 495 the incentive payments made to 1853(m)(1) of the Act. In the Medicaid
to title 42 of the Code of Federal qualifying MA organizations as the MA EHR incentive program this requirement
Regulations to implement the provisions EHR incentive program, and the for EPs and Medicaid eligible hospitals
of Title IV of Division B of ARRA incentive payments made under is found throughout section 1903(t) of
providing for incentive payments to Medicaid to eligible professionals and the Act, including in section
EPs, eligible hospitals, CAHs and eligible hospitals as the Medicaid EHR 1903(t)(6)(C) of the Act. Certified EHR
certain Medicare Advantage incentive program. When referring to technology is a critical component of
organizations for the adoption and the Medicare EHR incentive program, the EHR incentive programs, and the
demonstration of meaningful use of we are generally referring to both the Secretary has charged ONC, under the
certified EHR technology under the Medicare FFS EHR and the MA EHR authority given to her in the HITECH
Medicare program or the Medicaid incentive programs. Act, with developing the criteria and
program. 1. Definitions mechanisms for certification of EHR
The HITECH Act creates incentives technology. Therefore, we finalize our
under the Medicare Fee-for-Service Sections 4101, 4102, and 4201 of the proposal to use the definition of
(FFS), Medicare Advantage (MA), and HITECH Act use many identical or certified EHR technology adopted by
Medicaid programs for EPs, eligible similar terms. In this section of the ONC. ONC issued an interim final rule
hospitals and CAHs to adopt and preamble, we discuss terms for which with comment for the standards and
demonstrate meaningful use of certified we are finalizing uniform definitions for certification criteria for certified EHR
EHR technology, and payment the Medicare FFS, MA, and Medicaid technology at the same time our
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adjustments under the Medicare FFS EHR incentive programs. These proposed rule was issued. After
and MA programs for EPs, eligible definitions are set forth in part 495 reviewing the comments they received
hospitals, and CAHs who fail to adopt subpart A of the regulations. For and to address changes made in this
and demonstrate meaningful use of definitions specific to an individual final rule, ONC will be issuing a final
certified EHR technology. The three program, the definition is set forth and rule in conjunction with this final rule.
incentive programs contain many discussed in the applicable EHR When we refer to the ONC final rule, we
common elements and certain incentive program section. are referring to this final rule titled

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‘‘Health Information Technology: Initial b. Qualified Electronic Health Record opportunity to participate in either the
Set of Standards, Implementation In order for an EHR technology to be Medicare or Medicaid incentive
Specifications, and Certification Criteria eligible for certification, it must first programs, and once an EP has selected
for Electronic Health Record meet the definition of a Qualified a program, they are permitted to make
Technology. When we refer to the ONC Electronic Health Record. This term was a one-time switch from one program to
IFR, we are referring to the interim final defined by ONC in its in its IFR and the other. A common definition will
rule with comment period published in finalized by ONC in their final rule, and allow EPs to more easily understand
the Federal Register on January 13, we are finalizing our proposal to use the both incentive programs, and inform
2010. their decisions regarding participation
definition of qualified electronic health
Comment: Several commenters asked in either program.
record adopted by ONC in their final
for clarification on the definition of Under section 1886(n)(1) of the Act,
certified EHR technology. Currently, rule to be published concurrently with
this rule. the Medicare FFS EHR incentive
hospitals utilize multiple systems to payment is available to eligible
operate electronically. For example, Comment: We received a few
comments on the definition of qualified hospitals and CAHs for a ‘‘payment
some electronic operating systems feed year.’’ Section 1886(n)(2)(G) of the Act
EHR data and some systems pull EHR EHR technology. Commenters expressed
concerns regarding perceived gaps in defines the term ‘‘payment year’’ as a
data. Data from the two systems are then fiscal year beginning in 2011. As
extracted and manipulated to create a defining an EHR as qualified such as a
lack of the requirement for a narrative hospitals are paid based on the 12-
quality measure calculation. The month Federal fiscal year, we interpret
commenters’ inquired as to how these text for physicians (also known as
progress note). Another comment the reference to a ‘‘fiscal year’’ means the
systems can continue to be utilized even fiscal year beginning on October 1 of the
though, independently, these systems requested further clarification regarding
the requirement for a qualified EHR to prior calendar year and extending to
will not meet all certification standards. September 30 of the relevant year.
Some commenters expressed concern ‘‘capture and query information relevant
to health care quality’’ and ‘‘exchange Again, for the Medicaid EHR incentive
the ONC IFR did not include generation program, the HITECH Act uses the term,
of the data needed to demonstrate electronic health information with and
integrate such information from other ‘‘year of payment’’ (see section
meaningful use as a certification 1903(t)(5)(D)(ii) of the Act), rather than
requirement and that certified EHR sources.’’ For example, some might
believe that these requirements apply ‘‘payment year.’’ For the same reasons
technology requirements should also expressed in the proposed rule and
include compliance with HIPAA strictly to information contained within
the EHR or closed proprietary hospital summarized above for proposing a
standards as well as all relevant state common definition of ‘‘payment year’’
statutes for the state or states where it systems and not to information that
would have to be obtained from outside for EPs, and because hospitals will have
is installed. Commenters recommended the opportunity to simultaneously
various approaches to defining certified the four walls of the practice or the
extended (but closed) system. participate in both the Medicare and
technology especially in the early stages Medicaid EHR incentive programs, we
of the program. Some suggestions Response: We have referred those
comments to ONC who addresses them propose a common definition of
included, grandfathering existing
in their final rule. ‘‘payment year’’ and ‘‘year of payment’’
systems for a period of three years as
We are adopting the ONC definition for both programs.
long as the provider could meet specific
of Qualified Electronic Health Record at For purposes of the incentive
meaningful use objectives while
45 CFR 170.102. payments made to eligible hospitals and
requiring all upgrades to existing
CAHs under the Medicare FFS, MA and
systems to be certified, allowing all EHR c. Payment Year
products certified by the Certification Medicaid EHR incentive programs, we
Commission for Health Information As discussed in the proposed rule, proposed to define payment year and
Technology (CCHIT) at the criteria under section 1848(o)(1)(A)(i) of the Act year of payment at § 495.4, consistent
established for 2008 or later be deemed the Medicare FFS EHR incentive with the statutory definition, as ‘‘any
as meeting Stage 1 certification payment is available to EPs for a fiscal year beginning with 2011.’’
requirements or alternatively CMS ‘‘payment year.’’ Section 1848(o)(1)(E) of Comment: A commenter asked CMS
provide a process that can verify the Act defines the term ‘‘payment year’’ to identify the first possible payment
compliance of required features at no as a year beginning with 2011. While year for EPs, and hospitals and CAHs.
cost to providers or vendors as is done the Act does not use the term, ‘‘payment Response: The first payment year for
now with Enterprise Data Interchange year,’’ for the Medicaid EHR incentive EPs is any calendar year (CY) beginning
(EDI) claims processing. Some program, it does use the term ‘‘year of with CY 2011 and for eligible hospitals
commenters also offered other thoughts payment’’ throughout section 1903(t) of and CAHs is any fiscal year (FY)
on potential unintended consequences the Act, for example, at sections beginning with 2011.
of defining the EHR certification 1903(t)(3)(C), 1903(t)(4)(A), and Comment: The majority of
software process to include certifying 1903(t)(6)(C) of the Act. For all EPs in commenters favored our definition of
agencies that charge for the process. The the Medicare and Medicaid EHR ‘‘payment year’’ based on the different
commenters believed this could result incentive programs, we are proposing a existing fiscal periods for eligible
in continued new and revised common definition for both ‘‘payment professionals and hospitals. Additional
requirements to justify the certifying year’’ and ‘‘year of payment,’’ as ‘‘any support was received from some
entities’ existence and increase its calendar year beginning with 2011’’ at commenters whom explained that they
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revenue. § 495.4. In the proposed rule, we participated in performance-based


Response: We have referred those explained that this definition, which is initiatives, which define a payment year
comments to ONC who addresses them consistent with the statutory definition the same as the proposed rule.
in their final rule. of ‘‘payment year’’ under Medicare FFS, Response: After consideration of the
We are adopting the ONC definition would simplify the EHR incentive public comments received, we are
of certified EHR technology at 45 CFR programs for EPs. As discussed later in adopting our proposed definition of
170.102 in this final rule. this preamble, EPs will have the ‘‘payment year’’ in the Medicare and

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Medicaid EHR incentive programs as for an incentive in CY 2013, they would Comment: As stated above, many
described above. still be eligible to receive incentives for commenters requested clarification on
Comment: The majority of comments an additional four payment years. For non-consecutive payment.
received regarding the definition of a hospitals, however, starting with FY Response: This comment is addressed
payment year asked whether payment 2017 payments must be consecutive. above.
years must be consecutive for an EP or This rule is required by section Comment: A commenter requested
eligible hospital to receive all years of 1903(t)(5)(D) of the Act, which states CMS to clarify the consequences for a
incentive payments. that after 2016, no Medicaid incentive hospital that originally qualified and
Response: In the proposed rule, we payment may be made to an eligible received incentive payments the first
defined the second, third, fourth, fifth, hospital unless ‘‘the provider has been year, but in a subsequent year failed to
and sixth payment year, respectively, to provided payment * * * for the qualify as a meaningful user of certified
mean ‘‘the second, third, fourth, fifth, previous year.’’ As a result, Medicaid EHR technology.
and sixth calendar or Federal fiscal year, Response: Meaningful use will be
eligible hospitals must receive an
respectively, for which an EP or eligible assessed on a year-by-year basis as we
incentive in FY 2016 to receive an
hospital receives an incentive payment.’’ establish different Stages of meaningful
incentive in FY 2017 and later years.
However, section 1848(o)(1)(E) of Act use criteria for different years. If an EP
Starting in FY 2016, incentive payments
defines the second through fifth or an eligible hospital including a CAH
must be made every year in order to
payment years for an EP as each has failed to demonstrate meaningful
continue participation in the program. use of certified EHR technology for a
successive year immediately following
In no case may any Medicaid EP or certain payment year, the EP, eligible
the first payment year for such
eligible hospital receive an incentive hospital, or CAH will not be qualified
professional for the Medicare FFS and
after 2021. We have revised our for incentive payments for that payment
MA EHR incentive programs. Similarly,
section 1886(n)(2)(G)(ii) of the Act regulations at § 495.4 to incorporate year. However, upon successful
defines the second through fourth these statutory requirements. demonstration as a meaningful EHR
payment years for an eligible hospital or Comment: Some commenters user in subsequent years, an EP, eligible
CAH as requiring the years to be requested that CMS clarify the impact hospital or CAH may be eligible to
‘‘successive’’ and ‘‘immediately on EPs when they change practices in receive an incentive payment. As
following’’ the prior year. This the middle of the incentive payment discussed above, however, for the
requirement, that each payment year program; in other words, if an EP leaves Medicare program, the failure of the
‘‘immediately follow’’ the prior year, a practice in year two of the incentive eligible hospital or CAH to demonstrate
means that every year subsequent to the payment program and goes to another meaningful use in the subsequent year,
first payment year is a payment year practice, does that EP forfeit the ability will affect the total payments that
regardless of whether an incentive to continue collecting incentive hospital is eligible to receive, as,
payment is received by the EP, eligible payments for years 3 through 5? pursuant to the statute, the hospital is
hospital or CAH. For example, if a treated as skipping a payment year.
Response: A qualifying EP that leaves
Medicare EP receives an incentive in CY Payment adjustments apply to Medicare
one practice for another may still be
2011, but does not successfully providers who are unable to
eligible to receive subsequent incentive
demonstrate meaningful use or demonstrate meaningful use starting in
payments if the EP is a meaningful EHR
otherwise fails to qualify for the 2015.
user in the new practice. The incentive Comment: One commenter asked if
incentive in CY 2012, CY 2012 still payment is tied to the individual EP,
counts as one of the EP’s five payment CMS could apply the same Medicaid
and not to his or her place of practice. EP’s first year incentive eligibility
years and they would only be able to
receive an incentive under the Medicare d. First, Second, Third, Fourth, Fifth, requirements of adopting, implementing
EHR incentive program for three more and Sixth Payment Year or upgrading to certified EHR
years as CY 2013 would be there third technology to Medicare physicians
payment year. In this example, the In accordance with sections instead of demonstration of meaningful
maximum incentive payment that 1848(o)(1)(A)(ii), 1886(n)(2)(E), use.
would apply for this Medicare EP not 1814(l)(3)(A), 1903(t)(4)(B), and Response: The HITECH Act allows
practicing predominately in a health 1903(t)(5)(A) of the Act, for EPs, eligible Medicaid EPs and eligible hospitals to
professional shortage area (HPSA) hospitals, and CAHs that qualify for receive an incentive for the adoption,
would be $18,000 in 2011, and $8,000 EHR incentive payments in a payment implementation, or upgrade of certified
in 2013 as outlined in section year, the amount of the payment will EHR technology in their first
1848(o)(1)(B) of the Act. The EP would depend in part on whether the EP or participation year. In subsequent years,
have qualified for a maximum incentive hospital previously received an these EPs and eligible hospitals must
payment of $12,000 in 2012, but did not incentive payment and, if so (for the demonstrate that they are meaningful
qualify as a meaningful user for this Medicare EHR incentive program) when users. There are no parallel provisions
year. No incentives may be made under the EP or hospital received his or her under the Medicare EHR incentive
the Medicare EHR incentive program first payment. We proposed to define program that would authorize us to
after 2016. the first payment year to mean the first make payments to Medicare EPs,
The same rule, however, does not CY or Federal fiscal year (FY) for which eligible hospitals, and CAHs for the
apply to the Medicaid EHR incentive an EP, eligible hospital, or CAH receives adoption, implementation or upgrade of
program. For that program, payments an incentive payment. Likewise, we certified EHR technology. Rather, in
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may generally be non-consecutive. If an proposed to define the second, third, accordance with sections 1848(o)(2),
EP or eligible hospital does not receive fourth, fifth, and sixth payment year, 1886(n)(3)(A), and 1814(l)(3)(A) of the
an incentive payment for a given CY or respectively, to mean the second, third, Act, Medicare incentive payments are
FY then that year would not constitute fourth, fifth, and sixth CY or FY, only made to EPs, eligible hospitals, and
a payment year. For example, if a respectively, for which an EP, eligible CAHs for the demonstration of
Medicaid EP receives incentives in CY hospital, or CAH receives an incentive meaningful use of certified EHR
2011 and CY 2012, but fails to qualify payment. technology.

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44320 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

After consideration of the public expected training needs and other EP or eligible hospital demonstrates
comments received, we are finalizing unexpected hindrances, may cause an meaningful use and full year EHR
the definitions of First payment year as EP, eligible hospital, or CAH to reporting periods for subsequent
proposed. For the Medicare EHR potentially miss a target start date. payment years.
incentive programs, we are modifying Comment: Some commenters
supported the 90-day reporting period f. Meaningful EHR User
the definitions of second, third, fourth,
fifth payment year to make clear that proposed for the first payment year. One Section 1848(o)(1)(A)(i) of the Act,
these years are ‘‘each successive year commenter requested that exceptions, limits incentive payments under the
following the first payment year.’’ For per the provider request, be considered Medicare FFS EHR incentive program to
the Medicaid EHR incentive program, individually in cases of compliance for an EP who is a ‘‘meaningful EHR user.’’
we included definitions of first, second, less than the 90 days (for example, 85 Similarly, section 1886(n)(1) and 1814(l)
third, fourth, fifth and sixth payment days). Commenters preferred the 90-day of the Act, limits incentive payments
year that make clear that these are the reporting period overall and many under the Medicare FFS EHR incentive
years for which payment is received. suggested it be used for subsequent program to an eligible hospital or CAH,
The regulations can now be found at years as well. We also received respectively, who is a ‘‘meaningful EHR
§ 495.4 of our regulations. comments questioning why Medicaid user.’’ Section 1903(t)(6)(C)(i)(II) of the
providers would need to conform to the Act limits incentive payments for
e. EHR Reporting Period 90-day reporting period in order to payment years other than the first
In the proposed rule, we proposed a adopt, implement or upgrade certified payment year to a Medicaid EP or
definition of EHR Reporting Period for EHR technology. eligible hospital who ‘‘demonstrates
purposes of the Medicare and Medicaid Response: We do believe that for meaningful use of certified EHR
incentive payments under sections program integrity it is crucial to technology.’’ We proposed to define at
1848(o), 1853(l)(3), 1886(n), 1853(m)(3), maintain a consistent reporting period. § 495.4 the term ‘‘meaningful EHR user’’
1814(l) and 1903(t) of the Act. For these Basing the incentive payments on as an EP, eligible hospital, or CAH who,
sections, we proposed that the EHR meaningful use implies a minimum for an EHR reporting period for a
reporting period would be any level of use in order to receive the payment year, demonstrates meaningful
continuous 90-day period within the incentive payment. The timeframe is use of certified EHR technology in the
first payment year and the entire part of the determination of whether use form and manner consistent with our
payment year for all subsequent is meaningful and therefore requires a standards (discussed below).
payment years. In our proposed rule, we minimum as well. Given the short time Comment: Several commenters
did not make any proposals regarding period as compared to the entire year, indicated there is a need to align
the reporting period that will be used we do not believe an exception process measures and programs, to avoid having
for purposes of the payment is needed. However, we agree with to report similar measure standards to
adjustments that begin in 2015. We commenters that an EHR reporting different Federal, State and other
intend to address this issue in future period for demonstrating adoption, entities.
rulemaking, for purposes of Medicare implementation or upgrading certified Response: We concur with the goal of
incentive payment adjustments under EHR technology by Medicaid EPs and alignment to avoid redundant and
sections 1848(a)(7), 1853(l)(4), eligible hospitals is unnecessary and are duplicative reporting and seek to
1886(b)(3)(B)(ix), 1853(m)(4), and removing it for the final rule in this accomplish this to the extent possible
1814(l)(4) of the Act. instance. Similarly, Medicaid EPs and now and in future rulemaking.
For the first payment year only, we eligible hospitals who are demonstrating Comment: Several commenters
proposed to define the term EHR meaningful use for the first time in their suggested that CMS considers EPs,
reporting period at § 495.4 of our second payment year, will have a 90- eligible hospitals, and CAHs who are
regulations to mean any continuous 90- day reporting period to maintain parity participating in certain existing
day period within a payment year in with Medicare providers’ first programs as meaningful EHR users. The
which an EP, eligible hospital or CAH meaningful use payment year. We do commenters contended that the
successfully demonstrates meaningful not believe that after successfully standards followed by participants in
use of certified EHR technology. The demonstrating meaningful use, a 90-day these programs are equivalent to those
EHR reporting period therefore could be period is appropriate for subsequent we proposed to adopt for purposes of
any continuous period beginning and years. The reasons for using the 90-day demonstrating meaningful use. The
ending within the relevant payment period instead of the full year are based programs recommended by commenters
year. Starting with the second payment on potential delays in implementing are—
year and any subsequent payment years certifying EHR technology. Once • Qualified Health Information
for a given EP, eligible hospital or CAH, certified EHR technology is Exchange Networks; and
we proposed to define the term EHR implemented these are no longer • Medicare Electronic Health Record
reporting period at § 495.4 to mean the applicable. Demonstration Program.
entire payment year. In our discussion After consideration of the public Response: We do not agree that
of considerations in defining comments received and with the participation in these programs would
meaningful use later in this section we clarification described above for be the equivalent to demonstrating
discuss how this policy may be affected adopting, implementing or upgrading, meaningful use in accordance with the
by subsequent revisions to the we are finalizing the 90-day reporting criteria under the EHR incentive
definition of meaningful use. period for the first payment year based programs. Most of these programs place
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For the first payment year, we stated on meaningful use as proposed for a heavy focus on one of the five
in the proposed rule our belief that Medicare EPs, eligible hospitals and priorities of meaningful use discussed
giving EPs, eligible hospitals and CAHs CAHs and full year EHR reporting in the next section such as reporting
flexibility as to the start date of the EHR periods for subsequent payment years. clinical quality measures or the
reporting period is important, as For Medicaid EPs and eligible hospitals, exchange of health information, tailored
unforeseen circumstances, such as the EHR reporting period will be a 90- to the individual program’s goals. For
delays in implementation, higher than day period for the first year a Medicaid example, the goal of the Medicare

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Electronic Health Record Demonstration In the proposed rule we explained continuous quality improvement and
Program, for example, which was that in defining meaningful use we ease of information exchange. By having
started in 2009 and pre-dates passage of sought to balance the sometimes these functionalities in certified EHR
the HITECH Act, is to reward delivery competing considerations of improving technology at the onset of the program
of high-quality care supported by the health care quality, encouraging and requiring that the EP, eligible
adoption and use of electronic health widespread EHR adoption, promoting hospital or CAH become familiar with
records in physician small to medium- innovation, and avoiding imposing them through the varying levels of
size primary care practices. The purpose excessive or unnecessary burdens on engagement required by Stage 1, we
of this program is to encourage adoption health care providers, while at the same believe we will create a strong
and increasingly sophisticated use of time recognizing the short timeframe foundation to build on in later years.
EHRs by small to medium-sized primary available under the HITECH Act for Though some functionalities are
care practices. While this goal is similar providers to begin using certified EHR optional in Stage 1, as outlined in
to the overall objective of the HITECH technology. discussions later in this rule, all of the
Act, the requirements for the Based on public and stakeholder functionalities are considered crucial to
demonstration are not as broad-based as input received prior to publishing the maximize the value to the health care
that of the HITECH Act, and payment proposed rule, we consider a phased system provided by certified EHR
incentives are based on the level of use approach to be most appropriate. Such technology. We encourage all EPs,
over the duration of the program, which a phased approach encompasses eligible hospitals and CAHs to be
will vary by practice. Therefore, it is not reasonable criteria for meaningful use proactive in implementing all of the
based on currently available technology functionalities of Stage 1 in order to
appropriate to deem practices
capabilities and provider practice prepare for later stages of meaningful
participating in the EHR Demonstration
experience, and builds up to a more use, particularly functionalities that
as meaningful users for purposes of the
robust definition of meaningful use, improve patient care, the efficiency of
HITECH Act. The HITECH Act also
based on anticipated technology and the health care system and public and
requires use certified EHR technology as
capabilities development. The HITECH population health. The specific criteria
defined by ONC to qualify for incentive Act acknowledges the need for this
payments. While CCHIT has certified for Stage 1 of meaningful use are
balance by granting the Secretary the discussed at section II.2.c of this final
EHR technology in the past, the ONC discretion to require more stringent
regulation ‘‘Establishment of the rule.
measures of meaningful use over time.
Temporary Certification Program for Ultimately, consistent with other • Stage 2: Our goals for the Stage 2
Health Information Technology; Final provisions of law, meaningful use of meaningful use criteria, consistent with
Rule’’ (see 75 FR 36157) which certified EHR technology should result other provisions of Medicare and
establishes a temporary certifying body in health care that is patient centered, Medicaid law, expand upon the Stage 1
has yet to be established. Where evidence-based, prevention-oriented, criteria to encourage the use of health IT
possible, we have aligned the criteria efficient, and equitable. for continuous quality improvement at
required to demonstrate meaningful use Under this phased approach to the point of care and the exchange of
with existing programs like PQRI and meaningful use, we intend to update the information in the most structured
RHQDAPU as discussed in section criteria of meaningful use through format possible, such as the electronic
II.A.3 of this final rule. After future rulemaking. We refer to the initial transmission of orders entered using
consideration of the public comments meaningful use criteria as ‘‘Stage 1.’’ We computerized provider order entry
received, we are finalizing our currently anticipate two additional (CPOE) and the electronic transmission
definition of a meaningful EHR user as updates, which we refer to as Stage 2 of diagnostic test results (such as blood
proposed. and Stage 3, respectively. We expect to tests, microbiology, urinalysis,
update the meaningful use criteria on a pathology tests, radiology, cardiac
2. Definition of Meaningful Use biennial basis, with the Stage 2 criteria imaging, nuclear medicine tests,
a. Considerations in Defining by the end of 2011 and the Stage 3 pulmonary function tests, genetic tests,
Meaningful Use criteria by the end of 2013. The stages genomic tests and other such data
represent an initial graduated approach needed to diagnose and treat disease).
In sections 1848(o)(2)(A) and to arriving at the ultimate goal. For the final rule, we elaborate on our
1886(n)(3)(A) of the Act, the Congress • Stage 1: The Stage 1 meaningful use plans for Stage 2. We expect that stage
identified the broad goal of expanding criteria, consistent with other provisions two meaningful use requirements will
the use of EHRs through the term of Medicare and Medicaid law, focuses include rigorous expectations for health
meaningful use. In section 1903(t)(6)(C) on electronically capturing health information exchange, including more
of the Act, Congress applies the information in a structured format; demanding requirements for e-
definition of meaningful use to using that information to track key prescribing and incorporating structured
Medicaid eligible professionals and clinical conditions and communicating laboratory results and the expectation
eligible hospitals as well. Certified EHR that information for care coordination that providers will electronically
technology used in a meaningful way is purposes (whether that information is transmit patient care summaries to
one piece of a broader HIT structured or unstructured, but in support transitions in care across
infrastructure needed to reform the structured format whenever feasible); unaffiliated providers, settings and EHR
health care system and improve health implementing clinical decision support systems. Increasingly robust
care quality, efficiency, and patient tools to facilitate disease and expectations for health information
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safety. HHS believes this ultimate vision medication management; using EHRs to exchange in stage two and stage three
of reforming the health care system and engage patients and families and will support and make real the goal that
improving health care quality, efficiency reporting clinical quality measures and information follows the patient. We
and patient safety should drive the public health information. Stage 1 expect that Stage 2 will build upon
definition of meaningful use consistent focuses heavily on establishing the Stage 1 by both altering the expectations
with the applicable provisions of functionalities in certified EHR of the functionalities in Stage 1 and
Medicare and Medicaid law. technology that will allow for likely adding new functionalities which

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are not yet ready for inclusion in Stage technology and standards of care. eligible hospital, or CAH whose first
1, but whose provision is necessary to However, we expect the delivery of payment year is 2011 would have to
maximize the potential of EHR health care to evolve through the satisfy the Stage 2 criteria of meaningful
technology. As discussed later in this inception of the HITECH incentive use to receive the incentive payments.
final rule, we are making some programs and implementation of the We proposed that Medicare EPs, eligible
objectives of the Stage 1 of meaningful Affordable Care Act prior to finalizing hospitals, and CAHs whose first
use optional and other required. We will Stage 2. Furthermore, data collected payment year is 2012 must satisfy the
consider every objective that is optional from the initial attestations of Stage 1 criteria of meaningful use in
for Stage 1 to be required in Stage 2 as meaningful use will be used to ensure their first and second payment years
well as revaluate the thresholds and that the thresholds of the measures that (2012 and 2013) to receive the incentive
exclusions of all the measures both accompany the objectives in Stage 2 are payments. We anticipate updating the
percentage based and those currently a continue to aggressively advance the use criteria of meaningful use to Stage 2 in
yes/no attestation. Additionally, we may of certified EHR technology. Finally, we time for the 2013 payment year and
consider applying the criteria more continue to anticipate redefining our anticipate for their third payment year
broadly to all outpatient hospital objectives to include not only the (2014), an EP, eligible hospital, or CAH
settings (not just the emergency capturing of data in electronic format whose first payment year is 2012 would
department). but also the exchange (both have to satisfy the Stage 2 criteria of
• Stage 3: Our goals for the Stage 3 transmission and receipt) of that data in meaningful use to receive the incentive
meaningful use criteria are, consistent increasingly structured formats. As payments. We discussed in the
with other provisions of Medicare and appropriate, we intend to propose the proposed rule that Medicare EPs,
Medicaid law, to focus on promoting addition of new objectives to capture eligible hospitals, and CAHs whose first
improvements in quality, safety and new functions that are necessary to payment year is 2013 must satisfy the
efficiency leading to improved health maximize the potential of EHR Stage 1 criteria of meaningful use in
outcomes, focusing on decision support technology, but were not ready for Stage their first payment year (2013) to receive
for national high priority conditions, 1. For instance, we would consider the incentive payments. We anticipate
patient access to self management tools, adding measures related to CPOE orders updating the criteria of meaningful use
access to comprehensive patient data for services beyond medication orders.
to Stage 2 in time for the 2013 payment
through robust, patient-centered health The intent and policy goal for raising
year and therefore anticipate for their
information exchange and improving these thresholds and expectations is to
population health. second payment year (2014), an EP,
ensure that meaningful use encourages
We did not include regulatory eligible hospital, or CAH whose first
patient-centric, interoperable health
provisions for Stage 2 or Stage 3 in our payment year is 2013 would have to
information exchange across provider
proposal and with one exception satisfy the Stage 2 criteria of meaningful
organizations.
discussed under the CPOE objective, we We will continue to evaluate the use to receive the incentive payments.
are not finalizing Stage 2 or Stage 3 progression of the meaningful use We discussed in the proposed rule that
requirements at this time. However, we definition for consistency with the Medicare EPs, eligible hospitals, and
plan to build upon Stage 1 by increasing HITECH ACT and any future statutory CAHs whose first payment year is 2014
the expectations of the functionalities in requirements relating to quality must satisfy the Stage 1 criteria of
Stage 1 and adding new objectives for measurement and administrative meaningful use in their first payment
Stage 2. In our next rulemaking, we simplification. As the purpose of these year (2014) to receive the incentive
currently intend to propose that every incentives is to encourage the adoption payments. In the proposed rule, we
objective in the menu set for Stage 1 (as and meaningful use of certified EHR discussed the idea that alignment of
described later in this section) be technology, we believe it is desirable to stage of meaningful use and payment
included in Stage 2 as part of the core account for whether an EP, eligible year should synchronize for all
set. While allowing providers flexibility hospital or CAH is in their first, second, providers in 2015, and requested
in setting priorities for EHR third, fourth, fifth, or sixth payment comment on the need to create such
implementation takes into account their year when deciding which definition of alignment. After reviewing public
unique circumstances, we maintain that meaningful use to apply in the comment on this issue, our goal remains
all the objectives are crucial to building beginning years of the program. The HIT to align the stages of meaningful use
a strong foundation for health IT and to Policy Committee in its public meeting across all providers in 2015. However,
meeting the statutory objectives of the on July 16, 2009 also voiced its approval we acknowledge the concerns regarding
Act. In addition, as indicated in our of this approach. However, such the different Medicare and Medicaid
proposed rule, we anticipate raising the considerations are dependent on future incentive timelines, as well as concerns
threshold for these objectives in both rulemaking, so for this final rule Stage about whether Stage 3 would be
Stage 2 and 3 as the capabilities of HIT 1 criteria for meaningful use are valid appropriate for an EP’s, eligible
infrastructure increases. For Stage 2, we for all payments years until updated by hospital’s or CAH’s first payment year at
intend to review the thresholds and future rulemaking. any point in the future and believe the
measures associated with all Stage 1 We proposed that Medicare EPs, issue needs additional review and
objectives considering advances in eligible hospitals, and CAHs whose first discussion before we lay out a clear path
technology, changes in standard payment year is 2011 must satisfy the forward for 2015 and beyond. Therefore,
practice, and changes in the requirements of the Stage 1 criteria of we have decided to remove language in
marketplace (for example, wider meaningful use in their first and second the final rule discussing our possible
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adoption of information technology by payment years (2011 and 2012) to directions for any year beyond 2014. We
pharmacies) and propose, as receive the incentive payments. We will address the years beyond 2014 in
appropriate, increases in these anticipate updating the criteria of later rulemaking. Table 1 outlines how
requirements. meaningful use to Stage 2 in time for the we anticipate applying the respective
We recognize that the thresholds 2013 payment year and therefore criteria of meaningful use in the first
included in the final regulation are anticipate for their third and fourth years of the program, and how we
ambitious for the current state of payment years (2013 and 2014), an EP, anticipate applying such criteria for

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subsequent payment years, through engage in rulemaking to adopt the discussions in this preamble or final
2014. Please note that nothing in this criteria that will accompany Stages 2 rule as binding the agency to any
discussion restricts us from requiring and 3 of meaningful use, stakeholders specific definition for those future
additional stages of meaningful use should wait for those rulemakings to stages.
(beyond stage 3) through future determine what will be required for
rulemaking. In addition, as we expect to those Stages and should not view the

Please note that each of the EHR hospitals, and CAHs in all EHR reason for alignment at Stage 3 in 2015
incentive programs has different rules incentive programs in 2015. is that many of the barriers to
regarding the number of payment years Comment: Many commenters functionalities of EHRs that exist today
available, the last year for which requested that if there continued to be as may no longer exist in 2015. The
incentives may be received, and the last a year where all EPs, eligible hospitals existence of these barriers today is one
payment year that can be the first and CAHs must meet the same stage of of the primary reasons for having a
payment year for an EP, eligible meaningful use that that year be 2017, staged approach as opposed to requiring
hospital, or CAH. The applicable rather than 2015 as we had discussed in more robust meaningful use at the
payment years and the incentive the proposed rule. These commenters beginning of the program. Providers,
payments available for each program are asserted that EPs, eligible hospitals, and developers of EHRs, government and
also discussed in section II.C. of this CAHs whose first payment year is after non-governmental organizations are all
final rule for the Medicare FFS EHR 2011 might not have sufficient time to working to remove these barriers. We
incentive program, in section II.D. of reach the Stage 3 of meaningful use believe it is likely there will be success
this final rule for the MA EHR incentive criteria by 2015. Some commenters in removing many of these barriers,
program, and in section II.E. of this final pointed out that while the HITECH Act which would make many of the
rule for the Medicaid EHR incentive states that 2015 is the first year of compromises made in Stage 1 no longer
program. payment adjustments, it provides for necessary by 2015. However, due to the
Comment: Numerous commenters escalation of the payment adjustments many comments on alignment starting
noted that it is inappropriate to align the so that they do not reach their full levels in 2015 and our plan to engage in
Medicaid EHR incentive payment until 2017. additional more rounds of rulemaking,
program with the Medicare program due we are removing discussion of actual
to the lack of penalties in the Medicaid Response: As we explained in the
proposed rule, equity in the level of alignment between the first payment
program and due to the option for year of an EP, eligible hospital, or CAH
Medicaid providers to participate in meaningful use across all EPs, eligible
hospitals, and CAHs subject to the and the Stage of meaningful use they
their first year by adopting, will be expected to meet for all years
implementing, or upgrading certified payment adjustment was not the only
reason for our plan that all EPs, eligible after 2014. Our policies for 2015 and
EHR technology. subsequent years will be determined
Response: This was not the only hospitals, and CAHs satisfy the Stage 3
criteria for either the Medicare or through future rulemaking.
reason for having all EPs, eligible
hospitals, and CAHs align by 2015. Medicaid EHR incentive programs. The Comment: Several commenters
However, as we are not addressing achievement of many of the ultimate requested that CMS base the payment
stages of meaningful use beyond 2014 in goals of meaningful use of certified EHR adjustments on Stage 1 of meaningful
this final rule, potential alignment is not technology are dependent on a critical use regardless of the EP, eligible
discussed. We will reconsider this mass of EPs, eligible hospitals, and hospital, or CAH’s prior participation in
comment in future rulemaking. CAHs all being meaningful EHR users. the incentive program.
The stages of criteria of meaningful Exchange of health information is most Response: We thank commenters for
use and how they are demonstrated are valuable when it is so robust that it can the thoughtful comments received, and
described further in this final rule and be relied upon to provide a complete or will take their input into consideration
will be updated in subsequent nearly complete picture of a patient’s when in future rulemaking when we
rulemaking to reflect advances in HIT health. For example, robust Stage 3 consider whether to require that EPs,
products and infrastructure. We note meaningful use by an EP does not assist eligible hospitals, and CAHs satisfy the
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that such future rulemaking might also that EP in avoiding ordering a stage 3 definition of meaningful use in
include updates to the Stage 1 criteria. duplicative test, if the EP with order to avoid reduced payments under
We invited comment on our information on the original test is only Medicare for their professional services
alignment between payment year and a Stage 1 meaningful EHR user and is and inpatient hospital services
the criteria of meaningful use not yet exchanging that information. beginning 2015. We reiterate, however,
particularly in regards to the need to This dependency is key to the need to that in this final rule we are only
create alignment across all EPs, eligible get to Stage 3 for all providers. Another adopting criteria that we expect will
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44324 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

apply in 2011 and 2012. We have also to hold providers accountable for the respectively.) Under section 1903(t)(8)
outlined the expected progression of expenditure of public funds and to of the Act to the maximum extent
stages of meaningful use criteria until protect against fraud and abuse. practicable, we are directed to avoid
2014. However, we are not in this rule Response: We likewise are concerned duplicative requirements from Federal
finalizing regulations that address the with the potential fraud and abuse. and State governments to demonstrate
meaningful use standards that apply in However, Congress for the HITECH Act meaningful use of certified EHR
2015 and thereafter. specifically authorized submission of technology. Provisions included at
Comment: Numerous commenters information as to meaningful use section 1848(o)(1)(D)(iii) of the Act also
requested that we specifically propose through attestation. CMS is developing contain a Congressional mandate to
objectives and measures for Stage 2 and an audit strategy to ameliorate and avoid duplicative requirements for
3. We also received recommendations address the risk of fraud and abuse. meaningful use, to the extent
on what those objectives and, in rare b. Common Definition of Meaningful practicable. Finally, section 1903(t)(8) of
cases, measures should be. We Use Under Medicare and Medicaid the Act allows the Secretary to deem
discussed some of these objectives in satisfaction of the requirements for
the proposed rule and discuss them Under sections 1848(o)(1)(A)(i), meaningful use of certified EHR
again in this final rule in section II.d. 1814(l)(3)(A), and 1886(n)(1) of the Act, technology for a payment year under
Others are highly related to existing an EP, eligible hospital or CAH must be Medicare to qualify as meaningful use
objectives, while still others were not a meaningful EHR user for the relevant under Medicaid.
discussed in any way in the proposed EHR reporting period in order to qualify We stated in the proposed rule that
rule. The suggested objectives and for the incentive payment for a payment we believe that given the strong level of
measures for Stages 2 and 3 include the year in the Medicare FFS EHR incentive interaction on meaningful use
following: program. Sections 1848(o)(2)(A) and encouraged by the HITECH Act, there
• Use of evidence-based order sets. 1886(n)(3)(A) of the Act provide that an would need to be a compelling reason
• Electronic medication EP and an eligible hospital shall be to create separate definitions for
administration record (eMAR). considered a meaningful EHR user for Medicare and Medicaid. We declared in
• Bedside medication administration an EHR reporting period for a payment the proposed rule that we had found no
support (barcode/RFID). year if they meet the following three such reasons for disparate definitions in
• Record nursing assessment in EHR. requirements: (1) Demonstrates use of our internal or external discussions. To
• Record nursing plan of care in EHR. certified EHR technology in a the contrary, stakeholders have
• Record physician assessment in meaningful manner; (2) demonstrates to expressed strong preferences to link the
EHR. the satisfaction of the Secretary that Medicare and Medicaid EHR incentive
• Record physician notes in EHR. certified EHR technology is connected programs wherever possible. Hospitals
• Multimedia/Imaging integration. in a manner that provides for the are entitled to participate in both
• Generate permissible discharge electronic exchange of health programs, and we proposed to offer EPs
prescriptions electronically. information to improve the quality of an opportunity to switch between the
• Contribute data to a PHR. health care such as promoting care Medicare and Medicaid EHR incentive
• Record patient preferences coordination, in accordance with all programs. Therefore, we proposed to
(language, etc). laws and standards applicable to the create a common definition of
• Provide electronic access to patient- exchange of information; and (3) using meaningful use that would serve as the
specific educational resources. its certified EHR technology, submits to definition for EPs, eligible hospitals and
• Asking patients about their the Secretary, in a form and manner CAHs participating in the Medicare FFS
experience of care. specified by the Secretary, information and MA EHR incentive program, and
Response: With one exception on clinical quality measures and other the minimum standard for EPs and
discussed under the CPOE objective, we measures specified by the Secretary. eligible hospitals participating in the
continue to believe that finalizing The HITECH Act requires that to receive Medicaid EHR incentive program. We
specific objectives and measures for a Medicaid incentive payment in the clarified that under Medicaid this
later stages is inappropriate. One of the initial year of payment, an EP or eligible proposed common definition would be
greatest benefits of the phased stage hospital may demonstrate that they have the minimum standard. We proposed to
approach is the ability to consider the engaged in efforts to ‘‘adopt, implement, allow States to add additional objectives
impact and lessons of the prior stage or upgrade certified EHR technology.’’ to the definition of meaningful use or
when formulating a new stage. Many Details, including special timeframes, modify how the existing objectives are
commenters supported our discussion on how we define and implement measured; the Secretary would not
of later stages for this very reason. In ‘‘adopt, implement, and upgrade’’ are in accept any State alternative that does
addition, we do not believe it is section II.D.7.b.2 of this final rule. For not further promote the use of EHRs and
appropriate to finalize objectives for any subsequent payment years, or the first healthcare quality or that would require
stage of meaningful use that were not payment year if an EP or eligible additional functionality beyond that of
specifically discussed in the proposed hospital chooses, section certified EHR technology. See section
rule, as doing so would deprive the 1903(t)(6)(C)(i)(II) of the Act, prohibits II.D.8. of this final rule for further
public the opportunity to comment on receipt of an incentive payment, unless details.
the objective in question. Nevertheless, ‘‘the Medicaid provider demonstrates For hospitals, we proposed to exercise
we thank commenters for the thoughtful meaningful use of certified EHR the option granted under section
comments received, and expect to take technology through a means that is 1903(t)(8) of the Act and deem any
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their input into consideration when in approved by the State and acceptable to Medicare eligible hospital or CAH who
future rulemaking we consider the Secretary, and that may be based is a meaningful EHR user under the
additional or revised criteria and upon the methodologies applied under Medicare EHR incentive program and is
measures to adopt for the stage 2 and section 1848(o) or 1886(n).’’ (Sections otherwise eligible for the Medicaid
stage 3 definitions of meaningful use. 1848(o) and 1886(n) of the Act refer to incentive payment to be classified as a
Comment: A commenter indicated the Medicare EHR incentive programs meaningful EHR user under the
that attestation is an insufficient means for EPs and eligible hospitals/CAHs Medicaid EHR incentive program. This

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Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations 44325

is applicable only to eligible hospitals EHR incentive program during Stage 1 this request in their State Medicaid HIT
and CAHs, as EPs cannot of meaningful use, these are limited to: Plan, should address any potential
simultaneously receive an incentive Objective: Generate lists of patients by barriers for providers in achieving this
payment under both Medicare and specific conditions to use for quality objective.
Medicaid. improvement, reduction of disparities, Objective: Capability to submit
We solicited comments as to whether research, or outreach. electronic syndromic surveillance data
there are compelling reasons to give the Measure: Generate at least one report to public health agencies and actual
States additional flexibility in creating listing patients of the EP or eligible transmission according to applicable
disparate definitions beyond what was hospital with a specific condition. law and practice.
proposed. In addition, if commenting in Example: Generate lists of patients Measure: Performed at least one test
favor of such disparate definitions, we with the following conditions: of certified EHR technology’s capacity to
also asked interested parties to comment depression, diabetes, obesity, etc. This submit electronic syndromic
on whether the proposal of deeming would not be for reporting to the State surveillance data to public health
meeting the Medicare definition as but to draw EPs’ or eligible hospitals’ agencies and follow-up submission if
sufficient for meeting the Medicaid attention in order to better manage their the test is successful (unless none of the
definition remains appropriate under patient population. States would also be public health agencies to which an EP
the disparate definitions. This is permitted to request CMS approval to or eligible hospital submits such
applicable only to hospitals eligible for include this in the core set for all EPs information have the capacity to receive
both the Medicare and Medicaid and/or eligible hospitals. the information electronically).
incentive programs. Furthermore, if a Objective: Capability to submit Example: State could specify the
State has CMS-approved additional electronic data to immunization standards-based means of transmission
meaningful use requirements, hospitals registries of Immunization Information and/or the destination of this data.
deemed as meaningful users by Systems and actual submission in States would also be permitted to
Medicare would not have to meet the accordance with applicable law and request CMS approval to include this
State-specific additional meaningful use practice. objective in the core list for all EPs and
requirements in order to qualify for the Measure: Performed at least one test eligible hospitals. The justification for
Medicaid incentive payment. of certified EHR technology’s capacity to this request in their State Medicaid HIT
Comment: Most commenters believe submit electronic data to immunization Plan, should address any potential
that States should not be allowed the registries and follow up submission if barriers for providers in achieving this
option to add to or change the the test is successful (unless none of the objective.
meaningful use requirements for the immunization registries to which the EP We reiterate that we will not approve
Medicaid EHR incentive program. The or eligible hospital submits such any requests that would require EHR
commenters’ main reason for information have the capacity to functionality above and beyond that
standardizing the meaningful use received the information electronically). included in the ONC EHR certification
requirements for both Medicare and Example: State could point to a criteria as finalized for Stage 1 of
Medicaid is to eliminate administrative specific immunization registry that meaningful use.
burden on both providers and EHR supports standards-based transmission Comment: Several commenters
vendors to accommodate programming of data and dictate how that information requested that CMS affirm the ability of
and reporting using different technical is transmitted. States would also be States to require additional meaningful
specifications for the same or similar permitted to request CMS approval to use criteria for all eligible professionals
measures. include this objective in the core list for and hospitals (pursuant to §§ 495.316(a),
Response: After consideration of the all EPs and eligible hospitals. The 495.316(d)(2)), regardless of whether
comments received, we are finalizing justification for this request in their those entities were deemed eligible
the provisions regarding possible State Medicaid HIT Plan, should through Medicare.
differences in the definition of address any potential barriers for Response: Section 1903(t)(8) provides
meaningful use between Medicare and providers in achieving this objective. authority for the Secretary to ‘‘deem
Medicaid with the following revisions. Objective: Capability to submit satisfaction of requirements for * * *
We believe that over time the option to electronic data on reportable (as meaningful use for a payment year
add to or change the floor definition of required by state or local law) lab results under title XVIII to be sufficient to
meaningful use might represent an to public health agencies and actual qualify as meaningful use under
important policy tool for States and submission in accordance with [1903(t)].’’ We continue to believe that
therefore CMS plans to review and applicable law and practice. allowing deeming ensures that hospitals
adjudicate these requests over the Measure: Performed at least one test eligible for both programs are able to
duration of the program. For Stage 1 of of certified EHR technology’s capacity to focus on only one set of measures,
meaningful use, we have revised the submit electronic data on reportable lab without requiring duplication of effort
definition of meaningful use in response results to public health agencies and or confusion regarding meaningful use
to the many comments and are requiring follow-up submission if the test is standards. Thus, hospitals eligible for
an overall lower bar and an approach successful (unless none of the public both Medicare and Medicaid incentive
that is more flexible. On the other hand, health agencies to which an eligible payments will be deemed for Medicaid
we wish to support the ability for States hospital submits such information have if they have met the meaningful use
to reinforce their public health priorities the capacity to receive the information definition through Medicare, even if a
and goals based upon their existing electronically). State has an approved State-specific
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public health infrastructure and Example: State could specify the definition of meaningful use. States
maturity. For that reason, we, for Stage standards-based means of transmission cannot withhold a Medicaid EHR
1, will only entertain States’ requests to and/or the destination of this data. incentive payment from dually eligible
tailor the Stage 1 meaningful use States would also be permitted to hospitals if they have met all the
definition as it pertains specifically to request CMS approval to include this eligibility criteria for Medicaid, and
public health objectives and data objective in the core list for all and have met the Medicare definition for
registries. For purposes of the Medicaid eligible hospitals. The justification for meaningful use.

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Because of this comment, we are Further details about this policy option MedPAC, was to divide the meaningful
revising section § 495.4 of our will be included in future rulemaking use objectives into two categories, a
regulations to indicate that eligible and subject to public comment. ‘‘core set’’ of objectives and ‘‘menu set’’
hospitals who are meaningful users of objectives. To be a considered a
c. Stage 1 Criteria for Meaningful Use
under the Medicare EHR incentive meaningful user under this approach, an
payment program are deemed as In the proposed rule we proposed that EP, eligible hospital, or CAH would be
meaningful users under the Medicaid to qualify as a meaningful EHR user for required to satisfy (1) all core set of
EHR incentive payment program, and 2011, EPs, eligible hospitals or CAHs objectives, and (2) a specified
need not meet additional criteria must demonstrate that they meet all of percentage of the menu set of objectives,
imposed by the State. While this is not the objectives and their associated with the EP, eligible hospital, or CAH
a new requirement, it was not measures as set forth in proposed free to select which of the menu set of
previously listed in regulations. § 495.6. We further proposed and objectives it would satisfy. For example,
Comment: A commenter asked that finalize in this final rule that except if five objectives were in the core set all
CMS adopt and affirm the deeming where otherwise indicated, each EPs, eligible hospitals, and CAHs would
approach in its final rule and ensure objective and its associated measure have to meet those objectives. If twenty
that the regulatory language reflects this must be satisfied by an individual EP as objectives were in the menu set, then
approach. determined by unique National Provider EPs, eligible hospitals, and CAHs would
Response: We agree and have Identifiers (NPIs) and an individual not have to meet one or more of those
included in the final rule regulation hospital as determined by unique CMS objectives. Commenters varied widely
language that hospitals that are certification numbers (CCN). as to which objectives should be
meaningful users under the Medicare included in the core set of objectives, as
Discussion of Whether an EP, Eligible
EHR Incentive Program are deemed well as the percentage of menu set
Hospital or CAH Must Meet All Stage 1
meaningful users under the Medicaid objectives an EP, eligible hospital, or
Meaningful Use Objectives and Their
EHR Program. CAH must satisfy.
Associated Measures
Comment: Several commenters Some commenters suggested that we
requested that CMS not deem hospitals Comment: Commenters almost simply reduce the number of objectives
having met the meaningful use unanimously said that requiring an EP, required for Stage 1 of meaningful use.
requirements for the Medicare EHR eligible hospital or CAH to meet all of Recommendations in this regard varied
Incentive Payment, as having fulfilled the objectives and their associated from reducing the required objectives to
the meaningful use requirements for the measures in order to qualify as a only just a few (the lowest number being
State’s Medicaid EHR Incentive meaningful EHR user was too ambitious three), limiting the required objectives
Payment. The commenters noted that if given the current state of EHR to only to those objectives that affect
a State sought for acute care hospitals to technology, adoption levels, the health outcomes of individual patients,
participate in their statewide health timeline for certification of EHR to targeted elimination of a few
information exchange and yet those technologies, the realities of objectives.
hospitals did not have to do so in order implementing EHR technology and the Finally, some commenters suggested
to qualify for both the Medicare and timeline proposed for Stage 1 of that we eliminate all of the measures
Medicaid EHR Incentive Payments, then meaningful use in our proposed rule. associated with the Stage 1 meaningful
they would have no motivation to do so. Most of the commenters suggested use objectives and only require that EPs,
The commenters would like acute care alternatives that they believed would eligible hospitals, and CAHs attest that
hospitals eligible for both the Medicare support the health care policy priorities they have attempted to meet each of the
and Medicaid EHR Incentive Program to of Stage 1. Several different alternatives objectives.
have to comply with any State-specific were proposed. The first alternative Response: After reviewing the
meaningful use requirements, in would be to require a specified comments, we agree that requiring that
addition to the Medicare floor percentage of the Stage 1 meaningful EPs, eligible hospitals, and CAHs satisfy
definition. use objectives and associated measures, all of the objectives and their associated
Response: In consideration of the with an EP, eligible hospital or CAH free measures in order to be considered a
comments received, CMS adopts its to select which of the objectives and meaningful EHR user would impose too
proposed preamble language about associated measures it would satisfy. great a burden and would result in an
deeming hospitals and adds the For example under our proposed unacceptably low number of EPs,
corresponding regulation text. This is objectives and associated measures, if eligible hospitals, and CAHs being able
necessary for Stage 1 of meaningful use an EP were required to meet 20 percent, to qualify as meaningful EHR users in
in particular, where we believe it is then an EP would be considered a the first two years of the program. In
crucial to prevent additional burden on meaningful EHR user if he or she considering an alternative approach, we
providers and foster eligible hospitals’ satisfied any five of the proposed have sought to develop an alternative
path to successful EHR adoption and twenty–five objectives and associated that is responsive to some degree to all
meaningful use. In addition, as already measures. Most commenters suggesting the concerns raised by the commenters.
noted, for Stage 1, we will not entertain this alternative envisioned that later We have tried to reduce the
States’ requests to alter the floor stages of meaningful use would require requirements both in number required
definition of meaningful use as codified that EPs, eligible hospitals, and CAHs and in the thresholds of the associated
in this final rule except for specific satisfy a higher of the percentage of the measures and provide some flexibility
public health objectives. That thereby objectives and associated measures. For as well. At the same time, however, we
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reduces the possible differences example if 20 percent of the objectives must be mindful of the relevant
between the Medicare and Medicaid and associated measures were required statutory requirements. Sections 1848
definitions of meaningful use. As part of for Stage 1, then 50 percent might be (o)(2)(A) and 1886(n)(3) of the Act,
Stage 2 of meaningful use, CMS might required in Stage 2. specify three requirements for
consider States requests to tailor After a fixed percentage, the meaningful use: (1) Use of certified EHR
meaningful use as it pertains to health suggestion next favored by commenters, technology in a meaningful manner (for
information exchange, for example. including the HIT Policy Committee and example, electronic prescribing); (2) that

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the certified EHR technology is can achieve in the areas of public objectives satisfied by an EP, eligible
connected in a manner that provides for health, privacy and security, hospital, or CAH.
the electronic exchange of health engagement of patients and their After consideration of the public
information to improve the quality of families and efficiency of care that may comments received, we are establishing
care; and (3) that, in using certified EHR not improve health outcomes, but have a core set of objectives with associated
technology, the provider submits to the significant other benefits such as measures and a menu set of objectives
Secretary information on clinical quality engaging patients more fully in with associated measures. In order to
measures and such other measures decisions affecting their health and qualify as a meaningful EHR user, an
selected by the Secretary. We believe reducing costs through increased EP, eligible hospital, or CAH must
that each EP, eligible hospital, and CAH efficiency of care. We believe that all of successfully meet the measure for each
must meet at least one objective within these have a significant impact on objective in the core set and all but five
each of the three requirements for health outcome priorities. Therefore, we of the objectives in the menu set. With
meaningful use. We are concerned that do not categorically reduce the number one limitation, an EP, eligible hospital,
if we were to give EPs, eligible of objectives for Stage 1 definition of or CAH may select any five objectives
hospitals, and CAHs full discretion to meaningful use. We consider requests to from the menu set to be removed from
select which meaningful use objectives defer an objective to later stages of the consideration for the determination of
they will satisfy, some providers would meaningful use criteria or eliminate a qualifying as a meaningful EHR user.
not choose one or more objectives specific objective below in our Further discussion of the objectives,
within each of the three statutory discussion of each objective. including additional details about their
requirements for meaningful use. Comment: Another alternative that inclusion in the core set, can be found
Furthermore, we are concerned that was recommended by a significant at each objective.
affording EPs, eligible hospitals, and We believe that establishing both a
number of commenters was that we base
CAHs such flexibility as to which core and a menu set adds flexibility and
the incentive payment amount on the
meaningful use objectives to meet allows the minimum statutory set to be
number of stage 1 meaningful use
would delay many of the goals outlined met. In determining the objectives to
objectives satisfied by an EP or eligible
for meaningful use in section II.a.2. of include in the core set, we looked at all
hospital, with those satisfying more
this final rule. If in choosing what comments, especially those of the HIT
objectives eligible for a higher incentive
objectives to defer, one provider chooses Policy Committee and other
payment amount. While some
to focus on improving processes to commenters who recommended some
commenters varied in the specifics or
improve healthcare quality, another required and optional elements. The
did not provide specifics, generally we
HITECH Act requires the use of health
chooses to focus on being able to take this to mean that if an EP, eligible information technology in improving
exchange health information and yet hospital, or CAH met half of the the quality of health care, reducing
another on engaging patients and objectives then they would receive half medical errors, reducing health
families it is possible that we would fail of the incentive payment they would disparities, increasing prevention and
to accomplish any of these goals at a have received had they met all the improving the continuity of care among
population level. For these reasons, we objectives. health care settings. In defining the core
do not believe it would be appropriate Response: The HITECH Act does not set of meaningful use objective, we
to afford providers the unlimited give us the authority to award partial believe the most crucial aspect to
flexibility to select which of the payments. As discussed elsewhere in consider is meeting the three statutory
meaningful use objectives they will this final rule, sections 1848(o)(1)(A) of guidelines provided in the HITECH Act
meet. Rather, as explained below, we the Act specifies the payment incentive and discussed in section II.A.2.a of this
believe providers at a minimum should amount to which an EP who is a final rule. Second is to identify those
have to satisfy a core set of objectives in meaningful EHR user is entitled. objectives that are most crucial to laying
order to qualify as meaningful EHR Similarly, section 1886(n)(2) of the Act the foundation for obtaining value from
users. sets forth a formula for calculation of meaningful use of certified EHR
Similarly, while we agree that merely incentive payment amount to which an technology. Third, we believe that
reducing the number of objectives eligible hospital that is a meaningful meaningful use should be patient-
would make meaningful use easier to EHR user is entitled. Similarly, section centered so we focus on getting the most
achieve for most providers, we believe 1814(l)(3)(A) of the Act sets forth a value to the patient. We believe the
that this reduction does not afford the formula for calculation of incentive recommendation of the HIT Policy
same flexibility to all providers to payment amount to which an eligible Committee accomplishes third criteria,
account for their individual difficulties hospital that is a meaningful EHR user but falls short of the first and second. To
in meeting meaningful use that some of is entitled. Similarly, section accomplish the first criteria, we add the
the other alternatives do as allowing a 1903(t)(4)(B) of the Act sets parameters objective of submitting clinical quality
provider to choose certain objectives to for determining the Medicaid EHR measures to CMS or the States and the
defer. Due to any number of incentive for Medicaid EP. None of objective of exchanging key clinical
circumstances such as EHR adoption these parameters are related to information among providers of care
level, availability of health information meaningful use. Similarly, section and patient authorized entities. To
exchange network, size of practice or 1903(t)(5)(A) of the Act sets forth a accomplish the second, we add several
hospital, etc., an objective that is easy formula for calculation of the incentive additional objectives to the core set of
for one EP to achieve might be very payment amount to which a Medicaid measures as critical elements pertinent
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difficult for another EP. Under this eligible hospital is entitled. As we do to the management of patients. We have
alternative, no allowance is made for not have the authority to alter these received a number of comments in
those differences. Finally, we disagree statutory formulas for calculating the support of these particular measures as
that meaningful use should be limited to incentive payment amounts under critical to the management of patients
improving the health outcomes of Medicare and Medicaid, we cannot pro (maintaining an up-to-date problem list,
individual patients. There are rate the incentive payment amount active medication list, active allergy list,
significant gains that meaningful use based on the number of meaningful use smoking history and incorporate clinical

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44328 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

lab tests into EHR as structured data) in In addition, achieving Stage 1 a core set objective. Similarly, any
comparison to other requirements. The meaningful use means demonstration of eligible hospital or CAH that did not
addition of two other functional progress in each of the five healthcare have any requests for electronic copy of
objectives (drug-drug and drug-allergy outcome priorities outlined in the discharge instructions would not be able
features) as core measures are for proposed rule and discussed again later to become a meaningful EHR user. In
improved patient-safety. All of the listed in this section. Only one of these addition, if this were to occur for a
elements are integral to the initial or on- priorities is not represented in the core significant number of menu set
going management of a patient’s current set, population and public health. As we objectives, the flexibility for the EP,
or future healthcare. While each have discussed in this section we do not eligible hospital, or CAH to use the five
element is important in the management want any priority to be overlooked due objectives to account for other concerns
of patients in and of itself, the aggregate to the flexibility we have added to Stage such as implementation struggles or
of the elements elevates the importance 1 of meaningful use; therefore, all EPs workflow process redesign would be
of clinical information to not only the and hospitals must choose at least one curtailed. To account for this
primary provider but for all members of of the population and public health possibility, we have modified each
the interdisciplinary team involved in measures to demonstrate as part of the objective and measure to indicate when
the patient’s care. The HITECH Act menu set. This is the only limitation there is an option for an EP, eligible
statutorily requires the use of health placed on which five objectives can be hospital, or CAH to report that the
information technology in improving deferred from the menu set. objective/measure is inapplicable to
the quality of health care, reducing Discussion on Whether Certain EP, them, because they have no patients or
medical errors, reducing health Eligible Hospital or CAH Can Meet all no or insufficient number of actions that
disparities, increasing prevention, and Stage 1 Meaningful Use Objectives would allow calculation of the
improving the continuity of care among Given Established Scopes of Practice meaningful use measure. This will
health care settings. These core set of allow an EP, eligible hospital, or CAH
measures are also foundational and In the proposed rule, we specifically to qualify as a meaningful EHR user
aligned with each other. For example, encouraged comments on whether without being required to meet
electronic copies of health information certain providers may have difficulty objectives we have specified as
given to patient will be useless if it does meeting one or more of the objectives potentially inapplicable. We note that
not contain basic information such as a due to their provider type or chosen the exclusions to meaningful use
specialties objectives/measures are specific to each
problem list, medication list or allergy
Comment: We received many
list. Exchange of information to other objective/measure. In our discussion of
comments, both general and specific,
members of the health care team across each specific objective/measure (which
that certain providers or specialists may
settings will depend on having not be able to comply with certain occurs later in this preamble), we have
structured data of these elements. objectives because they are beyond the identified specific exclusions where
Therefore, in support of the HITECH Act scope of their licensing authority or they exist. Providers wishing to claim
in meeting the statutory requirements, because they are outside the scope of that an objective/measure is
we have expanded the core set of their standard of practice. For example, inapplicable to them would need to
measures to include these fundamental chiropractors do not have prescribing meet the criteria of such an exception.
elements to improve patient care. Below authority and thus may not make use of After consideration of the public
we list the objectives included in the an EHR technology’s e-prescribing comments received, we have identified,
core set of meaningful use objectives. function and rheumatologists may not for each meaningful use objective,
—Use CPOE require information on vital signs. whether the EP, eligible hospital, or
—Implement drug to drug and drug While comments on this potential non- CAH may attest that they did not have
allergy interaction checks applicability primarily focused on EPs, any patients or insufficient actions on
—E-Prescribing (EP only) we did receive comments that some which to base a measurement of a
—Record demographics objectives may not be relevant to meaningful use for the EHR reporting
—Maintain an up-to-date problem list smaller or specialized eligible hospitals period. For objectives in the core set,
—Maintain active medication list as well. such an attestation would remove the
—Maintain active medication allergy Response: We believe the division of objective from consideration when
list the meaningful use objectives into a determining whether an EP, eligible
—Record and chart changes in vital core set and a menu set may minimize hospital, or CAH is a meaningful EHR
signs the impact of including among the user. In other words, the EP, eligible
—Record smoking status meaningful use objectives one or more hospital, or CAH could satisfy the core
—Implement one clinical decision objectives that certain providers or set objectives by satisfying all remaining
support rule specialists may be unable to satisfy as objectives included in the core set. For
—Report CQM as specified by the the EP, eligible hospital, or CAH can objectives in the menu set, such an
Secretary defer five objectives from the menu set. attestation would also remove the
—Electronically exchange key clinical However, if the EP, eligible hospital or objective from consideration when
information CAH has an insurmountable barrier to determining whether an EP, eligible
—Provide patients with an electronic meeting an objective in the core set or hospital, or CAH is a meaningful EHR
copy of their health information a significant number in the menu set user. For example, if for one objective
—Provide patients with an electronic then the problem remains. For example, included in the menu set an EP attests
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copy of their discharge instructions without any consideration on an EP, that he or she did not have any patients
(Eligible Hospital/CAH Only) eligible hospital or CAH’s capability to or insufficient actions during the EHR
—Provide clinical summaries for meet the measure associated with a core reporting period on which to base a
patients for each office visit (EP Only) objective any EP that could not order measurement of a meaningful use
—Protect electronic health information medications requiring a prescription objective, rather than satisfy 5 of the 10
created or maintained by certified would not be able to become a meaningful use objectives included in
EHR meaningful EHR user as e-prescribing is the menu set for EPs, the EP need only

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satisfy 4 of the 9 remaining meaningful certified EHR technology. An EP for multiple locations and only has certified
use objectives included in the menu set who does not conduct 50 percent of EHR technology for 80 percent of their
for EPs their patient encounters in any one patient encounters, then the
practice/location would have to meet denominator is only those unique
EPs Practicing in Multiple Practices
the 50 percent threshold through a patients seen at locations where
Another situation where flexibility combination of practices/locations certified EHR technology is available.
may be needed in order for an EP to equipped with certified EHR We reiterate that this is not to account
become a meaningful EHR user is the technology. For example, if the EP for certified EHR technology downtime,
situation where an EP may provide care practices at both a Federally Qualified Certified EHR technology is available at
in multiple practices or multiple Health Center (FQHC) and within his or a location if it is available at the start of
locations. We proposed a policy to her individual practice, we would the EHR reporting period regardless of
account for EPs practicing in multiple include in our review both of these its actual availability for any given day
practices and settings. We discussed in locations and certified EHR technology during the EHR reporting period.
the proposed rule that we believe it is would have to be available at the After consideration of the comments
unlikely for an EP to use one record location where the EP has at least 50 received, we are finalizing this
keeping system for one patient percent of their patient encounters. requirement as proposed.
population and another system for Comment: Some commenters
another patient population at one Discussion of the Burden Created by the
recommended that 50 percent or more
location. We are concerned about the Measures Associated With the Stage 1
of the patient encounters must occur at
application of the measures associated Meaningful Use Objectives
the practice location that receives the
with the meaningful use objectives for incentive payment. Comment: Many commenters
EPs who see patients in multiple Response: As discussed in section expressed concerns about the
practices or multiple locations. If an EP II.A.4 of this final rule, an EP may difficulties of capturing the
does not have certified EHR technology assign their incentive payment to other denominators for the measures that are
available at each location/practice practices. We do not believe that expressed as percentages. They pointed
where they see patients it could become limiting practices and EPs to only out that the formulas in the proposed
impossible for the EP to successfully considering the location that receives an rule would require providers to conduct
become a meaningful EHR user based on incentive payment provides advantages labor-intensive counts of paper
the measures associated with the to the program. The requirement documents such as prescriptions or
meaningful use objectives. We do not suggested by commenters would laboratory results in order to compute
seek to exclude EPs who meaningfully potentially cause some EPs not to meet the denominators of the percentage
use certified EHR technology when it is the 50 percent threshold even if through based measures. Some commenters
available because they also provide care a combination of practices they may use suggested that we adopt alternative
in another practice where certified EHR certified EHR technology for far more measurement mechanisms, for example
technology is not available. Therefore, than 50 percent of their patient establishing simple counts of electronic
we proposed that all measures be encounters. occurrences, while others proposed that
limited to actions taken at practices/ Comment: Some commenters denominators be computed utilizing
locations equipped with certified EHR requested clarification of our proposed only data collected in the certified EHR
technology. A practice is equipped if statement ‘‘Therefore, we proposed that technology.
certified EHR technology is available at all measures be limited to actions taken Response: We acknowledge that the
the beginning of the EHR reporting at practices/locations equipped with percentage-based measures, as
period for a given geographic location. certified EHR technology’’ expressed in the proposed rule, would
Equipped does not mean the certified Response: We mean this statement to create a reporting burden for EPs,
EHR technology is functioning on any be that as long as an EP has certified eligible hospitals, and CAHs, and we
given day during the EHR reporting EHR technology available for 50 percent examined a number of alternatives that
period. Allowances for downtime and or more of their patient encounters potentially reduce the burden of
other technical issues with certified during the EHR reporting period they reporting.
EHR technology are made on an only have to include those encounters In the proposed rule, we discussed
objective-by-objective basis as discussed where certified EHR technology is the option of counts instead of
later in this section. We are concerned available at the start of the EHR percentages and due to comments
that seeing a patient without certified reporting period. We discuss the received have reassessed this option in
EHR technology available does not measures later in this section of the final the final rule. This approach clearly has
advance the health care policy priorities rule, but an illustrative example would the advantage of simplifying the
of the definition of meaningful use. We be the objective of maintain an up-to- process. For example, rather than
are also concerned about possible date problem list. The measure counting the number of prescriptions
inequality of different EPs receiving the associated with this objective is ‘‘More transmitted electronically and then
same incentive, but using certified EHR than 80% of all unique patients seen by dividing by the total number of
technology for different proportions of the EP or admitted to the eligible prescriptions, the EP would simply
their patient population. We believe that hospital’s or CAH’s inpatient or need to count the number of
an EP would have the greatest control of emergency department (POS 21 or 23) electronically transmitted prescriptions
whether certified EHR technology is have at least one entry or an indication until a benchmark number is passed. If
available in the practice in which they that no problems are known for the the benchmark number is exceeded,
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see the greatest proportion of their patient recorded as structured data.’’ then the provider meets the measure.
patients. We proposed that to be a Therefore, if an EP only practices at one However, there are several shortcomings
meaningful EHR user an EP must have location or has certified EHR technology to this approach. First, we received little
50 percent or more of their patient available at all practice locations then input from commenters as to where the
encounters during the EHR reporting the denominator would be all unique benchmark numbers for the various
period at a practice/location or patients seen during the EHR reporting objectives should be set and any
practices/locations equipped with period. However, if an EP practices at benchmark set now would not benefit

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44330 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

from public comment without believe that it is reasonable to require an limited set of data, but an EP, eligible
significantly delaying the Medicare and EP, eligible hospital, or CAH to know hospital, or CAH would still have to
Medicaid EHR incentive programs. (One how many unique patients they care for have sufficient information in certified
exception was that a number of in the EHR reporting period and EHR technology to meet the measures
commenters suggested using the PQRI therefore maintain that denominator associated with Stage 1 of meaningful
measure for e-prescribing, which is the where it applies. The maintenance of use. For example, an EP might be able
generation of at least one eRx associated measures using the patient as the to save a record with just a patient’s
with a patient visit on 25 or more denominator as encompassing all name, but as the record would lack any
unique events during the reporting patients ensures a certain level of information this patient would count in
period.) Setting the limit too high would utilization of certified EHR technology the denominator, but not the numerator
disadvantage small providers, since they by the EP, eligible hospital, or CAH. If for many objectives. Electronic Copy of
would have smaller patient populations, a measure encompassing all patients has a Patient’s Health Information Provided
while setting the limit too low would a threshold of 80 percent, then at least upon Request Example: An EP
create requirements for larger providers 80 percent of the patients’ records must maintains 1,000 patient records in their
that would be so limited as to be be maintained using certified EHR certified EHR technology. Of those
meaningless. A larger provider could technology otherwise the EP, eligible patients, fifty make requests for
implement the functionality for a much hospital or CAH could not possibly electronic copies of their health
shorter period than the EHR reporting meet the threshold. We note a number information. The EP provides all of the
period and meet the count. In either of measures included in the core set electronic copies within three business
case, it would be difficult to establish a (such as ‘‘Record Demographics’’ and days. The denominator is 50, the
trajectory in later stages that would ‘‘Maintain an Up-to-Date Problem List’’) numerator is 50, and the EP’s percentage
result in meaningful progress being require an analysis of all unique is 100 percent. If the EP captures
made by both small and large providers. patients, and not just patients whose requests for information as structured
We then assessed the option of records are maintained in certified EHR data, the calculation could be automated
limiting the occurrences counted in the technology As discussed later the by the certified EHR technology. If the
denominator to those included in the thresholds for maintaining an up-to-date EP does not capture all the requests as
provider’s certified EHR technology. As problem list, medication list and structured data then more manual
an example, if an EP captures 1,000 medication allergy list are set at 80 review may be required. We will likely
prescriptions as structured data in percent. We believe these thresholds revisit the methodology in Stage 2,
certified EHR technology, and will create a baseline that ensures that where we would expect that at least
electronically transmits 500 of these EPs, eligible hospitals and CAHS are basic EHR functionality has been
prescriptions, the EP’s certified EHR maintain a minimum percentage of implemented throughout the provider
technology generated score would be 50 patient records in certified EHR enterprise.
percent. This approach does simplify technology, and allows the provider After consideration of public
the computation process, since this community to advance toward the comments, we are limiting the following
approach does not have to take into longer-term objective of capturing all objectives and their associated measures
account whether some prescriptions patient data in certified EHR to patients whose records are
were not included or included as technology. For those measures that maintained using certified EHR
unstructured data in the certified EHR focus on the recording of actions or technology. Specific information on
technology. However, it does not
subset of patients to generate the how to determine inclusion in the
demonstrate the extent to which the
denominator, we limit the measures to denominator and numerator is
provider has used the certified EHR
the information for patients whose discussed in the full discussion of each
technology. For example, a provider that
records are maintained in certified EHR objective later in this final rule.
has captured only 10 prescriptions in
technology. We offer the following • Use CPOE
the certified EHR technology as
structured data, but writes 1,000
examples that relate to the e-prescribing • Generate and transmit permissible
and the provision of electronic copy of prescriptions electronically (eRx)
prescriptions because the provider
achieved only a limited use of their
a patient’s health information: • Record and chart changes in vital
certified EHR technology would also E-Prescribing Example: An EP orders signs
score 50 percent by electronically 1,000 prescriptions for patients whose • Record smoking status for patients
transmitting only 5 prescriptions records are maintained in their certified 13 years old or older
according to an automatic report from EHR technology and 500 of those are • Record advance directives for
the certified EHR technology. Again, transmitted electronically. The EP’s patients 65 years old or older
this methodology does not lead denominator is 1,000 prescriptions, the • Incorporate clinical lab-test results
providers toward an upward trajectory numerator is 500 prescriptions, and into certified EHR technology as
of both certified EHR technology their score is 50 percent. If the EP structured data
deployment and accomplishment of captures all 1,000 prescriptions as • Provide patients with an electronic
meaningful use. structured data the calculation could be copy of their health information
We selected a third option, which we automated by the certified EHR (including diagnostic test results,
believe addresses the shortcomings of technology. If the EP does not capture problem list, medication lists,
the second option while still preserving all 1,000 prescriptions as structured medication allergies), upon request
much of the simplicity of that approach. data than more manual review may be • Provide patients with an electronic
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In our approach, we focus on those required. We would define ‘‘records copy of their discharge instructions at
measures whose denominator is not maintained in the certified EHR time of discharge, upon request
based on all patients, but rather a subset technology’’ to include any patient for • Provide clinical summaries for
of patients or actions such as the which sufficient data was entered in the patients for each office visit
ordering of a lab test or the recording of certified EHR technology to allow the • Send reminders to patients per
a patient’s request for an electronic copy record to be saved, and not rejected due patient preference for preventive/
of their discharge instructions. We to incomplete data. This may be a more follow-up care

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• Perform medication reconciliation today. For some objectives, all aspects of discussed in the following section. More
at relevant encounters and each the objective are within the control of detailed specifications and guidance on
transition of care the EP, eligible hospital, or CAH. Other calculating the measures will be issued
• Provide summary care record for objectives rely on electronic exchange soon after the publication of this final
each transition of care and referral with partners or external infrastructure rule.
Discussion on Meaningful Use over which EPs, eligible hospitals and As we described in the proposed rule,
Relationship to Certified EHR CAHs may have little influence and no in discussing the objectives that
Technology control. We have attempted to constitute the Stage 1 criteria of
accommodate these differences when meaningful use, we adopted a structure
Comment: We received several we select the Stage 1 measure for a derived from recommendations of the
comments requesting more specific given objective. The measure more HIT Policy Committee of grouping the
information of how certified EHR objectives under care goals, which are in
accurately reflects our view of what is
technology will accomplish meaningful turn grouped under health outcomes
feasible for Stage 1 than the objective
use. Some commenters expressed policy priorities. We believe this
itself. The certification criteria
concern that patient clinical outcome structural grouping provides context to
necessarily reflect more on the measure
measurement and improvement was not the individual objectives; however, the
than the objective, as full compliance
addressed explicitly in the requirements grouping is not itself an aspect of
of certified EHR technology, but rather with an objective is beyond the scope of
what can be accomplished for a meaningful use. The criteria for
the requirements focused data entry and meaningful use are based on the
provision of data electronically. significant number of EPs, eligible
hospitals or CAHs in our timeframe for objectives and their associated
Response: One of the main purposes
Stage 1. This rationale was our assertion measures.
of certifying EHR technology is to
in the proposed rule as the justification We will now review the comments for
provide the EP, eligible hospital, or
for measures that represent less than full each objective and measure and make
CAH with confidence that the
achievement of their objective. This is changes to our original proposal or
technology will not be the limiting
further supported by some of the finalize as proposed.
factor in the achievement of meaningful
comments received although for any (1) Objectives and Their Associated
use. As such, all questions of how or
given objective the comments Measures
will certified EHR technology be able to
addressing that objective were a small The HIT Policy Committee identified
accomplish meaningful use broadly or
fraction of the total number of as its first health outcomes policy
at a specific objective level are best
comments received and views on how priority improving quality, safety,
answered by ONC. CMS and ONC have
much a measure should allow for less efficiency and reducing health
worked closely since the enactment of
than full achievement varied widely disparities. The HIT Policy Committee
the HITECH Act to ensure certification
among those commenting. Although we also identified the following care goals
fully supports meaningful use. We
received over 2,000 public comments, to address this priority:
explicitly link each meaningful use
the number of specific comments • Provide access to comprehensive
objective to certification criteria for
addressing an individual objective were patient health data for patient’s
certified EHR technology. The
relatively small ranging from 40 to 200. healthcare team.
capabilities and standards that are
We reviewed those comments and made • Use evidence-based order sets and
certified are those that are used to meet
specific changes to measures in the CPOE.
the Stage 1 objectives of meaningful use.
discussion of each objective. We • Apply clinical decision support at
This way we ensure that certified EHR
reiterate that achievement of the the point of care.
technology can accomplish meaningful
measure always equates to achievement • Generate lists of patients who need
use and meaningful use has the
of the objective for Stage 1 of care and use them to reach out to those
intended consequences of improving the
meaningful use. We also reiterate that patients.
healthcare priorities that make up
certified EHR technology will always be • Report information for quality
meaningful use.
able to support achievement of the improvement and public reporting.
Discussion on the Relationship Between measure by including the necessary As we explained in the proposed rule,
a Stage 1 Meaningful Use Objective and functionalities. However, as with any for the last care goal, the HIT Policy
Its Associated Measure technology, certified EHR technology is Committee proposed the goal as ‘‘Report
Comment: Many commenters pointed only as good as the information it to patient registries for quality
out gaps between what they believed contains and getting information into improvement, public reporting, etc.’’ We
were the anticipated results from an certified EHR technology is heavily have modified this care goal, because
objective and the results that are dependent on processes developed by we believe that patient registries are too
measured by the associated measure. A the EP, eligible hospital, or CAH. It is narrow a reporting requirement to
particular concern of some of these for this reason that all measures, even accomplish the goals of quality
commenters is cases where the those for objective whose aspects are improvement and public reporting. We
certification criteria supports the fully under the control of the EP, note that the HIT Policy Committee’s
measure, but in their view fell short of eligible hospital, or CAH, represent less recommended objectives include the
supporting the objective. than full fulfillment of the objective to reporting of quality measures to CMS.
Response: In the proposed rule, we varying degrees. As stated, for We do not believe that CMS would
attempted to draw a clear distinction demonstrating meaningful use and any normally be considered a ‘‘patient
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between the objective and the associated follow up review by CMS or the States, registry’’. We also removed the phrase
measure. The objectives represent a successfully meeting the associated ‘‘etc.’’ We believe that the level of
wide range of activities some of which measure always equates to successfully ambiguity created by ‘‘etc’’ is not
are commonplace for EPs, eligible meeting the objective. Updated appropriate for Federal regulations.
hospitals, and CAHs using EHRs today, information on the associated measures NPRM EP Objective: Use CPOE.
while others are ambitious goals even including the numerator, denominator, NPRM Eligible Hospital Objective: Use
for the most sophisticated EHR user of thresholds and exclusions are as CPOE for orders (any type) directly

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44332 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

entered by the authorizing provider (for example, entering a medication order Second, this requirement will improve
example, MD, DO, RN, PA, NP). using CPOE allows the EHR to provide patient-safety because of the alignment
In the proposed rule, we described feedback on whether the medication of ordering medications in a structured
CPOE as entailing the provider’s use of may have adverse reactions with other data format will enable providers to
computer assistance to directly enter medications the patient is taking. create registries of patients for potential
medical orders (for example, Another benefit of CPOE is that greatly medical recalls, participate in
medications, consultations with other simplifies the workflow process of surveillance for potential sentinel
providers, laboratory services, imaging inputting information into certified EHR events and life-threatening side effects
studies, and other auxiliary services) technology in a structured way to of new medications. Third, other
from a computer or mobile device. The populate the patient record. measures involving transitions of care
order is also documented or captured in Comment: Several commenters asked documents and summary of care
a digital, structured, and computable that we further specify who could enter document will require the entry of an
format for use in improving safety and the order using CPOE. Some active medication list. After
organization. We said that for Stage 1 commenters stated that only the consideration of the public comments
criteria, it will not include the ordering provider should be permitted received, we are finalizing the
electronic transmittal of that order to the to enter the order. These commenters meaningful use objective for EPs at
pharmacy, laboratory, or diagnostic stated that the ordering professional 495.6(d)(1)(i) and for eligible hospitals,
imaging center. needs to be presented with clinical and CAHs at 495.6(f)(1)(i) as ‘‘Use CPOE
Comment: A majority of commenters decision support at the time of entry for medication orders directly entered
recommended that EPs, eligible and that the relay of an order to another by any licensed healthcare professional
hospitals, and CAHs be allowed to defer individual is a source of potential error. who can enter orders into the medical
CPOE for varying lengths of time Other commenters recommended that record per state, local and professional
ranging from 2012 to 2017. The any licensed healthcare professional or guidelines’’.
commenters cited various reasons for indeed any individual (licensed or not) NPRM EP Measure: CPOE is used for
deferment including that CPOE is an who receives the order from the at least 80 percent of all orders.
advanced clinical function that typically ordering provider be permitted to NPRM Eligible Hospital or CAH
is the last process to be implemented perform the CPOE. The most common Measure: For eligible hospitals, CPOE is
due to the need to build the entire argument presented by these used for 10 percent of all orders.
infrastructure to support the CPOE commenters is that this is currently how In the proposed rule under CPOE, we
process. Other commenters noted an CPOE is handled in practice and a shift discussed several concepts related to
increased burden as if the orders cannot to entry by only the ordering provider any associated measure of any objective
be transmitted, then duplicate paper would be too disruptive to workflow. that relies on a percentage calculation.
orders will have to be produced which Response: We agree with those These are the use of a percentage versus
can lead to patient safety risks. commenters who recommend allowing a count; setting a threshold for measures
Commenters also noted that CPOE any licensed healthcare professional to not requiring the electronic exchange of
appears in the latter stages of the enter orders using CPOE. We further information; EPs practicing in multiple
Certification Commission for Healthcare refine this recommendation to be that locations, some of which may not have
Information Technology (CCHIT) EHR any licensed healthcare professional can certified EHR technology available, and
implementation process. A minority, enter orders into the medical record per the patient population to which the
but significant number of comments state, local and professional guidelines. measure would apply. All except the
encouraged CMS to maintain CPOE for While we understand that this policy last of these received extensive
2011. Those commenters in favor of may decrease opportunities for clinical comments and are addressed in
retaining CPOE in 2011 believed that decision support and adverse comment and response sections earlier
CPOE is a basic EHR feature that should interaction, we believe it balances the in this section. In the proposed rule, we
be a standard offering of a certified EHR potential workflow implications of said that we would base the measures
technology and is critical to improving requiring the ordering provider to enter associated with the objectives on both
quality of care through audit trails and every order directly, especially in the the Medicare/Medicaid patient
alerting of delinquent order and/or hospital setting. We disagree with population and all other patients as
delinquent deferred orders. commenters that anyone should be well. We said that we believe it is
Response: We have determined that allowed to enter orders using CPOE. unlikely that an EP would use one
CPOE should be included in the core set This potentially removes the possibility record keeping system for one patient
of measures for Stage 1 in order to of clinical decision support and advance population and another system for
advance meaningful use. CPOE is a interaction alerts being presented to another patient population at one
foundational element to many of the someone with clinical judgment, which location and that requiring reporting
other objectives of meaningful use negates many of the benefits of CPOE. differences based on payers would
including exchange of information and Comment: We received requests for actually increase the burden of meeting
clinical decision support. Many clarification of this objective and what meaningful use. We received very few
commenters, including several types of orders would meet this comments on this aspect of our
physician associations, the HIT Policy requirement. proposed rule and those that were
Committee and members of Congress Response: Our intent in the proposed received were generally supportive of
through their endorsement of the HIT rule was to capture orders for this proposal. Therefore, we are
Policy Committee’s recommendation, medications, laboratory or diagnostic finalizing the policy that all meaningful
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recommended that CPOE be required in imaging. use measures be calculated based on the
Stage 1. CPOE has been a major However, after careful consideration eligible provider’s entire patient
initiative of US hospitals for over a of the comments, we are adopting an population (except where otherwise
decade and is a foundational incremental approach by only requiring noted).
functionality to many of the activities medication orders for Stage 1. First, this Comment: Nearly every commenter
that further the health care policy supports the objectives of e-prescribing, who commented on CPOE objected to
priorities of meaningful use. For drug-drug and drug-allergy checks. our proposal to limit this measure to the

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inpatient department (Place of Service enough to constitute meeting the had any type of medication order.
Code 21) for the eligible hospital or objective for Stage 1 of meaningful use. However, whether a medication order is
CAH. Commenters stated that this Response: We have previously appropriate for every practice could
limitation was inappropriate given the discussed the merits of a percentage vary significantly by scope of practice;
manner in which hospitals use EHR based measure over a count based therefore, for the final rule, we are
technology. To account for current measure earlier in this section under the further limiting the denominator to
practice, the commenters recommended discussion of the burden created by the patients with at least one medication
the measures be expanded to include measures associated with the Stage 1 listed in their medication list. We
the emergency department (ED) (POS meaningful use objectives. However, we believe that this limitation will reduce
23). Other reasons cited by commenters do try to seek a balance reducing the providers’ burden as compared to
were that orders begin in the ED and burden on providers while still ensuring accounting for all orders. To further
remain open as the patient transitions to the progression of meaningful use of reduce the burden on providers, we also
inpatient (for example, infusions), certified EHR technology. In the next will limit the numerator to unique
transitioning from paper documentation comment/response, we discuss changes patients with at least one medication
in the ED to electronic for subsequent to this measure that respond to concerns order entered using CPOE. Because we
care is unsafe as it can result in missed regarding burden. have reduced provider burden by
information, and/or transcription errors Comment: Many commenters limiting the denominator and numerator
as the initial allergies and medications representing EPs as well as other as discussed above, we believe that a
are entered into the system, significant commenters recommended lowering the corresponding increase in the CPOE
data collection occurs in the ED that CPOE threshold for EPs. Those threshold is appropriate for hospitals
would not be included in the system, commenters representing EPs generally and CAHs. For stage 1, we are finalizing
the exclusion of the ED creates recommended parity with eligible a threshold for CPOE of 30 percent for
disincentives to adoption and that the hospitals at 10 percent, while other EPs, eligible hospitals, and CAHS. We
ED is a hybrid of temporal and commenters recommending a reduction believe this relatively low threshold, in
functional services that are neither generally recommended 50 percent. combination with the limitation to only
Response: With CPOE, we had a medication orders, will allow hospitals
purely ambulatory nor inpatient.
unique situation of disparate thresholds and EPs to gain experience with CPOE.
Response: We agree with the between EPs and hospitals. This was
commenters, and therefore are However, as providers gain greater
due to recommendations prior to the experience with CPOE, we believe it is
expanding this objective and its proposed rule by the HIT Policy
associated measure to the emergency reasonable to expect greater use of the
Committee. Eligible hospitals were function. As explained above, we also
room (POS 23). More information on granted an even lower threshold for this
place of service codes is available at believe CPOE is foundational to many
particular requirement. The reason other objectives of meaningful use. For
http://www.cms.gov/ given for this recommendation was that
PlaceofServiceCodes/. Furthermore, these reasons, we believe it is
CPOE is one of the last functionalities reasonable to expect providers to move
given the revision to the HITECH Act to be implemented in the hospital to a 60 percent threshold at Stage 2 of
that changed hospital based eligible setting. Commenters point out that meaningful use. Thus, for this measure,
professionals to include only the setting holds true for EPs as well. As discussed we are finalizing, for Stage 2 of
of inpatient and emergency departments above, given the limitations we are meaningful use, that EPs, eligible
and all of the benefits of integration of placing on the numerator and hospitals and CAHs must meet a 60
these two departments spelled out by denominator for calculating the CPOE percent threshold for CPOE. Therefore,
commenters we will adopt both percentage, we no longer see a we are finalizing a Stage 2 measure for
departments when considering the compelling reason to maintain disparate CPOE at § 495.6(h) for EPs and § 495.6(i)
measure of eligible hospitals or CAHs thresholds for the EPs and the eligible for eligible hospitals and CAHs as ‘‘More
unless we find there are unique hospital/CAH. than 60 percent of all unique patients
circumstances of an objective and its Comment: Commenters have with at least one medication in their
associated measure that would preclude suggested that our proposal to count an medication list seen by the EP or
the inclusion of the emergency action per unique patients could be admitted to the eligible hospital’s or
department for meaningful use. This applied to the measure for CPOE as well CAH’s inpatient or emergency
change does not affect the incentive through a revised measure of ‘‘[a]t least department (POS 21 or 23) during the
payment calculation described in 10% of unique patients seen by the EP EHR reporting period have at least
section II.B. of this final rule or admitted to the eligible hospital or medication one order entered using
Comment: We received several CAH have at least one order entered CPOE’’.
recommendations from commenters that using CPOE.’’ Commenters also pointed Comment: We received several
the requirement of a percentage to CPOE as an example of a case where comments asking for clarification of the
measurement for determining whether adequate lead time is necessary to term unique patient in response to
an EP, eligible hospital or CAH meets implement certified EHR technology. various objectives.
this objective should be replaced with a Response: At the heart of this new Response: In the proposed rule, we
numerical count for CPOE and many basis for this measure is the assumption state, ‘‘the reason we propose to base the
other measures associated with that every patient would have at least measure on unique patients as opposed
percentage thresholds. The two main one order that could be entered using to every patient encounter, is that a
reasons given for switching to numerical CPOE. We believe this is a reasonable problem list would not necessarily have
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counts are the burden of calculating the assumption for EPs, eligible hospitals to be updated at every visit.’’ To further
percentage if it cannot be done and CAHs. According to analysis of describe the concept of ‘‘unique patient’’
automatically using certified EHR 25,665 office-based visits in the 2005 we mean that if a patient is seen by an
technology and the assertion that if an National Ambulatory Medical Care EP or admitted to an eligible hospital’s
EP, eligible hospital, or CAH does Survey, 31 percent of visits included a or CAH’s inpatient or emergency
something a specific number of times it new medication order, and 44 percent department (POS 21 or 23) more than
can be assumed that it is done often included at least one refill; 66 percent once during the EHR reporting period

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44334 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

then for purposes of measurement they certified EHR technology of the hospital. CAH’s inpatient or emergency
only count once in the denominator for For EPs, we already address department (POS 21 or 23) during the
the measure. All the measures relying transmission of the medication order in EHR reporting period
on the term ‘‘unique patient’’ relate to a separate objective for e-prescribing. • Numerator: The number of patients
what is contained in the patient’s Therefore, we finalize the proposal that in the denominator that have at least
medical record. Not all of this the transmission of the order is not one medication order entered using
information will need to be updated or included in the objective or the CPOE.
even be needed by the provider at every associated measure for Stage 1. • Threshold: The resulting percentage
patient encounter. This is especially After consideration of the public must be more than 30 percent in order
true for patients whose encounter comments received, we are modifying for an EP, eligible hospital or CAH to
frequency is such that they would see the meaningful use measure for EPs at meet this measure.
the same provider multiple times in the 495.6(d)(1)(ii) of our regulations and for Exclusion: If an EP’s writes fewer than
same EHR reporting period. Measuring eligible hospitals, and CAHs at one hundred prescriptions during the
by every patient encounter places an § 495.6(f)(1)(ii) of our regulations to EHR reporting period they would be
undue burden on the EPs, eligible ‘‘More than 30 percent of all unique excluded from this requirement as
hospitals and CAHs and may have patients with at least one medication in described previously in this section in
unintended consequences of affecting their medication list seen by the EP or our discussion whether certain EP,
the provision of care to patients merely admitted to the eligible hospital’s or eligible hospital or CAH can meet all
to comply with meaningful use. Given CAH’s inpatient or emergency Stage 1 meaningful use objectives given
the emphasis placed on the reporting department (POS 21 or 23) during the established scopes of practices. We do
burden by commenters as described in EHR reporting period have at least not believe that any eligible hospital or
the beginning of this section, we believe medication one order entered using CAH would have less than one hundred
that our concerns about the burden of CPOE’’. prescriptions written for patients
measurement were well founded. We We further specify that in order to admitted to their inpatient and
also continue to believe that the use of meet this objective and measure, an EP, emergency departments during the EHR
patient encounters could have eligible hospital, or CAH must use the reporting period.
unintended consequences on the capabilities Certified EHR Technology NPRM EP/Eligible Hospital Objective:
provision of care by providers. includes as specified and standards at Implement drug-drug, drug-allergy,
Comment: Some commenters asked 45 CFR 170.304(a) for EPs and 45 CFR drug-formulary checks
whether the CPOE objective and 170.306(a) for eligible hospitals and In the proposed rule, we did not
associated measure require transmission CAHs. The ability to calculate the elaborate on this objective.
of the order. Most of these commenters measure is included in certified EHR Comment: Many commenters
were opposed to such transmission in technology. Thus, for example, an EP, requested clarification as to what
Stage 1 for various reasons such as the eligible hospital or CAH must use a formulary the checks would be
cost of developing interfaces between certified functionality in entering the conducted against.
EHRs and laboratory and radiology medication order, and could not use a Response: Ideally, this check would
service providers, the volume of functionality that has been added by the be performed against any formulary that
transmissions would outpace the EHR vendor, but that is outside the may affect the patient’s welfare, inform
capacity to connect, HIE infrastructure scope of the certification. We believe the provider as to the best drug to
is not yet mature enough and the lack this rule is necessary to ensure that the prescribe or provide the patient and
of the requirement for non-eligible EP, eligible hospital, or CAH is actually provider information on the drug’s cost
entities to participate (for example, making meaningful use of ‘‘certified’’ to both the patient and any third party
laboratory vendors, pharmacies). Some EHR technology, and is not using non- payer. We recognize, however, that not
commenters supported the inclusion of certified technology. In addition, every available third party payer,
the transmission of the order as they requiring providers to use pharmacy benefit management,
believed this would provide better functionalities that are certified will preferred drug list is standardized and
outcomes than if the transmission was ensure the interoperability of made available for query through
not required. information maintained in the EHR as certified EHR technology. As we cannot
Response: In the proposed rule, we providers will be able to operate through this regulation impose such a
stated, ‘‘For Stage 1 criteria, we propose according to consistent standards. We requirement on every developer of a
that it will not include the electronic believe this standardization and formulary, we do not require that an EP/
transmittal of that order to the consistency is key to realizing the goal eligible hospital/CAH would have to
pharmacy, laboratory, or diagnostic of using EHR technology to improve accommodate every formulary in their
imaging center.’’ While a few health care. implementation. However, at a
commenters recommended that this As noted previously in this section minimum an EP/eligible hospital/CAH
objective be changed to require under our discussion of the burden must have at least one formulary that
transmission, given the large opposition created by the measures associated with can be queried. This may be an
to the objective and measure as the Stage 1 meaningful use objectives, internally developed formulary or an
proposed and the reasons commenters the only patients that are included in external formulary. The formularies
presented against transmission, it would the denominator are those patients should be relevant for patient care
not be responsive to the vast majority of whose records are maintained using during the prescribing process. To
commenters to expand this objective certified EHR technology. further address this, we expect that this
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beyond our proposal. We agree with the To calculate the percentage, CMS and measure will be expanded to be counted
commenters that said the HIE ONC have worked together to define the on a transactional basis for future stages.
infrastructure is still being developed in following for this objective: Comment: Commenters suggested
most parts of the country. Furthermore, • Denominator: Number of unique separating the objective into one
we note that in the hospital setting, patients with at least one medication in objective for the clinical checks (drug-
most medication orders would not their medication list seen by the EP or drug and drug-allergy) and a second
require transmission outside of the admitted to an eligible hospital’s or objective for the administrative check

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Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations 44335

(drug-formulary). The rationale stated receiving too many alerts, begins to give providers the necessary
for the division was that clinical ignore and/or override the alerts. information to make informed clinical
measures are focused on preventing Receiving too many alerts can result in decisions for improved delivery of
medication errors versus encouraging slowing the provider down rendering patient care.
consideration of cost when prescribing the alert useless. Commenters In addition, we are finalizing the
medications. In addition, the two types recommended some changes to the meaningful use objective at for EPs at
involve connections to different kinds of objective and associated measure to § 495.6(e)(1)(i) and for eligible hospitals
resources (drug safety information mitigate the risk of ‘‘alert fatigue’’ such and CAHs at § 495.6(g)(1)(i) of our
versus formulary information). as limiting the checks for interactions to regulations as ‘‘Implement drug-
Response: We agree that these should only the most critical medications or formulary checks.’’
be separate objectives for the reasons allowing for adjustment of risk levels NPRM EP/Eligible Hospital Measure:
stated by the commenters and split them rather than an on/off functionality. The EP/eligible hospital/CAH has
accordingly. Response: We recognize ‘‘alert fatigue’’ enabled the drug-drug, drug-allergy, and
Comment: We received comments is a potential occurrence with drug-drug drug-formulary check functionality
that these functions were really part of and drug-allergy checks. However, In the proposed rule we discussed
CPOE and electronic prescribing. meaningful use seeks to utilize the that the capability of conducting
Commenters most commonly noted that capabilities of certified EHR technology automated drug-drug, drug-allergy, and
the drug formulary is part of electronic and any means to address alert fatigue drug-formulary checks is included in
prescribing, as is currently the case requires a critical evaluation of each the certification criteria for certified
under the Medicare e-Prescribing alert. We believe this is beyond the EHR technology. This automated check
program. scope of the definition of meaningful provides information to advise the EP,
Response: While we agree that the use. We believe these checks are eligible hospital, or CAH’s decisions in
drug-drug, drug-allergy, drug-formulary valuable and improve patient care and prescribing drugs to a patient. The only
checks, CPOE, e-prescribing meaningful therefore do not remove them to address
use objectives all serve the same broader action taken by the EP, eligible hospital,
alert fatigue. or CAH is to consider this information.
goal of ensuring accurate ordering and Comment: Commenters recommended
prescribing that takes into account all Many current EHR technologies have
food allergies be included in the drug-
available information about the patient the option to disable these checks and
allergy check as some drugs contain
the functions and their readiness for the certification process does not
ingredients that are contraindicated in
Stage 1 of meaningful use are distinct. require the removal of this option.
individuals with certain allergies.
In terms of functions, CPOE and e- Response: We certainly agree that Therefore, in order to meet this
prescribing could be performed without some allergies other than drug can objective, an EP, eligible hospital, or
the drug to drug, drug-allergy or drug- interact with drugs; however, as we CAH would be required to enable this
formulary checks. Similarly, it is not stated under our discussion of the functionality and ensure they have
necessary for CPOE or e-Prescribing to objective ‘‘Medication Allergy List’’, the access to at least one drug formulary.
take place in order for a drug to drug ability to identify other types of allergies While this does not ensure that an EP,
allergy check to occur. In terms of in a useful way are not yet available to eligible hospital or CAH is considering
readiness and ability to measure the extent necessary to require them in the information provided by the check,
progress for Stage 1 of meaningful use, Stage 1 of meaningful use. This it does ensure that the information is
CPOE and e-prescribing both are certainly does not preclude any EP, available.
percentage based measures of a distinct eligible hospital, or CAH from working After consideration of the public
activity that creates a record even in with the designers of their certified EHR comments received on the objective, we
today’s EHR’s and paper patient records. technology to include this functionality. believe the measure as proposed
The viewing and consideration of Comment: A commenter requested requires more clarity on the length of
information presented to the provider clarification as to whether the drug- time for which the functionality must be
on possible drug interactions is not a drug, drug-allergy and drug-formulary enabled, which we clarify to be the
similarly distinct activity and does not checks are required for contrast media entire EHR reporting period. Therefore,
currently create a record. So while the and imaging agents used by radiologists. we are modifying the meaningful use
goal of these functionalities is similar, Response: We do not link the checks measure for ‘‘Implement drug-drug and
we believe drug-drug, drug-allergy, to specific drugs or agents. However, we drug-allergy checks for the entire EHR
drug-formulary checks create unique note that is common practice in reporting period’’ for EPs at
concerns for implementation and radiology to identify a patient’s past § 495.6(d)(2)(ii) and for eligible
demonstration of meaningful use, and drug and food allergies and take hospitals and CAHs at § 495.6(f)(2)(ii) of
therefore we maintain them as separate appropriate interventions if necessary. our regulations to ‘‘The EP/eligible
objectives. Therefore, the drug-drug, drug-allergy hospital/CAH has enabled this
Comments: Several commenters and drug-formulary checks would be functionality for the entire EHR
expressed concern of ‘‘alert fatigue’’ appropriate prior to administration of reporting period.’’
occurring with drug-drug interaction contrast media and imaging agents to We further specify that in order to
checks. Alert fatigue or otherwise patients. meet this objective and measure, an EP,
known as ‘‘pop-up’’ fatigue is a After consideration of the public eligible hospital, or CAH must use the
commonly perceived occurrence with comments received, we are finalizing capabilities Certified EHR Technology
electronic medical records and clinical the meaningful use objective for EPs at includes as specified and standards at
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decision support tools in which alerts § 495.6(d)(2)(i) and for eligible hospitals 45 CFR 170.302(a). The ability to
are presented to the user when a and CAHs at § 495.6(f)(2)(i) as calculate the measure is included in
potential safety issue is identified by the ‘‘Implement drug-drug and drug-allergy certified EHR technology.
system (for example, drug to drug checks.’’ We include this objective in the As this objective only requires that
interaction). The alerts, while beneficial core set as it is integral to the initial or functionalities of certified EHR
in some cases, can result in a type of on-going management of a patient’s technology be enabled, we do not
‘‘fatigue’’ whereby the provider, after current or future healthcare and would believe that any EP, eligible hospital or

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44336 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

CAH would need an exclusion for this After consideration of the public piece of information is presented to the
objective and its associated measure. comments received, we are modifying EP, eligible hospital, or CAH. The EP,
After consideration of the public the meaningful use objective for EPs at eligible hospital, or CAH can then use
comments received on the objective, we § 495.6(d)(3)(i) and for eligible hospitals their judgment in deciding what further
are modifying the meaningful use at § 495.6(f)(3)(i) of our regulations to probing or updating may be required
measure for ‘‘Implement drug-formulary ‘‘Maintain an up-to-date problem list of given the clinical circumstances.
checks’’ for EPs at § 495.6(e)(1)(ii) and current and active diagnoses’’. Comment: Commenters stated that
for eligible hospitals and CAHs at We include this objective in the core this measure should be replaced with
§ 495.6(g)(1)(ii) of our regulations to set as it is integral to the initial or on- either a simple attestation of yes, the
‘‘The EP/eligible hospital/CAH has going management of a patient’s current problem list exists or the percentage of
enabled this functionality and has or future healthcare and would give the measure should be replaced with a
access to at least one internal or external providers the necessary information to count. Alternatively, that the percentage
formulary for the entire EHR reporting make informed clinical decisions for should be maintained, but that the
period.’’ improved delivery of patient care. threshold should be lowered.
We further specify that in order to NPRM EP/Eligible Hospital Measure: Commenters generally supported this
meet this objective and measure, an EP, At least 80 percent of all unique patients lowering of the threshold for one or all
eligible hospital, or CAH must use the seen by the EP or admitted to the of the following reasons: It may require
capabilities Certified EHR Technology eligible hospital or CAH have at least a change in traditional workflow;
includes as specified and standards at one entry or an indication of none implementation and rollout of certified
45 CFR 170.302(b). The ability to recorded as structured data. EHR technology creates unforeseeable
In the proposed rule, we introduced system downtimes, complications, and
calculate the measure is included in
the concept of ‘‘unique patients’’ in the the required clinical classification
certified EHR technology.
discussion of this objective. We received systems are not geared toward clinical
The consideration of whether a drug
many comments requesting clarification information.
is in a formulary or not only applies
of this term and address those in the Response: For reasons discussed
when considering what drug to
comment and response section under earlier in this section under our
prescribe. Therefore, we believe that any
our discussion of the CPOE measure. discussion of the burden created by the
EP who writes fewer than one hundred Comment: A few commenters stated measures associated with the Stage 1
prescriptions during the EHR reporting that ‘‘None’’ is not a clinically relevant meaningful use objectives, we believe a
period should be excluded from this term and should be replaced with no percentage is a more appropriate
objective and associated measure as known problem or no problem. measure than those suggested by
described previously in our discussion Response: Our intent is not to dictate comments. As this objective relies solely
of whether certain EP, eligible hospital the exact wording of the specific value. on a capability included as part of
or CAH can meet all Stage 1 meaningful Rather we are focused on the overall certified EHR technology and is not, for
use objectives given established scopes goal of making a distinction between a purposes of Stage 1 criteria, reliant on
of practices. blank list because a patient does not the electronic exchange of information,
NPRM EP/Eligible Hospital Objective: have known problems and a blank list we believe it is appropriate to set a high
Maintain an up-to-date problem list of because either no inquiry of the patient percentage threshold. In the proposed
current and active diagnoses based on has been made, or problems have been rule, we set the percentage required for
ICD–9–CM–CM or SNOMED CT® recorded through other means. As long successful demonstration at 80 percent.
In the proposed rule, we described the as the indication accomplishes this goal Though full compliance (that is, 100
term ‘‘problem list’’ as a list of current and is structured data, we do not believe percent) is the ultimate goal, 80 percent
and active diagnoses as well as past it is necessary to prescribe the exact seemed an appropriate standard for
diagnoses relevant to the current care of terminology, thus leaving that level of Stage 1 meaningful use as it creates a
the patient. detail to the designers and users of high standard, while still allowing room
Comment: Several commenters noted certified EHR technology. for technical hindrances and other
that the coding of problem lists at the Comment: Commenters requested barriers to reaching full compliance. We
point of care is outside the normal clarification of the term ‘‘up-to-date’’. proposed 80 percent for every measure
workflow process and would be Response: The term ‘‘up-to-date’’ with a percentage that met the criteria
disruptive. means the list is populated with the of relying solely on a capability
Response: We did not and do not most recent diagnosis known by the EP, included as part of certified EHR
intend that coding of the diagnosis be eligible hospital, or CAH. This technology and are not, for purposes of
done at the point of care. This coding knowledge could be ascertained from Stage 1 meaningful use criteria, reliant
could be done later and by individuals previous records, transfer of information on the electronic exchange of
other than the diagnosing provider. from other providers, or querying the information. Commenters generally
Comment: Commenters suggested patient. However, not every EP has agreed with this alignment; however,
including ICD–10–CM, the Diagnostic direct contact with the patient and they disagreed that 80 percent
and Statistical Manual of Mental therefore has the opportunity to update sufficiently allows for ‘‘technical
Disorders and explicitly allowing the list. Nor do we believe that an EP, hindrances and other barriers’’.
subsets of SNOMED CT®. eligible hospital, or CAH should be Commenters have highlighted numerous
Response: We have removed the required through meaningful use to barriers towards successfully meeting an
references to specific standards, as we update the list at every contact with the 80 percent threshold including
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believe specifying the relevant patient. There is also the consideration technical barriers, barriers to
standards falls within the purview of of the burden that reporting places on implementation, applicability to all
ONC. For ONC’s discussion of this the EP, eligible hospital, or CAH. The patients and all provider types eligible
functionality and the relevant standards measure, as finalized, ensures the EP, for the EHR incentives, patient
including response to the above eligible hospital, or CAH has a problem requested exclusions and others. We
comment, we refer readers to ONC’s list for patients seen during the EHR address some of these with specific
final rule. reporting period, and that at least one exclusions from the measure as

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discussed previously in this section reliant on electronic exchange of Schedule II can be found at http://
under our discussion of whether certain information, we are setting the www.deadiversion.usdoj.gov/schedules/
EP, eligible hospital or CAH can meet percentage at 50 percent. This was the orangebook/e_cs_sched.pdf). Any
all Stage 1 meaningful use objectives most commonly recommended prescription not subject to these
given established scopes of practices. percentage for these objectives that rely restrictions would be permissible. We
Although some technical issues exist, solely on a capability included as part note that the Department of Justice
recording an up-to-date problem list of certified EHR technology and do not recently released a notice of proposed
remains largely within the individual rely on the electronic exchange of rulemaking that would allow the
provider’s control and does not rely to information. electronic prescribing of these
a large degree on some external sender After consideration of the public substances; however, given the already
or receiver of structured electronic comments received, we are modifying tight timeframe for Stage 1 of
health data. In addition, there is a the meaningful use measure for EPs at meaningful use we are unable to
standard of practice for collecting the § 495.6(d)(3)(i) and for eligible hospitals incorporate any final changes that may
elements required for an up-to-date at § 495.6(f)(3)(i) of our regulations to result from that proposed rule.
problem list. Although the commenters ‘‘More than 80 percent of all unique Therefore, the determination of whether
may be right that some clinical patients seen by the EP or admitted to a prescription is a ‘‘permissible
workflow needs to change, that is an the eligible hospital’s or CAH’s prescription’’ for purposes of the eRx
integral part of meaningful use of EHRs. inpatient or emergency departments meaningful use objective should be
Although we do not expect all clinical (POS 21 or 23) have at least one entry made based on the guidelines for
workflow to adapt in Stage 1, there is an or an indication that no problems are prescribing Schedule II controlled
expectation that the clinical workflow known for the patient recorded as substances in effect when the notice of
necessary to support the Stage 1 priority structured data’’. proposed rulemaking was published on
of data capture and sharing will be in We further specify that in order to January 13, 2010. We define a
place in order to effectively advance meet this objective and measure, an EP, prescription as the authorization by an
meaningful use of EHRs. In addition, eligible hospital, or CAH must use the EP to a pharmacist to dispense a drug
given the wide range of activities that capabilities Certified EHR Technology that the pharmacist would not dispense
must occur for meaningful use, we includes as specified and standards at to the patient without such
believe that most EPs, eligible hospitals 45 CFR 170.302(c). The ability to authorization. We do not include
and CAHs will have fully rolled out the calculate the measure is included in authorizations for items such as durable
capabilities required by this objective certified EHR technology. medical equipment or other items and
and the others with an 80 percent To calculate the percentage, CMS and services that may require EP
threshold prior to the start of the EHR ONC have worked together to define the authorization before the patient could
reporting period thereby reducing the following for this objective: receive them. These are excluded from
likelihood of unexpected system • Denominator: Number of unique the numerator and the denominator of
downtime and other implementation patients seen by the EP or admitted to the measure.
complications. an eligible hospital’s or CAH’s inpatient Comment: Some commenters
For situations in which there is an or emergency department (POS 21 or 23) recommended combining this objective
existing standard of practice and during the EHR reporting period. and measure with other meaningful use
complying is fundamentally within the • Numerator: The number of patients objectives such as CPOE or the drug-
provider’s control and where the in the denominator who have at least drug, drug-allergy, drug-formulary
objective relies solely on a capability one entry or an indication that no checks
included as part of certified EHR problems are known for the patient
technology and is not, for purposes of Response: We addressed these
recorded as structured data in their
Stage 1 criteria, reliant on the electronic comments under our discussion of the
problem list.
exchange of information, for the final • Threshold: The resulting percentage CPOE objective.
rule, we adopt, the reasonably high must be more than 80 percent in order After consideration of the public
threshold of 80 percent. We believe for an EP, eligible hospital, or CAH to comments received, we are finalizing
existing infrastructure and expectations meet this measure. the meaningful use objective at
support this relatively high target. This We do not believe that any EP, 495.6(d)(4)(i) as proposed.
foundational step of structured data eligible hospital, or CAH would be in a We have also included this objective
capture is a prerequisite for many of the situation where they would not need to in the core set. Section 1848(o)(2)(A)(i)
more advanced functionalities (for know at least one active diagnosis for a of the Act specifically includes
example, clinical decision support, patient they are seeing or admitting to electronic prescribing in meaningful use
clinical quality measurement, etc.) for their hospital. Therefore, there are no for eligible professionals. This function
which a solid evidence base exists for exclusions for this objective and its is the most widely adopted form of
improved quality, safety and efficiency associated measure. electronic exchange occurring and has
of care. Without having most of a NPRM EP Objective: Generate and been proven to reduce medication
provider’s up-to-date problem lists in transmit permissible prescriptions errors. We included this objective in the
structured, electronic data, that provider electronically (eRx). core set based on the combination of the
will have major challenges in building Comment: Some commenters maturity of this objective, the proven
more advanced clinical processes going requested clarification of the term benefits and its specific mention as the
forward. ‘‘permissible prescription.’’ only example provided in the HITECH
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For other situations, where the Response: As discussed in the Act for what is meaningfully using
objective may not be fundamentally proposed rule, the concept of only certified EHR technology.
within the provider’s control and is not permissible prescriptions refers to the NPRM EP Measure: At least 75
an existing standard of practice, but current restrictions established by the percent of all permissible prescriptions
where objective continues to rely solely Department of Justice on electronic written by the EP are transmitted
on a capability that is included as part prescribing for controlled substances in electronically using certified EHR
of certified EHR technology and is not Schedule II. (The substances in technology.

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In the proposed rule, we said that given that this objective relies on calculate the measure is included in
while this measure does rely on the electronic exchange. While we continue certified EHR technology.
electronic exchange of information to believe this is the case, two particular As noted previously in this section
based on the public input previously issues raised by commenters caused us under our discussion of the burden
discussed and our own experiences to reconsider our threshold. The first is created by the measures associated with
with e-prescribing programs, we believe the argument to include pharmacies in the Stage 1 meaningful use objectives,
this is the most robust electronic the Medicare and Medicaid EHR the prescriptions in the denominator are
exchange currently occurring and incentive programs to ensure only those for patients whose records
proposed 75 percent as an achievable compliance on the receiving end. Non- are maintained using certified EHR
threshold for the Stage 1 criteria of participation by pharmacies was technology.
meaningful use. Though full compliance presented by commenters as a major To calculate the percentage, CMS and
(that is, 100 percent) is the ultimate barrier to e-Prescribing. The second is ONC have worked together to define the
goal, 75 percent seemed an appropriate patient preference for a paper following for this objective:
standard for Stage 1 meaningful use as prescription. In regards to the first • Denominator: Number of
it creates a high standard, while still argument, we do not have the ability to prescriptions written for drugs requiring
allowing room for technical hindrances impose requirements on pharmacies a prescription in order to be dispensed
and other barriers to reaching full through the HITECH legislation. other than controlled substances during
compliance. However, prescriptions transmitted the EHR reporting period.
Comment: A majority of commenters electronically have been growing at an • Numerator: The number of
commenting on this measure believe the exponential rate. The number of prescriptions in the denominator
75 percent threshold is too high. Several prescriptions sent electronically generated and transmitted
issues were raised to explain why the increased by 181 percent from 2007 to electronically.
commenters believe the threshold is too 2008 according to comments received. • Threshold: The resulting percentage
high. The first is that barriers to e- The number of pharmacies is also must be more than 40 percent in order
prescribing exist at the pharmacies and increasing rapidly. Yet this growth is for an EP, eligible hospital, or CAH to
they must be brought into the process to uneven across the country and we wish meet this measure.
ensure compliance on the receiving end. to accommodate all EPs and do lower As addressed in other objectives and
The second represents the most the threshold based on this argument. In in comment response, this objective and
common barrier cited by commenters regards to the second argument, we also associated measure do not apply to any
and that is patient preference for a paper have neither the ability nor the desire to EP who writes fewer than one hundred
prescription over e-prescribing. A limit patient preference. We considered prescriptions during the EHR reporting
patient could have this preference for allowing an EP to exclude from the period, as described previously in this
any number of reasons cited by denominator those instances where a section under our discussion of whether
commenters such as the desire to shop patient requested a paper prescription. certain EP, eligible hospital or CAH can
for the best price (especially for patients However, the burden of tracking when meet all Stage 1 meaningful use
in the Part D ‘‘donut hole’’), the ability this occurs, the disincentive it would objectives given established scopes of
to obtain medications through the VA, create for EPs to work with patients on practices.
lack of finances, indecision to have the establishing a relationship with a NPRM EP/Eligible Hospital Objective:
prescription filled locally or by mail pharmacy and the hindrance to moving Maintain active medication list.
order and desire to use a manufacturer forward with e-prescribing lead us to Comment: Commenters requested
coupon to obtain a discount. Other address this through further reduction clarification of the term ‘‘active
barriers mentioned by individual of the threshold as opposed to an medication list.’’
commenters were the limited exclusion. To address these concerns we Response: We define an active
functionality of current e-prescribing are lowering the threshold for the e- medication list as a list of medications
systems such as the inability to prescribing measure to 40 percent. As that a given patient is currently taking.
distinguish refills from new orders. pointed out by commenters, After consideration of the public
Suggestions for addressing these e-prescribing it is not yet standard of comments received, we are finalizing
difficulties were either to lower the practice and there may be important this objective for EPs at § 495.6(d)(5)(i)
threshold (alternatives recommended external barriers beyond the provider’s and for eligible hospitals and CAHs at
ranged from ten to fifty percent) or control. In particular, for e-prescribing, § 495.6(f)(4)(i) of our regulations as
replacing the percentage with a providers are dependent upon an proposed.
numerical count of 25 to align with the external receiver of electronic health We include this objective in the core
2010 Medicare e-Prescribing program. data, and there are significant variations set as it is integral to the initial or on-
Of the comments received that depending on where the provider going management of a patient’s current
requested a specific lower threshold, practices. or future healthcare and would give
about half of them suggested a 50 After consideration of the public providers the necessary information to
percent threshold, and about half comments received, we are modifying make informed clinical decisions for
suggested a threshold of 25 percent to the meaningful use measure at improved delivery of patient care.
30 percent. § 495.6(d)(4)(ii) of our regulations to NPRM EP/Eligible Hospital Measure:
Response: We are finalizing the use of ‘‘More than 40 percent of all permissible At least 80 percent of all unique patients
a percentage threshold for the reasons prescriptions written by the EP are seen by the EP or admitted by the
discussed previously in this section transmitted electronically using eligible hospital have at least one entry
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under our discussion of the burden certified EHR technology’’. (or an indication of ‘‘none’’ if the patient
created by the measures associated with We further specify that in order to is not currently prescribed any
the Stage 1 meaningful use objectives. In meet this objective and measure, an EP, medication) recorded as structured data.
the proposed rule, we pointed out that eligible hospital, or CAH must use the As with the objective of maintaining
we ‘‘believe this is the most robust capabilities Certified EHR Technology a problem list, we clarify that the
electronic exchange currently occurring’’ includes as specified and standards at indication of ‘‘none’’ should distinguish
to justify a high threshold of 75 percent 45 CFR 170.304(b). The ability to between a blank list that is blank

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Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations 44339

because a patient is not on any known information. This is commonly patient is not currently prescribed any
medications and a blank list because no accomplished by creating fixed fields medication) recorded as structured
inquiry of the patient has been made. As within a record or file, but not solely data’’.
long as the indication accomplishes this accomplished in this manner. For We further specify that in order to
goal and is structured data, we do not example, in this case for it to be meet this objective and measure, an EP,
believe it is necessary to prescribe the structured, if the patient is on aspirin, eligible hospital, or CAH must use the
exact terminology, preferring to leave then that information should be in the capabilities Certified EHR Technology
that level of detail to the designers and system so that it can be automatically includes as specified and standards at
users of certified EHR technology. identified as a medication and not as an 45 CFR 170.302(d). The ability to
Comment: Commenters stated that the order, note, or anything else. An calculate the measure is included in
measure should be replaced with a example of unstructured data would be certified EHR technology.
numerical count or attestation and that the word aspirin, but no ability of the To calculate the percentage, CMS and
the threshold was too high for reasons system to identify it as a medication. ONC have worked together to define the
including the lack of current electronic Comment: A few commenters pointed following for this objective:
exchange of information, difficulty out their current health information • Denominator: Number of unique
capturing information as structured data system vendor does not utilize RxNorm patients seen by the EP or admitted to
and lack of readiness of HIE as its standard. an eligible hospital’s or CAH’s inpatient
infrastructure. Response: This is a certification issue or emergency departments (POS 21 or
Response: We are finalizing the use of best addressed in the ONC final rule. 23) during the EHR reporting period. A
a percentage for the reasons discussed We therefore have referred these definition of unique patient is discussed
previously in this section under our comments to ONC for their under the objective of CPOE.
discussion of the burden created by the consideration. • Numerator: The number of patients
measures associated with the Stage 1 Comment: We received comments in the denominator who have a
meaningful use objectives. For the same suggesting that this requirement could medication (or an indication that the
reasons we explained under the create additional privacy/security patient is not currently prescribed any
discussion of up-to-date problem list, concerns for patients who do not want medication) recorded as structured data.
medication list is a functionality for all physicians and their clinical staff to • Threshold: The resulting percentage
which there is an existing standard of have access to their entire medication must be more than 80 percent in order
practice, it is foundational data capture history. Examples provided included for an EP, eligible hospital, or CAH to
function to make more advanced antidepressant, antipsychotic or erectile meet this measure. Detailed discussion
clinical processes possible, and dysfunction medications. of the more than 80 percent threshold
complying is fundamentally within the Response: We are only concerned can be found under the objective of
provider’s control. Therefore, we with medications that are known to the maintaining an up-to-date problem list.
maintain the reasonably high threshold provider through querying the patient, We do not believe that any EP, eligible
of 80 percent because the existing their own records and the transfer of hospital or CAH would be in a situation
infrastructure and expectations support records from other providers. where they would not need to know
this target. Meaningful use cannot address whether their patients are taking any
Comment: Commenters requested situations where the information is medications. Therefore, there are no
clarification as to whether the measure withheld from the EP, eligible hospital, exclusions for this objective and its
is limited to patients seen during the or CAH by the patient or by other associated measure.
EHR reporting period. providers. We understand that some NPRM EP/Eligible Hospital Objective:
Response: Yes, the measure applies to patients would prefer not to have their Maintain active medication allergy list.
all unique patients seen by the EP or entire medical history available to all Comment: We received comments
admitted to the eligible hospital’s or physicians and clinical staff. We also that limiting this list to medication
CAH’s inpatient or emergency understand that laws in some states allergies instead of all allergies was not
departments (POS 21 or 23) during the restrict the use and disclosure of consistent with efficient workflow and
EHR reporting period. information (including that related to that all allergies should be housed in the
Comment: A few commenters medication) that may reveal that a same location within the EHR.
expressed concern regarding the patient has a specific health condition Commenters also highlighted that lack
requirement that the entry must be (for example, HIV). Recording data in a of knowledge of other allergies such as
recorded as ‘‘structured data.’’ The structured manner will facilitate the latex and food allergies could lead to
commenters state that there may not be implementation of these preferences significant harm to the patient.
a code for over the counter, and policies in an electronic Response: We agree that information
homeopathic or herbal products and environment. It is easier to identify and on all allergies, including non-
that would penalize the provider even potentially withhold specific data medication allergies, provide relevant
though the data is collected and elements that have been recorded in a clinical quality data. However, while we
recorded. structured format than information agree that collecting all allergies would
Response: The distinction between recorded as free text. be an improvement, current medication
structured data and unstructured data After consideration of the public allergy standards exists in a structured
applies to all types of information. comments received, we are modifying data format that may be implemented in
Structured data is not fully dependent the meaningful use measure for EPs at Stage 1. We hope to expand this
on an established standard. Established § 495.6(d)(5)(ii) and for eligible measurement to include all allergies as
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standards facilitate the exchange of the hospitals at § 495.6(f)(4)(ii) of our the standards evolve and expand to
information across providers by regulations to ‘‘More than 80 percent of include non-medication allergies. We
ensuring data is structured in the same all unique patients seen by the EP or believe EP/eligible hospitals/CAHs
way. However, structured data within admitted to the eligible hospital’s or should continue to document all
certified EHR technology merely CAH’s inpatient or emergency allergies, regardless of origin, consistent
requires the system to be able to identify departments (POS 21 or 23) have at least with standard of care practice for that
the data as providing specific one entry (or an indication that the EP/eligible hospital/CAH. We encourage

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44340 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

them to work with the designers of their level of detail to the designers and users CAH’s inpatient or emergency
certified EHR technology to make this of certified EHR technology. departments (POS 21 or 23) have at least
documentation as efficient and Comment: Given that the measure is one entry (or an indication that the
structured as possible. only a one time check for a single entry, patient has no known medication
Comment: A commenter inquired one commenter questioned whether this allergies) recorded as structured data’’.
why the Substance Registration System measure truly constitutes maintenance We further specify that in order to
Unique Ingredient Identifier (UNII) was of an ‘‘active’’ list. meet this objective and measure, an EP,
not indicated for use until 2013 yet the Response: We agree that this measure eligible hospital, or CAH must use the
measure requires the information to be does not ensure that every patient under capabilities Certified EHR Technology
recorded as structured data. the care of every EP, eligible hospital, or includes as specified and standards at
Response: Any standards for the CAH has an active or up-to-date 45 CFR 170.302(e). The ability to
structured vocabulary for medication medication list. However, not every EP calculate the measure is included in
allergies or other aspects of meaningful comes in contact with the patient, and certified EHR technology.
use are included in ONC final rule. therefore has the opportunity to update To calculate the percentage, CMS and
Structured data does not require an the list. Nor do we believe that an EP, ONC have worked together to define the
established standard as discussed under eligible hospital, or CAH should be following for this objective:
the objective of maintaining a required through meaningful use to • Denominator: Number of unique
medication list. update the list at every contact with the patients seen by the EP or admitted to
Comment: We received a few patient. There is also the consideration an eligible hospital’s or CAH’s inpatient
comments requesting a definition of of the burden that reporting places on or emergency departments (POS 21 or
‘‘allergy.’’ the EP, eligible hospital, or CAH. The 23) during the EHR reporting period.
Response: We adopt the commonly measure as finalized ensures that the The definition of ‘‘a unique patient’’ is
held definition of an allergy as an EP, eligible hospital, or CAH has not provided under the objective of CPOE.
exaggerated immune response or ignored having a medication allergy list • Numerator: The number of unique
reaction to substances that are generally for patients seen during the EHR patients in the denominator who have at
not harmful. The definition is derived reporting period and that at least one least one entry (or an indication that the
from Medline Plus, a service of the U.S. piece of information on medication patient has no known medication
National Library of Medicine and the allergies is presented to the EP, eligible allergies) recorded as structured data in
National Institutes of Health. hospital, or CAH. The EP, eligible their medication allergy list.
After consideration of the public hospital, or CAH can then use their • Threshold: The percentage must be
comments received, we are finalizing judgment in deciding what further more than 80 percent in order for an EP,
the meaningful use objective for EPs at probing or updating may be required eligible hospital, or CAH to meet this
495.6(d)(6)(i) and for eligible hospitals given the clinical circumstances at measure. Detailed discussion of the
and CAHs at 495.6(f)(5)(i) as proposed. hand. Therefore, we are maintaining the rationale more than 80 percent
We include this objective in the core measure of a one-time check for a single threshold can be found at under the
set as it is integral to the initial or on- entry. objective of maintain an up-to-date
going management of a patient’s current Comment: Several commenters problem list.
or future healthcare and would give recommended eliminating the We do not believe that any EP,
providers the necessary information to percentage measurement and allowing eligible hospital or CAH would be in a
make informed clinical decisions for the provider to attest that active situation where they would not need to
improved delivery of patient care. medication lists are maintained in the know whether their patients have
NPRM EP/Eligible Hospital Measure: certified EHR technology. medication allergies and therefore do
At least 80 percent of all unique patients Response: We are retaining a not establish an exclusion for this
seen by the EP or admitted to the percentage for the reasons discussed measure.
eligible hospital have at least one entry previously in this section under our NPRM EP Objective: Record the
(or an indication of ‘‘none’’ if the patient discussion of the burden created by the following demographics: Preferred
has no medication allergies) recorded as measures associated with the Stage 1 language, insurance type, gender, race
structured data. meaningful use objectives. For the same and ethnicity, and date of birth.
Comment: Multiple commenters reasons we explained under the NPRM Eligible Hospital Objective:
noted that ‘‘none’’ is not a typical value discussion of up-to-date problem list, Record the following demographics:
to describe the absence of allergies in medication-allergy list is a functionality Preferred language, insurance type,
medical documentation and should be for which there is an existing standard gender, race and ethnicity, date of birth,
replaced with ‘‘no known allergies of practice, it is foundational data and date and cause of death in the event
(NKA),’’ ‘‘no known drug allergies capture function to make more of mortality.
(NKDA)’’ or ‘‘no known medication advanced clinical processes possible, In the proposed rule, we noted that
allergies (NKMA).’’ and complying is fundamentally within race and ethnicity codes should follow
Response: Our intent is not to dictate the provider’s control. Therefore, we current federal standards published by
the exact wording of the specific value. maintain the reasonably high threshold the Office of Management and Budget
Rather we are focused on the overall of 80 percent because the existing (http://www.whitehouse.gov/omb/
goal of making a distinction between a infrastructure and expectations support inforeg_statpolicy/#dr). We maintain
blank list that is blank because a patient this target. that proposal for the final rule.
does not have known allergies and a After consideration of the public Comment: Some commenters
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blank list because no inquiry of the comments received, we are modifying requested clarification of whether all of
patient has been made or no information the meaningful use measure for EPs at the demographics are required and
is available from other sources. As long § 495.6(d)(6)(ii) and for eligible under what circumstances no indication
as the indication accomplishes this goal hospitals at § 495.6(f)(5)(ii) of our might be acceptable. Examples of
and is structured data, we do not believe regulations to ‘‘More than 80 percent of acceptable circumstances from
it is necessary to prescribe the exact all unique patients seen by the EP or commenters include patient
terminology, preferring to leave that admitted to the eligible hospital’s or unwillingness to report, language

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Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations 44341

barriers, and requirement to report _statpolicy/#dr). We continue to believe EHRs that currently report on HRSA
ethnicity and/or race contrary to some that these standards should be applied UDS Insurance Type standards account
state laws. for purposes of implementing the Stage for multiple types of insurance by
Response: In general, we do require 1 meaningful use objectives, but will maintaining separate Reporting
that all demographic elements that are consider whether alternative standards Insurance Groups and deriving the
listed in the objective be included in a or additional clarification would be Insurance Type data from the primary
patient’s record in certified EHR appropriate for future stages of insurance company on the encounter
technology. However, we do not desire, meaningful use criteria. We believe it is and mappings to that Insurance Type
nor could we require, that a patient beyond the scope of the definition of Reporting Group. This information is
provide this information if they are meaningful use to provide additional documented at the patient demographic
otherwise unwilling to do so. Similarly, definitions for race and ethnicity level or the patient encounter/progress
we do not seek to preempt any state beyond what is established by OMB. In note. Given the complexity of defining
laws prohibiting EPs, eligible hospitals, regards to patients who do not know insurance type and attributing it to
or CAHs from collecting information on their ethnicity, EPs, eligible hospitals, patients in an agreed upon way, we are
a patient’s ethnicity and race. Therefore and CAHs should treat these patients eliminating ‘‘insurance type’’ from this
if a patient declines to provide the the same way as patients who decline to meaningful use objective.
information or if capturing a patient’s provide the race or ethnicity, that is, Comment: A minority of commenters
ethnicity or race is prohibited by state they should identify in the patient commenting on this objective
law, such a notation entered as record that the patient declined to recommended that CMS remove cause
structured data would count as an entry provide this information. of death from the objective for eligible
for purposes of meeting the measure. Comment: Some commenters hospitals. The most common rationale is
Comment: Several commenters asked requested additional clarity on that the coroner or medical examiner
for clarity on the definition of preferred insurance type and others officially determines cause of death
language. Commenters also indicated recommended the elimination of when the case is referred to them. By
that standards are in development (ISO insurance type due to the complexity of law, the hospital cannot declare a cause
639 and ANSIX12N Claim/Reporting insurance coverage, the function of the of death in these cases.
Transaction). Some commenters also EHR as a medical tool and not a Response: When a patient expires, in
requested that we include the financial one, the volatility of this the routine hospital workflow, a
requirement that the EP, eligible information due to patients frequently clinician evaluates the patient to
hospital or CAH also communicate with changing plans and concerns that pronounce the patient’s death. The
the patient in their preferred language. information on a patient’s insurance
Response: Preferred language is the clinician typically documents in the
status will have a possible behavioral patient’s chart, the sequence of events
language by which the patient prefers to influence on the providers if this
communicate. This is just a record of leading to the patient’s death, conducts
information were presented.
the preference. We do not have the the physical exam and makes a
Response: Classifying insurance
authority under the HITECH Act to preliminary assessment of the cause of
involves two distinctions—the source of
require providers to actually coverage and insurance design. Source death. We are requiring that eligible
communicate with the patient in his or of coverage refers to the type of funding, hospitals record in the patient’s EHR the
her preferred language, and thus do not such as public, private or self-pay. The clinical impression and preliminary
require EPs, eligible hospitals, and design of the insurance program, such assessment of the cause of death, and
CAHs to do so in order to qualify as a as health maintenance program (HMO), not the cause of death as stated in any
meaningful EHR user as suggested by preferred provider organization (PPO), death certificate issued by the
some commenters. In regards to high-deductible consumer directed Department of Health or the coroner’s
standards, those would be adopted plan, fee-for-service, etc. Although not office.
under the ONC final rule. specified in the proposed rule, by Comment: A few commenters
Comment: Some commenters also insurance type we were referring to the requested inclusion of Advanced
requested clarity on the definition of first distinction—the source of funding Directives under this objective as
race and ethnicity. Some commenters for the insurance. We found two recommended by the HIT Policy
noted an Institute of Medicine report initiatives that could provide clarity on Committee.
entitled ‘‘Race, Ethnicity and Language type. The first is the ‘‘Source of Payment Response: We discuss advance
Data: Standardization for Health Care Typology’’ developed by the Public directives separately in this final rule
Quality Improvement’’, which makes Health Data Standards Consortium under its own objective.
recommendations for how to ask (http://www.phdsc.org/standards/payer- Comment: Several commenters
questions to collect information and typology.asp). The consortium is recommended requiring the submission
builds on the OMB Standards for currently in the process of working with of the demographic data to CMS.
language, race and ethnicity. Some States to implement this typology. The Response: Stage 1 of meaningful use
commenters were also concerned about other initiative is established in the seeks to ensure certified EHR
situations where the available choices Uniform Data Set (UDS) collected by technology has the capability to record
were not granular enough, did not HRSA (http://www.hrsa.gov/data- demographic information and that those
properly account for mixed race and statistics/health-center-data/ capabilities are utilized. We believe the
ethnicity, and when the patient did not index.html). The information in the information recorded for this measure is
know their ethnicity. UDS contains several caveats, however, for provider use in the treatment and
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Response: In the proposed rule, we that make it difficult to be used by all care of their patients and therefore
said that EPs, eligible hospitals and EPs, eligible hospitals and CAHs, and it should not be submitted to CMS at this
CAHs, should use the race and ethnicity does not accommodate patients with time.
codes that follow current federal multiple types of insurance such as Comment: Commenters suggested
standards published by the Office of those dually eligible for Medicare and requiring the use of the demographic
Management and Budget (http:// Medicaid or for those with both data from this measure to stratify
www.whitehouse.gov/omb/inforeg Medicare and MediGap coverage. Many clinical quality measure reporting and

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44342 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

the generation of reports for patient standard of practice, we are adopting Comment: Over two thirds of the
outreach and quality initiatives. the lower threshold of 50 percent (rather commenters commenting on this
Response: While we encourage all than 80 percent). objective expressed concern about the
providers and EHR developers to work After consideration of the public applicability of the listed vital signs to
together to develop reporting from the comments received, we are modifying all provider types and care settings.
EHR system for use in the improvement the meaningful use measure for EPs at Response: While this objective could
of population and public health, for § 495.6(d)(7)(ii) and for eligible be met by receiving this information
purposes of becoming a meaningful EHR hospitals at § 495.6(f)(6)(ii) of our from other providers or non-provider
user in Stage 1, we only require the regulations to ‘‘More than 50 percent of data sources, we recognize that the only
recording of the specified all unique patients seen by the EP or guaranteed way for a provider to obtain
demographics. admitted to the eligible hospital’s or this information is through direct
After consideration of the public CAH’s inpatient or emergency patient interaction and that this
comments received, we are modifying department (POS 21 or 23) have information is not always routinely
meaningful use objective at demographics recorded as structured provided from the EP ordering a service
§ 495.6(d)(7)(i) of our regulations for EPs data’’. because of a direct patient interaction.
to ‘‘Record the following demographics: We further specify that in order to EPs who do not see patients 2 years or
Preferred language, gender, race and meet this objective and measure, an EP, older would be excluded from this
ethnicity, and date of birth’’. eligible hospital, or CAH must use the requirement as described previously in
After consideration of the public capabilities Certified EHR Technology this section under our discussion of
comments received, we are modifying includes as specified and standards at whether certain EP, eligible hospital or
meaningful use objective at 45 CFR 170.304(c) for EPs and 45 CFR CAH can meet all Stage 1 meaningful
§ 495.6(f)(6)(i) of our regulations for 170.304(b) for eligible hospitals and use objectives given established scopes
eligible hospitals and CAHs to ‘‘Record CAHs. The ability to calculate the of practices. We would also allow an EP
the following demographics: Preferred measure is included in certified EHR who believes that measuring and
language, gender, race and ethnicity, technology. recording height, weight and blood
date of birth, and date and preliminary To calculate the percentage, CMS and pressure of their patients has no
cause of death in the event of mortality ONC have worked together to define the relevance to their scope of practice to so
in the eligible hospital or CAH’’. following for this objective: attest and be excluded.
We include this objective in the core • Denominator: Number of unique Comment: Several commenters stated
set as it is integral to the initial or on- patients seen by the EP or admitted to this objective should be removed in
going management of a patient’s current an eligible hospital’s or CAH’s inpatient favor of clinical quality measures
or future healthcare, recommended by or emergency departments (POS 21 or addressing BMI and blood pressure as
the HIT Policy Committee and would 23) during the EHR reporting period. A these measures serve the same purpose
give providers the necessary unique patient is discussed under the and to require both is to require
information to make informed clinical objective of CPOE. duplicative reporting.
decisions for improved delivery of • Numerator: The number of patients Response: We disagree that these two
patient care. in the denominator who have all the measures serve the same purpose and
NPRM EP/Eligible Hospital Measure: elements of demographics (or a specific therefore that the measure should be
At least 80 percent of all unique patients exclusion if the patient declined to eliminated in favor of clinical quality
seen by the EP or admitted to the provide one or more elements or if measures addressing BMI and blood
eligible hospital have demographics recording an element is contrary to state pressure. The objective included here
recorded as structured data. law) recorded as structured data. seeks to ensure that information on
Comment: Commenters said that this • Threshold: The resulting percentage height, weight and blood pressure and
should be replaced with a count or must be more than 50 percent in order the extractions based on them are
attestation or alternatively that the for an EP, eligible hospital or CAH to included in the patient’s record.
threshold was too high. meet this measure. Most EPs and all Furthermore, the objective seeks to
Response: We are maintaining a eligible hospitals and CAHs would have ensure that the data is stored in a
percentage for the reasons discussed access to this information through direct structured format so that it can be
previously in this section under our patient access. Some EPs without direct automatically identified by certified
discussion of the burden created by the patient access would have this EHR technology for possible reporting
measures associated with the Stage 1 information communicated as part of or exchanging. We also note that the
meaningful use objectives. However, we the referral from the EP who identified clinical quality measure focuses on a
do reduce the threshold to over 50 the service as needed by the patient. smaller subset of the patient population.
percent as this objective meets the Therefore, we did not include an After consideration of the public
criteria of relying solely on a capability exclusion for this objective and comments received, we are finalizing
included as part of certified EHR associated measure. the objective for EPs at 495.6(d)(8)(i)
technology and is not, for purposes of NPRM EP/Eligible Hospital Objective: and for eligible hospitals and CAHs at
Stage 1 criteria, reliant on the electronic Record and chart changes in the 495.6(f)(7)(i) as proposed.
exchange of information. In contrast to following vital signs: height, weight and We include this objective in the core
our discussion of maintaining an up-to- blood pressure and calculate and set as it is integral to the initial or on-
date problem list/medication list/ display body mass index (BMI) for ages going management of a patient’s current
medication allergy list, we believe that 2 and over; plot and display growth or future healthcare and would give
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some demographic elements (especially charts for children 2–20 years, including providers the necessary information to
race, ethnicity and language) are not as BMI. make informed clinical decisions for
straightforward to collect as objective In the proposed rule, we described improved delivery of patient care.
data elements and therefore the why we included growth charts in this NPRM EP/Eligible Hospital Measure:
standard of practice for demographic objective. The reason given was that For at least 80 percent of all unique
data is still evolving. As we believe this BMI was not a sufficient marker for patients age 2 and over seen by the EP
measure may not be within current younger children. or admitted to the eligible hospital,

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record blood pressure and BMI; access to height, weight and blood 45 CFR 170.302(f). The ability to
additionally, plot growth chart for pressure information on the patient can calculate the measure is included in
children age 2 to 20. put that patient in the numerator. certified EHR technology.
Comment: Commenters suggested Comment: Some commenters As noted previously in this section
replacement of the percentage requested clarification regarding the role under our discussion of the burden
measurement with a count or attestation of both the EP/eligible hospital/CAH created by the measures associated with
or alternatively that that the threshold and the certified EHR technology for the the Stage 1 meaningful use objectives,
was too high. calculation of BMI and the plotting and the percentage is based on patient
Response: We are retaining a displaying of growth charts. Other records that are maintained using
percentage for the reasons discussed commenters recommended the certified EHR technology. To calculate
previously in this section under our exclusion of growth charts for certain the percentage, CMS and ONC have
discussion of the burden created by the patients and care settings. Another worked together to define the following
measures associated with the Stage 1 commenter also expressed the desire for for this objective:
meaningful use objectives. However, we the exclusion of growth charts for • Denominator: Number of unique
did reduce the threshold from 80 patients over the age of 18, inpatient patients age 2 or over seen by the EP or
percent to greater than 50 percent as this care settings and more specifically, non- admitted to an eligible hospital’s or
objective meets the criteria of relying pediatric inpatient care settings. CAH’s inpatient or emergency
solely on a capability included as part Response: We believe a clarification is department (POS 21 or 23) during the
of certified EHR technology and is not, in order about which of the listed vital EHR reporting period. A unique patient
for purposes of Stage 1 criteria, reliant signs are data inputs to be collected by is discussed under the objective of
on the electronic exchange of the EP/eligible hospital/CAH and which CPOE.
information. In addition, in contrast to are calculations made by the certified
• Numerator: The number of patients
the measures associated with EHR technology. The only information
in the denominator who have at least
maintaining an up-to-date problem list, required to be inputted by the provider
one entry of their height, weight and
an active medication list, and an active is the height, weight and blood pressure
blood pressure are recorded as structure
medication-allergy list, we believe that of the patient. The certified EHR
data.
for many specialties, the current technology will calculate BMI and the
practice on vital signs may not be as growth chart if applicable to patient • Threshold: The resulting percentage
well-established. We believe there may based on age. As this requirement must be more than 50 percent in order
not be the same level of consensus imposes no duty or action on the for an EP, eligible hospital, or CAH to
regarding the relevance to patient care provider, we see no reason to limit its meet this measure. As addressed in
of vital signs for many specialties and availability to any EP, eligible hospital, other objectives and in comment
the frequency with which such vital or CAH based on setting or other response, an EP who sees no patients 2
signs should be collected. Thus, for this consideration. Concerns on presentation years old or younger would be excluded
measure, we adopt a percentage of 50 and interface are best left to designers of from this requirement as described
percent, rather than 80 percent. certified EHR technology and users. previously in this section under our
Comment: Commenters requested Finally, as certified EHR technology is discussion of whether certain EP,
clarification of the frequency and able to automatically generate BMI and eligible hospital or CAH can meet all
methods of recording the vital signs the growth chart if height and weight Stage 1 meaningful use objectives given
included in the measure. are entered as structured data we see no established scopes of practices. We
Response: As discussed in the reason to include BMI and growth chart would also allow an EP who believes
objective, the EP/eligible hospital/CAH in the measure. We therefore will limit that all three vital signs of height,
is responsible for height, weight and the final measure to data requiring weight and blood pressure have no
blood pressure so we will focus our provider data entry points. relevance to their scope of practice to so
discussion on those items. First, we do Comment: A few commenters attest and be excluded. However, we
not believe that all three must be suggested that ‘‘reported height’’ by the believe this attestation and exclusion
updated by a provider at every patient patient should be acceptable when from recording height, weight, and
encounter nor even once per patient measurement is not appropriate such as blood pressure does not hold for other
seen during the EHR reporting period. in the case of severe illness. patient specific information collection
For this objective we are primarily Response: We agree and would allow objectives, like maintaining an active
concerned that some information is height self-reported by the patient to be medication allergy list. We do not
available to the EP/eligible hospital/ used. believe that any EP would encounter a
CAH, who can then make the After consideration of the public situation where the patient’s active
determination based on the patient’s comments received, we are modifying medication and allergy list is not
individual circumstances as to whether the meaningful use measure for EPs at pertinent to care and therefore would be
height, weight and blood pressure needs 495.6(d)(8)(ii) and for eligible hospitals outside of the scope of work for an EP.
to be updated. The information can get § 495.6(f)(7)(ii) of our regulations to ‘‘For We believe the exclusion based on EP
into the patient’s medical record as more than 50 percent of all unique determination of their scope of practice
structured data in a number of ways. patients age 2 and over seen by the EP for the record vital signs objective, as
Some examples include entry by the EP/ or admitted to eligible hospital’s or written in Stage 1, should be studied for
eligible hospital/CAH, entry by someone CAH’s inpatient or emergency relevance in further stages. We do not
on the EP/eligible hospital/CAH’s staff, department (POS 21 or 23), height, believe eligible hospitals or CAHs
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transfer of the information electronically weight and blood pressure are recorded would ever only have a patient
or otherwise from another provider or as structured data’’. population for patients 2 years old or
entered directly by the patient through We further specify that in order to younger or that these vital signs would
a portal or other means. The measure meet this objective and measure, an EP, have no relevance to their scope of
hinges on access of the information. eligible hospital, or CAH must use the practice. Therefore, we do not include
Therefore, any EP/eligible hospital/CAH capabilities Certified EHR Technology an exclusion for eligible hospitals or
that sees/admits the patient and has includes as specified and standards at CAHs.

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44344 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

NPRM EP/Eligible Hospital Objective: smoking be included in the objective for format so that it can automatically be
Record smoking status for patients 13 children and adolescents. identified by certified EHR technology
years old or older Response: Including second-hand as smoking status for possible reporting
In the proposed rule, we explained smoking introduces much more or exchanging. We also note that the
that we believe it is necessary to add an variability into the objective as to what clinical quality measure only focuses on
age restriction to this objective as we do constitutes a level of exposure and patients 18 years or older, while the
not believe this objective is applicable difficulty in measuring it successfully objective focuses on patients 13 years or
to patients of all ages and there is no with different age limits to different older. In addition, many quality
consensus in the health care community aspects. For instance, how much measures related to smoking are
as to what the appropriate cut off age exposure is acceptable for a given age coupled with follow-up actions by the
may be. We encouraged comments on and how is such exposure determined? provider such as counseling. We
whether this age limit should be How would these differing requirements consider those follow-up actions to be
lowered or raised. We received many be accounted for by certified EHR beyond the scope of what we hope to
comments on the age limit and address technology? As with the change from achieve for this objective for Stage 1 of
them below. smoking status to tobacco use, we meaningful use.
Comment: Several commenters believe this introduces an unacceptable After consideration of the public
requested a different age limitation. level of complexity for Stage 1 of comments received, we are finalizing
Commenters suggested ages anywhere meaningful use. For Stage 1 of the meaningful use objective for EPs at
between 5 years old up to 18 years old. meaningful use we are not adding § 495.6(d)(9)(i) and for eligible hospitals
Response: For the purposes of this second hand smoke exposure to this at § 495.6(f)(8)(i) of our regulations as
objective and for meaningful use, our objective. However, we remind EPs, proposed.
eligible hospitals and CAHs that nothing We include this objective in the core
interest is focused on when a record of
about the criteria for meaningful use set as it is integral to the initial or on-
smoking status should be in every
prevents them from working with their going management of a patient’s current
patient’s medical record. Recording
EHR developer to ensure that their EHR or future healthcare and would give
smoking status for younger patients is
system meets their needs and the needs providers the necessary information to
certainly not precluded. We do believe
of their patient population. We make informed clinical decisions for
there would be situations where an EP/
encourage all EPs, eligible hospitals and improved delivery of patient care.
eligible hospital/CAH’s knowledge NPRM EP/Eligible Hospital Measure:
CAHs to critically review their
about other risk factors would indicate At least 80 percent of all unique patients
implementation in light of their current
that they should inquire about smoking 13 years old or older seen by the EP or
and future needs both to maximize their
status if it is unknown for patients admitted to the eligible hospital have
own value and to prepare for future
under 13 years old. However, in order ‘‘smoking status’’ recorded.
stages of meaningful use.
to accurately measure and thereby Comment: We received comments In the proposed rule, discussion of
assure meaningful use, for this objective asking at what frequency the this measure referenced other sections
we believe that the age limit needs to be information must be recorded and exclusively.
high enough so that the inquiry is whether the information can be Comment: We received comments
appropriate for all patients. Therefore, collected by support staff. recommending alternative thresholds
we are maintaining the age limitation at Response: We clarify that this is a for this measure. Commenters provided
13 years old or older. check of the medical record for patients thresholds ranging from anything
Comment: Some commenters 13 years old or older. If this information greater than zero to 60 percent in stage
suggested expanding smoking status to is already in the medical record 1.
any type of tobacco use. available through certified EHR Response: In the proposed rule, we
Response: While we agree that an technology, we do not intend that an established a consistent threshold for
extended list covering other types of inquiry be made every time a provider measures not requiring the exchange of
tobacco use may provide valuable sees a patient 13 years old or older. The information. For the final rule, (other
insight for clinical care for certified EHR frequency of updating this information than up-to-date problem list, active
technology ONC has adopted the CDC’s is left to the provider and guidance is medication list and active medication-
NHIS standard recodes for smoking provided already from several sources allergy list), we have lowered the
status. This will provide a standard set in the medical community. The threshold associated with these
of questions across providers and information could be collected by any measures to 50 percent. In our
standardize the data. The extended list member of the medical staff. discussion of the objective, we noted
does not make the collection of multiple Comment: We received a number of many concerns by commenters over the
survey questions clear. For example, a comments recommending either appropriate age at which to inquire
patient may be a current tobacco user as removing this objective to record about smoking status. There were also
well as a smoker. For these reason in smoking status from the HIT considerable differences among
Stage 1 we will use the standards functionality objectives or removing the commenters as to what the appropriate
adopted by ONC for certified EHR smoking measure from the core clinical inquiry is and what it should include.
technology at 45 CFR 170.302(g). For quality measures as these measures Due to these concerns, we do not
future stages, we will review this serve the same purpose and to require believe this objective and measure fit
measure for possible inclusion of other both is to require duplicative reporting. into the threshold category described
questions. This is a minimum set. We Response: We disagree that these two under up-to-date problem lists and
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do not intend to limit developers of EHR measures serve the same purpose and therefore we adopt a 50 percent (rather
technology from creating more specific therefore only one should be included. than an 80 percent) threshold for this
fields or to limit EPs/eligible hospitals/ The objective included here seeks to measure. After consideration of the
CAHs from recording more specific ensure that information on smoking public comments received, we are
information. status is included in the patient’s modifying the meaningful use measure
Comment: We also received record. Furthermore, that the for EPs at § 495.6(d)(9)(ii) and for
comments requesting that second-hand information is stored in a structured eligible hospitals at § 495.6(f)(8)(ii) of

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our regulations to ‘‘More than 50 percent indicating that an advance directive optometrists, chiropractors,
of all unique patients 13 years old or exists or by including the contents of dermatologists, and radiologists are just
older seen by the EP or admitted to the the advance directive; (2) the objective a few examples of EPs who would only
eligible hospital’s or CAH’s inpatient or seems relevant only to a limited and require information about a patient’s
emergency departments (POS 21 or 23) undefined patient population when advance directive in rare circumstances.
have smoking status recorded as compared to the patient populations to For other meaningful use objectives, we
structured data’’. which other objectives of Stage 1 of have focused our exclusions on rare
We further specify that in order to meaningful use apply; and (3) we situations, which would not be the case
meet this objective and measure, an EP, believe that many EPs would not record for this objective. Therefore, we do not
eligible hospital, or CAH must use the this information under current include this objective for EPs.
capabilities Certified EHR Technology standards of practice. Dentists, After consideration of the public
includes as specified and standards at pediatricians, optometrists, comments received, we are including
45 CFR 170.302(g). The ability to chiropractors, dermatologists, and this meaningful use objective for eligible
calculate the measure is included in radiologists are just a few examples of hospitals and CAHs at § 495.6(g)(2)(i) of
certified EHR technology. EPs who would require information our regulations as ‘‘Record whether a
As noted previously in this section about a patient’s advance directive only patient 65 years old or older has an
under our discussion of the burden in rare circumstances. advanced directive as structured data ’’.
created by the measures associated with Comment: We received several NPRM EP/Eligible Hospital Measure:
the Stage 1 meaningful use objectives, comments including a comment from N/A.
the percentage is based on patient the HIT Policy Committee that we While we did not receive specific
records that are maintained using should include advance directives in percentage recommendations from
certified EHR technology. the final rule. The HIT Policy commenters, this objective is the
To calculate the percentage, CMS and Committee clarified that this would be recording of a specific data element as
ONC have worked together to define the an indication of whether a patient has structured data in the patient record.
following for this objective: an advanced directive. Furthermore, This is identical to other objectives with
• Denominator: Number of unique they recommend limiting this measure established measures such as, recording
patients age 13 or older seen by the EP to patients 65 and older. We received vital signs, recording demographics and
or admitted to an eligible hospital’s or other comments that said this should be recording smoking status. Therefore, we
CAH’s inpatient or emergency a requirement for eligible hospitals. adopt the measure format and the lower
departments (POS 21 or 23) during the Other commenters reported that having threshold (50 percent) from those
EHR reporting period. A unique patient this information available for the patient objectives. We also believe that this
is discussed under the objective of would allow eligible hospitals to make information is a level of detail that is
maintaining an up-to-date problem list. decisions that were better aligned with not practical to collect on every patient
• Numerator: The number of patients the patient’s expressed wishes. admitted to the eligible hospital’s or
in the denominator with smoking status Response: In the proposed rule, we CAH’s emergency department, and
recorded as structured data. said that confusion as to whether this therefore, have limited this measure
• Threshold: The resulting percentage objective would require an indication of only to the inpatient department of the
must be more than 50 percent in order the existence of an advanced directive hospital.
for an EP, eligible hospital, or CAH to or the contents of the advance directive In the final rule, this meaningful use
meet this measure. As addressed in itself would be included in certified measure for eligible hospitals at
other objectives, EPs, eligible hospitals EHR technology was one of the reasons § 495.6(g)(2)(ii) of our regulations: ‘‘More
or CAHs who see no patients 13 years for not including the objective in Stage than 50 percent of all unique patients 65
or older would be excluded from this 1 of meaningful use. We expressed years old or older admitted to the
requirement as described previously in concerns that the latter would not be eligible hospital’s or CAH’s inpatient
this section under our discussion of permissible in some states under department (POS 21) have an indication
whether certain EP, eligible hospital or existing state law. As commenters have of an advance directive status recorded
CAH can meet all Stage 1 meaningful clarified that advance directives should as structured data’’.
use objectives given established scopes be just an indication of existence of an We further specify that in order to
of practices. Most EPs and all eligible advance directive and recommended a meet this objective and measure, an EP,
hospitals and CAHs would have access population to apply the measure to, we eligible hospital, or CAH must use the
to this information through direct reinstate this objective for eligible capabilities Certified EHR Technology
patient access. Some EPs without direct hospitals and CAHs. We believe that the includes as specified and standards at
patient access would have this concern over potential conflicts with 45 CFR 170.306(h). The ability to
information communicated as part of state law are alleviated by limiting this calculate the measure is included in
the referral from the EP who identified to just an indication. We also believe certified EHR technology.
the service as needed by the patient. that a restriction to a more at risk As noted previously in this section
Therefore, we did not include an population is appropriate for this under our discussion of the burden
exclusion based on applicability to measure. By restricting the population created by the measures associated with
scope of practice or access to the to those 65 years old and older, we the Stage 1 meaningful use objectives,
information for this objective and believe we focus this objective the percentage is based on patient
associated measure. appropriately on a population likely to records that are maintained using
NPRM EP/Eligible Hospital Objective: most benefit from compliance with this certified EHR technology.
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Record advance directives. objective and its measure. This objective To calculate the percentage, CMS and
In the proposed rule, we discussed is in the menu set so if an eligible ONC have worked together to define the
this objective, but did not propose it as hospital or CAH finds they are unable following for this objective:
a requirement for demonstrating to meet it then can defer it. However, we • Denominator: Number of unique
meaningful use, for a number of reasons, believe many EPs would not record this patients age 65 or older admitted to an
including: (1) It was unclear whether information under current standards of eligible hospital’s or CAH’s inpatient
the objective would be met by practice. Dentists, pediatricians, department (POS 21) during the EHR

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reporting period. A unique patient is still being developed. Therefore, we Comment: A majority of commenters
discussed under the objective of CPOE. stated our belief that 80 percent is too commenting on this measure believe the
• Numerator: The number of patients high a threshold for the Stage 1 criteria proposed 50 percent threshold is too
in the denominator with an indication of meaningful use. As an alternative, we high. Suggestions for alternative
of an advanced directive entered using proposed 50 percent as the threshold thresholds ranged from more than zero
structured data. based on our discussions with EHR to eighty percent. Some commenters
• Threshold: The resulting percentage vendors, current EHR users, and suggested that the percentage
must be more than 50 percent in order laboratories. We then invited comment calculation be replaced with a numeric
for eligible hospital or CAH to meet this on whether 50 percent is feasible for the count.
measure. An exclusion, as described Stage 1 criteria of meaningful use. Response: We are finalizing a
previously in this section under our Finally, we indicated that we anticipate percentage calculation for the reasons
discussion of whether certain EP, raising the threshold in future stages of discussed previously in this section
eligible hospital or CAH can meet all meaningful use as the capabilities of under our discussion of the burden
Stage 1 meaningful use objectives given HIT infrastructure increase. We received created by the measures associated with
established scopes of practices, would several comments on the the Stage 1 meaningful use objectives.
apply to an eligible hospital or CAH appropriateness of this 50 percent We based the 50 percent threshold in
who admits no patients 65 years old or threshold and discuss them in the the proposed rule on our discussions
older during the EHR reporting period. comment and response section below. with EHR vendors, current EHR users,
NPRM EP/Eligible Hospital Objective: Comment: Commenters requested and laboratories and specifically
Incorporate clinical lab-test results into clarification as to whether the measure requested comment on whether the 50
EHR as structured data. includes only electronic exchange of percent threshold was feasible. While
In the proposed rule, we defined information with a laboratory or if it only a small number of commenters
structured data as data that has a also includes manual entry. commented on this objective, those that
specified data type and response Response: We encourage every EP, did were overwhelming in favor of
categories within an electronic record or eligible hospital and CAH to utilize either a count or a lower threshold. EPs
file. We have revised that definition for electronic exchange of the results with especially were concerned with our
the final rule as discussed below. the laboratory based on the certification inability to impose any requirements on
Comment: Some commenters and standards criteria in the 45 CFR laboratory vendors. Based on the
requested clarification on what 170.302(h). If results are not received in comments received, we have modified
constitutes structured data. this manner, then they are presumably our assessment of the current
Response: The distinction between received in another form such as fax, environment for incorporating lab
structured data and unstructured data telephone call, mail, etc. These results results into certified EHR technology,
applies to all types of information. then must be incorporated into the and believe that a threshold lower than
Structured data is not fully dependent patient’s medical record in some way. fifty percent is warranted. We want to
on an established standard. Established We encourage that this way use create a threshold that encourages, but
standards facilitate the exchange of the structured data; however, that raises the does not require, the electronic
information across providers by concerns about the possibility of exchange of this information and
ensuring data is structured in the same recording the data twice; for example commenters indicated that 50 percent
way. However, structured data within scanning the results and then entering was too high given the current state of
certified EHR technology merely the results as structured data. electronic exchange of lab results.
requires the system to be able to identify Telephoned results could be entered Therefore, we lower the threshold to 40
the data as providing specific directly. We also recognize the risk of percent.
information. This is commonly entry error, which is why we highly Comment: Commenters requested
accomplished by creating fixed fields encourage the electronic exchange of the clarification on what types of
within a record or file, but not solely results with the laboratory, instead of laboratories could generate the lab
accomplished in this manner. manual entry through typing, option results.
After consideration of the public selecting, scanning or other means. Response: The focus of this objective
comments received, we finalize the Reducing the risk of entry error is one is to get as many lab results as possible
meaningful use objective or EPs at of the primary reasons we lowered the into a patient’s electronic health record
§ 495.6(e)(2)(i) and eligible hospitals measure threshold for Stage 1 during as structured data. Limiting the
and CAHs at § 495.6(g)(3)(i) as which providers are changing their objective to a specific type of laboratory
proposed. workflow processes to accurately would not further this objective so
NPRM EP/Eligible Hospital Measure: incorporate information into EHRs therefore we leave it open to all lab tests
At least 50 percent of all clinical lab through either electronic exchange or and laboratories.
tests results ordered by the EP or by an manual entry. However, for this Comment: Several commenters
authorized provider of the eligible measure, we do not limit the EP, eligible expressed concern regarding the
hospital during the EHR reporting hospital or CAH to only counting financial burden of establishing lab
period whose results are either in a structured data received via electronic interfaces, especially for smaller
positive/negative or numerical format exchange, but count in the numerator all hospitals and practices.
are incorporated in certified EHR structured data. By entering these Response: The ability to exchange
technology as structured data. results into the patient’s medical record information is a critical capability of
In the proposed rule, we identified as structured data, the EP, eligible certified EHR technology. Exchange
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this objective and associated measure as hospital or CAH is accomplishing a task between lab and provider and provider
dependent on electronic exchange and that must be performed regardless of to provider of laboratory results reduces
therefore requiring special consideration whether the provider is attempting to errors in recording results and prevents
in establishing the threshold. We said demonstrate meaningful use or not. We the duplication of testing. Therefore, we
that we are cognizant that in most areas believe that entering the data as continue to include this objective
of the country, the infrastructure structured data encourages future within Stage 1 of meaningful use
necessary to support such exchange is exchange of information. although as noted above the measure

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does not rely on the electronic exchange period by the EP or authorized Comment: We received a few
of information between the lab and the providers of the eligible hospital or CAH comments requesting the removal of the
provider. for patients admitted to an eligible terms ‘‘reduction of disparities’’ and
Comment: We received comments hospital’s or CAH’s inpatient or ‘‘outreach’’ as there are no actionable
requesting a listing of laboratory tests emergency department (POS 21 & 23) items or measures associated with the
with results that are in a numerical or whose results are expressed in a term. We also received comments that
positive/negative format. positive or negative affirmation or as a the measurement should include the
Response: We consider it impractical number. requirement that the lists be stratified by
to develop an exhaustive list of such • Numerator: The number of lab test race, ethnicity, preferred language, and
tests. Moreover, we believe further results whose results are expressed in a gender for initiatives targeted at
description of these tests is unnecessary. positive or negative affirmation or as a reducing disparities.
It should be self-evident to providers number which are incorporated as Response: We disagree that actions to
when a test returns a positive or structured data. reduce disparities or conduct outreach
negative result or a result expressed in • Threshold: The resulting percentage could not be guided by this report,
numeric characters. In these case, the must be more than 40 percent in order especially if stratified and aggregated
results should be incorporated into a for an EP, eligible hospital, or CAH to reports of many providers are combined
patient’s EHR as structured data. meet this measure. within large organizations or among
Comment: Several commenters If an EP orders no lab tests whose organizations. While we do not require
pointed out that many current EHR results are either in a positive/negative such stratification or aggregation or
vendors do not support the use of or numeric format during the EHR specify specific uses, that does not
LOINC® codes and there is no federal reporting period they would be preclude them.
regulatory requirement for labs to excluded from this requirement as Comment: Some commenters
transmit using this code set or for that described previously in this section requested clarification of the term
matter, any structured code set. under our discussion of whether certain specific condition.
Response: Standards such as LOINC® EP, eligible hospital or CAH can meet Response: Specific conditions are
codes are included in the ONC final all Stage 1 meaningful use objectives those conditions listed in the active
rule. However, this measure requires given established scopes of practices. patient problem list.
incorporation of lab test results as We do not believe any eligible hospital After consideration of the public
structured data, but does not include a or CAH would order no lab tests whose comments received, we are modifying
requirement for transmission or results are either in a positive/negative the meaningful use objective for EPs at
electronic receipt of the results using or numeric format during the EHR § 495.6(e)(3)(i) and for eligible hospitals
certified EHR technology. reporting period. at § 495.6(g)(4)(i) of our regulations to
After consideration of the public NPRM EP/Eligible Hospital Objective: ‘‘Generate lists of patients by specific
comments received, we are modifying Generate lists of patients by specific conditions to use for quality
the meaningful use measure for EPs at conditions to use for quality improvement, reduction of disparities,
§ 495.6(e)(2)(ii) and eligible hospitals at improvement, reduction of disparities, research, or outreach’’.
§ 495.6(g)(3)(ii) of our regulations to research, and outreach. NPRM EP/Eligible Hospital Measure:
‘‘More than 40 percent of all clinical lab Comment: A few commenters Generate at least one report listing
tests results ordered by the EP or by an recommended eliminating this patients of the EP or eligible hospital
authorized provider of the eligible requirement because they believe it is with a specific condition.
hospital or CAH for patients admitted to redundant of clinical quality reporting. In the proposed rule, we said that an
its inpatient or emergency department Response: We disagree that this is EP or eligible hospital is best positioned
(POS 21 or 23) during the EHR reporting redundant of clinical quality reporting. to determine which reports are most
period whose results are in either in a Clinical quality reporting does not useful to their care efforts. Therefore, we
positive/negative or numerical format guarantee usability for all the purposes do not propose to direct certain reports
are incorporated in certified EHR in the objective. One example of such a be created. However, in order to ensure
technology as structured data’’. use is a provider could not only the capability can be utilized we
We further specify that in order to generate list of patients with specific proposed to require EPs and hospitals to
meet this objective and measure, an EP, conditions, but could stratify the output attest to the ability of the EP or eligible
eligible hospital, or CAH must use the using other data elements in the hospital to create a report listing
capabilities Certified EHR Technology certified EHR technology that are patients by specific condition and to
includes as specified and standards at entered as structured data. The lists attest that they have actually done so at
45 CFR 170.302(h). The ability to could also be utilized at an aggregate least once. We received comments on
calculate the measure is included in level for purposes of research into this and address them and any revisions
certified EHR technology. disparities, which could result in to the proposed rule in the comment
As noted previously in this section targeted outreach efforts. and response section below.
under our discussion of whether certain Comment: Some commenters Comment: Commenters requested
EP, eligible hospital or CAH can meet requested that if we finalize our clarification that only one report per
all Stage 1 meaningful use objectives proposal to only require one report that EHR reporting period is required to
given established scopes of practices, we change the ‘‘and’’ in the objective to meet the measure.
the percentage is based on labs ordered ‘‘or’’. Response: Yes, only one report in
for patients whose records are Response: We are finalizing our required for any given EHR reporting
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maintained using certified EHR measurement of only requiring one period. The report could cover every
technology. report for Stage 1 of meaningful use and patient whose records are maintained
To calculate the percentage, CMS and will change ‘‘and’’ to ‘‘or’’. However, we using certified EHR technology or a
ONC have worked together to define the note that all measures will be subset of those patients at the discretion
following for this objective: reconsidered in later stages of of the EP, eligible hospital or CAH.
• Denominator: Number of lab tests meaningful use and multiple reports Comment: A few commenters
ordered during the EHR reporting could be required in those stages. suggested the measure should be

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44348 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

expanded to require submission of the calculate the measure is included in the core set. Section 1886 (n)(3)(A)(iii)
report to CMS or the States or to the certified EHR technology. of the Act specifically includes
local health department. As this measure relies on data submitting clinical quality measures in
Response: Submission raises many contained in certified EHR technology meaningful use for eligible hospitals
questions about what types of the list would only be required to and CAHs. Section 1903(t)(6)(D) of the
information can be sent to different include patients whose records are Act also anticipates that the
entities, how the information is used, maintained using certified EHR demonstration of meaningful use may
patient consent for sending the technology as discussed previously in include quality reporting to the States
information, and many of the issues, this section under our discussion of the for the Medicaid program.
which add considerable complexity to burden created by the measures NPRM EP Measure: For 2011, an EP
this meaningful use objective. associated with the Stage 1 meaningful would provide the aggregate level data
Therefore, we are not requiring use objectives. for the numerator, denominator, and
submission of the report to CMS, the We do not believe anything included exclusions through attestation as
States or local health departments for in this objective or measure limit any discussed in section II.A.3 of this final
Stage 1 of meaningful use. We do note EP, eligible hospital or CAH from rule. For 2012, an EP would
that this is one of the objectives for completing the measure associated with electronically submit the measures that
which a State can submit modifications this objective, therefore, we do not are discussed in section II.A.3. of this
to CMS for approval. include an exclusion. final rule.
Comment: Several commenters NPRM EP Objective: Report Specific comments on the quality
requested a list of condition categories, ambulatory quality measures to CMS measures themselves are discussed in
a model report or the core data elements (or, for EPs seeking the Medicaid section II.A.3 of this final rule.
required to satisfy the measure. incentive payment, the States). After consideration of the public
Response: As stated in the rule, we Specific comments on the quality comments received, we are finalizing
believe an EP, eligible hospital, or CAH measures are discussed in section II.A.3 this meaningful use objective at
is best positioned to determine which of this final rule. § 495.6(d)(10)(ii) as proposed.
reports are most useful to their care We are finalizing this meaningful use NPRM Eligible Hospital Measure: For
efforts. Therefore, we do not propose to objective at § 495.6(d)(10)(i) of our 2011, an eligible hospital or CAH would
direct certain reports be created. regulations ‘‘Report ambulatory clinical provide the aggregate level data for the
Comment: For eligible hospitals, quality measures to CMS (or, for EPs numerator, denominator, and exclusions
commenters stated that the analysis of seeking the Medicaid incentive through attestation as discussed in
patient data is derived from post- payment, the States)’’ to better align section II.A.3 of this final rule. For 2012,
discharge coding of diagnosis and with the descriptions in section II.A.3. an eligible hospital or CAH would
procedures and not problem lists. In response to our revised electronically submit the measures as
Response: We do not specify that the requirements for meeting meaningful discussed in section II.A.3. of this final
list is limited to being generated from use, we are including this objective in rule. Specific comments on the quality
the data problem list; rather, for the the core set. Section 1848 (o)(2)(A)(iii) measures are discussed in section II.A.3
definition of conditions we refer of the Act specifically includes of this final rule. After consideration of
providers to those conditions contained submitting clinical quality measures in the public comments received, we are
in the problem list. meaningful use for EPs. Section finalizing this meaningful use objective
Comment: One commenter stated that 1903(t)(6)(D) of the Act also anticipates at 495.6(f)(9)(ii) as proposed.
for privacy and confidentiality reasons, that the demonstration of meaningful NPRM EP Objective: Send reminders
patients should be allowed to opt out of use may include quality reporting to the to patients per patient preference for
any provider outreach initiatives. States for the Medicaid program. preventive/follow-up care.
Response: Stage 1 of meaningful use NPRM Eligible Hospital Objective: In the proposed rule, we described
does not require the submission of these Report ambulatory quality measures to patient preference as the patient’s
reports to other entities; rather, we CMS (or, for eligible hospitals seeking choice between internet based delivery
require that the provider generate these the Medicaid incentive payment, the or delivery not requiring internet access.
reports for their own use. We therefore States). We are revising that description based
do not believe the generation of such We make a technical correction to this on comments as discussed below.
reports raises privacy and objective from the proposed rule to Comment: Commenters have pointed
confidentiality concerns. We ensure that it is clear to the public that out that requirements to accommodate
understand, however, that some patients we were referring to hospital quality reasonable requests by individuals to
may have concerns about such lists measures. receive communications by means other
being exchanged with others and will Specific comments on the quality than the means preferred by the
consider such concerns should future measures are discussed in section II.A.3 provider already exist under HIPAA at
meaningful use requirements focus on of this final rule. 45 CFR 164.522(b).
exchange of these reports. After consideration of the public Response: As we stated in the
After consideration of the public comments received, we are finalizing proposed rule, patient preference refers
comments received, we are finalizing this meaningful use objective at to the patient’s preferred means of
the meaningful use measure for EPs at § 495.6(d)(9)(i) to account for our transmission of the reminder from the
§ 495.6(e)(3)(ii) and for eligible hospitals technical correction and to better align provider to the patient, and not
and CAHs at § 495.6(g)(4)(ii) of our with the descriptions in section II.A.3 as inquiries by the provider as to whether
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regulations as proposed. ‘‘Report hospital clinical quality the patient would like to receive
We further specify that in order to measures to CMS (or, for eligible reminders. In the proposed rule, we had
meet this objective and measure, an EP, hospitals seeking the Medicaid proposed that patient preference be
eligible hospital, or CAH must use the incentive payment, the States)’’. limited to the choice between internet
capabilities Certified EHR Technology In response to our revised based or non-internet based. In order to
includes as specified and standards at requirements for meeting meaningful avoid unnecessary confusion and
45 CFR 170.302(i). The ability to use, we are including this objective in duplication of requirements, EPs meet

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Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations 44349

the aspect of ‘‘per patient preference’’ of the age limit. In order to increase the • Numerator: The number of patients
this objective if they are accommodating probability that a patient whose records in the denominator who were sent the
reasonable requests as outlined in 45 are maintained in certified EHR appropriate reminder.
CFR 164.522(b), which are the guidance technology will be eligible for a • Threshold: The resulting percentage
established under HIPAA for reminder we change the age limit of the must be more than 20 percent in order
accommodating patient requests. population to 65 years old or older or for an EP to meet this measure.
After consideration of the public 5 years old or under. We believe that As addressed in other objectives and
comments received, we are finalizing older patient populations are more in comment responses, if an EP has no
the meaningful use objective at likely to have health statuses that will patients 65 years old or older or 5 years
§ 495.6(e)(4)(i) of our regulations as indicate the need for reminders to be old or younger with records maintained
proposed. sent and this segment of the population using certified EHR technology that EP
NPRM EP Measure: Reminder sent to is have higher rates of chronic diseases is excluded from this requirement as
at least 50 percent of all unique patients which will require coordination in described previously in this section
seen by the EP or admitted to the preventive care such as vaccine under our discussion of whether certain
eligible hospital that are 50 and over. reminders. Likewise, the 5 years old and EP, eligible hospital or CAH can meet
For the final rule, we are changing the under population will require a all Stage 1 meaningful use objectives
measure to recognize that this is an EP multitude of childhood vaccinations given established scopes of practices.
only objective. Therefore, we make the such as influenza and will benefit from NPRM EP/Eligible Hospital Objective:
technical correction of striking ‘‘or reminders. However, we do not believe Document a progress note for each
admitted to the eligible hospital’’. that changing the age limit of the encounter. In the proposed rule, we
Comment: Commenters indicated that discussed this objective, but did not
affected population will result in 50
‘‘practice management systems’’ or propose it for Stage 1 of meaningful use.
percent of every patient whose records
‘‘patient management systems’’ are We noted our belief that documentation
maintained in certified EHR technology
commonly used for this function and of progress notes is a medical-legal
requiring a reminder during the EHR
that integrating them into certified EHR requirement and a component of basic
reporting period. This is especially true
technology would be expensive and EHR functionality, and is not directly
for the first payment year when the EHR
time consuming for little value in related to advanced processes of care or
reporting period is only 90 days. We are
return. improvements in quality, safety, or
Response: While we disagree with also concerned about the variability
efficiency.
commenters who suggest there is little among specialists’ scopes of practice Comment: We received a limited
to no value in having information about that may affect the number of patients number of comments regarding our
reminders sent to patients available in the denominator for which a decision not to include documentation
across all the systems used by the reminder is appropriate. Therefore, we of progress notes as an objective. The
provider, we do not assert that such lower the threshold to 20 percent. The commenters generally fell into three
integration of systems must be in place EP has the discretion to determine the categories: Those who supported
to meet this measure. ONC provides for frequency, means of transmission and inclusion of this objective in the final
a modular approach that would allow form of the reminder limited only by the rule, those who supported its inclusion
these systems to be certified as part of requirements of 45 CFR 164.522(b) and only if certain caveats are met and those
certified EHR technology. any other applicable federal, state or who supported our proposal not to
Comment: Some commenters pointed local regulations that apply to them. include it as an objective for Stage 1 of
out that many patients seen during an After consideration of the public meaningful use. Concerns raised by
EHR reporting period will not be sent a comments received, we are modifying those supporting the inclusion of this
reminder during that same period. the meaningful use measure at objective included the possibility that
Commenters said this is especially true § 495.6(e)(4)(ii) to ‘‘More than 20 percent an EP may keep paper progress notes in
for the 90-day EHR reporting period, but of all patients 65 years or older or 5 conjunction with use of certified EHR
for some services could be true of the years old or younger were sent an technology as prescribed by Stage 1 of
full year EHR reporting period as well. appropriate reminder during the EHR meaningful use and that such a choice
Other commenters also pointed out that reporting period’’. by EPs would create the possibility of
reminders are not limited to the older We further specify that in order to handwriting illegibility, loss of
population and that children especially meet this objective and measure, an EP information and reduced access to
may require many reminders on must use the capabilities Certified EHR health information by both patients and
immunizations. Technology includes as specified and other providers. Another concern raised
Response: We agree with commenters standards at 45 CFR 170.304(d). The is that if the objective is not included in
that many patients not seen during the ability to calculate the measure is the criteria for the definition of
EHR reporting period would benefit included in certified EHR technology. meaningful use designers of EHR
from reminders. As the action in this As noted previously in this section technology will not include the function
objective is the sending of reminders, under our discussion of the burden in their products. The advocates in the
we base the revised measure on that created by the measures associated with second category agree with the above,
action. This focus is supported by the Stage 1 meaningful use objectives, but only support inclusion with certain
numerous public comments, including the denominator is based on patients caveats. Some of these caveats include
those by the HIT Policy Committee. whose records are maintained using preserving the option of transcription,
Therefore, we are changing the voice recognition software, and direct
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certified EHR technology.


requirement to account for all patients entry by an EP or any combination of
whose records are maintained using To calculate the percentage, CMS and these. Another caveat is that progress
certified EHR technology regardless of ONC have worked together to define the notes not be required to be entered as
whether they were seen by the EP following for this objective: structured data. The third category
during the EHR reporting period. This • Denominator: Number of unique supports exclusion of progress notes as
greatly expanded denominator caused patients 65 years old or older or 5 years an objective for two fundamentally
us to reconsider both our threshold and older or younger. different reasons. Some commenters

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44350 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

supported exclusion because they ordering, along with the ability to track EPs would report on at least five clinical
believe that the volume of objectives compliance with those rules. quality measures from section II.A.3 of
was already too high for Stage 1 of First, we make a technical correction. the proposed rule and eligible hospitals
meaningful use and therefore opposed On page 1856 of the proposed rule, we will all report on at least five.
anything that would increase the described this objective for eligible Response: We accept the argument
volume. hospitals as ‘‘Implement five clinical that there is value in focusing initial
Other commenters agree with our decision support rules relevant to CDS efforts on a single CDS rule in
proposal that progress notes is already specialty or high clinical priority, order to get it right the first time and lay
a fundamental part of current EHR including for diagnostic test ordering, the foundation for future, broader CDS
products and did not represent a move along with the ability to track implementation. This will help to
that advances the use of EHRs. compliance with those rules.’’ The prevent the unintended negative
Response: We predicated our underlined language was consequences associated with poorly
discussion in the proposed rule on the inappropriately carried over from the EP implemented CDS systems when
assumption that progress notes are a objective in this instance and in the providers have attempted to do too
component of basic EHR functionality. regulation text. The table contained our much too soon.
We still believe this is the case and have intended language of ‘‘Implement 5 We agree that the appropriate balance
not received evidence to the contrary. clinical decision support rules related to is to require some degree of meaningful
However, we failed to clearly articulate a high priority hospital condition, use of CDS in Stage 1 without
the ramifications of our belief. Our view including diagnostic test ordering, along overburdening providers with too many
continues to be that an EP who with the ability to track compliance areas to focus on at once. Since CDS is
incorporates the use of EHRs into a with those rules.’’ Many commenters one area of health IT in which
practice and complies with meaningful pointed this discrepancy out to us and significant evidence exists that it can
use criteria is unlikely to maintain we appreciate their diligence. have a substantial positive impact on
Comment: Nearly half of the the quality, safety and efficiency of care
separate paper progress notes outside of
commenters mentioning clinical
the EHR system. We believe that the delivery, it is important that it be
decision support suggested that the term
potential disruption in workflow of the included as a core objective with this
needed additional clarification. Some
efforts to merge paper progress notes more limited expectation. That
commenters said that the term was too
with the other records in certified EHR requirement will assure that all
vague and open to interpretation while
technology in order to have a complete meaningful users have taken the first
others said it was too specific. Other
medical record far outweighs the burden steps in CDS implementation but allow
commenters provided recommendations
of electronically capturing progress them to focus as necessary on a single
on what a clinical decision support rule
notes. Moreover, we continue to believe high-priority area at the outset in order
should mean or which elements it
this is a highly unlikely scenario. As to ensure that they can devote the
should include. These were evidence-
with any meaningful use objective, it is based medicine templates, decision appropriate level of attention to their
important to have clear, definitive trees, reminders, linked online first CDS priority. We anticipate that
definitions. However, our observations resources, scientific evidence, and this will set the foundation for much
of discussions held in public forums by consensus. more expansive CDS support in the near
the medical community and review of Response: In the proposed rule, we future.
literature have led us to conclude that described clinical decision support as Comment: A commenter inquired if
it not possible to provide a clear, HIT functionality that builds upon the modification of the clinical decision
definitive definition of a progress note foundation of an EHR to provide support tool negates the EHR’s
at this time. We note that commenters persons involved in care processes with certification status.
recommending the documentation of a general and person-specific information, Response: We believe this is a
progress note be included as an intelligently filtered and organized, at question on certification status and is
objective did not attempt to define the appropriate times, to enhance health outside of the scope of this rule. ONC
term. Nor did commenters suggest an and health care. We purposefully used discusses what would affect Certified
associated measure. We continue to a description that would allow a EHR Technology’s certified status in
believe that there is insufficient need provider significant leeway in their final rule (75 FR 36157) entitled
and upon review believe there is determining the clinical decision ‘‘Establishment of the Temporary
insufficient consensus regarding the support rules that are more relevant to Certification Program for Health
term progress note to include this their scope of practice and benefit their Information Technology’’.
objective for Stage 1 of meaningful use. patients in the greatest way. In the After consideration of the public
After consideration of the public proposed rule, we asked providers to comments received, we are modifying
comments received, we do not include relate the rules they select to clinical the meaningful use objective for EPs at
this meaningful use objective in the priorities and diagnostic test ordering. 495.6(d)(11)(i) to ‘‘Implement one
final rule. We do not believe that adding a more clinical decision support rule relevant
NPRM EP/Eligible Hospital Measure: limiting description to the term clinical to specialty or high clinical priority
N/A. decision support would increase the along with the ability to track
NPRM EP Objective: Implement five value of this objective. We believe that compliance with that rule.’’
clinical decision support rules relevant this determination is best left to the After consideration of public
to specialty or high clinical priority, provider taking into account their comments received, we are modifying
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including for diagnostic test ordering, workflow and patient population. the meaningful use objective for eligible
along with the ability to track Comment: Several commenters hospitals and CAHs at § 495.6(f)(10)(i) of
compliance with those rules. objected to the requirement of five our regulations as ‘‘Implement one
NPRM Eligible Hospital Objective: clinical decision support rules when the clinical decision support rule related to
Implement 5 clinical decision support HIT Policy Committee only a high priority hospital condition along
rules related to a high priority hospital recommended one. Others disagreed with the ability to track compliance
condition, including diagnostic test with our proposed assertion that most with that rule.’’

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We believe that clinical decision objective for clinical decision support that are traditionally part of practice
support is one of the most common rules relates to the associated measures. management systems;
tools that uses the information collected Response: While an integral part of —Private payers may customize the
as structured data included in the core the objective and certified EHR HIPAA-recognized standard
set and therefore also include clinical technology, we did not include this transactions, which limits the ability
decision support in the core as the aspect of the objective in the measure of practices to obtain accurate
information needed to support it are for Stage 1 of meaningful use. An EP, information prior to receiving an
already included in the core set. eligible hospital, or CAH is not required Explanation of Benefits based on the
NPRM EP/Eligible Hospital Measure: to demonstrate to CMS or the States its actual services provided and negates
Implement five clinical decision compliance efforts with the CDS many of the benefits of having
support rules relevant to the clinical recommendations or results for Stage 1 standardized transactions;
quality metrics the EP/Eligible Hospital either at initial attestation or during an —Workers’ compensation and auto
is responsible for as described further in subsequent review of that attestation. insurers do not accept electronic
section II.A.3. of this final rule. After consideration of the public claims; and
In the proposed rule, we said that comments received, we are modifying —Many providers use clearinghouses
clinical decision support at the point of the meaningful use measure for EPs at and they requested that the burden of
care is a critical aspect of improving § 495.6(e)(11)(ii) and for eligible electronic submission be shifted to
quality, safety, and efficiency. Research hospitals and CAHs at § 495.6(g)(10)(ii) the clearinghouse.
has shown that decision support must to ‘‘Implement one clinical decision Response: In our proposed rule, we
be targeted and actionable to be support rule. specifically cite that the existence of
effective, and that ‘‘alert fatigue’’ must be We further specify that in order to standard transactions available under
avoided. Establishing decision supports meet this objective and measure, an EP, HIPAA for submitting claims as a reason
for a small set of high priority eligible hospital, or CAH must use the for including this objective as a
conditions, ideally linked to quality capabilities Certified EHR Technology meaningful use objective for Stage 1. We
measures being reported, is feasible and includes as specified and standards at also disagree that this objective is
desirable. Meaningful use seeks to 45 CFR 170.304(e) for EPs and 45 CFR outside the scope of meaningful use as
ensure that those capabilities are 170.306(c). The ability to calculate the defined by the HITECH legislation. The
utilized. measure is included in certified EHR HITECH legislation states the Secretary
Comment: Commenters, both in the technology. shall seek to improve not only health
requests for clarification of the term Given the added flexibility added to care quality, but also the use of
clinical decision support and explicitly this measure in the final rule, we do not electronic health records. In addition,
in response to this measure, expressed believe that any EP, eligible hospital, or we note that sections 1848(o)(2)(A) and
concern about the linkage to a particular CAH would be in a situation where they 1886(n)(3)(A) of the Act provide that to
quality measure. could not implement one clinical be considered a meaningful EHR user,
Response: We agree that such linkage decision support rules as described in an EP, eligible hospital, or CAH must
puts constraints on the provider and the measure. Therefore, there are no demonstrate use of certified EHR
eliminates many types of clinical exclusions for this objective and its technology in a meaningful manner as
decision support rules that may be associated measure. defined by the Secretary. In the
beneficial. Therefore, we revise this NPRM EP/Eligible Hospital Objective: Medicaid context, any demonstration of
measure to require that at least one of Submit claims electronically to public meaningful use must be ‘‘acceptable to
the five rules be related to a clinical and private payers. the Secretary’’ under 1903(t)(6). We
quality measure, assuming the EP, Comment: Over three quarters of believe this language gives us broad
eligible hospital or CAH has at least one those commenting on this objective discretion to require the use of certified
clinical quality measure relevant to their recommended that it be eliminated for EHR technology in a manner that not
scope of practice. However, we strongly various reasons. The majority of the only improves health care quality, but
encourage EPs, eligible hospitals and other commenters requested a results in gains in efficiency, patient
CAHs to consider the clinical quality modification. Reasons given are: engagement and enhances privacy and
measures as described in section II.A.3 —Electronic claims submission is security. Under the broad definition of
when deciding which additional rules already covered under HIPAA; electronic health record established by
to implement for this measure. —Electronic claims submission is not ONC in their final rule, electronic
Comment: Several commenters, part of traditional EHR technology; exchange of eligibility information and
including the HIT Policy Committee, —Billing systems would have to be claims submission could certainly
recommended that we focus at least one certified adding to cost and burden of improve the use of electronic health
clinical decision support rule on compliance with meaningful use even records.
efficiency of care. though when electronic claims We believe that inclusion of
Response: In light of decision to limit submission for Medicare is already in administrative simplification in
the objective to one clinical decision place for all by the very smallest of meaningful use is an important long-
support rule, we do not believe that it providers; term policy goal for several reasons.
is appropriate to further to link that rule —Electronic claims submission falls First, administrative simplification can
to specific requirements and therefore outside of the scope of the statutory improve the efficiency and reduce
give the EP, eligible hospital or CAH mandate given by Congress to unnecessary costs in the health care
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discretion on what to focus the clinical implement the HITECH legislation to system as a whole; the small percentage
decision support rule used to satisfy this improve care delivery through broad of paper claims submitted represent a
measure. scale adoption and utilization of disproportionate administrative cost for
Comment: A few commenters asked Electronic Health Record health plans; the reconciliation of
for clarification of how the ‘‘* * * with technologies. This function does not billing charges for services not eligible
the ability to track compliance with impact the quality of care delivered for payment creates a significant burden
those rules’’ language of the proposed and relies on product components for providers, health plans, and most

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significantly, for patients. Second, the We therefore intend to include Congress to implement the HITECH
integration of administrative and administrative transactions as a part of legislation in such a way as to
clinical information systems is Stage 2 of meaningful use, and expect improve care delivery through broad
necessary to support effective providers and vendors to take this into scale adoption and utilization of
management and coordinated care in consideration in their decisions leading Electronic Health Record
physician practices. The ability to up to 2013. technologies. This function does not
leverage clinical documentation in Comment: Commenters focusing on impact the quality of care delivered
support of appropriate charge capture how meaningful use would translate and relies on product components
(for example, for preventive counseling, into the Medicare Advantage program that are traditionally part of practice
or immunizations provided), the ability said that the measure of checking management systems;
to link lists of patients needing clinical eligibility electronically and submitting —Information returned on typical
reminders with patient contact claims electronically for 80 percent of electronic eligibility checks is of little
information, the ability to stratify patients seen would not be possible. use to providers—as responses are
quality measures by patient They explained that for most of their usually a yes/no answer on coverage,
demographic factors (for example, race/ visits, there is no insurance company but not the specificity of coverage;
ethnicity) and insurer status (for with which to check, and there is no —The current poor adoption rate of the
example, Medicare beneficiaries), are insurance company to whom to submit use of electronic eligibility
examples. claims. They described themselves as a verification is indicative of the
In addition, there are important capitated system and for most of the deficiencies in current methods;
benefits to the inclusion of patient visits, the concept of checking —Once eligibility checking becomes
administrative transactions in criteria eligibility and submitting claims in not easy to use and reliable, no incentive
and standards for the certification of relevant. will be required as providers will
EHR technologies. The option of Response: This comment illustrates adopt the process readily;
modular certification provides an the difficulties in adopting FFS —Payers do not guarantee their
opportunity for eligible professionals Medicare meaningful use measures for eligibility results;
and hospitals to use practice qualifying MA organizations, MA- —Many payers are still not in
management systems or clearinghouses affiliated hospitals and MA EPs. For compliance with the HIPAA 270/271
that provide these functions as purposes of determining meaningful use electronic eligibility standard.
components of their certified EHR in a Medicare Advantage environment, Therefore the objective should only be
technologies. However, we recognize we agree that submitting claims required if compliance with the
there is not current agreement as to electronically is not a useful standard in standard by health plans can be
which systems constitute an EHR and a capitated environment where virtually guaranteed; and
that many entities may view their all patients are members of the same —Private payers may customize the
billing system to be outside their EHR insurance plan. HIPAA-recognized standard
and that the vendors of some practice After consideration of the public transactions, which limits the ability
management systems that provide these comments received, we are not of practices to obtain accurate
functionalities in doctors’ offices today finalizing the objective ‘‘Submit claims information prior to receiving an
may not be prepared to seek electronically to public and private Explanation of Benefits based on the
certification for these legacy products in payers’’. actual services provided and negates
2010/2011. We also recognize that the NPRM EP/Eligible Hospital Measure: many of the benefits of having
introduction of the X12 5010 standards At least 80 percent of all claims filed standardized transactions.
in January 2012 would further electronically by the EP or the eligible
complicate the certification process for hospital. Response: In our proposed rule, we
stage 1. We also acknowledge that we do We received many comments on the specifically cite the existence of the
not have the ability to impose additional difficulty in calculating this measure. standard transaction for eligibility
requirements on third-party payers or However, as all measures are tied to checks available under HIPAA as an
clearinghouses to participate in this objectives and we do not finalize this enabling factor for the inclusion this
exchange beyond what is required by objective we also do not finalize the objective. As with the electronic claims
HIPAA. Based on these considerations, measure. submission objective discussed above,
we are not including this objective in NPRM EP/Eligible Hospital Objective: we disagree that this objective is outside
the final rule for Stage 1 of meaningful Check insurance eligibility the scope of meaningful use as defined
use. electronically from public and private by the HITECH legislation. The HITECH
However, the introduction of these payers. legislation requires the Secretary to seek
new X12 5010 standards, and the Comment: Over three quarters of to improve not only health care quality,
coming introduction of ICD–10 in 2013 those commenting on this objective but also the use of electronic health
provides an opportunity for change in recommended that it be eliminated for records. Under the broad definition of
Stage 2 of meaningful use. In order to various reasons. Some of the most electronic health record established by
meet these and other administrative common reasons for elimination are: ONC in their final rule, electronic
simplification provisions, most —Electronic eligibility checks are exchange of eligibility information
providers will have to upgrade their already covered under HIPAA; could certainly improve the use of
practice management systems or —Electronic eligibility checks are not electronic health records. However, we
implement new ones. This provides an part of traditional EHR technology; recognize there is not current agreement
srobinson on DSKHWCL6B1PROD with RULES2

important opportunity to achieve —Billing and practice management as to which systems constitute an EHR
alignment of capabilities and standards systems that are used for electronic and that many entities may view their
for administrative transactions in EHR eligibility checks would have to be practice management system to be
technologies with the administrative certified as certified EHR technology outside their EHR. We also acknowledge
simplification provisions that the adding to cost and burden; that we do not have the ability to
Affordable Care Act provides for health —Electronic eligibility checks is outside impose additional requirements on
plans and health plan clearinghouses. of the scope of the mandate given by third-party payers to participate in this

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Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations 44353

exchange beyond what is required by information (including diagnostics test harm to the patient or another
HIPAA. Third-party payers can provide results, problem list, medication lists, individual.
simple yes/no responses, modify the allergies) upon request. Response: As previously discussed for
standard transactions and do not have to NPRM Eligible Hospital Objective: patient preference, we do not seek to
guarantee their results. We agree with Provide patients with an electronic copy conflict with or override HIPAA through
commenters that this significantly of their health information (including meaningful use requirements. Therefore,
devalues the results of this objective. diagnostic test results, problem list, an EP, eligible hospital, or CAH may
However, we do believe that as medication lists, allergies, discharge withhold information from the
electronic records and exchange based summary, procedures), upon request electronic copy of a patient’s health
on this and considerations that The purpose of this objective is to information in accordance with the
commenters nearly universally provide a patient’s health information to regulations at 45 CFR 164.524, Access of
considered this to not be a function of them electronically and in a human individuals to protected health
EHR, we are not including this objective readable format and in accordance with information.
in the final rule for Stage 1 of the standards specified in the ONC final Comment: Commenters requested
meaningful use. However, we do believe rule subject to its availability to the clarification of the term ‘‘health
that inclusion of a robust system to provider electronically and any information’’ or alternatively a list of
check insurance eligibility withholding under regulations related to elements required to satisfy the
electronically is an important long term the HIPAA Privacy Act at 45 CFR objective.
policy goal for meaningful use of Response: Subject to the withholding
164.524, Access of individuals to
certified EHR technology and we intend described above, an EP, eligible
protected health information.
to include this objective as well as hospital, or CAH should provide a
In the proposed rule, we indicated
electronic claims submission Stage 2. patient with all of the health
that electronic copies may be provided
After consideration of the public information they have available
through a number of secure electronic electronically. At a minimum, this
comments received, we are not methods (for example, personal health
finalizing the objective to ‘‘Check would include the elements listed in the
record (PHR), patient portal, CD, USB ONC final rule at 45 CFR 170.304(f) for
insurance eligibility electronically from drive). We have changed this
public and private payers’’ or any EPs and 45 CFR 170.306(d) for eligible
description in response to comments to hospitals and CAHs as required for EHR
modification thereof. Given that we are that when responding to patient
not finalizing the objective, we also are technology to become certified.
requests for information, the EP, eligible Comment: Several commenters
not finalizing the associated EP and hospital, or CAH should accommodate
eligible hospital/CAH measures. indicated that a provider should be
patient requests in accordance with 45 allowed to charge a fee for providing an
The second health outcomes policy
CFR 164.524, Access of individuals to electronic copy of a patient’s health
priority identified by the HIT Policy
protected health information. The information.
Committee is to engage patients and
objective provides additional criteria for Response: We do not have the
families in their healthcare. The
meeting meaningful use concerning the authority under the HITECH Act to
following care goal for meaningful use
electronic copy or provision of regulate fees in this manner. Rather, the
addresses this priority:
• Provide patients and families with information that the EP, eligible hospital charging of fees for this information is
timely access to data, knowledge, and or CAH maintains in or can access from governed by the HIPAA Privacy Rule at
tools to make informed decisions and to the certified EHR technology and is 45 CFR 164.524(c)(4) (which only
manage their health. maintained by or on behalf of the EP, permits HIPAA covered entities to
As explained in the proposed rule, we eligible hospital or CAH. charge an individual a reasonable, cost-
do not intend to preempt any existing Comment: We received requests for based fee for a copy of the individual’s
Federal or State law regarding the clarification that only information that health information). We would expect
disclosure of information to minors, the EP, eligible hospital, or CAH has these costs to be very minimal
their parents, or their guardians in available electronically must be considering that the ability to generate
setting the requirements for meaningful provided to the patient. the copy is included in certified EHR
use. For this reason, we defer to existing Response: Yes, we limit the technology. Additional clarification on
Federal and State laws as to what is information that must be provided the fee that a HIPAA covered entity may
appropriate for disclosure to the patient electronically to that information that impose on an individual for an
or their family. For purposes of all exists electronically in or accessible electronic copy of the individual’s
objectives of the Stage 1 criteria of from the certified EHR technology and health information will be addressed in
meaningful use involving the disclosure is maintained by or on behalf of the EP, upcoming rulemaking.
of information to a patient, a disclosure eligible hospital or CAH. We believe it Comment: Commenters pointed out
made to a family member or a patient’s is impractical to require information that the general term ‘‘allergies’’ is
guardian consistent with Federal and maintained on paper to be transmitted inconsistent with other objectives of
State law may substitute for a disclosure electronically. Furthermore, given the Stage 1 and with the capabilities
to the patient. other criteria of Stage 1 of meaningful mandated by certification under the
Comment: Several commenters use, we believe sufficient information ONC IFR, which address only
requested that all objectives under the will be available through certified EHR medication allergies.
health care policy priority be combined, technology, especially given the Response: As we have stated on
as they are redundant. inclusion of many of the foundational several other objectives, we encourage
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Response: We disagree that they are objectives that were included in the core all EPs, eligible hospitals, and CAHs to
redundant and believe each serves a set. work with their EHR technology
unique purpose. We will more fully Comment: Commenters pointed out designers to make capabilities most
describe those purposes in the that the HIPAA Privacy Rule permits relevant to their individual practices of
discussion of each objective. licensed healthcare professionals to care. However, we have maintained that
NPRM EP Objective: Provide patients withhold certain information if its at a minimum the capabilities that are
with an electronic copy of their health disclosure would cause substantial part of certification should be included

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44354 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

and those should be the basis for information demonstrates one of the recorded in the certified EHR
meaningful use so we do modify this many benefits health information technology then the certified EHR
objective to medication allergies to align technology can provide. We also believe technology should be able to calculate
it with other objectives and certification. that certified EHR technology will the measure. Recording patient requests
After consideration of the public provide EPs, eligible hospitals, and for certain actions should be part of the
comments received, we are modifying CAHs more efficient means of providing expectations of meaningful use of
the meaningful use objective for EPs at copies of health information to patients, certified EHR technology. If the EP,
§ 495.6(d)(12)(i) of our regulations to which is why we proposed that a eligible hospital, or CAH records the
‘‘Provide patients with an electronic request for an electronic copy be requests using certified EHR technology,
copy of their health information provided to the patient within 48 hours. certified EHR technology will be able to
(including diagnostics test results, In the final rule, we further point out assist in calculating both the numerator
problem list, medication lists, that this objective is limited to health and denominator. If the requests are
medication allergies) upon request’’ and information maintained and provided recorded by another means at the choice
for eligible hospitals and CAHs at electronically while HIPAA can require of the provider, the provider would be
§ 495.6(f)(11)(i) of our regulations to the retrieval, copying and mailing of responsible for determining the
‘‘Provide patients with an electronic paper documents. For this reason, we do denominator.
copy of their health information not believe the timeframes under this Comment: Commenters inquired if
(including diagnostic test results, meaningful use objective and the third-party requests for information are
problem list, medication lists, HIPAA Privacy Rule must be aligned. included in the denominator.
medication allergies, discharge However, we appreciate that the 48- Response: Only specific third party
summary, procedures), upon request’’. hour timeframe may be burdensome for requests for information are included in
We include this objective in the core some providers, particularly for those the denominator. As we stated in the
set as it is integral to involving patients providers who do not operate 24/7. We opening discussion for this health care
and their families in their provision of therefore are lengthening the timeframe priority, providing the copy to a family
care and was recommended by the HIT to three business days. Business days member or patient’s authorized
Policy Committee for inclusion in the are defined as Monday through Friday representative consistent with federal
core set. excluding federal or state holidays on
NPRM EP/Eligible Hospital Measure: and state law may substitute for a
which the EP, eligible hospital, or CAH disclosure of the information to the
At least 80 percent of all patients who or their respective administrative staffs
request an electronic copy of their patient and count in the numerator. A
are unavailable. As an example if a request from the same would count in
health information are provided it patient made a request for an electronic
within 48 hours. the denominator. All other third party
copy of their health information on
In the proposed rule, we pointed out requests are not included in the
Monday then the EP, eligible hospital,
that all patients have a right under numerator or the denominator.
or CAH would have until the same time
ARRA to an electronic copy of their Comment: Commenters inquired if
on Thursday to provide the information
health information. We said that our asking the patient to register for their
assuming there were no intervening
purpose for including it in meaningful own personal health record (PHR)
holidays. If provision of the copy
use was to ensure that this requirement satisfies the intent of the objective.
involves the mailing of physical
in met in a timely fashion. We also said electronic media, then it would need to Response: EPs, eligible hospitals and
that providing patients with an be mailed on the Thursday. CAHs are to provide the information
electronic copy of their health Comment: Some commenters believed pursuant to the reasonable
information demonstrates one of the the 80 percent threshold was too high or accommodations for patient preference
many benefits health information introduced examples of extraordinary under 45 CFR164.522(b). To be included
technology can provide and we believe circumstances such as natural disasters in this measure, the patient has already
that it is an important part of becoming or system crashes that would indicate a requested an electronic method. While
a meaningful EHR user. We received lower threshold is needed to having a third party PHR certainly
requests for clarifications on what must accommodate them. would be one method, assuming the
be provided and in what timeframe. We Response: We reduce the threshold to provider could populate the PHR with
address those requests in the comment over 50 percent as this objective meets all the information required to meet this
and response section below. We note the criteria of relying solely on a objective. The provider should provide
here that participation in the Medicare capability included as part of certified the same level of assistance to the
and Medicaid EHR incentive programs EHR technology and is not, for purposes patient that would be provided as if
is voluntary. Nothing in the Stage 1 of Stage 1 criteria, reliant on the they maintained their own patient
criteria of meaningful use supersedes or electronic exchange of information, as portal.
exempts an EP, eligible hospital or CAH explained under our discussion of the Comments: Comments were received
from complying with otherwise objective of maintain an up-to-date requesting the format and media for the
applicable requirements to provide problem list. As this is a relatively new provision of the health information.
patients with their health information. capability that was not available to Response: As this is for use by the
Comment: An overwhelming majority either providers or patients before the patient, the form and format should be
of commenters commenting on this introduction of EHRs, we do not believe human readable and comply with the
objective indicated that the 48-hour it meets the same standard of practice as HIPAA Privacy Rule, as specified at 45
time frame is too short and inconsistent maintaining an up-to-date problem list CFR 164.524(c). In addition, efforts
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with the HIPAA Privacy Rule. and therefore adopt a threshold of 50 should be made to make it easily
Response: We discuss the reasoning percent (rather than 80 percent). understandable to the patient. The
for the time frame in the proposed rule. Comment: We received comments media could be any electronic form
We state that this measure seeks to that were concerned about the reporting such as patient portal, PHR, CD, USB
ensure that a patient’s request is met in burden of this requirement. fob, etc. As stated in the previous
a timely fashion. Providing patients Response: We believe that as long as response, EPs, eligible hospitals and
with an electronic copy of their health the request by the patient is accurately CAHs are expected to make reasonable

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accommodations for patient preference procedures at time of discharge, upon should be included in the discharge
as outlined in 45 CFR 164.522(b). request. instructions.
After consideration of the public The purpose of this objective is to Response: This objective simply refers
comments received, we are modifying provide the option to patients to receive to the option of the electronic provision
the meaningful use measure for EPs at their discharge instructions of instructions that would be provided
§ 495.6(d)(12)(i) and for eligible electronically. Discharge instructions to the patient. We believe eligible
hospitals at § 495.6(f)(11)(i) of our would not necessarily be included in a hospitals are the appropriate entity to
regulations to ‘‘More than 50 percent of copy of health information and it is determine the information that should
all patients of the EP or the inpatient or unlikely that a patient would request a be included in the discharge
emergency departments of the eligible copy of their health information at every instructions.
hospital or CAH (POS 21 or 23) who discharge. This objective is unique to Comment: Comments were received
request an electronic copy of their eligible hospitals and CAHs. requesting the format and media for the
health information are provided it Comment: We received several discharge instructions.
within 3 business days.’’ comments suggesting that we eliminate Response: As this is for use by the
We further specify that in order to or clarify the term ‘‘procedures.’’ patient, the form and format should be
meet this objective and measure, an EP, Response: As we believe the terms human readable and comply with the
eligible hospital, or CAH must use the ‘‘instructions’’ and ‘‘procedures’’ are HIPAA Privacy Rule, as specified at 45
capabilities Certified EHR Technology interchangeable as used in this CFR 164.524(c). In addition, efforts
includes as specified and standards at objective, we are removing the term should be made to make it easily
45 CFR 170.304(f) for EPs and 45 CFR ‘‘procedures’’ from the objective. We left understandable to the patient. The
170.306(d) for eligible hospitals and this term in the provision of electronic media could be any electronic form
CAHs. The ability to calculate the copy of health information as the term such as patient portal, PHR, CD, USB
measure is included in certified EHR ‘‘instructions’’ is not in that objective. fob, etc. EPs, eligible hospitals and
technology. We clarify that the term ‘‘instructions’’ CAHs are expected to make reasonable
As the provision of the electronic means any directions that the patient accommodations for patient preference
copy is limited to the information must follow after discharge to attend to as outlined in 45 CFR 164.522(b).
contained within certified EHR any residual conditions that need to be After consideration of the public
technology, this measure is by addressed personally by the patient, comments received, we are finalizing
definition limited to patients whose home care attendants, and other the objective at 495.6(f)(12)(i) of our
records are maintained using certified clinicians on an outpatient basis. regulations as proposed.
EHR technology as described previously Comment: Commenters pointed out We include this objective in the core
in this section under our discussion of that the HIPAA Privacy Rule permits set as it is integral to involving patients
the burden created by the measures licensed healthcare professionals to and their families in their provision of
associated with the Stage 1 meaningful withhold certain information if its care and was recommended by the HIT
use objectives. disclosure would cause substantial Policy Committee for inclusion in the
To calculate the percentage, CMS and harm to the patient or another core set.
ONC have worked together to define the individual. NPRM Eligible Hospital Measure: At
following for this objective: Response: We reiterate that it is not least 80 percent of all patients who are
• Denominator: The number of our intent for the meaningful use discharged from an eligible hospital and
patients of the EP or eligible hospital’s objectives to conflict or override the who request an electronic copy of their
or CAH’s inpatient or emergency HIPAA Privacy Rule through discharge instructions and procedures
departments (POS 21 or 23) who request meaningful use requirements. Therefore are provided it.
an electronic copy of their electronic an EP, eligible hospital, or CAH may Comment: Some commenters believed
health information four business days withhold information from the the 80 percent threshold was too high or
prior to the end of the EHR reporting electronic copy to the extent they are introduced examples of extraordinary
period. permitted or required to do so in circumstances that would indicate that
• Numerator: The number of patients accordance with the regulations at 45 a lower threshold is needed to
in the denominator who receive an CFR 164.524. accommodate them.
electronic copy of their electronic health Comment: Some commenters Response: We reduce the threshold to
information within three business days. recommended that hospitals should be over 50 percent as this objective meets
• Threshold: The resulting percentage required to either provide every patient the criteria of relying solely on a
must be more than 50 percent in order an electronic copy of their discharge capability included as part of certified
for an EP, eligible hospital, or CAH to instructions or at least inform them of EHR technology and is not, for purposes
meet this measure. As addressed in the option to receive it electronically. of Stage 1 criteria, reliant on the
other objectives and in comment Response: We believe it would be too electronic exchange of information.
response, if the EP, eligible hospital, or burdensome to provide every patient an However, as this is a relatively new
CAH has no requests from patients or electronic copy of his or her discharge capability that was not available to
their agents for an electronic copy of instructions. Furthermore, we anticipate either providers or patients before the
patient health information during the that many, if not most, patients will introduction of EHRs we do not believe
EHR reporting period they would be prefer a paper copy during the years of it meets the same standard of practice as
excluded from this requirement as Stage 1. While we certainly encourage maintaining an up-to-date problem list
described previously in this section eligible hospitals to inform their and therefore adopt a threshold of 50
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under our discussion of whether certain patients of the option to receive their percent (rather than 80 percent).
EP, eligible hospital or CAH can meet discharge instructions electronically, we Comment: Some commenters
all Stage 1 meaningful use objectives do not see requiring this as within the expressed concern about the reporting
given established scopes of practices. scope of meaningful use of certified burden imposed by this requirement.
NPRM Eligible Hospital Objective: EHR technology for Stage 1. Response: We believe that as long as
Provide patients with an electronic copy Comment: Comments were received the request by the patient is accurately
of their discharge instructions and requesting a clarification of the data that recorded in the certified EHR

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44356 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

technology then the certified EHR hospital’s or CAH’s inpatient or updates the EP’s knowledge of the
technology should be able to calculate emergency department (POS 21 or 23) patient’s health. We said we judged 96
the measure. We believe that recording and who request an electronic copy of hours to be a reasonable amount of time
patient requests for certain actions that their discharge instructions are to ensure that certified EHR technology
involve the use of certified EHR provided it.’’ is up to date and welcomed comment on
technology should be part of EPs, We further specify that in order to if a shorter or longer time is
eligible hospitals and CAHs standard meet this objective and measure, an EP, advantageous. We did receive comments
practice. If the eligible hospital or CAH eligible hospital, or CAH must use the on the time frame and have revised it as
records the requests using certified EHR capabilities Certified EHR Technology discussed below in the comment and
technology, certified EHR technology includes as specified and standards at response section.
will be able to assist in calculating both 45 CFR 170.306(e). The ability to Comment: We received comments
the numerator and denominator. If the calculate the measure is included in recommending that ‘‘access’’ be clarified
requests are recorded by another means certified EHR technology. to determine whether this is online
at the choice of the provider, the As with the previous objective, the access as indicated in the ONC
provider would be responsible for provision of the electronic copy of the certification criteria for certified EHR
determining the denominator. discharge summary is limited to the technology or just electronic access.
Comment: Several of the comments information contained within certified Response: We believe we
requested clarification of the timeframe EHR technology; therefore this measure inadvertently created confusion by
in which the discharge instructions is by definition limited to patients listing the examples of electronic media
should be provided to the patient. whose records are maintained using (CD or USB drive) in which this access
Response: As discussed previously, certified EHR technology as described could be provided. As many
this objective simply refers to the option previously in this section under our commenters inferred, it was our
of the electronic provision of discussion of the burden created by the intention that this be information that
instructions that would be provided to measures associated with the Stage 1 the patient could access on demand
the patient at the time of discharge. meaningful use objectives. such as through a patient portal or PHR.
Therefore, we believe for the To calculate the percentage, CMS and We did not intend for this to be another
information to be useful to the patient, ONC have worked together to define the objective for providing an electronic
the instructions themselves or following for this objective: copy of health information upon
instructions on how to access them • Denominator: Number of patients request.
electronically should be furnished at the discharged from an eligible hospital’s or Comment: Several commenters
time of discharge from the eligible CAH’s inpatient or emergency requested that all objectives included in
hospital or CAH. department (POS 21 or 23) who request the health care policy priority ‘‘engage
Comment: Some comments expressed an electronic copy of their discharge patients and their families’’ be
concern that providing an electronic instructions and procedures during the combined, as they are redundant.
copy of discharge instructions to the EHR reporting period. Response: We disagree that they are
patient at the time of discharge would • Numerator: The number of patients redundant and believe each serves a
disrupt workflows and lengthen the in the denominator who are provided an unique purpose. We regret any
discharge process resulting in reduced electronic copy of discharge confusion created by the inclusion of
bed turnover in emergency departments. instructions. CD or USB drive as examples of
Response: As discussed previously, • Threshold: The resulting percentage electronic media caused in the intent of
this objective simply refers to the option must be more than 50 percent in order this measure. The difference between
of the electronic provision of for an EP, eligible hospital, or CAH to electronic access and an electronic copy
instructions that would be provided to meet this measure. is that a patient with electronic access
the patient at the time of discharge. We As addressed in other objectives and can access the information on demand
do not believe the provision of an in comment response, if the eligible at anytime while a patient must
electronic copy of the discharge hospital or CAH has no requests from affirmatively request an electronic copy
instructions, upon request, at the time of patients or their agents for an electronic from the EP, eligible hospital or CAH at
discharge alters current workflow or copy during the EHR reporting period a specific time and the information in
lengthens the discharge process. A they would be excluded from this the copy is current only as of the time
patient could be provided instructions requirement as described previously in that the copy is transferred from the
on how to access an Internet Web site this section under our discussion of provider to the patient.
where they can get the instructions or whether certain EP, eligible hospital or Comment: Some commenters asserted
asked to provide an e-mail address or CAH can meet all Stage 1 meaningful that some results and other sensitive
simply be handed electronic media use objectives given established scopes information are best communicated at a
instead of or in addition to a paper of practices. face-to-face encounter.
copy. NPRM EP Objective: Provide patients Response: We agree that there may be
After consideration of the public with timely electronic access to their situations where a provider may decide
comments received, we are modifying health information (including lab that electronic access of a portal or
the meaningful use measure at results, problem list, medication lists, Personal Health Record is not the best
§ 495.6(f)(12)(ii) of our regulations to and allergies) within 96 hours of the forum to communicate results. Within
‘‘More than 50 percent of all patients information being available to the EP. the confines of laws governing patient
access to their medical records, we
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who are discharged 1 from an eligible In the proposed rule, we described


timely as within 96 hours of the would defer to EP’s, eligible hospital or
1 Please note that although the final rule
information being available to the EP CAH’s judgment as to whether to hold
meaningful use measures refer to patients through either the receipt of final lab information back in anticipation of an
discharged from an emergency department, such actual encounter between the provider
emergency room releases are not eligible hospital results or a patient interaction that
discharges for purpose of determining hospital
and the patient. Furthermore just as in
payment incentives under section 1886(n) of the respect to ‘‘inpatient’’ hospital services pursuant to the provision of electronic copy, an EP
Act. Section 1886(n) payments are only with section 1886(n)(1)(A) of the Act. may withhold information from being

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accessible electronically by the patient systems that have actively promoted patients may not have internet access,
in accordance with regulations at 45 such technologies have been able to may not be able or interested in the use
CFR 164.524. Any such withholding achieve active use by over 30 percent of of a patient portal.’’ Health systems that
would not affect the EP’s, eligible their patients, but this may not be have actively promoted such
hospital’s or CAH’s ability to meet this realistic for many practices in the short technologies have been able to achieve
objective as that information would not term. We received comments on this active use by over 30 percent of their
be included. We do not believe there justification for the threshold and patients. However, this 30 percent
would be a circumstance where all requests for clarification, which are threshold may not be realistic for many
information about an encounter would addressed in the comment and response practices in the short term and therefore
be withheld from the patient and section below. serves justification for the 10 percent
therefore no information would be Comment: Some commenters threshold. However, the objective and
eligible for uploading for electronic expressed concern about the calculation measure focus on the availability of the
access. If nothing else, the information of the percentage and expressed the access and the timeliness of the data in
that the encounter occurred can be preference to use an absolute count it, not its utilization. Therefore, we
provided. Please note that providers instead of a percentage. focus on the fact that more than 10
must comply with all applicable Response: We acknowledge there are percent of unique patients seen during
requirements under the HIPAA Privacy unique concerns about calculating this the EHR reporting period could access
Rule, including 45 CFR 164.524. percentage as it involves determining it and that the information is timely.
Comment: We received several the timeliness of the information. The EP is not responsible for ensuring
comments stating that the time frame of Certified EHR technology would be able that 10 percent request access or have
96 hours is too burdensome for EPs. to ascertain the time from when the the means to access. However, we
Response: While we believe that 96 information was entered into its system encourage EPs to make the availability
hours is sufficient, most EPs do not to when the information was available of electronic access known to their
operate 24/7. Therefore, we will limit for electronic access. As certified EHR patients.
the timeframe to business days, in effect technology can provide the access, any Comment: A commenter inquired
changing the timeframe from 96 hours perceivable delay or requirement for about the provider’s liability versus the
in the proposed rule to four business affirmative action would be built in by EHR technology vendor for a security
days. Business days are defined as the user to allow for review of the breach of the system.
Monday through Friday excluding information before posting. Certified
Response: Depending on the facts
federal or state holidays on which the EHR technology could not be
surround the security breach, the
EP, eligible hospital or CAH or their distinguish the difference in time when
provider may be liable for a violation
respective administrative staffs are the information was available to the
under the HIPAA Privacy and Security
unavailable. provider and when it was entered into
Rules, as well as under any other
Comment: Commenters pointed out certified EHR technology. However, we
see no reasonable way to track this time applicable federal or state laws.
that allergies is inconsistent with other
frame that does not impose a heavy Additionally, there may be
objectives of Stage 1 and with the
burden on the EP. Therefore, for the circumstances where the EHR
capabilities mandated by certification
measure, we define the four business technology vendor acted as a business
under the ONC final rule.
Response: As we have stated on days time frame as the time frame when associate and may potentially have
several other objectives, we encourage the information is updated in the liability under the HIPAA Privacy and
all EPs, eligible hospitals, and CAHs to certified EHR technology to when it is Security Rules. The issue of business
work with their EHR technology available electronically to the patient, associate liability under the HIPAA
designers to make capabilities as unless the provider indicates that the Privacy and Security Rules will be
relevant to their individual practices of information should be withheld. It is addressed in upcoming rulemaking.
care as possible. However, we maintain acceptable for a provider to set an After consideration of the public
that at a minimum the capabilities that automated withhold on certain comments received, we are modifying
are part of certification should be information at their discretion. As we the meaningful use measure for EPs at
included in certified EHR technology so have discussed previously in this § 495.6(d)(6)(ii) of our regulations to ‘‘At
we do modify this objective to section, we do not believe absolute least 10 percent of all unique patients
medication allergies to align it with counts are an adequate substitute for seen by the EP are provided timely
other objectives and certification. percentage calculations. (available to the patient within four
After consideration of the public Comment: We received comments business days of being updated in the
comments received, we are modifying requesting clarification on what data certified EHR technology) electronic
the objective for EPs at § 495.6(d)(6)(i) of must be made available. access to their health information
our regulations to ‘‘Provide patients with Response: Certified EHR technology subject to the EP’s discretion to
timely electronic access to their health must be able to make certain data withhold certain information’’.
information (including lab results, available according to the ONC final We further specify that in order to
problem list, medication lists, rule. At a minimum, the data specified meet this objective and measure, an EP,
medication allergies) within four in the ONC final rule at 45 CFR eligible hospital, or CAH must use the
business days of the information being 170.304(g) must be available subject to capabilities Certified EHR Technology
available to the EP’’. the ability of the provider to withhold includes as specified and standards at
NPRM EP Measure: At least 10 it discussed previously. 45 CFR 170.304(g). The ability to
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percent of all unique patients seen by Comment: Commenters suggested that calculate the measure is included in
the EP are provided timely electronic some EPs might not have 10 percent of certified EHR technology.
access to their health information. their patient population who desire or To calculate the percentage, CMS and
In the proposed rule, we said that we could utilize such access. ONC have worked together to define the
recognize that many patients may not Response: We agree that this is a following for this objective:
have internet access, may not be able or possibility. We stated in the proposed • Denominator: Number of unique
interested to use a patient portal. Health rule that ‘‘we recognize that many patients seen by the EP during the EHR

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44358 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

reporting period. A unique patient is of the office visit. Samples of the situation. However, we still believe that
discussed under the objective of CPOE. suggested visits are— an EP should be able to withhold
• Numerator: The number of patients —Level 4 or level 5 evaluation and information if its disclosure would
in the denominator who have timely management services; cause substantial harm to the patient or
(available to the patient within four —Visits conducted at the conclusion of another individual. Therefore, if in their
business days of being updated in the an episode of care; judgment substantial harm may arise
certified EHR technology) electronic —Visits conducted at each transition of from the disclosure of particular
access to their health information care; information, an EP may choose to
online. —Visits relevant to specific conditions withhold that particular information
• Threshold: The resulting percentage such as asthma; and from the clinical summary
must be at least 10 percent in order for —Provider to patient face-to-face visits. Comment: Most commenters noted
an EP to meet this measure. that other than ‘‘at the time of the visit’’,
Response: We believe that a clinical
As addressed in other objectives and there was no specific time period given
summary should be provided at all
in comment response, if an EP neither in which to comply with this objective.
office visits included in the definition of
orders nor creates any of the If CMS intended ‘‘at the time of the visit’’
office visit as defined in this final rule.
information listed in the ONC final rule to mean before the patient leaves the
We believe all of the office visits
45 CFR 170.304(g) and therefore building or upon the patient’s request,
described in our definition result in the
included in the minimum data for this neither are possible due to workflow
EP rendering a clinical judgment that
objective during the EHR reporting and review processes. Most commenters
should be communicated to the patient.
period they would be excluded from assumed we would associate the 48
Comment: Commenters requested
this requirement as described hours related to the ‘copy’ requirement
CMS define ‘‘clinical summary’’ and
previously in this section under our or the 96 hours related to the ‘access’
offered several specific data elements requirement to address this comment
discussion of whether certain EP, that should be included in the
eligible hospital or CAH can meet all and stated that both were too short a
definition such as patient name, period for a clinical visit summary.
Stage 1 meaningful use objectives given provider name, date of visit, location of
established scopes of practices. Others recommended the 30-day
visit, reason for visit, updated timeframe for the provision information
NPRM EP Objective: Provide clinical medication list, laboratory orders, set forth under the HIPAA Privacy Rule.
summaries for patients for each office diagnostic orders, patient instructions Response: We agree that our proposed
visit. based on discussions with the provider objective lacked specificity about the
In the proposed rule, we discussed and a nutrition care management plan. time to comply. To provide such
why we were basing the objective on Response: After reviewing the specificity, we adopt the timeframe of
office visits rather than encounters. We comments we define clinical summary three business days from our objective
said that we did want encounter to be as an after-visit summary that provides of providing electronic health
construed to mean every time a provider a patient with relevant and actionable information to the patient. That is three
interacts with the patient. We received information and instructions containing, business days following the day of the
comments requesting that we further but not limited to, the patient name, visit excluding holidays as described in
define office visit and address those in provider’s office contact information, the providing electronic health
the comment and response section date and location of visit, an updated information to the patient objective.
below. In discussing the measure in the medication list and summary of current Comment: Several commenters
proposed rule, we also said that the medications, updated vitals, reason(s) requested changes to the media through
clinical summary can be provided for visit, procedures and other which this information could be
through a PHR, patient portal on the instructions based on clinical provided. Differing commenters
web site, secure email, electronic media discussions that took place during the recommended eliminating the paper
such as CD or USB fob, or printed copy. office visit, any updates to a problem option, while others recommended only
The after-visit clinical summary list, immunizations or medications the paper option.
contains an updated medication list, administered during visit, summary of Response: We believe that more
laboratory and other diagnostic test topics covered/considered during visit, options give the EP needed flexibility.
orders, procedures and other time and location of next appointment/ The EP could choose any of the listed
instructions based on clinical testing if scheduled, or a recommended means from the proposed rule of PHR,
discussions that took place during the appointment time if not scheduled, list patient portal on a Web site, secure
office visit. of other appointments and testing email, electronic media such as CD or
Comment: We received requests for patient needs to schedule with contact USB fob, or printed copy. If the EP
clarification as to what constitutes an information, recommended patient chooses an electronic media, they
‘‘office visit’’. decision aids, laboratory and other would be required to provide the patient
Response: An office visit is defined as diagnostic test orders, test/laboratory a paper copy upon request. Both forms
any billable visit that includes: (1) results (if received before 24 hours after can be and should be produced by
Concurrent care or transfer of care visits, visit), and symptoms. certified EHR technology.
(2) Consultant visits and (3) Prolonged Comment: Commenters pointed out Comment: Several commenters
Physician Service without Direct (Face- that the HIPAA Privacy Rule permits indicated that a provider should be
To-Face) Patient Contact (tele-health). A licensed healthcare professionals to allowed to charge a fee for providing the
consultant visit occurs when a provider withhold certain information if its copy.
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is asked to render an expert opinion/ disclosure would cause substantial Response: As this is a proactive
service for a specific condition or harm to the patient or another requirement on the part of the EP and
problem by a referring provider. individual. not a response to a request from the
Comment: Some commenters believed Response: As the EP is proactively patient, we do not believe it is
the requirement for the provision of a providing this information to the appropriate to charge the patient a fee
clinical summary at an office visit patient, 45 CFR 164.524 of the HIPAA for this copy. We note that we give the
should be linked to the type or purpose Privacy rule does not apply to this EP considerable flexibility in the

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Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations 44359

manner in which the copy is provided eligible hospital, or CAH must use the knowledge resources integrated with
including the provision of a paper copy. capabilities Certified EHR Technology current EHRs were provided. The HIT
The only accommodation an EP is includes as specified and standards at Policy Committee amended their
required to make is the provision of a 45 CFR 170.304(h). The ability to recommendation in their comments on
paper copy that can be automatically calculate the measure is included in the proposed rule to:
generated certified EHR technology. We certified EHR technology. —EPs and hospitals should report on
therefore believe that costs of this will As with the previous objective, the the percentage of patients for whom
be negligible. provision of the clinical summary is they use the EHR to suggest patient-
Comment: A number of commenters limited to the information contained specific education resources.
expressed concern regarding whether within certified EHR technology; Other recommended language for the
the current available technology could therefore this measure is by definition objective includes:
produce a summary of the required limited to patients whose records are —Provide patients educational
information in a standardized format, maintained using certified EHR information that is specific to their
the use of clinical nomenclature rather technology as described previously in health needs as identified by
than lay terms and the fact that some this section under our discussion of the information contained in their EHR
providers use multiple modules to burden created by the measures technology such as diagnoses and
document the care of the patient. associated with the Stage 1 meaningful demographic data, and
Response: We believe it is appropriate use objectives. —The original HIT Policy Committee
to leave the design of EHR technology To calculate the percentage, CMS and objective of ‘‘Provide access to patient-
systems and their outputs to the system ONC have worked together to define the specific education resources upon
developers and the EHR technology following for this objective: request.’’
users. However, we note that the • Denominator: Number of unique
capability to meet this objective is patients seen by the EP for an office Response: We are convinced by
included in the ONC final rule at 45 during the EHR reporting period. A commenters that the availability of
CFR 170.304(h) as a criteria for certified unique patient is discussed under the education resources linked to EHRs is
EHR technology and we are confident objective of using CPOE. more widely available than we had
that vendors will be able to produce • Numerator: Number of patients in indicated in the proposed rule.
certified EHR technologies. the denominator who are provided a Therefore, for the final rule we will
After consideration of the public clinical summary of their visit within include this objective for the Stage 1 of
comments received, we are finalizing three business days. meaningful use. We note that the new
the objective for EPs at § 495.6(d)(13)(i) • Threshold: The resulting percentage recommendation of the HIT Policy
of our regulations as proposed. must be more than 50 percent in order Committee is a hybrid of a measure and
We include this objective in the core for an EP, eligible hospital, or CAH to an objective, whereas in developing the
set as it is integral to involving patients meet this measure. meaningful use criteria we consistently
and their families in their provision of As addressed in other objectives, EPs identify both an objective and
care and was recommended by the HIT who have no office visits during the associated measure. However, we agree
Policy Committee for inclusion in the EHR reporting period would be with the HIT Policy Committee and
core set. excluded from this requirement as others that the objective and associated
NPRM EP Measure: Clinical described previously in this section measure should make clear that the EP,
summaries provided to patients for at under our discussion of whether certain eligible hospital or CAH should utilize
least 80 percent of all office visits. EP, eligible hospital or CAH can meet certified EHR technology in a manner
Comment: Some commenters believed all Stage 1 meaningful use objectives where the technology suggests patient-
the threshold was too high or should be given established scopes of practices. specific educational resources based on
replaced with a numerical count or NPRM EP/Eligible Hospital Objective: the information stored in the certified
attestation. ‘‘Provide access to patient-specific EHR technology. Therefore, we are
Response: We reduce the threshold to education resources upon request.’’ including a revised version of this
over 50 percent as this objective meets In the proposed rule, we discussed objective in the final rule for Stage 1 of
the criteria of relying solely on a this objective, but did not propose it. meaningful use.
capability included as part of certified We stated that there was a paucity of We also believe it is necessary to state
EHR technology and is not, for purposes knowledge resources that are integrated what level of EP, eligible hospital and
of Stage 1 criteria, reliant on the with EHR, and that also are widely CAH discretion is available when
electronic exchange of information. available. We also noted that the ability deciding whether to provide education
Also, as this is a relatively new to provide education resources in resources identified by certified EHR
capability that was not available to multiple languages might be limited. We technology to the patient. Therefore, we
either providers or patients before the stated our intent to further explore the include the phrase ‘‘if appropriate’’,
introduction of EHRs, we do not believe objective in subsequent stages of which allows the EP or the authorized
it meets the same standard of practice as meaningful use. provider in the eligible hospital or CAH
maintaining an up-to-date problem list Comment: We received many final decision on whether the education
and therefore adopt a threshold of 50 comments, including comments from resource is useful and relevant to a
percent (rather than 80 percent). both the HIT Policy Committee and specific patient.
After consideration of the public MedPAC, to include this measure in the After consideration of the public
comments received, we are modifying final rule. These commenters disagreed comments received, we are including
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the meaningful use measure for EPs at with our assertion in the proposed rule this meaningful use objective for EPs at
§ 495.6(d)(13)(ii) of our regulation to that ‘‘there is currently a paucity of § 495.6(e)(6)(i) and eligible hospitals
‘‘Clinical summaries provided to knowledge resources that are integrated and CAHs at § 495.6(g)(5)(i) of our
patients for more than 50 percent of all within EHRs, that are widely available, regulations as ‘‘Use certified EHR
office visits within 3 business days’’. and that meet these criteria, particularly technology to identify patient-specific
We further specify that in order to in multiple languages.’’ Specific education resources and provide those
meet this objective and measure, an EP, examples of the availability of resources to the patient if appropriate’’.

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NPRM EP/Eligible Hospital Measure: • Exchange meaningful clinical Comment: Commenters requested
Not applicable. information among professional health clarification of the term ‘‘patient
Comment: CMS received a comment care team. authorized entities.’’
requesting an 80 percent threshold of NPRM EP Objective: Capability to Response: By ‘‘patient authorized
appropriate patients and/or caregivers exchange key clinical information (for entities’’, we mean any individual or
receiving patient-specific educational example, problem list, medication list, organization to which the patient has
materials. In addition, the HIT Policy allergies, and diagnostic test results), granted access to their clinical
Committee’s revised objective suggests a among providers of care and patient information. Examples would include
patient based percentage. authorized entities electronically. an insurance company that covers the
Response: As with the addition of the patient, an entity facilitating health
NPRM Eligible Hospital Objective: information exchange among providers
recording of advance directives, we are
Capability to exchange key clinical or a personal health record vendor
able to relate this measure to one that
information (for example, discharge identified by the patient. A patient
is based on patients and can be
summary, procedures, problem list, would have to affirmatively grant access
accomplished solely using certified EHR
medication list, allergies, diagnostic test to these entities.
technology. As this objective requires
results), among providers of care and Comment: Commenters requested
more than just the recording of
patient authorized entities clarification of the term ‘‘exchange.’’
information in certified EHR
electronically. Response: We expect that this
technology, we adopt a lower threshold
of 10 percent. In the proposed rule, we defined the information, when exchanged
After consideration of the public term ‘‘diagnostic test results ’’ as all data electronically, would be exchanged in
comments received, we are including needed to diagnose and treat disease, structured electronic format when
this meaningful use measure for EPs at such as blood tests, microbiology, available (for example, drug and clinical
§ 495.6(e)(6)(ii) and eligible hospitals at urinalysis, pathology tests, radiology, lab data). However, where the
cardiac imaging, nuclear medicine tests, information is available only in
§ 495.6(g)(5)(ii) of our regulations as
and pulmonary function tests. We unstructured electronic formats (for
‘‘More than 10 percent of all unique
maintain this description for the final example, free text and scanned images),
patients seen by the EP or admitted to
rule. We said that when the information we would allow the exchange of
the eligible hospital’s or CAH’s
was available in a structured format we unstructured information. We believe
inpatient or emergency department
expected that it be transferred in a that the electronic exchange of
(POS 21 or 23) are provided patient-
structured format. However, if it was information is most efficient when it is
specific education resources’’.
unavailable in a structured format, that exchanged from a provider’s certified
We further specify that in order to
the transmission of unstructured data EHR technology to another certified
meet this objective and measure, an EP,
was permissible. We provide additional EHR technology either directly or
eligible hospital, or CAH must use the through an entity facilitating health
capabilities Certified EHR Technology information on structured data in the
comment and response section, but information exchange using structured
includes as specified and standards at data that can be automatically identified
45 CFR 170.302(m). The ability to maintain for the final rule the concept
that the exchange can be of structured by the receiving system and integrated
calculate the measure is included in into the receiver’s records. However, we
certified EHR technology. or unstructured data.
know that much information cannot
To calculate the percentage, CMS and Comment: Commenters requested
currently be, and may never be,
ONC have worked together to define the clarification of the term ‘‘key clinical
transmitted in the way we just
following for this objective: information.’’
described.
• Denominator: Number of unique Response: By ‘‘clinical information’’, Comment: Commenters requested
patients seen by the EP or admitted to we mean all data needed to diagnose clarification of the term ‘‘structured
the eligible hospital’s or CAH’s and treat disease, such as blood tests, data.’’
inpatient or emergency department microbiology, urinalysis, pathology Response: This distinction between
(POS 21 or 23) during the EHR reporting tests, radiology, cardiac imaging, structured data and unstructured data
period. A unique patient is discussed nuclear medicine tests, and pulmonary applies to all types of information. We
under the CPOE objective. function tests. We leave it to the have previously defined structured data
• Numerator: Number of patients in provider’s clinical judgment as to in this section. To ensure that certified
the denominator who are provided identifying what clinical information is EHR technology has a certain level of
patient education specific resources. considered key clinical information for functionality, ONC at 45 CFR 170.304(i)
• Threshold: The resulting percentage purposes of exchanging clinical for EPs and 45 CFR 170.306(f) for
must be more than 10 percent in order information about a patient at a eligible hospitals and CAHs specified
for an EP, eligible hospital, or CAH to particular time with other providers of certain types of information that a
meet this measure. care. The examples we provided in the certified EHR technology must be able
We do not believe that any EP, eligible proposed rule and the final rule below to exchange to become certified. ONC
hospital, or CAH will not have more are not intended to be exhaustive. ONC also provided standards to support this
than 10 percent of their patients eligible in their final rule provides a minimum exchange. These standards do not
to receive patient specific education set of information that certified EHR preclude a vendor of EHR technology
resources and therefore do not believe technology must be able to exchange in from enabling its product to exchange
an exclusion is necessary for this order to be certified. A provider’s additional types of information nor limit
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objective. determination of key clinical the provider’s discretion (either in


The third health outcomes policy information could include some or all of exchanging more or less) in deciding
priority identified by the HIT Policy this information as well as information what information is key and should be
Committee is to improve care not included in the ONC final rule at 45 exchanged about a given patient at a
coordination. The HIT Policy CFR 170.304(i) for EPs and 45 CFR given time.
Committee recommended the following 170.306(f) for eligible hospitals and Comment: Commenters expressed
care goals to address this priority: CAHs. concern that the exchange of key

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clinical information via certified EHR exchange of information. We said that Response: While the use of test
systems requires a unique or national we are aware that in most areas of the patient information may increase the
patient identifier to ensure accurate country, the infrastructure necessary to risk that the system will not be testing
exchange. support such exchange is still being to its full capability, given the privacy
Response: While such an identifier developed. Therefore, for the Stage 1 and security concerns surrounding the
could facilitate an exchange, it need criteria of meaningful use we proposed transmission of actual patient
only be unique to the parties involved that EPs and eligible hospitals test their information we do not require it for the
in the exchange and need not be ability to send such information at least purposes of a test. Therefore, the use of
national in scope, nor is a specific once prior to the end of the EHR test information about a fictional patient
unique identifier necessary for reporting period. We proposed that the that would be identical in form to what
successful exchanges. Many current testing could occur prior to the would be sent about an actual patient
health information exchanges have had beginning of the EHR reporting period. would satisfy this objective.
success identifying patients by a We also said that if multiple EPs are Comment: Commenters suggested
combination of several elements of using the same certified EHR technology deferring the measure to a later stage
information without a separate in a shared physical setting, the testing due to the lack of a mature HIE
independent identifier. would only have to occur once for a infrastructure and/or to emulate the
Comment: Commenters pointed out given certified EHR technology, as we Health Information and Management
that the general term ‘‘allergies’’ is do not see any value to running the System Society (HIMSS) EMR Adoption
inconsistent with other objectives of same test multiple times just because Model.
Stage 1 and with the capabilities multiple EPs use the same certified EHR Response: We agree that many areas
mandated by certification under the technology. Finally, we attempted to of the country currently lack the
ONC final rule, which uses the term define an ‘‘exchange’’ as the clinical infrastructure to support the electronic
‘‘medication allergies’’. information must be sent between exchange of information. As the goal of
Response: As we have stated on different clinical entities with distinct this meaningful use objective is to
several other objectives, we encourage certified EHR technology and not ensure that certified EHR technology
all EPs, eligible hospitals, and CAHs to between organizations that share a has the capability to electronically
work with their certified EHR certified EHR. We received many exchange key clinical information, we
technology designers to make comments requesting further only require a single test.
capabilities most relevant to their clarification on these concepts and we After consideration of the public
individual practices of care. However, attempt to provide additional comments received, we are finalizing
we have maintained that at a minimum information in the comment and the meaningful use measure at
the capabilities that are part of response section below. § 495.6(d)(14)(ii) and § 495.6(f)(13)(ii) of
certification should be included so we Comment: Commenters expressed our regulations as proposed.
modify the example to change allergies concern that the receiving entities are We further specify that in order to
to medication allergies to align it with not required to have the same meet this objective and measure, an EP,
other objectives and certification. capabilities as meaningful users of eligible hospital, or CAH must use the
After consideration of the public certified EHR technology. capabilities Certified EHR Technology
comments received, we are modifying Response: The HITECH Act does not includes as specified and standards at
the meaningful use objective for EPs at provide us the authority to require any 45 CFR 170.304(i) for EPs and 45 CFR
§ 495.6(d)(14)(i) of our regulations to entity (medical provider or otherwise) to 170.306(f) for eligible hospitals and
‘‘Capability to exchange key clinical conform to certain standards and CAHs. The ability to calculate the
information (for example, problem list, criteria unless they seek to become a measure is included in certified EHR
medication list, medication allergies, meaningful EHR user. The Act also technology. EPs, eligible hospitals, and
and diagnostic test results), among limits the entities that are eligible to CAHs should attempt to identify one
providers of care and patient authorized become meaningful EHR users. In other entity with whom to conduct a
entities electronically’’ and for eligible developing the associated measure for test of the submission of electronic data.
hospitals and CAHs at § 495.6(f)(13)(i) to this objective, we have ensured that This test must include the transfer of
‘‘Capability to exchange key clinical eligible providers will be able to meet either actual or ‘‘dummy’’ data to the
information (for example, discharge this objective as long as there is one chosen other entity. The testing could
summary, procedures, problem list, other entity with which they can test occur prior to the beginning of the EHR
medication list, medication allergies, their capability. As electronic exchange reporting period, but must occur prior to
diagnostic test results), among providers is not constrained by distance, we are the end of the EHR reporting period and
of care and patient authorized entities confident that every provider seeking to every payment year would require its
electronically’’. test their system will be able to find own, unique test as infrastructure for
In response to our revised another entity with which to conduct health information exchange is expected
requirements for meeting meaningful such test. to mature over time. Therefore, if an
use, we included this objective in the Comment: Commenters asked eligible hospital or CAH were to become
core set. Section 1848 (o)(2)(A)(ii) of the whether the test needs to be ‘‘live’’ or if a meaningful EHR user in 2011 for their
Act specifically includes electronic it could be a ‘‘simulation.’’ first payment year, they would have to
exchange of health information in Response: As specified in the conduct another, unique test to become
meaningful use for eligible proposed rule, this test must involve the a meaningful EHR user in 2012 for their
professionals. actual submission of information to second payment year. If multiple EPs
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NPRM EP/Eligible Hospital Measure: another provider of care with distinct are using the same certified EHR
Performed at least one test of certified certified EHR technology or other technology in a shared physical setting,
EHR technology’s capacity to system capable of receiving the the testing would only have to occur
electronically exchange key clinical information. once for a given certified EHR
information. Comment: Commenters asked technology, as we do not see any value
In the proposed rule, we identified whether the use of ‘‘test’’ or ‘‘dummy’’ to running the same test multiple times
this objective as reliant on the electronic data is permissible. just because multiple EPs use the same

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44362 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

certified EHR technology. To be not believe this objective should be Comment: Some commenters
considered an ‘‘exchange’’ for this deferred to a later stage. requested clarification on which EP,
objective and measure the clinical Comment: Commenters requested eligible hospital or CAH would conduct
information must be sent between additional clarity of the term ‘‘relevant the medication reconciliation. The one
different legal entities with distinct encounter.’’ Only a few suggestions on to whom the patient is transferred or the
certified EHR technology or other such clarity were provided by one who transfers the patient.
system that can accept the information commenters. Two examples of Response: When conducting
and not between organizations that commenters’ recommendations are medication reconciliation during a
share certified EHR technology. CMS ‘‘when a prescription is generated’’ and transfer of care, we believe that it is the
will accept a yes/no attestation to verify ‘‘a significant change in the patient’s EP, eligible hospital or CAH that
all of the above for EPs, eligible condition that resulted in change in receives the patient into their care that
hospitals, and CAHs. medication regimen which could should conduct the medication
As the measure already accounts for include significant change in dosing of reconciliation. It is for this provider that
the possibility of a failed test and we are more than 1 medication, identification the information is most crucial, as they
confident that everyone will be identify of a new medical condition, decline in will be making the future clinical
an entity with which to conduct a test, functional status or change in advanced judgments regarding the patient.
we do not believe an exception is directive.’’ Therefore, we revise this objective and
required for EPs, eligible hospitals or Response: We finalize our proposal by its associated measure to reflect this
CAHs. defining ‘‘relevant encounter’’ as an clarification.
NPRM EP/Eligible Hospital Objective: encounter during which the EP, eligible Comment: Commenters requested a
Perform medication reconciliation at hospital or CAH performs a medication standard list be defined for the process
relevant encounters and each transition reconciliation due to new medication or including prescription and non
of care. long gaps in time between patient prescription medications, herbal
encounters or for other reasons products, dietary supplements,
In the proposed rule, we described
determined appropriate by the EP, prescriber, drug name, regimen and
‘‘medication reconciliation’’ as the
eligible hospital or CAH. Essentially an allergies.
process of identifying the most accurate
encounter is relevant if the EP, eligible Response: We believe the information
list of all medications that the patient is
hospital, or CAH judges it to be so. This included in the process of medication
taking, including name, dosage,
flexibility has implications for the reconciliation is appropriately
frequency and route, by comparing the measure that were not fully considered determined by the provider and patient.
medical record to an external list of in the proposed rule. We will discuss After consideration of the public
medications obtained from a patient, those below in connection with our comments received, we are modifying
hospital or other provider. We maintain discussion of the associated measure. the meaningful use objective for EPs at
this description for the final rule. We Comment: Commenters requested § 495.6(e)(7)(i) and for eligible hospitals
also described ‘‘relevant encounter’’ and additional clarity of the term ‘‘transition and CAHs at § 495.6(g)(6)(i) of our
‘‘transition of care’’; however, as we of care.’’ A few suggestions were regulations to ‘‘The EP, eligible hospital
received comments requested additional provided by commenters including or CAH who receives a patient from
clarification of these terms we address expanding the description to include all another setting of care or provider of
them in the comment and response transfers to different settings within a care or believes an encounter is relevant
section below. hospital or revising the definition to should perform medication
Comment: Several commenters ‘‘the movement of a patient from one reconciliation’’.
requested that this objective be deferred setting of care (hospital, ambulatory NPRM EP/Eligible Hospital Measure:
until it can be conducted using the primary care practice, ambulatory Perform medication reconciliation for at
exchange of electronic information specialty care practice, long-term care, least 80 percent of relevant encounters
between certified EHR technology. home health, rehabilitation facility) to and transitions of care.
Other commenters believed that the another’’. Comment: Commenters believed it
process is not one for avoiding Response: In the proposed rule we was an unjustifiable burden to record
medication errors, but a human clarified ‘‘transition of care’’ as the which encounters were relevant and
workflow process supported by the transfer of a patient from one clinical which were not given our flexible
EHR, and not an automated EHR setting (inpatient, outpatient, physician definition of ‘‘relevant encounter’’.
process. office, home health, rehab, long-term Response: We agree that the inclusion
Response: We certainly look forward care facility, etc.) to another or from one of relevant encounters creates a burden
to a time when most medication EP, eligible hospital, or CAH (as defined that one commenter described as ‘‘non-
reconciliation occurs as an automated by CCN) to another. We believe that value-added work’’. We also believe that
process within the EHR reconciling different settings within one hospital when the EP, eligible hospital, or CAH
information that has been exchanged. using certified EHR technology would identifies the encounter as relevant, it is
However, it is unlikely that an have access to the same information so unlikely that the EP, eligible hospital, or
automated process within the EHR will reconciliation would not be necessary. CAH would then not carry out the
fully supplant the medication We modify our clarification to account medication reconciliation. For these
reconciliation conducted between the for some of the revisions provided. We reasons, we are removing relevant
provider and the patient. In order for clarify ‘‘transition of care’’ as the encounters from the measure for this
this automated reconciliation process to movement of a patient from one setting objective.
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occur and be useful, the relevant of care (hospital, ambulatory primary Comment: Commenters said the
structured data exchanged needs to be care practice, ambulatory specialty care percent measurements should be
as accurate as possible. Requiring practice, long-term care, home health, replaced with a numerical count or an
medication reconciliation as part of rehabilitation facility) to another. We attestation the objective has been met or
meaningful use in Stage 1 lays the also clarify that the receiving eligible the demonstration of the capability by
groundwork for future reliable hospital or EP would conduct the performing one test of certified EHR
electronic exchange. We therefore do medication reconciliation. technology’s capacity to present

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providers with patient medication § 495.6(e)(7)(ii) and for eligible hospitals we proposed to add this objective in
information that supports the and CAHs at § 495.6(g)(6)(ii) of our order to be able to include the
reconciliation of medications at time of regulations to ‘‘The EP, eligible hospital recommended measure. Furthermore,
admission and discharge. Other or CAH performs medication we add referrals because the sharing of
commenters stated the proposed 80 reconciliation for more than 50 percent the patient care summary from one
percent threshold was too high. of transitions of care in which the provider to another communicates
Response: We are maintaining a patient is transitioned into the care of important information that the patient
percentage for the reasons discussed the EP or admitted to the eligible may not have been able to provide, and
previously in this section. However, we hospital’s or CAH’s inpatient or can significantly improve the quality
do reduce the threshold to over 50 emergency department (POS 21 or 23)’’. and safety of referral care, and reduce
percent as this objective meets the We further specify that in order to unnecessary and redundant testing. We
criteria of relying solely on a capability meet this objective and measure, an EP, received support for this inclusion from
included as part of certified EHR eligible hospital, or CAH must use the commenters and include this objective
technology and while not absolutely capabilities Certified EHR Technology in the final rule for the reasons outlined
reliant on electronic exchange of includes as specified and standards at in the proposed rule. We did receive
information, it does involve the 45 CFR 170.302(j). The ability to comments requesting clarifications
exchange of information between calculate the measure is included in around this objective and address them
providers and therefore we adopt a certified EHR technology. in the comment and response section
threshold of 50 percent (rather than 8 As discussed previously in this below.
percent). section under our discussion of the Comment: We received several
Comment: Commenters requested we burden created by the measures comments that requested clarification as
align this objective with The Joint associated with the Stage 1 meaningful to the purpose of this objective.
Commission National Patient Safety use objectives, we only include in the Response: The purpose of this
Goal on medication reconciliation (Goal denominator transitions of care related objective is to ensure a summary of care
8) in order to decrease confusion, to patients whose records are record is provided to the receiving
prevent the slowing of adoption of best maintained using certified EHR provider when a patient is transitioning
practices and match current hospital technology. To calculate the percentage, to a new provider or has been referred
reconciliation processes. CMS and ONC have worked together to to another provider while still
Response: CMS understands the define the following for this objective: remaining under the care of the referring
commenters’ concerns regarding • Denominator: Number of transitions provider. If the provider to whom the
possible confusion if the meaningful use of care during the EHR reporting period referral is made or to whom the patient
medication reconciliation requirement for which the EP or eligible hospital’s or is transitioned to has access to the
differs from The Joint Commission’s CAH’s inpatient or emergency medical record maintained by the
requirement for those facilities department (POS 21 to 23) was the referring provider then the summary of
accredited by that organization. receiving party of the transition. care record would not need to be
However, currently there is no finalized • Numerator: The number of provided. The most common example
Joint Commission standard as the transitions of care in the denominator cited by commenters was a referral
Commission is currently in the process where medication reconciliation was during which patient remains an
of re-evaluating their National Patient performed. inpatient of the hospital. Finally, unlike
Safety Goal 8 (Accurately and • Threshold: The resulting percentage with medication reconciliation, where
completely reconcile medications across must be more than 50 percent in order the receiving party of the transfer
the continuum of care) given the for an EP, eligible hospital, or CAH to conducts the action, the transferring
difficulties that many organizations are meet this measure. If an EP was not on party would provide the summary care
having in meeting the complex the receiving end of any transition of record to the receiving party.
requirements. In the absence of a care during the EHR reporting period Comment: Commenters requested
definitive Joint Commission standard to they would be excluded as previously additional clarity of the term ‘‘transition
take into consideration, this is not discussed in this section under our of care’’. A few suggestions were
possible. discussion of whether certain EP, provided by the commenters including
Comment: Some commenters eligible hospital or CAH can meet all expanding the description to include all
expressed the desire to expand the Stage 1 meaningful use objectives given transfers to different settings within a
scope of the measure to include the established scopes of practices. We do hospital or revising the definition to
clinical decision making and patient not believe that any eligible hospital or ‘‘the movement of a patient from one
counseling and education by a CAH would be in a situation where they setting of care (hospital, ambulatory
pharmacist. would not need to know the precise primary care practice, ambulatory,
Response: We believe that is both medications their patients are taking. specialty care practice, long-term care,
beyond the scope of meaningful use as NPRM EP/Eligible Hospital Objective: home health, rehabilitation facility) to
pharmacists are not eligible Provide summary care record for each another’’.
professionals for the EHR incentive transition of care or referral. Response: In the proposed rule we
programs and that the provision of In the proposed rule, we pointed out clarified that the term transition of care
patient counseling is more aligned with that this objective was not explicitly means a transfer of a patient from one
the objectives of clinical quality included in the HIT Policy Committee’s clinical setting (inpatient, outpatient,
measures. Information from the recommended objectives, but that they physician office, home health, rehab,
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medication reconciliation could be used did include a measure for the ‘‘percent long-term care facility, etc.) to another
for the basis of clinical decision support of transitions in care for which or from one EP, eligible hospital, or
rules, but is not in and of itself a clinical summary care record is shared.’’ We said CAH (as defined by CMS Certification
decision. that we believe that in order for a Number (CCN) to another. We believe
After consideration of the public measure to be relevant it must that different settings within a hospital
comments received, we are modifying correspond to an objective in the using certified EHR technology would
the meaningful use measure for EPs at definition of meaningful use. Therefore, have access to the same information so

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44364 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

providing a clinical care summary Response: We are maintaining a eligible hospital, or CAH to meet this
would not be necessary. We further percentage for the reasons discussed measure.
clarify transition of care as the previously in this section. However, we As addressed in other objectives and
movement of a patient from one setting do reduce the threshold to over 50 in comment response, if an EP does not
of care (hospital, ambulatory primary percent as this objective meets the transfer a patient to another setting or
care practice, ambulatory, specialty care criteria of relying solely on a capability refer a patient to another provider
practice, long-term care, home health, included as part of certified EHR during the EHR reporting period then
rehabilitation facility) to another. technology and while not absolutely they would have a situation of a null
Comment: Some commenters reliant on electronic exchange of denominator as described would be
requested clarification on which EP, information, it does involve the excluded from this requirement as
eligible hospital or CAH should provide exchange of information between described previously in this section
the summary of care document; the one providers and therefore we adopt a under our discussion of whether certain
to whom the patient is transferred or threshold of 50 percent (rather than 80 EP, eligible hospital or CAH can meet
referred or the one who transfers or percent). all Stage 1 meaningful use objectives
refers the patient. Comment: There were concerns about given established scopes of practices.
Response: We believe that it is the EP, the ability of certified EHR technology We do not believe that any eligible
eligible hospital or CAH that transfers or to calculate this measure. As long as an hospital or CAH would be in a situation
refers the patient to another setting of EP, eligible hospital, or CAH records the where they would never transfer a
care or provider that should provide the order for a referral or transfer as patient to another care setting or make
summary of care document. It is for this structured data and a record is made a referral to another provider.
provider that has the most recent that the summary care record was The fourth health outcomes policy
information on the patient that may be provided then certified EHR technology priority identified by the HIT Policy
crucial to the provider to whom the will be able to calculate this measure. Committee is improving population and
patient is transferred or referred. After consideration of the public public health. The HIT Policy
Therefore, we revise this objective and comments received, we are modifying Committee identified the following care
the meaningful use measure for EPs at goal to address this priority:
its associated measure to reflect this
clarification.
§ 495.6(e)(8)(ii) and for eligible hospitals • The patient’s health care team
and CAHs at § 495.6(g)(7)(ii) of our communicates with public health
Comment: Commenters asked for
regulations to ‘‘The EP, eligible hospital agencies.
clarification on how the summary of
or CAH who transitions or refers their The goal as recommended by the HIT
care record should be transferred.
patient to another setting of care or Policy Committee is ‘‘communicate with
Response: The goal is to get the
provider of care provides a summary of public health agencies.’’ In the proposed
summary care record into the next
care record for more than 50 percent of rule, we explained that we found this
provider’s possession. While we highly
transitions of care and referrals’’. goal to be somewhat ambiguous, as it
encourage all EPs, eligible hospitals, We further specify that in order to does not specify who must
and CAHs to explore ways to meet this objective and measure, an EP, communicate with public health
accomplish the transfer using electronic eligible hospital, or CAH must use the agencies. We propose to specify ‘‘the
exchange, we realize that this capability capabilities Certified EHR Technology patient’s health care team’’ as the
is still in the development stages. included as specified and standards at individuals who would communicate
Therefore, an EP, eligible hospital, or 45 CFR 170.304(i) for EPs and 45 CFR with public health agencies.
CAH could send an electronic or paper 170.306(f) for eligible hospitals and NPRM EP/Eligible Hospital Objective:
copy of the summary care record CAHs. The ability to calculate the Capability to submit electronic data to
directly to the next provider or could measure is included in certified EHR immunization registries and actual
provide it to the patient to deliver to the technology. submission where required and
next provider, if the patient can As discussed previously in this accepted.
reasonably expected to do so. Certified section under our discussion of the In the proposed rule, we did not
EHR technology would be used to burden created by the measures elaborate on this objective.
generate the summary of care record and associated with the Stage 1 meaningful Comment: Some commenters
to document that it was provided to the use objectives, we only include in the suggested out that not every EP, eligible
patient or receiving provider. denominator transitions of care and hospital, or CAH administers
After consideration of the public referrals related to patients whose immunization. Therefore, as proposed,
comments received, we are modifying records that are maintained using this objective and its associated measure
the meaningful use objective for EPs at certified EHR technology. To calculate would require an EP, eligible hospital,
§ 495.6(e)(8)(i) and for eligible hospitals the percentage, CMS and ONC have or CAH to implement and test a
and CAHs at § 495.6(g)(7)(i) of our worked together to define the following capability that they would not use.
regulations to ‘‘The EP, eligible hospital for this objective: Response: We acknowledge that this
or CAH who transitions their patient to • Denominator: Number of transitions objective is not relevant to all EPs,
another setting of care or provider of of care and referrals during the EHR eligible hospitals or CAHs. Therefore, in
care or refers their patient to another reporting period for which the EP or this final rule, we clarify that this
provider of care should provide eligible hospital’s or CAH’s inpatient or objective and its associated measure
summary care record for each transition emergency department (POS 21 to 23) apply only to EPs, eligible hospitals or
of care or referral’’. was the transferring or referring CAHs that administer one or more
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NPRM EP/Eligible Hospital Measure: provider. immunizations during the EHR


Provide summary of care record for at • Numerator: The number of reporting period.
least 80 percent of transitions of care transitions of care and referrals in the Comment: Some commenters
and referrals. denominator where a summary of care recommended revising the language of
Comment: Commenters said that this record was provided. the immunization objective to be
should be replaced with a count and • Threshold: The percentage must be consistent with the language of the
that the threshold was too high. more than 50 percent in order for an EP, syndromic surveillance objective by

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replacing ‘‘where required and accordance with to applicable law and standardization of means and form of
accepted’’ with ‘‘according to applicable practice. submission.
law and practice.’’ NPRM EP/Eligible Hospital Measure: Response: Standards for content
Response: First, we make a technical Performed at least one test of certified exchange and vocabulary are
correction. The objective listed for EPs EHR technology’s capacity to submit established in the ONC final rule at 45
on page 1858 of the proposed rule listed electronic data to immunization CFR 170.302(k). As meaningful use
this objective as ‘‘Capability to submit registries (unless none of the seeks to utilize certified EHR technology
electronic data to immunization immunization registries to which the for purposes of the test and subsequent
registries and actual submission where EP, eligible hospital, or CAH submits submission (if test was successful) these
possible and accepted.’’ The objective such information have the capacity to are the standards that should be
was intended to be ‘‘Capability to submit receive the information electronically). utilized. While we encourage all
electronic data to immunization In the proposed rule, we identified providers and registries to work together
registries and actual submission where this as an objective where more to develop efficient, electronic
required and accepted’’ for EPs, eligible stringent requirements may be submission of immunization
hospitals, and CAHs. It is written as established for EPs and hospitals under information to all registries where it can
such in every other instance in the the Medicaid program in states where be used to improve population and
proposed rule including the regulation this capability exists. This is just one public health, for purposes of becoming
text. Second, in response to the example of a possible State proposed a meaningful EHR user, we only require
comment that ‘‘where required and modification to meaningful use in the a single test and follow up submission
accepted’’ be replaced with ‘‘according Medicaid EHR incentive program. This if that test is successful.
to applicable law and practice’’, we see ability for the States is also included in Comment: Commenters suggested
little distinction between the two in our final rule. deferring the measure to a later stage
terms of requirement as applicable law Comment: As with the objective of due to the lack of a mature HIE
and practice would be the things exchanging key clinical information, infrastructure.
imposing a requirement. Therefore, we some commenters asked whether the Response: We agree that many areas
adopt the proposed language, but test needs to be ‘‘live’’ or if it could be of the country currently lack the
modify the language slightly to ‘‘in a ‘‘simulation’’. Some commenters infrastructure to support the electronic
accordance with applicable law and suggested that a simulation where the exchange of information. As meaningful
practice’’. We do note however, that ability was tested without being use seeks to ensure certified EHR
applicable law and practice do not transmitted to another party should be technology has the capability to submit
guarantee every receiving entity will be sufficient. Others suggested that the test electronic data to registries, we only
able to accept it electronically. Our needs to include transmission or require a single test if a receiving entity
measure for meeting this objective is difficulties in actual sending is available and follow up submission
one test of electronic data submission information might not be uncovered. only if that test is successful. If none of
and if the test is successful follow up Response: As specified in the the immunization registries to which
submission to that one entity. We do not proposed rule, this test must involve the the EP, eligible hospital or CAH submits
seek to enforce through meaningful use actual submission of information to a information has the capacity to receive
every law and practice that may require registry or immunization information the information electronically, then this
submission of immunization data. We system, if one exists that will accept the objective would not apply.
also make another consistency change to information. Comment: Commenters requested
the objectives under the health care Comment: Commenters asked clarification whether on a failed
policy goal of improving population and whether the use of ‘‘test’’ or ‘‘dummy’’ attempted test satisfies the criteria of
public health. In this objective, we data is permissible. this measure and whether EPs in a
describe the capability as submitting Response: While the use of test group setting using identical certified
electronic data. In the other objectives patient information may increase the EHR technology would only need to
under this goal we describe the risk that the system will not be testing conduct a single test, not one test per
capability as providing electronic data. to its full capability, given the privacy EP.
We believe that functionally these terms and security concerns surrounding the Response: A failed attempt would
are interchangeable, but to avoid any transmission of actual patient meet the measure. We highly encourage
confusion we adopt the same term of information we do not require it for the EPs, eligible hospitals, and CAHs to
‘‘submit’’ electronic data across all three purposes of a test. Therefore, the use of work with their vendor and the
objectives. test information about a fictional patient receiving entity with whom they tested
Comment: Some commenters that would be identical in form to what to identify the source of the failure and
suggested that the term ‘‘Immunization would be sent about an actual patient develop remedies, but for Stage 1 of
Information Systems (IIS)’’ has replaced would satisfy this objective. However, meaningful use a failed attempt would
the term ‘‘registry’’ and is referred to as we note that this is one of the objectives meet the requirements. We had
such by the Centers for Disease Control that a State may modify in accordance indicated in the proposed rule that only
(CDC). with the discussion in II.A.2.c. of the one test is required for EPs practicing in
Response: We modified the objective proposed rule. Therefore, more stringent a group setting that shares the same
to account for both terms. After requirements may be established for EPs certified EHR technology. We maintain
consideration of the public comments and eligible hospitals under the that proposal for the final rule.
received, we are modifying the Medicaid program in states where this Comment: Commenters recommended
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meaningful use objective for EPs at capability exists. the inclusion of electronically reporting
§ 495.6(e)(9)(i) and for eligible hospitals Comment: Commenters expressed to other types of registries in addition to
and CAHs at § 495.6(g)(8)(i) of our concern about the burden of multiple immunization registries such as disease-
regulations to Capability to submit requirements for submission from specific registries such as the Cystic
electronic data to immunization Federal, State, and local government Fibrosis Registry.
registries or Immunization Information agencies or non-governmental registries. Response: While we encourage all
Systems and actual submission in They also raised the issue of lack of providers and registries to work together

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44366 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Rules and Regulations

to develop efficient, electronic health agencies and actual submission none of the public health agencies to
submission of information to all where it can be received. which eligible hospital submits such
registries where it can be used to In the proposed rule, we did not information have the capacity to receive
improve population and public health, elaborate on this objective. the information electronically).
for purposes of becoming a meaningful Comment: A few commenters In the proposed rule, we identified
EHR user, we only require a single test requested this objective be applied to this as an objective where more
utilizing immunization data and follow EPs as long as the EHR Certification stringent requirements may be
up submission if that test is successful. requirements are met. A commenter established for eligible hospitals under
After consideration of the public remarked that electronic submission of the Medicaid program in states where
comments received, we are modifying reportable lab results should not put an this capability exists. This is just one
the meaningful use measure for EPs at additional burden on the providers as example of a possible State proposed
§ 495.6(e)(9)(ii) and for eligible hospitals the EHR would be able to automate this modification to
and CAHs at § 495.6(g)(8)(ii) of our process. Comment: Commenters asked
regulations to ‘‘Performed at least one Response: We based the limitation on whether the test needs to be ‘‘live’’ or if
test of certified EHR technology’s the recommendation of the HIT Policy it could be a ‘‘simulation’’.
capacity to submit electronic data to Committee who in turn went through a Response: As specified in the
immunization registries and follow up considerable public development proposed rule, this test must involve the
submission if the test is successful process. We do not believe that burden actual submission of information to a
(unless none of the immunization of reporting was the only limiting factor public health agency, if one exists that
registries to which the EP, eligible in keeping this objective from being will accept the information.
hospital, or CAH submits such applied to EPs; therefore, we maintain Comment: Commenters asked
information have the capacity to receive our proposal to limit this objective to whether the use of ‘‘test’’ or ‘‘dummy’’
the information electronically)’’. eligible hospitals and CAHs. EPs usually data is permissible.
We further specify that in order to send out lab test to other organizations Response: While the use of test
meet this objective and measure, an EP, on which reporting burdens may fall. patient information may increase the
eligible hospital, or CAH must use the Comment: Commenters requested that risk that the system will not be testing
capabilities Certified EHR Technology the actual transmission of the to its full capability, given the privacy
includes as specified and standards at information be required. and security concerns surrounding the
45 CFR 170.302(k). The ability to Response: In the discussion of the transmission of actual patient
calculate the measure is included in reporting immunization data objective, information we do not require it for the
certified EHR technology. We require we discussed at length the need to align purposes of a test. Therefore, the use of
that an EP, eligible hospital, or CAH the language for the three objectives test information about a fictional patient
determine if they have given any included under the health care policy that would be identical in form to what
immunizations during the EHR priority of improve population and would be sent about an actual patient
reporting period. Those that have not public health, which is one of the five would satisfy this objective. However,
given any immunizations during the priorities of the Stage 1 definition of we note that this is one of the objectives
EHR reporting period are excluded from meaningful use. Our interpretation is that a State may modify as discussed
this measure according to the discussion that the three phrases result in the same previously in this section. Therefore,
of whether certain EP, eligible hospital outcome, but introduce confusion due more stringent requirements may be
or CAH can meet all Stage 1 meaningful to the varied wordings. As commenters established for EPs and eligible
use objectives given established scopes strongly preferred the phrase ‘‘according hospitals under the Medicaid program
of practices. If they have given to applicable law and practice’’, we will in states where this capability exists.
immunizations during the reporting so modify this objective. We do note Comment: Commenters requested that
period, they should then attempt to however that applicable law and one national standard be established for
locate a registry or IIS with whom to practice does not guarantee every reporting lab results to public health
conduct a test of the submission of receiving entity will be able to accept it agencies.
electronic data. This test must include electronically. Our measure for meeting Response: Standards for content
the transfer of either actual or ‘‘dummy’’ this objective is one test of electronic exchange and vocabulary are
data to the chosen registry or IIS. The data submission and if the test is established in the ONC final rule at 45
testing could occur prior to the successful, a follow up submission to CFR 170.306(g). While we encourage all
beginning of the EHR reporting period, that one entity. We do not seek to providers and public health agencies to
but must occur prior to the end of the enforce through meaningful use every work together to develop efficient,
EHR reporting period. EPs in a group law and practice that may require electronic submission of reportable lab
setting using identical certified EHR submission of lab results. results to all public health agencies, for
technology would only need to conduct After consideration of the public purposes of becoming a meaningful EHR
a single test, not one test per EP. If the comments received, we are modifying user, we only require a single test and
test is successful, then the EP, eligible the meaningful use objective for eligible follow up submission if that test is
hospital, or CAH should institute hospitals and CAHs at § 495.6(g)(9)(i) of successful.
regular reporting to that entity in our regulations to ‘‘Capability to submit Comment: Commenters suggested
accordance with applicable law and electronic data on reportable (as deferring the measure to a later stage
practice. CMS will accept a yes/no required by state or local law) lab results due to the lack of a mature HIE
attestation to verify all of the above for to public health agencies and actual infrastructure and lack of a clear
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EPs, eligible hospitals or CAHs that submission in accordance with standard for exchanging bio-
have administered immunizations applicable law and practice’’. surveillance data.
during the EHR reporting period. NPRM Eligible Hospital Measure: Response: We agree that many areas
NPRM Eligible Hospital Objective: Performed at least one test of certified of the country currently lack the
Capability to provide electronic EHR technology capacity to provide infrastructure to support the electronic
submission of reportable (as required by electronic submission of reportable lab exchange of information. As meaningful
state or local law) lab results to public results to public health agencies (unless use seeks to ensure certified EHR

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technology has the capability to submit EHR technologies are covered under the EHR technology’s capacity to provide
electronic data to public health ONC final rule and do support the electronic syndromic surveillance data
agencies, we only require a single test if automatic identification of the requisite to public health agencies (unless none
a receiving entity is available and follow data and its electronic capture. This of the public health agencies to which
up submission only if that test is greatly limits the cost, complexity and an EP, eligible hospital, or CAH submits
successful. burden of this objective. such information have the capacity to
After consideration of the public Comment: Commenters requested that receive the information electronically).
comments received, we are modifying an actual transmission be required. In the proposed rule, we identified
the meaningful use measure for eligible Response: In discussing the reporting this as an objective where more
hospitals and CAHs at § 495.6(g)(9)(ii) of immunization data objective, we stringent requirements may be
our regulations to ‘‘Performed at least focused on the need to align the established for EPs and hospitals under
one test of certified EHR technology’s language for the three objectives the Medicaid program in states where
capacity to provide electronic contained in under the health care this capability exists. This is just one
submission of reportable lab results to policy priority of improving population example of a possible State proposed
public health agencies and follow-up and public health. Our interpretation is modification to meaningful use.
submission if the test is successful that the three phrases result in the same First, a technical correction, in the
(unless none of the public health outcome, but introduce confusion with proposed rule we incorrectly stated that
agencies to which eligible hospital or the current language. We adopted the the capability to send electronic data to
CAH submits such information have the language from this objective for the immunization registries was included in
capacity to receive the information others. We do note however that the certification standards for certified
electronically)’’. applicable law and practice does not EHR technology. We intended for this
We further specify that in order to guarantee every receiving entity will be data to be sent to public health agencies
meet this objective and measure, an EP, able to accept it electronically. Our and ONC in their final rule at 45 CFR
eligible hospital, or CAH must use the measure for meeting this objective is 170.304(l) correctly stated this
capabilities Certified EHR Technology one test of electronic data submission capability as such.
includes as specified and standards at and if the test is successful, then follow Comment: Commenters asked
45 CFR 170.306(g). The ability to up submission to that one entity based whether the test needs to be ‘‘live’’ or if
calculate the measure is included in on the reporting requirements of that it could be a ‘‘simulation’’.
certified EHR technology. Eligible entity. We do not seek to enforce Response: As specified in the
hospitals and CAHs should attempt to through meaningful use every law and proposed rule, this test must involve the
identify one public health agency with practice that may require submission of actual submission of information to a
whom to conduct a test of the lab results. public health agency, if one exists that
submission of electronic data. This test Comment: Some commenters
must include the transfer of either will accept the information.
requested a clarification of the term
actual or ‘‘dummy’’ data to the chosen Comment: Commenters asked
‘‘public health agencies.’’
public health agency. The testing could Response: A public health agency is whether the use of ‘‘test’’ or ‘‘dummy’’
occur prior to the beginning of the EHR an entity under the jurisdiction of the data is permissible.
reporting period, but must occur prior to U.S. Department of Health and Human Response: While the use of test
the end of the EHR reporting period. If Services, tribal organization, State level patient information may increase the
the test is successful, then the eligible and/or city/county level administration risk that the system will not be testing
hospital or CAH should institute regular that serves a public health function. to its full capability, given the privacy
reporting to that entity according to Comment: Some commenters and security concerns surrounding the
applicable law and practice. CMS will recommended that providers be transmission of actual patient
accept a yes/no attestation to verify all required to satisfy either electronic information we do not require it for the
of the above for eligible hospitals and submission to immunization registries purposes of a test. Therefore, the use of
CAHs. or electronic submission of syndromic test information about a fictional patient
NPRM EP/Eligible Hospital Objective: surveillance data to a public health that would be identical in form to what
Capability to provide electronic agency, but not both. would be sent about an actual patient
syndromic surveillance data to public Response: We disagree. We believe would satisfy this objective. However,
health agencies and actual transmission these are fundamentally different types we note that this is one of the objectives
according to applicable law and of information. Each may impose that a State may modify in accordance
practice. unique requirements in terms of ability with the discussion in II.A.2.c. of the
In the proposed rule, we did not to exchange information on both the EP, proposed rule. Therefore, more stringent
elaborate on this objective. eligible hospital, or CAH and the requirements may be established for EPs
Comment: Half of the commenters receiving entity. Therefore, a test for one and eligible hospitals under the
commenting on this objective does not prove or disprove the ability to Medicaid program in states where this
recommended that the objective be exchange information for the other. capability exists.
deferred to Stage 2 or 3 as the objective After consideration of the public Comment: A few commenters
is considered expensive, complex and comments received, we are modifying expressed confusion as to the required
imposes significant administrative the meaningful use objective for EPs at ferquency of the test.
burdens on EPs, eligible hospitals and § 495.6(e)(10)(i) and eligible hospitals Response: As stated in the proposed
CAHs unless the certified EHR and CAHs at § 495.6(g)(10(i) of our rule, the required frequency of a test in
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technologies support the automate, regulations to ‘‘Capability to submit Stage 1 for EPs, eligible hospitals, and
electronic capture of the requisite data. electronic syndromic surveillance data CAHs is at least once prior to the end
Response: The measure for this to public health agencies and actual of the EHR reporting period. We further
objective accounts for the possibility submission in accordance with clarify that each payment year would
that such electronic exchange of applicable law and practice.’’ require it own unique test.
syndromic data is not possible. NPRM EP/Eligible Hospital Measure: Comment: Commenters requested that
Standards and certification for certified Performed at least one test of certified one national standard be established for

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reporting syndromic surveillance data to We further specify that in order to Comment: We received considerable
public health agencies. meet this objective and measure, an EP, support from many commenters who
Response: Standards for content eligible hospital, or CAH must use the supported this objective and measure as
exchange and vocabulary are capabilities Certified EHR Technology proposed.
established in the ONC final rule. While includes as specified and standards at Response: We appreciate the support
we encourage all providers and public 45 CFR 170.302(l). The ability to of these commenters for our proposed
health agencies to work together to calculate the measure is included in objective and measure.
develop efficient, electronic submission certified EHR technology. EPs, eligible Comment: Commenters requested
of syndromic surveillance data to all hospitals, and CAHs should attempt to clarification of appropriate technical
public health agencies, for purposes of identify one public health agency with capabilities.
becoming a meaningful EHR user, we whom to conduct a test of the Response: The ONC final rule
only require a single test and follow up submission of electronic data. This test specifies certain capabilities that must
submission if that test is successful. must include the transfer of either be in certified EHR technology. For the
Comment: Commenters suggested actual or ‘‘dummy’’ data to the chosen objective we simply mean that a
deferring the measure to a later stage public health agency. The testing could technical capability would be
due to the lack of a mature HIE occur prior to the beginning of the EHR appropriate if it protected the electronic
infrastructure. reporting period, but must occur prior to health information created or
Response: We agree that many areas the end of the EHR reporting period. If maintained by the certified EHR
of the country currently lack the the test is successful, then the EP, technology. All of these capabilities
infrastructure to support the electronic eligible hospital, or CAH should could be part of the certified EHR
exchange of information. As meaningful institute regular reporting to that entity technology or outside systems and
use seeks to ensure certified EHR according to applicable law and programs that support the privacy and
technology has the capability to submit practice. CMS will accept a yes/no security of certified EHR technology. We
electronic data to public entities, we attestation to verify all of the above for could not develop an exhaustive list.
only require a single test if a receiving eligible hospitals and CAHs. Furthermore as we state in the proposed
entity is available and follow up If an EP does not collect any rule compliance with HIPAA privacy
submission only if that test is reportable syndromic information on and security rules is required for all
successful. We note that this measure their patients during the EHR reporting covered entities, regardless of whether
only applies if there is a public health period, then they are excluded from this or not they participate in the EHR
agency with the capacity to receive this measure according to the discussion of incentive programs. Furthermore,
information. whether certain EP, eligible hospital or compliance with the HIPAA Privacy
Comment: Commenters requested CAH can meet all Stage 1 meaningful and Security Rules constitutes a wide
clarification on whether a failed use objectives given established scopes range of activities, procedures and
attempted test satisfies the measure and of practices. infrastructure. We rephrased the
whether EPs in a group setting using The fifth health outcomes policy objective to ensure that meaningful use
identical certified EHR technology priority is to ensure adequate privacy of the certified EHR technology supports
would only need to conduct a single and security protections for personal compliance with the HIPAA Privacy
test, not one test per EP. health information. The following care and Security Rules and compliance with
Response: A failed attempt would goals for meaningful use address this fair sharing data practices outlined in
meet the measure. We highly encourage priority: the Nationwide Privacy and Security
EPs, eligible hospitals, and CAHs to • Ensure privacy and security Framework (http://healthit.hhs.gov/
work with their vendor and the protections for confidential information portal/server.pt/gateway/PTARGSl0l
receiving entity with whom they tested through operating policies, procedures, 10731l848088l0l0l18/
to identify the source of the failure and and technologies and compliance with NationwidePSlFramework-5.pdf), but
develop remedies, but for Stage 1 of applicable law. do not believe meaningful use of
meaningful use a failed attempt would • Provide transparency of data certified EHR technology is the
meet the requirements. We had sharing to patient. appropriate regulatory tool to ensure
indicated in the proposed rule that only NPRM EP/Eligible Hospital Objective: such compliance with the HIPAA
on test is required for EPs practicing in Protect electronic health information Privacy and Security Rules.
a group setting that shares the same created or maintained by the certified Comment: Several commenters urged
certified EHR technology. We maintain EHR technology through the CMS not to finalized requirements for
that proposal for the final rule. implementation of appropriate technical the fair data sharing practices set forth
After consideration of the public capabilities. in the Nationwide Privacy and Security
comments received, we are modifying In the proposed rule, we discussed Framework and to clarify the policies to
the meaningful use measure for EPs at how we were relating the objectives which CMS is referring.
§ 495.6(e)(10)(ii) and eligible hospitals presented by the HIT Policy committee Response: While we stated in the
and CAHs at § 495.6(g)(10)(ii) of our more tightly to the meaningful use of proposed rule we rephrased the
regulations to ‘‘Performed at least one certified EHR technology as opposed to objective to ensure ‘‘compliance with
test of certified EHR technology’s the broader success of the EP, eligible fair sharing data practices outline in the
capacity to provide electronic hospital or CAH in ensuring privacy and Nationwide Privacy and Security
syndromic surveillance data to public security. The primary reason we gave Framework,’’ we did not propose any
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health agencies and follow-up was that the proper vehicle for ensuring practices or policies related to the
submission if the test is successful privacy and security is the HIPAA Nationwide Privacy and Security
(unless none of the public health Privacy and Security Act and that we Framework and do not finalize any in
agencies to which an EP, eligible sought with this objective to ensure that this final rule.
hospital, or CAH submits such certified EHR technology does not Comment: Several commenters
information have the capacity to receive impede an EP’s, eligible hospital’s or requested the elimination of this
the information electronically.)’’ CAH’s ability to comply with HIPAA. objective as redundant to HIPAA.

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Response: We do not see meaningful and CAHs at § 495.6(f)(14)(i) of our health information. We have maintained
use as an appropriate regulatory tool to regulations as proposed. this discussion for the final rule, but
impose different, additional, and/or We include this objective in the core modified the measure to account for
inconsistent privacy and security policy set. We believe maintaining privacy and requests discussed in the comment and
requirements from those policies security is crucial for every EP, eligible response section below.
already required by HIPAA. With that hospital or CAH that uses certified EHR Comment: Some commenters
said, we do feel it is crucial that EPs, technology and was recommended by requested clarification of the phrase
eligible hospitals, and CAHs evaluate the HIT Policy Committee for inclusion ‘‘implement security updates as
the impact certified EHR technology has in the core set. necessary’’.
on their compliance with HIPAA and NPRM EP/Eligible Hospital Measure: Response: A security update would be
the protection of health information in Conduct or review a security risk required if any security deficiencies
general. Therefore, we retain this analysis in accordance with the were identified during the risk analysis.
objective and measure for meaningful requirements under 45 CFR 164.308 A security update could be updated
use in the final rule. (a)(1) and implement security updates software for certified EHR technology to
Comment: We received hundreds of as necessary. be implemented as soon as available, to
comments that requested the In the proposed rule, we discussed changes in workflow processes, or
cancelation of the EHR incentive the role of certified EHR technology in storage methods or any other necessary
payment program due to the privacy privacy and security. We said that while corrective action that needs to take
and security risks imposed by the certified EHR technology provides tools place in order to eliminate the security
implementation and use of certified for protecting health information, it is deficiency or deficiencies identified in
EHR technology. not a full protection solution. Processes the risk analysis. To provide better
Response: We are required by the and possibly tools outside the scope of clarity on this requirement, we are
ARRA to implement the EHR incentive certified EHR technology are required. modifying the measure.
programs and cannot cancel them. We Therefore, for the Stage 1 criteria of After consideration of the public
seek to mitigate the risks to the security meaningful use we propose that EPs and comments received, we are modifying
and privacy of patient information by eligible hospitals conduct or review a the meaningful use measure for EPs at
requiring EPs, eligible hospitals, and security risk analysis of certified EHR § 495.6(d)(15)(ii) and eligible hospitals
CAHs to conduct or review a security technology and implement updates as and CAHs at § 495.6(f)(14)(ii) of our
risk analysis in accordance with the necessary at least once prior to the end regulations ‘‘Conduct or review a
requirements under 45 CFR 164.308 of the EHR reporting period and attest security risk analysis per 45 CFR
(a)(1) and implement security updates to that conduct or review. The testing 164.308(a)(1) of the certified EHR
as necessary. could occur prior to the beginning of the technology, and implement security
After consideration of the public EHR reporting period. This is to ensure updates and correct identified security
comments received, we are finalizing that the certified EHR technology is deficiencies as part of its risk
the meaningful use objective for EPs at playing its role in the overall strategy of management process.’’
§ 495.6(d)(15)(i) and eligible hospitals the EP or eligible hospital in protecting BILLING CODE 4120–01–P
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BILLING CODE 4120–01–C sufficiently in advance of the EHR 1886(n)(3)(B)(ii) of the Act, we will
3. Sections 4101(a) and 4102(a)(1) of the reporting period for 2011, so that continue to rely on an attestation
HITECH Act: Reporting on Clinical adequate time has been provided either methodology for reporting of clinical
Quality Measures Using EHRs by EPs, for such specifications to be certified, or quality measures as a requirement for
Eligible Hospitals, and CAHs 3 for EHR vendors to code such demonstrating meaningful use of
specifications into certified systems. certified EHR technology for payment
a. General Therefore, for 2011, we proposed that year 2012. We stated in the proposed
As discussed in the meaningful use Medicare EPs, eligible hospitals, and rule that should we not have the
background in section II.A.2.a. there are CAHs use an attestation methodology to capacity to accept information on
three elements of meaningful use. In submit summary information to us on clinical quality measures electronically
this section, we discuss the third clinical quality measures as a condition in 2012, we would inform the public of
requirement: using certified EHR of demonstrating meaningful use of this fact by publishing a notice in the
technology, the EP, eligible hospital, or certified EHR technology, rather than Federal Register and providing
CAH submits to the Secretary, in a form electronic submission. instructions on how this information
and manner specified by the Secretary, We proposed that from the Medicaid should be submitted to us.
information for the EHR reporting perspective, delaying the onset of We also are finalizing in this final rule
period on clinical quality measures and clinical quality measures electronic that States must identify for us in their
other measures specified by the reporting until 2012 addresses concerns State Medicaid HIT Plans how they plan
Secretary. The submission of other about States having the ready to accept data from Medicaid providers
measures is discussed in section II.A.2.c infrastructure to receive and store who seek to demonstrate meaningful
of this final rule. The two other clinical quality measures data before use by reporting on clinical quality
elements of meaningful use are then. More importantly, we recognized measures, either via attestation or via
discussed in section II.A.2.d.1 of this that since Medicaid providers are electronic reporting, subject to our prior
final rule. eligible to receive incentive payments approval. If they initiate their program
b. Requirements for the Submission of for adopting, implementing, or by accepting attestations for clinical
Clinical Quality Measures by EPs, upgrading certified EHR technology, quality measures, they must also
Eligible Hospitals, and CAHs Medicaid providers may not be focused describe how they will inform providers
on demonstrating meaningful use until of their timeframe to accept submission
Sections 1848(o)(2)(B)(ii) and 2012 or later. of clinical quality measures
1886(n)(3)(B)(ii) of the Act provide that We stated that we anticipate that for electronically. We expect that States
the Secretary may not require the the 2012 payment year we will have will have the capacity to accept
electronic reporting of information on completed the necessary steps to have electronic reporting of clinical quality
clinical quality measures unless the the capacity to receive electronically measures by their second year
Secretary has the capacity to accept the information on clinical quality measures implementing their Medicaid EHR
information electronically, which may from EHRs, including the promulgation incentive program.
be on a pilot basis. of technical specifications for EHR For purposes of the requirements
In the proposed rule, we stated that vendors to use for obtaining certification under sections 1848(o)(2)(A)(iii) and
we do not anticipate that HHS will of their systems. Therefore, for the 1886(n)(3)(iii) of the Act, we defined
complete the necessary steps for us to Medicare EHR incentive program ‘‘clinical quality measures’’ to consist of
have the capacity to electronically beginning in CY 2012 we proposed that measures of processes, experience, and/
accept data on clinical quality measures an EP using a certified EHR technology or outcomes of patient care,
from EHRs for the 2011 payment year. or beginning in FY 2012 an eligible observations or treatment that relate to
We believe that it is unlikely that by hospital or CAH using a certified EHR one or more quality aims for health care
2011 there will be adequate testing and technology, as appropriate for clinical such as effective, safe, efficient, patient-
demonstration of the ability to receive quality measures, must submit centered, equitable, and timely care. We
the required transmitted information on information on clinical quality measures noted that certain statutory limitations
a widespread basis. The capacity to electronically, in addition to submitting apply only to the reporting of clinical
accept information on clinical quality the other measures described in section quality measures, such as the
measures also would depend upon the II.2.d.2, in order for the EP, eligible requirement discussed in the previous
Secretary promulgating technical hospital, or CAH to be a meaningful paragraph prohibiting the Secretary
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specifications for EHR vendors with EHR user, regardless of whether CY from requiring the electronic reporting
respect to the transmission of 2012 is their first or second payment of information on clinical quality
information on clinical quality measures year. However, if the Secretary does not measures unless the Secretary has the
3 For purposes of this final rule, the term ‘‘eligible
have the capacity to accept the capacity to accept the information
hospital’’ for the Medicaid EHR incentive program
information on clinical quality measures electronically, as well as other statutory
is inclusive of Critical Access Hospitals (CAHs) as electronically in 2012, consistent with requirements for clinical quality
sections 1848(o)(2)(B)(ii) and measures that are discussed below in
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section II.A.3.c.1 of this final rule. These eligible hospitals use certified EHR for which clearly defined electronic
limitations apply solely to the technology to capture the data elements specifications have been finalized by the
submission of clinical quality measures, and calculate the results for certain date of display of this final rule.
and do not apply to other measures of clinical quality measures. Further, we Finalized clinical quality measures are
meaningful EHR use. The clinical proposed that EPs, eligible hospitals, listed in Table 6 for EPs and Table 7 for
quality measures on which EPs, eligible and CAHs demonstrate that they have eligible hospitals and CAHs. We also
hospitals, or CAHs will be required to satisfied this requirement during the clarify that while States may not have
submit information using certified EHR EHR reporting period for 2011 through the capacity to accept electronic
technology, the statutory requirements attestation. We also proposed to require reporting of clinical quality measures in
and other considerations that were used that Medicare EPs, eligible hospitals, 2011 or their first year implementing
to select these measures, and the and CAHs attest to the accuracy and their Medicaid EHR incentive program,
reporting requirements are described completeness of the numerators and we expect that they will have such
below. denominators for each of the applicable capacity by their second
With respect to Medicaid EPs and measures. Finally, in accordance with implementation year. However, if they
eligible hospitals, we noted that section our authority under sections do not, as with the Federal government,
1903(t)(6) of the Act recognizes that the 1848(o)(C)(i)(V) and 1886(n)(3)(C)(i)(V) the State would continue to rely on an
demonstration of meaningful use may of the Act, which grants us broad attestation methodology for reporting
also include the reporting of clinical discretion to specify the means through clinical quality measures as a
quality measures to the States. We which EPs, eligible hospitals, and CAHs requirement for demonstrating
proposed that in the interest of demonstrate compliance with the meaningful use of certified EHR
simplifying the program and guarding meaningful use criteria, we proposed technology, subject to CMS prior
against duplication of meaningful use that EPs, eligible hospitals, and CAHs approval via an updated State Medicaid
criteria, the clinical quality measures demonstrate their use of certified EHR HIT plan.
adopted for the Medicare EHR incentive technology to capture the data elements Comment: A few commenters
program, would also apply to EPs and and calculate the results for the requested that the definition of ‘‘clinical
eligible hospitals in the Medicaid EHR applicable clinical quality measures by quality measures’’ be expanded to
incentive program. reporting the results to us for all include ‘‘appropriate clinical
Despite the statutory limitation applicable patients. For the Medicaid prevention.’’
prohibiting the Secretary from requiring incentive program, we proposed that Response: We agree that appropriate
the electronic submission of clinical States may accept provider attestations clinical prevention is a pertinent topic
quality measures in the Medicare EHR in the same manner to demonstrate for clinical quality measures, but we do
incentive program, if HHS does not have not believe the definition of clinical
meaningful use in 2011. However, we
the capacity to accept this information quality measures needs to delineate
indicated that we expect that most
electronically, as previously discussed, every aspect of quality care included in
Medicaid providers will qualify for the
the Secretary has broad discretion to the definition.
incentive payment by adopting, Comment: Several commenters said it
establish requirements for meaningful
implementing, or upgrading to certified will be difficult to develop the EHR
use of certified EHR technology and for
EHR technology, and therefore will not capability to capture, integrate and train
the demonstration of such use by EPs,
need to attest to meaningful use of staff regarding measure specifications if
eligible hospitals, and CAHs. Although
certified EHR technology in 2011, for the clinical quality measures are not
we proposed to require the electronic
their first payment year. posted with sufficient time to allow
submission of information on clinical
quality measures in 2012, we stated that We stated that we recognize that these activities. Other commenters said
we do not desire this to delay the use considerable work needs to be done by there is insufficient time allowed for
of certified EHR technology by EPs, measure owners and developers with vendors to retool their products and
eligible hospitals, and CAHs to measure respect to the clinical quality measures complete development of the reports
and improve clinical quality. that we proposed. This includes and/or systems. Several commenters
Specifically, we stated that using EHR completing electronic specifications for indicated that the clinical quality
functionalities that support measures, implementing such measures have not been tested, and
measurement of clinical quality is specifications into EHR technology to reliability and validity testing should be
critical to a central goal of the HITECH capture and calculate the results, and performed. Other commenters indicated
Act, improving health care quality. implementing the systems, themselves. that standard, clearly defined electronic
Measuring quality is a fundamental We also recognized that some measures specifications do not exist and new
aspect of improving such quality, are further developed than others, as specifications should be pilot tested and
because it allows EPs, eligible hospitals, discussed in the measures section (see published for stakeholder/public
and CAHs to receive quantitative 75 FR 1871) of the proposed rule. comment. A commenter requested that
information upon which they can then Nevertheless we stated our belief that CMS establish an explicit process for
act in order to improve quality. overall there is sufficient time to development and testing of evidence
Accordingly, although we did not complete work on measures and based electronically specified measures
propose under sections measures specifications so as to allow (eMeasure), and ensure adequate time
1848(o)(2)(A)(iii) and 1886(n)(3)(A)(iii) vendors and EPs, eligible hospitals, and for field testing.
of the Act to require that for 2011 EPs, CAHs to implement such systems. We Response: In general we agree with
eligible hospitals, and CAHs report stated that it was our intention not to the desirability of having electronic
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clinical quality measures to us or States finalize those specific measures should specifications available, pilot tested,
electronically, we proposed to require as the necessary work on measure and published for stakeholder viewing
an additional condition of specifications not be completed for sufficiently in advance so as to allow
demonstrating meaningful use of particular measures according to the adequate time for modifications if
certified EHR technology under sections timetable we discuss below. As we necessary and vendors to incorporate
1848(o)(2)(A)(i), 1886(n)(3)(A)(ii), and discuss below, we finalize in this final them into certified EHR technology, and
1903(t)(6) of the Act that EPs and rule only those clinical quality measures for EPs, eligible hospitals, and CAHs to

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integrate the measures into their implement and train staff on the clinical quality measures endorsed by
operations and train staff on the measures we adopt in this final rule. the NQF, including NQF endorsed
measures. In this case, however, there is measures that have previously been
c. Statutory Requirements and Other
a process for certification of certified selected for the Physician Quality
Considerations for the Selection of
EHR technology which includes testing Reporting Initiative (PQRI) program.
Clinical Quality Measures for Electronic Similarly, we stated that when selecting
of the capability of the certified EHR. Submission by EPs, Eligible Hospitals,
The final rule issued by ONC (found the clinical quality measures eligible
and CAHs hospitals and CAHs must report in order
elsewhere in this issue of the Federal
Register) provides that certified EHR (1) Statutory Requirements for the to demonstrate meaningful use of
technology must have the ability to Selection of Clinical Quality Measures certified EHR technology in accordance
calculate clinical quality measures as for Electronic Submission by EPs, with section 1886(n)(3)(B)(i)(I) of the
specified by us. We interpret this Eligible Hospitals, and CAHs Act, we will give preference to the
requirement to mean that certified EHR Sections 1848(o)(2)(B)(i)(II) and clinical quality measures selected from
technology must have the capability to 1886(n)(3)(B)(i) of the Act require that those endorsed by the NQF or that have
calculate those clinical quality measures prior to any clinical quality measure previously been selected for the
being selected, the Secretary will RHQDAPU program. In some instances
selected in this final rule based on the
publish in the Federal Register such we proposed measures for EPs, eligible
specifications we select and post on the
measure and provide for a period of hospitals, and CAHs that are not
CMS Web site. In order to provide
public comment on such measure. The currently NQF endorsed in an effort to
sufficient time for vendors to retool include a broader set of clinical quality
their products and complete proposed clinical quality measures for
measures. In the proposed rule, we
development of the necessary reports EPs, eligible hospitals, and CAHs for
noted that the HITECH Act does not
and/or systems for calculation of the 2011 and 2012 payment were listed in
require the use of NQF endorsed
results for the required clinical quality Tables 3 through 21 of the proposed rule
measures, nor limit the measures to
measures, and for certifying bodies to (see 75 FR 1874 through 1900).
those included in PQRI or RHQDAPU.
test and certify that EHR technologies In the proposed rule, we noted that
We stated that if we, professional
adequately do so, we are adopting only for purposes of selecting clinical quality
societies, or other stakeholders identify
those electronic specifications that are measures on which EPs will be required
clinical quality measures which may be
posted on the CMS Web site as of the to submit information using certified
appropriate for the EHR incentive
date of display of this final rule. We EHR technology, section
programs, we will consider those
believe testing that is part of the process 1848(o)(2)(B)(i)(I) of the Act, as added
measures even if they are not endorsed
for certification of EHR technology will by section 4101 of the HITECH Act,
by the NQF or have not been selected
substitute for testing that might states that the Secretary shall provide for the PQRI or RHQDAPU programs,
otherwise occur. Additionally, some of preference to clinical quality measures subject to the requirement to publish in
the selected measures have undergone that have been endorsed by the entity the Federal Register such measure(s) for
with a contract with the Secretary under a period of public comment.
various amounts of testing already. For
section 1890(a) of the Act, as added by We proposed certain clinical quality
example, the Emergency Department
section 183 of the Medicare measures for EPs, eligible hospitals, and
Throughput, Stroke and Venous
Improvement for Patients and Providers CAHs, and listed these measures in
Thromboembolism (VTE) measures
Act (MIPPA) of 2008. For submission of Tables 3 through 21 of the proposed rule
mentioned by the commenter were
clinical quality measures by eligible (see 75 FR 1874–1900) for use in the
tested during the January 2010 hospitals and CAHs, section
Connectathon and demonstrated at the 2011 and 2012 payment years. We
1886(n)(3)(B)(i)(I) of the Act, as added stated that no changes (that is, additions
Health Information and Management by section 4102(a) of the HITECH Act,
Systems Society (HIMSS) 2010 of clinical quality measures) would be
requires the Secretary to provide made after publication of the final rule,
Interoperability Showcase which preference to those clinical quality
demonstrated the use of the measures by except through further rulemaking.
measures that have been endorsed by However, we stated that we may make
participating vendors. However, we the entity with a contract with the administrative and/or technical
expect the EHR certification process to Secretary under section 1890(a) of the modifications or refinements, such as
carry out the necessary testing to assure Act, as added by section 183 of the revisions to the clinical quality
that applicable certified EHR technology MIPPA, or clinical quality measures that measures titles and code additions,
can calculate sufficient number of EP, have been selected for the purpose of corrections, or revisions to the detailed
eligible hospital and CAH clinical applying section 1886(b)(3)(B)(viii) of specifications for the 2011 and 2012
quality measures required to qualify for the Act (that is, measures that have been payment year measures. We stated that
the meaningful use incentive program. selected for the Reporting Hospital the 2011 specifications for user
In order to permit greater participation Quality Data for Annual Payment submission of clinical quality measures
by EHR vendors, including specialty Update (RHQDAPU) program). would be available on our Web site
EHRs, the certification program (see On January 14, 2009, the U.S. when they are sufficiently developed or
ONC final rule found elsewhere in this Department of Health and Human finalized. Specifications for the EHR
issue of the Federal Register) will Services awarded the contract required incentive programs must be obtained
permit EHRs to be certified if they are under section 1890(a) of the Act to the only from the specifications documents
able to calculate at a minimum three National Quality Forum (NQF). for the EHR incentive program clinical
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clinical quality measures in addition to Therefore, we explained in the proposed quality measures.
the six core and alternative core rule that when selecting the clinical Comment: Numerous comments were
measures. In addition, the fact that EPs, quality measures EPs must report in received regarding the criteria for
eligible hospitals, and CAHs can adopt order to demonstrate meaningful use of selection of clinical quality measures.
an EHR reporting period toward the end certified EHR technology in accordance Some commenters noted the importance
of FY/CY 2011, we believe, will provide with section 1848(o)(2)(B)(i)(I) of the of scientific and medical evidence
additional time for providers to Act, we will give preference to the supporting the measure, as well as

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concerns regarding how the clinical measures, nor limit the measures to requires that we give preference to
quality measures are maintained. Many those produced by any particular clinical quality measures that are NQF
other commenters indicated that all developer or adopted or supported by endorsed. However, it does not require
clinical quality measures should be any particular organization, such as the exclusive use of NQF endorsed
evidence-based and up-to-date with those suggested by the commenters. We measures, nor limit the measures to
current medical standards. Several gave preference to NQF endorsed those produced by any particular
commenters communicated support for clinical quality measures in this final developer nor be adopted by any
using NQF; Hospital Quality Alliance rule. However, we do not adopt a policy particular organization. In this case, all
(HQA); Ambulatory care Quality that would restrict the Secretary’s clinical quality measures we are
Alliance (AQA); and the American discretion of beyond what is required by finalizing are NQF endorsed and have
Medical Association-Physician the statute. Measures listed in the current electronic specifications as of
Consortium for Performance proposed rule that did not have an NQF the date of display of this final rule.
Improvement (AMA–PCPI) clinical identifying number were not NQF Effective with the publication of this
quality measures. Another commenter endorsed. final rule, these specifications are final
suggested that measures that have a With respect to specific organizations, for clinical quality measure reporting
related U.S. Preventative Services Task we have received broad input regarding under the HITECH Act beginning with
Force (USPSTF) recommendation clinical quality measures including from 2011 and 2012. The detailed electronic
should follow the USPSTF guidelines many organizations mentioned by specifications of the clinical quality
and the regulations should allow for commenters and have considered their measures for EPs, eligible hospitals, and
clinical quality measures to be updated comments in determining which CAHs are displayed on the CMS Web
as the evidence base changes. Another clinical quality measures to finalize in site at http://www.cms.gov/
commenter indicated CMS should this final rule. We also note that, for QualityMeasures/03_Electronic
ensure that all clinical quality measures NQF endorsed measures, the NQF Specifications.asp#TopOfPage.
are endorsed through a stakeholder provides a venue for public and member
Sections 1848(o)(2)(B)(iii) and
consensus process. Commenters also input as a part of the endorsement
1886(n)(3)(B)(iii) of the Act requires that
questioned why some clinical quality process. With respect to commenters
in selecting clinical quality measures,
measures in the proposed rule do not urging consideration of whether the
the Secretary shall seek to avoid
have identifiers for example, NQF scientific and medical evidence support
redundant or duplicative reporting
number and another commenter the measure, whether the clinical
quality measures are evidence-based otherwise required, including reporting
indicated some of the clinical quality
and consistent with current medical under section 1848(k)(2)(C) of the Act
measures titles were different in the
standards, and how the clinical quality (the PQRI program) and eligible
clinical quality measure tables. Some
measures are maintained, we note that reporting under section
commenters also stated that clinical
these factors are part of the NQF 1886(b)(3)(B)(viii) of the Act
quality measures should be phased in,
process, as well as standard measure (RHQDAPU program). For EPs, when
implementing the clinical quality
development processes. We are the proposed rule was issued there was
measures by clinically related sets, and
that all CMS proposed clinical quality committed to working with national, no statutory authority to provide PQRI
measures should be NQF endorsed. State and local associations to identify incentive payments for services
Some commenters suggested that or develop additional electronically furnished for 2011 or subsequent years.
CMS should consult with other quality specified clinical quality measures, Since then, the PQRI incentive payment
measure stakeholders, such as, NQF, the particularly for pediatric populations, for 2011 has been authorized. We
Hospital Quality Alliance (HQA), and for later stages of meaningful use. acknowledge there is overlap within the
the National Committee for Quality In selecting clinical quality measures clinical quality measure reporting for
Assurance (NCQA), The Joint for the Medicare EHR incentive EPs in the EHR incentive program with
Commission (TJC), and Regional Health program, the Secretary is required to the PQRI incentive program. However,
Improvement Collaboratives to verify provide for notice in the Federal the reporting periods in these two
the validity, reliability, and Register with public comment. This incentive programs are different.
appropriateness of proposed clinical provides broad public input which we Currently, the PQRI has a six and a
measures. In addition when developing, fully consider. However, as we stated in twelve month reporting period. The
validating and recommending clinical the proposed rule, we are finalizing the reporting period for the HITECH EHR
quality measures for the pediatric policy that technical specifications for incentive program for the first payment
population, a commenter suggested clinical quality measures are developed year is 90 days, which does not meet the
CMS include consultation with the and finalized through the sub-regulatory PQRI reporting requirement of six or
Child Healthcare Corporation of process. Further, this requirement does twelve month reporting period, as
America (CHCA) or the National not pertain to the Medicaid EHR currently provided. However, in the
Association of Children’s Hospitals incentive program. We expect to second payment year of the HITECH
(NACHRI). develop a process in the future to solicit EHR incentive program the reporting
Response: The HITECH Act requires public input on Medicaid-specific period is one year, and the PQRI
that we give preference to clinical clinical quality measures for future reporting period, would be
quality measures that are NQF stages of meaningful use, if needed. synchronous. The requirement for
endorsed. NQF is the only organization However, because there are no such qualification for PQRI is subject to a
that we are aware of which is in Medicaid-specific measures in this final separate regulation. Although there may
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compliance with the requirements of rule, and all measures apply uniformly be additional issues beyond the
National Technology Transfer and across both the Medicare and Medicaid reporting periods, we anticipate efforts
Advancement Act (NTTAA), to endorse EHR incentive program, we have not to avoid redundant and duplicative
quality measures through voluntary developed such a process in this final reporting in PQRI of the same clinical
consensus standards. However, the rule. quality measures as required in the EHR
HITECH Act does not require the After consideration of the public incentive program. We envision a single
exclusive use of NQF endorsed comments received, the HITECH Act reporting infrastructure for electronic

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submission in the future, and will strive to align the hospital quality initiative Medicare and Medicaid EHR incentive
to align the EHR incentive program and programs to seek to avoid redundant programs:
PQRI as we develop the reporting and duplicative reporting of quality • Clinical quality measures that are
framework for clinical quality measures measures for eligible hospitals and included in, facilitate alignment with, or
to avoid redundant or duplicative CAHs. allow determination of satisfactory
reporting. Further, we also note that the Comment: Many commenters also reporting in other Medicare (for
Affordable Care Act (Pub. L. 111–148) suggested aligning clinical quality example, PQRI or the RHQDAPU
requires that the Secretary develop a measure reporting across federal program), Medicaid, and Children’s
plan to integrate the EHR incentive agencies (for example, HRSA, CMS) as Health Insurance Program (CHIP)
program and PQRI by January 1, 2012. well as across programs, (for example, program priorities.
In doing so we expect to further address PQRI, CHIP, Medicare and Medicaid) to • Clinical quality measures that are
the issue of redundant and duplicative avoid duplicative and redundant quality widely applicable to EPs and eligible
reporting. For eligible hospitals and performance reporting. Additionally, hospitals based on the services provided
CAHs, for the EHR incentive program, several commenters suggested that for the population of patients seen.
• Clinical quality measures that
we are finalizing one set of 15 clinical similar clinical quality measures and/or
promote CMS and HHS policy priorities
quality measures for both Medicare and quality data efforts included in the
related to improved quality and
Medicaid. For Stage 1 (for clinical proposed rule are included in other
efficiency of care for the Medicare and
quality measures Stage 1 is 2011 and clinical quality recognition programs
Medicaid populations that would allow
beginning in 2012), none of the finalized and EPs who successfully report in
us to track improvement in care over
15 clinical quality measures for eligible these programs via a certified EHR
time. These current and long term
hospitals and CAHs are currently should be deemed to have successfully
priority topics include: prevention;
included in the RHQDAPU program, reported in the EHR incentive program.
management of chronic conditions; high
and therefore there is no issue of Other commenters suggested using the
cost and high volume conditions;
redundant and duplicative reporting PQRI reporting process to satisfy the elimination of health disparities;
based upon the HITECH Act. meaningful use requirement under the healthcare-associated infections and
Nevertheless, clinical quality measures EHR incentive program for EPs. Another other conditions; improved care
in the EHR incentive program for commenter indicated that clinical coordination; improved efficiency;
eligible hospitals and CAHs were quality measures employed by this improved patient and family experience
electronically specified for use in the program and others will be valuable if of care; improved end-of-life/palliative
RHQDAPU program with the EPs using EHRs have an in-depth care; effective management of acute and
anticipation to place these measures in understanding of how to leverage the chronic episodes of care; reduced
RHQDAPU once we have completed technology and the data they produce to unwarranted geographic variation in
and implemented the mechanism to improve care. A number of commenters quality and efficiency; and adoption and
accept quality measures through requested that only clinical quality use of interoperable HIT.
electronic submission. For the future, measures chosen for use in the • Clinical quality measures that
we do not anticipate having one set of RHQDAPU program should be address or relate to known gaps in the
clinical quality measures for the EHR considered for implementation in the quality of care and measures that
incentive program and another set for EHR incentive program for eligible through the PQRI program, performed at
RHQDAPU. Rather, we anticipate a hospitals and CAHs that qualify for both low or highly variable rates.
single set of hospital clinical quality incentives. Additionally, the • Clinical quality measures that have
measures, most of which we anticipate commenters stated they would like the been recommended for inclusion in the
can be electronically specified. We note process for avoiding duplicative EHR incentive by the HIT Policy
some of the RHQDAPU quality reporting clearly defined. Committee.
measures, for example HCAHPS Response: The HITECH Act requires We noted in the proposed rule that
experience of care measures, do not that the Secretary seek to avoid the Children’s Health Insurance
lend themselves to EHR reporting. redundant and duplicative reporting, Program Reauthorization Act (CHIPRA)
Similarly, certain outcome quality with specific reference to PQRI for EPs of 2009 (Pub. L. 111–3) Title IV, section
measures, such as the current and RHQDAPU for eligible hospitals 401 requires the Secretary to publish a
RQHDAPU readmission measures, are and CAHs. We have sought to avoid core set of clinical quality measures for
based on claims rather than clinical duplicative and redundant reporting in the pediatric population. We stated that,
data. In the future, we anticipate the implementation of the HITECH Act to the extent possible, we would align
hospitals that report RHQDAPU as discussed elsewhere in our responses the clinical quality measures selected
measures electronically would receive to comments in this final rule. We will under the EHR incentive program with
incentives from both the RHQDAPU and seek to align quality initiative programs the measures selected under the
EHR incentive program, in addition to in future rulemaking. CHIPRA core measure set. Included in
properly reporting any required quality the proposed clinical quality measures
(2) Other Considerations for the
measures that are not able to be derived were nine clinical quality measures
Selection of Clinical Quality Measures
from EHRs; this is however subject to pertaining to pediatric providers. Four
for Electronic Submission by EPs,
future rulemaking. Further, in the of these nine measures were on the list
Eligible Hospitals, and CAHs
future, for hospitals that do not report of CHIPRA initial core measures that
electronically we anticipate that they In addition to the requirements under were recommended to the Secretary by
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may only qualify for an incentive sections 1848(o)(2)(B)(i)(I) and the Subcommittee to AHRQ’s National
through the RHQDAPU program, and 1886(n)(3)(B)(i)(I) of the Act and the Advisory Committee (SNAC). In our
not through the EHR incentive program. other statutory requirements described proposed rule, we noted that not all
Again this is subject to future above, we also proposed applying the CHIPRA initial measures recommended
rulemaking. We envision a single following considerations to the selection to the Secretary were applicable to EHR
reporting infrastructure for electronic of the clinical quality measures for technology or to the EHR incentive
submission in the future, and will strive electronic submission under the payment program. For example, some of

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the measures are population-based, Since the publication of the proposed also in the published CHIPRA initial
survey-derived, or not yet NQF rule, the CHIPRA core measure set has core measure set. These clinical quality
endorsed. We stated that new or been published in a final rule (see 74 FR measures are shown below in Table 4:
additional measures for the next 68846 through 68849). In this EHR
iteration of the CHIPRA core set would incentive program final rule, there are
have EHR extractability as a priority. four clinical quality measures that are

Due to the concurrent CHIPRA and Web site and solicited comments on our years the scope and variety of measures
ARRA HIT implementation activities, approach. that address these factors will expand.
we believe there is an exciting We received various comments as to Comment: Commenters requested a
opportunity to align the two programs our proposed considerations for definition for ‘‘Eligible Provider and
and strive to create efficiencies for selection of clinical quality measures for Non-Qualifying Eligible Provider’’ with
States and pediatric providers, where submission by EPs, eligible hospitals, respect to the provider’s ability to meet
applicable. Similarly, the adult quality and CAHs. meaningful use if there are no
measures requirements enacted in the Comment: One commenter said that appropriate clinical quality measures to
ACA will provide another opportunity there needs to be longer than nine report, the application of financial
for CMS to align its quality measures months for the look back for capturing penalties beginning in 2015, and the
programs for consistency and to clinical quality measures data. Several handling of exclusions. Another
maximize use of electronic reporting. As commenters indicated that baseline commenter stressed the need for
these programs move forward, we will measurements that have used the detailed information regarding what is
continue to prioritize consistency in clinical quality measure in the past have included and excluded in the numerator
clinical quality measure selection for not been performed. Commenters also and denominator for each measure so as
providers when possible. recommended the linkage of clinical to ensure that certified EHR
We solicited comments on the decision support to clinical quality technology’s programmed analytics
inclusion or exclusion of any clinical measures to strengthen quality capture all patients who meet the
quality measure or measures proposed improvement efforts. A commenter relevant criteria and to ensure that
for the 2011 and 2012 payment years, supported our inclusion of measures clinical quality measures are properly
and to our approach in selecting clinical that address both quality and resource evaluated. Others indicated that
quality measures. use efficiency. Another commenter reporting measures electronically will
We stated in the proposed rule that indicated support for the clinical quality reduce administrative reporting costs.
we do not intend to use notice and measures as represented in the proposed Other commenters supported the ability
comment rulemaking as a means to rule. to report ‘‘N/A’’ for clinical quality
update or modify clinical quality Response: The look back for capturing measures where an insufficient
measure specifications. A clinical clinical quality measures is the period denominator exists. Other commenters
quality measure that has completed the of time for which data would be urged that CMS not include any clinical
consensus process through NQF has a considered as applying to the measure quality measures in Stage 1 of
designated party (usually, the measure calculation. The look back period for a Meaningful Use because they believe
developer/owner) who has accepted clinical quality measure and the method Stage 1 should focus on the initial
responsibility for maintenance of the of documentation of prior information is implementation of certified EHR
clinical quality measure. In general, it is defined by the clinical quality measure systems and its use for patient care, and
the role of the clinical quality measure specification. The clinical quality that EPs must gain experience with their
owner, developer, or maintainer/ measures require reporting and not certified EHR technology before
steward to make basic changes to a achievement on particular performance attesting to the accuracy and
clinical quality measure in terms of the thresholds. We agree with the completeness of numerators,
numerator, denominator, and commenters regarding the benefits of denominators and quality calculations
exclusions. We proposed that the linking clinical decision support tools to generated from these systems.
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clinical quality measures selected for the clinical quality measures, and Response: While some commenters
the 2011 and 2012 payment year be anticipate that as EHR technology recommended we not include any
supplemented by our technical evolves, many of the clinical quality clinical quality measures in Stage 1
specifications for EHR submission. We measures will be supported by clinical (2011 and beginning in 2012), as
proposed to post the complete clinical decision support tools. We also agree previously described for Stage 1 EPs are
quality measures specifications with the benefits of efficiency measures required to attest to the clinical quality
including technical specifications to our and we expect that in future program measures calculated results (numerator,
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denominator, and exclusions) as stage. Additionally, the electronic adequate time to communicate and
automatically calculated by the certified specifications, as posted on the CMS implement the electronic specification
EHR technology. Given that the Web site at the time of publication of for 2011 clinical quality measure
statutory requirement for clinical this final rule, are final. We intend to requirements. Additionally, one
quality measures is an element of expand the clinical quality measures commenter expressed concern that the
meaningful use, we believe that again for Stage 2 of meaningful use, additional clinical quality measures
providing this information on clinical which we anticipate will first be required for 2011 reporting will not be
quality measures is appropriate for effective for the 2013 payment year. As posted by CMS in time for careful
Stage 1 (2011 and beginning in 2012). required by the HITECH Act for the review and assessment, since currently
We would expect that the patient for Medicare EHR incentive program, prior there are only 15 measures
whom a clinical quality measure does to selecting any new clinical quality electronically specified and posted.
not apply will not be included in the measure(s) for Stage 2 of meaningful Commenters requested clinical quality
denominator of the clinical quality use, we will publish notice of the measures to be posted with
measure. If not appropriate for a proposed measure(s) and request and implementation guides for each quality
particular EP we would expect that consider public comments on the reporting metric to ensure successful
either patients would not appear in the proposed measures. We note that the reporting.
denominator of the measure (a zero Medicaid EHR incentive program does Response: We have limited the
value) or an exclusion would apply. not have the same statutory requirements for clinical quality
Therefore reporting ‘‘N/A’’ is not requirement. If future stages of measure reporting for eligible hospitals
necessary. Exclusion parameters—that meaningful use include clinical quality and CAHs to the 15 measures that were
is, information on what is included and measures specific for Medicaid electronically specified and posted at
excluded in the numerator and providers, we will consider a process to the time of publishing the proposed
denominator for a clinical quality receive public input on such measures. rule. All measures specifications for
measure–are included in the measure Comment: One commenter suggested clinical quality measures selected are
specifications. We agree that reporting that only measures chosen for use in the final effective upon publication of the
measures electronically will reduce pay-for-reporting program should be EHR incentive program final rule.
administrative reporting costs, however considered for implementation in the
d. Clinical Quality Measures for EPs
as discussed in this final rule we will EHR incentive program.
not require electronic submission of Response: We selected clinical quality For the 2011 and 2012 EHR reporting
clinical quality measures until 2012. measures that are broadly applicable for periods, based upon the considerations
Also discussed earlier in this final rule, the 2011 and 2012 EHR incentive for selecting clinical quality measures
we believe collecting clinical quality program. Many clinical quality discussed above, we proposed certain
measure data is an important part of measures used in other Medicare pay- clinical quality measures that were
meaningful use. for-reporting programs are not identified in the proposed rule (see 75
Comment: A commenter indicated applicable to all Medicaid eligible FR 1874–1889) for EPs. Tables 4 though
that CMS should take ownership of each providers, such as pediatricians, 19 of the proposed rule divided the
of the EP clinical quality measures so certified nurse-midwives, and children’s clinical quality measures identified in
that CMS can then adjudicate issues hospitals. Table 3 into core measures and specialty
related to the clinical quality measures, Comment: Commenters suggested group measures (see 75 FR 1890 through
instead of referring the EP to the alignment between measures with 1895). The concept of core measures
measure owner. One commenter vocabulary standards, in order to and specialty group measures is
believes that EPs and their specialty promote interoperability of clinical data. discussed below.
societies should be the only owners of Stage 1 allows alternative vocabularies We also stated that some measures
EP clinical quality measures. for problems, drugs, and procedures; were in a higher state of readiness than
Response: We are the owner/ and measures should only be included others, and requested comment on each
developer for certain clinical quality if alternative specifications using all measure’s state of readiness for use in
measures. More commonly, we use the Stage 1 vocabularies are provided. the EHR incentive programs. For those
clinical quality measures developed and Commenters recommended measures where electronic
owned by others, who are then incorporating HL7, LOINC, SNOMED, specifications did not, at the time of the
responsible for the clinical quality ICD–9, and ICD–10 for data exchange. proposed rule, exist, we solicited
measure specifications as endorsed by Response: Standards for certified comment on how quickly electronic
NQF. Numerous measures have been EHRs, including vocabulary standards, specifications could be developed, and
developed over the years by various are included in ONC’s final rule (found the period of time required from final
organizations and CMS, and therefore elsewhere in this issue of the Federal posting of the electronic specifications
we do not believe that specialty Register). for final measures to ensure the effective
societies should be the only owners of Comment: Commenter recommended implementation of the measures. We
EP clinical quality measures. The that in the beginning stages of stated our intention to publish
HITECH Act does not suggest or require implementation of the EHR incentive electronic specifications for the
that we should be the sole owner/ programs, CMS should base its reporting proposed clinical quality measures on
developer of clinical quality measures. initiatives on existing industry models the CMS Web site as soon as they
Comment: A commenter questioned to prevent delays, consumer mistrust, become available from the measure