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THE 2009 Health Information Technology Act

The 2009 Health Information Technology Act

True Financial Incentives or More Government Control?

Sara Small

Mt St Mary's College

A Thesis Presented to the Faculty of the Graduate School of Business

December 13, 2009


The 2009 Health Information Technology Act ii

ACKNOWLEDGMENT

Thank you to Dr Mark Alhanati, Dr Janet Robinson, Dr. Peter Antoniou and to Katherine

Whitman for the honor of participating in the first MBA Cohort at Mount St Mary’s College. This

creative and dynamic curriculum has provided a wealth of experience and knowledge within a unique

and stimulating learning environment. The MBA program allowed me to return to the classroom after

a 33 year hiatus and also afforded me the opportunity to experience my first international trip!

The successful completion of this thesis would not have been possible without the help and

support from my faculty advisor, Dr. David Burkitt. His advice, guidance and direction allowed me

to remain focused and on track during the short time frame allowed for the completion of this thesis.

His academic and professional career experience was invaluable. Thank you, David for helping me

over the rough spots and guiding me through a complex process.

Finally, my thanks to my husband, Ben who provided constant assistance and domestic

support that enabled me to spend countless hours away from home working with other students,

completing projects and studying. Ben’s encouragement to pursue my studies often pushed his loyal

support to the limits! The completion of this degree would not have been possible without his

unconditional love and commitment. Thank you, husband!


THE 2009 Health Information Technology Act

Abstract

SMALL, S.P., The 2009 Health Information Technology Act-True Financial Incentives- or
More Government Control? Master of Business Administration, Mount St. Mary’s College,
December 2009.

The computerization of medical records has been recommended as a means to reduce

medical errors as well as costs, paperwork, time and redundancy. In addition to creating and

maintaining medical records electronically, linking those records through interoperable data

exchange is seen as a primary requirement toward increasing the efficiency and safety of care

delivery. Interoperability is viewed as a solution that will allow providers in any location instant

access to a patient's health and treatment history.

There are significant challenges facing Health Information Technology and electronic health

records, including structural, technical, financial and social/cultural issues. Although none of these

represent insurmountable barriers, they all require viable solutions. To promote adoption of these

technologies, the federal government has passed legislation designed to move toward their goal of

creating an electronic health record for each person in the United States by 2014.

The purpose of this qualitative study of the 2009 Health Information Technology Act is to

determine if Hospital Chief Executive Officers perceive the financial incentives as a welcome

opportunity to modernize their information management systems, or is a basis for the Government to

increase their control of healthcare. A grounded theory model was utilized to analyze the results from

multiple data sources to finalize this theory.


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List of Tables

Table 1: The State of Health Information Technology in California ….……... 11

Table 2: Summary of Federal Government Health IT ………………….……… 15

Table 3: Cost of Healthcare Facility Regulations………………………………. 16

Table 4: Medicare Hospital Incentives……………………………………….…. 57

Table 5: Medicare Hospital Incentives……………………….…………………. 59

Table 6: Medicare Penalties…………………………………….…………..….… 60

Table 7: Medicaid Incentives for Hospitals………………….………………….. 63

Table 8: Top Issues Confronting Hospitals……………….…………………….… 70

Table 9: Literature review open coding model………………..……………..…… 82

Table 10: Excessive government regulations…………………………………….. 83

Table 11: The ARRA adds increased layers of bureaucratic regulation………..… 84

Table 12: Implementation of a “certified” electronic record ..……………..……. 85

Table 13 Identification of required standards…………………………..……….... 86

Table 14: Uniform standards defining clinical care protocols………..………… 87

Table 15: The ARRA is in reality the outline for total government control…… 89

Table 16: The stimulus money outlined in ARRA is a benefit………………… 89

Table 17: The government requirements and regulations……………………… 90

Table 18: The increased regulatory agencies…………………………………… 91


THE 2009 Health Information Technology Act

Table 19: E H R will make it easier for organizations………………….……… 92

Table 20: Linking the patient healthcare records of our organization………… 93

Table 21: Government penalties for failing to implement……………………… 94

Table 22: Respondent Location ………………………………………….…..… 95

Table 23: Number of years in this occupation…………………..……………… 95

Table 24: Respondents Gender…………………………………………..….…... 96

Table 25: Respondent Age Range ……………………………………..….….…. 96

Table 26: Healthcare Organization’s Tax Status of Respondents……………….. 97

Table 27: Has your organization implemented an electronic medical record?........ 97


The 2009 Health Information Technology Act vi

GLOSSARY OF TERMS

AHIMA. American Health Information Management Association


AHRQ. Agency for Healthcare Research and Quality
ANSI. American National Standards Institute
ANSI-ASC. American National Standards Institute, Accredited Standards Committee
ARRA. American Recovery and Reinvestment Act of 2009
AS. Administration Simplification Act
ASC. Accredited Standards Committee
Business Associate. A person or organization that performs a function or activity on behalf of a
covered entity but is not part of the covered entity’s workforce
CCHIT. Certification Commission for Healthcare Information Technology
CDC. Centers for Disease Control and Prevention
CDS. Clinical Decision Support
CEO. Chief Executive Officer
Certificate of Need. Laws which control building of new healthcare facilities and services.
CFR. Combined Federal Register
CHARITY CARE. Healthcare provided for free or at a reduced cost to low income patients.
CHHS. California Health and Human Services Agency
CIM. Clinical Information Management
CIO. Chief Information Officer
CIS. Clinical Information System
Clearinghouse. Electronic entity that translates nonstandard formatted data into standard data
elements or into a standard transaction format.
CMS. Centers for Medicare & Medicaid Services
Covered Entity. A health plan, clearinghouse, or a health care provider that transmits health
information in an electronic form.
CPOE. Computerized Physician Order Entry
DISA. Data Interchange Standards Association
Disclosure. Release of information by an entity to persons or organizations outside of that entity.
EDI. Electronic Data Interchange
THE 2009 Health Information Technology Act

E H R. Electronic Health Record- health related information for an individual that can be accessed
by more than one health care organization.
EHNAC. Electronic Healthcare Network Accreditation Commission
EMC. Electronic Medical Claim
EMR. Electronic Medical Record – synonymous with Electronic Patient Record (EPR), and
Computerized Patient Record (CPR). Patient health record of services within one health care
organization
EMTALA. Emergency Medical Treatment and Labor Act. This act requires hospitals to provide
emergency treatment to individuals, regardless of insurance status or their ability to pay.
FACA. Federal Advisory Committee Act
FALSE CLAIMS ACT. Act which allows individuals to file a complaint against an entity that files
false claims for medical care to the Government.
FAST. Federal Adoption of Standards for Health IT.
FDA. Food and Drug Administration
FEA. Federal Enterprise Architecture
FFP. Federal Financial Participation
FHA. Federal Health Architecture
FHIPR. Federal Health Information Planning and Reporting
FHISE. Federal Health Information Sharing Environment
FHITSOP. Federal Health IT Standards Organization Participation
FSS. Federal Security Strategy
FSWG. Federal Security Work Group
FTF. Federal Transition Framework
Functionality. Systems that can support the activities and perform the functions for which they were
intended.
GAO. Government Accounting Office
HCFA. Health Care Finance Agency, responsible for oversight of the U.S. Medicare Program
HI. Health Information
HIE. Health Information Exchange
HEDIS. Health Plan Employer Data and Information Set (Measures managed care program
performance indicators)
HIMSS. Health Information Management Systems Society
HIO. Health Information Organization
HIPAA. Healthcare Insurance Portability and Accountability Act of 1996 (Public Law 104-191)
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HISB. Health Informatics Standards Board


HISE. Health Information Sharing Environment
HISPC. Health Information Security and Privacy
HIT. Health Information Technology
HITECH Act. Health Information Technology for Economic and Clinical Health Act
HITPC. Health Information Technology Policy Council.
HITSP. Health Information Technology Standards Panel
HL7. Health Level Seven - Founded in 1987, HL7 is a not-for-profit Standards Developing
Organization (SDO) that specializes in developing standards for the exchange of clinical data among
disparate health care computer applications the American National Standards Institute accredits HL7.
HOSPITAL CONVERSION REGULATIONS. Laws regulating the conversion of for profit
hospitals to non profit status.
ICD- International Classification of Diseases
Interoperability. Ensuring that systems implement the recognized standards and can exchange
information and work with other systems.,
IRB. Institutional Review Board
IT. Information Technology
ITA. Information Technology Architecture
ISO. International Organization for Standardization
ISO/TC215. International Organization for Standards, Technical Committee 215 - Health
Informatics
JCAHO. Joint Commission for the Accreditation of Health Care Organizations
Limited English Proficiency. Laws which require hospitals to provide interpreter services to
patients that do not speak English.
Meaningful Use. “Meaningful users” of an electronic health record to be defined by the Federal
Government as a requirement for receiving stimulus dollars.
MUMPS. Massachusetts General Hospital Utility Multi-Programming System. A healthcare
programming language created in the late 60’s.

NAHDO. National Association of Health Data Organizations


NCQA. National Committee for Quality Assurance
NCVHS. National Committee on Vital and Health Statistics
NHIE. Nationwide Health Information Exchange
NHIN. Nationwide Health Information Network
NIH. National Institutes of Health
THE 2009 Health Information Technology Act

NLM. National Library of Medicine


OCR. Office of Civil Rights
OIG. Office of Inspector General.
OIS. Office of Interoperability and Standards
OMB. Office of Management and Budget
ONC. Office of the National Coordinator (preferred abbreviation for ONCHIT).
ONCHIT. Office of the National Coordinator for Health Information Technology
PHC. Personalized Health Care
PHI. Personal Health Information
PHR. Personal Health Record
PHSA. Public Health Services Act
PITAC. President’s Information Technology Advisory Committee
RHIO. Regional Health Information Organization.
SAMSA. Substance Abuse and Mental Health Services Administration
SDO. Standards Development Organization
Security. System protection of personal health information
SLHIE. State Level Health Information Exchange Consensus Project
SMHP State Medicaid HIT Plan
SNOMED. Systemized Nomenclature of Medicine
VHA. Veterans Health Administration
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The 2009 Health Information Technology Act 1

TABLE OF CONTENTS

Page

DEED OF DECLARATION …………………………………………… ii

APPROVAL SHEET …………………………………………………… iii

ACKNOWLEDGMENT . . . . . . . . . . . . . . . . . . . . . . . . …….. . . . . . . . iv

ABSTRACT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . … . . . . . . . . . v

LIST OF TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . … .. . . . vi

GLOSSARY OF TERMS……………………………………………….. viii

Chapter 1: INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . 4

Background of the Study .......................... . 4

History of Electronic Health Record…………………………… 7

Statement of the Problem. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Chapter 2: LITERATURE REVIEW……………………………………. 10

Current State …………………………………………………… 10

American Recovery and Reinvestment Act……………………… 12

Purpose of Recovery Act HIT Incentives………………………… 14

Federal Regulatory Issues and Requirements……………………… 15

Health Information Privacy………………………………… 20

Civil Rights……………………………………………….. 26

Food and Drugs…………………………………………… 27

Fraud & Prevention Detection……………………………. 28


The 2009 Health Information Technology Act 2

Information Management…………………………………. 29

Medical and Healthcare…………………………………… 31

Other Federal Laws……………………………………….. 32

Regulatory Agencies and Responsibilities ………………………… 36

California Legislation and Action Plans…………………………. 47

Medicare –Centers for Medicare and Medicaid Services (CMS) 56

State Medicaid………………………………………….. 60

Costs…………………………………………………………. 64

Savings………………………………………………………….. 65

Benefits…………………………………………………………. 66

Barriers………………………………………………………….. 69

Privacy Concerns……………………………………………….. 72

Chapter 3: RESEARCH METHODOLOGY……………………… 74

Grounded Theory Model……………………………………… 74

Data Sources…………………………………..……………… 76

Study population for survey…………………………… 76

Literature Review…………………………….……….. 78

Data Collection………………………………………………. 79

Data Analysis…………………………….……………..……. 80

Chapter 4: ANALYSIS…………………………..……………… 82

Literature Coding Results……………………………………. 82

Survey Results ………………………………………………. 83


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Chapter 5 CONCLUSION ……………………………………… 98

References…………………………………………………………….. 103

Appendix

Appendix A Privacy Sections in Order of Appearance in ARRA.. 123

Appendix B Literature Review: Open Coding Model……………. 124

Appendix C Title 42 Federal Public Health Regulations ………… 127

Appendix D Public Health Services Act………………………….. 130

Appendix D “Meaningful Use” Documents………………………. 132

Appendix E Certified Inpatient E H R Products………………….. 133

Appendix F Hospital CEO Survey………………………………... 135

Appendix G MSMC IRB Exemption Letter………………………. 138


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Chapter 1

INTRODUCTION

Background to the Study

Health Information Technology-Electronic Health Records (HIT-EHR) is a broad term

that refers to the generation, storage, and transmission of electronic health information.

Information management is central to the healthcare system, and HIT-EHR is widely viewed as

the necessary step to bring healthcare into the 21st century. It is argued that HIT-EHR will reduce

overall healthcare costs, improve quality, and increase efficiency throughout the healthcare

system. However many are still skeptical as to its real impact given the substantial investment

required to implement it.

To put this in context, U.S. healthcare spending was $2.1 trillion in 2006, and at least

$250 billion in California. U.S. spending is projected to grow to $4 trillion by 2015, with direct

administrative costs accounting for more than 7 percent of the total U.S. health spending.

However, when the administrative costs of hospitals and doctors are added to those of insurers

and Government, the administrative costs are estimated to be 31 percent of total health care

spending. These administrative costs are estimated to be 30 to 70 percent higher than in other

countries that also have mixed public-private systems (Department of Health, 2009).

The leading nations in adopting HIT-EHR, such as Britain and New Zealand, have

achieved 98 percent participation by primary care physicians. In the United States about 28

percent of primary care physicians use HIT-EHRs and less than 20% of hospitals (The
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Commonwealth Fund, 2009). Other sectors of the U.S. economy (for example, banking) have

successfully digitalized their operations, but healthcare has been slow to make the transition.

While the development and wide-scale use of HIT-EHR has experienced obstacles, it is gaining

ground in both the public and private sectors (Girosi, 2004).

For decades, hospitals and other medical service providers have been enticed by the

prospect of establishing electronic health record systems to improve the efficiency of their

medical care and reduce medical errors. Automating the health record process has the potential to

provide a host of benefits, most notably by reducing medical errors. For example, as many as

98,000 Americans die each year as a result of preventable medical records (Taylor, 2005).

Electronic medical record systems could significantly reduce this number. A much cited 2005

Rand Corp (Rand 2005) study of the use of medical record automation found that a savings of

$77 billion annually could be realized. However, it is widely believed that the cost of

implementing electronic health records systems is responsible for low adoption rates (Rand,

2005).

The United States health care system is at risk due to increasing demand, spiraling costs,

inconsistent and poor quality of care, and inefficient, poorly coordinated care systems. Some

evidence suggests that health information technology can improve the efficiency, cost

effectiveness, quality, and safety of medical care delivery by making best practice guidelines and

evidence based databases immediately available to clinicians, and by making computerized

patient records available throughout a health care network (The Markle Foundation, 2009).

However, much of the evidence is based on a small number of systems developed at academic

medical centers, or studies using mixed models to project organizational changes, costs, and the
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time required for implementation (Hillestad, 2005).. Definitive information regarding the true

value of systems is not widely identified within the literature. (Price Waterhouse, 2009).

Most medical records are still stored on paper which means that they cannot be used to

coordinate care, routinely measure quality or reduce medical errors. It is important to understand

the barriers to implementation of these technologies. Most often, capital cost is cited as an

impediment to adoption of medical information technology; however, the story grows more

complicated in the framework of the complex American health care system where government

sources pay for the majority of health care services (Acker, 2004). One Commentator has noted:

“most HIT-enabled savings go to insurers and patients, while most adoption and care

improvement costs are borne by providers” (Ferman, 2006). Thus, it would seem that the

incentives to adopt health information technology are misaligned.

Successful implementation of an electronic medical record requires overcoming more

than the financial burden. Additional barries include a lack of standards, ill defined certification

requirements, privacy concerns, and lack of clarity regarding the anticipated government

regulations (Garrido, 2004). To address the financial burden, the federal government has recently

offered a solution in the form of public funding, grants and payment incentives. The law creates

two key concepts to determine whether providers qualify for the HIT incentives: they must

demonstrate “meaningful use” of HIT and use a “qualified or certified” E H R (AHHR, 2009).

The formal definition of “meaningful use” has yet to be defined. The overarching Nationwide

goals of HIT investments are to improve healthcare quality, reduce growth in costs, stimulate

innovation, and protect privacy (Health Information, 2009). However, there remains concern

regarding the lack of standards, incomplete defining of “meaningful use and the qualifications of
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“certified” records. This ambiguity puts resources at risk and has the potential to leave healthcare

organizations in a vulnerable position as they attempt to navigate through the regulatory

minefield.

Regulations impose a considerable burden on the U.S. healthcare system. Some of these

include EMTALA (Emergency Medical Treatment and Labor Act), HIPAA (Health Insurance

Portability and Accountability Act), Charity Care, hospital conversion regulations, limited

English proficiency requirements, fraud and abuse reporting requirements, False Claims Act,

Medicare and Medicaid antifraud statutes, Stark I and II laws, medical record regulations,

Certificate of Need regulations, Medicare Conditions of Participation, pharmaceutical price

regulations and quality related regulations to name a few. Hospitals bear considerable expense to

insure compliance with these types of regulations, which adds a significant financial burden to an

already ailing system (Conover, 2004).

History of Electronic Health Records (EHRs)

The first known medical record was developed by Hippocrates, in the fifth century B.C.

He prescribed two goals:

• A medical record should accurately reflect the course of disease.

• A medical record should indicate the probable cause of disease (NIH, 2005).

These goals are still appropriate. Electronic health record systems can also provide

additional functionality, such as interactive alerts to clinicians, interactive flow sheets, and

tailored order sets, all of which cannot be done with paper-based systems (Amatayakul, 2005).

The first EHRs began to appear in the 1960s. “By 1965, Summerfield and Empey reported that at

least 73 hospitals and clinical information projects and 28 projects for storage and retrieval of
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medical documents and other clinically-relevant information were underway”(Asp, 2003).

Many of today’s EHRs are based on the pioneering work done in academic medical

centers and for major government clinical care organizations. These early projects had

significant technical and programmatic issues, including non-standard vocabularies and system

interfaces, which remain implementation challenges today. But they led the way, and many of the

ideas they pioneered (and some of the technology, such as the MUMPS language) are still used today

(NIH, 2005).

Problem Statement

This study will strive to answer the following questions:

1. Will the advantage of accessing the stimulus money be perceived as a true benefit,

or will the increased regulations for health care providers be another

barrier that prevents adoption?

2. Is the goal of the stimulus plan intended to simply motivate health care

organizations and providers to transition to an electronic record or is it the

beginning of government run healthcare services?

To further develop the understanding of the question, the American Recovery and

Reconciliation Act of 2009, introduces much needed financial incentives for implementing an

electronic medical record, but it also adds significant regulatory requirements, as well as extends

the oversight of the government into new areas of the healthcare delivery system. Over the past

decade, HIT has been a voluntary initiative for healthcare providers. The ARRA is a federal law

that identifies increased funding and regulations with stricter privacy laws and more onerous

fines. The Office of the National Coordinator (ONC) is granted broad new powers and an
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additional $2 billion in funding (American Medical Association, 2009). Electronic medical

records are intended to allow healthcare providers to improve the quality of care, decrease costs

and improve patient safety within a framework that allows all providers to jointly share and

manage the health care information of its citizens (Brailer, 2009).

The very low levels of adoption of electronic health records in U.S. hospitals suggest that

policymakers face substantial obstacles to the achievement of healthcare performance goals that

depend on health information technology. The federal stimulus bill promises billions of dollars in

incentive payments to doctors and hospitals that buy and use the systems, with penalties starting

in 2015 for those who don't make the switch (Beatty, 2009). In the hospital setting, the Chief

Executive Officer is traditionally the “decision maker.” What impact has the ARRA had on their

decision to implement (or not) an electronic medical record system? Is the role of the

government within the healthcare setting appropriate? What is the perception of these executives

regarding the impact of the financial stimulus for adoption and use of Health Information

Technology by the federal government? These are the questions this study will review and

answer.
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CHAPTER 2

REVIEW OF RELATED LITERATURE

Current State

U.S. health care providers make minimal use of HIT compared to other health systems in

the industrialized world. Per a white paper published by The Commonwealth Fund in 2009: 17%

of U.S. Physicians and 8-10% of U.S. Hospitals have at least a basic electronic health record. In

most European countries, as well as New Zealand and Australia 80-100% of primary care

physicians have electronic healthcare records (EHRs) (The Commonwealth Fund, 2009).

Healthcare is among the least automated industries in the nation. Studies have estimated

that the healthcare industry as a whole is almost 20 years behind the rest of the nation’s

industries with respect to digitalization. Limitations in software, hardware and networking

technologies has made electronic healthcare records difficult to affordably implement

(Blumethal, 2009).

According to the Centers for Disease Control (CDC, 2007 ), 29.2% of physicians said

they use full or partial clinical EHRs, however only 4% said they used a fully functional record

system ( Hing, 2007). The majority of the research indicates that very few hospitals have a

comprehensive electronic system for recording clinical information and only a small minority

have even a basic system. However, many institutions have parts of an electronic-records system

in place, suggesting that policy interventions could increase the prevalence of electronic health

records in U.S. hospitals faster than our low adoption levels might suggest (HIMSS, 2009).
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From a national interoperability perspective, much of the infrastructure is not in place.

Key components have not yet been defined. This includes:

• The rules that specify how to send information back and forth,

• Legal business rules in place to guide organizations in order for them to exchange

data,

• Identified standards for health care organizations to use as a model for

implementing an electronic medical record system,

• Clinical standards for electronic systems,

• The ability to allow patient medical records to be shared or moved about in the

system.

• Software flexibility and customization capabilities due to out-dated programming

technology(American Hospital Association, 2007).

Table 1

The State of Health Information Technology in California

Fully Implemented 13%

Partially Implemented 42%

Not Implemented 45%

Source: California HealthCare Foundation. January 2007

Health IT is moving from a voluntary initiative over the past decade to a highly regulated
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one with new rule-making government committees, stricter privacy laws and more onerous fines.

With billions in new funding and government regulations, the health IT market should quickly

expand far beyond the provider segment, providing new opportunities for health plans,

pharmaceutical companies and other vendors (Argawal, 2002).

Less than 2% of acute care hospitals have a comprehensive electronic-records system,

and, (depending on the definition used), between 8 and 12% of hospitals have a basic electronic-

records system. The official definition requires the system to include the presence of

functionalities for physicians' notes and nursing assessments. Information systems in more than

90% of U.S. hospitals do not even meet the requirement for this type of basic electronic-records

system (HIMSS, 2007).

The majority of U.S. hospitals are in the early stages of EMR transformation (AHA,

2007). Although levels of adoption of electronic health records are low, various components that

underlie electronic record systems have been widely implemented. A sizable proportion of

hospitals reported that laboratory and transcribed reports, radiological images (PACS),

medication lists, and some decision-support functions are available in electronic format

(American Hospital, 2007). Others reported that they plan to upgrade their information systems

to an electronic-records system by adding functionalities, such as computerized provider-order

entry (CPOE), physicians’ notes and nursing assessments (Jha, 2009).

The American Recovery and Reinvestment Act of 2009

On February 17, 2009, President Barack Obama signed into law the American Recovery

and Reinvestment Act of 2009, H.R. 1 (ARRA, 2009). More commonly referred to as ARRA or

the Recovery Act, this provides substantial financial incentives to assist providers with the
The 2009 Health Information Technology Act 13

purchase and implementation of HIT systems. In addition to assisting with financing, a key

element to the widespread adoption and use of HIT is the development of uniform electronic

standards that allow various systems to communicate with each other (American Medical

Association, 2009). ARRA requires the Department of Health and Human Services (HHS) to

develop standards by December 31, 2009 (AHRQ ,2009) .

The Recovery Act includes financial incentives and penalties to be paid through the

Medicare program with very specific time frames for implementation. In addition, ARRA,

includes over $20 billion to aid in the development of a robust IT infrastructure for healthcare

and to assist providers and other entities in adopting and using health IT. Total funding for health

IT is as follows:

• $2 billion for the Office of the National Coordinator ,

• $20.819 billion in incentives through the Medicare and Medicaid reimbursement

systems to assist providers to adopting EHRs,

• $4.7 billion for the National Telecommunications and Information

Administration’s Broadband Technology Opportunities Program,

• $2.5 billion for the U.S. Department of Agriculture’s Distance Learning,

Telemedicine, and Broadband Program,

• $1.5 billion for construction, renovation, and equipment for health centers through

the Health Resources and Services Administration,

• $1.1 billion for comparative effectiveness research within the Agency for

Healthcare Research and Quality (AHRQ), National Institutes of Health (NIH),

and the Department of Health and Human Services (HHS),


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• $85 million for health IT, including tele-health services, within the Indian Health

Service,

• $500 million for the Social Security Administration,

• $50 million for information technology within the Veterans Benefits

Administration ,

• In addition, it establishes HIT Policy and Standards Committees that are

comprised of public and private stakeholders to provide recommendations on the

HIT policy framework, standards, implementation specifications, and certification

criteria for electronic exchange and use of health information (Department of

Health, 2009).

Purpose of Recovery Act HIT Incentives

The primary purpose of this Act is to stimulate the economy through investments in

infrastructure, unemployment benefits, transportation, education, and healthcare (ARRA, 2009).

With respect to healthcare, one of the goals is to reduce long-term costs by modernizing

healthcare through the use of information technology.

The majority of the funds are incentive payments that will go to Medicaid and Medicare

providers that are able to demonstrate "meaningful use" of health information technology. The

requirements that define “meaningful use” have not yet been published. Providers that serve

patients from both programs will be required to choose one source of reimbursement only

(AHRQ, 2009).

Medicare: Eligible hospitals will receive a base funding of $2M with additional funds

provided according to a statutorily prescribed formula related to discharge data. The program
The 2009 Health Information Technology Act 15

also creates a penalty system which begins in 2015 (CMS, 2009).

Medicaid: The purpose of the 100 percent provider incentive payments to certain

eligible Medicaid providers is to encourage the adoption and meaningful use of certified EHR

technology (CMS, 2009).

While the incentive payments are expected to be used for certified EHR technology and

support services, including maintenance and training necessary for the adoption and operation of

such technology, the incentive payments are not direct reimbursement for such activities. They

are intended to serve as an incentive for eligible providers to adopt the use of “certified” EHR

technology (Binder, 2009).


T ab le 2

S u m m a ry of F ed era l G overn m en t H ea lth IT S tra teg ic G oa ls a n d O b jectives: 2 0 0 8 -2 0 1 2


Goal 1. Patient-focused Health Objective 1.1: Objective 1.2: Objective 1.3: Objective 1.4:
Care
F a c ilita te e le c tr o n ic e x c h a n g e , E n a b le th e m o v e m e n t o f e le c tr o Pn ic
r o m o te n a tio n w id e d e p lo y m eEnsta
t b lish m e c h a n ism s fo r m u lti-
a c c e ss, a n d u se o f e le c tr o n ic h e ah lth
e a lth in fo r m a tio n to su p p o r t o f e le c tr o n ic h e a lth r e c o r d s sta k e h o ld e r p r io r ity - se ttin g a n d
in fo r m a tio n , w h ile p r o te c tin g th ep a tie n ts’ h e a lth a n d c a r e n e e d s.( E H R s) a n d p e r so n a l h e a lth d e c isio n - m a k in g .
p r iv a c y a n d se c u r ity o f p a tie n ts’ r e c o r d s ( P H R s) a n d o th e r
h e a lth in fo r m a tio n . c o n su m e r h e a lth I T to o ls.

Goal 2. Population Health Objective 2.1: Objective 2.2: Objective 2.3: Objective 2.4:

A d v a n c e p r iv a c y a n d se c u r ity E n a b le e x c h a n g e o f h e a lth P r o m o te n a tio n w id e a d o p tio n Eostaf b lish c o o r d in a te d o r g a n iza tio n a l


p o lic ie s, p r in c ip le s, p r o c e d u r e s, ina nfodr m a tio n to su p p o r t p o p u la tio nte- c h n o lo g ie s to im p r o v e p r o c e sse s su p p o r tin g in fo r m a tio n u se
p r o te c tio n s fo r in fo r m a tio n a c c e ss o r iein n te d u se s. p o p u la tio n a n d in d iv id u a l h e a lth
fo r. p o p u la tio n h e a lth .
p o p u la tio n h e a lth .

Source: Federal Health IT Strategic Plan 2008-2012

Federal Regulatory Issues and Requirements

There is much debate as to the role that the federal government should play in the

promotion of HIT-EHR. Some argue that HIT-EHR development should be left completely to the

private sector. Middleton believes that the market has failed given the current state of HIT-EHR

adoption, and that government guidance and standardization is necessary to jumpstart


The 2009 Health Information Technology Act 16

widespread implementation ( Walker et al., 2005). Both Bower and Taylor, et al., suggest that

major government intervention is the only hope of success, in the form of subsidies, mandates,

and substantial policy directives. (Taylor, 2005)

According to a study by the Cato Institute (Conover, 2004), the burden of regulation in

the health care industry is staggering. The study provides a detailed analysis of the cost of

regulation in the health care sector, prior to the current slew of new agencies and regulations

recommended for implementation of the electronic medical record. This study (Conover, 2004)

identifies the cost of regulation of health facilities, health professionals, health insurance, drugs

and medical devices, and the medical tort system, including the costs of defensive medicine. The

calculations include a deduction of identifiable tangible benefits of regulation. With that said,

the estimate is considerable, amounting to $169.1 billion annually. The study suggests that the

cost of health service regulation outweighs benefits by a two to one cost. (Conover, 2004).

Table 3

Cost of Health Facilities Regulation (millions of 2002 dollars)


Costs Benefits
Type of Regulation Expected Minimum Maximum Expected Minimum Maximum Net Cost Percent

Access $11,755 $2,184 $29,544 $3,805 $700 $8,928 $7,950 31.7%


EMTALA $4,436 $1,261 $10,965 $2,146 $421 $4,930 $2,290 9.1%
Hospital uncopensated care pools $6,678 $698 $16,591 $1,524 $233 $3,601 $5,154 20.6%
Hospital community service requirements $317 $123 $961 $135 $46 $397 $182 70.0%
Limited English proficiency requirements $324 $102 $1,027 $0 $0 $0 $324 0.0%
1.3%
Costs $14,130 $11,948 $273,339 $14,837 $20,748 $27,094 -$707 -2.8%
Health care fraud and abuse $3,209 $2,224 $9,945 $2,154 $1,808 $2,912 $1,055 4.2%
Facility medical records (incl privacy) $1,068 $696 $92,178 $1,222 $996 $1,450 -$154 -0.6%
Organ transplant regulation $1,815 $1,653 $1,785 $1,804 $280 $4,644 $11 0.0%
Certificate of need $110 $26 $157,859 $0 $5,067 $0 $110 4.0%
Hospital rate setting $69 $57 $3,023 $51 $4,421 $0 $18 0.4%
Pharmaceutical price regulation $7,626 $7,163 $8,149 $9,606 $8,176 $18,088 -$1,980 0.1%
Other cost-related facilities regulations $233 $129 $400 $0 $0 $0 $233 -7.9%
0.9%
Quality $21,798 $9,595 $57,592 $3,973 $3,973 $3,973 $17,825 71.1%
Hospital accreditation/ licensure $8,640 $833 $31,885 $0 $0 $0 $8,640 34.5%
Nursing home accreditation/licensure $3,581 $1,963 $6,821 $3,973 $3,973 $3,973 -$392 -1.6%
Other facilities accreditation/licensure $2,078 $465 $7,447 $0 $0 $0 $2,078 8.3%
Peer Review $2,063 $1,314 $5,481 $0 $0 $0 $2,063 8.2%
Clinical Laboratory Improvement Act (CLIA) $3,236 $3,065 $3,466 $0 $0 $0 $3,236 12.9%
Other quality-related facilities regulations $2,200 $1,955 $2,492 $0 $0 $0 $2,200 8.8%

GRAND TOTAL $47,683 $23,727 $360,475 $22,615 $25,421 $39,995 $25,068 100%

Source: Cato Institute (Conover, 2004)


The 2009 Health Information Technology Act 17

Subsequently, the ARRA has been signed. The Recovery Act includes significant funding

for the implementation and management of the incentive program as well as the ongoing support

for providers meeting the qualifications of a certified electronic medical record system, and

additional funding for the required regulatory reporting agencies. The new law requires the

Department of Health and Human Services, and the Office of the National Coordinator for

Health Information Technology (ONC), to adopt a rule-making process of initial standards,

implementation specifications and certification criteria by December 31, 2009 (AMA, 2009).

The new regulatory requirements are a complex array of additional governmental layers.

When reading the following, consider the depth and comprehension level required to administer

a successful electronic system while complying with the regulations that are integrated into the

newly defined HITECH landscape. A clear understanding of all applicable laws and regulations

is a basic requirement for holding a position of leadership in a Hospital, particularly at the Chief

Executive Officer level.

Health Information Technology for Economic and Clinical Health Act (HITECH)

On February 17, 2009 the American Recovery and Reinvestment Act of 2009 commonly

referred to as “the Stimulus Bill,” was signed into law by the federal government. Included in

this law is $19.2 Billion which is intended to be used to increase the use of Electronic Health

Records (EHR) by physicians and hospitals; this portion of the bill is called, the Health

Information Technology for Economic and Clinical Health Act, or HITECH Act. The

government firmly believes in the benefits of using electronic health records and is ready to

invest federal resources to proliferate its use. (Ways and Means, 2009).
The 2009 Health Information Technology Act 18

Meaningful Use

Two important elements have yet to be defined. This includes the official definition of

“meaningful use,” and the specifications required for becoming a “certified” electronic health

record (Health IT, 2009). The meaningful use workgroup of the HIT Policy Committee has

released its initial recommendations for a definition of "meaningful use" of electronic health

records. The definition is important because under the economic stimulus law, providers must

"meaningfully use" EHRs to receive financial incentives from Medicare and Medicaid (Health IT

Committee, 2009).

These initial recommendations do not include a formal definition of meaningful use.

They include the initial recommendation of the functionalities that will be required by 2011

when incentive payments begin. "This is the beginning of a conversation that will continue for

some time," said David Blumenthal, M.D., the National Coordinator for Health Information

Technology, during a meeting of the HIT Policy Committee, a public-private advisory group.

Blumenthal added that "there is a long way to go" before a final definition of meaningful use is

achieved (Goedert,2009).

The workgroup's initial recommendations include 22 objectives--most covering inpatient

and outpatient care for EHRs in 2011. These include, among others:

• Use CPOE for all order types including medications,

• Implement drug-drug, drug-allergy and drug-formulary checks,

• Maintain an up-to-date problem list,

• Generate and transit permissible prescriptions electronically,

• Maintain an active medication allergy list,


The 2009 Health Information Technology Act 19

• Send reminders to patients per their preference for preventive and follow-up-care,

• Document a progress note for each encounter,

• Provide patients with an electronic copy or electronic access to clinical

information such as lab results, problem list, medication lists and allergies,

• Provide clinical summaries for patients for each encounter,

• Exchange key clinical information among providers of care,

• Perform medication reconciliation at relevant encounters,

• Submit electronic data to immunization registries where required and accepted,

• Provide electronic submissions of reportable lab results to public health agencies,

• Provide electronic surveillance data to public health agencies according to

applicable law and practice, and,

• Comply with federal and state privacy/security laws and the fair data sharing

practices in HHS’ Nationwide Privacy and Security Framework, released in

December 2008 (Health Information Technology, 2009).

“Certified” Electronic Health Record

The rules and regulations for meeting the requirements of a “certified” electronic health

record are still under discussion, with preliminary models identified for 2011 (Health IT, 2009).

The Certification Commission launched its updated and new 2011 Certification Programs on

October 7, 2009. In addition to its established, CCHIT Certified Comprehensive Certification

Programs, the Commission also launched a more limited ARRA certification program(health

Information, 2009).

The CCHIT Certified 2011 program inspects products against comprehensive


The 2009 Health Information Technology Act 20

functionality, interoperability, and privacy and security criteria using the Commission’s

published methods. Products must be fully compliant. They must also meet or exceed

applicable proposed Federal standards for certified EHR technology to support the 2011-2012

incentives under the American Recovery and Reinvestment Act of 2009 (Health IT, 2009)

The ARRA certification component of both programs is considered preliminary because

the definitions of meaningful use, criteria, and standards have been proposed but not yet finalized

by the US Department of Health and Human services(Certification Commission, 2009).

Health Information Privacy

ARRA layers on new privacy protections and prosecution powers to discourage

unauthorized access to patient information. Under ARRA, even a brief unauthorized look at a

medical record can result in large monetary fines for individuals and facilities. Through a wide

range of provisions, Congress used ARRA as an attempt to increase patient trust that the

healthcare industry will protect their personal information (Healy, 2009).

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

The Privacy Rule provides federal protections for personal health information held by

covered entities and gives patients an array of rights with respect to that information. At the same

time, the Privacy Rule is balanced so that it permits the disclosure of personal health information

needed for patient care and other important purposes.

The Act is defined as follows:

“The Standards for Privacy of Individually Identifiable Health Information

(“Privacy Rule”) establishes, for the first time, a set of national standards for the

protection of certain health information. The U.S. Department of Health and Human
The 2009 Health Information Technology Act 21

Services (“HHS”) issued the Privacy Rule to implement the requirement of the Health

Insurance Portability and Accountability Act of 1996 (“HIPAA”).1 The Privacy Rule

standards address the use and disclosure of individuals’ health information—called

“protected health information” by organizations subject to the Privacy Rule — called

“covered entities,” as well as standards for individuals' privacy rights to understand and

control how their health information is used. Within HHS, the Office for Civil Rights

(“OCR”) has responsibility for implementing and enforcing the Privacy Rule with respect

to voluntary compliance activities and civil money penalties” (Department of Health and

Human Services, 2009).

The ARRA has tightened existing Privacy Rules to meet the demands of the electronic

Medical Record. The privacy and security of electronic health information must be ensured as

this information is maintained and transmitted electronically. (OCR, 2009).

The Uniform Healthcare Information Act

The National Conference of Commissioners on Uniform State Laws has promulgated a

standard state privacy statute known as the Uniform Healthcare Information Act. The Act is

supported by the American Medical Association.

The main thrust of the Uniform Act is:

• Medical records may be released only with the patient’s consent,

• A subpoena may be required to release medical information in a legal context,

• Patients have access to their own records.

The Act sets forth stern penalties for noncompliance. Of great interest to third party

payers is the provision of many of the state statutes which deals with fraud and health care
The 2009 Health Information Technology Act 22

records. The statutes of some states prevent a provider from testifying for or against a patient

without the patient’s consent. These are called privileged communication statutes (National

Conference, 1985).

Data Breach

The data breach notification regulations are the first of the ARRA privacy provisions to

take effect. The Department of Health and Human Services(HHS), will oversee organizations

that qualify as covered entities and business associates under HIPAA. The Federal Trade

Commission (FTC) will oversee everyone else, including vendors of personal health records. The

law requires both HHS and the FTC to create and publish final interim regulations by August 16,

2009. The provisions become effective 30 days after publication (ARRA, 2009).

Administrative Simplification: Title II, Subtitle F. (HIPAA)

This section grants authority to mandate the use of standards for the electronic exchange

of healthcare data, to specify what medical and administrative code sets should be used within

the standards (Health Insurance, 1996).

Accounting for Disclosures

ARRA requires healthcare facilities using EHR systems to provide patients with a fuller

accounting of disclosures, including disclosures for treatment purposes and other routine

healthcare operations. This is a significant change from the current HIPAA laws, which exempt

treatment, payment and business operations disclosure (Appendix A).

Restrictions of Certain Disclosures

ARRA gives patients the right to prevent the disclosure of health data to their health

insurance plans if they paid for treatments out of their own pockets. EHR systems will have to
The 2009 Health Information Technology Act 23

adapt to accommodate such requests (Appendix A).

Electronic Copies

ARRA requires any provider using an EHR system to produce an electronic copy of a

patient’s health record upon request. Under HIPAA, providers are required to give a copy of a

patient’s record in the format requested, but only if documents are “readily producible” in that

format. Many EHR systems in use are not up to that challenge (Appendix A).

Liability for Business Associates

ARRA has several provisions that extend HIPAA privacy, security, and administrative

requirements to business associates. Business Associates (BA) are individuals or an organization

that performs a function or activity on behalf of a covered entity, but is not a part of the covered

entity’s workforce. Covered entities must update their business associate agreements to

incorporate these new provisions. Among the changes, ARRA requires business associates to

respond to any privacy noncompliance on the part of the covered entities. Security breach,

restrictions and disclosures, sales of health information, consumer access, business associate

obligations and agreements (OCR, 2009).

Improved Enforcement

The Recovery Act carries a number of items Congress lumped together as” improved

enforcement”. Many of these also relate to Section 1177(a) of the Social Security Act (42

U.S.C. 1320) which established the penalties as we currently know them (ARRA, 2009).

Noncompliance Due to Willful Neglect

Increased penalties due to willful neglect is a violation for which the Secretary is required

to impose a penalty. For the penalty to be levied, the Secretary must formally investigate any
The 2009 Health Information Technology Act 24

complaint of a violation of a provision of HIPAA privacy. When the investigation indicates a

violation due to willful neglect a penalty will be imposed. This change will apply to penalties

that occur more than 2 years after the enactment date. The Secretary is to publish final

regulations related to this requirement not later than 18 months after the ARRA enactment

(ARRA, 2009).

Distribution of Certain Civil Monetary Penalties Collected

This provision calls for any civil monetary penalty (or monetary settlement collected with

respect to an offense punishable under ARRA privacy provisions or the Social Security Act

(HIPAA) to be transferred to the HHS Office of Civil Rights for the purpose of enforcing the

provisions of these ARRA provisions. The Government Accounting Office (GAO) is to submit a

report to the Secretary within 18 months of enactment, with recommendations for a methodology

under which an individual who is harmed by an act that constitutes an offense to the ARRA

provisions or HIPAA may receive a percentage of any civil monetary penalties or monetary

settlement collected. Then, within three years of enactment, the Secretary shall establish

regulations based on the GAO recommendations. The methodology will apply with respect to

civil monetary penalties or monetary settlements imposed on or after the effective date of the

regulation (ARRA, 2009).

Tiered Increase in Amount of Civil Monetary Penalties

The ARRA modifies the Social Security Act Penalties. In this case a tiered set of

penalties is established as follows:

Where there is a violation that it is established when the person did not

know (and by exercising reasonable diligence would not have known) that such
The 2009 Health Information Technology Act 25

person violated a provision, a penalty for each violation will be at least $100 for

each violation, not to exceed $25,000 (ARRA, 2009, p.158).

Where there is a violation and the violation was due to reasonable cause

and not to willful neglect, a penalty for each such violation will be at least $1,000

for each violation, not to exceed $100,000 for each violation (ARRA, 2009).

Where there is a violation and violation was due to willful neglect: If the

violation is corrected, a penalty of $10,000 will be required for each violation, not

to exceed $250,000. If the violation is not corrected as described, a penalty in the

amount of $50,000 will be required not to exceed $1,500.000 (ARRA, 2009).

The Nationwide Privacy and Security Framework for Electronic Exchange of

Individually Identifiable Health Information:

The principles of the Nationwide Privacy and Security Framework for Electronic

Exchange of Individually Identifiable Health Information establishes a single, consistent

approach to address the privacy and security challenges related to electronic health information

exchange through a network for all persons, regardless of the legal framework that may apply to

a particular organization (ONC, 2009).

CMS Security Standards:

The Administrative Simplification provisions of the Health Insurance Portability and

Accountability Act of 1996 (HIPAA, Title II) required the Department of Health and Human

Services to establish National Standards for the security of electronic health care information.

The final rule adopting HIPAA standards for security was published in the Federal Register on

February 20, 2003. This final rule specifies a series of administrative, technical, and physical
The 2009 Health Information Technology Act 26

security procedures for covered entities to use to assure the confidentiality of electronic protected

health information. (CMS, 2009).

Civil Rights

Title VI of the Civil Rights Act of 1964

While ARRA has not modified awardees’ civil rights obligations, which are referenced in

the HHS Grants Policy Statement, these obligations remain a requirement of Federal law.

Recipients and sub-recipients of ARRA funds or other federal financial assistance must comply

with Title VI of the Civil Rights Act of 1964 (prohibiting race, color, and national origin

discrimination) (Title VI, 1964).

Section 504 of the Rehabilitation Act of 1973

Requires hospitals to validate that they protect patients from disability discrimination

(Rehabilitation, 1973).

Title IX of the Education Amendments of 1972

Requires hospitals to insure that they prohibit sex discrimination in education and

training programs, discrimination on the basis of sex in Federally supported education programs

is also prohibited (Title IX, 1972).

The Age Discrimination Act of 1975

Prohibits hospitals from age discrimination in the provision of services (Age, 1975).

Public Health Service Act

Titles VI and XVI of the Public Health Service Act require health facilities that received

certain Federal funds (“Hill-Burton” funds) to provide certain services to members of its

designated community (Appendix D)


The 2009 Health Information Technology Act 27

Section 542 of the Public Health Service Act, as amended, bars discrimination in

admission or treatment against substance abusers suffering from medical conditions by

Federally-assisted hospitals and outpatient facilities (Appendix D).

Food and Drugs

The Food and Drugs Act of 1906

The first of more than 200 laws that constitute one of the world's most comprehensive

and effective networks of public health and consumer protections (Pure, 1906).

The Federal Food, Drug, and Cosmetic Act of 1938

Among other provisions, the law authorized the FDA to demand evidence of safety for

new drugs, issue standards for food, and conduct factory inspections (FDA, 2009).

The Kefauver-Harris Amendments of 1962

Inspired by the Thalidomide tragedy in Europe, this amendment strengthened the rules

for drug safety and required manufacturers to prove their drugs' effectiveness (FDA, 2009).

The Medical Device Amendments of 1976

The law applied safety and effectiveness safeguards to new devices (FDA, 2009).

Food and Drug Administration Amendments Act of 2007.

This law represents a very significant addition to FDA authority. Among the many

components of the law, the Prescription Drug User Fee Act (PDUFA) and the Medical Device

User Fee and Modernization Act (MDUFMA) have been reauthorized and expanded. These

programs will ensure that FDA staff has the additional resources needed to conduct the complex

and comprehensive reviews necessary to approve new drugs and devices (FDA, 2007).

Electronic Records: Electronic Signatures


The 2009 Health Information Technology Act 28

The regulations in this part set forth the criteria under which the agency considers

electronic records, electronic signatures, and handwritten signatures executed in electronic

records to be trustworthy, reliable, and generally equivalent to paper records and handwritten

signatures executed on paper (Electronic, 2003).

Fraud Prevention & Detection

Safe Harbor Regulation

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA),

identifies the final rules for Safe Harbor under the anti-kick back statute to protect certain

arrangements involving goods, items, services, donations, and loans provided by individuals and

entities to certain health centers that are funded under section 330 of the Public Health Service

Act. The goods, items, services, donations, or loans must contribute to the health center’s ability

to maintain or increase the availability, or enhance the quality, of services available to a

medically underserved population (OIG, 2006)

Provider Self-Disclosure Protocol

The Self-Disclosure Protocol is intended to be a vehicle under which the provider

community can voluntarily disclose self-discovered evidence of potential fraud in an attempt to

avoid the costs and disruptions that may be associated with a Government-directed investigation

and with civil or administrative litigation. The Office of the Inspector General (OIG) verifies the

information contained in the provider's submission and evaluates the matter for potential fraud

issues.. While the OIG does not speak for the Department of Justice or other agencies, they are

consulted, as appropriate, regarding the resolution of Self-Disclosure Protocol matters (Levinson,

2009).
The 2009 Health Information Technology Act 29

HHS Recovery Act Oversight

The American Recovery and Reinvestment Act of 2009 (Recovery Act) provides the

Office of Inspector General (OIG), with $17 million in funding for oversight and review. The

Recovery Act provided an additional $31,250,000 to the OIG for the purpose of ensuring the

proper expenditure of funds under Medicaid. OIG will assess whether HHS is using the $165.4

billion in Recovery Act funds in accordance with legal and administrative requirements and that

they are meeting the accountability objectives defined by the Office of Management and Budget

(OIG, 2009).

Whistleblower Protections under the Recovery Act

The ARRA , provides protections for certain individuals who make specified disclosures

relating to Recovery Act funds. Any non-federal employer receiving recovery funds is required

to post a notice of the rights and remedies provided under this section of the Act (OIG, 2009).

Information Management

HHS Recovery Act

The purpose is to increase access to health care, protect those in greatest need, create

jobs, expand educational opportunities, lay the groundwork for successful health reform, and

provide immediate relief to states and local communities. HHS has been entrusted with carefully

investing $167 billion of taxpayer’s funds for these purposes, and is committed to making every

dollar count (Federal Health, 2009).

The HHS Recovery Act lays a solid foundation for health reform, and makes a down

payment on the President’s “Zero to Five” plan of early care and education of children by

promoting access to health insurance and increasing the number of health care professionals
The 2009 Health Information Technology Act 30

through

• Additional grants to healthcare workforce training institutions,

• Computerizing Americans’ health records, which will improve the quality of

healthcare,

• reduce medical errors, and prevent unnecessary health care spending,

• Advancing scientific and biomedical research and development related to health

and human services,

• Promoting economic and social well-being of individuals, families, and

communities,

• Strengthening necessary healthcare services for medically underserved

individuals ,

• Providing healthcare services to American Indians and Alaska Natives

(Department of Health, 2009).

Freedom of Information Act (FOIA)

This is a federal statue that allows individuals to request access to Federal agency

records, except to the extent records are protected from disclosure by the Freedom of

Information Act (Justice Department,2009).

§ 482.24 Condition of Participation: Medical record services.

Every hospital that accepts payment for Medicare and Medicaid patients must comply

with the Center for Medicare and Medicaid Conditions of Participation. This regulation includes

specific instructions for hospitals as well as defining criteria and standards for medical records.

This includes the organization and staffing requirements for the medical records department, the
The 2009 Health Information Technology Act 31

standardized format and the retention requirements for the records. It also identifies each of the

specific types of documents that must be present, as well as the required content and

documentation standards (CMS, 2009).

Substance Abuse Rules

Federal laws relating to substance abuse records came into being due to the sensitivity of

such information. These special rules apply where the facility has any special substance

abuse care unit. General medical care is not affected. There are stern monetary penalties for non-

compliance (SAMSA, 2004).

Joint Commission on Accreditation of Healthcare Organization Standards

Specifically defines required standards for hospitals and healthcare organizations with

respect to the content of the medical record, including IM.2.20 –data integrity, IM.2.30 addresses

continuity and disaster recovery for both hard copy and electronic records, and a myriad of other

very specific requirements for organizations seeking accreditation. This accreditation process is

required for all Medicare providers (The Joint Commission, 2009).

Medical and Healthcare

Title 42: Public Health

Specific portion of the United States Code that identifies requirements for public health,

social welfare, and civil rights. Specific requirements for hospitals and record keeping

regulations are outlined (See Appendix C).

Section 3012 of the Public Health Service Act

The Health Information Technology Extension Program (Extension Program), authorized

by Section 3012 of the Public Health Service Act as amended by ARRA - will establish a
The 2009 Health Information Technology Act 32

collaborative consortium of Health Information Technology Regional Extension Centers

facilitated by the national Health Information Technology Research Center. The Extension

Program will offer providers across the nation, technical assistance in the selection, acquisition,

implementation, and “ meaningful ” an EHR to improve health care quality and outcomes

(Public Health, 2009).

Federal Medical Care Recovery Act (FMCRA)

The Medical Care Recovery Act provides that, when the government treats or

pays for the care of a military member, retiree, or dependent, it may recover its expenses

from any third party legally liable for the injury or disease. The key to understanding the

complexities of the FMCRA is to realize that the Federal Government operates one of the

largest health care systems in the world (MCRA, 2007).

Other Federal Laws

In addition to being subject to HIPAA and Substance Abuse Confidentiality

Requirements, healthcare organizations may be subject to several federal laws that touch in some

way on privacy of health information. The Preamble to the Privacy Rule lists the following

applicable laws: Privacy Act of 1974, Family Educational Rights and Privacy Act, Freedom of

Information Act, Employee Retirement Income Security Act of 1974 (ERISA), Gramm-Leach-

Bliley Act, federally funded health programs regulations, Food, Drug and Cosmetic Act, Clinical

Laboratory Improvement Amendment, federal disability and non-discrimination laws, and U.S.

Safe Harbor Privacy Principles. In addition, many federal regulations require disclosure of

specific PHI for specific purposes in specific circumstances (Miller, 2007).


The 2009 Health Information Technology Act 33

Federal Rule of Evidence, Article VIII

Defines the requirements that a record must have to meet the federal and state rules of

evidence to stand as a legal business record (Federal Rule, 1997).

ONC’s Federal HIT-EHR Strategic Plan: 2008-2012:

This plan brings together all HIT-EHR Federal efforts in a coordinated fashion, setting a

number of goals, objectives, and strategies. The goals include privacy and security,

interoperability, widespread adoption, and collaborative governance. The plan catalogs activities

from many Federal agencies that focus on HIT (Federal Health,2008).

The Patient Safety and Quality Improvement Act of 2005 (PSQIA)

Establishes a voluntary reporting system to enhance the data available to assess and

resolve patient safety and health care quality issues. To encourage the reporting and analysis of

medical errors, PSQIA provides Federal privilege and confidentiality protections for patient

safety information called patient safety work product. Patient safety work product includes

information collected and created during the reporting and analysis of patient safety events

(Department of Health, 2005).

Stark Laws

Congress included a provision in the Omnibus Budget Reconciliation Act of 1989

(OBRA 1989) which barred self-referrals for clinical laboratory services under the Medicare

program, effective January 1, 1992. This provision is known as "Stark I". The law included a

series of exceptions to the ban in order to accommodate legitimate business arrangements. A

number of observers recommended extending the ban to other services and programs. The

Omnibus Budget Reconciliation Act of 1993 (OBRA 1993) expanded the restriction to a range of
The 2009 Health Information Technology Act 34

additional health services and applied it to both Medicare and Medicaid; this legislation, known

as "Stark II," also contained clarifications and modifications to the exceptions in the original law.

Minor technical corrections to these provisions were included in the Social Security

Amendments of 1994 (Centers for Medicare, 2009).

On August 1,2006 Health and Human Services (HHS) Secretary Mike Leavitt

announced the issuance of final regulations(published in the Federal Register on August 8, 2006)

creating new information technology exceptions under the Federal Stark law and safe harbors

under the Federal Anti-Kickback statute. The issuance of these regulations substantially increases

the ability of hospitals and other providers of Medicare and Medicaid services to donate

information technology to physicians without violating the Stark law or Anti-Kickback statute.

The changes include:

• Provision of Information Technology Items or Services to Physicians at Fair

Market Value,

• Pre-Existing Exception for Community-Wide Health Information Systems,

• Electronic Prescribing Items and Services,

• Electronic Health Records Items and Services,

• Interoperability Requirement,

• Receipt of Items or Services Not Condition for Doing Business with Donor,

• Prohibition Against Eligibility for Items or Services Based on “Volume or Value

of Referrals” (O’Brien, 2006).

Physician Payment of 15% of Donor’s Cost under EHR Exception

Under the EHR exception, perhaps the most significant change from the proposed
The 2009 Health Information Technology Act 35

regulations is a requirement that the physician pay 15% of the donor’s cost for the EHR items

and services, before receipt of the items and services (CMS, 2009).

Donated Technology Not Equivalent to Technology Physician Already Possesses

The donated technology must not be technically or functionally equivalent to technology

that the physician already possesses.

Parallel Safe Harbors Under Federal Anti-Kickback Statute

The final information technology safe harbors under the Federal Anti-Kickback statute

are essentially identical to the information technology exceptions under the Federal Stark law. If

the Federal Stark law applies (because there is a financial relationship between a physician and a

provider of designated health services), any referral of a Medicare or Medicaid patients for

designated health services is prohibited, unless the referral falls within one of the Stark

exceptions. Only such referrals as qualify under one of the exceptions is permitted(CMS, 2009).

The Federal Anti-Kickback statute prohibits the offer, payment or receipt of any financial

inducement in exchange for the referral of Medicare or Medicaid patients. The safe harbors

provide immunity for arrangements that satisfy their requirements. The failure to qualify for a

safe harbor, however, does not mean that an arrangement is unlawful.

Risk to Tax-Exempt Status: Prohibitions Against Private Benefit and Inurement

In order to prevent or minimize the risk to a hospital’s tax-exempt status, the hospital

should be able to document and demonstrate the benefit which it or the community derives from

the donation arrangement. For example, it can be argued that providing information technology

items or services to physicians on its medical staff furthers the provision of safer and more

effective patient care and advances the overall health of the community served by the hospital.
The 2009 Health Information Technology Act 36

The issuance of the subject final regulations substantially increases the ability of hospitals

and other providers of Medicare or Medicaid services to donate information technology to

physicians without violating the Federal Stark law and the Federal Anti-Kickback statute. Such

arrangements will need to be carefully structured with appropriate agreements compliant with the

subject exceptions and safe harbors (O’Brien, 2006).

The Federal Advisory Committee Act (FACA)

This federal law governs the behavior of federal advisory committees. Specifically, the

Act restricts the formation of committees to those that are deemed essential, limits their powers

to provision of advice to officers and agencies in the executive branch of the Federal

Government and also limits the length of their term (Federal Advisory Committee, 1994).

Regulatory Agencies and Their Responsibilities

Multiple federal and state regulatory agencies play key roles in the implementation,

strategy and management of this program. The individual agencies and their role are outlined as

follows:

Agency for Healthcare Research and Quality (AHRQ)

AHRQ is a significant funding source for research and development across the HIT-EHR

spectrum, with $166 million in grants and contracts specific to this effort. Funding is awarded to

collect HIT-EHR data and to stimulate investment in HIT-EHR products. The Agency for

Healthcare Research and Quality's mission is to improve the quality, safety, efficiency, and

effectiveness of healthcare for all Americans. Information from AHRQ's research helps people

make more informed decisions and improve the quality of healthcare services. AHRQ was

formerly known as the Agency for Health Care Policy and Research (AHRQ, 2009).
The 2009 Health Information Technology Act 37

The American Health Information Community

The American Health Information Community (AHIC) is a federal advisory body,

chartered in 2005, to make recommendations to the Secretary of the U.S. Department of Health

and Human Services on how to accelerate the development and adoption of health information

technology (American Health, 2005).

American National Standards Institute (ANSI)

This organization accredits various standards-setting committees, and monitors their

compliance with the open rule-making process they are required to follow to obtain ANSI

accreditation. HIPAA prescribes that the standards mandated under it be developed by ANSI-

accredited bodies (American National, 2009).

The Centers for Disease Control and Prevention (CDC)

To improve and support state health departments’ capacity for rapid scale of healthcare

associated infections (HAI) prevention, dissemination of HHS evidence-based practices within

hospitals, targeted monitoring and investigation of the changing epidemiology. Also require

access to healthcare data and voluntary reports of hospital-related infections to the Centers for

Disease Control and Prevention (CDC, 2007).

Certification Commission for Healthcare Information Technology (CCHIT)

CCHIT is a collaboration among three industry associations that are developing federal

certification criteria and an inspection process for HIT-EHR under a three-year contract awarded

in 2005 from HHS. Interoperability and security standards are central to certification. The

Commission to date has certified over 100 ambulatory and inpatient systems as meeting federal

guidelines (Certification, 2011).


The 2009 Health Information Technology Act 38

The eHealth Initiative,

A nonprofit organization that is dedicated to the promotion of HIT-EHR development.

This organization is the best-known funding source for regional HIT efforts (eHealth, 2009).

Electronic Healthcare Network Accreditation Commission (EHNAC)

This organization tests transactions for consistency with the HIPAA requirements and

subsequently accredits healthcare clearinghouses (State Alliance, 2009).

Federal Communications Commission (FCC)

As directed in the American Recovery and Reinvestment Act of 2009, the Federal

Communications Commission will develop a national broadband plan and consult with the

National Telecommunications and Information Administration of the Department of Commerce

in their implementation of the Broadband Technology Opportunities Program. The Secretary of

Commerce, in consultation with the FCC and following Congressional notification, may transfer

funds to the FCC for carrying out these responsibilities.

Federal HealthCare Architecture (FHA)

The Federal Healthcare Architecture is responsible for ensuring that federal agencies can

seamlessly exchange health data between and among themselves, with state, tribal and local

governments; and with private sector healthcare organizations.

In addition, they leverage federal expertise in creating a cross-agency health information

interoperability architecture framework that provides a common vocabulary, simple tools and

lifecycle processes (Federal Healthcare, 2009).

Food and Drug Administration (FDA)

The FDA will receive data from existing reporting systems regarding adverse events, as
The 2009 Health Information Technology Act 39

well as provide support and regulatory guidance for pharmaceuticals and medical devices. They

are responsible for regulations related to electronic signatures used in electronic medical records

(Food and Drug, 2009).

Health Informatics Standards Board (HISB)

An ANSI-accredited standards group has developed an inventory of candidate standards

for consideration as possible HIPAA standards (Health Informatics, 2009).

The Health Information Security and Privacy Collaboration (HISPC)

Established in June 2006 by RTI International through a contract with the U.S.

Department of Health and Human Services, HISPC originally comprised 34 states and territories.

HISPC phase 3 began in April 2008, and now comprises 42 states and territories. This

organization’s goal is to address the privacy and security challenges presented by electronic

health information exchange through multi-state collaboration. Each HISPC participant

continues to have the support of its state or territorial governor and maintains a steering

committee and contact with a range of local stakeholders to ensure that developed solutions

accurately reflect local preferences (Health Information, 2009).

Health Information Technology Regional Centers

A Federal Register Notice and Request for Comments has been published announcing

the draft description of the program for establishing regional extension centers to assist providers

seeking to adopt and become meaningful users of health information technology, as authorized

by the American Recovery and Reinvestment Act of 2009 (Health Information, 2009).

Health IT Policy Committee

The ARRA provides that the HIT Policy Committee be created under the Federal
The 2009 Health Information Technology Act 40

Advisory Committee Act (FACA) and charged this committee with making recommendations to

the National Coordinator for Health Information Technology. They are responsible for the

development of a policy framework for the implementation and adoption of a nationwide health

information infrastructure, including standards for the exchange of patient medical information.

Among the areas for infrastructure standards, the Policy Committee is to consider:

• Implementation specifications shall include named standards, architectures, and

software schemes for the authentication and security of individually identifiable

health information and other information as needed to ensure the reproducible

development of common solutions across disparate entities,

• Technologies that protect the privacy of health information and promote security

in a qualified electronic health record including the segmentation and protection

from disclosure of specific and sensitive individually identifiable health

information,

• To minimize the reluctance of patients to seek care (or disclose information about

a condition) because of privacy concerns,

• To develop technologies that allow individually identifiable health information to

be rendered unusable, unreadable, or indecipherable to unauthorized individuals

when such information is transmitted in the nationwide health information

network or physically transported outside of the secured, physical perimeter of a

health care provider, health plan, or healthcare clearing house (HIT Policy, 2009).

Health IT Standards Committee

The ARRA requires the HIT Standards Committee be created under FACA and charged
The 2009 Health Information Technology Act 41

with making recommendations to the National Coordinator for Health Information Technology

on standards, implementation specifications, and certification criteria for the electronic exchange

and use of health information. Initially, the HIT Standards Committee will focus on the policies

developed by the Health IT Policy Committee (HIT Standards, 2009).

Health Resources and Services Administration (HRSA)

This agency of the U.S. Department of Health and Human Services, is the principal

Federal Agency charged with increasing access to health care for those who are medically

underserved (Health Resources, 2009).

The Healthcare Information Technology Standards Panel (HITSP)

This is a cooperative partnership between the public and private sectors. The Panel was

formed for the purpose of harmonizing and integrating standards that will meet clinical and

business needs (Healthcare Panel, 2009).

HHS Patient Safety Task Force

Federal and state agencies, accrediting bodies and other organizations collect data that

can provide insights into the causes of medical errors and strategies to increase patient safety, but

these separate sources of information are difficult to compare and analyze. In April 2001,

Secretary Thompson created the HHS Patient Safety Task Force to coordinate the efforts of these

various data-collection sources to promote more consistent, effective use of the information

(Department of Health, 1999).

Inspector General (IG)

Each federal agency has an Inspector General (IG) responsible for overseeing how

federal funds are spent and for working with the agency to minimize fraud, waste, and abuse. IGs
The 2009 Health Information Technology Act 42

for agencies who received Recovery Act funds are reviewing their stimulus spending to ensure

Recovery-related projects meet legal and administrative requirements. The IGs are also

reviewing their agencies administrative practices to ensure that effective controls are in place for

managing Recovery funds (Inspector General, 2009).

National Center for Health Statistics (NCHS)

A federal organization within the CDC that collects, analyzes and distributes health care

statistics. The NCHS maintains the ICD-9 CM codes (National Center, 2009).

National Association of Health Data Organizations (NAHDO)

The National Association of Health Data Organizations (NAHDO) is a national, not-for-profit

membership organization dedicated to improving health care through the collection, analysis,

dissemination, public availability, and use of health data.

NAHDO provides leadership in health care information management and analysis,

promotes the availability of and access to health data, and encourages the use of data to make

informed decisions and guide the development of health policy. NAHDO provides information

on current issues and strategies to develop a nationwide, comprehensive, integrated health

information system, sponsors educational programs, provides assistance, and serves as a forum

to foster collaboration and the exchange of ideas and experiences among collectors and users of

health data (National Association, 2009).

National Committee on Vital and Health Statistics (NCVHS)

The National Committee on Vital and Health Statistics was established by Congress to

serve as an advisory body to the Department of Health and Human Services on health data,

statistics and national health information policy. It fulfills important review and advisory
The 2009 Health Information Technology Act 43

functions relative to health data and statistical problems of national and international interest,

stimulates or conducts studies of such problems and makes proposals for improvement of the

Nation’s health statistics and information systems. In 1996, the Committee was restructured to

meet expanded responsibilities under the Health Insurance Portability and Accountability Act of

1996 (National Committee, 2009).

The National Health Information Network (NHIN):

To provide a secure, nationwide, interoperable health information infrastructure that will

connect providers, consumers, and others involved in supporting health and healthcare (National

Health Information, 2009).

National Committee for Quality Assurance (NCQA)

This organization accredits managed care plans or HMOs. Their role will expand to

include certification of those organizations to insure they are compliant with HIPAA

requirements. This organization maintains the (HEDIS) Health Employer Data and Information

Sets (National Committee, 2009).

National Uniform Billing Committee (NUBC)

This organization is chaired and hosted by the American Hospital Association. They

maintain the UB04 institutional billing form and the data element specifications for both the

hardcopy form and the electronic format. The NUBC has a formal consultative role under

HIPAA for all transactions affecting institutional healthcare services (National Uniform, 2009).

Office for Civil Rights (OCR)

Responsible for the enforcement of Health Insurance Portability and Accountability Act

(Office of Civil Rights, 2009).


The 2009 Health Information Technology Act 44

Office of the Inspector General (OIG):

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-

452 (as amended), is to protect the integrity of Department of Health and Human Services

programs, as well as the health and welfare of the beneficiaries of those programs. Within this

capacity they maintain legal access to all health records throughout the United States (Office of

the Inspector, 2009).

The Office of the National Coordinator for Health Information Technology (ONC)

The ONC serves as the resource for the entire health system to support the adoption of

health information technology for the promotion of nationwide health information exchange to

improve healthcare. ONC is organizationally located within the Office of the Secretary for the

U.S. Department of Health and Human Services. (Office of the Inspector, 2009).

ONC is the principal Federal entity charged with coordination of nationwide efforts to

implement and use the most advanced health information technology and the electronic exchange

of health information. The position of National Coordinator was created in 2004, through an

Executive Order, and legislatively mandated in the Health Information Technology for

Economic and Clinical Health Act [HITECH Act] of 2009. The Coordinator’s responsibilities

include: drafting HIT-EHR policy, establishing strategic action plans, and acting as a guiding

force in nationwide electronic healthcare record development (Office of the Inspector, 2009).

Office of Recovery Act Coordination

This Office will ensure that HHS fully implements the Act’s requirements. This includes

ensuring that programs are designed to meet the Recovery Act’s objectives, that reporting due

dates are met, performance outcomes are established and tracked, risks of fraud and abuse are
The 2009 Health Information Technology Act 45

mitigated, and that the public is kept informed through the Web and other means of

communication.

Once programs are in place, this office will be responsible for reporting, auditing, and

investigating for fraud and abuse; and protecting the confidentiality and integrity of HHS data

systems (Monegain, 2009).

Recovery Accountability and Transparency Board

The Recovery Board oversees Recovery Act spending and prevents and detects fraud,

waste and mismanagement of the recovery fund expenditures (Recovery Board, 2009).

Regional Health Information Organizations (RHIOs)

These are entities in which local healthcare providers and plans agree to communicate

health information over a standardized electronic network. It is estimated that there are between

100 and 200 RHIOs nationwide. They range in size from statewide structures to local city efforts

and are mainly funded by federal funds, regional providers, and philanthropic grants (Regional

Health, 2009).

State Alliance for eHealth:

The State Alliance was created through an HHS contract with the National Governors

Association (NGA) in 2006. The State Alliance for e-Health is a consensus-based, executive-

level body of state elected and appointed officials, formed to address the unique role state

governments can play in facilitating adoption of interoperable electronic HIE. It is also intended

to be a forum through which stakeholders can work together to identify new inter- and intrastate-

based policies and best practices and explore solutions to programmatic and legal issues related

to the exchange of health information (State eHealth, 2009).


The 2009 Health Information Technology Act 46

State Level Health Information Exchange Consensus Project

The State-level Health Information Exchange Consensus Project is managed through a

contract with American Health Information Management Association’s Foundation of Research

and Education. The project’s main objective is to provide a forum for ONC to work with states

to ensure all health information exchange activities throughout the Unites States align. This is a

forum that enables ONC to disseminate information about the national agenda and for the states

based efforts to inform the federal government thereby enabling a nationwide alignment of all

health information exchange activities (State Level, 2009).

United States Department of Health and Human Services (HHS)

To coordinate and manage the complexity of HHS’ role in the Recovery Act, HHS

established an Office of Recovery Act Coordination (United States Department of Health, 2009).

United States Department of Agriculture (USDA)

The Rural Development Broadband Program supports the expansion of broadband service in

rural areas through financing and grants to projects that provide access to high speed service to

facilitate economic development in locations without sufficient access to such service (USDA,

2009)

Veterans Administration

To provide software development, staff, and associated supplies and equipment to support

implementation of the Post-9/11 GI Bill and to support upgrades to other VHA systems. The

VHA Office of Information also provides use of an electronic medical record through their demo

system that is down loadable on their website (VA, 2009).


The 2009 Health Information Technology Act 47

California Legislation and Action Plans

Achieving electronic health information exchange (HIE) through the application

of health information technology (HIT) is one of the cornerstones of the overall healthcare

reform strategy in California. This includes implementation of interoperable HIE, key strategies

to achieve the goals of better health care outcomes, efficiencies in the delivery of healthcare, and

strengthening emergency and disaster response preparedness.

The California Health and Human Services Agency (CHHS) serves as the lead,

coordinating all HIE and HIT issues for the State. CHHS works with the State Chief Information

Officer (OCIO), the Department of Managed Care and the Transportation and Housing Agency

to oversee the State’s HIE and HIT related efforts (Wulsin, 2008).

The structure for achieving these goals is as follows:

Governance

Establish a governance structure that achieves broad-based stakeholder collaboration with

transparency, buy-in and trust. Set goals, objectives and performance measures for the exchange

of health information that reflect consensus among the health care stakeholder groups, and

finalize requirements related to meaningful use criteria to be established by the Secretary through

the rulemaking process (California health, 2009).

The governance structure is also responsible for:

• Ensure the coordination, integration, and alignment of efforts with Medicaid and

public health programs through efforts of the State Health IT Coordinators,

• Establish mechanisms to provide oversight and accountability of HIE to protect

the public interest,


The 2009 Health Information Technology Act 48

• Account for the flexibility needed to align with emerging nationwide HIE

governance that will be specified in future program guidance.

Finance

Develop the capability to effectively manage funding necessary to implement the State

Strategic Plan. This should include establishing financial policies and implementing procedures

to monitor spending and provide appropriate financial controls.

Develop a path to sustainability including a business plan with feasible public/private

financing mechanisms for ongoing information exchange among health care providers and with

those offering services for patient engagement and information access (California HIE, 2009).

Technical Infrastructure

Develop or facilitate the creation of a statewide technical infrastructure that supports

statewide HIE. While states may prioritize among these HIE services according to its needs, HIE

services to be developed include:

• Electronic eligibility and claims transactions

• Electronic prescribing and refill requests

• Electronic clinical laboratory ordering and results delivery

• Electronic public health reporting (immunizations, notifiable laboratory

results) .

• Develop or facilitate the creation and use of shared directories and

technical services, as applicable for the state’s approach for statewide

HIE(California HIE, 2009).


The 2009 Health Information Technology Act 49

Business and Technical Operations

• Provide technical assistance as needed to HIOs and others developing HIE

capacity within the state,

• Coordinate and align efforts to meet Medicaid and public health requirements for

HIE and evolving meaningful use criteria,

Monitor and plan for remediation of the actual performance of HIE throughout the

state,

• Document how the HIE efforts within the state are enabling meaningful use

(California HIE, 2009).

Legal/Policy

These issues include the identification and harmonization of the federal and state legal

and policy requirements that enable appropriate health information exchange services that will be

developed in the first two years.

Implement enforcement mechanisms that ensure those implementing and maintaining

health information exchange services have appropriate safeguards in place and adhere to legal

and policy requirements that protect health information, thus engendering trust among HIE

participants (California HIE, 2009).

Ensure policies and legal agreements needed to guide technical services prioritized by the

state are implemented and evaluated as a part of annual program evaluation (California HIE,

2009).

To facilitate the implementation of this plan, a variety of multidisciplinary workgroups

have been organized to coordinate the efforts. These include:


The 2009 Health Information Technology Act 50

EHR Loan Programs (LOAN)

The EHR Loan Programs Workgroup seeks ways to provide capital to assist physicians

and hospitals purchase and upgrade certified electronic health records, and train staff and

personnel to become meaningful users of EHRs. They also will investigate how to provide

capital to support the secure exchange of health information. Finally the work group will

develop a business plan, sustainability model, ROI, underwriting and solvency requirements for

the loan fund (E H R Loan, 2009).

Regional Health IT Extension Program (REC)

The REC work group aims to facilitate the purchase and meaningful use of electronic

health records by 85% of physicians and 55% of hospitals including 45% of critical access

hospitals by 2014 to meet Federal goals. It will also identify centers to provide services to

improve healthcare quality, safety and efficiency, including sharing and disseminating best

practices in health IT adoption and use. Finally, it will establish governance, operational,

business, and sustainability models for the REC that will meet the needs of the diverse group of

priority audiences (Regional Health, 2009).

Research And New Technologies (RNT) Workgroup

The RNT workgroup’s overarching goal is to innovate and apply technology to maximize

integration, utilization, effectiveness and efficiency of electronic healthcare information. It will

also seek to maximize the potential for stimulus funding for research meaningful to achieve

California HIT objectives by creating a powerful, broad-based multi-disciplinary consortium.

Finally the workgroup will establish a process for disseminating knowledge, technology,

education and training from Healthcare Information Enterprise Integration Research Consortium
The 2009 Health Information Technology Act 51

(HIEIRC) efforts (Research and New, 2009).

Workforce Training and Development (Workforce)

This work group will develop plans to ensure an ample and adequately trained workforce

exists to support broad dissemination of HIT to improve the quality and safety of healthcare. It

is also charged with the goal of expanding medical health informatics programs for healthcare

and IT students, with a preference for existing programs less than 6 months in length. Finally the

workgroup seeks to maximize federal stimulus funding payments to create and support the HIT

workforce in California (California Workforce, 2009).

Broadband/Telehealth Workgroup

The purpose of this workgroup is to ensure that the State's Health IT and Exchange

Strategic Plan includes the critical issues of Broadband and Telehealth/Telemedicine services in

California (California broadband, 2009).

California Office of HIPAA Implementation

Effective August 1, 2008, the California Office of HIPAA Implementation (CalOHI)

changed its name to the Office of Health Information Integrity (CalOHII). This change was made

to reflect the Office's expanding new role supporting the Health and Human Services Agency’s

health information exchange (HIE) initiatives (California Office, 2209).

California Privacy and Security Advisory Board

The California Privacy and Security Advisory Board (CalPSAB) provides private and

public collaboration to address and coordinate health information exchange (HIE) privacy and

security efforts in California. The CalPSAB's four committees; Privacy, IT Security, Legal, and

Education will analyze issues, develop and evaluate the effectiveness of alternative solutions,
The 2009 Health Information Technology Act 52

and present recommendations to the CalPSAB. The CalPSAB will prioritize the work of the

committees, review and approve their recommendations, and present approved recommendations

for consideration by the Secretary of the California Health and Human Services Agency

(California Privacy, 2009).

CalPSAB Security Committee

The California Privacy and Security Advisory Board (CalPSAB) Security Committee will

develop and propose security standards for the protection of electronically exchanged health

information. The standards will define the level of protection healthcare entities and their

systems that exchange health information will require. The standards will also serve to provide

entities specific and clear guidance on the level of protection necessary for their information

systems that engage in electronic health information exchange. The Security Committee will

also address security practices and functions that may impede the progress of interoperable

electronic health information exchange (California Security, 2009). The Security Committee’s

primary tasks are:

• Examine national security standards promulgated by Standards Development

Organizations (SDOs) applicability to interoperable electronic health information

exchange in California,

• Identify security standards gaps for California not addressed by national

standards,

• Recommend security standards for California to the Privacy & Security Advisory

Board (PSAB), and

• Develop an implementation strategy for the proposed solutions.


The 2009 Health Information Technology Act 53

CalPSAB Privacy Committee

The California Privacy and Security Advisory Board (CalPSAB) Privacy Committee will

establish and maintain patient privacy standards for the exchange of health information

consistent with California and federal laws (California Privacy, 2009).

The California Privacy and Security Advisory Board (CalPSAB) Legal Committee

The Legal Committee is responsible for recommending methods to harmonize applicable

state and federal laws concerning privacy and security standards for the exchange of health

information and to recommend a legal structure to support the protection of individual privacy in

an electronic health exchange. The committee consists of attorneys and other individuals from a

broad spectrum of private and public entities and concerned community members (California

Privacy, 2009).

Education Committee Overview

The California Privacy and Security Advisory Board (CalPSAB) Education Committee

will develop educational strategies for entities engaged in health information exchange (HIE).

Implementation of these strategies will increase understanding of how the standards work and

ultimately increase confidence in the HIE systems. The Committee’s work will provide a

framework for entities to develop their own educational strategies. The Committee will identify

educational opportunities and tools, and determine how to target stakeholder audiences with

specific training communication (Drumm, 2009).

The California Regional Health Information Organization

California Regional Health Information Organization (CalRHIO) is a non profit statewide

organization seeking to create a secure HIE network. It is currently in Phase I of implementation


The 2009 Health Information Technology Act 54

to establish a Statewide Online On Demand Information Service that offers: a master patient

index, record locator service, e-Rx, and a query for medication history. The Service will include

an integration hub that has the ability to translate data across different EHR systems and an EHR

gateway, which will provide physician EHR systems with national lab data. CalRHIO is

collaborating with Hewlett Packard, Medicity, Perot Systems, EHR systems, and most recently

Cisco Systems, in order to build the $300 million structure. CalRHIO anticipates enabling

electronic access for providers and patients to 90 percent of Californians’ health information by

2014.(Wulsin & Doughtery, 2008).

The California HealthCare Foundation (CHCF) has developed ELINCS, an electronic

exchange for patients’ laboratory data, and is encouraging its statewide adoption. CHCF also

offers grants and technical assistance to providers interested in adopting the system.(California

Healthcare Foundation, 2007)

On a local level, several communities around the state are attempting to develop

HIEs for their providers. Specific efforts include the Securing Health Access and Record

Exchange in Mendocino County and the Santa Cruz RHIO. The Santa Barbara County Care Data

Exchange, one of the first and most widely known HIEs in the United States, recently lost

funding from CHCF after eight years of development and was never fully implemented. A

common pitfall of grant-funded systems like the Santa Barbara Exchange is the inability to

become self sustainable within a restricted grant period. Long Beach recently received an HHS

award for an HIE trial called the Long Beach Network for Health (Health Management

Technology, 2009). The initial goal of this program is to link the Emergency Departments of five

Los Angeles metropolitan hospitals and to build a database of patients’ electronic records. Easier
The 2009 Health Information Technology Act 55

access to these hospital records is expected to substantially reduce emergency room wait times

and limit medical errors (California HIE, 2009).

Patient Privacy

State laws cover several areas related to privacy of health information. These include

regulation of health insurance, regulation of organizations that perform certain administrative

functions such as utilization review or third-party administration, licensure requirements for

various medical specialties and medical organizations (including requirements for record-

keeping and disclosure), access to medical records by patients, guardians and other interested

parties, reporting of information to the state and local authorities, for example, birth and death or

disease incidence, use of information for quality assurance and health care operations, issuance

of notices of privacy practices, and reporting and providing access to law enforcement

authorities. In recent years many states have also passed confidentiality laws related to specific

conditions or types of health information. Examples include laws related to mental health

records, HIV/AIDS, reproductive rights and genetic testing (HIMSS,2009).

The HIPAA legislation explicitly addresses interaction between federal and state law.

Generally, "covered entities" are required to comply with both HIPAA and state law whenever

possible. If it is not possible to comply with both, HIPAA preempts any contrary provision of

state law, including state law provisions that require written records rather than electronic ones

(HIPAA, 1996). State law is not preempted in the following circumstances:

• When state law is necessary for regulation of insurance or health plans,


The 2009 Health Information Technology Act 56

• prevention of fraud and abuse, or reporting on health care system operations and

costs,

• When state law addresses controlled substances,

• When a state law relates to reporting of disease or injury, child abuse, birth, or

death, public health surveillance, or public health investigation or intervention,

• When a provision of state law is more stringent than the requirements of the

federal Privacy Rule (HIMSS, 2009).

Medicare-Centers for Medicaid and Medicare Services (CMS)

Medicare is the Federal health insurance program that covers most people age 65 and

older. Some younger people who are disabled or who have End-Stage Renal Disease (permanent

kidney failure) are also eligible for coverage. As the largest purchaser of healthcare in the United

States, there have been numerous calls for Medicare to invest in HIT-EHR. CMS recently

invested $150 million in HIT-EHR demonstration projects, and in June 2008 announced the

selection of twelve community partners to assist in this effort. Over a five-year period, the

project will give bonus payments to as many as 1,200 providers who use CCHIT certified HIT-

EHR products. It will provide financial incentives for improved quality of care through their use

of HIT-EHR. CMS encourages other private and public payers to offer similar financial

incentives. (CMS, 2009).


The 2009 Health Information Technology Act 57

Medicare Incentives for Hospitals

Table 4

Medicare Hospital Incentives


Incentive Payments for a Typical 500 Bed Hospital with
An Average Occupancy Rate of 85%

Payment Incentive per Year 1 Year 2 Year 3 Year 4 Cumulative


Component Unit 100% 75% 50% 25% Total
Base Pay $2,000,000.00 $2,000,000.00 $2,000,000.00
(1st year
only)
Bonus per
d/c 1,150 $200 $4,370,000 $3,227,500 $2,185,000 $1,082,500 $10,865,000
(min)-
23,000(max
TOTAL $6,370,000.00 $3,227,500.00 $2,185,000.00 $1,082,500.00 $12,865,000.00

Incentive payments are provided, beginning with October 2010, for eligible hospitals and

Payment Incentive Year 1 Year 2 Year 3 Year 4 Cumulative


Component Per Unit 100% 75% 50% 25% Total
Base
payment $2,000,000 $2,000,000 $2,000,000
(Year 1 only)
Bonus per
discharge
from $200 $4,370,000 $3,227,500 $2,185,000 $1,082,500 $10,865,000
1,150(min) to
23,000 (max)
discharges

TOTAL 6,370,000 $3,227,500 $2,185,000 $1,082,500 $12,865,000


critical access hospitals (CAHs) that are meaningful EHR users. An eligible hospital that is a
The 2009 Health Information Technology Act 58

meaningful EHR user could receive up to four years of financial incentives payments, beginning

with fiscal year 2011. There will be no payments to hospitals that become meaningful EHR users

after 2015. The incentive payment for each eligible hospital would be calculated based on the

product of (1) an initial amount, (2) the Medicare share, and (3) a transition factor. The initial

amount is the sum of a $2 million base year amount plus a dollar amount based on the number of

discharges for each eligible hospital The Medicare share is a fraction based on estimated

Medicare fee-for-service and managed care inpatient bed days divided by estimated total

inpatient bed-days and modified by charges for charity care (CMS, 2009). The transition factor

phases down the incentive payments over the four-year period.

The factor equals 1 for the first payment year, ¾ for the second payment year, ½ for the

third payment year, and ¼ for the fourth payment year, and zero thereafter. The Secretary has

discretion to use other data if the required data to calculate the incentive payment formula does

not exist.

The transition factor is modified for those eligible hospitals that first become meaningful

EHR users beginning in 2014. Such hospitals would receive payments as if they became

meaningful EHR users beginning in 2013 (for example, if a hospital were to begin EHR

meaningful use in 2014, the transition factor used for the year would be ¾ instead of 1, ½ for the

second year, ¼ for the third year, and zero thereafter ) (CMS, 2009).
The 2009 Health Information Technology Act 59

Table 5

Medicare Hospital Incentives

Incentive Payments for a Typical 100 Bed Hospital with an Average

Occupancy Rate of 50%

Payment Incentive Year 1 Year 2 Year 3 Year 4 Cumulative


Component Per Unit 100% 75% 50% 25% Total
Base payment
(Year 1 only) $2,000,00 $2,000,000 $2,000,000
0
Bonus per
discharge from
1,150(min) to $200 $563,400 $422,550 $281,700 $140,850 $1,408,500
23,000 (max)
discharges

TOTAL $2,563,400 $422,550 $281,700 $140,850 $3,408,500

Market Basket Adjustments for Hospitals that are not Meaningful Users

Eligible hospitals that are not meaningful users for a fiscal year would receive a net reduction of ¼, ½, and ¾ of the

market basket update that would apply in 2015, 2016, 2017 and thereafter, respectively (CMS, 2009). CMS defines a

“Market Basket” as:

“ The market basket is described as a fixed-weight index because it

answers the question of how much more or less it would cost, at a later time, to

purchase the same mix of goods and services that was purchased in a base period.

As such, it measures "pure" price changes only. A market basket is constructed in

three steps. First, a base period is selected and total base period expenditures are

estimated for mutually exclusive and exhaustive spending categories based upon

type of expenditure. Then the proportion for total costs that each spending
The 2009 Health Information Technology Act 60

category represents is determined. These proportions are called cost or

expenditure weights. The second step is to match each expenditure category to an

appropriate price/wage variable, called a price proxy. In the third and final step,

the price level for each spending category price proxy is multiplied by the

expenditure weight for that category. The sum of these products (that is, weights

multiplied by proxied index levels) for all cost categories yields the composite

index level in the market basket in a given year” (CMS, 2009).

Table 6

Loss in Medicare Reimbursement for 500-Bed Hospital that Fails


to Implement a Government-Certified E H R
Year Penalty
2015 $ 966,000.00
2016 $ 2,054,000.00
2017 $ 3,177,000.00

Source: PriceWaterhouseCooper, 2008

The Secretary of HHS may, on a case-by-case basis, exempt a hospital if requiring the

hospital to be a meaningful EHR user would result in a significant hardship Centers for Medicare

(2009).

State Medicaid

Medicaid is a federal/state partnership program that provides health benefits to certain

low-income Americans, including children, their parents, pregnant women, the elderly and

people with disabilities. Over the course of this fiscal year, some 51 million people who would

otherwise not have access to regular health care rely on Medicaid (Centers for Medicare and

Medicaid, 2009).
The 2009 Health Information Technology Act 61

Because Medicaid is a partnership, states and the Federal Government each have a role in

designing and paying for each state's program. While states have some flexibility in determining

what benefits they provide, who will be eligible and how much they will pay health care

providers, they must work within federal guidelines. In turn, the federal government pays a

portion of each state's Medicaid costs. These matching dollars are referred to as Federal Medical

Assistance Percentage (FMAP) payments (CMS, 2009).

The amount of FMAP a state gets is based upon the state's relative wealth, with lower per

capita income states receiving higher FMAP’s. Medicaid funding percentages can range from a

minimum of 50 percent of costs, to as high as 83 percent. (For FY2009, the highest state

matching rate is nearly 76 percent, for Mississippi). FMAP funding is adjusted incrementally

each year based on economic changes in the states, but Congress can increase funding across the

board at any time (CMS, 2009).

As part of the American Recovery and Reinvestment Act of 2009, Congress acted to

temporarily increase FMAP payments for all states during the current recession. Each state will

get a general 6.2 percent increase in its FMAP and States with relatively high growth in

unemployment rates will receive additional increases based on quarterly unemployment statistics

(Centers for Medicare, 2009). Funding increases will be in effect from FY 2009 until the first

quarter of FY 2011.

The Recovery Act establishes 100 percent Federal Financial Participation (FFP) for

States to provide incentive payments to eligible Medicaid providers to purchase, implement, and

operate (including support services and training for staff) certified EHR technology. It also

establishes 90 percent FFP for State administrative expenses related to carrying out this provision
The 2009 Health Information Technology Act 62

(CMS, 2009).

Medicaid Incentive Program Qualifications

Certain classes of Medicaid professionals and hospitals are eligible for incentive

payments to encourage the adoption and use of certified EHR technology. Eligible

professionals include physicians, dentists, certified nurse-midwives, nurse practitioners,

and physician assistants who are practicing in Federally Qualified Health Centers (FQHCs) or

Rural Health Clinics led by a physician assistant (CMS, 2009)

Eligible professionals must meet minimum Medicaid patient volume percentages, and

must waive rights to duplicative Medicare EHR incentive payments. Eligible professionals may

receive up to 85 percent of the net average allowable costs for certified EHR technology,

including support and training (determined on the basis of studies that the Secretary will

undertake), up to a maximum level, and incentive payments are available for no more than a 6-

year period (CMS, 2009).

To be eligible for incentive payments not associated with the initial

adoption/implementation/upgrade of EHR technology, the provider must demonstrate

meaningful use of the EHR technology through a means approved by the State and acceptable to

the Secretary. In determining what is “meaningful use,” a State must ensure that populations

with unique needs, such as children, are addressed. A State may also require providers to report

clinical quality measures as part of the meaningful use demonstration. In addition, to the extent

specified by the Secretary, the EHR technology must be compatible with State or Federal

administrative management systems.


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Table 7

Medicaid Incentives for Hospitals

Example: If E H R Cost = $5,000,000 and Medicaid Patient Volume = 15%

Transition
Year Factor Factor x Cost Total
Year 1 1 1 x $5,000,000 $ 5,000,000.00
Year 2 3/4 3/4 x $5,000,000 $ 3,750,000.00
Year 3 1/2 1/2 x $5,000,000 $ 2,500,000.00
Year 4 1/4 1/4 x $5,000,000 $ 1,250,000.00
Total 4 year sum $ 12,500,000.00

Aggregated payment maximum = Total 4 year sum x Medicaid Share


Medicaid Share= Medicaid Patient Volume

15% x $12,500,000 = $1,875,000.00

50% of aggregatedpayment maximum could be received in one year

OR

90% could be received in a two-year period

10% administrative fee for State match, including tracking of meaningful use
conducting oversight, and pursuing initiatives to encourage adoption.
The 2009 Health Information Technology Act 64

Eligible providers may not receive an incentive under both Medicare and Medicaid in a

given year. CMS and the States will develop means to prevent such duplicate payments. CMS

expects that the prevention of duplicative payments will be addressed more fully through notice

and comment rulemaking (CMS, 2009).

In addition to the incentive opportunities for providers, State Medicaid programs are

eligible for funding to administrate the incentive program. The rules and regulations for meeting

the qualifications for that funding are extensive as well as inordinately detailed. This information

is available for further review on the CMS website (CMS, 2009).

Costs

A 2005 study focuses on the benefits and costs that would accrue to and be sustained as a

result of widespread adoption of HIT. The benefits of health information technology are clear in

theory, but adoption rates lag in the United States, and real statistical results have been limited

(Hilstead, 2005).

Rand researchers Federico Girosi et al., calculated a model which demonstrated a cost of

$98 billion for hospitals based upon a 90 percent national implementation of HIT-EHR over a

fifteen-year period. Using similar extrapolation data, the study estimated that a full-scale hospital

HIT-EHR system would cost between 1.8 percent and 3 percent of total yearly expenditures over

a four-year implementation period. This calculation equates to a national cost of $6.5 billion per

year, or $97.4 billion over a fifteen year time frame (Girosi et al, 2005).

Multiple researchers noted that providers are identified as bearing the majority of the cost

(including the direct software and hardware purchases, expenses associated with implementation,
The 2009 Health Information Technology Act 65

training, maintenance, and productivity recovery), while the insurers and patients reap most of

the financial benefits from HIT-EHR adoption (Argawal, 2002).

An increasing number of studies measure the value and cost effectiveness of CPOE,

EHR, bar coding, e-prescribing and other types of HIT. These reviews tend to focus on patient

safety improvements, financial benefits from quality and efficiency improvements, and the

development of a business case for HIT (Brown, 2005). These types of studies in particular, can

play an important role in supporting the adoption of financial incentive programs. In addition,

they emphasize the misalignment of costs and benefits among individual stakeholders adopting

technology and provide actuarial analyses and evidence for development of a business case and

ROI for HIT. There continues to be minimal information available regarding the real cost of

adoption within with the majority of research. In addition, they tend to use models incorporating

inordinately high (90-100%) implementation by providers within their models (Taylor, 2005).

According to a study by Christopher Conover for the Cato Institute, the cost of health

service regulations dwarf other costs imposed by government intervention in the health care

sector, and cannot be dismissed as a key factor in driving the cost of implementation of a

national electronic infrastructure out of reach for most providers (Conover,2004).

Savings

RAND researchers used empirical evidence to estimate potential cost savings from

implementation of HIT-EHR at a national level. They found an immediate potential savings of

$80 billion (following a hypothetical and optimist overnight 100% adoption rate) with an annual

mean savings of $40 billion over the next fifteen years. In-patient care accounts for roughly three

quarters of the savings These savings are attributable to reductions in length of stay and
The 2009 Health Information Technology Act 66

increased nurse and doctor productivity. These numbers are based exclusively on models built

with projected assumptions by these researchers, and not on any available real time data.

(Hillestad et al., 2005)

The Rand study estimates the healthcare savings through 2016, as a direct result of

increased productivity and compares it to other industries that converted to an electronic system.

Wide-scale HIT-EHR adoption resulting in a productivity improvement of 1.5 percent (similar to

productivity gains from IT investments in retail/wholesale) would result in cumulative spending

decreases in healthcare spending through 2016, of $346 billion. If implementation instead

increased productivity by four percent (equal to half of the telecommunication industry increase),

cumulative healthcare spending through 2016, would decrease by about $813 billion. The

cumulative potential efficiency savings by 2016 would be almost $468 billion for hospital

systems. In light of the high costs attributable to regulatory overlay, these savings seem overly

optimistic (Hillestad et al, 2005).

Benefits

The AHRQ funded a study to systematically review the benefits and costs of HIT-EHR in

order to better provide payers and providers with an understanding of its value. After an

extensive literature search of over 4,000 articles, the study ultimately utilized 257 articles to

determine an analysis of the affects of HIT-EHR implementation (Southern California Evidence,

2006). Southern California Evidence-Based Practice Center highlight five major themes

addressing improvement opportunities in both quality and efficiency. They included:

Quality

• Increased delivery of patient care by physicians that adheres to evidence-based


The 2009 Health Information Technology Act 67

guidelines and protocols, most often as a result of automated reminders and

computerized decision supports,

• Improvements in care in conformity to guidelines ,

• Enhanced capacity of providers and plans to perform surveillance and monitoring

for disease conditions and care delivery,

• Able to assist with identification of adverse drug events, examine their cause, and

develop programs to decrease their frequency ,

• marked decreases in identification time of county-based disease outbreaks (2.5

day decrease) as well as hospital acquired infections (65 percent decrease from

130 hrs to 46 hrs) with HIT-EHR systems,

• Reduction in medical errors.

Benchmark hospitals showed various improvements with HIT-EHR implementation,

including a decrease in the number of antibiotic-associated adverse drug reaction events , a

decrease in hospital lengths-of-stay for these patients and a decrease in hospital costs per patient

from improved medication dosing (prescribed dosing within recommended range, centered on

antibiotics and anticoagulation drugs).

Efficiency

• Reduced utilization of unnecessary care

• Decreases in lab and radiology testing

Other researchers argue that increases in quality of care generally reduce utilization of

services thus benefiting insurers – without an effective payment reward system to physicians and

hospitals, due to a reduction in volume. It is unclear who will ultimately reap the cost savings
The 2009 Health Information Technology Act 68

benefits of HIT-EHR investments: the plan, the providers, or the ultimate payers (government,

employers, and individuals buying coverage (Hackbarth & Milgate, 2005).

HIT is seen by many as a pre requisite to improving quality of healthcare delivery and

containing costs in a $2.4 trillion health care economy. (Acker, 2004). Benefits identified by

other research sources include:

• Reduced medical and medication errors

• elimination of duplicative testing and unnecessary paperwork

• Making the cost and quality of health care services more transparent;

• Access to information;

• View of comparative effectiveness of treatments;

• Elimination of payment for ineffective treatments;

• Improved public health monitoring;

• Improved patient outcomes;

• Decreased emergency department encounters;

• Improve security and privacy;

• Allow providers and patients to make informed decisions;

• Practice evidence based medicine;

• Decreased deaths due to medical errors (Hillestad, 2005)

Research also indicates that implementation will create a more efficient and convenient

delivery of care, without having to wait for the exchange of records or paperwork, and without

requiring unnecessary or repetitive tests or procedures, earlier diagnosis and characterization of

disease, with the potential to thereby improve outcomes and reduce costs and a reduction in
The 2009 Health Information Technology Act 69

adverse events through an improved understanding of each patient’s particular medical history,

potential for drug-drug interactions, or (eventually) enhanced understanding of a patient's

metabolism or even genetic profile and likelihood of a positive or potentially harmful response to

a course of treatment (Goodman, 2001).

Other identified benefits include increased efficiencies related to administrative tasks,

allowing for more interaction with and transfer of information to patients, caregivers, and clinical

care coordinators and monitoring of patient care, increased public health monitoring and disease

management, and improved emergency care (Lohr, 2009).

Research predicts that the major gains from HIT will come from its potential to

effectively exchange health care information. Studies suggest that the overall business case for

HIT depends on the degree to which health data can be efficiently exchanged between different

computer systems. Without this capability, health data cannot follow patients as they obtain care

from different providers. Although broad scale use of HIT applications such as electronic health

records can provide direct benefits such as eliminating illegible handwriting,. EHR adoption

alone won’t ensure that digital health data can be exchanged (Amatayakul, 2005).

A growing body of literature has emerged that is focused on healthcare quality in the US

including the potential of HIT to reduce medical errors, improve patient safety, and improve the

overall quality of care. Many healthcare stakeholders view HIT as an integral part of the quality

movement in this country (Battani, 2009).

Barriers

A variety of barriers to HIT adoption and quality improvements continue to persist in the

health care system including (AHA, 2007).


The 2009 Health Information Technology Act 70

• High HIT implementation costs,

• Physician resistance,

• Technical and infrastructure obstacles.

Table 8

Top Issues C onfronting Hospitals: 2008

ISSUE 2006 2007 2008


Financial C hallenges 72% 70% 77%
Patient Safety and Q uality n/a n/a 43%
C are for the Uninsured 37% 38% 41%
Physician/Hospital relations 40% 35% 32%

Source: American College of Healthcare Executives


respondents: Hospital C EO 's

In addition, a significant increase in regulations, a lack of clarity regarding key issues, and

confusion over ownership of the medical record in a multi-system information exchange network

continue to be viewed as significant concerns and barriers (Beatty, 2009).

The existing fragmented provider system also makes it difficult to implement

comprehensive quality improvements through the use of HIT. For example, over an extended

period of time, patients may use multiple providers or healthcare facilities in a variety of

geographic settings. Unless each provider or facility maintains compatible technologies,

providers and patients are unable to benefit from health information exchange and the resultant

improvements in safety, efficiency, and overall quality of care (Goodman, 2009).

Health care stakeholders are becoming increasingly aware that financial incentives may

help overcome some of these barriers to HIT adoption and promote improvements in quality.

However, despite evidence that is beginning to show a positive correlation between the use of
The 2009 Health Information Technology Act 71

external incentives (for example, bonus payments for improved quality outcomes, direct

compensation for HIT investments) and technology uptake in physicians’ offices (disease

registries, CPOE, e-prescribing), adoption of HIT incentive programs is not yet wide spread

(Hing, 2007).

For some, the investment is not worth the expense. In one survey of healthcare

information technology executives, 20% of respondents cited lack of adequate financial support

as the most significant barrier to successfully implementing information technology at their

organization (California Healthcare 2007).

Physicians are skeptical of the value of EMRs. On the physician and provider side, there

are concerns about how information technology may affect the provider role and the disruption

to their workflow. Other concerns include the increased time needed to enter data and the

potential for a system to have limited usability at the point of care (Tanner, 2005).

Consumers are concerned about security breaches. Ensuring the security and privacy of

EMR systems remains a substantial challenge, one that will be central to continued system

adoption, as there is little doubt that improved system security will help drive automation (Cohen

2008).

Institutions have to make big changes in the way they do business. Transitioning to an

EMR system will require extensive changes in a healthcare organization’s business processes, as

well as in the computer hardware and software needed to support and run the EMR (Taylor,

2005).

Technical issues abound. The proprietary basis of many EMR products raises key issues

regarding the interoperability of systems, including the need for standard underlying reference
The 2009 Health Information Technology Act 72

vocabularies and presentation formats for clinical data. EMR adoption must be able to grow with

the information technology and healthcare environment, including new technologies such as

handheld devices, wireless communications, biometrics, continuous speech recognition, new

imaging techniques, web access, and personal health record support via the Internet (Stead,

2005).

Privacy Concerns

Privacy and security also are constant liabilities in the development of digitalized

personal health information. Shared data must be de-identified and encrypted in transit, then re-

identified for proper use by the receiver. Although information available on a network or

database can be secured, many still fear its vulnerability. Numerous federal and state

organizations are working to develop standards and best practices (AIS, 2009). The Health

Insurance Portability and Accountability Act (HIPAA) plays an important role. HIPAA

Transaction and Code Sets (TCS) standards are the security cornerstone of HIT-EHR systems

(HIPAA, 1996).

A study conducted by researchers at MIT and the University of Virginia, found that EMR

adoption is often slowest in states with strong regulations for safeguarding the privacy of medical

records (Miller, 2007).

On average, the number of hospitals deploying EMR systems is as much as 30% lower in

states where healthcare providers are forced to comply with strong privacy laws than it was in

states with less stringent privacy requirements. The strict privacy rules often make it more

difficult and more expensive for hospitals to exchange and transfer patient information, thereby

reducing the value of an EMR system (Miller & Tucker, 2007):


The 2009 Health Information Technology Act 73

"Despite EMR's effectiveness at reducing medical errors and improving baseline

indicators of patient health, hospitals are deterred from adopting it by strong

health care privacy laws."

The results of the research, which looked at EMR adoption in 19 states over a 10-year

period, suggests that there's a trade-off between achieving fast adoption of EMR technology and

strong health care privacy laws. "Policy-makers are going to have to choose how much EMR

adoption they want and at what cost to patient privacy" (Tucker, 2007).

Among the welcomed provisions in the ARRA, are those that require health care

organizations and professionals to implement better controls over who can access and share

different categories of medical information. Also seen as long overdue is a provision that

prohibits health care providers from selling protected health information in electronic medical

records and imposes limitations on the marketing of such data. Such requirements have been

considered long overdue in the health care sector. "However, if the end result of Obama's new

privacy legislation is to add extra layers of complexity and necessitate hospital-specific

customization of privacy filters, then there is the potential for there to be a negative effect,"

(Tucker, 2007)..

If a state law allows only specific groups of people within an organization to access

specific kinds of medical information, a hospital might need to implement filters and access

controls to comply with the requirement. This customization can greatly add to the cost of

implementation, often resulting in slower adoption of an EMR (American College, 2009).


The 2009 Health Information Technology Act 74

CHAPTER 3

RESEARCH METHODOLOGY

Grounded Theory Model

The design of this research was qualitative using the Grounded Theory Model. Grounded

theory is a strategy of inquiry in which the researcher derives a general, abstract theory of a

process, action, or interaction grounded in the views of participants. (Cresswell, 2009) This

model uses multiple stages of data collection. Data collection for this study, included surveys

submitted to Hospital Executives and a comprehensive review of the applicable literature.

This research method operates in a reverse fashion from traditional research. In lieu of

beginning by researching and developing a hypothesis, the first step is data collection, through a

variety of methods. From the data collected, the key points are marked with a series of codes,

which are extracted from the text. The codes are grouped into similar concepts in order to make

them more workable. From these concepts, categories are formed, which are the basis for the

creation of a theory.(Denzin, 1994). This contradicts the traditional model of research, where the

researcher chooses a theoretical framework, and only then applies this model to the study.

Grounded theory research looks for meaning and understanding to build an innovative

model. Data collection and sources are directed by the findings of the analyzed data, rather then

by specification prior to collecting data. The process involves a three part coding strategy:

1. Open Coding-the data is broken down and clustered into descriptive categories.
The 2009 Health Information Technology Act 75

2. Axial Coding: The descriptive categories identified in the open coding phase are

re-evaluated for their relationships

3. Selective Coding: Categories gradually evolve into a more specific order. (Glaser,

1995).

The model can best be further clarified by the words:

GROUNDED: Rooted in behavior, words and actions of those under study

THEORY: A relationship model that usefully and pragmatically links diverse facts ( the

connection must represent the best fit with the data )

The theory must ultimately meet three criteria: it must (1) fit, (2) be relevant and (3)

adaptable (Strauss, 1990).

1. Fitness is defined as follows:

The categories (elements) of the theory must (1) fit the data, the data can

not be forced in to pre-existing categories and the categories must emerge

from the data and be modified by the data

2. The theory must be relevant. This is defined as follows:

A theory should be able to explain what happened, predict what will happen

and interpret what is happening

3. Finally the theory must be adaptable-

which means it must be modifiable based on new data..

Theoretical sampling is an active process in which discoveries (made during data

gathering, observation, and literature review) direct the researcher to the next area of inquiry or

potential data source. Glaser explains theoretical sampling:


The 2009 Health Information Technology Act 76

“Theoretical sampling is the process of data collection for generating theory whereby the analyst

jointly collects, codes, and analyzes his data and decides what data to collect next and where to

find them, in order to develop his theory as it emerges. This process of data collection is

controlled by the emerging theory. The initial decisions are not based on a preconceived

theoretical framework”. (Glasser & Strauss, 1967)

Data Sources

Study Population

Hospital Chief Executive Officers were chosen as the subjects to be queried via a survey.

This level of leadership was selected due to their position within the organizational structure.

Traditionally, the final decision making process (for example, whether the organization should

purchase an electronic medical record) traditionally resides at this leadership level. Chief

Executive Officers are in a unique position that requires an objective review and oversight of key

findings and information to insure they guide their organization in the best direction while

remaining compliant with regulatory issues.

The survey included six questions related to demographic information. The purpose of

these questions was to validate the diversity of responses. The candidates were chosen through

“purposeful sampling.” “Purposeful sampling is a method of selecting participants for the study

who are identified as being expert informants who can help the researcher best understand the

research question” (Creswell, 2009). The sample size was determined as a result of the nature of

the grounded theory method, which does not require a large subject sample in order to generate a

theory. The subjects’ ages ranged from 40 to over 60. There were 29% female and 71% male

subjects.
The 2009 Health Information Technology Act 77

• All survey candidates were advised that their responses would remain

confidential.

• Subjects who participated were chosen when they responded to the survey.

• The subjects were either known to the researcher, or were recommended by peers

within the health care industry.

• Those subjects who responded self-reported that they matched the inclusion

criteria.

• Subjects work in the hospital setting, holding the position of Chief Executive

Officer.

• Demographic location of participants is varied.

Confidentiality was maintained by the researcher on behalf of the respondents. All

responses to the survey questions were received directly by the researcher without any personal

identifying information. This was accomplished by sending the survey via U.S. mail, with a

return self addressed envelope enclosed. The survey did not request the name of the respondent

or the name of the facility that employs them.

Consideration with respect to word choice was reviewed to insure that questions were

unambiguous and that respondents were able to read the questions smoothly. The length of the

survey was kept to a minimum to insure that respondents were able to complete their responses

as quickly as possible. Questions were developed to insure a clear response as well as to insure

that there was no implication of bias in the data gathering process. The questions were designed

to focus on formulating and categorizing key research questions regarding the perception of the

government’s role in the implementation of an electronic medical record and the value of the
The 2009 Health Information Technology Act 78

proposed stimulus dollars available to hospitals.

The design of the survey was based on findings identified in the literature review. The

survey was developed within the context of achieving my research goals. In keeping with that

goal, the survey addressed the following:

• Demographic information

• Perceived benefits of the stimulus dollars for implementation of an electronic

medical record

• Perceived role of the government in regulating healthcare delivery.

Literature Review

Literature pertinent to the emerging themes in the qualitative data ( for example,

government regulation of electronic medical records and related fields) was sampled, as well.

The “traditional” literature review that is typical of health services research papers becomes a

part of the data collection in a grounded theory study. This approach is valuable to the generation

of theory because it “…transcends, organizes, and synthesizes large numbers of existing studies”

(Glaser, 1992,p. 34). In addition, grounded theorists recommend distancing oneself from

predefined problems and concerns found in the literature when beginning a grounded theory

study (Glaser, 1998). Although it is important to know the literature well enough to define a

research question, a researcher must maintain openness throughout the data gathering phase of

the research study.

Grounded theory research contrasts with quantitative inquiries in that there is no review

of the literature in the area of the study before data collection. The rationale for this argument is

to avoid biasing the investigators’ attempts to develop concepts and ideas from the data that
The 2009 Health Information Technology Act 79

actually fit the data. Selective sampling of the literature is recommended and generally follows

or takes place concurrently with data analysis. As theory begins to emerge, researchers carry out

a literature review to learn what has been published about the emerging concepts (Creswell,

2009).

Data Collection

The data collection was separated into three parts. The first was a comprehensive review

of the literature related to all components of the ARRA and its anticipated impact on the

implementation of an electronic medical record in the hospital setting. This was conducted via

open coding. This form identifies concepts and theories, allowing for an identification of key

issues.

The next form of data collection was through the development of a survey to be

submitted to hospital chief executive officers. This survey was developed based upon axial

coding of the issues and theories that were identified in the literature review. The questions were

close ended. Surveys were distributed to Hospital Chief Executive Officers, due to their

leadership and decision making role in the hospital setting. Each subject was asked to respond to

a series of questions concerning the government's role in the implementation and development of

the electronic medical record.

The first section of the survey included demographic information: age, number of years

in the field, the tax status of their facility, and the current status of their healthcare organization

with respect to implementation of an electronic medical record. There were six questions related

to demographic information.

The second part of the survey included specific questions that were developed as an
The 2009 Health Information Technology Act 80

outcome of the literature review. These questions emerged from the readings in the literature as

well as the open coding model. The survey was submitted to the Mount St. Mary’s College

Internal Review Board, and was identified as ‘exempt’ (Appendix G).

The researcher developed a set of initial questions which were then discussed and refined

by the thesis advisor. The responses to the survey were reviewed and prioritized based upon a

statistical review of the responses

Data Analysis

Building a theory from data using the grounded theory method includes a tactic proposed

by Glaser and Strauss (Glaser, 1967) called the Constant Comparative Method. This is a process

in which data is “broken down, conceptualized, and put back together in new ways” (Strauss &

Corbin, 1990b, p. 57). The literature was initially reviewed using open coding. This method

involves identifying, naming, categorizing and describing phenomena found in the text.

Essentially, each line, sentence and paragraph is read with an intent to answer the repeated

question “what is this about?”

The initial review of the literature resulted in the identification of basic categories. This

was accomplished by identifying topics, key phrases and concept, giving each distinct idea or

incident a name. All similar ideas or incidents were given the same name as every concept was

categorized into an exclusive and distinct group. The analysis of the text from the survey

responses will be compared until a consistent number of categories emerge.

After the initial concepts were discovered and categorized, the second level of analysis,

known as axial coding, was used to determine the relationship between categories and the

conditions that gave rise to it. The topic study is traditionally identified through this form of
The 2009 Health Information Technology Act 81

coding (Creswell, 2009). It provides for an opportunity to obtain a deeper understanding of the

representative subjects by researching them in detail. This is traditionally a basic framework of

generic relationships. Finally, selective coding is used. This allows the researcher to analyze the

results to identify and draw conclusions based upon the information gleaned (Denzin, 1994).

Some of the tools that were used to aid in this process were 3” by 5” lined index cards, a

number of different colored highlight pens, post-it-notes and a memo process to differentiate the

concepts. Survey results were put into an excel spreadsheet, with the responses calculated

statistically to identify trends. A theoretical notation process was used which utilizes a post- it-

note to identify anything found in the text or codes that relates to the literature. The final theory

and conclusion is essentially the integration of all these data elements.


The 2009 Health Information Technology Act 82

Chapter 4

Analysis

This purpose of this study of the 2009 Health Information Technology Act is to determine

if the incentives are perceived as intrusive or manipulative to health care provider’s business

decisions or a correction of a reimbursement anomaly that is welcomed as an opportunity to

modernize their information management systems and transform the care they deliver.

Literature Coding Results

The open coding of the literature revealed the following topics and categories:
Table 9
Literature Review Open Coding Model

Identified Topics

Barriers Cost Implementation

Basics Definition Privacy

Benefits Impact of Stimulus Regulations

Standards Status Status in Hospitals

Strategy Timing Stimulating Adoption

Source: Appendix B
The 2009 Health Information Technology Act 83

Survey Results

The identified theories and topics revealed by the literature were used to develop the

survey questions. Closed- ended questions were used in the survey. Closed-ended questions

have a finite set of answers from which the respondent chooses. The benefit of closed-ended

questions is that they are easy to standardize and data gathered lends itself to statistical analysis.

Closed-ended questions also allow the respondent to complete the survey quickly which insured

that the imposition was kept to a minimum. The closed ended questions used on the survey and

the responses received were as follows:

Table 10

Excessive government regulations have created a formidable barrier


for healthcare organizations and providers to treat patients

Strongly Agree 43%

Agree 53%

Strongly Disagree 4%

96% of the responses to this survey question affirmed that government regulations in

place today create barriers for hospitals to treat their patients. This question validates the degree

to which hospital leadership perceives the regulations as a negative burden in the delivery of
The 2009 Health Information Technology Act 84

patient care. Health care organizations must provide services to patients while remaining

compliant with a vast array of regulations. In addition, they are focused on improving efficiency

and reducing costs while insuring they meet all of the regulatory standards. Healthcare

organizations must be engaged in strategic thinking about how they will be positioned to meet

the requirements and regulations within a changing and complex landscape.

Table 11

The ARRA adds increased layers of bureaucratic regulation and cost to


an industry that is already over-regulated and suffering a severe economic crisis

Strongly Agree 30%

Agree 66%

Strongly Disagree 4%

Ninety Six percent of respondents agreed that the ARRA adds even more layers of

bureaucratic regulations and costs. This is a significant concern during the current economic

recession which is creating financial challenges for hospitals. Although historically hospitals

have been recession proof, this is not the case in 2009. This is due primarily to the downturn in

the market and the adverse impact on hospital’s bond ratings and borrowing capacity. The
The 2009 Health Information Technology Act 85

recession has caused decreased operating margins, decreases in cash, declines in patient revenues

and investment loses. The cost for hospital’s to meet regulatory requirements is significant. The

goals outlined in the ARRA will add additional expense to hospitals as they work toward meeting

the new regulations.

Table 12

Implementation of a “certified” electronic record within the time frame identified


in the ARRA will ultimately benefit the financial health of our organization

Strongly Agree 33%

Agree 57%

Strongly Disagree 10%

Although the legal definition of a “certified” electronic medical record is not yet

complete, 91% of the respondents agree that implementation of an electronic medical record

within the required time frame will benefit their financial health. This is a valid answer given the

financial incentives ($2 Million for base year, and up to $12 million based upon individual

facility Medicare patient volumes). In addition, failure to complete the implementation within

that time frame will result in financial penalties of up to $3 million per year by 2015.

Organizations that treat Medicare and / or Medicaid patients that are not compliant will suffer
The 2009 Health Information Technology Act 86

financial penalties. In general, hospitals face financial gain through incentive payments, but face

a significant negative impact on their financial health through penalties should they fail to meet

the required deadlines. Regardless of the ultimate components identified within certification, it is

in the financial best interest of all health care organizations to meet the deadlines.

Table 13
Identification of required standards for all aspects of the electronic
Health care record should be the responsibility of the federal government.

Strongly Agree 14%


Agree 52%
Strongly Disagree 34%

The information architecture that has been outlined as a goal in ARRA is to facilitate the

sharing of patient information among providers, payers and others. The federal government

foresees a national health information network consisting of regional health information

organizations that freely exchange information. The ability to meet this goal requires

standardized code sets . 68% of the respondents to this survey believe this should be done at the

Federal Government level. This will ultimately need to be recognized by non-government payers

as well, which would in all likelihood require further federal legislation. Organizations that have

a system in place may be in a vulnerable position if their existing system does not meet these

requirements, which have not yet been defined.


The 2009 Health Information Technology Act 87

Table 14
Uniform standards defining clinical care protocols should become a
national model identified by the federal government as a component of the
“certified” electronic medical record.

Strongly Agree 24%


Agree 52%
Strongly Disagree 24%

Clinical Protocols are a series of action items for a particular patient based explicitly upon

that patient’s medical record. Clinical Protocols are sometimes referred to as treatment guidelines

and are based upon accepted standards of care. The protocols typically are displayed to a

physician during the charting process within the EMR and optimally offer a physician the choice

between applicable options or may identify an alert based upon the patient’s condition. The use

of standardized protocols will reduce medical risks and afford much better care for patients.

When these standards are designed correctly, it affords the physician a tremendous edge when it

comes to patient care. It improves the quality of care and minimizes errors.

In the past, historical knowledge was passed on through experience and hands-on training

in medical education programs. Today evidence-based decision support, high quality literature

studies and clinical practice guidelines are seen as the most comprehensive method to

disseminate information. Physicians in general prefer not to use this type of a template, and there

remains much controversy over which clinical standards should be certified, and who should be

responsible for the selection of the applicable criteria.


The 2009 Health Information Technology Act 88

Eighty-one percent of the respondents indicated that the uniform clinical model should be

specified by the Federal Government. Opponents believe that the standards should be designed

by clinical care givers based on research outcomes and accepted standards of practice within

each medical sub-specialty. The Federal Government will spend $1.1 Billion to create the

Federal Coordinating Council for Comparative Effectiveness Research. This council will

provide advice to the federal government about the value of various medical treatments.

According to the summary featured in a discussion draft to the bill,” interventions that are found

to be less effective and in some cases more expensive will no longer be prescribed.” (Tanner,

2009). The HHS website further identifies the roll of this council:

“Comparative effectiveness research provides information on the relative


strengths and weakness of various medical interventions. Such research will give
clinicians and patients valid information to make decisions that will improve the
performance of the U.S. health care system”

The responses were evenly balanced between Strongly Agree (24%) and Strongly

Disagree (24 % ). The varied responses may be reflective of either the lack of specific

knowledge regarding the requirements for an electronic medical record, or the preference to

provide a standardized framework for the delivery of care. There is a significant level of concern

among healthcare providers that relying on the government to identify these standards puts the

decisions into a strictly financially driven model, rather than a utilizing the results from strong

methodologies identified through the analysis of medical evidence research and clinical trials.
The 2009 Health Information Technology Act 89

Table 15:

The ARRA is in reality the outline for total government control of the
Health care delivery system in the United States.

Strongly Agree 14%


Agree 34%
Strongly Disagree 52%

52% of the responses strongly disagreed with this statement that the purpose of

the ARRA is an outline for total government control of healthcare. The response is inconsistent

with the answers outlined in Table 10 and 11 in which hospital leadership see government

regulations as excessive and that the ARRA adds increased layers of bureaucratic regulations.

Based upon the current heavily regulated healthcare environment, coupled with a lack of clarity

on many of the requirements, my expectation would have been a marked increase in strongly

agree responses.

Table 16
The stimulus money outlined in ARRA is a benefit that has caused us
to implement an electronic healthcare system in a shorter time frame than
originally planned,.

Strongly Agree 28%


Agree 52%
Strongly Disagree 20%
The 2009 Health Information Technology Act 90

81% indicated that they initiated their E H R process in a shorter time frame due

to the financial incentives outlined in the incentive package. In light of the amounts available to

hospitals, I would expect this to be 100% strongly agreed, however the receipt of the incentive

dollars does not necessarily align with the financial outlay required to install a system. Access to

capital may still be a reason for delay, as well as some of the more common barriers to

implementation which are identified in Table 8.

Table 17
The government requirements and regulations outlined for a “certified”
EMR are appropriate

Strongly Agree 24%


Agree 57%
Strongly Disagree 19%

The regulations continue to change and are not yet finalized. It is anticipated that the

published criteria will be further adjusted to meet the final 2011 “meaningful use” objectives

required by the U.S. Dept of Health and Human Services to qualify for ARRA funding. Many of

the E H Rs in place today may not meet those requirements. At present there are approximately

17 in-patient hospital electronic medical record systems that are certified ( see Appendix F). The

current criteria includes:


The 2009 Health Information Technology Act 91

(A) includes patient demographic and clinical health information, such as medical

history and problem lists; and

B) has the capacity—

(i) to provide clinical decision support;

(ii) to support physician order entry;

(iii) to capture and query information relevant to health care quality; and

(iv) to exchange electronic health information with, and integrate such

information from other sources.

81% of the respondents to this question agreed that the requirements for achieving

“certification” of their electronic medical records by the Federal Government are appropriate.

Table 18
The increased regulatory agencies required to implement and monitor
the HIT initiatives add layers of unnecessary government expense

Strongly Agree 33%


Agree 57%
Strongly Disagree 10%

A significant component of the funds assigned to ARRA for electronic medical records

is to support various regulatory agency activity. Ninety percent of responses indicated that this

funding represents unnecessary spending. The amount of monies allocated to regulatory


The 2009 Health Information Technology Act 92

agencies is of concern in light of the current economic recession, coupled with the

overwhelming pressure on healthcare organizations to decrease the cost of care to provide

treatment to their patients.

Table 19
E H R will make it easier for organizations to be compliant with the new
security and privacy regulations.

Strongly Agree 33%


Agree 57%
Strongly Disagree 10%

The new privacy and security regulations will add significant administrative requirements

to hospital organizations. In addition to traditional patient privacy requirements, they will now

need to track and record all types of entities that access a patient record. This includes users that

are allowed to access the record under existing laws. This is an extraordinary burden that would

not be possible without an electronic system. In light of the changes to these laws, the response

of 90% to the question is appropriate. Electronic records will allow organizations to more readily

establish tracking systems to monitor all access to records.


The 2009 Health Information Technology Act 93

Table 20
Linking the patient healthcare records of our organization into a
regional or national database will adversely impact the financial health of our
organization through decreased reimbursement

Strongly Agree 10%


Agree 43%
Strongly Disagree 47%

The ability to link health care records into any type of a national database does not yet

exist. Studies show that improving documentation, which is driven by standards built within an

electronic medical record, increase reimbursement. In addition, decreasing unnecessary tests,

which is filtered through the clinical standards defined within the electronic medical record,

decreases costs. Whether linking of the patient records in a national database will impact

reimbursement, is not known. Studies indicate that utilization of an electronic medical record

increases reimbursement for hospitals. Although 53% of the respondents agreed that they

anticipated decreased reimbursement, in general they may not be familiar with this detail. This is

a potential limitation of the study.


The 2009 Health Information Technology Act 94

Table 21
Government penalties for failing to implement an electronic health
record that meets all the requirements by 2015 is not realistic.

Strongly Agree 33%


Agree 43%
Strongly Disagree 24%

Transitioning to an electronic medical record system that meets all the requirements is not

an application that can be purchased off the shelf and installed immediately. This is an

inordinately difficult process for any healthcare organization. The benefits and barriers have been

previously identified. Although the objective is appropriate, the vast number of hospital systems

that are not utilizing electronic medical record systems further impacts the ability of the industry

to meet the goals and deadlines identified in this time frame. This coupled with the number of

“certified” systems and the ability of those vendors to provide the requisite goods and services

will also contribute toward the success of meeting the goals.

76% of the respondents to the survey question agreed that the deadline was not realistic.

Demographics

The demographics of the hospital CEO’s that participated were as follows:


The 2009 Health Information Technology Act 95

Table 22
Respondent Location:

California 61% Illinois 5%

Nevada 9% Arizona 5%

Illinois 5% Tennessee 5%

Arizona 5% Washing 5%

The majority of respondents reside in California. California healthcare is burdened by

additional regulations due to the bipartisan nature of the state legislature. In light of their
typically larger portion of government payer case mix the response rate is somewhat indicative
of that dependence.

Table 23
Number of years in this occupation:

Less than 1 5% 6-10 Years 4%

16-20 years 5% Greater than 20 years 86%


The 2009 Health Information Technology Act 96

The majority of respondents have extensive experience in the healthcare industry which

is expected given the qualifications required for this position. The lengthy tenure in this industry

has exposed them to multiple economic downturns as well as participating in an industry that

has undergone significant changes due to technology. Their experience is significant with respect

to knowledge of the industry.

Table 24

Respondents Gender

Female 29%

Male 71%

Although 78% of the workforce in health care is women they remain under representing

in executive leadership positions. The gender breakdown for this survey is higher than national

estimates, which report that 12% of hospital chief executive officers are women.

Table 25

Respondent Age Range

41.50 14%

51-60 62%

Greater than 60 24%


The 2009 Health Information Technology Act 97

The age range is expected given the number of years of experience in the industry
identified by the prior question.

Table 26

Healthcare Organization’s Tax Status of Respondents

Not for Profit 100%

In light of the increased regulatory reporting requirements for non profit organizations, I
would have expected a stronger level of concern from these respondents regarding the question
that the ARRA is an opportunity for the Federal Government to take ownership of the healthcare
system. The response to many of the questions in light of their tax status is all the more
interesting.

Table 27

Has your organization implemented an electronic medical record?

Yes we are preparing now 31%

We’re in the process of implementing 48%

Yes we have a system in place that meets the 21%

Guidelines outlined in the ARRA

All respondents have chosen to implement an electronic medical record.


The 2009 Health Information Technology Act 98

CHAPTER 5

CONCLUSION

The ARRA introduces much needed financial incentives for implementing an electronic

medical record, but it also adds significant regulatory requirements, as well as extends the

oversight of the government into new areas of the healthcare delivery system. Although the

incentive payments will not match the costs, hospitals will adopt the required technology to

maintain their financial health. This is primarily the result of the anticipated penalties outlined

for organizations that do not implement a certified E H R within the required time frame.

Within a grounded theory study, theory is shaped by the data as the information is

analyzed and categorized. The intent of modeling the data sources is to identify a theory or

result. To return to the initial questions stated previously for this study, “ will the advantage of

accessing the stimulus money be perceived as a true benefit, or will the increased regulations for

health care providers be another barrier that prevents adoption?” All respondents indicated that

they agreed that excessive government regulations have created a formidable barrier for their

organization and their ability to treat patients. In addition, they agreed that the increased

regulatory agencies required to implement and monitor the HIT initiatives add layers of

unnecessary government expense.

Based upon the results of the study, the perception of hospital leaders is that the stimulus

money is a true benefit. For a facility that treats Medicare and Medicaid patients,

implementation of an electronic medical record is essentially a financial requirement due to the


The 2009 Health Information Technology Act 99

anticipated monetary penalties. The dependence upon Government reimbursement is a key

driver of behavior, as hospital leadership insures that the appropriate infrastructure is in place to

provide services to this patient population The stimulus monies motivated 81% of the

respondents to implement EHRs in a shorter time frame- but was not the reason for the

implementation. The perception of hospital leadership is that the incentive payments are a

welcome benefit.

An additional purpose of the study was to determine if the perception of hospital leaders

was that the goal of the stimulus plan is in reality an attempt by the federal government to

increase their control over health care services. In spite of the agreement by respondents that the

ARRA adds increased regulation to an already over-burdened system (96%), the majority (81%)

agreed that the requirements and regulations outlined for a “certified” E M R are appropriate

In addition, 66% indicated that identification of required standards should be the

responsibility of the federal government, while 81% also agreed that the federal government

should also be responsible for defining the clinical care protocols of an electronic record. In

addition, the perception of the respondents is that the ARRA is not an outline for increased

government control of healthcare.

The establishment of clinical care standards is a contentious issue between providers and

payers. One argument is that standards cannot be defined because each patient is unique, the

variables are often complex and that the deductive reasoning and creative process leads to a

successful diagnosis and treatment. On the other side, formal standards define a set of

expectations that are known in advance. This standardized road map reduces liability and cost.

To date the development of clinical standards has not been widely defined, and is currently based
The 2009 Health Information Technology Act 100

upon the choices of individual providers or healthcare organizations. Physician groups contend

that the standards should not be defined by any payer, government or otherwise. This is due to a

concern that standards will be financially driven in lieu of appropriate clinical methodologies

based upon evidence based research. The respondents had previously agreed that health care is

over regulated, and yet the majority also agrees that this additional task should be added to the

list of regulatory activities.

Finally, regarding their perception that the ARRA is in reality the outline for total

government control of the healthcare delivery system in the United States, only 14% strongly

agreed, 38% agreed, and 52% disagreed strongly with that statement. The response to this

question is in contrast to the overall general ratings of the other questions. The increased

regulations and additional expense allotted to new regulatory agencies would seem to indicate

that the Federal Government is usurping additional control over the healthcare delivery system.

The American Recovery and Reinvestment Act of 2009 contains 407 pages of rules,

regulations, and restrictions and increased government spending. The stated intent is to:

Make supplemental appropriations for job preservation and creation, infrastructure

investment, energy efficiency and science, assistance to the unemployed, and

State and local fiscal stabilization, for the fiscal year ending September 30,

2009, and for other purposes.(ARRA,2009)

Is the goal of the healthcare portion of the stimulus plan intended to simply motivate

healthcare organizations and providers to transition to an electronic record or is it the beginning

of government run healthcare services? The perception of healthcare leaders is that the plan is as

stated, a motivator for health care organizations to transition to an electronic healthcare system
The 2009 Health Information Technology Act 101

that is defined by the Federal Government, but not controlled by the Federal Government.

Medicare and Medicaid represent approximately 60% of the patient population receiving

services in U.S. hospitals. These organizations impose a financial burden placed on healthcare

organizations to meet the regulatory requirements coupled with a disparity in payment amounts

that rarely covers the cost of care continues to grow.

Healthcare is one of America’s most controlled and socialized industries. The

benchmarks and goals used to measure the effectiveness of a Hospital Chief Executive Officer

continues to change on a continuous basis. The identification of very specific standards,

electronic and clinical, provide hospital leaders with a very clear black and white roadmap. This

format will allow them to more clearly identify which services they will get paid for, how much

they will get paid, and what the requirements are. Although this view is contrary to that of other

stakeholders, the identified perception of hospital Chief Executive Officers aligns with their role

within the organization and provides them with an opportunity to improve their leadership role

within a complex industry.

Recommendations for Additional Research

Discussions of healthcare costs traditionally place the blame on the shoulders of those

that provide care. In reality the cost of health services regulation outweigh the benefits by two-

to-one and cost the average household over $1,500.00 per year (Conover, 2004). These estimates

are based upon regulations in place prior to those identified in this study.

The current administration has determined that adding additional regulations and

regulatory agencies will provide the assistance necessary to dramatically reduce the financial

cost of healthcare. Today Americans are debating whether we ought to continue with a policy of
The 2009 Health Information Technology Act 102

greater government control over health care decisions, or should the control be returned back to

the consumer. At present, whoever controls the health care dollars will ultimately make the key

health care decisions. The government spends almost 50 cents out of every health care dollar

(Goodman, 2009). The concentration of economic power in healthcare resides with the

government. Historically, government-funded health care has resulted in increased administrative

cost to providers, and a rationing of care to patients.

The incentives are sending the wrong message as are the potential penalties. The high

cost of health services regulation is responsible for more than seven million Americans lacking

health insurance (Conover, 2004). The focus should be on reduction of government agencies and

spending with respect to the elimination of excess cost of healthcare services at the State and

Federal level. This housecleaning and intensive review of monetary waste should be an urgent

priority for policymakers.


The 2009 Health Information Technology Act 103

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APPENDIX A
The 2009 Health Information Technology Act 124

Appendix B

Literature Review: Models and Theories Using Open Coding Model

Theory/Topic Discussion Source


ARRA Overview of the American AHRQ 2009
Recovery and Reinvestment Act
Barriers Increased concerns by physicians American College of Foot and
regarding implementation of an Ankle Surgeons
electronic medical record system
Barriers Discussion of the improvement to Brown,Bailey & Miller, 2005
patient safety that will be gained
through information technology
Barriers Review of key questions regarding Tanner, 2005
the current healthcare reform
Barriers review of risks, barriers and Thakkar, 2006
benefits of implementing an HER
in a hospital
Basics HIT basic information Wulsin, 2008
Benefits Best practices in health records Amatayakul & Work, 2005
Benefits Look at the future of electronic AHIMA, 2003
records
Benefits review of reality vs. the promises Goodman, 2009
made regarding the value of an
EMR
Benefits review of innovative options Lohr, 2009
Cost review of the over-regulation of Conover, 2004
healthcare and the enormous cost
to the entire system for supporting
all the agencies
Costs Review of modeling to identify Rand study, 2005
savings and costs of an EMR
Costs costs, benefits analysis using a Hillestad et al, 2005
modeling system to identify impact
on an EMR
Costs Report reviewing the financial Rand study, 2005
advantages to HIT
Definition Review of a conceptual model for Asp, Lone, Peters, 2003
clinical documentation and an
electronic health record
Impact of Stimulus review of the stimulus and the Goldstiein, 2009
increase in hospital
implementations of EHRs
The 2009 Health Information Technology Act 125

Implementation Review of Kaiser experience with Garrido et al , 2004


implementing a fully integrated
EMR throughout their system
Implementation Current status of utilization of Jha, 2009
EMRs in US hospitals
Implementation review of stimulus package for Lieberman, 2009
health care
Privacy Concern that the new stimulus Brailer, 2009
package could impinge on
Americans' health privacy
Privacy discussion regarding the Cohen, 2008
availability of private health details
to online users
Privacy will electronic records make it Healy, 2009
easier to insure privacy of our
records, or will they be less safe?
Privacy Review of privacy concerns and Healy, 2009
electronic medical records
Privacy Report identifying the concern of Uhruh, 2009
placing full access to medical
records in the hands of the
government
Regulations Compliance risk review of an AIS Compliance
electronic medical record system
Regulations Review of Medicaid regulations Binder & Grady 2009
impacted by the ARRA
Regulations review of applicable regulations Centers for Disease Control,
2007
Regulations requirements for use of health Centers for Medicare and
information technology and Medicaid Services, 2009
stimulus monies available by
meeting requirements
Regulations review of Title IV requirements as CMS, 2009
outlined by Medicare and Medicaid
Regulations Overview of the ARRA Department of Health and
implementation plan Human Services, 2009
Regulations Review of all the new regulations Federal HIT Committee, 2009
Regulations review of meaningful use and HIMSS, 2009
certification criteria
Regulations review of the "required" elements Price Waterhouse Coopers,
and the financial impact on 2009
hospitals that choose not to
implement an EMR
Regulations should government become more Taylor et al, 2005
aggressive in promoting HIT?
Standards review of appropriate methods for California Healthcare
identification of standards in the foundation, 2007
electronic record
The 2009 Health Information Technology Act 126

Theory/Topic Discussion Source

Status Annual report of the US Hospital IT HIMSS, 2007


Market

Status A look at the future of healthcare in Battani & Zywiak, 2009


the year 2015

Status of Review of the progress of hospital AMA, 2007


implementation in use of information technology
hospitals
Stimulating adoption Discussion of the barriers and the Blumenthal, 2009
value of pro-actively implementing
an E H R
Strategy review of a strategy for Catholic Healthcare West, 2009
implementation of a clinical
information system within a large
healthcare network
Timing Recommendation that it's time for Bass & Johnson, 2008
hospitals to act quickly to
implement an electronic record
The 2009 Health Information Technology Act 127

APPENDIX C

Title 42 Federal Public Health Regulations

SUBCHAPTER A--GENERAL PROVISIONS


Claims Collection and Compromise
CIVIL MONEY PENALTIES, ASSESSMENTS, AND EXCLUSIONS
CIVIL MONEY PENALTIES AND ASSESSMENTS
EXCLUSIONS

PART 403—SPEPECIAL PROGRAMS AND PROJOECTS


State Regulatory Programs
Voluntary Certification Program: General Provisions
Recognition of State Reimbursement Control Systems
Religious Nonmedical Health Care Institutions-Benefits, Conditions of Participation and Payment
Medicare Prescription Drug Discount Card and Transitional Assistance Program
Medical Services Coverage Decisions That Relate to Health Care Technology
Suspension of Payment, Recovery of Overpayments, and Repayment of Scholarships and loans
Suspension and Recoupment of Payment to Providers and Suppliers and Collection
Private Contracts
Criteria for Determining Reasonable Charges
Reconsiderations and Appeals Under Medicare Part A
Appeals Under the Medicare Part B Program
Determinations, Redeterminations, Reconsiderations, and Appeals Under Original Medicare
Initial Determinations
Redeterminatations
Reconsiderations
Reopenings
Expedited Access to Judicial Review
Applicability of Medicare Coverage Policies
Medicare Appeals Council Review
Expedited Determinations and Reconsiderations of Provider Service Terminations
Provider Reimbursement Determinations and Appeals
Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services
HOSPITAL INSURANCE ELIGIBILITY AND ENTITLEMENT
Hospital Insurance Without Monthly Premiums
Premium Hospital Insurance
Special Circumstances That Affect Entitlement to Hospital Insurance
SUPPLEMENTARY MEDICAL INSURANCE (SMI) ENROLLMENT AND ENTITLEMENT
Individual Enrollment and Entitlement for SMI
State- Buy-In Agreements
PREMIUMS FOR SUPPLEMENTARY MEDICAL INSURANCE
Amount of Monthly Premiums
Deductions from Monthly Benefits
HOSPITAL INSURANCE BENEFITS
Inpatient Hospital Services and Inpatient Critical Access Hospital Services
§ 409.10 Included services.
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§ 409.11 Bed and board.


§ 409.12 Nursing and related services, medical social services; use of hospital or CAH facilities
§ 409.13 Drugs and biologicals.
§ 409.14 Supplies, appliances, and equipment.
§ 409.15 Services furnished by an intern or a resident-in-training.
§ 409.16 Other diagnostic or therapeutic services.
§ 409.17 Physical therapy, occupational therapy, and speech-language pathology services
§ 409.18 Services related to kidney transplantations.
Posthospital SNF Care
Requirements for Coverage of Posthospital SNF Care
Home Health Services Under Hospital Insurance
Scope of Hospital Insurance Benefits
SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
Patient Rehabilitation Facility Services
EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT
§ 411.1 Basis and scope.
Insurance Coverage That Limits Medicare Payment: General Provisions
§ 411.20 Basis and scope.
§ 411.21 Definitions.
§ 411.22 Reimburs obligations of prim payers and entities that received payment from primary payers
Limitations on Medicare Payment for Services Covered Under Workers' Conpensation
§ 411.40 Gneral provisions.
Limitations on Medicare Payment for Services Covered Under Liabiity or No Fault Insurance
§ 411.50 General provisions.
Limitations on Payment for Services Covered Under Group Health Plans: General Provisions
Special Rules for Individuals Eligible or Entitled on the Basis of ESRD
Financial Relationships Between Physicians and Entities Furnishing Designated Health Services
PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES
§ 412.1 Scope of part.
§ 412.2 Basis of payment.
Conditions for Payment Under the Prospective Payment Systems for Inpatient Operating
Costs and Inpatient Capital Related Costs
§ 412.40 General requirements.
§ 412.42 Limitations on charges to beneficiaries.
§ 412.44 Medical review requirements: Admissions and quality review.
§ 412.46 Medical review requirements: Physician acknowledgement.
§ 412.48 Denial of payment as a result of admissions and quality review.
§ 412.50 Furnishing of inpatient hospital services directly or under arrangements
§ 412.52 Reporting and recordkeeping requirements.
§ 412.60 DRG classification and weighting factors.
§ 412.62 Federal rates for inpatient operating costs for fiscal year 1984.
§ 412.63 Federal rates for inpatient operating costs for Federal fiscal years 1984-2004
§ 412.64 Federal rates for inpatient operating costs for Federal fiscal year 2005-subsequent fiscal years
Determination of Transition Period Payment Rates for the Prospective
Payment System for Inpatient Operating Costs
§ 412.70 General description.
§ 412.71 Determination of base-year inpatient operating costs.
§ 412.72 Modification of base-year costs.
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§ 412.73 Determination of the hospital-specific rate based on a Federal fiscal year 1982 base period

Determination of the hospital-specific rate for inpatient operating costs based on a Federal fiscal year 1987 base
§ 412.75 period
§ 412.76 Recovery of excess transition period payment amounts resulting from unlawful claims
Determination of the hospital-specific rate for inpt oper costs based on a Fed fiscal year 1987 base period costs
§ 412.77 for sole community hospitals based on a Fiscal fiscal year 1996 base period
Payment for Outlier Cases
§ 412.80 Outlier cases: General provisions.
§ 412.82 Payment for extended length-of-stay cases (day outliers).
§ 412.84 Payment for extraordinarily high-cost cases (cost outliers).
§ 412.86 Payment for extraordinarily high-cost day outliers.
§ 412.87 Additional payment for new medical services and technologies: General provisions
§ 412.88 Additional payment for new medical service or technology.
Payment Adjustment for Certain Replaced Devices
§ 412.89 Payment adjustment for certain replaced devices.
Special Treatment of Certain Facilities Under the Prospective
Payment System for Inpatient Operating Costs
§ 412.90 General rules.
§ 412.92 Special treatment: Sole community hospitals.
Payments to Hospitals Under the Prospective Payment System
§ 412.110 Total Medicare payment.
§ 412.112 Payments determined on a per case basis.
§ 412.113 Other payments.
§ 412.115 Additional payments.
§ 412.116 Method of payment.
§ 412.120 Reductions to total payments.
§ 412.125 Effect of change of ownership on payments under the prospective payment systems
§ 412.130 Retroactive adjustments for incorrectly excluded hospitals and uniits
Criteria and Conditions for Redesignation
§ 412.230 Criteria for an individual hospital seeking redesignation to another rural area or an urban area
PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES
§ 412.300 Scope of subpart and definition.
§ 412.302 Introduction to capital costs.
§ 412.304 Implementation of the capital prospective payment system.
Basic Methodology for Determining the Federal Rate for Capital- Related Costs
§ 412.308 Determining and updating the Federal rate.
Determination of Transition Period Payment Rates for Capital-Related Costs
§ 412.324 General description.
Prospective Payment System for Inpatient Hospital Services of Inpatient Psychiatric Facilities
§ 412.400 Basis and scope of subpart.
Prospective Payment System for Long-Term Care Hospitals
§ 412.500 Basis and scope of subpart.
§ 412.503 Definitions.
Rehabilitatiion Hospitals and Rehabilitation Unit Prospective Payment System
§ 412.600 Basis and scope of subpart.
§ 412.602 Definitions.
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APPENDIX D

Public Health Service Act

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

Subchapter I - Administration and Miscellaneous Provisions

Part A - Administration

Part B - Miscellaneous Provisions

Subchapter II - General Powers and Duties

Part A - Research and Investigation

Part B - Federal-State Cooperation

Part F - Licensing of Biological Products and Clinical Laboratories

Subpart 1 - Biological Products

Subpart 2 - Clinical Laboratories

Subpart 3 - Mammography Facilities

Part G - Quarantine and Inspection

Subchapter III - National Research Institutes

Part H - General Provisions

Subchapter XV Health Information and Health Promotion

• §300u-1 Grants and Contracts for Research Programs; Authority of Secretary; Review of Applications; Additional
Functions; Periodic Public Survey
• §300u-3 Grants and Contracts for Information Programs; Authority of Secretary; Particular Activities
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Subchapter XIX Vaccines

Part 1 - National Vaccine Program

Part 2 - National Vaccine Injury Compensation Program

Subpart A - Program Requirements

Subpart B - Additional Remedies

Subpart C - Assuring a Safer Childhood Vaccination Program in the United States

Subpart D - General Provisions

Subchapter XXI - Research with Respect to Acquired Immune Deficiency Syndrome

Part B - Research Authority

Subchapter XXIV - HIV Health Care Services Program

Part D - General Provisions


The 2009 Health Information Technology Act 132

APPENDIX E
Meaningful Use Documents
• From ONC:

o In June 2009, ONC staff identified a subset of providers eligible for incentive payments who
were likely to have different needs of their EHRs than primary care providers (e.g.,
specialists and non-physician providers). ONC convened brief calls with representatives
from these provider groups to promote a better understanding of how EHRs and meaningful
use would impact their work.

 Summary of 6/09 Comments from Non-physician and Specialist Physician Providers

• From CMS:

o Details for: Medicare and Medicaid Health Information Technology: Title IV of the American
Recovery and Reinvestment Act

• From HIT Policy Committee:

o August 14, 2009 meeting

 Meaningful Use Workgroup Update

 FINAL Meaningful Use Objectives and Measures: 2011-2013-2015

o July 16, 2009 meeting

 Meaningful Use Objectives and Measures: 2011-2013-2015 (early version)

o Summary of Public Comments Received on Draft Meaningful Use Matrix Developed by


Meaningful Use Workgroup of Health IT Policy Committee (June 2009)

• From HIT Standards Committee:

o August 20, 2009 meeting

 HIT Standards Committee Meaningful Use Measures Data Elements Grid

 HIT Standards Committee Summary of Clinical Operations Workgroup

 HIT Standards Committee Privacy & Security Workgroup - Standards Applicable to


ARRA Requirements

• From the National Committee on Vital and Health Statistics (NCVHS):

o Observations on "Meaningful Use" of Health Information Technology (6/01/09)

o Report of Hearing on "Meaningful Use" of Health Information Technology (5/18/09)

Location:http://healthit.hhs.gov/portal/server.pt?

open=512&objID=1325&&PageID=16490&mode=2&in_hi_userid=11113&cached=true
The 2009 Health Information Technology Act 133

APPENDIX F

Certification Commission for Health Information Technology


CCHIT

Inpatient EHR Products


Date Certification
Company Product Certification
Certified Expires

Cerner Millennium PowerChart 2007


Cerner Corporation 1/22/2008 1/22/2011 2007
Fully Certified

CPSI (Computer
CPSI System 16
Programs and 11/5/2007 11/5/2010 2007
Fully Certified
Systems), Inc.

Eclipsys Sunrise Acute Care 4.5 SP4


11/5/2007 11/5/2010 2007
Corporation Fully Certified

EpicCare Inpatient Clinical System


Epic Systems
Spring 2008 11/12/2008 11/12/2010 2008
Corporation
Fully Certified

Epic Systems EpicCare Inpatient Spring 2007


11/5/2007 11/5/2010 2007
Corporation Fully Certified

Centricity Enterprise Version 6


GE Healthcare 6/30/2008 6/30/2011 2007
Fully Certified

Healthcare Healthcare Management Systems


Management 7.0 11/5/2007 11/5/2010 2007
Systems, Inc. Fully Certified

Clinical Information Systems (CIS)


Healthland, Inc. 9.0.0 6/13/2008 6/13/2011 2007
Fully Certified

McKesson Provider Horizon Clinicals Suite ER 7.8.2


5/29/2008 5/29/2011 2007
Technologies Pre-Market

Advanced Clinical Systems Client


MEDITECH Server 5.6 1/22/2008 1/22/2011 2007
Fully Certified

MAGIC 5.6
MEDITECH 1/22/2008 1/22/2011 2007
Fully Certified

Opus Healthcare OpusClinicalSuite 2.3


6/18/2009 6/18/2011 2008
Solutions Pre-Market
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Prognosis Health
ChartAccess 1.0
Information 11/5/2007 11/5/2010 2007
Fully Certified
Systems

INVISION Clinicals with Siemens


Pharmacy and Medication
Siemens Medical
Administration Check (MAK) V27.0/ 1/22/2008 1/22/2011 2007
Solutions USA Inc
V24.0
Fully Certified

MedSeries4 (MS4) Clinical Suite with


Siemens Pharmacy and Medication
Siemens Medical
Administration Check (MAK) V28.10/ 6/12/2008 6/12/2011 2007
Solutions USA Inc
V24.0
Fully Certified

Soarian Clinicals (with Siemens


Pharmacy and Medication
Siemens Medical
Administration Check) (MAK) V2.0C6 11/5/2007 11/5/2010 2007
Solutions USA Inc
(Pharmacy V24.1)
Fully Certified

SOWSIA Ondemand Healthcare uHPM 7Plus


Healthcare M1 7/16/2009 7/16/2011 2008
Solutions, Inc Pre-Market
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Appendix G

Survey

Are the benefits of financial stimulus dollars to implement healthcare


Information technology an advantage or really about increased government
control?

The attached survey is a component of my MBA thesis project for Mount St. Mary’s College in Los
Angeles, California. I would like to respectfully request no more than five minutes of your time to complete the
attached survey. As a health care executive, your experience is vital to the completion of this research project.

Your cooperation is of course voluntary, and will be kept confidential. All survey response data will be for
statistical purposes only. A copy of the findings is available to you upon request.

The thesis topic concerns the Obama administration funding via the American Recovery and Reinvestment
Act of 2009 (ARRA) to hospitals and ambulatory clinics to implement electronic medical record (EMR) solutions so
that the nation can better share and manage the health care information of its citizens. The purpose of this survey is
to investigate the perception of hospital executives about the impact of the financial stimulus for adoption and use of
Health Information Technology (HIT) by the federal government.

If you have any questions regarding this survey or the general research area, please feel free to contact my
advisor, David Burkitt, Phd., at Mount St Mary’s College, MBA Program. Email: dburkitt@aol.com.

Thank you in advance for your valuable contribution.

Please return this survey via U.S. Mail in the enclosed envelope to:

Sara Small
St Johns Hospitals
Financial Services Building
2415 Antonio Avenue
Camarillo, California 93010-1414
Fax (818) 818-502-7709
Email: sara.small@chw.edu
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1. In which state do you work?      

2. Which of the following best describes your health care organization’s tax status:

Not for profit


For profit
Government
Other, specify      
Don’t know

3. How many years have you worked in this occupation? (select one)
Less than 1 year 1-5 years 6-10 years
11-15 years 16-20 years over 20 years

4. Gender Male Female

5. Your Age Group (select one


20-30 31-40 41-50 51-60 Over 60

6. Has your organization implemented an electronic medical record system?


No, we’re just starting to think about it
No immediate plans
Yes, we are preparing now
We’re in the process of implementing now
Yes we have a system in place that meets the guidelines outlined in the ARRA
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SURVEY QUESTIONS

How strongly do you agree or disagree with the following statements:

1. Excessive government regulations have created a formidable barrier for healthcare organizations and
providers to treat patients

2. The ARRA adds increased layers of bureaucratic regulation and cost to an industry that is already
over-regulated and suffering a severe economic crisis.

3. The ARRA is in reality the outline for total government control of the healthcare delivery system in the
United States.

4. Implementation of a “certified” electronic record within the time frame identified in the ARRA will
ultimately benefit the financial health of our organization

5. Identification of required standards for all aspects of the electronic health care record should be the
responsibility of the federal government

6. Uniform standards defining clinical care protocols should become a National model identified by the
federal government as a component of the “certified” electronic record.

7. The stimulus money outlined in ARRA is a benefit that has caused us to implement an electronic health
care system in a shorter time frame than originally planned.

8. The government requirements and regulations outlined for A “certified” EMR are appropriate

9. The increased regulatory agencies required to implement and monitor the Health Information Technology
initiatives add layers of unnecessary government expense

10. E H R will make it easier for organizations to be compliant with the new security and privacy regulations

11. Linking the patient healthcare records of our organization into a regional or national database will
adversely impact the financial health of our organization through decreased reimbursement

12. Government penalties for failing to implement an electronic health record that meets all the requirements
by 2015 is not realistic.
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APPENDIX H

Letter of Response Regarding Research Project

November 2, 2009

Name: Sara Small

Faculty Advisor: David Burkitt, Ph.D.


Mount St. Mary’s College
Doheny Campus
Los Angeles, CA 90007

Dear Ms. Small:

Thank you for submitting your Application for Approval of Human Subjects Research entitled “MBA Thesis
Survey” to the Mount St. Mary's College Human Subjects Committee (HSC). The HSC appreciates the work you
and your Research Advisors, Dr. Burkitt have done on your protocol.

Following the Federal guidelines, the Human Subjects Committee of Mount St. Mary’s College has reviewed the
above-titled research project, as submitted in the Application for Approval of Human Subjects Research form. We
have determined that the policies for the protection of human subjects have been met.

On November 2, 2009 it was determined that your research study met criteria for EXPEDITED review under:

Title 45 CFR, Part 46.110 as it presents no more than minimal risk to participants and your protocol
meets the requirements of § 46.111(a) regarding minimal risk, risks are reasonable in relationship to the
benefits, selection of subjects is equitable, informed consent will be sought from each prospective subject,
informed consent will be appropriately documented, adequate provision for monitoring data collected
ensures the safety of subjects, and privacy and confidentiality are protected.

On November 2, 2009 it was also determined that your research study met Exempt status criteria under §45 CFR
46.101 (b)(2) or (b)(3) for Tests, Surveys, Interviews, or Public Behavior Observation in which the:

Information is recorded in such a manner that human subjects cannot be identified, directly or through
identifiers liked to the subjects; and disclosure of the responses outside the research does not place the
subjects at risk of criminal or civil liability; and is not damaging to the subjects’ financial standing,
employability or reputation.

Please note that your research must be conducted according to the proposal that was submitted to the HSC. Any
changes to the proposal which involve human subjects must be approved by the HSC prior to implementation.

Good luck in your research!

Sincerely,

Robin Gordon, Ph.D.


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Chair, MSMC Human Subjects Committee


rgordon@msmc.la.edu (213) 477-2624

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