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2009 Health Information Technology Act

2009 Health Information Technology Act

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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

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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 15 16 57 59 60 63 70 82 83 84 85 86 87 89 89 90 91

Table 2: Summary of Federal Government Health IT ………………….……… Table 3: Cost of Healthcare Facility Regulations………………………………. Table 4: Medicare Hospital Incentives……………………………………….…. Table 5: Medicare Hospital Incentives……………………….…………………. Table 6: Medicare Penalties…………………………………….…………..….… Table 7: Medicaid Incentives for Hospitals………………….………………….. Table 8: Top Issues Confronting Hospitals……………….…………………….… Table 9: Literature review open coding model………………..……………..…… Table 10: Excessive government regulations…………………………………….. Table 11: The ARRA adds increased layers of bureaucratic regulation………..… Table 12: Implementation of a “certified” electronic record ..……………..……. Table 13 Identification of required standards…………………………..……….... Table 14: Uniform standards defining clinical care protocols………..………… Table 15: The ARRA is in reality the outline for total government control…… Table 16: The stimulus money outlined in ARRA is a benefit………………… Table 17: The government requirements and regulations……………………… Table 18: The increased regulatory agencies……………………………………

THE 2009 Health Information Technology Act Table 19: E H R will make it easier for organizations………………….……… Table 20: Linking the patient healthcare records of our organization………… Table 21: Government penalties for failing to implement……………………… Table 22: Respondent Location ………………………………………….…..… Table 23: Number of years in this occupation…………………..……………… Table 24: Respondents Gender…………………………………………..….…... Table 25: Respondent Age Range ……………………………………..….….…. Table 26: Healthcare Organization’s Tax Status of Respondents……………….. Table 27: Has your organization implemented an electronic medical record?........ 92 93 94 95 95 96 96 97 97

The 2009 Health Information Technology Act

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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)

The 2009 Health Information Technology Act 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

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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
TABLE OF CONTENTS

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Page

DEED OF DECLARATION …………………………………………… APPROVAL SHEET …………………………………………………… ACKNOWLEDGMENT . . . . . . . . . . . . . . . . . . . . . . . . …….. . . . . . . . ABSTRACT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . … . . . . . . . . . LIST OF TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . … .. . . .

ii iii iv v vi viii 4 4 7 8 10 10 12 14 15 20 26 27 28

GLOSSARY OF TERMS……………………………………………….. Chapter 1: INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . Background of the Study .......................... .

History of Electronic Health Record…………………………… Statement of the Problem. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 2: LITERATURE REVIEW……………………………………. Current State …………………………………………………… American Recovery and Reinvestment Act……………………… Purpose of Recovery Act HIT Incentives………………………… Federal Regulatory Issues and Requirements……………………… Health Information Privacy………………………………… Civil Rights……………………………………………….. Food and Drugs…………………………………………… Fraud & Prevention Detection…………………………….

The 2009 Health Information Technology Act Information Management…………………………………. Medical and Healthcare…………………………………… Other Federal Laws……………………………………….. Regulatory Agencies and Responsibilities ………………………… California Legislation and Action Plans…………………………. Medicare –Centers for Medicare and Medicaid Services (CMS) State Medicaid………………………………………….. Costs…………………………………………………………. Savings………………………………………………………….. Benefits…………………………………………………………. Barriers………………………………………………………….. Privacy Concerns……………………………………………….. Chapter 3: RESEARCH METHODOLOGY……………………… 29 31 32 36 47 56 60 64 65 66 69 72 74 74 76 76 78 79 80 82 82 83

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Grounded Theory Model……………………………………… Data Sources…………………………………..……………… Study population for survey…………………………… Literature Review…………………………….……….. Data Collection………………………………………………. Data Analysis…………………………….……………..……. Chapter 4: ANALYSIS…………………………..………………

Literature Coding Results……………………………………. Survey Results ……………………………………………….

The 2009 Health Information Technology Act

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Chapter 5

CONCLUSION ………………………………………

98 103

References…………………………………………………………….. Appendix Appendix A Appendix B Appendix C Privacy Sections in Order of Appearance in ARRA.. Literature Review: Open Coding Model……………. Title 42 Federal Public Health Regulations …………

123 124 127 130 132 133 135 138

Appendix D Public Health Services Act………………………….. Appendix D “Meaningful Use” Documents………………………. Appendix E Appendix F Certified Inpatient E H R Products………………….. Hospital CEO Survey………………………………...

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

The 2009 Health Information Technology Act Chapter 1

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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

The 2009 Health Information Technology Act 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

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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

The 2009 Health Information Technology Act 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

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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

The 2009 Health Information Technology Act

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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

The 2009 Health Information Technology Act 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

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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

The 2009 Health Information Technology Act 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).

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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.

The 2009 Health Information Technology Act CHAPTER 2

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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).

The 2009 Health Information Technology Act 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,

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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 Partially Implemented Not Implemented

13% 42% 45%

Source: California HealthCare Foundation. January 2007

Health IT is moving from a voluntary initiative over the past decade to a highly regulated

The 2009 Health Information Technology Act

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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 electronicrecords 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 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

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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),

The 2009 Health Information Technology Act •

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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 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).

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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 Care Objective 1.1: Objective 1.2: Objective 1.3: Objective 1.4:

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 P ico m o te n a tio n w id e d e p lo y m e n t b lish m e c h a n ism s fo r m u ltinr E sta a c c e ss, a n d u se o f e le c tr o n ic h e a lth 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 he a 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 E sta b lish c o o r d in a te d o r g a n iza tio n a l of p o lic ie s, p r in c ip le s, p r o c e d u r e s, in n dr m a tio n to su p p o r t p o p u la tio n - c h n o lo g ie s to im p r o v e a fo te 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 ssr ie n te d u se s. o in p o p u la tio n a n d in d iv id u a l h e a lthr. p o p u la tio n h e a lth . fo 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 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

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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)
Type of Regulation Access EMTALA Hospital uncopensated care pools Hospital community serv requirements ice Limited English proficiency requirements Costs Health care fraud and abuse Facility medical records (incl priv acy) Organ transplant regulation Certificate of need Hospital rate setting Pharmaceutical price regulation Other cost-related facilities regulations Quality Hospital accreditation/ licensure Nursing home accreditation/licensure Other facilities accreditation/licensure Peer Rev iew Clinical Laboratory Improv ement Act (CLIA) Other quality-related facilities regulations GRAND TOTAL Source: Cato Institute (Conover, 2004) Expected $11,755 $4,436 $6,678 $317 $324 $14,130 $3,209 $1,068 $1,815 $110 $69 $7,626 $233 $21,798 $8,640 $3,581 $2,078 $2,063 $3,236 $2,200 $47,683 Costs Minimum $2,184 $1,261 $698 $123 $102 $11,948 $2,224 $696 $1,653 $26 $57 $7,163 $129 $9,595 $833 $1,963 $465 $1,314 $3,065 $1,955 $23,727 Maximum $29,544 $10,965 $16,591 $961 $1,027 $273,339 $9,945 $92,178 $1,785 $157,859 $3,023 $8,149 $400 $57,592 $31,885 $6,821 $7,447 $5,481 $3,466 $2,492 $360,475 Expected $3,805 $2,146 $1,524 $135 $0 $14,837 $2,154 $1,222 $1,804 $0 $51 $9,606 $0 $3,973 $0 $3,973 $0 $0 $0 $0 $22,615 Benefits Minimum $700 $421 $233 $46 $0 $20,748 $1,808 $996 $280 $5,067 $4,421 $8,176 $0 $3,973 $0 $3,973 $0 $0 $0 $0 $25,421 Maximum $8,928 $4,930 $3,601 $397 $0 $27,094 $2,912 $1,450 $4,644 $0 $0 $18,088 $0 $3,973 $0 $3,973 $0 $0 $0 $0 $39,995 Net Cost $7,950 $2,290 $5,154 $182 $324 -$707 $1,055 -$154 $11 $110 $18 -$1,980 $233 $17,825 $8,640 -$392 $2,078 $2,063 $3,236 $2,200 $25,068 Percent 31.7% 9.1% 20.6% 70.0% 0.0% 1.3% -2.8% 4.2% -0.6% 0.0% 4.0% 0.4% 0.1% -7.9% 0.9% 71.1% 34.5% -1.6% 8.3% 8.2% 12.9% 8.8% 100%

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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 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

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"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,

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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 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)

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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 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

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“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 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

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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 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

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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 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

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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

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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

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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 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

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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 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

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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 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

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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 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,

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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

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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 noncompliance (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 collaborative consortium of Health Information Technology Regional Extension Centers facilitated by the national Health Information Technology Research Center. The Extension

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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-LeachBliley 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 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:

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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

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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 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

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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.

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

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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 ANSIaccredited 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 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

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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

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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

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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 with making recommendations to the National Coordinator for Health Information Technology

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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 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

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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 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

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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 Office of the Inspector General (OIG): The mission of the Office of Inspector General (OIG), as mandated by Public Law 95452 (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

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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 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

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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, executivelevel 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 intrastatebased 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 State Level Health Information Exchange Consensus Project The State-level Health Information Exchange Consensus Project is managed through a

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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 California Legislation and Action Plans

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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 • 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

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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 Business and Technical Operations • Provide technical assistance as needed to HIOs and others developing HIE capacity within the state, •

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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 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

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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 (HIEIRC) efforts (Research and New, 2009). Workforce Training and Development (Workforce)

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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 and present recommendations to the CalPSAB. The CalPSAB will prioritize the work of the

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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 CalPSAB Privacy Committee

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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 to establish a Statewide Online On Demand Information Service that offers: a master patient

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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

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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 recordkeeping 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,

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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 HITEHR 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 Medicare Incentives for Hospitals Table 4 Medicare Hospital Incentives Incentive Payments for a Typical 500 Bed Hospital with An Average Occupancy Rate of 85%

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Payment Incentive per Year 1 Component Unit 100% Base Pay (1st year only)
$2,000,000.00 $2,000,000.00

Year 2 75%

Year 3 50%

Year 4 25%

Cumulative Total
$2,000,000.00

Bonus per d/c 1,150 $200 (min)23,000(max TOTAL

$4,370,000

$3,227,500 $2,185,000 $1,082,500 $10,865,000

$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 Component Base payment (Year 1 only) Bonus per discharge from 1,150(min) to 23,000 (max) discharges TOTAL 6,370,000 $3,227,500 $2,185,000 $1,082,500 $12,865,000 $4,370,000 $3,227,500 $2,185,000 $1,082,500 $10,865,000 Incentive Per Unit $2,000,000 Year 1 100% $2,000,000 Year 2 75% Year 3 50% Year 4 25% Cumulative Total $2,000,000

$200

critical access hospitals (CAHs) that are meaningful EHR users. An eligible hospital that is a

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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 Table 5 Medicare Hospital Incentives Incentive Payments for a Typical 100 Bed Hospital with an Average Occupancy Rate of 50%

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Payment Component Base payment (Year 1 only) Bonus per discharge from 1,150(min) to 23,000 (max) discharges TOTAL

Incentive Per Unit $2,000,00 0 $200

Year 1 100% $2,000,000

Year 2 75%

Year 3 50%

Year 4 25%

Cumulative Total $2,000,000

$563,400

$422,550

$281,700

$140,850

$1,408,500

$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 category represents is determined. These proportions are called cost or

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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 2015 2016 2017 $ $ $ Penalty 966,000.00 2,054,000.00 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).

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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 (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

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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 6year 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.

The 2009 Health Information Technology Act Table 7
Medicaid Incentives for Hospitals Example: If E H R Cost = $5,000,000 and Medicaid Patient Volume = 15% Transition Factor 1 3/4 1/2 1/4

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Year Year 1 Year 2 Year 3 Year 4

Factor x Cost 1 x $5,000,000 3/4 x $5,000,000 1/2 x $5,000,000 1/4 x $5,000,000 Total 4 year sum

Total $ 5,000,000.00 $ 3,750,000.00 $ 2,500,000.00 $ 1,250,000.00 $ 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.

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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 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

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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 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

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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 guidelines and protocols, most often as a result of automated reminders and computerized decision supports, • • Improvements in care in conformity to guidelines ,

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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 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)

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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 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

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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 • • • High HIT implementation costs, Physician resistance, Technical and infrastructure obstacles.

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Table 8 Top Issues C onfronting Hospitals: 2008 ISSUE Financial C hallenges Patient Safety and Q uality C are for the Uninsured Physician/Hospital relations 2006 72% n/a 37% 40% 2007 70% n/a 38% 35% 2008 77% 43% 41% 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 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

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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

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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 reidentified 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):

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"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).

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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.

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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 adaptablewhich 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:

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“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 • All survey candidates were advised that their responses would remain confidential. • • Subjects who participated were chosen when they responded to the survey.

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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 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.

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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 actually fit the data. Selective sampling of the literature is recommended and generally follows

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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

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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

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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- itnote 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.

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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 Basics Benefits Standards Strategy Source: Appendix B Cost Definition Impact of Stimulus Status Timing Implementation Privacy Regulations Status in Hospitals Stimulating Adoption

The 2009 Health Information Technology Act 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

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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 patient care. Health care organizations must provide services to patients while remaining

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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

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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

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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 Agree Strongly Disagree

14% 52% 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 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.

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Strongly Agree Agree Strongly Disagree

24% 52% 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.

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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 Table 15:

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The ARRA is in reality the outline for total government control of the Health care delivery system in the United States.

Strongly Agree Agree Strongly Disagree

14% 34% 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 Agree Strongly Disagree

28% 52% 20%

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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 Agree Strongly Disagree

24% 57% 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 (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

91

Strongly Agree Agree Strongly Disagree

33% 57% 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 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.

92

Strongly Agree Agree Strongly Disagree

33% 57% 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 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

93

Strongly Agree Agree Strongly Disagree

10% 43% 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 Table 21 Government penalties for failing to implement an electronic health record that meets all the requirements by 2015 is not realistic.

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Strongly Agree Agree Strongly Disagree

33% 43% 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 Table 22 Respondent Location:

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California Nevada Illinois Arizona

61% 9% 5% 5%

Illinois Arizona Tennessee Washing

5% 5% 5% 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 16-20 years

5% 5%

6-10 Years Greater than 20 years

4% 86%

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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 Male

29% 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 51-60 Greater than 60 14% 62% 24%

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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 We’re in the process of implementing Yes we have a system in place that meets the Guidelines outlined in the ARRA 31% 48% 21%

All respondents have chosen to implement an electronic medical record.

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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 anticipated monetary penalties. The dependence upon Government reimbursement is a key

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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

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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 that is defined by the Federal Government, but not controlled by the Federal Government.

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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 twoto-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

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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.

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case of electronic medical record.s (University of Virginia and Massachusetts Institute of Technology). Monegain, B. (2009, March 12). HHS new office of recovery act coordination to oversee stimulus money. Healthcare IT News. Retrieved from: http://www.healthcareitnews.com/news/hhs-new-office-recovery-act-coordinationoversee-stimulus-money. National Association of Health Data Organizations. (2009). Retrieved from: www.hando.org. National Center for Health Statistics. (2009). Retrieved from www.cdc.gov/nchs/. National Committee for Quality Assurance. (2009). Retrieved from www.ncqa.org. National Committee on Vital and Health Statistics. (2009). Retrieved from www.ncchs.hhs.gov/. National health Information Network. (2009). Retrieved from: http://healthit.hhs.gov/portal/server.pt?open=512&mode=2&cached=true&objID=1142. National Institutes of Health. (2005, April) Electronic health record overview. National Institutes of Health. National Center for Research Resources. McLean, Va. National Uniform Billing Committee. (2009). Retrieved from www.nubc.org. National Conference of Commissioners on Uniform State Laws. (1985) National Uniform Healthcare Information Act. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/10274535. O’Brien, J.P. (2006, August). HHS announces new Federal Stark law exceptions. Client Advisory. Retrieved from: http://www.kattenlaw.com/files/Publication/f7653806-4484-

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47c3-84bc-53e46dd2aa7f/Presentation/PublicationAttachment/01625f8c-d2ed-4783-b2fb 66ab4f76305/hhs%20announces%20new%20federal%20stark%20law%20exceptions.pdf Office of Civil Rights. (2009). Retrieved from: http://healthit.hhs.gov/portal/server.pt? open=512&mode=2&cached=true&objID=1142. Office of Civil Rights.(2009). The HIPAA Privacy Rule and Electronic Health Information Exchange in a Networked Environment. Retrieved from: http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/healthit/introduction.pdf Office of Civil Rights.(2009). The HIPAA Privacy Rule’s Right of Access and Health Information Technology. Retrieved from: http://www.hhs.gov/ocr/privcy/hipaa/understading/special/healthit/eaccess.pdf Office of the Inspector General.(2009). HHS Recovery Act oversight. Retrieved from: http://oig.hhs.gov/recovery/. Office of the Inspector General.(2006, August 8). Medicare and State health care programs: fraud and abuse; safe harbors for certain electronic prescribing and electronic health records arrangements under the anti-kickback statute; final rule. Department of Health and Human Services .42 CFR Part 1001. Retrieved from: http://oig.hhs.gov/authorities/docs/06/OIG%20E-Prescribing%20Final%20Rule %20080806.pdf Office of the Inspector General.(2009). Whistleblower protections under the Recovery Act. Section 1553 of Division A, Title XV of the American Recovery and Reinvestment Act of 2009. Retrieved from: http://www.oig.dot.gov/recovery/whistleblower_protections.jsp. Office of the National Coordinator for Health Information Technology .(2008 December 15).

The 2009 Health Information Technology Act Nationwide privacy and security framework for electronic exchange of individually identifiable health information. Retrieved from:

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http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_10731_848088_0_0_18/Nati onwidePS_Framework-5.pdf. Price Waterhouse Coopers. (2009, April). Rock and a hard place. Retrieved from Price Waterhouse Coopers website: http://www.pwc.com/us/en/healthcare/publications/rockand-a-hard-place.jhtml. Public Health Services Act, 2009.(2009, May 28). Federal Register: May 28, 2009 (Volume 74, Number 101)][Notices] [Page 25550-25552] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr28my09-67]. Pure Food and Drugs Act of 1906. (1906). United States Statutes at Large (59th Cong., Sess. I, Chp. 3915, p. 768-772). Retrieved from http://www.hnet.org/~hst203/documents/pure.html. Recovery Accountability and Transparency Board. (2009). Retrieved from: http://www.recovery.gov/About/board/Pages/TheBoard.aspx. Rehabilitation Act of 1973. (1973). Public Law 93-112. 93rd Congress, H.R. 8070. September 26, 1973. Retrieved from: http://www.dotcr.ost.dot.gov/documents/ycr/REHABACT.HTM . Regional Health Information Organizations. (2009). Retrieved from: http://www.himss.org/asp/topics_rhio.asp. Southern California Evidence-based Practice Center. (2006, April). Costs and benefits of health information technology. Evidence Report, Technology Assessment Number 132. AHRQ Publication No. 06-E006. Retrieved from:

The 2009 Health Information Technology Act http://www.ahrq.gov/downloads/pub/evidence/pdf/hitsyscosts/hitsys.pdf. State Alliance for eHealth. (2009). Retrieved from: http://healthit.hhs.gov/portal/server.pt?

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open=512&objID=1241&parentname=CommunityPage&parentid=1&mode=2&in_hi_us erid=10741&cached=true. State Level Health Information Exchange Consensus Project. (2009). Retrieved from: http://www.slhie.org/. Stead, W., Kelly, B.J., Koldner, R.M. (2005, March/April).Achievable steps toward building a national health information infrastructure in the United States. Journal of the American Medial Informatics Association. Volume 23. Number 2. Strauss, A and Corbin, J. (1994) .Grounded Theory Methodology; an overview. In Denzin N.K and Lincoln Y.S. Handbook of Qualitative Research. London. Sage. Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment. (2004, June).The confidentiality of alcohol and drug abuse patient records regulation. Retrieved from: http://www.hipaa.samhsa.gov/Part2ComparisonCleared.htm. Swartz, N. (2004). A prescription for electronic health records. Information Management Journal, 38(4), 20. Retrieved from http://www.allbusiness.com/technology/1806481.html. Tanner, M. (2009, September 9). Halfway to where? answering the key questions of health care reform. The Cato Institute. Policy Analysis no. 643 . Washington, DC: The Cato Institute. Taylor, R., Bower, A., Girosi, F., Bigelow, J., Fonkych, K., & Hillestad, R. (2005). Promoting health information technology: is there a case for more aggressive government action?. Health Affairs, 24, 1234-1245. Retrieved from:

The 2009 Health Information Technology Act http://content.healthaffairs.org/cgi/content/full/24/5/1234 Thakkar, M., & Davis, D. C. (2006) . Risks, barriers and benefits of EHR systems: a comparative study based on size of hospital [White paper]. Retrieved from AHIMIA website: http://library.ahima.org/xpedio/groups/public/documents/ahima/bok1_ 031779.html.

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The Advisory Board (2009, May 14,). Stimulus bill update: funding opportunities for hospitals and health systems (The Advisory Board). Washington, DC: The Advisory Board. The Commonwealth Fund. (2009, February). International survey: US slow to adopt health it (The Commonwealth Fund). New York: The Commonwealth Fund. The Cleveland Clinic .(2009). It all starts with the electronic medical record. Retrieved from Cleveland Clinic: http://my.clevelandclinic.org/patients/records/electronic.aspx. The Dorenfest Institute. (2005). The financial systems hospital IT market, 1998-2005. Retrieved from HIMSS: http://www.allbusiness.com/technology/180648-1.html. The Joint Commission. (2009). Joint Commission Requirements. Retrieved from: http://www.jointcommission.org/Standards/. The Markle Foundation. (2009). Achieving the health IT objectives of the American Recovery and Reinvestment Act. A framework for ‘Meaningful Use’ and ‘Certified or Qualified’ E H R. The Markle Foundation. Connecting for Health. New York: The Markle Foundation. Retrieved from: http://www.markle.org/downloadable_assets/20090430_meaningful_use.pdf The Rand Corporation. (2005). Health information technology can HIT lower costs and improve quality? (The Rand Corporation). Retrieved from Rand Health website:

The 2009 Health Information Technology Act http://www.rand.org/pubs/research_briefs/RB9136/index1.html. Title VI of the Civil Rights Act of 1964. (1964). 42 U.S.C. § 2000d et seq. Retrieved from: http://www.justice.gov/crt/cor/coord/titlevi.php.

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Title IX, Education Amendments of 1972. (1972). Title 20 U.S.C. Sections 1681-1688. Retrieved from: http://www.dol.gov/oasam/regs/statutes/titleIX.htm. United States Department of Justice. (2009). Freedom of Information Act. Retrieved from http://www.justice.gov/oip/foia_guide09.htm Unruh, B. (2009). Economic stimulus? feds want your medical records. World Net Daily. Retrieved from www.wnd.com/indexd.php?fa=PAGE.view&pageID=873222. Walker, J., Pan, E., Johnston, D., Adler-Milstein, J., Bates, D. W., & Middleton, B. (2005). The value of health care information exchange and interoperability. Health Tracking, 5, 11-18. Wangsness, L. (2009, January 1,). Letter highlights hurdles in digitizing health records specialists tell Obama current systems flawed. The Boston Globe, ed. The Boston Globe Ways and Means Committee. (2009, January 16). Title IV - Health Information Technology for Economic and Clinical Health Act. Prepared by the Majority Staff of the Committees on Energy and Commerce. Retrieved from http://waysandmeans.house.gov/media/pdf/110/hit2.pdf. Wulsin, L., & Doughtery, A. (2008). The HIT primer. (California Research Bureau). Sacramento, California: California State Library Research Bureau. Retrieved from: http://www.library.ca.gov/crb/08/08-013.pdf

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APPENDIX A

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Appendix B

Literature Review: Models and Theories Using Open Coding Model Theory/Topic
ARRA Barriers

Discussion
Overview of the American Recovery and Reinvestment Act Increased concerns by physicians regarding implementation of an electronic medical record system Discussion of the improvement to patient safety that will be gained through information technology Review of key questions regarding the current healthcare reform review of risks, barriers and benefits of implementing an HER in a hospital HIT basic information Best practices in health records Look at the future of electronic records review of reality vs. the promises made regarding the value of an EMR review of innovative options review of the over-regulation of healthcare and the enormous cost to the entire system for supporting all the agencies Review of modeling to identify savings and costs of an EMR costs, benefits analysis using a modeling system to identify impact on an EMR Report reviewing the financial advantages to HIT Review of a conceptual model for clinical documentation and an electronic health record review of the stimulus and the increase in hospital implementations of EHRs

Source
AHRQ 2009 American College of Foot and Ankle Surgeons Brown,Bailey & Miller, 2005

Barriers

Barriers Barriers

Tanner, 2005 Thakkar, 2006

Basics Benefits Benefits Benefits Benefits Cost

Wulsin, 2008 Amatayakul & Work, 2005 AHIMA, 2003 Goodman, 2009 Lohr, 2009 Conover, 2004

Costs Costs

Rand study, 2005 Hillestad et al, 2005

Costs Definition

Rand study, 2005 Asp, Lone, Peters, 2003

Impact of Stimulus

Goldstiein, 2009

The 2009 Health Information Technology Act
Implementation Review of Kaiser experience with implementing a fully integrated EMR throughout their system Current status of utilization of EMRs in US hospitals review of stimulus package for health care Concern that the new stimulus package could impinge on Americans' health privacy discussion regarding the availability of private health details to online users will electronic records make it easier to insure privacy of our records, or will they be less safe? Review of privacy concerns and electronic medical records Report identifying the concern of placing full access to medical records in the hands of the government Compliance risk review of an electronic medical record system Review of Medicaid regulations impacted by the ARRA review of applicable regulations requirements for use of health information technology and stimulus monies available by meeting requirements review of Title IV requirements as outlined by Medicare and Medicaid Overview of the ARRA implementation plan Review of all the new regulations review of meaningful use and certification criteria review of the "required" elements and the financial impact on hospitals that choose not to implement an EMR should government become more aggressive in promoting HIT? review of appropriate methods for identification of standards in the electronic record Garrido et al , 2004

125

Implementation Implementation Privacy

Jha, 2009 Lieberman, 2009 Brailer, 2009

Privacy

Cohen, 2008

Privacy

Healy, 2009

Privacy Privacy

Healy, 2009 Uhruh, 2009

Regulations Regulations Regulations Regulations

AIS Compliance Binder & Grady 2009 Centers for Disease Control, 2007 Centers for Medicare and Medicaid Services, 2009

Regulations Regulations Regulations Regulations Regulations

CMS, 2009 Department of Health and Human Services, 2009 Federal HIT Committee, 2009 HIMSS, 2009 Price Waterhouse Coopers, 2009

Regulations Standards

Taylor et al, 2005 California Healthcare foundation, 2007

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Status

126 Source
HIMSS, 2007

Discussion
Annual report of the US Hospital IT Market A look at the future of healthcare in the year 2015 Review of the progress of hospital use of information technology Discussion of the barriers and the value of pro-actively implementing an E H R review of a strategy for implementation of a clinical information system within a large healthcare network Recommendation that it's time for hospitals to act quickly to implement an electronic record

Status

Battani & Zywiak, 2009

Status of implementation in hospitals Stimulating adoption

AMA, 2007

Blumenthal, 2009

Strategy

Catholic Healthcare West, 2009

Timing

Bass & Johnson, 2008

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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.

The 2009 Health Information Technology Act
§ 409.11 § 409.12 § 409.13 § 409.14 § 409.15 § 409.16 § 409.17 § 409.18 Bed and board. Nursing and related services, medical social services; use of hospital or CAH facilities Drugs and biologicals. Supplies, appliances, and equipment. Services furnished by an intern or a resident-in-training. Other diagnostic or therapeutic services. Physical therapy, occupational therapy, and speech-language pathology services Services related to kidney transplantations.

128

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 § 411.20 § 411.21 § 411.22 § 411.40 § 411.50 Basis and scope. Basis and scope. Definitions. Reimburs obligations of prim payers and entities that received payment from primary payers Gneral provisions. General provisions. Insurance Coverage That Limits Medicare Payment: General Provisions

Limitations on Medicare Payment for Services Covered Under Workers' Conpensation Limitations on Medicare Payment for Services Covered Under Liabiity or No Fault Insurance 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 § 412.2 Scope of part. Basis of payment. Costs and Inpatient Capital Related Costs § 412.40 § 412.42 § 412.44 § 412.46 § 412.48 § 412.50 § 412.52 § 412.60 § 412.62 § 412.63 § 412.64 General requirements. Limitations on charges to beneficiaries. Medical review requirements: Admissions and quality review. Medical review requirements: Physician acknowledgement. Denial of payment as a result of admissions and quality review. Furnishing of inpatient hospital services directly or under arrangements Reporting and recordkeeping requirements. DRG classification and weighting factors. Federal rates for inpatient operating costs for fiscal year 1984. Federal rates for inpatient operating costs for Federal fiscal years 1984-2004 Federal rates for inpatient operating costs for Federal fiscal year 2005-subsequent fiscal years Payment System for Inpatient Operating Costs § 412.70 § 412.71 § 412.72 General description. Determination of base-year inpatient operating costs. Modification of base-year costs.

Conditions for Payment Under the Prospective Payment Systems for Inpatient Operating

Determination of Transition Period Payment Rates for the Prospective

The 2009 Health Information Technology Act
§ 412.73 § 412.75 § 412.76 § 412.77 § 412.80 § 412.82 § 412.84 § 412.86 § 412.87 § 412.88 § 412.89 Determination of the hospital-specific rate based on a Federal fiscal year 1982 base period

129

Determination of the hospital-specific rate for inpatient operating costs based on a Federal fiscal year 1987 base period 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 for sole community hospitals based on a Fiscal fiscal year 1996 base period Outlier cases: General provisions. Payment for extended length-of-stay cases (day outliers). Payment for extraordinarily high-cost cases (cost outliers). Payment for extraordinarily high-cost day outliers. Additional payment for new medical services and technologies: General provisions Additional payment for new medical service or technology. Payment adjustment for certain replaced devices. Payment System for Inpatient Operating Costs

Payment for Outlier Cases

Payment Adjustment for Certain Replaced Devices Special Treatment of Certain Facilities Under the Prospective § 412.90 § 412.92 § 412.110 § 412.112 § 412.113 § 412.115 § 412.116 § 412.120 § 412.125 § 412.130 § 412.230 § 412.300 § 412.302 § 412.304 § 412.308 § 412.324 § 412.400 § 412.500 § 412.503 § 412.600 § 412.602 General rules. Special treatment: Sole community hospitals. Total Medicare payment. Payments determined on a per case basis. Other payments. Additional payments. Method of payment. Reductions to total payments. Effect of change of ownership on payments under the prospective payment systems Retroactive adjustments for incorrectly excluded hospitals and uniits Criteria for an individual hospital seeking redesignation to another rural area or an urban area Scope of subpart and definition. Introduction to capital costs. Implementation of the capital prospective payment system. Determining and updating the Federal rate. General description. Basis and scope of subpart. Basis and scope of subpart. Definitions. Basis and scope of subpart. Definitions.

Payments to Hospitals Under the Prospective Payment System

Criteria and Conditions for Redesignation PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES

Basic Methodology for Determining the Federal Rate for Capital- Related Costs Determination of Transition Period Payment Rates for Capital-Related Costs Prospective Payment System for Inpatient Hospital Services of Inpatient Psychiatric Facilities Prospective Payment System for Long-Term Care Hospitals

Rehabilitatiion Hospitals and Rehabilitation Unit Prospective Payment System

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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

The 2009 Health Information Technology Act
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

131

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 APPENDIX E Meaningful Use Documents

From ONC:

132

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   o  o •

August 14, 2009 meeting Meaningful Use Workgroup Update FINAL Meaningful Use Objectives and Measures: 2011-2013-2015 July 16, 2009 meeting Meaningful Use Objectives and Measures: 2011-2013-2015 (early version) 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 o

Observations on "Meaningful Use" of Health Information Technology (6/01/09) 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

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APPENDIX F
Certification Commission for Health Information Technology

CCHIT

Inpatient EHR Products
Company Product Cerner Millennium PowerChart 2007 Fully Certified CPSI System 16 Fully Certified Sunrise Acute Care 4.5 SP4 Fully Certified EpicCare Inpatient Clinical System Spring 2008 Fully Certified EpicCare Inpatient Spring 2007 Fully Certified Centricity Enterprise Version 6 Fully Certified Healthcare Management Systems 7.0 Fully Certified Clinical Information Systems (CIS) 9.0.0 Fully Certified Horizon Clinicals Suite ER 7.8.2 Pre-Market Advanced Clinical Systems Client Server 5.6 Fully Certified MAGIC 5.6 Fully Certified OpusClinicalSuite 2.3 Pre-Market Date Certified 1/22/2008 Certification Expires 1/22/2011 Certification

Cerner Corporation CPSI (Computer Programs and Systems), Inc. Eclipsys Corporation Epic Systems Corporation Epic Systems Corporation GE Healthcare Healthcare Management Systems, Inc. Healthland, Inc. McKesson Provider Technologies MEDITECH

2007

11/5/2007

11/5/2010

2007

11/5/2007

11/5/2010

2007

11/12/2008

11/12/2010

2008

11/5/2007 6/30/2008

11/5/2010 6/30/2011

2007 2007

11/5/2007

11/5/2010

2007

6/13/2008

6/13/2011

2007

5/29/2008

5/29/2011

2007

1/22/2008

1/22/2011

2007

MEDITECH Opus Healthcare Solutions

1/22/2008 6/18/2009

1/22/2011 6/18/2011

2007 2008

The 2009 Health Information Technology Act
Prognosis Health Information Systems ChartAccess 1.0 Fully Certified INVISION Clinicals with Siemens Pharmacy and Medication Administration Check (MAK) V27.0/ V24.0 Fully Certified MedSeries4 (MS4) Clinical Suite with Siemens Pharmacy and Medication Administration Check (MAK) V28.10/ V24.0 Fully Certified Soarian Clinicals (with Siemens Pharmacy and Medication Administration Check) (MAK) V2.0C6 (Pharmacy V24.1) Fully Certified Ondemand Healthcare uHPM 7Plus M1 Pre-Market

134

11/5/2007

11/5/2010

2007

Siemens Medical Solutions USA Inc

1/22/2008

1/22/2011

2007

Siemens Medical Solutions USA Inc

6/12/2008

6/12/2011

2007

Siemens Medical Solutions USA Inc

11/5/2007

11/5/2010

2007

SOWSIA Healthcare Solutions, Inc

7/16/2009

7/16/2011

2008

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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. 2.

In which state do you work?       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 11-15 years 16-20 years Female 6-10 years over 20 years

4. 5.

Gender

Male

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 The ARRA adds increased layers of bureaucratic regulation and cost to over-regulated and suffering a severe economic crisis. an industry that is already

2.

3.

The ARRA is in reality the outline for total government control of the healthcare delivery system in the United States. Implementation of a “certified” electronic record within the time frame identified in the ARRA will ultimately benefit the financial health of our organization Identification of required standards for all aspects of the electronic health care record should be the responsibility of the federal government Uniform standards defining clinical care protocols should become a National model identified by the federal government as a component of the “certified” electronic record. 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. The government requirements and regulations outlined for A “certified” EMR are appropriate The increased regulatory agencies required to implement and monitor the Health Information Technology initiatives add layers of unnecessary government expense

4.

5.

6.

7.

8. 9.

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.

The 2009 Health Information Technology Act
Chair, MSMC Human Subjects Committee rgordon@msmc.la.edu (213) 477-2624

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