What is and how does the HITECH provision of the ARRA affect the Health Care System and Health Care outcomes?

Class final paper for Course: Issues and cases in Health Care Financing and Administration, Professor Marc Thibodeau

Student: Theodore L. Van Patten, Jr.

12/23/2010

Abstract: A monumental task is at hand, the Health Information Technology for Economic and Clinical Act (HITECH) that was passed into law in February of 2009 as part of the American Recovery and Reinvestment Act (ARRA). This is a huge undertaking that will take a decade to come to fruition. What will happen to the Health Care System landscape and will the goals of better health care outcomes be realized? This paper gives a background of the Act and tries to answer these questions.

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Table of Contents I. Summary ............................................................................................................................................... 3

II. Definitions and Background .................................................................................................................. 3

A. What is the Health Information Technology for Economic and Clinical Act (HITECH) provision that is part of the American Recovery and Reinvestment Act of 2009 (ARRA)? .............................................. 3

B. Electronic Health Records (EHR) and Electronic Medical records (EMR), is there a difference? ..... 4

C. Why EHR? .......................................................................................................................................... 4

D. How much money is allocated to HITECH? ....................................................................................... 4

E. What is the new office of the National Coordinator for Health Information Technology (ONC) and its duties? .................................................................................................................................................. 4

F. Who is the chief guru of ONC? .......................................................................................................... 5

G. What is Health Information Exchange (HIE)?.................................................................................... 5

H. What is “meaningful use?” ............................................................................................................... 5

I. What is the Health Information Technology Research Center (HITRC) and what are Regional Extension Centers (REC) and their roles? ................................................................................................. 5

J. What are Beacon communities? ....................................................................................................... 6

K. What are the Authorized Testing and Certification Bodies (ATCB)? ................................................ 6

L. What is the Certified HIT Products List (CHPL)? ................................................................................ 6

M. How does HITECH change HIPAA? ................................................................................................ 6

III. Process .............................................................................................................................................. 7

A. How will the funds be used and distributed? ................................................................................... 7

B. What is the process? ......................................................................................................................... 7

IV. Conclusions ....................................................................................................................................... 8

A. How will HITECH affect providers and hospitals practices? ............................................................. 8

B. How will HITECH affect software vendors? .................................................................................... 10

C. Will HITECH produce better health care outcomes and reduce healthcare costs? ........................ 10

V. Appendix ............................................................................................................................................. 11

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I. Summary Since the passing of the provision the “Health Information Technology for Economic and Clinical Act” (HITECH) in February 2009, there has been tremendous buzz in the Health Care Community regarding Health Information Exchange (HIE) and Electronic Health Records (EHR). New government agencies have been created and new funding incentives have been initiated. Millions of dollars have been spent. Software companies are clamoring, reinventing themselves, and gobbling up each other, all for potential new customers in Health care information technology. IT professionals are rewriting their resumes, new websites, and more experts than one can count. And health care professionals scratching their heads and wondering how this affects them. But what does it all mean; this paper provides some background, definitions, and processes and tries to reach some conclusions.

I selected this topic for this class because I am in IT and working in a healthcare organization, so was interested in what HITECH was all about. My goal for this paper was to have anyone that reads it have a good understanding of HITECH and to pull resources together in an organized manner so they wouldn’t have to surf the web and government sites getting the information. Most of the background information is taken right from their sources and referenced as such so if the reader wanted to researcher further they can. The conclusions are my own and based on some research and also just my personal observations following the HITECH since its inception and writing this paper.

As stated on the CMS.gov website the “HITECH’s incentives and assistance programs seek to improve the health of Americans and the performance of their health care system through “meaningful use” of EHRs to achieve five health care goals: To improve the quality, safety, and efficiency of care while reducing disparities; To engage patients and families in their care; To promote public and population health; To improve care coordination; and To promote the privacy and security of EHRs.” The concept is that like the financial industry where anyone can access their banking information on secure websites and through secure cards, why can’t personal health information behave in the same way. This will take cooperation, standards and policies that apply to all entities involved with health information with the result of lower health care costs and better health outcomes.

II. Definitions and Background

A. What is the Health Information Technology for Economic and Clinical Act (HITECH) provision that is part of the American Recovery and Reinvestment Act of 2009 (ARRA)?

The Health Information Technology for Economic and Clinical Health (HITECH) Act goals are; “to improve health care quality, safety, and efficiency through the promotion of health information technology (HIT) and the electronic exchange of health information. And “…to adopt standards, implementation specifications, and certification criteria to enhance the interoperability, functionality, utility, and security of health information technology to adopt an initial set of standards, implementation specifications, and certification criteria, and permits their adoption through an interim final rule.”1

1 Federal Register: October 13, 2010 (Volume 75, Number 197), From the Federal Register Online via GPO Access

[wais.access.gpo.gov]

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B. Electronic Health Records (EHR) and Electronic Medical records (EMR), is there a difference?

“The principal difference between an EMR and an EHR is the ability to exchange information interoperably. An EMR aligns with the prevailing state of electronic records today (whether the record is branded an EMR or an EHR). However, the movement of the industry is toward electronic records that are capable of using nationally recognized interoperability standards, which is a key defining component of an EHR. With the passage of time, electronic records not capable of exchanging information interoperably will lose their relevance. Thus the term EMR is on course for eventual retirement.”2

C. Why EHR? Electronic health records improve care by enabling functions that paper records cannot deliver. EHRs can: 3

make a patient’s health information available when and where it is needed

care is better coordinated because a patient’s total health information together in one place, and always be current

support better follow-up information for patients

improve patient and provider convenience

link information with patient computers to point to additional resources

improve safety through their capacity to bring all of a patient’s information together and automatically identify potential safety issues

providing “decision support” capability to assist clinicians

deliver more information in more directions, while reducing “paperwork” time for providers

improve privacy and security

Reduce costs through reduced paperwork, improved safety, reduced duplication of testing, and most of all improved health through the delivery of more effective health care.

Be used to compute information not just contain or transmit information. 3

D. How much money is allocated to HITECH? This will be approximately $27 Billion over 10 years. Some reports show that federal government will spend $36 billion between 2011 and 2015 on incentives for hospitals and physicians to purchase health IT.4 There are provisions of additional funding in the law. Being in IT I think that we will see this number increase over time.

E. What is the new office of the National Coordinator for Health Information Technology (ONC) and its duties?

The Office of the National Coordinator of Health Information Technology (ONC) is a division of the Health and Human Services Office and specifies the purpose of the Office and the duties of the National Coordinator. {Figure 1 – Org Chart}

2 Defining Key Health Information Technology Terms April 28, 2008; The National Alliance for Health Information

Technology Report to the Office of the National Coordinator for Health Information Technology 3 CMS Office of Public Affairs 202-690-6145 ELECTRONIC HEALTH RECORDS AT A GLANCE;

http://www2.cms.gov/apps/media/press/factsheet.asp?Counter=3788&intNumPerPage=10&checkDate=&checkKey=&srchType=1&numDays=3500&srchOpt=0&srchData=&keywordType=All&chkNewsType=6&intPage=&showAll=&pYear=&year=&desc=false&cboOrder=date 4 Behind the numbers: Medical cost trends for 2011; Price Waterhouse Health http://pwchealth.com/cgi-

local/hregister.cgi?link=reg/Behind_the_numbers_Medical_cost_trends_for_2011.pdf

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The ONC is responsible for all goals and objectives listed in HITECH.5

F. Who is the chief guru of ONC? On March 20, 2009 President Obama selected Dr. David Blumenthal as the National Coordinator for Health Information Technology through the Department of Health and Human Services new Office of the National Coordinator for Health Information Technology (ONC).

“Dr. Blumenthal most recently served as a physician and director of the Institute for Health Policy at The Massachusetts General Hospital/Partners HealthCare System in Boston, Mass. He was also Samuel O. Thier Professor of Medicine and Professor of Health Care Policy at Harvard Medical School. There, he also served as director of the Harvard University Interfaculty Program for Health Systems Improvement. Prior to that, he was senior vice president at Boston’s Brigham and Women’s Hospital and served as executive director of the Center for Health Policy and Management and as a lecturer on Public Policy at the John F. Kennedy School of Government.” 6

G. What is Health Information Exchange (HIE)? Health information exchange (HIE) is defined as “the mobilization of healthcare information electronically across organizations within a region, community or hospital system.”

“HIE provides the capability to electronically move clinical information among disparate health care information systems while maintaining the meaning of the information being exchanged. The goal of HIE is to facilitate access to and retrieval of clinical data to provide safer, more timely, efficient, effective, equitable, patient-centered care. HIE is also useful to Public Health authorities to assist in analyses of the health of the population.”7

H. What is “meaningful use?” [There are several stages to “meaningful use,”] “…the Stage 1 criteria for “meaningful use” focuses on electronically capturing health information in a coded format, using that information to track key clinical conditions, communicating that information for care coordination purposes, and initiating the reporting of clinical quality measures and public health information.”8

I. What is the Health Information Technology Research Center (HITRC) and what are Regional Extension Centers (REC) and their roles?

“The Health Information Technology Research Center (HITRC) was created to support the RECs by disseminating materials that, in turn, support and address the needs of

5 H.R. 1 American Recovery and Reinvestment Act As Signed into Law Summary of Health Related Provisions:

Section 3001 6 Friday, March 20, 2009 News Release “HHS Names David Blumenthal As National Coordinator for Health

Information Technology” http://www.hhs.gov/news/ 7 http://en.wikipedia.org/wiki/Health_information_exchange

8 Details for: CMS FINALIZES DEFINITION OF MEANINGFUL USE OF CERTIFIED ELECTRONIC HEALTH RECORDS (EHR)

TECHNOLOGY; Friday, July 16, 2010 CMS Office of Public Affairs http://www.cms.gov/apps/media/press/factsheet.asp?Counter=3794&intNumPerPage=10&checkDate=&checkKey=&srchType=1&numDays=3500&srchOpt=0&srchData=&keywordType=All&chkNewsType=6&intPage=&showAll=&pYear=&year=&desc=&cboOrder=date

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prioritized providers. The HITRC identifies and shares best practices in EHR adoption, meaningful use, and provider support.”

“The RECs are the vehicles for the dissemination of technical assistance, guidance and information on best practices to health care providers working to become meaningful users of Electronic Health Records (EHRs).”9

J. What are Beacon communities? “Beacon Communities will coordinate with the Regional Extension Center Program and State Health Information Exchange Program in their geographic areas, including the Health Information Technology Research Center (HITRC), to develop and disseminate best practices for the adoption and meaningful use of electronic health records and to facilitate national goals for widespread use of health IT. A core challenge that these communities will address is assisting other communities in identifying specific ways to use health IT for practical improvements in care.”10

K. What are the Authorized Testing and Certification Bodies (ATCB)? “Authorized Testing and Certification Bodies (ATCBs) are selected by the Office of the National Coordinator for Health Information Technology (ONCHIT). The ONC-ATCBs are required to test and certify EHRs as outlined in the Standards and Certification Criteria Final Rule. A certified EHR will let eligible professionals (EPs) and eligible hospitals (EHs) the systems will support the requirements they must meet to achieve meaningful use.”11

L. What is the Certified HIT Products List (CHPL)? “The CHPL will be a public service and would integrate into a single aggregate source all certified product information. The CHPL would also represent all of the Complete EHRs and HER Modules that could be used to meet the definition of Certified EHR Technology.”12

M. How does HITECH change HIPAA? Securing medical records in electronic form is one of the big challenges for HITECH, especially since the law has included “business associates.”

“Before the HITECH Act, the HIPAA privacy and security requirements applied only indirectly to business associates; business associates were not directly required to implement any of the detailed requirements of the HIPAA privacy and security rules. Before the HITECH Act, any privacy or security requirements were made applicable to business associates only through a BAA created between a covered entity and a business associate. A business associate that failed to abide by the BAA only faced a breach of contract claim from the covered entity, and was not subject to any

9 Planning for Adoption The Early Direction of Regional Extension Centers: eHealth Initiative Survey of Regional

Extension Centers September 2010; http://www.ehealthinitiative.org/uploads/file/9-7-2010_Regional_Extension_Survey_report_v5.pdf 10

http://healthit.hhs.gov/portal/server.pt?open=512&mode=2&objID=1933 11

ONC-ATCB Update – New EHR Certifier Posted by Roberta on Sep 20, 2010 http://www.hitechanswers.net/onc-atcb-update-new-ehr-certifier/ 12

Frequently Asked Questions: on Establishment of the Temporary Certification Program for Health Information Technology Final Rule June 21, 2010 http://www.himss.org/content/files/HHS_TempCertification_FAQs.pdf

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administrative or criminal penalties. Effective February 17, 2010, pursuant to the HITECH Act, many of the HIPAA standards will apply directly to business associates, and business associates will be subject to the same civil and criminal penalties as covered entities.”13

III. Process

A. How will the funds be used and distributed? Most of the initial funding has been used for research and infrastructure not only for the new ONC Office, but for the certification program and REC centers. Here is a list of the HITECH closed funding as of December 2010 listed on the ONC website:14

Health Information Technology Extension Program (Specific Regions) Regional Extension Centers

Beacon Community Cooperative Agreement Program (2 additional Beacon Communities)

State Health Information Exchange Cooperative Agreement Program

Health Information Technology Extension Program (Regional Extension Centers

Rounds 1 and 2)

Curriculum Development Centers

Community College Consortia to Educate Health Information Technology Professionals

Program of Assistance for University-Based Training

Competency Examination for Individuals Completing Non-Degree Training

Strategic Health IT Advanced Research Projects (SHARP) Program

The funding that is now becoming available is funding for the eligible professionals physicians and hospitals, private and public, to be used for EHR and HIE. “Eligible professionals can receive as much as $44,000 over a five-year period through Medicare. For Medicaid, eligible professionals can receive as much as $63,750 over six years. Medicaid providers can receive their first year’s incentive payment for adopting, implementing and upgrading certified EHR technology but must demonstrate meaningful use in subsequent years in order to qualify for additional payments.”15

After 2015, further financial incentives will not be available and penalties will kick in. There will be a 1% reduction in Medicare fees per year, up to 3% by 2017. 14

B. What is the process? How will be the CMS EHR incentive program registration process work? {See ARRA process flow chart in index, figure 3}

13

Business Associate Agreements under the HITECH Act: A Summary of Policy and Legal Issues for the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) http://www.himss.org/content/files/GuidanceBAA%20PolicyLegal%20IssuesHHS_2.pdf 14

http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__hitech_and_funding_opportunities/1310 15

CMS Office of Public Affairs, 202-690-6145, ELECTRONIC HEALTH RECORDS AT A GLANCE fact sheet; http://www2.cms.gov/apps/media/press/factsheet.asp?Counter=3788&intNumPerPage=10&checkDate=&checkKey=&srchType=1&numDays=3500&srchOpt=0&srchData=&keywordType=All&chkNewsType=6&intPage=&showAll=&pYear=&year=&desc=false&cboOrder=date

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Providers, Hospitals, and eligible professionals start the process by going to the CMS website, http://cms.gov/EHRIncentivePrograms/ starting in January 2011 to start the registration process. It is recommended that they should enroll with the regional REC centers before hand to help them through the process.15

According to NextGov.com website report dated December 17, 2010; “RECs have enrolled more than 28,000 providers, including more than 1,000 per week, on average, during the last three months.”16

IV. Conclusions

A. How will HITECH affect providers and hospitals practices? According to the American Medical Association official response letter to CMS, dated March of 2010, the medical community is “supportive and committed” to the meaningful use of EHR in physicians practices but had some concerns.

“[They] feel strongly that the Stage1 criteria proposed by CMS for achieving meaningful use of EHRs is too aggressive and if adopted, will deter many physicians from participating in the Medicare and Medicaid incentive programs. This runs counter to the intent of ARRA, which clearly indicated that demonstrating meaningful use should progress over time.”17 “Unrealistic timelines and criteria will only serve to undermine this effort.” The AMA also stated that they are very concerned that “there is currently no member of the Health IT Policy Advisory Committee—the advisory body established under ARRA to recommend a framework to the U.S. Department of Health and Human Services (HHS) for the development and adoption of nationwide health information Infrastructure—who represents small physician offices, despite the fact that small Physician practices represent 80 percent of all outpatient office visits.” In the 34 page letter the AMA also expressed 6 other concerns and procedures and concluded that they don’t feel that physician offices should not be penalized for not meeting meaningful use. In a New York Post article entitled “ObamaCare fight of the MDs” on December 10, 2010 they reported The Physicians Foundation asked 2,400 doctors and American Medical Association members what they thought of the new law; a full 67 percent were against it. 18 There are two main concerns, the projected 15 million new Medicaid enrollees and the costs of EHR as a result of the new health care law. Where will the new primary care physicians come from and how will small physicians’ offices afford the costs of upgrading their software systems?

16

http://healthitupdate.nextgov.com/2010/12/recs_receive_more_outreach_tools.php?oref=latest_posts 17

•AMA's meaningful use sign-on letter, March 15, 2010; http://www.ama-assn.org/ama/pub/physician-resources/solutions-

managing-your-practice/health-information-technology/hit-resources-activities.shtml 18

http://www.nypost.com/p/news/opinion/opedcolumnists/obamacare_flight_of_the_mds_2zWYU1R9DYG4K6dJ8oj8gP#ixzz194m1S14e

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CDW conducted a survey published on December 13, 2010 stating that 66% sited hardware/software costs were the number one concern. {Figure 2} CDW also calculated that the first year of EHR implementation would cost $120,000 in both lost revenues and outlays per Physician and $30,000 per year re-occurring. But they also estimate an increase of 15% of patients and productivity gain will add $151,000 per year per physician once the system is fully implemented. 19 Amednews.com covering the AMA Interim Meeting in November 2010 reported the captured the current feeling of the AMA by this comment from AMA Trustee Steven J. Stack, MD; "These are challenging times. ... It is worth the effort to be able to collect data and collaborate with each other for the betterment of the patient, but we have reasons to be concerned and worried about what the future holds." 20 Another concern is the requirement for incentives is that you must have a Medicaid patient volume of at least 30 percent. The first exception is that a pediatrician may have at least 20 percent patient volume attributable to those who are receiving medical assistance under the Medicaid program, as estimated in accordance with a methodology established by HHS.21 This influences the choices by physicians to not see Medicaid patients to seeing Medicaid patients, which is part of the overall goal of the government to make sure the underserved and not insured population is added to the Medicaid roles. Which is a good thing, but some members of the AMA feel that this is government intrusion into their practice. My personal opinion, based on my limited experience in a Cerner EHR implementation and other IT projects, is that IT projects take time and more money than originally anticipated. I played a small part working with lab results being electronically submitted to a web based “Power Chart,” then providers would log into a secure web portal to get lab results. The great thing was that once the labs where done, they were instantly available. One major issue was that Dr. Offices didn’t want to change their processes. They were so accustomed to getting faxes and using the paper faxes to dictate work flow, that they still wanted the fax option. They felt that going to the portal was great, but they would still print out the lab results and put it in the paper chart. This defeated the whole purpose of e-lab results. This is a small example of how the cultural and business process changes in these smaller offices could be a stumbling block to this initiative. Many would need to update their computers, bandwidth and train staff on new processes. This all costs time and money. Beyond all the technical issues, there will also need to be tremendous marketing efforts in assuring the public that their health information is protected. There is still concern about identity theft on the internet, imagine the uproar if personal health information became public knowledge.

19

http://newsroom.cdwg.com/features/feature-12-13-10.html 20

http://www.ama-assn.org/amednews/2010/11/22/prsg1122.htm 21

http://www.ama-assn.org/ama1/pub/upload/mm/472/faq-ehr-incentive-programs.pdf

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B. How will HITECH affect software vendors? In order to participate in HITECH vendors have to be certified EHR vendors. This is a process conducted by the ATCBs and so far there are 157 certified EHR products22 listed as Ambulatory certified and 57 certified Inpatient products. This alone should indicate the desire of EHR vendors desire to be part of the HITECH initiative. This is a boom for the HIT industry. The Wall Street Journal in an October 2010, quoted Glen Tullman, chief executive of the health-care IT company Allscripts Healthcare Solutions Inc. as saying, “We're at the beginning of the single fastest transformation of any industry in U.S. history." 23 Many large companies have already merged with or bought smaller companies and this article predicts that this trend is going to continue for 2011.

There is also plenty of room for growth in the EHR industry; depending on what survey you see the US lags other countries in EHR usage. {Figure 4} This table shows that the US has a 17% Ambulatory EHR usage and a respectable 10% Hospital EHR usage. No matter what resource you find it’s clear that interoperable health information exchange between health care entities is far behind the banking industry. Capital spending for Health IT is at the forefront of many hospitals and private practices in the next 5 years.

Many of the big companies like Meditech, Allscripts, Cerner, GE Health Care, Mckesson and Epic Systems Corp are certified EHR vendors. These companies had the resources to qualify for certifications, but some smaller new “cloud based” vendors feel that this is unfair to them, “Should [they] buy proprietary software, and ignore the trends toward open cloud technologies? The computing industry is undergoing a radical shift toward the “as a service” delivery model. The problem is that the stimulus funds were released too quickly for most cloud computing companies to qualify their offerings for the technical definition of meaningful use.”24 These agile companies feel that these legacy systems are outdated and based on older technology and will cost the customers more in the long term. It’s like the stimulus money will be used by these dinosaurs to pay for them overhauling there systems and not really helping the providers and hospital systems. “Many healthcare CIOs are questioning the lifespan and long-term costs of ownership if they invest into older client-server technologies.” 24

One thing is for sure, the Health Information Technology industry will be one to watch in the coming years and the landscape is changing. You can check out vendor rankings on the KLAS website http://www.klasresearch.com/News/Top20/BestInKLASsw.aspx

C. Will HITECH produce better health care outcomes and reduce healthcare costs?

In my opinion, yes, ultimately the Health Information Technology for Economic and

Clinical Act (HITECH) will produce better health care outcomes and reduce costs. If, one,

all involved keep these two goals in focus throughout this process. And secondly, not

because it’s such a great plan or that it will solve all the issues. But because it begins to

addresses an infrastructure that has been neglected, it’s like rebuilding the highway

systems in America, but in this case it’s the Health Information Highway (HIH, my term).

22

http://onc-chpl.force.com/ehrcert/EHRProductSearch 23 "Health-Care IT Sector Shaking Up As Medical World Goes Digital," Wall Street Journal (October 15, 2010).

24 http://news.yahoo.com/s/prweb/20101214/bs_prweb/prweb4874944_4

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There are still major concerns; the standardization of health record data (Health

Information Exchange HIE) that can be shared interoperable with any health care

software system, the security of personal health information, the CIOs concerns about

their return on investment in selecting the right software vendor, the medical

community (the feet on the ground) continue to be listened to, and now that we have

started down this road the commitment to see it through to the end. So much ground

work has already been done and I think that the ONC has set up a great infrastructure.

These next 3 years are just the start to actually seeing large scale implementations. I

think we will see monumental failures from greedy, “in it for the quick buck” and vapor

ware vendors. But we will also see legitimate long term vendors committed to the goals

have great successes as well.

V. Appendix

Figure 1 –ONC Org Chart

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Figure 2 – CDW Survey

Figure 3 - from Harvard presentation by John Halamka, MD, MS

Figure 4 - http://www.hsph.harvard.edu/phat/index.html http://chilmarkresearch.com/2009/11/19/phat-mash-up-healthcare-it/