Certification

Certification of electronic health records has been a hot topic in health IT over the last few weeks. The concept of HHS Certification of electronic health record systems was unveiled to the public at the July open meeting of the Health IT Policy Committee (see link below.) The proposed plan is to require HHS Certification of an EMR in order for a user to qualify for incentives under Recovery Act (ARRA) legislation. Certification in the past has only been performed by the Certification Commission for Health Information Technology (CCHIT.) Now it looks like that is about to change. Responsibilities for testing and certification under ARRA were assigned to the National Institute for Standards and Technology (NIST.)
The certification process requires two components. First, a set of requirements must be established. Then electronic health record systems must be tested for compliance with these requirements. CCHIT has listed its requirements in a set of test scripts to which potential buyers and vendors may refer. The scripts are the product of many hours of volunteer committee work. All of the committees have multiple stakeholder representation. The bar to achieve certification has been raised by CCHIT annually. This is outlined in the CCHIT roadmap. A second arm of CCHIT is responsible for the testing of systems. The jurors who perform the evaluations for certification, for the most part, are active clinicians. For further information visit the CCHIT web site: http://www.cchit.org.
An important question is: What is the purpose of certification? There are a number of answers to this question. Certification is often viewed as a seal of approval by industry. For example, within a very short period of time after CCHIT began certification of electronic record systems many of the most well-known vendors applied. Also, many provider professional organizations supported CCHIT certification in their recommendations to members considering purchase of electronic medical record systems (EMRs.) Also, the federal government required certification for certain safe harbor exceptions from the Stark Anti-kickback Law. A reasonable purpose of certification is to provide assurance that the EMRs will deliver a defined level of functionality. This may help a potential purchaser screen vendor systems before a final purchase decision is made.
Under ARRA, certification will assure that the system meets the level of functionality required by the Meaningful Use definition. A clinician will be required to use a certified system in order to qualify for the financial incentives offered by ARRA. It appears that certification criteria will be set by the HIT Policy Committee in the future. Current proposals show progressive enhancement of the requirements during each two year certification cycle. This progressive "raising of the bar" poses significant technical and financial challenges for both vendors and purchasers. Many providers may choose to forego the ARRA incentives for just this reason.
So what organization will perform the actual certification? ARRA is somewhat vague on this issue. Rule making by the Secretary of the Department Health and Human Services, based on advice from the Office of the National Coordinator for Health IT (ONC) and the HIT Policy Committee, will determine the final arrangement. The preeminent role of CCHIT seems to be in jeopardy. It seems the plan is to make certification available through a number of designated entities. We will have to wait to see how this is determined in the final proposed rule that is due out by the end of the year.
NIST will have a more important role than it has had in the past. While NIST is a respected federal agency, I am not aware that it has played a major role evaluating HIT in the past. NIST has helped provided some important tools for software testing and validation though. Certainly, increased funding for its expanded role in health care will be needed. Whether it has the personnel or necessary experience to carry out its assigned role will need to be watched carefully. A visit to the NIST web site will provide a good idea of what had been the focus of NIST activities http://www.nist.gov.
Should all certification programs concentrate on the ARRA certification requirements? There is a real danger that ARRA will distort the certification landscape. For example, ARRA does not provide incentives for most providers of children's health care. Hospital-employed providers are not eligible for incentives. Also, many behavioral health providers and the specially adapted systems they use may not be included. An important gap is the lack of incentives for long term care facilities. Providers must also consider the health record needs of the 40%-70% of their patients for which ARRA does not apply. Therefore, there still may be good reasons for these groups to use certified systems that do not conform to the ARRA requirements.
What is the future role for CCHIT? The decisions by the HIT Policy Committee over the last several weeks certainly set CCHIT on less secure ground. The leadership of CCHIT has responded to the challenges of the ARRA legislation by expanding committee membership and developing new committees. They have outlined new certification pathways that address some of the previous criticism leveled at CCHIT. There is no foundation to the criticism that vendors have a disproportionate influence. Multiple stakeholders are well-represented on CCHIT committees. The criticism that the CCHIT process is biased because it both develops the test criteria and performs the testing itself is not necessarily valid. Test criteria development and testing are two well-segregated processes within CCHIT, supervised and performed by mostly separate staff.
Where are the gaps? Health IT implementations still fail at an alarming rate. In general, they are very expensive and take a long time to complete. Often user support post implementation is not what it should be. Some functions are excessively complex and difficult to use. True interoperability remains elusive and only occurs at a relatively few sites in the U.S. today. Future certification requirements must address the problem of usability and human factors engineering. Even though this will be difficult, it is important to develop objective, testable criteria and promulgate best practices. I think that certification should somehow assess the difficulty of the implementation process, need for training, and need for vendor support post implementation.
(The author has a personal interest in and a commitment to the certification process. He has been selected as a volunteer for the new advanced interoperability committee established by CCHIT this year. He has attended one CCHIT meeting thus far.)

7/21/09

Meaningful Use (MU) and Incentives to adopt Health IT

The term Meaningful Use has gained special significance as a result of the early 2009 ARRA legislation. A tremendous amount has been written about MU in the last 5 months. The Office of the National Coordinator for Health IT (ONC) and the HIT Policy Committee has been honing in on a final definition that is due to be delivered by the end of the year. This floating definition has stirred considerable concern for organizations involved with health IT in numerous roles. A major challenge for those determining strategic plans will be to decide to what extent to align with MU requirements.
The financial incentives for clinicians under ARRA apply primarily to the treatment of Medicare and Medicaid patients. Overall this may represent up to 40% of medical care in the U.S. Incentive payments are tied to Meaningful Use of electronic medical records (EMRs.) Since ARRA is front-loaded the greatest rewards are only available for those who become meaningful users in a very short period of time. But later, financial penalties kick in. Many knowledgeable health IT professionals, aware of current EMR adoption rates by providers and hospitals in the U.S., standards implementation limitations, infrastructure needs, and other technical requirements, believe that the timelines are unrealistic.
The question is whether ARRA and decisions determined by ONC and the advisory committees will become the backbone for strategic planning by clinicians and their organizations with respect to health IT over the next four to eight years. This is the course that provides the greatest opportunity for financial rewards for adoption of EMRs. However, relatively few providers are positioned to take full advantage of the incentives. Those most likely to be able to take advantage of the incentives are those that have already adopted EMRs. On the other hand, ARRA and MU have the potential to significantly distort the health care ecosystem. Many subsets of patients and providers are not even considered in the legislation (changes to HIPPA under ARRA is another issue that I am not considering here.) Some examples are children, behavioral health patients, and those in long term care facilities. Perhaps an approach that considers ARRA as just one of many components to consider in planning for the future will be best.
My viewpoint is that there is danger that the health IT agenda in the Obama administration will be driven primarily by a few bureaucrats with limited outside input. My sense is that the ONC position under President Bush put much more credence in public-private collaboratives. I think this was a good thing. Many of the organizations established during the past four years run the risk of being marginalized by the current approaches the new administration is taking.

Introduction

This is the first issue of my HIT blog. I have personal opinions, points of view, and experiences that may be of interest to others. Up front, I want to make it clear that what I write here only represents my personal opinions. My aim is not to serve as an official spokesperson for any of the organizations with which I participate.

Background

I practiced orthopedic surgery for over 26 years in a wide variety of practice settings, including: private practice, community hospitals, community-based academic medical centers, university level academic training programs, the VA, Kaiser Permanente, and the Indian Health Service. My training for medical school and residency was at the University of California, San Francisco. Years after finishing residency, I took a fellowship in foot and ankle surgery.
My last practice setting was solo practice in a remote urban area, Yuma, Arizona. All the orthopedists in Yuma practiced independently. I became exhausted by the required ED call, not so much because of its frequency, but because of the intensity and severity of the level of trauma I was required to cover. I rarely got any sleep when on call and usually worked all the following day. Uncompensated care, under-compensated care, escalating malpractice premiums and risk, difficulty arranging transfers of care and back-up coverage, decreased physical endurance (I was 57 when I closed my practice) chronic fatigue and the associated lousy life-style were also issues for me. I realize this particular combination of issues commonly confront orthopedists in other communities.
I have had a long interest in technology. I bought one of the early Macs the year they first came on the market. I received telemedicine training through the Arizona Telemedicine Program 12 years ago. I have been looking into using electronic medical records for about 10 years. I bought a LCD projector to use for presenting basic orthopedic lectures with PowerPoint when they were considerably more expensive than they are now. I developed a basic, media-based, orthopedic resident training curriculum for the major subspecialties areas in orthopedics that incorporated concepts of faculty-resident collaboration, up-to-date educational materials created by national/international subject matter experts and an easy-to-administer weekly objective testing program. I adopted a web-based practice management application in my last practice.
My interest in health information technology (HIT) bloomed with my involvement in the vendor selection process we went through at the local hospital in choosing an enterprise electronic medical record system. I was one of the physician champions and had the opportunity to represent the clinician viewpoint at many of the stages of the project. I had a “Eureka” moment and decided to pursue a second career in HIT. I thought it would be a good idea to compensate for my lack of practical knowledge in the field by obtaining an academic credential and training. In what seemed like the blink of an eye, I applied to and was accepted in the distance learning program at Northwestern University. I will describe my experiences as an adult student sometime soon. Suffice to say it was an intense, 20 month, odyssey that I just completed last month.
My special interests in HIT are: HIT policy, interoperability, health information exchange, and privacy/security/infrastructure. My goal is to be involved at the local, state and national level. I am on an IT committee at the local hospital. My state level involvement to date includes committee work with a non-profit organization, Arizona Health-e Connection, and I have worked on vendor selection for an ambulatory EMR in a project sponsored by our state Medicaid agency. National involvement has been with several organizations: IHE, HITSP, HIMSS, and recently, CCHIT. You’ve got to love all the acronyms.

Goal

I hope to communicate to others my passion for HIT. I expect to contribute several posts a week. I want to inform others about some of the innovative developments in health IT that are occurring around us and spur others to contribute in this important effort.