Impact of meaningful-use criteria on EMR developers

The term MU came into existence with the passage of the February 2009 American Recovery & Reinvestment Act (ARRA), which included the term meaningful use — but did not define it — as a precondition for receiving reimbursement by physicians who adopted EMRs. The idea was to encourage 100,000 physicians currently using paper-based charts in one- to 10-doctor practices to adopt EMRs that achieved MU and allowed them to put away their paper charts. It was a lofty goal.

And it was left to the Department of Health and Human Services (HHS) to define the MU term in a timely manner. On Jan. 9, 2010 — almost 11 months after ARRA was passed — the term MU was defined in a 220-page document issued by HHS. This document drew tens of thousands of pages of comments from various stakeholders who were unhappy with various aspects of the MU definition and certification requirements. One such comment was a letter from the United States Senate issued on March 2, 2010, signed by 27 senators (from both parties) to Charlene Frizzera, acting administrator, Centers for Medicare and Medicaid Services, taking issue with various MU provisions. A subsequent letter dated March 30, 2010, to Kathleen Sebelius, secretary, Department of Health and Human Services, and signed by a broad coalition of 37 senators (from both parties), asked for a flexible approach to encourage hospital and physician participation in the inventive program. The current status is that the comments are being digested and a new (final) version of MU is expected to be issued in the Federal Register by the time you read this article.

Not surprisingly, in this climate of regulatory uncertainty, neither hospitals nor physicians are rushing to buy EMRs, since they have no way of knowing if they will ultimately be reimbursed for their expenditures. Their reluctance is impacting the EMR market in some profound ways. The ARRA legislation was supposed to stimulate the adoption of EMR — but has it had that effect? In fact, there is mounting evidence that ARRA has not had uniformly positive impact. The EMR market has become more complex, more expensive and less stable since ARRA was passed, as many physicians and hospitals, initially poised to purchase EMRs in 2009 and 2010, have retreated to the EMR market sidelines to camp out until the MU issues are finally clarified. Survey results suggest that for a segment of the market, Washington's actions have driven the EMR market into a 15-month (and counting) market stagnation. For some EMR developers, the impact of Washington's bureaucratic delay has been like an elephant wading into a kid's plastic EMR swimming pool and then sitting down — squashing a few kids (EMR developers) in the process and squeezing out most of the water (EMR orders) it contained. Here is the data.

Since we are halfway through 2010, the EMR Benchmark posed the question: “How are the continuing delays in defining MU impacting your business in 2010?” Figure 2 provides the following insights.

Therefore, seven times more EMR developers are adversely impacted by Washington's delays in clarifying MU, than those that are positive affected.

In justifying ARRA the Obama administration claimed that unemployment would be held at 8 percent or below.

Now it is at approximately 10 percent nationally, but what about in the EMR market? After all, EMR adoption is a key underpinning of the massive health reform bill just forced through the Congress by the Democrats. What are some of these negative impacts of MU? How does failure to clarify MU impact jobs in the EMR segment, which is one of the things ARRA was supposed to address. The answers are illuminated by Figure 3.

However under ARRA, CCHIT-certification was no longer sufficient for the federal government, so it legislated a new process for MU certification, raising the question: “If CCHIT certification is not sufficient for MU certification, what purpose does CCHIT certification continue to serve and why should EMR developers pay CCHIT a fee of $40,000 over three years for a certification that is essentially insufficient to assure physicians that their EMR is reimbursable under meaningful user certification?” What further relevance does CCHIT have in the midst of the National Institute of Standards and Technology (NIST) now handling MU testing and other independent entities providing MU certification compliance? When asked in the MSP 2010 EMR Benchmark about their continued support of CCHIT, some EMR developers don't think they will continue CCHIT certification, but opinion is divided, as shown in Figure 6.

Whatever the Congressional Democrats thought was wrong with CCHIT, rather than fix it or eliminate CCHIT, they chose to create a much more elaborate and convoluted approach to MU certification. Remember, they did this before they even had a definition for MU. Here is the latest on the MU certification process — which, like MU itself, is still not defined 15 months after the ARRA legislation was passed by Congress.

Meaningful-use certification issues
MU certification requires new certification organizations because the CCHIT organization is not sufficient by itself. The ONC has proposed a two-stage approach in establishing the new federal electronic health record (EHR) certification process. The first MU certification would be a temporary stage and part of the mandate would be to establish different methods for testing and certifying EHR products. These would become the ONC-approved bodies, which could establish their own testing of EHR/EMR developer systems. CCHIT could be one of these bodies. The goal of these temporary testing bodies would be to expedite the evaluation process. The second stage, the proposed permanent process, is much more complex and bureaucratic. It involves individual testing laboratories that would be accredited by the National Institute of Standards and Technology (NIST), an independent ONC-approved accreditor (ONC-AA), and multiple ONC authorized certification bodies (ONC-ACBs). These permanent evaluators would certify products based in part on the independent testing results. Don't worry about that though; EHR/EMR developers will just be adding the overhead costs into the prices of the EMR products they develop and tax dollars will be funding the increase in size of these federal agencies. Not a good idea? Apparently several organizations are also concerned about this approach. The American Hospital Association recently issued the following statement to the ONC:

“While we understand that the temporary process is meant to provide an expedited process to ensure certified products are available on the market as soon as possible, the two-stage approach for certification will prolong the current instability in the health IT marketplace, which ONC should take steps to limit. In the near term, the market will be negatively affected by queues for certification; rapid growth in demand for vendors' products; limited vendor capacity to support installations; and health IT workforce shortages. Linking the two certification programs and building confidence in the value of certification under the process will provide a measure of assurance for those buying and selling certified products.” (Source: AHA Web site)

Indeed, one of the widest reaching new proposals from Medicare and Medicaid (CMS), in its notice of proposed rule making, or NPRM, was for the ONC-ACBs to conduct surveillance of certified EHRs after they have been tested, certified and installed. That means that CMS is not content with testing of EMRs/EHRs alone, but wants them to be tested after they are in use in the hospital setting. Even the FDA does not require that for drugs, but apparently this regulatory expansion is needed for EMR systems. But on what basis? Again, the AHA commented:

“Surveillance of installed, certified products is … a new concept in health IT that, as the NPRM notes, raises many questions. It is difficult for stakeholders to answer those questions, however, without a better understanding of what the process is meant to accomplish, what it will entail, and how the results of surveillance efforts will be used. 

“We request, therefore, that ONC conduct and make available to the public a thorough study on the purpose, scope and process for surveillance of certified EHRs. The study should involve consultation with all relevant stakeholders and include, among other things, a clear discussion of the expected benefits of surveillance; a summary of alternative approaches to surveillance; a discussion and estimate of the expected impact on stakeholders, including providers whose facilities are chosen for the surveillance process; examples of how surveillance has been conducted in related areas, such as NIST's program to validate cryptographic modules for conformance to Federal Information Processing Standard Publication (FIPS) 140-2; a comparison of the surveillance process to other forms of accreditation in healthcare, such as required accreditations for healthcare providers to comply with Medicare conditions of participation; and a discussion of how the results of surveillance might be used by the federal government, by vendors and by purchasers of systems.

“In considering the process for surveillance from the provider perspective, relevant questions include: Will surveillance only involve interactions with the vendor, or will the ONC-ACBs also involve providers with installed systems? If providers with installed systems are involved, how will the ONC-ACB choose them? What notice will be required? If surveillance is conducted at a particular provider site, what activities will take place? Will the ONC-ACB need access to a provider's information systems? If so, how will HIPAA privacy requirements be met? Will a business associate agreement be required? Will the ONC-ACB introduce new data to a provider's system to conduct tests? If so, what assurances will the provider have the ONC-ACB will not negatively impact its system? How will costs incurred by the provider be reimbursed?

A thorough study will, no doubt, bring to light additional questions.” (Source: AHA Web site)

Our conclusions
How long will it take to sort all of this new bureaucracy out and what will that cost? If MU definition clarification is any barometer (now in its 15th month and counting), then CCHIT certification should be sorted out sometime in 2011. But, October 1, 2010 is the date for the first year's MU self-certifications under the ARRA legislation, with reimbursement to begin in January, 2011. If MU isn't clarified until July 2010 (something that is by no means certain) how much time will EMR developers have to bring their EMRs into compliance with October 1, 2010 MU standards? To be fair, EMR developers have been given a guidance document of what most (not all) of the 2010 MU standards are likely to be, but most physicians, even those with current EMRs deployed, are not aware of MU requirements.

NaviNet Press published a survey on March 19, 2010 that stated,”63 percent (of physicians surveyed) were unaware or unsure of what the 'meaningful-use' reporting requirements were.” So even if physicians who are current EMR users receive software that supports all 2010 MU functionality, how will they be able to “self-certify” they have meet EVERY MU requirement by the Oct. 1, 2010 dead line? Remember, as the current law is constructed, miss one MU criteria, and you are disqualified from meeting the entire standard — the “all-or-nothing” criteria.

We conclude that few, if any, EMR-enabled physician practices will be able to certify that they have achieved three months of MU performance by Oct. 1, 2010 — certainly no practices that did not already have a deployed EMR or even started adopting in 2010. So what benefit will the Oct 1, 2010 incentive have? Effectively, none; it's an empty pot at the end of the 2010 EMR rainbow. Whether Congressional candidates will figure this out before the November 2010 elections is doubtful, as the end of the 2010 Congressional session is rapidly approaching, so they will likely leave their mess and go back to their districts to campaign on the masterful way ARRA “rescued” the U.S. healthcare system.

The next question is, “How many practices that start the adoption process in 2010 are likely to become certified meaningful users by Oct 1, 2011, the second deadline where full reimbursement is still possible?” The answer is highly uncertain because the typical time to plan and adopt an EMR, and achieve MU is 12- 15 months. After that, the total reimbursement for physician adopters of EMR that achieve MU, falls off dramatically, and then the penalties start. But none of the legislators who gave us ARRA are asking, “Why should an eligible professional (EP — term for person able to become a meaningful user of an EMR) be penalized because the Washington policy makers and bureaucrats took almost two years to define two words — meaningful use?”

EMRs and EHRs are great technologies that are essential for any truly integrated healthcare system to work in America, but to date every action the government has taken has generally slowed down the EMR adoption process and/or hurt many EMR developers (particularly smaller EMR developers). The meaningful use section of the 2010 MSP/Andrew EMR Benchmark is but one small snippet of the overall scope of this EMR research.

We also track a list of more than 680 features that key EMR developer solutions implement, cataloging all practice specialties their products support, determining which computer practice management systems they integrate with, what PQRI and other quality measures they implement and much more. This information is available from MSP's EHR Selector Web site (www.ehrselector.com) and our EMR Constructor Web sites, and will appear in future articles published over the next few months in Nelson and MSP publications. For readers who wish to acquaint themselves with EMRs and the EMR adoption process, we suggest obtaining a copy of “Successfully Choosing Your EMR: 15 Crucial Decisions” (Wiley-Blackwell at www.wiley.com or through the www.amazon.com Web site). A brief matrix of key features will be included in the next issue.

About the authors and MSP
Arthur Gasch, co-author of “Successfully Choosing Your EMR: 15 Crucial Decisions,” founded Medical Strategic Planning (MSP) in 1992. MSP is a NJ-based medical market research firm, offering the MSP EHR Selector as the only interactive, Web-based, critically vetted EMR product comparison tool that includes MU, HIPAA and PQRI criteria and the latest KLAS Research EMR product-satisfaction scores. Learn more about MSP at www.medsp.com. Formerly manager of market research for Siemens Corporation's electro medical division, Gasch has spoken on EMRs at Digestive Week, TEPR, the World Congress, AHIMA and other national medical conferences, and was moderator of the EMR panel at the October 2009 sixth annual NJ Biotechnology Conference for United Nation Trade Consuls. He was contributing editor for Biomedical Business & Technology newsletter from 1992 to 1996 and is publisher of Industry Alert, an MSP publication on emerging technologies to the U.S. hospital market. Art can be reached at [email protected].

Bill Andrew was the first HIMSS Lifetime Member, executive VP of the MSP EHR business unit, founder of Andrew & Associates, and creator of the EMR Survey, which became the MSP/Andrew EMR Benchmark, the most comprehensive EMR product compendium of the North American EMR market. Andrew established Andrew & Associates to provide EMR consulting services to the industry, prior to joining MSP. The EMR Survey was established by Andrew in collaboration with Dr. Richard Dick, Ph.D. (former study director, IOM CPR Study), and Dr. Robert Bruegel, Ph.D. Andrew also established the first industry-wide survey on EMR work-flow management systems, data that has now been incorporated into the MSP/Andrew EMR Benchmark. Bill can be reached at [email protected]

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