Impact of meaningful-use criteria on EMR developers: insights from the 2010 MSP/Andrew EMR Benchmark.
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.
Meaningful use-related EMR Benchmark questions
EMR Benchmark question: "How did the delay in defining MU affect company (EMR developer) revenues in 2009?" (See Figure 1.) While many EMR developers said they felt no impact, 11 percent saw a benefit from ARRA; EMR sales were down for 29 percent of EMR developers in 2009, so ARRA's net impact was adverse on EMR developers by a factor of 3:1.
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.
The results of the continued delay in resolving MU is becoming worse. In 2010 the group positively affected shrinks to 8 percent, and the group unaffected by the delay in defining MU shrinks to only 37 percent (down from 61 percent a year ago), while those that are adversely affected grows from 29 percent to 56 percent.
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.
In 2009, there was some positive impact on jobs for 32 percent of EMR vendors. Yet there was negative impact, as well, for 11 percent who reported it caused layoffs. EMR developers with existing market share, who were receiving annual maintenance fees from current users of legacy and proprietary computer platforms, could afford to add new employees, building for the time when MU was clarified, and the EMR market would reignite. However, newer EMR developers without large installed bases (paying maintenance revenues) and without a war chest of venture capital funding, would have to layoff employees to keep their reduced income in balance by reducing expenses (reducing headcount). Yet these are the very EMR products that support current standards and have the latest hardware platforms. But that was only the initial impact in 2009. Now it is mid-year 2010 so what is the impact now? Figure 4 indicates the impact.
Eleven percent of EMR developers had to reduce jobs in 2009, and 8 percent had to reduce jobs again in 2010. However, while 32 percent of the EMR developers added jobs in 2009, only 16 percent planned to add more in 2010. For 76 percent of the EMR developers the delay in MU definition had no impact on jobs. So the ARRA legislation, through July 2010, has caused 24 percent of EMR developers to either add or reduce jobs. The number of EMR developers adding jobs from 2009 to 2010 dropped by 50 percent (16 percent to 8 percent) and the number of EMR developers reducing headcount (layoffs) improved by 3 percent (from 11 percent in 2009 to 8 percent in 2010). Because of adjustments in costs and revenues between 2009 and 2010, 76 percent of EMR developers say that continued delays in MU will NOT affect their employment. Jobs would hopefully be the last thing to change, as most EMR developers will take other actions before laying off staff. One such action is to increase EMR prices to boost revenues. In fact, we have included these questions in our EMR Benchmark. The results are shown in Figure 5.
About 43 percent of EMR developers have increased their EMR costs as a result of government MU and other certifications that are now required for ARRA reimbursement. The remaining 57 percent have not. The average price per provider for EMR deployment was about $43,000 in 2007, before CCHIT certification costs ( $40,000 for three years) and MU certification (price unknown) and many new development costs were added onto these baseline costs. So, today's EMR is a more expensive product than it was just 5 years ago--before all the government intervention in the healthcare market took off. CCHIT certification and its role in the future of EMR development are somewhat confused. Before ARRA, the government funded the creation of CCHIT, which was charged with improving the rate of adoption of EMRs. CCHIT decided that mandating what an EMR should do and then certifying the EMRs that met their definition--by giving a "CCHIT Certification" to an EMR--would expedite adoption, but it did not. It was very effective however at increasing EMR costs. Subsequent legislation required CCHIT certification as a precondition of government reimbursement under programs like the Stark "Safe Harbor" legislation.
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.
Almost 25 percent of the EMR developers who participated in the MSP EMR Benchmark plan to discontinue CCHIT certification going forward. For them it has little ongoing value. An additional 15 percent are considering discontinuing it. Five percent don't have CCHIT certification now, so the question isn't relevant to them. But 58 percent do plan to continue CCHIT certification, in spite of the expenses of having two different certifications--and the value of CCHIT in the overall process, which seems highly questionable given MU definitions. If MU is required, why should another organization layer on additional requirements, and charge vendors to test them separately?
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 understand ing 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)
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.
By Arthur Gasch, founder, MSP; and Bill Andrew, executive VP, 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, AH IMA 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 firstname.lastname@example.org.
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 FMR 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@example.com
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Figure 1--Copyright 2010 by MSP. All rights reserved. How did the delay in defining MU affect company revenues in 2009? Negative Impact 21% No Impact 61% Positive Impact 11% Very Negative Impact 8% Note: Table made from pie chart. Figure 2--Copyright 2010 by MSP, All rights reserved. How are continued MU delays impacting your business in 20107 * Negative Impact 53% * No Impact 37% * Positive Impact 3% * Very Negative Impact 3% * Very Positive Impact 5% Note: Table made from pie chart. Figure 3--Copyright 2010 by MSP. All rights reserved. How did ARRA & MU regulations affect employment at your company in 2009? * It has crested jobs 32% * It has had no impact on jobs 58% * It has reduced jobs 11% Note: Table made from pie chart. Figure 4--Copyright 2010 by MSP. All rights reserved. If MU is not finalized until 7/2010 or later, how will it affect employment? * It has created jobs 16% * It has no impact on jobs 76% * It has reduced jobs 8% Note: Table made from pie chart. Figure 5--Copyright 2010 by MSP. All rights reserved. How have government regulations and MU affected the cost of your EMR? * Greatly increased 8% * Increased 35% * No impact 57% Note: Table made from pie chart. Figure 6--Copyright 2010 by MSP. All rights reserved. Now that there is MU certification, will you continue to seek CCHIT-certification? * No 23% * Not Applicable 5% * Not Sure 15% * Yes 58% Note: Table made from pie chart.