Reckless REC Wrecking

The Health Information Technology Extension Program, created and funded by ONC, has completed funding for all 62 Regional Extension Centers (REC), with a grand total of well over half a billion dollars and, predictably, criticism of the program was immediately forthcoming. The RECs are supposedly an impediment to free EHR markets and doomed to failure from the start, which may seem a bit contradictory if you think about it. Anyway, before making further statements and assertions regarding the “recklessness” of the RECs, or the impeding “train wreck” they represent, it may be beneficiary to take a closer look at the program.

Overview

The HIT Extension Program consists of 62 RECs, at least one for each State and territory, and one national Research Center (RC). The stated goal of the program is “to provide outreach and support services to at least 100,000 priority primary care providers within two years”. The individual RECs are supposed to conduct outreach and education campaigns in their respective States and inform physicians on the latest HIT developments and available programs and incentives. The RECs are also chartered to offer support and guidance to physicians selecting and implementing EHRs, particularly Primary Care docs in small practices and in underserved areas. These are the doctors that were left out by the regular market process because they were hard to reach, too expensive to implement and too poor to bother with. While the individual RECs are locally oriented, with feet on the ground in each State and each County, the RC is basically a National forum for RECs to share information and exchange lessons learned.

Funding

Other than a small amount of seed money, RECs are not handed out all those hundreds of millions of dollars of grant funds. RECs are paid for performance. For each physician they touch and manage to recruit, the RECs are paid about $1500. If and when the provider implements an EHR, the RECs receive another equal payment. The last third of the money is handed to the REC if, and only if, the provider achieves Meaningful Use. This arrangement is only in effect for two years. All those who believe that RECs are bound to fail should be reassured by the fact that in that dire case most of the allocated funds will remain with ONC. The RECs are expected to use the ONC seed money and find a way to become sustainable businesses after ONC ceases to support them financially.

Effectively, ONC is funding the start-up of 62 Social Businesses. A Social Business is a business whose purpose is not to amass profits for its founders and shareholders, but instead to better society and solve one social problem; a profitable and sustainable business, not a charity. As any venture capitalist knows, funding a startup is risky business and most startups never make it to the finish line. But some do, and there are strategies that investors employ to both minimize their own risk and maximize the likelihood of success for the entire portfolio. By providing the RECs with centralized operational oversight and by instituting milestone funding, ONC is doing exactly what a careful investor, managing other people’s money, would do.

Timeline

The argument goes something like this: The RECs are running out of time and there is no way they can create thousands of Meaningful Users in a short two years, or what is left of those two years. The common wisdom is that it takes many months, sometimes over a year, to transition a practice from paper to EHR, let alone Meaningful Use. That may be true for your average 30 docs practice. The RECs are not dealing with large multi-specialty practices in suburbia. They are dealing with the solo doc in Booneville, Arkansas. It shouldn’t take longer than 3 to 4 months to get a solo primary care practice from paper charts to Meaningful Use, if the doctor is willing. Granted, the time left for collecting maximum Medicare incentives is rather short, but the RECs constituents are those administering health care to the poor and underserved, many of whom will be receiving incentives from Medicaid. There is plenty of time for Medicaid incentives. And if some RECs fail, as some inevitably will, and are unable to deliver Meaningful Users, they will forfeit most of their allocated grant money. Tax payers in this case will not foot the bill for failure.

Resources

We all know that the Meaningful Use gold rush is creating a shortage of qualified EHR implementation resources, so how are all those RECs going to staff their operations? They certainly cannot compete with private market salaries, since the ONC seed capital comes up very short. Strangely enough, most RECs managed to build their infrastructure already, but will there be enough funds to hire HIT experts and will anybody want to take a job which may prove to be very temporary indeed? It is very unlikely that RECs will attract experienced EHR implementers who are used to flying out to client sites, staying at nice hotels, renting cars and having all their expenses paid while on the road. RECs cannot afford these resources, and RECs do not need these types of resources either. RECs are not selling and implementing EHRs. They are there to see that the vendor does a good job and serve as the physician advocate during the process. Many RECs are University based and others were created by traditional Quality Improvement non-profits. None of them are starting from scratch and, like every startup, they will have to come up with innovative solutions. Some already have, others will learn from those examples and, as John Moore aptly predicts, the remainder will not be around after 2012.

Free Market

Here is my favorite gripe against the REC concept. The RECs are selecting a handful of preferred EHR vendors to recommend to their clients and therefore are interfering with the free market. Particularly since most RECs seem to select the same usual EHR suspects. Along the same lines it can be argued that every hospital Group Purchasing Organization (GPO) is interfering with the free market and so are Sam’s Club and Costco and any other discount for volume program. Why are the RECs consistently selecting EHRs from a small group of about a dozen products when we all “know” that there are 400 EHRs out there? Perhaps it is because there are not 400 viable EHRs out there. There never were. There very well may be 400, or more, companies selling, or trying to sell, EHR software, but very few of those companies ever made it into the main stream and even fewer have enough stability, or appeal, to be a viable choice for an informed consumer. It is worth noting that the EHRs the RECs are selecting are the same ones that physicians independently selected prior to the RECs creation, and thus the ones with the largest existing market share. Perhaps one size does not fit all, but certain sizes do fit most, and anyway, RECs are by definition committed to work with any EHR a physician chooses, whether recommended by the REC or not. When you compare this with the non-profit North Shore Long Island Jewish Health System spending $400 million to roll out one particular EHR to 7000 physicians, I don’t think the RECs are skewing the “free market” too much.

For anybody wondering about the existence of a dark side in the RECs EHR selection process, I would suggest reading the latest EHR selection press release from the Ohio REC. The selection criteria for Ohio seem pretty straight forward: adequate functionality, capacity to do the work, willingness to hire and train Ohio citizens, support provided exclusively in the U.S. and commitment to ongoing certification. Looks rather reasonable to me. By the way, the Ohio REC reported about 40 vendor applications, which makes one wonder where exactly are the other 350 EHR vendors hiding.

Innovation

How about “stifling innovation”? Are the RECs holding back the future of HIT by selecting old “legacy” EHRs? There is no question that the RECs are selecting what they, and most reasonable folks, consider safe products, products that have been around for a while, products with a sizeable install base and products backed by financially stable companies. Would you buy a car from Stimulus Motors, Inc., who’s been in business for 12 months, has 5 employees in the U.S. and 3 customers, just because they advertise usage of “latest technologies”? What are “latest technologies”? If you look at the “legacy” EHRs selected by the RECs, most boast .NET or the latest Java software, industry standard databases, browsers, rich thin clients and even Natural Language Processing engines. The assumption that all innovation must come from 2 guys in a garage is largely a fallacy. Besides, a truly valuable innovation should be able to make its way through any market, whether it is a completely new paradigm or the much exulted iPhone proprietary model. Personally, I hope we don’t devolve back to days when a particular software product was inextricably tied to a particular piece of hardware, and for lack of a better term, call it innovation, but this is better left for another day and another post.

Full Disclosure: I have a financial interest in EHRpathway, LLC which is currently providing consulting services to the Missouri State REC.

Calling Dr. Berwick

On April 27, 2004, President George Bush signed Executive Order 13335 establishing the position of the National Health Information Technology Coordinator. Six years, a recession, a change of administration, a couple of major legislations and a multitude of billions of dollars later, the Office of the National Coordinator for Health Information Technology (ONCHIT) is finally on the road to delivering on the original vision behind that executive order.

The stated mission of ONCHIT, as reiterated in the HITECH Act, was the creation of a nationwide interoperable health information technology infrastructure that makes pertinent information available at the point of care, improves health care quality and coordination, reduces health care costs and disparities and does all that while protecting privacy and security. While the 2004 executive order did not go into much operational detail, the HITECH Act provided instruction on the structure and strategy for building the HIT infrastructure. It is interesting to note that the HITECH Act is comprised of two Titles; Title XIII in Division A which outlines the activities expected from ONCHIT and Title IV in Division B which creates the Medicare & Medicaid stimulus incentives to eligible providers. The notorious “Meaningful Use” term appears only in Title IV and only as a prerequisite for stimulus incentives from CMS and is loosely defined by certified technology, electronic prescribing, information exchange and reporting on clinical quality measures. Additional guidance is provided on the selection of clinical quality measures to be in accordance with Section 1890(a) of the Social Security Act, which awards CMS $10 million every year for contracting development of such measures. Meaningful Use seems a rather benign litmus test for CMS to administer prior to dispersing any stimulus incentives. So why is it that “Meaningful Use” became the defining substance of the ONCHIT mission?

From the first meetings of ONCHIT (or ONC for short), Meaningful Use was seen as the centerpiece for the definition of a roadmap to that elusive nationwide interoperable health information technology (HIT) infrastructure. Meaningful Use Stage 1, Stage 2 and Stage 3 were presented as the milestones on the roadmap to success and, as such, ONC assumed an active role in defining the various Meaningful Use stages. Basically, the interoperable HIT infrastructure is not defined according to the capabilities it must have, but instead it is defined in terms of what users of the emerging infrastructure must achieve in order to obtain incentives. This was largely hailed as a wonderful approach. Instead of just building standards and tools to facilitate a nationwide information exchange, we first mandate what we want to exchange, how it should be recorded, who should record it and where it should be reported, and only then do we build the infrastructure to support our mandates. We then throw in some cash and some penalties just to be sure that if we build it, they will indeed come. Sounds very reasonable, except who is “we”?

Now that Stage 1 of Meaningful Use has been largely put to bed (a few minor adjustments not withstanding), ONC is turning its attention to Stage 2 and perhaps Stage 3. Presumably there will be more of what Stage 1 required, many of the capabilities required in Stage 1 will morph into requirements for actual execution, more data will need to be captured and actually exchanged, more standards will be defined and more clinical performance measures will need to be reported. And just like Stage 1, it seems that ONC is leading the charge for Meaningful Use, instead of CMS who will end up just publishing the requirements. No surprises here, except a brand new workgroup of the Health IT Policy Committee chaired by Dr. Blumenthal himself – a Quality Measures workgroup. There is already a Clinical Quality workgroup in the Health IT Standards Committee, so I was intrigued by the policy aspects of quality measures and ONC’s need to address them.

From listening to the first meeting of the Quality Measures workgroup, it seems this is a group of well-intentioned and very talented folks trying to figure out what clinical indicators should be required for Meaningful Use Stage 2 and Stage3 reporting. The main considerations cited in this meeting were parsimony and HIT-sensitivity; parsimony, in the sense of few broadly applicable measures and HIT-sensitivity in the sense of measures best enabled by EHR technology. The entire conversation (transcribed here) is most interesting. The ONC workgroup is aiming at thoroughly examining work done by traditional quality measures builders, such as NQF, and coming up with its own recommendations to support various health care and health care policy goals. The discussion ranged from how clinical measures should support sustainability goals of federally funded Health Information Exchanges (HIE) to their ability to enable operations of Accountable Care Organizations (ACO) to the fact that lipids measurements should be stratified by risk factors.

It seems that ONC is not solely in the business of providing tools and standards to enable the practice of quality medical care as defined by CMS, but it is actively engaged in deciding how medicine will be practiced in the future. I am not entirely certain how this transformation occurred or whether the initial intent was indeed to have Health Information Technology drive the practice of medicine.

And where is CMS? Where is Dr. Berwick?

By all accounts, the most experienced and knowledgeable visionary leader when it comes to quality of health care, is the new CMS Administrator, Dr. Donald Berwick. From his position as Vice President of Quality-of-Care Measurement for the Harvard Community Health Plan, to the Quality Improvement in Health Care demonstration project, and finally to the Institute for Healthcare Improvement (IHI), one would be hard pressed to find anyone better suited to guide health care quality improvements and shape the meaning of Meaningful Use.
So why is it that health care quality improvements and measurements are left to the technology folks? Isn’t this where Dr. Berwick was supposed to provide unrivaled leadership for the entire nation?

Diffusion of EHR Innovation

No matter what your opinion of Electronic Health Records (EHR) is, you would probably agree that the concept of computerizing medical records represents an innovation of sorts. The spread of innovation, or its diffusion, has been researched and modeled by Rogers[1] as a bell shaped advancement through populations of Innovators, Early Adopters, Early Majority, Late Majority and Laggards (the blue curve in the figure below). At some point during this spread of an innovative solution a Critical Mass of adopters, or Tipping Point, is reached and the innovation is assured widespread diffusion (Gladwell[2]).  Adoption is usually described by an S-shaped curve of adopters vs. time, and the rate of adoption is the slope of the S-shaped curve at any given time (the red curve in the figure).

The Tipping Point occurs right after the rate of adoption assumes its largest value which will be maintained throughout most of the adoption process. It is worth noting that the diffusion of innovation model is not predictive. Many innovations linger and die within the Innovator circle. Another important aspect of the model is that the time variable is not constrained. Depending on the rate of adoption, it may take weeks, months or many years for an Innovation to spread throughout a given population. There is no question that EHR adoption is slowly moving up on the ascending side of a classic diffusion model bell curve, but is it moving fast enough? Is the tipping point visible? Are we there yet?

In order to answer these questions and assess where we are on the path to EHR adoption, we must examine the elements affecting diffusion of new ideas, objects or practices, i.e. Innovations, as they pertain to EHRs.

The Innovation – Not all things classified as Innovations are equal and this may explain why some succeed in becoming main stream and others fail. Rogers[1] suggests four defining characteristics of innovation:

• Relative Advantage – To what degree is the EHR perceived to be better than the practice it aims to supersede – paper charts? The daily debates on the merits of EHR in various health care forums are stark testimony to the fact that potential users are sharply divided on the answer to this question. For some, EHRs are increasing efficiency and improving quality of care for patients. For others, EHRs are impediments to quality of care and an endless money pit for the practice. The biggest advertised advantage of EHRs, interoperability, is little more than a promissory note issued by EHR proponents to prospective adopters. The Government is adding an advantage in the form of stimulus incentives and future financial penalties for non-adoption. This advantage seems to be significant for hospitals and large groups, but less so for small private practices.
• Compatibility – Are EHRs compatible with existing values, past experiences and needs of potential adopters? Here EHRs are being propelled onto the much larger stage of health care reform. They are no longer a humble replacement of pen & paper and fax machines. EHRs are instruments of change; a change from treating one patient at a time the best you can, to considering value-based strategies for the benefit of entire populations, and considering those right at the point of care. This seems to be a major departure from a value system created and enriched across many generations of medical doctors.
• Complexity – Simplicity is always a virtue. The complexity of hospital EHRs, with their unwieldy CPOE modules, has created a perception of EHRs being rigid and unduly complicated tools, which take years to master.  The simple ambulatory EHRs available today, have failed to change these perceptions. To be fair, EHRs are inherently more complex than a piece of paper, but that should not necessarily deter adoption. After all, the wheel was more complex than walking, and making fire was extremely hard initially.
• Trialability – Experimenting with small parts of an innovation before taking the final leap reduces adopters’ risk and anxiety. EHRs can be, and mostly are, implemented in stages, particularly in hospitals. In the ambulatory sector there was a trend to implement electronic prescribing as a trial before complete computerization. Perhaps the best exercise of Trialability for EHRs is the free trials offered by too few vendors.
• Observability – An innovation is more likely to be adopted if its results are easily visible to others. This of course assumes that the results are positive. Unfortunately, successful implementations of EHRs are uneventful and largely anonymous, while their failing counterparts, usually associated with astronomic losses in funds and sometimes lives, are very visible, heavily advertised and frankly more interesting. There is no news in a 3 physician practice in Omaha installing a mid-priced EHR and having no problems to report.

Communication Channels – The news and evaluation of an innovation are spread throughout the community by various means, from mass media to informal peer to peer communications. As every EHR vendor knows, the latter is the most prevalent and effective method of disseminating messages amongst physicians. It is also a very slow method of creating awareness and unless the innovation is indisputably positive, much confusion is created by conflicting messages from friends and colleagues, thus slowing down the diffusion process. The Government’s intervention, with all its glorious publicity and billions of dollars in support of the innovation, is doing wonders in bypassing the conventional “word of mouth” diffusion mechanism. The downside is that EHR is now associated with Big Government and a particular flavor of politics.

Time – Time is involved in diffusion of innovation in several ways.

• On an individual level the innovation–decision process goes through five stages known as: knowledge – persuasion – decision – implementation – confirmation. In EHR industry parlance, these translate to: research – assessment – selection – implementation – adoption. The shorter the innovation-decision individual cycle is and the more people actually complete it without dropping out in its midst and the more positive their adoption experience is, the faster an innovation is expected to diffuse. For EHRs this cycle can range anywhere between a few months for a small practice to several years for a large hospital. The Government imposed Meaningful Use schedules are shortening the innovation-decision cycle for those racing to qualify for maximum incentive. Perversely, the inadequate time allowed for implementation will also increase failure rates and adverse events, which does not bode well for long term diffusion rates.
• Diffusion is also affected by the Innovativeness of the population targeted by the innovation. Here is where we encounter the accusations of physician being inherently opposed to technological advancements, and the counter arguments based on the number of iPhones and iPads already owned by physicians, not to mention all the advanced technologies in imaging, surgery and other medical fields, which are readily embraced by the medical community. When it comes to EHRs though, most docs don’t mind being very late adopters or even laggards.
• The rate of adoption dictates how much time it will take for an innovation to diffuse throughout the system. Unfortunately for EHRs, the rate of adoption is heavily dependent on the 5 characteristics of an innovation and none of those are particularly stellar for EHRs. This is why the rate of EHR adoption prior to HITECH has been lingering at the bottom of a very wide S-curve. The Government intervention, which as mentioned above is increasing the financial advantage, is making a marked difference in the rate of adoption effectively pushing EHRs up the S-curve.

The Context – Innovations are diffused within the boundaries of a social system. The structure, norms and leadership of a system also affect the diffusion of innovations.  Systems whose members are similar in education, social status and beliefs (homophilous) are not well suited to rapid change and innovation. Physicians arguably do form such system. The historical low rates of EHR adoption could be attributed to lack of accepted opinion leaders in general, and those who view EHRs as a positive innovation in particular. The public personas that have an MD after their name and relentlessly advocate for EHR adoption are usually not practicing physicians and as such, are not accepted as respected opinion leaders by most practicing doctors.

The diffusion patterns described so far are assuming that the innovation is optional for any given individual. However, innovations are not always an individual choice. Sometimes the decision to innovate is Authority Driven. Authority driven innovations are faster to be adopted and depending on the level of coercion, may follow a completely different path. Up to HITECH, individual physicians in private practice considered EHRs optional. Those employed by hospitals or large groups were experiencing the effects of authority driven innovation all along, thus the much larger adoption rates in those sectors. Although EHRs are not yet mandatory, the increasing pressure exerted by Government incentives, regulations and penalties is changing the diffusion patterns of the EHR innovation.

Keep in mind that Government exertions do not need to continue until every physician in the country has purchased an EHR. They only need to ensure a critical mass of EHR adopters is created and the mythical Tipping Point is reached. The Tipping Point is usually observed at about 15% adoption under normal circumstances and is marked by the emergence of opinion leaders who adopted the Innovation. EHRs and health care in general are anything but normal and I would expect a larger percentage of adoption to be required before EHRs “take off” in a self-sustaining fashion. As to respected opinion leaders, there are none.

So are we there yet? I don’t think so, but we are awfully close.
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1. Everett M. Rogers (1995), Diffusion of Innovations (Fourth Edition), New York, Free Press.
2. Malcolm Gladwell (2000), The Tipping Point: How Little Things Can Make a Big Difference, New York, Little Brown.