It’s time to revive the discussion of electronic health record software in light of the new federal regulations that define criteria for meaningful use and also set criteria for the EHR technologies that must be implemented by doctors and hospitals in order for them to become, and be paid for being, “meaningful users of certified EHR technology.”
While most of the public commentary so far has been directed to the NPRM on meaningful use, the real news here relates to the de-construction of EHRs that is described in the interim final rule covering EHR standards and implementation specifications. Of course, the NPRM and IFR are by design tightly linked. But the NPRM on meaningful use is primarily a set of instructions for doctors and hospitals about how to participate in the incentive payment programs established statutorily under ARRA/HITECH. The rule on EHR technology certification criteria, on the other hand, is a playbook intended for vendors and developers who want to qualify their products to meet the expected demand by meaningful users in those programs.
The revolution in the marketplace, if it occurs, will come from the changes to EHR technology blueprinted in the IFR, regardless of when, which, or how many doctors and hospitals become meaningful users. Let me explain.
Every software program has a “core.” The core is both actual and metaphorical, consisting of primary code routines around which others are constructed and subservient, as well as business logic which subsumes the purposes served by the application. The software core for traditional EHRs has been the routines for producing a “super bill” and documenting the evaluation and management steps taken by the provider, the goal being to capture all justifiable charges of the visit or hospital stay according to the rules set by the payers. Not to put too fine a point on it, it’s been all about the money. To the extent that EHRs have offered any return on investment to physicians and hospitals using them they have done so by helping to maximize the amount of charges claimed so reimbursements will be higher. This can border on abuse and even fraud, as physical exams are too easily “documented” by the push of an EHR button, but not actually performed. The engine driving this has been the fee-for-service payment system and all its costly, even bizarre complexity.
What Congress/HHS/ONC have now done is attempt to regulate into existence an entirely new software core for what is hereafter to be known as “EHR technology.” This new core is built around decision support and quality, rather than around charge maximization.
It’s a profound change, one that recalls the tradition of quality improvement and safety enhancement of which this is the latest incarnation. It has deep roots in the writings of Deming, Donabedian, Crosby, Leape, and, more recently Donald Berwick and David Blumenthal. Meaningful use creates a software core that focuses on data capture for individuals and for populations of individuals, along with the deployment of quite specific operations to be performed on and with those data, all of which relate to quality. These operations automate (that is, make more efficient) a number of key processes such as medication prescribing and order entry; they seek to improve quality through computational recall of information that is required for decisions about care; and they enhance safety by popping up alerts and reminders as close to the point of care as possible.
One of the more important of these operations is the reporting out of data organized into functional and clinical quality measures with a numerator and a denominator. Another important operation is the making accessible to patients/consumers of copies of their health summary data in standardized and computable electronic format that can be rendered as human readable documents, too. The latter may not only be a new tool in the box of quality tools, but a disruptive innovation in the sense described by Clayton Christensen in his many books and articles on technological innovation.
Now, merely redefining the core software functionality required of EHR technology used in the HITECH incentive payment programs may not be enough change to be revolutionary, although it’s a very good thing. However, the mandate for a new software core is accompanied by three additional and very specific regulatory directives included in the IFR. Taken together, they create an entirely new blueprint for the health IT industry to follow.
The first of these is the establishment of a new and HHS-controlled certification process, separate and apart from the industry-led Commission on Certification of HIT, or CCHIT. The language in the IFR makes clear that this break was intentional and carefully considered by those at the very top of the administration: “…the Secretary has decided not to adopt previously recognized certification criteria developed in 2006 [that is,by CCHIT] as any of the certification criteria in this interim final rule.” (Emphasis and notation added.) This one of the very few places in the document where the Secretary of HHS is invoked.
What the IFR says is that with respect to EHR technology going forward under HHS auspices CCHIT’s criteria are irrelevant. CCHIT may apply to become one of the certifying entities under the new regime for EHR technology certification being set up by HHS — and its heavy certification criteria may continue to be used by vendors on a voluntary basis — but it is no longer primum inter pares.
This is an important signal to the industry, because critics of CCHIT’s certification process, including myself, have pointed out that its costs and complexity have acted as a discouragement to technological innovation and a barrier to entry into the market by small companies whose software would likely be lower cost, easier to use, and less risky to implement. CCHIT in effect acted as judge and jury for its own industry’s definition of EHR software, inhibiting alternative approaches that would embrace component or modular architectures, web-based delivery also known as “software-as-a-service,” and practical means of achieving interoperable data exchange between applications from different vendors. Now, with HHS Certification replacing both CCHIT’s criteria and methodology, the government will be setting the terms for innovation and competition in this market, not a relatively small number of established vendors whose representatives served on the leadership boards and commissions of CCHIT. It’s a whole new ball game, as they say.
Secondly, the framers of the IFR explicitly encourage EHR technology vendors to develop products and services using a modular or component model, as an alternative approach to the single vendor, integrated EHR product model favored by the legacy vendors They use the analogy of plug-and-play as typified by modern audio and video equipment, writing:
“An innovative and competitive HIT marketplace needs to exist much like the marketplace for consumer electronics, where, for the purpose of setting up a home theater, a television, DVD player, and stereo system can be purchased from three different manufacturers, from a single manufacturer, or as a complete system from one manufacturer. To that end, we believe that it will be common in the near future for Certified EHR Technology to be assembled from several replaceable and swappable EHR Modules. For example, an EHR Module specifically designed to enable electronic health information exchange may be implemented for the purposes of interoperability and participation in a health information organization, regional health information organization, or some other consortium whose purpose is to enable the electronic exchange of health information.”
I think a better choice of analogy would have been to compare modular EHR technology with the way add-ons and plug-ins are available to enhance and extend the display and management of information in web browsers, or the manner in which the Apple iPhone apps store offers consumers downloadable applications that run on the iPhone OS platform. Regardless, the intent of HHS to influence the marketplace in a direction away from the legacy monolithic, single-vendor, one-size-fits-all model, is still very clear.
And, finally, the IFR authors open the door to innovation through clear-cut separation of content data exchange standards from transport and networking standards. They wisely offer the industry choices among similar and emerging content exchange standards, for example including both the CCR standard and the HL7 version of the CCR, as ways in which to use XML to standardize patient summary health data for movement across the network. However, the major breakthrough in the regs has less to do with the standards per se than with the clear directive to make it the norm that any application on the network must be able to consume data from any other application.
The reason this is so important to innovation is that it frees individuals and groups with potentially new and valuable ways of presenting or handling the data from having to worry about pre-existing applications to which their new app or device would have to conform. Developers and software engineers crave this kind of freedom of creative expression, and entrepreneurs understand that new business models for health IT will be available only if developers have the data in easily accessible standardized format for their work.
Taken together, these reforms will have profound changes on the marketplace for EHR technology over the next five years. Already, new entrants are poised to bring innovative products and services to the 85% of physicians who don’t yet use EHR technology in their practices. PracticeFusion, Optum/UnitedHealth, Medicity, RMDNetworks, Relay Health, Covisint, DocSite, AthenaHealth, and McKesson/HP are among the companies who have recently announced a “meaningful use EHR technology” offering that makes use of a “platform” with some degree of exchangeable, modular applications, along the lines of what is described in the IFR. And there will be many others. Costs for these products are generally lower, and in some cases significantly lower, than the comprehensive EHRs with which they will be competing.
The confusion that is a concomitant of very swift technology paradigmatic change, combined with billions of dollars of federal market subsidy, and in the context of new regulatory control and market influencing directives, will be intense for the near term. Doctors and hospitals will not be able to easily discern which product offerings among the many new and older EHR technologies are best suited for them, their practices, and their patients.
But when the dust settles — and it will settle — we may just find that EHR technologies are at the center of a health care system capable of improving quality and helping all parties to make better medical decisions.
David C. Kibbe, MD, MBA, is a Family Physician and Senior Advisor to the American Academy of Family Physicians who consults on healthcare professional and consumer technologies.