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Meaningful Use, Stage 3: Competing Visions for “Interoperability,” and Continuing Criticism
October 20, 2014

A month after the Centers for Medicare & Medicaid Services (CMS) published a Final Rule providing some flexibility to hospitals and physicians trying to meet the Meaningful Use (MU) requirements, the future direction of the MU program is at a crossroads.  There is presently no official guidance as to what Stage 3 will entail.  CMS was originally slated to publish a draft rule for Stage 3 of MU this fall.  Because the onset of Stage 3 was delayed for a year (as part of the recent Final Rule), however, the regulatory timeline may also be pushed back.

At the same time, a tremendous outcry has developed in the past year for “interoperability” between different electronic health record (EHR) products.  The demand has been sharpened by the inclusion of Stage 2 MU measures that require a fairly high degree of interoperability, such as the Transition of Care measure, as well as the likelihood that those requirements will only become more stringent in Stage 3.

Against this backdrop, two very interesting commentaries came out last week.  The first was an open letter from the American Medical Association to CMS and the Office of the National Coordinator for Health Information Technology (ONC), the parts of the federal government responsible for the MU program and for certification of EHR technology, respectively.  The second was the Final Report of the JASON Report Task Force, a group commissioned by certain advisory committees to ONC.  Both sources are openly critical of the trajectory of the MU program, and both present alternate visions and detailed recommendations for a sharply different and narrowed Stage 3 that focuses primarily on interoperability concerns.

The American Medical Association’s October 14, 2014 Letter

 The AMA’s letter categorizes a long list of grievances with the implementation to date of the MU program.  It emphasizes the administrative burden of the MU program on physicians, as well as the increased “cognitive burden” that using EHR systems imposes on physicians in their day-to-day practice, and makes specific recommendations to reduce both.

The AMA acknowledges the potential that EHRs have for more efficient care and better coordination and sharing of health data; however, it stresses that existing MU requirements “are having the opposite effect” and often “decrease the efficiency of patient visits.”  It advocates that all EHR vendors adopt what it calls “User Centered Design,” so as to reduce cognitive burden and its impact on physician effectiveness.

The letter reserves special criticism for what it views as the failure of the MU program to prioritize interoperability, which it says has imposed hidden costs upon providers.  It singles out ONC’s decision to adopt the C-CDA (Consolidated Clinical Document Architecture) file format as the format of choice for the interoperability requirements of Stage 2.  Because C-CDA is a “draft standard” that is subject to change, the letter argues, this decision has led to “wild variation” in the way vendors have implemented that standard in their products, and, as a result, “limited interoperability.”

 The AMA also suggests the following changes be made to Stage 3: 

  • Make the MU measures relating to interoperability optional.  The AMA’s letter suggests the View/Download/Transmit, Transition of Care, and Secure Messaging measures of Stages 1 and/or 2 be made optional.  They require interoperability with other providers and communications with patients and are therefore the hardest to achieve.
  • Abandon the “all or nothing approach.”  Currently, eligible hospitals and physicians must satisfy 100% of the MU program’s requirements.  If they do not, they do not receive MU incentives and are subject to MU penalties (e.g., payment adjustments).  The AMA proposes a threshold of 50% compliance with MU requirements for avoiding an MU penalty and a 75% threshold for receiving an MU incentive.
  • Abandon the concept of “core” and “menu” measures.  The AMA advocates a single set of measures.
  • Cease measuring compliance with MU measures by whether a provider has achieved certain percentages and thresholds (e.g., numerators and denominators). The AMA believes these are too technical and unnecessary to achieve MU.
  • Expand hardship exceptions.  The AMA suggests several ways to broaden the hardship exception process (CMS’ process for providers to request that they not be assessed an MU penalty for failing to demonstrate MU).  For instance, it suggests that exceptions be extended to providers who are required to report data through the Physician Quality Reporting System (PQRS), because of the administrative burden that results from the current lack of coordination between PQRS and MU reporting requirements.
  • Provide opportunity for public notice and comment with respect to the development of new Clinical Quality Measures (eCQMs).  According to the AMA, the process by which eCQMs are developed is not transparent.  The AMA letter also proposes that CMS develop a process to eliminate existing eCQMs that “no longer follow the latest clinical evidence.”

 The October 15, 2014 JASON Task Force Final Report

 The JASON Report Task Force Final Report (Final Report) was published on October 15, 2014, the day following the AMA letter.  Though the Final Report grows out of different concerns, it echoes many of the same concerns as the AMA letter regarding interoperability.

JASON is an independent group of scientists who advises the federal government on matters of science and technology.  In November 2013, JASON released a report, A Robust Health Data Infrastructure, that was highly critical of MU Stages 1 and 2.  The JASON report concluded that “[t]he current lack of interoperability among . . . EHRs” was “a major impediment,” and further, that “[t]he criteria for Stage 1 and Stage 2 . . . fall short of achieving meaningful use in any practical sense.”  (JASON report at p. 5-6.)  It urged CMS to take a radical new approach with Stage 3 and to use Stage 3 to create “a truly interoperable health data infrastructure.”  Towards this end, the JASON report encouraged EHR vendors to develop publicly available software connectors, known as “APIs,” to facilitate standardize record formats, vocabularies, and search algorithms.

For reasons that are not entirely clear, ONC did not publicly release the JASON report until April 2014, six months later.  After releasing the JASON report, ONC also assembled a “JASON Report Task Force,” a short-term joint workgroup organized under the auspices of ONC’s Health IT Policy Committee and its Health IT Standards Committee.  The goal of the JASON Report Task Force, which was comprised of eighteen members, drawn from hospitals, physician groups, EHR vendors, and the government, was to analyze the recommendations of the JASON report and provide recommendations to ONC. 

The Final Report, shaped over the course of ten meetings and public comment sessions, strikes a balance— agreeing with the overall thrust of the JASON report, but softening its tone and refining its suggestions.  (It is accompanied by a helpful slide deck, available here.)

Consistent with the JASON report, the Final Report recommends that MU Stage 3 be used as “a pivot point to begin the transition to an API-based interoperability paradigm” and that “a Public API” be included in the next specification for Certified EHR Technology.  Towards this end, the Final Report recommends that MU Stage 3 requirements should be “sharply limited” in return for “focused requirements targeting interoperability.”

On the other hand, the Final Report disputes the JASON report’s finding that no progress has been made towards interoperability in Stages 1 and 2.  It notes that the JASON report was issued nearly a year ago (belated release notwithstanding).  Since November 2013, the Final Report suggests, the market demand for interoperability in EHRs has increased dramatically, and the increased market demand has begun to spur the development of new, commercially available solutions.

The Final Report also disagrees with the JASON report’s contention that the federal government can implement a revolutionary new health IT architecture solely through a regulatory change, e.g., by adopting a radical new direction for Stage 3.  “Such tight synchronization,” the Final Report notes, would require a much higher degree of coordination of public and private levers than exists today, and could perhaps require new regulatory authority.”  (This echoes the findings of ONC’s recent 2014 Report to Congress, which notes that, among other barriers to interoperability, “practice patterns have not changed” to enable the widespread exchange of patient health information.)  The Final Report also notes that meeting timelines would be very difficult, given that less than a year remains before Stage 3 requirements must be issued.

Rather than prescribing a “single, top-down architecture for nationwide interoperability,” the Final Report recommends that the federal government follow the same principles that allowed the Internet to develop and grow and adopt “a set of standards and principles based on internet-style patterns and building blocks.”  The Final Report provides a number of discrete recommendations on this front.

So, What Will Stage 3 Look Like? 

Back in February of this year, a working group of ONC’s Health IT Policy Committee released a set of Stage 3 Draft Recommendations.  Though that working group emphasized that interoperability was a “top priority,” its recommendations were essentially an outgrowth of the MU measures for Stages 1 and 2, albeit streamlined and consolidated.  The AMA letter and Final Report, in contrast, present a completely different vision of what Stage 3 should be – de-emphasizing the counting of numerators and denominators in favor of an ambitious interoperability architecture. 

It remains to be seen what approach CMS and ONC will adopt in the coming year.  One thing is clear: the government is focused on big-picture interoperability, even beyond MU and beyond Stage 3.  Last week, ONC released a draft “Interoperability Roadmap,” which builds upon the 10-year vision statement it released back in June (covered in this blog here).  Although CMS, not ONC, will ultimately promulgate the Stage 3 measures, ONC is responsible for the forthcoming 2017 Edition EHR Standard.  The direction ONC takes with this standard is likely to be as important as the outcome of Stage 3 itself, given that vendors who wish to develop EHRs capable of achieving Stage 3 MU and beyond will likely have to meet 2017 Edition criteria.

In any case, it is hard to imagine that the Final Report’s detailed policy recommendations, the JASON report, and pressure from groups such as the AMA and others, will not affect the way MU standards are shaped.  The answer will come soon.

For additional information, please contact Eric Chan in Los Angeles at 310.551.8111 or Steve Phillips in San Francisco at 415.875.8500.

For media inquiries, please contact Barrett McBride at bmcbride@health-law.com or 916.456.5855.