Thursday, August 27, 2009

Certification and Practice Fusion

The HITECH portion of the American Recovery and Reinvestment Act of 2009 (ARRA) contains a provision that encourages physicians to adopt Electronic Health Records (EHR) systems. It offers bonuses to Medicare payments from 2011-2015 that cumulatively can amount to $44,000 to physicians who can demonstrate “meaningful use” of a “certified EHR.” The Office of the National Coordinator (ONC) is charged with developing these definitions, as advised by the Health IT Policy Committee and the Health IT Standards Committee.

The HIT Policy Committee’s Certification and Adoption Workgroup presented their initial recommendations on August 14, 2009, and laid out a certification approach that is significantly different from past practice. They propose a new definition of certification, referred to as “HHS Certification,” which is needed for access to HITECH bonus payments: “HHS Certification means that a system is able to achieve minimum government requirements for security, privacy, and interoperability, and that the system is able to produce the Meaningful Use results that the government expects.” They go on to make the following recommendations:

  1. focus Certification on Meaningful Use
  2. leverage Certification process to improve progress on Security, Privacy, and Interoperability
  3. improve objectivity and transparency of the certification process
  4. expand Certification to include a range of software sources: open source, self-developed, etc.
  5. develop a Short-Term Certification Transition plan

The ONC is recommending multiple certification organizations, and using “test harnesses” that will enable purchasers and vendors to easily self-test their EHR software. This is a markedly different direction from the past, where CCHIT was the sole certifying organization for EHRs. CCHIT was created by a vendor trade organization (HIMSS) and spun off as a stand-alone private non-profit that secured a designation from HHS to be the exclusive EHR certifying body. Not having a national HIT policy in place that defined what is meaningful about EHR use, CCHIT created a set of criteria based on (1) Functionality, (2) Interoperability, and (3) Security. Each year, new criteria were added to the requirements (never removed), which resulted in “feature bloat” and became increasingly product- and feature-focused – around 500 items were included in their 2008 certification criteria, and many of them were specifications apropos legacy client/server software (the kinds of systems that dominate HIMSS).

With a shift away from the CCHIT monopoly on certification, and toward a more pluralistic HHS Certification process needed for access to HITECH money, the going-forward relevance of CCHIT is called into question. Not surprisingly, CCHIT has been very active, and has even proposed their own new certification process that it plans to unveil in October 2009 (not waiting for the HHS Certification final details). Clearly, the process of HHS Certification continues to evolve, and CCHIT (as one of many eventual certifying bodies) continues to try to re-fit itself into the new framework.

Somewhat disturbingly, CCHIT continues to maintain a pathway of “traditional” certification, based on its historic (some call it “bloated”) criteria set, though it is not necessary for access to HITECH bonus funding. The value of such “full certification” is questionable, as it is superfluous to Meaningful Use. In fact, the ONC proposes that “for products that completed 2008 certification, permit an incremental certification process against ‘Gap Criteria,’ which includes a privacy review” – in other words, CCHIT certification does not necessarily guarantee HHS Certification, and migration to the new standards might be necessary.

So where does Practice Fusion stand in this dynamic and evolving scenario? We have a top-priority commitment to achieving HHS Certification, as this process emerges. Other than HHS Certification, CCHIT certification does not add benefit, and may even be a step backwards (since its criteria set are so client/server and feature-centric) – it is HHS Certification that “counts” and qualifies physicians for access to HITECH bonus funding. We are monitoring and participating in this process actively, and will pursue HHS Certification as quickly as the finalized criteria and certification pathways are set into place.

Robert Rowley, MD – Chief Medical Officer, Practice Fusion, Inc.

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Glenn Laffel, MD, PhD - Dr. Laffel is a physician with a PhD in Health Policy from MIT and serves as Practice Fusion's Senior VP, Clinical Affairs.

Robert Rowley, MD - Dr. Rowley is a family practice physician and Practice Fusion’s Chief Medical Officer.

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