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ONC Makes a Move

March 4, 2010
by David Raths
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HCI’s David Raths examines the new Certification regime.

There’s a lot of detail and a few unruly new acronyms (ONC-ATCB for ONC-Authorized Testing and Certification Body) to sort through in the 184-page Certification Notice of Proposed Rulemaking released March 2 by the Office of the National Coordinator.

As the ONC admits, it is forced by the Medicare incentive timetable into a slightly awkward two-step process in which it would establish a temporary certification program so that testing can begin this year. That program will be followed by a permanent program that would separate the responsibilities for performing testing and certification, introduce accreditation requirements, and would include the potential for certifying other types of health information technology besides EHRs.

On the one hand, the proposal seems to be pretty much what people expected based on recommendations of the Health IT Policy Committee, and many industry observers have applauded the shift in focus from certifying software feature lists to how the technology is actually deployed.

Edmund Billings, MD, chief medical officer and executive vice president of product at open source EHR vendor Medsphere Systems Corp., wrote about this change in emphasis last November in a piece in For the Record magazine. “In a shift away from the CCHIT’s previous focus on comprehensive feature function criteria, the revamped EHR certification standards will be relatively simple,” he wrote. “This time, there will be no focus on vendor-locking features. Instead, the committee will place an emphasis on desired uses and results—more practical for clinical purposes—and work on security, privacy, and interoperability issues.”

CCHIT will continue as a certifying body, but it is expected to be only one of several such entities, with NIST overseeing standards development. One question is how many organizations will apply to be certification bodies. How many are needed? ONC states that it anticipates only three applicants under the temporary certification program.” As far as I know, only one organization other than CCHIT has announced it would apply to be a certifying body: the Texas-based Drummond Group Inc., an interoperability testing lab. ONC estimates it will have six applicants under the permanent program.

Although many people applaud the new focus and ending CCHIT’s monopoly, the new certification regime may add new helpings of complexity to the plates of CIOs, who are still trying to digest the meaningful use proposals. To give just one example, the certification NPRM discusses how certification doesn’t neatly mesh with the flexibility proposed by CMS for when hospitals can begin to apply for the first stage of meaningful use:

“As proposed, eligible professionals and eligible hospitals who seek to have their first payment year begin in 2013 or 2014 would only need to meet meaningful use stage 1 requirements; however, the Certified EHR Technology they would need to use would need to meet the most recent certification criteria adopted by the Secretary, which at that time would be in support of meaningful use stage 2. As a result, should CMS finalize its proposed staggered approach for meaningful use stages, these eligible professionals and eligible hospitals would need to use “meaningful use stage 2 Certified EHR Technology” even though they would only have to meet meaningful use stage 1 metrics.”

In other words, organizations will have to shop for EHRs and modules certified by year, not by meaningful use stage, although ONC notes that “this apparent inconsistency would exist only for the years 2013 and 2014.” But recognizing that this is likely to confuse a lot of people, ONC ends this section of the NPRM with: “We request comments on ways to ensure greater clarity in the certification of Complete EHRs and EHR Modules.”

Once the Medicare and Medicaid EHR incentive program funding ends, what will motivate healthcare organizations to continue with this certification regime if they perceive it as costly or onerous? Perhaps by that time the certifications will be required not just for incentive payments but for any Medicare payments at all.