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First Look at Temporary Certification Final Rule

June 21, 2010
by David Raths
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Five firms to apply to be temporary certifying bodies

On June 18 the Office of the National Coordinator for Health IT came out with the 206-page final rule surrounding its temporary EHR certification program, providing some specifics about how it will handle EHR modules and self-developed systems.

As the ONC admits, it is forced by the Medicare incentive timetable into a slightly awkward two-step process in which it is establishing a temporary certification program so that testing can begin this year. ONC expects to replace the temporary regime with a permanent program beginning Jan. 1, 2012.

So what did the ONC change between the proposed and final rules? The short answer is not much. But in responding to the large volume of comments to the proposed rule, ONC revealed some of its thinking about how the transition from temporary to permanent certification regimes will take place and how the testing of modules will take place.

One piece of news: ONC now believes that five firms will apply to become ONC-ATCBs, the clunky acronym given to temporary certifying bodies, and that “approximately 93 commercial/open source Complete EHRs and 50 EHR Modules will be tested and certified under our proposed temporary certification program.” Previously, it was thought only two or three firms would apply.

In fact, ONC officials believe that the potentially larger number of certifiers could create competitive pressure to drive the cost of applying for certification down. ONC agreed with the comments it received that it would be inappropriate for the certifying bodies to try to test the interoperability of EHR modules.

“Module integration is inappropriate primarily because of the impracticalities pointed out by commenters related to the numerous combinations of EHR Modules that will likely exist and the associated technical, logistical, and financial costs of determining EHR Module-to-EHR Module integration,” it wrote. If a module developer presents an integrated bundle, ONC would allow the testing and certification of the bundle only if it was capable of meeting all the applicable certification criteria and would otherwise constitute a complete EHR.

Many commenters asked that their EHR systems certified previously by CCHIT be “grandfathered” into certification approval. But ONC says grandfathering “provides neither assurance nor confidence for eligible professionals and eligible hospitals that their existing HIT will have the capacity to support their attempts to meet meaningful use Stage 1 objectives and measures…. Furthermore, while a deeming of this sort may address a very short-term need of existing HIT users, we believe it would significantly undercut our long-term policy goals and objectives, as well as provide eligible professionals and eligible professionals with a false sense of security.”

ONC tried to reassure people that modifying an EHR purchased from a vendor wouldn’t necessarily invalidate its certified status. “We believe it is possible for an eligible professional or eligible hospital to modify a Complete EHR or EHR Module’s certified capability provided that due diligence is taken to prevent such a modification from adversely affecting the certified capability or precluding its proper operation.”

The final rule’s numerous clarifications and the overlapping schedules of all the moving parts of ONC’s efforts highlight the complexity of this endeavor. Now the real work begins, as the new certification program must shift from concept to reality.