Rules for designating EHR Certification bodies now defined

On Tuesday, March 2nd, the Office of the National Coordinator (ONC) for Health IT released a new Notice of Proposed Rulemaking (NPRM) detailing how Certifying Bodies will go about testing and certifying EHRs. Using HHS-certified EHRs is required for physicians to have access to ARRA/HITECH incentive funds that will begin to become available in 2011.

Previously, the Centers for Medicare and Medicaid Services (CMS) had released a Meaningful Use NPRM, which is currently in the 60-day open comment period. This proposal specifies the 25 different categories of Meaningful Use that a physician needs to demonstrate in order to be eligible for incentive money – although these proposals have undergone modification and won’t be finalized until after March 15th.

Simultaneously, the ONC released an Interim Final Rule (IFR) on Certification, which details the capabilities an EHR system must have in order to become certified. Notably, the IFR introduced the concept of “Certified EHR Technology,” acknowledging that it may be unlikely for a single product to be able to address all 25 categories. Certified EHR Technology can be achieved either through a single Certified EHR (which does everything in one package), or through a collection of EHR Modules, each of which are certified to accomplish one or several of the categories and which can be mixed-and-matched to achieve the desired overall functionality.

What was missing was the process of designating ONC-Authorized Testing and Certification Bodies (a new acronym in the space: ONC-ATCB). Up until now, CCHIT and Drummond have expressed interest in becoming such Certification Bodies, though others may also follow suit now that the process is better defined. An easier-to-manage bookmarked copy of the NPRM can be found here.

This new document introduces a new concept. Given that the time is short before certification of EHRs need to be in place before the 2011 deadline (and we have expressed our concern about this previously), the new NPRM describes (1) Temporary Certification, and (2) Permanent Certification.

The Temporary Certification for ONC-ATCBs is a short-term stopgap, and the open comment period for this part of the NPRM is 30 days (it is 60 days for comments on the Permanent Certification portion of the NPRM). It is intended to cover the period from Q2 2010, and sunset after Q1 2012; Permanent Certification will begin Q1 2012 and continue on an ongoing basis subsequently.

We certainly applaud the release of the detailed process by which EHR Certification can proceed, and understand the reasoning behind a quick Temporary process, to be followed by a Permanent process down the road.

The main concern I would pose is this one: when the doors open up and one or more ONC-ATCBs are designated, there will be a crush of vendors (estimated 180+ different vendors in the EHR space) cramming to get in the door simultaneously, seeking certification. What if a vendor fails one or more Modules? Do they have to go to the back of the line for re-examination? Will that impede the designation of Certified EHRs and hamper overall EHR adoption (which is, after all, the whole purpose behind this process)?

A method to consider is how the Joint Commission for Accreditation of Healthcare Organizations (JCAHO) goes about accrediting hospitals and other healthcare organizations. The accreditation process is intensive and detailed, as anyone who has been through a JCAHO survey will attest. Few hospitals, who fail the testing process significantly, will lose their accreditation status. Few hospitals, on the other end of the spectrum, will become accredited with no contingencies. Most hospitals will have a few findings that don’t quite “make the mark” in some areas, but will be granted accreditation “with contingencies” – these contingencies will subsequently be re-addressed by a focused follow-up survey to ensure that compliance with the regulations has been met.

This may be a good model to follow. If Temporary Certification in a given module is pretty close (is “90% there”), then Certification “with contingencies” may still allow for designation of Certification status (and thus allow the vendor to help physicians meet Meaningful Use in time for 2011) – and the contingencies need to be cleaned up in a short, focused period of time (perhaps by the time of Permanent Certification).

Exactly how each ONC-ATCB will function remains to be seen. We’ll see how certification happens in a way that balances “getting very good product out the door quickly” with certifying EHRs that are safe and effective. Following the JCAHO model of accreditation (with or without contingencies) might be a good lesson to learn from experience in an adjacent field.

But the gates are open, and candidate organizations that wish to become Authorized Testing and Certification Bodies are now able to step forward.


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