CHIME, CCHIT: ONC's certification rule creates, perpetuates uncertainty
The temporary certification program in the notice of proposed rulemaking (NPRM)  on certification programs for health IT has the potential to prolong uncertainty and instability, according to the Certification Commission for Health IT (CCHIT) and the College of Healthcare Information Management Executives (CHIME). The organizations made their comments separately to the Office of the National Coordinator for Health IT (ONC).

The NPRM proposes two certification programs, one temporary and another permanent, which, according to the Ann Arbor, Mich.-based CHIME, provides short-term solutions for certification and solves the need to approve applications quickly.

However, “the introduction of two separate schemes…carries a risk of continuing the uncertainty and promoting needless product replacement in the marketplace,” CHIME’s letter read.

CCHIT’s concern is that the EHR projects from the temporary certification program represent long-term, permanent investments by providers and hospitals, and the success of the HITECH incentives depends on increasing the confidence of providers in making those investments.

“Calling the program, and the resulting certifications, ‘temporary’ could undermine that goal by prolonging, rather than reducing, current levels of uncertainty,” CCHIT stated.

“Interim” would be more appropriate, according to CCHIT, because it is used in federal rulemaking to denote regulatory actions that are fully in effect but will be replaced with more refined versions in the future. CHIME suggested calling the process an interim one “that builds on current certification strategies and is ‘harmonized’ with the eventual permanent certification process.”

The Chicago-based CCHIT also cited the temporary program's “sunset clause,” whereby the program ends on the date when the National Coordinator names at least one ONC-Authorized Certification Body (ACB) under the permanent certification program. This would create an unpredictable and awkward transition between the two programs, according to CCHIT. It would also cause a confusing period where providers still eligible for incentives under Stage I from 2012 through 2014 would be forced to buy or upgrade to Stage II-certified EHRs.

As an alternative, CCHIT recommended a “simple and easily understood approach to specify that ONC-Authorized Testing and Certification Bodies (ATCBs) are only authorized to test and certify against Stage I criteria. Certification against Stage II and III criteria can only be performed by ONC-ACBs.”

CCHIT further stated that Stage I certifications should remain valid as long as Stage I incentives are available (through 2014), since the status of ONC-ATCBs is limited to Stage I certification and there is no need for a sunset of their authorization.

Separately, CHIME recommended that:
  • Changes in certification requirements be made only when they are necessary to meet meaningful use evolution or advance interoperability, not just because a certain amount of time has passed.
  • If the Centers for Medicare & Medicaid Services maintains the “adoption year” approach originally advanced in proposed regulations, providers should not be required to have products certified for capabilities not required in the current adoption year.
  • Individual EHR modules be certified to ensure that they can communicate according to adopted standards, and that the interoperability of those modules as used by providers be deemed as certified.
  • Health IT vendors fully disclose functions for which their products are certified and fully disclose known compatibility issues.
  • In the event of a certification body losing its authority to certify products, vendors should have six months to recertify products, and providers should not be penalized for a change in a product’s certified status if they are still able to demonstrate the meaningful use of the technology.