Certification details still unknown
The massive new federal rule on defining “meaningful use” of health information technology issued by the CMS on Dec. 30, 2009 has been getting most of the attention in health IT circles. But a smaller companion rule simultaneously released by HHS’ Office of the National Coordinator also will affect providers and developers of electronic health-record systems.
The ONC was designated under the federal stimulus law to keep programs for “the voluntary certification of health IT as being in compliance with applicable certification criteria adopted” by HHS. As such, it issued an interim final rule designed to lay out what vendors need to do to be “qualified” under a definition in the stimulus law and “certified” against criteria established through federal rulemaking by a
certification organization “recognized” by the ONC.
Still to come is a new rule to be written to cover how certification bodies will be selected and “recognized,” according to David Blumenthal, head of the ONC. This critical third rule, “we hope to issue shortly,” Blumenthal said at a Dec. 30 news conference. Until then, and until the public comment period closes and ONC responds, the linchpin EHR-certification process will remain in limbo.
Meanwhile, HHS appears to be distancing itself from the not-for-profit Certification Commission for Health Information Technology, which HHS encouraged the private sector to launch in 2004 and which HHS has supported financially since 2005. CCHIT had been recognized in the past as a certifying body, but, Blumenthal said, “Its future status will be governed by the regulatory process that is ongoing right now. So, I think it’s premature to talk about the implications of any particular set of certification criteria that CCHIT or anybody else has put forward or will put forward.”
Mark Segal, vice chairman of the Electronic Health Record Association of the Chicago-based Healthcare Information and Management Systems Society and director of government and industry affairs for GE Healthcare IT, said there remains “a reasonable expectation that CCHIT will be one of those” organizations that ONC will approve for EHR testing and certification. “As a practical matter,” Segal said, “the fact that you’ve been certified up until now means you have a lot of the functionality in place.”
CCHIT Chairman Mark Leavitt said he fully expects CCHIT to meet the requirements ONC develops to qualify as a “recognized” certification body under the EHR subsidy program.
In any event, vendors that have been following CCHIT’s criteria are likely to have a leg up on becoming certified EHR vendors under the stimulus law. “Those vendors who have kept with the certification are closest to meeting those meaningful-use requirements,” said Mark Wagner, director of ambulatory research for health IT market research firm KLAS Enterprises.
Blumenthal: “We hope to issue” the third rule shortly.