CCHIT began testing and certifying EHRs in 2006 and last year announced it would bifurcate its testing program in an attempt to adapt it to the new realities of the meaningful-use criteria imposed by the American Recovery and Reinvestment Act of 2009, also known as the stimulus law.
Under the stimulus law, hospitals and eligible professionals—for the most part, office-based physicians—can qualify for federal subsidies for the purchase and support of health IT if they demonstrate they are using a “certified” EHR in a “meaningful manner.”
A proposed rule was released by the CMS on Dec. 30, 2009, providing a detailed definition of “meaningful use” and an outline of the operations of the Medicare and Medicaid programs through which the EHR subsidies will be dispensed.
Also that day, the ONC released a companion interim final rule, or IFR, on the criteria EHRs must be tested against to be certified. Public comment periods on both of those rules run through March 15, and both rules remain subject to change.
The stimulus law also gave the ONC the authority to establish a process by which the government would recognize organizations as qualified to test and certify EHRs as capable of meeting meaningful-use criteria.
Working with the National Institute of Standards and Technology, HHS came up with its rule on selecting certification bodies, which was until last week a key missing element in the regulatory structure of the IT subsidy program.
The latest rule outlines a temporary procedure for authorizing certification bodies that will remain effective until early 2012 when it will be replaced by a permanent accreditation process.
Instead of waiting for this authorization process to be developed, however, CCHIT began last year moving ahead with the expectation that it will pass muster against whatever authorization regime the ONC produces. It continues to offer what it calls its “comprehensive” testing and certification program that it started using in 2006 and has intensified since, but more recently added a “modular” certification program tailored to what it expects will be the final meaningful-use criteria.
CCHIT began accepting vendors into the new certification programs earlier this year.
“We have a certification program that's up-to-date with the IFR,” said CCHIT Chairman Mark Leavitt. “We have 46 products in process, 23 in each. Half are modular and half comprehensives.”
Before Blumenthal made his announcement, much of the talk at the HIMSS show was about the missing regulatory piece for anointing certification bodies.
According to the ONC, a final rule on the new selection process for certification bodies should be ready this spring, with the first certifications done by summer.
Officials with several IT vendors at the HIMSS show said the lack of regulatory clarity had slowed IT sales and product innovation while providers expressed anxiety about meeting meaningful-use targets by program deadlines.
Leavitt, who is retiring from CCHIT this month, said he had sensed the mood.
“I've been in health IT for 25 years,” Leavitt said in an interview before Blumenthal's announcement. “I've never been through a time of greater anxiety and confusion than I have now. And that's not what you want to drive adoption. You want some confidence and clear goals.”
CCHIT Executive Director Alisa Ray said CCHIT is still assessing the 184-page rule.
Ray said CCHIT will have an all-day staff meeting and a meeting of the full commission later this week to review the rule.
“There is still some ambiguity,” Ray said, but added, “We're still confident we'll be an interim body, that we'll qualify for whatever rules they've laid out.”
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