The relationship between HHS and CCHIT cooled off late last year. Until then, CCHIT had been testing and certifying EHRs since 2006, mostly to federally approved criteria.
CCHIT certification once was deemed by former HHS Secretary Mike Leavitt as good enough to qualify an electronic health-record systems for use by hospitals wanting to subsidize EHR purchases for their affiliated physicians under a federal program of Stark and anti-kickback waivers.
In fact, CCHIT was created at the behest of David Brailer, M.D., the first head of the Office of the National Coordinator for Health Information Technology at HHS, who in mid-2004 called for the creation of a private-sector organization to test and certify EHRs to make them more sellable to office-based physicians. In 2006, HHS awarded CCHIT a $7.5 million, three-year contract, which was subsequently extended.
Last December, however, David Blumenthal, M.D., the current head of the ONC, announced that CCHIT would no longer enjoy its preferred status in certifying EHR systems when it came to the new federal EHR subsidy initiatives under the American Recovery and Reinvestment Act of 2009.
The stimulus law authorized Blumenthal to “keep or recognize a program or programs for the voluntary certification of health information technology,” but Blumenthal said he would not exercise that authority and merely anoint CCHIT as, basically, Leavitt had done four years earlier.
Instead, according to Blumenthal, if CCHIT wanted to continue to play a role in certifying EHRs to federal criteria, it would have to apply like any other organization under a new program to recognize certification bodies, a program yet to be fully developed by the ONC under a formalized process of federal rulemaking.
To put even more distance between HHS and CCHIT, Blumenthal stripped CCHIT of its previously held authority to certify EHR systems for Stark and anti-kickback waivers.
In early March, Blumenthal announced the release of a first draft of proposed rules by which the ONC would select what could be a new cadre of certification organizations.
The 184-page document outlines a temporary procedure in which the ONC will select an organization or organizations to test and certify EHR systems. This is similar to the setup HHS had with CCHIT. The temporary process will last only until early 2012 when it will be replaced by a permanent accreditation process, also outlined in the rule, in which the testing and certification functions will be separated.
As the only up-and-running certification body for EHRs, CCHIT should have a leg up on any would-be competitors, at least in the short run.
In an interview, Bell says that meeting the ONC application criteria and becoming ONC-“authorized” to test and certify EHR systems under the stimulus law will be one of her three top priorities coming into the job. Bell served at ONC as director of its Office of Health Information Technology Adoption and represented the ONC on the CCHIT board of commissioners from 2006 to 2008.
CCHIT spokeswoman C. Sue Reber, who participated in the call with Bell, says the organization is ready to apply for authorization right now, based on procedures outlined in the proposed rule released in March, but the ONC has informed them it won't be taking applications until a final rule is drafted, which is expected this spring. The public-comment period on the proposed rule ended April 16.
Can CCHIT apply to HHS for its new role, receive authorization, set up a testing and certification program under the new rules, and have EHR systems tested and certified by Oct. 1 when the first “payment year” begins on the Medicare portion of the EHR subsidy program? Bell says CCHIT will be ready to do its part.
“I think the bottom line of all of that is we're committed to making sure all of that is going to happen and that the certification commission is not the weak link in all that process,” Bell says. “Having said that, in the beginning, the criteria probably aren't going to change tremendously from what we thought they were going to be. I don't think someone is going to rewrite the whole script.”
Bell says one of her other two immediate priorities as CCHIT chairwoman is to keep all operations and testing programs running smoothly.
“Clearly, we want to make sure there is no break in the process, and people can be assured they have consistent service going forward,” she says.
Her third and final priority, Bell says, is planning “how we'll expand going forward to be nimble enough to go where the program needs to go.”
