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    • New NPRM on the Block

    New NPRM on the Block

    March 3, 2010added by Michelle R. Wood

    As I reported yesterday, the Office of the National Coordinator (ONC) has released a new Notice of Proposed Rulemaking (NPRM) explaining how the EHR certification process will work. Since HITECH requires meaningful use of a certified EHR, this rule is an important part of the puzzle. I've created a bookmarked PDF of the rule to make it a little easier to navigate.

    The following are my thoughts on the NPRM after a very brief skim. I'll post a more in-depth summary after it's been posted to the Federal Registry.

    New acronyms to know:

    • ONC-AA = ONC-Approved Accreditor
    • ONC-ACB = ONC-Authorized Certification Body
    • ONC-ATCB = ONC-Authorized Testing and Certification Body

    Testing v. Certification
    As you might notice from the above definitions, there's a distinction made between testing and certification. Here's the best differentiation of the terms (found on page 35):

    "A fundamental difference between testing and certification is that testing is intended to result in objective, unanalyzed data. In contrast, certification is expected to result in an overall assessment of the test results, consideration of their significance, and consideration of other factors to determine whether the prerequisites for certification have been achieved."

    Temporary v. Permanent
    There are two certification models being set up: a temporary one, to run up to Stage 2, and then a permanent one. While both models are introduced in the NPRM, they're to be treated as two different proposals, with two different final rules eventually being published. The temporary one will have a 30 day public comment period so it can quickly be finalized, while the permanent model will use the standard 60 days.

    The most important distinction between the two is that ONC is going to be responsible for certifying EHRs accrediting EHR certification bodies under the temporary system (edited 3/4/10, see comments below for more information). The permanent one is supposed to take effect " ... once the permanent certification program is established and at least one certification body has been authorized by the National Coordinator" (page 22). The temporary certification is supposed to give those organizations wanting to become certifying bodies time to meet all the requirements set by the rule.

    There's some uncertainty in the rule over what to do if no one's ready to certify in 2013, since ONC doesn't want to become the HITECH incentives dispenser indefinitely. Of course, CCHIT has already said they're ready to go on their blog. No word yet from their possible competitor Drummond Group.

    Temporary and Permanent Certification by Fiscal Year Quarters

    I wasn't going to post this table to start with, since it's on the HHS HIT website and in the NPRM already, but then everyone else was including it on their blogs. To assuage my conscience for going with the flow, here's some additional information:

    • Remember that the quarters are based on the federal government's fiscal year, which runs October 1 through September 30.
    • Also remember that hospitals can begin to qualify for HITECH beginning this October, in time with the new fiscal year, while providers need to wait for the beginning of 2011's calendar year next January.

    Comments
    Since there's two different (eventual) rules coming for temporary and permanent certification, ONC requests that you label your comments with specific section titles. I'll post a link to the comments page at Recovery.gov as soon as it becomes available. Meanwhile, you can share your thoughts on the new NPRM here.

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    John Lynn on March 3, 2010

    I don't think that ONC is going to do the temporary cert. I haven't had a chance to read the full regulation, but I'm quite sure that ONC won't be the certifying body. Even if it's during the temporary period.

    Also, at HIMSS I heard about another possible EHR certification organization. I'll be posting about it soon on http://www.emrandhipaa.com

    Michelle R. Wood on March 4, 2010

    Thanks for pointing that out John, you're right about ONC not giving out the temporary certification. There's even a whole long section about how to become a temporary certifier.

    I kept going back through the rule, trying to find what made me think that, and found it on page 36: "Under the temporary certification program, the National Coordinator would serve in a role similar to an accreditor .... However, we do not believe that this would be an optimal or practical approach for the long-term because specialized accreditors in the private sector are better equipped to react effectively and efficiently to changes in the HIT market and to more rigorously oversee the certification bodies they accredit." So ONC will accredit the certifying bodies for the temporary program, not certify the EHRs themselves.

    Again, thanks for the clarification. I'll look forward to reading more about a new possible certification org, once you've had time to recover from HIMSS.

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