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One-on-One With CCHIT Chair Mark Leavitt, Part II

October 27, 2009
by Anthony Guerra
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In this part of our interview, Leavitt says when HITECH made certification a requirement, CCHIT responded with “Preliminary ARRA 2011.”

As the long and winding river that is EHR certification rolls along, CCHIT recently opened up its latest iteration of testing to the public. The two new offerings are “CCHIT 2011 Comprehensive” Certification and, in line with what is known today about “meaningful use,” Preliminary ARRA 2011 Certification. To drill down on the distinction between these two programs, and to learn more about CCHIT’s progress overall, HCI Editor-in-Chief Anthony Guerra talked with CCHIT Chair Mark Leavitt.

(Part I)

GUERRA: What are your thoughts on some of the recommendations the Policy Committee has made?

LEAVITT: It doesn’t really matter. What’s more important is that they’ve made recommendations, and it’s really ONC and CMS that will be making the final decision. And those are the things that we’re looking forward to. So we’re able to use the committee’s recommendations as clues. I think, sometimes, there are very good clues about what the final rules will be; other times they’re not such good clues, because some of the recommendations may or may not be implementable.

For example, the Policy Committee called this new form of certification that’s strictly limited to the government standard, “HHS certification.” You’ll notice in launching the program, we didn’t call it that. We called it Preliminary ARRA certification. The reason is; first of all, we don’t know if HHS will choose to call it that. There may be some issues with naming it for a government agency when the government agency itself is not doing the inspection. It’s not like the FDA – which absolutely is in charge of regulating and inspecting – so it’s called FDA approved. This is a third-party organization that’s actually doing the inspection, so we didn’t feel comfortable using the term HHS, and we don’t know if that will be the eventual term. That’s another example where the recommendation is interesting, but we don’t know if that will prove to be the final decision or not, so we held off on using that term.

GUERRA: CCHIT has commented on what’s been put out so far. I assume the organization will comment on the final rule at the end of December?

LEAVITT: Absolutely. When we comment, we not only send the comments but we publish them, because our own operation needs to be very transparent. People need to see what we’re doing. So we generally publish our comments ourselves as well as submitting them. And yes, we will have comments when Dec. 31 rolls around; we’re expecting three sets of materials to come out.

We know there will be a notice of proposed rulemaking from CMS regarding the meaningful use definition. We know there will be an interim final rule from ONC regarding the standards in certification criteria, and we believe there will be a notice of proposed rulemaking from ONC regarding the accreditation of certifying bodies.

The CMS notice of proposed rulemaking, we know, has a 60-day comment period which is required by statute. We’ll definitely be submitting comments during that period, and to the extent comments may be made about the other two documents; we’ll do that as well.

GUERRA: What’s the process for establishing a CCHIT comment letter? Obviously it’s approved by you, what about Alisa Ray (CCHIT executive director)?

LEAVITT: We have different processes. When we have time, we respond. The recent committee actions have not allowed sufficient time for organizations, large organizations with volunteers, to respond. So when they put out something with a seven- or a 10-day comment period, it’s very difficult to do, but with the 60-day comment period, we’ll basically go all the way to our volunteers or our various expert panels and workgroups. And they will draft comments that will come up through the commission for approval. Those will then be submitted, basically, on behalf of the entire organization. Sometimes, when there’s a very short time, the commission only may respond. At times, it may be so short that I as the chair or, along with Alisa Ray as the executive director, can only respond. We do that only if we are reasonably confident that it represents the opinions of the organization. So it just depends on the time available to us.

GUERRA: What was the organization’s response to the recommendations of splitting the establishment of certification criteria from the testing, and introducing the opportunity for multiple testing entities?

LEAVITT: First was the question of focusing certification on meaningful use, and we said, “We agree on a need for a new basic certification limited to the minimum set of criteria necessary to meet the functional chapters of this statute and achieve a meaningful use objective.”

So we agreed on that, and we actually announced the concept in June before it came out from the Policy Committee. But we had called it our “M” certification pathway. I think we were using that term back even in April, perhaps at the time of the NCVHS hearing, or perhaps it came out a little later.

The second point was improving security, privacy and interoperability, and we agreed with the need to increase progress in all those areas.