(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.

The next comment was improving the objectivity and transparency of the certification process. It’s interesting because, in the slides that they presented, they said they didn’t see any evidence that there was any failure of objectivity and transparency in the certification process, that it was a matter of appearances which some people have raised. They said that they had not seen any evidence of any kind of inappropriate influence. So we agreed that it was appropriate for ONC to develop an accreditation process in an independent body to accredit certifying organization. We let them know we intended to apply for that, and we look forward to fulfilling those requirements.

And then another one of their recommendations was to expand certification to include open source and self-developed software. That is also something we had already talked about how to do, and how to move forward with site certification, particularly for self-developed EHRs.

So I think we responded and analyzed the recommendations constructively and pointed out that really there wasn’t much divergence in their recommendations from the plans we were already undertaking.  

GUERRA: Hospitals need to be on a certified product to ensure they get the stimulus money. If Preliminary ARRA gets them that, why would they want Comprehensive CCHIT 2011?

LEAVITT: Well, we’ve heard from them over and over. We’ve heard from provider groups, we’ve heard from the specialties that the marketplace was not making adequate progress in making the products they needed with all the features they needed. There’s more than just federal standards, there are other requirement they have as providers, such as supporting workflows and maintaining a legally adequate record. They really thought CCHIT was a way to have a community conversation and move the entire marketplace forward.

So we’ve had nothing but positive feedback from people that have engaged with us and gotten involved in reviewing our work, either participating as volunteers or commenting on it. We’ve had lots of positive feedback that we were doing things they felt are needed. I’d like to acknowledge, if you take a segment of that huge healthcare community, there’s a segment for whom our work was not necessary. If you take the sophisticated CIO, which may be the target readership of your magazine, it really wasn’t built for them. And if you have a sophisticated IT organization and a top notch CIO, you don’t need us. You can figure out what’s a good product.

But more than half of all hospitals are small, and more than two-thirds of all doctors practice in a small office – 10 or fewer physicians – and they may not even have an IT department, let alone a sophisticated IT department. They value the help, they value the extra evaluation.

The issue was once ARRA was passed, things changed. Before ARRA, certification was really voluntary. If you thought it was helpful to you, you could say, “I only want a certified product.” If you didn’t think it was helpful, you could ignore it. Once ARRA passed, with its incentives and penalties, if you don’t have a certified product and achieve meaningful use, everything changes. It was no longer a voluntary program.

The new situation really required having a more flexible program, including for the more sophisticated customers who didn’t need that extensive evaluation. That’s what the basic Preliminary ARRA program is all about – flexibility, just checking that it meets the standards and, if it does, we’re out of the way. The product is also dramatically less expensive – it starts as low as $6,000 for a product that has just one or two modules.

GUERRA: So you’ve gotten around the criticism that extremely detailed certification will stifle the market?

LEAVITT: Yes. That’s why we have the Preliminary ARRA Certification Program. Not only does it not have detailed criteria, it’s modular. So you don’t even have to create a system that meets all of the criteria. You can fix them up one by one. There are basically 28 modules, and they exactly match the 28 meaningful use objectives. There’s actually 28 objectives, 24 apply to inpatient and 26 apply to ambulatory, but it’s largely a common set of tags.

The vendor or developer will decide which of those objectives they support. We don’t care if there’s 28 separate products to support the 28 different objectives or someone does them all, that’s fine. It doesn’t matter. They’ll decide which ones they support, come and be tested against the relevant standards; other times it’s an interoperability standard. If you say you do e-prescribing, you’ve got to use an e-prescribing standard. If you say, you do CMS quality reporting, you’ve got to use the CMS quality measure standard. All of them have to meet the basic security standards. If it handles personal health information, and basically all of these things do, they can be certified. There’s another thing about functionality – we require no details about how it works, and nothing at all about features.

GUERRA: Do you think you’ll get more applications for CCHIT Comprehensive or Preliminary ARRA?

LEAVITT: I think we’re going to get about half and half. We got some idea because of the town hall polling and also the “Get Certified” seminar. I think we’ll see a pretty good number. They may not all sign up the first day, but signs are that the mix is going to be about 50-50. Maybe about half will come for the CCHIT Certified Comprehensive Program and half for ARRA.

Part III