GUERRA: I think there is still some uncertainty about CCHIT’s new programs. Would you like to go over them to start us off?

LEAVITT: I think that’s a good idea. On Oct. 7, we opened all of our 2011 certification programs – now we have two that we’re launching. One is called the CCHIT Certified 2011, and we’ve referred to that as the Comprehensive Program, and the other is called the Preliminary ARRA 2011 Certification. And people may choose to refer to that as a modular program, but it’s really just a certification that’s offered in a modular way. We used to talk about a site certification as being a third pathway, but what had become clear to us is that the site certification is an option for either of those. So site certification is just one option under the Preliminary ARRA 2011 program, and it’s also available under the CCHIT Comprehensive. You can think of it as two paths to certification and, in each case, it could be a vendor product or a site that comes to be certified.

GUERRA:  And we should think of the modular as the Preliminary now?

LEAVITT: Let me explain the two. The goal of the CCHIT Comprehensive Program is maximum assurance. So we’re basically trying to deliver to providers additional help in selecting an EHR. In the case of the Preliminary ARRA 2011 program, the main goal is flexibility. We’re trying to create a program that presents the lowest possible barriers to developers, to vendors, to providers who have followed any of a variety of pathways to develop products or to assemble products, and not create a barrier for them receiving the ARRA incentive, if those products meet the federal standards.

GUERRA: And then you’ve got your gap certification which would be for any additional requirements that are added to certification by the government?

LEAVITT: Yes, but let me make something clear. The CCHIT Comprehensive Program also meets or exceeds the Preliminary ARRA requirements, though both programs will potentially need an incremental test if any of the standards or criteria exceed those that have been proposed to date by ONC or by the Policy and Standards Committees.

GUERRA: There will be a gap available for both of them?

LEAVITT: Right. The CCHIT Comprehensive Program also includes certification against the federal standards. The Preliminary ARRA is only against the federal standards. So if there is a gap and we need to do an incremental test on products and services from either certification program, we will need to come through with a gap test to get that corrected.

GUERRA: The Policy Committee recommended a gap certification process that could be used against CCHIT ’08 Certified products. Is it accurate that you decided not to go in that direction?  

LEAVITT: Yes, we’re not following that particular recommendation. And the issue is that of maintaining a level playing field. There are many vendors that have not been previously certified that would like access to the marketplace. There are also vendors that certified in earlier years, such as 2007 or 2006, who may have been planning to re-certify against our 2009 criteria. So to shut all of those out and only allow the 2008 certified vendors access to this program would clearly constrict the marketplace unnaturally and unfairly. So we have created a level playing field. All vendors are welcome, whether previously certified or whether they have done 2008 before or a different year, they can choose to apply for either of these two programs.

GUERRA: Organizations that have received certification get to the front of the line when it’s time for gap testing, correct?

LEAVITT: First of all, let me just discourage you from using the term gap. We call it incremental testing. We don’t know if it will be necessary or not. In fact, if we thought there would be a lot of new standards still emerging, we might have decided not to launch the preliminary certification now. So we feel pretty good that the standards and criteria won’t be more rigorous than what have been published. We’re just offering the incremental testing as a contingency if there is a new standard that comes out or there’s a change.

The reason we would give priority to those who have already moved forward is that’s just good customer service. If you offer a service or a product and you find a new standard has emerged and the product is no longer compliant with the new standards, you need to correct that before you start selling new products to other people. That’s just the basic picture of this. And what’s more, that test should be very simple. We don’t expect large amounts of new materials to be covered. So we can do those tests very quickly, very simply, and we’ll get those done right away when the final rules and the final meaningful use matrix is available.

GUERRA: You had some training sessions or discussions in Chicago recently?

LEAVITT: We had a one-day seminar which we call the “Get Certified” session. It was on Oct. 1. We had anticipated maybe a couple of hundred, at the most, based on some polling we did during our Sept. 3 town hall, and they kind of blew the doors off it, we had to keep enlarging it into a bigger room and we ended up ultimately with about 320 attendees. In some cases, a vendor might send more than one attendee, so it wasn’t 320 distinct vendors, but I think it was more than 250 vendors and developers represented. There were also a fair number who didn’t even have a product on the market yet.

So, we had a very good indication that our new programs were making certification available to a wider variety of technology developers and providers than before, and I think that’s good news.  It speaks favorably about the new program meeting the need that we saw out there to broaden access to certification.

It was a full day eight-hour session, and we had very positive feedback. Great questions were asked. And we know that some people wanted to come but couldn’t make the date. So we are going to make it available in a recorded format sometime soon; because we recorded the audio and we’ll have the audio and the slides and the questions and the transcript of it available.

GUERRA: I received questions from someone who attended that I would like to ask you now. First off, “The highest rate of failure to become certified is for the privacy and security modules. What is the most common mistake?”

LEAVITT: The highest failure rate was in security when we first started certifying in 2006. And it had to do with the audit trail. A fair number of products either didn’t have an audit trail or the audit trail was not thorough enough. In 2007 and 2008, the vendor community realized that our criteria in test scripts really set forth what we expected and so that phenomenon went away. We had a much lower failure rate in 2008, all the vendors came adequately prepared and made it through, so that suggests our open book policy of publishing the criterion test scripts to everyone in advance had the desired effect. People who don’t have a product that can meet the criteria don’t need to come and test and waste their money. If they look at the criteria and their product can do all those things, they can come and get certified.

We’re still developing the site certification program. And we’re not going to release a preliminary version of the site certification. We will wait for the final rules to begin doing site certification. And the reason for that is when you come for a site certification, you’ve already implemented your EHR. Then we don’t have the issue of delay that we do for people who would wait to buy an EHR until after all the rules are final, and the accreditation process is complete. They wouldn’t be able to have it implemented in time to meet the 2011 incentive. They might even miss the 2012. So it’s urgent to get that program out there. For sites who come to be certified, they already have their technology, and rather than put them through it twice or have to do an incremental certification, we’ll wait until we have the final rules. We’ll also be working on how to do it with an absolute minimum of cost because affordability would be a big issue for small practices or small hospitals, so we have to find a way to do it for much less cost than we do now. And we’re going to be working on it in the coming months.

GUERRA: Her other question is, “As I prepare to submit my home grown ‘interoperable application’ for CCHIT certification, I’m a little concerned that the reviewers are volunteers from other HIT companies. Imagine GM having to approve Ford’s new technology.’

LEAVITT: I think anyone who has read any of our Web site materials or have ever heard me present should realize that the jurors are absolutely forbidden to have any financial relationship with any vendor. They cannot work for them. They cannot have stock in them. They cannot have a family relationship with someone who works for an HIT vendor. So we have an absolute strict rule against that.

GUERRA: So that’s just a misunderstanding.

LEAVITT: That’s probably just a misunderstanding. Yes.

GUERRA: CCHIT was moving along when all of a sudden ARRA and HITECH came and blew everything up. Can you tell me what that was like?

LEAVITT: Well, I think that we should first of all look forward rather than backward. So the most important thing is that the law was passed and we have potentially large incentives, and a key element of the incentives is to use certified EHRs. So we have to step up to meet that increased demand. I’ve been predicting that we need to see the adoption rates triple. If we’re going to meet the goals, if we’re going to go anywhere near halfway there, with half of the providers using EHRs by 2014; the number who adopt the EHRs per year will have to go way up. So it seems clear we need a way to accommodate a wider variety of providers, a larger number of vendors, a wider selection of products and services and even, potentially by 2014, some very new designs and some very new models and some very new platforms.

That’s why we realized we needed to both scale up in terms of volume and also broaden the applicability and the accessibility to certification. That’s why we introduced a new program. We did not, however, want to throw all the work we had done away, because there have been four years of hard work by hundreds of volunteers. It pretty much represents tens of thousands of hours, and it certainly represents a federal investment. We had three years of federal support, about $3.5 million a year, so it’s totaling something like $7.5 million.

And we didn’t want to see that investment lost. So we wanted to build on what we had done, yet we had to innovate. That’s why you see the two programs — the CCHIT program is very much like the program we’ve been doing, but we were able to actually make it more rigorous and continue to tailor it to different specialties and settings.

At the same time, Preliminary ARRA is brand new. It’s lean, and it’s flexible. And I think it really follows closely the theme of one of the recommendations of the Policy Committee which was that they didn’t want to see government-approved certification be a stamp of approval for products or a recommendation of products. They just wanted it to be for the basics; to say if it meets the government standards. If so, then it should be certified, and that Preliminary ARRA program follows that design very closely.

GUERRA: What has your interaction with the Policy Committee been like? Are they consulting with you? Do they dictate to you? Are they asking for your opinion? Do they have regular meetings with you?

LEAVITT: Well, first of all, we’re an independent non-profit, and they are a federal advisory committee. So on an official basis they may ask us to appear in one of their meetings or they may ask us questions between meetings. They may ask us for data. We’ve been communicating actively. In other words, we’ve sometimes been asked for information and we provided it, or been asked to appear at the meeting and we show up.

At other times we offer information that’s unsolicited; we say, “We have some information that we think is helpful. Here’s a model of what criteria might look like or here are elements of meaningful use that we think might be practical, and here are some of the elements that we think are more problematic.”

So we’ve been offering advice and feedback, just as many other organizations have been doing during this time. We don’t have an official coupling. They really don’t have standing to tell us how to conduct the affairs of our organization, nor do we have standing to make decisions on their behalf.

Part II