In a recent interview with iHealthBeat, National Coordinator for Health IT David Blumenthal discussed the timeline for issuing final rules on "meaningful use," standards and certification criteria and the certification process, as well as "NHIN Direct," the health IT work force and the likelihood of the country meeting President Obama's goal of providing all Americans with an EHR by 2014.
Blumenthal said that CMS has received more than 2,000 comments on the notice of proposed rulemaking describing how health care providers can demonstrate meaningful use of certified electronic health records to qualify for incentive payments under the 2009 federal economic stimulus package and that the Office of the National Coordinator for Health IT has received more than 300 comments on the interim final rule describing required certification standards for EHR technology.
Blumenthal noted that the Administrative Procedure Act limits what he can say about the comments and the rulemaking process; however, he said, "We'll look at [all of the comments] carefully, we'll take them all very seriously, and we expect that we'll get a better rule after the comment period than we had in the proposed stage."
Blumenthal said, "We are hoping to have read them all, analyzed them all, responded to them and published our final rules by late spring, early summer."
The transcript of the rest of the interview follows.
iHealthBeat
: Earlier this month at the HIMSS conference, you announced the release of the long-awaited Notice for Proposed Rulemaking on the electronic health record certification process. The NPRM establishes a temporary and permanent certification program. It also separates the responsibility for performing testing and certification of EHR systems. What was the reasoning behind doing those two things?
Blumenthal: We wanted a temporary program that was simpler to get started because of the need for speed in preparing for meaningful use Stage 1 in 2011. For that purpose, we didn't set up in the temporary process an accreditation program, which would require extra time.
The National Institute on Standards and Technology, which is the federal government's authority on certification, believes strongly that an accreditation process is the international gold standard for designating certification bodies, but it takes longer if you have to pick accreditors and then the accreditors have to do the certification process. And, we thought that it would be a year to 18 months to get that kind of a process up and going, and that was too long.
So we decided -- and this is actually what our Policy Committee recommended -- that we needed a transitional or temporary process that would be rigorous enough but not as rigorous as we would like for a permanent process. So in that temporary process, the Office of the National Coordinator, rather than accrediting bodies, will designate certifying organization and certifying bodies.
Also, in the ideal certification process, the National Institute on Standards and Technology believes that testing and certification should be separately accrediting. There are separate accrediting bodies for testing and certification -- they tend to have different kinds of expertise. The National Institute on Standards and Technology actually maintains an organization that certifies testers, but the Office of the National Coordinator will have to choose on a competitive basis accrediting organizations to accredit certifiers.
In the temporary stage, under the somewhat more relaxed rule, we are not requiring separate designation of testing and certification. We're going to recognize bodies that do either or both. But in the permanent program, there will be separate accreditation of testing and certification. A single organization might do them both, but they would have to be accredited for those two functions separately.
I'd say in the temporary program, the ONC is playing a larger role. In the permanent process, ONC will step back and let professional groups that concern themselves with testing and certification provide the quality control on those processes.
iHealthBeat
: So far, the Certification Commission for Health IT and the Drummond Group have expressed interest in becoming certification bodies. Some stakeholders have cautioned that the certification process could become confusing if there are too many testing and certification groups. Is there an ideal number of organizations that you would like to see involved in the process?
Blumenthal: No. We believe that, on the whole, competition and choice will be a positive factor in the certification process. As you know, there has been concern in the past that there were not enough options. We want to make sure that there are options in the future but that all those options are accredited and therefore meet the quality standards that the field expects.
iHealthBeat:
In the short term, the health IT funding included in the federal stimulus package could potentially exacerbate the health IT work force shortage that already exists in the U.S. Where will this work force come from and do you believe they'll be trained in time for the meaningful use deadlines?
Blumenthal: Well, last time I looked, there was a pretty high unemployment rate in the United States -- 9.7% was the last figure I saw. I think there's an incredibly large appetite for new, exciting forms of employment that have a vibrant future like the health IT field. So, I'm not worried at all that we'll be short of applicants -- qualified applicants -- for an HIT work force. I think a greater challenge is getting them trained and converted to this new profession in time to meet the meaningful use deadlines.
We have already awarded grants to community colleges for this purpose, and we're going to be very shortly releasing a series of other work force grants to support community colleges in training health information technology professionals. I think those people are going to start coming out of their training programs in less than a year. Some will start enrolling this fall and then graduate in three to six months thereafter and start filling up our regional extension centers and the hospital informatics departments and the vendor-based or vendor-supported consulting groups that will help with achieving meaningful use.
iHealthBeat
: In February, ONC announced the launch of "NHIN Direct," a streamlined version of the standards and services of the Nationwide Health Information Network that aim to broaden the participants exchanging health information. Do you foresee NHIN Direct eventually replacing the current NHIN model?
Blumenthal: No, not at all. NHIN Direct is a project that we've undertaken in the spirit that we want to make sure that there are diverse set of opportunities for providers to exchange information, a diverse set of ways, a diverse set of paths toward the kind of exchange that will be required for meaningful use. The NHIN -- as this office supported it and as it continues to support it -- is a terrific method of exchanging information at a sophisticated level, with many uses. And, I think in many ways represents the model for the future. But, it requires a fair degree of investment and sophistication to participate in.
We don't think that small providers, rural providers will all be capable of immediately participating in the NHIN, and we want to meet them where they are, we want to provide them customer service and so we want to make available a variation on NHIN that is more about direct exchange from party to party and less about ... exchange between multiple parties simultaneously.
Our hope is that these concepts, these models of exchange, will be complimentary [and] that they will in fact be two versions of the same system -- a system that meets the diverse needs for exchange among the nation's providers and consumers. If we could evolve toward the NHIN in its more mature and complex form, I think we would be well served by that. But, we want to make sure that everybody has a useable, effective, convenient method of exchange.
iHealthBeat
: According to 2009 preliminary results from CDC's
National Ambulatory Medical Care Survey
, about 20.5% of U.S. physicians reported having basic EHR systems, and 6.3% reported having a fully functional system. Other studies show that only 1.5% of hospitals have a comprehensive EHR system in place. Given those EHR adoption statistics, how realistic is President Obama's goal of providing all U.S. residents with an EHR by 2014?
Blumenthal: Well, it's a stretch goal, but it's a goal that I think will get the most out of our efforts and out of our systems, and we're going to do our very best to meet it. As you know, technologies follow S-shaped adoption curves, and I think we're about to go into a takeoff phase. I think that the meaningful use incentives have changed the psychology about electronic health records and that we're going to start seeing them spread quickly through peer pressure and changed expectations. So, I think we have an excellent chance of getting to that goal by 2014.