One-on-One with David Blumenthal, M.D., National Coordinator for Health IT (Part 2)

Now that the comment period on the proposed meaningful use rule has ended, it is up to the Centers for Medicare and Medicaid Services and the Office of the National Coordinator for Health Information Technology to weigh the merits of those comments and develop a final rule, which is expected sometime in May or June. CIOs and EHR vendors are anxiously waiting to learn whether greater flexibility may be included in Stage 1 meaningful use requirements. Recently, Healthcare Informatics Senior Contributing Editor David Raths sat down with David Blumenthal, M.D., the National Coordinator for Health Information Technology, in his Washington office to discuss meaningful use and certification issues.

In part 1 of the interview, Raths spoke with Dr. Blumenthal about broad issues around meaningful use criteria and about provider (hospital and physician) perspectives on meaningful use. Below is the concluding portion of the April 13 interview, which focuses on concerns providers have expressed regarding the interim final rule.

Healthcare Informatics: Some commenting groups have questioned the decision to include administrative transactions, claims submission, and eligibility as part of certified electronic health record (EHR) technology. They note that HIPAA explicitly enables an entity to use a clearinghouse to perform these transactions rather than performing them directly from its practice management systems or EHR. They note that the ONC proposal would require providers to change business processes that have no impact on improving quality and safety. Why is it important that electronic claims submission and eligibility become part of the certification criteria for EHR technology?

David Blumenthal, M.D.: Two reasons. First, for providers who don’t provide administrative data electronically, there are substantial administrative costs that insurers bear. And those costs are spread across the entire insurance system. If you ask insurance companies where they spend a lot of their administrative costs, it will be on a very small fraction of providers who don’t have sophisticated billing systems. The new health reform law invests a considerable amount of time and energy on something called administrative simplification, which involves simplifying the billing and eligibility processes. That depends on a minimum level of electronic sophistication on the part of providers, and meaningful use is the only leverage we have over the providers, so there is a compelling fiscal rationale for this. I also think there is another reason for doing this. In a private and secure environment, being able to provide electronic information on cost and on quality of care is absolutely essential to improving and modernizing our health care system. So the folks whose doctors don’t have their administrative data in electronic form will never know how efficient their doctors and hospitals are. And that’s a big hole in accountability.

HCI: Some groups, such as the HIMSS EHR Association, have said the interim final rule (IFR) did not go far enough in establishing specific technical specifications — for instance, a consistent set of transport services for document exchange or specific security and privacy standards. Was there a balance that had to be struck between flexibility and specificity? Was there concern that some implementation specifications were not mature enough?

Blumenthal: We are trying to balance flexibility and specificity. In the area of security and privacy, we were advised that this is a very dynamic sector, and that the cyber-security initiative of the president was developing new security solutions at a rapid rate and that if we put in rules or specifications that were likely to be outdated very quickly, we could be doing a disservice to vendors and to the field. In the area of communications or interoperability, there are two solutions, CCR [Continuity of Care Record] and CCD [Continuity of Care Document], both of which have very strong advocates, and we thought the market needed to sort that out further before we wrote one or the other standard into a rule. We also were told that some of the implementation specifications that people would have liked us to include in the rule were not mature, and had not been fully tested, and that they were not standard in the sense of being widely used, and that there could be considerable unintended costs to requiring their use. We needed more time to test them and assess them.

HCI: The HIMSS EHR vendors group also disagreed with the IFR’s assessment of how many of them qualify as small businesses and how much it would cost to prepare for certification. They say that the ONC analysis regarding small-business impact and the need for a regulatory impact analysis is incorrect because CCHIT membership data shows that more than 75 percent of the ambulatory EHR marketplace falls under the small-business label of less than $25 million in annual revenue. They also contend that the costs will be much higher than ONC estimates for preparing a product for certification. Will ONC review these figures in light of their claims?

Blumenthal: Well, I don’t know the data you are referring to, so I don’t want to comment on it. We are developing a certification process that we think will be considerably more efficient than the old process. It’s hard to respond to that point without commenting on the certification process itself and the certification criteria. The implicit concern is that the certification process will be too costly. Our goal is to create a certification process that is a lot less costly.

HCI: Although the idea of establishing a new certification regime has been praised, the creation of the temporary certification body has drawn some criticism. The College of Healthcare Information Management Executives (CHIME) issued a statement saying that it is “very concerned that the introduction of a two-stage approach for certification will prolong the current instability in the health IT marketplace, which exists because of the un-finalized status of meaningful use and certification regulations.” CHIME also said that the introduction of both a temporary and a permanent certification scheme “carries a risk of continuing the uncertainty and promoting needless product replacement in the marketplace.” How do you respond to those concerns?

Blumenthal: We need to fulfill the congressional mandate to make it possible for meaningful users of certified electronic health records to get compensated in 2011 and 2012. We also think it’s necessary to have a certification process that meets the open and transparent standards that this administration believes in and that the field has called for. So together, those things require that: a) we have certification criteria that we’ve written into a rule; and b) we have a process that can implement those criteria. To do that rapidly seems to require we have some kind of process we can get up and running quickly. That process cannot have the rigor that a long-term process requires. So it does seem to me that there is a logic in the legislation and in the policy that leads us directly toward the idea of this transitional process. The HIT Policy Committee strongly recommended that approach.

HCI: I wanted to ask you about the rollout of NHIN Direct. I was listening to a March 24 meeting of the HIT Standards Committee, in which Dr. Doug Fridsma, acting director of the ONC’s Office of Interoperability and Standards, described both the types of use cases the project will address and how it relates to the long-standing work on NHIN. But when it got to the Q&A session, committee members seemed unclear about the concept of NHIN Direct. Some thought the new effort might lead to confusion about how NHIN Direct fits in with ongoing health information exchange efforts and cause providers to hesitate to make sure that what they are doing is not superseded later. If people on the HIT Standards Committee are confused about the concept, what does that likely say about the understanding of the average care provider or average consumer?

Blumenthal: We have a Policy Committee working group that has put forward this idea, and the Policy Committee endorsed the idea, so I wouldn’t say there is universal confusion. There was a meeting at one time and one place where some members of the Standards Committee were having trouble making the transition from the traditional concept of the NHIN to a new version of it. But I am quite confident that the communication process will get clarified. This is a new frontier. We are moving into new territory. We want to meet our consumers and customers where they are, and giving them an all-or-nothing, take-it-or-leave-it approach to information exchange doesn’t strike me as wise policy. We need to give them multiple routes — compatible, consistent routes — to information exchange, and I personally believe that NHIN Direct will co-exist with the NHIN, and that many of the users of Direct will migrate toward the NHIN over time once they get used to the electronic record, its functionalities, and the requirements for exchange.