DAVID C. KIBBE and BRIAN KLEPPER
A surprise move by ONC/HHS indicates the wheels may be falling off health IT reform at about the same rate they've fallen off Democrats' broader health reforms.
David Blumenthal and his staff have unveiled two separate plans to test and certify EHR technology products and services. We don't think this is a good idea. We've supported the purpose and spirit of the ARRA/HITECH incentive programs, and believe ONC's/HHS' re-definition of EHR technology puts it on a trajectory to improve the quality and efficiency of health care in the U.S. But this recently-announced two-stage EHR technology certification plan bears all the marks of a hastily drawn up blueprint that, if rushed into production, could easily collapse of its own bureaucratic weight.
The new Proposed Rule puts vendors through the wringer, twice. As defined by ONC, vendors with "complete EHRs" and those with "EHR modules" will have to find an "ONC-approved testing and certification body" (ONC-ATCB) that will take them through a "temporary certification program" from now until end of 2011. Then in 2012, under a "permanent certification program," they'll have to switch over to a National Voluntary Laboratory Accreditation Program (NVLAP)-accredited testing body for testing, after which they must seek an "ONC-approved certification body" (ONC-ACB, not to be confused with ONC-ATCB) that can provide certification. The ONC-ATCB will be accredited by ONC, but the ONC-ACBs will be accredited by an "ONC-approved accreditor" (ONC-AA).
Confused? This is just the start. We can't imagine many federal agency Notices of Proposed Rule Making (NPRM) that have created, in a single document, more new acronyms. And the prose in the document can challenge even the most focused minds. For example, the drafters of the NPRM recognize that things could get a little complicated, saying:
"Should CMS finalize its proposed staggered approach for meaningful use stages, we recognize that some confusion within the HIT industry may arise during 2013 and 2014 because of this apparent inconsistency and the divergent use of the term “meaningful use.”
But, then they go on to clarify:
"We would anticipate, therefore, that ONC-ACBs would clearly indicate the certification criteria used when certifying Complete EHRs and/or EHR Modules, and identify certifications according to the calendar year and month rather than the meaningful use stage to reflect the currency of the certification criteria against which the Complete EHRs and/or EHR Modules have been certified. Consequently, if an eligible professional or eligible hospital were seeking to obtain a certified Complete EHR or certified EHR Module in 2014, for instance, that eligible professional or eligible hospital would look for Complete EHRs and EHR Modules certified in accordance with certification criteria current in 2014, rather than Complete EHRs and EHR Modules certified as meeting certification criteria intended to support meaningful use Stage 1, Stage 2, or Stage 3. We request comments on ways to ensure greater clarity in the certification of Complete EHRs and EHR Modules."
Got that? Glad they're requesting comments, though we're not sure where to start. The use of the word "staggered" to describe ONC's programs is apt: this new NPRM is going to leave a lot of people staggering, as in punch drunk.
We would like to see ONC and HHS abandon temporary certification in favor of a single, permanent certification process, even if it means delaying testing and certification until mid- or late 2011. The hurry appears to be related to the need to have at least some EHR technology tested and certified by the end of 2010, so at least some physicians and hospitals can meet the meaningful use criteria. That would require them to use "certified EHR technology" by the official start year for the incentive programs, 2011.
But we don't think this timetable makes sense any longer, and the rush may jeopardize the whole program. Between meaningful use, accreditation, testing, and certification, there are simply too many moving parts to implement and coordinate in too short a time.
Delays seem inevitable. For example, we know that the release of the meaningful use final rule will be postponed until early summer and perhaps longer due to the large number of comments received and their implications. A consortium of physician membership groups will soon recommend that the meaningful use criteria be simplified. It also predicts that many small and medium sized medical practices will sit on the sidelines during 2011 and 2012, rather than rush into risky attempts to meet the meaningful use requirements. In addition, CMS has said it won't be ready to accept EHR technology product and service data until 2012, at the earliest. That timeline could be ambitious by about a year.
The ONC/HHS interim final rule (IFR) may have inadvertently caused another kind of delay. It set initial standards and implementation specifications for EHR technology - we applauded this - endorsing a modular EHR technology approach that opens the door to industry innovation. But it will take time for market entrants to bring modules and components to their customers, and perhaps longer to integrate different EHR vendors' modules in plug-and-play fashion. In other words, by opening up the market, ONC/HHS created circumstances that will almost certainly delay the goals it seeks.
So what if, to get the certification process right, ONC were to postpone payments by one year? It would be worth it.
The "permanent certification" plan in this new NPRM is very reasonable. Under it, NIST would be involved in setting up the testing of EHR technology software under the auspices of the National Voluntary Laboratory Accreditation Program. A single accrediting body would be chosen by ONC/HHS to oversee, supervise, and accredit the certification entities, following established international standards, including the International Organization for Standardization's (ISO) standards 17011 and Guide 65, that have guided conformity assessment in numerous industries, and ISO 17025 that is used for assuring quality of testing and calibration laboratories.
So each vendor would follow an orderly progression: first, ensuring that the product meets the technical testing criteria and then, having passed those technical tests, moving on to certification. The stability of this process has much to commend it.
We're not alone in thinking that delaying the EHR incentives start date is a good idea. At a HIMSS session on Monday, March 1, Congressman Tom Price (R-Ga.), an orthopedic surgeon, said that ONC's delay in issuing guidance on the certification process has prompted him to organize Congressional members. They'll send a letter to federal officials asking to postpone the start date for for demonstrating meaningful use to qualify for incentive payments. Price said members of Congress are currently collecting signatures for the letter and could send it to HHS within a week.
David Blumenthal is smart, dedicated, and is hiring many talented, experienced people into ONC. But rushing ARRA/HITECH's policy and statute beyond what is humanly possible could ultimately be at cross-purposes with the very goals they're trying to achieve.