On the road to promoting physician adoption of healthcare information technology, HHS last year dropped a regulatory log in its own path.
And, as if laying a corduroy road to perdition, the agencys actionswhich could hamper adoption of electronic health recordswere taken with what government officials insist are good intentions.
HHS has long talked about boosting physician uptake of EHRs. One way has been to encourage hospitals and healthcare systems to subsidize their cost. EHR adoption rates, particularly among office-based physicians in small groups or solo practices, remain in single or low double digits, according to industry surveys. A key barrier to adoption, nearly all of those surveys have found, is the high cost of purchasing and implementing the systems. Hence the idea of hospital subsidies.
Last year, HHS cleared a regulatory path for hospitals to provide those subsidies by granting would-be IT providers two legal waivers: one was an exception from Stark prohibitions against giving remuneration to physicians for referrals; the other was a legal safe harbor from federal anti-kickback laws.
At the same time, the federal government seeksperhaps even more so than EHR adoptionto promote clinical IT systems that can communicate with each other, or so-called interoperability. So the agencys regulatory relief measures had a catch.
To qualify for the legal waivers, the government required that all EHRs subsidized by hospitals and integrated healthcare organizations must be interoperable; that is, able to exchange data with other IT systems. And that interoperability requirement had a couple of caveats as well, spelled out in the pair of documents released Aug. 8, 2006, by the CMS and the HHS inspector generals office (See box, p. 29).
Those rules provide that the interoperability test could be met only in one of two ways. One was that a hospital, on its own authority, could attest that the system it is offering with a subsidy is interoperable under a specified set of HHS definitions and a rigorous set of standards, according to industry experts contacted for this story.
The other way was a hospital could offer an EHR that was tested and certified as interoperable by an outside organization with deeming authority from HHS. On the surface, this second path seemed to be a much easier and legally less-risky route, but, as it turns out, one that also has pitfalls.
For now, the only organization with EHR deeming authority is the not-for-profit but federally supported Certification Commission for Healthcare Information Technology. From the governments perspective, however, there was a drawback. The only interoperability requirement in the initial CCHIT 2006 set of criteria was that an EHR had to be able to electronically receive laboratory results. But, in later years, CCHIT planned to add interoperability criteria, and that, apparently, was a strong enough commitment to interoperability for HHS Secretary Mike Leavitt. In October 2006, Leavitt granted CCHIT deeming authority under the Stark and anti-kickback waivers program.
By then, 22 vendors had lined up for CCHITs first round of EHR testing. Included in that group of early-bird vendors were many of the largest developers of clinical IT systems for hospitals. Twenty-four of those vendors EHRs received certification either on July 18 or July 31, 2006. For three years after those dates, under CCHIT rules, those vendors can advertise and sell their products as having been certified under the 2006 CCHIT criteria.
But under HHS rules for the Stark and anti-kickback waivers, those certifications are valid for only one year. To remain eligible for waivers under CCHIT deeming authority, a hospital or healthcare organization would have to provide physicians with an EHR whose vendor had resubmitted it for testing before its 12-month window had closed.
At deadline, according to public postings of vendor certification status on CCHITs Web site, only five of those 22 early-bird EHR vendors have recertified their systems under the expanded interoperability criteria CCHIT adopted for 2007. Thus, 17 vendors have seen their 12-month interoperability windows slam shut under HHS Stark and anti-kickback waiver rules. They include four out of five systems offered by developers of so-called enterprise clinical IT systems that power entire hospitals.
This appears to be a systemic problem with the HHS/CCHIT certification scheme. Another 12 vendors certified their EHRs through CCHIT in the second batch of systems that were tested. Their certifications came through on Oct. 23, 2006. Only one of those EHRs had been recertified by deadline for this story. Thus, the window on 11 more EHR systems could close later this month.
This lack of synchronizationbetween the 12-month HHS certification requirement; the annual CCHIT cycle for testing against newer, more stringent criteria; the three-year duration of CCHIT certification for other purposes; the variable product development cycles of EHR vendors; and the equally variable and sometimes much more attenuated IT purchasing cycle for hospital and health systemsis causing headaches for a lot of people in the industry.