Part two of a two-part series (read part one here):
As HHS tries to promote two healthcare information technology policies at onceenticing physicians to adopt electronic health-record systems while coercing software vendors to use common data exchange standardsthe government appears to have impeded the former by imposing the latter.
HHS and the CMS last year granted waivers of federal laws that otherwise would have prohibited government-endorsed subsidies by hospitals and other providers to physicians for the purchase of electronic health-record systems. But the government also required that hospitals either attest that the EHRs they provide doctors are interoperable under the governments own rigorous definition, or provide systems certified as interoperable by an independent organization, which, so far, means the federally supported Certification Commission for Health Information Technology.
In this second of a two-part series, industry observers react to the HHS dual-policy initiative, and particularly an HHS interoperability requirement that EHRs be CCHIT-certified every 12 months.
Legal yellow light
Andrew Blustein, a partner with the law firm of Garfunkel, Wild & Travis in Great Neck, N.Y., urges hospital leaders to use caution in approaching physician EHR subsidies.
"For a hospital to choose to purchase a product that has not been certified within that (12-month) time period seems to be a risk that is not worth taking," Blustein says. "That puts the emphasis on the hospital deciding if someone is interoperable, and if they are wrong, they could be out of compliance with Stark. There may be some hospitals expert enough to make that determination, whether it is interoperable, but there are others that are not. But I dont see why they should take the risk. Vendors should go out and get their certifications.
"If a hospital were to purchase software and then discover it wasn't on the list, then they have not done exactly what the regulation said," Blustein warns. "They have not steered clear. It doesn't mean automatically their whole Stark world comes tumbling down, but if you can avoid risk, then avoid it. There are significant criminal and civil sanctions for noncompliance."
IT system vendors, not surprisingly, have a different take on HHS' orders other than just salute and march. They began trying to persuade the government to avoid the current situation in February at the annual meeting of the Healthcare Information and Management Systems Society in New Orleans. There, members of the HIMSS-affiliated Electronic Health Record Vendors Association warned HHS officials of the impending problem. They followed up with a March 14 letter to Karen Bell, the physician director of information technology adoption at HHS' Office of the National Coordinator for Health Information Technology. The vendors argued that the current 12-month scheme would hurt not only vendors but also providers and, ultimately, physicians, who would be unable to obtain subsidized EHRs because the requirement could never be met, thus rendering the waivers useless.
The reality of the IT industry is that "software updates are scheduled typically every 18-24 months," according to the letter. "Changing the product version, or adding an additional version in the middle of an implementation cycle, would make implementation almost infeasible."
Patients, too, could be affected, according to the letter. "It is not in the best interest of the patient, physician, donating entity or vendor to accelerate the development of a product as critical to patient care as an EHR to meet an arbitrary 12-month period." The vendors asked HHS to "clarify that a valid three-year CCHIT certification satisfies the deeming provision of the regulations."