New federal regulations released by HHS to put e-prescribing tools and electronic health records into the hands of physicians more rapidly could run broadside into a health information technology bill that -- as written -- would override a main component of the rules. Moreover, one physician group argues the new rules don't go far enough to encourage more use of electronic tools and records.
The new regulations allow hospitals and other organizations to donate e-prescribing, electronic health records technology and support services to physicians. The regulations create broader exceptions and safe harbors to federal fraud-and-abuse laws, in terms of qualified donors and recipients.
The CMS, after weighing input from the health and IT industries, developed two exceptions to physician self-referral laws that allow hospitals and other organizations to provide doctors with technology and training used predominately for interoperable EHRs and e-prescribing. Under the regulations, recipients must cover 15% of the cost of e-records technology and services.
Under one of the two exceptions to the fraud-and-abuse laws released last week, HHS would require computer equipment to be interoperable and certified by a deeming body "at the time that it is provided to the physicians." Interoperable, as defined by HHS, means that the software is able to "communicate and exchange data accurately, effectively, securely and consistently" with other IT systems.
HHS' inclusion of interoperabilty certification as a requirement for Stark and anti-kickback safe harbors is a problem because, while an HHS-sponsored group is developing a criterion for testing EMR interoperability, it isn't likely to be ready by May 2007.
And there's the rub. "The rule says that you have to donate something interoperable, which means no one donates anything right now," said David Merritt, a project director at the Center for Health Transformation. "None of it is interoperable."
The Certification Commission for Healthcare Information Technology, which was tapped to develop a certification process to ensure interoperability, functionality and security of electronic health records, has only a nominal provision in place right now requiring products to be interoperable. Next May, the CCHIT is expected to beta test interoperability standards. But that's still several months past the HHS deadline, expected to be early October.
What's more, in legislation passed last year in the Senate and only two weeks ago in the House, federal lawmakers have been hesitant to include provisions that require any type of interoperability standards. Unless a stipulation is added in the coming weeks, as the House and Senate bills are reconciled, the legislation would effectively trump the HHS regulation.
HHS Secretary Mike Leavitt said in speeches he commends Congress for moving forward on health IT legislation, but scolded members for not including the requirement. Regardless, even without the interoperability issue, there are enough differences between the House and Senate versions to already ensure a robust negotiation process, said Bruce Merlin Fried, a partner with Sonnenschein, Nath & Rosenthal. If members from both chambers haggle over interoperability, it could potentially detour -- or derail -- the prospect of having the bill pass this year. "My guess is that at the end of the day, since the administration has actually acted and the industry has applauded (the rules)," the bill will pass without the provision, Fried predicted.
Politics aside, physician associations argue that the rules miss their target. Patrick Hope, legislative counsel at the American College of Physicians, said the rules don't go far enough in addressing the financial issues. Interoperability, he said, is a canard. "It's the No. 1 misunderstanding between the administration and Congress," he said.
Hope said both parties have put all their chips on revising the Stark and anti-kickback laws as being the "silver bullet" that will lead to widespread IT adoption. While physicians largely view e-prescribing and EHRs as legitimate vehicles to better ensure patient safety, they're often handcuffed from implementing them because of the high costs that come with installation and upkeep.