Anti-fraud and abuse regulations, on the books for years, were meant to prevent doctors from receiving kickbacks from hospitals and participating in other anti-competitive behavior. However, as the federal government has pushed the nation's health-care providers into digitizing inefficient and mistake-ridden paper processes, those so-called Stark regulations have gotten in the way. Many doctors' offices—especially smaller practices—don't have the technology and financial resources to deploy interoperable e-health records and e-prescribing systems that government researchers say are needed, and the Stark rules prevent them from accepting donated assistance.
The exceptions and safe harbors announced today by HHS let physicians accept donations of e-prescribing software, e-health record systems, and training services from hospitals, health plans, and other certain entities.
A donated e-health record systems saves doctors the cost of deploying that software in their offices and improves the likelihood that most Americans will have electronic health records by 2014, a goal set by President Bush.
"Electronic health records help doctors provide higher quality patient care, improved efficiency and with less hassle," said U.S. Health Secretary Michael Leavitt during a teleconference on Tuesday announcing the exemptions. "By removing barriers, these regulation changes will help physicians get these systems in place and working for patients faster."
The exceptions, which go into effect Aug. 8, aren't without restrictions. For instance, the donated e-health record software must be certified as being interoperable with other systems, and e-prescribing software from one supplier must not restrict or limit compatibility with other e-prescribing systems.
During the teleconference, Leavitt lauded the Senate and House of Representatives in recently passing their own health IT bills that contain provisions aimed at accelerating the adoption of health-care IT.
However, Leavitt complained that the House bill contains the "flaw" of not requiring that health-care providers adopt interoperable health IT. Without that language being part of a final statute, he says, doctors and hospitals run the risk of using e-health systems that only work in closed communities.