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At press time, the Department of Health and Human Services (HHS) was set to release the final Stark II self-referral regulations after nearly a decade of delay. The final rule was scheduled to go on display today or tomorrow and is slated for publication later this week.
All indications are that doctors and hospitals will have their hands full digesting all the changes included in the final rule. "The OIG basically had to rewrite the whole set of regulations that HCFA [Health Care Financing Administration] published a few years ago," says Dan Mulholland, a partner with Horty Springer in Pittsburgh. From the standpoint of providers, that can only be an improvement, he adds.
The HHS’ Office of Inspector General (OIG) provided technical assistance in drafting the final regulation. The Office of Management and Budget also was part of the final clearance process.
Regardless of the shape of the final regulations, this might not be the final act for the contentious Stark II regulations. The next round could take place in Congress, where outgoing House Ways & Means Health Subcommittee Chairman Rep. Bill Thomas (R-CA) has introduced legislation that would strip the compensation portion of the law, widely considered to be its most problematic component.
With a thin Republican majority in the House, that will be no easy task. "I think they are going to have a hard time changing any of this because you start amending Stark and somebody jumps on you and says that you are in favor of fraud," asserts Mulholland.
In 1989, Congress passed the Stark I regulation, named after its main sponsor, Rep. Pete Stark (D-CA). That law sought to block physicians from inappropriately referring patients to facilities in which they had a financial interest. Four years later, Stark II extended those prohibitions to hospitals, home health, and numerous other providers. For better or worse, providers now have a regulation to guide their actions in that area.
Meanwhile, the final budget signed by President Clinton on Dec. 21 includes a "bare-bones" measure that reauthorizes the OIG’s advisory opinion process indefinitely. When the process originally was established in the face of some resistance by the OIG, it was authorized for only three years. Once in place, the advisory opinion process found few critics.
Unfortunately, attempts to modify the statute by including certain Freedom of Information Act (FOIA) protections fell short. Those protections would have shielded providers from trial lawyers who make FOIA requests and later use the information disclosed in qui tam filings against them.
Health care advocates also had hoped that the OIG’s current 60-days to issue opinions would be extended to 90 days, and that trade associations would be allowed to request advisory opinions on behalf of their members. But those changes never found their way into the legislation signed by the president .
Perhaps the most far-reaching change in the process that was advocated but not adopted was one that would have made the opinions binding to all providers as opposed to just the requester.
The budget also includes a $32 million — or 68% — increase for the Nursing Home Initiative to boost federal oversight and inspection of nursing homes. There were no other big-ticket items in the area of health care fraud and abuse enforcement, however.