From the Chair

On November 19, 1999, the OIG issued two regulatory packages. The first contained a number of "clarifications" to existing safe harbors (which had originally been proposed in 1994), along with a number of new safe harbors, which were published in proposed form in 1993. The second package contained an interim final safe harbor regulation regarding the "risk sharing" exception to the federal antikickback statute, established by HIPAA. This regulation was developed through a negotiated rulemaking process and follows a report of the negotiated rulemaking committee, issued January 22,1998.

The publication of these regulations was long-awaited and much anticipated. As expected, however, the regulations do not create any broad new protections for health care business transactions and/or relationships. In some aspects, they do provide additional flexibility, however, for example, with respect to the discount safe harbor. Also as expected, the documents raise almost as many questions as they answer.

I was pleased to participate in a recent teleconference regarding these documents sponsored by the American Health Lawyers Association. In preparation for that teleconference, Bill Mathias and I created an extensive memorandum detailing and analyzing the two regulatory packages. This HLA Special Supplement reproduces those materials for your reference.

We expect that many questions will continue to arise as a result of the publication of these documents, and look forward to the opportunity to respond to your questions and concerns.

Sandy Teplitzky, Department Chair