November 6, 1991

Good Intentions Do Pave Road to Safe Harbors, But Taking Contravention Avenues Remains Risky

JAMA. 1991;266(17):2330-2335. doi:10.1001/jama.1991.03470170014003

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NEARLY FOUR MONTHS have passed since Richard Kusserow, inspector general for the US Department of Health and Human Services (DHHS), issued safe harbor regulations to help "self-referring" physicians steer clear of federal antikickback investigations.

Additional safe harbors, plus interpretive rules, are expected early in 1992.

But when these original regulations were issued, few physicians who had invested in health care facilities to which they refer patients found themselves within these safe harbors. Most of them, instead, had to decide whether to restructure, divest, or remain vulnerable to potential criminal and civil sanctions under the 1977 Medicare and Medicaid antikickback statute.

Critical 40%  To fall within safe harbors, no more than 40% of a facility may be owned by those in a position to refer patients to that facility. And referrals from owners should contribute no more than 40% of the facility's business. Under these new regulations, a hospital is also