2 Key Stark Law items: Strict liability and volume or value

Physicians Practice December 28, 2023
Rachel V. Rose, JD, MBA

A look at the self-referral law.

The Physician Self-Referral Law aka Stark Law (“Stark I”), was first signed into law in 1989. Since then, Stark II was passed in 1993 with three phases of implementing regulations. Recently, I was asked to present on avoiding liability with a specific focus on physician contracts. Physician agreements take many forms, including physician-hospital contracts, agreements with medical device or pharmaceutical companies, office rental agreements, and physician-ownership in ambulatory surgery centers (ASCs), just to name a few.

How does one avoid liability under Stark, as well as a potential False Claims Act case? The simple answer is meet an exception “to the referral prohibition related to compensation arrangements.” (42 C.F.R. 411.357). It is important to...

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