At the end of 2020, the US Department of Health and Human Services Office of Inspector General and Centers for Medicare and Medicaid Services issued final rules modifying and expanding upon the regulatory safe harbors and exceptions to the federal Anti-Kickback Statute and the Stark Law, respectively.

In Part 2 of this two-part series, Mintz’s Karen Lovitch and Rachel Yount return to examine the changes to the Stark Law regulations, including new defined terms, modifications to existing exceptions, and the government’s efforts to ease compliance burdens associated with this strict liability statute.