In just two weeks, on January 19, 2021, a sweeping set of changes to the federal physician self-referral law (or “Stark Law”) and anti-kickback statute (“AKS”) regulations go into effect. These changes, which are part of the U.S. Department of Health and Human Services (“HHS”) “Regulatory Sprint to Coordinated Care,” are the most significant changes to the Stark Law and AKS in a decade. There are hundreds of pages of preamble guidance and revised regulation text setting forth these sweeping changes from the Centers for Medicare & Medicaid Services (“CMS”) and HHS Office of Inspector General (“OIG”).
These white papers provide an in-depth summary of the changes to these regulations, including key provisions from CMS and OIG preamble guidance.