New HHS Rules for AKS Safe Harbors and Stark Law Exceptions

On Friday, November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) finalized two rules: (1) the “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements” rule (the “AKS Final Rule”), adopting changes to the safe harbor provisions of the Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7b(b), and (2) the “Modernizing and Clarifying the Physician Self-Referral Regulations” rule (the “Stark Final Rule”), adopting changes to the physician self-referral law known as the Stark Law, 42 U.S.C. § 1395nn. The two rules come as part of HHS’s Regulatory Sprint to Coordinated Care, an agenda aiming to remove potential regulatory barriers to care coordination and value-based care. The two rules were initially proposed in October 2019, but they have been undergoing detailed review by OMB. The new rules go into effect on January 19, 2021.