Lexology March 3, 2021
The Department of Health and Human Services (“HHS”), in collaboration with the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the Inspector General (“OIG”), has issued two final rules clarifying certain regulatory terms and adding and amending exceptions and safe harbors to accommodate “value” transactions under the Anti-Kickback Statute (“AKS”), the federal Physician Self-Referral Law (the “Stark Law”), and the Civil Monetary Penalties Law (the “CMP Law”). These changes, as we noted in our discussion of the proposed regulations, are arguably the most significant changes in the Stark Law, AKS, and the CMP Law in recent history.
The White House announced a regulatory freeze and encouraged the new administrators of the relevant agencies to review and, if...