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OIG proposed rule revises federal Anti-Kickback Statute and CMP Law

Jamie B. Gelfman (jamie.gelfman@nelsonmullins.com) is a Health Law Attorney in the Fort Lauderdale, Florida, office of Nelson Mullins. Timothy S. Wombles (timothy.wombles@nelsonmullins.com) is a Health Law Attorney in the Orlando, Florida, office of Nelson Mullins.

In 2018, the United States Department of Health and Human Services (HHS) launched the Regulatory Sprint to Coordinated Care initiative (the initiative) to align existing regulations with and remove regulatory impediments to the healthcare industry’s shift toward value-based and coordinated care payment models. The initiative covered the regulations implementing the Stark Law,[1] federal Anti-Kickback Statute (AKS),[2] and Civil Monetary Penalty Law (CMPL).[3] In furtherance of the initiative, on August 27, 2018, HHS’s Office of Inspector General (OIG) issued a Request for Information seeking recommendations from the public regarding modifying or adding safe harbors to the AKS and exceptions to the CMPL’s definition of “remuneration.”[4] After receiving 359 responses from various stakeholders, on October 9, 2019, OIG issued a Notice of Proposed Rulemaking, “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements” (the proposed rule).[5] A high-level summary of this proposed rule follows.

On the same day, the Centers for Medicare & Medicaid Services (CMS) issued its proposed rule addressing the regulations implementing the Stark Law, which is summarized in “CMS issues long-awaited Stark proposed rulemaking” (also in this issue of Compliance Today).

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