HHS Finalizes New Protections under the AKS and Stark Law for Value-Based Arrangements and Other Significant Revisions to Modernize Fraud and Abuse Rules

On Friday, November 20, 2020, the Department of Health and Human Services (HHS) released four significant Final Rules, including the Office of Inspector General (OIG) rule: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements (the AKS Final Rule), as well as the Centers for Medicare and Medicaid Services (CMS) rule: Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations (the Stark Law Final Rule).  These two separate, but related, final rules comprise the core activities of the Trump administration's "Regulatory Sprint to Coordinated Care."

Advisories highlighting the key provisions for the Stark Law Final Rule and the AKS Final Rule are linked below.  Additionally, on November 24, Arnold & Porter published an Advisory describing a separate final rule that provides for significant changes to the Anti-Kickback Statute (AKS) safe harbors that protect pharmaceutical manufacturer arrangements with Medicare Part D plan sponsors, Medicaid managed care organizations (MCOs), and pharmacy benefit managers (PBMs).

If you have any questions about any of the topics discussed in these Advisories, please contact your Arnold & Porter attorney or any of the Advisories' authors.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.