On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) published its long-awaited and highly anticipated final rule updating regulations promulgated under the Physician Self-Referral or “Stark” law (the OIG simultaneously published updates to the Anti-Kickback Statute regulations). Among other things, CMS introduced new Stark exceptions for certain “value-based arrangements,” the donation

On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS) safe harbors, and the Beneficiary Inducements Civil Monetary Penalties (CMP) regulations.  The changes to the regulations go into effect on January 19, 2021 (except for one change to the Physician Self-Referral Law that becomes effective January 1, 2022). In a separate rule also released November 20th, HHS removed safe harbor protection for rebates involving prescription pharmaceuticals and created a new safe harbor for certain point-of-sale reductions in price on prescription pharmaceuticals and pharmacy benefit manager service fees.

The full text of each rule is available below.


Continue Reading Physician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules