On October 9th, the Centers for Medicare and Medicaid Services (CMS) released two proposed rules that, if finalized, would reduce some of the regulatory requirements and create new exceptions for the Physician Self-Referral law, also known as the Stark Law, and the Federal Anti-Kickback Statute and Civil Monetary Penalty (CMP) Law. The changes are intended to clarify and expand exceptions for providers engaged in value-based arrangements, in which payment is based at least partially on meeting targets for the cost of care. While the two rules are coordinated, they do not line up in all particulars (for example, in the criteria for “meaningful” or “substantial” downside risk).
The attached document summarizes several major provisions of each rule. The Stark Law proposed rule is available here, and the Federal Anti-Kickback Statute and CMP Law proposed rule is available here.