On January 31st, the Department of Health and Human Services (HHS) released a proposal to exclude a wide range of rebates on prescription drugs from “safe harbor” protections under the Anti-Kickback Statute (AKS) of the Social Security Act.
The rule proposes an effective date of January 1, 2020. HHS will accept comments on the rule through April 1, 2019. A summary of the proposed rule is attached. The fact sheet can be found here and the full proposed rule can be found here.