HHS proposes to remove rebates from the Anti-Kickback Statute’s “discount” safe harbor and add new safe harbor for point-of-sale discounts.

On January 31, 2019, the Department of Health and Human Services (HHS) announced a proposed rule that would remove the safe harbor protection under the Anti-Kickback Statute (AKS) for rebates paid by manufacturers to Medicare Part D plan sponsors, Medicare Advantage plan sponsors that offer prescription drug coverage, Medicaid managed care organizations (MCOs), and the pharmacy benefit managers (PBMs) under contract with them. At the same time, the proposed rule would add two new anti-kickback safe harbors to protect discounts provided to beneficiaries at the point of sale, and protect certain fees that manufacturers pay to PBMs.