Anti-Kickback Safe Harbor Provisions: HHS and OIG Changes to Regulate and Restrict Remuneration

The U.S. Department of Health and Human Services (HHS) and the Office of Inspector General (OIG) issued proposed regulations that amend the safe harbor provisions under the federal Anti-Kickback Statute (AKS) to exclude pharmaceutical manufacturer discounts to PBMs and Medicare Part D and Medicaid managed care plans from safe harbor protection.

Such rebates to health plan sponsors and PBMs have been a central piece in drug distribution and reimbursement in the U.S. These changes could dramatically impact consumers and supply chain stakeholders.

The amendments also create new safe harbor provisions for point-of-sale discounts on prescription drugs as well as PBM service fees. The point-of-sale-discounts safe harbor requires the discount to be set in advance and applied at the point of sale. A rebate may be involved only if the discount is given to the pharmacy through a chargeback.

OIG is requesting and accepting public comments until Apr. 8, 2019. The proposed rule would go into effect on Jan. 1, 2020.

Listen as our authoritative panel examines the proposed amendments to AKS safe harbor protection. The panel will explore the removal of protection for rebates to PBMs and health plans and the new safe harbors for point-of-sale discounts and service fees. The panel will discuss how those in the healthcare industry will be impacted and can take advantage of the changes and ensure compliance.