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.

1. Overview and background of proposed rulemaking
2. Removal of safe harbor protections for PBM and health plan rebates
3. New safe harbors
   1. Point-of-sale discounts
   2. PBM service fees
4. Impact of the changes
5. What stakeholders in the healthcare industry and counsel need to do

The panel will review these and other key issues:

• What is the impact of the changes on drug distribution and reimbursement?
• What is the scope of application of the proposed changes?
• What must stakeholders in the healthcare industry do to ensure compliance with the safe harbor changes?