HHS' Proposed Rule to Change AKS Safe Harbor Protection for Rebates in the Drug Supply Chain




April 4, 2019 12:30PM–1:30PM


As part of the Trump administration’s efforts to lower drug prices and reduce patient out-of-pocket costs, HHS-OIG published a Proposed Rule to change the anti-kickback statute's (AKS) safe harbor protection for manufacturer rebates in the drug supply chain. In the current public policy discussion over drug pricing, it is hard to overstate the significance of this proposal. The current rebate model for the drug supply chain has been in existence for close to 30 years. The Proposed Rule, if implemented, would fundamentally change the system in the Medicare Part D and Medicaid managed care programs with transformative implications for manufacturers, health plans, pharmacy benefit managers, pharmacies and others.

Join Foley Hoag attorneys Thomas Barker, Lisa Wood and Ross Margulies for a webinar on April 4, 2019, as they share insights from Tom and Ross' recently published white paper. They will describe how the current drug rebate system developed in response to three important events that occurred in the 1990s.

Topics to be discussed

  • What is the Federal anti-kickback statute and what are its related safe harbors?
  • How did we arrive at the current rebating system, which has at its genesis three important events that occurred in the 1990s?
  • How does the Proposed Rule from HHS-OIG use the Federal anti-kickback statute and other laws to eliminate or restrict drug rebates?
  • What is the potential timing of the Proposed Rule and recently introduced legislation and the likely impact for the current drug supply chain?

This discussion is intended to provide you with an overview of the current policy discussion on rebate and insights to take back and apply to your organizations.