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

Sponsored by Foley Hoag LLP

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.

Foley Hoag attorneys Thomas Barker, Lisa Wood and Ross Margulies present a webinar sharing insights from Tom and Ross' recently published white paper. They describe how the current drug rebate system developed in response to three important events that occurred in the 1990s.

Topics 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?

Click here to download the slides.