4 February 2019 - The Trump Administration has proposed eliminating certain rebates drug manufacturers pay pharmacy benefit managers and insurers.
Specifically, safe harbour protection - which exempts rebates from anti-kickback laws - would be removed for rebates drug manufacturers pay to PBMs operating in Medicare and Medicaid, as well as Medicare Part D plans and Medicaid managed care organisations. Without safe-harbour protections, rebate monies retained by pharmacy benefit managers (PBMs), Part D and Medicaid plans, would be considered illegal kickbacks.
A new safe harbour would be established for rebates offered directly to patients picking up their prescriptions at the pharmacy, as well as fixed-fee service arrangements between drug manufacturers and PBMs, Part D and Medicaid plans.
In a statement, Department of Health and Human Services (HHS) Secretary Alex Azar railed against PBM rebates as “a hidden system of kickbacks to middlemen” that increases drug costs for U.S. residents.