FEBRUARY 6, 2019

Administration Proposes Repealing Safe Harbor for Drug Rebates

By Gina Shaw

Rebates paid by drug manufacturers to insurers and pharmacy benefit managers (PBMs) in exchange for preferred formulary status would be declared illegal kickbacks under a new rule proposed by the Trump administration on Jan. 31. 

The rule proposes rolling back safe harbor protections for the rebates, which had kept them from violating federal anti-kickback statutes. It applies to rebates offered directly to Medicare Part D plan sponsors and Medicaid Managed Care Organizations