HHS suggests transforming safe harbors for Part D drug rebates

By Robert King  | January 31, 2019

HHS issued a long-awaited proposed rule on Thursday that excludes the rebates drugmakers pay to pharmacy benefit managers on Medicare Part D plans from protections from anti-kickback laws. 

The proposed rule also applies to safe harbor protections for Medicare managed-care organizations. 

The agency instead will propose new safe harbor protections to protect certain PBM service fees and another protection for certain price reductions made at the point of sale.

“This proposal has the potential to be the most significant change in how Americans’ drugs are priced at the pharmacy counter, ever, and finally ease the burden of the sticker shock that millions of Americans experience every month for the drugs they need,” HHS Secretary Alex Azar said in a statement.