Public Policy Alert

The Trump Administration yesterday continued its rulemaking efforts impacting the biopharmaceutical industry with a proposed regulation on Medicare safe harbors from federal anti-kickback laws. The U.S. Department of Health and Human Services (HHS) rule would remove the safe harbor from federal anti-kickback laws that is currently applied to rebates negotiated between manufacturers and pharmacy benefit managers (PBMs). The proposal would also create a new safe harbor that would protect discounts offered to Patients at the pharmacy counter. Finally, the proposal would create safe harbors related to fixed fee service arrangements between manufacturers and PBMs.
BioNJ is reviewing the proposed regulation for impact on New Jersey's life sciences sector. However, we continue to support market-based efforts to reduce the cost Patients pay at the pharmacy counter while promoting Patient access to innovative treatments.  
More information on the proposed rule is available here. The rule is slated for Federal Register publication on February 6 with a 60-day stakeholder comment period. 

Please contact John Slotman, BioNJ Vice President, Government Affairs, at or 609.890.3185 should you have any questions.  
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