HHS/OIG Finalizes Rule Stripping PBM Rebates of Safe Harbor Protection

On November 20, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued a Final Rule to finalize a February 6, 2019 proposal stripping rebates received from drug manufacturers by pharmacy benefit managers (PBMs) from safe harbor protection under the Anti-Kickback Statute (AKS), creating new safe harbors to incentivize point-of-sale (POS) discounts passed on to patients, and protecting certain PBM fees. While HHS/OIG made some modifications to the proposed rule, the main thrust of the proposal was unchanged.

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