OIG Analyzes Market Share Rebates and Bundled Discounts Under the Discount Safe Harbor

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On December 18, 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published favorable Advisory Opinion 25-11, approving various discount structures, including bundled discounts and rebates contingent on achieving market share requirements, a biopharmaceutical manufacturer (Requestor) offers its customers on three vaccines (Arrangement)….
By: Bass, Berry & Sims PLC
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