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August 29, 2025   
Health Law Weekly

U.S. Court in DC Rejects Drug Maker’s Challenge to “New Formulation” Definition for Medicaid Rebates

  • August 29, 2025

The Centers for Medicare & Medicaid Services (CMS’) broad regulatory definition of “new formulation” of a drug to include new-strength versions for determining Medicaid rebates that pharmaceutical manufacturers owe did not exceed the agency’s statutory authority, the U.S. District Court for the District of Columbia held August 27, rejecting a challenge brought by drug maker Chiesi USA.

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