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Calculation of the Per Unit Part B Drug Rebate Amount (1) Identification of the Specified Amount for the Applicable Calendar Quarter In the calculation of the rebate amount for a Part B rebatable drug, we are statutorily required to compare the inflation-adjusted payment amount to the specified amount, which is the amount set forth in section 1847A(i)(3)(A)(ii)(I) of the Act

A product marketed with therapeutic claims can fall inside medicines law regardless of what the vial says

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