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Manufacturer Release 007

Guidance for : The Centers for Medicare & Medicaid Services (CMS) is releasing this notice to provide guidance to manufacturers on three topics. First, we are providing guidance regarding the treatment of rebates provided to Medicare Advantage (MA) plans (including MA plans that offer prescription drug coverage (MA-PD plans)) for Medicare Part B utilization in the manufacturer�s determination of best price, calculation of a drug�s Average Manufacturer Price (AMP) for inhalation, infusion, instilled, implanted, or injectable (5i) drugs (5i AMP) and Average Sales Price (ASP). Second, we are providing guidance to manufacturers that wish to voluntarily terminate from the Medicaid Drug Rebate Program (MDRP) on the best approach to notifying CMS of their intent to terminate their National Drug Rebate Agreement (NDRA).

Download the Guidance Document

Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: April 29, 1993

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DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.