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Accuracy of Drug Manufacturers' Quarterly Pricing Data

CMS uses manufacturer-reported average sales price (ASP) and average manufacturer price (AMP) data to calculate Medicaid rebate amounts and Part B drug reimbursements. When these data are not accurate, CMS and States might not set appropriate reimbursement or rebate amounts for drugs. This can result in CMS, States, and Medicare beneficiaries paying more for these drugs. The Social Security Act provides a mechanism for monitoring market prices and limiting potentially excessive ASP-based payment amounts by requiring the OIG to compare ASPs with AMPs. As part of this comparison, each quarter OIG manually reviews publicly available documentation from manufacturers' websites and other sources, as appropriate, to validate the drug product and pricing information for selected national drug codes (NDCs). OIG may correct data associated with certain NDCs or exclude certain drug codes from the quarterly comparison if it identifies potential errors or inconsistent data. This study will determine the number of NDCs reported to CMS by manufacturers that contained potential errors in ASP and/or AMP data as well as the number of drug codes excluded from quarterly comparisons because of potential errors in the manufacturers' data.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY)
June 2019 Centers for Medicare & Medicaid Services Accuracy of Drug Manufacturers' Quarterly Pricing Data Office of Evaluation and Inspections OEI-03-19-00200 2020