Accuracy of Drug Classification Data Used to Collect Medicaid Rebates

For Federal payments to be available for covered outpatient drugs provided under Medicaid, drug manufacturers are generally required to enter into rebate agreements with the Secretary of Health and Human Services and pay quarterly rebates to States. Under the Medicaid Drug Rebate Program, drug manufacturers must provide the Centers for Medicare & Medicaid Services (CMS) with the average manufacturer price (AMP) and, if applicable, best price for each of their covered outpatient drugs. The rebate amount for a drug is based in part on whether the drug manufacturer classifies it as an innovator, i.e., a single-source or an innovator, multiple-source product, or a non-innovator, multiple-source product. We will review CMS's Medicaid drug rebate classification data and evaluate the accuracy of innovator and non-innovator classifications for drugs. We will also review the procedures CMS has in place to ensure that manufacturers are in compliance with the requirements of the Medicaid Drug Rebate Program.

Announced or Revised	Agency	Title	Component	Report Number(s)	Expected Issue Date (FY)
Completed	Centers for Medicare & Medicaid Services	Accuracy of Drug Classification Data Used to Collect Medicaid Rebates	Office of Evaluation and Inspections	OEI-03-17-00100	2017