M-3.1. Centers for Medicare and Medicaid Services

The Medicaid Drug Rebate Program (MDRP) is an arrangement between Centers for Medicare & Medicaid Services (CMS), state Medicaid agencies, and participating drug manufacturers. The MDRP partially offsets the federal and state costs of most outpatient prescription drugs dispensed to Medicaid beneficiaries. Manufacturers must enroll with CMS and sign agreements to pay rebates on all drugs dispensed to people enrolled in Medicaid before HHSC considers the drug for inclusion on the Texas Medicaid formulary. HHSC requires a CMS-approved National Drug Rebate Agreement (NDRA) to commence the certificate of information process.

Refer to the Medicaid NDRA information at medicaid.gov/medicaid/prescriptiondrugs/medicaid-drug-rebate-program/medicaid-national-drug-rebateagreement/index.html for instructions on participating in the MDRP.

M-3.1.1. Reporting Requirements

To maintain Drug Data Reporting (DDR) status with CMS, manufacturers must report initial product and pricing information to CMS on all covered outpatient drugs within 30 days of the end of the month and quarter of the optimal effective date.

Each month and quarter, manufacturers must submit pricing data to CMS within 30 days of the end of each respective monthly and quarterly period and should be updated as often as necessary. Manufacturers should report or update product data and pricing corrections as soon as they become available to CMS. When a manufacturer markets a new drug, they should submit information to the Medicaid DDR system to ensure the United States Food and Drug Administration (FDA) lists the drug.

Refer to the Federal Register's Announcement of Medicaid Drug Rebate Program National Rebate Agreement (March 2018) (https://www.federalregister.gov/documents/2018/03/23/2018-05947/medicaid-program-announcement-of-medicaid-drug-rebate-program-national-rebate-agreement) to learn more.