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.