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Action Required to Remain in Medicaid Drug Rebate Program: Updated National Drug Rebate Agreement
Rebate Agreement • March 26th, 2018

On March 23, 2018, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final notice for the Medicaid National Drug Rebate Agreement (NDRA) CMS-2397-FN (Final Notice) (83 FR 12770 ) that announced changes to the NDRA which will be applicable as of the March 23, 2018 publication date. The updated NDRA incorporates legislative and regulatory changes that have occurred since the NDRA was last published on February 21, 1991, and also makes editorial and structural revisions, such as references to the updated Office of Management and Budget (OMB)-approved data collection forms and electronic data reporting. The NDRA reaffirms the manufacturer’s responsibilities to correctly and consistently report drug product and pricing data to CMS in a timely manner, and refers to the statutory and regulatory citations for the definitions of single source, innovator multiple source, and non-innovator multiple source drugs.

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