For the first time since the enactment of the Medicaid Drug Rebate Program (MDRP), the Centers for Medicare and Medicaid Services (CMS) revised the Medicaid National Drug Rebate Agreement (NDRA) entered into between drug manufacturers and the U.S. Department of Health and Human Services (HHS).
Drug manufacturers with existing active NDRAs now have until September 30, 2018, to execute and submit the revised NDRA if they wish to continue participating in the MDRP.
Published in the Federal Register (83 Fed. Reg. 12770 (Mar. 23, 2018)), the final revised NDRA contains several noteworthy changes from the version currently in effect including:
The MDRP is a complex system, involving the analysis and application of interrelated federal and state laws. The revisions listed above are not an exhaustive list of the changes found in the new NDRA. Manufacturers wishing to continue their participation in the MDRP now have six months to assess these changes and how they impact their operations and policies and to submit a new NDRA.
The foregoing was prepared for general information purposes only. This information is not legal advice and is not to be acted upon as such.