ADDENDUM–Updated Agreement: National Drug Rebate Agreement Between Thethe Secretary of Health and Human ServicesNational Drug Rebate Agreement • September 17th, 2020
The Secretary, on behalf of the U.S. Department of Health and Human Services and all States and the District of Columbia (except to the extent that they have in force an Individual State Agreement)states which have a Medicaid State Plan approved under 42 U.S.C. section 1396a, and the Labelermanufacturer, on its own behalf, for purposes of section 4401 of the Omnibus Budget Reconciliation Act of 1990, Pub. L. No. 101-508, and section 1927 of the Social Security Act (hereinafter referred to as "the Act"), 42 U.S.C. 1396sr-8, hereby agree to the following:
ADDENDUM –Updated Agreement: National Drug Rebate Agreement Between the Secretary of Health and Human ServicesNational Drug Rebate Agreement • September 17th, 2020
The Secretary, on behalf of the U.S. Department of Health and Human Services and all states which have a Medicaid State Plan approved under 42 U.S.C. 1396a, and the manufacturer, on its own behalf, for purposes of section 1927 of the Social Security Act (“the Act”), 42 U.S.C. 1396r-8, hereby agree to the following:
Action Required to Remain in Medicaid Drug Rebate Program: Updated National Drug Rebate AgreementNational Drug 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.
