Rebate Reduction Requests underSections 11101 and 11102 of the Inflation Reduction Act (CMS-10858) - IRA

The Centers for Medicare & Medicaid Services (CMS) is requesting review and approval of data collection related to section 11101 and 11102 of the Inflation Reduction Act of 2022 (IRA; P.L. 117-169). Under the authority in sections 11101 and 11102 of the IRA, CMS is implementing the Medicare Part B Drug Inflation Rebate Program and the Medicare Part D Drug Inflation Rebate Program codified in section 1847A(i) and section 1860D-14B of the Social Security Act (“the Act”), respectively. The statute provides that CMS must reduce or waive the rebate amount for a Part B biosimilar biological product and generic Part D rebatable drug or biosimilar when CMS determines there is a severe supply chain disruption, such as a disruption caused by a natural disaster or other unique or unexpected event. CMS also must reduce or waive the rebate amount for a generic Part D rebatable drug if CMS determines that without such reduction or waiver, the drug is likely to be described as in shortage during a subsequent applicable period. Some of the information and supporting documentation needed for CMS to make a determination regarding a severe supply chain disruption and the likelihood of a future shortage are held by manufacturers and are not available to CMS. For CMS to determine whether there is a severe supply chain disruption or likelihood of future shortage, in accordance with sections 1847A(i)(3)(G)(ii), 1860D-14B(b)(1)(C)(ii), and 1860D-14B(b)(1)(C)(iii) of the Act, a manufacturer must submit a request and supporting documentation (as described in Appendix A, B, C, and D, as applicable) to CMS to receive consideration for a rebate reduction.

The latest form for Rebate Reduction Requests underSections 11101 and 11102 of the Inflation Reduction Act (CMS-10858) - IRA expires 2027-07-31 and is listed under ICR 202407-0938-012.

Rebate Reduction Request Form

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