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Negotiation Data Elements Submissions Open

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The Negotiation Data Elements and Drug Price Negotiation Process information collection request (ICR) form for initial price applicability year 2027 (CMS-10849, OMB 0938-1452)* is open for submissions from manufacturers and the public. *

The Inflation Reduction Act (IRA) of 2022 established the Medicare Drug Price Negotiation Program (Negotiation Program) to negotiate maximum fair prices for certain high expenditure, single source drugs. For the second cycle of the Negotiation Program, initial price applicability year 2027, CMS selected for negotiation 15 high expenditure, single source drugs covered under Part D.

Manufacturers of selected drugs that sign an Agreement with CMS must submit their information through the CMS Health Plan Management System (HPMS) website [ https://hpms.cms.gov/app/ng/home/ ]_ _by March 1, 2025. Manufacturers must be registered for access to the CMS HPMS. For additional information about CMS HPMS user access, please visit: https://www.cms.gov/about-cms/information-systems/hpms/user-id-process.

Members of the public may optionally submit evidence about the selected drug and their alternative treatments by March 1, 2025 via the following web link: https://hpms.cms.gov/app/ng/pblc_cmt/.

For questions, please contact IRARebateandNegotiation@cms.hhs.gov.  

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Centers for Medicare & Medicaid Services




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