January 30, 2026

Drug Price Negotiation Information Collection for Initial Price Applicability Year 2028

The Drug Price Negotiation information collection request (ICR) form for initial price applicability year 2028 (CMS-10849, OMB 0938-1452) will be open for submissions from manufacturers and the public no later than 11:59 PM EST today, January 30, 2026.  

Under the Medicare Drug Price Negotiation Program (Negotiation Program), CMS negotiates with manufacturers to establish maximum fair prices for certain high expenditure, single source drugs. For the third cycle of the Negotiation Program, initial price applicability year 2028, CMS selected for negotiation 15 high expenditure, single source drugs payable under Part B and/or covered under Part D. CMS also selected one drug for renegotiation during the third cycle of negotiations (initial price applicability year 2028), based on criteria required by the law. 

Manufacturers of selected drugs that sign an Agreement with CMS must submit their negotiation data elements information through the CMS Health Plan Management System (HPMS) website by March 1, 2026. 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 selected drugs and their alternative treatments by March 1, 2026 via the following web link: https://hpms.cms.gov/app/ng/pblc_cmt/.  

The approved ICR (CMS-10849, OMB 0938-1452) is available for viewing on OMB’s website. Click “all” to see full details. 

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