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Centers for Medicare & Medicaid ServicesAnnouncement: Inflation Reduction Act and Medicare.

July 2, 2024

 

Medicare Drug Price Negotiation Program: Negotiation Data Elements and Drug Price Negotiation Process Initial Information Collection Request Published for Comment

CMS announces the release of an information collection request on Negotiation Data Elements and Drug Price Negotiation Process for Initial Price Applicability Year 2027 of the Medicare Drug Price Negotiation Program. The Negotiation Data Elements and Drug Price Negotiation Process initial information collection request (ICR) for initial price applicability year 2027 can be found in the Federal Register. [ https://www.federalregister.gov/documents/2024/07/02/2024-14582/agency-information-collection-activities-proposed-collection-comment-request ] The full text of the ICR can also be found at CMS' PRA website [ https://www.cms.gov/regulations-and-guidance/legislation/paperworkreductionactof1995/pra-listing/cms-10849 ]. Comments are due by *September 3, 2024,* and can be submitted at this comment submission link [ https://www.regulations.gov/docket/CMS-2024-0198/document ].

This package contains two parts: 1) the "Negotiation Data Elements", which includes the data CMS would consider as the basis for determining offer(s) and counteroffer(s) throughout the negotiation process based on the submissions required from a participating drug company and the optional submissions from the public on the selected drug and its therapeutic alternative(s), and 2) the "Drug Price Negotiation Process", which includes the data and information CMS would consider if a participating drug company submits a counteroffer for a selected drug during the negotiation process.

Participating drug companies will submit their information through the CMS Health Plan Management System (HPMS) website [ https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fhpms.cms.gov%2Fapp%2Fng%2Fhome%2F&data=05%7C01%7Cmichelle.wojcicki2%40cms.hhs.gov%7C0a5d6519dee24317101c08db928cae00%7Cfbdcedc170a9414bbfa5c3063fc3395e%7C0%7C0%7C638264905134021689%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=SyOQ1niVJgp6NYbaTnnNci21OFtvJSjTqtQLCiv%2BoXg%3D&reserved=0 ]. Instructions for participating drug companies to gain access to the CMS HPMS are available at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/HPMS/UserIDProcess. Members of the public may optionally submit evidence about therapeutic alternatives of the selected drugs via a publicly available web link that will be available through CMS.gov. Technical instructions will be forthcoming from CMS.

For initial price applicability year 2027, submission of the Negotiation Data Elements by participating drug companies and the public is due by March 1, 2025. CMS will issue initial offers to the participating drug companies by June 1, 2025, and counteroffers, if applicable, will be due 30 days after receipt of the initial offer.

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