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This paper describes how real-world evidence could improve CMS decision-making and creates a best practices checklist to help CMS evaluate the quality of any manufacturer-submitted evidence. The checklist was developed in four steps: (i) identification of the IRA requirements for determining the maximum fair price through a review of official guidance from CMS, (ii) assessment of provisions that could be supported by real-world evidence (RWE) in addition to clinical trial evidence, (iii) literature review on existing best-practice guidelines relevant to RWE, and (iv) consolidation of these RWE guidelines into a checklist through a series of web conference discussions among experts. The checklist aims to improve the quality of the information available to CMS during the drug price negotiation process.<\/jats:p>","DOI":"10.1093\/haschl\/qxaf030","type":"journal-article","created":{"date-parts":[[2025,3,23]],"date-time":"2025-03-23T05:01:37Z","timestamp":1742706097000},"source":"Crossref","is-referenced-by-count":0,"title":["Use of real-world evidence in the Medicare Drug Price Negotiation Program: A checklist for the Centers for Medicare and Medicaid Services and manufacturers"],"prefix":"10.1093","volume":"3","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0235-5289","authenticated-orcid":false,"given":"Sean R","family":"Tunis","sequence":"first","affiliation":[{"name":"Center for Evaluation of Value and Risk in Health, Tufts Medical Center , Boston, MA 02111 ,","place":["United States"]},{"name":"Rubix Health LLC, Baltimore, MD 21210, United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8444-5979","authenticated-orcid":false,"given":"Jason","family":"Shafrin","sequence":"additional","affiliation":[{"name":"Alfred E. 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