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. 2025 Apr 1;8(4):e255077.
doi: 10.1001/jamanetworkopen.2025.5077.

Research Derived From Medicare's Coverage With Evidence Development Program

Affiliations

Research Derived From Medicare's Coverage With Evidence Development Program

Guneet S Janda et al. JAMA Netw Open. .
No abstract available

Plain language summary

This cross-sectional study assesses published research articles about medical items and services approved by the Coverage With Evidence Development program to characterize their scientific impact.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Mooghali reported receiving grants from Arnold Ventures during the conduct of the study. Dr Ramachandran reported receiving grants from Arnold Ventures—Laura and John Arnold Foundation provided for the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT) during the conduct of the study; receiving personal fees from ReAct-Action on Antibiotic Resistance Strategic Policy Program, grants from Stavros Niarchos Foundation, and grants from the US Food and Drug Administration (FDA) outside the submitted work; and serving as Chair of the FDA Task Force for Doctors for America in an unpaid, volunteer capacity. Dr Wallach reported receiving grants from Arnold Ventures for the Yale CRRIT during the conduct of the study; grants from National Institute on Alcohol Abuse and Alcoholism of the National Institutes of Health (NIH), Johnson & Johnson, and FDA (through the Yale-Mayo Center for Excellence in Regulatory Science and Innovation); and personal fees from Hagens Berman Sobol Shapiro LLP and Dugan Law Firm APLC outside the submitted work. Dr Dhruva reported receiving grants from Arnold Ventures during the conduct of the study; receiving funding support from the Department of Veterans Affairs outside the submitted work; and serving on the Institute for Clinical and Economic Review California Technology Assessment Forum and Medicare Evidence Development and Coverage Advisory Committee outside the submitted work. Dr Ross reported receiving grants from Arnold Ventures during the conduct of the study; grants from the FDA, Johnson & Johnson, Medical Devices Innovation Consortium, Agency for Healthcare Research and Quality, and National Heart, Lung, and Blood Institute of the NIH outside the submitted work; serving as an expert witness at the request of Relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc that was settled September 2022; and being Chair of the Medicare Evidence Development & Coverage Advisory Committee (unpaid) and a member of the New England Comparative Effectiveness Public Advisory Council for ICER outside the submitted work. No other disclosures were reported.

References

    1. Centers for Medicare & Medicaid Services . Guidance for the public, industry, and CMS staff: Coverage with Evidence Development. Accessed February 8, 2025. https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-do...
    1. Zeitler EP, Gilstrap LG, Coylewright M, Slotwiner DJ, Colla CH, Al-Khatib SM. Coverage with Evidence Development: where are we now? Am J Manag Care. 2022;28(8):382-389. doi:10.37765/ajmc.2022.88870 - DOI - PubMed
    1. Lakdawalla D, Tunis S, Neumann P, Whicher D, Zeitler E, Liden B. A roadmap for improving Medicare’s application of Coverage with Evidence Development. Value Health. 2024;27(9):1191-1195. doi:10.1016/j.jval.2024.05.008 - DOI - PubMed
    1. Dhruva SS, Ramachandran R, Ross JS. Medicare’s national coverage determination for aducanumab - a one-off or a pragmatic path forward? N Engl J Med. 2022;387(17):1539-1541. doi:10.1056/NEJMp2210198 - DOI - PubMed
    1. Mooghali M, Moneer O, Janda G, Dhruva SS, Ross JS, Ramachandran R. Assessing Medicare’s Coverage with Evidence Development program. Health Aff (Millwood). 2025;44(1):32-39. doi:10.1377/hlthaff.2024.00814 - DOI - PubMed