Regulatory and reimbursement reform for cellular, acellular, and matrix-like products (CAMPs)

 

In August 2025, a national meeting was held in Washington, D.C., gathering 32 experts from across clinical, academic, manufacturing, legal and policy sectors to address the clinical, regulatory, and economic landscape of CAMPs. This consensus document summarizes key discussions from that meeting and the panel recommendations are aimed at improving the regulatory and reimbursement environment for CAMPs in the U.S., while concurrently ensuring Medicare beneficiaries have equitable access to advanced therapies for wound healing and amputation avoidance. 

Authors: William H Tettelbach,MD, FACP, FIDSA, FUHM, MAPWCA, CWSP, David G Armstrong,MD, Daniel Kapp, MD Jonathan Johnson, MD, MBA, CWSP, FAPWCA, Jeffrey A Niezgoda, MD, FACHM, MAPWCA, Ryan Dirks, MS, PA, CWS Michael Shin, MD, Stuart Oertli, MS, Bob Bartlett, MD, CPE, MAPWCA, Martha R Kelso RN, CHWS, DAPWCA, HBOT, Robert Odell, Salvatore Leo, Garrett Grinsfelder, Terrence Mabry, Marshall Medley, DO, FACOS, CWS-P, Michael Del Piano, Howard Walthall, Benjamin A Kimball

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A Win for Access - Not the End of Reform: The CAMPs LCD Withdrawal and the Work Ahead

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JWC: Rethinking regulatory tiers: Medicare real-world evidence shows CAMP outcomes are independent of FDA regulatory classification