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The Centers for Medicare & Medicaid Services (CMS) continually reviews emerging evidence on skin substitute products and is committed to considering the latest clinical research. To support this effort, CMS invites product sponsors, manufacturers, researchers, and other interested parties to voluntarily submit full-text clinical evidence relevant to the medically necessary use of these products in the Medicare population. CMS has heard from several manufacturers and product sponsors that they did not have sufficient time to submit clinical information during the previous review period. To ensure all interested parties have an opportunity to share relevant evidence, CMS is providing an additional opportunity for submissions. Interested parties may find it helpful to review the November 2025 consensus, Clinical Trials for Cellular, Acellular, and Matrix-Like Products (CAMPs): An Evidence Consensus, which provides guidance for identifying high-quality clinical evidence. CMS requests that peer-reviewed publications and other high-quality, publicly available information on skin substitute products be submitted as PDF attachments to: CAGInquiries@cms.hhs.gov |
| Centers for Medicare & Medicaid Services (CMS) has sent this update. To contact Centers for Medicare & Medicaid Services (CMS) go to our contact us page. |
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