Skin Substitute Access and Payment Reform Act of 2025
Sponsored By: Senator Bill Cassidy
Introduced
Summary
Creates a unified Medicare payment and coverage framework for skin substitute products. The bill would set a new single payment method, define which products count as skin substitutes, and require a consolidated billing code by January 1, 2026.
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Bill Overview
Analyzed Economic Effects
3 provisions identified: 1 benefits, 0 costs, 2 mixed.
Medicare coverage and reporting rules
If enacted, starting January 1, 2026 Medicare would evaluate skin substitute products under the usual 'reasonable and necessary' test. The Secretary could only find a product unsafe for contamination, serious infectious disease, or serious adverse reactions. The Secretary could not deny coverage solely by analyzing clinical evidence. Manufacturers would not have to report average sales price under certain ASP reporting rules.
One Medicare payment for skin substitutes
If enacted, Medicare would pay one set amount for all skin substitute products starting January 1, 2026. The amount would be a volume-weighted average using fourth-quarter 2023 payment limits and units billed Oct 1–Dec 31, 2023. From 2027 onward the amount would be adjusted by the CPI‑U change through June of the prior year. The Secretary must also create a single billing and payment code for these products by January 1, 2026.
Define which skin products qualify
If enacted, the bill would define a 'skin substitute product' as a cellular, biological, or synthetic material applied to a wound and meant to stay in the wound bed. It would include products cleared or authorized under certain FDA or Public Health Service pathways. It would exclude items meant to be removed before resorption (like dressings), and would exclude liquids, gels, powders, standard drugs, and licensed biologics.
Sponsors & CoSponsors
Sponsor
Bill Cassidy
LA • R
Cosponsors
Maggie Hassan
NH • D
Sponsored 9/17/2025
Cory Booker
NJ • D
Sponsored 10/28/2025
Roll Call Votes
No roll call votes available for this bill.
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