Skin Substitute Access and Payment Reform Act of 2025

This bill changes how Medicare pays for skin substitute products, which are used to treat chronic wounds like diabetic foot ulcers. It creates a new, single payment amount for all such products starting in 2026, based on a volume-weighted average of 2023 payment data, and updates that amount each year by inflation. It also defines what counts as a skin substitute product and sets new rules for coverage and billing.

Sec. 3, Payment reform for skin substitute products: Starting January 1, 2026, Medicare will pay for each skin substitute product using a single amount. That amount is the volume-weighted average of the payment allowance limits for all skin substitute products, calculated using the published payment limits from the fourth quarter of 2023 and the number of units billed from October 1 to December 31, 2023. For 2027 and later years, this amount will be increased by the change in the consumer price index for all urban consumers.

Sec. 3, Definition and other rules for skin substitute products: The bill defines a "skin substitute product" as a cellular, biological, or synthetic material applied to a wound and meant to stay in the wound bed, including products cleared or approved under certain FDA or Public Health Service pathways. It excludes temporary dressings, liquids, gels, powders, and products approved as drugs or biologics under other sections. By January 1, 2026, the Secretary must create a single billing and payment code for all skin substitute products. Starting that same date, all skin substitute products will be judged by the same criteria for Medicare coverage, unless the Secretary finds a product unsafe due to contamination or serious adverse reactions. The Secretary cannot deny coverage based only on clinical evidence about a product, and manufacturers do not have to report average sales prices for these products.