The "Skin Substitute Access and Payment Reform Act of 2025" seeks to reform Medicare payment rules for skin substitute products, which are advanced biological therapies used to treat chronic wounds. Congress finds that while these products are similarly safe and effective, current Medicare payment systems incentivize more expensive options and lead to significant price differences. The bill aims to address these challenges by recognizing the clinical value of these treatments while containing costs. Beginning January 1, 2026, the bill establishes a new payment methodology for skin substitute products based on a volume-weighted average of payment allowance limits from late 2023. This payment amount will be adjusted annually for inflation using the Consumer Price Index for all urban consumers . Furthermore, the Secretary of Health and Human Services must establish a single, consolidated billing and payment code for all skin substitute products by January 1, 2026. The legislation also defines "skin substitute product" to include cellular, biological, or synthetic materials intended to remain in the wound bed, excluding temporary dressings or liquid formulations. Importantly, it mandates that all skin substitute products be subject to the same criteria for determining if they are "reasonable and necessary" for treatment, unless deemed unsafe. Manufacturers will also be exempt from reporting average sales price for these products.
Skin Substitute Access and Payment Reform Act of 2025
USA119th CongressS-2561| Senate
| Updated: 7/31/2025
The "Skin Substitute Access and Payment Reform Act of 2025" seeks to reform Medicare payment rules for skin substitute products, which are advanced biological therapies used to treat chronic wounds. Congress finds that while these products are similarly safe and effective, current Medicare payment systems incentivize more expensive options and lead to significant price differences. The bill aims to address these challenges by recognizing the clinical value of these treatments while containing costs. Beginning January 1, 2026, the bill establishes a new payment methodology for skin substitute products based on a volume-weighted average of payment allowance limits from late 2023. This payment amount will be adjusted annually for inflation using the Consumer Price Index for all urban consumers . Furthermore, the Secretary of Health and Human Services must establish a single, consolidated billing and payment code for all skin substitute products by January 1, 2026. The legislation also defines "skin substitute product" to include cellular, biological, or synthetic materials intended to remain in the wound bed, excluding temporary dressings or liquid formulations. Importantly, it mandates that all skin substitute products be subject to the same criteria for determining if they are "reasonable and necessary" for treatment, unless deemed unsafe. Manufacturers will also be exempt from reporting average sales price for these products.