US SB2561

Establishes a single consolidated Medicare billing and payment code for all skin substitute products beginning January 1, 2026, replacing the current system with multiple codes and varying prices

Sets payment rates based on a volume-weighted average calculated from Q4 2023 payment allowance limits and claims data, with annual adjustments tied to the Consumer Price Index starting in 2027

Defines skin substitute products as cellular, biological, or synthetic materials applied to wounds and intended to remain in the wound bed, excluding temporary dressings, liquids, gels, powders, and FDA-approved drugs or biologics

Requires equal coverage criteria for all skin substitute products when determining medical necessity, prohibiting CMS from denying coverage based solely on clinical evidence analysis

Exempts skin substitute manufacturers from reporting average sales prices to Medicare, addressing the finding that current payment systems incentivize higher-priced products and have driven significant Medicare expenditure increases in 2024-2025