Skin Substitute Access and Payment Reform Act

The "Skin Substitute Access and Payment Reform Act" aims to significantly reform Medicare's payment and coverage policies for skin substitute products. This legislation explicitly adds these products to Medicare coverage and establishes a new, standardized payment methodology. Effective January 1, 2026, payment will be based on a volume-weighted average of Medicare payment allowance limits from October 2023, updated annually by the Consumer Price Index for All Urban Consumers. The bill defines a skin substitute product as a cellular, tissue, biological, or synthetic material applied to a wound, intended to remain, and marketed under specific FDA regulations, excluding temporary dressings, liquids, gels, or powders. To streamline billing, the Secretary of Health and Human Services is mandated to establish a consolidated billing and payment code for all skin substitute products by January 1, 2026. A key component of this reform is enhanced program integrity, targeting potential fraud, waste, and abuse. The Secretary will biennially identify the top 3% of providers, by total Medicare payment for skin substitute products, as outlier providers , publishing these lists and referring them to the Inspector General for investigation. Beginning in 2026, these outlier providers will face prepayment review of claims, and from 2027, they will be subject to prior authorization for skin substitute products. If an outlier provider's prior authorization denial rate exceeds 75% for six consecutive months starting January 1, 2028, it will be deemed an abuse of billing privileges, potentially leading to exclusion from Federal healthcare programs. The bill allocates $5 million annually from the Federal Supplementary Medical Insurance Trust Fund to CMS for fiscal years 2027 through 2030 to support these prior authorization measures.