Bill > S2561

This bill aims to reform Medicare payment rules for skin substitute products, which are advanced biological therapies used to treat chronic, non-healing wounds like diabetic foot ulcers. The legislation addresses challenges in pricing and payment by establishing a new payment methodology beginning January 1, 2026, based on a volume-weighted average of existing payment allowance limits. The bill defines skin substitute products as cellular, biological, or synthetic materials applied to wounds and intended to remain in the wound bed, excluding temporary wound coverings and certain other items. Under the new rules, all skin substitute products will be subject to the same criteria for determining medical necessity, and the Secretary of Health and Human Services cannot deem a product unreasonable or unnecessary based solely on clinical evidence. The bill seeks to reduce Medicare expenditures while recognizing the clinical value of these treatments, acknowledging that healthcare providers are best positioned to select the most appropriate product for individual patient needs. The payment amounts will be annually adjusted based on the consumer price index, and manufacturers will be exempt from certain reporting requirements, with the goal of creating a more consistent and fair payment system for these important medical products.

Budget and Finance

https://www.congress.gov/bill/119th-congress/senate-bill/2561/all-info