Findings

Congress finds the following: (1) Skin substitute products are advanced biological therapies used to treat chronic, non-healing wounds, such as diabetic foot ulcers and venous leg ulcers. Each year, more than 10,500,000 Medicare beneficiaries will require medical care for treatment of a wound. By improving healing rates and reducing the rate of lower limb amputation, skin substitute products improve the health and wellness of Medicare beneficiaries. (2) These treatments vary in makeup and source material, including human tissue-derived products, non-human, animal-derived products, and synthetic products. Studies show that different skin substitute products are similarly safe and effective in treating chronic wounds, and Medicare coverage does not currently differentiate between different types of lawfully marketed skin substitutes. Healthcare providers are well-informed about alternative skin substitute products and are in the best position to determine which specific product would best suit each specific patient based on the patient’s specific needs and the provider’s knowledge and experience. (3) The Centers for Medicare & Medicaid Services has faced challenges in determining consistent and accurate pricing and payment for services that involve skin substitute products, resulting in uncertainty and significant price differences among these products. (4) The Medicare payment systems in place at the date of enactment of this Act incentivize use of more expensive products and continued price increases while failing to recognize the similar clinical effects of skin substitute products. Medicare expenditures for skin substitute products rose significantly in 2024 and 2025. (5) It is therefore necessary to reform the Medicare payment and coverage rules for skin substitute products to appropriately recognize the well-established and known clinical value of these treatments while containing costs.