Medicare locks skin-wound treatment into 2023 prices, adds patient access delays
H.R. 5768 — Skin Substitute Access and Payment Reform Act · Filed by Buddy Carter (R-GA) · 7 cosponsors · Introduced Oct 17, 2025 · Referred to committee
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What it does
This bill creates a new Medicare payment system for skin substitute products (cellular, tissue, or synthetic materials applied to wounds) starting January 1, 2026. It sets initial payment rates based on 2023 volume-weighted averages, then ties future increases to inflation. The bill also establishes fraud-prevention measures: Medicare will identify the top 3% of skin substitute providers by payment volume, subject them to prepayment review and prior authorization, and potentially exclude those with high denial rates.
Why we flagged it
The bill's core function is to establish a new Medicare payment methodology for a specific product category (skin substitutes) and implement fraud-detection mechanisms. It is not a general healthcare reform but a targeted regulatory and payment restructuring.
What the text implies
- The payment formula locks in 2023 volume-weighted averages, which may not reflect current market conditions or clinical innovation. Manufacturers have no incentive to develop new products if payment is capped at historical volumes.
- Prior authorization requirements beginning January 1, 2027, may create access delays for patients with severe wounds, particularly in rural areas where prior authorization processing is slower.
The full analysis lists 5 implications of this text.
Who stands to gain
Skin substitute manufacturers (Organogenesis, Mimedx, Apligraf producers); Medicare administrative contractors (claims processing); Wound-care providers and hospitals with established skin substitute programs