Skin Substitute Access and Payment Reform Act
Sponsored By: Representative Carter (GA)
Introduced
Summary
Would create a federal Medicare framework to define, cover, and pay for skin substitute products. It would set a new payment method, require a single billing code, and add integrity controls like prepayment review and prior authorization for identified outlier providers.
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- Medicare patients with wounds: These products would be explicitly covered when they meet the bill's definition as cellular, tissue, biological, or synthetic materials used on wounds. Temporary dressings and liquid, gel, or powder items are excluded.
- Providers: A two-part payment system would apply to shipments furnished on or after Jan 1, 2026, with payment capped at 80 percent of the lesser of the actual charge or the new payment amount, and a consolidated billing code must be established by Jan 1, 2026.
- Manufacturers and program oversight: Skin substitute products would be excluded from drug/biologic reporting rules beginning Jan 1, 2026. The payment rate would be tied to a volume-weighted price from the October 2023 ASP pricing file with CPI-based updates starting in 2027, and the Centers for Medicare & Medicaid Services would get authority and funding for prepayment reviews, prior authorization for outliers, and enrollment revocation or exclusion for noncompliance.
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Bill Overview
Analyzed Economic Effects
4 provisions identified: 2 benefits, 0 costs, 2 mixed.
Medicare coverage rules for skin substitutes
If enacted, Medicare would add skin substitute products to items it can cover. The bill would define which products count: used on a wound, meant to stay in the wound, and marketed under certain FDA paths. It would exclude temporary dressings and products that are liquids, gels, or powders. For care in 2026, Medicare could not deny a specific skin substitute only because of clinical evidence reviews, unless it is unsafe due to contamination, serious infection, or serious reactions.
New checks on high-use Medicare skin substitute providers
By December 1, 2025, and every two years through 2035, CMS would name the top 3% of providers with the highest total Medicare payments for skin substitutes. On January 1, 2026, CMS would start prepayment claim review for those outliers unless certain safeguards are met. Prior authorization for those providers would begin no later than January 1, 2027, and could end once approval rates are above 90% for a set period. Starting January 1, 2028, if denial rates stay above 75% for six months, CMS would refer the provider for possible exclusion. The bill would fund this work at $5 million each year for FY2027–FY2030.
New Medicare payment and 20% coinsurance for skin substitutes
Starting January 1, 2026, Medicare would set one payment amount for skin substitutes. The 2026 amount would be a weighted average based on October 2023 prices and 2023 billed units. Each year after 2026, it would update by CPI-U for the 12 months ending in June of the prior year. Medicare would pay 80% of the lower of the provider’s charge or that set amount. You would usually owe the remaining 20% as coinsurance.
Simpler billing for skin substitute products
If enacted, HHS would create one billing and payment code for all skin substitute products by January 1, 2026. Starting January 1, 2026, these products would not be treated as drugs or biologics for certain Medicare reporting rules. This could make claims simpler and reduce some reporting steps. It would not by itself change your coinsurance.
Sponsors & CoSponsors
Sponsor
Carter (GA)
GA • R
Cosponsors
Veasey
TX • D
Sponsored 10/17/2025
Steube
FL • R
Sponsored 10/17/2025
McCormick
GA • R
Sponsored 10/17/2025
Hunt
TX • R
Sponsored 10/28/2025
Vindman
VA • D
Sponsored 10/28/2025
Ciscomani
AZ • R
Sponsored 11/25/2025
Bice
OK • R
Sponsored 12/26/2025
Roll Call Votes
No roll call votes available for this bill.
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