HR5768-119

What This Bill Does

The Skin Substitute Access and Payment Reform Act creates a Medicare Part B payment and oversight framework for skin substitute products used in wound care. It adds skin substitute products to the Social Security Act's medical and other health services and applies section 1847A payment rules to products furnished on or after January 1, 2026. For 2026, payment is based on a volume-weighted average of October 2023 ASP Pricing File payment limits and 2023 Part B claims units; for 2027 and later years, the prior-year amount is updated by CPI-U. The bill defines a skin substitute product as cellular, tissue, biological, or synthetic material applied to a wound and intended to remain in the wound bed, marketed under specified FDA or Public Health Service Act pathways, excluding temporary dressings and liquids, gels, powders, or similar items. Program integrity provisions require CMS every two years through 2035 to identify the top 3 percent of providers by Medicare skin-substitute payments, publish the outlier list, send it to the HHS Inspector General, apply prepayment review beginning January 1, 2026 unless specified conditions are met, apply prior authorization beginning no later than January 1, 2027, and refer suspected abuse for possible federal health program exclusion. For 2026, products share coverage criteria unless unsafe due to contamination, serious infectious disease, or serious adverse reactions, and CMS or MACs cannot deny a specific product solely based on clinical evidence analysis.

Who Benefits and How

Wound care patients benefit if Medicare coverage and payment for skin substitute products are more predictable starting in 2026. Skin substitute manufacturers benefit from a defined Medicare payment category and CPI-updated payment methodology. Wound care providers with compliant billing benefit from uniform coverage criteria and protection against product-specific evidence denials in 2026. CMS program integrity staff benefit from tools to identify, review, and refer high-payment outlier providers.

Who Bears the Burden and How

Outlier skin substitute providers face public listing, prepayment review, prior authorization, and possible Inspector General referral. CMS payment staff must calculate the 2026 volume-weighted payment amount and annual CPI updates. Medicare Administrative Contractors must administer coverage, prepayment review, and prior authorization limits. Federal Medicare financing bears payment obligations for covered products while trying to control fraud, waste, and abuse.

Key Provisions

• Adds skin substitute products to Medicare Part B payment under section 1847A for products furnished on or after January 1, 2026.
• Provides a 2026 volume-weighted average payment method using October 2023 ASP Pricing File and 2023 claims data.
• Requires CPI-U updates for 2027 and later payment amounts.
• Defines covered skin substitute products and excludes temporary dressings, liquids, gels, powders, and similar items.
• Requires CMS to identify the top 3 percent of skin-substitute providers by payment every two years through 2035.
• Requires public outlier lists, HHS Inspector General transmittal, prepayment review, prior authorization, and possible exclusion referrals.
• Protects 2026 coverage from product-specific denials based solely on clinical evidence analysis unless safety concerns exist.