Advanced Wound Care and Regenerative Medicine Access and Reform Act

This bill amends the Social Security Act to change how Medicare pays for skin substitute products, adds program integrity measures, and directs a review of FDA approval processes for certain human tissue products. It applies to payments starting January 1, 2026.

Sec. 2, Payment reform for skin substitute products: This section adds skin substitute products as a covered item under Medicare Part B. For 2026, the payment amount is a volume-weighted average of 2023 payment limits from the April 2023 ASP Pricing File, based on units billed in 2023. For 2027 and later, the amount is updated by the Consumer Price Index for All Urban Consumers. Medicare pays 80% of the lesser of the actual charge or this payment amount. Skin substitute products are defined as cellular, tissue, biological, or synthetic materials applied to a wound and intended to remain, excluding temporary dressings, and include products reimbursed under skin substitute codes before 2026. These products are excluded from certain drug reporting requirements starting 2026. The Secretary must establish a new billing and payment code for all skin substitute products by January 1, 2026.

Sec. 3, Equivalent reimbursement in outpatient sites of care: The Secretary must ensure that reimbursement for skin substitute products and their outpatient applications is the same regardless of where the product is applied.

Sec. 4, Enhancing program integrity for skin substitute products: Starting March 1, 2026, and every two years through 2035, the Secretary identifies the top 3% of providers by total Medicare payment for skin substitute products as outlier providers. These providers are publicly listed and referred to the HHS Inspector General for fraud assessment. From March 1, 2026, outlier providers face prepayment claim review unless they meet conditions like prior authorization or high approval rates. By January 1, 2027, prior authorization applies to outlier providers, with $5 million per year from 2027 to 2030 transferred from the Medicare trust fund for this purpose. If denial rates exceed 75% over six months, the Secretary must find an abuse of billing privileges and refer for possible exclusion from federal health programs. Payment is only for the reasonable and necessary portion of the product used, defined as the greater of 3 square centimeters or 120% of wound size, excluding wastage.

Sec. 5, Streamlining approval processes for human cells, tissues and cellular and tissue-based products: Within 18 months, the FDA must review approval processes for human cellular and tissue allografts and autografts not regulated only under section 361 of the Public Health Service Act, including liquid, gel, or powder forms. The review must identify opportunities to streamline requirements, consider a tiered risk-based framework, evaluate use of existing clinical data and real-world evidence, and assess harmonization with section 351 regulation. The FDA must consult manufacturers, tissue banks, clinicians, patient groups, payors, and professional societies. The review must consider modifications to manufacturing requirements, expedited review pathways, modular submissions, clinical endpoints, post-market surveillance, and international approaches. Draft guidance must be issued within 24 months and finalized within 12 months after public comment. A report to Congress is due within 30 months, including findings, recommendations, and impacts on patient access. This section does not reduce safety or efficacy standards for products subject to licensure under section 351.