Advanced Wound Care and Regenerative Medicine Access and Reform Act

This bill amends the Social Security Act to reform Medicare payment for skin substitute products , formally defining them and ensuring coverage effective January 1, 2026. A new payment methodology is established, setting the initial 2026 payment based on a volume-weighted average of 2023 Medicare allowance limits, with subsequent annual updates tied to the Consumer Price Index. The Secretary of Health and Human Services must create a consolidated billing and payment code by January 1, 2026, and ensure equivalent reimbursement regardless of the site of care. To enhance program integrity, the bill mandates the identification of outlier providers of skin substitute products every two years, subjecting them to prepayment claim review and prior authorization. Non-compliant outlier providers may face enrollment revocation or exclusion from federal healthcare programs. Payment for skin substitute products will only cover the reasonable and necessary portion used, excluding wastage, defined as the greater of 3 square centimeters or 120% of the treated wound size. Additionally, the legislation directs the Secretary, through the FDA, to conduct a comprehensive review of the approval process for certain human cells, tissues, and cellular and tissue-based products (HCT/Ps) not solely regulated under the Public Health Service Act. This review aims to streamline application requirements, review timelines, and evidentiary standards while maintaining safety and efficacy. It includes stakeholder consultation and specific considerations for modifying Chemistry, Manufacturing, and Controls (CMC) requirements and exploring expedited review pathways. Draft guidance implementing streamlining measures is due within 24 months, with a report to Congress within 30 months.