HR6852-119

What This Bill Does

The Advanced Wound Care and Regenerative Medicine Access and Reform Act changes Medicare payment and oversight for skin substitutes and regenerative wound-care products. It adds skin substitute products to Medicare-covered medical and other health services and applies section 1847A payment methods to skin substitutes furnished on or after January 1, 2026. It requires equivalent reimbursement for skin substitute products and outpatient applications of those products regardless of outpatient site of care. It also adds program-integrity controls: beginning March 1, 2026 and every two years through March 1, 2035, HHS must identify the top 3 percent of providers by total Medicare skin-substitute payments, publish the list, and send it to the HHS Inspector General for potential fraud, waste, or abuse assessment. Certain outlier providers face prepayment claim review and postpayment review rules. Finally, HHS through FDA must review approval processes for human cellular and tissue allografts and autografts not regulated only under section 361, including liquid, gel, or powder forms, and consider tiered risk-based review, existing clinical data, real-world evidence, registry data, and harmonization for products that may transition to section 351 regulation.

Who Benefits and How

Medicare patients with chronic wounds benefit if payment reform preserves access to skin substitutes across outpatient settings. Wound care providers benefit from clearer reimbursement rules, although high-payment outliers face scrutiny. Skin substitute manufacturers and tissue allograft developers benefit from a defined Medicare payment path and possible FDA approval streamlining. Tissue banks and procurement organizations benefit from required consultation in the FDA review.

Who Bears the Burden and How

CMS payment staff must implement section 1847A payment for skin substitutes and site-neutral outpatient reimbursement. HHS program-integrity staff must identify outlier providers, publish lists, and conduct prepayment or postpayment review. HHS Inspector General staff must assess referred outliers for fraud, waste, or abuse. FDA reviewers must complete the approval-process review and consult manufacturers, tissue banks, procurement organizations, clinicians, and other stakeholders.

Key Provisions

• Adds skin substitute products to Medicare-covered services and section 1847A payment beginning January 1, 2026.
• Requires equivalent reimbursement for skin substitute products and outpatient applications regardless of outpatient site of care.
• Requires HHS to identify and publish the top 3 percent of skin-substitute payment outlier providers every two years through 2035.
• Requires HHS Inspector General referral, prepayment review, and postpayment review for specified outlier providers.
• Directs HHS and FDA to review and streamline approval processes for human cellular and tissue allografts and autografts.