Advanced Wound Care and Regenerative Medicine Access and Reform Act
Sponsored By: Representative Evans (CO)
Introduced
Summary
Creates a dedicated Medicare payment framework for skin substitute products. H.R. 6852 would add skin substitutes to Medicare coverage and set a new, data-driven payment system that applies across care settings.
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Bill Overview
Analyzed Economic Effects
4 provisions identified: 2 benefits, 0 costs, 2 mixed.
New Medicare payments for wound products
If enacted, Medicare would adopt a single payment system for skin substitute wound products on January 1, 2026. CMS would create one billing code for all covered skin substitute products by that date. The 2026 payment would be a volume‑weighted average using the April 2023 ASP Pricing File and 2023 billed units. For 2027 and later years, the payment would be adjusted by the CPI‑U percent change for the 12 months ending the prior June. For products in the new category, Medicare would pay 80% of the lesser of the provider's charge or the new payment amount, and would only pay for the reasonable and necessary portion used (the greater of 3 square centimeters or 120% of the treated wound size). Payments would be the same no matter where you get outpatient treatment.
Medicare adds skin substitute coverage
If enacted, Medicare would add a new covered category for skin substitute products starting January 1, 2026. Covered products would be cellular, tissue, biological, or synthetic materials meant to remain in the wound and marketed under applicable FDA or Public Health Service authorities. The rule would exclude temporary dressings that are removed without resorption. The coverage would also explicitly include products Medicare reimbursed under prior skin substitute codes before January 1, 2026.
FDA review to speed tissue approvals
If enacted, the HHS Secretary would direct the FDA to review approval rules for certain human tissue allografts and autografts within 18 months. The review would look at evidence needs, timelines, and a possible tiered risk approach. The agency would consult manufacturers, clinicians, patients, payors, and scientists. FDA would issue draft guidance within 24 months and finalize it after public comment. FDA must also report to Congress within 30 months on findings and likely effects on access and public health.
Stricter reviews for high‑payment providers
If enacted, CMS would identify the top 3 percent of providers by skin substitute payments starting by March 1, 2026 and every two years through March 1, 2035. CMS would publish that list and send it to the HHS Inspector General. Claims from those outlier providers could face prepayment review beginning March 1, 2026, and CMS could apply prior authorization for such providers starting January 1, 2027. If denial rates for prior authorization exceed 75% for six or more months beginning January 1, 2028, CMS could seek exclusion for billing abuse. The bill would transfer $5 million per year from the Medicare trust fund to CMS for FY2027–FY2030 to run these reviews.
Sponsors & CoSponsors
Sponsor
Evans (CO)
CO • R
Cosponsors
Gooden
TX • R
Sponsored 2/3/2026
Roll Call Votes
No roll call votes available for this bill.
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