Advanced Wound Care and Regenerative Medicine Access and Reform Act
Sponsored By: Representative Evans (CO)
Introduced
Summary
Would standardize Medicare payment for skin substitute products while tightening who gets paid and speeding FDA review for certain human cell and tissue products. The bill creates a new Medicare payment category and method for skin substitutes and orders an FDA review to simplify approval paths for some cellular and tissue therapies.
Show full summary
- Medicare beneficiaries and patients would see consistent reimbursement for skin substitutes across sites of care, because payments would follow the new 1847A formula and a single consolidated billing code by January 1, 2026.
- Providers would be paid 80% of the lesser of their charge or the new payment amount. 2026 rates would come from a volume-weighted average using the April 2023 ASP file and CMS Part B data, with annual CPI-U updates from 2027.
- CMS would add program integrity checks that flag the top 3 percent of providers by skin substitute payments, start prepayment review March 1, 2026, allow prior authorization for outliers by January 1, 2027, and permit enrollment revocation for persistent noncompliance; the bill funds these reviews with a $5.0 million yearly transfer for 2027–2030.
- Manufacturers and regulators would face an 18-month FDA review of approval pathways for certain human cell and tissue products and must get draft guidance in 24 months and a final rule after comments, plus a Congressional report within 30 months.
*Would increase federal outlays by about $5.0 million per year from 2027 through 2030 to support prior authorization activities.*
Your PRIA Score
Personalized for You
How does this bill affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this bill and every other piece of legislation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Bill Overview
Analyzed Economic Effects
3 provisions identified: 1 benefits, 0 costs, 2 mixed.
New Medicare rules for skin substitutes
This bill would create a new Medicare coverage category called "skin substitute products." For 2026 Medicare would set a single payment amount based on a 2023 volume-weighted average, and Medicare would pay 80% of the lesser of your actual charge or that amount (effective January 1, 2026). Starting 2027 the payment amount would be updated each year by the CPI-U. The bill would require one consolidated billing code by January 1, 2026 and would stop Part B drug reporting for these products beginning January 1, 2026. Medicare payment would be limited to the portion actually used for the wound, defined as the larger of 3 square centimeters or 120% of the treated wound size.
FDA review of wound tissue rules
The bill would require the FDA to review how certain human tissue allografts and autografts are regulated within 18 months of enactment. The FDA would issue draft guidance by 24 months and report to Congress by 30 months about possible streamlining of application rules and timelines. The bill would also say that any streamlining must not weaken safety or effectiveness standards for products licensed under section 351.
Stricter provider reviews and prior authorization
The bill would identify the top 3% of providers by skin substitute payments and publish that outlier list by March 1, 2026 and every two years through March 1, 2035. Medicare would start prepayment review of those providers on March 1, 2026 and begin prior authorization for their skin substitute claims no later than January 1, 2027. If a provider's prior authorization approval rate exceeds 90% the Secretary may stop prior authorization; if denial rates exceed 75% over six months starting January 1, 2028 the provider could be referred for exclusion. The bill also transfers $5 million per year to CMS for prior authorization work for FY2027–FY2030.
Sponsors & CoSponsors
Sponsor
Evans (CO)
CO • R
Cosponsors
Rep. Gooden, Lance [R-TX-5]
TX • R
Sponsored 2/3/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov