Advanced Wound Care and Regenerative Medicine Access and Reform Act
- Sponsor
- Rep. Evans, Gabe [R-CO-8]
- Committees
- Ways and Means Committee (primary)
- Last action
- Dec 18, 2025
Bottom line
The bill aims to modernize Medicare payment for advanced wound care, enhance program integrity to combat fraud, and streamline FDA processes for regenerative medicine, potentially improving patient access while controlling costs.
What it actually does
This bill amends the Social Security Act to explicitly cover skin substitute products under Medicare Part B and establishes a new volume-weighted average payment methodology for these products, effective January 1, 2026. It mandates equivalent reimbursement for outpatient applications regardless of the site of care and introduces robust program integrity measures, including prepayment review and prior authorization for 'outlier providers.' Additionally, the bill directs the FDA to review and streamline the approval process for human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Proponents argue
Proponents argue this legislation will improve patient access to essential advanced wound care therapies by ensuring consistent Medicare coverage and fair, predictable reimbursement. They contend that the program integrity measures are crucial for protecting taxpayer dollars by preventing fraud and abuse, while the FDA streamlining efforts will accelerate the availability of innovative regenerative medicine products.
Opponents contend
Critics might raise concerns that, despite program integrity measures, the bill could lead to increased Medicare spending due to expanded coverage and utilization. Some providers may also argue that the stringent program integrity measures, such as prior authorization for 'outlier providers,' could create undue administrative burdens or inadvertently delay patient access to necessary treatments.
The bill is moderately complex due to its technical Medicare payment and FDA regulatory language, requiring careful reading to understand its full implications for healthcare providers, manufacturers, and Medicare beneficiaries.
Section 2(a)
Medicare Coverage of Skin Substitute Products
This provision amends the Social Security Act to explicitly include 'skin substitute products' as a covered item under Medicare Part B. This ensures that these advanced wound care treatments are eligible for reimbursement, clarifying their status within the Medicare program and potentially expanding access for beneficiaries.
Supporters argue
Supporters argue this ensures beneficiaries have access to necessary, modern wound care therapies, which can improve outcomes, reduce complications, and enhance quality of life.
Critics contend
No specific opposition is typically raised against explicit coverage of medically necessary treatments, though cost concerns might arise in conjunction with payment rates.
Tradeoffs
This provision balances the goal of ensuring patient access to advanced care with potential increases in Medicare expenditures.
Section 2(b)
Volume-Weighted Average Payment for Skin Substitutes
This section establishes a new payment methodology for skin substitute products under Medicare Part B, effective January 1, 2026. The initial payment for 2026 will be the volume-weighted average of Medicare payment allowance limits from the April 2023 ASP Pricing File, based on 2023 claims data. Subsequent annual updates will be tied to the percentage increase in the Consumer Price Index for All Urban Consumers.
Section 2(c)
Statutory Definition of Skin Substitute Product
This section defines 'skin substitute product' as a cellular, tissue, biological, or synthetic material applied to a wound, intended to remain within the wound bed, and marketed under specific FDA pathways (510(k), 513(f)(2), 515 of the FD&C Act, or 361 of the PHS Act). It explicitly excludes temporary dressings and includes products previously reimbursed under skin substitute codes prior to January 1, 2026.
Section 3
Site-Neutral Reimbursement for Skin Substitutes
This section mandates that the Secretary of Health and Human Services ensure reimbursement for skin substitute products and their outpatient application is equivalent to the payment amounts established under the new Section 1847A(b)(9) of the Social Security Act, regardless of the site of care where the product is applied. This aims to standardize payments across different healthcare settings.
Section 4(1) and (2)
Outlier Provider Identification and Prepayment Review
This provision requires the Secretary to identify the top 3% of providers by total Medicare payment for skin substitute products as 'outlier providers' every two years through 2035. These outlier providers will be subject to initial prepayment claim review unless they meet certain conditions, such as already being subject to prior authorization, having high approval rates, or demonstrating consistent billing practices. The list of outliers will be made public and transmitted to the OIG for fraud assessment.
Section 4(3) and (4)
Prior Authorization and Exclusion for Non-Compliant Outliers
Beginning January 1, 2027, this provision mandates prior authorization for skin substitute products furnished by outlier providers, with a mechanism for removal if approval rates exceed 90%. Furthermore, if an outlier provider's prior authorization denial rate exceeds 75% over six consecutive months starting January 1, 2028, it constitutes an 'abuse of billing privileges,' leading to potential enrollment revocation or exclusion from federal healthcare programs. The bill allocates $5 million annually from 2027-2030 for implementation.
Section 4(5)
Payment for Skin Substitute Product Wastage
This provision specifies that Medicare payment for skin substitute products will only be made for the 'reasonable and necessary portion' used in treatment, explicitly excluding wastage. This portion is defined as the greater of 3 square centimeters or 120% of the size of the treated wound, aiming to prevent overbilling for unused product.
Section 5
Streamlining FDA Approval for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
This section directs the Secretary of HHS, through the FDA Commissioner, to conduct a comprehensive review within 18 months of the approval process for HCT/Ps not solely regulated under Section 361 of the PHS Act (e.g., those processed into liquid, gel, or powder forms). The review will identify opportunities to streamline application requirements, review timelines, and evidentiary standards while maintaining safety and efficacy. It also mandates stakeholder consultation, the issuance of draft guidance within 24 months, finalized within 12 months after public comment, and a report to Congress within 30 months.
This section amends Section 1847A(f)(2)(A) of the Social Security Act to explicitly exclude skin substitute products from certain drug or biological reporting requirements under Medicare Part B, effective January 1, 2026.
Section 2(d)
Why it matters:This is standard legislative practice for making technical adjustments to existing statutes, often placed within sections related to the primary subject matter.
Case for: Proponents would argue this reduces administrative burden for manufacturers and providers by exempting skin substitutes from reporting requirements designed for traditional drugs, aligning with their unique nature and simplifying compliance.
Case against: Critics might argue that reduced reporting could diminish transparency regarding the utilization and costs of these products, making it harder for CMS to monitor their impact and ensure appropriate use.
Estimated impact: Reduces administrative overhead for manufacturers and potentially for CMS by removing a specific reporting obligation for skin substitute products.
This section directs the Secretary of Health and Human Services to establish a new, consolidated billing and payment code for all skin substitute products (as defined in the bill) by January 1, 2026.
Section 2(e)
Why it matters:This is an administrative directive, often placed in technical sections of a bill, rather than being a core policy change itself.
Case for: Proponents argue a single, consolidated code simplifies billing for providers and streamlines administration for Medicare, reducing complexity and potential errors in claims processing.
Case against: Some might argue that a single code could obscure differences between various skin substitute products, making it harder to track utilization of specific technologies or adjust payment for distinct product categories in the future.
Estimated impact: Simplifies billing processes for healthcare providers and administrative processes for CMS by consolidating multiple codes into one.