HR 5768119th CongressIn Committee

Skin Substitute Access and Payment Reform Act

Introduced: Oct 17, 2025

Sponsor: Rep. Carter, Earl L. "Buddy" [R-GA-1] (R-Georgia)

Standard Summary

Comprehensive overview in 1-2 paragraphs

H.R. 5768, the Skin Substitute Access and Payment Reform Act, would create a new, Medicare Part B payment framework for skin substitute products (defined cellular, tissue, biological, or synthetic materials used to treat wounds). It adds skin substitute products to the list of items payable under Part B, establishes a dedicated payment amount and a distinct billing code starting in 2026, and links subsequent updates to the Consumer Price Index. The bill also introduces program integrity provisions to identify and manage “outlier” providers that receive a disproportionately high amount of payment for these products, including prepayment review, potential prior authorization for certain outliers, and possible enrollment exclusion for noncompliant providers. It preserves current coverage criteria for 2026, with protections against denying coverage based solely on preliminary clinical analysis, and it defines what qualifies as a skin substitute product (excluding temporary dressings and liquids/gels). In short, the bill shifts how Medicare pays for skin substitute products, adds new administrative processes to monitor use and billing, and creates enforcement tools to curb potential abuse by providers.

Key Points

1Coverage and definition changes
2- Adds skin substitute products to the list of items payable under Medicare Part B (as defined in new subsection KK under 1861(s)(2)).
3- Defines skin substitute products as cellular, tissue, biological, or synthetic materials applied to a wound that remain in the wound bed, marketed under specific FDA or Health Act authorities, and excludes temporary coverings or liquids/gels.
4New payment structure
5- Establishes a new payment amount for skin substitute products under 1847A(b)(9); payment to providers in 2026 uses a volume-weighted average of Medicare payment limits for skin substitute products (based on October 2023 ASP Pricing File data and related CMS claims data).
6- Beginning in 2027 and each subsequent year, the payment amount for skin substitute products is updated by the percentage change in the CPI-U (June-to-June over the prior year).
7- The actual payment to providers is 80% of the lesser of the provider’s actual charge or the established payment amount.
8Administrative coding and reporting
9- Requires a new consolidated billing and payment code for all skin substitute products by January 1, 2026.
10- Excludes skin substitute products from certain reporting requirements that apply to drugs/biologicals (effective January 1, 2026).
11Program integrity and outlier controls
12- Creates special payment rules for skin substitute products under a new Section 1834(aa), including:
13- Identification of the top 3% of outlier providers (based on total payments for skin substitute products) every two years through 2035, with public disclosure and OIG referrals.
14- Beginning January 1, 2026, prepayment claim review for claims by outlier providers unless specified conditions are met (e.g., prior authorization under a new paragraph, or high denial/low approval rates indicating potential noncompliance).
15- Beginning January 1, 2027, prior authorization for skin substitute products furnished by identified outlier providers, with possible removal from prior authorization if approval rates are consistently high.
16- Funding for the program integrity measures ($5 million annually from 2027–2030).
17- Enrollment revocation or exclusion for noncompliant outlier providers starting January 1, 2028, with possible referrals to OIG for exclusion from Federal health care programs.
18- Maintains coverage criteria for skin substitute products in 2026, with safeguards against denying coverage solely based on clinical evidence, except if unsafe due to contamination or serious adverse events.

Impact Areas

Primary- Medicare Part B beneficiaries who receive skin substitute products (e.g., wound care patients) would be affected by a new payment amount and potential cost-sharing changes, as well as any changes in access due to outlier controls.Providers and suppliers- Providers and suppliers of skin substitute products would face a new payment structure (80% of the lesser of charge or new payment amount), a new billing code, and potential prepayment review or prior authorization if identified as outliers.- Administrators and billing staff would need to implement new coding, submission workflows, and payer rules related to skin substitute products.Program integrity and CMS operations- CMS and the OIG would implement new outlier detection, prepayment review, prior authorization, and potential exclusions, increasing oversight of skin substitute product claims and related billing practices.- A dedicated funding stream is created to support these integrity activities.Broader implications- Possible effects on pricing, access, and utilization of skin substitute therapies as providers adapt to the new payment benchmark and monitoring requirements.- Requires development of a new consolidated billing code and alignment with existing Medicare coverage rules for 2026 and beyond.

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