US Federal 2025-2026 Regular Session

US Federal House Bill HB5768

Introduced
 
Introduced
10/17/25  

Caption

Skin Substitute Access and Payment Reform Act

Summary

HB5768, the Skin Substitute Access and Payment Reform Act, would change how Medicare covers and pays for skin substitute products used in wound care. The bill adds these products to Medicare’s statutory coverage framework and directs the Secretary of Health and Human Services to create a single consolidated billing and payment code for them by January 1, 2026. It also establishes a new payment methodology beginning in 2026 based on a volume-weighted average of existing Medicare payment limits, with annual updates tied to the Consumer Price Index for All Urban Consumers. The bill defines “skin substitute product” as a cellular, tissue, biological, or synthetic material applied to a wound and intended to remain in the wound bed, while excluding temporary dressings and liquids, gels, powders, and similar products. It also removes these products from certain drug and biological reporting rules and requires Medicare to pay 80 percent of the lesser of the actual charge or the new payment amount. In addition, the bill directs HHS to establish a new billing and payment code for all such products, which would standardize claims processing and payment under Medicare Part B.

Impact

The bill would amend multiple provisions of the Social Security Act, primarily sections 1833, 1834, 1847A, and 1861, to create a distinct Medicare payment and coverage structure for skin substitute products. It would shift these products away from treatment as ordinary drugs or biologics for certain purposes, establish a new payment benchmark, and require Medicare contractors to use a consolidated billing code. The bill also adds program-integrity tools, including outlier-provider identification, prepayment review, prior authorization, and possible referral for exclusion from federal health care programs, which would affect providers, suppliers, and Medicare administrative contractors.

Sentiment

Based on the bill text and available context, the overall sentiment appears to be supportive of access and payment reform rather than partisan or highly contentious. The bill’s title and structure suggest an effort to improve Medicare payment predictability for providers while preserving beneficiary access to wound-care products. No committee transcripts or recorded votes were provided, so there is no documented floor or committee sentiment beyond the bill’s introduction and referral.

Contention

The main points of contention implied by the bill are payment levels, coverage standards, and fraud-control measures. Providers of skin substitute products may favor the consolidated code and the new payment methodology if it increases predictability or reimbursement, while Medicare program integrity concerns are addressed through outlier targeting, prepayment review, and prior authorization. The bill also limits Medicare contractors from denying coverage in 2026 based solely on clinical evidence analysis, which may be intended to prevent restrictive coverage determinations but could raise concerns among payers or oversight advocates about utilization and cost control. No specific stakeholder positions were included in the available materials.

Companion Bills

No companion bills found.

Previously Filed As

US SB2561

Skin Substitute Access and Payment Reform Act of 2025

US HB6852

Advanced Wound Care and Regenerative Medicine Access and Reform Act

US HB4299

Protecting Patient Access to Cancer and Complex Therapies Act

US HB8395

PACE Act of 2026 Payments Access and Consumer Efficiency Act of 2026

US HB6214

Kidney Care Access Protection Act

US SB2730

Kidney Care Access Protection Act

US SB1702

Access to Prescription Digital Therapeutics Act of 2025

US HB3288

Access to Prescription Digital Therapeutics Act of 2025

US HB8463

Pre-Payment Fraud Prevention and Treasury Data Access Act

US HB2902

SOAR Act of 2025 Supplemental Oxygen Access Reform Act of 2025

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