Advanced Wound Care and Regenerative Medicine Access and Reform Act
- Bill Number
- H.R. 6852
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-12-18: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Last Updated
- 2026-02-04T09:06:42Z
AI-Generated Summary
Purpose of the Legislation
The "Advanced Wound Care and Regenerative Medicine Access and Reform Act" (H.R. 6852) aims to improve Medicare coverage and payment for skin substitute products—materials used to treat wounds—while enhancing program integrity to prevent fraud and waste. It also seeks to streamline Food and Drug Administration (FDA) approval processes for certain human tissue-based products to increase patient access without compromising safety.
Key Provisions
- Medicare Coverage and Payment Reforms (Section 2):
- Explicitly includes skin substitute products (e.g., cellular or synthetic materials applied to wounds and left in place) as covered Medicare services starting January 1, 2026.
- Establishes a new payment system: For 2026, payments are based on a volume-weighted average of 2023 Medicare payment limits, calculated from billing data. Payments update annually using the Consumer Price Index (CPI) for urban consumers.
- Requires a single new billing code for all skin substitute products by January 1, 2026.
- Excludes these products from certain drug reporting requirements under Medicare.
- Limits Medicare payments to 80% of the lesser of the actual charge or the new payment amount.
- Equivalent Reimbursement Across Care Settings (Section 3):
- Ensures payments for skin substitute products and their application are the same whether provided in outpatient clinics, hospitals, or other Medicare-approved sites.
- Program Integrity Measures (Section 4):
- Outlier Provider Identification: By March 1, 2026, and every two years until 2035, the Secretary of Health and Human Services identifies the top 3% of providers (by total Medicare payments for skin substitutes) as "outliers" based on national provider IDs. These lists are public and shared with the HHS Inspector General (OIG) for fraud checks.
- Prepayment Review: Starting March 1, 2026, outlier providers face prepayment claim reviews unless they meet exceptions (e.g., high approval rates over 90% or consistent billing practices).
- Prior Authorization: From January 1, 2027, outliers require prior approval for claims; this ends if approval rates exceed 90%. Funds ($5 million annually from 2027–2030) are transferred from Medicare's trust fund to support this.
- Enrollment Actions: From January 1, 2028, outliers with denial rates over 75% for six months may face billing privilege revocation or exclusion from federal health programs via OIG referral.
- Wastage Limits: Payments cover only the "reasonable and necessary" portion used (at least 3 square centimeters or 120% of wound size), excluding excess waste for chronic or acute wounds.
- FDA Approval Streamlining (Section 5):
- Within 18 months of enactment, the FDA must review approval processes for human cellular/tissue products (e.g., allografts from donors or autografts from patients) not solely under basic safety rules, including those in liquid, gel, or powder forms.
- Review includes creating risk-based tiers, using real-world data to reduce trial needs, and harmonizing rules for products shifting to stricter oversight.
- Requires consultation with manufacturers, clinicians, patient groups, insurers, and experts.
- FDA must issue draft guidance within 24 months and finalize it after public comments; submit a report to Congress within 30 months on findings, actions, and impacts.
- Emphasizes maintaining safety/efficacy standards.
Significant Changes to Existing Law
- Medicare Amendments (Title XVIII of the Social Security Act): Adds skin substitutes as a covered benefit (new subsection (KK) under 1861(s)(2)); shifts payments from the Average Sales Price (ASP) method—used for drugs—to a fixed, data-based limit under Section 1847A, effective 2026. Introduces wastage rules and integrity tools (new subsection (aa) under 1834) not previously applied to these products.
- FDA Processes (Public Health Service Act): Directs a formal review and potential tiered framework for approvals under Sections 351/361, which could reduce duplicative requirements but preserve core safety rules—unlike current uniform standards that may delay market entry.
- No retroactive changes; prior reimbursements (pre-2026) remain grandfathered.
Potential Impacts
- Government Agencies: Increases workload for the Centers for Medicare & Medicaid Services (CMS) in implementing payments, reviews, and codes; FDA faces review and guidance mandates. HHS/OIG gains tools to combat fraud, with dedicated funding. Could reduce improper payments but raise administrative costs short-term.
- Citizens (Medicare Beneficiaries): Improves access to advanced wound treatments (e.g., for chronic conditions like diabetes-related ulcers) through clearer coverage and site-neutral payments, potentially lowering out-of-pocket costs. Integrity measures may limit over-treatment, benefiting program sustainability.
- International Relations: None directly addressed; focuses on domestic Medicare and FDA rules, though international regulatory approaches are considered in FDA review for benchmarking.
Main Stakeholders Affected
- Medicare Beneficiaries: Patients needing wound care, especially older adults with chronic wounds.
- Healthcare Providers: Wound care specialists, hospitals, and clinics (particularly high-volume "outlier" providers facing reviews and authorizations).
- Manufacturers and Suppliers: Companies producing skin substitutes and tissue products, benefiting from streamlined FDA approvals but adapting to new payment limits and billing codes.
- Government Entities: CMS (payment administration), FDA (approvals), HHS/OIG (oversight and fraud detection).
- Others: Tissue banks, patient advocacy groups, insurers (e.g., for alignment with Medicare), and professional societies in regenerative medicine.
Notable Legal, Constitutional, or Political Implications
- Legal: Strengthens Medicare fraud prevention under existing authorities (e.g., 42 CFR 424.535 for billing abuse), with clear definitions to avoid disputes over "skin substitutes" (excluding temporary dressings). Ensures due process via appealable reviews and high thresholds (e.g., 75–90% rates) for penalties.
- Constitutional: No apparent issues; aligns with Congress's spending power over Medicare and FDA's regulatory role, without infringing on free speech, privacy, or equal protection.
- Political: Promotes fiscal responsibility by capping payments and targeting waste (potentially saving Medicare funds), while expanding access—balancing industry and taxpayer interests. Bipartisan referral to key committees suggests broad appeal in healthcare reform debates.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (1)
Recent Actions
- 2025-12-18: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-12-18: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-12-18: Introduced in House
- 2025-12-18: Introduced in House
Bill Versions
- Advanced Wound Care and Regenerative Medicine Access and Reform Act — issued 2025-12-18 — PDF (17 pages)