H.R. 6852 — Advanced Wound Care and Regenerative Medicine Access and Reform Act

This section establishes Medicare Part B coverage for skin substitute products under section 1861(s)(2)(KK) (i.e., cellular, tissue, biological, or synthetic wound care materials intended to remain in the wound bed, FDA-cleared or approved under specified pathways, excluding temporary dressings; includes products reimbursed under prior skin substitute codes) and applies Average Sales Price (ASP) system payment limits to such products furnished on or after January 1, 2026. It sets the initial 2026 payment amount at the volume-weighted average of Medicare payment allowance limits from the April 2023 ASP Pricing File (calculated using 2023 Part B claims units from the CMS Integrated Data Repository), updated annually thereafter by the CPI-U for All Urban Consumers; requires the Secretary of Health and Human Services to establish a consolidated billing and payment code by January 1, 2026; and excludes skin substitute products from ASP manufacturer reporting requirements beginning that date. Under section 1833(a)(1), Medicare pays 80% of the lesser of the actual charge or the section 1847A(b)(9) payment amount for skin substitute products. (As background, skin substitute products treat chronic wounds such as diabetic foot ulcers and are currently paid under Medicare Part B at 80% of reasonable charges without ASP limits.)

This section directs the Secretary to ensure equivalent Medicare reimbursement for skin substitute products and their outpatient applications to the payment amounts specified in SSA §1847A(b)(9) (42 U.S.C. 1395w-3a(b)(9)), regardless of site of care. (Skin substitute products are biologicals applied to chronic wounds such as diabetic foot ulcers.)

This section establishes special payment rules for skin substitute products (i.e., as defined in 42 U.S.C. 1847A(c)(6)(J)) under Medicare Part B's durable medical equipment benefit. The rules require the Secretary, not later than March 1, 2026, and biennially through March 1, 2035, to identify the top 3% of providers by total prior-year payments for such products (as outlier providers), publish the list, and refer it to the HHS Office of Inspector General for fraud, waste, and abuse review. Starting March 1, 2026, the Secretary must conduct prepayment claim review for outlier providers' skin substitute product claims unless the provider is subject to prior authorization, has a claims approval rate exceeding 90%, or demonstrates billing consistent with coverage criteria. Beginning January 1, 2027, the Secretary must apply prior authorization to such products furnished by outlier providers (for a period determined appropriate), with removal possible if prior authorization approval exceeds 90%; this includes a $5 million annual transfer for FY2027-FY2030 from the Federal Supplementary Medical Insurance Trust Fund to the CMS Program Management Account. Beginning January 1, 2028, if an outlier provider's prior authorization denial rate exceeds 75% for 6 or more consecutive months, the Secretary must deem an abuse of billing privileges to exist and refer the provider to the HHS Inspector General for potential exclusion from federal health care programs under SSA section 1128(b)(6). The rules further limit payment to the reasonable and necessary portion of skin substitute products used to treat chronic or acute wounds, excluding wastage and defined as the greater of 3 square centimeters or 120% of the treated wound size. (Thus, these measures target high-volume providers to enhance program integrity and reduce improper payments for wound care products.)

This section directs the Secretary of HHS, acting through the FDA Commissioner and not later than 18 months after enactment, to (1) conduct a comprehensive review of the approval process for human cellular and tissue allografts and autografts not regulated solely under section 361 of the Public Health Service Act (i.e., those regulated as biologics under section 351 requiring licensure), including products processed into liquid, gel, or powder forms; (2) identify opportunities to streamline application requirements, review timelines, and evidentiary standards while maintaining safety and efficacy oversight; (3) consider a tiered review framework based on risk factors such as degree of manipulation, processing methods, mode of administration, and clinical safety profile; (4) evaluate pre-market clinical evaluation needs and the use of existing clinical data, real-world evidence, or registry data to reduce duplicative trials; and (5) assess harmonization mechanisms for section 361 products potentially transitioning to section 351 regulation. The review must consult specified stakeholders (e.g., manufacturers, clinicians, patient organizations, payors) and consider modifications such as to Chemistry, Manufacturing, and Controls (CMC) requirements, expedited review pathways, modular submissions, clinical endpoints, post-market surveillance, and international approaches. Not later than 24 months after enactment, the Secretary must issue draft guidance on identified streamlining measures (finalized within 12 months of public comments), and not later than 30 months after enactment, submit a report to the Senate HELP Committee and House Energy and Commerce Committee detailing findings, actions, legislative recommendations, and estimated impacts on patient access and public health. This section preserves all applicable safety and efficacy standards for section 351-licensed products.