American Patients First Act of 2026

The American Patients First Act of 2026 establishes a new payment rate of $457 per square centimeter for skin substitute products used in Medicare between 2027 and 2030, provided these products are manufactured entirely within the United States using domestically sourced materials. To ensure compliance, the bill defines these products as those made from U.S. human tissue or synthetic materials and requires that all harvesting, processing, and manufacturing occur exclusively in the country, though the Secretary of Health and Human Services may grant temporary waivers for up to 180 days if domestic supply shortages threaten patient access. The legislation also introduces stricter oversight measures, including prepayment claim reviews, prior authorization requirements for certain providers, and limits on payment if a product was purchased for less than a specific threshold price. Additionally, the act mandates that only providers certified by specific wound care organizations can bill for these products and restricts reimbursement for wastage or repeated applications without clinical improvement. Finally, the bill requires the HHS to submit a report to Congress by 2030 analyzing the cost of producing these products and evidence of their effectiveness.