American Patients First Act of 2026
- Sponsor
- Rep. Sessions, Pete [R-TX-17]
- Committees
- Ways and Means Committee (primary)
- Last action
- Jul 27, 2026
Bottom line
The bill aims to control Medicare spending on skin substitute products, enhance program integrity, and promote domestic manufacturing, but could significantly alter reimbursement for providers and market access for manufacturers.
What it actually does
This bill amends the Social Security Act to significantly reform Medicare payment for skin substitute products. It establishes a fixed payment rate of $457 per square centimeter for these products, introduces stringent domestic sourcing and distribution requirements, and implements new program integrity measures including prepayment claim review, prior authorization, and provider certification mandates. The bill also allocates funding for CMS program management related to these new oversight activities.
Proponents argue
Proponents would argue that the bill is essential for curbing potential overbilling and fraud within the Medicare system for skin substitute products, ensuring that taxpayer dollars are spent efficiently. They would also highlight the benefits of strengthening domestic supply chains for critical medical products, fostering American jobs, and providing clear, predictable reimbursement for providers.
Opponents contend
Opponents might contend that the fixed payment rate of $457 per square centimeter is arbitrary and could lead to under-reimbursement for providers, potentially limiting patient access to innovative or higher-cost, yet effective, treatments. They may also argue that the strict domestic sourcing requirements could restrict product availability and increase costs, while the new program integrity measures could impose excessive administrative burdens on legitimate healthcare providers.
The bill is moderately complex due to its technical amendments to the Social Security Act and detailed program integrity rules, requiring careful reading to understand its full implications.
Section 1
Short Title
This section establishes the official short title of the Act as the 'American Patients First Act of 2026'. This title is used for easy reference and public identification of the legislation.
Supporters argue
Supporters would argue that a clear, concise short title helps in public discourse and legislative tracking, signaling the bill's intent to prioritize patient interests and efficient healthcare.
Critics contend
No specific opposition is typically raised against short titles, though critics might argue the title is misleading if they oppose the bill's substantive provisions.
Tradeoffs
None inherent in the title itself, beyond potential rhetorical framing.
Section 2(a) amending Section 1861(s)(2) of the Social Security Act
Explicit Medicare Coverage for Skin Substitute Products
This provision formally adds 'skin substitute products' to the list of items and services explicitly covered under Medicare Part B. This clarifies and solidifies the status of these products as a covered benefit, ensuring that Medicare beneficiaries can access these treatments.
Section 2(b)(1) amending Section 1847A(b)(1) of the Social Security Act
Establishment of Fixed Payment Rate for Skin Substitute Products
For skin substitute products furnished between January 1, 2027, and December 31, 2030, Medicare will pay a fixed amount of $457 per square centimeter. This provision aims to standardize costs and reduce variability in reimbursement for these products, replacing previous payment methodologies.
Section 2(c) adding Section 1847A(c)(6)(J) to the Social Security Act
Domestic Sourcing and Distribution Mandate for Skin Substitutes
This provision defines 'skin substitute product' to exclude products that do not meet specific domestic sourcing and distribution requirements. These include mandates that all human cellular/tissue material must be donated by U.S. citizens/nationals within the U.S., all manufacturing must occur exclusively in the U.S. in compliance with FDA/AATB standards, and distribution must be direct from the entity holding regulatory clearance. A waiver for domestic supply shortages is possible for up to 180 days.
Section 2(e)
Establishment of Consolidated Billing and Payment Code
This section directs the Secretary of Health and Human Services to establish a new, single billing and payment code for all skin substitute products by January 1, 2027. The goal is to streamline the billing process and standardize how these products are identified for reimbursement purposes under Medicare.
Section 3 adding Section 1834(bb)(1) to the Social Security Act
Enhanced Program Integrity through Prepayment Review and Prior Authorization
This provision mandates prepayment review for claims from 'specified providers' of skin substitute products starting January 1, 2027, unless certain conditions are met (e.g., high approval rates, prior authorization already in place). Beginning January 1, 2028, prior authorization will be applied to specified providers for 180 days. Providers with high denial rates (exceeding 75% for 6+ consecutive months) may face enrollment revocation or exclusion from federal healthcare programs.
Section 3 adding Section 1834(bb)(5) to the Social Security Act
Mandatory Provider Certification for Skin Substitute Application
This provision mandates that providers furnishing skin substitute products must hold specific certifications from recognized wound care organizations. These include certifications from the American Board of Wound Management, Wound, Ostomy and Continence Nursing Certification Board, National Alliance of Wound Care and Ostomy, or the American Foot Care Nurses Association.
The definition of 'skin substitute product' includes detailed domestic sourcing and distribution requirements. Specifically, all human cellular or tissue material must be donated by U.S. citizens/nationals within the U.S., all harvesting, processing, and manufacturing must occur exclusively within the U.S. in compliance with FDA and AATB standards, and distribution must be direct from the entity holding regulatory clearance, with limited exceptions.
Section 2(c) adding Section 1847A(c)(6)(J) to the Social Security Act
Why it matters:While definitions are a standard place for technical specifications, placing such extensive operational and supply chain requirements within a definition can make them less prominent than if they were in a standalone section.
Case for: Proponents would argue that these requirements are crucial for strengthening the domestic supply chain for critical medical products, ensuring product quality and safety through U.S. oversight, and promoting American jobs and economic resilience.
Case against: Critics might argue that these stringent criteria could severely limit the availability of skin substitute products, increase costs due to reduced competition, and potentially exclude innovative products from Medicare coverage if they cannot meet the strict domestic criteria, thereby harming patient access and choice.
Estimated impact: Potentially reshapes the entire market for skin substitute products eligible for Medicare reimbursement, favoring domestic manufacturers and supply chains.
For the period beginning January 1, 2027, and ending December 31, 2030, Medicare will not make payment for a skin substitute product if the provider furnishing such product obtained it for less than $342.75 per square centimeter.
Section 3 adding Section 1834(bb)(6) to the Social Security Act
Why it matters:This is a technical detail within a broader section on payment rules, which is a common legislative practice. However, its specific financial impact could be significant.
Case for: Proponents would argue this prevents providers from exploiting the fixed reimbursement rate by acquiring products at extremely low costs and profiting excessively from the difference, ensuring fair market practices and preventing potential fraud.
Case against: Critics might argue this provision limits competition and innovation by effectively setting a floor on product pricing, potentially preventing the use of more affordable, yet effective, skin substitute products and increasing overall costs to the system by disincentivizing cost-saving procurement.
Estimated impact: This provision could significantly influence the pricing strategies of manufacturers and procurement practices of providers for skin substitute products, potentially affecting market competition.