American Patients First Act of 2026
Sponsored By: Representative Sessions, Pete [R-TX-17]
Introduced
Summary
Creates a new Medicare payment and domestic sourcing system for skin substitute products. It defines skin substitutes as a Medicare-covered category, sets a dedicated per-square-centimeter payment, and adds U.S. donation, manufacturing, and distribution rules for wound-care products.
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Bill Overview
Analyzed Economic Effects
6 provisions identified: 3 benefits, 0 costs, 3 mixed.
New Medicare rules for skin substitutes
This bill would set a fixed Medicare payment of $457 per square centimeter for skin substitute products from January 1, 2027 through December 31, 2030. Medicare would pay 80% of the lesser of your bill or that amount, so beneficiaries would owe 20% of the allowed amount. Medicare payments would be barred if a provider bought the product for less than $342.75 per square centimeter. The bill would also limit payable area to the larger of 350 square centimeters or 120% of the wound size, exclude wastage, allow no more than three applications without documented improvement, and require provider wound-care certification.
Domestic sourcing rules for wound products
This bill would define which products count as skin substitutes and require U.S. sourcing and manufacturing. Human tissue would have to be donated by U.S. citizens, nationals, or lawful permanent residents, and donations and processing would have to occur inside the United States under FDA and industry standards. Distribution would be limited to the entity holding the applicable clearance, with limited third-party distributor exceptions, and that entity must file an annual attestation. The Secretary could grant a 180-day waiver if a domestic shortage would harm patient access.
2027 coverage protection for patients
This bill would bar Medicare from denying coverage during calendar year 2027 for a skin substitute product based only on that product's clinical evidence. The Secretary could still deny coverage if the product is unsafe because of contamination, infectious disease, or serious adverse reactions. This protects patient access to covered skin substitutes during 2027 unless there are safety problems.
New billing code and reporting relief
This bill would require the HHS Secretary to create a single consolidated billing and payment code for all skin substitute products by January 1, 2027. It would also exclude skin substitute products from certain drug and biologic reporting rules beginning January 1, 2027. If enacted, these steps would simplify claims coding and reduce some reporting duties for manufacturers and suppliers.
Public list of high-use skin providers
This bill would require the Secretary to identify the top 3 percent of providers by Medicare payments for skin substitute products and other high-use providers. The Secretary would publish that list by December 1, 2026 and every two years through December 1, 2036, and send it to the HHS Inspector General for fraud and abuse review. The bill would also flag providers with 15% or more of claims for these products.
Prepayment and prior authorization for providers
This bill would require CMS to do prepayment review of some skin substitute claims starting January 1, 2027. By January 1, 2028 CMS would apply 180-day prior authorization periods for specified providers, with exemptions if approval rates are high. Beginning January 1, 2029, repeated high denial rates could trigger referral for exclusion. To run these activities, $2.5 million would be transferred to CMS each year for FY2028 through FY2031, available until expended.
Sponsors & CoSponsors
Sponsor
Sessions, Pete [R-TX-17]
TX • R
Cosponsors
There are no cosponsors for this bill.
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov