S. 2561: Skin Substitute Access and Payment Reform Act of 2025
The Skin Substitute Access and Payment Reform Act of 2025 aims to modify the rules regarding Medicare payments for skin substitute products, which are used to treat chronic wounds such as diabetic ulcers. The Act has several key components:
Background
Skin substitute products are advanced therapies intended to promote healing in chronic, non-healing wounds. Over 10 million Medicare beneficiaries annually require treatment for such wounds. The Act acknowledges that these products come in various forms, including those derived from human tissue, animal sources, and synthetic materials. Current Medicare rules do not differentiate between types of skin substitutes, even though studies show they generally have similar safety and effectiveness in treating wounds.
Challenges in Current Payment System
The Centers for Medicare & Medicaid Services (CMS) has encountered challenges in pricing skin substitute products consistently, leading to significant price variability. The current Medicare payment system incentivizes the use of more expensive products without properly reflecting the value and clinical efficacy of different substitutes. This has contributed to rising Medicare spending on these products in recent years.
Key Provisions of the Bill
- Payment Reform: The Act reformulates payment rules to ensure that Medicare recognizes the clinical value of skin substitute products while aiming to manage costs. Starting January 1, 2026, payments will be based on a volume-weighted average of previously established payment limits for these products.
- Calculation of Payments: Payment amounts for skin substitute products in 2026 will be determined by calculating the sum of payment limits for various billing codes related to skin substitutes and dividing it by the number of units billed between October 2023 and December 2023.
- Adjustment to Payment Amounts: From 2027 onward, payment amounts will be adjusted annually based on the consumer price index increase.
- Definition of Skin Substitute Products: The bill defines “skin substitute products” to include cellular and synthetic materials applied to wounds. It excludes products that are temporary coverings or have compositions like gels or powders.
- New Billing Code: A consolidated billing and payment code for all skin substitute products will be established by January 1, 2026.
- Regulatory Framework: All skin substitutes will be judged under the same criteria for determining their necessity in medical treatment, unless safety issues are identified. Manufacturers will not have to report average sales prices for these products under previous rules.
Goals of the Bill
The primary goal of the bill is to make the payment process for skin substitutes more equitable and transparent while effectively managing costs for the Medicare program. By revising the payment structure, the bill aims to enhance patient access to necessary treatments and reduce the financial burdens on the healthcare system associated with wound care.
Relevant Companies
- BDX (Becton Dickinson and Company): As a leading medical technology company, Becton Dickinson manufactures various medical devices, including advanced wound care products that may fall under the skin substitute category.
- AXn (Axovant Gene Therapies Ltd.): This company develops gene therapies, including treatments that could involve skin substitutes for wound care.
- SHW (Sherwin-Williams Company): Known for coatings, this company may also be involved in products used for wound treatment, potentially impacted by changes in payment systems.
This is an AI-generated summary of the bill text. There may be mistakes.
Sponsors
3 bill sponsors
Actions
2 actions
| Date | Action |
|---|---|
| Jul. 31, 2025 | Introduced in Senate |
| Jul. 31, 2025 | Read twice and referred to the Committee on Finance. |
Corporate Lobbying
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