119-s2561

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2561 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 2561

 To amend title XVIII of the Social Security Act to reform the payment 
 rules regarding skin substitute products.

_______________________________________________________________________

 IN THE SENATE OF THE UNITED STATES

 July 31, 2025

 Mr. Cassidy introduced the following bill; which was read twice and 
 referred to the Committee on Finance

_______________________________________________________________________

 A BILL

 To amend title XVIII of the Social Security Act to reform the payment 
 rules regarding skin substitute products.

 Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

 This Act may be cited as the ``Skin Substitute Access and Payment 
Reform Act of 2025''.

SEC. 2. FINDINGS.

 Congress finds the following:

    (1) Skin substitute products are advanced biological 
 therapies used to treat chronic, non-healing wounds, such as 
 diabetic foot ulcers and venous leg ulcers. Each year, more 
 than 10,500,000 Medicare beneficiaries will require medical 
 care for treatment of a wound. By improving healing rates and 
 reducing the rate of lower limb amputation, skin substitute 
 products improve the health and wellness of Medicare 
 beneficiaries.

    (2) These treatments vary in makeup and source material, 
 including human tissue-derived products, non-human, animal-
 derived products, and synthetic products. Studies show that 
 different skin substitute products are similarly safe and 
 effective in treating chronic wounds, and Medicare coverage 
 does not currently differentiate between different types of 
 lawfully marketed skin substitutes. Healthcare providers are 
 well-informed about alternative skin substitute products and 
 are in the best position to determine which specific product 
 would best suit each specific patient based on the patient's 
 specific needs and the provider's knowledge and experience.

    (3) The Centers for Medicare & Medicaid Services has faced 
 challenges in determining consistent and accurate pricing and 
 payment for services that involve skin substitute products, 
 resulting in uncertainty and significant price differences 
 among these products.

    (4) The Medicare payment systems in place at the date of 
 enactment of this Act incentivize use of more expensive 
 products and continued price increases while failing to 
 recognize the similar clinical effects of skin substitute 
 products. Medicare expenditures for skin substitute products 
 rose significantly in 2024 and 2025.

    (5) It is therefore necessary to reform the Medicare 
 payment and coverage rules for skin substitute products to 
 appropriately recognize the well-established and known clinical 
 value of these treatments while containing costs.

SEC. 3. PAYMENT REFORM FOR SKIN SUBSTITUTE PRODUCTS.

    (a) In General.--

Section 1847A

    (b) of the Social Security Act (42 
U.S.C. 1395w-3a

    (b) ) is amended--

    (1) in paragraph

    (1) --
        (A) subparagraph
        (B) , by striking ``or'' at the 
 end;
        (B) in subparagraph
            (C) , by striking the period at 
 the end and inserting ``; or''; and
            (C) by adding at the end the following new 
 subparagraph:
 ``
            (D) in the case of a skin substitute product (as 
 defined in subsection
            (c) (6)
        (J) ), the amount determined 
 under paragraph

    (9) .''; and

    (2) by adding at the end the following new paragraph:
 ``

    (9) Skin substitute products.--
 ``
        (A) In general.--Beginning on January 1, 2026, 
 for any skin substitute product (as defined in 
 subsection
            (c) (6) ), the amount specified in this 
 paragraph is the volume-weighted average of the payment 
 allowance limit calculated under subparagraph
        (B) .
 ``
        (B) Volume-weighted average payment limit.--The 
 volume-weighted average of the payment allowance limit 
 of a skin substitute product under this paragraph is 
 determined by--
 ``
            (i) calculating the sum of the products 
 of--
 ``
            (I) the published payment 
 allowance limit for each billing and 
 payment code listed in the ASP Pricing 
 File published by the Secretary for the 
 fourth calendar quarter of 2023 for 
 each skin substitute product; and
 ``
            (II) the total number of units, 
 as specified under paragraph

    (2) , for 
 each billing and payment code described 
 in subclause
            (I) , billed with dates of 
 service from October 1, 2023, to 
 December 31, 2023, and listed in the 
 Integrated Data Repository for Part B 
 claims data; and
 ``
            (ii) dividing the sum calculated under 
 clause
            (i) by the total number of units under 
 subclause
            (II) .
 ``
            (C) Updates to payment amounts.--For 2027 and 
 each subsequent year, the amount specified in this 
 paragraph shall be adjusted for the percentage increase 
 in the consumer price index for all urban consumers 
 (U.S. city average) for the 12-month period ending with 
 June of the previous year.''.

    (b) Definition and Other Rules for Skin Substitute Products.--

Section 1847A
            (c) (6) of the Social Security Act (42 U.S.C. 1395w-
3a
            (c) (6) ) is amended by adding at the end the following new 
subparagraph:
 ``
        (J) Skin substitute products.--
 ``
            (i) In general.--The term `skin 
 substitute product'--
 ``
            (I) means a cellular, biological 
 or synthetic material or tissue applied 
 to a wound and intended to remain 
 within the wound bed, including a 
 product approved, cleared, or 
 authorized to 

section 510

    (k) , 
 513

    (f)

    (2) , or 515 of the Federal Food, 
 Drug, and Cosmetic Act (21 U.S.C. 
 360

    (k) , 260c

    (f)

    (2) , 360e) or 

section 361 of the Public Health Service Act 
 (42 U.S.C. 264), and their implementing 
 regulations; and
 ``
            (II) does not include--
 ``

    (aa) any product that is 
 intended to temporarily protect 
 or cover the wound bed and be 
 removed before complete 
 resorption, such as a dressing;
 ``

    (bb) any liquid, gel, 
 powder, or other similarly 
 constituted item; or
 ``
            (cc) any product that 
 would otherwise meet the 
 requirements of subclause
            (I) , 
 but is approved under 

section 505 of the Federal Food, Drug, 
 and Cosmetic Act (21 U.S.C. 
 355) or licensed under 

section 351

    (a) of the Public Health 
 Service Act (42 U.S.C. 262

    (a) ).
 ``
            (ii) Consolidated billing and payment 
 code.--Not later than January 1, 2026, the 
 Secretary shall establish a new billing and 
 payment code for all skin substitute products.
 ``
            (iii) Special rules.--Beginning on 
 January 1, 2026, the following rules shall 
 apply:
 ``
            (I) Each skin substitute product 
 shall be subject to the same criteria 
 when determining whether such skin 
 substitute product is reasonable and 
 necessary for the diagnosis or 
 treatment of illness or injury under 
 

section 1862

    (a)

    (1)
        (A) , unless 
 determined by the Secretary that such 
 product is unsafe based on evidence of 
 contamination, serious infectious 
 disease, or serious adverse reactions 
 caused by such product.
 ``
            (II) The Secretary may not 
 determine that a skin substitute 
 product is not considered reasonable 
 and necessary for the diagnosis or 
 treatment of illness or injury under 
 

section 1862

    (a)

    (1)
        (A) based solely on 
 analysis of any clinical evidence 
 relating to such product.
 ``
            (III) A manufacturer of a skin 
 substitute product shall not be 
 required to report the average sales 
 price for such product under 

section 1927

    (b)

    (3)
        (A)
            (iii) or subsection

    (f)

    (2) .''.
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