No official summary available for this bill.
[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).''.
<all>
Introduced in Senate
Read twice and referred to the Committee on Finance.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line