[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5768 Introduced in House (IH)]
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119th CONGRESS
1st Session
H. R. 5768
To amend title XVIII of the Social Security Act to adjust payment for
skin substitute products under the Medicare program.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 17, 2025
Mr. Carter of Georgia (for himself, Mr. Veasey, Mr. Steube, and Mr.
McCormick) introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committee on
Ways and Means, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend title XVIII of the Social Security Act to adjust payment for
skin substitute products under the Medicare program.
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''.
SEC. 2. PAYMENT REFORM FOR SKIN SUBSTITUTE PRODUCTS.
(a) Coverage of Skin Substitute Products.--Section 1861(s)(2) of
the Social Security Act (42 U.S.C. 1395x(s)(2)) is amended--
(1) in subparagraph (JJ), by adding ``and'' at the end; and
(2) by inserting after subparagraph (JJ) the following new
subparagraph:
``(KK) skin substitute products (as defined in
section 1847A(c)(6)(J)).''.
(b) Payment.--
(1) Payment amount.--Section 1847A of the Social Security
Act (42 U.S.C. 1395w-3a) is amended--
(A) in subsection (a)(1)--
(i) by striking the period at the end and
inserting ``; and'';
(ii) by striking ``shall apply to'' and
inserting ``shall apply--
``(A) to''; and
(iii) by adding at the end the following
new subparagraph:
``(B) to payment for skin substitute products (as
defined in subsection (c)(6)(J)) that are furnished on
or after January 1, 2026.'';
(B) in subsection (b)--
(i) in paragraph (1)--
(I) in the text preceding
subparagraph (A), by inserting ``or a
skin substitute product'' after ``drug
or biological'';
(II) in subparagraph (B), by
striking ``or'' at the end;
(III) in subparagraph (C), by
striking the period at the end and
inserting ``; or''; and
(IV) 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
(ii) in paragraph (2)--
(I) in subparagraph (A), by
inserting ``or a skin substitute
product'' after ``drug or biological'';
and
(II) in subparagraph (B), by
inserting ``, and, with respect to a
skin substitute product, a square
centimeter'' after ``pertaining to
liquids''; and
(iii) by adding at the end the following:
``(9) Skin substitute products.--
``(A) Payment amount.--
``(i) Initial payment amount.--For 2026,
the amount determined under this paragraph for
a skin substitute product is the volume-
weighted average of the Medicare payment
allowance limits for skin substitute products,
as determined under subparagraph (B).
``(ii) Annual update.--For 2027 and each
subsequent year, the amount determined under
this paragraph for a skin substitute product
for such year is equal to the amount determined
under this paragraph for the previous year,
adjusted by the percentage increase in the
Consumer Price Index for All Urban Consumers
(United States city average) for the 12-month
period ending with June of such previous year.
``(B) Volume-weighted average payment limit.--For
purposes of subparagraph (A)(i), the volume-weighted
average of the Medicare payment allowance limits for
skin substitute products is determined by--
``(i) calculating, with respect to each
billing and payment code listed in the October
2023 ASP Pricing File for each skin substitute
product, an amount equal to the product of--
``(I) the payment limit included in
such file with respect to such code;
and
``(II) the number of units (as
specified under paragraph (2))--
``(aa) billed with respect
to such code for a date of
service in 2023; and
``(bb) listed in the CMS
Integrated Data Repository for
Part B (Carrier & DME) claims
data;
``(ii) calculating the sum of all amounts
determined under clause (i); and
``(iii) dividing the sum calculated under
clause (ii) by the total number of units
determined under clause (i)(II).''.
(2) Conforming amendments.--Section 1833(a)(1) of the
Social Security Act (42 U.S.C. 1395l(a)(1)) is amended--
(A) in subparagraph (S)(i), by striking ``subject
to subparagraph (EE)'' and inserting ``subject to
subparagraphs (EE) and (II)'';
(B) by striking ``and (HH)'' and inserting
``(HH)''; and
(C) by inserting ``, and (II) with respect to skin
substitute products under section 1861(s)(2)(KK), the
amount paid shall be 80 percent of the lesser of the
actual charge or the payment amount established under
section 1847A(b)(9)'' before the semicolon at the end.
(c) Skin Substitute Product Defined.--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:
``(J) Skin substitute products.--The term `skin
substitute product'--
``(i) means a cellular, tissue, biological
or synthetic material that--
``(I) is applied to a wound and
intended to remain within the wound
bed; and
``(II) is marketed pursuant to
section 510(k), 513(f)(2), or 515 of
the Federal Food, Drug, and Cosmetic
Act, or section 361 of the Public
Health Service Act; and
``(ii) does not include--
``(I) a product that is intended to
temporarily protect or cover the wound
bed and be removed before complete
resorption (such as a dressing); or
``(II) a liquid, gel, powder, or
other similarly constituted item.''.
(d) Exclusion From Reporting Requirements.--Section 1847A(f)(2)(A)
of the Social Security Act (42 U.S.C. 1395w-3a(f)(2)(A)) is amended by
inserting ``(except that, beginning January 1, 2026, a drug or
biological so described does not include a skin substitute product (as
defined in subsection (c)(6)(J)))'' after ``products that are payable
under this part as a drug or biological''.
(e) Consolidated Billing and Payment Code.--Not later than January
1, 2026, the Secretary of Health and Human Services shall establish a
new billing and payment code for all skin substitute products (as
defined in subparagraph (J) of section 1847A(c)(6) of the Social
Security Act (42 U.S.C. 1395w-3a(c)(6)), as added by subsection (b)).
SEC. 3. ENHANCING PROGRAM INTEGRITY FOR SKIN SUBSTITUTE PRODUCTS.
Section 1834 of the Social Security Act (42 U.S.C. 1395m) is
amended by adding at the end the following new subsection:
``(aa) Special Payment Rules for Skin Substitute Products.--
``(1) Identification of outlier providers of skin
substitute products.--
``(A) In general.--Not later than December 1, 2025,
and every 2 years thereafter through December 1, 2035,
the Secretary shall determine the 3 percent of the
total number of providers of skin substitute products
that are outlier providers of skin substitute products.
``(B) Outlier providers of skin substitute
products.--The determination of an outlier provider of
skin substitute products under this paragraph shall be
based upon the providers (as identified by national
provider identification number) that received the
greatest total payment under this title for skin
substitute products furnished in the year preceding the
year in which the determination under subparagraph (A)
is made.
``(C) Referral to oig.--The Secretary shall--
``(i) make publicly available the list of
outlier providers of skin substitute products
identified under each determination under
subparagraph (A); and
``(ii) transmit such list to the Inspector
General of the Department of Health and Human
Services for the assessment of potential fraud,
waste, or abuse.
``(2) Initial prepayment claim review for certain outlier
providers.--
``(A) In general.--Beginning January 1, 2026, the
Secretary shall conduct prepayment review of claims for
skin substitute products submitted under this title by
an outlier provider of skin substitute products unless
1 or more of the conditions described in subparagraph
(B) is met with respect to such provider.
``(B) Limitation.--For purposes of subparagraph
(A), the conditions described in this subparagraph are,
with respect to an outlier provider of skin substitute
products, the following:
``(i) Skin substitute products furnished by
the provider are subject to prior authorization
under paragraph (3).
``(ii) The rate of approval for claims for
skin substitute products furnished by such
provider that are subject to prepayment review
under this paragraph exceeds 90 percent (as
determined over a period of time or number of
claims specified by the Secretary).
``(iii) The Secretary determines that the
billing practices of the provider are
consistent with the applicable coverage
criteria and requirements under this title.
``(3) Prior authorization for outlier providers of skin
substitute products.--
``(A) In general.--Beginning not later than January
1, 2027, subject to subparagraph (B), the Secretary
shall, for a period determined appropriate by the
Secretary, apply prior authorization for skin
substitute products that are furnished by an outlier
provider of skin substitute products identified under
paragraph (1).
``(B) Removal from prior authorization.--In the
event that the Secretary determines, with respect to an
outlier provider of skin substitute products, that the
rate of approval for requests for prior authorization
under this paragraph for skin substitute products
furnished by such provider exceeds 90 percent (as
determined over a period of time or number of claims
specified by the Secretary), the Secretary shall cease
to apply prior authorization under this paragraph for
skin substitute products furnished by such provider.
``(C) Funding.--For purposes of carrying out this
paragraph, the Secretary shall provide for the
transfer, from the Federal Supplementary Medical
Insurance Trust Fund under section 1841, to the Centers
for Medicare & Medicaid Services Program Management
Account, of $5,000,000 for each of fiscal years 2027
through 2030, to remain available until expended.
``(4) Enrollment revocation or exclusion of noncompliant
outlier providers.--
``(A) In general.--Beginning January 1, 2028, if
the rate of denial for requests for prior authorization
under paragraph (3) for skin substitute products
furnished by an outlier provider of skin substitute
products exceeds 75 percent over a period of 6 or more
consecutive months, the Secretary shall determine that
an abuse of billing privileges exists with respect to
such provider for purposes of section 424.535(a)(8)(ii)
of title 42, Code of Federal Regulations.
``(B) Referral for exclusion.--If the Secretary
determines under subparagraph (A) that an abuse of
billing privileges exists with respect to an outlier
provider of skin substitute products, the Secretary
shall direct the Inspector General of the Department of
Health and Human Services to determine whether such
provider should be excluded from participation in any
Federal health care program under section 1128(b)(6).
``(5) Medicare coverage criteria for skin substitute
products.--Any skin substitute product defined in section
1847A(c)(6)(J) of the Social Security Act and furnished during
2026 shall be subject to the same coverage criteria when
determining whether the skin substitute product is covered
under section 1862(a)(1)(A), unless such product is determined
by the Secretary to be unsafe based on evidence of
contamination, serious infectious disease, or serious adverse
reactions caused by the product. Neither the Secretary nor any
Medicare administrative contractor may determine, including
through a determination made pursuant to the prepayment review
program or prior authorization program described in paragraphs
(2) and (3), that a specific skin substitute product furnished
in 2026 is not covered by Medicare based solely on analysis of
the clinical evidence relating to that skin substitute product.
``(6) Skin substitute product defined.--In this subsection,
the term `skin substitute product' has the meaning given such
term in section 1847A(c)(6)(J).''.
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