I 
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 Representa-
tives 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’’. 
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SEC. 2. PAYMENT REFORM FOR SKIN SUBSTITUTE PROD-
UCTS. 
(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 amend-
ed— 
(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 fol-
lowing new subparagraph: 
‘‘(B) to payment for skin substitute prod-
ucts (as defined in subsection (c)(6)(J)) that 
are furnished on or after January 1, 2026.’’; 
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(B) in subsection (b)— 
(i) in paragraph (1)— 
(I) in the text preceding subpara-
graph (A), by inserting ‘‘or a skin 
substitute product’’ after ‘‘drug or bi-
ological’’; 
(II) in subparagraph (B), by 
striking ‘‘or’’ at the end; 
(III) in subparagraph (C), by 
striking the period at the end and in-
serting ‘‘; or’’; and 
(IV) by adding at the end the fol-
lowing new subparagraph: 
‘‘(D) in the case of a skin substitute prod-
uct (as defined in subsection (c)(6)(J)), the 
amount determined under paragraph (9).’’; and 
(ii) in paragraph (2)— 
(I) in subparagraph (A), by in-
serting ‘‘or a skin substitute product’’ 
after ‘‘drug or biological’’; and 
(II) in subparagraph (B), by in-
serting ‘‘, and, with respect to a skin 
substitute product, a square centi-
meter’’ after ‘‘pertaining to liquids’’; 
and 
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(iii) by adding at the end the fol-
lowing: 
‘‘(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 Medi-
care payment allowance limits for skin sub-
stitute products, as determined under sub-
paragraph (B). 
‘‘(ii) ANNUAL
UPDATE.—For 2027 
and each subsequent year, the amount de-
termined under this paragraph for a skin 
substitute product for such year is equal to 
the amount determined under this para-
graph 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
PAY-
MENT
LIMIT.—For purposes of subparagraph 
(A)(i), the volume-weighted average of the 
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Medicare payment allowance limits for skin sub-
stitute products is determined by— 
‘‘(i) calculating, with respect to each 
billing and payment code listed in the Oc-
tober 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 In-
tegrated 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).’’. 
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(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 
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‘‘(II) is marketed pursuant to 
section 510(k), 513(f)(2), or 515 of 
the Federal Food, Drug, and Cos-
metic Act, or section 361 of the Pub-
lic 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 dress-
ing); or 
‘‘(II) a liquid, gel, powder, or 
other similarly constituted item.’’. 
(d) 
EXCLUSION
FROM
REPORTING
REQUIRE-
MENTS.—Section 1847A(f)(2)(A) of the Social Security 
Act (42 U.S.C. 1395w–3a(f)(2)(A)) is amended by insert-
ing ‘‘(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 ‘‘prod-
ucts that are payable under this part as a drug or biologi-
cal’’. 
(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 pay-
ment code for all skin substitute products (as defined in 
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subparagraph (J) of section 1847A(c)(6) of the Social Se-
curity Act (42 U.S.C. 1395w–3a(c)(6)), as added by sub-
section (b)). 
SEC. 3. ENHANCING PROGRAM INTEGRITY FOR SKIN SUB-
STITUTE 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 SUB-
STITUTE PRODUCTS.— 
‘‘(1) IDENTIFICATION OF OUTLIER PROVIDERS 
OF SKIN SUBSTITUTE PRODUCTS.— 
‘‘(A) IN
GENERAL.—Not later than De-
cember 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 SUB-
STITUTE 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 great-
est total payment under this title for skin sub-
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stitute products furnished in the year preceding 
the year in which the determination under sub-
paragraph (A) is made. 
‘‘(C) REFERRAL TO OIG.—The Secretary 
shall— 
‘‘(i) make publicly available the list of 
outlier providers of skin substitute prod-
ucts identified under each determination 
under subparagraph (A); and 
‘‘(ii) transmit such list to the Inspec-
tor 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 sub-
paragraph (A), the conditions described in this 
subparagraph are, with respect to an outlier 
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provider of skin substitute products, the fol-
lowing: 
‘‘(i) Skin substitute products fur-
nished 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 prepay-
ment 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 cri-
teria and requirements under this title. 
‘‘(3) PRIOR AUTHORIZATION FOR OUTLIER PRO-
VIDERS OF SKIN SUBSTITUTE PRODUCTS.— 
‘‘(A) IN
GENERAL.—Beginning not later 
than January 1, 2027, subject to subparagraph 
(B), the Secretary shall, for a period deter-
mined appropriate by the Secretary, apply prior 
authorization for skin substitute products that 
are furnished by an outlier provider of skin sub-
stitute products identified under paragraph (1). 
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‘‘(B) REMOVAL FROM PRIOR AUTHORIZA-
TION.—In the event that the Secretary deter-
mines, with respect to an outlier provider of 
skin substitute products, that the rate of ap-
proval for requests for prior authorization 
under this paragraph for skin substitute prod-
ucts furnished by such provider exceeds 90 per-
cent (as determined over a period of time or 
number of claims specified by the Secretary), 
the Secretary shall cease to apply prior author-
ization 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 Supple-
mentary Medical Insurance Trust Fund under 
section 1841, to the Centers for Medicare & 
Medicaid Services Program Management Ac-
count, 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 
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authorization under paragraph (3) for skin sub-
stitute 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 pro-
vider 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 re-
spect to an outlier provider of skin substitute 
products, the Secretary shall direct the Inspec-
tor 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 sec-
tion 1128(b)(6). 
‘‘(5) MEDICARE COVERAGE CRITERIA FOR SKIN 
SUBSTITUTE PRODUCTS.—Any skin substitute prod-
uct 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 deter-
mining whether the skin substitute product is cov-
ered under section 1862(a)(1)(A), unless such prod-
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uct is determined by the Secretary to be unsafe 
based on evidence of contamination, serious infec-
tious 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 pre-
payment review program or prior authorization pro-
gram 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).’’. 
Æ 
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