I 
119TH CONGRESS 
1ST SESSION H. R. 6852 
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 
DECEMBER 18, 2025 
Mr. EVANS of Colorado introduced the following bill; which was referred to 
the Committee on Energy and Commerce, and in addition to the Com-
mittee 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 ‘‘Advanced Wound Care 
and Regenerative Medicine Access and 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 (II), by striking ‘‘and’’ at 
the end; 
(2) in subparagraph (JJ), by adding ‘‘and’’ at 
the end; and 
(3) 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: 
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‘‘(B) to payment for skin substitute prod-
ucts (as defined in subsection (c)(6)(J)) that 
are furnished on or after January 1, 2026.’’; 
and 
(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 
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(II) in subparagraph (B), by in-
serting ‘‘, and, with respect to a skin 
substitute product, a square centi-
meter’’ after ‘‘pertaining to liquids’’; 
and 
(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- 
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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 
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 April 
2023 ASP Pricing File for each skin sub-
stitute 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; 
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‘‘(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 ‘‘sub-
ject 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’— 
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‘‘(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 Cos-
metic Act, or section 361 of the Pub-
lic Health Service Act; and 
‘‘(ii) does not include a product that 
is intended to temporarily protect or cover 
the wound bed and be removed without re-
sorption such as a dressing; and 
‘‘(iii) the term ‘skin substitute prod-
uct’ shall include any products reimbursed 
pursuant to skin substitutes codes by the 
Medicare program at any time prior to 
January 1, 2026.’’. 
(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-
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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 
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. EQUIVALENT REIMBURSEMENT IN OUTPATIENT 
SITES OF CARE. 
The Secretary shall ensure that reimbursement for 
skin substitutes products and outpatient applications of 
skin substitute products are equivalent to those payment 
amounts outlined in Section 1847A of the Social Security 
Act (42 U.S.C. 1395w–3a(b)(9)), regardless of the site of 
care in which the skin substitute product is applied. 
SEC. 4. 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.— 
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‘‘(1) IDENTIFICATION OF OUTLIER PROVIDERS 
OF SKIN SUBSTITUTE PRODUCTS.— 
‘‘(A) IN GENERAL.—Not later than March 
1, 2026, and every 2 years thereafter through 
March 1, 2035, the Secretary shall determine 
the 3 percent of the total number of providers 
of skin substitute products that are outlier pro-
viders 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-
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 
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‘‘(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 March 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 
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 
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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). 
‘‘(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), 
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the Secretary may 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 
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. 
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‘‘(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) SKIN SUBSTITUTE PRODUCT WASTAGE.— 
‘‘(A) With respect to skin substitute prod-
ucts furnished for the treatment of chronic or 
acute wounds, payment shall be only made for 
the reasonable and necessary portion of the 
skin substitute product used in the treatment of 
the wound, excluding wastage. 
‘‘(B) For the purpose of subparagraph (A), 
the reasonable and necessary portion of the 
skin substitute product is defined as the greater 
of (i) 3 square centimeters, or (ii) 120 percent 
of the size of the treated wound. 
‘‘(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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SEC. 
5. 
STREAMLINING 
APPROVAL 
PROCESSES 
FOR 
HUMAN CELLS, TISSUES AND CELLULAR AND 
TISSUE-BASED PRODUCTS. 
(a) IN GENERAL.—Not later than 18 months after 
the date of enactment of this Act, the Secretary of Health 
and Human Services, acting through the Commissioner of 
Food and Drugs, shall— 
(1) conduct a comprehensive review of the ap-
proval process applied to human cellular and tissue 
allografts and autografts that are not subject to reg-
ulation only under section 361 of the Public Health 
Service Act, including those processed into liquid, 
gel, or powder forms; 
(2) identify opportunities to streamline applica-
tion requirements, review timelines, and evidentiary 
standards for such products while maintaining ap-
propriate safety and efficacy oversight; 
(3) consider the development of a tiered review 
framework based on risk assessment factors includ-
ing degree of manipulation, processing methods, 
mode or administration, and clinical safety profile; 
(4) evaluate the need for pre-market clinical 
evaluation and the appropriateness of leveraging ex-
isting clinical data, real-world evidence, and registry 
data to reduce duplicative clinical trial requirements 
where scientifically justified; and 
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(5) assess mechanisms to harmonize require-
ments between products currently regulated only 
under section 361 of the Public Health Service Act 
that may transition to section 351 regulation. 
(b) STAKEHOLDER CONSULTATION.—In conducting 
the review under paragraph (1), the Secretary shall con-
sult with— 
(1) manufacturers of human tissue allografts; 
(2) tissue banks and procurement organiza-
tions; 
(3) clinicians specializing in wound care, sur-
gical reconstruction, and regenerative medicine; 
(4) patient advocacy organizations; 
(5) health insurance payors; and 
(6) relevant scientific and medical professional 
societies. 
(c) CONSIDERATIONS.—The review shall specifically 
consider— 
(1) appropriate modifications to Chemistry, 
Manufacturing, and Controls (CMC) requirements 
reflecting the biological nature and donor-dependent 
variability of human tissue; 
(2) potential use of expedited review pathways, 
including priority review designations; 
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(3) opportunities for modular or staged applica-
tion submissions; 
(4) appropriate clinical endpoint criteria and 
study designs for different types of allografts and 
autografts; 
(5) post-market surveillance requirements as an 
alternative to pre-market evidence requirements; and 
(6) international regulatory approaches to simi-
lar products. 
(d) GUIDANCE.—Not later than 24 months after the 
date of enactment of this Act, the Secretary shall issue 
draft guidance implementing any streamlining measures 
identified under subsection (b), and shall finalize such 
guidance not later than 12 months after the close of the 
public comment period. 
(e) REPORT
TO CONGRESS.—Not later than 30 
months after the date of enactment of this Act, the Sec-
retary shall submit to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives a report on the review conducted under sub-
section (b), including— 
(1) findings and recommendations for regu-
latory streamlining; 
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