H.R. 5768

[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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