H.R. 6852

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6852 Introduced in House (IH)]

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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 
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 ``Advanced Wound Care and Regenerative 
Medicine Access and 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 (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 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.''; and
(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 April 
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 a product that is 
intended to temporarily protect or cover the 
wound bed and be removed without resorption 
such as a dressing; and
``(iii) the term `skin substitute product' 
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 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. 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 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 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 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 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 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 may 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) Skin substitute product wastage.--
``(A) With respect to skin substitute products 
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).''.

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 approval process 
applied to human cellular and tissue allografts and autografts 
that are not subject to regulation only under section 361 of 
the Public Health Service Act, including those processed into 
liquid, gel, or powder forms;
(2) identify opportunities to streamline application 
requirements, review timelines, and evidentiary standards for 
such products while maintaining appropriate safety and efficacy 
oversight;
(3) consider the development of a tiered review framework 
based on risk assessment factors including 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 existing clinical data, 
real-world evidence, and registry data to reduce duplicative 
clinical trial requirements where scientifically justified; and
(5) assess mechanisms to harmonize requirements 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 consult with--
(1) manufacturers of human tissue allografts;
(2) tissue banks and procurement organizations;
(3) clinicians specializing in wound care, surgical 
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;
(3) opportunities for modular or staged application 
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 similar 
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 Secretary shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives a report on the 
review conducted under subsection (b), including--
(1) findings and recommendations for regulatory 
streamlining;
(2) any administrative actions taken or proposed;
(3) recommendations for additional legislative action, if 
any; and
(4) estimated impacts on patient access and public health.
(f) Preservation of Safety Standards.--Nothing in this section 
shall be construed to reduce or eliminate safety or efficacy standards 
applicable to human tissue allografts or autografts subject to 
licensure under section 351 of the Public Health Service Act.
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