Bill Summary
The **Advanced Wound Care and Regenerative Medicine Access and Reform Act** amends Title XVIII of the Social Security Act to enhance access to advanced wound care treatments, particularly focusing on skin substitute products under the Medicare program. Key provisions of the legislation include the expansion of coverage for these products, a reformed payment framework that starts on January 1, 2026, and a clear definition of skin substitute products, which excludes temporary dressings.
The legislation also introduces enhanced program integrity measures, ensuring equivalent reimbursement rates across different care sites and establishing prepayment reviews for high-payment outlier providers. From 2027, prior authorization for skin substitutes will be required from these providers, with enforcement actions planned if denial rates are excessively high.
Additionally, the act mandates a comprehensive review of approval processes for human cellular and tissue products to streamline application requirements while maintaining safety and efficacy standards. Stakeholder consultations will inform this review, leading to recommendations for regulatory improvements aimed at enhancing patient access and public health. Overall, the act seeks to reform reimbursement practices, prevent fraud and waste, and expedite access to innovative wound care therapies.
Possible Impacts
Here are three examples of how people will be affected by the Advanced Wound Care and Regenerative Medicine Access and Reform Act:
1. **Increased Access to Advanced Treatments**: Patients with chronic wounds will benefit from expanded access to advanced wound care treatments, as skin substitute products will now be covered under Medicare. This change is expected to improve treatment outcomes and quality of life for individuals who require these specialized products, allowing them to receive more effective care without the burden of prohibitive costs.
2. **Enhanced Oversight and Protection Against Fraud**: Healthcare providers will face more stringent measures regarding the reimbursement of skin substitute products, including the identification of outlier providers and prepayment reviews. This will help ensure that patients receive care from providers who adhere to best practices and reduce the risk of fraud, ultimately leading to a more trustworthy healthcare system. However, it may also result in additional administrative burdens for some providers.
3. **Streamlined Approval Processes for New Products**: Manufacturers and clinicians will experience changes in the approval processes for human cellular and tissue products, which could lead to faster access to innovative treatments. This means that patients may benefit from new and potentially more effective therapies sooner, enhancing their overall treatment options. However, the emphasis on maintaining safety and efficacy standards means that while the process will be more efficient, it will not compromise patient safety.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6852 Introduced in House (IH)]
<DOC>
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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