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American Patients First Act of 2026
Introduced Jul 27, 2026 · Last action Jul 27, 2026 — 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.
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Summary
This legislation is called the American Patients First Act of 2026. It is being reviewed by a committee.
Full bill text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9972 Introduced in House (IH)]
<DOC>
119th CONGRESS
2d Session
H. R. 9972
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
July 27, 2026
Mr. Sessions 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 ``American Patients First Act of
2026''.
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 striking ``and'' at the end;
(2) in subparagraph (KK), by adding ``and'' at the end; and
(3) by inserting after subparagraph (KK) the following new
subparagraph:
``(LL) 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
during the period beginning on January 1, 2027, and
ending on December 31, 2030.''; 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)) furnished during the
period beginning on January 1, 2027, and ending on
December 31, 2030, $457 per square centimeter.''; 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''.
(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)(LL)
furnished during the period beginning on January 1,
2027, and ending on December 31, 2030, the amount paid
shall be 80 percent of the lesser of the actual charge
or the payment amount established under section
1847A(b)(1)(D)'' 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.--
``(i) In general.--Subject to clause (ii),
the term `skin substitute product'--
``(I) means a cellular, tissue,
biological or synthetic material that--
``(aa) is applied to a
wound and intended to remain
within the wound bed; and
``(bb) 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) includes any products
reimbursed pursuant to skin substitutes
codes under this title at any time
prior to January 1, 2027.
``(ii) Exclusions.--The term `skin
substitute product' does not include--
``(I) any product that is intended
to temporarily protect or cover the
wound bed and be removed without
resorption such as a dressing; or
``(II) any product that does not
meet the domestic sourcing and
distribution requirements described in
clause (iii), unless a waiver under
clause (iv) is in effect with respect
to such product.
``(iii) Domestic sourcing and distribution
requirements.--For purposes of clause (ii), the
domestic sourcing and distribution requirements
described in this clause are, with respect to a
product described in clause (i), the following:
``(I) All human cellular or tissue
material contained in such product was
donated by citizens or nationals of the
United States, or aliens lawfully
admitted for permanent residence in the
United States, and any such donation
was made within the United States in
accordance with applicable Federal law.
``(II) All harvesting and
processing (as applicable) and all
manufacturing of such product occurred
exclusively within the United States,
and such harvesting, processing, and
manufacturing was performed in
compliance with all applicable
standards of the Food and Drug
Administration and the American
Association of Tissue Banks.
``(III) The product is distributed
solely by the entity holding the
applicable clearance, approval, or
registration for such product under
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 no
intermediaries, or agents were involved
in the distribution of such product to
the furnishing provider, except that a
third-party distributor that adheres to
and is able to perform the contractual
requirements associated with the scope
of work and is qualified and able to
adhere to the legal and regulatory
requirements defined in the scope of
work may be involved in such
distribution.
``(IV) The entity described in
subclause (III) with respect to the
product submits to the Secretary, in
such form and manner as the Secretary
shall specify (but not less frequently
than annually), an attestation that the
product meets each of the requirements
under subclauses (I) through (III).
``(iv) Waiver.--The Secretary may waive the
requirements under clause (iii) with respect to
a specific product, for a period not to exceed
180 days, if the Secretary determines that a
domestic supply shortage exists and that a
waiver is necessary to protect patient access
to care.''.
(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, 2027, 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, 2027, 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 (c)).
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:
``(bb) Special Payment Rules for Skin Substitute Products.--
``(1) Prepayment claim review and prior authorization.--
``(A) Initial prepayment claim review for certain
providers.--
``(i) In general.--Beginning January 1,
2027, the Secretary shall conduct prepayment
review of claims for skin substitute products
submitted under this title by a specified
provider of skin substitute products unless 1
or more of the conditions described in clause
(ii) is met with respect to such provider.
``(ii) Limitation.--For purposes of clause
(i), the conditions described in this
subparagraph are, with respect to a specified
provider of skin substitute products, the
following:
``(I) Skin substitute products
furnished by the provider are subject
to prior authorization under
subparagraph (B).
``(II) The rate of approval for
claims for skin substitute products
furnished by such provider that are
subject to prepayment review under this
subparagraph 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.
``(B) Prior authorization for specified providers
of skin substitute products.--
``(i) In general.--Beginning not later than
January 1, 2028, subject to clause (ii), the
Secretary shall, for a period of 180 days,
apply prior authorization for skin substitute
products that are furnished by a specified
provider of skin substitute products.
``(ii) Removal from prior authorization.--
In the event that the Secretary determines,
with respect to a specified provider of skin
substitute products, that the rate of approval
for requests for prior authorization under this
subparagraph 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) Enrollment revocation or exclusion of
noncompliant outlier providers.--
``(i) In general.--Beginning January 1,
2029, if the rate of denial (as determined
after the exhaustion of all appeals and
reviews) for requests for prior authorization
under subparagraph (B) 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.
``(ii) Referral for exclusion.--If the
Secretary determines under clause (i) 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).
``(D) Specified provider of skin substitute
products defined.--
``(i) In general.--For purposes of this
paragraph, the term `specified provider of skin
substitute products' means--
``(I) an outlier provider of skin
substitute products, as determined
under clause (ii);
``(II) a provider with respect to
which, of all claims for payment under
this title submitted in the preceding
year, 15 percent or more of such claims
were for the provision of skin
substitute products; and
``(III) as the Secretary determines
appropriate, a provider of skin
substitute products that--
``(aa) is newly enrolled
under section 1866(j);
``(bb) has undergone a
change in ownership during the
preceding year;
``(cc) is a high risk
provider (as determined by the
Secretary under section 424.518
of title 42, Code of Federal
Regulations); or
``(dd) has a pattern or
practice of noncompliance with
conditions of participation
under this title or a high
percentage of previously denied
claims (as determined by the
Secretary).
``(ii) Identification of outlier providers
of skin substitute products.--
``(I) In general.--Not later than
December 1, 2026, and every 2 years
thereafter through December 1, 2036,
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.
``(II) 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 subclause (I) is
made.
``(III) Referral to oig.--The
Secretary shall--
``(aa) make publicly
available the list of outlier
providers of skin substitute
products identified under each
determination under subclause
(I); and
``(bb) transmit such list
to the Inspector General of the
Department of Health and Human
Services for the assessment of
potential fraud, waste, or
abuse.
``(E) 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 $2,500,000 for each of fiscal years 2028
through 2031, to remain available until expended.
``(2) Medicare coverage criteria for skin substitute
products.--Any skin substitute product furnished during 2027
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 2027
is not covered under this title based solely on analysis of the
clinical evidence relating to that skin substitute product.
``(3) Skin substitute product wastage.--
``(A) In general.--With respect to skin substitute
products furnished for the treatment of chronic or
acute wounds, payment may only be made under this title
for the reasonable and necessary portion of the skin
substitute product used in the treatment of the wound,
excluding wastage.
``(B) Reasonable and necessary defined.--For the
purpose of subparagraph (A), the term `reasonable and
necessary portion of the skin substitute product' means
the greater of--
``(i) 350 square centimeters; or
``(ii) 120 percent of the size of the
treated wound.
``(4) Limitation on repeated applications.--Payment may not
be made under this title for more than 3 distinct applications
of a skin substitute product with respect to the same wound if,
in the clinical judgment of the provider furnishing such
product, there has been no improvement in the wound.
``(5) Certification requirement.--Payment may only be made
under this title for a skin substitute product if the provider
furnishing such product is certified--
``(A) by the American Board of Wound Management as
a certified wound specialist or a certified wound care
specialist physician;
``(B) by the Wound, Ostomy and Continence Nursing
Certification Board as a certified wound care nurse
practitioner;
``(C) by the National Alliance of Wound Care and
Ostomy as wound care certified; or
``(D) by the American Foot Care Nurses Association
as a certified foot care specialist.
``(6) Limitation on provider discounts.--For the period
beginning on January 1, 2027, and ending on December 31, 2030,
payment may not be made under this title for a skin substitute
product if the provider furnishing such product obtained such
product for less than $342.75 per square centimeter.
``(7) 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. 4. REPORT.
(a) In General.--Not later than January 1, 2030, the Secretary of
Health and Human Services shall submit to the appropriate committees of
Congress a report on the wound care industry, including manufacturers
of skin substitute products, wound dressings, and related wound
management technologies. Such report shall include an analysis of--
(1) the cost of producing skin substitute products in the
United States; and
(2) patient access to skin substitute products, and the
evidence supporting the effectiveness of such products.
(b) Definitions.--In this section:
(1) Appropriate committees of congress.--The term
``appropriate committees of Congress'' means--
(A) the Committee on Energy and Commerce and the
Committee on Ways and Means of the House of
Representatives; and
(B) the Committee on Health, Education, Labor, and
Pensions and the Committee on Finance of the Senate.
(2) Skin substitute product.--The term ``skin substitute
product'' has the meaning given such term in subparagraph (J)
of section 1847A(c)(6) of the Social Security Act (42 U.S.C.
1395w-3a(c)(6)), as added by section 2(c).
<all>Official legislative text sourced from the public record (cached on CivicsHQ).
Official source
View the original bill, actions, and full legislative record on Congress.gov.
Status
In Committee
- 1Introduced
- 2Committee
- 3Floor
- 4Passed
- 5Signed
Timeline reflects current normalized status only. Full action history is not yet stored in the API.
Sponsors
- Rep. Sessions, Pete [R-TX-17]RHouseTX
Cosponsors
No cosponsors on record.
Votes
Voting records are not yet available for this bill.