Supporting Premature Infant Nutrition Act of 2025 · Introduced in House (2025-07-21) · Congress.wiki

H.R. 4569

119th CONGRESS 1st Session

To amend titles XIX and XXI of the Social Security Act and title XXVII of the Public Health Service Act to require no-cost coverage of human milk fortifier.

IN THE HOUSE OF REPRESENTATIVES · July 21, 2025 · Sponsor: Mr. McGarvey · Committee: Committee on Energy and Commerce

H.R. 4569
- SEC. 1. Short title
- SEC. 2. Requiring no-cost coverage of human milk fortifier

SEC. 1. Short title

This Act may be cited as the Supporting Premature Infant Nutrition Act of 2025.

SEC. 2. Requiring no-cost coverage of human milk fortifier

(a) Coverage under Medicaid
- (1) Mandatory coverage
  - (A) In general
    - Section 1902(a)(10)(A) of the Social Security Act () is amended by striking and (30)and inserting (30), and (32). 42 U.S.C. 1396a(a)(10)(A)
  - (B) Medically needy
    - Section 1902(a)(10)(C)(iv) of the Social Security Act () is amended by striking and (17)and inserting (17), and (32). 42 U.S.C. 1396a(a)(10)(C)(iv)
  - (C) Alternative benefit plans
    - Section 1937(b) of the Social Security Act () is amended by adding at the end the following new paragraph: 42 U.S.C. 1396u–7(b)
      - (9) Human milk fortifier
        
        Notwithstanding the previous provisions of this section, a State may not provide for medical assistance through enrollment of an individual with benchmark coverage or benchmark-equivalent coverage under this section unless, beginning on January 1, 2026, such coverage includes (and does not impose any deduction, cost sharing, or similar charge for) human milk fortifier described in section 1905(a)(32).
- (2) Inclusion as medical assistance
  - Section 1905 of the Social Security Act () is amended— 42 U.S.C. 1396d
    - in subsection (a)—
      - (i) in paragraph (31), by striking and at the end;
      - (ii) by redesignating paragraph (32) as paragraph (33); and
      - (iii) by inserting after paragraph (31) the following new paragraph:
        
        beginning January 1, 2026, human milk fortifier (as described in subsection (kk)); and
      - (kk) Human milk fortifier
        
        (1) In general
        
        For purposes of subsection (a)(32), the term human milk fortifier means a donor human milk-derived product that is furnished to an infant under 1 year of age if a specified professional determines that such donor human milk-derived product is medically necessary for the infant because—
        
        the infant’s gestational age at birth was 34 weeks or less;
        
        the infant—
        
        (i) had a birth weight of less than 1800 grams; or
        
        (ii) has a body weight below healthy levels, as determined by the specified professional; or
        
        the infant has a congenital or acquired condition and such donor human milk-derived product will—
        
        (i) improve such condition; or
        
        (ii) aid in the recovery of the infant with respect to such condition.
        
        (2) Definitions
        
        For purposes of this subsection, the following definitions apply:
        
        (A) Donor human milk-derived product
        
        The term donor human milk-derived product means a specialty nutritional product made from donor human milk wherein the donor human milk has been concentrated or one or more components have been removed.
        
        (B) Specified professional
        
        The term specified professional means a physician, nurse practitioner, physician’s assistant, registered dietician, or other licensed professional authorized by State statute to make the determination described in paragraph (1).
    - by adding at the end the following new subsection:
- (3) Prohibition of cost sharing
  - (A) In general
    - Section 1916 of the Social Security Act () is amended— 42 U.S.C. 1396o
      - (i) in subsection (a)(2)—
      - in subparagraph (I), by striking or at the end ;
      - in subparagraph (J), by striking at the end and inserting , or; and
        
        beginning January 1, 2026, human milk fortifier (as described in section 1905(a)(32)); and
      - by adding at the end the following new subparagraph:
      - (ii) in subsection (b)(2)—
      - in subparagraph (I), by striking or at the end ;
      - in subparagraph (J), by striking at the end and inserting , or; and
        
        beginning January 1, 2026, human milk fortifier (as described in section 1905(a)(32)); and
      - by adding at the end the following new subparagraph:
  - (B) Application to alternative cost sharing
    - Section 1916A(b)(3)(B) of the Social Security Act () is amended by adding at the end the following new clause: 42 U.S.C. 1396o–1(b)(3)(B)
      - (xv) Beginning January 1, 2026, human milk fortifier (as described in section 1905(a)(32)).
(b) Coverage under the Children’s Health Insurance Plan
- (1) In general
  - Section 2103 of the Social Security Act () is amended— 42 U.S.C. 1397cc
    - in subsection (a), by striking and (8)and inserting , (8), and (13); and
      - (13) Required coverage of human milk fortifier
        
        The child health assistance provided to a targeted low-income child shall include coverage of human milk fortifier (as described in section 1905(a)(32)).
    - in subsection (c), by adding at the end the following new paragraph:
- (2) Prohibition of cost sharing
  - Section 2103(e)(2) of the Social Security Act () is amended— 42 U.S.C. 1397cc(e)(2)
    - in the paragraph heading, by inserting before ; and
    - by inserting before .
- (3) Effective date
  - (A) In general
    - Subject to subparagraph (B), the amendments made by this subsection shall apply with respect to child health assistance furnished on or after January 1, 2026.
  - (B) Exception if State legislation required
    - In the case of a State child health plan for child health assistance under title XXI of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirement imposed by the amendments made by this subsection, the State child health plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet this additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature.
(c) Coverage under group health plans and group and individual health insurance
- (1) In general
  - Subpart II of part A of title XXVII of the Public Health Service Act () is amended by adding at the end the following new section: 42 U.S.C. 300gg–11 et seq.
    - A group health plan, and a health insurance issuer offering group or individual health insurance coverage, shall provide coverage for, and shall not impose any cost sharing requirements for, human milk fortifier (as described in section 1905(a)(kk) of the Social Security Act).
- (2) Effective date
  - The amendments made by this subsection shall apply to plan years beginning on or after January 1, 2026.

H.R. 4569

Table of contents

SEC. 1. Short title

SEC. 2. Requiring no-cost coverage of human milk fortifier