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<bill bill-stage="Introduced-in-House" dms-id="HCF1AF82753D140F3865F719E0B8A2CEF" public-private="public" key="H" bill-type="olc"><metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
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<dc:title>119 HR 4569 IH: Supporting Premature Infant Nutrition Act of 2025</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2025-07-21</dc:date>
<dc:format>text/xml</dc:format>
<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
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<distribution-code display="yes">I</distribution-code><congress display="yes">119th CONGRESS</congress><session display="yes">1st Session</session><legis-num display="yes">H. R. 4569</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20250721">July 21, 2025</action-date><action-desc><sponsor name-id="M001220">Mr. McGarvey</sponsor> (for himself, <cosponsor name-id="D000216">Ms. DeLauro</cosponsor>, and <cosponsor name-id="K000391">Mr. Krishnamoorthi</cosponsor>) introduced the following bill; which was referred to the <committee-name committee-id="HIF00">Committee on Energy and Commerce</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title display="yes">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.</official-title></form><legis-body id="H7638BF31B7C0448E863BFA50FAB23A04" style="OLC"> 
<section id="H9D5EE4E69E6D4BB8B8AB2354AA0DACDA" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Supporting Premature Infant Nutrition Act of 2025</short-title></quote>.</text></section> <section id="H78FD6FFD850D4043B4C3DCC39263F6AE"><enum>2.</enum><header>Requiring no-cost coverage of human milk fortifier</header> <subsection id="H88B590658C91421E9EC7D27594873A19"><enum>(a)</enum><header>Coverage under Medicaid</header> <paragraph id="HC2D1AA750BAD4159832E4A584966F1D1"><enum>(1)</enum><header>Mandatory coverage</header> <subparagraph id="HDF66FED047EA454E9CEB1EE0976C2EF4"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1902(a)(10)(A) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(a)(10)(A)</external-xref>) is amended by striking <quote>and (30)</quote> and inserting <quote>(30), and (32)</quote>.</text></subparagraph>
<subparagraph id="HC4744FDBF87E4947B4C373C89C0E3555"><enum>(B)</enum><header>Medically needy</header><text display-inline="yes-display-inline">Section 1902(a)(10)(C)(iv) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(a)(10)(C)(iv)</external-xref>) is amended by striking <quote>and (17)</quote> and inserting <quote>(17), and (32)</quote>.</text></subparagraph> <subparagraph id="H7A4CFAA610B64F8B95A1180064951AE2"><enum>(C)</enum><header>Alternative benefit plans</header><text>Section 1937(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396u-7">42 U.S.C. 1396u–7(b)</external-xref>) is amended by adding at the end the following new paragraph:</text>
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<paragraph id="HF6164A334B5E47E198B24538DB51F9D8"><enum>(9)</enum><header>Human milk fortifier</header><text display-inline="yes-display-inline">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).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph> <paragraph id="H8733D632AEE0407D9E95A138CC10F233"><enum>(2)</enum><header>Inclusion as medical assistance</header><text display-inline="yes-display-inline">Section 1905 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396d">42 U.S.C. 1396d</external-xref>) is amended—</text>
<subparagraph id="H349D1C63465B40F6A621AC78C0EA53F8"><enum>(A)</enum><text>in subsection (a)—</text> <clause id="HAFB4D3A4CA514912A96F8E85755E90B2"><enum>(i)</enum><text>in paragraph (31), by striking <quote>and</quote> at the end;</text></clause>
<clause id="HDAD3590E74F34005A42878354ECFD9D7"><enum>(ii)</enum><text>by redesignating paragraph (32) as paragraph (33); and</text></clause> <clause id="HA9FF9FCDA370494BA45A379234757AF1"><enum>(iii)</enum><text>by inserting after paragraph (31) the following new paragraph:</text>
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<paragraph id="H1CB1E485A468436182B90FB46CA8B787"><enum>(32)</enum><text display-inline="yes-display-inline">beginning January 1, 2026, human milk fortifier (as described in subsection (kk)); and</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph> <subparagraph id="HE829217D42AD41EEBBF8EAB7B16CF077"><enum>(B)</enum><text>by adding at the end the following new subsection:</text>
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<subsection id="H8142CFE93E3545B7A96F7C5075EF0BBC"><enum>(kk)</enum><header>Human milk fortifier</header>
<paragraph id="HFFEFCA8450FC49F884B274BC0C0C67BA"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of subsection (a)(32), the term <term>human milk fortifier</term> 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—</text> <subparagraph id="H5AC7F290487B456BA5F3DA6C13B1470B"><enum>(A)</enum><text>the infant’s gestational age at birth was 34 weeks or less;</text></subparagraph>
<subparagraph id="H7E0F0FE982504EAAA12D5C7E476B7306"><enum>(B)</enum><text>the infant—</text> <clause id="H6DFD9844AD63451EAA315242D262A8F1"><enum>(i)</enum><text>had a birth weight of less than 1800 grams; or</text></clause>
<clause id="H370C5BBA09174D83ABB3C2FEAA99D667"><enum>(ii)</enum><text>has a body weight below healthy levels, as determined by the specified professional; or</text></clause></subparagraph> <subparagraph id="H1C7C4EECF0074846B09FD11B076D6401"><enum>(C)</enum><text>the infant has a congenital or acquired condition and such donor human milk-derived product will—</text>
<clause id="H8A1DA80644194BAC82ACEC74B82AC1E5"><enum>(i)</enum><text>improve such condition; or</text></clause> <clause id="H2C133C190A0F47E8A05F778860EFC640"><enum>(ii)</enum><text>aid in the recovery of the infant with respect to such condition.</text></clause></subparagraph></paragraph>
<paragraph id="H237C63A24A48462D82243DE7C6B0822C"><enum>(2)</enum><header>Definitions</header><text>For purposes of this subsection, the following definitions apply:</text> <subparagraph id="HCD6267F90C9E47FE864B4E9F1B5201C3" commented="no"><enum>(A)</enum><header>Donor human milk-derived product</header><text display-inline="yes-display-inline">The term <term>donor human milk-derived product</term> 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.</text></subparagraph>
<subparagraph id="H970DD142F34E46E3B1BEE1777D36FB61"><enum>(B)</enum><header>Specified professional</header><text>The term <term>specified professional</term> 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).</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph> <paragraph id="H1847D82DCE29472F9F58AA23F5E21886"><enum>(3)</enum><header>Prohibition of cost sharing</header> <subparagraph id="H85D16C49ACFA4B2B8DE1EDAE47FEBFD4"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1916 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396o">42 U.S.C. 1396o</external-xref>) is amended—</text>
<clause id="H6C561CA71380404C9F0C7B88A85A8494"><enum>(i)</enum><text>in subsection (a)(2)—</text> <subclause id="H88A0B6B86D8B40AFABC7603D2EA24F26"><enum>(I)</enum><text>in subparagraph (I), by striking at the end <quote>or</quote>;</text></subclause>
<subclause id="H6F1E9614811147DBBC7FB9793DEB32F0"><enum>(II)</enum><text>in subparagraph (J), by striking at the end <quote>; and</quote> and inserting <quote>, or</quote>; and</text></subclause> <subclause id="H743664DBA7F04EDBA89DA5D1AB19607E"><enum>(III)</enum><text>by adding at the end the following new subparagraph:</text>
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<subparagraph id="HAD1386F37C9B4727AB5DEC02AB9043C0"><enum>(K)</enum><text display-inline="yes-display-inline">beginning January 1, 2026, human milk fortifier (as described in section 1905(a)(32)); and</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subclause></clause> <clause id="H323B12786DEE477DA6523E74EE64A141"><enum>(ii)</enum><text>in subsection (b)(2)—</text>
<subclause id="H2202290803EC4D299DD8A6663F2B3FBC"><enum>(I)</enum><text>in subparagraph (I), by striking at the end <quote>or</quote>;</text></subclause> <subclause id="HE0E245CD40EF459CBB0AC2CC48381EE2"><enum>(II)</enum><text>in subparagraph (J), by striking at the end <quote>; and</quote> and inserting <quote>, or</quote>; and</text></subclause>
<subclause id="H24657B51C93A4D31B72037CB255A0F66"><enum>(III)</enum><text>by adding at the end the following new subparagraph:</text> <quoted-block style="OLC" id="H5A60C97AC82B414898AFC160C2219F27" display-inline="no-display-inline"> <subparagraph id="H4FE5B6F781884568B0E9745F42A6E690"><enum>(K)</enum><text display-inline="yes-display-inline">beginning January 1, 2026, human milk fortifier (as described in section 1905(a)(32)); and</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subclause></clause></subparagraph>
<subparagraph id="H3AEBBBE659C6444AB84ABA6D03CD9641"><enum>(B)</enum><header>Application to alternative cost sharing</header><text display-inline="yes-display-inline">Section 1916A(b)(3)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396o-1">42 U.S.C. 1396o–1(b)(3)(B)</external-xref>) is amended by adding at the end the following new clause:</text> <quoted-block style="OLC" id="H541631A0366A412E8C026F6E4936055C" display-inline="no-display-inline"> <clause id="HB2D331D5CF734A769B47D101BD06D405"><enum>(xv)</enum><text display-inline="yes-display-inline">Beginning January 1, 2026, human milk fortifier (as described in section 1905(a)(32)).</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection>
<subsection id="H1811FE064F14488AB63F8F26F250D652" commented="no"><enum>(b)</enum><header>Coverage under the Children’s Health Insurance Plan</header>
<paragraph id="H5EB8F55CB0F240F8B9AA91921E35A2FD" commented="no"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 2103 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1397cc">42 U.S.C. 1397cc</external-xref>) is amended—</text> <subparagraph id="HB30DF2AA1BE9401583CC8B4F58155F95"><enum>(A)</enum><text>in subsection (a), by striking <quote>and (8)</quote> and inserting <quote>, (8), and (13)</quote>; and</text></subparagraph>
<subparagraph id="H5AC834FE504743C98B48294FE94041A9"><enum>(B)</enum><text>in subsection (c), by adding at the end the following new paragraph:</text> <quoted-block style="OLC" id="HD04D21A8F7E24DCCAD5449DC9DDE1B16" display-inline="no-display-inline"> <paragraph id="H8A76233A107A416081BDF7514BCA69A6" commented="no"><enum>(13)</enum><header>Required coverage of human milk fortifier</header><text display-inline="yes-display-inline">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)).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="HAE7A11CDA29C4081A192EA0AE3693824"><enum>(2)</enum><header>Prohibition of cost sharing</header><text>Section 2103(e)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1397cc">42 U.S.C. 1397cc(e)(2)</external-xref>) is amended—</text> <subparagraph id="H5ABEA229DB7442CBA172111A0E25BE44"><enum>(A)</enum><text>in the paragraph heading, by inserting <quote><header-in-text level="paragraph" style="OLC">human milk fortifier,</header-in-text></quote> before <quote><header-in-text level="paragraph" style="OLC">or pregnancy-related assistance</header-in-text></quote>; and</text></subparagraph>
<subparagraph id="H1F2613B299094A2BA3411B91A5289F3F"><enum>(B)</enum><text>by inserting <quote>human milk fortifier described in section 1905(a)(32),</quote> before <quote>or for pregnancy-related assistance</quote>.</text></subparagraph></paragraph> <paragraph id="H6F3B3B7D4C784D2BAB88F9816B360F46" commented="no"><enum>(3)</enum><header>Effective date</header> <subparagraph id="H8104E7CCFB99400EBE6CC5CFACF2C497" commented="no"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">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.</text></subparagraph>
<subparagraph id="HFB25EEBB45014027BBBC4F60F01B16D8" commented="no"><enum>(B)</enum><header>Exception if State legislation required</header><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph></subsection> <subsection id="HC70864438744434FA45AE99E99D9CCF7"><enum>(c)</enum><header>Coverage under group health plans and group and individual health insurance</header> <paragraph id="H8044756CA56D4641A3001E31060F04BE"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Subpart II of part A of title XXVII of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-11">42 U.S.C. 300gg–11 et seq.</external-xref>) is amended by adding at the end the following new section:</text>
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<section id="H4F38D5260A704B81802FAEE3606D94AE"><enum>2730.</enum><header>No-cost coverage of human milk fortifier</header><text display-inline="no-display-inline">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).</text></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="HC9983D6D290C420694164EA34F57CB61"><enum>(2)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendments made by this subsection shall apply to plan years beginning on or after January 1, 2026.</text></paragraph></subsection></section> 
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