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<dc:title>118 HR 5864 IH: Expanded Genetic Screening Act</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2023-10-02</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">118th CONGRESS</congress><session display="yes">1st Session</session><legis-num display="yes">H. R. 5864</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20231002">October 2, 2023</action-date><action-desc><sponsor name-id="F000466">Mr. Fitzpatrick</sponsor> (for himself and <cosponsor name-id="C001067">Ms. Clarke of New York</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 title XIX of the Social Security Act to provide for coverage under the Medicaid program of non-invasive prenatal genetic screening.</official-title></form><legis-body id="H4387DC6A7AB940F7832D629FE087B57B" style="OLC"> 
<section section-type="section-one" id="HE16ED527EFF54DF3AF23FB5BF5F32555"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Expanded Genetic Screening Act</short-title></quote>.</text></section> <section id="H84332298D8DF4CC3A49518D24FED7062"><enum>2.</enum><header>Medicaid coverage of non-invasive prenatal genetic screening</header> <subsection commented="no" display-inline="no-display-inline" id="HA3E14E8B5F4847039CA2762E59BDACEA"><enum>(a)</enum><header display-inline="yes-display-inline">In general</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> 
<paragraph commented="no" display-inline="no-display-inline" id="HB73000DD80444A238A0E074EB00D1D0F"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)(3)—</text> <subparagraph id="H7ADF319768944322A4D10A4A054B36FA"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking at the end <quote>and</quote>;</text></subparagraph> 
<subparagraph id="HD509907405BB4F0F831054B23FFE2136"><enum>(B)</enum><text>in subparagraph (B), by inserting <quote>and</quote> after the semicolon; and </text></subparagraph> <subparagraph id="H11B46A0558364EE0901D4778911A65BA"><enum>(C)</enum><text>by adding at the end the following new subparagraph:</text> 
<quoted-block style="OLC" display-inline="no-display-inline" id="H87016B8B5A844EFA9408C41E06FFC80B"> 
<subparagraph id="HCC39F84A64284D19A068E3745218ACF2"><enum>(C)</enum><text display-inline="yes-display-inline">non-invasive prenatal genetic screening for pregnant women of all age groups (provided in a facility, a home, or other setting), subject to the informed consent requirement described in subsection (jj);</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="HC4F121E690C84AB9AF3E8D31BD6D33E4"><enum>(2)</enum><text>by adding at the end the following new subsection:</text> 
<quoted-block id="HA3AB1F10138742358939A715E064CE71" style="OLC" act-name=""> 
<subsection id="H8755AC4EDE1744FFB00790D69E57798D"><enum>(jj)</enum><header>Informed consent requirement for non-invasive prenatal genetic screening</header> 
<paragraph commented="no" display-inline="no-display-inline" id="H86587F3109D34A1C8663A56EF2158602"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text>For purposes of subsection (a)(3)(C), the informed consent requirement described in this subsection for non-invasive prenatal genetic screening furnished to a pregnant woman is that, prior to furnishing the screening to the woman, the provider of the screening gives the woman a full disclosure that includes, at a minimum, the following information:</text> <subparagraph id="H66AB52C0747B4881ABB8EFF77D2EDE4B"><enum>(A)</enum><text>The limitations of the screening platform for any genetic screen or test with the goal to identify risk or diagnose a genetic condition. </text></subparagraph> 
<subparagraph id="H85EC6595D1FE439CB0B413CEDF4F6997"><enum>(B)</enum><text>Any potential interferences that may affect the screening's performance.</text></subparagraph> <subparagraph id="HEC426EDC59A64AD3ACCCA08D523AF305"><enum>(C)</enum><text>Information about predictive values used by the screening based on appropriate matching population and inherent risk factors based on age, family history, and other aneuploidy risk factors (such as ultrasound abnormalities).</text></subparagraph> 
<subparagraph id="H7D23209E6DCB45C4BDF33B313D1FDF31"><enum>(D)</enum><text>The need for follow-up diagnostic testing to confirm true positive results before decisions are made about irrevocable clinical intervention. </text></subparagraph></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H380F4A36CDFD4D09BC7AEA12A62E28A6"><enum>(2)</enum><header display-inline="yes-display-inline">No medical assistance available for screenings provided without consent</header><text>No payment may be made under section 1903(a) with respect to a non-invasive prenatal genetic screening that is furnished to a pregnant woman without meeting the requirement described in paragraph (1).</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> 
<subsection commented="no" display-inline="no-display-inline" id="H1935D039C09A45A4A01B9D129FAA6E9B"><enum>(b)</enum><header>Conforming amendment</header><text>Section 1903(i) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396b">42 U.S.C. 1396b(i)</external-xref>) is amended—</text> <paragraph commented="no" display-inline="no-display-inline" id="H61463DAED4EF47C6AF4AD287B29C558A"><enum>(1)</enum><text>in paragraph (26), by striking <quote>; or</quote>; </text></paragraph> 
<paragraph commented="no" display-inline="no-display-inline" id="H1CE8225E628D4C9DB8197D1A67D15A24"><enum>(2)</enum><text>in paragraph (27), by striking the period and inserting <quote>; or</quote>; and</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H81C590E3A6BA40D4971188BE2CD8EB63"><enum>(3)</enum><text>by inserting after paragraph (27) the following new paragraph: </text> 
<quoted-block id="H4C02D12442614D62A3C6877384DF111E" style="OLC" act-name=""> 
<paragraph id="H1504143EB2BE491BB5673FE4E4F80FA8"><enum>(28)</enum><text>with respect to amounts expended for non-invasive prenatal genetic screening services furnished to a pregnant woman, unless the informed consent requirement of section 1905(jj) is met.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section> </legis-body></bill>

