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<dc:title>119 HR 4993 IH: Joe Fiandra Access to Home Infusion Act of 2025</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2025-08-19</dc:date>
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<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. 4993</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20250819">August 19, 2025</action-date><action-desc><sponsor name-id="F000466">Mr. Fitzpatrick</sponsor> (for himself, <cosponsor name-id="D000628">Mr. Dunn of Florida</cosponsor>, and <cosponsor name-id="S001200">Mr. Soto</cosponsor>) introduced the following bill; which was referred to the <committee-name committee-id="HIF00">Committee on Energy and Commerce</committee-name>, and in addition to the Committee on <committee-name committee-id="HWM00">Ways and Means</committee-name>, 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</action-desc></action><legis-type>A BILL</legis-type><official-title display="yes">To amend title XVIII of the Social Security Act to provide coverage of external infusion pumps and non-self-administrable home infusion drugs under the Medicare program.</official-title></form><legis-body id="HCEB8A65896924457B44B5F094CC092AD" style="OLC"> 
<section id="HB0BF717D30394E53AF6986D90E0EEF9E" 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>Joe Fiandra Access to Home Infusion Act of 2025</short-title></quote>.</text></section> <section id="HAE540886107A434CB9937BE4516B9101" section-type="subsequent-section" display-inline="no-display-inline"><enum>2.</enum><header>Medicare coverage of external infusion pumps and non-self-administrable home infusion drugs</header> <subsection id="HB56BCD8D0C1E4423B6249BEF3829C0EC"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1861(n) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(n)</external-xref>) is amended by adding at the end the following new sentence:</text> 
<quoted-block style="OLC" id="HB9D75E589BCF4085913CECA202585518" display-inline="yes-display-inline"><text>Beginning with the first calendar quarter beginning on or after the date that is 1 year after the date of the enactment of this sentence, an external infusion pump and associated home infusion drug (as defined in subsection (iii)(3)(C)) or other associated supplies that do not meet the appropriate for use in the home requirement applied to the definition of durable medical equipment under section 414.202 of title 42, Code of Federal Regulations (or any successor to such regulation) shall be treated as meeting such requirement if each of the following criteria is satisfied:</text> <paragraph id="H5B8586D01383452B880F6B41B5D99EDA"><enum>(1)</enum><text>The prescribing information approved by the Food and Drug Administration for the home infusion drug associated with the pump instructs that the drug should be administered by or under the supervision of a health care professional.</text></paragraph> 
<paragraph id="H6F76F29D917046278834666168C8ED5F"><enum>(2)</enum><text>A qualified home infusion therapy supplier (as defined in subsection (iii)(3)(D)) administers or supervises the administration of the drug or biological in a safe and effective manner in the patient’s home (as defined in subsection (iii)(3)(B)).</text></paragraph> <paragraph id="HDBE81298998F40B795003CBD987569BA" commented="no"><enum>(3)</enum><text>The prescribing information described in paragraph (1) instructs that the drug should be infused at least 12 times per year—</text> 
<subparagraph id="H617C431ABF154E08BBC27B1DD9AC65E9"><enum>(A)</enum><text>intravenously or subcutaneously; or</text></subparagraph> <subparagraph id="HB71AB8C54F244324B64DC2ED951B074B"><enum>(B)</enum><text>at infusion rates that the Secretary determines would require the use of an external infusion pump.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> 
<subsection id="H35A702EFE31A4CFC977984A9CC67BFCC"><enum>(b)</enum><header>Cost sharing notification</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services shall ensure that patients are notified of the cost sharing for electing home infusion therapy compared to other applicable settings of care for the furnishing of infusion drugs under the Medicare program.</text></subsection></section> </legis-body></bill>

