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<bill bill-type="olc" bill-stage="Introduced-in-Senate" dms-id="A1" public-private="public" slc-id="S1-KEL25207-KNP-7G-8TJ"><metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
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<dc:title>119 S1058 IS: Preserving Patient Access to Home Infusion Act</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2025-03-13</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">II</distribution-code><congress>119th CONGRESS</congress><session>1st Session</session><legis-num>S. 1058</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20250313">March 13, 2025</action-date><action-desc><sponsor name-id="S327">Mr. Warner</sponsor> (for himself and <cosponsor name-id="S365">Mr. Scott of South Carolina</cosponsor>) introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSFI00">Committee on Finance</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>To amend title XVIII of the Social Security Act to clarify congressional intent and preserve patient access to home infusion therapy under the Medicare program, and for other purposes.</official-title></form><legis-body style="OLC" display-enacting-clause="yes-display-enacting-clause" id="H09D7460D40FB4E0997682725B0D7F66A"><section section-type="section-one" id="HB304DB3578BA4F91B1D67D1BEF1905B0"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Preserving Patient Access to Home Infusion Act</short-title></quote>.</text></section><section section-type="subsequent-section" id="HF51F4176F02E4A3E91E9E4D84F9FDA7C"><enum>2.</enum><header>Preservation of patient access to home infusion therapy under Medicare program</header><subsection id="H1E579BCA71F64AB3B95E4B31721ED05A"><enum>(a)</enum><header>Inclusion of pharmacy services</header><text display-inline="yes-display-inline">Section 1861(iii)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(iii)(2)</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="HC6C4DDC5ED39441DA6323EA6CF82046B"><enum>(1)</enum><text display-inline="yes-display-inline">in subparagraph (A), by inserting <quote>and pharmacy services</quote> after <quote>nursing services</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6D99C72CCCC543B7A7DDF3D11B877B25"><enum>(2)</enum><text>in subparagraph (B), by inserting <quote>, assessments, drug preparation and compounding, coordination and documentation of infusion therapy services in the plan of care</quote> after <quote>subsection (n))</quote>. </text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H21E3718138D1495396C6141B84AD97B7"><enum>(b)</enum><header>Payment</header><text>Section 1834(u)(1)(A) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(u)(1)(A)</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="HE3547FAB31214CAC807BF3D16A18BF2D"><enum>(1)</enum><text>in clause (i), by striking <quote>clause (iii)</quote> and inserting <quote>clauses (iii) and (iv)</quote>;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9069F029CD5F417CA0F68A49C2A6BB87"><enum>(2)</enum><text>in clause (ii) by inserting after the first sentence the following new sentence: <quote>For purposes of the previous sentence, a reference to payment to a qualified home infusion therapy supplier for an infusion drug administration calendar day in the home of such individual shall refer to payment for each day on which such a drug was administered to the individual (regardless of whether a qualified home infusion therapy supplier was physically present in the home of such individual on such date).</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBA7839B770AA43A9A66DFE3C703099A3"><enum>(3)</enum><text>in clause (iii)—</text><subparagraph commented="no" id="HC099EEE908D9407EBA711BD03EB4D3FF"><enum>(A)</enum><text>by striking <quote>The single payment amount</quote> and inserting the following: </text><quoted-block style="OLC" display-inline="no-display-inline" id="H029DF8EC2F224C2994C4231EFE069E4C"><subclause commented="no" id="H5F61EE3F90AA49DEAE7AE11EA5608D72"><enum>(I)</enum><header>In general</header><text display-inline="yes-display-inline">Subject to subclause (II), the single payment amount</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" id="HD83662A0603949388C747AD98416BE58"><enum>(B)</enum><text>by adding at the end the following new subclause:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HB30DF8DDBF104E49A71F1E6C07EC51FA"><subclause commented="no" id="H5EF6617230194378B1D7FC50D2E41ADF"><enum>(II)</enum><header>Transitional rule</header><text display-inline="yes-display-inline">For home infusion therapy furnished on or after January 1, 2026, and before January 1, 2030, the Secretary shall ensure that the single payment amount determined under this subparagraph reflects 5 hours of infusion for a particular therapy in a calendar day.</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HCAF9C11C504440DEA9EF105455EDEFE6"><enum>(4)</enum><text>by adding at the end the following new clause:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HB9544344FADA4AE39F314FB7373DE5CC"><clause commented="no" display-inline="no-display-inline" id="HE1EA48744E8C457C80477CC8C927F320"><enum>(iv)</enum><header>Special rule when a qualified home infusion therapy supplier not physically present in the individual's home</header><text>In the case where a qualified home infusion therapy supplier is not physically present in the individual's home on the day the home infusion drug is administered to the individual, the single payment amount under this subsection for items and services described in clause (i) furnished on such day to such individual shall be an amount equal to 50 percent of the amount that would have applied under this subsection for such items and services if such a supplier had been physically present.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H0F694CA17EE14366B273CBA35B0049CB"><enum>(c)</enum><header>Permitting nurse practitioners and physician assistants To establish and review a home infusion plan of care</header><text>Section 1861(iii)(1)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(iii)(1)(B)</external-xref>) is amended by striking <quote>physician (as defined in subsection (r)(1)) and is periodically reviewed by a physician</quote> and inserting <quote>physician (as defined in subsection (r)(1)) or a nurse practitioner or physician assistant (as those terms are defined in subsection (aa)(5)) and is periodically reviewed by a physician, nurse practitioner, or physician assistant</quote>.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="HA02017EC467640E3B58B3CD5C7C22677"><enum>(d)</enum><header>Effective date</header><text>The amendments made by this section shall apply with respect to items and services furnished on or after January 1, 2026.</text></subsection></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="HCA512E373E714894A2633B3796466348"><enum>3.</enum><header>Access to home infusion for non-pump drugs and biologicals</header><subsection id="H1BE4EF6764784A13BAF70F7066446FC0"><enum>(a)</enum><header>Modification of definition of home infusion drug</header><text display-inline="yes-display-inline">Section 1861(iii)(3) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(iii)(3)</external-xref>) is amended—</text><paragraph id="HC217BAD987914BDE939C7A2ED56B88B4"><enum>(1)</enum><text>in subparagraph (C), by inserting <quote>and, in the case of a drug or biological other than a specified non-pump drug or biological (as defined in subparagraph (E)),</quote> before <quote>through</quote>; and</text></paragraph><paragraph id="H94A21D2B69B7488F925BE6FD4BC193C4"><enum>(2)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HFBBDBCC98F304D9D98CF7830A7851331"><subparagraph id="H066B5D206E9E4607B55E0E58D41815B5" indent="up1"><enum>(E)</enum><text display-inline="yes-display-inline">The term <quote>specified non-pump drug or biological</quote> means a drug or biological that—</text><clause id="H2EF798E06E1A4840BF9E0E0A2D6C392C"><enum>(i)</enum><text display-inline="yes-display-inline">is administered intravenously but not through a pump that is an item of durable medical equipment (as defined in subsection (n)); and</text></clause><clause id="HC10FE3C4CEBB4BF280666C1DC7915854"><enum>(ii)</enum><text>is an antibacterial, antifungal, or antiviral (as categorized by the United States Pharmacopeia).</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HCAD8A8926DAF40B89581A260AEAFEFCC"><enum>(b)</enum><header>Clarification on billing</header><text>Section 1834(u) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(u)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H66D0E7FE3F794C24ADFC9F281FABCA48"><paragraph id="H830A4D8117554D11A9DBC9CFF1E55846"><enum>(8)</enum><header>Clarification on billing for a specified non-pump drug or biological</header><text display-inline="yes-display-inline">In the case of a qualified home infusion supplier (as defined in section 1861(iii)(3)(D)) that furnishes items and services described in subparagraphs (A) and (B) of section 1861(iii)(2) in coordination with the furnishing of a home infusion drug (as defined in section 1861(iii)(3)(C)) that is a specified non-pump drug or biological (as defined in section 1861(iii)(3)(E)) where the method of infusion utilized in furnishing such drug or biological does not involve a pump that is an item of durable medical equipment, payment under this subsection for the items and services described in subparagraphs (A) and (B) of section 1861(iii)(2) shall be made with respect to such drug or biological regardless of whether such drug or biological so furnished is payable under this part.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HEE90A3EADEE5433E9496DD79558491E5"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section shall apply with respect to items and services furnished on or after January 1, 2026.</text></subsection></section><section display-inline="no-display-inline" section-type="subsequent-section" id="HA36BF936C2D143598C4A516FC3968439"><enum>4.</enum><header>Modification of payment for home infusion supplies</header><text display-inline="no-display-inline">Section 1834(a) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(a)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HB61867875A0343F8A13819D32190CB03"><paragraph id="HAABC8FE40FC740DD96D2765821371F01"><enum>(23)</enum><header>Special payment rule for items and supplies furnished in conjunction with home infusion therapy</header><subparagraph id="HB864F8A9F8D649CBA46CEE50EB505E7D"><enum>(A)</enum><header>In general</header><text>Notwithstanding the preceding provisions of this subsection, no payment may be made under this subsection with respect to applicable items and services (as defined in subparagraph (B)) that are furnished on or after January 1, 2026, in conjunction home infusion therapy (as defined in section 1861(iii)(1)) for which payment is made under subsection (u) and which are so furnished on the same day as such home infusion therapy and with respect to the same home infusion drug (as defined in section 1861(iii)(3)(C)) for which such payment was so made.</text></subparagraph><subparagraph id="H5314437AAE85401BA7881DCC57C4CB21"><enum>(B)</enum><header>Applicable items and services defined</header><text>For purposes of subparagraph (A), the term <quote>applicable items and services</quote> means tubing, catheters, dressings, needles, syringes, and other supplies identified by HCPCS code A4221, A4222, or K0552 (or any successor code).</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section></legis-body></bill> 

