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<bill bill-stage="Introduced-in-House" dms-id="HFEC0EBB821494B66A9008F36D2D3A633" public-private="public" bill-type="olc"> 
<metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
<dublinCore>
<dc:title>109 HR 3547 IH: Safety Net Inpatient Drug Affordability Act</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2005-07-28</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>
</dublinCore>
</metadata>
<form> 
<distribution-code display="yes">I</distribution-code> 
<congress>109th CONGRESS</congress> <session>1st Session</session> 
<legis-num>H. R. 3547</legis-num> 
<current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber> 
<action> 
<action-date date="20050728">July 28, 2005</action-date> 
<action-desc><sponsor name-id="E000172">Mrs. Emerson</sponsor> (for herself, <cosponsor name-id="R000515">Mr. Rush</cosponsor>, <cosponsor name-id="B000420">Mr. Berry</cosponsor>, <cosponsor name-id="S001148">Mr. Simpson</cosponsor>, <cosponsor name-id="S001004">Mr. Strickland</cosponsor>, and <cosponsor name-id="J000255">Mr. Jones of North Carolina</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>To amend section 340B of the Public Health Service Act to increase the affordability of inpatient drugs for Medicaid and safety net hospitals.</official-title> 
</form> 
<legis-body id="HD265D3B82F5C439EA014431C7431CBEF" style="OLC"> 
<section id="H7992FA0A641240EFA864E623BCB6802" 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>Safety Net Inpatient Drug Affordability Act</short-title></quote>.</text></section> 
<section id="HA6EA5D785DBD41448E2BD6E9E0E487D7"><enum>2.</enum><header>Extension of discounts to inpatient drugs</header> 
<subsection id="HEAC66839C45542B9BCCD1400F1D56151"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 340B(b) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/256b">42 U.S.C. 256b(b)</external-xref>) is amended by inserting before the period the following: <quote>, except that, notwithstanding the limiting definition set forth in section 1927(k)(3) of the Social Security Act, the terms <term>covered outpatient drug</term> and <term>covered drug</term> include any inpatient or outpatient drug purchased by a hospital described in subsection (a)(4)(L)</quote>.</text></subsection> 
<subsection id="HBD569F99255C45B08BCC75C3D6DAF55E"><enum>(b)</enum><header>Payment of medicaid rebates on inpatient drugs</header><text>Section 340B(c) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/256b">42 U.S.C. 256b(c)</external-xref>) is amended to read as follows:</text> 
<quoted-block id="HA98E4265602C47998FB699EFDC06EAED" style="OLC"> 
<subsection id="H0EA040629F224DB7A6EFD2C109130066"><enum>(c)</enum><header>Payment of medicaid rebates on inpatient drugs</header> 
<paragraph id="H06BFCE9554794FFEA4C4F0303BB69BD"><enum>(1)</enum><header>In general</header><text>For the cost reporting period covered by the most recently filed Medicare cost report, a hospital described in subsection (a)(4)(L) shall provide to each State with an approved State plan under title XIX of such Act—</text> 
<subparagraph id="H20450862FE294262A1F11056BD1049A5"><enum>(A)</enum><text>a rebate on the estimated annual costs of single source and innovator multiple source drugs provided to Medicaid recipients for inpatient use; and</text></subparagraph> 
<subparagraph id="HF98D52C42FA74B4EBD78000041C743D8"><enum>(B)</enum><text>a rebate on the estimated annual costs of noninnovator multiple source drugs provided to Medicaid recipients for inpatient use.</text></subparagraph></paragraph> 
<paragraph id="H4E3B42AAFD5D4ED6A718DD53DE66E36"><enum>(2)</enum><header>Calculations of rebates</header> 
<subparagraph id="HDB911F698A4B496B80D63F659DB93FB1"><enum>(A)</enum><header>Single source and innovator multiple source drugs</header><text>For purposes of paragraph (1)(A)—</text> 
<clause id="H4A2523D89A4A4DB18FD98D617D60A72D"><enum>(i)</enum><text>the rebate under such paragraph shall be calculated by multiplying the estimated annual costs of single source and innovator multiple source drugs provided to Medicaid recipients for inpatient use by the minimum rebate percentage described in section 1927(c)(1)(B) of the Social Security Act;</text></clause> 
<clause id="H8B8F481EC01E4F5C80C39EB4D2607C38"><enum>(ii)</enum><text>the estimated annual costs of single source drugs and innovator multiple source drugs provided to Medicaid recipients for inpatient use under clause (i) shall be equal to the product of—</text> 
<subclause id="H77685678821B47A28FD80774D81410C6"><enum>(I)</enum><text>the hospital’s actual acquisition costs of all drugs purchased during the cost reporting period for inpatient use;</text></subclause> 
<subclause id="H8D775B25F1B846F5A7009254D580DFEC"><enum>(II)</enum><text>the Medicaid inpatient drug charges as reported on the hospital’s most recently filed Medicare cost report divided by total inpatient drug charges reported on the cost report; and</text></subclause> 
<subclause id="HF7B64231E0B348ACACD0005B7E880218"><enum>(III)</enum><text>the percent of the hospital’s annual inpatient drug costs described in subclause (I) arising out of the purchase of single source and innovator multiple source drugs; and</text></subclause></clause> 
<clause id="H3EA418A3F94D40FD8B756F9341C16328"><enum>(iii)</enum><text>the terms <term>single source drug</term> and <term>innovator multiple source drug</term> have the meanings given such terms in section 1927(k)(7) of the Social Security Act.</text></clause></subparagraph> 
<subparagraph id="HF4DEBDD3778C458086698481D1854FEA"><enum>(B)</enum><header>Noninnovator multiple source drugs</header><text>For purposes of subparagraph (1) (B)—</text> 
<clause id="H0F1F3DDB89E34AE0BAC1666F6CA9416F"><enum>(i)</enum><text>the rebate under such paragraph shall be calculated by multiplying the estimated annual costs of noninnovator multiple source drugs provided to Medicaid recipients for inpatient use by the applicable percentage as defined in section 1927(c)(3)(B) of the Social Security Act;</text></clause> 
<clause id="HC374182EC05943CFB0F957DC72663019"><enum>(ii)</enum><text>the estimated annual costs of noninnovator multiple source drugs provided to Medicaid recipients for inpatient use shall be equal to the product of—</text> 
<subclause id="H3800A5F3CB0744A6ABF3C3E6770063EC"><enum>(I)</enum><text>the hospital’s actual acquisition cost of all drugs purchased during the cost reporting period for inpatient use;</text></subclause> 
<subclause id="HEB4637BD3514463E0015537D007BF2AA"><enum>(II)</enum><text>the Medicaid inpatient drug charges as reported on the hospital’s most recently filed Medicare cost report divided by total inpatient drug charges reported on the cost report; and</text></subclause> 
<subclause id="H60144AFDAD714BA4AFC1D3DA4085F74D"><enum>(III)</enum><text>the percent of the hospital’s annual inpatient drug costs described in subclause (I) arising out of the purchase of noninnovator multiple source drugs; and</text></subclause></clause> 
<clause id="H66E5C78DB5594624A309AEBB62316531"><enum>(iii)</enum><text>the term <term>noninnovator multiple source drug</term> has the meaning given such term in section 1927(k)(7) of the Social Security Act.</text></clause></subparagraph></paragraph> 
<paragraph id="HC6D1A5B0D38F4D8C86141E2FC0FE00F"><enum>(3)</enum><header>Payment deadline</header><text display-inline="yes-display-inline">The rebates provided by a hospital under paragraph (1) shall be paid within 90 days of the filing of the hospital’s most recently filed Medicare cost report.</text></paragraph> 
<paragraph id="H8C85BBD30C5241C9B9C319C53BD40014"><enum>(4)</enum><header>Offset against medical assistance</header><text>Amounts received by a State under this subsection in any quarter shall be considered to be a reduction in the amount expended under the State plan in the quarter for medical assistance for purposes of section 1903(a)(1) of the Social Security Act.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> 
<subsection id="H0CAC60FD116645F082AABAE4F5B9A0FA"><enum>(c)</enum><header>Clarification that group purchasing prohibition for certain hospitals is not applicable to inpatient drugs</header><text>Section 340B(a)(4)(L)(iii) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/256b">42 U.S.C. 256b(a)(4)(L)(iii)</external-xref>) is amended by inserting <quote>(not including such drugs purchased for inpatient use)</quote> after <quote>covered outpatient drugs</quote>.</text></subsection></section> 
<section id="H3E3BA330D9E14DED0035ADEB104096A8"><enum>3.</enum><header>Providing access to discounted drug prices for critical access hospitals</header> 
<subsection id="HCF87A2888B4946B9B957D762BD0674BA"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 340B of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/256b">42 U.S.C. 256b</external-xref>) is amended—</text> 
<paragraph id="H80A7DB4789654D39ACE57F17EA25F1F"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)(4), by adding at the end the following:</text> 
<quoted-block style="OLC" id="H73BEAB85290F4A6FABC668047907049" display-inline="no-display-inline"> 
<subparagraph id="HE576B945CB9040749939BF7DE9A9E2D4"><enum>(M)</enum><text display-inline="yes-display-inline">An entity that—</text> 
<clause id="H149DCCF7A85F45648DCEFC2D08206D36"><enum>(i)</enum><text display-inline="yes-display-inline">is a critical access hospital (as determined under section 1820(c)(2) of the Social Security Act); and</text></clause> 
<clause id="HE95AE77A31D54DCF996B14D3AE91E51C"><enum>(ii)</enum><text display-inline="yes-display-inline">does not obtain covered outpatient drugs though a group purchasing organization or other group purchasing arrangement (not including such drugs purchased for inpatient use).</text></clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></paragraph> 
<paragraph id="H3807BA2995B3497B9EBF229DBC423BF2"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b), as amended by section 2(a), by inserting <quote>or subsection (a)(4)(M)</quote> after <quote>subsection (a)(4)(L)</quote>; and</text></paragraph> 
<paragraph id="H6655787759B44BEEA619F61F79EC00E1"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (c)(1), as added by inserting <quote>or subsection (a)(4)(M)</quote> after <quote>subsection (a)(4)(L)</quote>.</text></paragraph></subsection> 
<subsection id="HB5D250E28CE74A2986DE44A87F65F234"><enum>(b)</enum><header>Exclusion from medicaid best price calculations</header><text display-inline="yes-display-inline">Section 1927(c)(1)(C)(i)(I) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(c)(1)(C)(i)(I)</external-xref>) is amended by inserting <quote>and to critical access hospitals described in section 340B(a)(4)(M) of such Act</quote> after <quote>Public Health Service Act</quote>.</text></subsection> 
<subsection id="HFF54A674D3FC41BB9360D7E82FF49150"><enum>(c)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendments made by this section shall apply to drugs purchased on or after January 1, 2006.</text> </subsection></section> 
</legis-body> 
</bill> 


