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<bill bill-stage="Introduced-in-Senate" dms-id="A1" public-private="public">
<metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
<dublinCore>
<dc:title>116 S476 IS: Creating Transparency to Have Drug Rebates Unlocked (C–THRU) Act of 2019</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2019-02-13</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">II</distribution-code>
<congress>116th CONGRESS</congress><session>1st Session</session>
<legis-num>S. 476</legis-num>
<current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber>
<action>
<action-date date="20190213">February 13, 2019</action-date>
<action-desc><sponsor name-id="S247">Mr. Wyden</sponsor> (for himself, <cosponsor name-id="S307">Mr. Brown</cosponsor>, <cosponsor name-id="S277">Mr. Carper</cosponsor>, and <cosponsor name-id="S314">Mr. Tester</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 titles XI and XVIII of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers.</official-title>
</form> 
<legis-body display-enacting-clause="yes-display-enacting-clause" id="H8C73107300D54733B1DEF2587F757B1B"> 
<section id="S1" 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>Creating Transparency to Have Drug Rebates Unlocked (C–THRU) Act of 2019</short-title></quote>.</text> </section> <section id="id2755742D4F4A4F28B622248E8F38637A"><enum>2.</enum><header>Public disclosure of drug discounts</header> <subsection id="idF56ABE50008D499EBB9BF1D811BC9E08"><enum>(a)</enum><header>In general</header><text>Section 1150A of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320b-23">42 U.S.C. 1320b–23</external-xref>) is amended—</text> 
<paragraph id="id67A0D1AEE55E4FF091E876E26CE148A5"><enum>(1)</enum><text>in subsection (c), in the matter preceding paragraph (1), by striking <quote>this section</quote> and inserting <quote>subsection (b)(1)</quote>; and</text> </paragraph> <paragraph id="id2CB46AEC436B4B18BA485D0563E4BF62"><enum>(2)</enum><text>by adding at the end the following new subsection:</text> 
<quoted-block display-inline="no-display-inline" id="id05405FCBEE694DA8997CD832A239CCAC" style="OLC"> 
<subsection id="idAC049B7B1DF74326BF9339F71CA3766E"><enum>(e)</enum><header>Public availability of certain information</header><text>In order to allow patients and employers to compare PBMs’ ability to negotiate rebates, discounts, and price concessions and the amount of such rebates, discounts, and price concessions that are passed through to plan sponsors, beginning January 1, 2020, the Secretary shall make available on the Internet website of the Department of Health and Human Services the information provided to the Secretary under paragraphs (2) and (3) of subsection (b) with respect to each PBM. The Secretary shall ensure that such information is displayed in a manner that prevents the disclosure of information on rebates, discounts, and price concessions with respect to an individual drug or an individual plan.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection> <subsection id="id95149E42AB654EE68A5636423BB17F79"><enum>(b)</enum><header>Effective date</header><text>The amendments made by subsection (a) shall take effect on January 1, 2020.</text> </subsection></section>
<section id="id24071856864449169505AB9FB8AA76EF"><enum>3.</enum><header>Minimum drug discounts required To be passed through to the plan sponsor</header> 
<subsection id="id7931654F593542A8B27893D28C9B605A"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1150A of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320b-23">42 U.S.C. 1320b–23</external-xref>), as amended by section 2(a)(2), is amended—</text> <paragraph id="id2826C85D8B3E494D8AE14CC684554B03"><enum>(1)</enum><text>in the heading, by inserting <quote><header-in-text level="section" style="OLC">; minimum drug discounts required to be passed through to the plan sponsor</header-in-text></quote> before the period at the end; and</text> </paragraph>
<paragraph id="id6E01A3D4C52F4661A4979DD270234493"><enum>(2)</enum><text>by adding at the end the following new subsection:</text> <quoted-block display-inline="no-display-inline" id="idC1053D435B664D97A82DB66107F9C8A9" style="OLC"> <subsection id="id7AF80A84A8AD4E5984E102A0A1043BF4"><enum>(f)</enum><header>Minimum drug discounts required To be passed through to the plan sponsor</header> <paragraph id="id1CDCBE53B2AE4D56BECB3F82C7F360F1"><enum>(1)</enum><header>Requirement</header><text>Beginning January 1, 2022, a PBM that manages prescription drug coverage under a contract with a PDP sponsor or MA organization described in subsection (b)(1) or a qualified health benefits plan described in subsection (b)(2), shall, with respect to the plan sponsor of a health benefits plan, pass through to the plan sponsor a minimum percent (as established by the Secretary) of the aggregate amount of the rebates, discounts, or price concessions that the PBM negotiates that are attributable to patient utilization under the plan.</text> </paragraph>
<paragraph id="id5B509D2E143A4353ADED7E58086A15B2"><enum>(2)</enum><header>Establishment</header><text>The Secretary shall establish the minimum percent described in paragraph (1) in such a manner as will ensure that patients receive the maximum benefit of rebates, discounts, or price concessions while taking into account the costs of negotiating such rebates, discounts, and price concessions.</text> </paragraph> <paragraph id="idFEB53D6DFF954244801F6EF14B57EB4E"><enum>(3)</enum><header>Enforcement</header><text>A PDP sponsor of a prescription drug plan or an MA organization offering an MA–PD plan under part D of title XVIII may not contract with a PBM that is not in compliance with the requirement under paragraph (1).</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection>
<subsection commented="no" display-inline="no-display-inline" id="id94F9F00D35F04908B659B740D204AD58"><enum>(b)</enum><header display-inline="yes-display-inline">Effective date</header><text display-inline="yes-display-inline">The amendments made by subsection (a) shall take effect on January 1, 2022.</text> </subsection></section> <section id="id7EA5E7D551FD49448C150BC54D6F7E34"><enum>4.</enum><header>Part D negotiated prices required to take into account all price concessions at the point-of-sale</header> <subsection id="id783689C3F8F247989231F6983A58F933"><enum>(a)</enum><header>In general</header><text>Section 1860D–2(d)(1)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(d)(1)(B)</external-xref>) is amended—</text> 
<paragraph id="id9D790E7215BB485D90D2AB730CEE7A6B"><enum>(1)</enum><text>by striking <quote><header-in-text level="subparagraph" style="OLC">prices</header-in-text>.—For purposes</quote> and inserting “<header-in-text level="subparagraph" style="OLC">prices</header-in-text>.—</text> <quoted-block display-inline="no-display-inline" id="id8527DCA3AF5D47CF972CC76F60B1A7AF" style="OLC"> <clause id="idA6ADDA60266B4C57AD193DD90D7EA350"><enum>(i)</enum><header>In general</header><text>For purposes</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block> </paragraph>
<paragraph id="idDB68F0DE506545B491613D74D7FC03C3"><enum>(2)</enum><text>by adding at the end the following new clause:</text> <quoted-block display-inline="no-display-inline" id="idDCF3B8CD53E145579E371F76071A5BFE" style="OLC"> <clause id="idC4E3E6D3A97E45A7B85E2C2375F15C0E"><enum>(ii)</enum><header>Negotiated prices at point-of-sale</header> <subclause id="id02A4FA7EC31346C2B2B6474D876865DF"><enum>(I)</enum><header>In general</header><text>Negotiated prices for covered part D drugs described in clause (i), including all price negotiated concessions, shall be provided at the point-of-sale of the covered part D drug. If the negotiated price, including all negotiated price concessions, is not possible to calculate at the point-of-sale, an approximate negotiated price (as established by the Secretary) shall be used under the prescription drug plan or MA–PD plan.</text> </subclause>
<subclause id="id0EEBF4DF337A437E9880AFA194840BDA"><enum>(II)</enum><header>Approximate negotiated price</header><text>In determining an approximate negotiated price for a covered part D drug under subclause (I), the Secretary shall ensure that—</text> <item id="idCF3A67F994DD40C0899BEF8952935B1C"><enum>(aa)</enum><text>such price reflects the estimated negotiated price that is based on the previous year’s negotiated price concessions negotiated under the plan for all or similar covered part D drugs or is based on such other factors as the Secretary may determine appropriate; and</text> </item>
<item id="id8EEB5AFE9C6E40D69CCBB991E6EB8777"><enum>(bb)</enum><text>the use of such price does not prevent the use of value-based contracts between drug manufacturers, PDP sponsors, MA organizations, and pharmacies.</text></item></subclause></clause><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection> <subsection id="id186C218171704938B621DFD0D6901848"><enum>(b)</enum><header>Effective date</header><text>The amendments made by subsection (a) shall apply to plan years beginning on or after January 1, 2021.</text></subsection></section>
</legis-body>
</bill> 


