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<bill bill-stage="Introduced-in-House" dms-id="H1C812EA0C2564F3DA764CB8176EA31AB" public-private="public" key="H" bill-type="olc"><metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
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<dc:title>118 HR 10362 IH: Patients Before Monopolies Act of 2024</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2024-12-11</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">118th CONGRESS</congress><session display="yes">2d Session</session><legis-num display="yes">H. R. 10362</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20241211">December 11, 2024</action-date><action-desc><sponsor name-id="H001086">Mrs. Harshbarger</sponsor> (for herself and <cosponsor name-id="A000148">Mr. Auchincloss</cosponsor>) introduced the following bill; which was referred to the <committee-name committee-id="HJU00">Committee on the Judiciary</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title display="yes">To prohibit pharmacy benefit managers and pharmacies from being under common ownership, and for other purposes.</official-title></form><legis-body id="H5921BABEB63E475D9C1512C3350AE1DF" style="OLC"><section id="HD337113A275F48309B7A71AB3164DE1C" 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>Patients Before Monopolies Act of 2024</short-title></quote> or the <quote><short-title>PBM Act of 2024</short-title></quote>.</text></section><section commented="no" display-inline="no-display-inline" id="H5B25025A00EA4BA7A8D577F4D163C466"><enum>2.</enum><header>Prohibitions relating to anticompetitive pharmacy ownership</header><subsection commented="no" display-inline="no-display-inline" id="H08955F2907C1455C8F4B1D0A70A3C042"><enum>(a)</enum><header display-inline="yes-display-inline">Prohibition on pharmacy ownership by entities providing insurance or pharmacy benefit management services</header><paragraph commented="no" display-inline="no-display-inline" id="H9BC087D0503E4BCA8E6C3C29704615B4"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">It shall be unlawful for any person to both—</text><subparagraph id="HCF333B1640354D01BE58EC3E44E79A34"><enum>(A)</enum><text>directly or indirectly own, operate, control, or direct the operation of the whole or any part of a pharmacy; and</text></subparagraph><subparagraph id="H76C993AA27E3473FB0B68A50D7BFAF82"><enum>(B)</enum><text>directly or indirectly own, operate, or control the whole or any part of—</text><clause commented="no" display-inline="no-display-inline" id="HFE4E30BCB13A40EC96EDB57333120B3D"><enum>(i)</enum><text display-inline="yes-display-inline">an insurance company; or</text></clause><clause commented="no" display-inline="no-display-inline" id="H60F6638812A24BABB7AA1B698EABD4B0"><enum>(ii)</enum><text display-inline="yes-display-inline">a pharmacy benefit manager.</text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0C8D0C235C7544F9850212C2FE93B57F"><enum>(2)</enum><header>Divestment</header><text>Not later than 3 years after the date of enactment of this Act, any person in violation of subsection (a) shall divest the pharmacy of such person.</text></paragraph></subsection><subsection id="H23B969F072284DAAAB6AE736AF461397"><enum>(b)</enum><header>Civil actions</header><paragraph commented="no" display-inline="no-display-inline" id="H2489C356CC58471199D3AF0128B2B0F1"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text>When the Inspector General of the Department of Health and Human Services, the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice, the Federal Trade Commission, or an attorney general of a State has reason to believe that a person is in violation of subsection (a), such Inspector General, Assistant Attorney General, Federal Trade Commission or attorney general of a State may bring a civil action in an applicable district court of the United States for the relief described in paragraph (2).</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H5A3C77D600D54257B2DC492F53B27D59"><enum>(2)</enum><header>Injunctive and equitable relief</header><text display-inline="yes-display-inline">In any action described in paragraph (1), the applicable court, on a finding that a person is in violation of subsection (a), shall issue an order requiring such person—</text><subparagraph commented="no" display-inline="no-display-inline" id="HEB8BA9AA9C024F038D85EF6A7766A7E4"><enum>(A)</enum><text display-inline="yes-display-inline">to cease and desist from such violation, and, if applicable, divest the pharmacy services of such person; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HAF6EFA52CEDE47139642D712D43DC670"><enum>(B)</enum><text display-inline="yes-display-inline">to disgorge any revenue received from the pharmacy from the sale of prescription drugs during the period of such violation.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDFA0D0B35FA347A1B630C522306EF6EB"><enum>(3)</enum><header>Other relief</header><text display-inline="yes-display-inline">In addition to any relief obtained under paragraph (2), the court may grant any other equitable relief necessary to redress and prevent recurrence of the violation.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H081BD83FDACF4419A76C40ED8FA2CA2F"><enum>(4)</enum><header>Deposit</header><text>Any revenue received from the sale of prescription drugs disgorged pursuant to an action under this subsection shall be deposited in a fund created by the Federal Trade Commission and distributed by the Federal Trade Commission to be put to use in the interest of serving the health care needs of the harmed community, including consumers overcharged at vertically integrated pharmacies.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H2D9C2B4B99044D2E98FE74D191216CCF"><enum>(c)</enum><header>FTC review</header><paragraph commented="no" display-inline="no-display-inline" id="HF3883780394243E0921A2792DF047E34"><enum>(1)</enum><header display-inline="yes-display-inline">Reporting required</header><text>Any divestment of a pharmacy or pharmacy benefit manager required under subsection (a) shall be reported to the Federal Trade Commission and the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice under section 7A of the Clayton Act (<external-xref legal-doc="usc" parsable-cite="usc/15/18a">15 U.S.C. 18a</external-xref>) without respect to the thresholds under subsection (a)(2) of that section. </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD3D9764800464A4EBCD92F99556C125F"><enum>(2)</enum><header>Tolling of divestment period during review</header><text display-inline="yes-display-inline">The divestment period under subsection (a) shall be tolled during the pendency of any waiting period required under section 7A of the Clayton Act (<external-xref legal-doc="usc" parsable-cite="usc/15/18a">15 U.S.C. 18a</external-xref>).</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3641EF72F5C34C0A87C7DFB02E93CA95"><enum>(3)</enum><header display-inline="yes-display-inline">Review of effect of divestiture</header><text>With respect to each divestiture undertaken pursuant to subsection (a), in addition to any applicable review under section 7A of the Clayton Act (<external-xref legal-doc="usc" parsable-cite="usc/15/18a">15 U.S.C. 18a</external-xref>), the Federal Trade Commission and the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice shall review the effect on competition, financial viability, and the public interest—</text><subparagraph commented="no" display-inline="no-display-inline" id="H5DB7AD7BC96D432482648620C1558515"><enum>(A)</enum><text display-inline="yes-display-inline">of the divestiture; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0E459399D32B4663892EECA9C3368006"><enum>(B)</enum><text display-inline="yes-display-inline">of the subsequent acquisition of the divested pharmacy by the acquiring person.</text></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HFFC7833F0EB743D8A86F91ECF8F2A30D"><enum>(d)</enum><header>Rulemaking authority</header><text>The Federal Trade Commission shall promulgate rules to carry out this section. Such rules shall not diminish any obligation under this section.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="H445688395E314EACAC5F00829847ED64"><enum>(e)</enum><header>Rule of construction</header><text>Nothing in this section shall be construed to limit the authority of the Federal Trade Commission, the Inspector General of the Department of Justice, the Department of Health and Human Services, or the attorney general of a State under any other provision of law.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="HDCD9443397C647A0A9E5DB152757A9F6"><enum>(f)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this section:</text><paragraph id="H19A19C12FAB6418B89778C640124D04B"><enum>(1)</enum><header>Health plan</header><text>The term <term>health plan</term> means any public or private health insurance plan. </text></paragraph><paragraph id="H5747DB6A5EF042B08CF2BCF386B17234"><enum>(2)</enum><header>Person</header><text>The term <term>person</term> has the meaning given the term in section 8 of the Sherman Act (<external-xref legal-doc="usc" parsable-cite="usc/15/7">15 U.S.C. 7</external-xref>). </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4365E453AA2645F6B2294DF07D9F8844"><enum>(3)</enum><header>Pharmacy</header><subparagraph commented="no" display-inline="no-display-inline" id="H6982688766FD447F9495F1577CDC2412"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The term <term>pharmacy</term> means any person, business, or entity licensed, registered, or otherwise permitted by a State or a territory of the United States to dispense, deliver, or distribute a controlled substance, prescription drug, or other medication—</text><clause commented="no" display-inline="no-display-inline" id="H6D37A7167CF84586B6E9D4BF1FA79462"><enum>(i)</enum><text display-inline="yes-display-inline">to the general public; or </text></clause><clause commented="no" display-inline="no-display-inline" id="H5F95CA2407E34C91BFC03278630C9473"><enum>(ii)</enum><text display-inline="yes-display-inline">to a bed patient for immediate administration. </text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H85A23B756393438DAF6AC9BB7EDC17B3"><enum>(B)</enum><header>Inclusions</header><text display-inline="yes-display-inline">The term <term>pharmacy</term> includes—</text><clause commented="no" display-inline="no-display-inline" id="H9AD33826C22F40D3A4DBD04C6255F85C"><enum>(i)</enum><text display-inline="yes-display-inline">a mail-order pharmacy;</text></clause><clause commented="no" display-inline="no-display-inline" id="H968A82A27D3C4C04BD95BEE5CFEE7797"><enum>(ii)</enum><text display-inline="yes-display-inline">a specialty pharmacy;</text></clause><clause commented="no" display-inline="no-display-inline" id="H15F0078887C8422E9FCF3CF37F802C32"><enum>(iii)</enum><text display-inline="yes-display-inline">a retail pharmacy;</text></clause><clause commented="no" display-inline="no-display-inline" id="HF2C415BCC93F4D31914199748F75D18D"><enum>(iv)</enum><text display-inline="yes-display-inline">a nursing home pharmacy;</text></clause><clause commented="no" display-inline="no-display-inline" id="H99ADD6DCDB324996A29CBAB9D82B796C"><enum>(v)</enum><text display-inline="yes-display-inline">a long-term care pharmacy;</text></clause><clause commented="no" display-inline="no-display-inline" id="H325B1C5AB4A945329A54D5459D636AFC"><enum>(vi)</enum><text display-inline="yes-display-inline">a hospital pharmacy; </text></clause><clause commented="no" display-inline="no-display-inline" id="H07F0A95466244068B3BD7CB81FD17D06"><enum>(vii)</enum><text display-inline="yes-display-inline">an infusion or other outpatient treatment pharmacy;</text></clause><clause id="H84DC26EFE920465F91D6FBE62E249CC9"><enum>(viii)</enum><text>any organization the National Provider Identifier (NPI) registration of which has 1 or more taxonomy codes under the pharmacy section of the National Uniform Claim Committee (or a subsequent organization); and </text></clause><clause commented="no" display-inline="no-display-inline" id="H674F256B22FA4300AFE839D5F32A094E"><enum>(ix)</enum><text display-inline="yes-display-inline">any other type of pharmacy. </text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0CCF9D15E85440D895265C854A770BBB"><enum>(4)</enum><header display-inline="yes-display-inline">Pharmacy benefit manager</header><text>The term <term>pharmacy benefit manager</term> means any person, business, or other entity, such as a third-party administrator, regardless of whether such person, business, or entity identifies itself as a pharmacy benefit manager, that, either directly or indirectly through an intermediary (including an affiliate, subsidiary, or agent) or an arrangement with a third party—</text><subparagraph id="HB29C50B09EA74674A70AA9D0B04BB170"><enum>(A)</enum><text>acts as a negotiator of prices, rebates, fees, or discounts for prescription drugs on behalf of a health plan or health plan sponsor; </text></subparagraph><subparagraph id="HF59B9B00CEFF410183195855F3AF1E19"><enum>(B)</enum><text>contracts with pharmacies to create pharmacy networks and designs and manages such networks; or </text></subparagraph><subparagraph id="HDBD1CC46253C473B982A937CADDF4CF5" commented="no" display-inline="no-display-inline"><enum>(C)</enum><text>manages or administers the prescription drug benefits provided by a health plan, including the processing and payment of claims for prescription drugs, arranging alternative access to or funding for prescription drugs, the performance of utilization management services, including drug utilization review, the processing of drug prior authorization requests, the adjudication of appeals or grievances related to the prescription drug benefit, contracting with network pharmacies, controlling the cost of covered prescription drugs, or the provision of related services. </text></subparagraph></paragraph></subsection></section></legis-body></bill> 

