119 S4189 IS: Improving Needed Safeguards for Users of Lifesaving Insulin Now Act of 2026
U.S. Senate
2026-03-25
text/xml
EN
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.
1.Short title; table of contents(a)This Act may be cited as the Improving Needed Safeguards for Users of Lifesaving Insulin Now Act of 2026
or the INSULIN Act of 2026
.(b)The table of contents for this Act is as follows:Sec. 1. Short title; table of contents.Sec. 2. Sense of Congress.TITLE I—Commercial market patient protectionsSec. 101. Requirements with respect to cost-sharing for certain insulin products.Sec. 102. Application to retiree and certain small group plans.Sec. 103. Administration.TITLE II—Pharmacy benefit manager transparency and rebate reformSec. 201. Full rebate on insulin pass-through to plan.TITLE III—Biosimilar biological product and generic drug competition and affordabilitySec. 301. Ensuring timely access to generics.Sec. 302. Expediting competitive biosimilar competition.Sec. 303. Insulin competition report.TITLE IV—Programs for providing affordable insulin to uninsured individualsSec. 401. Pilot program for providing affordable insulin to uninsured individuals.Sec. 402. GAO study on uninsured individuals who use insulin.Sec. 403. Insulin resource center and hotline for uninsured individuals.2.It is the sense of Congress that Congress should enact subsequent legislation that provides for an offset for any costs to the Federal Government resulting from the enactment of this Act.<enum>I</enum><header>Commercial market patient protections</header><section id="idCEDB8684E0CC4711B21D98964E244D42"><enum>101.</enum><header>Requirements with respect to cost-sharing for certain insulin products</header><subsection id="idB24AE2F2414B4547934B49D461B967E4"><enum>(a)</enum><header>In general</header><text>Part D of title XXVII of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-111">42 U.S.C. 300gg–111 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id2321E9BBCD1D46C08DE793D6B1EBE77F"><section id="id94C16274D9924631AE4DC39E0F30D09B"><enum>2799A–12.<?LEXA-Enum 2799A–12.?></enum><header>Requirements with respect to cost-sharing for certain insulin products</header><subsection id="HA6DBA3999D8B41C5B3F22AB05B8E5504"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">For plan years beginning on or after January 1, 2027, a group health plan or health insurance issuer offering group or individual health insurance coverage shall provide coverage of selected insulin products, and with respect to such products, shall not—</text><paragraph id="H80EBF90FF7AC466EA3A14999F94DBBC2"><enum>(1)</enum><text>apply any deductible; or</text></paragraph><paragraph id="idd31d02522a204554b204430e27aed029"><enum>(2)</enum><text>impose any cost-sharing requirements in excess of, per 30-day supply—</text><subparagraph id="idcbb4d0949f11475fa454f2b87e5e2c79"><enum>(A)</enum><text>for any applicable plan year beginning before January 1, 2028, $35; or</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0ca4ab1a8711468c9a213524b2074bdc"><enum>(B)</enum><text display-inline="yes-display-inline">for any plan year beginning on or after January 1, 2028, the lesser of—</text><clause commented="no" display-inline="no-display-inline" id="id22aca4a15d8d4d06b9633536caf098fa"><enum>(i)</enum><text display-inline="yes-display-inline">$35; or</text></clause><clause id="H4D678C4B8821476FB776CF8C41E65B84"><enum>(ii)</enum><text>the amount equal to 25 percent of the negotiated price of the selected insulin product net of all price concessions received by or on behalf of the plan or issuer, including price concessions received by or on behalf of third-party entities providing services to the plan or issuer, such as pharmacy benefit management services or third party administrators.</text></clause></subparagraph></paragraph></subsection><subsection id="H41A5FB3635924A939D823C977E80403E"><enum>(b)</enum><header>Definitions</header><text>In this section:</text><paragraph id="H7EAA66B733974CEB9243B8FDC8C1A9A6"><enum>(1)</enum><header>Selected insulin products</header><text>The term <term>selected insulin products</term> means, for any plan year beginning on or after January 1, 2027, at least one of each dosage form (such as vial, pen, or inhaler dosage forms) of each different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, and pre-mixed) of insulin, when such form is licensed and marketed, as selected by the group health plan or health insurance issuer.</text></paragraph><paragraph id="H5F1D45530899466CA5867D1E03894760"><enum>(2)</enum><header>Insulin</header><text>The term <term>insulin</term> means insulin that is licensed under subsection (a) or (k) of section 351 and continues to be marketed pursuant to such licensure.</text></paragraph></subsection><subsection id="H8FB3DBFD11664B8D927A9F089E06550E"><enum>(c)</enum><header>Out-of-Network providers</header><text>Nothing in this section requires a plan or issuer that has a network of providers to provide benefits for selected insulin products described in this section that are delivered by an out-of-network provider, or precludes a plan or issuer that has a network of providers from imposing higher cost-sharing than the levels specified in subsection (a) for selected insulin products described in this section that are delivered by an out-of-network provider.</text></subsection><subsection id="H0483953A0962419486FBBBF996E94DEE"><enum>(d)</enum><header>Rule of construction</header><text>Subsection (a) shall not be construed to require coverage of, or prevent a group health plan or health insurance issuer from imposing cost-sharing other than the levels specified in subsection (a) on, insulin products that are not selected insulin products, to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law.</text></subsection><subsection commented="no" id="H7C3B0025E5404A5797DE486F0B9DC1A7"><enum>(e)</enum><header>Application of cost-Sharing towards deductibles and out-of-Pocket maximums</header><text>Any cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="idea2fdaeee7a14c5e9c119a596fb365a8"><enum>(f)</enum><header>Other requirements</header><text display-inline="yes-display-inline">A group health plan or health insurance issuer offering group or individual health insurance coverage shall not impose, directly or through an entity providing pharmacy benefit management services, any prior authorization or other medical management requirement, or other similar conditions, on selected insulin products, except as clinically justified for safety reasons, to ensure reasonable quantity limits and as specified by the Secretary.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H2683040838004363B7A3A8B63BBE2FA6"><enum>(b)</enum><header>No effect on other cost-Sharing</header><text>Section 1302(d)(2) of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18022">42 U.S.C. 18022(d)(2)</external-xref>) is amended by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H70F16A6090534164ADFF45ADDA782992"><subparagraph id="HE8CD9AD30C074C8A93D3F3893ACF33B5"><enum>(D)</enum><header>Special rule relating to insulin coverage</header><text display-inline="yes-display-inline">For plans years beginning on or after January 1, 2028, the exemption of coverage of selected insulin products (as defined in section 2799A–12(b) of the Public Health Service Act) from the application of any deductible pursuant to section 2799A–12(a)(1) of such Act, section 727(a)(1) of the Employee Retirement Income Security Act of 1974, or <external-xref legal-doc="usc" parsable-cite="usc/26/9827">section 9827(a)(1)</external-xref> of the Internal Revenue Code of 1986 shall not be considered when determining the actuarial value of a qualified health plan under this subsection.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HB401D9C85FD04F13BB6C9D000C65415F"><enum>(c)</enum><header>Coverage of certain insulin products under catastrophic plans</header><text>Section 1302(e) of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18022">42 U.S.C. 18022(e)</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H771F1E5804CF4BE48314BD46AF56396F"><paragraph id="H20875DF4279945D08E232A6DD3100102"><enum>(4)</enum><header>Coverage of certain insulin products</header><subparagraph id="H38202A74DB09441EB9ADD4A0954E1200"><enum>(A)</enum><header>In general</header><text>Notwithstanding paragraph (1)(B)(i), for plan years beginning on or after January 1, 2027, a health plan described in paragraph (1) shall provide coverage of selected insulin products, in accordance with section 2799A–12 of the Public Health Service Act, before an enrolled individual has incurred, during the plan year, cost-sharing expenses in an amount equal to the annual limitation in effect under subsection (c)(1) for the plan year.</text></subparagraph><subparagraph id="HA4620B58AEC246B3A8F22A63A3C049D9"><enum>(B)</enum><header>Terminology</header><text>For purposes of subparagraph (A)—</text><clause id="H9D64CD88F63B4D88A55583AFE80FAAE9"><enum>(i)</enum><text>the term <term>selected insulin products</term> has the meaning given such term in section 2799A–12(b) of the Public Health Service Act; and</text></clause><clause id="HBAC5351E25BC41858665E1E8A2673DB3"><enum>(ii)</enum><text>the requirements of section 2799A–12 of such Act shall be applied by deeming each reference in such section to <quote>individual health insurance coverage</quote> to be a reference to a plan described in paragraph (1).</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="id9BDD9364D93C4D01A2A5DF8DB83AD285"><enum>(d)</enum><header>ERISA</header><paragraph id="H6AA4CB38D7C247F28922494F995F37B2"><enum>(1)</enum><header>In general</header><text>Subpart B of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1185">29 U.S.C. 1185 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HB1572098C1DB41AFA2E01117B6C76564"><section id="H7E90B73D642B4EE18F2929A0DA67288E"><enum>727.</enum><header>Requirements with respect to cost-sharing for certain insulin products</header><subsection id="H0A7D4CAC7D9147A7929B6AF30CEF4779"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">For plan years beginning on or after January 1, 2027, a group health plan or health insurance issuer offering group health insurance coverage shall provide coverage of selected insulin products, and with respect to such products, shall not—</text><paragraph id="HE5064166FB194A80A725FE47A6D78D04"><enum>(1)</enum><text>apply any deductible; or</text></paragraph><paragraph id="ida4c7b896ce724997ae1cc10bedc74128"><enum>(2)</enum><text>impose any cost-sharing requirements in excess of, per 30-day supply—</text><subparagraph id="iddd86605ff6d7467fb5104df201cd9cb9"><enum>(A)</enum><text>for any applicable plan year beginning before January 1, 2028, $35; or</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idacbeb28ac4f14c42abfbfa043d340bf9"><enum>(B)</enum><text display-inline="yes-display-inline">for any plan year beginning on or after January 1, 2028, the lesser of—</text><clause commented="no" display-inline="no-display-inline" id="idf4c3ce0009b94185a0b7f4f075cabc81"><enum>(i)</enum><text display-inline="yes-display-inline">$35; or</text></clause><clause id="HF873859D5F8C4258815E27D5D669DA90"><enum>(ii)</enum><text>the amount equal to 25 percent of the negotiated price of the selected insulin product net of all price concessions received by or on behalf of the plan or issuer, including price concessions received by or on behalf of third-party entities providing services to the plan or issuer, such as pharmacy benefit management services or third party administrators.</text></clause></subparagraph></paragraph></subsection><subsection id="HCB9776243F724592B879DFA6074F0E0A"><enum>(b)</enum><header>Definitions</header><text>In this section:</text><paragraph id="id36b4801857a04cdca52698f174244e8a"><enum>(1)</enum><header>Selected insulin products</header><text>The term <term>selected insulin products</term> means, for any plan year beginning on or after January 1, 2027, at least one of each dosage form (such as vial, pen, or inhaler dosage forms) of each different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, and pre-mixed) of insulin, when such form is licensed and marketed, as selected by the group health plan or health insurance issuer.</text></paragraph><paragraph id="HA286E1CBB3A843D3847DD6F75C04E2AD"><enum>(2)</enum><header>Insulin</header><text>The term <term>insulin</term> means insulin that is licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>) and continues to be marketed pursuant to such licensure.</text></paragraph></subsection><subsection id="HCC677363853C4F7AADDDC5C23BF2A625"><enum>(c)</enum><header>Out-of-Network providers</header><text>Nothing in this section requires a plan or issuer that has a network of providers to provide benefits for selected insulin products described in this section that are delivered by an out-of-network provider, or precludes a plan or issuer that has a network of providers from imposing higher cost-sharing than the levels specified in subsection (a) for selected insulin products described in this section that are delivered by an out-of-network provider.</text></subsection><subsection id="HA5E6334E7F9143B6A061817A5AC39127"><enum>(d)</enum><header>Rule of construction</header><text>Subsection (a) shall not be construed to require coverage of, or prevent a group health plan or health insurance issuer from imposing cost-sharing other than the levels specified in subsection (a) on, insulin products that are not selected insulin products, to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law.</text></subsection><subsection commented="no" id="H9463030A88FB438CA547E12688BC90A9"><enum>(e)</enum><header>Application of cost-Sharing towards deductibles and out-of-Pocket maximums</header><text>Any cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="id773d73c5dfe24cdf9164c27a492c1102"><enum>(f)</enum><header>Other requirements</header><text display-inline="yes-display-inline">A group health plan or health insurance issuer offering group health insurance coverage shall not impose, directly or through an entity providing pharmacy benefit management services, any prior authorization or other medical management requirement, or other similar conditions, on selected insulin products, except as clinically justified for safety reasons, to ensure reasonable quantity limits and as specified by the Secretary.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="HE83A8B8E3C6C4AD383939A85C7145C8E"><enum>(2)</enum><header>Clerical amendment</header><text>The table of contents in section 1 of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1001">29 U.S.C. 1001 et seq.</external-xref>) is amended by inserting after the item relating to section 726 the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HA2E7D70B8478432FA0D2F0C0F088943A"><toc regeneration="no-regeneration"><toc-entry level="section">Sec. 727. Requirements with respect to cost-sharing for certain insulin products.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HCF0C25F68C194F6A871E245D474EE095"><enum>(e)</enum><header>Internal Revenue Code</header><paragraph id="HF59722988DCA49FFB877BA108AA95B50"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Subchapter B of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/100">chapter 100</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H5D68250DAE1946BF9D4DC3E4331DB975"><section id="HAE3A942C8789456AB1D805388FBE02E9"><enum>9827.</enum><header>Requirements with respect to cost-sharing for certain insulin products</header><subsection id="H7EB92EDB059740309FE7225D11772EBC"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">For plan years beginning on or after January 1, 2027, a group health plan shall provide coverage of selected insulin products, and with respect to such products, shall not—</text><paragraph id="H4EAD769D9F534CE2B3792380917A3FCF"><enum>(1)</enum><text>apply any deductible; or</text></paragraph><paragraph id="H699DA04086D34C64B205C9EB5EF92092"><enum>(2)</enum><text>impose any cost-sharing requirements in excess of, per 30-day supply—</text><subparagraph id="H0F57B14FF963481194CA97F3AFBAB918"><enum>(A)</enum><text>for any applicable plan year beginning before January 1, 2028, $35; or</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id16275b26e524416cac5484ee8842eb75"><enum>(B)</enum><text display-inline="yes-display-inline">for any plan year beginning on or after January 1, 2028, the lesser of—</text><clause commented="no" display-inline="no-display-inline" id="id2bacc0ded58146f98ff935172c4a7a3e"><enum>(i)</enum><text display-inline="yes-display-inline">$35; or</text></clause><clause id="HBEFFA4C515F54D9A8319BA0786AE7F54"><enum>(ii)</enum><text>the amount equal to 25 percent of the negotiated price of the selected insulin product net of all price concessions received by or on behalf of the plan, including price concessions received by or on behalf of third-party entities providing services to the plan, such as pharmacy benefit management services or third party administrators.</text></clause></subparagraph></paragraph></subsection><subsection id="H7DDB2D0DA23B4DDF918C43822ED8EA66"><enum>(b)</enum><header>Definitions</header><text>In this section:</text><paragraph id="id4827DD18D9BC4F549972957D73A78846"><enum>(1)</enum><header>Selected insulin products</header><text>The term <term>selected insulin products</term> means, for any plan year beginning on or after January 1, 2027, at least one of each dosage form (such as vial, pen, or inhaler dosage forms) of each different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, and pre-mixed) of insulin, when such form is licensed and marketed, as selected by the group health plan.</text></paragraph><paragraph id="H2833996BF654425A9299B0BC554BDD87"><enum>(2)</enum><header>Insulin</header><text>The term <term>insulin</term> means insulin that is licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>) and continues to be marketed pursuant to such licensure.</text></paragraph></subsection><subsection id="H4CFFEC8A346D4C2BB8665C91A2FE5C45"><enum>(c)</enum><header>Out-of-Network providers</header><text>Nothing in this section requires a plan that has a network of providers to provide benefits for selected insulin products described in this section that are delivered by an out-of-network provider, or precludes a plan that has a network of providers from imposing higher cost-sharing than the levels specified in subsection (a) for selected insulin products described in this section that are delivered by an out-of-network provider.</text></subsection><subsection id="H769AC0FA803347B0A18B9854056EB709"><enum>(d)</enum><header>Rule of construction</header><text>Subsection (a) shall not be construed to require coverage of, or prevent a group health plan from imposing cost-sharing other than the levels specified in subsection (a) on, insulin products that are not selected insulin products, to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law.</text></subsection><subsection commented="no" id="H6D2E3E3A2FAD4CA597D6A6B367CE8468"><enum>(e)</enum><header>Application of cost-Sharing towards deductibles and out-of-Pocket maximums</header><text>Any cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="ida18ad5442b0a4d738bb0c14f0ed2a4f8"> <enum>(f)</enum> <header>Other requirements</header> <text display-inline="yes-display-inline">A group health plan shall not impose, directly or through an entity providing pharmacy benefit management services, any prior authorization or other medical management requirement, or other similar conditions, on selected insulin products, except as clinically justified for safety reasons, to ensure reasonable quantity limits and as specified by the Secretary.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="H24F6DAB0A0314B8A82CEFCCD7B8A2844"><enum>(2)</enum><header>Clerical amendment</header><text>The table of sections for subchapter B of chapter 100 of such Code is amended by adding at the end the following new item:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HD6E9A73DC40C467480DB7785B508E9FD"><toc regeneration="no-regeneration"><toc-entry level="section">Sec. 9827. Requirements with respect to cost-sharing for certain insulin products.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section><section id="id4DEEE19451B94A16B7EE9A39E0A5C3C3"><enum>102.</enum><header>Application to retiree and certain small group plans</header><subsection id="idF02E4BEE690E4873A101A118D515CEB8"><enum>(a)</enum><header>ERISA</header><text display-inline="yes-display-inline">Section 732(a) of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1191a">29 U.S.C. 1191a(a)</external-xref>) is amended by striking <quote>section 711</quote> and inserting <quote>sections 711 and 727</quote>.</text></subsection><subsection id="idE3EAD247378D463D8FCE9AF504A89F6E"><enum>(b)</enum><header>IRC</header><text>The Internal Revenue Code of 1986 is amended—</text><paragraph id="idC929C6694AF04004B64DEF9DF7D6FDD3"><enum>(1)</enum><text>in section 9831(a), by adding at the end the following flush text:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id3D6851D9B98B4799A3E1CBB599ED2C6B"><quoted-block-continuation-text quoted-block-continuation-text-level="subsection">Paragraph (2) shall not apply to the requirements under sections 9811 and 9827.</quoted-block-continuation-text><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="id990D4194924E4BAB94878B7E55DC46CE"><enum>(2)</enum><text>in section 4980D(d)(1), by striking <quote>section 9811</quote> and inserting <quote>section 9811 or 9827</quote>.</text></paragraph></subsection></section><section id="id98BAA2D84D864762B3F1AD866BE3C2D6"><enum>103.</enum><header>Administration</header><subsection commented="no" id="id051138FB14F34FA3A353B98ACB8C5B02"><enum>(a)</enum><header>Implementation</header><text>Notwithstanding any other provision of law, the Secretary of Health and Human Services, the Secretary of Labor, and the Secretary of the Treasury may implement the provisions of, including the amendments made by, this title for plan years that begin on or after January 1, 2027, and end not later than January 1, 2030, by subregulatory guidance, program instruction, or otherwise.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="idED639B5EF13D485F9908398F0A86B64A"><enum>(b)</enum><header>Non-Application of the Paperwork Reduction Act</header><text><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/44/35">Chapter 35</external-xref> of title 44, United States Code (commonly referred to as the <quote>Paperwork Reduction Act of 1995</quote>), shall not apply to the provisions of, including the amendments made by, this title.</text></subsection></section><enum>II</enum><header>Pharmacy benefit manager transparency and rebate reform</header><section commented="no" id="id6688CAAB31F5424CB154F1A8153E4C23"><enum>201.</enum><header>Full rebate on insulin pass-through to plan</header><subsection commented="no" display-inline="no-display-inline" id="id94c3263cf41046e898809f55c5fb27db"><enum>(a)</enum><header display-inline="yes-display-inline">PHSA</header><text display-inline="yes-display-inline">Part D of title XXVII of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-111">42 U.S.C. 300gg–111 et seq.</external-xref>), as amended by section 101, is further amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id2C4468B9199644C0ACDD0BFCEEFF03B4"><section id="idc6d37827fbd444429778a5b442e2dd48"><enum>2799A–13.</enum><header>Full rebate on insulin pass-through to plan</header><subsection commented="no" id="ida12111e6f0af4087ae7747aa92c8df29"><enum>(a)</enum><header>In general</header><text>A pharmacy benefits manager, a third-party administrator of a group health plan, a health insurance issuer offering group health insurance coverage, or an entity providing pharmacy benefits management services under such health plan or health insurance coverage shall remit 100 percent of rebates, fees, alternative discounts, and all other remuneration received from a pharmaceutical manufacturer, distributor or any other third party, that are related to utilization of insulin under such health plan or health insurance coverage, to the group health plan.</text></subsection><subsection commented="no" id="id7af168fb1f9c46e0b51622ee73fad3a2"><enum>(b)</enum><header>Form and manner of remittance</header><text>Such rebates, fees, alternative discounts, and other remuneration shall be—</text><paragraph commented="no" id="id2f1d75641ed74653bd4d391511cc5010"><enum>(1)</enum><text>remitted to the group health plan in a timely fashion after the period for which such rebates, fees, or other remuneration is calculated, and in no case later than 90 days after the end of such period;</text></paragraph><paragraph commented="no" id="id0efa2b5fe0864ea3b72ecf5394534b29"><enum>(2)</enum><text>fully disclosed and enumerated to the group health plan sponsor; and</text></paragraph><paragraph commented="no" id="id1aa5d2db474e451684a9cdc56e491204"><enum>(3)</enum><text>available for audit by the plan sponsor, or a third-party designated by a plan sponsor no less than once per plan year.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="id5e482ac1b83648a9b702ddbb1d57f9fa"><enum>(b)</enum><header>ERISA</header><paragraph id="id3d554e2127144ab2a929301cc722b4bb"><enum>(1)</enum><header>In general</header><text>Subpart B of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1185">29 U.S.C. 1185 et seq.</external-xref>), as amended by section 101, is further amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id70c1aa805e6341d39e8137a9f3b57057"><section id="idc487900325f14ae897989248db01939a"><enum>728.</enum><header>Full rebate on insulin pass-through to plan</header><subsection commented="no" id="idf943c2a4cc1e43e8becbd59fa5502b08"><enum>(a)</enum><header>In general</header><text>A pharmacy benefits manager, a third-party administrator of a group health plan, a health insurance issuer offering group health insurance coverage, or an entity providing pharmacy benefits management services under such health plan or health insurance coverage shall remit 100 percent of rebates, fees, alternative discounts, and all other remuneration received from a pharmaceutical manufacturer, distributor or any other third party, that are related to utilization of insulin under such health plan or health insurance coverage, to the group health plan.</text></subsection><subsection commented="no" id="idc8ba0ef984c3409abfdef996d942911e"><enum>(b)</enum><header>Form and manner of remittance</header><text>Such rebates, fees, alternative discounts, and other remuneration shall be—</text><paragraph commented="no" id="idc78f6ca6fd8146e7a899271131b8949c"><enum>(1)</enum><text>remitted to the group health plan in a timely fashion after the period for which such rebates, fees, or other remuneration is calculated, and in no case later than 90 days after the end of such period;</text></paragraph><paragraph commented="no" id="idb75c128ca6b6498c86bd08976f33a12e"><enum>(2)</enum><text>fully disclosed and enumerated to the group health plan sponsor; and</text></paragraph><paragraph commented="no" id="id596960eb95774890983c1ca29982af0a"><enum>(3)</enum><text>available for audit by the plan sponsor, or a third-party designated by a plan sponsor no less than once per plan year.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="id936b5bef3b0a40a7bcea7f3284624e1b"><enum>(2)</enum><header>Clerical amendment</header><text>The table of contents in section 1 of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1001">29 U.S.C. 1001 et seq.</external-xref>), as amended by section 101, is further amended by inserting after the item relating to section 727 the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id2eac70a93d5646c888db8f29a225e8d4"><toc regeneration="no-regeneration"><toc-entry level="section">Sec. 728. Full rebate on insulin pass-through to plan.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="id68e786c0b605462ca4f0712bbc25d29c"><enum>(c)</enum><header>Internal Revenue Code</header><paragraph id="id7d8e7c96e0154ba4868dfe9ab6e71187"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Subchapter B of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/100">chapter 100</external-xref> of the Internal Revenue Code of 1986, as amended by section 101, is further amended by adding at the end the following new section:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id3e9feab20a7f400e87bb936186c40eba"><section id="idea2dd4a77796437bab28715cee9281a1"><enum>9828.</enum><header>Full rebate on insulin pass-through to plan</header><subsection commented="no" id="idb4480c2f13944c198630d43ce0428260"><enum>(a)</enum><header>In general</header><text>A pharmacy benefits manager, a third-party administrator of a group health plan, or an entity providing pharmacy benefits management services under such health plan shall remit 100 percent of rebates, fees, alternative discounts, and all other remuneration received from a pharmaceutical manufacturer, distributor or any other third party, that are related to utilization of insulin under such health plan, to the group health plan.</text></subsection><subsection commented="no" id="idd285b16088e541fb83986244397961fd"><enum>(b)</enum><header>Form and manner of remittance</header><text>Such rebates, fees, alternative discounts, and other remuneration shall be—</text><paragraph commented="no" id="id0ea06ff97318463f8c1900025b9d2cd6"><enum>(1)</enum><text>remitted to the group health plan in a timely fashion after the period for which such rebates, fees, or other remuneration is calculated, and in no case later than 90 days after the end of such period;</text></paragraph><paragraph commented="no" id="idb96dfb50a5e342e58170f8085bacbd2f"><enum>(2)</enum><text>fully disclosed and enumerated to the group health plan sponsor; and</text></paragraph><paragraph commented="no" id="id5722809cfc9643328b30a2d44ea3174c"><enum>(3)</enum><text>available for audit by the plan sponsor, or a third-party designated by a plan sponsor no less than once per plan year.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="idebc20f73f8a74652ac3c194a174f7678"><enum>(2)</enum><header>Clerical amendment</header><text>The table of sections for subchapter B of chapter 100 of such Code, as amended by section 101, is further amended by adding at the end the following new item:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id708432bb532a47aeaec2f6a81c67dd47"><toc regeneration="no-regeneration"><toc-entry level="section">Sec. 9828. Full rebate on insulin pass-through to plan.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section><enum>III</enum><header>Biosimilar biological product and generic drug competition and affordability</header><section id="ida58bb93c-e04e-46c0-ac18-afdde89034f2" changed="not-changed"><enum>301.</enum><header>Ensuring timely access to generics</header><text display-inline="no-display-inline">Section 505(q) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(q)</external-xref>) is amended—</text><paragraph id="id91a93553-4c88-4360-b75a-2c1c426837d9" changed="not-changed"><enum>(1)</enum><text>in paragraph (1)—</text><subparagraph id="id5f18e963-d9a4-47b2-a658-7836d0cb9f8d" changed="not-changed"><enum>(A)</enum><text>in subparagraph (A)(i), by inserting <quote>, 10.31,</quote> after <quote>10.30</quote>;</text></subparagraph><subparagraph id="idc70a17d7-bb24-4234-bf09-eef4c514df50" changed="not-changed"><enum>(B)</enum><text>in subparagraph (E)—</text><clause id="id5fa340e2-65f4-4019-9e21-017c02ae4b86" changed="not-changed"><enum>(i)</enum><text>by striking <quote>application and</quote> and inserting <quote>application or</quote>;</text></clause><clause id="id67c00fcc-4ca8-4104-ad64-61156f3a525e" changed="not-changed"><enum>(ii)</enum><text>by striking <quote>If the Secretary</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" changed="not-changed" id="idf96c6886-729d-4a30-95c8-f67d274bdde4"><clause id="id0989534b-035a-49ff-9a53-b98e7fbc287c" changed="not-changed"><enum>(i)</enum><header>In general</header><text>If the Secretary</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></clause><clause id="id8fa0a821-f800-4dbd-8caa-aa884a389a83" changed="not-changed"><enum>(iii)</enum><text>by striking the second sentence and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" changed="not-changed" id="ideebbad50-a37d-4e4a-858f-fbb7a8541eb1"><clause id="id2251f570-9f29-4fec-92be-06265e041b09" changed="not-changed"><enum>(ii)</enum><header>Primary purpose of delaying</header><subclause id="id5bf9f4cc-eb85-47cb-8865-5a3e7c2946df" changed="not-changed"><enum>(I)</enum><header>In general</header><text>In determining whether a petition was submitted with the primary purpose of delaying an application, the Secretary may consider the following factors:</text><item id="id285ad1af-70cf-47f0-a3a0-49e250aecdc4" changed="not-changed"><enum>(aa)</enum><text>Whether the petition was submitted in accordance with paragraph (2)(B), based on when the petitioner knew or reasonably should have known the relevant information relied upon to form the basis of such petition.</text></item><item id="id9678cf44-621a-4425-8e8d-5dd68882cbf9" changed="not-changed"><enum>(bb)</enum><text>Whether the petitioner has submitted multiple or serial petitions or supplements to petitions raising issues that reasonably could have been known to the petitioner at the time of submission of the earlier petition or petitions.</text></item><item id="id5e66e0ed-1dfd-46e8-8f6a-48d612a1189a" changed="not-changed"><enum>(cc)</enum><text>Whether the petition was submitted close in time to a known, first date upon which an application under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act could be approved.</text></item><item id="idb0682143-ab65-4012-9220-c906bbbd2617" changed="not-changed"><enum>(dd)</enum><text>Whether the petition was submitted without relevant data or information in support of the scientific positions forming the basis of such petition.</text></item><item id="idc920ae8b-9f81-4748-8a64-912e9e09d1b1" changed="not-changed"><enum>(ee)</enum><text>Whether the petition raises the same or substantially similar issues as a prior petition to which the Secretary has responded substantively already, including if the subsequent submission follows such response from the Secretary closely in time.</text></item><item id="id97129738-2db1-4cce-882a-a8e656b381dc" changed="not-changed"><enum>(ff)</enum><text>Whether the petition requests changing the applicable standards that other applicants are required to meet, including requesting testing, data, or labeling standards that are more onerous or rigorous than the standards the Secretary has determined to be applicable to the listed drug, reference product, or petitioner’s version of the same drug.</text></item><item id="idd1add92d-199d-4e69-a2df-4e4bb135f665" changed="not-changed"><enum>(gg)</enum><text>The petitioner's record of submitting petitions to the Food and Drug Administration that have been determined by the Secretary to have been submitted with the primary purpose of delay.</text></item><item id="id92880917-4824-4dc5-943a-0457ec226ca8" changed="not-changed"><enum>(hh)</enum><text>Other relevant and appropriate factors, which the Secretary shall describe in guidance.</text></item></subclause><subclause id="idee28926c-a3da-44aa-b236-341189e591f0" changed="not-changed"><enum>(II)</enum><header>Guidance</header><text>The Secretary may issue or update guidance, as appropriate, to describe factors the Secretary considers in accordance with subclause (I).</text></subclause></clause><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="id54433e6d-f0e3-4aeb-8f45-69cc4845388a" changed="not-changed"><enum>(C)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" changed="not-changed" id="id15a8b7a7-79d6-4fd2-afd1-6f606f003f5e"><clause id="id7093e5a5-b8f4-4209-8a0a-5ec246ac550c" changed="not-changed"><enum>(iii)</enum><header>Referral to the Federal Trade Commission</header><text>The Secretary shall establish procedures for referring to the Federal Trade Commission any petition or supplement to a petition that the Secretary determines was submitted with the primary purpose of delaying approval of an application. Such procedures shall include notification to the petitioner by the Secretary.</text></clause><after-quoted-block>; </after-quoted-block></quoted-block></subparagraph><subparagraph id="id481ac47c-0a5b-4216-8b06-e07ccba28ab2" changed="not-changed"><enum>(D)</enum><text>by striking subparagraph (F);</text></subparagraph><subparagraph commented="no" id="id90c423bd-e6e3-4d7b-9fb2-80bc36e28b51" changed="not-changed"><enum>(E)</enum><text>by redesignating subparagraphs (G) through (I) as subparagraphs (F) through (H), respectively; and</text></subparagraph><subparagraph id="id3e5d79a0-a5b5-4cb4-a006-84edc24165db" changed="not-changed"><enum>(F)</enum><text>in subparagraph (H), as so redesignated, by striking <quote>submission of this petition</quote> and inserting <quote>submission of this document</quote>;</text></subparagraph></paragraph><paragraph id="ida1fc6af6-f3ab-4dde-a4d2-a9363e4a6874" changed="not-changed"><enum>(2)</enum><text>in paragraph (2)—</text><subparagraph id="ida947751a-716c-40fc-a36c-4c0a1f94e784" changed="not-changed"><enum>(A)</enum><text>by redesignating subparagraphs (A) through (C) as subparagraphs (C) through (E), respectively;</text></subparagraph><subparagraph id="id9faf66a3-86a6-4c74-8104-5544f3933533" changed="not-changed"><enum>(B)</enum><text>by inserting before subparagraph (C), as so redesignated, the following:</text><quoted-block style="OLC" display-inline="no-display-inline" changed="not-changed" id="id9685a396-0601-4f3b-a2ea-638283d4f0df"><subparagraph id="idd04229dd-b3dd-4610-9c89-5072bda62ded" changed="not-changed"><enum>(A)</enum><header>In general</header><text>A person shall submit a petition to the Secretary under paragraph (1) before filing a civil action in which the person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act. Such petition and any supplement to such a petition shall describe all information and arguments that form the basis of the relief requested in any civil action described in the previous sentence.</text></subparagraph><subparagraph id="idf941870e-0bb9-4f72-874b-208be607bca5" changed="not-changed"><enum>(B)</enum><header>Timely submission of citizen petition</header><text>A petition and any supplement to a petition shall be submitted within 60 days after the person knew, or reasonably should have known, the information that forms the basis of the request made in the petition or supplement.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph id="id41bb8e52-fb44-4084-bba1-22561739791f" changed="not-changed"><enum>(C)</enum><text>in subparagraph (C), as so redesignated—</text><clause id="ide578e653-a0a3-4e79-8cca-c0c36d7b306d" changed="not-changed"><enum>(i)</enum><text>in the heading, by striking <quote><header-in-text level="subparagraph" style="OLC">within 150 days</header-in-text></quote>;</text></clause><clause id="id2f6ac947-76e3-47bf-80ce-e3ffa6207127" changed="not-changed"><enum>(ii)</enum><text>in clause (i), by striking <quote>during the 150-day period referred to in paragraph (1)(F),</quote>; and</text></clause><clause id="id2adf0cd2-bf68-42c4-a6bf-a62b650212d7" changed="not-changed"><enum>(iii)</enum><text>by amending clause (ii) to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" changed="not-changed" id="idaa0ea4ad-a131-49b8-9f9c-c742c7775e62"><clause id="id272d9829-76c2-4500-97ce-01f6d4b844ca" changed="not-changed"><enum>(ii)</enum><text>on or after the date that is 151 days after the date of submission of the petition, the Secretary approves or has approved the application that is the subject of the petition without having made such a final decision.</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="idd0a17fc2-576c-4467-b3ac-5564b43bc99c" changed="not-changed"><enum>(D)</enum><text>by amending subparagraph (D), as so redesignated, to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" changed="not-changed" id="idb09658e2-6381-4794-a0ce-4054ea738b9e"><subparagraph id="id5f1cd6cc-b2be-44eb-951e-6a402e7adcf6" changed="not-changed"><enum>(D)</enum><header>Dismissal of certain civil actions</header><clause id="id28959ab9-7db7-498c-ba4e-b5cb0a740533" changed="not-changed"><enum>(i)</enum><header>Petition</header><text>If a person files a civil action against the Secretary in which a person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act without complying with the requirements of subparagraph (A), the court shall dismiss without prejudice the action for failure to exhaust administrative remedies.</text></clause><clause id="id1fca24d2-6974-4400-ace4-17aa2d81396c" changed="not-changed"><enum>(ii)</enum><header>Timeliness</header><text>If a person files a civil action against the Secretary in which a person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act without complying with the requirements of subparagraph (B), the court shall dismiss with prejudice the action for failure to timely file a petition.</text></clause><clause id="idc897063a-3539-400e-ae78-0f7184c57bc9" changed="not-changed"><enum>(iii)</enum><header>Final response</header><text>If a civil action is filed against the Secretary with respect to any issue raised in a petition timely filed under paragraph (1) in which the petitioner requests that the Secretary take any form of action that could, if taken, set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act before the Secretary has taken final agency action on the petition within the meaning of subparagraph (C), the court shall dismiss without prejudice the action for failure to exhaust administrative remedies.</text></clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph id="id61c7cf80-cf31-4778-a527-dfae72e30233" changed="not-changed"><enum>(E)</enum><text>in clause (iii) of subparagraph (E), as so redesignated, by striking <quote>as defined under subparagraph (2)(A)</quote> and inserting <quote>within the meaning of subparagraph (C)</quote>; and</text></subparagraph></paragraph><paragraph id="id27364711-a1d6-477f-ba8c-76c878be1bc5" changed="not-changed"><enum>(3)</enum><text>in paragraph (4)—</text><subparagraph id="ide3e4fd3f-e50b-4f91-842e-6416738be674" changed="not-changed"><enum>(A)</enum><text>by striking <quote><header-in-text level="paragraph" style="OLC">Exceptions</header-in-text></quote> and all that follows through <quote>This subsection does</quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Exceptions.—</header-in-text>This subsection does</quote>;</text></subparagraph><subparagraph id="id95343acf-1517-4d9f-9d82-80689b38ce90" changed="not-changed"><enum>(B)</enum><text>by striking subparagraph (B); and</text></subparagraph><subparagraph id="id97eb7e70-6dbf-4666-82af-ad04260b956a" changed="not-changed"><enum>(C)</enum><text>by redesignating clauses (i) and (ii) as subparagraphs (A) and (B), respectively, and adjusting the margins accordingly.</text></subparagraph></paragraph></section><section id="idd43b376cc7804a0096a703a3785acabc"><enum>302.</enum><header>Expediting competitive biosimilar competition</header><subsection commented="no" display-inline="no-display-inline" id="id37a7c8a694de425b9dc4834643854212"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 351(k) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id21F6AD7F6A2948FDBBC60659B69A6B71"><paragraph id="id97c07a1920e14671957b4b3e4e1af0ec"><enum>(10)</enum><header>Expediting competitive biosimilar competition</header><subparagraph commented="no" display-inline="no-display-inline" id="id832b371aafcb414eb56b06f437e8a803"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text>The Secretary may, at the request of the sponsor of an application under this subsection for a biosimilar biological product that is designated as a competitive biosimilar therapy pursuant to subsection (b), expedite the development and review of such application under this subsection.</text></subparagraph><subparagraph id="ida8299d152ffb447a943daa8b5475e2b0"><enum>(B)</enum><header>Designation process</header><clause id="id7b17b2a1f10049928db1ea8093613094"><enum>(i)</enum><header>Request</header><text>The sponsor of an application under this subsection may request the Secretary to designate the drug as a competitive biosimilar therapy. A request for such designation may be made concurrently with, or at any time prior to, the submission of a biosimilar biological product license application under this subsection.</text></clause><clause id="id4dd8576b3b4346ceb1b5bd61dfa352df"><enum>(ii)</enum><header>Criteria</header><text>A biological product is eligible for designation as a competitive biosimilar therapy under this paragraph if the Secretary determines that there is inadequate biosimilar competition.</text></clause><clause id="id53518a5242b448e59607651dddf3eeea"><enum>(iii)</enum><header>Designation</header><text>Not later than 60 calendar days after the receipt of a request under clause (i), the Secretary may—</text><subclause id="id749872f7bab845039b92032cf028ab08"><enum>(I)</enum><text>determine whether the biosimilar biological product that is the subject of the request meets the criteria described in clause (ii); and</text></subclause><subclause id="id161f5eff1a6f4c8cbe8bab0faef62f5f"><enum>(II)</enum><text>if the Secretary finds that such product meets such criteria, designate the biosimilar biological product as a competitive biosimilar therapy.</text></subclause></clause></subparagraph><subparagraph commented="no" id="idf41a4381bcbb4d1dbb3643586408d817"><enum>(C)</enum><header>Actions</header><text>In expediting the development and review of an application under subparagraph (A), the Secretary may, as requested by the applicant, take actions including the following:</text><clause commented="no" id="id063b9c059a444f8cb967a08ac471b31f"><enum>(i)</enum><text>Hold meetings with the sponsor and the review team throughout the development of the biosimilar biological product prior to submission of the application under this subsection.</text></clause><clause commented="no" id="idad9b82ec85e14f77aa48953bce314a8b"><enum>(ii)</enum><text>Provide timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the data necessary for approval is as efficient as practicable.</text></clause><clause commented="no" id="id7b8755e0043d4e61bc795cef0859488a"><enum>(iii)</enum><text>Involve senior managers and experienced review staff, as appropriate, in a collaborative, coordinated review of such application, including with respect to biological product-device combination products and other complex products.</text></clause><clause commented="no" id="id92914ccc38534166b3fe02152eb5e03c"><enum>(iv)</enum><text>Assign a cross-disciplinary project lead—</text><subclause commented="no" id="idee8aecd90e2b423694b5c017ec2f0658"><enum>(I)</enum><text>to facilitate an efficient review of the development program and application, including manufacturing inspections; and</text></subclause><subclause commented="no" id="idbd50c2ae502343249460431ff5ad37e0"><enum>(II)</enum><text>to serve as a scientific liaison between the review team and the applicant.</text></subclause></clause></subparagraph><subparagraph id="id0679e69a3eaf420cbbf25ecb2b9167dd"><enum>(D)</enum><header>Inspections</header><text>With respect to an application described in subparagraph (A), in the case of an inspection report that finds approval of such biological product is dependent upon remediation of a facility, if the applicant attests that necessary changes have been made to the facility, the Secretary shall expedite reinspection of such facility, including establishing a set timeline to reinspect the facility or make a determination about the response of the applicant and whether to approve the application.</text></subparagraph><subparagraph id="idcb4b34022417483e81d8c3331210da7c"><enum>(E)</enum><header>Reporting requirement</header><text>Not later than 1 year after the date of licensure under this subsection with respect to a biosimilar biological product for which the development and review is expedited under this paragraph, the holder of the license of such biosimilar biological product shall report to the Secretary on whether the biosimilar biological product has been marketed in interstate commerce since the date of such licensure.</text></subparagraph><subparagraph commented="no" id="idc9c1f9b0e10148e99224cacd0544489d"><enum>(F)</enum><header>Inadequate biosimilar competition</header><text>In this paragraph, the term <term>inadequate biosimilar competition</term> means, with respect to a biological product, there are fewer than 3 licensed biological products on the list published under paragraph (9)(A) (not including biological products on the discontinued section of such list) that are biosimilar biological products with the same reference product.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section id="id4CCD1A24E7F44565A8722B85B490C403"><enum>303.</enum><header>Insulin competition report</header><text display-inline="no-display-inline">Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, in collaboration with the Administrator for the Centers for Medicare & Medicaid Services and the Commissioner of Food and Drugs, shall—</text><paragraph id="id2134E41932594037BEA1EC9346352A39"><enum>(1)</enum><text>complete a study to determine the extent of, and causes of, delays in getting insulin products to market, and the market dynamics and extent biosimilar biological product development and competition could increase, or is increasing, the number of biological products approved and available to patients, including by examining barriers to—</text><subparagraph commented="no" id="idD533A2DA7CE240648282EEA6D9438244"><enum>(A)</enum><text>placement of biosimilar biological products on health insurance formularies;</text></subparagraph><subparagraph commented="no" id="id74EC1E98775C4557BCBDA94591F198BC"><enum>(B)</enum><text>market entry of insulin product in the United States, as compared to other highly developed nations; and</text></subparagraph><subparagraph commented="no" id="idFB2D1E7123B44306AB4D273449815C85"><enum>(C)</enum><text>patient and provider education around biosimilar biological products; and</text></subparagraph></paragraph><paragraph id="idB3EADC24923448DD8471401FF430DD62"><enum>(2)</enum><text>submit a report to Congress that describes the results of the study conducted pursuant to paragraph (1) and recommended policy solutions.</text></paragraph></section><enum>IV</enum><header>Programs for providing affordable insulin to uninsured individuals</header><section id="HDFCD804EDF2245D98D6A2D399D5C4FE2"><enum>401.</enum><header>Pilot program for providing affordable insulin to uninsured individuals</header><text display-inline="no-display-inline">Part P of title III of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280g">42 U.S.C. 280g et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block id="id0911ED2AA0FB4B26A1F9CF07AD52D15C" display-inline="no-display-inline" style="OLC"><section id="id8ef15638008c4a7f93013f92137ed946"><enum>399V–8.<?LEXA-Enum 399V–8.?></enum><header>Pilot program for providing affordable insulin to uninsured individuals</header><subsection id="id137B186B121C4F929593F03FF928A840"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall conduct a 5-year pilot program under which the Secretary awards grants to 10 States for purposes of providing affordable insulin to uninsured individuals.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="idc0fa66c41acc4af8a10afd368a4a6143"><enum>(b)</enum><header>Awards</header><text>The Secretary shall award grants under this section to 10 States that—</text><paragraph commented="no" display-inline="no-display-inline" id="id2e6a6483bc7347c1812dd1f957a512a4"><enum>(1)</enum><text display-inline="yes-display-inline">submit an application to the Secretary, at such time, in such manner, and containing such information as the Secretary may require; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id637b10f9dd5f492f9a36d6a69dd1b529"><enum>(2)</enum><text>have high rates of uninsured individuals and individuals diagnosed with diabetes, which may include high rates of newly diagnosed diabetes.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id41b2e778859f4bb8b425ad65dd3a3ea3"><enum>(c)</enum><header display-inline="yes-display-inline">Use of funds</header><text>A State shall use the grant funds received under this section for any of the following purposes:</text><paragraph commented="no" display-inline="no-display-inline" id="id606b1f0b58c342d0abf8e48026c79052"> <enum>(1)</enum> <text display-inline="yes-display-inline">To assist in the purchase or dispensing of insulin, through Federally qualified health centers and retail community pharmacies, for uninsured individuals.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idb3bfdbc03d1043bf88cc4a6879e4770f"><enum>(2)</enum><text display-inline="yes-display-inline">To enroll individuals in programs under which drug manufacturers provide financial or medication assistance to low-income individuals, in order to assist such individuals in obtaining insulin.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0e7593a4144448dd95265409da7eb6ff"> <enum>(3)</enum> <text>To allow Federally qualified health centers to establish new, or maintain or expand existing, on-site pharmacies owned and operated by the health center that provide low-cost insulin to patients, and to allow retail community pharmacies to provide low-cost insulin to patients.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id16481bc8c407452d977cd6701c3b7e49"><enum>(4)</enum><text display-inline="yes-display-inline">To engage in other activities to assist uninsured individuals in obtaining insulin, as the Secretary determines appropriate.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id9ffeae3844a94a54bd26e44ca495ff6f"><enum>(d)</enum><header>Formula</header><text display-inline="yes-display-inline">The Secretary shall establish a formula for purposes of determining the grant amount under this section for each State. Such formula shall—</text><paragraph commented="no" display-inline="no-display-inline" id="id35ce7b4555f34113a71279add3aac119"><enum>(1)</enum><text display-inline="yes-display-inline">provide for a minimum amount that will be provided to each State; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id99232a478ccf41a29730b2accd223b0b"><enum>(2)</enum><text display-inline="yes-display-inline">take into account the rates of individuals with type 1 or type 2, insulin-dependent diabetes and of uninsured individuals in each State for purposes of determining any additional amounts provided to a State.</text></paragraph></subsection><subsection id="id34052554a229407ca95c8755b0784572"><enum>(e)</enum><header>Accountability and Oversight</header><text>A State receiving a grant under this section shall, not later than 1 year after receiving the grant, submit a report to the Secretary that includes—</text><paragraph commented="no" display-inline="no-display-inline" id="idc74ccffef517430dbae77107f6656d9f"><enum>(1)</enum><text display-inline="yes-display-inline">a description of the purposes for which the grant funds received by the State were expended in the preceding fiscal year, and the activities of the State under the grant during such year; and</text></paragraph><paragraph id="id641cfec786354c8c825dee9e01c908fb"><enum>(2)</enum><text>the number of individuals served through the grant.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id16b5a1356a9141599bb79dcaed9bca81"><enum>(f)</enum><header display-inline="yes-display-inline">Definitions</header><text>In this section:</text><paragraph id="id4C3D26B546D94113AC65C5197D867F25"><enum>(1)</enum><header>Affordable</header><text>The term <term>affordable</term>, with respect to insulin, means that the out-of-pocket cost to the individual for the insulin is not more than $35 per 1-month supply.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id99a3742fc9d642f88080b36966c1eb2d"><enum>(2)</enum><header display-inline="yes-display-inline">Federally-qualified health center</header><text>The term <term>Federally-qualified health center</term> has the meaning given such term in section 1905(l)(2) of the Social Security Act.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idced442309e874dc985e6a3150092d86d"><enum>(3)</enum><header display-inline="yes-display-inline">Insulin</header><text>The term <term>insulin</term> means insulin that is licensed under subsection (a) or (k) of section 351 and continues to be marketed under such section.</text></paragraph><paragraph id="id0d5902853d75480fb1983d2333b787c9"><enum>(4)</enum><header>Retail community pharmacy</header><text>The term <term>retail community pharmacy</term> has the meaning given such term in section 1927(k)(10) of the Social Security Act.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7d4abe34a55e4752bb9cece2dc202c39"><enum>(5)</enum><header display-inline="yes-display-inline">Uninsured individual</header><text>The term <term>uninsured individual</term> means an individual who—</text><subparagraph commented="no" display-inline="no-display-inline" id="idfe384662dbac4d1ba0ea539ac36d23f7"><enum>(A)</enum><text display-inline="yes-display-inline">is a citizen of the United States or a qualified alien (as defined in section 431(b) of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996);</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id521cb7bd14a94a57a95d0f1fb7ecf937"><enum>(B)</enum><text display-inline="yes-display-inline">does not qualify for coverage under a Federal health care program (as defined in section 1128B(f) of the Social Security Act), the health program established under <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/89">chapter 89</external-xref> of title 5, United States Code, or a group health plan or group health insurance coverage (as defined in section 2791); and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide6014bfd16724f7c97f1fdb0aa186a2c"><enum>(C)</enum><text display-inline="yes-display-inline">is not entitled to a premium assistance tax credit under <external-xref legal-doc="usc" parsable-cite="usc/26/36B">section 36B</external-xref> of the Internal Revenue Code of 1986.</text></subparagraph></paragraph></subsection><subsection id="id5eb2b877f28a41998bf1f2f84a486735" commented="no" display-inline="no-display-inline"><enum>(g)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">To carry out this section, there is authorized to be appropriated $100,000,000 for fiscal year 2027, to remain available until expended.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="id32bf0fc828ed42eda78509137a8eaacd"><enum>402.</enum><header>GAO study on uninsured individuals who use insulin</header><subsection commented="no" display-inline="no-display-inline" id="id3bbd3bfecf2c472583a083b2d441282b"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Comptroller General of the United States shall conduct a study, in consultation with patient, clinical, and provider groups and other experts, and not later than 2 years after the date of enactment of this Act, issue a report, on the characteristics of uninsured individuals who use insulin. Such study and report shall, to the extent data is available, include consideration of—</text><paragraph commented="no" display-inline="no-display-inline" id="ided7de0276c6c4aaea4b2c0fbe19c70c2"><enum>(1)</enum><text>any States or regions in which there is a higher prevalence of such individuals;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2cf569e15f9d4bc1aba0730ce522cd65"><enum>(2)</enum><text>any identifiable potential reasons for uninsured status;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id56dc833f9d7e48bc8e1e3592c98254af"><enum>(3)</enum><text>demographic characteristics of such individuals, such as race and ethnicity; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc8b3af6f3faa45c09d64418b7cb38adc"><enum>(4)</enum><text>income level of such individuals.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id5e5775626df24175ae0dee67a9fca9ba"><enum>(b)</enum><header>Definitions</header><text>In this section, the terms <term>insulin</term> and <term>uninsured individual</term> have the meanings given such terms in section 399V–8 of the Public Health Service Act, as added by section 401.</text></subsection></section><section commented="no" display-inline="no-display-inline" id="id8ced824e7e234ab5bee3d002b8e4449a"><enum>403.</enum><header>Insulin resource center and hotline for uninsured individuals</header><subsection id="id376d1d6352a14402ace4890284705a36"><enum>(a)</enum><header>In general</header><text>The Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) shall award a grant to an eligible entity for purposes of—</text><paragraph commented="no" display-inline="no-display-inline" id="id6662487a08ae4727ab9407c1c4ee5b4b"><enum>(1)</enum><text display-inline="yes-display-inline">establishing and maintaining a resource center of assistance programs offered by manufactures or other entities that are available to uninsured individuals seeking affordable insulin; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0f0337f6f85140e19cc4ab4593feb045"><enum>(2)</enum><text display-inline="yes-display-inline">conducting the public education activities described in subsection (c)(7).</text></paragraph></subsection><subsection id="id15503796791c4b7991495126cae81b65"><enum>(b)</enum><header>Eligible entities</header><text>To be eligible to receive the grant under subsection (a), an entity shall—</text><paragraph commented="no" display-inline="no-display-inline" id="idb7d156f70b9e4de7924956a5a7a8e587"><enum>(1)</enum><text display-inline="yes-display-inline">be a trade, industry, or professional association, community- and consumer-focused nonprofit entity, or other entity, as determined by the Secretary that—</text><subparagraph commented="no" display-inline="no-display-inline" id="idd18e35712b6c4959923712f19950ffb1"><enum>(A)</enum><text display-inline="yes-display-inline">is capable of carrying out the duties described in subsection (c);</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1ff438b0060a421485fd6746d18e9ffa"><enum>(B)</enum><text display-inline="yes-display-inline">meets the standards described in subsection (e); and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide4489bc3703744e8a79e444c24c02855"><enum>(C)</enum><text display-inline="yes-display-inline">provides information consistent with the standards developed under subsection (f); and</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id528fe056d73948a49dcf9aeefdf837cd"><enum>(2)</enum><text>submit an application to the Secretary, at such time, in such manner, and containing such information as the Secretary may require, including information demonstrating that the entity—</text><subparagraph commented="no" display-inline="no-display-inline" id="id5a2769b5ddb64721b6ef10dcbcea81ee"><enum>(A)</enum><text display-inline="yes-display-inline">has existing relationships, or could readily establish relationships, with consumers (including uninsured individuals), health care providers, manufacturers of insulin, social service providers, pharmacies, and other experts that the Secretary determines appropriate, to meet the goals of this section; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id95b6d01714a1465d8de68a9e71383f85"><enum>(B)</enum><text>has, or will establish, partnerships with, and solicit feedback from, other entities in other industries, professional associations, and community- and consumer-focused nonprofit organizations, to meet the goals of this section.</text></subparagraph></paragraph></subsection><subsection id="id67f40f87db3e41cfa2009983e1564b96"><enum>(c)</enum><header>Duties</header><text>An entity that receives a grant under this section shall—</text><paragraph commented="no" display-inline="no-display-inline" id="id64ec04bcb3f14b5e97af37501fff4d32"><enum>(1)</enum><text display-inline="yes-display-inline">distribute fair and impartial information concerning eligibility for manufacturer, foundational, and other assistance programs available to patients seeking affordable insulin;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfd1ac208c4f240aa8e5da5eff38859ba"><enum>(2)</enum><text display-inline="yes-display-inline">facilitate enrollment in manufacturer assistance programs or other assistance programs for uninsured individuals;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7460c4a5231349cdb9f503e8cf014571"><enum>(3)</enum><text>make available to the public, through a standardized website, a clearinghouse of support available to patients, including—</text><subparagraph commented="no" display-inline="no-display-inline" id="idfacf2c0857ba49649fc459b9645bc04f"> <enum>(A)</enum> <text>a link to Federally qualified health centers and other providers, by ZIP Code;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id98455d6770544485a634ac3720aad2ab"><enum>(B)</enum><text display-inline="yes-display-inline">a link to retail community pharmacies, by ZIP Code; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idf799a567bacf4ecd8c4278988b16275d"><enum>(C)</enum><text display-inline="yes-display-inline">information about how to enroll in health insurance;</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id52e36e9acbaf4851a76e8fea356b2eee"><enum>(4)</enum><text display-inline="yes-display-inline">provide information in a manner that is culturally and linguistically appropriate;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id146c9d63e89b4ba18875ee0ae51bb3a7"><enum>(5)</enum><text>establish a hotline through which individuals may reach experts with questions about access to insulin, and that—</text><subparagraph commented="no" display-inline="no-display-inline" id="id2038e65168b54897907cfb80773a4437"> <enum>(A)</enum> <text display-inline="yes-display-inline">is a 24/7 real-time hotline;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide9a8c40c006b4e88808d7ee9fe7f3b1d"><enum>(B)</enum><text display-inline="yes-display-inline">provides voice and text support; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id5f852ffcccfd4177b69e813631b8a675"><enum>(C)</enum><text display-inline="yes-display-inline">is staffed by navigators or licensed health care professionals;</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfbe547c56a9a4be6a3181032be1709ea"><enum>(6)</enum><text>provide guidance to hospitals on how to share the website and hotline with patients; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id68b63257972b4f898455a4039d6d8ad0"><enum>(7)</enum><text>conduct public education activities, in collaboration with the Department of Health and Human Services, to raise awareness of the availability of all manufacturer, foundational, and other assistance programs available to patients seeking affordable insulin, with a focus on uninsured individuals; including by—</text><subparagraph id="id8e47c5f5593d4bfd9bc143e239a1cd0d"><enum>(A)</enum><text>partnering with community health centers, hospitals, retail community pharmacies, and community-based organizations with a focus on access to affordable medicine; and</text></subparagraph><subparagraph id="id79c7272d758b49fca37f63a026961a02"><enum>(B)</enum><text>working with State and local health departments to target the programs carried out using the grant to underserved communities.</text></subparagraph></paragraph></subsection><subsection id="id092af6967c9447749dcd222922fa547b"><enum>(d)</enum><header>Duties of the Secretary</header><text>The Secretary shall—</text><paragraph commented="no" display-inline="no-display-inline" id="id063564c0e0364b8e8f19870d53927032"><enum>(1)</enum><text display-inline="yes-display-inline">ensure adequate maintenance of the resource center established by the entity receiving a grant under subsection (a);</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id240596f5623e473585673a625dc6860d"><enum>(2)</enum><text>publicize such resource center on the website of the Department of Health and Human Services and across Federal agencies, as the Secretary determines appropriate; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd3e0a99e7d5c4b78bd996c1fcec7e9b9"><enum>(3)</enum><text>ensure that such resource center meets the standards under subsection (e), and withdraw the grant and make an award to a different eligible entity in the case that an eligible entity fails to meet such standards.</text></paragraph></subsection><subsection id="id367cf8e17e5d4b7d9a3abdfc2594eb35"><enum>(e)</enum><header>Standards</header><text>The Secretary shall establish standards for the resource center under this section, including provisions to ensure that the entity receiving a grant under this section is qualified to engage in the activities described in this section and to avoid conflicts of interest. Under such standards, such entity—</text><paragraph commented="no" display-inline="no-display-inline" id="idaf60a439a8e0408bb5c84262a937137a"><enum>(1)</enum><text display-inline="yes-display-inline">shall not—</text><subparagraph commented="no" display-inline="no-display-inline" id="id7c85060c6f3744dd9d93be8c881ef0a4"><enum>(A)</enum><text display-inline="yes-display-inline">be a manufacturer of insulin products; or</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7031d6c35c4b4d32a290487b160659d9"><enum>(B)</enum><text display-inline="yes-display-inline">receive any consideration directly or indirectly from any manufacturer of insulin products in connection with the enrollment of any individuals in an assistance program; and</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id01a9bb10677d4d1698e282214a4d8fc9"><enum>(2)</enum><text>shall provide information that is fair, accurate, and impartial.</text></paragraph></subsection><subsection id="id374966f259044cac9988dd0072f3af4e"><enum>(f)</enum><header>Data collection and evaluations</header><text>The Secretary may collect data and conduct evaluations with respect to the services provided by the resource center described in this section for purposes of assessing the extent to which the provision of the services—</text><paragraph id="id3e53f3fe157d47bfbc9678fb8ddfcf32"><enum>(1)</enum><text>reduces out of pocket insulin costs for uninsured individuals;</text></paragraph><paragraph id="idfa9d9e2f8be54df3b596c5be2287c02b"><enum>(2)</enum><text>increases awareness of assistance programs or foundational support available for uninsured individuals; and</text></paragraph><paragraph id="idcdab8f6a1fbe49718ea4f83474a1b9ea"><enum>(3)</enum><text>improves utilization of the resources described in paragraph (2) by uninsured individuals.</text></paragraph></subsection><subsection id="id65f609867ac84905b3d93459ce350758"><enum>(g)</enum><header>Reports to Congress</header><text>The Secretary shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and make publicly available, annual reports on the activities carried out under this section, including any changes in the availability or scope of assistance programs offered by insulin manufacturers and information about the number of individuals who use the resource center, including the website or hotline.</text></subsection><subsection id="idD841B757C4364290951F1CC63112EA9F"><enum>(h)</enum><header>Definitions</header><text>In this section—</text><paragraph id="idF0B9F11AE9DF49B090C7629092D0D4FF"><enum>(1)</enum><text>the term <term>assistance program</term> means a program to assist patients in obtaining a drug at a reduced cost, and includes third-party payments, financial assistance, discounts, product vouchers, and other reductions in out-of-pocket expenses;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1cf594265e274f72a8bb2882b41bd205"><enum>(2)</enum><text>the term <term>Federally-qualified health center</term> has the meaning given such term in section 1905(l)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396d">42 U.S.C. 1396d(l)(2)</external-xref>);</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6dc9c3effdd7481d82e12509f3aa6b04"><enum>(3)</enum><text display-inline="yes-display-inline">the term <term>insulin</term> means insulin that is licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>) and continues to be marketed pursuant to such licensure;</text></paragraph><paragraph id="ide8c740bb0a3943679cdd6b744366b515"> <enum>(4)</enum> <text>the term <term>retail community pharmacy</term> has the meaning given such term in section 1927(k)(10) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(k)(10)</external-xref>); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd63d37bb775e4c5c85fc4ffaf4c498d6"><enum>(5)</enum><text display-inline="yes-display-inline">the term <term>uninsured individual</term> means an individual who—</text><subparagraph commented="no" display-inline="no-display-inline" id="id803e0923f5404e9dbb47be1ea333e4d9"><enum>(A)</enum><text display-inline="yes-display-inline">does not qualify for coverage under a Federal health care program (as defined in section 1128B(f) of the Social Security Act (42 U.S.C. 1320a–7b(f))), the health program established under <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/89">chapter 89</external-xref> of title 5, United States Code, or a group health plan or group health insurance coverage (as defined in section 2791 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-91">42 U.S.C. 300gg–91</external-xref>)); and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA72C12B5F09242519C9DA172FD6F1F56"><enum>(B)</enum><text display-inline="yes-display-inline">is not entitled to a premium assistance tax credit under <external-xref legal-doc="usc" parsable-cite="usc/26/36B">section 36B</external-xref> of the Internal Revenue Code of 1986.</text></subparagraph></paragraph></subsection><subsection id="idC61D38FC582D49F5A91E68E568DFEBED" commented="no" display-inline="no-display-inline"><enum>(i)</enum><header>Funding</header><text>To carry out this section, there are authorized to be appropriated $2,000,000 for each of fiscal years 2027 through 2032.</text></subsection></section>