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<distribution-code display="yes">II</distribution-code><congress>117th CONGRESS</congress><session>1st Session</session><legis-num>S. 1018</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20210325">March 25, 2021</action-date><action-desc><sponsor name-id="S311">Ms. Klobuchar</sponsor> (for herself and <cosponsor name-id="S397">Mr. Braun</cosponsor>) introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSHR00">Committee on Health, Education, Labor, and Pensions</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>To amend the Public Health Service Act to authorize grants for acquiring equipment and supplies capable of performing same-day clinical laboratory testing in a point-of-care setting, and to assist laboratories in meeting the cost of acquiring high-throughput equipment, and for other purposes.</official-title></form><legis-body display-enacting-clause="yes-display-enacting-clause"><section section-type="section-one" id="S1"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Access to Technology and Equipment for Same-day Tests (TESTs) Act</short-title></quote> or the <quote><short-title>Access to TESTs Act</short-title></quote>.</text></section><section section-type="subsequent-section" id="H8AADAA0F6B5B43FBA9CFB930DACE72F7"><enum>2.</enum><header>Grants for same-day point-of-care testing in communities</header><text display-inline="no-display-inline">Section 2821 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-31">42 U.S.C. 300hh–31</external-xref>) is amended—</text><paragraph id="H9606D8553E6A49C188A1DB536339AD13"><enum>(1)</enum><text>by redesignating subsection (b) as subsection (d); and</text></paragraph><paragraph id="H9CF7505B2EED4DC7B03845453F90ABEC"><enum>(2)</enum><text>by inserting after subsection (a) the following new subsection:</text><quoted-block style="OLC" id="HB562B867E5A74F2F81A8D3F13C3C6830"><subsection id="HABBED6EB56FC4EC2A3E7310EC9A79D8D"><enum>(b)</enum><header>Grants for same-Day point-of-Care testing in communities</header><paragraph id="HB476F0FD59504C369CA6751B6EC42DD6"><enum>(1)</enum><header>Grants</header><text display-inline="yes-display-inline">The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award grants to eligible entities to assist such entities in acquiring legally marketed same-day point-of care tests (as defined by the Director), equipment, and supplies, including molecular, serological, and antigen tests.</text></paragraph><paragraph id="H53A88789F1DB4DDC817B9660A284C965"><enum>(2)</enum><header>Eligibility</header><text>To be eligible for a grant under paragraph (1), an entity shall—</text><subparagraph id="H3ECB298DEA154B9099F470C09C666A45"><enum>(A)</enum><text>be—</text><clause id="H1E58ADA67FC34CC992A63D90650947DB"><enum>(i)</enum><text>a hospital;</text></clause><clause id="HEF08EE8F21634F37A3B18BA4825EDAC6"><enum>(ii)</enum><text>a primary care facility;</text></clause><clause id="H1C502BF9783C4DED965F21199ED3FF56"><enum>(iii)</enum><text>a clinic;</text></clause><clause id="H184F737F45E6472B8041E6BFC64750BB"><enum>(iv)</enum><text>a physician; or</text></clause><clause id="HC2F35A81DAB7463BA6117A10844483F0"><enum>(v)</enum><text>another type health care provider as the Secretary may define;</text></clause></subparagraph><subparagraph id="ida05acdee9532472fa200b931f6b98b27"><enum>(B)</enum><text>be qualified to have the same-day point-of-care testing performed at the entity as a result of operating under a Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, under section 353; and </text></subparagraph><subparagraph id="H0316069A758C4A26994783AEDB080E45"><enum>(C)</enum><text>submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may reasonably require.</text></subparagraph></paragraph><paragraph id="H4AE8539C387045D38BC8642167194F70"><enum>(3)</enum><header>Use of funds</header><text display-inline="yes-display-inline">Amounts received through a grant under this subsection shall be used to purchase legally marketed same-day point-of-care testing and materials as are necessary to administer, store, and process such tests.</text></paragraph><paragraph id="HECD57751DDE74A6A8824D3D144076F2C"><enum>(4)</enum><header>Amount of grant</header><text>The amount of a grant under paragraph (1) may not exceed $20,000.</text></paragraph><paragraph id="H5FF8BE5371D54625B127450D79C2FC99"><enum>(5)</enum><header>Priority in making awards</header><text>In awarding grants under paragraph (1), the Secretary shall give priority first to eligible entities providing services to underserved populations in rural areas and then to eligible entities providing services to medically underserved populations (as defined in section 330(b)(3)) in rural areas. The Secretary may then award such grants to eligible entities serving all other areas.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="idA2DB736303B64C85A5041831A434CA8B"><enum>3.</enum><header>Grants for laboratories to acquire high-throughput diagnostic equipment</header><text display-inline="no-display-inline">Section 2821 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-31">42 U.S.C. 300hh–31</external-xref>) is amended by inserting after subsection (b) (as added by section 2), the following new subsection:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idCF5DDF86D2DD4F2CA2775F60E554A919"><subsection id="H16FA52350C574FC8A297B63220EE6C1A"><enum>(c)</enum><header>Grants for laboratories To acquire high-Throughput diagnostic equipment</header><paragraph id="HFED5E21F746149358B07DD0D3157C04F"><enum>(1)</enum><header>Grants</header><text display-inline="yes-display-inline">The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award grants to eligible entities to assist such entities in purchasing high-throughput diagnostic equipment and related supplies.</text></paragraph><paragraph id="H81D523C923444F7C9B9A6E7646527167"><enum>(2)</enum><header>Eligibility</header><text>To be eligible for a grant under paragraph (1), an entity shall—</text><subparagraph id="H114E4006393940808F3D47C0CD86AFB7"><enum>(A)</enum><text>be—</text><clause id="H5D09808F6A9C45FF87F49CE34247DBD0"><enum>(i)</enum><text>a State, local, or Tribal public health laboratory;</text></clause><clause id="H0DA2C617B4154123A51E88A82DB91929"><enum>(ii)</enum><text>a laboratory within a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention; or</text></clause><clause id="HD1601F9A03DC4310B591CB38EFDC3F39"><enum>(iii)</enum><text>a consortium of 2 or more entities described in any of clauses (i) and (ii); and</text></clause></subparagraph><subparagraph id="HD463BB473F45494C8AFD0A44ACBE0F2D"><enum>(B)</enum><text>submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may reasonably require.</text></subparagraph></paragraph><paragraph id="HD3C307604ABA4A7BA18D3956A1A18BC3"><enum>(3)</enum><header>Use of funds</header><text display-inline="yes-display-inline">Amounts received through a grant under this subsection shall be used to purchase high-throughput diagnostic equipment and such materials as are necessary to administer, store, and process such tests.</text></paragraph><paragraph id="HC786003200BE43F4B0DC861ED793E6E7"><enum>(4)</enum><header>Amount of grant</header><text>The amount of a grant under paragraph (1) may not exceed $2,000,000, except in the case of eligible entity described in paragraph (2)(A)(iv).</text></paragraph><paragraph id="H019E4209334848B99924FB518E07CC57"><enum>(5)</enum><header>High-throughput diagnostic equipment defined</header><text display-inline="yes-display-inline">In this subsection, the term <term>high-throughput diagnostic equipment</term> means legally marketed equipment and supplies capable of performing multichannel analysis for use in clinical laboratory testing, including diagnostic, serological, and antigen tests.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="id2FE5C4EDE8FD4C4A948D29A09E08190E"><enum>4.</enum><header>Authorization of appropriations</header><text display-inline="no-display-inline">Section 2821(d) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-31">42 U.S.C. 300hh–31</external-xref>) (as so redesignated by section 2) is amended—</text><paragraph id="H0203901E475A44D1AAA037EE30116623"><enum>(1)</enum><text>by redesignating paragraphs (1), (2), and (3) as subparagraphs (A), (B), and (C), respectively, and moving the margin of each such redesignated subparagraph 2 ems to the right;</text></paragraph><paragraph id="HBEE733D27EAC4167A256E66B6F797B23"><enum>(2)</enum><text display-inline="yes-display-inline">by striking <quote>There are authorized to be appropriated to carry out this section</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H55800D48627545D9A74C77BBF0380C06"><paragraph id="H938B0BDFE07B4C56959D27F47E4549EA"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">There are authorized to be appropriated to carry out subsection (a)</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="HE7ED4F8E1AEC4FC696BED6E36954A538"><enum>(3)</enum><text>by adding at the end, the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H0123CE8224D748F69EF8EEAD9D1CD7CE"><paragraph id="H0B02F9BC5B1D4C06820566FFCE3A3287"><enum>(2)</enum><header>Authorization of Appropriations</header><subparagraph id="HAD45800988A049D8BCB2FB043FBC8633"><enum>(A)</enum><header>Testing grants</header><text display-inline="yes-display-inline">For the purpose of carrying out subsection (b), there is authorized to be appropriated $500,000,000 for fiscal year 2021, to remain available until expended.</text></subparagraph><subparagraph id="idE480C68F36E546D4ACB4AD4AFB85FB87"><enum>(B)</enum><header>Equipment grants</header><text>For the purpose of carrying out subsection (c), there is authorized to be appropriated $250,000,000 for fiscal year 2021, to remain available until expended. </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HCF0561AD9FC145B888FAFC0E1BEBB3BA"><enum>(C)</enum><header>Administrative expenses</header><text>Of the amount made available to carry out subsection (b) or (c) for any fiscal year, the Secretary may not use more than 5 percent of such amount for the expenses of administering this section.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section></legis-body></bill> |
