II 117th CONGRESS 1st Session S. 1018 IN THE SENATE OF THE UNITED STATES March 25, 2021 Ms. Klobuchar (for herself and Mr. Braun ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL 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.

1. Short title This Act may be cited as the Access to Technology and Equipment for Same-day Tests (TESTs) Act or the Access to TESTs Act . 2. Grants for same-day point-of-care testing in communities Section 2821 of the Public Health Service Act ( 42 U.S.C. 300hh–31 ) is amended— (1) by redesignating subsection (b) as subsection (d); and (2) by inserting after subsection (a) the following new subsection: (b) Grants for same-Day point-of-Care testing in communities (1) Grants 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. (2) Eligibility To be eligible for a grant under paragraph (1), an entity shall— (A) be— (i) a hospital; (ii) a primary care facility; (iii) a clinic; (iv) a physician; or (v) another type health care provider as the Secretary may define; (B) 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 (C) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may reasonably require. (3) Use of funds 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. (4) Amount of grant The amount of a grant under paragraph (1) may not exceed $20,000. (5) Priority in making awards 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. . 3. Grants for laboratories to acquire high-throughput diagnostic equipment Section 2821 of the Public Health Service Act ( 42 U.S.C. 300hh–31 ) is amended by inserting after subsection (b) (as added by section 2), the following new subsection: (c) Grants for laboratories To acquire high-Throughput diagnostic equipment (1) Grants 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. (2) Eligibility To be eligible for a grant under paragraph (1), an entity shall— (A) be— (i) a State, local, or Tribal public health laboratory; (ii) a laboratory within a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention; or (iii) a consortium of 2 or more entities described in any of clauses (i) and (ii); and (B) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may reasonably require. (3) Use of funds 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. (4) Amount of grant 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). (5) High-throughput diagnostic equipment defined In this subsection, the term high-throughput diagnostic equipment means legally marketed equipment and supplies capable of performing multichannel analysis for use in clinical laboratory testing, including diagnostic, serological, and antigen tests. . 4. Authorization of appropriations Section 2821(d) of the Public Health Service Act ( 42 U.S.C. 300hh–31 ) (as so redesignated by section 2) is amended— (1) 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; (2) by striking There are authorized to be appropriated to carry out this section and inserting the following: (1) In general There are authorized to be appropriated to carry out subsection (a) ; and (3) by adding at the end, the following new paragraph: (2) Authorization of Appropriations (A) Testing grants 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. (B) Equipment grants 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. (C) Administrative expenses 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. .