Access to TESTs Act

II 117TH CONGRESS 1ST SESSION S. 1018 To amend the Public Health Service Act to authorize grants for acquiring equipment and supplies capable of performing same-day clinical labora- tory testing in a point-of-care setting, and to assist laboratories in meeting the cost of acquiring high-throughput equipment, and for other purposes. 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, Edu- cation, Labor, and Pensions A BILL To amend the Public Health Service Act to authorize grants for acquiring equipment and supplies capable of per- forming 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 18:18 Apr 20, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1018.IS S1018 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 1018 IS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Access to Technology 2 and Equipment for Same-day Tests (TESTs) Act’’ or the 3 ‘‘Access to TESTs Act’’. 4 SEC. 2. GRANTS FOR SAME-DAY POINT-OF-CARE TESTING 5 IN COMMUNITIES. 6 Section 2821 of the Public Health Service Act (42 7 U.S.C. 300hh–31) is amended— 8 (1) by redesignating subsection (b) as sub- 9 section (d); and 10 (2) by inserting after subsection (a) the fol- 11 lowing new subsection: 12 ‘‘(b) GRANTS FOR SAME-DAY POINT-OF-CARE TEST- 13 ING IN COMMUNITIES.— 14 ‘‘(1) GRANTS.—The Secretary, acting through 15 the Director of the Centers for Disease Control and 16 Prevention, shall award grants to eligible entities to 17 assist such entities in acquiring legally marketed 18 same-day point-of care tests (as defined by the Di- 19 rector), equipment, and supplies, including molec- 20 ular, serological, and antigen tests. 21 ‘‘(2) ELIGIBILITY.—To be eligible for a grant 22 under paragraph (1), an entity shall— 23 ‘‘(A) be— 24 ‘‘(i) a hospital; 25 ‘‘(ii) a primary care facility; 26 VerDate Sep 11 2014 18:18 Apr 20, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1018.IS S1018 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 1018 IS ‘‘(iii) a clinic; 1 ‘‘(iv) a physician; or 2 ‘‘(v) another type health care provider 3 as the Secretary may define; 4 ‘‘(B) be qualified to have the same-day 5 point-of-care testing performed at the entity as 6 a result of operating under a Certificate of 7 Waiver, Certificate of Compliance, or Certificate 8 of Accreditation, under section 353; and 9 ‘‘(C) submit to the Secretary an applica- 10 tion at such time, in such manner, and con- 11 taining such information as the Secretary may 12 reasonably require. 13 ‘‘(3) USE OF FUNDS.—Amounts received 14 through a grant under this subsection shall be used 15 to purchase legally marketed same-day point-of-care 16 testing and materials as are necessary to administer, 17 store, and process such tests. 18 ‘‘(4) AMOUNT OF GRANT.—The amount of a 19 grant under paragraph (1) may not exceed $20,000. 20 ‘‘(5) PRIORITY IN MAKING AWARDS.—In award- 21 ing grants under paragraph (1), the Secretary shall 22 give priority first to eligible entities providing serv- 23 ices to underserved populations in rural areas and 24 then to eligible entities providing services to medi- 25 VerDate Sep 11 2014 18:18 Apr 20, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1018.IS S1018 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 1018 IS cally underserved populations (as defined in section 1 330(b)(3)) in rural areas. The Secretary may then 2 award such grants to eligible entities serving all 3 other areas.’’. 4 SEC. 3. GRANTS FOR LABORATORIES TO ACQUIRE HIGH- 5 THROUGHPUT DIAGNOSTIC EQUIPMENT. 6 Section 2821 of the Public Health Service Act (42 7 U.S.C. 300hh–31) is amended by inserting after sub- 8 section (b) (as added by section 2), the following new sub- 9 section: 10 ‘‘(c) GRANTS FOR LABORATORIES TO ACQUIRE 11 HIGH-THROUGHPUT DIAGNOSTIC EQUIPMENT.— 12 ‘‘(1) GRANTS.—The Secretary, acting through 13 the Director of the Centers for Disease Control and 14 Prevention, shall award grants to eligible entities to 15 assist such entities in purchasing high-throughput 16 diagnostic equipment and related supplies. 17 ‘‘(2) ELIGIBILITY.—To be eligible for a grant 18 under paragraph (1), an entity shall— 19 ‘‘(A) be— 20 ‘‘(i) a State, local, or Tribal public 21 health laboratory; 22 ‘‘(ii) a laboratory within a public 23 health laboratory network coordinated or 24 VerDate Sep 11 2014 18:18 Apr 20, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1018.IS S1018 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 1018 IS managed by the Centers for Disease Con- 1 trol and Prevention; or 2 ‘‘(iii) a consortium of 2 or more enti- 3 ties described in any of clauses (i) and (ii); 4 and 5 ‘‘(B) submit to the Secretary an applica- 6 tion at such time, in such manner, and con- 7 taining such information as the Secretary may 8 reasonably require. 9 ‘‘(3) USE OF FUNDS.—Amounts received 10 through a grant under this subsection shall be used 11 to purchase high-throughput diagnostic equipment 12 and such materials as are necessary to administer, 13 store, and process such tests. 14 ‘‘(4) AMOUNT OF GRANT.—The amount of a 15 grant under paragraph (1) may not exceed 16 $2,000,000, except in the case of eligible entity de- 17 scribed in paragraph (2)(A)(iv). 18 ‘‘(5) HIGH-THROUGHPUT DIAGNOSTIC EQUIP- 19 MENT DEFINED.—In this subsection, the term ‘high- 20 throughput diagnostic equipment’ means legally 21 marketed equipment and supplies capable of per- 22 forming multichannel analysis for use in clinical lab- 23 oratory testing, including diagnostic, serological, and 24 antigen tests.’’. 25 VerDate Sep 11 2014 18:18 Apr 20, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1018.IS S1018 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 1018 IS SEC. 4. AUTHORIZATION OF APPROPRIATIONS. 1 Section 2821(d) of the Public Health Service Act (42 2 U.S.C. 300hh–31) (as so redesignated by section 2) is 3 amended— 4 (1) by redesignating paragraphs (1), (2), and 5 (3) as subparagraphs (A), (B), and (C), respectively, 6 and moving the margin of each such redesignated 7 subparagraph 2 ems to the right; 8 (2) by striking ‘‘There are authorized to be ap- 9 propriated to carry out this section’’ and inserting 10 the following: 11 ‘‘(1) IN GENERAL.—There are authorized to be 12 appropriated to carry out subsection (a)’’; and 13 (3) by adding at the end, the following new 14 paragraph: 15 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 16 ‘‘(A) TESTING GRANTS.—For the purpose 17 of carrying out subsection (b), there is author- 18 ized to be appropriated $500,000,000 for fiscal 19 year 2021, to remain available until expended. 20 ‘‘(B) EQUIPMENT GRANTS.—For the pur- 21 pose of carrying out subsection (c), there is au- 22 thorized to be appropriated $250,000,000 for 23 fiscal year 2021, to remain available until ex- 24 pended. 25 VerDate Sep 11 2014 18:18 Apr 20, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1018.IS S1018 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 1018 IS ‘‘(C) ADMINISTRATIVE EXPENSES.—Of the 1 amount made available to carry out subsection 2 (b) or (c) for any fiscal year, the Secretary may 3 not use more than 5 percent of such amount for 4 the expenses of administering this section.’’. 5 Æ VerDate Sep 11 2014 18:18 Apr 20, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\S1018.IS S1018 pamtmann on DSKBC07HB2PROD with BILLS