Access to TESTs Act

I 117TH CONGRESS 1ST SESSION H. R. 747 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 HOUSE OF REPRESENTATIVES FEBRUARY 3, 2021 Ms. DEGETTE (for herself and Mr. BUCSHON) introduced the following bill; which was referred to the Committee on Energy and Commerce 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 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Access to Technology 4 and Equipment for Same-day Tests Act’’ or the ‘‘Access 5 to TESTs Act’’. 6 VerDate Sep 11 2014 22:08 Feb 22, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H747.IH H747 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 747 IH SEC. 2. GRANTS FOR SAME-DAY POINT-OF-CARE TESTING 1 IN COMMUNITIES. 2 Section 2821 of the Public Health Service Act (42 3 U.S.C. 300hh–31) is amended— 4 (1) by redesignating subsection (b) as sub- 5 section (d); and 6 (2) after making such redesignation, by insert- 7 ing after subsection (a) the following new subsection: 8 ‘‘(b) GRANTS FOR SAME-DAY POINT-OF-CARE TEST- 9 ING IN COMMUNITIES.— 10 ‘‘(1) GRANTS.—The Secretary, acting through 11 the Director of the Centers for Disease Control and 12 Prevention, shall award grants to eligible entities to 13 assist such entities in acquiring legally-marketed 14 equipment and supplies capable of performing, stor- 15 ing, and processing same-day clinical laboratory test- 16 ing, including molecular, serological, and antigen 17 tests, in a point-of-care setting. 18 ‘‘(2) ELIGIBILITY.—To be eligible for a grant 19 under paragraph (1), an entity shall— 20 ‘‘(A) be— 21 ‘‘(i) a hospital; 22 ‘‘(ii) a primary care facility; 23 ‘‘(iii) a clinic; 24 ‘‘(iv) a pharmacy; 25 ‘‘(v) a physician; or 26 VerDate Sep 11 2014 22:08 Feb 22, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H747.IH H747 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 747 IH ‘‘(vi) such other type of health care 1 provider as the Secretary may determine 2 for purposes of this section; 3 ‘‘(B) be in compliance with section 353 4 (commonly referred to as the ‘Clinical Labora- 5 tory Improvement Amendments of 1988’); and 6 ‘‘(C) submit to the Secretary an applica- 7 tion at such time, in such manner, and con- 8 taining such information as the Secretary may 9 reasonably require. 10 ‘‘(3) AMOUNT OF GRANT.—The amount of a 11 grant under paragraph (1) may not exceed $20,000. 12 ‘‘(4) PRIORITY.—In awarding grants under 13 paragraph (1), the Secretary shall give highest pri- 14 ority to eligible entities providing services to— 15 ‘‘(A) underserved populations in rural 16 areas; and 17 ‘‘(B) medically underserved populations (as 18 defined in section 330(b)(3)).’’. 19 SEC. 3. GRANTS FOR LABORATORIES TO ACQUIRE HIGH- 20 THROUGHPUT DIAGNOSTIC EQUIPMENT. 21 Section 2821 of the Public Health Service Act (42 22 U.S.C. 300hh–31) is amended by inserting after sub- 23 section (b) (as added by section 2) the following new sub- 24 section: 25 VerDate Sep 11 2014 22:08 Feb 22, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H747.IH H747 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 747 IH ‘‘(c) GRANTS FOR LABORATORIES TO ACQUIRE 1 HIGH-THROUGHPUT DIAGNOSTIC EQUIPMENT.— 2 ‘‘(1) GRANTS.—The Secretary, acting through 3 the Director of the Centers for Disease Control and 4 Prevention, shall award grants to eligible entities to 5 assist such entities in purchasing high-throughput 6 diagnostic equipment and related supplies to admin- 7 ister, store, and process molecular, serological, and 8 antigen tests. 9 ‘‘(2) ELIGIBILITY.—To be eligible for a grant 10 under paragraph (1), an entity shall— 11 ‘‘(A) be— 12 ‘‘(i) a State, local, or Tribal public 13 health laboratory; 14 ‘‘(ii) a laboratory within a public 15 health laboratory network coordinated or 16 managed by the Centers for Disease Con- 17 trol and Prevention; 18 ‘‘(iii) a laboratory not described in 19 clause (i) or (ii) that the Secretary deter- 20 mines (at the Secretary’s discretion) pro- 21 vides population-based testing for the pre- 22 vention and control of infectious, commu- 23 nicable, genetic, or chronic diseases; or 24 VerDate Sep 11 2014 22:08 Feb 22, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H747.IH H747 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 747 IH ‘‘(iv) a consortium of 2 or more enti- 1 ties described in any of clauses (i) through 2 (iii); and 3 ‘‘(B) submit to the Secretary an applica- 4 tion at such time, in such manner, and con- 5 taining such information as the Secretary may 6 reasonably require. 7 ‘‘(3) AMOUNT OF GRANT.—The amount of a 8 grant under paragraph (1) may not exceed 9 $2,000,000, except in the case of eligible entity de- 10 scribed in paragraph (2)(A)(iv). 11 ‘‘(4) HIGH-THROUGHPUT DIAGNOSTIC EQUIP- 12 MENT DEFINED.—In this subsection, the term ‘high- 13 throughput diagnostic equipment’ means legally- 14 marketed equipment capable of performing multi- 15 channel analysis for use in clinical laboratory test- 16 ing, including molecular, serological, and antigen 17 tests.’’. 18 SEC. 4. AUTHORIZATION OF APPROPRIATIONS. 19 Section 2821(d) of the Public Health Service Act (42 20 U.S.C. 300hh–31(d)) (as redesignated by section 2) is 21 amended to read as follows: 22 (1) by striking ‘‘There are authorized to be ap- 23 propriated to carry out this section’’ and inserting 24 the following: 25 VerDate Sep 11 2014 22:08 Feb 22, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H747.IH H747 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 747 IH ‘‘(1) IN GENERAL.—There is authorized to be 1 appropriated to carry out subsection (a)’’; and 2 (2) by adding at the end, the following: 3 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 4 ‘‘(A) TESTING GRANTS.—For carrying out 5 subsection (b), there is authorized to be appro- 6 priated $500,000,000 for fiscal year 2021, to 7 remain available until expended. 8 ‘‘(B) EQUIPMENT GRANTS.—For carrying 9 out subsection (c), there is authorized to be ap- 10 propriated $250,000,000 for fiscal year 2021, 11 to remain available until expended. 12 ‘‘(C) ADMINISTRATIVE EXPENSES.—Of the 13 total amount made available to carry out sub- 14 sections (b) and (c) for any fiscal year, the Sec- 15 retary may not use more than 5 percent of such 16 amount for the expenses of administering such 17 subsections.’’. 18 Æ VerDate Sep 11 2014 22:08 Feb 22, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H747.IH H747 pamtmann on DSKBC07HB2PROD with BILLS