TEST Act

II 116TH CONGRESS 2D SESSION S. 4163 To amend the Public Health Service Act to provide for timely and effective systematic testing to improve biosurveillance activities and practices. IN THE SENATE OF THE UNITED STATES JULY 2, 2020 Mr. GARDNER (for himself, Mr. BENNET, Mr. ROMNEY, and Ms. SINEMA) in- troduced the following bill; which was read twice and referred to the Com- mittee on Health, Education, Labor, and Pensions A BILL To amend the Public Health Service Act to provide for timely and effective systematic testing to improve bio- surveillance activities and practices. 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 ‘‘Timely and Effective 4 Systematic Testing Act’’ or the ‘‘TEST Act’’. 5 SEC. 2. BIOSURVEILLANCE FACILITIES AND CAPACITIES OF 6 THE CDC. 7 (a) IN GENERAL.—Section 319D of the Public 8 Health Service Act (42 U.S.C. 247d–4) is amended— 9 VerDate Sep 11 2014 04:01 Jul 13, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4163.IS S4163 pbinns on DSKJLVW7X2PROD with BILLS 2 •S 4163 IS (1) In subsection (a)(3)— 1 (A) in subparagraph (C), by striking 2 ‘‘and’’ at the end; 3 (B) in subparagraph (D), by striking the 4 period and inserting ‘‘; and’’; and 5 (C) by adding at the end the following: 6 ‘‘(E) improving coordination with Federal, 7 State, local, Tribal, and territorial public health 8 officials and other Federal agencies as appro- 9 priate, including the Centers for Medicare & 10 Medicaid Services, to identify gaps and align 11 payment incentives to improve electronic case 12 reporting capability.’’; 13 (2) in subsection (c)— 14 (A) in paragraph (3)(A)(iv), by inserting 15 ‘‘(such as commercial, academic, and other hos- 16 pital laboratories)’’ after ‘‘clinical laboratories’’; 17 (B) in paragraph (5)— 18 (i) in subparagraph (A)— 19 (I) in the matter preceding clause 20 (i), by striking ‘‘and operating’’ and 21 inserting ‘‘, operating, and updating’’; 22 (II) in clause (iv), by striking 23 ‘‘and’’ at the end; 24 VerDate Sep 11 2014 04:01 Jul 13, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4163.IS S4163 pbinns on DSKJLVW7X2PROD with BILLS 3 •S 4163 IS (III) in clause (v), by striking the 1 period and inserting a semicolon; and 2 (IV) by adding at the end the fol- 3 lowing: 4 ‘‘(vi) integrate and update applicable 5 existing systems and networks supported 6 by the Centers for Disease Control and 7 Prevention and in collaboration with State, 8 local, Tribal, and territorial public health 9 officials, including public health surveil- 10 lance and disease detection systems; and 11 ‘‘(vii) direct the Centers for Disease 12 Control and Prevention in coordination 13 with the Centers for Medicare & Medicaid 14 Services to assess the gaps in current re- 15 porting systems and evaluate grants and 16 payment mechanisms to improve electronic 17 case reporting capabilities.’’; and 18 (ii) in subparagraph (B)— 19 (I) in clause (i), by inserting 20 ‘‘and 60 days after the date of enact- 21 ment of the TEST Act of 2020’’ after 22 ‘‘Innovation Act of 2018’’; 23 (II) in clause (ii), by inserting 24 ‘‘epidemiologists, clinical microbiolo- 25 VerDate Sep 11 2014 04:01 Jul 13, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4163.IS S4163 pbinns on DSKJLVW7X2PROD with BILLS 4 •S 4163 IS gists, pathologists and laboratory ex- 1 perts, health information technology 2 developers, experts in health informa- 3 tion technology market economics, 4 public and private entities engaged in 5 the evaluation of health information 6 technology performance, data sharing 7 networks, such as health information 8 exchanges, security experts,’’ after 9 ‘‘forecasting);’’; and 10 (III) in clause (iii)— 11 (aa) in subclause (V), by 12 striking ‘‘and’’ at the end; 13 (bb) in subclause (VI), by 14 striking the period; and 15 (cc) by adding at the end 16 the following: 17 ‘‘(VII) strategies to integrate lab- 18 oratory and epidemiology systems and 19 capabilities to conduct and report 20 rapid and accurate laboratory tests; 21 ‘‘(VIII) ways to improve the col- 22 lection, disaggregation, and reporting 23 of appropriate demographic data to 24 support population health strategies 25 VerDate Sep 11 2014 04:01 Jul 13, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4163.IS S4163 pbinns on DSKJLVW7X2PROD with BILLS 5 •S 4163 IS and to better understand and address 1 health disparities; and 2 ‘‘(IX) an evaluation of the Dig- 3 ital Bridge project and subsequent 4 lessons on strategies to improve the 5 exchange of electronic health informa- 6 tion between public health agencies 7 and health care providers and facili- 8 ties for the purpose of timely, accu- 9 rate, and accessible disease surveil- 10 lance.’’; and 11 (C) in paragraph (6)— 12 (i) in subparagraph (A)— 13 (I) in clause (iii)— 14 (aa) in subclause (III), by 15 striking ‘‘and’’ at the end; 16 (bb) in subclause (IV), by 17 inserting ‘‘, including the ability 18 to conduct and report on rapid 19 and accurate laboratory testing 20 during a public health emer- 21 gency’’ before the semicolon; and 22 (cc) by adding at the end 23 the following: 24 VerDate Sep 11 2014 04:01 Jul 13, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4163.IS S4163 pbinns on DSKJLVW7X2PROD with BILLS 6 •S 4163 IS ‘‘(V) improve coordination and 1 collaboration, as appropriate, with 2 other Federal departments; and 3 ‘‘(VI) implement applicable les- 4 sons learned from recent public health 5 emergencies to address gaps in situa- 6 tional awareness and biosurveillance 7 capabilities, including an evaluation of 8 ways to improve the collection, 9 disaggregation, and reporting of de- 10 mographic data to support population 11 health strategies and to better under- 12 stand and address health disparities;’’; 13 (II) in clause (iv), by striking 14 ‘‘and’’ at the end; 15 (III) in clause (v), by striking the 16 period and inserting ‘‘including a jus- 17 tification for those dates for how they 18 will further the goal of addressing 19 both current and potential future in- 20 fectious disease outbreaks; and’’; and 21 (IV) by adding at the end the fol- 22 lowing: 23 ‘‘(vi) identifies and demonstrates 24 measurable steps the Secretary will take to 25 VerDate Sep 11 2014 04:01 Jul 13, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S4163.IS S4163 pbinns on DSKJLVW7X2PROD with BILLS 7 •S 4163 IS further develop and integrate infectious 1 disease detection, including expanding ca- 2 pabilities to conduct and report on rapid 3 and accurate diagnostic laboratory testing 4 during a public health emergency, and im- 5 prove coordination and collaboration with 6 State, local, Tribal, and territorial public 7 health officials, clinical laboratories (in- 8 cluding commercial, hospital and academic 9 labs), and other entities with expertise in 10 public health surveillance.’’; 11 (ii) by redesignating subparagraph 12 (B) as subparagraph (C); and 13 (iii) by inserting after subparagraph 14 (A), the following: 15 ‘‘(B) REPORTS.—Not later than one 16 month after the date of enactment of the TEST 17 Act, and every 90 days thereafter, the Secretary 18 shall report on the status of the Department of 19 Health and Human Services’ biosurveillance 20 modernization and assessment progress with re- 21 spect to both current and potential future infec- 22 tious disease outbreaks.’’; 23 (3) in subsection (d)— 24 VerDate Sep 11 2014 04:01 Jul 13, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S4163.IS S4163 pbinns on DSKJLVW7X2PROD with BILLS 8 •S 4163 IS (A) in paragraph (2)(C), by inserting ‘‘, in- 1 cluding any public-private partnerships entered 2 into to improve such capacity’’ before the semi- 3 colon; and 4 (B) in paragraph (3)— 5 (i) in subparagraph (B), by striking 6 ‘‘and’’ at the end; 7 (ii) in subparagraph (C), by striking 8 the period and inserting ‘‘; and’’; and 9 (iii) by adding at the end the fol- 10 lowing: 11 ‘‘(D) may establish, enhance, or maintain 12 a system or network for the collection of data 13 to provide for early detection of infectious dis- 14 ease outbreaks, near real-time access to rel- 15 evant electronic data and integration of elec- 16 tronic data and information from public health 17 and other appropriate sources, such as labora- 18 tories, hospitals, and epidemiology systems, to 19 enhance the capability to conduct rapid and ac- 20 curate diagnostic laboratory tests to provide for 21 disease detection.’’; 22 (4) in subsection (f)(1)(A), by inserting ‘‘pa- 23 thologists, clinical microbiologists, laboratory profes- 24 sionals, epidemiologists,’’ after ‘‘forecasting),’’; and 25 VerDate Sep 11 2014 04:01 Jul 13, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4163.IS S4163 pbinns on DSKJLVW7X2PROD with BILLS 9 •S 4163 IS (5) in subsection (h), by adding at the end the 1 following: ‘‘Such evaluation shall include identifica- 2 tion of any gaps in biosurveillance and situational 3 awareness capabilities identified related to recent 4 public health emergencies, any immediate steps 5 taken to address such gaps, and any long-term plans 6 to address such gaps, including relate to activities 7 authorized under this section.’’. 8 (b) COORDINATION.—The Administrator of the Cen- 9 ters for Medicare & Medicaid Services shall coordinate 10 with Centers for Disease Control and Prevention to assess 11 the gaps in current reporting systems and evaluate grants 12 and payment mechanisms to improve electronic case re- 13 porting capabilities for purposes of section 14 319D(c)(5)(A)(vii) of the Public Health Service Act (as 15 added by subsection (a)). 16 SEC. 3. NATIONAL HEALTH SECURITY STRATEGY. 17 Section 2802(b)(2) of the Public Health Service Act 18 (42 U.S.C. 300hh–1(b)(2)) is amended— 19 (1) in subparagraph (A), by inserting ‘‘such as 20 by integrating laboratory and epidemiology systems 21 and capability to conduct and report on rapid and 22 accurate laboratory tests,’’ after ‘‘detection, identi- 23 fication,’’; and 24 VerDate Sep 11 2014 04:01 Jul 13, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S4163.IS S4163 pbinns on DSKJLVW7X2PROD with BILLS 10 •S 4163 IS (2) in subparagraph (B), by inserting ‘‘labora- 1 tory testing,’’ after ‘‘services and supplies,’’. 2 SEC. 4. EPIDEMIOLOGY-LABORATORY CAPACITY GRANTS. 3 Section 2821(a) of the Public Health Service Act (42 4 U.S.C. 300hh–31(a)) is amended— 5 (1) in paragraph (3), by striking ‘‘and’’; 6 (2) in paragraph (4), by striking the period and 7 inserting ‘‘; and’’; and 8 (3) by adding at the end the following: 9 ‘‘(5) supporting State and local public health 10 departments activities related to biosurveillance and 11 disease detection, including activities related to sec- 12 tion 319D.’’. 13 Æ VerDate Sep 11 2014 04:01 Jul 13, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6301 E:\BILLS\S4163.IS S4163 pbinns on DSKJLVW7X2PROD with BILLS