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) 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 provide for 

timely and effective systematic testing to improve biosurveillance activities and practices. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Timely and Effective 

5 Systematic Testing Act’’ or the ‘‘TEST Act’’. 

6 SEC. 2. BIOSURVEILLANCE FACILITIES AND CAPACITIES OF 

7 THE CDC. 

8 (a) IN GENERAL.—Section 319D of the Public 

9 Health Service Act (42 U.S.C. 247d–4) is amended— 


pbinns on DSKJLVW7X2PROD with BILLS
2 

•S 4163 IS

1 (1) In subsection (a)(3)— 

2 (A) in subparagraph (C), by striking 

3 ‘‘and’’ at the end; 

4 (B) in subparagraph (D), by striking the 

5 period and inserting ‘‘; and’’; and 

6 (C) by adding at the end the following: 

7 ‘‘(E) improving coordination with Federal, 

8 State, local, Tribal, and territorial public health 

9 officials and other Federal agencies as appro10 priate, including the Centers for Medicare & 

11 Medicaid Services, to identify gaps and align 

12 payment incentives to improve electronic case 

13 reporting capability.’’; 

14 (2) in subsection (c)— 

15 (A) in paragraph (3)(A)(iv), by inserting 

16 ‘‘(such as commercial, academic, and other hos17 pital laboratories)’’ after ‘‘clinical laboratories’’; 

18 (B) in paragraph (5)— 

19 (i) in subparagraph (A)— 

20 (I) in the matter preceding clause 

21 (i), by striking ‘‘and operating’’ and 

22 inserting ‘‘, operating, and updating’’; 

23 (II) in clause (iv), by striking 

24 ‘‘and’’ at the end; 


pbinns on DSKJLVW7X2PROD with BILLS
3 

•S 4163 IS

1 (III) in clause (v), by striking the 

2 period and inserting a semicolon; and 

3 (IV) by adding at the end the fol4 lowing: 

5 ‘‘(vi) integrate and update applicable 

6 existing systems and networks supported 

7 by the Centers for Disease Control and 

8 Prevention and in collaboration with State, 

9 local, Tribal, and territorial public health 

10 officials, including public health surveil11 lance and disease detection systems; and 

12 ‘‘(vii) direct the Centers for Disease 

13 Control and Prevention in coordination 

14 with the Centers for Medicare & Medicaid 

15 Services to assess the gaps in current re16 porting systems and evaluate grants and 

17 payment mechanisms to improve electronic 

18 case reporting capabilities.’’; and 

19 (ii) in subparagraph (B)— 

20 (I) in clause (i), by inserting 

21 ‘‘and 60 days after the date of enact22 ment of the TEST Act of 2020’’ after 

23 ‘‘Innovation Act of 2018’’; 

24 (II) in clause (ii), by inserting 

25 ‘‘epidemiologists, clinical microbioloVerDate 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

1 gists, pathologists and laboratory ex2 perts, health information technology 

3 developers, experts in health informa4 tion technology market economics, 

5 public and private entities engaged in 

6 the evaluation of health information 

7 technology performance, data sharing 

8 networks, such as health information 

9 exchanges, security experts,’’ after 

10 ‘‘forecasting);’’; and 

11 (III) in clause (iii)— 

12 (aa) in subclause (V), by 

13 striking ‘‘and’’ at the end; 

14 (bb) in subclause (VI), by 

15 striking the period; and 

16 (cc) by adding at the end 

17 the following: 

18 ‘‘(VII) strategies to integrate lab19 oratory and epidemiology systems and 

20 capabilities to conduct and report 

21 rapid and accurate laboratory tests; 

22 ‘‘(VIII) ways to improve the col23 lection, disaggregation, and reporting 

24 of appropriate demographic data to 

25 support population health strategies 


pbinns on DSKJLVW7X2PROD with BILLS
5 

•S 4163 IS

1 and to better understand and address 

2 health disparities; and 

3 ‘‘(IX) an evaluation of the Dig4 ital Bridge project and subsequent 

5 lessons on strategies to improve the 

6 exchange of electronic health informa7 tion between public health agencies 

8 and health care providers and facili9 ties for the purpose of timely, accu10 rate, and accessible disease surveil11 lance.’’; and 

12 (C) in paragraph (6)— 

13 (i) in subparagraph (A)— 

14 (I) in clause (iii)— 

15 (aa) in subclause (III), by 

16 striking ‘‘and’’ at the end; 

17 (bb) in subclause (IV), by 

18 inserting ‘‘, including the ability 

19 to conduct and report on rapid 

20 and accurate laboratory testing 

21 during a public health emer22 gency’’ before the semicolon; and 

23 (cc) by adding at the end 

24 the following: 


pbinns on DSKJLVW7X2PROD with BILLS
6 

•S 4163 IS

1 ‘‘(V) improve coordination and 

2 collaboration, as appropriate, with 

3 other Federal departments; and 

4 ‘‘(VI) implement applicable les5 sons learned from recent public health 

6 emergencies to address gaps in situa7 tional awareness and biosurveillance 

8 capabilities, including an evaluation of 

9 ways to improve the collection, 

10 disaggregation, and reporting of de11 mographic data to support population 

12 health strategies and to better under13 stand and address health disparities;’’; 

14 (II) in clause (iv), by striking 

15 ‘‘and’’ at the end; 

16 (III) in clause (v), by striking the 

17 period and inserting ‘‘including a jus18 tification for those dates for how they 

19 will further the goal of addressing 

20 both current and potential future in21 fectious disease outbreaks; and’’; and 

22 (IV) by adding at the end the fol23 lowing: 

24 ‘‘(vi) identifies and demonstrates 

25 measurable steps the Secretary will take to 


pbinns on DSKJLVW7X2PROD with BILLS
7 

•S 4163 IS

1 further develop and integrate infectious 

2 disease detection, including expanding ca3 pabilities to conduct and report on rapid 

4 and accurate diagnostic laboratory testing 

5 during a public health emergency, and im6 prove coordination and collaboration with 

7 State, local, Tribal, and territorial public 

8 health officials, clinical laboratories (in9 cluding commercial, hospital and academic 

10 labs), and other entities with expertise in 

11 public health surveillance.’’; 

12 (ii) by redesignating subparagraph 

13 (B) as subparagraph (C); and 

14 (iii) by inserting after subparagraph 

15 (A), the following: 

16 ‘‘(B) REPORTS.—Not later than one 

17 month after the date of enactment of the TEST 

18 Act, and every 90 days thereafter, the Secretary 

19 shall report on the status of the Department of 

20 Health and Human Services’ biosurveillance 

21 modernization and assessment progress with re22 spect to both current and potential future infec23 tious disease outbreaks.’’; 

24 (3) in subsection (d)— 


pbinns on DSKJLVW7X2PROD with BILLS
8 

•S 4163 IS

1 (A) in paragraph (2)(C), by inserting ‘‘, in2 cluding any public-private partnerships entered 

3 into to improve such capacity’’ before the semi4 colon; and 

5 (B) in paragraph (3)— 

6 (i) in subparagraph (B), by striking 

7 ‘‘and’’ at the end; 

8 (ii) in subparagraph (C), by striking 

9 the period and inserting ‘‘; and’’; and 

10 (iii) by adding at the end the fol11 lowing: 

12 ‘‘(D) may establish, enhance, or maintain 

13 a system or network for the collection of data 

14 to provide for early detection of infectious dis15 ease outbreaks, near real-time access to rel16 evant electronic data and integration of elec17 tronic data and information from public health 

18 and other appropriate sources, such as labora19 tories, hospitals, and epidemiology systems, to 

20 enhance the capability to conduct rapid and ac21 curate diagnostic laboratory tests to provide for 

22 disease detection.’’; 

23 (4) in subsection (f)(1)(A), by inserting ‘‘pa24 thologists, clinical microbiologists, laboratory profes25 sionals, epidemiologists,’’ after ‘‘forecasting),’’; and 


pbinns on DSKJLVW7X2PROD with BILLS
9 

•S 4163 IS

1 (5) in subsection (h), by adding at the end the 

2 following: ‘‘Such evaluation shall include identifica3 tion of any gaps in biosurveillance and situational 

4 awareness capabilities identified related to recent 

5 public health emergencies, any immediate steps 

6 taken to address such gaps, and any long-term plans 

7 to address such gaps, including relate to activities 

8 authorized under this section.’’. 

9 (b) COORDINATION.—The Administrator of the Cen10 ters for Medicare & Medicaid Services shall coordinate 

11 with Centers for Disease Control and Prevention to assess 

12 the gaps in current reporting systems and evaluate grants 

13 and payment mechanisms to improve electronic case re14 porting capabilities for purposes of section 

15 319D(c)(5)(A)(vii) of the Public Health Service Act (as 

16 added by subsection (a)). 

17 SEC. 3. NATIONAL HEALTH SECURITY STRATEGY. 

18 Section 2802(b)(2) of the Public Health Service Act 

19 (42 U.S.C. 300hh–1(b)(2)) is amended— 

20 (1) in subparagraph (A), by inserting ‘‘such as 

21 by integrating laboratory and epidemiology systems 

22 and capability to conduct and report on rapid and 

23 accurate laboratory tests,’’ after ‘‘detection, identi24 fication,’’; and 


pbinns on DSKJLVW7X2PROD with BILLS
10 

•S 4163 IS

1 (2) in subparagraph (B), by inserting ‘‘labora2 tory testing,’’ after ‘‘services and supplies,’’. 

3 SEC. 4. EPIDEMIOLOGY-LABORATORY CAPACITY GRANTS. 

4 Section 2821(a) of the Public Health Service Act (42 

5 U.S.C. 300hh–31(a)) is amended— 

6 (1) in paragraph (3), by striking ‘‘and’’; 

7 (2) in paragraph (4), by striking the period and 

8 inserting ‘‘; and’’; and 

9 (3) by adding at the end the following: 

10 ‘‘(5) supporting State and local public health 

11 departments activities related to biosurveillance and 

12 disease detection, including activities related to sec13 tion 319D.’’. 

Æ 


pbinns on DSKJLVW7X2PROD with BILLS