II 116th CONGRESS 2d Session S. 4163 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. Short title This Act may be cited as the Timely and Effective Systematic Testing Act or the TEST Act . 2. Biosurveillance facilities and capacities of the CDC (a) In general Section 319D of the Public Health Service Act ( 42 U.S.C. 247d–4 ) is amended— (1) In subsection (a)(3)— (A) in subparagraph (C), by striking and at the end; (B) in subparagraph (D), by striking the period and inserting ; and ; and (C) by adding at the end the following: (E) improving coordination with Federal, State, local, Tribal, and territorial public health officials and other Federal agencies as appropriate, including the Centers for Medicare & Medicaid Services, to identify gaps and align payment incentives to improve electronic case reporting capability. ; (2) in subsection (c)— (A) in paragraph (3)(A)(iv), by inserting (such as commercial, academic, and other hospital laboratories) after clinical laboratories ; (B) in paragraph (5)— (i) in subparagraph (A)— (I) in the matter preceding clause (i), by striking and operating and inserting , operating, and updating ; (II) in clause (iv), by striking and at the end; (III) in clause (v), by striking the period and inserting a semicolon; and (IV) by adding at the end the following: (vi) integrate and update applicable existing systems and networks supported by the Centers for Disease Control and Prevention and in collaboration with State, local, Tribal, and territorial public health officials, including public health surveillance and disease detection systems; and (vii) direct the Centers for Disease Control and Prevention in coordination with the Centers for Medicare & Medicaid Services to assess the gaps in current reporting systems and evaluate grants and payment mechanisms to improve electronic case reporting capabilities. ; and (ii) in subparagraph (B)— (I) in clause (i), by inserting and 60 days after the date of enactment of the TEST Act of 2020 after Innovation Act of 2018 ; (II) in clause (ii), by inserting epidemiologists, clinical microbiologists, pathologists and laboratory experts, health information technology developers, experts in health information technology market economics, public and private entities engaged in the evaluation of health information technology performance, data sharing networks, such as health information exchanges, security experts, after forecasting); ; and (III) in clause (iii)— (aa) in subclause (V), by striking and at the end; (bb) in subclause (VI), by striking the period; and (cc) by adding at the end the following: (VII) strategies to integrate laboratory and epidemiology systems and capabilities to conduct and report rapid and accurate laboratory tests; (VIII) ways to improve the collection, disaggregation, and reporting of appropriate demographic data to support population health strategies and to better understand and address health disparities; and (IX) an evaluation of the Digital Bridge project and subsequent lessons on strategies to improve the exchange of electronic health information between public health agencies and health care providers and facilities for the purpose of timely, accurate, and accessible disease surveillance. ; and (C) in paragraph (6)— (i) in subparagraph (A)— (I) in clause (iii)— (aa) in subclause (III), by striking and at the end; (bb) in subclause (IV), by inserting , including the ability to conduct and report on rapid and accurate laboratory testing during a public health emergency before the semicolon; and (cc) by adding at the end the following: (V) improve coordination and collaboration, as appropriate, with other Federal departments; and (VI) implement applicable lessons learned from recent public health emergencies to address gaps in situational awareness and biosurveillance capabilities, including an evaluation of ways to improve the collection, disaggregation, and reporting of demographic data to support population health strategies and to better understand and address health disparities; ; (II) in clause (iv), by striking and at the end; (III) in clause (v), by striking the period and inserting including a justification for those dates for how they will further the goal of addressing both current and potential future infectious disease outbreaks; and ; and (IV) by adding at the end the following: (vi) identifies and demonstrates measurable steps the Secretary will take to further develop and integrate infectious disease detection, including expanding capabilities to conduct and report on rapid and accurate diagnostic laboratory testing during a public health emergency, and improve coordination and collaboration with State, local, Tribal, and territorial public health officials, clinical laboratories (including commercial, hospital and academic labs), and other entities with expertise in public health surveillance. ; (ii) by redesignating subparagraph (B) as subparagraph (C); and (iii) by inserting after subparagraph (A), the following: (B) Reports Not later than one month after the date of enactment of the TEST Act, and every 90 days thereafter, the Secretary shall report on the status of the Department of Health and Human Services’ biosurveillance modernization and assessment progress with respect to both current and potential future infectious disease outbreaks. ; (3) in subsection (d)— (A) in paragraph (2)(C), by inserting , including any public-private partnerships entered into to improve such capacity before the semicolon; and (B) in paragraph (3)— (i) in subparagraph (B), by striking and at the end; (ii) in subparagraph (C), by striking the period and inserting ; and ; and (iii) by adding at the end the following: (D) may establish, enhance, or maintain a system or network for the collection of data to provide for early detection of infectious disease outbreaks, near real-time access to relevant electronic data and integration of electronic data and information from public health and other appropriate sources, such as laboratories, hospitals, and epidemiology systems, to enhance the capability to conduct rapid and accurate diagnostic laboratory tests to provide for disease detection. ; (4) in subsection (f)(1)(A), by inserting pathologists, clinical microbiologists, laboratory professionals, epidemiologists, after forecasting), ; and (5) in subsection (h), by adding at the end the following: Such evaluation shall include identification of any gaps in biosurveillance and situational awareness capabilities identified related to recent public health emergencies, any immediate steps taken to address such gaps, and any long-term plans to address such gaps, including relate to activities authorized under this section. . (b) Coordination The Administrator of the Centers for Medicare & Medicaid Services shall coordinate with Centers for Disease Control and Prevention to assess the gaps in current reporting systems and evaluate grants and payment mechanisms to improve electronic case reporting capabilities for purposes of section 319D(c)(5)(A)(vii) of the Public Health Service Act (as added by subsection (a)). 3. National health security strategy Section 2802(b)(2) of the Public Health Service Act ( 42 U.S.C. 300hh–1(b)(2) ) is amended— (1) in subparagraph (A), by inserting such as by integrating laboratory and epidemiology systems and capability to conduct and report on rapid and accurate laboratory tests, after detection, identification, ; and (2) in subparagraph (B), by inserting laboratory testing, after services and supplies, . 4. Epidemiology-laboratory capacity grants Section 2821(a) of the Public Health Service Act ( 42 U.S.C. 300hh–31(a) ) is amended— (1) in paragraph (3), by striking and ; (2) in paragraph (4), by striking the period and inserting ; and ; and (3) by adding at the end the following: (5) supporting State and local public health departments activities related to biosurveillance and disease detection, including activities related to section 319D. .