[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 4163 Introduced in Senate (IS)]

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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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Timely and Effective Systematic 
Testing Act'' or the ``TEST Act''.

SEC. 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)).

SEC. 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,''.

SEC. 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.''.
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