Title: LuLu’s Law
Policy area: Health

Summary:
National Sepsis Data Trust, Outcomes, and Innovation Act or LuLu's Law
This bill directs the Department of Health and Human Services (HHS) to address sepsis. (Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection.)
In particular, HHS must

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4827 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 4827

To authorize the Secretary of Health and Human Services to establish a 
national sepsis data trust, and to fund State-based pilots and programs 
       to establish interoperable State-based sepsis data trusts.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 13, 2022

Mr. Cassidy (for himself and Mr. Casey) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To authorize the Secretary of Health and Human Services to establish a 
national sepsis data trust, and to fund State-based pilots and programs 
       to establish interoperable State-based sepsis data trusts.

    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 ``National Sepsis Data Trust, 
Outcomes, and Innovation Act'' or ``LuLu's Law''.

SEC. 2. TREATING AND ELIMINATING THE BURDEN OF SEPSIS.

    Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended by adding at the end the following:

``SEC. 399V-7. TREATING AND ELIMINATING THE BURDEN OF SEPSIS.

    ``(a) Definition; Designation.--
            ``(1) Definition of sepsis.--Not later than 120 days after 
        the date of enactment of the National Sepsis Data Trust, 
        Outcomes, and Innovation Act, the Secretary shall issue a rule 
        specifying a definition of sepsis. Such definition may specify 
        that sepsis is a life-threatening organ dysfunction caused by a 
        dysregulated host response to infection. Such definition shall 
        be standardized across departments, agencies, and other 
        entities within the Department of Health of Human Services.
            ``(2) Nationally notifiable disease.--The Secretary, acting 
        through the Director of the Centers for Disease Control and 
        Prevention, shall take such steps as may be necessary to 
        include sepsis on the list of nationally notifiable diseases 
        published by the Centers for Disease Control and Prevention.
    ``(b) National Strategy.--
            ``(1) In general.--The Secretary shall develop a national 
        strategy--
                    ``(A) to treat and eliminate the burden of sepsis, 
                with the specific goals of, with respect to sepsis--
                            ``(i) coordinating data (including through 
                        the data trust established under subsection 
                        (d));
                            ``(ii) spurring research; and
                            ``(iii) developing diagnostic tools and 
                        treatments;
                    ``(B) to decrease instances of sepsis and mitigate 
                long-term health effects of sepsis; and
                    ``(C) that includes specific actions to be taken to 
                treat and eliminate the burden of sepsis among at-risk 
                populations identified pursuant to paragraph (3).
            ``(2) Coordination.--In developing the strategy under 
        paragraph (1), the Secretary may coordinate among agencies 
        within the Department of Health and Human Services and other 
        Federal agencies, academic institutions, and non-profit 
        organizations.
            ``(3) At-risk populations.--The Secretary shall identify 
        population groups the Secretary determines to be at a higher 
        risk for contracting sepsis, which shall include--
                    ``(A) children;
                    ``(B) pregnant women or women in the one year 
                postpartum period;
                    ``(C) active members of the Armed Forces and 
                veterans;
                    ``(D) disabled and elderly individuals;
                    ``(E) individuals residing on federally-recognized 
                Tribal lands; and
                    ``(F) such other groups as the Secretary determines 
                to be at higher risk for contracting sepsis.
    ``(c) State-Based Sepsis Data Trust Pilot Programs.--
            ``(1) In general.--Subject to the availability of 
        appropriations, the Secretary shall award grants to not more 
        than 5 States to establish pilot programs--
                    ``(A) to collect into State-based sepsis data 
                trusts that use standardized data formats and coding 
                (as determined by the Secretary) de-identified patient 
                data concerning--
                            ``(i) demographic information about each 
                        case of sepsis in each such State;
                            ``(ii) administrative information with 
                        respect to each such case, including the date 
                        of diagnosis and the source of information;
                            ``(iii) pathological and genetic material 
                        characterizing each such case (including 
                        deoxyribonucleic acids (DNA), ribonucleic acids 
                        (RNA), single cell RNA, genes, chromosomes, 
                        genotype, alleles, epigenetic alteration or 
                        modifications to DNA or RNA, single nucleotide 
                        polymorphisms (SNPs), uninterpreted data that 
                        results from analysis of a biological sample 
                        from a diagnosed sepsis patient or other 
                        source, and any information extrapolated, 
                        derived, or inferred therefrom);
                            ``(iv) clinical information, including 
                        relevant diagnoses, treatment, and patient-
                        reported outcomes of the individuals with 
                        sepsis and sepsis survivors;
                            ``(v) with respect to each case of sepsis 
                        in each such State, the number of staff working 
                        in the relevant unit of the health care 
                        provider involved;
                            ``(vi) provider payments that result from a 
                        sepsis diagnosis; and
                            ``(vii) other elements determined 
                        appropriate by the Secretary; and
                    ``(B) to combine and connect data so collected 
                among such States.
            ``(2) Data trust guidelines.--
                    ``(A) In general.--The Secretary shall establish 
                governance guidelines, data access requirements, 
                privacy and security protocols, and other such 
                standards as may be required to support the 
                establishment of interoperable State-based sepsis data 
                trusts for purposes of the national sepsis data trust 
                to be established under subsection (d).
                    ``(B) Data sharing.--The guidelines established 
                under subparagraph (A) shall specify that--
                            ``(i) no entity participating in the data 
                        trust may share patient data with any entity 
                        not participating in the data trust; and
                            ``(ii) an entity shall agree, as a 
                        condition on participation in the data trust to 
                        not share any patient data with any entity not 
                        participating in the data trust.
            ``(3) Selection criteria.--In reviewing applications 
        submitted by States for grants under this section, the 
        Secretary shall consider whether the States submitting such 
        applications demonstrate established partnerships with a range 
        of public and private stakeholders. Of the States that 
        demonstrate such partnerships, the Secretary shall select--
                    ``(A) at least one State that has a death rate from 
                septicemia of greater than 15 people per 100,000 people 
                per year and 1,500 deaths per year for the 5 calendar 
                years preceding the declaration of the public health 
                emergency with respect to COVID-19;
                    ``(B) at least one rural State with above average 
                sepsis mortality rate;
                    ``(C) a selection of other States in such a manner 
                as to ensure diversity of population density, 
                geographic location, and general health care access and 
                infrastructure; and
                    ``(D) other States in such a matter as to ensure 
                geographic and population diversity.
            ``(4) Alternative criteria.--If no State meeting the 
        criteria specified in paragraph (3) establishes a pilot program 
        in coordination with the Secretary within 3 years of the date 
        of enactment of the National Sepsis Data Trust, Outcomes, and 
        Innovation Act, the Secretary may identify alternative 
        requirements for such States.
            ``(5) Reporting.--Not later than 18 months after the date 
        on which a State successfully (as determined by the Secretary) 
        establishes a State-based sepsis data trust using funds 
        received through a grant under this subsection, the State shall 
        submit to the Secretary a report. Such report shall include, 
        with respect to the State-based sepsis data trust involved--
                    ``(A) the process by which the State established 
                the data trust, including governance and data access 
                rules;
                    ``(B) the process by which data was collected, de-
                identified, and standardized across multiple data 
                systems;
                    ``(C) implementation barriers experienced and the 
                course of corrective action taken to address these 
                barriers; and
                    ``(D) lessons learned through the establishment of 
                the data trust.
            ``(6) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this subsection 
        $5,000,000 for each of fiscal years 2023 through 2028.
    ``(d) National Sepsis Data Trust.--
            ``(1) In general.--The Secretary shall establish a national 
        sepsis data trust to improve research, outcomes, and innovation 
        in support of the national strategy developed under subsection 
        (b) (including the actions to be taken pursuant to paragraph 
        (1)(C) of such subsection). Such national sepsis data trust 
        shall--
                    ``(A) accelerate innovation that seeks to improve 
                sepsis prevention, diagnosis, treatment, outcomes, and 
                survivor support, including through--
                            ``(i) advancing the pace of academic 
                        research; and
                            ``(ii) catalyzing more investment in 
                        mechanisms that provide promise in the early 
                        recognition and expeditious treatment of 
                        sepsis;
                    ``(B) support public health efforts to improve 
                sepsis care, particularly in underserved geographic 
                areas and among at-risk and underserved communities;
                    ``(C) improve the targeting of antimicrobial drugs 
                and other substances for the treatment of sepsis, 
                promoting both better care and improved antimicrobial 
                stewardship;
                    ``(D) coordinate and integrate the development of 
                State-based sepsis data trusts, including by defining 
                data elements to be included in State-based sepsis data 
                trusts, including self-reported data on age, race, 
                ethnicity, primary language, membership in a federally-
                recognized Tribe, status as a member of the Armed 
                Forces, status as a veteran, status as pregnant or 
                recently pregnant, and any other data the Secretary 
                determines appropriate;
                    ``(E) provide for appropriate privacy and security 
                of de-identified data in the data trust by--
                            ``(i) prohibiting any entity participating 
                        in the data trust from sharing patient data 
                        with any entity not participating in the data 
                        trust; and
                            ``(ii) ensuring that an entity agrees, as a 
                        condition on participation in the data trust to 
                        not share any patient data with any entity not 
                        participating in the data trust; and
                    ``(F) allow access to data de-identified data in 
                the data trust by health care providers and other 
                entities participating in the data trust.
            ``(2) State grants and contracts.--
                    ``(A) In general.--In addition to awarding grants 
                under subsection (c), the Secretary may award grants 
                directly to States to support the development and 
                operation of State-based sepsis data trusts (or award 
                grants or contracts to academic or nonprofit 
                organizations designated by a State to operate the 
                State-based sepsis data trust involved) to combine and 
                connect data collected by the State concerning--
                            ``(i) demographic information about each 
                        case of sepsis in each such State;
                            ``(ii) administrative information with 
                        respect to each such case, including the date 
                        of diagnosis and the source of information;
                            ``(iii) pathological and genetic data 
                        characterizing each such case;
                            ``(iv) clinical information, including 
                        relevant diagnoses, treatment, and patient-
                        reported outcomes of the individuals with 
                        sepsis and sepsis survivors; and
                            ``(v) other elements, as the Secretary 
                        determines appropriate.
                    ``(B) Matching funds.--The Secretary may award a 
                grant or contract under paragraph (2) only if the State 
                involved (or the academic or nonprofit private 
                organization designated by a State to operate the 
                State-based sepsis data trust involved) agrees, with 
                respect to the costs of the program to be funded 
                through the award, to make available (directly or 
                through donations from public or private entities) non-
                Federal contributions toward such costs in an amount 
                that is not less than 25 percent of such costs.
                    ``(C) Data trust guidelines.--The guidelines 
                developed under subsection (c)(2) shall apply with 
                respect to State-based sepsis data trusts established 
                under this paragraph in the same manner and to the same 
                extent as such guidelines apply with respect to State-
                based sepsis data trusts established under subsection 
                (c) (including the data sharing limitations specified 
                in paragraph (2)(B) of such subsection).
            ``(3) Report on government sepsis data activities and 
        resources.--Not later than 180 days after the date of enactment 
        of the National Sepsis Data Trust, Outcomes, and Innovation 
        Act, the Secretary shall submit to the Committee on Health, 
        Education, Labor, and Pensions of the Senate and the Committee 
        on Energy and Commerce of the House of Representatives a report 
        containing the following:
                    ``(A) An outline of existing Federal efforts to 
                collect and make available data on sepsis and its 
                associated conditions, including existing Federal 
                repositories of sepsis-relevant de-identified patient 
                data.
                    ``(B) A summary of the use of these sepsis data by 
                third parties, including public health professionals, 
                physicians and nurses, and researchers.
                    ``(C) A description of Federal efforts to improve 
                care related to sepsis and infection in underserved 
                populations and communities that experience 
                disproportionately poor health outcomes.
    ``(e) Definitions.--In this section:
            ``(1) De-identified.--The term `de-identified' means, with 
        respect to data in a data trust established under or pursuant 
        to this section, information that has been de-identified (and 
        remains de-identified) in accordance with the applicable 
        requirements of section 164.514 of title 45, Code of Federal 
        Regulations (or any successor regulation).
            ``(2) National sepsis data trust.--The term `national 
        sepsis data trust' means an interoperable, de-identified, 
        privacy-protected collection, curation, and storage system that 
        contains de-identified data from a variety of sources 
        established by individual States, with data made available to 
        entities and individuals approved by the Secretary.''.
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