II 117th CONGRESS 2d Session S. 4827 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.

1. Short title This Act may be cited as the National Sepsis Data Trust, Outcomes, and Innovation Act or LuLu’s Law . 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: 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. .