I 118th CONGRESS 2d Session H. R. 8078 IN THE HOUSE OF REPRESENTATIVES April 18, 2024 Ms. Sherrill (for herself and Mr. Bucshon ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To authorize Federal support of States in piloting interoperable State-based repositories of sepsis cases, and for other purposes.

1. Short title This Act may be cited as the Sepsis Harm and Cost Reduction Act or the LuLu’s Law . 2. Findings Congress finds the following: (1) Sepsis affects 1.7 million people in the United States each year, and results in 350,000 adult deaths annually. (2) Sepsis is a leading cause of maternal mortality in the United States. (3) Sepsis is a leading cause of rising newborn mortality in the United States. (4) Nearly 7,000 children die from sepsis annually in the United States. (5) Many survivors face life-long after-effects of sepsis, including 14,000 annually who receive amputations. (6) Each hour a septic patient goes untreated increases the risk of death by as much as 8 percent. (7) Sepsis is the leading cause of death in United States hospitals, and the leading cause of hospital readmissions. (8) Sepsis hospitalizations cost Medicare $41.8 billion in 2019. (9) Sepsis is responsible for $62 billion in hospitalization costs annually. (10) Additional information about sepsis could help improve timely diagnosis and treatment, reducing loss of life, harm and costs due to sepsis. 3. Reducing 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–8. Reducing the burden of sepsis (a) Definition of sepsis Not later than 120 days after the date of the enactment of the Sepsis Harm and Cost Reduction 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. (b) State-based sepsis repository pilot programs (1) In general Subject to the availability of appropriations for a fiscal year, the Secretary shall award grants to not more than 5 States each fiscal year to establish pilot statewide sepsis repositories. (2) Application A State seeking a grant under paragraph (1) shall submit to the Secretary an application at such time, in such manner, and containing— (A) a certification that the State has established a sepsis advisory committee, in accordance with paragraph (3); and (B) such other information as the Secretary may require. (3) Sepsis Advisory Committee (A) Duties A State sepsis advisory committee referred to in paragraph (2)(A) shall— (i) advise the State in the design, development, and operation of the statewide sepsis repository; (ii) ensure that all information included in the sepsis repository is de-identified and privacy protected; and (iii) assist in securing voluntary participation in, and contributions of information to, the sepsis repository by organizations and entities in the State. (B) Composition A State sepsis advisory committee referred to in paragraph (2)(A) shall be composed of multidisciplinary and diverse membership that represents a variety of stakeholders, including clinical specialties, public health officials, epidemiologists, statisticians, data scientists, payers, patient safety advocates, and individuals or organizations that represent sepsis survivors, family members of sepsis patients, and populations that are most affected by sepsis or experience the greatest disparities in sepsis outcomes. (4) Selection Criteria In selecting States to receive a grant under this subsection, the Secretary shall select, from among the States submitting an application for such a grant that meets the requirements of paragraph (2)— (A) at least 1 State that has a death rate from sepsis 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 1 rural State with an above average sepsis mortality rate; (C) a diverse array of other States in such a manner as to ensure diversity of population density, geographic location, and general healthcare access and infrastructure; and (D) other States in such a manner as to ensure geographic and population diversity. (5) Alternative criteria If no State meeting the criteria specified in paragraph (4) establishes a pilot program in coordination with the Secretary within 36 months after the date of enactment of this section, the Secretary may identify alternative requirements for such States. (6) Sepsis repository activities A State receiving a grant under this subsection shall use funds received through the grant to, in consultation with the applicable State sepsis advisory committee established pursuant to paragraph (2), establish a statewide sepsis repository that integrates— (A) demographic information about each case of sepsis in such State; (B) administrative information with respect to each such case; (C) characterizations of each such case, including pathological analysis and uninterpreted data; (D) clinical information, including relevant diagnoses, treatment, and patient-reported outcomes of the individuals with sepsis and sepsis survivors; and (E) provider payments that result from a sepsis diagnosis. (7) Guidelines The Secretary shall establish governance guidelines, information access requirements, privacy and security protocols, and other such standards as may be necessary to support the establishment of interoperable statewide sepsis repositories. (8) State reporting Not later than 18 months after the date on which a State successfully establishes a statewide sepsis repository 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 repository— (A) the process by which the State established the repository; (B) the process by which information regarding sepsis was collected, de-identified, and standardized across multiple contributing systems; (C) implementation barriers experienced and the State’s response to address such barriers; and (D) lessons learned through the establishment of the repository. (9) Best practices relating to the implementation of statewide sepsis repositories The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall collect from the recipients of grants awarded under this subsection, and disseminate, not later than 18 months after receiving data from grant recipients, and at least once each fiscal year thereafter— (A) lessons learned and best practices in the design, development, implementation, and operation of statewide sepsis repositories; and (B) lessons learned and best practices on identifying and decreasing sepsis-related events through the implementation and operation of statewide sepsis repositories. (10) Authorization of appropriations There are authorized to be appropriated to carry out this subsection $5,000,000 for each of fiscal years 2025 through 2030. (c) National sepsis repository (1) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish a national sepsis repository to improve research, outcomes, and innovation in support of the national strategy developed under subsection (d). Such national sepsis repository shall— (A) accelerate innovation that seeks to improve sepsis prevention, diagnosis, treatment, outcomes, and survivor support, including through advancing the pace of academic research and 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 under-served 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 with States and State sepsis advisory committees in the development of statewide sepsis repositories, including by defining data elements to be included in statewide sepsis repositories; and (E) provide for appropriate privacy and security of de-identified information in the repository. (2) Rule of construction Nothing in paragraph (1) shall be construed as requiring a State to provide data to the national sepsis repository established under such paragraph. (d) National sepsis action plan The Secretary shall develop a national action plan to reduce the incidence of sepsis, improve outcomes, and reduce the clinical and economic burden of sepsis. (1) In general The Secretary shall create a sepsis advisory committee to advise the Secretary in the development of a sepsis action plan. The sepsis advisory committee shall include a multidisciplinary and diverse membership that represents a variety of stakeholders, including clinical specialtists, public health officials, epidemiologists, payors, patient safety advocates, and individuals or organizations that represent sepsis survivors, family members of sepsis patients, and populations that are most affected by sepsis or experience the greatest disparities in sepsis outcomes. (2) Elements of sepsis action plan The sepsis action plan developed under paragraph (1) may include— (A) increasing research; (B) spurring innovation; (C) incentivizing development of diagnostic tools and treatments; (D) coordinating among agencies within the Department of Health and Human Services and other Federal agencies, academic institutions, and non-profit organizations; (E) coordinating information assembled through the statewide sepsis repositories; (F) identifying populations that are at higher risk for contracting sepsis or for disparate sepsis outcomes; and (G) detailing specific actions to be taken to address and eliminate the burden of sepsis, including among at-risk populations. (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) Sepsis Repository The term sepsis repository means an interoperable, de-identified, privacy-protected collection system that contains de-identified data from a variety of sources established by individual States. .