[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8078 Introduced in House (IH)]

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118th CONGRESS
  2d Session
                                H. R. 8078

To authorize Federal support of States in piloting interoperable State-
      based repositories of sepsis cases, and for other purposes.


_______________________________________________________________________


                    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.

    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 ``Sepsis Harm and Cost Reduction Act'' 
or the ``LuLu's Law''.

SEC. 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.

SEC. 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:

``SEC. 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.''.
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