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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8078 Introduced in House (IH)]
<DOC>
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.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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