I 
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 interoper-
able State-based repositories of sepsis cases, and for 
other purposes. 
Be it enacted by the Senate and House of Representa-
tives 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. 
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(2) Sepsis is a leading cause of maternal mor-
tality 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 annu-
ally in the United States. 
(5) Many survivors face life-long after-effects of 
sepsis, including 14,000 annually who receive ampu-
tations. 
(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 hos-
pitalization costs annually. 
(10) Additional information about sepsis could 
help improve timely diagnosis and treatment, reduc-
ing 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: 
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‘‘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 speci-
fy that sepsis is a life-threatening organ dysfunction 
caused by a dysregulated host response to infection. Such 
definition shall be standardized across departments, agen-
cies, and other entities within the Department of Health 
of Human Services. 
‘‘(b) STATE-BASED SEPSIS REPOSITORY PILOT PRO-
GRAMS.— 
‘‘(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 reposi-
tories. 
‘‘(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 es-
tablished a sepsis advisory committee, in ac-
cordance with paragraph (3); and 
‘‘(B) such other information as the Sec-
retary may require. 
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‘‘(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, de-
velopment, and operation of the statewide 
sepsis repository; 
‘‘(ii) ensure that all information in-
cluded in the sepsis repository is de-identi-
fied and privacy protected; and 
‘‘(iii) assist in securing voluntary par-
ticipation in, and contributions of informa-
tion to, the sepsis repository by organiza-
tions and entities in the State. 
‘‘(B) COMPOSITION.—A State sepsis advi-
sory committee referred to in paragraph (2)(A) 
shall be composed of multidisciplinary and di-
verse membership that represents a variety of 
stakeholders, including clinical specialties, pub-
lic health officials, epidemiologists, statisticians, 
data scientists, payers, patient safety advocates, 
and individuals or organizations that represent 
sepsis survivors, family members of sepsis pa-
tients, and populations that are most affected 
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by sepsis or experience the greatest disparities 
in sepsis outcomes. 
‘‘(4) SELECTION CRITERIA.—In selecting States 
to receive a grant under this subsection, the Sec-
retary shall select, from among the States submit-
ting 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 dec-
laration of the public health emergency with re-
spect 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 popu-
lation 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) estab-
lishes a pilot program in coordination with the Sec-
retary within 36 months after the date of enactment 
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of this section, the Secretary may identify alter-
native 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 re-
spect to each such case; 
‘‘(C) characterizations of each such case, 
including 
pathological 
analysis 
and 
uninterpreted data; 
‘‘(D) clinical information, including rel-
evant diagnoses, treatment, and patient-re-
ported outcomes of the individuals with sepsis 
and sepsis survivors; and 
‘‘(E) provider payments that result from a 
sepsis diagnosis. 
‘‘(7) GUIDELINES.—The Secretary shall estab-
lish governance guidelines, information access re-
quirements, privacy and security protocols, and 
other such standards as may be necessary to support 
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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 estab-
lished the repository; 
‘‘(B) the process by which information re-
garding sepsis was collected, de-identified, and 
standardized across multiple contributing sys-
tems; 
‘‘(C) implementation barriers experienced 
and the State’s response to address such bar-
riers; and 
‘‘(D) lessons learned through the establish-
ment of the repository. 
‘‘(9) BEST PRACTICES RELATING TO THE IM-
PLEMENTATION
OF
STATEWIDE
SEPSIS
REPOSI-
TORIES.—The Secretary, acting through the Direc-
tor of the Centers for Disease Control and Preven-
tion, shall collect from the recipients of grants 
awarded under this subsection, and disseminate, not 
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later than 18 months after receiving data from grant 
recipients, and at least once each fiscal year there-
after— 
‘‘(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 devel-
oped under subsection (d). Such national sepsis re-
pository shall— 
‘‘(A) accelerate innovation that seeks to 
improve sepsis prevention, diagnosis, treatment, 
outcomes, and survivor support, including 
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