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 interoperable State-based repositories of sepsis cases, and for 

other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Sepsis Harm and Cost 

5 Reduction Act’’ or the ‘‘LuLu’s Law’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 

8 (1) Sepsis affects 1.7 million people in the 

9 United States each year, and results in 350,000 

10 adult deaths annually. 


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1 (2) Sepsis is a leading cause of maternal mor2 tality in the United States. 

3 (3) Sepsis is a leading cause of rising newborn 

4 mortality in the United States. 

5 (4) Nearly 7,000 children die from sepsis annu6 ally in the United States. 

7 (5) Many survivors face life-long after-effects of 

8 sepsis, including 14,000 annually who receive ampu9 tations. 

10 (6) Each hour a septic patient goes untreated 

11 increases the risk of death by as much as 8 percent. 

12 (7) Sepsis is the leading cause of death in 

13 United States hospitals, and the leading cause of 

14 hospital readmissions. 

15 (8) Sepsis hospitalizations cost Medicare $41.8 

16 billion in 2019. 

17 (9) Sepsis is responsible for $62 billion in hos18 pitalization costs annually. 

19 (10) Additional information about sepsis could 

20 help improve timely diagnosis and treatment, reduc21 ing loss of life, harm and costs due to sepsis. 

22 SEC. 3. REDUCING THE BURDEN OF SEPSIS. 

23 Part P of title III of the Public Health Service Act 

24 (42 U.S.C. 280g et seq.) is amended by adding at the end 

25 the following: 


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1 ‘‘SEC. 399V–8. REDUCING THE BURDEN OF SEPSIS. 

2 ‘‘(a) DEFINITION OF SEPSIS.—Not later than 120 

3 days after the date of the enactment of the Sepsis Harm 

4 and Cost Reduction Act, the Secretary shall issue a rule 

5 specifying a definition of sepsis. Such definition may speci6 fy that sepsis is a life-threatening organ dysfunction 

7 caused by a dysregulated host response to infection. Such 

8 definition shall be standardized across departments, agen9 cies, and other entities within the Department of Health 

10 of Human Services. 

11 ‘‘(b) STATE-BASED SEPSIS REPOSITORY PILOT PRO12 GRAMS.— 

13 ‘‘(1) IN GENERAL.—Subject to the availability 

14 of appropriations for a fiscal year, the Secretary 

15 shall award grants to not more than 5 States each 

16 fiscal year to establish pilot statewide sepsis reposi17 tories. 

18 ‘‘(2) APPLICATION.—A State seeking a grant 

19 under paragraph (1) shall submit to the Secretary 

20 an application at such time, in such manner, and 

21 containing— 

22 ‘‘(A) a certification that the State has es23 tablished a sepsis advisory committee, in ac24 cordance with paragraph (3); and 

25 ‘‘(B) such other information as the Sec26 retary may require. 


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1 ‘‘(3) SEPSIS ADVISORY COMMITTEE.— 

2 ‘‘(A) DUTIES.—A State sepsis advisory 

3 committee referred to in paragraph (2)(A) 

4 shall— 

5 ‘‘(i) advise the State in the design, de6 velopment, and operation of the statewide 

7 sepsis repository; 

8 ‘‘(ii) ensure that all information in9 cluded in the sepsis repository is de-identi10 fied and privacy protected; and 

11 ‘‘(iii) assist in securing voluntary par12 ticipation in, and contributions of informa13 tion to, the sepsis repository by organiza14 tions and entities in the State. 

15 ‘‘(B) COMPOSITION.—A State sepsis advi16 sory committee referred to in paragraph (2)(A) 

17 shall be composed of multidisciplinary and di18 verse membership that represents a variety of 

19 stakeholders, including clinical specialties, pub20 lic health officials, epidemiologists, statisticians, 

21 data scientists, payers, patient safety advocates, 

22 and individuals or organizations that represent 

23 sepsis survivors, family members of sepsis pa24 tients, and populations that are most affected 


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1 by sepsis or experience the greatest disparities 

2 in sepsis outcomes. 

3 ‘‘(4) SELECTION CRITERIA.—In selecting States 

4 to receive a grant under this subsection, the Sec5 retary shall select, from among the States submit6 ting an application for such a grant that meets the 

7 requirements of paragraph (2)— 

8 ‘‘(A) at least 1 State that has a death rate 

9 from sepsis of greater than 15 people per 

10 100,000 people per year and 1,500 deaths per 

11 year for the 5 calendar years preceding the dec12 laration of the public health emergency with re13 spect to COVID–19; 

14 ‘‘(B) at least 1 rural State with an above 

15 average sepsis mortality rate; 

16 ‘‘(C) a diverse array of other States in 

17 such a manner as to ensure diversity of popu18 lation density, geographic location, and general 

19 healthcare access and infrastructure; and 

20 ‘‘(D) other States in such a manner as to 

21 ensure geographic and population diversity. 

22 ‘‘(5) ALTERNATIVE CRITERIA.—If no State 

23 meeting the criteria specified in paragraph (4) estab24 lishes a pilot program in coordination with the Sec25 retary within 36 months after the date of enactment 


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1 of this section, the Secretary may identify alter2 native requirements for such States. 

3 ‘‘(6) SEPSIS REPOSITORY ACTIVITIES.—A State 

4 receiving a grant under this subsection shall use 

5 funds received through the grant to, in consultation 

6 with the applicable State sepsis advisory committee 

7 established pursuant to paragraph (2), establish a 

8 statewide sepsis repository that integrates— 

9 ‘‘(A) demographic information about each 

10 case of sepsis in such State; 

11 ‘‘(B) administrative information with re12 spect to each such case; 

13 ‘‘(C) characterizations of each such case, 

14 including pathological analysis and 

15 uninterpreted data; 

16 ‘‘(D) clinical information, including rel17 evant diagnoses, treatment, and patient-re18 ported outcomes of the individuals with sepsis 

19 and sepsis survivors; and 

20 ‘‘(E) provider payments that result from a 

21 sepsis diagnosis. 

22 ‘‘(7) GUIDELINES.—The Secretary shall estab23 lish governance guidelines, information access re24 quirements, privacy and security protocols, and 

25 other such standards as may be necessary to support 


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1 the establishment of interoperable statewide sepsis 

2 repositories. 

3 ‘‘(8) STATE REPORTING.—Not later than 18 

4 months after the date on which a State successfully 

5 establishes a statewide sepsis repository using funds 

6 received through a grant under this subsection, the 

7 State shall submit to the Secretary a report. Such 

8 report shall include, with respect to the repository— 

9 ‘‘(A) the process by which the State estab10 lished the repository; 

11 ‘‘(B) the process by which information re12 garding sepsis was collected, de-identified, and 

13 standardized across multiple contributing sys14 tems; 

15 ‘‘(C) implementation barriers experienced 

16 and the State’s response to address such bar17 riers; and 

18 ‘‘(D) lessons learned through the establish19 ment of the repository. 

20 ‘‘(9) BEST PRACTICES RELATING TO THE IM21 PLEMENTATION OF STATEWIDE SEPSIS REPOSI22 TORIES.—The Secretary, acting through the Direc23 tor of the Centers for Disease Control and Preven24 tion, shall collect from the recipients of grants 

25 awarded under this subsection, and disseminate, not 


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1 later than 18 months after receiving data from grant 

2 recipients, and at least once each fiscal year there3 after— 

4 ‘‘(A) lessons learned and best practices in 

5 the design, development, implementation, and 

6 operation of statewide sepsis repositories; and 

7 ‘‘(B) lessons learned and best practices on 

8 identifying and decreasing sepsis-related events 

9 through the implementation and operation of 

10 statewide sepsis repositories. 

11 ‘‘(10) AUTHORIZATION OF APPROPRIATIONS.— 

12 There are authorized to be appropriated to carry out 

13 this subsection $5,000,000 for each of fiscal years 

14 2025 through 2030. 

15 ‘‘(c) NATIONAL SEPSIS REPOSITORY.— 

16 ‘‘(1) IN GENERAL.—The Secretary, acting 

17 through the Director of the Centers for Disease 

18 Control and Prevention, shall establish a national 

19 sepsis repository to improve research, outcomes, and 

20 innovation in support of the national strategy devel21 oped under subsection (d). Such national sepsis re22 pository shall— 

23 ‘‘(A) accelerate innovation that seeks to 

24 improve sepsis prevention, diagnosis, treatment, 

25 outcomes, and survivor support, including 


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1 through advancing the pace of academic re2 search and catalyzing more investment in mech3 anisms that provide promise in the early rec4 ognition and expeditious treatment of sepsis; 

5 ‘‘(B) support public health efforts to im6 prove sepsis care, particularly in underserved 

7 geographic areas and among at-risk and under8 served communities; 

9 ‘‘(C) improve the targeting of antimicrobial 

10 drugs and other substances for the treatment of 

11 sepsis, promoting both better care and improved 

12 antimicrobial stewardship; 

13 ‘‘(D) coordinate with States and State sep14 sis advisory committees in the development of 

15 statewide sepsis repositories, including by defin16 ing data elements to be included in statewide 

17 sepsis repositories; and 

18 ‘‘(E) provide for appropriate privacy and 

19 security of de-identified information in the re20 pository. 

21 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in 

22 paragraph (1) shall be construed as requiring a 

23 State to provide data to the national sepsis reposi24 tory established under such paragraph. 


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1 ‘‘(d) NATIONAL SEPSIS ACTION PLAN.—The Sec2 retary shall develop a national action plan to reduce the 

3 incidence of sepsis, improve outcomes, and reduce the clin4 ical and economic burden of sepsis. 

5 ‘‘(1) IN GENERAL.—The Secretary shall create 

6 a sepsis advisory committee to advise the Secretary 

7 in the development of a sepsis action plan. The sep8 sis advisory committee shall include a multidisci9 plinary and diverse membership that represents a 

10 variety of stakeholders, including clinical specialtists, 

11 public health officials, epidemiologists, payors, pa12 tient safety advocates, and individuals or organiza13 tions that represent sepsis survivors, family mem14 bers of sepsis patients, and populations that are 

15 most affected by sepsis or experience the greatest 

16 disparities in sepsis outcomes. 

17 ‘‘(2) ELEMENTS OF SEPSIS ACTION PLAN.—The 

18 sepsis action plan developed under paragraph (1) 

19 may include— 

20 ‘‘(A) increasing research; 

21 ‘‘(B) spurring innovation; 

22 ‘‘(C) incentivizing development of diag23 nostic tools and treatments; 

24 ‘‘(D) coordinating among agencies within 

25 the Department of Health and Human Services 


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1 and other Federal agencies, academic institu2 tions, and non-profit organizations; 

3 ‘‘(E) coordinating information assembled 

4 through the statewide sepsis repositories; 

5 ‘‘(F) identifying populations that are at 

6 higher risk for contracting sepsis or for dis7 parate sepsis outcomes; and 

8 ‘‘(G) detailing specific actions to be taken 

9 to address and eliminate the burden of sepsis, 

10 including among at-risk populations. 

11 ‘‘(e) DEFINITIONS.—In this section: 

12 ‘‘(1) DE-IDENTIFIED.—The term ‘de-identified’ 

13 means, with respect to data in a data trust estab14 lished under or pursuant to this section, information 

15 that has been de-identified (and remains de-identi16 fied) in accordance with the applicable requirements 

17 of section 164.514 of title 45, Code of Federal Reg18 ulations (or any successor regulation). 

19 ‘‘(2) SEPSIS REPOSITORY.—The term ‘sepsis re20 pository’ means an interoperable, de-identified, pri21 vacy-protected collection system that contains de22 identified data from a variety of sources established 

23 by individual States.’’. 

Æ 


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