[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4827 Introduced in Senate (IS)]
<DOC>
117th CONGRESS
2d Session
S. 4827
To authorize the Secretary of Health and Human Services to establish a
national sepsis data trust, and to fund State-based pilots and programs
to establish interoperable State-based sepsis data trusts.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 13, 2022
Mr. Cassidy (for himself and Mr. Casey) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To authorize the Secretary of Health and Human Services to establish a
national sepsis data trust, and to fund State-based pilots and programs
to establish interoperable State-based sepsis data trusts.
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 ``National Sepsis Data Trust,
Outcomes, and Innovation Act'' or ``LuLu's Law''.
SEC. 2. TREATING AND ELIMINATING 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-7. TREATING AND ELIMINATING THE BURDEN OF SEPSIS.
``(a) Definition; Designation.--
``(1) Definition of sepsis.--Not later than 120 days after
the date of enactment of the National Sepsis Data Trust,
Outcomes, and Innovation 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.
``(2) Nationally notifiable disease.--The Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, shall take such steps as may be necessary to
include sepsis on the list of nationally notifiable diseases
published by the Centers for Disease Control and Prevention.
``(b) National Strategy.--
``(1) In general.--The Secretary shall develop a national
strategy--
``(A) to treat and eliminate the burden of sepsis,
with the specific goals of, with respect to sepsis--
``(i) coordinating data (including through
the data trust established under subsection
(d));
``(ii) spurring research; and
``(iii) developing diagnostic tools and
treatments;
``(B) to decrease instances of sepsis and mitigate
long-term health effects of sepsis; and
``(C) that includes specific actions to be taken to
treat and eliminate the burden of sepsis among at-risk
populations identified pursuant to paragraph (3).
``(2) Coordination.--In developing the strategy under
paragraph (1), the Secretary may coordinate among agencies
within the Department of Health and Human Services and other
Federal agencies, academic institutions, and non-profit
organizations.
``(3) At-risk populations.--The Secretary shall identify
population groups the Secretary determines to be at a higher
risk for contracting sepsis, which shall include--
``(A) children;
``(B) pregnant women or women in the one year
postpartum period;
``(C) active members of the Armed Forces and
veterans;
``(D) disabled and elderly individuals;
``(E) individuals residing on federally-recognized
Tribal lands; and
``(F) such other groups as the Secretary determines
to be at higher risk for contracting sepsis.
``(c) State-Based Sepsis Data Trust Pilot Programs.--
``(1) In general.--Subject to the availability of
appropriations, the Secretary shall award grants to not more
than 5 States to establish pilot programs--
``(A) to collect into State-based sepsis data
trusts that use standardized data formats and coding
(as determined by the Secretary) de-identified patient
data concerning--
``(i) demographic information about each
case of sepsis in each such State;
``(ii) administrative information with
respect to each such case, including the date
of diagnosis and the source of information;
``(iii) pathological and genetic material
characterizing each such case (including
deoxyribonucleic acids (DNA), ribonucleic acids
(RNA), single cell RNA, genes, chromosomes,
genotype, alleles, epigenetic alteration or
modifications to DNA or RNA, single nucleotide
polymorphisms (SNPs), uninterpreted data that
results from analysis of a biological sample
from a diagnosed sepsis patient or other
source, and any information extrapolated,
derived, or inferred therefrom);
``(iv) clinical information, including
relevant diagnoses, treatment, and patient-
reported outcomes of the individuals with
sepsis and sepsis survivors;
``(v) with respect to each case of sepsis
in each such State, the number of staff working
in the relevant unit of the health care
provider involved;
``(vi) provider payments that result from a
sepsis diagnosis; and
``(vii) other elements determined
appropriate by the Secretary; and
``(B) to combine and connect data so collected
among such States.
``(2) Data trust guidelines.--
``(A) In general.--The Secretary shall establish
governance guidelines, data access requirements,
privacy and security protocols, and other such
standards as may be required to support the
establishment of interoperable State-based sepsis data
trusts for purposes of the national sepsis data trust
to be established under subsection (d).
``(B) Data sharing.--The guidelines established
under subparagraph (A) shall specify that--
``(i) no entity participating in the data
trust may share patient data with any entity
not participating in the data trust; and
``(ii) an entity shall agree, as a
condition on participation in the data trust to
not share any patient data with any entity not
participating in the data trust.
``(3) Selection criteria.--In reviewing applications
submitted by States for grants under this section, the
Secretary shall consider whether the States submitting such
applications demonstrate established partnerships with a range
of public and private stakeholders. Of the States that
demonstrate such partnerships, the Secretary shall select--
``(A) at least one State that has a death rate from
septicemia 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 one rural State with above average
sepsis mortality rate;
``(C) a selection of other States in such a manner
as to ensure diversity of population density,
geographic location, and general health care access and
infrastructure; and
``(D) other States in such a matter as to ensure
geographic and population diversity.
``(4) Alternative criteria.--If no State meeting the
criteria specified in paragraph (3) establishes a pilot program
in coordination with the Secretary within 3 years of the date
of enactment of the National Sepsis Data Trust, Outcomes, and
Innovation Act, the Secretary may identify alternative
requirements for such States.
``(5) Reporting.--Not later than 18 months after the date
on which a State successfully (as determined by the Secretary)
establishes a State-based sepsis data trust 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 State-based sepsis data trust involved--
``(A) the process by which the State established
the data trust, including governance and data access
rules;
``(B) the process by which data was collected, de-
identified, and standardized across multiple data
systems;
``(C) implementation barriers experienced and the
course of corrective action taken to address these
barriers; and
``(D) lessons learned through the establishment of
the data trust.
``(6) Authorization of appropriations.--There are
authorized to be appropriated to carry out this subsection
$5,000,000 for each of fiscal years 2023 through 2028.
``(d) National Sepsis Data Trust.--
``(1) In general.--The Secretary shall establish a national
sepsis data trust to improve research, outcomes, and innovation
in support of the national strategy developed under subsection
(b) (including the actions to be taken pursuant to paragraph
(1)(C) of such subsection). Such national sepsis data trust
shall--
``(A) accelerate innovation that seeks to improve
sepsis prevention, diagnosis, treatment, outcomes, and
survivor support, including through--
``(i) advancing the pace of academic
research; and
``(ii) 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 underserved 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 and integrate the development of
State-based sepsis data trusts, including by defining
data elements to be included in State-based sepsis data
trusts, including self-reported data on age, race,
ethnicity, primary language, membership in a federally-
recognized Tribe, status as a member of the Armed
Forces, status as a veteran, status as pregnant or
recently pregnant, and any other data the Secretary
determines appropriate;
``(E) provide for appropriate privacy and security
of de-identified data in the data trust by--
``(i) prohibiting any entity participating
in the data trust from sharing patient data
with any entity not participating in the data
trust; and
``(ii) ensuring that an entity agrees, as a
condition on participation in the data trust to
not share any patient data with any entity not
participating in the data trust; and
``(F) allow access to data de-identified data in
the data trust by health care providers and other
entities participating in the data trust.
``(2) State grants and contracts.--
``(A) In general.--In addition to awarding grants
under subsection (c), the Secretary may award grants
directly to States to support the development and
operation of State-based sepsis data trusts (or award
grants or contracts to academic or nonprofit
organizations designated by a State to operate the
State-based sepsis data trust involved) to combine and
connect data collected by the State concerning--
``(i) demographic information about each
case of sepsis in each such State;
``(ii) administrative information with
respect to each such case, including the date
of diagnosis and the source of information;
``(iii) pathological and genetic data
characterizing each such case;
``(iv) clinical information, including
relevant diagnoses, treatment, and patient-
reported outcomes of the individuals with
sepsis and sepsis survivors; and
``(v) other elements, as the Secretary
determines appropriate.
``(B) Matching funds.--The Secretary may award a
grant or contract under paragraph (2) only if the State
involved (or the academic or nonprofit private
organization designated by a State to operate the
State-based sepsis data trust involved) agrees, with
respect to the costs of the program to be funded
through the award, to make available (directly or
through donations from public or private entities) non-
Federal contributions toward such costs in an amount
that is not less than 25 percent of such costs.
``(C) Data trust guidelines.--The guidelines
developed under subsection (c)(2) shall apply with
respect to State-based sepsis data trusts established
under this paragraph in the same manner and to the same
extent as such guidelines apply with respect to State-
based sepsis data trusts established under subsection
(c) (including the data sharing limitations specified
in paragraph (2)(B) of such subsection).
``(3) Report on government sepsis data activities and
resources.--Not later than 180 days after the date of enactment
of the National Sepsis Data Trust, Outcomes, and Innovation
Act, the Secretary shall submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives a report
containing the following:
``(A) An outline of existing Federal efforts to
collect and make available data on sepsis and its
associated conditions, including existing Federal
repositories of sepsis-relevant de-identified patient
data.
``(B) A summary of the use of these sepsis data by
third parties, including public health professionals,
physicians and nurses, and researchers.
``(C) A description of Federal efforts to improve
care related to sepsis and infection in underserved
populations and communities that experience
disproportionately poor health outcomes.
``(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) National sepsis data trust.--The term `national
sepsis data trust' means an interoperable, de-identified,
privacy-protected collection, curation, and storage system that
contains de-identified data from a variety of sources
established by individual States, with data made available to
entities and individuals approved by the Secretary.''.
<all>