[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6166 Introduced in House (IH)]
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116th CONGRESS
2d Session
H. R. 6166
To amend the Public Health Service Act to authorize and support the
creation and dissemination of cardiomyopathy education, awareness, and
risk assessment materials and resources to identify more at-risk
families, to authorize research and surveillance activities relating to
cardiomyopathy, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 10, 2020
Mr. Kim (for himself and Mr. Barr) introduced the following bill; which
was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to authorize and support the
creation and dissemination of cardiomyopathy education, awareness, and
risk assessment materials and resources to identify more at-risk
families, to authorize research and surveillance activities relating to
cardiomyopathy, 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 ``Cardiomyopathy Health Education,
Awareness, Research, and Training in the Schools Act of 2020'' or the
``HEARTS Act of 2020''.
SEC. 2. MATERIALS AND RESOURCES TO INCREASE EDUCATION AND AWARENESS OF
CARDIOMYOPATHY AMONG SCHOOL ADMINISTRATORS, EDUCATORS,
AND FAMILIES.
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 new
section:
``SEC. 399V-7. MATERIALS AND RESOURCES TO INCREASE EDUCATION AND
AWARENESS OF CARDIOMYOPATHY AMONG SCHOOL ADMINISTRATORS,
EDUCATORS, AND FAMILIES.
``(a) Materials and Resources.--Not later than 18 months after the
date of the enactment of this section, the Secretary, in conjunction
with the Director of the Centers for Disease Control and Prevention (in
this section referred to as the `Director') shall develop public
education materials and resources to be disseminated to school
administrators, educators, school health professionals, coaches,
families, guardians, caregivers, and other appropriate individuals. The
materials and resources shall include--
``(1) background information to increase education and
awareness of cardiomyopathy among school administrators,
educators, and families;
``(2) guidelines regarding the placement of automated
external defibrillators in schools, early childhood education
programs, and child care centers;
``(3) training information on automated external
defibrillators and cardiopulmonary resuscitation; and
``(4) recommendations for how schools, early childhood
education programs, and child care centers can develop and
implement a cardiac emergency response plan.
``(b) Dissemination of Materials and Resources.--Not later than 30
months after the date of the enactment of this section, the Secretary,
through the Director, shall disseminate the materials and resources
developed under subsection (a) in accordance with the following:
``(1) Distribution by state educational agencies.--The
Secretary shall make available such materials and resources to
State educational agencies to distribute--
``(A) to school administrators, educators, school
health professionals, coaches, families, guardians,
caregivers, and other appropriate individuals, the
cardiomyopathy education and awareness materials and
resources developed under subsection (a)(1);
``(B) to parents, guardians, or other caregivers,
the risk assessment for individuals with or at risk for
cardiomyopathy developed pursuant to section 399V-
8(b)(1); and
``(C) to school administrators, educators, school
health professionals, and coaches--
``(i) the guidelines described in
subsection (a)(2);
``(ii) the training information described
in subsection (a)(3); and
``(iii) the recommendations described in
subsection (a)(4).
``(2) Dissemination to health departments and
professionals.--The Secretary shall make available the
materials and resources developed under subsection (a) to State
and local health departments, pediatricians, hospitals, and
other health professionals, such as nurses and first
responders.
``(3) Posting on website.--
``(A) CDC.--
``(i) In general.--The Secretary, through
the Director, shall post the materials and
resources developed under subsection (a) on the
public internet website of the Centers for
Disease Control and Prevention.
``(ii) Additional information.--The
Director is encouraged to maintain on such
public internet website such additional
information regarding cardiomyopathy as deemed
appropriate by the Director.
``(B) State educational agencies.--State
educational agencies are encouraged to create public
internet webpages dedicated to cardiomyopathy and post
the materials and resources developed under subsection
(a) on such webpages.
``(c) Definitions.--In this section:
``(1) The term `school administrator' means a principal,
director, manager, or other supervisor or leader within an
elementary school, secondary school, State-based early
childhood education program, or child care center.
``(2) The term `school health professional' means a health
professional serving at an elementary school, secondary school,
State-based early childhood education program, or child care
center.
``(3) The terms `early childhood education program',
`elementary school', and `secondary school' have the meanings
given to those terms in section 8101 of the Elementary and
Secondary Education Act of 1965.
``(d) Authorization of Appropriations.--For carrying out this
section and section 399V-8, there is authorized to be appropriated
$1,000,000 for each of fiscal years 2021 through 2025.''.
SEC. 3. RESEARCH AND SURVEILLANCE ACTIVITIES RELATING TO
CARDIOMYOPATHY.
(a) CDC Research and Surveillance.--Part P of title III of the
Public Health Service Act (42 U.S.C. 280g et seq.), as amended by
section 2, is further amended by adding at the end the following new
section:
``SEC. 399V-8. RESEARCH AND SURVEILLANCE ACTIVITIES RELATING TO
CARDIOMYOPATHY.
``(a) Reports on CDC National Cardiomyopathy Surveillance Research
Activities.--
``(1) Initial report.--Not later than June 1, 2021, the
Secretary, acting through the Director of the Centers for
Disease Control and Prevention, shall submit to Congress an
initial report on findings and data generated from surveillance
and research activities conducted by the Centers for Disease
Control and Prevention to improve the understanding of the
prevalence and epidemiology of cardiomyopathy across the
lifespan, from birth to adulthood, with particular interest in
the following:
``(A) The health care costs, utilization, and
natural history of individuals with cardiomyopathy, in
both the pediatric and adult population.
``(B) The number of adults and children affected by
cardiomyopathy, as well as age-specific mortality.
``(2) Final report.--Not later than January 1, 2026, the
Secretary, acting through the Director of the Centers for
Disease Control and Prevention, shall submit to Congress a
final report on the content described in paragraph (1).
``(3) Public access.--Subject to paragraph (4), the reports
submitted under this subsection shall be made available to the
public.
``(4) Patient privacy.--The Secretary shall ensure that
this subsection is carried out in a manner that complies with
the requirements applicable to a covered entity under the
regulations promulgated pursuant to section 264(c) of the
Health Insurance Portability and Accountability Act of 1996.
``(b) Improving Risk Assessments for Individuals With
Cardiomyopathy.--
``(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
shall develop and make publicly available a risk assessment for
individuals with or at risk for cardiomyopathy. Such risk
assessment shall, at a minimum, include the following:
``(A) Background information of the prevalence,
incidence, and health impact of cardiomyopathy,
including all forms of cardiomyopathy and their effects
on pediatric, adolescent, and adult individuals.
``(B) A worksheet with variables and conditions for
an individual or health care provider to use in
assessing whether the individual is at risk for
cardiomyopathy.
``(C) A worksheet with variables and stages of
progression for an individual or health care provider
to use in assessing whether and to what extent
cardiomyopathy has progressed in the individual.
``(D) Guidelines on cardiomyopathy screenings for
individuals who are at risk for, or have a family
history of, cardiomyopathy.
``(2) Stakeholder input.--In carrying out paragraph (1),
the Director of the Centers for Disease Control and Prevention
shall seek input from external stakeholders including--
``(A) representatives from national patient
advocacy organizations expert in all forms of
cardiomyopathy;
``(B) representatives from medical professional
societies that specialize in the care of adults and
pediatrics with cardiomyopathy; and
``(C) representatives from other relevant Federal
agencies.
``(c) Cardiomyopathy Defined.--For purposes of this section, the
term `cardiomyopathy' means a heart disease that affects the heart's
muscle (myocardium)--
``(1) the symptoms of which may vary from case to case,
including--
``(A) cases in which no symptoms are present
(asymptomatic); and
``(B) cases in which there are symptoms of a
progressive condition that may result from an impaired
ability of the heart to pump blood, such as fatigue,
irregular heartbeats (arrhythmia), heart failure, and,
potentially, sudden cardiac death; and
``(2) the recognized types of which include dilated,
hypertrophic, restrictive, arrhythmogenic right ventricular
dysplasia, and left ventricular non-compaction.''.
(b) Federal Working Group.--
(1) In general.--Not later than one year after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall convene an interdisciplinary working group for
the purpose of expanding cardiomyopathy research.
(2) Duties.--The working group shall--
(A) develop a research strategy to address the gaps
in knowledge on the molecular and genetic causes of
cardiomyopathy in children;
(B) identify approaches that could result in the
development of preventive and disease-directed
therapies specific to pediatric cardiomyopathies and
heart failure; and
(C) explore novel clinical trial methodologies and
end points in an effort to optimize successful
completion of clinical trials in this rare patient
population.
(3) Membership.--The Secretary shall appoint to the working
group members representing a range of stakeholders outside of
the Federal Government with subject matter expertise relating
to cardiomyopathy, including--
(A) pediatric cardiologists with expertise in the
diagnosis and treatment of children with
cardiomyopathies and heart failure and clinical trials
related to the pediatric population;
(B) geneticists with expertise in pediatric
cardiomyopathy and heart failure;
(C) cardiovascular molecular biologists;
(D) pharmacologists;
(E) research scientists with expertise in
cardiomyopathy and heart failure; and
(F) other stakeholders with relevant expertise, as
determined by the Secretary.
(4) Report to congress.--Not later than 2 years after the
date of the enactment of this Act, the Working Group shall
publish and submit to Congress a report that contains--
(A) a description of the activities of the working
group;
(B) the findings and recommendations of the working
group with respect to each of the topics described in
paragraph (2); and
(C) the recommendations of the working group
relating to actions that Federal agencies and Congress
can take to implement the recommendations described in
subparagraph (B).
(5) No compensation.--A member of the working group shall
serve without compensation.
(6) Termination.--The working group shall terminate on the
date on which the working group submits the report under
paragraph (4).
(7) Cardiomyopathy defined.--For purposes of this
subsection, the term ``cardiomyopathy'' means a heart disease
that affects the heart's muscle (myocardium)--
(A) the symptoms of which may vary from case to
case, including--
(i) cases in which no symptoms are present
(asymptomatic); and
(ii) cases in which there are symptoms of a
progressive condition that may result from an
impaired ability of the heart to pump blood,
such as fatigue, irregular heartbeats
(arrhythmia), heart failure, and, potentially,
sudden cardiac death; and
(B) the recognized types of which include dilated,
hypertrophic, restrictive, arrhythmogenic right
ventricular dysplasia, and left ventricular non-
compaction.
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