[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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