[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1222 Reported in Senate (RS)]

<DOC>





                                                       Calendar No. 555
115th CONGRESS
  2d Session
                                H. R. 1222


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           February 27, 2018

     Received; read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

                            August 15, 2018

              Reported by Mr. Alexander, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 AN ACT


 
To amend the Public Health Service Act to coordinate Federal congenital 
  heart disease research efforts and to improve public education and 
     awareness of congenital heart disease, and for other purposes.

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

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Congenital Heart Futures 
Reauthorization Act of 2017''.</DELETED>

<DELETED>SEC. 2. NATIONAL CONGENITAL HEART DISEASE SURVEILLANCE 
              SYSTEM.</DELETED>

<DELETED>    Section 399V-2 of the Public Health Service Act (42 U.S.C. 
280g-13) is amended to read as follows:</DELETED>

<DELETED>``SEC. 399V-2. NATIONAL CONGENITAL HEART DISEASE RESEARCH, 
              SURVEILLANCE, AND AWARENESS.</DELETED>

<DELETED>    ``(a) In General.--The Secretary shall--</DELETED>
        <DELETED>    ``(1) enhance and expand research and surveillance 
        infrastructure to study and track the epidemiology of 
        congenital heart disease (in this section referred to as 
        `CHD'); and</DELETED>
        <DELETED>    ``(2) award grants to eligible entities to 
        undertake the activities described in this section.</DELETED>
<DELETED>    ``(b) National Congenital Heart Disease Study.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary shall plan, 
        develop, implement, and submit one or more reports to the 
        Congress on a study to improve understanding of the 
        epidemiology of CHD across the lifespan, from birth to 
        adulthood, with particular interest in the following:</DELETED>
                <DELETED>    ``(A) Health care utilization of those 
                affected by CHD.</DELETED>
                <DELETED>    ``(B) Demographic factors associated with 
                CHD, such as age, race, ethnicity, gender, and family 
                history of individuals who are diagnosed with the 
                disease.</DELETED>
                <DELETED>    ``(C) Outcome measures, such that analysis 
                of the outcome measures will allow derivation of 
                evidence-based best practices and guidelines for CHD 
                patients.</DELETED>
        <DELETED>    ``(2) Permissible considerations.--The study under 
        this subsection may--</DELETED>
                <DELETED>    ``(A) gather data on the health outcomes 
                of a diverse population of those affected by 
                CHD;</DELETED>
                <DELETED>    ``(B) consider health disparities among 
                those affected by CHD, which may include the 
                consideration of prenatal exposures; and</DELETED>
                <DELETED>    ``(C) incorporate behavioral, emotional, 
                and educational outcomes of those affected by 
                CHD.</DELETED>
        <DELETED>    ``(3) Public access.--Data generated from the 
        study under this subsection shall be made available--</DELETED>
                <DELETED>    ``(A) for purposes of CHD research, 
                subject to appropriate protections of personal privacy, 
                including protections required by paragraph (4); 
                and</DELETED>
                <DELETED>    ``(B) to the public, subject to paragraph 
                (4) and with appropriate exceptions for protection of 
                personal privacy.</DELETED>
        <DELETED>    ``(4) Patient privacy.--The Secretary shall ensure 
        that the study under 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.</DELETED>
<DELETED>    ``(c) Eligibility for Grants.--To be eligible to receive a 
grant under subsection (a)(2), an entity shall--</DELETED>
        <DELETED>    ``(1) be a public or private nonprofit entity with 
        specialized experience in CHD; and</DELETED>
        <DELETED>    ``(2) submit to the Secretary an application at 
        such time, in such manner, and containing such information as 
        the Secretary may require.</DELETED>
<DELETED>    ``(d) Authorization of Appropriations.--To carry out this 
section, there is authorized to be appropriated $4,000,000 for each of 
fiscal years 2018 through 2022.''.</DELETED>

<DELETED>SEC. 3. CONGENITAL HEART DISEASE RESEARCH.</DELETED>

<DELETED>    Section 425 of the Public Health Service Act (42 U.S.C. 
285b-8) is amended to read as follows:</DELETED>

<DELETED>``SEC. 425. CONGENITAL HEART DISEASE.</DELETED>

<DELETED>    ``(a) In General.--The Director of the Institute may 
expand, intensify, and coordinate research and related activities of 
the Institute with respect to congenital heart disease, which may 
include congenital heart disease research with respect to--</DELETED>
        <DELETED>    ``(1) causation of congenital heart disease, 
        including genetic causes;</DELETED>
        <DELETED>    ``(2) long-term outcomes in individuals with 
        congenital heart disease, including infants, children, 
        teenagers, adults, and elderly individuals;</DELETED>
        <DELETED>    ``(3) diagnosis, treatment, and 
        prevention;</DELETED>
        <DELETED>    ``(4) studies using longitudinal data and 
        retrospective analysis to identify effective treatments and 
        outcomes for individuals with congenital heart disease; 
        and</DELETED>
        <DELETED>    ``(5) identifying barriers to lifelong care for 
        individuals with congenital heart disease.</DELETED>
<DELETED>    ``(b) Coordination of Research Activities.--The Director 
of the Institute may coordinate research efforts related to congenital 
heart disease among multiple research institutions and may develop 
research networks.</DELETED>
<DELETED>    ``(c) Minority and Medically Underserved Communities.--In 
carrying out the activities described in this section, the Director of 
the Institute shall consider the application of such research and other 
activities to minority and medically underserved communities.</DELETED>
<DELETED>    ``(d) Report From NIH.--Not later than 1 year after the 
date of the enactment of the Congenital Heart Futures Reauthorization 
Act of 2017, the Director of NIH, acting through the Director of the 
Institute, shall provide a report to Congress--</DELETED>
        <DELETED>    ``(1) outlining the ongoing research efforts of 
        the National Institutes of Health regarding congenital heart 
        disease; and</DELETED>
        <DELETED>    ``(2) identifying--</DELETED>
                <DELETED>    ``(A) future plans for research regarding 
                congenital heart disease; and</DELETED>
                <DELETED>    ``(B) the areas of greatest need for such 
                research.''.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Congenital Heart Futures 
Reauthorization Act of 2017''.

SEC. 2. NATIONAL CONGENITAL HEART DISEASE RESEARCH, SURVEILLANCE, AND 
              AWARENESS.

    Section 399V-2 of the Public Health Service Act (42 U.S.C. 280g-13) 
is amended to read as follows:

``SEC. 399V-2. NATIONAL CONGENITAL HEART DISEASE RESEARCH, 
              SURVEILLANCE, AND AWARENESS.

    ``(a) In General.--The Secretary shall, as appropriate--
            ``(1) enhance and expand research and data collection 
        efforts related to congenital heart disease, including to study 
        and track the epidemiology of congenital heart disease to 
        understand health outcomes for individuals with congenital 
        heart disease across all ages;
            ``(2) conduct activities to improve public awareness of, 
        and education related to, congenital heart disease, including 
        care of individuals with such disease; and
            ``(3) award grants to entities to undertake the activities 
        described in this section.
    ``(b) Activities.--
            ``(1) In general.--The Secretary shall carry out 
        activities, including, as appropriate, through a national 
        cohort study and a nationally-representative, population-based 
        surveillance system, to improve the understanding of the 
        epidemiology of congenital heart disease in all age groups, 
        with particular attention to--
                    ``(A) the incidence and prevalence of congenital 
                heart disease in the United States;
                    ``(B) causation and risk factors associated with, 
                and natural history of, congenital heart disease;
                    ``(C) health care utilization by individuals with 
                congenital heart disease;
                    ``(D) demographic factors associated with 
                congenital heart disease, such as age, race, ethnicity, 
                sex, and family history of individuals who are 
                diagnosed with the disease; and
                    ``(E) evidence-based practices related to care and 
                treatment for individuals with congenital heart 
                disease.
            ``(2) Permissible considerations.--In carrying out the 
        activities under this section, the Secretary may, as 
        appropriate--
                    ``(A) collect data on the health outcomes, 
                including behavioral and mental health outcomes, of a 
                diverse population of individuals of all ages with 
                congenital heart disease, such that analysis of the 
                outcomes will inform evidence-based practices for 
                individuals with congenital heart disease; and
                    ``(B) consider health disparities among individuals 
                with congenital heart disease, which may include the 
                consideration of prenatal exposures.
    ``(c) Awareness Campaign.--The Secretary may carry out awareness 
and educational activities related to congenital heart disease in 
individuals of all ages, which may include information for patients, 
family members, and health care providers, on topics such as the 
prevalence of such disease, the effect of such disease on individuals 
of all ages, and the importance of long-term, specialized care for 
individuals with such disease.
    ``(d) Public Access.--The Secretary shall ensure that, subject to 
subsection (e), information collected under this section is made 
available, as appropriate, to the public, including researchers.
    ``(e) Patient Privacy.--The Secretary shall ensure that the data 
and information collected under this section are made available in a 
manner that, at a minimum, protects personal privacy to the extent 
required by applicable Federal and State law.
    ``(f) Eligibility for Grants.--To be eligible to receive a grant 
under subsection (a)(3), an entity shall--
            ``(1) be a public or private nonprofit entity with 
        specialized experience in congenital heart disease; and
            ``(2) submit to the Secretary an application at such time, 
        in such manner, and containing such information as the 
        Secretary may require.
    ``(g) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated such sums as may be necessary 
for each of fiscal years 2019 through 2023.''.

SEC. 3. REPORT.

    Not later than 3 years after the date of enactment of the 
Congenital Heart Futures Reauthorization Act of 2017, the Secretary of 
Health and Human Services 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 
summarizing any activities carried out pursuant to section 399V-2 of 
the Public Health Service Act (as amended by section 2), including 
planned activities, and a summary of any research findings and ongoing 
research efforts, gaps, and areas of greatest need within the 
Department of Health and Human Services regarding congenital heart 
disease in patients of all ages.
                                                       Calendar No. 555

115th CONGRESS

  2d Session

                               H. R. 1222

_______________________________________________________________________

                                 AN ACT

To amend the Public Health Service Act to coordinate Federal congenital 
  heart disease research efforts and to improve public education and 
     awareness of congenital heart disease, and for other purposes.

_______________________________________________________________________

                            August 15, 2018

                       Reported with an amendment