[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