IN THE SENATE OF THE UNITED STATES
November 5, 2015
Mr. Durbin (for himself and Mr. Casey) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
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.
This Act may be cited as the
Congenital Heart Futures Reauthorization Act of 2015.
National congenital heart disease cohort study and awareness campaign
Section 301 of the Public Health Service Act (42 U.S.C. 241) is amended by adding at the end the following—
National congenital heart disease cohort study
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall plan, develop, implement, and submit annual reports to the Congress on surveillance and research activities of the Centers for Disease Control and Prevention, including a cohort study to improve understanding of the epidemiology of congenital heart disease (referred to in this subsection and subsection (g) as
CHD) across the lifespan, from birth to adulthood, with particular interest in the following:
Health care utilization and natural history of those affected by CHD.
Demographic factors associated with CHD, such as age, race, ethnicity, gender, and family history of individuals who are diagnosed with the disease.
Outcome measures, such that analysis of the outcome measures will allow derivation of evidence-based best practices and guidelines for CHD patients.
The study under this subsection may—
gather data on the health outcomes of a diverse population of those affected by CHD;
consider health disparities among those affected by CHD which may include the consideration of prenatal exposures; and
incorporate behavioral, emotional, and educational outcomes of those affected by CHD.
Subject to paragraph (4), the data generated from the studies under this subsection shall be made available to CHD researchers subject to appropriate privacy protections, and aggregate data from such studies shall be made available to the public.
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.
Congenital heart disease awareness campaign
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish and implement an awareness, outreach, and education campaign regarding CHD across the lifespan. The information expressed through such campaign may—
emphasize that CHD is the most prevalent birth defect;
identify CHD as a condition that affects those diagnosed throughout their lives; and
promote the need for pediatric, adolescent, and adult individuals with CHD to seek and maintain lifelong, specialized care.
The campaign under this subsection shall—
utilize collaborations or partnerships with other agencies, health care professionals, and patient advocacy organizations that specialize in the needs of individuals with CHD; and
include the use of print, film, or electronic materials distributed via television, radio, Internet, or other commercial marketing venues.
Congenital heart disease research
Section 425 of the Public Health Service Act (42 U.S.C. 285b–8) is amended by adding the end the following:
Report from NIH
Not later than 1 year after the date of enactment of the Congenital Heart Futures Reauthorization Act of 2015, the Director of NIH, acting through the Director of the Institute, shall provide a report to Congress—
outlining the ongoing research efforts of the National Institutes of Health regarding congenital heart disease; and
future plans for research regarding congenital heart disease; and
the areas of greatest need for such research.