[Congressional Record Volume 155, Number 46 (Tuesday, March 17, 2009)]
[Senate]
[Pages S3180-S3182]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN (for himself and Mr. Cochran):
  S. 621. A bill 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; to the Committee on Health, Education, Labor, and Pensions.
  Mr. DURBIN. Mr. President, I rise to speak on legislation I am 
introducing today that relates to congenital heart disease 
research. Congenital heart disease is a rapidly growing national health 
problem. Congenital heart defects are the most common and most deadly 
form of birth defects, affecting nearly 1 percent of births, 
approximately 36,000 a year. In fact, a child is born with a congenital 
heart defect every 15 minutes. A congenital heart defect occurs when 
heart structures are malformed, missing or in the wrong place. There 
are over 30 types of congenital heart defects. These defects cause 
congenital heart disease--cardiovascular problems caused by the birth 
defect.

  The good news is that modern medicine has made major advances in 
treating heart defects in newborns. In 1950, a child born with a 
congenital heart defect only had a 20 percent chance of surviving, but 
today that number has increased to 90 percent. Due to the increase in 
childhood survival rates, the congenital heart disease population 
increases by an estimated 5 percent every year.
  However, the bad news is that there is no cure for congenital heart 
disease. Even survivors of successful childhood intervention face 
lifelong risks, including heart failure, rhythmic disorders, stroke, 
renal dysfunction, and neurocognitive dysfunction. Sadly, the estimated 
life expectancy for those with congenital heart disease is 
significantly lower than for the general population. The life 
expectancy for those born with moderately complex heart defects is 55, 
while the estimated life expectancy for those born with highly complex 
defects is between 35 and 40.
  Unfortunately, fewer than 10 percent of adults living with complex 
congenital heart disease currently receive the cardiac care they need, 
and many don't know that they should have life-long specialized health 
surveillance. Even with access to the best care, living with congenital 
heart disease involves risk. But for people who don't have the medical 
care or who don't have it promptly, the risks of premature death or 
disability are much higher.
  In 2004, the National Heart, Lung, and Blood Institute convened a 
working group on congenital heart disease. This group recommended 
developing a research network for clinical research, establishing a 
national database of patients, and creating an outreach education 
program on the need for continued cardiac care.
  Today, I am pleased to introduce the Congenital Heart Futures Act, 
which builds on these recommendations in several ways. First, the 
legislation authorizes the Centers for Disease Control and Prevention, 
CDC, to lead a comprehensive public education and awareness campaign 
around congenital heart disease. Next, it authorizes a National 
Congenital Heart Disease Registry at the CDC to track the epidemiology 
of congenital heart disease and creates an advisory committee to 
provide expert information and advice to CDC. And, finally, it 
authorizes congenital heart disease research through NHLBI.
  Despite the prevalence and seriousness of congenital heart disease, 
research, data collection, education, and awareness are limited. The 
Congenital Heart Futures Act will help prevent premature death and 
disability in this rapidly growing but dramatically underserved 
population.
  I say to those who are interested in promoting health research, this 
is an area where we can expend more effort and save more lives. I hope 
my colleagues will take a look at this legislation which we are 
introducing today and join me in cosponsoring it.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed int he Record.
  There being no objection, the text of the bill was ordered to be 
placed in the Record as follows:

                                 S. 621

         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 ``Congenital Heart Futures 
     Act''.

     SEC. 2. FINDINGS.

         Congress finds the following:
         (1) Congenital heart defects are the most common and most 
     deadly group of birth defects and affect nearly 1 percent of 
     all live

[[Page S3181]]

     births, approximately 36,000 births a year. A child is born 
     with a congenital heart defect every 15 minutes.
         (2) Congenital heart disease is a rapidly-growing 
     national health problem. Childhood survival has risen from 
     below 20 percent in 1950 to more than 90 percent today. Due 
     to the increase in childhood survival, the congenital heart 
     disease population increases by an estimated 5 percent every 
     year.
         (3) Approximately 800,000 children and 1,000,000 adults 
     in the United States are now living with congenital heart 
     disease and require highly-specialized life-long cardiac 
     care.
         (4) There is no cure for congenital heart disease. Even 
     survivors of successful childhood treatment can face life-
     long risks from congenital heart disease, including heart 
     failure, rhythmic disorders, stroke, renal dysfunction, and 
     neurocognitive dysfunction.
         (5) Less than 10 percent of adults living with complex 
     congenital heart disease currently receive recommended 
     cardiac care. Many individuals with congenital heart disease 
     are unaware that they require life-long specialized health 
     surveillance. Delays in care can result in premature death 
     and disability.
         (6) The estimated life expectancy for those with 
     congenital heart disease is significantly lower than for the 
     general population. The life expectancy for those born with 
     moderately complex heart defects is 55, while the estimated 
     life expectancy for those born with highly complex defects is 
     between 35 and 40.
         (7) Despite the prevalence and seriousness of the 
     disease, Federal research, data collection, education, and 
     awareness activities are limited.
         (8) The strategic plan of the National Heart, Lung, and 
     Blood Institute completed in 2007 notes that ``successes over 
     several decades have enabled people with congenital heart 
     diseases to live beyond childhood, but too often inadequate 
     data are available to guide their treatment as adults''.
         (9) The strategic plan for the Division of Cardiovascular 
     Diseases at the National Heart, Lung and Blood Institute, 
     completed in 2008, set goals for congenital heart disease 
     research, including understanding the development and genetic 
     basis of congenital heart disease, improving evidence-based 
     care and treatment of children with congenital and acquired 
     pediatric heart disease, and improving evidence-based care 
     and treatment of adults with congenital heart disease.

     SEC. 3. PUBLIC EDUCATION AND AWARENESS OF CONGENITAL HEART 
                   DISEASE.

         Title III of the Public Health Service Act (42 U.S.C. 241 
     et seq.) is amended by adding at the end the following:

        ``PART S--PROGRAMS RELATING TO CONGENITAL HEART DISEASE

     ``SEC. 399HH. PUBLIC EDUCATION AND AWARENESS OF CONGENITAL 
                   HEART DISEASE.

         ``(a) In General.--The Secretary, acting through the 
     Director of the Centers for Disease Control and Prevention 
     and in collaboration with appropriate congenital heart 
     disease patient organizations and professional organizations, 
     may directly or through grants, cooperative agreements, or 
     contracts to eligible entities conduct, support, and promote 
     a comprehensive public education and awareness campaign to 
     increase public and medical community awareness regarding 
     congenital heart disease, including the need for life-long 
     treatment of congenital heart disease survivors.
         ``(b) Eligibility for Grants.--To be eligible to receive 
     a grant, cooperative agreement, or contract under this 
     section, an entity shall be a State or private nonprofit 
     entity and shall submit to the Secretary an application at 
     such time, in such manner, and containing such information as 
     the Secretary may require.''.

     SEC. 4. NATIONAL CONGENITAL HEART DISEASE REGISTRY.

         Title III of the Public Health Service Act (42 U.S.C. 241 
     et seq.), as amended by section 3, is further amended by 
     adding at the end the following:

     ``SEC. 399II. NATIONAL CONGENITAL HEART DISEASE REGISTRY.

         ``(a) In General.--The Secretary, acting through the 
     Director of the Centers for Disease Control and Prevention, 
     may--
         ``(1) enhance and expand infrastructure to track the 
     epidemiology of congenital heart disease and to organize such 
     information into a comprehensive, nationwide registry of 
     actual occurrences of congenital heart disease, to be known 
     as the `National Congenital Heart Disease Registry'; or
         ``(2) award a grant to one eligible entity to undertake 
     the activities described in paragraph (1).
         ``(b) Purpose.--The purpose of the Congenital Heart 
     Disease Registry shall be to facilitate further research into 
     the types of health services patients use and to identify 
     possible areas for educational outreach and prevention in 
     accordance with standard practices of the Centers for Disease 
     Control and Prevention.
         ``(c) Content.--The Congenital Heart Disease Registry--
         ``(1) may include information concerning the incidence 
     and prevalence of congenital heart disease in the United 
     States;
         ``(2) may be used to collect and store data on congenital 
     heart disease, including data concerning--
         ``(A) demographic factors associated with congenital 
     heart disease, such as age, race, ethnicity, sex, and family 
     history of individuals who are diagnosed with the disease;
         ``(B) risk factors associated with the disease;
         ``(C) causation of the disease;
         ``(D) treatment approaches; and
         ``(E) outcome measures, such that analysis of the outcome 
     measures will allow derivation of evidence-based best 
     practices and guidelines for congenital heart disease 
     patients; and
         ``(3) may ensure the collection and analysis of 
     longitudinal data related to individuals of all ages with 
     congenital heart disease, including infants, young children, 
     adolescents, and adults of all ages, including the elderly.
         ``(d) Coordination With Federal, State, and Local 
     Registries.--In establishing the National Congenital Heart 
     Registry, the Secretary may identify, build upon, expand, and 
     coordinate among existing data and surveillance systems, 
     surveys, registries, and other Federal public health 
     infrastructure, including--
         ``(1) State birth defects surveillance systems;
         ``(2) the State birth defects tracking systems of the 
     Centers for Disease Control and Prevention;
         ``(3) the Metropolitan Atlanta Congenital Defects 
     Program; and
         ``(4) the National Birth Defects Prevention Network.
         ``(e) Public Access.--The Congenital Heart Disease 
     Registry shall be made available to the public, including 
     congenital heart disease researchers.
         ``(f) Patient Privacy.--The Secretary shall ensure that 
     the Congenital Heart Disease Registry is maintained in a 
     manner that complies with the regulations promulgated under 
     section 264 of the Health Insurance Portability and 
     Accountability Act of 1996.
         ``(g) Eligibility for Grant.--To be eligible to receive a 
     grant under subsection (a)(2), 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.''.

     SEC. 5. ADVISORY COMMITTEE ON CONGENITAL HEART DISEASE.

         Title III of the Public Health Service Act (42 U.S.C. 241 
     et seq.), as amended by section 4, is further amended by 
     adding at the end the following:

     ``SEC. 399JJ. ADVISORY COMMITTEE ON CONGENITAL HEART DISEASE.

         ``(a) Establishment.--The Secretary, acting through the 
     Director of the Centers for Disease Control and Prevention, 
     may establish an advisory committee, to be known as the 
     `Advisory Committee on Congenital Heart Disease' (referred to 
     in this section as the `Advisory Committee').
         ``(b) Membership.--The members of the Advisory Committee 
     may be appointed by the Secretary, acting through the Centers 
     for Disease Control and Prevention, and shall include--
         ``(1) at least one representative from--
         ``(A) the National Institutes of Health;
         ``(B) the Centers for Disease Control and Prevention; and
         ``(C) a national patient advocacy organization with 
     experience advocating on behalf of patients living with 
     congenital heart disease;
         ``(2) at least one epidemiologist who has experience 
     working with data registries;
         ``(3) clinicians, including--
         ``(A) at least one with experience diagnosing or treating 
     congenital heart disease; and
         ``(B) at least one with experience using medical data 
     registries; and
         ``(4) at least one publicly- or privately-funded 
     researcher with experience researching congenital heart 
     disease.
         ``(c) Duties.--The Advisory Committee may review 
     information and make recommendations to the Secretary 
     concerning--
         ``(1) the development and maintenance of the National 
     Congenital Heart Disease Registry established under section 
     399II;
         ``(2) the type of data to be collected and stored in the 
     National Congenital Heart Disease Registry;
         ``(3) the manner in which such data is to be collected;
         ``(4) the use and availability of such data, including 
     guidelines for such use; and
         ``(5) other matters, as the Secretary determines to be 
     appropriate.
         ``(d) Report.--Not later than 180 days after the date on 
     which the Advisory Committee is established and annually 
     thereafter, the Advisory Committee shall submit a report to 
     the Secretary concerning the information described in 
     subsection (c), including recommendations with respect to the 
     results of the Advisory Committee's review of such 
     information.''.

     SEC. 6. CONGENITAL HEART DISEASE RESEARCH.

         Subpart 2 of part C of title IV of the Public Health 
     Service Act (42 U.S.C. 285b et seq.) is amended by adding at 
     the end the following:

     ``SEC. 425. CONGENITAL HEART DISEASE.

         ``(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--
         ``(1) causation of congenital heart disease, including 
     genetic causes;

[[Page S3182]]

         ``(2) long-term outcomes in individuals with congenital 
     heart disease, including infants, children, teenagers, 
     adults, and elderly individuals;
         ``(3) diagnosis, treatment, and prevention;
         ``(4) studies using longitudinal data and retrospective 
     analysis to identify effective treatments and outcomes for 
     individuals with congenital heart disease; and
         ``(5) identifying barriers to life-long care for 
     individuals with congenital heart disease.
         ``(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.
         ``(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.''.

     SEC. 7. AUTHORIZATION OF APPROPRIATIONS.

         There are authorized to be appropriated to carry out the 
     amendments made by this Act such sums as may be necessary for 
     each of fiscal years 2010 through 2014.
                                 ______