[Congressional Record Volume 149, Number 73 (Thursday, May 15, 2003)]
[Senate]
[Pages S6509-S6512]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DODD (for himself and Mr. DeWine):
  S. 1068. A bill to amend the Public Health Service Act to establish 
grant programs to provide for education and outreach on newborn 
screening and coordinated followup care once newborn screening has been 
conducted, and for other purposes; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. DODD. Mr. President, I am pleased today to join with my colleague 
Senator DeWine to introduce legislation to protect the most vulnerable 
members of our society: newborn infants. As a first-time dad of a 20-
month old baby girl, I now know the joy of being able to experience 
every pleasure that comes with being a father. What I also now share 
with parents everywhere is a constant sense of worry about whether our 
kids are doing well, are feeling well, and are safe. Nothing is of 
greater importance than the health and well-being of our children.
  Thanks to incredible advances in medical technology, it is now 
possible to test newborns for more than 30 genetic and metabolic 
disorders. Many of these disorders, if undetected, would lead to severe 
disability or death. However, babies that are properly diagnosed and 
treated can go on to live healthy lives. In the most direct sense, 
newborn screening saves lives.
  Frighteningly, the disorders that newborn screening tests for can 
come without warning. For most of these disorders, there is no medical 
history of the condition in the family, no way to predict the health of 
a baby based on the health of the parents. Although the disorders that 
are tested for are quite rare, there is a chance that any one newborn 
will be affected--a sort of morbid lottery. In that sense, this is an 
issue that has a direct impact on the lives of every family.
  Fortunately, screening has become common practice in every State. 
Each year, over four million infants have blood taken from their heel 
to detect these disorders that could threaten their life and long-term 
health. As a result, about one in 4,000 babies is diagnosed with one of 
these disorders. That means that newborn screening could save 
approximately 1,000 lives each year. That is 1,000 tragedies that can 
possibly be averted--families left with the joy of a new infant rather 
than absolute heartbreak.
  That is the good news. However, there is so much more to be done. For 
every baby saved, another two are estimated to be born with potentially 
detectable disorders that go undetected because they are not screened. 
These infants and their families face the prospect of disability or 
death from a preventable disorder. Let me repeat that--disability or 
death from a preventable disorder. The survival of a newborn may very 
well come down to the State in which it is born. Only two States, 
including my home state of Connecticut thanks to recent legislation, 
will test for all 30 disorders. While the number of genetic and 
metabolic disorders screened for varies among different states, the 
vast majority test for eight or fewer.
  The General Accounting Office, GAO, released a report in March 
highlighting the need for this legislation. According to the report, 
most States do not educate parents and health care providers about the 
availability of tests beyond what is mandated by the State. States also 
reported that they do not have the

[[Page S6510]]

resources to purchase the technology and train the staff needed to 
expand newborn screening programs. Finally, even when States do detect 
an abnormal screening result, the majority do not inform parents 
directly.
  Last year, I chaired a hearing on this issue during which I related a 
story that illustrates the impact of newborn screening, or the lack of 
newborn screening, in a very personal sense. Jonathan Sweeney is a 
three-year-old from Brookfield, CT. At the time of his birth, the State 
only tested for eight disorders. He was considered a healthy baby, 
although he was a poor sleeper and needed to be fed quite frequently. 
One morning in December of 2000, Jonathan's mother, Pamela, found 
Jonathan with his eyes wide open but completely unresponsive. He was 
not breathing and appeared to be having a seizure. Jonathan was rushed 
to the hospital where, fortunately, his life was saved. He was later 
diagnosed with L-CHAD, a disorder that prevents Jonathan's body from 
turning fat into energy.
  Despite this harrowing tale, Jonathan and his family are extremely 
fortunate. Jonathan is alive, and his disorder can be treated with a 
special diet. He has experienced developmental delays that most likely 
could have been avoided had he been tested for L-CHAD at birth. This 
raises a question. Why was he not tested? Why do 47 States still not 
test for L-CHAD?
  The primary reason for this unfortunate reality is the lack of a 
consensus on the Federal level about what should be screened for, and 
how a screening program should be developed. Twenty disorders can only 
be detected using a costly piece of equipment called a Tandem Mass 
Spectrometer. Currently, only 21 States have this resource.
  Many health care professionals are unaware of the possibility of 
screening for disorders beyond what their State requires. Parents, and 
I include myself, are even less well-informed. My daughter Grace was 
born in Virginia, where they screen for nine disorders. I was extremely 
relieved when all of those tests came out negative. However, at that 
time I did not know that this screening was not as complete as it could 
have been. My ignorance had nothing to do with my love for my daughter 
or my capability as a parent. The fact is that the majority of parents 
do not realize that this screening occurs at all, nor are they familiar 
with the disorders that are being screened for. In fact, only one out 
of four States inform parents that they have the option to obtain 
testing for disorders that are not included on the State's screening 
program. For that reason, one of the most important first steps that we 
can take to protect our children is to educate parents and health care 
professionals.

  In the Children's Health Act of 2000, I supported the creation of an 
advisory committee on newborn screening within the Department of Health 
and Human Services. The purpose of this committee would be to develop 
national recommendations on screening, hopefully eliminating the 
arbitrary disparities between states that currently exist. The 
Children's Health Act also included a provision to provide funding to 
States to expand their technological resources for newborn screening. 
Unfortunately, funds were not appropriated for either of these 
provisions. Senator DeWine and I have led a campaign to secure $25 
million in appropriations needed for this crucial initiative. It is 
unconscionable for us to not do all we can to help prevent children 
from dying of treatable disorders.
  The legislation that we are introducing today, the Newborn Screening 
Saves Lives Act of 2003, seeks to address the shocking lack of 
information available to health care professionals and parents about 
newborn screening. Every parent should have the knowledge necessary to 
protect their child. The tragedy of a newborn's death is only 
compounded by the frustration of learning that the death was 
preventable. This bill authorizes $10 million in fiscal year 2004, and 
such sums as are necessary through fiscal year 2008, to HRSA for grants 
to provide education and training to health care professionals, State 
laboratory personnel, families and consumer advocates.
  Our legislation will also provide States with the resources to 
develop programs of follow-up care for those children diagnosed by a 
disorder detected through newborn screening. While these families are 
the fortunate ones, in many cases they are still faced with the 
prospect of extended and complex treatment or major lifestyle changes. 
We need to remember that care does not stop at diagnosis. For that 
reason, this bill authorizes $5 million in fiscal year 2004, and such 
sums as are necessary through FY 2008, to HRSA for grants to develop a 
coordinated system of follow-up care for newborns and their families 
after screening and diagnosis.
  Finally, the bill directs HRSA to assess existing resources for 
education, training, and follow-up care in the States, ensure 
coordination, and minimize duplication; and also directs the Secretary 
to provide an evaluation report to Congress two and a half years after 
the grants are first awarded and then after five years to assess impact 
and effectiveness and make recommendations about future efforts.
  I urge my colleagues to support this important initiative so that 
every newborn child will have the opportunity for a long, healthy and 
happy life; and to spare thousands of families from an avoidable 
tragedy.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 1068

       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 ``Newborn Screening Saves 
     Lives Act of 2003''.

     SEC. 2. FINDINGS.

       Congress finds the following:
       (1) Currently, it is possible to test for at least 30 
     disorders through newborn screening.
       (2) There is a lack of uniform newborn screening throughout 
     the United States. While a newborn with a debilitating 
     condition may receive screening, early detection, and 
     treatment in one location, in another location the condition 
     may go undetected and result in catastrophic consequences.
       (3) Each year more than 4,000,000 babies are screened to 
     detect conditions that may threaten their long-term health.
       (4) There are more than 2,000 babies born every year in the 
     United States with detectable and treatable disorders that go 
     unscreened through newborn screening.

     SEC. 3. AMENDMENT TO PUBLIC HEALTH SERVICE ACT.

       Part Q of title III of the Public Health Service Act (42 
     U.S.C. 280h et seq.) is amended by adding at the end the 
     following:

     ``SEC. 399AA. NEWBORN SCREENING.

       ``(a) Authorization of Grant Programs.--
       ``(1) Grants to assist health care professionals.--From 
     funds appropriated under subsection (h), the Secretary, 
     acting through the Associate Administrator of the Maternal 
     and Child Health Bureau of the Health Resources and Services 
     Administration (referred to in this section as the `Associate 
     Administrator') and in consultation with the Advisory 
     Committee on Heritable Disorders in Newborns and Children 
     (referred to in this section as the `Advisory Committee'), 
     shall award grants to eligible entities to enable such 
     entities to assist in providing health care professionals and 
     State health department laboratory personnel with--
       ``(A) education in newborn screening; and
       ``(B) training in--
       ``(i) relevant and new technologies in newborn screening; 
     and
       ``(ii) congenital, genetic, and metabolic disorders.
       ``(2) Grants to assist families.--From funds appropriated 
     under subsection (h), the Secretary, acting through the 
     Associate Administrator and in consultation with the Advisory 
     Committee, shall award grants to eligible entities to enable 
     such entities to develop and deliver educational programs 
     about newborn screening to parents, families, and patient 
     advocacy and support groups.
       ``(3) Grants for newborn screening followup.--From funds 
     appropriated under subsection (h), the Secretary, acting 
     through the Associate Administrator and in consultation with 
     the Advisory Committee, shall award grants to eligible 
     entities to enable such entities to establish, maintain, and 
     operate a system to assess and coordinate treatment relating 
     to congenital, genetic, and metabolic disorders.
       ``(b) Application.--An eligible entity that desires to 
     receive a grant under this section shall submit an 
     application to the Secretary at such time, in such manner, 
     and accompanied by such information as the Secretary may 
     require.
       ``(c) Selection of Grant Recipients.--
       ``(1) In general.--Not later than 120 days after receiving 
     an application under subsection (b), the Secretary, after 
     considering the approval factors under paragraph (2), shall 
     determine whether to award the eligible entity a grant under 
     this section.
       ``(2) Approval factors.--
       ``(A) Requirements for approval.--An application submitted 
     under subsection (b) may not be approved by the Secretary 
     unless

[[Page S6511]]

     the application contains assurances that the eligible 
     entity--
       ``(i) will use grant funds only for the purposes specified 
     in the approved application and in accordance with the 
     requirements of this section; and
       ``(ii) will establish such fiscal control and fund 
     accounting procedures as may be necessary to assure proper 
     disbursement and accounting of Federal funds paid to the 
     eligible entity under the grant.
       ``(B) Existing programs.--Prior to awarding a grant under 
     this section, the Secretary shall--
       ``(i) conduct an assessment of existing educational 
     resources and training programs and coordinated systems of 
     followup care with respect to newborn screening; and
       ``(ii) take all necessary steps to minimize the duplication 
     of the resources and programs described in clause (i).
       ``(d) Coordination.--The Secretary shall take all necessary 
     steps to coordinate programs funded with grants received 
     under this section.
       ``(e) Use of Grant Funds.--
       ``(1) Grants to assist health care professionals.--An 
     eligible entity that receives a grant under subsection (a)(1) 
     may use the grant funds to work with appropriate medical 
     schools, nursing schools, schools of public health, internal 
     education programs in State agencies, nongovernmental 
     organizations, and professional organizations and societies 
     to develop and deliver education and training programs that 
     include--
       ``(A) continuing medical education programs for health care 
     professionals and State health department laboratory 
     personnel in newborn screening;
       ``(B) education, technical assistance, and training on new 
     discoveries in newborn screening and the use of any related 
     technology;
       ``(C) models to evaluate what a newborn should be screened 
     for and when and where that screening should take place;
       ``(D) models to evaluate the prevalence of, and assess and 
     communicate the risks of, newborn disorders, including the 
     prevalence and risk of certain newborn disorders based on 
     family history;
       ``(E) models to communicate effectively with parents and 
     families about--
       ``(i) the process and benefits of newborn screening;
       ``(ii) how to use information gathered from newborn 
     screening;
       ``(iii) the meaning of screening results, including the 
     rate of false positives;
       ``(iv) the right of refusal of newborn screening; and
       ``(v) the potential need for followup care after newborns 
     are screened;
       ``(F) information and resources on coordinated systems of 
     followup care after newborns are screened;
       ``(G) information on the disorders for which States require 
     and offer newborn screening and options for newborn screening 
     relating to conditions in addition to such disorders;
       ``(H) information on supplemental newborn screening that 
     the States do not require and offer but that parents may 
     want; and
       ``(I) other items to carry out the purpose described in 
     subsection (a)(1) as determined appropriate by the Secretary.
       ``(2) Grants to assist families.--An eligible entity that 
     receives a grant under subsection (a)(2) may use the grant 
     funds to develop and deliver to parents, families, and 
     patient advocacy and support groups, educational programs 
     about newborn screening that include information on--
       ``(A) what is newborn screening;
       ``(B) how newborn screening is performed;
       ``(C) who performs newborn screening;
       ``(D) where newborn screening is performed;
       ``(E) the disorders for which the State requires newborns 
     to be screened;
       ``(F) different options for newborn screening for disorders 
     other than those included by the State in the mandated 
     newborn screening program;
       ``(G) the meaning of various screening results including 
     the rate of false positives;
       ``(H) the prevalence and risk of newborn disorders, 
     including the increased risk of disorders that may stem from 
     family history;
       ``(I) coordinated systems of followup care after newborns 
     are screened; and
       ``(J) other items to carry out the purpose described in 
     subsection (a)(2) as determined appropriate by the Secretary.
       ``(3) Grants for quality newborn screening followup.--An 
     eligible entity that receives a grant under subsection (a)(3) 
     shall use the grant funds to--
       ``(A) expand on existing procedures and systems, where 
     appropriate and available, for the timely reporting of 
     newborn screening results to individuals, families, primary 
     care physicians, and subspecialists in congenital, genetic, 
     and metabolic disorders;
       ``(B) coordinate ongoing followup treatment with 
     individuals, families, primary care physicians, and 
     subspecialists in congenital, genetic, and metabolic 
     disorders after a newborn receives an indication of the 
     presence of a disorder on a screening test;
       ``(C) ensure the seamless integration of confirmatory 
     testing, tertiary care medical services, comprehensive 
     genetic services including genetic counseling, and 
     information about access to developing therapies by 
     participation in approved clinical trials involving the 
     primary health care of the infant;
       ``(D) analyze data, if appropriate and available, collected 
     from newborn screenings to identify populations at risk for 
     disorders affecting newborns, examine and respond to health 
     concerns, recognize and address relevant environmental, 
     behavioral, socioeconomic, demographic, and other relevant 
     risk factors; and
       ``(E) carry out such other activities as the Secretary may 
     determine necessary.
       ``(f) Reports to Congress.--
       ``(1) In general.--Subject to paragraph (2), the Secretary 
     shall submit to the appropriate committees of Congress 
     reports--
       ``(A) evaluating the effectiveness and the impact of the 
     grants awarded under this section--
       ``(i) in promoting newborn screening--

       ``(I) education and resources for families; and
       ``(II) education, resources, and training for health care 
     professionals;

       ``(ii) on the successful diagnosis and treatment of 
     congenital, genetic, and metabolic disorders; and
       ``(iii) on the continued development of coordinated systems 
     of followup care after newborns are screened;
       ``(B) describing and evaluating the effectiveness of the 
     activities carried out with grant funds received under this 
     section; and
       ``(C) that include recommendations for Federal actions to 
     support--
       ``(i) education and training in newborn screening; and
       ``(ii) followup care after newborns are screened.
       ``(2) Timing of reports.--The Secretary shall submit--
       ``(A) an interim report that includes the information 
     described in paragraph (1), not later than 30 months after 
     the date on which the first grant funds are awarded under 
     this section; and
       ``(B) a subsequent report that includes the information 
     described in paragraph (1), not later than 60 months after 
     the date on which the first grant funds are awarded under 
     this section.
       ``(g) Definition of Eligible Entity.--In this section, the 
     term `eligible entity' means--
       ``(1) a State or a political subdivision of a State;
       ``(2) a consortium of 2 or more States or political 
     subdivisions of States;
       ``(3) a territory;
       ``(4) an Indian tribe or a hospital or outpatient health 
     care facility of the Indian Health Service; or
       ``(5) a nongovernmental organization with appropriate 
     expertise in newborn screening, as determined by the 
     Secretary.
       ``(h) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section--
       ``(1) $15,000,000 for fiscal year 2004; and
       ``(2) such sums as may be necessary for each of fiscal 
     years 2005 through 2008.''.

  Mr. DeWINE. Mr. President, I rise today, along with my colleague from 
Connecticut, Senator Dodd, to introduce the Newborn Screening Saves 
Lives Act of 2003, a bill designed to improve genetic newborn screening 
programs in this country. Our legislation would provide education 
grants for physicians and parents, as well as grants to states, to 
improve follow-up and tracking of those children who receive a positive 
result from a heelstick screening for metabolic, genetic, infectious, 
or other congenital conditions that threaten their health and well-
being.
  Each year, newborn screening identifies an estimated 3,000 babies 
with conditions like sickle cell diseases and homocystinuria that, if 
left undetected, would otherwise have had dire consequences. But, 
despite their clear importance, our newborn screening systems are 
fragmented. Quite simply, all children do not have access to the same 
genetic tests. Where a child is born determines the tests that he or 
she receives. In my home state of Ohio, we test for 12 disorders, while 
right across the border in Kentucky, they test for only four, and in 
Pennsylvania, only six. In Massachusetts, on the other hand, newborns 
are tested for 29 disorders.
  Compounding this problem, parents often are not sufficiently informed 
of the number of tests available in their individual states and what 
those tests can help accomplish. Physicians may not know to educate 
parents, or physicians may talk to parents too late in the birthing 
process for it to make a difference. Also, state health departments may 
not follow up adequately with the parents of a child who receives a 
positive test result, and health departments may not have the capacity 
to effectively record or track a large number of positive results.
  The bill we are introducing today would go a long way toward 
streamlining the current newborn screening system by offering grants to 
states to accomplish the following:
  Build and expand existing procedures and systems to report test 
results to individuals and families, primary care physicians, and 
specialists;

[[Page S6512]]

  Coordinate ongoing follow-up treatment with individuals, families, 
and primary care physicians after a newborn receives an indication of 
the presence of a disorder on a screening test;
  Ensure seamless integration of confirmatory testing, tertiary care, 
genetic services, including counseling, and access to evolving 
therapies by participation in approved clinical trials involving the 
primary health care of the infant; and
  Analyze collected data to identify populations at high risk, examine 
and respond to health concerns, and recognize and address relevant 
environmental, behavioral, socioeconomic, demographic, and other 
factors.
  Senator Dodd and I recently requested that the General Accounting 
Office examine state newborn screening programs. The results of this 
study were troubling. The GAO found that many children are not 
receiving critical, life-saving tests due, in part, to strained state 
budgets that cannot fund newborn screening initiatives.
  The grant program established by our bill seeks to help states 
maintain and expand their newborn screening programs. Our legislation 
would be a good start toward ensuring that all newborns receive equal 
access to genetic tests and that their follow-up care, if needed, is 
available and coordinated. The importance of these screenings cannot be 
overstated. It can mean the difference between life and death for a 
newborn. And that, Mr. President, is something we must address.
  I urge my colleagues to support this important children's health 
legislation.
                                 ______