Newborn screening funding
American Academy of Neurology, American Academy of Pediatrics, Association of Public Health Laboratories, Association of Maternal and Child Health Programs, Child Neurology Society, Congenital Adrenal Hyperplasia Research Education and Support (CARES) Foundation, Hunters Hope, March of Dimes Foundation, National Organization for Rare Disorders, Save Babies Through Screening Foundation, Shire, The Arc and United Cerebral Palsy call on Congress to fund the Newborn Screening Saves Lives Act (P.L. 110-204).
Newborn screening is a successful preventive public health activity. In 2008, Congress demonstrated once again the broad based support for this important health activity with a unanimous vote for the Newborn Screening Saves Lives Act (P.L. 110-204). To fulfill the intention of the law, HRSA and CDC were funded to help support state newborn screening programs and to provide technical assistance in the form of quality assurance for laboratories responsible for evaluating newborn screening tests for heritable disorders that can be treated if the condition is identified immediately after birth.
Newborn screening: Basic facts
- Newborn screening is the early identification of infants affected by certain genetic, metabolic, hormonal and/or functional conditions.
- Screening detects disorders in newborns that, if left untreated, can cause death, disability, intellectual disabilities and other serious illnesses.
- If diagnosed early, these conditions can be successfully treated.
- The American College of Medical Genetics, the American Academy of Pediatrics, the March of Dimes and the Secretary's Advisory Committee on Heritable Disorders recommend screening all newborns for 29 treatable disorders and reporting on an additional 25 disorders.
Health Resources and Services Administration
Across the nation, state and local governments are experiencing significant budget shortfalls. Due to this pressure, newborn screening programs are threatened by funding cuts. While the ramifications, such as discontinuing screening for certain conditions or inability to purchase appropriate technology, can vary by state, any newborn screening program funding cut puts infants at risk for permanent disability or even death. Additional federal support is needed for states to sustain and strengthen their newborn screening programs.
A $5 million increase over FY10 would enable states to continue implementation of the Newborn Screening Saves Lives Act. Specifically funds would be available to:
- Enhance, improve or expand the capacity of State newborn screening programs to provide screening, counseling and health care services to newborns and children;
- Assist in educating health care professionals about newborn screening and support training in relevant new technologies;
- Develop and deliver educational programs about newborn screening programs, treatment and specialty services to parents, families and patient advocacy and support groups; and
- Establish, maintain and operate a system to assess and coordinate treatment for disorders.
Centers for Disease Control and Prevention
CDC's Environmental Health Laboratory houses the only comprehensive program in the world devoted to ensuring the accuracy of newborn screening tests. Because of the Newborn Screening Quality Assurance Program (NSQAP), parents and doctors can trust the results of newborn screening tests.
The Newborn Screening Coalition recommends providing a $3 million increase over FY10 to CDCís NSQAP. CDC will continue to harness the latest advances in science and technology so that more babies can be detected accurately and treated quickly. Specifically, CDC will:
- Fund state public health laboratories so new screening tests are developed, refined and pilot studies are conducted for specific disorders (e.g., Severe Combined Immune Deficiency or SCID, Pompe Disease, Metachromatic Leukodystrophy).
- Develop and provide comprehensive quality assurance services for new tests as they are evaluated in pilot studies and implemented into routine newborn screening practice. For example, the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children recently recommended adding screening for SCID to the nation's uniform screening panel. This policy recommendation, should the Secretary concur, will move SCID into a routine practice, which immediately increases the demand upon CDC to provide quality assurance services for SCID testing nationwide.
FY11 recommended report language
Heritable Disorders--The Committee provides $15,013,000 to continue the heritable disorders (newborn) screening program. Newborn screening is a valuable public health activity which has prevented the morbidity and mortality of countless newborns; however the Committee understands that disparities among state newborn screening systems persist. The Committee provides funding for HRSA to expand and enhance education of families and health care providers about newborn screening and award grants to States to expand and improve their newborn screening programs, train personnel and purchase laboratory equipment.
Newborn Screening Quality Assurance Program (NSQAP)--The Committee provides $10,903,000 to CDC's Environmental Health Laboratory which houses the Newborn Screening Quality Assurance Program. The Committee applauds CDC's efforts to ensure the quality of tests that detect disorders in more than thousands of babies by providing training, consultation, guidelines, proficiency testing and reference materials to nearly 500 laboratories responsible for newborn screening. The Committee is pleased that this program has supported pilot projects in several states and encourages CDC to continue this support through developing and providing comprehensive quality assurance services for new tests as they are evaluated in pilot studies and implemented into routine newborn screening practice.
In 2009, NSQAP:
- Ensured the quality of tests that detected disorders in more than 5,000 babies.
- Collaborated with the College of American Pathologists (CAP) and the American College of Medical Genetics (ACMG), to design a new proficiency testing program covering 48 disorders from the
- ACMG, recommended Core Panel and Secondary Targets.
- Funded and trained 16 scientists from 15 state newborn screening laboratories in state-of-the-art methods using DNA technology.
- Assured the quality of research methods during assay development for Krabbe disease in the state of New York.
- Funded two states (Wisconsin and Massachusetts) to undertake pioneering research project that will introduce and sustain screening for Severe Combined Immune Deficiency (SCID) into routine practice.
- Funded four states (California, Iowa, New York, and Utah) to implement population-based surveillance of confirmed newborn screening cases, to enhance the data collection process and the quality of national data sets, and to assess the public health impact and short-term outcomes of newborns with detected conditions.
- Provided funding and technical support to the Indian Health Service (IHS) for a pilot study to test for SCID in newborns from the Western Navajo Reservation in Arizona.
- Funded three states (Delaware, Texas, and Utah) to evaluate the effectiveness of using second-tier tests in newborn screening. These tests will ensure that all disorders are properly identified and will reduce the number of children who test positive, but do not have the disease (false positive).
For more information contact Emil Wigode or Carolyn Mullen, March of Dimes Office of Government Affairs (202) 659-1800.
Frequently Asked Questions
What federal agencies are involved in premature birth research?
Multiple federal agencies support prematurity-related research but among the most engaged are the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health and Maternal and Infant Health Research within the Centers for Disease Control and Prevention.
Where can I learn more about the National Children's Study?
The March of Dimes has advocated for the study since its inception, realizing the critical information that will come from systematically examining the effects of environmental and other influences on the health and development of 100,000 children across the United States.
Why is the data collected from birth certificates important?
Information that is collected on birth certificates is vital to understand trends, to determine the infant mortality rate, and to guide decisions for intervention programs and for research. State laws require birth certificates to be completed for all births, and federal law mandates national collection and publication of births and other vital statistics data by the National Center for Health Statistics, which is part of the Centers for Disease Control and Prevention. Learn more on the NCHS website and understand the strict privacy standards covering individuals.