On June 24, 2014, the U.S. House of Representatives passed the Newborn Screening Saves Lives Act of 2013 (H.R. 1281). This legislation, which is critically important to the four million newborns that are born in the United States each year, would make important improvements to existing federal law governing newborn screening activities. Similar legislation (S. 1417) passed in the U.S. Senate in January.
Nearly every baby born in the nation has blood collected, by way of a heel prick, to be screened for genetic disorders. Newborn screening helps parents find out if their baby has certain medical conditions so that babies can get treatment right away.
While disorders rare, approximately one in every 300 newborns has a condition that can be detected through early screening. These babies often appear to be healthy, but become sick a few days later.
Timely screening, diagnosis, and follow-up of certain medical conditions can often preserve or dramatically improve the life of the baby and his or her family. It can also reduce health care spending, follow-up care, and life-long assistance associated with the effects of the condition.
Below is a summary of key provisions included in the House-passed bill. The bill will now return to the U.S. Senate before being sent to President Barak Obama for signature.
Summary of Key Provisions: Newborn Screening Saves Lives Act (H.R. 1281)
Section 1: Short Summary
- Names the bill the "Newborn Screening Saves Lives Reauthorization Act of 2014.
- Reauthorizes the Health Resources and Services Administration grants that are intended to improve newborn screening programs, educate parents and health care providers about newborn screening, and improve follow-up care for infants with a condition that is identified through newborn screening.
- Allows grants to be used to improve the timely collection, delivery, receipt, and screening of specimens, and diagnosis of heritable disorders in newborns.
- Reauthorizes Health Resources Services Administration grants that are intended to evaluate the effectiveness of screening, counseling, testing, and follow-up of newborns and children at risk for heritable disorders, including assessment of child health and development outcomes through adolescence.
- Reauthorizes the Advisory Committee on Heritable Disorders in Newborns and Children for five years. If at the end of fiscal year 2019 the Advisory Committee has not been extended by statute, then the Advisory Committee may be deemed an advisory committee established by the President or an officer of the Federal Government.
- Establishes a 9-month timeline for the Advisory Committee to review conditions that have been nominated to be added to the recommended uniform screening panel.
- Reduces the amount of time in which the Secretary of Health and Human Services has to accept or reject the Advisory Committee's recommendations from 180 days to 120 days. If the Secretary is unable to make a determination within the 120-day period, then the Secretary shall notify the Committee and the appropriate congressional committees of such determination and rationale, as well as an action plan for consideration of the pending recommendation.
- Reauthorizes the Health Resources Services Administration's Clearinghouse for Newborn Screenings.
- Requires the Clearinghouse to maintain current information on the number of conditions for which screening is conducted in each state; and disseminate available evidence-based guidelines related to diagnosis, counseling with respect to conditions detected by newborn screening.
- Reauthorizes the Centers for Disease Control and Prevention's Newborn Screening Quality Assurance Program, which is intended to ensure the accuracy of newborn screening.
- Allows for the coordination of surveillance activities, including standardized data collection and reporting and data sharing with state-based monitoring programs.
- Reauthorizes the Interagency Coordinating Committee on Newborn and Quality Screening which examines existing newborn screening activities and provides recommendations to states as recommended by the Advisory Committee on Heritable Disorders in Newborns in Children.
- Formally adds the Food and Drug Administrator to the Committee.
- Requires the Secretary of Health and Human Services, acting through the Centers for Disease Control and Prevention and the State Departments of Health, to update the national contingency plan for newborn screening as needed and at least every five years.
- The Contingency Plan, which was issued in 2011, provided states with standards for maintaining continuity of newborn testing, follow-up, referral, and treatment of disorders identified in newborn screening, during a public health emergency.
- Reauthorizes the Hunter Kelly Newborn Screening program, which supports grants to develop and improve technologies related to newborn screening.
- Allows the Hunter Kelly program to: (1) provide research findings and data for newborn conditions that are under review by the Advisory Committee on Heritable Disorders in Newborns and Children; and (2) conduct pilot studies on conditions that are recommended by the Advisory Committee on Heritable Disorders in Newborns and Children.
- Authorizes $11.9 million for the Health Resources Services Administration's newborn screening programs for fiscal years 2015-2019.
- Authorizes $8 million for the Center for Disease Control and Prevention's Lab Quality Program for fiscal years 2015-2019.
- Requires the Government Accountability Office to submit a report to Congress concerning the timeliness of screening for heritable disorders in newborns, including a summary of best practices available to states and health providers, within two years.
- Requires the Secretary of Health and Human Services to submit a report to Congress on newborn screening activities and spending levels.