WASHINGTON, D.C. 12/11/14 — The U.S. House of Representatives has passed H.R. 1281, The Newborn Screening Saves Lives Reauthorization Act, and now goes to President Obama to be signed into law.
The legislation passed the Senate on Monday after an amendment was added related to the privacy of newborn screening samples and use in research. Newborn screening is a state-run public health program that identifies infants who may have genetic, metabolic, congenital conditions that may not be apparent at birth. The act will provide $19.9 million to renew federal programs that provide support for states to ensure that every newborn is tested for at least 31 conditions present at birth which, to improve and expand screening programs, provide education and enhance quality improvement initiatives for screening and information technology.
"We are thrilled to join our colleagues in the policy and advocacy community in commending Congress in reauthorizing a program that saves countless newborn lives," said Newborn Foundation co-founder and CEO, Annamarie Saarinen. "With newborn screening, babies with catastrophic yet treatable diseases and disorders can be diagnosed quickly and treated appropriately."
If detected late or undetected and untreated, these conditions can lead to serious disability or death. Saarinen’s own daughter was in heart failure before being diagnosed with Critical Congenital Heart Disease (CCHD) at two days old — prompting the organization to take a leading role in the addition of point-of-care pulse oximetry screening to the Routine Uniform Screening Panel (RUSP) for all U.S. newborns.
"The clinical community sees firsthand how late or missed diagnosis of serious health conditions in newborns can result in death or disability,” stated Lazaros Kochilas, MD, MSCR, Newborn Foundation advisor and associate professor of pediatrics at the University of Minnesota. "Newborn screening is a public health imperative that requires investment and improvement to continue to serve all babies."
Other amendments to the legislation include:
- Government Accountability Office (GAO) tracking and reporting on the timeliness of newborn screening
- CDC evaluation of lab quality and surveillance activities so state labs can collect and share standardized data
- Convening a committee of federal experts to give recommendations on improving timeliness for newborn screening
The legislation does not require public reporting of hospitals' and states' performance — with each state developing its own rules and mandates around reporting.
The Newborn Screening Saves Lives Reauthorization Act reauthorizes the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHD), the expert committee that reviews newborn screening tests and makes recommendations to the Secretary in adding conditions to the RUSP. It also includes new timeliness and tracking measures aimed at eliminating delays in newborn screening so babies with deadly yet treatable genetic disorders are diagnosed quickly. A Milwaukee Journal Sentinel investigation last year that found thousands of hospitals were not sending newborn blood samples to state labs in a timely fashion.
According to the March of Dimes, one in every 300 infants has a condition that can be detected through newborn screening. Currently 42 states and Washington D.C. require screening for at least 29 of 31 treatable core conditions, with newborn screening for CCHD being among the most recent adopted by more than 40 states.
In 2008, Congress passed the original Newborn Screening Saves Lives Act (P.L. 110-204) in 2008, establishing national newborn screening guidelines, which lead to improved quality and consistency in testing among the states. President Obama is expected to sign the legislation within the next 10 days.