The U.S. Senate has passed H.R. 1281, the Newborn Screening Saves Lives Reauthorization Act. The bill now returns to the House of Representatives for affirmation of the changes made by the Senate.
“Passage of the Newborn Screening Saves Lives Reauthorization Act is a victory for child health,” stated March of Dimes President Dr. Jennifer L. Howse. “One in every 300 infants has a condition that can be detected through newborn screening, which allows for early intervention and treatment to prevent disability or death. The March of Dimes commends the U.S. Congress for acting to protect the health of infants across our nation.”
Sponsored by Senators Kay Hagan (D-NC) and Orrin Hatch (R-UT) in the Senate and Reps. Lucille Roybal-Allard (D-CA) and Mike Simpson (R-ID) in the House, the Newborn Screening Saves Lives Reauthorization Act will renew federal programs that provide support for state efforts to ensure that every newborn is tested for at least 31 conditions present at birth which, if undetected and untreated, can lead to serious disability or death. The bill reauthorizes federal programs that provide assistance to states to improve and expand their newborn screening programs; support parent and provider education; and ensure laboratory quality and surveillance for newborn screening programs.
“The March of Dimes commends our champions, Senators Kay Hagan and Orrin Hatch and Representatives Lucille Roybal-Allard and Mike Simpson, for their tireless advocacy on behalf of our nation’s most vulnerable infants,” Dr. Howse stated. “Their dedicated efforts on behalf of this legislation have made its passage possible. The March of Dimes is proud to have worked with them and an array of other organizational partners to support this vital initiative.”
In addition, the legislation would reauthorize the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHD), a committee of experts that reviews newborn screening tests and makes recommendations to the Secretary as to whether to add them to the Recommended Uniform Screening Panel (RUSP). The SACHD’s authorization expired in April 2013, compelling the Secretary appoint a temporary, two-year discretionary version of the committee so its important work could continue. The bill also tasks SACHD with providing recommendations to ensure timeliness in transporting and processing newborn screening tests and communicating results to health care professionals and families. Delays in this process can result in death or severe lifelong adverse consequences for newborns.
The Senate added brief language designating any federally-funded research involving newborn bloodspots collected after March 2015 to be considered human subjects research for the purposes of the Common Rule. This means that such research will require informed consent from parents before these bloodspots can be used for research; it does not, however, apply to the screening of individual newborns for the required disorders. This provision does not require such consent to be obtained before the initial bloodspot is collected and tested. Bloodspots collected prior to March 2015 will not be covered by the amendment.
In the U.S., newborn screening is a state-run public health program that identifies infants who may have genetic, metabolic, hormonal or functional conditions that may not be apparent at birth. If left untreated, these conditions can cause serious illness, lifelong disabilities and even death. In many cases, early diagnosis and treatment can prevent or reduce the severity of these conditions. Currently, the Secretary recommends that every state screen newborns for 31 core conditions; another condition, Pompe disease, has been recommended by the SACHD and is awaiting Secretarial approval. Approximately 1 in every 300 newborns in the U.S. has a condition that can be detected through screening.
In 2008, Congress passed the original Newborn Screening Saves Lives Act (P.L. 110-204), which established national newborn screening guidelines and helped facilitate comprehensive newborn screening in every state. Prior to passage of P.L. 110-204, the number and quality of newborn screening tests varied greatly from state to state. In 2007, only 10 states and the District of Columbia required infants to be screened for all the recommended disorders. Today, 42 states and the District of Columbia require screening for at least 29 of the 31 treatable core conditions.