Newborn Screening Saves Lives Reauthorization Act Goes to President for Signature into Law

Bill will ensure quality and consistency of universal newborn screening programs

Washington District of Columbia | Wednesday, December 10, 2014

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The U.S. House of Representatives has passed H.R. 1281, the Newborn Screening Saves Lives Reauthorization Act. The bill now goes to President Obama to be signed into law.

“Passage of this legislation is a major victory for newborns and families, and it shows that the health of our nation’s infants crosses all boundaries of party, geography, and political viewpoint,” stated March of Dimes President Dr. Jennifer L. Howse. “Given that one in every 300 infants has a condition that can be detected through this screening, newborn screening represents an indispensable investment in health, families, and our economy. The March of Dimes is deeply grateful to Representatives Lucille Roybal-Allard (CA) and Mike Simpson (ID) and Senators Kay Hagan (NC) and Orrin Hatch (UT) for their tireless commitment to this vital legislation.”

“I introduced the Newborn Screening Saves Lives Reauthorization Act because all babies deserve the same opportunity to be screened and treated for life-threatening illnesses, no matter where they are born or how much money their families have,” said Congresswoman Roybal-Allard, the original sponsor of H.R. 1281. “Newborn screening tests are able to detect genetic and metabolic diseases in about 12,000 babies each year. By identifying and treating these conditions as early as possible, we give children the best chance to lead long, healthy, and active lives. The programs in this bill will promote newborn screening policies that are high-quality and available to all. I am very glad that Congress has reauthorized this critical bill, and I look forward to the President signing it into law.”

“I am so pleased to see the House pass the Newborn Screening Saves Lives Reauthorization Act and send it to the President for his signature,” said Congressman Simpson. “I have repeatedly said that this bill is as important as any we will pass this year. These crucial screening tests detect conditions that are too often undetectable at birth and if left untreated can cause disability, developmental delay, illness, or even death.

“Besides the obvious benefit to families who suffer an enormous emotional and economic burden when a one of these conditions goes undiagnosed for too long, this legislation is a powerful tool for savings in our already overburdened health care system,” added Simpson. “As a former dentist, I have seen the value of diagnosing and treating a condition early in a child’s life, and this bill will help strengthen newborn screening across the country.”

The Senate passed H.R. 1281 on Monday, December 8 after months of delay were resolved by the addition of an amendment related to the privacy of newborn screening samples. 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.

“I am pleased that, through cooperation with my colleagues from both sides of the aisle, these important programs will be reauthorized and more newborns and their families will benefit from the early detection of treatable illnesses,” said Senator Hagan, Chair of the Senate Subcommittee on Children and Families. “As a mother and grandmother, this legislation is close to my heart, as no child should have to suffer from a condition that can be easily cared for.”

Senator Hatch stated: “When I first sponsored this bill in 2008, we created national newborn screening guidelines and helped improve comprehensive newborn screening in every state. Today, I’m proud that 42 states and Washington D.C. require screening for at least 29 of 31 treatable core conditions. Reauthorizing this program means that newborns will have a better shot at dealing with these conditions thanks to early diagnosis. I’m pleased to support it once again.”
In addition to the provision noted above, 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. It 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.

About March of Dimes

The March of Dimes is the leading nonprofit organization for pregnancy and baby health. For more than 75 years, moms and babies have benefited from March of Dimes research, education, vaccines, and breakthroughs.

For the latest resources and health information, visit our websites marchofdimes.org and nacersano.org. To participate in our annual signature fundraising event, visit marchforbabies.org. If you have been affected by prematurity or birth defects, visit our shareyourstory.org community to find comfort and support. For detailed national, state and local perinatal statistics, visit peristats.org. You can also find us on Facebook or follow us on Twitter.