Should Federal Support for Newborn Screening Be Reauthorized? (H.R. 482)
Do you support or oppose this bill?
What is H.R. 482?
(Updated November 22, 2021)
This bill — the Newborn Screening Saves Lives Reauthorization Act of 2021 — would reauthorize funding for the Newborn Screening Saves Lives Act, which supports federal activities that assist states in improving and expanding their newborn screening programs, supporting parent and provider newborn screening education and ensuring laboratory quality and surveillance.
This bill’s key provisions are:
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Reauthorization of funding for Health Resources and Services Administration (HRSA) grants to help states expand and improve their screening programs, educate parents and health care providers, and improve follow-up care for infants with a condition detected through newborn screening;
- Reauthorization of the Centers for Disease Control and Prevention (CDC) Newborn Screening Quality Assurance Program, which is the nation’s only comprehensive program devoted to ensuring the accuracy of newborn tests;
- Reauthorization of the National Institutes of Health (NIH) Hunter Kelly Newborn Screening program, which funds research aimed at identifying new treatments for conditions that can be detected through newborn screening and developing new screening technologies;
- Reauthorization of the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children, which provides states with a Recommended Uniform Screening Panel (RUSP) to help ensure every infant is screened for conditions which have a known treatment; and
- Directing the National Academy of Science to develop policy recommendations to modernize the nation’s newborn screening system.
The Newborn Screening Saves Lives Act was last reauthorized in 2014. Federal newborn screening programs expired on September 30, 2019.
Argument in favor
Newborn screening saves babies’ lives: up to 12,000 babies with treatable genetic conditions are found through newborn genetic screening each year. Catching these conditions early improves babies’ quality of life and saves families and the government money in the long term.
Argument opposed
Those who oppose newborn screening’s expansion raise valid concerns about conflict with religious beliefs, costs of administering tests for rare diseases with costly exams and privacy. Especially in light of recent data breaches at major companies and California law enforcement’s use of genetic information to catch the Golden State Killer suspect, there are valid concerns about government access to newborns’ genetic information.
Impact
Newborns in the U.S.; newborn screening; states’ newborn screening programs; federal support for newborn screening; HRSA grants to help states expand and improve their screening programs; CDC Newborn Screening Quality Assurance Program; NIH Hunter Kelly Newborn Screening program; National Academy of Science; Advisory Committee on Heritable Disorders in Newborns and Children; and the Recommended Uniform Screening Panel (RUSP).
Cost of H.R. 482
During the 116th Congress, the Congressional Budget Office (CBO) estimated that this bill would cost $240 million over the five-year period from 2020-2024.
Additional Info
In-Depth: Sponsoring Rep. Lucille Roybal-Allard reintroduced this bill from the 116th Congress to reauthorize critical federal activities that help states improve and expand newborn screening programs, support parent and provider newborn screening education, and ensure laboratory quality and surveillance:
“Our bipartisan Newborn Screening Saves Lives Reauthorization Act continues the oversight, coordination, and advancements that have made newborn health screening one of the great public health success stories of our age. I am very grateful for the longtime support of my colleague, Congressman Mike Simpson, who was critical in our efforts to pass both the original bill and the 2014 reauthorization. I’m also grateful for the work of two other public health champions, Assistant Speaker Katherine Clark and my Maternity Caucus co-chair, Jaime Herrera Beutler. We all share a belief that where a baby is born should not determine its chance at a healthy future. The Newborn Screening Saves Lives Reauthorization Act will help ensure all newborn babies receive the comprehensive and consistent testing they need to live healthy, happy, and productive lives.”
Sen. Maggie Hassan (D-NH), sponsor of this bill’s Senate companion, says:
“Anyone with a newborn is anxious to ensure that their baby is healthy and remains that way. This bipartisan legislation will help educate parents about the importance of screening their newborns and provide funding to help states strengthen this important public health program. I am proud to introduce this bipartisan bill that will expand comprehensive testing to newborns and help save lives.”
When she cosponsored this legislation in the 116th Congress, Rep. Jaime Herrera Beutler (R-WA) added:
“When we make the effort early on to help children live full, healthy lives, that effort makes a profound difference throughout our communities. Every year, thousands of babies are born with health conditions that require early detection so doctors and parents can intervene with proper treatment. Through early intervention and treatment, children can be spared from serious, long-term health issues. I’m proud to join this bipartisan effort to ensure that comprehensive newborn screening programs continue and are improved to protect more babies.”
Original cosponsor Rep. Mike Simpson (R-ID) added the following statement about this bill during the 116th Congress:
“I believe early detection and preventative medicine are some of the best ways to saves lives and reduce the cost of care. There is perhaps no greater example of this than newborn screening and this bill delivers the tools that allow nearly 12,000 babies each year to identify conditions that are rare but treatable. I applaud my friend and colleague Congresswoman Roybal-Allard for her work on this issue and I look forward to working with her again to advance this important legislation.”
The American Association for Clinical Chemistry (AACC) was among a number of organizations that supported this bill in the 116th Congress. In a press release, the organization wrote:
“Almost all infants born in the U.S. undergo newborn screening, which is the practice of testing newborns for medical conditions that can cause disabilities, illness, or even death if not diagnosed and treated early. The Newborn Screening Saves Lives Reauthorization Act of 2019 will renew essential federal newborn screening programs for the next five years. The legislation will also help these programs to address new conditions and leverage emerging technologies, in addition to commissioning a report from the National Academy of Medicine to make recommendations for modernizing newborn screening initiatives.”
AACC CEO Janet B. Kreizman added:
“We would like to thank Representatives Roybal-Allard and Simpson for introducing this important legislation, which is critical to ensuring the health of the more than 4 million infants born in the U.S. each year. Newborn screening is one of the most successful public health programs of our time, and federal involvement plays a crucial role in both maintaining and advancing this initiative.”
In a 2014 article in Law and the Public’s Health, researchers wrote that some newborn screening tests may be controversial due to concerns about costs, religious freedom and privacy:
“[T]ests may be more controversial, however, based on their cost, reliability, and predictive value, as well as the availability and success of treatment. This uncertainty about testing technology in a newborn context contributes to variation in both health care practice and state policy standards. Even when the correct standard is clear, it can take a long time for public policy to catch up with technology. When the standard of care itself is uncertain, variation in public policy can be even more pronounced. Furthermore, in the case of newborn testing, uncertainty in the science of predictive testing and treatment combines with issues of privacy and religious and cultural beliefs. Public health policy tends to intervene decisively when the science is sound and the resulting balance of interests around the protection of health is clear. As the scientific questions grow fuzzier, the balance of interests begins to shift as well. This is particularly true where the issue at hand involves the rights of parents to determine the course of medical care for their children.”
In a 2014 Newsweek article, Susan Scutti expounded on these concerns, writing that “many states have created biobanks funded by genetic material left over from our screening tests, and, even more surprising, our specimens may be used for purposes we do not fully understand or for which we have not granted informed consent.” At that time, Scutti wrote that while infants’ blood samples are retained for a couple of years at most, 12 states kept samples in biobanks for 21 years or longer to use the genetic information for research and analysis. In May 2018, CBS San Francisco reported that California was one of a handful of states that stores infants’ remaining blood spots indefinitely for research purposes, using a state-run biobank to do so.
In defense of California’s practice, Dr. Fred Lorey, former director of the California Genetic Disease Screening Program, explained that blood spot samples are invaluable to researchers “because these samples are needed to create new testing technology,” identify new diseases and improve current tests — all of which ultimately saves more babies. Additionally, Lorey notes that blood spots’ sale to researchers (at $20-40 per spot) allows the California Genetic Disease Program to be self-supporting, as required by regulations.
This legislation has 54 bipartisan House cosponsors, including 42 Democrats and 12 Republicans. Its Senate companion, sponsored by Sen. Maggie Hassan (D-NH), has two bipartisan cosponsors (one from each party). The EveryLife Foundation for Rare Diseases supports this legislation in the current session of Congress.
In the 116th Congress, this bill passed the House by voice vote with the support of 50 bipartisan cosponsors, including 34 Democrats and 16 Republicans. It was subsequently held up due to disagreement among lawmakers regarding a proposed amendment that would have required parents to opt-in to allow their newborn’s unidentified dried blood spot (DBS) to be used for research. The bill’s Senate companion, sponsored by Sen. Hassan, had 12 bipartisan Senate cosponsors, including eight Democrats and four Republicans.
During the 116th Congress, this legislation was endorsed by the American Academy of Pediatrics; American Association for Clinical Chemistry (AACC); American College of Medical Genetics and Genomics; Association of Maternal & Child Health Programs; Association of Public Health Laboratories; Cystic Fibrosis Foundation; Cure SMA; EveryLife Foundation for Rare Diseases; Expecting Health at Genetic Alliance; Hunter's Hope Foundation; Immune Deficiency Foundation; March of Dimes; Muscular Dystrophy Association; National Organization for Rare Disorders (NORD); and Parent Project Muscular Dystrophy (PPMD).
Of Note: In the U.S., newborn screening is a state-run public health program that identifies infants who may have genetic, metabolic or hearing disorders that may not be apparent at birth. If left untreated, these conditions can cause serious illness, lifetime disabilities and even death. In many cases, early diagnosis and treatment can prevent or lessen the severity of these conditions. Approximately 1 in every 187 newborns in the U.S. has a condition that can be detected through screening.
Before the original Newborn Screening Saves Lives Act was enacted in 2008, only 10 states and the District of Columbia required infants to be screened for a complete panel of recommended disorders. Additionally, there was no federal repository of information on the diseases. When the Newborn Screening Saves Lives Act was enacted, it:
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Established grant programs to provide education in congenital, genetic, and metabolic disorders;
- Established grant programs for training in newborn screening technologies;
- Established grant programs to coordinate follow-up care;
- Created an increase of consumer awareness and knowledge of family support services, research, and other resources in newborn screening;
- Improved laboratory quality standards;
- Developed a national contingency plan if a public health situation arises; and
- Established a central online clearinghouse for genetic conditions in newborns.
Todday, all 50 states and the District of Columbia screen for at least 30 of the 35 currently-recommended core conditions. Thanks to this, over 12,000 babies with one of these treatable rare conditions are identified each year.
However, Rep. Roybal-Allard’s office notes that “critical gaps and challenges still remain.” For example, discrepancies in the number of tests given from state to state cause children to slip through the gaps, leading to death or permanent disability from otherwise treatable conditions.
Reps. Roybal-Allard and Simpson were the original cosponsors of the Newborn Screening Saves Lives Act, which was passed and signed into law in 2008 and last reauthorized in 2014.
Media:
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Sponsoring Rep. Lucille Roybal-Allard (D-CA) Press Release (117th Congress)
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Senate Companion Legislation Sponsor Sen. Maggie Hassn (D-NH) Press Release (117th Congress)
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Sponsoring Rep. Lucille Roybal-Allard (D-CA) Press Release (116th Congress)
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Cosponsoring Rep. Jaime Herrera Beutler (R-WA) Press Release (116th Congress)
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CBO Cost Estimate (116th Congress)
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American Association for Clinical Chemistry (AACC) Press Release (In Favor, 116th Congress)
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March of Dimes Press Release (In Favor, 116th Congress)
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EveryLife Foundation for Rare Diseases (In Favor, 116th Congress)
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Immune Deficiency Foundation Press Release (In Favor, 116th Congress)
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March of Dimes Fact Sheet
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EveryLife Foundation for Rare Diseases
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Law and the Public’s Health (Context)
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Newsweek (Context)
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CBS News (Context)
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The President’s Council on Bioethics Staff Discussion Paper (Context)
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Causes (116th Congress Summary)
Summary by Lorelei Yang
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