Newborn Screening Progress
As we look back at achievements in newborn screening, we are reminded that there is much progress still to be made to ensure that newborn screening keeps pace with science. We will never stop fighting for newborn screening policies that enable every baby in America to receive a diagnosis and access to lifesaving treatments at the earliest possible moment.
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How We Got Here
Since the inception of newborn screening in America in the 1960s, much progress has been made in the early detection and treatment of preventable intellectual and physical disabilities and life-threatening diseases. Each year, new screening tests are developed to diagnose diseases before it is too late to receive treatment. Furthermore, there has been a growing interest in states to enhance and expand newborn screening.
2025
Virginia adopts RUSP alignment legislation. The law implements a three-year timeline in which screening must begin for all RUSP conditions while also ensuring that Virginia can review non-RUSP conditions.
In April, the Advisory Committee for Heritable Disorders in Newborns and Children was disbanded, temporarily terminating the only federal evidence-review process for newborn screening conditions.
2024
Tennessee adopts RUSP alignment legislation. The law implements a three-year timeline in which the screening must begin in order for new conditions to be added to the federal Recommended Uniform Screening Panel (RUSP).
2023
Texas adopts RUSP alignment legislation. The law implements a three-year timeline in which the screening must begin for new conditions added to the federal Recommended Uniform Screening Panel (or RUSP) and ensures that the Texas Department of State Health Services shall provide an annual report to state leadership that outlines the department’s capacity to implement additional nationally recommended newborn screening tests, including the ability to add conditions within two years of addition to the RUSP. Read more.
2022
Mississippi, Iowa, Maryland, and Pennsylvania adopt RUSP alignment legislation. The laws and regulations require states to screen for, or consider screening for, all conditions included on the federal Recommended Uniform Screening Panel (RUSP), implement a timeline in which screening must begin, and ensure resources are available for the states to add new RUSP conditions. Click here to read more about the efforts in Mississippi, Iowa, or Maryland.
2021 – July
Ohio and Arizona sign into law newborn screening bills that will help save the lives of hundreds of babies born in these states each year. The laws, referred to as RUSP alignment legislation, require the states to screen newborn babies for any disorder on the federal Recommended Uniform Screening Panel (or RUSP), implements a timeline in which the screening must begin, and ensures that resources will be available to fund all conditions added to the RUSP in the future. Read more.
2021 – May
Georgia signs into law a bill that will help save the lives of more than 700 babies born in Georgia each year. The legislation requires the state to screen newborn babies for any disorder on the federal Recommended Uniform Screening Panel (RUSP), implements a timeline in which the screening must begin, and ensures that resources will be available to fund all conditions added to the RUSP in the future. Read more.
2019 – 2020
The current Reauthorization remains stagnated in the Senate. Following passage in the House in July 2019, the Senate HELP committee has yet to hold a markup on the bill. Below are key provisions found in the House bill:
- Reauthorizes the Health Resources and Services Administration (HRSA) grants to states to expand and improve their screening programs, educate parents and health care providers, and improve follow-up care for infants with a detected condition.
- Provides HRSA new ability to award grants to address pilot studies and to help re-engage patients who did not receive recommended follow-up appointments.
- Reauthorizes the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC).
- Directs ACHDNC to make the RUSP nomination process more transparent.
- Directs the National Academy of Medicine to conduct a study on how to modernize the newborn screening program.
2019 – September
Congressman Eric Swalwell (CA) reintroduced H.R. 4393, the Advancing Access to Precision Medicine Act. This legislation would ensure access to DNA sequencing clinical services for children and young adults living with undiagnosed conditions, and for whom these services are currently out of reach.
2017
Florida unanimously passed newborn screening legislation (SB1124) in just three months. The Foundation led the lobby efforts of more than 86 patient organizations that supported the bill. This law requires the state’s Genetics and Newborn Screening Advisory Council to consider conditions within one year of them being added to the RUSP and implement the Council’s decision within 18 months. In August 2018, the Foundation organized patients to testify before the Council in support of adding Pompe and mucopolysaccaridosis I (MPS I) to the list of screened conditions. As a result of this effort, the Council voted to add these conditions, after years of delay. In February 2019, the Committee voted to add spinal muscular atrophy (SMA) to the list of screened conditions, less than seven months after the disease was added to the RUSP.
2016
California unanimously passed the RARE Foundation-sponsored newborn screening legislation (SB1095) in just seven months. The Foundation coalesced 120 patient organizations to support the bill. This law requires newborn screening for a condition within two years of its addition to the federal Recommended Uniform Screening Panel (RUSP).
2014
The NBSSLA was first reauthorized in 2014, focusing on improving follow-up services and timeliness of the screening process.
- Follow-up services are the process of notifying the parents and physicians of a positive test to ensure the baby can receive proper attention.
- Newborns are typically screened within 24–48 hours after birth, with a second round of screening occurring 10–14 days after birth. However, at the time of the 2014 reauthorization, screenings were often not occurring within the specified timeframe, and the ACHDNC was working on recommendations to solve that issue.
2008
In 2008, Congress passed the original Newborn Screening Saves Lives Act, which established national newborn screening guidelines and helped facilitate comprehensive newborn screening in every state.
Key Provisions:
- Authorized HRSA to issue grants to enhance, improve, or expand screening services through
training and education.
- Expanded definition of responsibilities of the ACHDNC (see ACHDNC Box).
- Established a clearinghouse for newborn screening information about current educational,
support, and services intended for both families and healthcare professionals.
- Established a program at the Centers for Disease Control and Prevention (CDC) to help maintain laboratory quality and surveillance.
- Established the Hunter Kelly Research Program, the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to coordinate and expand research in newborn screening.
2005
The ACHDNC endorsed the ACMG recommendations on standardization, which includes 29 conditions they recommended for inclusion on state newborn screening panels. By 2007, only ten states required infant screening for all the ACMG recommended conditions.
2003
Health Resources and Services Administration (HRSA) commissions the American College of Medical Genetics (ACMG) to standardize newborn screening procedures.
2000
The first federal newborn screening legislation is passed: The Children’s Health Act (CHA). The newborn screening section of the CHA created the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) as well as established Department of Health and Human Services (HHS) grants for state and local public health agencies to improve and evaluate newborn screening. While the ACHDNC capacities were limited to mainly providing advice on the issuing of grants, its creation was an important step forward.
Advocate in Your State
Every voice, in every state, matters. Many healthcare regulations and bills that impact the rare disease community are made at the state level. Learn what’s happening in your state.
