Source: United States House of Representatives – Congressman Scott Peters (52nd District of California)
Washington, D.C. – Today, Representatives Scott Peters (D-CA), Gus Bilirakis (R-FL), Marc Veasey (D-TX), Troy Balderson (R-OH), Kevin Mullin (D-CA), Mike Carey (R-OH), Chrissy Houlahan (D-PA), and Maria Elvira Salazar (R-FL) introduced the Genomic Answers for Children’s Health Act, a bill to clarify that children enrolled in Medicaid who have a suspected rare disease or genetic disorder can access genomic sequencing, a diagnostic tool that has quickly become the standard of care, to help get answers more quickly.
The Genomic Answers for Children’s Health Act was inspired by Project Baby Bear, led by Rady Children’s Hospital in San Diego from 2018 to 2020. The study found that the use of these rapid diagnostic tests to help patients get treated more quickly can save lives and thousands of dollars in unnecessary health care costs per patient. Project Baby Bear’s success prompted other states to follow suit and begin their own pilot programs: Project Baby Manatee in Florida, Project Baby Deer in Michigan, and Project Baby Badger in Wisconsin.
“San Diego is home to groundbreaking scientific innovations, especially in genomics, which helps diagnose and treat some of the world’s most pressing diseases,” said Rep. Peters. “It’s hard enough for parents and families to face an unknown medical future for a young child and they should have access to every available diagnostic tool. Medicaid coverage for whole genome sequencing will allow doctors to better target treatments and improve children’s lives. I will continue to work with my colleagues on both sides of the aisle to turn innovation into real results for patients.”
“The Genomic Answers for Children’s Health Act takes an important step toward improving outcomes for children facing rare, complex, and often undiagnosed medical conditions,” said Rep. Bilirakis. “For too many families, the search for answers can take years-often involving countless tests, ongoing uncertainty, and significant emotional and financial strain. This legislation clarifies access to advanced genomic sequencing and research tools that can lead to earlier diagnoses, more targeted treatments, and better care for children with rare diseases. This legislation also continues important momentum started by several states, including my home state of Florida, which passed the groundbreaking Sunshine Genetics Act last year.”
“Too many families spend years searching for answers while their child’s condition worsens,” said Rep. Veasey. “The Genomic Answers for Children’s Health Act requires Medicaid to cover whole genome and whole exome sequencing to ensure children and their families can receive accurate and timely diagnoses. This bill is about empowering families with the hope, clarity, and tools necessary to take charge of their child’s health.”
“For families of children with rare and undiagnosed conditions, there are often more questions than answers. Genetic and genomic testing gives physicians the tools to properly diagnose and treat sooner. The Genomic Answers for Children’s Act removes barriers so more children can access this life-changing diagnostic technology and begin receiving the treatment they need,” said Rep. Balderson
“I’m proud to co-lead the Genomic Answers for Children’s Health Act because far too many children with rare diseases wait years for a diagnosis. With millions of kids affected by conditions that are often genetic and hard to identify, this bill helps families get answers sooner so children can receive the right care at the right time. Earlier clarity can make all the difference for a child’s health and a family’s peace of mind,” said Rep. Mullin.
“The Genomic Answers for Children’s Health Act would improve outcomes for some of our medically fragile individuals,” Rep. Carey said. “This legislation takes steps to ensure that children all across the country have access to diagnostics that can help families and their physicians understand the root causes of their health conditions, which will in turn allow them to receive more timely and appropriate treatments. I’m proud to support this legislation because all Americans deserve the chance to live to the fullest potential, regardless of their underlying health disorders.”
“I’m proud to support the Genomic Answers for Children’s Health Act, which will allow more children across our nation to access this powerful tool, providing them and their families with the more accurate diagnosis they need and deserve,” said Rep. Salazar. “Genomic sequencing is revolutionizing the way we approach healthcare. In my district, Nicklaus Children’s Hospital uses it as a core component of its Pharmacogenomics Program.”
“Every family with a critically ill child suffering from an acute condition of unknown origin deserves a swift diagnosis,” said Patrick Frias, MD, Co-President & CEO of Rady Children’s Health. “The Rady Children’s Institute for Genomic Medicine has been at the forefront of eliminating the diagnostic odyssey for neonatal and pediatric rare diseases. We are profoundly thankful to Rep. Scott Peters for his unwavering dedication to ensuring that all patients have access to this transformative diagnostic tool.”
“The Genomic Answers for Children’s Health Act would meaningfully expand access to actionable diagnostic testing services for our youngest patients with serious disease,” said Susan Van Meter, President, ACLA. “Clinical laboratories play a central role in delivering high-quality genomic testing, providing the sequencing, analysis, and interpretation that help clinicians reach accurate diagnoses and guide care. By clearly recognizing whole genome and whole exome sequencing, uniquely suited for diagnosing rare diseases, as covered Medicaid services, promoting awareness, and requiring CMS to evaluate access and outcomes, this legislation would help ensure children can receive medically necessary testing without delay and benefit from earlier diagnoses, more targeted treatments, and improved health outcomes.”
“We support this bill so that the type of insurance a child has isn’t a barrier to accessing potentially life-saving genetic testing,” said Bob Fasinski, Board Member, Avery’s Hope.
“Early genomic diagnosis is essential. Without it, we miss critical windows when disease-modifying therapies can change the trajectory of a child’s life. Access to sequencing isn’t a luxury — it’s the foundation of effective rare disease care,” said Cat Lutz, Vice President Rare Disease Translational Center and Professor, The Jackson Laboratory.
“Michigan Rare Coalition urges lawmakers to support, The Genomic Answers for Children’s Health Act, requiring comprehensive Medicaid coverage of medically necessary genomic sequencing for critically ill, undiagnosed infants and children, recognizing that timely access to these tests can mean the difference between life and death for some of our most vulnerable little ones. Genomic sequencing can accurately identify an underlying rare or genetic condition when standard-of-care testing has failed. By standardizing access and coverage, Medicaid can reduce the downstream costs often associated with a delayed diagnosis, hospitalizations, and invasive testing. Access to a Diagnosis = Better Health Outcomes + Reduced Long Term Costs,” said Leslie Baldwin, Co-Founder, President and CEO, MI Rare Alliance.
Background:
More than 30 million Americans live with a rare disease, and over half are children. For many families, the search for a diagnosis—often called the “diagnostic odyssey”—can take 4 to 8 years, involve multiple misdiagnoses, numerous tests that do not yield the needed answers, and cost thousands of dollars in additional health care expenses. Whole genome sequencing and whole exome sequencing can dramatically shorten this process and provide patients with answers in days or weeks to improve health outcomes and reduce costs.
The legislation clarifies that genomic sequencing is covered under Medicaid’s Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) benefit for eligible children in both inpatient and outpatient settings and directs states to implement an inpatient diagnosis-related group add-on payment to support access in hospital settings. Studies show that genomic sequencing is not only clinically effective, but also cost-efficient in certain cases, and major medical organizations recommend its use for pediatric patients with suspected rare diseases or undiagnosed conditions.
This bill is endorsed by: Rady Children’s Hospital, Aimed Alliance, Ambry Genetics, American Clinical Laboratory Association, Avery’s Hope, Baylor Genetics, The Bonnell Foundation, Born a Hero Research Foundation, Bronson Children’s Hospital, Child Neurology Foundation, Children’s Minnesota, COMBINEDBrain, CureLGMD2i, Firefly Fund, National Association of Genetic Counselors, Genome Medical, Genomic Answers for Children’s Health Alliance, Histiocytosis Association, The Jackson Laboratory, KIF1A.org, MI Rare Alliance, Michigan Chapter of the American Academy of Pediatrics (MI AAP), Michigan Hospital Association, NW Rare Disease Coalition, PWSA|USA, Rare Rising, Undiagnosed Diseases Network Foundation.
Read the full bill text here, a one-pager here, and a section-by-section here.
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