Bilirakis Leads Introduction of Bipartisan Legislation to Ensure Medicaid Coverage for Genomic Sequencing in Children

Washington, D.C. - Today, Representatives Gus Bilirakis (R-FL), Scott Peters (D-CA), 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 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."

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.

The Genomic Answers for Children's Health Act was also inspired, in part 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'ssuccess prompted other states to follow suit and begin their own pilot programs: Project Baby Manateein Florida, Project Baby Deerin Michigan, and Project Baby Badgerin 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."

"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.

"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."

This bill is endorsed by: Rady Children's Hospital, National Society of Genetic Counselors, Ambry Genetics, Avery's Hope, Firefly Fund, Histiocytosis Association, NW Rare Disease Coalition, Born a Hero Research Foundation, Rare Rising, Children's Minnesota, Baylor Genetics, American Clinical Laboratory Association, Michigan Chapter of the American Academy of Pediatrics (MI AAP), Genome Medical, MI Rare Alliance, The Bonnell Foundation, Bronson Children's Hospital, Aimed Alliance, KIF1A.org,CureLGMD2i, PWSA|USA, Child Neurology Foundation, Michigan Hospital Association, and Genomic Answers for Children's Health Alliance.