Washington, DC – Today, Childhood Cancer Caucus Co-Chairs Congresswoman Jackie Speier (D-CA) and Congressman Michael McCaul (R-TX) introduced the bipartisan Clinical Trial Coverage Act to require insurers to cover out-of-network routine care for clinical trial participants if no in-network provider is available. This provision would ensure adult and child patients can access clinical trials without paying significant out-of-pocket costs for physician services.

“Clinical trials have the unique potential to help patients benefit from advanced research and the latest in cutting-edge therapeutics. But as the Co-Chair of the Childhood Cancer Caucus, I have heard from countless families that they can’t afford to participate in clinical trials even though they may significantly improve their child’s quality of life, or even save their child’s life,” Rep. Speier said. “Adults and families with children fighting for their survival must never be forced to choose between the health care they need or putting food on the table and keeping a roof over their heads. Our legislation ensures patients and families can afford this vital care and avoid steep billing surprises. It also promotes greater diversity in the patients who enroll in and benefit from clinical trials, strengthening efforts to develop the medicines of the future.”

“Children diagnosed with cancer deserve the best chance at survival. An already overwhelmed family facing one of life’s most daunting challenges should be given every opportunity to participate in clinical trials that can truly make a difference, without worrying about out-of-network costs. By increasing participation and access to clinical trials, cures and effective treatments will be discovered and generations of children and those facing cancer will benefit,” Rep. McCaul said.

Rep. Speier introduced and passed similar legislation in the California State Senate in 2000.

Current federal law already requires private insurers to cover routine services for clinical trials from in-network providers, but some patients may not have an in-network provider who offers access to a particular trial. For these patients, paying the full price for services in clinical trials may be their only option, excluding many from participating in these trials. The Clinical Trial Act will ensure many of these patients are finally able to benefit from potentially life-saving clinical trials.

The Clinical Trial Coverage Act is supported by numerous medical and patient advocacy organizations, including the St. Baldrick’s Foundation, Pediatric Brain Tumor Foundation, Leukemia & Lymphoma Society, Association of Pediatric Hematology/Oncology Nurses, Children’s Cancer Cause, Rally Foundation for Childhood Cancer Research, and the Alliance for Childhood Cancer.

Quotes from endorsing organizations are below.

“Childhood cancer research uniquely depends on clinical trials to advance care and treatment for kids facing a cancer diagnosis. In many cases, clinical trials provide kids with cancer the best or only treatment option available and appropriate for their condition. The Clinical Trial Coverage Act would require insurers to cover out-of-network routine care costs for clinical trial participants if the provider operating the trial is not in-network. By reducing this financial barrier to clinical trial participation, the Clinical Trial Coverage Act will allow more kids with cancer to enroll in clinical trials,” said Kathleen Ruddy, CEO of the St. Baldrick’s Foundation.

"Clinical trials aren’t a last resort or an after-thought for children with brain cancer. They’re a necessity. Existing treatments are decades old and often do more harm than good to children’s smaller bodies and developing brains. Access to clinical trials and the potential for improved outcomes should not be a financial burden for families who are supporting their children through the toughest battles of their lives. The Pediatric Brain Tumor Foundation whole-heartedly supports the Clinical Trial Coverage Act, and we appreciate Rep. Speier's hard work and dedication to children battling cancer and their families," said Courtney Davies, President and CEO of the Pediatric Brain Tumor Foundation.

“Participation in clinical trials is particularly important to this patient population and vital in establishing the standard of care for pediatric cancer patients. As children have unique biology, clinical trials help researchers discover the best ways to treat them. During a clinical trial, patients may need to see specialists that are considered by their insurance companies as out of network providers. Such a situation can result in unnecessary denial and interruption of coverage and delays in life-saving care. The threat of denials of insurance coverage may cause children with cancer to forgo clinical trials enrollment. Families may be forced to undergo additional insurance review at a time of great stress. The Clinical Trials Coverage Act of 2022 would address this problem by eliminating out-of-network denials for routine care,” said Steve Wosahla, CEO of the Children’s Cancer Cause.

“Imagine a clinical trial is available for you or your loved one, yet your insurance company will not cover the costs because the trial is out-of-network. Rally Foundation for Childhood Cancer Research watches our families encounter this and it is heartbreaking,” said Dean Crowe, Founder and CEO of Rally Foundation for Childhood Cancer Research. “The Clinical Trial Coverage Act is a vitally important piece of legislation because it will require insurance companies to provide coverage if no in-network clinical trial is available. Not only is it the right thing for patients to have the opportunity to enroll in clinical trials, but critical and valuable medical advances are derived from trials providing new standards of care with fewer side effects. Thank you Congresswoman Speier for your leadership and vision.”

Click here for a copy of the bill text.