Coalition urges Congress to ensure Medicaid patients coverage to participate in clinical trials

A broad coalition is calling for Congress to ensure that Medicaid patients are guaranteed coverage to participate in potentially life-saving clinical trials.

In a letter (PDF) to Congressional leaders, the coalition urged Congress to include the bipartisan Clinical Treatment Act in a healthcare extenders package, which is expected to pass this spring.

The letter was signed by leaders of 106 organizations representing patients, providers, medical researchers, survivors, and families. It urged lawmakers to include H.R. 913 in the upcoming "must-pass" healthcare extenders package to ensure clinical trial coverage for Medicaid patients.

Organizations backing the bill include the Association for Clinical Oncology, the American Medical Association, the American Heart Association and the American Cancer Society Cancer Action Network. 

The legislation, introduced by Rep. Ben Ray Luján (D-NM) and Rep. Gus Bilirakis (R-FL), would ensure states cover routine care costs of participation in an approved clinical trial for Medicaid enrollees with life-threatening conditions. It currently has 28 cosponsors from both political parties.

In the letter, the organizations noted that Medicaid insures nearly one-fifth of the U.S. population and is the only major payer that is not required by federal law to cover routine costs, such as physician visits and laboratory tests, associated with participating in a clinical trial.

Only 11 states require their Medicaid programs to cover the costs, leaving as many as 42.2 million Medicaid patients potentially without coverage.

“Importantly, clinical trials often provide patients with the best—perhaps only—treatment options for their condition,” the organizations wrote. “Without the guarantee of coverage, however, many Medicaid beneficiaries do not have the latest technological and scientific advancements as a treatment option.”

Coverage would have little to no impact on the overall cost of care to Medicaid programs, they said. The cost of any investigative device or drug would continue to be covered by the clinical trial sponsor. Routine costs only include the non-experimental costs of treating a patient who is participating in a clinical trial. These are part of standard care and would be incurred whether or not a patient participates in a clinical trial.

"Without fair coverage, patients with Medicaid are being excluded from potentially life-saving clinical trials. This is a simple fix and one that should be addressed by Congress as soon as possible," said Monica Bertagnolli, M.D., chair of the Association for Clinical Oncology, an affiliated professional organization of the American Society of Clinical Oncology.

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The organizations hope to get the legislation included as part of a package of health program extenders that Congress must fund before current funding expires May 22.

The supporters of the legislation said the bill would also improve the quality of clinical research and reduce health disparities as Medicaid insures a large portion of people from under-represented minority and ethnic groups who are not well represented in clinical trial enrollment.