Organizations representing patients, providers, medical researchers, survivors, and their families joined together to call on Congress to improve access to clinical trials for patients with life-threatening diseases. The coalition, which is made up of 86 supporting organizations, is urging Congress to pass the bipartisan CLINICAL TREATMENT Act (H.R. 913), which would guarantee coverage of the routine care costs of clinical trial participation for Medicaid enrollees with a life-threatening condition.

“Clinical trials have tremendous potential to help patients with life-threatening illnesses, and for patients with cancer, clinical trials often offer the best available treatment option. It is imperative that every patient, regardless of how they are insured, have access to clinical trials,” said 2019-2020 ASCO president Howard A. “Skip” Burris, MD, FACP, FASCO.

Nearly 20% of Americans receive their health insurance coverage through Medicaid. However, unlike Medicare and private and commercial payers, Medicaid is not federally required to cover routine care costs (like physician visits and laboratory studies) for clinical trials. Although some states require their Medicaid programs to cover these costs, there are still as many as 42.2 million Medicaid patients that are potentially without this needed coverage. Without the guarantee of coverage, many Medicaid beneficiaries with life-threatening conditions do not have the latest technologic and scientific advancements as a treatment option.

“When it comes clinical trials, [patients with cancer] on Medicaid should get the same standard of coverage as those with private insurance. Trial sponsors already pay for the experimental treatments; what this bill does is ensure Medicaid covers the day-to-day costs that would be incurred regardless of whether the patient is enrolled in a trial. Without this legislation Medicaid patients who join a trial can be denied coverage all together, creating a major barrier to participating in a clinical trial. Congress should act now to address this significant barrier to medical progress and provide equal access to clinical research,” said American Cancer Society Cancer Action Network (ACS CAN) president Lisa Lacasse.

Passing the CLINICAL TREATMENT Act could also help improve the validity of clinical research data and the quality of new treatments for all patients. Medicaid insures a large portion of people from under-represented minority and ethnic groups who are not well represented in clinical trial enrollment. Lack of participation in clinical trials from the Medicaid population means these patients are not reflected in the outcome of the clinical research.

“This legislation is a step toward advancing the AMA’s mission of reducing disparities and increasing health equity to improve the health of all populations. This legislation takes aim at a Medicaid regulation that disproportionately affects communities of color and underserved populations. We commend the bill’s sponsors for recognizing this health equity issue in the Medicaid program and look forward to the legislation becoming law,” said American Medical Association (AMA) president Patrice A. Harris, MD, MA.

Providing coverage for the routine costs of clinical trials would have a minimal effect on overall care costs. In most cases, these costs consist of coverage for care that patients would be receiving anyway. The cost of the investigational device or drug would still be covered by the trial sponsor.

Among those organizations supporting the bill are ASCO, the American Medical Association, the American Heart Association, and the American Cancer Society Cancer Action Network. All 86 supporting organizations sent a letter to Congress endorsing the bill and urging quick action to address this important issue.

For more information:

• View an infographic about the bill.
• Read the community endorsement letter.
• Read a detailed overview of the bill.
• Learn more about  financial barriers to clinical trial participation.

For more information about how ASCO is leading the charge to help patients access clinical trials, visit ASCO in Action.