Clinical Trials

Financial Considerations

Clinical trials are vital for advancements in cancer research and treatment, yet patient participation is low. Cost concerns may be one reason patients decline to volunteer. Research shows that many patients believe their insurance company won’t provide reimbursement and choose not to participate to avoid adding to their out-of-pocket expenses. Before dismissing the idea of participating because of the cost, read on to learn about the resources, such as the Affordable Care Act, that are available to assist.

The Affordable Care Act requires all private insurance companies to cover routine patient-care costs from in-network providers associated with an approved clinical trial. Patient-care costs include those related to doctor visits, hospital stays and some testing procedures that are part of standard care, which would be incurred in a clinical trial and in standard treatment. An approved trial is defined as a trial in any phase that is aimed at preventing, detecting or treating cancer. Research costs, which are directly related to the clinical trial and include drugs and procedures, are typically covered by the trial sponsor.

The consent form that patients sign to participate in a trial always contains a section on which costs are covered by the trial and which are the responsibility of the patient or the patient’s insurance policy. Before you sign the consent form, it is extremely important to address all of your cost and payment questions and concerns. Make sure this section also clarifies services not covered but recommended as part of follow-up and ongoing care. This clarification will help identify some of the costs that are likely not covered by your plan. For example, your insurance company may not consider follow-up tests and imaging studies done solely for data collection and analysis as part of routine patient-care costs. Participation in an unapproved trial may result in your insurance declining coverage. Even though clinical trial coverage has expanded, you should still discuss costs with the clinical trial administrators and reach out to your insurance company for an explanation of coverage.

It’s important to note that federal requirements associated with the Affordable Care Act do not apply to grandfathered health plans. The federal law does not pre-empt any state laws that require a clinical trials policy for state-regulated plans. The federal requirements are minimums, but states may impose additional requirements.

Always explore your plan benefits with your insurance company before volunteering for a clinical trial. You may be pleasantly surprised to learn you can have access to an innovative treatment and be an integral part of cancer research without incurring a great deal of additional expense.


Clinical Trial Costs: Government Assistance

Some federal programs help pay the costs of care for patients enrolled in clinical trials:

  • Medicare covers portions of clinical research studies, such as trials designed to evaluate how well a cancer drug works. Medicare Part A and/or Medicare Part B cover some visits, such as office visits and tests, in certain qualifying clinical research studies. Talk with your medical team before proceeding to ensure you understand their recommendations, the costs and whether Medicare will cover the expenses.
  • TRICARE is the Department of Defense’s health care program. In partnership with the National Cancer Institute (NCI), the Department of Defense now offers participation in phase I, II and III NCI-sponsored cancer clinical trials as a TRICARE benefit.
  • The Department of Veterans Affairs (VA) allows eligible veterans to participate in NCI-sponsored clinical trials at VA Medical Centers. All phases and types of NCI-sponsored trials are included.
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