The Financial Side of Clinical Trials
Clinical trials are the driving force behind advances made in cancer treatments. Yet patient participation in clinical trials is low and concerns about cost have been a major barrier. In fact, in one survey, 60 percent of respondents said they had not participated in a trial because they thought their insurance company would not provide reimbursement, and 42 percent said they chose not to participate because they were worried about the amount of out-of-pocket expenses. Under the Affordable Care Act, however, all insurance companies must cover the routine patient costs from an in-network provider associated with an approved clinical trial, making trials a much more affordable option than before.
An approved trial is defined as a trial in any phase that is aimed at preventing, detecting or treating cancer or another life-threatening disease. It must either be federally funded or approved, be conducted under an FDA investigational new drug application, or be exempt from the necessity of an FDA investigational new drug application. If you want to participate in an unapproved trial, your insurance may refuse to cover it, so talk to your insurance provider before proceeding.
Health care costs associated with your medical care while participating in a clinical trial fall into two categories:
- Patient care costs are costs related to the normal treatment plan associated with your diagnosis and/or general ailments. These include costs related to going to the doctor, any stays in the hospital and certain testing procedures, and these are covered by your insurance according to your plan language.
- Research costs are costs directly related to the clinical trial study, such as the study drug, study-related procedures, testing performed for research purposes and additional doctor visits. These are typically covered by the trial sponsor.
Even with expanded clinical trials coverage, be sure to discuss costs with the clinical trial administrators and reach out to your insurance company to clarify coverage. Before the clinical trial begins, ask for a detailed list and clarification of what services will be covered by the trial sponsor, as well as what isn’t covered but recommended as part of follow-up and ongoing care. This will help identify some of the costs that are likely not covered by your plan. For example, your insurance company may not consider the follow-up tests and scans provided solely for data collection and analysis as part of routine patient costs. Locate current clinical trials seeking patients at one of the following websites:
- Center for Information and Study on Clinical Research Participation
- National Cancer Institute
- National Institutes of Health
It’s important to emphasize 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.