Clinical Trials and Insurance Issues

Once you've identified a clinical trial you may want to join, you'll need to consider how your care will be paid for. Insurance coverage for clinical trials varies depending on the treatment, the insurance company and the health insurance policy. The study sponsor may cover some of the clinical trial costs. Most studies provide the drug or treatment free of charge. Other costs may or may not be covered by health insurance plans.

Speak with the clinical trial sponsor and your insurance provider to learn who'll be responsible for costs during the study's duration. Find out whether your treatment costs will be paid by the clinical trial sponsor, your insurance provider or by you, especially if you're uninsured or don't have adequate medical insurance.

Generally, the study sponsor covers the costs of:

  • The research doctors' and nurses' time
  • The drug being studied

Routine costs that you'd have whether you were in a clinical trial or not may not be covered by the sponsor or insurer. These costs can include:

  • Doctor's visits
  • Hospitalizations
  • Laboratory tests
  • Drugs that aren't part of the study design 

Getting the Insurance Information You Need

Try these strategies to determine the costs you'll be responsible for:

  • Talk with your doctor, nurse, social worker or the study contact person to find out whether the study drug is provided free of charge or low-cost from the drug company.
  • Ask your healthcare providers and your insurance representative to tell you which expenses are covered by your insurance plan.
  • If your insurance company won't pay treatment costs or denies your claims, contact the drug manufacturer or advocacy groups for assistance. Your healthcare provider can contact them as well. Organizations that may have information and suggestions to help you appeal denied insurance claims include:
  • Ask your own doctor or the research study contact to send information to your insurance company about the benefits of the study. They may also point out to your insurer that other companies have paid for such treatment. You may need to provide more information once the study begins.
  • If you have Medicare, find out what clinical trial costs are covered. If you're enrolled in a federally funded clinical trial, Medicare pays for routine care costs (such as office visits and regular medical tests). Learn more about this coverage online at Centers for Medicare and Medicaid Service website or call (800) 633-4227.

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