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Learn About Clinical Trials

  • Updated: 11/02/2012

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How Insurance Companies Decide

Health insurance companies consider certain factors when deciding if they will cover the costs of clinical trials. Factors in your favor include whether:

  • You live in a state that requires coverage for clinical trials. Some states have laws or special agreements that require health insurance companies to pay for routine care you receive in a clinical trial. For more information, see States That Require Health Plans to Cover Patient Care Costs in Clinical Trials.
  • Language in your health insurance policy allows coverage of routine patient care in a clinical trial
  • The trial is medically necessary. This is often decided on a case-by-case basis.
  • The trial is a phase 3 trial and the routine care costs of the trial are about the same as the routine care costs for standard therapy.
  • There is no standard therapy for your type and stage of cancer.
  • The trial is sponsored by the National Cancer Institute.

How to Manage Insurance Issues

There are several steps you can follow to deal with insurance coverage issues when deciding to enter a clinical trial. Here are some things to try:

  • Work closely with your doctor. Ask your doctor if there is someone on his or her staff who can help with health insurance issues. This person might be a financial counselor or research coordinator. Or, this person might work in the hospital's patient finance department.
  • Work closely with the research coordinator or research nurse. Ask the research coordinator or nurse if other patients have had problems getting their health insurance companies to cover their costs. If so, you might ask the research coordinator or nurse for help in sending information to your health insurance company that explains why this clinical trial would be appropriate for you. This package might include:
    • Medical journal articles that show possible patient benefits from the treatment that is being tested
    • A letter from your doctor that explains why the trial is medically necessary. Or a letter from the researcher that explains the clinical trial.
    • Support letters from patient advocacy groups
Helpful Hint: Be sure to keep your own copy of any materials that are sent to your health insurance company.
  • Work with your health insurance company. If your doctor does not have a staff person to help with insurance issues, call the customer service number on the back of your health insurance card. Ask to speak to the benefit plan department. The following are important questions:
    • Does the health insurance plan cover routine patient care in clinical trials?
    • If so, is an authorization required? An authorization means the health insurance company will review information about the clinical trial before deciding to cover it.
    • If your health insurance company requires an authorization, what information do you need to provide? Examples might include copies of your medical records, a letter from your doctor, and a copy of the consent form for the trial. (It is a good idea to get the name and contact information of the person you are talking to.)
    • If an authorization is not required, you don't have to do anything else. But, it is a good idea to request a letter from your health insurance company that states an authorization is not needed for you to take part in the clinical trial.
Helpful Hint: Every time you call your health insurance company, make a note of who you are speaking with, the date, and the time.
  • Understand the costs related to the trial. Ask your doctor or the trial's contact person about the costs that must be covered by you or your health insurance.
  • Work closely with your employer's benefits manager. This person may be able to help you work with your health insurance company.
  • Give your health insurance company a deadline. Ask the hospital or cancer center to set a target date for when you should start treatment. This can help to ensure that coverage decisions are made promptly.

What you can do if your claim is denied after you begin taking part in a trial

If your claim is denied, contact the billing office for help. The billing manager may know how to appeal your health insurance company's decision.

You can also read your health insurance policy to find out what steps you can follow to make an appeal. Ask your doctor to help you. It might help if he or she contacts the medical director of your health plan.