Things you can do to get your health insurance to cover a clinical trial

How health insurers decide to cover clinical trial costs

Ways to learn more

Clinical Trials and Insurance Coverage

As you think about taking part in a clinical trial, you will face the issue of how to cover the costs of care. Even if you have health insurance, your plan may not cover all of the costs related to receiving treatment in a clinical trial. This is because some health insurance companies define clinical trials as "experimental."

Costs involved in treatment clinical trials and who pays for them

There are two types of costs associated with a clinical trial: patient care costs and research costs.

Patient care costs fall into two groups:

Routine care costs are those related to treating your cancer, whether you are in a trial or receiving standard therapy. These costs include:

• Doctor visits
• Hospital stays
• Lab tests
• X-rays and scans

These costs are often covered by health insurance.

Extra care costs are those related to taking part in a clinical trial. These costs might include extra tests that you need as part of the trial, but not as part of your routine care.
These costs are not always covered by health insurance.

Research costs are those related to conducting the trial. Examples include:

• Research doctor and nurse time
• Analysis of results
• Clinical tests performed purely for research purposes
  

These costs are often covered by the organization sponsoring the trial.

Back to Top Things you can do to get your health insurance to cover a clinical trial

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 patient benefits from the treatment that is being tested
  • A letter of medical necessity
  • Letters from researchers that explain 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.
  • Ask if your health insurance plan covers routine patient care in clinical trial.
  • If your health insurance covers routine patient care in a clinical trial, ask if an authorization is 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, ask the following:
    • 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.
    • 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 a clinical trial.

Helpful Hint: Every time you call your health insurance company, make a note of who you are speaking with, the date, and 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 research coordinator or nurse for the clinical trial. He or she will know how to appeal your health insurance company's decision. If your treatment in the trial is taking place in your doctor's office, ask the office billing manager for help.

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.

Back to Top How health insurers decide to cover clinical trial costs

Health insurance companies consider certain factors when deciding if they will cover the costs of clinical trials. Some of the factors in your favor may 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 III trial. A health insurance company may be willing to cover a phase III trial because the treatments have already been successful with a number of people.
• 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 Institutes of Health or one of the groups it supports.

If you have Medicare

Medicare will pay for routine costs in most treatment clinical trials that are funded by federal agencies, such as the National Institutes of Health. To find out more, see the NCI booklet If You Have Cancer and Have Medicare... You Should Know About Clinical Trials. You might also find the following links helpful:

Centers for Medicare and Medicaid Services

List of NCI materials about Medicare and clinical trials coverage

Back to Top Ways to learn more

It's never easy to deal with financial issues when you or a loved one faces cancer. For more information and resources for dealing with finances related to cancer, see the NCI Fact Sheet Financial Assistance and Other Resources for People With Cancer and the directory of National Organizations That Offer Services to People With Cancer and Their Families.

You might also find the following publications helpful.

Facing Forward Series: Life After Cancer Treatment

What Cancer Survivors Need to Know about Health Insurance

The Managed Care Answer Guide

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