Clinical Trials 101

Most insurers pay for medical costs relating to clinical trials the subject of which is treatment, early-detection or diagnosis. Prevention trials are generally not covered.

Several states, including Maryland and Rhode Island, mandate that health insurance coverage extend to clinical trials for people with a life threatening condition.

To improve the chances of your insurer paying for the costs, take the following steps which are based on recommendations of the National Institutes of Health:

Step 1. Understand the costs associated with the trial.   

Ask the trial coordinator about any costs that must be covered by you or your health plan (those costs not directly covered by the trial itself).

Are these costs significantly higher than those associated with the standard care for your condition?

Step 2. Ask about the experience of other patients in the trial. 

Have their plans paid for their care?

Have there been any persistent problems with coverage?

How often have the trial’s administrators been successful in getting plans to cover patient care costs?

Step 3. Understand the provisions of your health plan.  

What provisions are there in your insurance about clinical trials? If you don’t have a copy of the plan, request one.

If there is a specific exclusion for “experimental treatment,” look closely at the policy to see how the plan defines such treatment and under what conditions it might be covered. If it is not clearly defined, call your plan representative, and ask for specific information about clinical trials coverage.

Step 4. Try to enlist the help of a source of influence.

If you have your insurance through an employer or another group, speak with an employee benefits manager to find out how to best state your case and find out if the employer will support your claim for insurance payment.

This can be especially effective for larger companies, which provide insurance coverage for a large number of employees.

Step 5. Coordinate the request to the insurer with your doctor and the administrator of the clinical trial.

Insurance payment for trial related costs is often dependent upon the words or phrasing used by the doctor.

Depending on the requirements of your insurance policy, when you request pre-approval, or submit a claim, the wording should track as closely as possible the wording in the insurance policy.

If there have been problems with insurance companies paying the trial costs in the past, talk with your doctor and the trial coordinator about sending an information package to the insurer. The package should include studies supporting the procedure's safety, benefits, and medical appropriateness. This package might also include:

• Publications from peer-reviewed literature about the proposed therapy that demonstrate patient benefits.
• A letter that uses the language in the insurance contract to explain why the treatment, screening method, or preventive measure should be covered.
• Letters from researchers that explain the clinical trial.
• Support letters from your physician and patient advocacy groups.

Step 6. If the insurer's decision will be the deciding factor about whether you will join the trial, set a deadline to answer.  

Ask the trial coordinator to set a target date for the trial therapy. This will help to ensure that coverage decisions are made promptly.

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