Insurance Coverage and Clinical Trials

Federal law requires most health insurance plans to cover routine patient care costs in clinical trials under certain conditions. Such conditions include:

• You must be eligible for the trial
• The trial must be an approved clinical trial
• The trial does not involve out-of-network doctors or hospitals, if out-of-network care is not part of your plan

Also, if you do join an approved clinical trial, most health plans cannot refuse to let you take part or limit your benefits.

What are approved clinical trials?

Approved clinical trials are research studies that:

• Test ways to prevent, detect, or treat cancer or other life-threatening diseases
• Are funded or approved by the federal government, have submitted an IND application to the FDA , or are exempt from the IND requirements. IND stands for Investigational New Drug. In most cases, a new drug must have an IND application submitted to the FDA in order to be given to people in a clinical trial.

Which costs are not covered?

Health plans are not required to cover the research costs of a clinical trial. Examples of these costs include extra blood tests or scans that are done purely for research purposes. Often, the trial sponsor will cover such costs.

Plans are also not required to cover the costs of out-of-network doctors or hospitals, if the plan does not usually do so. But if your plan does cover out-of-network doctors or hospitals, they are required to cover these costs if you take part in a clinical trial.

Which health plans are not required to cover clinical trials?

Grandfathered health plans are not required to cover routine patient care costs in clinical trials. These are health plans that existed in March 2010, when the Affordable Care Act became law. But, once such a plan changes in certain ways, such as reducing its benefits or raising its costs, it will no longer be a grandfathered plan. Then, it will be required to follow the federal law.

Federal law also does not require states to cover routine patient care costs in clinical trials through their Medicaid plans.

How do I figure out which costs, if any, my health plan will pay for if I take part in a clinical trial?

You, your doctor, or a member of the research team should check with your health plan to find out which costs it will cover.