Clinical Trials: State Laws About Insurance Coverage

Clinical trials are research studies to test new drugs or treatments in people. These studies compare treatments that are being used today (standard treatments) with others that may be better. Before a new treatment is used on people, it’s studied in the lab. If lab studies suggest it might work, the next step is to test its value for patients. These human studies are called clinical trials.

Clinical trials are an important part of cancer care. In most cases, when a patient volunteers for and enrolls in a clinical trial, the cost of tests, procedures, drugs, extra doctor visits, and any research related to the study itself is covered by the group that sponsors the clinical trial. The sponsor of the clinical trial may be a government agency such as the National Cancer Institute, a drug company, or some other agency.

Sometimes a health insurance plan may define the care of a patient in a clinical trial as “experimental” or “investigational.” When this happens, insurance may not even cover the costs of what’s really routine care. This routine care includes costs for things like doctor visits, hospital stays, and tests or treatments that you would have needed even if you were not taking part in a clinical trial.

It’s important for cancer patients to have insurance that covers clinical trials. Lack of insurance coverage can keep patients who might want to be in a clinical trial from taking part in one. This slows down the pace of new advances in cancer treatment and care.

If you have Medicare, you may know that it pays for many of the routine medical costs for people with cancer who are in approved clinical trials. This is true no matter where in the US you live (see below, “Medicare and Medicaid coverage”). Starting in 2014, the Affordable Care Act requires other insurers nationwide to cover these costs too. You can read more about this in the section “How to find out more about your health plan’s clinical trial coverage.”

In the meantime, many states have laws in place regarding insurance coverage for clinical trials. The next section tells you about laws and special agreements that require insurance plans to cover a patient’s medical expenses during a clinical trial.