Insurance Coverage for Clinical Trials

A growing number of states have passed legislation or instituted special agreements requiring health plans to pay the cost of routine medical care you receive as a participant in a clinical trial. (NCI 2004)

"Routine patient care costs" are the usual costs of medical care, such as doctor visits, hospital stays, clinical laboratory tests, or x-rays that you would receive whether or not you were participating in a clinical trial. Some health plans don’t cover these costs once you join a trial, even though studies have shown that when health plans do cover the costs associated with clinical trials, this does not significantly increase their cost of cancer care overall. (Chirikos, Ruckdeschel et al. 2001; NIH 2004)

Lack of such coverage is a significant barrier to many patients who might otherwise enroll in a trial. Lack of coverage also makes it harder for researchers to successfully conduct trials that could improve prevention and treatment options.

These laws and agreements do not cover the research costs associated with the conduct of the trial, such as tests purely performed for research purposes. In most cases, such costs would be paid for by the group sponsoring the trial, such as the National Cancer Institute or a pharmaceutical company.

INSURANCE COVERAGE: CALIFORNIA
Senate Bill 37 - Effective August 2001

What clinical trials are covered?
Phase I, II, III, and IV clinical trials with a therapeutic intent for patients with cancer and recommended by a treating physician. Trial must either involve a drug exempt from a New Drug Application (NDA) under federal regulations or be approved by one of the following:
· National Institutes of Health (NIH)
· US Food and Drug Administration
· US Department of Defense
· US Department of Veterans Affairs

Who is required to pay?
All California insurers, including the state's Medicaid program and other medical assistance programs.

Other key criteria:
Plan may restrict coverage to services in California unless protocol is not provided at a California hospital or by a California physician.

HOW CAN I FIND DETAILS ON THE LAWS IN MY STATE?
The following states have passed laws requiring insurers to cover costs related to participation in clinical trials: Arizona, California, Connecticut, Delaware, Georgia, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, Ohio, Rhode Island, Vermont, Virginia, and West Virginia. Detailed information about the specific laws of each state can be found on the following website:
www.cancer.gov/clinicaltrials/learning/laws-about-clinical-trial-costs.

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