For more information about insurance coverage of clinical trial costs, see this feature's main page: States That Require Health Plans to Cover Patient Care Costs in Clinical Trials.

Legislation: Senate Bill 761

Effective: July 1999

What clinical trials are covered?

Phase II, III, and IV clinical trials for the treatment, supportive care, early detection, and prevention of cancer. The trial must be approved by one of the following:

• a cooperative group funded by a component of the National Institutes of Health
• U.S. Food and Drug Administration
• U.S. Department of Veterans Affairs
• U.S. Department of Defense
• a federally funded general clinical research center
• the Coalition of National Cancer Cooperative Groups

Also, the clinical trial protocol must have been reviewed and approved by a qualified Institutional Review Board (IRB) operating within the state that has a multiple project assurance contract approved by the Office of Protection from Research Risks, U.S. Department of Health and Human Services.

Who is required to pay?

Health maintenance organizations, preferred provider organizations, the State Employee Benefits Group Program, other specified insurers.

Other key provisions:

• There is no clearly superior, noninvestigational approach.
• The available clinical or preclinical data provide a reasonable expectation that the treatment will be as effective as the noninvestigational alternative.
• The patient has signed an IRB-approved informed consent form.