For more information about insurance coverage of clinical trial costs, see this feature's main page: States That Require Health Plans to Pay for Clinical Trial Costs. 1 Legislation: House Bill 837 2 Effective: July 2005 What clinical trials are covered? Phase I, II, III, and IV clinical trials for the treatment of cancer approved by one of the following: National Institutes of Health (NIH) U.S. Food and Drug Administration (FDA), in the form of an Investigational New Drug Application U.S. Department of Defense U.S. Department of Veterans Affairs Who is required to pay? Any health benefit plan offered by an employer; excludes individually underwritten health insurance policies. Other key criteria: The subject of the trial must evaluate a drug, medical device or service that falls within a Medicare benefit category. Limits coverage to those drugs, medical devices, and services that have been approved by the FDA and that are used in the clinical managment of the patient.