Should insurance be responsible for the cost of care while a patient is enrolled in a clinical trial?

Myth: Insurance companies are not responsible for charges if a patient is in a clinical trial. This issue continues to be a focus of debate and contention among insurance companies, sponsoring agencies, and the treating site. Answer: Payment responsibility for patients in a clinical trial has been an ongoing source of contention between the sponsoring company and patients’ health insurance. Some legislation addresses part of this issue. The Code of Federal Regulations (CFR) states, “Charging for an investigational drug in a clinical trial under an IND (investigational new drug) is not permitted without the prior written approval of FDA [U.S. Food and Drug Administration]” (Clinical Research Resources, 2004). (For simplicity, all investigational agents, biologics, and drugs will be referred to as “drug.”) This regulation clearly states that if the drug under investigation is not FDA approved, the sponsoring company cannot charge for it and must provide the drug free to the patient. The regulation only addresses the cost of the drug, not the administration, technical charges, or care involved in the trial. In June 2000, President Clinton signed a law directing Medicare to pay for medical care of patients involved in clinical trials (Bennett et al., 2000). A July 9, 2007, Medicare policy permitted payment for the “investigational item, if the item is otherwise covered outside of a clinical trial” (U.S. Department of Health and Human Services, 2007). Medicare currently is working on standards related to clinical trials, and many large insurance companies will follow Medicare’s billing guidelines. However, insurance companies in some states can set their own standards for clinical trial coverage. Several states have enacted legislation or engaged in agreements related to clinical trial coverage of standard of care (SOC) costs. New Jersey, California, and Rhode Island are among the states that promote coverage of trial expenses to help recruit clinical trials participants (McBride, 2003).