Health insurance coverage for experimental treatments has generated significant debate and frequent litigation in recent years. In many cases, denials of coverage for investigational therapies constitute economically and ethically sound policy. This article argues, however, that health insurance providers should be required to cover experimental treatments in limited circumstances, namely, when they are administered in phase III clinical trials to patients with terminal illnesses who are likely to die within two years. This coverage mandate would help the sickest patients, who have no other treatment options, and would benefit medical researchers, who often face a dearth of patients willing to enroll in clinical trials.

The author recommends that the coverage requirement be included in federal law, perhaps as an amendment to HIPAA. In addition, federal law should mandate health insurance reimbursement for off-label drug use so long as the particular use is recognized in a standard reference compendia or in a national, peer-reviewed professional journal. Finally, the article argues that the proposed federal legislation should require insurers to provide independent, expert reviews of any decisions to deny a terminally ill patient coverage for off-label drug use or experimental treatment administered in a Phase III clinical trial. Such reviews would eliminate much litigation and avoid emotionally draining and costly delays for patients desperately waiting for decisions regarding potentially life-saving therapy.


Health Insurance, Clinical Trials

Publication Date


Document Type


Place of Original Publication

Oregon Law Review

Publication Information

78 Oregon Law Review 203 (1999)


COinS Sharona Hoffman Faculty Bio