A Proposal for Federal Legislation to Address Health Insurance Coverage for Experimental and Investigational Treatments

Oregon Law Review, Vol. 78, p. 203, 1999

48 Pages Posted: 30 Mar 2000 Last revised: 24 May 2014

Sharona Hoffman

Case Western Reserve University School of Law

Abstract

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.

JEL Classification: K32

Suggested Citation

Hoffman, Sharona, A Proposal for Federal Legislation to Address Health Insurance Coverage for Experimental and Investigational Treatments. Oregon Law Review, Vol. 78, p. 203, 1999. Available at SSRN: https://ssrn.com/abstract=214131

Sharona Hoffman (Contact Author)

Case Western Reserve University School of Law ( email )

11075 East Boulevard
Cleveland, OH 44106-7148
United States
216-368-3860 (Phone)

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