This note focuses on the highly publicized coverage disputes involving HDCr/ABMT for the treatment of breast cancer to illustrate the problems inherent in courts judging medical technology and legislatures politicizing medical technology. The problems exist, however, with respect to every developing medical technology for which there is no consensus on its safety and effectiveness. Part II of this note depicts the typical scenario involving a patient with metastatic breast cancer. Part III outlines the drug approval process and off-label drug use. Part IV describes HDCT/ABMT treatment and discusses the lack of consensus regarding its efficacy for the treatment of breast cancer. Exclusionary provisions in insurance contracts for experimental treatments are discussed in Part V. Part VI examines how courts have dealt with coverage disputes. Part VII discusses discrimination claims relative to coverage denials. Part VIII identifies the Office of Personnel Management's directive and state legislation that has been enacted or is being considered to address the reimbursement problem relative to HDCT/ABMT treatment for breast cancer. Part IX discusses the dangers of politicizing medicine. This note concludes with recommendations that federal legislation be enacted which sets out a clear definition of "experimental" medical treatment, a uniform policy on off-label drug use, and mandates coverage of patient care costs when associated with an approved clinical cancer trial.
Note, What Is Experimental Medical Treatment: A Legislative Definition Is Needed, 44 Clev. St. L. Rev. 67 (1996)