Smith v. Newport News Shipbuilding Health Plan

Valerie Smith (plaintiff) had breast cancer. The cancer was in remission, but Smith was concerned it would reoccur in an incurable form. Smith asked her insurer, Newport News Shipbuilding Health Plan, Inc. (the plan) (defendant), to precertify coverage for high-dose chemotherapy (HDCT). HDCT involved chemotherapy at doses so high that the patient could not survive without a bone marrow transplant. At Duke University Medical Center (Duke), where Smith was to be treated, the mortality rate for HDCT was 1–3 percent. The plan’s administrator, Connecticut General Life Insurance Company (CIGNA), denied coverage on grounds that HDCT, as an experimental or investigatory treatment, was not medically necessary. The plan’s definition of necessary treatments excluded experimental or investigatory treatments. The plan’s definition of experimental or investigatory treatments included treatments lacking sufficient research for CIGNA to evaluate the treatments’ safety and efficacy or treatments that were not beneficial, safe, or effective outside a research setting. Duke appealed CIGNA’s denial of coverage. The appeal was heard by an independent Medical Care Ombudsman Program (MCOP). The first MCOP reviewer, Dr. Christopher Desch, considered the preliminary findings of a Dutch study showing that HDCT improved survival rates and another study describing doubt about the benefits of HDCT. The MCOP review denied coverage. Duke appealed again. The second MCOP reviewer, Dr. Michael Grossbard, concluded that the difference in the survival rate for patients receiving HDCT and those on standard doses was not significant. The MCOP again denied coverage. Smith sued in federal district court, arguing that denial of coverage violated the Employee Retirement Income Security Act (ERISA). Smith asked for a declaratory judgment that the plan covered HDCT and a preliminary injunction requiring the plan to cover her HDCT treatment immediately. Smith produced evidence implying that over 12,000 women had received HDCT.