Boldon v. Humana Insurance Co.

Michael Boldon (plaintiff) was diagnosed with advanced unrescetable hepatocellular carcinoma (HCC), a rare form of terminal liver cancer, which was considered an orphan disease because fewer than 16,000 patients are diagnosed with it annually in the United States. Boldon was advised that he was not eligible for a liver transplant, but his radiologist recommended treating him with TheraSphere, which the Food and Drug Administration had approved for neoadjuvant (before) transplant for HCC patients. Limited clinical studies showed that TheraSphere was an effective way to reduce tumor size and prolong the lives of HCC patients. Boldon’s physician concluded that TheraSphere was the best treatment for Boldon because it was most likely to prolong Boldon’s life and less likely to produce the negative effects associated with alternative treatments. Boldon’s insurer, Humana Insurance Co. (defendant), denied coverage based on its medical director’s review, which was based solely on Humana’s policy exclusion for experimental or investigational drugs, and not on Boldon’s medical record or the medical director’s independent judgment or familiarity with TheraSphere, which was none. Boldon’s physician appealed the denial, and an independent review affirmed the denial. A review from the Arizona Department of Insurance denied coverage because it found that Boldon had not had surgery or a transplant so he could not qualify for neoadjuvant treatment. Both appeals found that the lack of Phase III clinical trials precluded a finding of efficaciousness notwithstanding evidence of safety and efficaciousness from limited trials noted in the literature. Boldon sought judicial relief. Humana argued that under the terms of the plan, it had discretion to interpret the plan and decide coverage questions.