31 Fla. L. Weekly D1122a
Health maintenance organizations — Coverage — Exclusions — Experimental or investigational services — Exception — Drug prescribed for treatment of cancer that has been approved by FDA for at least one indication, provided drug is recognized for treatment of covered person’s cancer in Standard Reference Compendium or recommended for treatment of covered person’s cancer in medical literature — Error to enter summary judgment and final judgment awarding damages in favor of plaintiff in action against HMO which denied coverage for TheraSphere treatment for plaintiff’s cancer after finding that exception to exclusion for experimental or investigational services was inapplicable because TheraSphere was a “device,” not a “drug” — Lack of definitions for terms “device” and “drug” does not violate section 641.31(4), which requires a clear and understandable statement of any limitations on services or kinds of services to be provided, and does not make exclusion for experimental or investigational services inapplicable to plaintiff’s claim — Read in context, plan provides adequate notice as to services to which a subscriber is entitled and the limitations on those services or kinds of services — Because trial court’s decision largely rested on erroneous conclusion that plan violated statute, summary judgment and final judgment are reversed — Further, trial court did not consider substance of medical expert’s affidavit, which specifically outlined why TheraSphere treatment does not meet the requirements of the exception and stated that plaintiff was not diagnosed with type of cancer for which FDA had approved treatment with TheraSphere and that TheraSphere was not drug recognized for treatment of plaintiff’s diagnosed condition; two of the articles on which plaintiff relied address only the treatment of a type of cancer other than that with which plaintiff was diagnosed — Remand for further proceedings