Bomba de Insulina nos Planos de Saúde: Tema 1.316 do STJ e Cobertura Extrarrol

Objectives: to analyze how STJ Theme 1,316 applies the ADI 7,265 criteria for coverage outside the ANS list to continuous insulin infusion systems. Methods: qualitative, bibliographic and documentary legal research, with content analysis of legislation, ADI 7,265, Theme 1,316 and the motions for clarification decided in August 2026. Results: the STJ classified the system as a medical device, presumed general efficacy and ANS-assessment requirements satisfied, and kept individualized proof of clinical indication, lack of an adequate listed alternative, and regulatory registration. Limitation: documentary study of recent precedents. Conclusions: the ruling standardizes part of the evidentiary burden without removing case-specific technical review.