Overview

• By majority, the Supreme Court deemed it constitutional to require plans to cover treatments beyond the ANS list when five cumulative conditions are met.
• The criteria include a prescription by a qualified physician or dentist, no express ANS denial or pending inclusion analysis, lack of an adequate alternative on the list, robust evidence of efficacy and safety, and Anvisa registration.
• The ruling also imposes judicial safeguards: judges must verify a prior request to the operator, consult Natjus, avoid rulings based solely on a medical report, and notify ANS when granting a preliminary order.
• The lineup was 7–4 for adopting the filters, with Barroso, Nunes Marques, André Mendonça, Cristiano Zanin, Luiz Fux, Dias Toffoli, and Gilmar Mendes in the majority, and Flávio Dino, Alexandre de Moraes, Edson Fachin, and Cármen Lúcia dissenting on setting parameters.
• The case reviewed Law 14.454/2022—passed after the STJ’s taxative-rol decision—and answered a challenge by Unidas, resulting in a framework that allows off-list coverage under tighter, evidence-based controls.