STF Upholds Law on Health Plan Coverage, Sets Five-Point Test for Off-List Care

Overview

• By a 7–4 majority, the Court kept the ANS list as a reference and confirmed that off‑list treatments may be ordered only if five cumulative requirements are met.
• The criteria are: qualified prescription, no express ANS denial or pending inclusion review, no adequate alternative in the rol, robust scientific evidence of efficacy and safety, and Anvisa registration.
• Judges must verify prior request to the operator, consult NATJUS, avoid rulings based solely on a patient’s medical report, and notify ANS if a provisional order is granted.
• The minority of four justices agreed the law is valid but argued that defining exceptions belongs to the health regulator ANS rather than the Supreme Court.
• Consumer advocates such as Idec warn the stricter test will hinder access for beneficiaries, while industry groups say clearer rules could curb litigation and support sector sustainability.