Medicamentos fora do Rol da ANS: desafios jurídicos do custeio pelos planos de saúde (Lei nº 14.454/22) e a decisão do STF (ADI 7.265)

Abstract

This article examines the main legal challenges related to the coverage of medications not included in the List of Health Procedures and Events of the National Supplementary Health Agency (ANS), a topic that gained relevance after the enactment of Law No. 14.454/2022 and the recent decision of the Brazilian Supreme Federal Court (STF) in ADI 7.265. The 2022 legislation changed the traditional understanding of the list’s legal nature by establishing criteria for the coverage of off-label treatments and health technologies not listed by the regulatory agency. At the same time, the STF consolidated guidelines regarding the mandatory and exceptional coverage of such therapies, affirming the mitigated taxative nature of the list and the requirements that must be observed for the funding of non-listed treatments. The study analyzes the normative, doctrinal, and jurisprudential evolution of the subject, emphasizing the tension between the contractual freedom of health insurance operators and the protection of the consumer-patient, especially within the context of the fundamental right to health. It also addresses the practical impacts of the new rules for beneficiaries, operators, and the Judiciary, as well as future challenges in the periodic updating of the list and in ensuring access to effective and safe health technologies. The article concludes that, although the legislation and the STF’s decision represent advances in standardizing the legal understanding, interpretative uncertainties remain and demand continued attention from the legal and regulatory community.