Supreme Court raises bar for health plan treatment coverage

The ruling, concluded on Thursday (18) by majority vote, represents a victory for health plans, even though the request to strike down Law No. 14,454 of 2022 was denied. The law requires coverage for treatments outside the ANS list, but it previously only set two conditions. In the prevailing opinion, Justice Luís Roberto Barroso added three more, bringing the total to five.

The provisions of the law had been challenged by the National Union of Self-Management Health Institutions (Unidas), which argued that the obligation was unconstitutional because it imposed broader duties on private companies than those binding on the State itself (ADI 7265).

The justices upheld the requirement for coverage of treatments outside the ANS list, provided all five conditions are cumulatively met: prescription by a qualified physician or dentist; no express denial by ANS or pending analysis of a list update; absence of an adequate therapeutic alternative for the patient’s condition within the ANS list; proof of efficacy and safety of the treatment based on high-level scientific evidence; and registration with the Brazilian Health Regulatory Agency (ANVISA).

The Court also ruled that, when reviewing lawsuits demanding coverage, judges must verify whether there is evidence of a prior request to the health plan with either a denial, unreasonable delay, or omission. In cases where courts order coverage, ANS must be notified to assess whether the treatment should be included in the mandatory list.

The decision establishes that the burden of proof lies with the plaintiff, though judges may shift this burden at their discretion under the Civil Procedure Code.

Most justices followed the opinion of Justice Barroso, who argued that the criteria are based on STF precedents in Themes 6 and 1234, which defined objective parameters for lawsuits demanding medicines from the public health system (SUS). He was joined by Justices Nunes Marques, Cristiano Zanin, André Mendonça, Luiz Fux, Dias Toffoli, and Gilmar Mendes.

Justice Mendes noted that the case involves about one-quarter of the Brazilian population, who rely on private health care. He argued that replicating the criteria already established for public health was necessary to avoid imbalance in the supplementary system, which could burden the SUS.

Justice Flávio Dino opened the dissent and was in the minority. Like Justice Barroso, he voted for the validity of the legal provision that the ANS list is the basic reference for plans. However, he argued there was no need for the Court to step into the role of Congress or the regulator. He maintained that the law already required observance of ANS’s technical rules and that further requirements were unnecessary. His view was supported by Justices Edson Fachin, Alexandre de Moraes, and Cármen Lúcia.

The ruling was praised by Gustavo Ribeiro, president of the Brazilian Association of Health Plans (ABRAMGE), who said it “restores Brazil to a global standard of legal certainty.” He argued that the prior framework created significant instability for the sector and noted that, over the past three years, the industry faced a negative impact of R$25 billion due to fraud and lawsuits demanding coverage outside the ANS list.

He expressed hope that the decision will eventually lower premiums.

Consumer advocates, however, see the ruling as a setback. Attorney Fernando Padilha, representing the Brazilian Association for the Protection of Health Plan Consumers (Saúde Brasil) in the case, said the decision “creates barriers to access and shifts major responsibility to patients, favoring only those who can afford strong legal representation.”

He warned that requiring patients and families to gather high-level scientific evidence would make the process costlier and more complex.

Attorney Marcos Patullo, partner at Vilhena Silva Advogados, also criticized the outcome, saying the new requirements will make coverage more bureaucratic and time-consuming. “Although coverage outside the list remains possible, the cumulative demands will delay access and increase red tape,” he said.

For José Luiz Toro, legal consultant of Unidas and president of the Brazilian Institute of Supplementary Health Law (IBDSS), the decision clarified the distinction between public and private health. “It is the State’s duty to provide broad and universal health care. Expanding private coverage without predictability only drives up costs, pushing beneficiaries out of the private system and overburdening SUS,” he said.