Brazilian Supreme Court rules on coverage of non-listed treatments by health plans

On September 18, 2025, Brazil’s Federal Supreme Court (“STF”) concluded the judgment of Direct Action of Unconstitutionality (“ADI”) No. 7,265, filed by the National Union of Self-Managed Health Institutions (“UNIDAS”). ADI No. 7,265 challenged the constitutionality of requiring coverage for treatments and procedures not included in the list issued by the Brazilian Supplementary Healthcare Agency (“ANS”) – provided there is scientific evidence of efficacy or a recommendation for incorporation by the National Commission for the Incorporation of Technologies in the Unified Health System (“CONITEC”), as established in Law No. 14,454/2022, which amended Law No. 9,656/1998 (“Health Plans Law”).

During the judgment, the STF upheld the constitutionality of the provision but redefined the cumulative criteria that must be demonstrated by the claimant to ensure coverage of procedures and treatments not included in the ANS list, as outlined below:

• Existence of a prescription for the procedure or treatment issued by a physician or dentist;
• No express denial by ANS or pending analysis regarding the inclusion of the procedure or treatment in a Proposal for Updating the List (“PAR”);
• Absence of an adequate therapeutic alternative for the patient’s condition within the ANS list;
• Demonstration of the procedure or treatment’s efficacy and safety, supported by high-level scientific evidence; and
• Registration of the procedure or treatment with the Brazilian Health Regulatory Agency (“ANVISA”), whenever required by law.

Additionally, the STF established that, when assessing requests for coverage, the Judiciary must:

• Verify whether a prior request was submitted to the health plan provider, including any denial, unreasonable delay, or omission in authorizing the treatment or procedure not incorporated into the ANS list;
• Examine any act of non-incorporation issued by ANS, without, however, reviewing the technical-administrative merits of the agency’s decision;
• Consult the Judiciary’s Technical Support Center (“NATJUS”) or qualified technical experts regarding the recommended procedure or treatment. The decision cannot be based solely on the claimant’s prescription, report, or medical opinion.

If the court approves the request, the Judiciary must notify ANS to assess the possibility of including the procedure or treatment in the list of mandatory coverages.

For more information, access the vote in full.

Demarest’s Life Sciences & Healthcare team is available to provide any additional clarification that may be required.