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ANS' List of Procedures is exhaustive, according to the Brazilian Superior Court of Justice. What does this mean for us?

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On June 8, 2022, Brazil witnessed the unfolding of another chapter involving healthcare plans, patients and the Brazilian Agency of Supplementary Health (ANS), this time at the headquarters of the Brazilian Superior Court of Justice (STJ), in Brasilia.

As such, the Second Panel of the Superior Court of Justice, in the records of Special Appeal #1.886.929 and Special Appeal 1.889.704, by 6 votes (Justices Luis Felipe Salomão, Vilas Bôas Cueva, Raul Araújo, Isabel Gallotti, Marco Buzzi, and Marco Aurélio Bellizze) to 3 (Justices Nancy Andrighi, Paulo de Tarso, and Moura Ribeiro) understood that, as a rule, the list of procedures and events established by the Brazilian Agency of Supplementary Health was exhaustive, and health care providers were not obliged to cover unlisted treatments. However, parameters were set so that, in exceptional situations, the plans cover unlisted procedures, such as therapies with medical recommendation, without a therapeutic substitute in the list, and that have proof of technical bodies and approval by institutions regulating the sector.

At the end of the trial, the thesis of Justice Vilas Bôas Cueva prevailed, which was approved by the majority and incorporated into the vote by the Reporting-Justice Luis Felipe Salomão. As such, the following has been determined:

1. The list of procedures and events in supplementary health is, as a rule, exhaustive;

2.  The healthcare plan or insurance provider is not obliged to pay for treatment not included in ANS' list if there is already another effective and safe procedure for the patient's cure incorporated into the list ;

3. Contracting extended coverage or negotiating a contractual amendment to cover an extra-role procedure is possible;

4. If there is no therapeutic substitute or the procedures on the ANS' list are exhausted, there may be exceptional coverage of the treatment indicated by the attending physician or dentist, provided that (i) the incorporation of the procedure into the supplementary healthcare list was not explicitly rejected by the ANS; (ii) there is proof of effectiveness of the treatment in the light of evidence-based medicine; (iii) there are recommendations from renowned national (such as Conitec and Natjus) and foreign technical bodies; and (iv) whenever possible, inter-institutional dialogue between judges is carried out with entities or those with technical expertise in the field of health, including the Commission for Updating the List of Procedures and Events in Supplementary Health, without shifting the jurisdiction of the judgment to the Federal Court, in the face of ad cause passive illegitimacy by the ANS.

5. Another exception are procedures not provided for in ANS' list (i) therapies with clear recommendation from the Brazilian Council of Medicine (CFM) with proven efficiency for specific treatments and (ii) drugs for treating cancer and off-label prescription (medicine used for treatment with unapproved indication).

This new position by the Brazilian Superior Court of Justice represents a change to the precedents previously applied in the Brazilian courts, which, until then, considered ANS’ list of procedures as an example, i.e., the list represented the minimum to be compulsorily covered by health plans. On the other hand, the decision disagrees with what had been massively proclaimed by the media, in that procedures unlisted by the ANS should no longer be covered by healthcare plans, as the Superior Court of Justice has set aside the hypotheses and conditions for this to occur, as described in the table above.

Despite the existing controversy on the subject, what is really surprising is why doesn't the legislator, or even the ANS itself, determine whether the aforementioned list prepared by them is exemplary or exhaustive, by means of administrative acts. Why wait for the judiciary branch?

Furthermore, it is an issue that involves constitutional aspects, given that Article 196 of the Brazilian Constitution recommends the following:

Article 196 – Health is a right of all and a duty of the State and shall be guaranteed by means of social and economic policies aimed at reducing the risk of illness and other hazards and at the universal and equal access to actions and services for its promotion, protection and recovery.

Now, if health is a right of all and a duty of the State, how does one restricts access to treatments supported by the government? Supposedly, and as the Superior Court of Justice understood, by seeking accreditation institutions or experts that can validate whether a particular procedure or treatment, unlisted by the ANS, is indeed effective or not. Unfortunately, the solution, which could be considered adequate, is not perfect, as the issue will hardly be analyzed only from a scientific perspective but mainly from a political one. This will unconstitutionally frustrate the access of patients to innovative and highly effective procedures or treatments, but not provided in ANS' list, which is quite deficient, not even considering procedures already consolidated in the market, such as robotic surgeries and some types of chemo- and radiotherapy.

Currently, ANS' list of procedures can be reviewed every 6 months. And without a doubt, its major role is to guarantee certain treatments on the one hand but, on the other hand, to prevent healthcare plans from going bankrupt, as any health service needs predictability in regard to its costs so as to maintain sustainability.

The issue is quite complex, considering the increasingly spectacular advancement of medicine, already introducing numerous novelties such as, for example, immunotherapy, monoclonal antibodies, gene therapy, photosensitive drugs remotely activated by laser, in addition to medicines for rare diseases afflicting people which have no alternative until very recently.

Another highly questionable point is the role of the ANS in limiting the number of sessions of therapies for those with various types of disabilities, including autism, when the agency is aware that such a limitation to the number of sessions is not sufficient for the intended treatment.

It is more than likely that this discussion will end up in the Brazilian Supreme Court (STF), considering, as mentioned above, the existing constitutional bias in the regulation of access to health.

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