The increasing number of lawsuits involving health insurance plans is nothing new in Brazil. This stems from the freedom granted by the Federal Constitution, which states that healthcare is open to private initiative, thus allowing operators to operate in the sector.
This opening, while necessary to supplement the public health system, has also increased points of tension between beneficiaries and operators, especially in the face of coverage denials, adjustments considered abusive, and differing interpretations regarding the extent of contractual obligations.
It is important to remember that health insurance contracts are typical consumer relationships that are bilateral: on one side, consumers who benefit from an essential service, and on the other, operators who provide a complex and fundamental service for the perpetuation of human life.
Law No. 9.656/1998, known as the Health Plans Law, emerged in this context to regulate private health insurance plans, defining rules for their operation. The central objective was to balance the contractual relationship, correcting abusive practices that were recurrent until then and bringing greater legal security to both parties.
Given the public nature of these activities and the inalienable right to health, as stipulated in Article 197 of the Federal Constitution, the ANS — an autonomous agency under a special regime established by Law No. 9.961/2000 — was created with the aim of playing a central role in strengthening the regulatory framework of the sector.
The Agency assumed supervisory and regulatory functions, taking on the responsibility of ensuring the quality of services provided by the operators, monitoring their economic and financial sustainability, and protecting the rights of health plan beneficiaries.
But what is the practical relevance of the ANS in this context?
One of the most important responsibilities assigned to the ANS (National Agency for Supplementary Health) is the creation of a list of procedures and health events that must be covered by health insurance providers.
This assignment is based on Article 4, III, of Law No. 9.961/2000, which confers upon the Agency the function of preparing the list of procedures and events that will be established as a basic reference for the purposes of the provisions of Law No. 9.656/1998.
This is an essential regulatory prerogative for standardizing a minimum mandatory coverage, guiding both consumers and operators on the extent of services that comprise supplementary health care.
ANS is also responsible for updating and structuring the list of procedures, in order to keep pace with scientific, technological and sanitary developments. This provision is outlined in RN No. 465/2021, which was developed based on guidelines that took into account the following aspects:
a) the principles of Health Technology Assessment – HTA;
b) adherence to the principles of Evidence-Based Healthcare (EBH); and
c) safeguarding the maintenance of the economic and financial balance of the sector.
However, in practice, the actions of health insurance companies are limited by consumer protection regulations, whose guidelines do not always align with the supplementary health insurance regime.
It is worth mentioning that the consolidated jurisprudence of the Superior Court of Justice (STJ) recognizes that, as a general rule, health plans are subject to the Consumer Protection Code — an understanding summarized in Precedent 608/STJ. The only exception applies to self-managed plans, whose mutualistic logic excludes the application of the Consumer Protection Code because they do not constitute a typical consumer relationship.
From this perspective, there is a counterpoint. The CDC (Consumer Protection Code) guarantees broad protection to the consumer against abusive clauses, especially when they compromise the essential core of the prescribed medical treatment.
The Health Plan Law establishes specific rules for coverage, adjustments, and cancellations, which, according to the principle of specialty, theoretically prevails over the general rules of the Consumer Protection Code (CDC) in the regulation of supplementary health, serving as a benchmark for contractual interpretation and evaluation of the legality of clauses.
The problem arises when these two rules do not align in a linear fashion. While the plan seeks to limit coverage when certain conditions are absent or excessively burdensome in an unjustified manner, the consumer also has the right to receive what was contracted and the respective essential treatments.
This conflict primarily stems from clauses that limit rights, such as those defining which procedures should or should not be covered by the operators, and the rules governing the cancellation of contracts. These points of tension frequently give rise to interpretative divergences, initially mobilizing administrative consumer protection agencies linked to the Public Prosecutor's Office in municipalities and states (such as PROCON and DECON), and potentially leading to litigation.
Ultimately, what is the nature of the list of procedures and events of the ANS (National Supplementary Health Agency) and its real impact?
In June 2022, the 2nd Section of the Superior Court of Justice (STJ) ruled that the list was, as a rule, exhaustive. Thus, the mandatory coverage of the plans would be limited to the listed procedures, generating an obligation on the part of the operator.
It was decided that if there is another procedure listed in the list that is effective, safe, and sufficient to treat the patient, the insurer is not obligated to cover a treatment outside the list, given the existence of an available therapeutic substitute.
However, it addressed the possibility of contracting extended coverage or negotiating a contractual addendum to guarantee procedures not included in the list.
Furthermore, in exceptional cases, if there is no therapeutic substitute or if all procedures on the list have proven insufficient, the judge could authorize the treatment indicated by the attending physician or dentist, provided that rigorous criteria are observed: the procedure must not have been expressly rejected by the ANS (National Supplementary Health Agency), there must be scientific evidence of its effectiveness, recommendations from national or international technical bodies must exist, and the judge may, if necessary, consult with specialists or the list update committee, without transferring jurisdiction of the case to the Federal Court.
Promulgation of Law No. 14.545/2022
The aforementioned decision generated significant public outcry, especially among families of people with autism, people with disabilities, and those with rare diseases, since several treatments recommended for these cases were not included in the ANS list.
Given this scenario, the National Congress enacted Law No. 14.454/2022, seeking to overcome the understanding established by the Superior Court of Justice (STJ).
The law amended Article 10 of the Health Plans Law (Law No. 9.656/1998), including paragraph 12, which establishes the illustrative nature of the ANS list, allowing procedures not listed to be covered provided they meet specific technical and medical criteria.
It is worth noting, however, that for a health plan to be obligated to cover the procedure or treatment, it must prove its effectiveness, as stipulated in §13, also inserted by Law No. 14.454/2022.
In short, Law No. 14.454/2022 now requires health plans to cover treatments or examinations not listed in the ANS (National Supplementary Health Agency) list, provided that certain technical criteria are met.
Judgment of ADI 7.265
The National Union of Self-Managed Health Institutions (Unidas) filed a Direct Action of Unconstitutionality (ADI) against Law No. 14.454/2022, arguing that the obligation imposed on health plans to cover procedures beyond those provided for in the ANS list would be unconstitutional.
The thesis argued that the regulation undermines the regulatory function of the ANS (National Supplementary Health Agency), harming the agency's role in defining and updating the list of mandatory procedures.
Furthermore, the organization argued that the law compromises the economic and financial balance of health plans, since it expands the obligation to provide coverage without clear cost criteria and also disregards constitutional provisions, including the complementary nature of health plans, as well as the principles of free enterprise, equality, and legal certainty.
STF's Understanding
By majority vote, the Court declared Law No. 14.454/2022 constitutional, conditioning its application on compliance with certain criteria, such as proof of treatment efficacy, the existence of a technical recommendation from specialized bodies, and respect for the limits established for the exceptional coverage of procedures outside the ANS list.
According to the Brazilian Supreme Court (STF), §13 of article 10 of Law No. 9.656/1998, as amended by Law No. 14.454/2022, creates an excessively open mechanism for making the ANS (National Supplementary Health Agency) list more flexible, considering that:
(i) its wording does not establish objective and verifiable technical criteria;
(ii) allows coverage for procedures not included in the list without any prior mediation or evaluation by the ANS; and
(iii) requires only the alternative fulfillment of one of the criteria provided for in the two paragraphs, which reduces the risk management capacity of the operators and potentially increases the judicialization of demands.
Established criteria
Thus, by establishing a more restrictive interpretation, the absence of a specific procedure in the ANS list, as a rule, prevents its judicial granting, unless it is cumulatively proven that the five objective requirements established by the STF are met, which are:
1) Prescription from a qualified professional
2) No veto or pending analysis by the ANS (National Supplementary Health Agency).
3) Absence of a therapeutic alternative in the current list
4) Scientific proof of efficacy and safety
5) Registration approved by Anvisa
The overall objective was to adapt the criteria that generate the obligation to cover treatments not listed in the ANS (National Supplementary Health Agency) list, observing the theses and conditions established by the STF (Supreme Federal Court), in order to make the law compatible with constitutional principles and legal certainty.
Although Law No. 14.454/2022 establishes a significant advance in the protection of the right to health, expanding coverage for essential procedures and recognizing the complexity of modern medicine, it also brings concrete challenges to the sustainability of health plans and to legal certainty, requiring clear criteria and a balance between consumer protection and risk management by operators.
In summary, Law No. 14.454/2022 represents a delicate balance between protecting the right to health and the limits of economic and regulatory management, demonstrating that legislative advances in the supplementary health sector require harmony between law, technique, and administrative prudence for their benefits to be fully realized.
References
BRAZIL. National Agency for Supplementary Health. New list of coverage for health plans comes into effect. 2018. Available at: https://www.ans.gov.br/aans/noticias-ans/consumidor/4279-novo-rol-de-cobertura-dos-planos-de-saúde-e.
Reicher, SC; Ribeiro, JCT; Costa, VF. Law 14.454/22: the controversy over taxativity and the possible risks to the rights of people with disabilities and rare diseases . Migalhas, De Peso, October 17, 2022. Available at: https://www.migalhas.com.br/depeso/375316/a-polemica-sobre-a-taxatividade-e-os-riscos-as-pessoas-com-deficiencia.
BRAZIL. Law No. 9.656, of June 04, 1998. Provides for private health care plans and insurance. Brasília, DF, June 03, 1998. Available at: http://www.planalto.gov.br/ccivil_03/leis/l9961.htm.
BRAZIL. Law No. 8.078, of September 11, 1990. Provides for consumer protection and other measures. Consumer Protection Code. Brasília, DF, September 12, 1990.
BRAZIL. Law No. 9.961, of January 28, 2000. Creates the National Supplementary Health Agency – ANS and provides other measures. Brasília, DF, January 29, 2000. Available at: http://www.planalto.gov.br/ccivil_03/leis/l9961.htm.
BRAZIL. Normative Resolution No. 428, of November 07, 2017. Updates the List of Procedures and Health Events, which constitutes the basic reference for minimum healthcare coverage in private health insurance plans contracted from January 1, 1999; establishes guidelines for healthcare; and revokes Normative Resolutions – RN No. 387, of October 28, 2015, and RN No. 407, of June 3, 2016. Rio de Janeiro, November 07, 2017. Available at: http://www.ans.gov.br/component/legislacao/?view=legislacao&task=TextoLei&format=raw&id=….
BRAZIL. Superior Court of Justice. Summary No. 608. Electronic Official Gazette, Brasília, April 17, 2018. Available at: https://scon.stj.jus.br/SCON/sumanot/toc.jsp?livre=(sumula%20adj1%20%27608%27).sub.. BRAZIL. Superior Court of Justice. 2nd Section. Appeal for Divergence in Special Appeal (EREsp) 1.886.929-SP, Rapporteur Justice Luis Felipe Salomão, decided on June 8, 2022. Information 740.
BRAZIL. Supreme Federal Court. Plenary. Direct Action of Unconstitutionality (ADI) 7.265/DF, Rapporteur Justice Luís Roberto Barroso, decided on September 18, 2025. Information 1191.
CARVALHO FILHO, José dos Santos. Manual of Administrative Law. 33rd ed. São Paulo: Atlas, 2019.
BRAZIL. Law No. 14.454, of September 21, 2022. Amends Law No. 9.656/1998 to provide for the scope of coverage within the scope of supplementary health insurance. Official Gazette of the Union : Brasília, DF, September 22, 2022. Available at: https://www.planalto.gov.br/ccivil_03/_ato2019-2022/2022/lei/L14454.htm.
BRAZIL. Supreme Federal Court. Plenary. Direct Action of Unconstitutionality (ADI) 7.265/DF , Rapporteur Justice Luís Roberto Barroso, decided on September 18, 2025. Information 1191.
