ABSTRACT

Purpose

To describe the impact of Judicialization on the performance of Cochlear Implant (CI) surgery in the Brazilian Unified Health System (SUS), including the public service and supplementary health.

Methods

A documentary survey of judgments of all National Courts and the Dominant Jurisprudence focused on CI surgery in the SUS from 2007 to 2019 was carried out through the Jusbrasil Platform using the term “cochlear implant” to carry out the search. A survey was also carried out on the DATASUS platform on how many uni and bilateral CI procedures were performed in the same period.

Results

According to DATASUS, from 2008 to 2019, 8,857 CI surgery procedures were performed by Public Entities or Health Plan Operators in the country. With regard to Judicialization, for requesting unilateral or bilateral CI surgery, a total of 216 processes were found, representing a total of 2.43% of Judicialization of Cochlear Implant (CI) surgery.

Conclusion

In view of the data, it is possible to perceive that the Judicialization of Health when we consider the CI surgery has represented a small portion of the cases, which does not demonstrate a large impact on the public budget and does not have an impact on the organization of the SUS.

Keywords:
Cochlear implant; Civil rights; Right to health; Public policy; Judicialization of health

RESUMO

Objetivo

Descrever o impacto da judicialização na realização da cirurgia de implante coclear no Sistema Único de Saúde do Brasil, incluindo o serviço público e a saúde suplementar.

Métodos

Foi realizado um levantamento documental de acórdãos de todos os tribunais nacionais e a jurisprudência dominante, voltados à cirurgia do implante coclear no Sistema Único de Saúde, no período de 2007 a 2019, por meio da Plataforma Jusbrasil, utilizando o termo “implante coclear” para realização da busca. Também foi realizado um levantamento na plataforma DATASUS (Departamento de Informação do Sistema Único de Saúde) sobre quantos procedimentos de implante coclear unilateral e bilateral foram realizados no mesmo período.

Resultados

De acordo com o DATASUS, no período de 2008 a 2019 foram realizados 8.857 procedimentos de cirurgia de implante coclear pelos entes públicos ou pelas operadoras dos planos de saúde no país. Com relação à judicialização para solicitação da cirurgia do implante coclear, unilateral ou bilateral, foram encontrados 216 processos, representando 2,43% dos casos.

Conclusão

A judicialização da saúde, quando se considera a cirurgia do implante coclear, tem representado uma parcela mínima dos casos, o que demonstra baixo impacto no orçamento público e não tem expressiva ação na organização do Sistema Único de Saúde.

Palavras-chave:
Implante coclear; Direitos civis; Direito à saúde; Política pública; Judicialização da saúde

INTRODUCTION

The American Speech-Language-Hearing Association (ASHA) classifies that 60% of communicative disorders arise from hearing impairments(¹1 ASHA: American-Speech-Language-Hearing Association. Committee on Infant Hearing: guidelines for audiologic screening of newborn infants who are at risk for hearing impairment. ASHA. 1989;31:89-92.) and the World Health Organization (WHO) estimates that untreated hearing losses result in an annual cost of 980 million dollars with healthcare costs, school support and lost of productivity(²2 WHO: World Health Organization. Deafness and hearing loss [Internet]. Geneva; 2024 [citado em 2022 Out 11]. Disponível em: http://www.who.int/mediacentre/factsheets/fs300/en/
http://www.who.int/mediacentre/factsheet... ).

Recently, WHO(³3 OMS: Organização Mundial de Saúde. OMS alerta que perda de audição pode afetar mais de 900 milhões até 2050. ONU News [Internet]; 2020 [citado em 2022 Out 11]. Disponível em: https://news.un.org/pt/story/2020/03/1705931
https://news.un.org/pt/story/2020/03/170... ) presented a conservative estimate of the global economic impact of untreated disabling hearing loss, with costs, assessed in 2015 international dollars (a unit of currency defined by the World Bank), that are in the range of US$ 750 to 750 billion worldwide, when including the cost of medical assistance without the grant of the electronic device; educational support for children with hearing loss greater than 50 dB in the better ear; the loss of productivity due to unemployment and premature retirement among people with hearing loss, and the social costs resulting from social isolation, communication difficulties and stigma. Therefore, hearing loss is a public health problem, and WHO recommends that each country develop national programs focusing on prevention, service provision and awareness(³3 OMS: Organização Mundial de Saúde. OMS alerta que perda de audição pode afetar mais de 900 milhões até 2050. ONU News [Internet]; 2020 [citado em 2022 Out 11]. Disponível em: https://news.un.org/pt/story/2020/03/1705931
https://news.un.org/pt/story/2020/03/170... ).

In Brazil, the Unified Health System (UHS) is the strategy adopted by the public authorities to implement healthcare in the country, with full, universal and equal access to the Brazilian population, being considered one of the largest public healthcare systems in the world.

In this context, for individuals with severe and profound hearing loss, who do not benefit from an individual sound amplification device (ISAD), there is consensus regarding the indication of a cochlear implant (CI) in the rehabilitation process, due to the vast scientific evidence of the benefits of this electronic device in the acquisition and development of children's oral language, as well as for the communication of individuals with post-lingual hearing loss(⁴4 Cordeiro BB, Banhara MR, Mendes CMC. Ganho auditivo e influência do tempo de privação auditiva na percepção de fala em usuários de implante coclear. Audiol Commun Res. 2020;25:e2282. http://dx.doi.org/10.1590/2317-6431-2019-2282.
http://dx.doi.org/10.1590/2317-6431-2019...

5 Sousa AF, Couto MIV, Martinho-Carvalho AC. Quality of life and cochlear implant: results in adults with postlingual hearing loss. Rev Bras Otorrinolaringol. 2018;84(4):494-9. http://dx.doi.org/10.1016/j.bjorl.2017.06.005. PMid:28728951.
http://dx.doi.org/10.1016/j.bjorl.2017.0... -⁶6 Angelo TCS, Moret ALM, Costa OA, Nascimento LT, Alvarenga KF. Qualidade de vida em adultos usuários de implante coclear. CoDAS. 2016;28(2):106-12. http://dx.doi.org/10.1590/2317-1782/20162015097. PMid:27191872.
http://dx.doi.org/10.1590/2317-1782/2016... ).

The use of CI by preschoolers provides a great advance in their social skills, allowing a satisfactory social interaction and helping both in the acquisition of oral and written language, during the school period^{( 5}5 Sousa AF, Couto MIV, Martinho-Carvalho AC. Quality of life and cochlear implant: results in adults with postlingual hearing loss. Rev Bras Otorrinolaringol. 2018;84(4):494-9. http://dx.doi.org/10.1016/j.bjorl.2017.06.005. PMid:28728951.
http://dx.doi.org/10.1016/j.bjorl.2017.0... ). In adult life, the implementation of CI enables normative social coexistence, providing effective communication and autonomous participation in society(⁶6 Angelo TCS, Moret ALM, Costa OA, Nascimento LT, Alvarenga KF. Qualidade de vida em adultos usuários de implante coclear. CoDAS. 2016;28(2):106-12. http://dx.doi.org/10.1590/2317-1782/20162015097. PMid:27191872.
http://dx.doi.org/10.1590/2317-1782/2016... ).

In this sense, the structuring of CI indication in UHS gained strength through Ordinance No. 1.278 of 1999, which approved for the first time the criteria for indication and contraindication of CI(⁷7 Brasil. Ministério da Saúde. Portaria nº 1.278, de 20 de outubro de 1999. Revogada. Diário Oficial da União [Internet]; Brasília; 1999 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/1999/prt1278_20_10_1999.html
http://bvsms.saude.gov.br/bvs/saudelegis... ). In 2014, new Ordinances were instituted, No. 18/SCTIE/MS of June 10, 2014(⁸8 Brasil. Ministério da Saúde. Portaria nº 18/SCTIE/MS, de 10 de junho de 2014. Torna pública a decisão de incorporar procedimentos relativos à assistência hospitalar à saúde auditiva (implante coclear e prótese auditiva ancorada no osso) no Sistema Único de Saúde - SUS. Diário Oficial da União [Internet]; Brasília; 2014 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/sctie/2014/prt0018_10_06_2014.html
http://bvsms.saude.gov.br/bvs/saudelegis... ) and No. 2.776 of December 18, 2014(⁹9 Brasil. Ministério da Saúde. Portaria nº 2.776, de 18 de dezembro de 2014. Aprova diretrizes gerais, amplia e incorpora procedimentos para a Atenção Especializada às Pessoas com Deficiência Auditiva no Sistema Único de Saúde (SUS). Diário Oficial da União [Internet]; Brasília; 2014 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2014/prt2776_18_12_2014.html
http://bvsms.saude.gov.br/bvs/saudelegis... ), followed by Ordinance No. 2.157 of December 23, 2015(¹⁰10 Brasil. Ministério da Saúde. Portaria nº 2.157, de 23 de dezembro de 2015. Altera os art. 8º e 24 da portaria nº 2.776/GM/MS, de 18 de dezembro de 2014. Diário Oficial da União [Internet]; Brasília; 2015 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2015/prt2157_23_12_2015.html
http://bvsms.saude.gov.br/bvs/saudelegis... ), which revoked the initial ordinance and presented updates to the general guidelines for specialized care procedures for people with hearing impairments in UHS.

However, it is possible to see that, even with a structured public hearing health policy, with specific technical criteria for the careful indication of CI, there is still a failure in the system, lack of or slow service provision and, at this moment, the family of the disabled person hearing impaired (minor) or the disabled person (adult) seek the Judiciary to have their rights met. This phenomenon is called judicialization of health. According to the Management Report of the Ministry of Health, referring to the year 2018, R$ 130.473.223.218,12 were spent on health, of which 1.31 billion with judicialization(¹¹11 Brasil. Ministério da Saúde. Relatório de gestão 2018 [Internet]. Brasília; 2018 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/publicacoes/relatorio_gestao_2018.pdf
http://bvsms.saude.gov.br/bvs/publicacoe... ).

When considering that judicialization has been a means of access to health for some citizens, the question - whether is the action of the Judiciary present, when considering the area of hearing, more specifically CI surgery - arose. Focusing on the analysis of judicialization in hearing health policy in Brazil, when considering CI, no studies were found in the researched literature.

Thus, the aim of this study was to describe the impact of judicialization on the performance of CI surgery in the Brazilian UHS, including the public service and supplementary health.

It is believed that the results obtained will allow understanding the impact of judicialization on the number of CI surgeries performed in Brazil and will be of great value in improving the quality of UHS public services, with the aim of overcoming inequalities.

METHODS

This is a quantitative study, of an exploratory and documentary nature, carried out in the Graduate Program in Speech-Language Pathology and Audiology of the Bauru School of Dentistry (Hearing Processes and Disorders Research Line), University of São Paulo, Bauru (SP).

The study did not need to be analyzed by an ethics committee, as secondary data presented in public Information systems were used to understand the national panorama of CI in UHS. The public information systems consulted were the UHS Information Department (DATASUS) and Jusbrasil. There was also no need for an Informed Consent Form (ICF), as there was no patient/subject involved in data collection.

DATASUS, which provides information to support objective analyzes of the health situation, was analyzed to verify the number of CI surgeries carried out by state and region of the country, in the period from 2007 to 2019, which is the period available on the platform.

Jusbrasil is a platform that compiles legal information through articles, case law, Official Gazettes and legislation, in a public format. A survey of rulings from all national courts and dominant jurisprudence, focusing on CI surgery in UHS, from 2007 to August 2019, was carried out in the platform.

In the “Jurisprudence” tab of the platform, all Brazilian courts were selected. To ensure that all processes were available, the generic term “cochlear implant” was used. After reading the content of the processes, those related to the request for unilateral or bilateral CI surgery, selected in order of date, that is, from the oldest to the most recent, were separated. In the selected processes, the following data were considered for analysis:

1. state: place of origin of the process, that is, where it was filed;

2. request: the surgery was requested from the public authority or supplementary healthcare;

3. characterization of the procedure: unilateral or bilateral surgery;

4. process data: whether there was a request for anticipated tutelage and what the result of this request was and whether the process was considered valid. Anticipated tutelage refers to the request granted before the case has its final decision.

The processes aimed at requesting unilateral or bilateral CI surgery were analyzed. The variables analyzed included the state of origin of the case, whether there was anticipated tutelage or not, and the final sentence of the case.

A descriptive analysis of the data, using percentages shown in graphs and tables, was carried out.

RESULTS

According to DATASUS, 8.857 unilateral and bilateral CI procedures were carried out by public entities or health plan operators from 2007 to 2019.

In the search for processes referring to the request for CI surgery, 995 processes were found between 2007 and 2019. Of these, 265 were brought in duplicate by the Jusbrasil Platform and 283 dealt with generic requests requested by the CI user, but not specifically the focus of the present study, such as, for example, retirement due to disability, granting of benefits, work accidents, among others.

Thus, 447 processes were focused on rehabilitation, with 231 processes covering the maintenance of CI and 216 the request for CI surgery, unilateral or bilateral.

Initially, it was found that 166 (76.8%) processes referred to requests for unilateral implantation and 50 (23.1%) for bilateral implantation. The distribution of the total number of unilateral and bilateral CI procedures performed by state and by public entities or health plan operators, according to the year of performance, is presented in Tables 1 and 2.

Table 1 shows the distribution of the 166 processes requesting unilateral CI, according to the state of origin and year it was filed.

Table 2 shows the distribution of the 50 processes requesting bilateral CI, according to the state of origin and year it was filed.

In the analysis of health care, Table 3 shows the distribution of unilateral and bilateral CI requests directed to public entities and health plan operators.

The final decisions of the unilateral and bilateral CI processes, compared to the request for anticipated tutelage, indicating whether the request was made to public entities or to health plan operators, are presented in Table 4.

The distribution of requests for unilateral and bilateral CI separated by the defendant in the case (public authorities or health plan operators), according to authorship (minor, adult, incapable), is shown in Table 5.

DISCUSSION

Brazil has one of the largest public health systems, covering more than 70% of the Brazilian population(¹¹11 Brasil. Ministério da Saúde. Relatório de gestão 2018 [Internet]. Brasília; 2018 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/publicacoes/relatorio_gestao_2018.pdf
http://bvsms.saude.gov.br/bvs/publicacoe... ). In this context, 8.857 CI surgeries were performed from January 2008 to October 2019. In the same period, 216 processes requesting CI were filed. Of these, 166 processes requested unilateral CI and 50 requested bilateral CI.

Unilateral CI has been provided for in the public system since 1999 and bilateral CI since 2014. On the other hand, the National Supplementary Health Agency (ANS) regulated both procedures in 2012(⁷7 Brasil. Ministério da Saúde. Portaria nº 1.278, de 20 de outubro de 1999. Revogada. Diário Oficial da União [Internet]; Brasília; 1999 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/1999/prt1278_20_10_1999.html
http://bvsms.saude.gov.br/bvs/saudelegis...

8 Brasil. Ministério da Saúde. Portaria nº 18/SCTIE/MS, de 10 de junho de 2014. Torna pública a decisão de incorporar procedimentos relativos à assistência hospitalar à saúde auditiva (implante coclear e prótese auditiva ancorada no osso) no Sistema Único de Saúde - SUS. Diário Oficial da União [Internet]; Brasília; 2014 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/sctie/2014/prt0018_10_06_2014.html
http://bvsms.saude.gov.br/bvs/saudelegis...

9 Brasil. Ministério da Saúde. Portaria nº 2.776, de 18 de dezembro de 2014. Aprova diretrizes gerais, amplia e incorpora procedimentos para a Atenção Especializada às Pessoas com Deficiência Auditiva no Sistema Único de Saúde (SUS). Diário Oficial da União [Internet]; Brasília; 2014 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2014/prt2776_18_12_2014.html
http://bvsms.saude.gov.br/bvs/saudelegis... -¹⁰10 Brasil. Ministério da Saúde. Portaria nº 2.157, de 23 de dezembro de 2015. Altera os art. 8º e 24 da portaria nº 2.776/GM/MS, de 18 de dezembro de 2014. Diário Oficial da União [Internet]; Brasília; 2015 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2015/prt2157_23_12_2015.html
http://bvsms.saude.gov.br/bvs/saudelegis... ,¹²12 Brasil. Agência Nacional de Saúde. Resolução normativa nº 261, de 28 de julho de 2011. Diário Oficial da União [Internet]; Brasília; 2011 [citado em 2022 Out 11]. Disponível em: http://www.ans.gov.br/component/legislacao/?view=legislacao&task=TextoLei&format=raw&id=MTc4Mg==
http://www.ans.gov.br/component/legislac... ).

The regulation of bilateral procedures in Brazil is still recent, which demonstrates the caution in incorporating procedures into UHS, inevitably resulting in delays for the patient to have access to treatment. In this sense, legal proceedings against public authorities requesting bilateral CI before 2014 and those directed at health plan operators before 2012 are justified by the lack of regulation(⁸8 Brasil. Ministério da Saúde. Portaria nº 18/SCTIE/MS, de 10 de junho de 2014. Torna pública a decisão de incorporar procedimentos relativos à assistência hospitalar à saúde auditiva (implante coclear e prótese auditiva ancorada no osso) no Sistema Único de Saúde - SUS. Diário Oficial da União [Internet]; Brasília; 2014 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/sctie/2014/prt0018_10_06_2014.html
http://bvsms.saude.gov.br/bvs/saudelegis...

9 Brasil. Ministério da Saúde. Portaria nº 2.776, de 18 de dezembro de 2014. Aprova diretrizes gerais, amplia e incorpora procedimentos para a Atenção Especializada às Pessoas com Deficiência Auditiva no Sistema Único de Saúde (SUS). Diário Oficial da União [Internet]; Brasília; 2014 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2014/prt2776_18_12_2014.html
http://bvsms.saude.gov.br/bvs/saudelegis... -¹⁰10 Brasil. Ministério da Saúde. Portaria nº 2.157, de 23 de dezembro de 2015. Altera os art. 8º e 24 da portaria nº 2.776/GM/MS, de 18 de dezembro de 2014. Diário Oficial da União [Internet]; Brasília; 2015 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2015/prt2157_23_12_2015.html
http://bvsms.saude.gov.br/bvs/saudelegis... ).

The pertinent question is: “Why did processes continue to be filed even after these regulations?” It is believed that there is a period for structuring the system, which requires time and financial resources, but not so long as to justify legal demands(¹³13 Reis C, Pimentel V, Machado L, Barbosa L. Saúde. In: Puga F, Castro LB, editores. Visão 2035: Brasil, país desenvolvido: agendas setoriais para alcance da meta [Internet]. Rio de Janeiro: BNDES; 2018. p. 289-312 [citado em 2022 Out 11]. Disponível em: https://web.bndes.gov.br/bib/jspui/bitstream/1408/16040/3/PRLiv214078_Visao_2035_compl_P.pdf
https://web.bndes.gov.br/bib/jspui/bitst... ).

Specifically, in the case of CI surgery, it is important to highlight that, as it is a highly complex procedure, the financial resource, in principle, is available, as it has a budget tied to it(¹¹11 Brasil. Ministério da Saúde. Relatório de gestão 2018 [Internet]. Brasília; 2018 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/publicacoes/relatorio_gestao_2018.pdf
http://bvsms.saude.gov.br/bvs/publicacoe... ).

CI, as an electronic device, requires responsibilities that justify the fact that a service cannot simply increase the number of surgeries offered to meet demand and, consequently, reduce judicialization in the area. Over the years, the post-surgical stage of treatment has demonstrated complex demands to be managed, such as, for example, the need for maintenance of CI accessories, exchange of the speech processor and, more recently, cochlear reimplantation, when considering the useful life of electronic equipment. It is also important to highlight that CI requires periodic monitoring of each patient, to map the device, by a speech-language and hearing therapist specialized in the area.

Regardless of the justifications, what is observed in the health sector is the lack or slowness of care, which leads the patient to seek the Judiciary(¹⁴14 Mansur SL. O fenômeno da judicialização na sociedade contemporânea. Jusbrasil [Internet]; 2016 [citado em 2022 Out 11]. Disponível em: https://samealuz.jusbrasil.com.br/artigos/389418859/o-fenomeno-da-judicializacao-na-sociedade-contemporanea
https://samealuz.jusbrasil.com.br/artigo... ).

According to the data in Tables 1 and 2, the states that were ahead in requests for unilateral and bilateral CI surgery were São Paulo, Rio Grande do Sul and Paraná. These data contradict the expectation that in regions with greater poverty and less access to public services judicialization would be more pronounced. However, this finding can be justified by the fact that in regions of greater wealth there is greater access to information and, as a result, citizens seek to enforce their rights. From this perspective, judicialization ends up favoring the population that lives in the richest states in the country(¹⁵15 Vargas-Peláez CM, Rover MR, Leite SN, Rossi Buenaventura F, Farias MR. Right to health, essential medicines, and lawsuits for access to medicines: a scoping study. Soc Sci Med. 2014 Nov;121:48-55. http://dx.doi.org/10.1016/j.socscimed.2014.08.042. PMid:25306409.
http://dx.doi.org/10.1016/j.socscimed.20... ).

On the other hand, the states of Acre, Amapá, Amazonas, Maranhão, Pará, Rondônia, Roraima, Sergipe and Tocantins were not mentioned and, consequently, did not present any process on CI (Tables 1 and 2). In an attempt to understand this finding, it is worth highlighting the fact that these locations do not have specialized care services for people with hearing impairment, which may make it difficult for CI to be adopted as a clinical approach in the treatment of hearing impairment, despite the fact that the medical prescription could be a way of putting pressure on states and healthcare providers to incorporate the procedure and offer care to the population of these states(¹⁶16 Brasil. Ministério da Saúde. Serviço de Atenção a Saúde Auditiva. Indicadores: serviço especializado: classificação: implante coclear [Internet]. Brasília; 2019 [citado em 2022 Out 11]. Disponível em: http://cnes2.datasus.gov.br/Mod_Ind_Especialidades_Listar.asp?VTipo=107&VListar=1&VEstado=00&VMun=00&VComp=00&VTerc=00&VServico=107&VClassificacao=005&VAmbu=&VAmbuSUS=&VHosp=&VHospSus=
http://cnes2.datasus.gov.br/Mod_Ind_Espe... ).

Another relevant aspect was the comparative analysis of requests, which demonstrated a greater number for unilateral CI surgery than for bilateral. Over the years, scientific evidence has shown that bilateral CI is the clinical approach to reestablish binaural hearing, which is related to the auditory abilities of sound localization and speech perception in noisy environments(¹⁷17 Hyppolito MA, Bento RF. Rumos do Implante Coclear bilateral no Brasil. Rev Bras Otorrinolaringol. 2012;78(1):2-3. http://dx.doi.org/10.1590/S1808-86942012000100001.
http://dx.doi.org/10.1590/S1808-86942012... ). Why, then, were there fewer processes requesting bilateral CI compared to processes requesting unilateral CI?

From a logical perspective, the processes are based on the medical report, with a prescription for the treatment that the professional believes to be appropriate for the case under analysis. Therefore, it is possible to infer that requests for unilateral CI continue to be the most common clinical approach, a finding consistent with what is described in the literature(¹⁷17 Hyppolito MA, Bento RF. Rumos do Implante Coclear bilateral no Brasil. Rev Bras Otorrinolaringol. 2012;78(1):2-3. http://dx.doi.org/10.1590/S1808-86942012000100001.
http://dx.doi.org/10.1590/S1808-86942012... ).

The data presented in Table 3 demonstrate that 124 processes (75%), of the total of 166 processes requesting unilateral surgery, were directed to health plan operators. In contrast, the number of lawsuits against UHS was 25.3% of all requests, which allows us to infer that, in the case of unilateral CI, UHS is providing a more effective service than health plans.

This result denotes surprise, because health plan operators are subject to the Consumer Protection Code (CPC) and ANS regulation and, by contract, are obliged to provide health care and provision. According to the data, the provision of this service has not corresponded to what is expected, resulting in the user having to take legal action to enforce their contract and oblige the operator to provide a service for which they are being remunerated to offer(¹²12 Brasil. Agência Nacional de Saúde. Resolução normativa nº 261, de 28 de julho de 2011. Diário Oficial da União [Internet]; Brasília; 2011 [citado em 2022 Out 11]. Disponível em: http://www.ans.gov.br/component/legislacao/?view=legislacao&task=TextoLei&format=raw&id=MTc4Mg==
http://www.ans.gov.br/component/legislac... ,¹⁸18 Brasil. Lei nº 8.078, de 11 de setembro de 1990. Código de Defesa do Consumidor. Dispõe sobre a proteção do consumidor e dá outras providências. Diário Oficial da União [Internet]; Brasília; 1990. [citado em 2022 Out 11]. Disponível em: http://www.planalto.gov.br/ccivil_03/Leis/L8078.htm
http://www.planalto.gov.br/ccivil_03/Lei... ).

When considering bilateral CI surgery, this panorama changes, as the number of lawsuits against the public sector has increased significantly (60%), being greater than those aimed at health plan operators (40%), as is can be seen in Table 3.

In this sense, it must be considered that bilateral CI surgery was incorporated as a procedure in UHS only in 2014, for subsequent gradual accreditation of services. If there is no significant change in the current scenario, demand will hardly be met in the medium term, as, associated with new cases, there are all users of unilateral CI, potential candidates for bilateral CI (in this case, 8.857 patients, according to data from DATASUS). According to one of the principles of UHS, universality, a patient who has an indication to undergo the second CI can undergo surgery in a public hospital, even if the first CI was obtained through a private health plan.

With regard to health plan operators, it should be noted that ANS regulated this procedure in 2012, which reinforces what was previously described, that is, the fragility in the provision of the service, now offered by contract. It is important to highlight that, when signing the contract with the operator, the user believes that they will have the necessary assistance if something bad happens to them(¹²12 Brasil. Agência Nacional de Saúde. Resolução normativa nº 261, de 28 de julho de 2011. Diário Oficial da União [Internet]; Brasília; 2011 [citado em 2022 Out 11]. Disponível em: http://www.ans.gov.br/component/legislacao/?view=legislacao&task=TextoLei&format=raw&id=MTc4Mg==
http://www.ans.gov.br/component/legislac... ,¹⁸18 Brasil. Lei nº 8.078, de 11 de setembro de 1990. Código de Defesa do Consumidor. Dispõe sobre a proteção do consumidor e dá outras providências. Diário Oficial da União [Internet]; Brasília; 1990. [citado em 2022 Out 11]. Disponível em: http://www.planalto.gov.br/ccivil_03/Leis/L8078.htm
http://www.planalto.gov.br/ccivil_03/Lei... ).

According to CDC, health plan operators are considered suppliers and provide health care services. In this sense, article 4 of CDC establishes the National Consumer Relations Policy, which aims to meet the needs of consumers, respect their dignity, health and safety, protect their economic interests, improve their quality of life, as well as transparency and harmony in consumer relations. This means that, by failing to comply with the contract signed with the user, health plans disrespects CDC and may even be sued and ordered to provide the necessary service to the user. Such conduct reinforces judicialization, since the consumer, in order to have their rights fulfilled, needs to make use of the Judiciary, forcing the operator to carry out what is stipulated in the contract(¹⁸18 Brasil. Lei nº 8.078, de 11 de setembro de 1990. Código de Defesa do Consumidor. Dispõe sobre a proteção do consumidor e dá outras providências. Diário Oficial da União [Internet]; Brasília; 1990. [citado em 2022 Out 11]. Disponível em: http://www.planalto.gov.br/ccivil_03/Leis/L8078.htm
http://www.planalto.gov.br/ccivil_03/Lei... ,¹⁹19 Boaventura T. Plano de saúde não pode negar tratamento prescrito por médico. Migalhas [Internet]; 2 out 2017 [citado em 2022 Out 11]. Disponível em: https://www.migalhas.com.br/dePeso/16,MI266410,61044-Plano+de+saude+nao+pode+negar+tratamento+prescrito+por+medico
https://www.migalhas.com.br/dePeso/16,MI... ).

According to article 5, section II of law 8.080/1990, which established UHS(²⁰20 Brasil. Lei nº 8.080, de 19 de setembro de 1990.Lei que institui o SUS. Diário Oficial da União [Internet]; Brasília; 1990 [citado em 2022 Out 11]. Disponível em: http://www.planalto.gov.br/ccivil_03/leis/L8080.htm
http://www.planalto.gov.br/ccivil_03/lei... ), the objectives of UHS are to promote public policies to promote the health of the population. These objectives, in the case of unilateral and bilateral CI, were fulfilled through Ordinances No. 1.278 of 1999, No. 18/SCTIE/MS of June 10, 2014, and No. 2.776 of December 18, 2014, followed by Ordinance No. 2.157 of December 23, 2015(⁷7 Brasil. Ministério da Saúde. Portaria nº 1.278, de 20 de outubro de 1999. Revogada. Diário Oficial da União [Internet]; Brasília; 1999 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/1999/prt1278_20_10_1999.html
http://bvsms.saude.gov.br/bvs/saudelegis...

8 Brasil. Ministério da Saúde. Portaria nº 18/SCTIE/MS, de 10 de junho de 2014. Torna pública a decisão de incorporar procedimentos relativos à assistência hospitalar à saúde auditiva (implante coclear e prótese auditiva ancorada no osso) no Sistema Único de Saúde - SUS. Diário Oficial da União [Internet]; Brasília; 2014 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/sctie/2014/prt0018_10_06_2014.html
http://bvsms.saude.gov.br/bvs/saudelegis...

9 Brasil. Ministério da Saúde. Portaria nº 2.776, de 18 de dezembro de 2014. Aprova diretrizes gerais, amplia e incorpora procedimentos para a Atenção Especializada às Pessoas com Deficiência Auditiva no Sistema Único de Saúde (SUS). Diário Oficial da União [Internet]; Brasília; 2014 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2014/prt2776_18_12_2014.html
http://bvsms.saude.gov.br/bvs/saudelegis... -¹⁰10 Brasil. Ministério da Saúde. Portaria nº 2.157, de 23 de dezembro de 2015. Altera os art. 8º e 24 da portaria nº 2.776/GM/MS, de 18 de dezembro de 2014. Diário Oficial da União [Internet]; Brasília; 2015 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2015/prt2157_23_12_2015.html
http://bvsms.saude.gov.br/bvs/saudelegis... ). The data obtained in the present study demonstrated that simply establishing criteria for carrying out CI is not enough to achieve the effectiveness of a health policy.

Even after the regulation of unilateral and bilateral CI by ANS, in 2012, and the regulations of the Ministry of Health, intended for UHS since 1999 for unilateral CI and 2014 for bilateral CI, processes regarding non-provision of the servisse continue to be filed (Table 3).

Table 4 presents the comparison between the final decisions and anticipated tutelage in unilateral and bilateral CI surgery. It is believed that such a comparison is important to verify whether there is a standard of action in the courts. As this is a high-cost surgery, after granting anticipated tutelage, the surgery is carried out, that is, the request is satisfied, even without a final decision, which is possible in cases of urgency and proven need in the process. In view of the data provided, it is believed that the courts have followed a trend of granting anticipated tutelage based on documents attached to the process in an assertive manner, as practically all concessions of anticipated tutelage were confirmed in the final decision(²¹21 Brasil. Lei nº 13.105, de 16 de março de 2015. Institui o Código de Processo Civil. Diário Oficial da União [Internet]; Brasília; 16 mar 2015 [citado em 2022 Out 11]. Disponível em: http://www.planalto.gov.br/ccivil_03/_ato2015-2018/2015/lei/l13105.htm
http://www.planalto.gov.br/ccivil_03/_at... ,²²22 Bastos A. Tutela de urgência: análise do art. 300 no Novo CPC. SAJADV [Internet]; 2019 [citado em 2022 Out 11]. Disponível em: https://blog.sajadv.com.br/tutela-de-urgencia-art-300/
https://blog.sajadv.com.br/tutela-de-urg... ).

There was only one negative final decision, after confirmation of anticipated tutelage, in the case of unilateral CI. In this specific case, the granting of anticipated tutelage was confirmed so that the health plan operator could carry out the procedure. The health plan operator, upon becoming aware of the concession, made accredited doctors available to perform the surgery, however, the author preferred a private doctor, believing that the health plan's doctors were not specialists in CI. When carrying out the private surgery, the author requested reimbursement of the amount paid, which was denied by the judge, since the plan authorized the procedure and the author refused to do so. Therefore, this was the only case in which anticipated tutelage was granted with a negative final decision

For bilateral CI surgery, in only one case, the author was only able to demonstrate the urgency of one of the implants and, therefore, the judge granted anticipated tutelage for just one CI.

The data in Table 5 demonstrate that there was inefficiency in the provision of services, both public and supplementary health, observed both for minors and adults.

Specific literature states that unilateral CI surgery is unquestionably technically effective when performed in the first years of life, according to indication and contraindication criteria(²³23 Silva BCS, Moret ALM, Silva LTDN, Costa OAD, Alvarenga KF, Silva-Comerlatto MPD. Glendonald Auditory Screening Procedure (GASP): marcadores clínicos de desenvolvimento das habilidades de reconhecimento e compreensão auditiva em crianças usuárias de implante coclear. CoDAS. 2019;31(4):e20180142. http://dx.doi.org/10.1590/2317-1782/20192018142. PMid:31433038.
http://dx.doi.org/10.1590/2317-1782/2019... ). However, even 20 years after the first Brazilian regulations, drawn up in accordance with scientific evidence of the benefits of CI in children, it can be seen, in Table 5, that the majority of processes were requested by minors(⁷7 Brasil. Ministério da Saúde. Portaria nº 1.278, de 20 de outubro de 1999. Revogada. Diário Oficial da União [Internet]; Brasília; 1999 [citado em 2022 Out 11]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/1999/prt1278_20_10_1999.html
http://bvsms.saude.gov.br/bvs/saudelegis... ). This data demonstrates that absolute priority, guaranteed to minors, is not being guaranteed in all cases, characterizing the ineffectiveness of the system. It is important to highlight that the Law and the Federal Constitution are in favor of the patient in this case and require the provision of priority care.

Additionally, the high number of adult cases was not expected, 45% of the total, since the criteria for indicating CI surgery in this age group are more restrictive, as, in congenital hearing loss, the patient must necessarily be oralized, a condition that is difficult to achieve in profound hearing loss with the use of an individual sound amplification device. In this study, there is not enough data to discuss this finding, as the processes at Jusbrasil do not provide specific information that would allow characterizing hearing loss, acquired or congenital, as well as whether the individual is oral or not.

As observed in the present study, the hearing health of people who were requesting CI, in most cases, was urgent, and delay could cause irreversible damage in the case of children. As a result, the patient's family, or even the patient himself, upon receiving a refusal from the health plan operator or realizing the slowness of the public system, turned to the Judiciary to perform the surgery or maintenance of the implanted equipment. The search for the Judiciary in this situation reflects the greatest difficulties that the family of a hearing impaired person may have: the right on paper, but not in practice.

However, when the patient demonstrates the urgency and relevance of the case, through the medical report, the judge grants anticipated tutelage as a way of guaranteeing the right to be useful in a timely manner(²¹21 Brasil. Lei nº 13.105, de 16 de março de 2015. Institui o Código de Processo Civil. Diário Oficial da União [Internet]; Brasília; 16 mar 2015 [citado em 2022 Out 11]. Disponível em: http://www.planalto.gov.br/ccivil_03/_ato2015-2018/2015/lei/l13105.htm
http://www.planalto.gov.br/ccivil_03/_at... ,²⁴24 Martins LA, Rigoni KPM. Tutela antecipada: natureza e requisitos para sua concessão. JUS [Internet]; 2015 [citado em 2022 Out 11]. Disponível em: https://jus.com.br/artigos/36095/tutela-antecipada-natureza-e-requisitos-para-sua-concessao
https://jus.com.br/artigos/36095/tutela-... ). Thus, the judicial system has assumed a facilitating role by implementing the right to CI quickly and, consequently, preventing the execution of the sentence from becoming unusable due to delay.

Considering the data, it is believed that the courts have acted with consideration and balance when granting anticipated tutelage, in each case, since anticipated tutelage has been confirmed, with the final decision in the same direction. The courts' caution and balance are very important, given that surgeries are high-cost and have finite budgets, both for public entities and health plan operators, which could place excessive burdens on health service providers, if the final decisions did not follow the same line as the grants of anticipated tutelage(¹⁵15 Vargas-Peláez CM, Rover MR, Leite SN, Rossi Buenaventura F, Farias MR. Right to health, essential medicines, and lawsuits for access to medicines: a scoping study. Soc Sci Med. 2014 Nov;121:48-55. http://dx.doi.org/10.1016/j.socscimed.2014.08.042. PMid:25306409.
http://dx.doi.org/10.1016/j.socscimed.20... ,²⁵25 Godois L. Direitos versus orçamentos: uma análise sobre o custo da judicialização da saúde no município de Cerro Largo/RS [dissertação]. Cerro Largo, RS: Universidade Federal da Fronteira Sul; 2017 [citado em 2022 Out 11]. Disponível em: https://rd.uffs.edu.br/handle/prefix/1891
https://rd.uffs.edu.br/handle/prefix/189... ).

As a limitation of this study, the impossibility of full access to legal proceedings stands out, which made other inferences and conclusions difficult.

CONCLUSION

Even after the regulation of unilateral and bilateral CI surgery, judicialization is present so that citizens seeking health care, both minors and adults, have access to their constitutionally guaranteed rights.

The richest states had the highest rate of judicialization and the judicial system has demonstrated consistency in its decisions, as anticipated tutelage was confirmed with a favorable final decision in all cases in which the citizen, through documents, demonstrated the need and urgency of the procedure.

As in other specialties, for citizens seeking health care, judicialization presents itself as a relevant and important access to their constitutionally guaranteed right. However, this is not a common practice, since, in unilateral and bilateral CI surgery, it represents 2.43% of the total number of surgeries performed, demonstrating a low impact on the public budget and without significant action in the organization of UHS.

ACKNOWLEDGMENTS

To the National Council for Scientific and Technological Development (CNPq) for financing and supporting the study.

REFERÊNCIAS

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