Access to Health: Understanding health coverage and the law

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Dear readers, my name is Ana Claudia Brandao, Judge of law, Post Doctorate in Biolaw through the University of Salamanca in Spain and also how President of the National Commission of Biolaw and Bioethics of ADFAS and it is with enthusiasm that we started our column on Law and Health. In this space, we will address current and relevant topics such as access to SUS (Unified Health System), coverage of health plans, available drugs and treatments, medical advances and access to new health technologies, including gene therapies, assisted human reproduction, birth, aging and death. These topics are part of our daily life and, many times, we do not have clear and precise information about them. Our mission is to provide accurate and up-to-date information about Law and healthso you can make informed decisions about your health and well-being.

If you are a health plan user e I was wondering what your plan actually covered, you are not alone. In 2022, many health plan users were concerned about the coverage of their plans, especially in relation to the list of National Integrative Health Agency (ANS).

The question that many have asked is whether the role of ANS is exhaustive or merely illustrative. This means that health plans are only required to cover what the REPLY list as due, or if they should cover everything that the doctor accompanying the user prescribes?

Also, many wonder whether it is necessary to go to court to get the desired treatment or medication. Unfortunately, many questions still remain on this topic.

Health is recognized as a right of all and a duty of the state by the Federal Constitution of Braziland is provided by both the government through the Unified Health System (SUS) as well as private initiative. According to the data of National Integrative Health Agency (ANS), 49.4 million Brazilians have a health plan. However, many doubts arise about the coverage of these plans and the refusals of the operators have led to the jurisprudence of the matter. Data of the Health Law Procedural Statistics Panel of National Council of Justice (CNJ) shows that more than 520,000 health-related lawsuits are pending in Brazilian courts. In order to standardize the agreement on the obligation to cover, the 2nd Section of the Supreme Court of Justice has judged the Special Appeal n. EREsp 1886929, the rapporteur’s agreement prevailing, Minister Luís Felipe Salomão, of whom the ANS list is exhaustive, but admits of exceptions.

With the decision of Superior Court of Justice, users would be entitled to the requested unlisted coverage only if they demonstrated that: i) the NSA had not rejected the procedure’s listing; ii) that there was evidence of the effectiveness of the treatment in the light of evidence-based medicine; iii) recommendation of renowned national and international technical bodies; And iv) participation, when possible, of people with expertise in the sector (experts).

Due to the mobilization of Associations of Patient Users of Health Plans against the limitation of user/patient rightson 21.09.2022 the Law 14.454 was sanctioned which amended the Law 9.656 of 1998. The new law establishes that the List of procedures and events in healthcare (repeats)Updated by REPLY, will only serve as a baseline guideline for private health plans contracted on or after January 1, 1999. The ANS should issue rules on scope of coverage, and off-list care should be covered as long as it is proven effective, based on scientific evidence; approval of National Commission for the Incorporation of Technologies in the Unified Health System (Conitec) or the recommendation of an internationally renowned health technology assessment body.

The issue, however, was not yet fully defined, as the decision of the STJ extension had been questioned in Federal Court of Justicebecause health is a constitutional right. On trial in the Plenary, in a virtual session which ended on 9/11/2022, the Court has decided, by majority, the filing of the Direct Action of Unconstitutionality (ADI) 7193 and das Complaints for violation of the fundamental precepts (ADPF) 986 and 990 which dealt with the list of coverages of the health plans, it being understood that the matter had been resolved by the Legislature.

In addition to the judgment of the ADI relating to the coverage list of health plans, the Plenary of the STF also examined and rejected ADI 7088 and 7183, filed by Brazilian Association for the Protection of Health Plan Consumers – Saúde Brasil and Brazilian Committee of Representative Organizations of Persons with Disabilities (CRPD). These actions questioned, in addition to the list, the deadlines for its update and the criteria to guide the drafting of a report by the commission.

THE stf considered the deadlines set for updating the list to be congruous and concluded that the resolution of REPLY guarantees the representativeness of the sectors involved, as well as that the economic evaluation contained in the updating process and the analysis of the financial impact of the merging of the requested treatments are necessary to guarantee the maintenance of the economic-financial sustainability of the health plans.

Currently, the scenario of the regulation of health plans in Brazil is still uncertain and the clash between the different interests involved it is not finished yet. The entrepreneurs of the sector understand that the text of the law 14.454 is very complete, which can generate insecurity for the user himself with respect to the prescribed therapies which are not always effective and for the sector as a whole, with economic impact for the user, and they are already fighting for more restrictive ANS regulationespecially the concept of what “scientific proof”. They also consider that the reduction of the deadline for updating the list from two years to six months, taking into account the technical analyzes and the budgetary impact, also with the participation of civil society, represents a guarantee for the access user to new technologies, with the safety that the patient needs. However, it is important to remember that the new law does not completely eliminate the judicialization of health, because in the event of a refusal by health professionals, however, it will be up to the Judiciary to examine their legitimacy on a case-by-case basis and to definitively decide the question. Furthermore, the ANS regulation has not yet been established and this regulation may influence the scope and interpretation of the law. Therefore, the current scenario is characterized by uncertainty and future developments are expected to better understand how this law will be applied and its impacts on integrative health in Brazil.

The information contained in this article does not reflect the opinion of Jornal Folha de Pernambuco and is the sole responsibility of its creators.