Regulatory changes to expedite the inclusion of therapeutic products in the private healthcare system

Maria Silvia Loureiro de Andrade Marques
Pinheiro Neto Advogados, São Paulo
msmarques@pn.com.br

Luciana Mayumi Sakamoto
Pinheiro Neto Advogados, São Paulo
Lsakamoto@pn.com.br

Camilla Fernandes Cardoso Marcellino
Pinheiro Neto Advogados, São Paulo
cmarcellino@pn.com.br

The Brazilian healthcare system comprises three subsectors: the integrated health system (SUS), one of the largest and most complex public health systems in the world, in which services are financed and provided by the government at federal, state and municipal levels; the for-profit and non-profit private subsector, in which services are financed in various ways with public and private funds; and the private health subsector, with different forms of healthcare plans, including a variety of insurance premiums and tax subsidies.

In the public sphere, the National Committee for Incorporation of Technologies into SUS (CONITEC) advises the Ministry of Health on incorporation, exclusion or alteration of healthcare technologies by SUS, on creation or alteration of clinical protocols and therapeutic guidelines and on updating of the National List of Essential Medicines (RENAME).^[1]

In this context, the law sets a period of 180 days (extendable for 90 days) for the decision-making process regarding the incorporation of healthcare technologies, which must be based on evidence and consider such aspects as efficacy, accuracy, effectiveness and safety of the technology and even its impact – not only from a financial perspective, but also from a social, organisational, ethical and legal point of view. CONITEC also undertakes economic evaluations of benefits and cost comparisons with existing technologies.

Within the sphere of private healthcare, the National Regulatory Agency for Private Health Insurance and Plans (ANS) defines the scope of coverage offered in private healthcare plans and sets the guidelines for determining coverage. Every two years, the List of Healthcare Procedures and Events (the ANS List) is revised and updated, then all procedures and treatments qualifying for compulsory coverage under private healthcare plans are made public, without prejudice to any additional coverage stipulated in private healthcare contracts.

ANS was strongly questioned by several healthcare market players – especially by consumer protection institutions, healthcare providers and the pharmaceutical industry – about the two-year time period for response to the submissions for incorporation of medical procedures and new medicines into the ANS List. The main argument is that technologies approved by the National Public Health Agency (ANVISA) that could potentially benefit thousands of patients may be available sooner than as provided by the regulation in force (Normative Ruling 439 of 2018).

According to ANS, between the registration of a new medicine and the inclusion of a procedure in the medical professional list, up to 43 months may elapse for ANS’s decision-making process regarding the incorporation of new technology. On the other hand, it is important to prioritise the transparency, predictability and legal certainty of the technical activities involved in evaluating the effectiveness, efficacy and economic impact of the inclusion of the new technology.

Within this scenario, ANS proposed to reshape the relevant administrative procedure, reducing the time period for publication and updating the ANS List, as provided in Normative Ruling No 470 published in the Official Gazette on 9 July 2021, to become effective as from 1 October 2021 (RN 470 of 2021).

Under the model adopted by this new ruling, a single timetable is not applicable to new technologies. The submission of proposals for updating the ANS List, the eligibility process (evaluation of its suitability) and the technical analysis take place throughout the year, under the responsibility of ANS technical area. It is an ongoing process designed to expedite technical evaluation by a qualified and limited team, following the principle of transparency and with the participation of society.

The presentation of preliminary recommendations, issuance of a public consultation and publication of the pertinent normative ruling with new incorporations and other updates (adjustments of guidelines and/or exclusions of procedures and events from the current ANS List) occur every six months, under a fixed schedule.

Therefore, every six months, a basket of technologies with complete technical analysis will be submitted for public consultation and for resolution of the ANS Board (DICOL), and the approved updates are published in January and July of each year.

Based on this new administrative procedure, a response time within 18 months is expected for each technology, comprising the submission, eligibility, technical analyses, discussions during technical meetings, public consultation, inclusions of annexes to the normative ruling, review and approval by the ANS Board.

There is also a change regarding the eligibility of proposals, with a more streamlined administrative process, in which the analysis of the criteria provided for in the pertinent regulation occurs as updating proposals are submitted.

Even before this change, ANS endeavoured to keep up with the speed of technology. It is noteworthy that ANS decided to incorporate tests for Covid-19 detection into the ANS List on an extraordinary basis, demonstrating its ability to anticipate and provide fast response to society at large.

RN 470 of 2021 constitutes a major step to expedite updating of mandatory coverage by private healthcare plans. However, while ANS has strived to speed up the ANS List updating process, it has been facing other challenges.

Based on the length of the ANS updating procedure and the necessary patient access to outpatient and home treatment with oral antineoplastic drugs, radiotherapy procedures for cancer treatment and haemotherapy, the Brazilian Congress approved Bill 6,330 of 2019, which proposes an amendment to Law 9,656 of 1998 (Law on Healthcare Plans) to make their coverage mandatory under private healthcare plans and insurances.

However, Brazilian President Jair Bolsonaro rejected Bill 6,330 on 27 July 2021. As stated by the Ministry of Health, automatic inclusion of such treatments without ANS technical analysis goes against public interest by disregarding aspects such as predictability, transparency and legal certainty for market players and civil society. The Ministry of Health also held that approval of Bill 6,330 of 2019 would compromise sustainability of the private healthcare market and create discrepancies in both treatments and technologies, giving priority to oncological patients to the detriment of others.

Due to the negative impact of such decision and as a means of avoiding overturning of the veto by Brazilian Congress – which will represent a defeat in the political arena – the Ministry of Heath prepared and sent a draft provisional measure for review to the ANS Chair to change the ANS List updating procedure. This provisional measure deals with automatic incorporation of healthcare procedures into the ANS List in the following events: expiration of the 180-day period, after submission of the technology without the ANS Board decision, until a final decision; and treatments duly approved by CONITEC in the public sphere (SUS).

In addition to the political battle, the ANS List also faces the judiciary over the actual limits on the minimum mandatory coverage. In the next few weeks, the Second Section of the Superior Court of Justice (STJ) will hear and adjudicate upon a case (EREsp 1.886.929/SP) in which the STJ Justices will decide what should prevail: the limits stipulated in the ANS List or the medical prescription (even if the treatment prescribed for the patient is not covered by the ANS List).

There are diverging opinions between the STJ panels, based on the court precedents. In brief, the Third Panel takes the view that ANS cannot place limits on the coverage of all illnesses listed in the International Statistical Classification of Diseases and Related Health Problems issued by the World Health Organisation (ICD-10), expressly mentioned in article 10 of Law 9,656 of 1998, to be covered in the default benefits package of the private healthcare plan (the ‘reference plan’). And the complexity of the ANS List cannot restrict patient access to healthcare (under a consumer relationship), placing the burden on the patient of evaluating all procedures and medical events covered by the healthcare plan and their possible bad or uninformed choice. Based on the imbalance between the parties (patients and healthcare operators), the ANS List should be deemed illustrative.

In contrast, the STJ Fourth Panel concluded that the ANS List assures the sharing of burdens and benefits between the parties to the private healthcare contract and the limitation of the risks assumed by the healthcare operator, promoting certainty and sustainability in the private healthcare system. Therefore, the ANS List should be considered as an exhaustive list, enabling a balanced use of resources.

As one can see, every change poses a challenge. ANS is making every effort, considering the relevance, complexity and certainty surrounding the inclusion of new technologies in the mandatory coverage of private healthcare plans. However, the involvement of political elements or the judicialisation of the limits stipulated in the ANS List, though designed to streamline the incorporation, cannot weaken predictability and sustainability of the private healthcare system.