Last Wednesday (September 21), the press trumpeted the enactment of a new law, especially the G1 news outlet, informing that healthcare providers are obliged to cover treatments outside the list of the Brazilian Supplementary Health Agency (ANS).
This is another chapter in the fierce dispute between providers and patients, mediated by the authorities. Healthcare providers claim an imbalance in their financial health, while patients denounce lack of coverage and excessive costs in their assistance.
On June 82022, as explained in a post on this blog, the Second Section of the Superior Court of Justice (STJ), in the appeals EREsp 1,886,929 and EREsp 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 ANS was exhaustive, with healthcare providers not being obliged to cover unlisted treatments, except for some exceptions, such as oncological products, with express recommendation by the Brazilian Medicine Council, and with off-label prescription (but with guaranteed effectiveness and safety profile).
This law is indeed Statute #14,454 of September 21, 2022, which amended Statute #9,656 of June 3, 1998, which regulates private health care plans.
Statute 14,454/2022 is small, but it brings deep changes in the relationship between healthcare plans and patients.
The first innovation is to submit the list of services provided by healthcare plans to the Consumer Defense Code (CDC). There has always been a discussion as to whether or not the CDC applies to the relationship between the patient and the health plan, as there was a jurisprudential chain (of higher court decisions) that did not understand the CDC's applicability as appropriate, even questioning whether there is a relationship of consumption. Now, there is no longer such discussion, given that the CDC's ruling over of the relationship between patients and health plans has become mandatory.
In addition, three new guidelines significantly alter this often troubled relationship between patients and healthcare plans:
1. The breadth of coverage in the scope of supplementary healthcare, including transplants and highly complex procedures, will be established in a rule to be created by the ANS, which will publish a list of procedures and events in supplementary healthcare, updated with each addition to the list.
2. The list of procedures and events in supplementary healthcare, updated by the ANS with each new addition to the list, constitutes the basic reference for private healthcare plans contracted as of January 1, 1999 and for contracts adapted to this Statute, also setting the healthcare guidelines.
3. In case of treatment or procedure prescribed by a physician or dentist unlisted by the ANS, coverage must be authorized by the healthcare plan provider when (i) there is evidence of effectiveness, in light of the healthcare sciences, based on scientific evidence and therapeutic plan; or (ii) there are recommendations from the National Commission for the Incorporation of Technologies in the Brazilian Public Health System (Conitec), or there is a recommendation from at least 1 (one) internationally renowned health technology assessment body, provided they are approved also for their national citizens.
Considering all the above, the most important thing is that the treatments provided for in ANS' list are once again exemplary, with healthcare plans having to cover any illnesses of insured patients, regardless of treatment.
With regard to the innovations themselves, however, there is a limitation that refers to the treatment or procedure written by a physician or assistant dentist that is not included in the ANS list, the coverage of which must only be authorized by the healthcare plan operator, provided that there is proof of effectiveness or there are recommendations by CONITEC or at least 1 internationally renowned healthcare technology assessment department. Indeed, the key issue of this provision is the conjunction OR, rather than AND. Were the conjunction AND, it would be necessary in addition to proof of effectiveness, in addition to the recommendation by CONITEC or by an international department. However, as the text stands, proof of effectiveness is sufficient (e.g. approval by a recognized regulatory agency in another country, scientific study, etc.) or approval by CONITEC or another international department.
For the patient, it is undoubtedly a great comfort to know that their healthcare plan cannot deny care, claiming that the treatment is not on ANS' list.
However, what about the financial balance of healthcare plans? The great truth is that neither the healthcare plan, nor the authorities nor patients themselves are capable of early diagnosing the possible diseases to which each one is under risk and that they will possibly develop in the coming years. On the other hand, the financial and pharmacoeconomics areas of healthcare plans already know what the big drains of resources are, i.e., prolonged hospital stays, treatment of rare diseases, high-cost drugs, innovative technologies, etc.
Healthcare plans must thus focus their efforts on working with the authorities, and especially with the ANS and the Ministry of Health itself, in order to establish guidelines, whether by enacting laws or administrative acts, that try to minimize or even limit the impact of situations that aggravate the financial imbalance of healthcare plans, reviewing from taxation to clinical protocols.
It's no easy task. After all, if it was, the problem would already be solved...