[:pb]

What is the Supplementary Healthcare System’s List of Healthcare Procedures and Events?

The Healthcare List of Procedures and Events is the list of procedures, which includes consultations, exams and treatments that must, by law, be offered by the Supplementary Healthcare System (SSS) as a minimum and mandatory coverage by health plan operators.

When was it instituted?

The first list was established by the regulatory agency of health plan operators in Brazil – ANS (National Supplementary Health Agency) and defined by the Resolution of the Supplementary Health Council in 1998.

The first was published in 2000 by Collegiate Board Resolution number 41 (RDC 41). After that, it was updated in 2001 (RDC 67) and again in 2004 by (RN 82), 2008 (RN 167), 2010 (RN 2011), 2011 (RN 262), 2013 (RN 338), 2015 (RN 387) Normative Resolutions. Finally, in 2017 we had the publication in the Official Gazette of the Union, RN, which becomes effective on January 2, 2018.

Who defines which procedures are included?

Periodic updates of the List of Procedures and Events in Healthcare are proposed by a technical group formed by government and ANS representatives, health professionals, healthcare plan operators and representatives of consumer protection entities that meet within the scope of the Committee Permanent Regulation of Health Care (COSAUDE).

After defining the necessary changes, the group presents the project for an evaluation by the society through an online public consultation. The proposal is then forwarded to the ANS Collegiate Board for approval and publication. COSAUDE meetings were, in this last List, held between November 2016 and March 2017.

What are the criteria for inclusion?

According to the ANS, “the inclusion of technologies is always preceded by a careful assessment, in line with the national health policy, and includes, in addition to scientific evidence, the social need and the availability of resources”.

In fact, “The decision making to include procedures in the List takes into account the epidemiology of the disease, the efficacy and safety of the technology, always based on the best scientific evidence (Evidence Based Medicine – EBM) so that it is safe for the population, but without losing sight of the costs involved and what they represent for the sustainability of the sector”.

The technical term for these assessments is Healthcare Technology Assessment (HTA), and includes assessment of cost-effectiveness and budgetary impact from the perspective of the Supplementary Healthcare System.

In addition, the agency evaluates a series of other criteria, including: “The existence of a provider network, the ease of use, handling, obtaining and making available the technology, inputs and raw materials are relevant aspects considered regarding the incorporation of the procedures”, this it is particularly relevant for medical devices, the so-called OPME (orthotics, prostheses and special materials) which are the inputs used in a given health intervention.

The process of inclusion of technologies in Brazilian health

The improvement of our society’s living conditions with a clear demographic transition (we are a country with fewer and fewer young people and older people) and epidemiological (with chronic diseases), added to the sophistication of health systems, causes an increase in costs for the healthcare system, so the incorporation of health technology procedures is a challenge for its managers.

Despite the constitutional principle that health is a right for all and a duty of the State, access to health is conditional on the existence of a budget allocation, therefore, the inclusion of procedures requires an assessment of cost-effectiveness and budgetary impact, based on technical-scientific criteria, to analyze the value and impact on the manager’s budget and what this incorporation would entail in the coming years, compared with that of other technologies already used by Supplementary Healthcare.

Difficulties in incorporating new technologies

In a context of scarce resources and decentralized decision-making processes, the ideal would be to create a universal and integrated healthcare system in its public and private face, with comprehensive and equitable care.

While this does not happen, a major challenge to be faced would be changes in posture such as the appointment of members to the commission according to their competence so that decisions are based on technical and not political criteria; increased transparency of the process; training of human resources; evaluation of the different types of economic evaluation studies (cost-effectiveness, cost-utility, cost-minimization) and promotion of partnerships with public and private entities and teaching hospitals to carry out technology evaluation studies.

Even though the political aspect will always exist, the various actors in healthcare systems will have to debate what has real value and which should be used in healthcare systems.

The process of incorporating health technologies in Brazil has been standardized for a few years when compared to other countries and, despite the high level of scientific evidence in the studies carried out for decision-making, there is still much to improve to achieve excellence in this process.

How to enter this market

As we have seen, incorporating a new healthcare technology into the Supplemental Healthcare System in Brazil is a complex and interactive process with the various actors in the system, which requires professionals specialized in health technology assessment, economic evaluations and with a high capacity for development of institutional relationships to gain broad access to healthcare systems.

In the next article we will break down all the necessary procedures to launch a product within this scenario.

—

Find out more details about our solutions and technical-scientific studies for the development and incorporation of technologies with better cost-effectiveness in public and private healthcare systems. Download our MAPES Cases & Soluções content now..

[:en]

What’s the rol of Supplementary Health Care System proceedments and events?

The rol of proceedments and events in health is the list of proceedments, that includes appointments, exams and treatments that should, by law, be offered by the Supplementary Health Care System as a minimal and required coverage by the health insurance operators.

When was it institutionalized?

The first list was stablished by the regulatory agency of the health plan operators in Brazil – ANS (Agência Nacional de Saúde Suplementar) and defined by the Resolução de Conselho de Saúde Suplementar in 1998.

The first was published in 2000 by the Resolução de Diretoria Colegiada number 41, (RDC 41). After that it was updated in 2001 (RDC 67), and one more time around 2004 by (RN 82), 2008 (RN 167), 2010 (RN 2011), 2011 (RN 262), 2013 (RN 238), 2015 (RN 387) normative resolutions. Lastly, in 2017 we had a publishment in the Diário Oficial da União the RN becomes effective in January 2^nd 2018.

Who defines which proceedments are included?

The frequent updates of the Rol of Proceedments and Events in Health are prupose by a technical group formed by the goverment representatives and the ANS, health profissionals, health insurance operators and consumer defense entities that get together in the scope of the Comitê Permanente de Regulação da Atenção à Saúde. (COSAUDE).

After deciding what things need to be changed, the project is presented to a society assessment through an online public consultation. So, the proposal is to put forward to the Diretoria Colegiada of ANS to its approval and publishment. The COSAUDE meetings were, in this last rol, accomplished between November 2016 and March 2017.

Which criterions are used for inclusion?

According to the ANS, “the inclusion of technologies is always preceded by a judicious assessment, lined up with the national health politics, and besides the scientific evidences, it contemplates the social need and the availability of resources”.

Indeed, “The decision taken to include proceedments in the rol thinks about the epidemiology of the disease, the effectiveness and the safety of the technology, always based on the best scientific evidence ( Evidence-Based Medicine – EBM) so it can be safe to people, but not forgetting about the costs involved and what they represent to the sustainability of the sector”.

The technical word to these assessments is Health Technology Assessment (Avaliação de Tecnologia em Saúde, ATS), and it’s included cost-effectiveness and budget impact assessments over the perspective of the Supplementary Health Care System.

Besides that, the agency evaluetes a serie of other criteria, including: “The existance of a network provider, the facility to use, handling, getting and making the technology available, insumes and feedstock are revelevant aspects considering the proceedering incorporation”, this is particulary relevant to the medical devices, the called (in Portuguese) OPME (bracing, prosthesis and special supplies) which are the input used in each intervention in health.

The process of inclusion of technologies in the Brazilian health

The improvement of life conditions in our society with a clear demographic condition (we are from a country with each time fewer young people and more elderly people) and epidemiological (with chronic diseases), adding the health systems sophistication, causes the increase of the costs to the health system, because of it the incorporation of technology proceedments in health is a challenge to its managements.

Besides the constitutional principal that health is everybody’s right and it’s ought to the country to give heath to people, the access to health is conditional on the existence of a budget , that’s why the inclusion of proceedments demands a cost-effectiveness assessment, and with a budgetary impact, based in technical-scientific  criteria to analyze what’s the price and the impact in the managment’s budge and what this incorporation would bring about on the next years, comparing to other technologies that have already been used by the Supplementary Health.

The difficulties to incorporate new technologies

In a context of scarce resources and decentralized decision-making processes, the ideal would be to create an universal health system and integrated in its public and private face, with full attention and equanimity.

While this doesn’t happen, a big challenge to face would be the behavior changes as the indication of members to the commission according to their competences so the decisions will be based on technical criteria, not on political criteria; Extending process transparency; Training the human resources; Assessment of the different kinds of economical assessment studies (cost-effectiveness, cost-utility, cost-minimization) and promoting partnerships with public and private entities and teaching hospitals to accomplish technology assessment studies.

Although, the politic aspect will always be there because the various actors of the health system will have to debate what has real value and what should be used in the health systems.

The process of incorporating technologies in health in Brazil is normalized for a few years, comparing to other countries, and besides the high level of scientific evidence of the performed studies to make decisions, there’s still a lot to improve to accomplish excellence in this process.

How to get in this market

As we have seen, incorporating a new technology related to health in the Supplementary Health Care System of Brazil is a complex and interactive process with many actors of the systems, what demands specialized professionals in health technology assessment, economic assessments and with a high capacity of developing institutional relationships to gain a big access to the health systems.

In the next article we will understand better all the proceedments we need to launch a product in this scenario.[:]