ANS: what it is and how health plans are regulated

Brazil’s National Supplementary Health Agency (ANS) is a special-status federal agency linked to the Ministry of Health, responsible for regulating, setting standards for and overseeing the health plan market in Brazil.

Its work sustains the balance between health plans, service providers and more than 50 million plan members, ensuring both economic viability and quality of care.

This article explains the responsibilities of ANS and its importance for Brazil’s private healthcare sector, which moves billions of reais and is essential to the population’s well‑being.

Origins and regulatory evolution

ANS was established by Law No. 9,961/2000 as a direct outgrowth of the Health Plans Law (Law No. 9,656/1998). Before this regulatory framework, the sector operated in an environment of high legal uncertainty, with opaque contracts, frequent coverage denials and price increases without clear criteria.

After the agency was created, the market came to be regulated on solid technical and legal foundations. Today, ANS works to preserve the stability of the system. It oversees everything from the economic and financial solvency of health plans to the processes for incorporating new technologies and therapies.

Strategic responsibilities of ANS

Unlike bodies focused exclusively on consumer protection, ANS performs a regulatory function of a technical, care-related and financial nature. Its main responsibilities include:

• Defining the List of Health Procedures and Events (Rol), which sets the mandatory minimum coverage for health plans.

• Monitoring the economic and financial capacity of health plans by requiring technical reserves and provisions. This is a way to reduce the risk of insolvency and ensure continuity of care for plan members.

• Mediating conflicts through the Preliminary Intermediation Notice (NIP), which allows the plan member to file a complaint, with a deadline for the health plan to resolve the issue before any administrative proceeding.

These responsibilities reflect three pillars of ANS’s work: regulating, overseeing and resolving disputes. The priority is the quick resolution of conflicts, to avoid overloading the court system.

Why is ANS vital to the private healthcare sector?

ANS exists to make the relationship between plan members and health plans fairer, and to prevent practices that undermine the sector’s financial sustainability. Without regulation, there would be an incentive for risk selection, with restrictions on enrolling older people or people with chronic diseases, for example. The agency prohibits this kind of conduct, ensuring more equitable access to health plans.

In addition, by establishing the TISS standard (Supplementary Health Information Exchange), ANS standardizes communication between providers and payers. This initiative reduces billing failures, increases the traceability of information and improves transparency throughout the revenue cycle.

Main normative and regulatory documents of ANS

The regulatory work of ANS is supported by an integrated set of laws, resolutions, technical manuals and monitoring instruments that guide care coverage, billing and oversight. This framework includes:

• Foundational laws, such as Law No. 9,656/1998 (Health Plans) and Law No. 9,961/2000, which created ANS.

• Normative Resolutions (RN), which set mandatory rules on coverage, price adjustments, care guarantees, sanctions and economic and financial balance.

• Administrative Resolutions (RA), which organize the agency’s internal operations and support regulatory decisions.

• Normative Instructions (IN), which detail the practical application of the RNs, especially on operational topics.

• The List of Health Procedures and Events, with its Utilization Guidelines (DUT), which defines the mandatory minimum coverage of health plans.

• The TISS standard, made up of organizational, content and communication manuals, which standardizes the exchange of information between payers and providers.

• TUSS (Unified Terminology for Supplementary Health), the basis for coding, billing, auditing and denial analysis.

• Monitoring and oversight instruments, such as the Denials Dashboard, Care Guarantee Monitoring and economic and financial indicators.

• Preliminary Intermediation Notice (NIP), a regulatory mechanism for mediation between plan members and health plans.

• Technical notes, notices and circular letters, which guide the interpretation and application of the rules.

• Public consultations, technical chambers and regulatory impact reports, which underpin the continuous evolution of ANS rules.

All of this documentation can be consulted on the ANS website.

The Rivio view

The regulatory complexity imposed by ANS creates a significant volume of obligations, indicators and deadlines. Failures to comply with the NIP, inconsistencies in the TISS standard or misinterpretation of the rules can result in fines, denials and avoidable financial losses.

In this context, Rivio’s artificial intelligence solutions turn regulation into a strategic advantage. By automating compliance analysis, monitoring regulatory indicators and integrating care and financial data, the Rivio platform lets managers focus their efforts on quality of care, while technology ensures operational efficiency, economic sustainability and full compliance with ANS requirements.