New ANS Regulation Requires Plans to Justify Denials and Meet Defined Deadlines

The new regulation from the National Supplementary Health Agency (ANS) regarding the relationship between health plan operators and their beneficiaries came into effect on July 1, 2025. The Normative Resolution (RN) No. 623/2024, according to ANS, aims to enhance the consumer experience by promoting greater agility, traceability, and resolution in services.

The change directly impacts over 52 million beneficiaries of medical assistance plans in the country, according to data from the Situation Room, a public consultation tool available on the ANS portal.

Complaints Prompted Rule Review

Since 2016, ANS had rules aimed at beneficiary service. However, the significant increase in complaints starting in 2019 highlighted the need for regulatory revision. “Previously, ANS's actions were predominantly punitive. Now, we want to encourage problem resolution at the source,” explains Eliane Medeiros, ANS's Director of Supervision, in a statement.

RN No. 623/2024 is considered the first pillar of ANS's responsive supervision model, which also includes RNs No. 483/2022 (supervision procedures) and No. 489/2022 (sanctions). The focus is on preventing failures, acting proactively, and promoting continuous improvements in the sector.

Main Obligations for Operators

RN No. 623/2024 defines a series of obligations that operators must fulfill, including:

- Addressing requests unrelated to procedure coverage;

- Allowing online tracking of requests by beneficiaries;

- Clearly disclosing, on the operator's website, the service channels, including the Ombudsman;

- Providing clear responses within regulatory deadlines;

- Justifying in writing any denial of coverage, even without a request from the beneficiary;

- Providing a protocol or registration number at the end of each service.

Additionally, operators must maintain in-person, telephone, and digital channel (such as website and app) services, operating 24 hours a day, seven days a week — including for assistance requests, such as scheduling exams and surgeries, and for contractual issues.

Extensions and Guarantees

With the new regulation, response times are now well-defined. For urgent and emergency situations, the response must be immediate, according to current legislation. For high-complexity procedures or those involving elective hospitalization, responses must be provided within 10 business days.

Other cases must be resolved within 5 business days. For requests that do not involve procedure coverage — such as adjustments, contract cancellations, or portability requests — the maximum response time is 7 business days.

Benefits administrators will also need to comply with the new regulation, respecting their limits of action and other points highlighted by ANS. According to the law firm Sobral Navarro Advogados, the changes represent a milestone as they expand service channels, guarantee the right to formal justifications, allow for review by the Ombudsman, and define clearer penalties for non-compliance with the rules.

What About Cannabis-Based Medications?

According to a technical opinion from ANS published in 2024, personal importation of cannabis products may be authorized by ANVISA, but these products do not have mandatory coverage by health plans, as they are not nationalized or registered in Brazil.

Furthermore, home-use cannabis-based medications are only covered when this is specified in the contract or in older plans not adapted to current legislation. This differentiation reinforces that registration with ANVISA is the main criterion for determining whether the medication will be covered by health plans.