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ANS opens public consultation to improve oversight model in Brazil

January 20th, 2025

On January 06, 2025, the Brazilian Supplementary Healthcare Agency (“ANS”) opened Public Consultation No. 147/25 to receive contributions on normative proposals that change:

In addition, the public consultation addresses the proposal of a new normative instruction to detail procedures to be adopted by the ANS for structuring and executing conduct “planned oversight actions” and other supervisory measures.

Interested parties must submit their contributions by March 07, 2025, through the ANS portal.

What is the goal of Public Consultation No. 147/25?

The ANS’ initiative seeks to improve the current oversight model, which mainly relies on individual analyses of demands between beneficiaries and operators through the Notice of Preliminary Intermediation (“NIP”). The constant increase in NIPs raised a red flag for ANS regarding its inefficiency in enforcing coercive measures and sanctions against violations.

The proposal has already undergone a Regulatory Impact Analysis (RIA) in Technical Note No. 10/24. In this RIA, the ANS identified a regulatory asymmetry, indicating that the ANS’ performance was outdated regarding the current market landscape.

The ANS proposal involves the development of a hybrid oversight model that maintains individual oversight through NIPs but complements it with strategic collective actions.

Among other proposed changes, Public Consultation No. 147/25 seeks to reformulate Chapter V of Normative Resolution No. 483/22 to establish the oversight categories below, in addition to a new normative instruction that would regulate such categories:

  • Preventive Planned Oversight Action (APP) – a low-complexity measure to be enforced when the ANS monitors an above-average or growing and unusual number of complaints.
  • Focal Planned Oversight Action (APF) – a medium-complexity measure to be enforced when the ANS deems a regulated agent’s performance unsatisfactory or if such regulated agent is ranked poorly in terms of complaints, which would result in measures taken by the ANS.
  • Structured Planned Oversight Action (APE) – a high-complexity measure to be enforced when a regulated agent’s performance is deemed unsatisfactory during other oversight actions or, at the ANS’ discretion, if such regulated agent is ranked poorly in terms of complaints and other oversight alternatives are insufficient.

In addition, the ANS seeks to update (increase) the values of fines, considered outdated and ineffective as corrective and coercive instruments for remedying violations, changing Normative Resolution No. 489/22.

Below are the new proposed amounts to be charged for certain violations subject to fines (this is not a complete list):

 

Conduct Amount charged in Normative Resolution No. 489/22  New proposed amount
Operating License

 

“Art. 18. Operate as a private healthcare plan operator without ANS authorization from the ANS”

·       BRL 250,000

 

·       BRL 10,000 daily fine

·       BRL 675,000

 

·       BRL 10,000 daily fine

Benefits administrator operation not aligned with its purpose and limits

 

“Article 18-A. To operate as a benefits administrator in disagreement with its purpose and limits provided for in the current regulations

 

N/A BRL 675,000
Product registration

 

“Article 19. To operate a product without registration before ANS”

 

BRL 250,000 BRL 675,000
Legitimacy of the contracting legal entity of a beneficiary in a collective policy

 

“Article 23-A. To enter into, maintain or intermediate a collective contract with a legal entity that is not legitimate as provided for in the current regulations

 

N/A BRL 675,000
Selling a portfolio without prior authorization from ANS

 

“Article 28. To sell or acquire a portfolio, fully or partially, without prior authorization from ANS

 

BRL 200,000 BRL 540,000
Corporate changes

 

“Article 31. To fail to comply with ANS regulations regarding a spin-off, incorporation, merger, modification, or partial or full transfer of controlling interest

 

BRL 250,000 BRL 675,000
Irregular or harmful practices

 

“Article 33. To conduct irregular or harmful practices against public health policy

 

BRL 250,000 BRL 675,000
Failure to comply with an order in a Structured Planned Oversight Action category

 

“Article 36. To fail to comply with an ANS order in a Structured Planned Oversight Action category

 

·       From BRL 200,000 to BRL 1 million.

 

·       Suspension from the administrator role for 30 to 180 days.

·       BRL 1 million for each violated order

 

·       Suspension from the administrator role for 30 days for each violated order. Recurring violations will result in temporary disqualification from the administrator role for one year without prejudice to the application of a fine

 

Urgency and emergency

 

“Article 103. To fail to ensure the beneficiary with the coverage provided for by law in urgent cases and emergencies”

BRL 250,000 BRL 675,000

 

Demarest’s Life Sciences and Healthcare team is available to provide any further clarifications that may be necessary.