Coverage denials and the ANS list after Law 14,454/2022: what hospitals, clinics and health plan operators need to know

After Law No. 14,454 of September 21, 2022, the list of procedures of Brazil's National Supplementary Health Agency (ANS), the regulator of private health plans, became the basic reference for health plan coverage rather than an absolute limit: treatment outside the list can be required, but only when technical criteria are met. On September 18, 2025, ruling on Direct Action of Unconstitutionality (ADI) 7265, the Federal Supreme Court (STF) upheld this possibility and set five cumulative requirements, including a prescription by the attending physician or dentist, no adequate therapeutic alternative on the list, scientific evidence of efficacy and safety, and registration with Anvisa. For operators, hospitals and clinics, this means that a denial must be technically reasoned, communicated within ANS deadlines and well documented, and that a coverage request must arrive supported by technical evidence.

From an exhaustive list to Law 14,454/2022

Law No. 9,656/1998, known as the Health Plans Law, gives the ANS the task of defining the scope of coverage through the list of procedures and events in supplementary health, updated with each new inclusion. For years, Brazilian courts disagreed on the nature of that list. On June 8, 2022, the Second Section of the Superior Court of Justice (STJ), in EREsp 1,886,929 and 1,889,704, held that the list was exhaustive as a rule, with parameters for exceptional coverage of procedures outside it.

Months later, Congress passed Law No. 14,454/2022, which added two paragraphs to article 10 of Law No. 9,656/1998. Paragraph 12 defines the list as the “basic reference” for plans contracted from January 1, 1999 and for contracts adapted to the law. Paragraph 13 provides that, when treatment prescribed by the attending physician or dentist is not on the list, the operator must authorize coverage provided that:

• there is evidence of efficacy, in light of health sciences, based on scientific evidence and a treatment plan; or
• there are recommendations from the National Commission for the Incorporation of Technologies in the SUS (Conitec) or from at least one internationally renowned health technology assessment body, provided they are also approved for that country's own nationals.

The same law reinforced, in article 1 of Law No. 9,656/1998, that operators are simultaneously subject to the Consumer Protection Code.

What the STF decided in ADI 7265

The action was filed by the National Union of Self-Managed Health Institutions (Unidas). By majority, with Justice Luís Roberto Barroso as rapporteur, the STF concluded that health plans must authorize treatments not on the list provided that five criteria are met cumulatively:

1. prescription by the attending physician or dentist;
2. the treatment must not have been expressly rejected by the ANS or be pending review for inclusion on the list;
3. no adequate therapeutic alternative on the list;
4. scientific evidence of efficacy and safety;
5. registration with the National Health Surveillance Agency (Anvisa).

According to the rapporteur, the criteria drew on the binding precedents of Themes 6 and 1,234, on court-ordered supply of medicines by Brazil's public health system (SUS), to prevent operators from bearing heavier obligations than the State without the support of robust scientific evidence. The Court also ruled that judges may only authorize treatment outside the list if these criteria are met and it is proven that the operator denied the request or that there was excessive delay or failure to authorize it. Four justices dissented, taking the view that the law was constitutional as written and that setting technical criteria was a task for the ANS.

In practice, the alternative between the items of paragraph 13 gave way to a set of cumulative requirements. The debate moves from legal theory to evidence.

Waiting times: RN 566/2022

Guaranteed access to care is governed by ANS Normative Resolution (RN) No. 566 of December 29, 2022. The maximum waiting times published by the ANS include:

• urgency and emergency: immediate care;
• basic consultation (pediatrics, internal medicine, surgery, gynecology and obstetrics) and dentist: up to 7 business days;
• consultation in other medical specialties: up to 14 business days;
• speech therapist, nutritionist, psychologist, occupational therapist, physiotherapist and obstetric nurse: up to 10 business days;
• clinical laboratory tests: up to 3 business days;
• outpatient diagnosis and therapy, day hospital, oral home cancer drugs, radiotherapy and hemotherapy: up to 10 business days;
• high-complexity procedures and elective hospitalization: up to 21 business days.

If no network provider is available within the deadline, the operator must offer a solution, such as a provider in a neighboring municipality or a private provider, with transport when needed. If the beneficiary pays for care because no such solution was offered, reimbursement must be full and made within 30 days of the request, according to the ANS.

For urgency and emergency, Law No. 9,656/1998 sets a maximum waiting period of twenty-four hours (article 12, V, “c”) and makes coverage mandatory (article 35-C). An emergency is a situation of immediate risk to life or of irreparable injury, declared by the attending physician; an urgency results from a personal accident or a complication during pregnancy.

Information duties: RN 623/2024

Since July 1, 2025, ANS Normative Resolution No. 623/2024, the successor to RN No. 395/2016, has governed how operators and benefit administrators respond to beneficiaries' requests. The points that weigh most in litigation:

• Protocol from the start: a protocol number must be provided as the first step of any interaction.
• Timely response: urgency and emergency require an immediate response (article 12, I). In other cases, the response follows deadlines in business days, and when the RN 566/2022 deadline is shorter, that deadline prevails. The ANS itself has clarified that RN 623 does not change waiting times.
• No generic answers: article 12, paragraph 5, prohibits answers such as “under review”, “processing” or “under audit” as a way of meeting deadlines.
• Reasoned denial: when denying coverage, the operator must communicate the decision with minimum information, in clear language, and explain how to request a review (article 16).
• Non-clinical requests: the beneficiary must be told within 7 business days whether the request was granted.

These duties coexist with the medical or dental board provided for in RN No. 424/2017, used when there is technical disagreement about the indication.

Litigation risks for operators

The STF ruling gave operators an objective benchmark, but it also raised the weight of evidence. If a request meets the five criteria and the operator denies it without technical grounds, or simply fails to respond, the delay or omission becomes precisely the requirement the STF set for court intervention. The main areas of exposure are:

• standardized denials, without analysis of the specific case and without citing the contract clause or technical basis;
• failure to meet RN 566/2022 deadlines, which opens the door to ANS complaints, inspections and urgent court requests;
• no documentary trail, with protocol, opinions and board review, showing that the request was analyzed;
• inconsistency between utilization review, customer service and ombudsman.

Risks for hospitals and clinics

Providers sit in the middle of the dispute: they perform the procedure, depend on authorization to be paid and are often the first point of contact for the patient. The most common risks are billing denials and non-payment for procedures performed without valid authorization, disputes over who bears the cost when an urgent case is treated before the operator responds and, in some cases, being named in lawsuits brought by the beneficiary.

The remedy is documentation. Medical reports that address the five criteria, with references to evidence and checks on Anvisa registration and on alternatives in the list, reduce denials and strengthen the provider's position if the case reaches the courts. Contracts with operators should also set out authorization workflows, deadlines and payment rules for urgent care.

Compliance checklist

1. Review denial templates so they address each criterion set by the STF.
2. Map RN 566/2022 and RN 623/2024 deadlines in the utilization review system, with alerts.
3. Ensure a protocol and record for every interaction with the beneficiary.
4. Standardize medical reports and authorization requests in hospitals and clinics.
5. Review operator-provider contracts on authorization, billing denials and urgent care.
6. Monitor updates to the list and technology incorporation recommendations.

How the firm can help

We work with health plan operators, hospitals, clinics and healthcare companies on regulatory advice, review of authorization workflows and denial templates, operator-provider contracts, defense before the ANS and coverage litigation. Each case depends on the technical evidence and the contract, and no outcome can be promised, but well-designed processes reduce the volume of disputes and court exposure.