CFM publishes new resolution on medical auditing and reinforces ethical, technical, and contractual limits

On October 23, 2025, the Brazilian Federal Council of Medicine (“CFM”) issued Resolution CFM No. 2,448/2025, which establishes new ethical guidelines for conducting medical audits in Brazil, with significant implications for the supplementary health sector. The regulation repeals Resolution No. 1,614/2001 and consolidates the rights, duties, and prohibitions applicable to the professional activities of medical auditors, assistants, and technical directors. The new rules aim to (i) establish medical auditing as an activity exclusive to physicians, (ii) safeguard clinical autonomy, and (iii) impose ethical limits on claim denials.

The text reinforces that auditing is an activity exclusive to physicians, establishes ethical criteria for claim denials, limits administrative interference in clinical decision-making, and expands the responsibilities of technical directors overseeing healthcare facilities.

Below is a summary of the main provisions of the new resolution.

Medical auditing

The resolution defines medical auditing as a qualified technical analysis of medical acts, processes, and procedures involving patient care. It is considered an activity exclusive to physicians and must be supported by scientific evidence, clinical guidelines, and existing therapeutic protocols. Medical audits must observe the autonomy of attending physicians in determining the best therapeutic plan for their patients.

Medical auditors: Medical auditors have been assigned specific rights, duties, and prohibitions regarding their professional practice, as outlined below.

Rights:

• Access all clarifications and documents necessary for the performance of their duties. The removal of medical records or copies from institutions is prohibited.
• Examine patients upon their consent or that of a legal representative.
• Conduct medical audits of hospitalized patients.

Duties:

• Act with ethics, impartiality, autonomy, and technical competence.
• Report any inconsistent or irregular service to the attending physician.
• Report any signs of ethical violations to the institution’s technical director.

Prohibitions:

• Interfere with therapeutic approaches that comply with recognized clinical guidelines, scientific evidence, and coverage provided by the Brazilian Supplementary Health Agency (“ANS”) or the Brazilian Unified Health System (“SUS”).
• Share their opinion with patients or refer them to other physicians.
• Transfer their responsibilities to other medical professionals.
• Disclose confidential information obtained during the medical auditing process.
• Deny reimbursement for procedures that were previously authorized, or pre-approved, and duly performed by the attending physician.

Attending physicians: Attending physicians have been assigned the following rights and duties.

Rights:

• Define the most appropriate course of action for patients, based on scientific evidence, duly recognized by SUS, and/or included in the list of procedures and health events established by the ANS.
• Be notified of any clinical assessment by a medical auditor of patients under their care, including permission to observe the procedure.

 Duties:

• Respond promptly and responsibly to requests and inquiries posed by medical auditors, while observing all ethical, technical, and legal principles required by the profession.

Technical directors: The regulation revises duties previously established in CFM Resolution No. 2,147/2016, primarily to reinforce the obligation to observe the attending physician’s autonomy, ensure that claim denials are justified and duly notified in writing to the attending physician, and ensure that medical audits are conducted exclusively by physicians, without sharing information with non-medical third parties.

New obligations assigned to technical directors include:

• Ensure that medical auditors act with technical autonomy, free from external interference.
• Prevent procedure denials that were previously authorized and duly performed.
• Prohibit any link between the auditor’s compensation and the number of claim denials issued.
• Forbid requests for additional reports or forms beyond the clinical indication provided by the attending physician for the authorization of complementary exams.
• Ensure recognition of the codes defined by the ANS Unified Supplementary Health Terminology, avoiding healthcare plan operators’ rules that change or restrict these standards.
• Prevent healthcare plan operators from grouping procedure codes without observing the individual coding established by the ANS.
• Refrain from changing or replacing therapies, orthoses, prostheses, and special materials (“OPME”) that have been properly prescribed by the attending physician and already authorized by healthcare plan operators, medical cooperatives, self-managed entities, or SUS administrators.

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