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Bruno Marcelos — Escritório de Advocacia

Pauta Regulatória · Daily brief

No. 48

Automatically translated from the Portuguese edition, which prevails in case of discrepancy. Ler em português

Federal Official Gazette

ANS PUBLIC CONSULTATION No. 166, OF DECEMBER 10, 2025

Art. 1 Public Consultation is hereby opened, for a period of 20 (twenty) days, from December 11 to 30, 2025, pursuant to art. 27 of RN No. 555 of 2022, for the submission of criticism and suggestions regarding the preliminary recommendation of non-incorporation for the technologies contained in UATs No. 178, 179 and 182.

ANS NORMATIVE RESOLUTION No. 653, OF DECEMBER 10, 2025

The summary of the RN provides: it amends annexes I and II of Normative Resolution – RN No. 465, of February 24, 2021, which governs the List of Health Procedures and Events (Rol) within the scope of Supplementary Health, in order to incorporate the drug Larotrectinib Sulfate, in the procedure ORAL ANTINEOPLASTIC THERAPY FOR THE TREATMENT OF CANCER (WITH USAGE GUIDELINE) for the treatment of pediatric patients with locally advanced or metastatic solid tumors positive for NTRK gene fusion; to incorporate the procedure NTRK – MUTATION TESTING (WITH USAGE GUIDELINE) for the eligibility diagnosis of pediatric patients with an indication for the use of a medication whose package insert requires analysis of the presence of NTRK gene fusion before treatment begins; to incorporate the procedure HISTOPLASMA ANTIGEN DETECTION (URINE); and to amend Usage Guideline No. 124 regarding the procedure IMMUNOPROPHYLACTIC THERAPY FOR RESPIRATORY SYNCYTIAL VIRUS (RSV) – drug Nirsevimab, in compliance with paragraphs 4 and 10 of art. 10 of Law No. 9,656/1998.

However, the body of the RN addresses the Internal Rules of the Commission for the Updating of the List of Health Procedures and Events in Supplementary Health. In this regard, see art. 1: Art. 1 This resolution governs the Internal Rules of the Commission for the Updating of the List of Procedures and Events in Supplementary Health – COSAÚDE, created by Law No. 14,307, of March 3, 2022, which amended Law No. 9,656, of June 3, 1998, with the function of advising the National Supplementary Health Agency – ANS in defining the scope of coverage within supplementary health, including transplants, and high-complexity procedures.

We await a corrigendum in the coming days.

ANS OPERATIONAL RESOLUTION No. 3,077, OF DECEMBER 8, 2025

Provides for the establishment of the special regime of Technical Direction at the health plan operator GOCARE PLANOS DE SAUDE LTDA.

ANS OPERATIONAL RESOLUTION No. 3,079, OF DECEMBER 9, 2025

Provides for the granting of special portability to the beneficiaries of the health plan operator ATITUDE SAÚDE ASSISTÊNCIA MÉDICA LTDA.

ANS OPERATIONAL RESOLUTION No. 3,080, OF DECEMBER 9, 2025

Provides for the granting of special portability to the beneficiaries of the health plan operator IDEAL SAÚDE ASSISTÊNCIA MÉDICA AMBULATORIAL LTDA

ANS news

ANS receives input on the new rule on portfolio transfers

Changes in the sector motivate the update of the rule, open for input until Jan 23, 2026

Open public consultations

  • CP 164. Public Consultation (CP) No. 164 aims to receive input on the preliminary recommendations related to health technologies proposed internally by ANS, originating from the incorporations of technologies into the Unified Health System (SUS) upon recommendation of the National Commission for the Incorporation of Technologies in the SUS (CONITEC), carried out in the period from May 2, 2019 to Sep 2, 2021. These proposals to update the Rol are being presented in accordance with art. 38 of RN No. 555, of 2022. The consultation also submits to social participation the Preliminary Report resulting from the 43rd technical meeting of the Commission for the Updating of the List of Procedures and Events in Supplementary Health (COSAÚDE), in compliance with art. 10, § 11, item III, of Law No. 9,656/1998, included by Law 14,307, of 2022, and with art. 26 of RN No. 555, of 2022. Deadline: Dec 23, 2025.
  • CP 165. Aims to receive input on the proposed Normative Resolution that governs the transfer of portfolios of private health care plans between private health care plan operators. Deadline: Jan 23, 2026.
  • CP 166. Aims to receive input on the preliminary recommendation of non-incorporation for the technologies contained in UATs No. 178, 179 and 182. Deadline: Dec 30, 2025.

Scheduled public hearings

There is no public hearing scheduled.

Open public calls for input

There are no open public calls for input.

Open public calls

No updates.

Other news

STJ: unilateral termination of plans must be notified, even in cases of fraud

Source: jota.info · read the full article

Hapvida (HAPV3) to revise 4Q24 regulatory financial statements following ANS requirement; consolidated financial statements will not be affected

Source: visnoinvest.com.br · read the full article

ANS holds webinar to disclose the economic and financial data for the 3rd quarter of 2025

Source: youtube.com · read the full article

Sources: Federal Official Gazette (DOU) and the ANS website. Press items link to the original article. This brief is for information only and does not constitute legal advice.