Federal Official Gazette
The Ministry of Health approved a set of new clinical protocols, diagnostic and therapeutic guidelines and protocols of use, effective upon publication. The following matters were covered:
- Ordinance No. 89 — Protocol of use of photodynamic therapy in superficial and nodular basal cell carcinoma;
- Ordinance No. 90 — Clinical Protocol and Therapeutic Guidelines for multiple myeloma;
- Ordinance No. 91 — Clinical Protocol and Therapeutic Guidelines for Hodgkin lymphoma;
- Ordinance No. 92 — Clinical Protocol and Therapeutic Guidelines for differentiated thyroid carcinoma;
- Ordinance No. 93 — Clinical Protocol and Therapeutic Guidelines for cutaneous melanoma;
- Ordinance No. 94 — Clinical Protocol and Therapeutic Guidelines for head and neck squamous cell carcinoma;
- Ordinance No. 95 — Clinical Protocol and Therapeutic Guidelines for adult chronic myeloid leukemia;
- Ordinance No. 96 — Clinical Protocol and Therapeutic Guidelines for esophageal carcinoma;
- Ordinance No. 97 — Clinical Protocol and Therapeutic Guidelines for prostate adenocarcinoma;
- Ordinance No. 98 — Clinical Protocol and Therapeutic Guidelines for malignant epithelial neoplasm of the ovary;
- Ordinance No. 99 — Clinical Protocol and Therapeutic Guidelines for follicular lymphoma;
- Ordinance No. 100 — Clinical Protocol and Therapeutic Guidelines for stomach adenocarcinoma;
- Ordinance No. 101 — Protocol of use of blinatumomab in Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia;
- Ordinance No. 102 — Clinical Protocol and Therapeutic Guidelines for gastrointestinal stromal tumor;
- Ordinance No. 103 — Clinical Protocol and Therapeutic Guidelines for clear cell renal cell carcinoma;
- Ordinance No. 104 — Brazilian guidelines for colorectal cancer screening;
- Ordinance No. 105 — Brazilian guidelines for cervical cancer screening, Part II, on the investigation, treatment and follow-up of women with positive results;
- Ordinance No. 106 — Clinical Protocol and Therapeutic Guidelines for breast cancer.
The documents govern diagnostic criteria, therapeutic indications, clinical follow-up, organization of care, and mechanisms of regulation, control and registration in the SUS. Most of them replace previously effective protocols.
Analysis: the ordinances update the organization of oncology care in the SUS and do not, by themselves, change the List of Health Procedures and Events (Rol) or the ANS Utilization Guidelines. Nevertheless, the set is relevant for health plan operators, hospitals and oncology services. We recommend comparing the new protocols against the Rol, the DUTs, internal authorization protocols and provider network contracts, especially as regards antineoplastic drugs, screening, clinical follow-up and technologies not expressly provided for in ANS regulations. The documents may also be used as a technical reference in care assessments and in disputes over treatments not included in the Rol.
PUBLIC CONSULTATION SCTIE/MS No. 107, OF OCTOBER 27, 2026
A public consultation was opened on the proposal to incorporate vutrisiran sodium into the SUS for the treatment of hereditary transthyretin-mediated amyloidosis in patients with stage I polyneuropathy.
The deadline for submissions is 20 days from publication, through the Conitec portal.
Analysis: the consultation does not result in immediate incorporation and does not change the ANS Rol. The technology, intended for a rare disease and associated with a high economic impact, deserves monitoring in view of Conitec’s forthcoming decision and its possible use as a technical reference in coverage requests in supplementary health.
https://www.in.gov.br/web/dou/-/consulta-publica-sctie/ms-n-107-de-27-de-outubro-de-2026-740658697
CFM RESOLUTION No. 2,472, OF SEPTEMBER 24, 2026
The Federal Council of Medicine (Conselho Federal de Medicina) ratified CME Ordinance No. 1/2026, which updates the list of recognized medical specialties and areas of practice, as well as the means of obtaining the respective qualifications for purposes of the Specialist Qualification Registry (RQE).
The new regulation recognizes 55 medical specialties and 64 areas of practice, including Cardiac Intensive Care and Maritime and Hyperbaric Medicine, which were not in the previous list.
The ordinance establishes, for each specialty and area of practice, the training requirements, the medical residency programs recognized by the National Medical Residency Commission (CNRM) and the specialist titles issued by the Brazilian Medical Association (AMB) accepted for registration with the Regional Councils of Medicine.
https://www.in.gov.br/web/dou/-/resolucao-cfm-n-2.472-de-24-de-setembro-de-2026-740664066
ANS news
Optional holiday (ponto facultativo) on October 30
ANS announced that there will be no in-person activities at its headquarters and service centers on Oct 30, 2026, due to an optional holiday (ponto facultativo).
Cosaúde debates inclusion of new technologies in the Rol
After analysis of the contributions received during public participation, four incorporation proposals advanced to final deliberation by the Board of Directors:
Cardiac contractility modulation (CCM) device: intended for patients with symptomatic chronic heart failure (NYHA III–IV), refractory to optimized pharmacological treatment, with ejection fraction between 25% and 45%, QRS below 130 ms and no indication for cardiac resynchronization therapy.
Next-generation sequencing (NGS) panel: for identifying genetic alterations in patients with advanced or metastatic non-squamous non-small cell lung cancer.
Tepotinib hydrochloride: for first-line treatment of patients with advanced non-small cell lung cancer with MET exon 14 skipping mutation.
21-gene genomic test for breast cancer: intended to support therapeutic decisions in patients with early-stage, HR-positive, HER2-negative breast cancer and specific conditions of lymph node involvement.
Two other technologies went through preliminary discussion and will proceed to public participation:
ivosidenib for advanced or metastatic cholangiocarcinoma with IDH1 R132 mutation, after prior systemic treatment; and
lenvatinib in combination with pembrolizumab for first-line treatment of advanced or metastatic clear cell renal cell carcinoma.
Analysis: the referral of the first four technologies to the Board of Directors represents progress in the regulatory process of updating the Rol, with potential care-related and economic repercussions for health plan operators, especially in cardiology and oncology.
Open public consultations
- CP 179. Subject: proposal to update ANS Normative Instruction – IN ANS No. 31, of December 19, 2022, which provides for the monitoring and assessment of operators’ guarantee of care for beneficiaries of health care plans. Deadline: from Oct 23, 2026 to Dec 7, 2026
Scheduled public hearings
There are no scheduled public hearings.
Open public calls for input
There are no scheduled public hearings.
Open public calls
There are no open public calls or targeted public participation processes.
Other news
“We want the inclusion of oral medications in supplementary health,” says Valderílio Azevedo, president of the Sociedade Brasileira de Reumatologia
Source: futurodasaude.com.br · 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.