Federal Official Gazette
LAW No. 15,524, OF SEPTEMBER 28, 2026:
Establishes the National Strategy for the Control and Assessment of the Quality of Health Care Provided by the Private Sector; and amends Law No. 9,782, of January 26, 1999.
Summary: Anvisa shall establish, according to the type of provider, quality standards and qualification attributes. The strategy will comprise the assessment of services and the periodic disclosure of results. The standards shall consider, among other aspects (art. 3): patient safety and treatment effectiveness; sufficiency of professionals, facilities and processes; promptness of care; patient-centered care; equity; and compliance with the rules of Anvisa and ANS.
Accreditation may be considered in the assessment, but will not replace inspections, oversight or other regulatory components. Failure by private providers to comply with the future standards may result in a daily fine of R$ 5,000, which may be increased by up to 100 times depending on the provider’s economic situation, without prejudice to civil liability and to consumer-protection or ANS sanctions (art. 7). Although directed at the private sector, the law provides that the standards must also be applied to public establishments. The rule entered into force on Sep 29, 2026.
Analysis: the law creates a new layer of health-authority assessment of care quality, with public disclosure of results and potentially high sanctions. Its operational effects will depend on regulation by Anvisa, which will have to define the standards, the assessment methods and the sanctioning procedure. Private hospitals, clinics and laboratories will be directly affected. Vertically integrated health plan operators will need to monitor the compliance of their own facilities; the others may need to review accreditation criteria, provider network monitoring, contractual clauses and audit workflows. The law does not amend the Rol nor, in itself, create new mandatory coverage. We recommend giving priority to monitoring Anvisa’s regulation and how it will be coordinated with ANS’s quality programs.
https://www.in.gov.br/web/dou/-/lei-n-15.524-de-28-de-setembro-de-2026-735106699
ORDINANCE SCTIE/MS No. 58, OF SEPTEMBER 28, 2026
The Ministry of Health has incorporated rituximab into SUS (the public health system) for the treatment of adult patients with moderate to severe pemphigus vulgaris.
Analysis: although rituximab is already listed in the Rol for certain clinical indications, its mandatory coverage does not yet specifically include pemphigus vulgaris. The publication of the decision to incorporate it into SUS triggers art. 10, § 10, of Law No. 9,656/1998 and requires ANS to include the technology for this indication in the Rol within up to 60 days. We recommend monitoring the issuance of the normative resolution and the possible creation or amendment of the corresponding Guideline for Use (Diretriz de Utilização), as well as preparing authorization systems and care protocols for the upcoming coverage.
https://www.in.gov.br/web/dou/-/portaria-sctie/ms-n-58-de-28-de-setembro-de-2026-735115268
ANS news
Cosaúde analyzes inclusion of technologies in the Rol
ANS has published the outcomes of the 55th Technical Meeting of Cosaúde:
cabozantinib for advanced neuroendocrine tumors and somatrogon for growth hormone deficiency will proceed to public participation and a new technical meeting; and
bronchoscopy with cryobiopsy for interstitial lung disease and cholangioscopy with lithotripsy for complex biliary stones will proceed to the final decision of the Board of Directors (DICOL).
Analysis: the outcomes do not yet change mandatory coverage. Bronchoscopy with cryobiopsy and cholangioscopy are at a more advanced stage and may be submitted to the final decision of the Board of Directors (DICOL) at upcoming meetings.
ANS Board of Directors has new composition
Civil servants were appointed by the President of the Republic to the positions of interim directors. The current composition of the DICOL is as follows:
Wadih Damous – President-Director and Director of Sector Development
Lenise Secchin – Director of Product Rules and Authorization
Carla de Figueiredo Soares – Interim Director of Operator Rules and Authorization
Francisco José D’Ângelo Pinto – Interim Director of Management
Celina Maria Ferro de Oliveira – Interim Director of Oversight
ANS consults operators’ ombudsman offices on service to beneficiaries
ANS sent the operators’ ombudsman offices a questionnaire on the capacity of the call centers and customer service centers (SACs) to resolve beneficiaries’ requests. The methodologies used by the ombudsman offices to monitor the resolution rate of the service will also be assessed, pursuant to RN No. 623/2024. Deadline: until Oct 20, 2026. Analysis: the consultation does not immediately change RN No. 623/2024, but may support its monitoring and future regulatory or enforcement measures. We recommend reviewing resolution-rate indicators, request records, the integration between SAC and the ombudsman office, and the documentation of the methodology adopted.
Open public consultations
- CP 176. Subject: preliminary recommendations against incorporating the technology contained in UAT No. 184 – Molecular DNA analysis; search for microdeletions by FISH (Fluorescent In Situ Hybridization); microsatellite instability (MSI), detection by PCR, paraffin block, SUBITEM OF THE DUT – 110.39 – Syndrome of clinically unrecognizable chromosomal abnormalities (array). Deadline: September 21 to October 10, 2026.
Scheduled public hearings
No public hearing is scheduled.
Open public calls for input
- The call for input addressed to the operators’ ombudsman offices, concerning the resolution rate of service channels and the monitoring provided for in RN No. 623/2024, is open until Oct 20, as detailed in item 2.1.
Open public calls
There are no open public calls or targeted public participation processes.
Other news
Weight-loss pens may reach SUS with up to 90% discount following actions by the Ministry of Health and Anvisa
Ministry of Health projects a budget of around R$ 1.5 billion per year to incorporate obesity drugs and guarantee free access for the population
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.