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Bruno Marcelos — Escritório de Advocacia

Pauta Regulatória · Daily brief

No. 241

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

Federal Official Gazette

No changes.

ANS news

No changes.

Open public consultations

  • CP 176. Subject matter: preliminary recommendations not to incorporate the technology contained in UAT No. 184 – Molecular DNA analysis; search for microdeletions by FISH (Fluorescente In Situ Hibridization); microsatellite instability (MSI), detection by PCR, paraffin block, DUT SUBITEM – 110.39 – Syndrome of chromosomal abnormalities not clinically recognizable (array). Deadline: September 21 to October 10, 2026.

Scheduled public hearings

There is no public hearing (AP) scheduled.

Open public calls for input

  • The call for input addressed to the health plan operators’ ombudsman offices, concerning the resolution capacity of the service channels and the monitoring provided for in Normative Resolution (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 social participation procedures.

Other news

STJ SETS CRITERION FOR REVIEW OF LOSS-RATIO PRICE ADJUSTMENTS IN GROUP PLANS

Case Law Bulletin No. 903 of the STJ published a judgment of the Fourth Panel in Special Appeal (REsp) No. 2,089,439/SP. The Court held that, once a price adjustment based on loss ratio applied to a group plan is found to be abusive, the appropriate percentage must be determined in the liquidation phase through actuarial calculations, and it is not possible to automatically replace it with the annual indices set by ANS for individual plans. The STJ reaffirmed that a loss-ratio price adjustment clause is not abusive in itself, but its application depends on clear and suitable actuarial justification. Analysis: the precedent rules out a solution frequently adopted in actions seeking review of price adjustments, namely the immediate application of the index for individual plans. For health plan operators, it reinforces the need for consistent, transparent actuarial documentation tied to the data of the relevant contract or pool. Once abusiveness is found, the judicial determination must preserve actuarial balance, rather than simply importing an index intended for another type of contract.

https://scon.stj.jus.br/SCON/GetPDFINFJ?edicao=0903

NEW STAGE OF THE NATIONAL PRESCRIPTION CONTROL SYSTEM GOES INTO OPERATION

As of today, the National Prescription Control System allows the electronic issuance of Prescription Notifications A, B and B2, including the traditional yellow and blue prescription forms, as well as notifications for systemic retinoids and thalidomide. The electronic flow also covers Special Control Prescriptions and Prescriptions Subject to Retention, such as those for antimicrobials and GLP-1 receptor agonists. Electronic issuance remains optional and paper documents remain valid. Until Oct 29, electronic prescriptions integrated and not integrated with the system may coexist. From Oct 30, Special Control Prescriptions and Prescriptions Subject to Retention issued electronically must be integrated with the national system. Analysis: hospitals, clinics, in-house services, telehealth platforms and pharmacies must verify the integration of their systems, access profiles, the use of the numbering provided by the health surveillance authority and the digital signature requirements. The change is sanitary and documentary in nature; it does not alter the classification of medicines or create any obligation of healthcare coverage.

https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/controlados/sncr?utm_source=chatgpt.com

UPDATE OF HEMOTHERAPY PROCEDURES ENTERS INTO FORCE

Source: chatgpt.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.