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Bruno Marcelos — Escritório de Advocacia

Pauta Regulatória · Daily brief

No. 245

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

Federal Official Gazette

NORMATIVE RESOLUTION ANS No. 681, OF OCTOBER 2, 2026

ANS has included in the Rol the procedure of peroral cholangioscopy with laser or electrohydraulic lithotripsy, for the treatment of complex biliary stones after failure of conventional endoscopic retrograde cholangiopancreatography – ERCP. Mandatory coverage takes effect on Nov 3, 2026.

https://www.in.gov.br/web/dou/-/resolucao-normativa-ans-n-681-de-2-de-outubro-de-2026-736576547

PUBLIC CONSULTATION ANS No. 178

ANS has opened a public consultation on the preliminary recommendations not to incorporate the following technologies:

somatrogon, UAT No. 208, for growth hormone deficiency in children aged three and older and adolescents; and

cabozantinib levomalate, UAT No. 213, for well-differentiated, unresectable, locally advanced or metastatic neuroendocrine tumors, after two or more therapies.

Deadline: from Oct 7 to 26, 2026. Contributions must be submitted through the form available on the ANS portal.

https://www.in.gov.br/web/dou/-/consulta-publica-ans-n-178-de-2-de-outubro-de-2026-736568199

ANS news

ANS presents August beneficiary figures

The National Supplementary Health Agency (ANS) releases today, Monday, Oct 5, the data on health plan beneficiaries for August: 53,164,516 in medical care plans and 37,311,529 in dental-only plans. These and other data can be consulted in the Sala de Situação (Situation Room), a research tool on information about the health plan sector available on the regulator’s portal.

The movement of beneficiaries into and out of operators is monitored by ANS through the turnover rate, which is calculated from enrollments (new beneficiaries, portfolio transfers, voluntary plan changes, etc.) and cancellations of ties (termination of a company’s group plan contract, beneficiaries leaving the sector, death, etc.).

In the last 12 months, 16,117,456 enrollments and 15,434,267 cancellations were reported in medical care plans, resulting in a turnover rate of 29.41%. In August, 1,237,646 enrollments and 1,175,486 cancellations were recorded, making up a turnover rate of 2.21%.

https://www.gov.br/ans/pt-br/assuntos/noticias-1/periodo-eleitoral/ans-apresenta-balanco-de-beneficiarios-de-agosto

Open public consultations

CP 176. Subject: preliminary recommendations not to incorporate 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, DUT SUBITEM – 110.39 – Syndrome of clinically unrecognizable chromosomal abnormalities (array). Deadline: September 21 to October 10, 2026.

CP 178. Subject: preliminary recommendations not to incorporate somatrogon and cabozantinib levomalate. Deadline: October 7 to 26, 2026.

Scheduled public hearings

No public hearing is scheduled.

Open public calls for input

The call for input directed to the operators’ ombudsman offices, concerning the resolution capacity of service channels and the monitoring provided for in RN No. 623/2024, is open until Oct 20.

Open public calls

There are no open public calls or targeted social participation processes.

Other news

PUBLIC CONSULTATION ANVISA No. 1,427, OF OCTOBER 2, 2026

Source: anvisalegis-empresa.datalegis.net · read the full article

Analysis: the proposal does not yet change the sanitary rules currently in force. The future mechanism may be of interest to health technology companies, hospitals, laboratories and vertically integrated operators that develop digital care solutions or other innovative products and services.

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.