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Bruno Marcelos — Escritório de Advocacia

Pauta Regulatória · Daily brief

No. 227

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

Federal Official Gazette

No changes.

ANS news

ANS Chief Executive Officer takes part in debate on the future of public and private health in Brazil

Wadih Damous joined a panel on the challenges and prospects of supplementary health at the event “A Saúde do Brasil em 2030: Onde Vamos Estar?”

https://www.gov.br/ans/pt-br/assuntos/noticias-1/periodo-eleitoral/diretor-presidente-da-ans-participa-de-debate-sobre-o-futuro-da-saude-publica-e-privada-no-brasil

ANS holds Public Hearing 69

Proposals for inclusion in the List of Health Procedures and Events (Rol), covering a cardiac implant and a genetic test for breast tumors, will be debated on Sep 16

https://www.gov.br/ans/pt-br/assuntos/noticias-1/periodo-eleitoral/ans-promove-audiencia-publica-69

Public Consultation 177: ANS receives contributions for update of the Rol

The public can submit information on the proposed inclusions of a cardiac implant and a genetic test until Sep 28

https://www.gov.br/ans/pt-br/assuntos/noticias-1/periodo-eleitoral/consulta-publica-177-ans-recebe-contribuicoes-para-atualizacao-do-rol

Open public consultations

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

CP 177. Subject: preliminary recommendations not to incorporate the technologies covered by UAT No. 205 – Implantation of a device for cardiac contractility modulation and UAT No. 209 – 21-gene test for genomic expression profiling of breast tumors. Deadline: September 9 to 28, 2026.

Scheduled public hearings

AP 69. Subject: proposals for inclusion in the List of Health Procedures and Events (Rol) of the following technologies:

  • Implantation of a device for cardiac contractility modulation, for the treatment of patients with symptomatic chronic heart failure (NYHA III–IV), refractory to optimized pharmacological treatment, with an ejection fraction between 25% and 45%, QRS complex <130 ms, and with no indication for cardiac resynchronization therapy; and
  • 21-gene test for genomic expression profiling of breast tumors, as support for therapeutic decision-making for patients with early-stage breast cancer (stages I, II and IIIA), hormone receptor positive (HR+), human epidermal growth factor receptor type 2 negative (HER2-), and node-negative disease or node-positive disease, with involvement of one to three lymph nodes.

Date: Sep 16, from 9 a.m. to 12 p.m. To take part in Public Hearing 69, registration is required by 5 p.m. on Sep 15, on the ANS portal. The recording will be available on the Agency’s website.

Open public calls for input

There is no open public call for input.

Open public calls

There are no open public calls.

Other news

– No changes.

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.