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Bruno Marcelos — Escritório de Advocacia

Pauta Regulatória · Daily brief

No. 228

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

Federal Official Gazette

No changes.

ANS news

ANS approves digital mammography with no age restriction

The Agency’s Board of Directors removes the guidelines for use (diretrizes de utilização) for coverage of the exam

https://www.gov.br/ans/pt-br/assuntos/noticias-1/periodo-eleitoral/ans-aprova-mamografia-digital-sem-restricao-de-idade

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 THE DUT – 110.39 – Syndrome of chromosomal abnormalities not clinically recognizable (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 to include the following technologies in the List of Health Procedures and Events (Rol):

  • 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 participate 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

Quem paga essa bomba? (Who pays for this bomb?) – by Ana Sofia Monteiro Signorelli and Ana Beatriz Robalinho

Source: jota.info · read the full article

CFM rule seeks to complement AI law and protect the medical act – by Antônio Saldanha Palheiro and Samuel Rodrigues de Oliveira

Source: conjur.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.