Federal Official Gazette
LAW No. 15,471, OF JULY 20, 2026
Establishes the National Health Strategy for the Health Economic-Industrial Complex (Ensceis); and amends Law No. 6,360 of September 23, 1976, Law No. 14,133 of April 1, 2021 (Public Procurement and Administrative Contracts Law), and Law No. 8,080 of September 19, 1990 (Organic Health Law). Note: text attached.
Note: Law No. 15,471 of July 20, 2026 established the National Health Strategy for the Health Economic-Industrial Complex, with the aim of reducing the country’s external dependence on strategic medicines, inputs, devices and technologies. The law strengthens instruments such as Productive Development Partnerships, local innovation programs, technology orders, preference margins, subsidized credit and regulatory priority for companies qualified as strategic. The presidential vetoes, in turn, removed some of the most intensive mechanisms for protecting domestic production, such as mandatory technological offsets in purchases of imported products, linking tariff policy to the competitiveness of these companies, and certain restrictions on the import of unregistered products.
Although the law is aimed mainly at SUS and does not impose direct obligations on health plan operators, its effects may reach supplementary health indirectly. Expanding domestic production may increase supply security, reduce exchange-rate exposure and foster greater competition among suppliers; conversely, benefits concentrated in a few companies may lead to protection of incumbents, higher prices or lower product diversity. For the sector, it will be especially important to monitor the regulation of accreditation criteria, regulatory priority, the definition of strategic products and the rules for supply to the public and private markets.
For further clarification: https://www.jota.info/saude/lula-sanciona-lei-do-complexo-economico-industrial-da-saude
ANS NORMATIVE RESOLUTION No. 676, OF JULY 17, 2026
Amends Annex II of Normative Resolution (RN) No. 465 of February 24, 2021, which governs the List of Health Procedures and Events (Rol) within Supplementary Health, to update Utilization Guideline (DUT) No. 158 of Annex II of RN No. 465/2021, relating to “OUTPATIENT INJECTABLE DRUG THERAPY (WITH UTILIZATION GUIDELINE)”, to ensure coverage of the drugs Testosterone undecylate; Testosterone cypionate; and the combination of four testosterone esters (Testosterone propionate, Testosterone phenylpropionate, Testosterone isocaproate and Testosterone decanoate) for the treatment of organic hypogonadotropic hypogonadism in adult men and male adolescents, in compliance with Art. 33 of RN No. 555/2022, Art. 19T of Law No. 8,080/1990, as amended by Law No. 14,313/2022, and paragraphs 4 and 10 of Art. 10 of Law No. 9,656/1998.
ANS NORMATIVE RESOLUTION No. 677, OF JULY 20, 2026
Amends ANS Normative Resolution No. 585 of August 18, 2023, which governs the criteria for changes to the hospital care network with regard to the replacement of hospital entities and network resizing by reduction.
ANS NORMATIVE INSTRUCTION No. 38, OF JULY 20, 2026
Amends ANS Normative Instruction No. 28 of December 16, 2022, which governs the Product Registration procedures.
Note: ANS published RN No. 677/2026 and IN No. 38/2026, approved at the 640th Meeting of the Board of Directors (DICOL), as part of the improvement of the Product Change System in the Health Plan Registry — RPS. The proposal had already been examined previously and returned to the collegiate body after a favorable opinion from the Agency’s Legal Counsel. On that occasion, DICOL highlighted two objectives: to enable electronic changes to the commercial name of products and to adapt the regulation of the hospital network to the new structure of the system.
IN No. 38/2026 amended Art. 17 of IN No. 28/2022 to establish that requests to change a product’s name must be made through the electronic system made available on the Operators Portal. The request will remain conditioned on prior payment of the Product Data Change Fee — TAP. The main innovation, therefore, is procedural: processing now takes place in ANS’s electronic environment, replacing the paper-based procedure previously adopted.
RN No. 677/2026, in turn, updated several items of Annex II of RN No. 585/2023 to replace references to the specific “Hospital Network Change Request” system with the broader electronic product change system. Requests for replacement of a hospital entity, network resizing by reduction and reconsideration of denials, as well as the reporting of the effective date of the change and the consultation of analysis results, will now be processed in this environment.
The changes are predominantly operational and terminological, with no modification of the substantive criteria applicable to equivalence between providers, impact on the covered population or communication to beneficiaries, which remain governed by RN No. 585/2023. Operators must nevertheless adapt their internal workflows to the new electronic system and follow the operational guidance that ANS will make available. Both RN No. 677/2026 and IN No. 38/2026 enter into force on August 3, 2026.
ANS PUBLIC CONSULTATION No. 174, OF JULY 20, 2026
A Public Consultation is hereby opened for a period of 20 (twenty) days, from July 23, 2026 to August 11, 2026, for the submission of criticism and suggestions regarding the preliminary recommendation for incorporation of the technology covered by UAT No. 201 – Bronchoscopy with cryobiopsy.
ANS OPERATIONAL RESOLUTION No. 3,157, OF JULY 17, 2026
Provides for the establishment of fiscal oversight (direção fiscal) at the operator AMEPLAN ASSISTÊNCIA MÉDICA PLANEJADA LTDA.
ANS OPERATIONAL RESOLUTION No. 3,156, OF JULY 17, 2026
Provides for the granting of special portability to the beneficiaries of POLIMÉDICA SAÚDE SOCIEDADE SIMPLES LTDA, ANS Registration No. 31.690-3.
ANS OPERATIONAL RESOLUTION No. 3,155, OF JULY 17, 2026
Provides for the granting of special portability to the beneficiaries of BRASIL ODONTO OPERADORA DE PLANOS ODONTOLÓGICOS LTDA, ANS Registration No. 42.156-1.
ANS OPERATIONAL RESOLUTION No. 3,154, OF JULY 17, 2026
Provides for the order to divest the portfolio of INTERCLÍNICAS PLANO VIDA USA OPERADORA DE SAÚDE LTDA.
ANS PERSONNEL ORDINANCE No. 201, OF JULY 17, 2026
Ms. Emiliana de Oliveira Castro, CPF No. XXX.636.309-XX, is hereby appointed to serve as fiscal director at the operator AMEPLAN ASSISTÊNCIA MÉDICA PLANEJADA LTDA, ANS Registration No. 39.473-4 and CNPJ No. 67.839.969/0001-21.
ANS PERSONNEL ORDINANCE No. 200, OF JULY 17, 2026
Ms. Maria Augusta Arruda de Assunção, CPF No. XXX.767.218-XX, is hereby dismissed from the role of liquidator’s assistant of ASSISTÊNCIA MÉDICA GLOBAL – AMEG LTDA – IN EXTRAJUDICIAL LIQUIDATION, with no ANS registration and CNPJ No. 32.266.698/0001-88, to which she was appointed by ANS Personnel Ordinance No. 69, published in the Federal Official Gazette (DOU) on March 18, 2026.
ANS PERSONNEL ORDINANCE No. 199, OF JULY 17, 2026
Ms. Maria Augusta Arruda de Assunção, CPF No. XXX.767.218-XX, is hereby dismissed from the role of liquidator’s assistant of ORION PROMOÇÕES E REPRESENTAÇÕES LTDA – IN EXTRAJUDICIAL LIQUIDATION, with no ANS registration and CNPJ No. 08.492.453/0001-94, to which she was appointed by ANS Personnel Ordinance No. 66, published in the Federal Official Gazette (DOU) on March 17, 2026.
ANS PERSONNEL ORDINANCE No. 198, OF JULY 17, 2026
Ms. Maria Augusta Arruda de Assunção, CPF No. XXX.767.218-XX, is hereby dismissed from the role of liquidator’s assistant of AP AREAL PARTICIPAÇÕES LTDA. – IN EXTRAJUDICIAL LIQUIDATION, with no ANS registration and CNPJ No. 01.870.896/0001-22, to which she was appointed by ANS Personnel Ordinance No. 59, published in the Federal Official Gazette (DOU) on March 17, 2026.
ANS PERSONNEL ORDINANCE No. 197, OF JULY 17, 2026
Ms. Maria Augusta Arruda de Assunção, CPF No. XXX.767.218-XX, is hereby dismissed from the role of liquidator’s assistant of VISION MED ASSISTÊNCIA MÉDICA LTDA – IN EXTRAJUDICIAL LIQUIDATION, ANS Registration No. 40.391-1 and CNPJ No. 01.518.211/0001-83, to which she was appointed by ANS Personnel Ordinance No. 67, published in the Federal Official Gazette (DOU) on March 17, 2026.
ANS PERSONNEL ORDINANCE No. 196, OF JULY 17, 2026
Mr. Tiago Duque de Almeida, CPF No. XXX.230.177-XX,, is hereby appointed to serve as liquidator’s assistant of VISION MED ASSISTÊNCIA MÉDICA LTDA – IN EXTRAJUDICIAL LIQUIDATION, canceled ANS Registration No. 40.391-1 and CNPJ No. 01.518.211/0001-83, for a period of 6 months, extendable if necessary, counted from 05/13/2026 (the date on which the current authorization expired), as provided in Arts. 20 and 21 of Normative Resolution (RN) No. 524 of 2022.
ANS PERSONNEL ORDINANCE No. 195, OF JULY 17, 2026
Ms. Fabiana Valéria de Schaira Zoboli, CPF No. XXX.212.288-XX, is hereby appointed to serve as liquidator’s assistant of VISION MED ASSISTÊNCIA MÉDICA LTDA – IN EXTRAJUDICIAL LIQUIDATION, canceled ANS Registration No. 40.391-1 and CNPJ No. 01.518.211/0001-83, for a period of 6 months, extendable if necessary, counted from 05/13/2026 (the date on which the current authorization expired), as provided in Arts. 20 and 21 of Normative Resolution (RN) No. 524 of 2022.
ANS news
Clarification note
The National Supplementary Health Agency (ANS) informs that there is no authorization or decision by the Board of Directors (DICOL) establishing an extraordinary price adjustment for individual and family health plans, nor any regulatory decision to that effect.
The only price adjustment authorized by ANS for individual and family contracts with anniversaries between May 2026 and April 2027 is the annual rate of 5.11%, calculated using a technical, transparent and widely known methodology. Group plans, in turn, are not subject to a price adjustment cap set by the Agency.
According to the Agency’s latest available report, Brazil has 52.97 million beneficiaries of medical care plans. Of this total, 44.49 million are in group plans and 8.45 million in individual or family plans, which represent 15.96% of the market.
In recent years, ANS has held discussions on the Health Plan Pricing and Price Adjustment Policy. Public Consultation (CP) No. 145 was suspended by court decision. Subsequently, after carrying out a new Regulatory Impact Assessment (AIR), the Agency held Public Consultation (CP) No. 159 between July 21 and October 19, 2025, with broad disclosure of the corresponding documentation.
The proposal submitted to public consultation provided for discussion of the technical review mechanism, with the aim of reconciling the sustainability of the sector with the protection of the public interest. Among the proposed criteria were proof of active marketing of the product (new entrants), actuarial demonstration of imbalance and the definition of a maximum limit for any application of the mechanism. The proposal also included measures relating to price adjustments of group plans, such as expanding the pooling of contracts (risk pool), setting a loss ratio target, prohibiting the accumulation of indices and strengthening transparency.
That said, the Agency clarifies:
- The existence of technical documents, drafts or internal studies is part of the regulatory routine of any state agency. The assessment of scenarios related to the sustainability of the sector is a legal duty of ANS and is not to be confused with a decision to approve or implement new price adjustment mechanisms.
- The discussion on the technical review mechanism was suspended by order of the Federal Courts in 2025. Subsequently, the Agency carried out a new Regulatory Impact Assessment (AIR) and held a new public consultation, with broad publicity of the documents and compliance with the applicable regulatory procedures.
- The only price adjustment authorized by ANS for individual and family contracts with anniversaries between May 2026 and April 2027 is the annual rate of 5.11%. This percentage was calculated using a technical methodology and corresponds to the maximum rate authorized by the Agency for these contracts. Applying a percentage higher than that authorized by ANS, except in the cases provided for in the regulations, constitutes noncompliance with the applicable regulation.
- The Board of Directors (DICOL) and the Presidency of ANS reiterate their commitment to protecting beneficiaries, complying with current legislation and preserving the economic and financial balance of the sector, which are essential foundations for the sustainability of supplementary health.
ANS reaffirms that its work is guided by technical rigor, transparency and strict compliance with the legal order.
The Agency further clarifies that speculation about supposed future price adjustments has no support in the regulatory decisions currently in force, and regrets the dissemination of hypothetical information or projections that may generate misinformation and insecurity among health plan beneficiaries.
ANS will continue to monitor compliance with the applicable regulations and to adopt, within the scope of its legal powers, the appropriate measures to ensure compliance with the authorized rate for individual and family plans, as well as to ensure that any future regulatory development is preceded by the technical studies, social participation processes and decisions provided for in the legislation.
Cosaúde holds its 53rd Technical Meeting
The National Supplementary Health Agency (ANS) will hold, on 7/29, from 9 a.m. to 4 p.m., the 53rd technical meeting of the Commission for the Update of the List of Health Procedures and Events in Supplementary Health (Cosaúde). The aim of this meeting is to discuss new proposals for including technologies in the List (Rol).
The meeting will be held on the Microsoft Teams platform and is reserved for members of the Commission. Other interested parties may follow the live broadcast on the ANS channel on YouTube.
See the full schedule below:
SESSION
TECHNOLOGY
INDICATION FOR USE
9 a.m. to 1 p.m.
UAT 206 – Tepotinib hydrochloride
(Preliminary Discussion)
First-line treatment of patients with advanced non-small cell lung cancer (NSCLC) who have a specific genetic alteration called METex14 (MET gene exon 14 skipping).
UAT 200 – Next-generation sequencing (NGS) panel
(Preliminary Discussion)
Identification of the EGFR, ALK, ROS1, RET, NTRK, BRAF, MET, KRAS and HER2 genes in advanced (IIIB to IV) or metastatic non-squamous non-small cell lung cancer (NSCLC)
2 p.m. to 4 p.m.
UAT 199 – Cholangiopancreatoscopy with laser or electrohydraulic lithotripsy
(Preliminary Discussion)
Treatment of complex biliary-pancreatic stones (stones located in the ducts that carry bile and that are difficult to remove)
Open public consultations
- CP 174. Subject: submission of criticism and suggestions regarding the preliminary recommendation for incorporation of the technology covered by UAT No. 201 – Bronchoscopy with cryobiopsy. Deadline: Jul 23, 2026 to Aug 11, 2026.
Scheduled public hearings
There are no scheduled public hearings.
Open public calls for input
There is no open public call for input.
Open public calls
Discount cards, prepaid cards, or related services. Deadline: From Jun 2, 2026 to Aug 3, 2026.
Other news
Política prepara mais medidas para o ´pacote de bondades´
Source: conteudos.xpi.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.