Brazil: Provisional Measure No. 1.067/2021 – agility and efficiency in the incorporation process of drugs by ANS

The Provisional Measure No. 1.067/2021 (“Measure”) was issued today (September 03) in the Union’s Official Gazette, aiming to improve the agility and efficiency of the incorporation process of drugs by the Brazilian Agency of Supplementary Health (“ANS”) for health plans. The Measure amends Law No. 9.656/1998, which regulates private health care plans and insurance. Below are the main modifications related to the list of mandatory coverage of procedures and drugs:

• Reduction the deadline for ANS to review the incorporation of drugs – which is now 120 days, renewable for another 60, in opposition to the 18 months previously in force;

• The Measure provided for the creation of the Commission of Update of the Supplementary Health List of Procedures and Events (“Commission”), to improve ANS’ cooperation with the Ministry of Health, and to assist with issues related to the coverage of transplants and other highly complex procedures;

• The Commission will be composed of at least one representative from each of the following entities: (i) Federal Council of Medicine; (ii) Federal Council of Dentistry; and (iii) Federal Council of Nursing.

• Finally, in case the technology is incorporated into the public health system by the Brazilian Commission of Technology Incorporation into the Public Health System (Conitec), it will automatically be included in the list of procedures and events in supplementary health.  

The provisions of the Measure are applicable to the processes in course on the date of its publication for the expansion of coverage in the supplementary health. The Measure came into force on the date of its publication.