The Superior Court of Justice (STJ) defined rules that guide when plans must pay for insulin pump used in the treatment of Diabetes Mellitus Type 1. The decision was taken unanimously in the 2nd Section of the court, in the judgment of Theme 1,316, and will now serve as a mandatory reference for courts across the country.
helps patients to control blood glucose levels by applying the hormone constantly. Although the device is not listed in the mandatory list of procedures of the National Supplementary Health Agency (ANS), the court stated that this does not automatically prevent coverage by the plans.
The Court also concluded that the insulin pump does not fall within the exceptions provided for in Law 9,656/1998, known as Health Plans Law. As a result, contractual clauses that automatically exclude coverage for this type of device may be considered invalid.
Another important point is that the rules of Law 14,454/2022, which expanded the possibility of covering treatments outside the ANS list, also apply to old health plan contracts, even those signed before the creation of the rule.
Despite opening the way for coverage, the court made it clear that coverage is not automatic. Each request must be analyzed individually by the Courtfollowing criteria defined by the Federal Supreme Court in the judgment of ADI 7265.
Among the requirements evaluated are the prescription made by a responsible doctor, the lack of an adequate therapeutic alternative on the ANS list and scientific proof of the effectiveness and safety of the treatment. It is also necessary that the device has rregistration with the National Health Surveillance Agency (Anvisa).
Furthermore, the patient must have previously requested treatment from the health plan and received a denial considered unjustified. When analyzing the case, the judge may consult specialized technical bodies, such as NatJus, to support the decision with medical and scientific evidence.
With the thesis established by the STJ, legal actions discussing insulin pump coverage must follow these parameters. In practice, the decision reduces obstacles used by operators to deny treatment, but maintains the individual assessment of each situation.