Plans trigger justice for reimbursement with medicines outside Anvisa | Economy

Health insurance
Sophia Bernardes

Health insurance

Health plan operators are resorting to Justice to charge users for high-cost drug expenses. They are based on Thesis 990 of the Superior Court of Justice (STJ), which in 2018 changed the understanding of most of the country’s Courts on the obligation of operators to cover medicines that were not registered with the National Health Surveillance Agency (Anvisa), but that were being prescribed by doctors to some patients, especially for cancer treatments.

In addition to questioning the payment of the medicines, the operators started to file a lawsuit asking for the reimbursement of costs related to the period in which the medicines were not registered. The STJ then began to determine reimbursement to health plans, even if consumers were supported by previous court decisions that ensured coverage.

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This was the case of economist Cláudio Salm, former director of IBGE, revealed by O Globo columnist Elio Gaspari last Sunday (26th). A user of the Unimed health operator for 20 years, Salm was diagnosed with lung cancer, and resorted to an imported drug. As the drug was not on the list of drugs registered with Anvisa, he went to court and obtained an injunction that assured him the right to reimbursement from the operator.

Months later, the drug entered the list of drugs registered with the regulatory body. In August 2019, Cláudio Salm died. Unimed then went to court, charging BRL 176,000.

Salm’s case became final in 2020, after a monocratic decision by Minister Marco Buzzi, of the Fourth Class of the STJ, and now the operator is charging the deceased’s estate. The defense of the economist’s family did not comment on the case.

high cost drug

Unimed-Rio reported that it started charging after the STJ’s understanding of the legality of the cooperative’s refusal to provide medicines without registration with Anvisa. The operator understands that the right to reimbursement of amounts spent on treatment for the period in which the medication was not authorized by the health agency to be used in Brazil is legal.

For lawyer Rafael Robba, specialist in Health Law at the Vilhena e Silva office, the change in the STJ’s understanding caused great legal uncertainty in the market, since there was a judicial decision for each patient ensuring the payment of medicines by the operators.

“The decision put consumers in a trap. These consumers, when they sought justice, relied on the understanding that, even without registration with Anvisa, operators could pay for (the medicines). After the change, the STJ did not any type of modulation on the subject, which made room for this charge from operators, putting the consumer in a situation of extreme vulnerability, because they are high-cost medicines”, he explains.

divergence of understanding

Although other cases are coming to the STJ, with requests for reimbursement from operators against customers, some cases are also being appealed to the Federal Supreme Court (STF), which has a different understanding.

In May, Minister Ricardo Lewandowki was the rapporteur for the case of a patient undergoing treatment for myeloma — a type of cancer that affects white blood cells — who had also obtained in court the right to cover a drug not registered by Anvisa. The reimbursement was now being charged by the health plan operator.

According to the minister, the user of the health plan should not be required to pay for the treatment carried out with the drug Revlimid in the period before the drug was registered with Anvisa. The minister cited in the decision the constitutional right to life and health, but also legal certainty, since the understanding was that the plan should bear the expense.

“Not all cases reach the STF. We hope that the Supreme Court, at some point, will change this understanding. Based on this thesis, operators began to appeal to the STJ, on a case-by-case basis, and it began to judge that they could charge consumers , especially those who received doses before registration with Anvisa”, evaluates lawyer Rafael Robba.

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