Chamber approves MP that forces plans to give oral chemotherapy

The Chamber of Deputies approved this Tuesday (14) a provisional measure that obliges health plans to offer home oral chemotherapy to their customers, as long as there is a medical prescription and the drugs are registered with Anvisa (National Health Surveillance Agency) .

This forecast was not in the text sent by the government and was included by Congresswoman Silvia Cristina (PDT-RO), rapporteur of the project. The proposal was approved in a symbolic vote and goes to the Senate.​

The text says that, within 10 days after the prescription, the plans must directly offer the patient or their legal representative home antineoplastic treatment for oral use, whether through their own network, accredited, contracted or referenced.

This supply can occur fractionally per cycle. The text determines that it is proven that the patient or his legal representative received guidance on the use, conservation and eventual disposal of the drug.

In July, President Jair Bolsonaro (PL) vetoed a bill that makes it mandatory for private health plans to provide coverage for home treatments for oral cancer.

The federal government argued that the measure, if effective, would cause a financial impact on the market for private plans and this would result in an increase in the amounts paid by policyholders. The project vetoed by Bolsonaro allowed a period of 48 hours for the medication to be delivered to the patient. The veto must be appreciated in a Congressional session this Friday (17th).

The provisional measure approved on Tuesday changes the law on health plans to establish that the ANS will have 120 days extendable for another 60 calendar days to complete the administrative process and update the list of procedures.

According to the report, the administrative update processes that involve home antineoplastic treatments for oral use should be analyzed as a matter of priority.

If the ANS does not have a conclusive statement by the deadline, the drug, product or procedure will automatically be included in the list until the agency decides. The purpose of the measure is to guarantee the continuity of the assistance started even if the decision of the body is unfavorable to inclusion.

According to the MP, technologies evaluated and positively recommended by Conitec (National Commission for the Incorporation of Technologies in the Unified Health System) and incorporated into the SUS will be included in the list of supplementary health procedures within 60 days.

The text creates the Commission for Updating the List of Procedures and Events in Supplementary Health, which will be responsible for advising the ANS. The body will be composed of a representative appointed by the Federal Council of Medicine and a representative of the medical specialty society, depending on the therapeutic area or use of technology to be analyzed, appointed by the Brazilian Medical Association.

The committee will also comprise a representative of an entity that represents consumers of health plans, a representative of an entity that represents service providers in Supplementary Health, a representative of an entity that represents health plan operators and representatives of professional areas of related to the event or procedure under review.

The committee must present a report that will consider the scientific evidence on the efficacy, accuracy, effectiveness and safety of the drug, product or procedure analyzed, recognized by the competent body for registration or authorization for use.

The document must also contain the comparative economic evaluation of the benefits and costs in relation to the coverage already provided for in the list of procedures and the analysis of the financial impact of the expansion of coverage in the scope of supplementary health.

The MP also says that the ANS will issue rules for compliance with the law within 180 days.