Question 14360 — health

Summary

Mr. Jérôme Legavre questions the Minister of Health and Prevention about the fitting of non-precious metal dental prostheses of the chrome-cobalt type, the nomenclature of which is HBLD038. He also questions him about overpayments claimed from health professionals by the primary health insurance fund for having prescribed dental prostheses in a material other than non-precious metal. He finally asks her about an application immediate 100% coverage of new zirconia prostheses. Experts from the Risk Assessment Committee (RAC) proposed the classification of cobalt as CMR: carcinogen category 1B (suspected hazard), mutagen 2 (suspected hazard) and toxic for reproduction 1B (suspected hazard), based on investigations and evaluations. The investigations were carried out by the European Chemicals Agency (ECHA) and the assessments were been carried out by the CER. The latter showed “germ cell mutagenicity” of the metal cobalt on the gastrointestinal tract at repeated doses of cobalt/cobalt chloride ingestion. Thus, in September 2017, the CER requested the revision of the classification of metallic cobalt in the European Union REACH regulation (registration, evaluation and authorization of chemicals, i.e. “registration, evaluation and authorization of chemical substances). Therefore, the metal cobalt has been reclassified as a CMR 1B substance. Cobalt has been classified as CMR CE under the CLP regulation since October 1, 2021: carcinogen category 1B: may cause cancer. Mutagenic category 2: likely to induce genetic abnormalities. Reprotoxic category 1B: may harm fertility. From May 27, 2025, MDR Regulation (EU) 2017/745 will apply to all medical devices and therefore cobalt. Dental prostheses made of non-precious metal such as chrome-cobalt would therefore seem to pose a problem. There would be a risk for patients covered by complementary health insurance, the most deprived patients and for health professionals who work with cobalt. Indeed, since the new convention of 2020, the CPAM requires dental surgeons to install crowns and metal bridges made of non-precious alloys (cobalt-chromium) on the posterior teeth for patients benefiting from complementary solidarity health insurance or dependent on the rest at zero cost. They are no longer authorized to carry out a replacement therapeutic procedure by paying the same price, which calls into question their power to prescribe. This was the case before 2018 with the old convention which allowed one crown to be reimbursed metal-ceramic or ceramic at the cost of a metal crown. The supplement was the responsibility of the healthcare professional or the patient. The provision of care has therefore decreased by removing this alternative even though the cost is the same. This creates discrimination between patients who have the financial means to access high-quality care and others on whom a metal alloy is imposed. Article 6 of the Declaration of human and citizen rights states that “the law must be the same for everyone”. Therefore, all individuals in the same situation must be treated equally. For these reasons, health professionals, considering the potential carcinogenic risk of cobalt, have continued to substitute metal-ceramic or ceramic dental prostheses for metal, regardless of the patient's diet. The CPAM is now asking them for undue when these are preventive medical acts, based on equality in law and without additional cost. In order to remedy the inconsistency of this situation, it would first be appropriate to cancel the overpayments so as not to sanction these health professionals. Then and with the objective of removing all risks, it would be sufficient for the measure to immediately apply which provides that from January 1, 2026, prostheses in Zirconia may be prescribed on posterior teeth to replace the non-precious metal alloy. He wants to know his position on the subject.

Machine translation from French. The official text remains authoritative.

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1. 16 January 2024

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• Jérôme Legavre · auteur

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