LFSS 2023: creation of a new accreditation system for teleconsultation companies

Article 53 of the Social Security Financing Act for 2023 (LFSS) created a new accreditation system for teleconsultation companies.

The purpose of this accreditation is to allow the reimbursement by the health insurance of teleconsultations performed by teleconsultation companies (more specifically performed by health professionals they employ).

Such accreditation aims to ensure that teleconsultation activities meet a certain level of quality and transparency. Indeed, teleconsultation companies were not subject to a specific regulatory framework and were therefore lacking legal certainty.

In order to be accredited, and benefit from this new regime, teleconsultation companies must meet the following conditions:

  • obtain approval from the ministers responsible for social security and health (a decree will be published to set out the terms and conditions for the granting of such approval);
  • operate in the form of a commercial company governed by the French commercial code;
  • have the purpose (whether exclusive or not) of offering teleconsultations;
  • must not be under the control of a supplier, distributor or manufacturer of medicinal products, medical devices, with the exception of devices allowing teleconsultations to be performed;
  • their activity must comply with the rules relating to the protection of personal data and the interoperability and security reference systems.

Regarding the operational conditions of teleconsultation companies:

  • teleconsultations companies concerned by the new accreditation are the ones employing the physicians who will administer the teleconsultations services as salaries;
  • if several physicians are employed, a medical committee must be set up. Such committee must include patients’ representatives and is in particular responsible for ensuring the coherence of the continuing medical training of the physicians employed by the company;
  • the teleconsultation company must draw up an action plan (after the opinion of its medical committee) to ensure compliance with its obligations. The action plan must then be sent to the National Council of the professional board of Physicians (Conseil national de l’Ordre des Médecins – CNOM) and the ministers responsible for social security and health.

The LFSS for 2023 also specifies that the High authority of Health (Haute Autorité de Santé – HAS) will be in charge of publishing a reference framework of good professional practices relating to the quality and accessibility of teleconsultations and of proposing methods for evaluating teleconsultation companies.

The date of entry into force of these provisions will be determined by decree and will be no later than 31 December 2023.

 

Written by
Johanna Harelimana
Johanna Harelimana
I am a junior associate, with experience advising clients on regulatory matters across several sectors, especially in life sciences, food and beverages, and environmental sectors. I currently offer both French and international clients legal advice on product's qualification, clinical trials, market access, price and reimbursement, anti-gift regulation, advertising and promotion, e-health (including telemedicine), as well as drafting contracts (distribution, professional services, clinical trial agreements, etc). I also assist with regulatory advice on other products such as cosmetics, biocide, phytopharmaceuticals and novel food.
Alexandre Vuchot
Alexandre Vuchot
I'm a partner in Bird & Bird's international Commercial group, based in Paris, where I provide our clients with strategic commercial advice. With both French and English qualifications in commercial and corporate law, I have extensive experience of transactional matters. I am able to offer comprehensive advice on all aspects of general business law. I assist on commercial contracts covering distribution, franchise, sales, agency, cooperation and procurement arrangements, acting for suppliers and customers particularly in the retail, tech & comms, life sciences, as well as gaming, entertainment and sport sectors.

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