Teleconsultations in France: a future (r)evolution for commercial companies? | Hogan Lovells

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The social security financing bill for 2023 (PLFSS), currently under discussion in Parliament, presents an important development in the organization of teleconsultation in France. The proposal for article 28 of the PLFSS, as recently presented to the French Senate, provides for the creation of an approval scheme for teleconsultation companies, as well as the reimbursement of teleconsultations by the Assurance Maladie (AMO) to approved companies. .

What is the objective of this new accreditation regime and what are its conditions of application?

Article 28 of the PLFSS, as presented to the Senate, has the primary objective of allowing teleconsultation companies, under certain conditions, to carry out teleconsultation acts reimbursed by the French SHI.

To this end, in the current state of the drafting of the text, companies will have to fulfill various conditions to obtain approval:

  1. structuring conditions. Teleconsultation companies must:
    • be approved by the ministers responsible for social security and health;
    • have the exclusive or non-exclusive purpose of offering medical teleconsultations;
    • operate in the form of a commercial company (civil company forms are excluded).
  2. ownership terms. Teleconsultation companies must not be under the control, as defined by commercial law, of a natural or legal person acting as a supplier, distributor or manufacturer of medicinal products or medical devices, with the exception of devices allowing the accomplishment of an act of teleconsultation.
  3. operational conditions. Teleconsultation companies must:
    • ensure that their digital tools and services comply with the rules relating to the protection of personal data as well as the rules of interoperability, security and ethics applicable to digital health services;
    • employ physicians on a salaried basis who will administer the teleconsultation services;
    • set up a medical commission, if they employ several doctors. This medical committee must include patient representatives and its purpose is to: (i) give an opinion on the company’s medical policy and its action plan, (ii) contribute to the definition of its medical policy and the development of the policy for the continuous improvement of the quality and safety of care, and (iii) ensure the consistency of the continuing medical training of the company’s salaried doctors;
    • after consulting the medical committee, provide an action plan with monitoring indicators to ensure compliance with the obligations applicable to them.

What controls are offered by the authorities?

Approved teleconsultation companies will be subject to different types of control and evaluation:

  • follow-up by the ministers of social security and health to obtain a renewal of accreditation;
  • monitoring by the departmental council of French doctors with jurisdiction over:
    • the action plan intended to ensure compliance with the obligations incumbent on the company concerned; and
    • the company’s annual activity report.

These elements must be submitted both to the competent departmental council of doctors and to the ministers of social security and health.

  • monitoring by the French Digital Health Agency (Digital Health Agency – ANS), or any other certification body accredited under certain conditions, to ensure compliance with interoperability, security and ethical standards for teleconsultation services;
  • an assessment made by the High Authority for Health (High Authority of Health – HAS), relating to the quality of teleconsultation within the framework of a reference system of good professional practices to be published by HAS.

What would change under the new regime?

The objective of this new system is to allow the reimbursement of acts carried out by teleconsultation companies which, by virtue of the proposed approval, meet a certain level of quality and transparency.

On the other hand, the current absence of rules on teleconsultation companies, combined with the restrictive rules for reimbursement of teleconsultation acts, has led to an uncertain regulatory framework.

Various forms of structures are currently being set up on the market, including a combination of commercial and associative structures via health centers or partnerships with liberal practice structures. Like other health arrangements (for example in the sectors of medical biology, veterinary medicine, odontology and medical radiology), the establishment of these structures requires legal engineering, without being able to always respond in a fully satisfactory manner to the needs of market players.

It is hoped that the new regime will provide a framework for the development and effective organization of this promising market.

What would be the next steps for the adoption of the text?

The current preliminary draft provides that various aspects will have to be specified by decree. In particular, the procedures for obtaining approval, its duration and the conditions for suspending or withdrawing the approval granted will have to be developed.

Consequently, this new regime would probably not be applicable the day after the publication of the social security financing law for 2023, but could come into force a few months later.

What can we expect at this stage of the discussions on this draft article?

The Senate has already proposed amendments. One aims to completely remove the proposed scheme, while others aim to introduce additional conditions into the accreditation scheme.

Some of these amendments aim to:

  • submit the management of teleconsultation acts to the requirements of the care pathway;
  • limit the number of procedures covered in a given period;
  • subject the reimbursement of the teleconsultation to an authorization from the competent Regional Health Agency (Regional Health Agency) where the business is physically located;
  • condition the reimbursement on the validation of the quality and reliability criteria of the digital equipment;
  • include a physical presence in some local care pathways;
  • require licensed companies to comply with Health Data Hosting Certification standards (Health data hosting).

The French National Assembly had already added conditions to the scheme originally proposed. Therefore, we expect additional conditions to be introduced. We will continue to monitor whether the new regime, if enacted, will achieve the original objective of strengthening the accessibility of teleconsultation in France.

Next steps

Telehealth and other health service providers need to be aware of these developments and the impact they have on their operations in France.

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