The Social Security Financing Bill for 2023 (PLFSS), currently under discussion in Parliament, presents an important evolution in the organization of teleconsultation in France. Proposed Article 28 of the PLFSS, as recently presented to the French Senate, provides for the creation of an accreditation regime for teleconsultation companies, as well as the reimbursement of teleconsultations by the French Health Insurance System (SHI) to accredited companies.
What is the objective of this new accreditation regime and what are its conditions of application?
The primary objective of Article 28 of the PLFSS, as introduced to the Senate, is to allow teleconsultation companies, under certain conditions, to perform teleconsultation acts reimbursed by the French SHI.
To this end, as the text is currently drafted, companies will have to meet various conditions to obtain accreditation:
- structuring conditions. Teleconsultation companies will have to:
- be approved by the ministers in charge of 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).
- ownership conditions. Teleconsultation companies must not be under the control, as defined by commercial law, of a natural or legal person acting as supplier, distributor or manufacturer of medicines or medical devices, apart from devices allowing the performance of a teleconsultation act.
- operational conditions. Teleconsultation companies will have to:
- ensure that their digital tools and services comply with the rules relating to the protection of personal data as well as the interoperability, security and ethical guidelines applicable to digital health services;
- employ as salaries physicians, who will administer the teleconsultation services;
- set up a medical committee, if they employ several physicians. This medical committee must include patients’ 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 to the development of the continuous improvement policy of the quality and safety of care, and (iii) ensure the coherence of the continuing medical training of the company's salaried physicians;
- after consulting the medical committee, provide an action plan with monitoring indicators to ensure compliance with the obligations applicable to them.
What are the proposed authorities’ control ?
Accredited teleconsultation companies will be subject to different types of control and evaluation:
- a monitoring by social security and health ministers to obtain a renewing accreditation;
- a monitoring by the competent French departmental board of physicians on:
- the action plan designed to ensure compliance with the obligations at the expense of the concerned company; and
- the annual report of the company’s activities.
These elements must be submitted to both the competent French departmental board of physicians and social security and health ministers.
- a monitoring by the French Digital Health Agency (Agence du Numérique en Santé - ANS), , or any other accredited certification body under certain conditions, to ensure compliance with interoperability, security and ethical standards of teleconsultation services;
- an evaluation made by the French Health Authority (Haute Autorité de Santé - HAS), regarding the quality of teleconsultation under guidelines of good professional practices to be published by the HAS.
What would change under the new regime?
The objective of this new system is to permit the reimbursement of procedures performed by teleconsultation companies, which, by virtue of the proposed accreditation, meet a certain level of quality and transparency.
By contrast, the current lack of rules on teleconsultation companies, combined with the restrictive rules for the reimbursement of teleconsultation acts, has led to an uncertain regulatory framework.
Various forms of structures are currently being implemented on the market, including a combination of commercial and associative structures via health centers or partnerships with liberal practice structures. Like other health montages (for example, in the medical biology, veterinary medicine, dentistry and medical radiology sectors), implementing these structures requires legal engineering, without the ability always to meet the needs of market players in a completely satisfactory manner.
It is hoped that the new regime will provide a framework for the development and efficient organization of this promising market.
What would be the next steps of the text’s adoption?
The current draft bill provides that various aspects will have to be specified by decree. In particular, procedures for obtaining the accreditation, its duration, and the conditions for suspending or withdrawing the given accreditation will have to be developed.
As a result, this new regime would likely not be applicable the day after the publication of the Social Security Financing Act for 2023, but could come into effect a few months later.
What can we expect at this point from discussions of this draft article?
The Senate has already proposed amendments. One aims to remove the proposed regime altogether, while others are intended to introduce additional conditions to the accreditation regime.
Among these amendments, some aim to:
- submit the coverage of teleconsultation procedures to the requirements of the care pathway;
- limit the number of procedures covered in a given period;
- submit teleconsultation reimbursement to an authorization of the competent Regional Health Agency (Agence Régionale de Santé) where the company is physically located;
- condition reimbursement upon validation of quality and reliability criteria of the digital equipment;
- include a physical presence in certain local treatment pathways;
- require approved companies to comply with the ,Health Data Hosting Certification standards (Hébergement des données de santé).
The French National Assembly had already added conditions to the initially proposed regime. As a result, we expect that additional conditions may be introduced. We will continue to monitor whether the new regime, if enacted, will achieve the initial objective of strengthening the accessibility of teleconsultation in France.
Next steps
Telehealth and other health care service providers should be mindful of these developments and the impact they have on their operations in France.
Please contact Mikael Salmela, Fabien Charissoux and Joséphine Pour for guidance on this news or on French regulations applicable to telemedicine.
Authored by Mikael Salmela, Joséphine Pour, and Fabien Charissoux.
