WhileArticle 53 of the French Social Security Financing Act (LFSS) for 2023 filled the legal void concerning the status of telemedicine companies and access to reimbursement for teleconsultation acts performed by salaried healthcare professionals working within these structures, this consecration appears to have been left to one side by the public authorities to date, in the absence of an implementing decree (and specific provisions), leaving operators in the sector still in a state of uncertainty.

As a reminder, telemedicine is defined as " any form of remote medical practice using information and communication technologies", in accordance with the provisions of article L.6316-1 of the French Public Health Code (CSP). It includes the telemedicine acts listed in article R. 6316-1 of the CSP, which are: teleconsultation, tele-expertise, remote medical monitoring, remote medical assistance and medical response.

To date, two teleconsultation business models can be implemented by commercial companies:

• Companies providing information systems that offer healthcare professionals the use of a digital tool that does not include the provision of care. In this case, the activity consists solely of providing the healthcare professional with a digital tool enabling him or her to carry out teleconsultation procedures. The healthcare professional is solely responsible for billing the health insurance company; the company does not interfere with the act of medicine and the healthcare professional's relationship with his or her patients;
• Companies offering teleconsultation services that include healthcare services.

To fill the legal void left by this second model, the LFSS for 2023 proposed an ad-hoc legal framework for these telemedicine companies.

The introduction of this measure in the healthcare offering meets a triple objective: to meet healthcare needs, to improve the quality of practices and care, and to guarantee the equity and coherence of teleconsultation with other existing care modalities. This status is described as " ad-hoc " in that it represents a gradual move towards full legal status, given the unprecedented nature of this type of business model.

HEALTH INSURANCE COVER FOR TELECONSULTATION PROCEDURES

Obtaining approval

The LFSS for 2023 therefore added teleconsultation companies to the list of healthcare professionals and operators authorized to bill health insurance, set out in Article L.162-1-7 of the Social Security Code (CSS), giving them true "healthcare operator" status.

In order to bill for care provided by salaried doctors, these teleconsultation companies must, in accordance with articles L. 4081-1 to L. 4081-4 of the CSP, obtain approval from the Ministers of Health and Social Security. To do so, three cumulative conditions must be met:

• The nature of the legal structure: only commercial companies governed by the French commercial code (SARL, SA, SAS and SCA) whose corporate purpose, whether exclusive or not, is to offer teleconsultation services, are eligible for approval. This excludes SCPs and SELs, since the professionals who make them up are already authorized to bill health insurance directly for teleconsultation procedures;
• Conflict of interest : teleconsultation companies must not be controlled, within the meaning of article L. 233-3 of the French Commercial Code, by a natural or legal person engaged in the supply, distribution or manufacture of medicines, medical devices or in vitro diagnostic medical devices, with the exception of devices enabling teleconsultation;
• The teleconsultation company's digital tools and services must comply with the rules on personal data protection (RGPD), as well as the interoperability, security and ethics guidelines drawn up by the digital health agency (ANS) (article L. 1470-5 CSP).

Once this approval has been obtained, billing will be authorized on a temporary basis, for a period to be set by decree. On this point, theimpact study of September 25, 2022 for the PLFSS for 2023, as well as the information made public on the draft decree currently under discussion, intend to set this period at an initial duration of 2 years. Renewal should be for 3 years. Renewal would be conditional on a reassessment of the teleconsultation company's compliance with specifications.

Compliance with health insurance reimbursement rules set out in the medical convention

Article L. 4081-4 of the CSP stipulates that, as with healthcare professionals and other healthcare operators, teleconsultation companies must comply with the "rules for reimbursement by the health insurance scheme set out in the medical convention".

The principle of respecting the care pathway is therefore applicable to teleconsultation companies(endorsement no. 6). This means that only teleconsultations carried out within the care pathway defined by law and the medical convention will be covered. The application of this principle responds in particular to the concerns expressed by the CNAM in its report on the misuse of telemedicine , in which it highlights the risks of "uberization" of teleconsultation.

The exception provided for in rider no. 6, whereby compliance with the care pathway can be set aside when the patient does not have a preferred doctor, may however be applicable under certain conditions set out in the same rider. This exception concerns the following situations: the patient does not have a designated attending physician, or his or her attending physician is not available within a timeframe compatible with the patient's state of health.

However, telemedicine is not unlimited. Ratification no. 9 of the French medical convention stipulates that telemedicine by a doctor covered by the convention may not exceed 20% of his or her total volume of activity covered by the convention over a calendar year. In the case of doctors not covered by the agreement (hospital doctors, salaried doctors, etc.), the proportion of telemedicine activity must remain in the minority.

In order to provide guidance to teleconsultation companies, the HAS has been entrusted with a new mission: to draw up a reference framework for good professional practice in teleconsultation, presenting criteria for the renewal of the accreditation of teleconsultation companies that apply for it, and proposing assessment methods for monitoring compliance with the reference framework, which is decisive for its renewal.

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GOOD PROFESSIONAL PRACTICE GUIDELINES FOR TELECONSULTATION PUBLISHED

Article L. 161-37 2° of the French Health and Social Security Code (CSS) has tasked the French National Authority for Health (HAS) with drawing up a set of best practices and assessment methods applicable to teleconsultation companies.

In order to fulfill this mission as effectively as possible, HAS launched a late public consultation from October 25 to November 15, 2023, to gather opinions and suggestions on the draft version of the organizations concerned by teleconsultation carried out by physicians employed by these companies. The referential was published on December 22, 2023 and is structured into 3 chapters:

• Chapter 1 - Organization for implementing teleconsultation. The teleconsultation company can use this chapter as a basis for its internal assessment.
• Chapter 2 - Carrying out teleconsultation, each user doctor employed by this company can refer to it for information on best practices.
• Chapter 3 - Teleconsultation quality system, every user-customer of this company will be able to find the expected quality and the teleconsultation process.

Please note that these criteria do not cover all the legal or contractual obligations with which the teleconsultation company must comply. These standards are in addition to the legal, regulatory, ethical and contractual requirements in force.

A "gradual" ramp-up announced

According to the information made public, the ad hoc status of these teleconsultation companies will be implemented progressively, and will therefore not be effective on January¹, 2024; the future decree has not yet been published. The decree should prohibit billing beyond the agreed sector 1 fees, and limit the number of doctors employed by a teleconsultation company to 20% of the total volume of agreed remote activity over a calendar year. Given that teleconsultation companies cannot change their business model overnight, a period of adaptation and transition should be provided to enable them to adapt to the new requirements.

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