The law aimed at improving the framework for French health care centers has finally been published!

Hogan Lovells

Hogan Lovells[co-author: Saliha Rhaimoura]

The French law n° 2023-378 of 19 May 2023 on the supervision of health care centers has finally been published in the Journal Officiel. The text, which has reached a consensus, was adopted without major changes. This text is the result of a politically-motivated desire to regulate health care centers, following various health scandals. The principal aim is to make health care centers more accountable to patients and public authorities, by naming "responsible persons" as well as increasing authorization requirements and penalties for failure to comply with set rules.

The law reinforcing the rules applicable to health centers or their branches providing dental, ophthalmological and orthoptic care was published in the Journal Officiel on Saturday 20 May 2023. This law incorporates most of the provisions of the bill initially tabled on 18 October 2022, aimed at strengthening the legal framework applicable to these structures, an analysis of which can be found here.

The law was definitively adopted by Parliament on 9 May 2023, following a vote in the Senate on second reading, based on the version unanimously adopted by the National Assembly on 28 March 2023.

The articles relating to the prevention of conflicts of interest, the identification of health care professionals by a personal number distinct from the structure, and the applicable sanctions regime were adopted in a version in line with that adopted by the National Assembly on second reading.

Indeed, the senators considered that it was in the best interests of both patients and the industry that the text should come into force as quickly as possible.

Since the draft law of 18 October 2022, a few changes have been adopted during parliamentary debates:

  • inclusion of orthoptic activities in the scope of application: the approval procedure has been extended to include orthoptic activities;

  • new compliance visit: the inspection visit, scheduled within the year following the issue of provisional approval, may be carried out by a person mandated by the Agence régionale de santé (ARS, French Regional Health Agency), which is not obliged to inform the health care center of his or her identity, so as not to give them the opportunity or the time to conceal elements that could reveal inadequacies;

  • publication of suspension and closure measures taken against health care centers: a national register will list health care centers affected by a suspension or closure measure. This register will be made available to all government departments and social security bodies, according to the law. A decree will specify the information contained in the register, and how it is to be implemented. This measure will undoubtedly enable the government services to better monitor the establishment of these health care centers across the country;

  • information on the deconvention of health care centers: with regard to the ban on requests for advanced payment of complete treatment, Parliament has amended the article initially set out in the bill to include a provision aimed at better informing patients in the event of a center being deconventioned by the health insurance scheme, which means that the French social security regime will not reimburse anymore the treatments and health care products provided to patients. The aim of this provision is to provide patients with more information on the progression of health care expenses and procedures not covered by the health insurance scheme;

  • patient records retention: in response to the problems encountered when certain health care centers were closed, and to the difficulties for patients to access their medical records, the manager of these centers is now obliged to inform the competent conseil départemental de l’Ordre (departmental council of the Order) of the measures taken to ensure the preservation of and access to these records by the patients.

This law, passed in the wake of several health scandals, provides for an initial strengthening of the rules governing dental, ophthalmological and orthoptic health care centers. However, this system is still largely based on the powers of the ARS and their ability to inspect the health care centers covered by the law. Even though this reinforcement seems to address certain identified needs, this law is likely notably a first step in strengthening the legal framework applicable to these health care centers and other similar structures.

A major point not directly addressed by the new law is the financial structuring of health care centers. In particular the interposition, in certain cases, of associative structures and commercial companies, which has already given been identified by the authorities as a major problem and has given rise to numerous discussions and debates. The question now is whether the new legal framework applicable to health care centers will radically change market practices in terms of financial structuring of these centers, or whether a new law will be necessary.

Next steps

Implementing decrees are still awaited, to complete the legal framework implemented to regulate health care centers. The government also has six months from promulgation of the law to submit a report to Parliament on the resources to be allocated to ARS to enable them to fulfill their new missions with regard to health care centers in accordance to this law.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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