The Law No. 2023-378 of May 19, 2023 aims to strengthen compliance oversight of health centers, the number of which has grown since the prior approval required by the Regional Health Agencies (ARS) was replaced in 2009 by less stringent compliance declarations, leading to a number of health and administrative incidents.
The main measures introduced by the 2023 law include:
- The submission of required information prior to the opening of a healthcare facility by the legal representative of the managing entity to the Director General of the l’ARS(regional health agency), including the healthcare plan, declarations of conflicts of interest for all members of the governing body, and contracts between the managing entity and third-party companies.
- Improving the quality and safety of care by establishing a medical or dental committee responsible for regularly submitting its reports to the Regional Health Agency (ARS).
- Guarantees of transparency for patients by making information available on the premises and websites of health centers, including the precise identification and roles of all physicians and dental surgeons practicing there, whether on a part-time basis or as substitutes.
- Some information requirements in the event of a health center closure to be provided to (i) the Director General of the ARS, the director of the local health insurance fund, and the president of the departmental council of the relevant professional associations within 7 days in the event of an immediate closure or 15 days in the event of a planned closure, and (ii) to patients to ensure an organized and transparent transition of their care.
This decree is part of a series of reforms aimed at strengthening the oversight and regulation of healthcare centers, particularly following the adoption of the Valletoux Act on December 27, 2023. This act notably expanded the role of financial courts in the oversight of healthcare centers.
Among the points clarified by this decree are:
- The procedures for the certification of financial statements by a certified public accountant, which is mandatory for facilities with annual revenues exceeding 153,000 euros.
- The required documentation for the accreditation necessary to open a healthcare facility.
- The responsibilities and operating conditions of the medical or dental committee to meet the policy objective of continuously improving the quality, relevance, and safety of care.
- The creation of a national registry of suspension and closure measures for health centers, aimed, on the one hand, at ensuring the effectiveness of measures to suspend or close a health center and their effects, and, on the other hand, at facilitating the competent authorities’ ability to carry out their duties of monitoring and overseeing the activities of health centers.
There is a detailed schedule of administrative fines and penalty payments for violations, with an annual cap not to exceed 500,000 euros.
