[co-author: Saliha Rhaimoura]
The French law n° 2023-378 of May 19, 2023 on the supervision of health centers has finally been published in the Journal Officiel. The text, which reached consensus, was adopted without substantial changes. This text is the result of a politically motivated desire to regulate health centers, following various health scandals. The main objective is to make health centers more accountable towards patients and public authorities, appointing “responsible” and increasing authorization requirements and penalties for non-compliance with established rules.
The law reinforcing the rules applicable to health centers or their branches that provide dental, eye and orthoptic care has been published in the Official Gazette Official Gazette Saturday 20 May 2023. This law transposes most of the provisions of the bill initially presented on 18 October 2022, aimed at strengthening the regulatory framework applicable to these structures, the analysis of which can be found Here.
The law was definitively adopted by Parliament on May 9, 2023, following a second reading vote by the Senate, based on the version unanimously adopted by the National Assembly on March 28, 2023.
The articles relating to the prevention of conflicts of interest, the identification of healthcare professionals by means of a personal number distinct from the facility and the applicable sanctions regime were adopted in a version in line with that adopted by the National Assembly in the second reading.
Indeed, the Senators felt it was in the best interests of both patients and industry for the text to go into effect as quickly as possible.
Since the bill of 18 October 2022, some changes have been adopted during the parliamentary debates:
inclusion of orthotic activities in the scope: the authorization procedure has been extended to orthotic activities;
new compliance visit: the inspection visit, scheduled within the year following the release of the provisional approval, can be carried out by a person appointed by the Regional health agency (ARS, French Regional Health Agency), which is not obliged to communicate its identity to the healthcare facility, in order not to give it the opportunity or time to hide elements that could reveal inadequacies;
publication of the suspension and closure measures adopted against healthcare facilities: a national register will register the health centers affected by a suspension or closure measure. This register will be made available to all government departments and social security institutions, according to the law. A decree will specify the information contained in the register and the methods of implementation. This measure will undoubtedly allow government services to better monitor the establishment of these health centers throughout the country;
information on the deconvention of health centers: with regard to the prohibition of requests for advance payment of complete treatment, Parliament modified the article initially envisaged in the bill by inserting a provision aimed at better informing patients in the event of disapproval of a center by the health insurance company, which it means that the French social security system will no longer reimburse the care and health products provided to patients. The objective of this provision is to provide patients with more information on the trend of health care expenses and procedures not covered by the health insurance scheme;
preservation of patient medical records: in response to the problems encountered during the closure of some health centers, and the difficulties for patients to access their medical records, the manager of these centers is now obliged to inform the competent departmental council of the order (departmental council of the Order) of the measures taken to ensure the conservation and access to these records by patients.
This law, passed in the wake of various health scandals, provides for an initial strengthening of the discipline of dental, ophthalmological and orthoptic health centres. However, this system is still largely based on the powers of the ARS and their ability to inspect health centers covered by the law. While this strengthening appears to respond to certain identified needs, this law is probably notably a first step towards strengthening the legal framework applicable to these health centers and other similar establishments.
An important point not addressed directly by the new law is the financial structuring of health centres. In particular the interposition, in some cases, of associative structures and commercial companies, which has already 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 centers will radically change market practices in terms of financial structuring of these centers or whether a new law will be needed.
The implementing decrees are still awaited, to complete the regulatory framework implemented to regulate health facilities. The government also has six months from the promulgation of the law to submit a report to Parliament on the resources to be allocated to the ARS to allow it to fulfill the new missions in the field of health centers pursuant to this law.
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