Description
Here we describe the French healthcare system which is a centralised system with universal and mandatory coverage provided through Statutory Health Insurance (SHI), financed primarily through compulsory health insurance contributions (salary deductions and taxes) supplemented by government funding. The system features centralised policy setting and involves multiple institutional actors at both national and regional levels. At the national level, the Ministère de la Santé (MoH) oversees national health priorities, allocates budgets, and defines strategies for public healthcare, allocating funds to Regional Health Agencies (ARS) through its Directorate-General of Health (DGS). The Haute Autorité de Santé (HAS) is the main independent health authority, playing a central role in HTA and the evaluation of medical devices, including IVDs. Under HAS, three key committees lead HTA: the Commission de la Transparence (CT) assesses pharmaceuticals, the Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS) evaluates medical devices and health technologies for inclusion in the List of Reimbursable Products and Services (LPPR), and the Commission d’Évaluation des actes Diagnostiques (CEDiag), created in 2023, reviews diagnostic tests for inclusion in the NABM and CCAM coding systems and is dedicated to evaluating IVDs.
The Union Nationale des Caisses d’Assurance Maladie (UNCAM) coordinates France’s three main public health insurance schemes (Caisse Nationale d’Assurance Maladie (CNAM), Mutualité Sociale Agricole (MSA), and Régime Social des Indépendants/Sécurité Sociale des Indépendants (RSI/SSI)), setting reimbursement rates, negotiating national agreements with healthcare professionals, and representing SHI in discussions with HAS and CEPS. As the primary public health insurance fund, Caisse Nationale d’Assurance Maladie (CNAM) manages the régime général, covering the majority of residents. The Comité Économique des Produits de Santé (CEPS) negotiates the prices of reimbursed pharmaceuticals, diagnostics, and medical devices based on HAS evaluations. The Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) regulates the safety, efficacy, and market access of medicines and IVDs. The Santé publique France (French Public Health Agency) is crucial for public health surveillance, epidemiology, prevention, and crisis preparedness. At the regional level, Agences Régionales de Santé (ARS) implement national health policy, plan and organise care delivery, allocate resources to providers, oversee public health initiatives, and monitor service quality. The Institut National du Cancer (INCa) coordinates national cancer strategies and supports research, prevention, and diagnostics policy. It plays a pivotal role in coordinating funding through national cancer plans and establishing networks of excellence to strengthen cancer care and research infrastructure across France. INSERM (Institut National de la Santé et de la Recherche Médicale) complements this mission by advancing medical research and innovation. While INSERM contributes significantly to the scientific evidence base that may support reimbursement applications. Reimbursement for diagnostic tests in France is structured around the Nomenclature des Actes de Biologie Médicale (NABM) for laboratory tests, the Classification Commune des Actes Médicaux (CCAM) for technical procedures, and the Liste des Produits et Prestations Remboursables (LPPR) for medical devices, reagents, and test kits, particularly for ambulatory care. Innovative diagnostics may access temporary reimbursement via the Référentiel des Innovations Hors Nomenclature (RIHN 2.0) framework, which facilitates early access and interim funding while real-world evidence (RWE) is collected, typically for a limited period of 3 years. For inpatient settings, reimbursement operates through Tarification à l’Activité (T2A), based on Diagnosis-Related Groups (DRGs) known as Groupes Homogènes de Séjours (GHS), where hospitals receive a fixed bundled payment per patient stay covering all services, including diagnostics.
🎧 Listen: Navigating French Oncology – Access and Reimbursement for Diagnostics
