Skip to main content

Market access for medical technologies in France

A brief overview of key market access pathways and challenges for medical devices, in-vitro diagnostic tests in France

sdfg

Key topics

There is only one key theme describing market access for medical technologies in France:

  • Reimbursement: payment mechanism via DRG system, add-on reimbursement via LPPR List

There is no separate funding (approval by the payer) or health technology assessment challenges in France. HTA is integrated into reimbursement decision-making. 

France has a number of innovative payment schemes for medical technologies. 

dx

Reimbursement

Reimbursements for hospital procedures are made solely via a DRG system, which is called “Groupe Homogène de Maladies” (GHM). All hospitalizations, as well as day case procedures and ambulatory treatments, are reimbursed via DRG.

The DRG system has several components.

Diagnosis-related groups:

  • Each DRG in the French system has four severity levels, from level 1 (lowest severity) to level 4 (highest severity). The severity level is determined by the length of the stay, the presence of complications, the type of procedure performed, etc. There are also DRGs for a short stay, which can cover hospital day care or one-day hospitalizations
  • DRGs are determined by the combination of a procedure code (CCAM) and a diagnosis code (ICD-10). 
  • DRG tariffs differ between public, private not-for-profit, and private for-profit hospitals. Private for-profit hospitals have lower tariffs, but physicians practicing there receive a fee for every procedure performed, based on fees determined for each CCAM code.

Add-on reimbursement (LPPR list):

  • This is an add-on reimbursement category for selected implantable (Title III) or invasive non-implantable (Title V) devices.
  • The LPPR list is primarily managed by the French National Authority for Health (Haute Autorité de Santé, HAS). The industry can either make a brand-specific or a generic application to request the inclusion of its products into the LPPR catalog. Technologies for which evidence is considered sufficient are listed, and their price is determined at the national level. The price is based on the level of added value the device provides compared to the current standards of care in France.
  • Clinical assessment is performed by National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS), and price negotiation is performed by Economic Committee on Healthcare Products (CEPS).
  • The DRG system is approved annually. The DRG system is administered by the Technical Agency for Hospital Information (Agence technique de l'information sur l'hospitalisation, ATIH). Neither the industry nor the providers have a direct impact on the development of the DRG system. However, some lobbying groups can have an impact.
111

Specifics for IVD tests

In-vitro diagnostic tests are reimbursed using a fee-for-service mechanism via NABM Nomenclature.

Innovative tests are funded by the Ministry of Labor, Health, and Solidarity  via RIHN and Supplementary List mechanisms. 

However, in 2023, the reform of this innovation framework was announced, and in spring 2024 the authorities announced the details of the reform. In the summer of 2024, the Ministry of Health released the 2024 List of IVD tests outside the Nomenclature (LAHN), which is the merged 2023 RIHN List and the Supplementary List, with a total of 616 tests. Currently, the French High Authority for Health (HAS) is evaluating expensive tests listed in the LAHN with the purpose of deciding whether these tests will be granted permanent reimbursement or will be excluded from coverage within the statutory health insurance. Cleaning the current AHN List will allow for the financing of truly innovative tests patients need. 

Finally, the authorities launched a new process for the registration of new innovative tests in the new List under the RIHN 2.0 framework.

MTRC has experience with more than 300 projects in France

News and insights

Recommendations about add-on reimbursement for medical devices in France in December 2024

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the December 2024 meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Three favorable opinions were published concerning the registration of new medical devices in the List of Reimbursable Products and Services (LPPR). They relate to breast reconstruction and medical aids.

New CCAM codes to be introduced in France

On December 24, 2024, the decision of the National Union of Health Insurance Funds (UNCAM) regarding the update of the CCAM Classification of procedure codes was published in the Official Journal of the French Republic. Changes include registration of three new procedure codes, modification of billing notes for certain procedures, and amendment of modifiers. The updates are expected to come into force on February 1, 2025.

New application process for coverage within the RIHN 2.0 framework in France

On November 29, 2024, the Ministry of Health and Access to Care published an Order outlining the requirements for application files to request coverage of innovative biology or pathology procedures within the new RIHN 2.0 framework. The Order concerns the application file model and list of supporting documents for coverage requests

Get in touch

Contact us to discuss your needs and learn about our services