France

In the middle of April 2023, the French National Authority for Health (HAS) published a decision modifying its internal regulations establishing the “Commission for the Evaluation of Diagnostic, Prognostic, and Predictive Technologies (CEDiag)”. This Commission is responsible for preparing the opinions and decisions of the HAS relating to the evaluation of health technologies for diagnostic, prognostic or predictive purposes.

On March 31, 2023, the Agency for Technical Hospital Information published the 2023 DRG tariffs and tariffs for other packages and supplements.

On March 31, 2023, the Ministry of Health and Prevention published the Decree in the Official Journal of the French Republic that defines an application process for the early coverage of digital medical devices for therapeutic purposes and medical telemonitoring by health insurance.

On March 24, 2023, the French National Authority for Health (HAS) announced a three-year experiment on the health economic evaluation of digital medical devices (DMD). This will allow manufacturers to voluntarily provide a budget impact analysis (indicating a cost-saving effect on the healthcare system) that can support the registration of their DMDs in the LPPR List and a pricing decision.

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in March 2023. Fifteen recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular and peripheral vascular, endocrine, endoscopy, gastrointestinal, surgical, and diagnostic imaging devices, as well as medical aids.

In the middle of March 2023, the updated version of the intra-DRG list was published. Changes include the introduction of several devices for thrombo-aspiration into the list and the deletion of a few devices from the list.

On March 17, 2023, the French National Authority for Health (HAS) published an update on its recommendations for techniques to be used within the organized breast cancer screening. HAS recommends introducing mammography by tomosynthesis in association with the reconstruction of a synthetic 2D image.

On March 2, 2023, the decision of the National Union of Health Insurance Funds relating to the update of the CCAM Nomenclature of procedure codes was published in the Official Journal of the French Republic. Changes include registration of new procedure codes, modification and removal of some existing codes. Newly introduced codes concern cardiovascular procedures, interventional radiology, orthopedics, peripheral vascular procedures, and others.

On March 8, 2023, the Ministry of Health and Prevention published an Order in the Official Journal of the French Republic on the coverage of the INTERVAPOR system for lung volume reduction under Forfait innovation program.

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in February 2023. Twenty-eight recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular and peripheral vascular, neurovascular, ophthalmological, spine, and orthopedic devices, surgical procedures, as well as medical aids.

On January 31, 2023, the Order approving Addendum 11 to the National Convention for Laboratory Directors was published in the Official Journal of the French Republic. The Addendum implements financial measures provided for by the Social Security Financing Act – reduces the reimbursement tariffs for the tests registered in the main reimbursement catalog for IVD tests in France Nomenclature of Medical Biology Acts (NABM).

The French National Authority for Health (HAS) released new recommendations about transitional coverage of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in January 2023. Two opinions were published regarding devices from two technology groups.