France

The French Ministry of Solidarity and Health constantly announces the new experiments initiated under Article 51 of the Social Security Financing Act. These experiments are focused on various topics concerning medical technologies and the organization of care. At the end of July, three new experiments related to the system of care for people with disabilities, families with overweight children, and homeless drug users were announced.

On July 30, 2021, the final version of the French DRG manual was published on the website of the Technical Agency for Information on Hospitalizations (ATIH). No new DRGs or other changes compared to the preliminary version published in March 2021 have been introduced.

On July 29, 2021, the French Ministry of Solidarity and Health published the instruction related to the 2021 application for coverage with evidence development programs. In the instruction, the specific fields of research, the application procedures, and the deadlines for applications for different types of projects (PHRC, PRME, PREPS, PRT) are specified.

On June 24, 2021, the list of awarded PHRC and PRME projects, submitted in 2020, was published. A total of 137 PHRC and nine PRME projects were awarded, and they concern various technology groups, such as gynecology, nephrology, neurology, cardiovascular, etc.

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 June 2021. Recommendations concern cardiovascular and peripheral vascular devices, orthopedic devices, liquid for embolization, and medical aids.

On June 18, 2021, the Ministry of Solidarity and Health published an Order in the Official Journal of the French Republic in relation to the innovation package (forfait innovation) for the test ONCOGRAMME aimed at predicting the effectiveness of chemotherapy with regard to non-operable metastatic colorectal cancer.

Transitional coverage of certain products and services (prise en charge (PEC) transitoire), according to article L165-1-5 of the Social Security, is a newly-established pathway to obtain reimbursement for CE-marked medical devices intended for the treatment of rare or serious diseases, or compensation for a disability. The coverage is provided for 12 months with an opportunity for renewal before submitting an application for inclusion in the List of Reimbursable Products and Services (LPPR).

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 May 2021. Recommendations concern orthopedic devices, cardiovascular, peripheral vascular, and neurovascular devices, medical aids, and pulmonary artery pressure sensor.

On March 31, 2021, the Order of the Ministry of Solidarity and Health on the 2021 DRG system was published in the Official Journal of the French Republic. The Order includes information on the 2021 updates of the DRG system, DRG tariffs, supplements for private and public hospitals, as well as the tariffs for specific packages (emergency treatment package, ATU; small equipment package, FFM; safety and hospital environment package, SE; administration package for pharmaceutical products, services, and specialties in a hospital environment, APE) applicable to the procedures performed in a hospital environment but without hospitalization, etc.

On March 22, 2021, the repository of innovative laboratory tests (RIHN) and the Supplementary list were published. No new codes for IVD tests have been introduced and no codes were removed in the new versions of catalogs.

On February 18, 2021, the updated List of Reimbursable Products and Services (LPPR) was published. It contains new devices included in the LPPR list in January-February 2021, as well as other modifications made during this period. The newly-included devices belong to the cardiovascular (TAVI), ENT (cochlear and brainstem implants), and diagnostic imaging (FFR) technology groups.

On March 1, 2021, the Technical Agency for Information on Hospitalizations (ATIH) published the preliminary version of the French DRG manual for 2021.