France

On January 18, 2021, a new version of the List of Reimbursable Products and Services (LPPR) was published. It contains new devices included in the LPPR list in November-December 2020, as well as other modifications made during this period. Newly-introduced devices belong to the cardiovascular (coronary stents), orthopedic, neuromodulation (deep brain stimulation), peripheral vascular (stent-grafts to treat aortic abdominal aneurysm), and other areas of care.

On December 30, 2020, the French National Authority for Health (HAS) published a report "Economic evaluation of telemonitoring to inform public decision-making", based on the systematic literature review. According to the results of the review, telemonitoring can be considered as a way to improve the organization of care and reduce care costs.

On December 31, 2020, the French National Authority for Health (HAS) published a methodological guide clarifying aspects related to the organizational impact of health technologies under the evaluation. As the organizational impact can be documented when submitting an evaluation file for a drug, medical device, or a procedure, the guide aims to define the types of organizational impact and to propose criteria to measure these effects.

On December 16, 2020, the Ministry of Solidarity and Health issued a few Orders on the registration of certain endoprostheses by Cook Medical in the List of Reimbursable Products and Services (LPPR) for add-on reimbursement. Conditions of reimbursement for vascular endoprostheses were specified.

On November 27, 2020, the National Committee for the evaluation of medical devices and health technologies (CNEDiMTS) at the French National Authority for Health (HAS) released a recommendation about the registration of flash self-monitoring glucose system FREESTYLE LIBRE 2 in the LPPR list.

In November 2020, the new intra-DRG was published on the website of the French Ministry of Solidarity and Health. A new chapter was added for urogenital implants - “Implantable devices for the treatment of female stress urinary incontinence.”

On October 16, 2020, the Order of the Ministry of Solidarity and Health in relation to the new experiment on reinforced support for the elderly people (DRAD) was published in the Official Journal of the French Republic. The experiment offers a solution to elderly people with loss of autonomy who wish to stay at home, for whom "classic" support from home services is not more sufficient.

On October 14, 2020, the French National Authority for Health (HAS) announced the ongoing update of the submission file guides to support companies who requested reimbursement for medical devices with a system of machine learning (artificial intelligence).

On October 15, 2020, the French National Authority for Health (HAS) published the report “New techniques of bariatric surgery: identification, the status of advancement and opportunities to evaluate,” in which they outlined three techniques currently diffusing in France (SADI-Sleeve, Endosleeve, and Sleeve Gastrectomy with Transit Bipartition). All three methods are the subject of ongoing clinical studies, and the evaluation will be initiated at the end of these studies.

On October 11, 2020, the French Ministry of Solidarity and Health published an Order in the French Official Journal relating to the coverage of CARMAT TAH by innovation package for the period of 48 months from the date of the beginning of the trial.

On August 6, 2020, the Ministry of Solidarity and Health published an Order (of August 4, 2020) listing the rotational atherectomy systems ROTAPRO and ROTALINK PLUS of the company Boston Scientific under Title V of the list of reimbursable products and services provided for in Article L. 165-1 of the Social Security Code (LPPR List).

At the beginning of August 2020, the French National Authority for Health (HAS) issued a favorable opinion on the inclusion of the genome detection of SARS-CoV-2 by gene amplification on saliva samples to the innovation package (forfait innovation) according to the article L. 165-1-1 of the social security code. The package is approved by the Ministry of Solidarity and Health, after consultation with HAS.