France

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.

In July 2020, the French National Authority for Health (HAS) issued an update of the methodological guide for the economic evaluation of medical technologies. The main changes aimed to improve the interpretation of the results and the uncertainty, to clarify technical points, and to integrate methodological changes that have occurred since 2011.

The French National Authority for Health (HAS) released new decisions about intra-DRG reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in July 2020. Decisions concern cardiac sutureless valve bioprostheses and implantable devices for the treatment of urinary incontinence.

The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of many medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in August 2020. Decisions concern cartilage implant, energy return prosthetic feet, and Yttrium-90 microspheres.

The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of many medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in July 2020. Decisions concern drug-eluting coronary stents, TAVI, orthopedic appliances, wound dressing, stoma obturator, toric intraocular lens.

On the 28th of July 2020, in the Official Journal of French Republic (JORF), an Order for the inclusion of the web application MOOVCARE POUMON intended for the medical telemonitoring of relapses and complications in patients with non-progressive lung cancer in the French List of Products and Healthcare Services Qualifying for Reimbursement (LPPR) was published. The application is already included in the LPPR list in section 1, “Materials and treatments in the home, dietary products, items for dressings,” chapter 1, section 7, and a specific sub-section 7, which has been created for web applications and software for remote monitoring.

The French High Authority for Health (HAS) develops national diagnostic and care protocols whose objective is to guarantee the quality and safety of care delivery within the French setting. In the first half of 2020, national diagnostic and care protocols have been developed for eighteen topics.