In brief

The Social Security Financing Bill (SSFB) for 2022, which is currently being examined by Parliament, contains several measures in the field of e-health. It notably defines the overall architecture and the different parameters for the financing of remote medical monitoring activities, including digital medical devices used in the course of these activities.

One key measure of the SSFB is the generalization of the coverage of remote medical monitoring by the health insurance.

Remote medical monitoring is defined by the French Public Health Code as an act of telemedicine "the purpose of which is to allow a medical professional to remotely interpret the data necessary for the medical monitoring of a patient and, if necessary, to make decisions relating to the care of this patient". Remote medical monitoring activities encompass two elements: medical monitoring as well as use of digital medical devices.

Currently, the reimbursement of remote medical monitoring is organized through an experimental phase (ETAPES program) concerning five chronic pathologies. With the COVID-19 health crisis, not only has the number of patients included in this program increased, but other parallel remote monitoring organizations have also emerged. This experimental phase will end by 1 August 2022. However, given that remote medical monitoring undeniably meets public health objectives, the SSFB contemplates to perpetuate and generalize the reimbursement of remote medical monitoring activities.

To this end, the SSFB defines which remote medical monitoring activities and which digital medical devices used in the context of these activities should be eligible for general financing by the health insurance. As such, only medical monitoring activities carried out by a "remote monitoring operator" declared to the competent regional health agency (ARS) should be eligible for reimbursement by the health insurance. Also, only CE-marked digital medical devices which "collect, analyze and transmit physiological, clinical or psychological data, and issue alerts when predefined threshold values are exceeded, and their collection accessories" should be eligible for coverage by the health insurance.

In order to be covered by the health insurance system, remote monitoring activities will be evaluated by the French National Authority for Health (HAS) and then registered on a new reimbursement list ("List"). Before approving the registration on the List, HAS will evaluate the existence of "an improvement in medical activities" either in relation to the same care activities without remote monitoring; or in relation to remote monitoring medical activities that are already covered by the health insurance system. After registration on the List, the appropriateness of admission for reimbursement will be assessed on an ongoing basis, subject to evaluation of the effective use of the digital medical device for remote monitoring by the patient and of patient data generated in the course of care against indicators defined by the HAS.

Finally, the SSFB enables the HAS to gradually withdraw medical monitoring activities registered on the List if they are considered to be less relevant from a medical standpoint.

This provision has not been adopted yet and is only a draft, but we can wonder whether such system would not impact patients that would have to adapt (again) to new solutions and would discourage companies from developing innovative solutions.