Remote monitoring – Signing of an agreement between the Ministry of Health and Prevention and representatives of operators of digital medical remote monitoring devices

Remote monitoring allows a medical professional to remotely interpret the patient’s health data, collected at their place of residence, and to make decisions relating to their care. Its advantages can be multiple (organizational, clinical), and its benefits represent real changes in the lives of patients and healthcare professionals.

The aim is thus to improve patient follow-up through interactive and personalized remote medical care, to prevent complications, in particular by limiting the risk of hospitalization, to improve their quality of life, to ensure care as close as possible to the place of residence and to strengthen the coordination of healthcare professionals around the patient.

The entry into common law of remote surveillance is the culmination of an experimental framework

Since 2014, telemonitoring has been the subject of an experiment, entitled “STAGES”, which has allowed its derogatory management in five chronic pathologies: diabetes, heart failure, renal failure, respiratory failure, and implantable heart prostheses.

At the same time, article 51 has allowed the implementation of experiments at the territorial level including remote monitoring, in the field of gestational diabetes, severe heart failure, or even in ophthalmology. These experiments, complementary to the framework of ETAPES, will provide data on the solutions and associated organizations.

Support for this successful organizational innovation through experimentation supported by the State is the result of joint work between health professionals and businesses.

France – Pioneer in common law coverage of remote monitoring

Thus, article 36 of the social security financing law (LFSS) for 2022 has created a unique model of common law support specific to remote monitoringcombining the remuneration of the medical follow-up carried out by a remote monitoring operator and that of the associated digital medical device.

In order to ensure the quality of care and patient safety, this care is subject to a favorable assessment by the French National Authority for Health and compliance of digital solutions with the interoperability and safety standards established by the Digital Health Agency.

Following discussions with the various stakeholders (representatives of industrialists and healthcare professionals), the negotiations resulted in a satisfactory agreement for all the players. This agreement is materialized in particular by the publication of tariff decrees defining the various packages provided, but also by the establishment of a monitoring committee to attest to our common desire to ensure the establishment and implementation of this activity under common law.

In parallel with these first negotiations, the ministry naturally wishes to finalize the work initiated with the professionals for the increase of certain complex treatments.

France is the first country of the European Union to establish a long-term framework for the reimbursement by Health Insurance of medical telemonitoring providing a clinical benefit or improving the organization of care. This major advance will allow patients to benefit from this new modality.

These tariff decrees complement an already existing regulatory framework following the publication of the implementing decrees in December 2022:

For the actors present in the ETAPES experimental framework, the transition is possible on 1is July 2023. The other remote monitoring solutions can now begin the process for registration with clear visibility of all the regulatory and pricing elements present.

Support for actors to access reimbursement

Remote surveillance players are supported in their efforts to obtain reimbursement for their solution:

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