France is the first country in the European Union to establish a long-term framework for the reimbursement by Health Insurance of medical remote monitoring 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:
- an implementing decree from the Council of State on the procedures for assessment, registration for reimbursement and payment for medical telemonitoring activities ;
- a simple decree on the declaration of medical telemonitoring activities of operators to regional health agencies .
For the actors present in the experimental ETAPES framework, the transition is possible on July 1, 2023. The other remote monitoring solutions can now begin the procedures 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:
- The Digital Health Agency opened a counter in August 2022 to allow manufacturers to anticipate their procedures and start submitting their evidence;
- With an ad hoc organization for the evaluation of digital medical devices (contact: Guichetnumerique@has-sante.fr ), the Haute Autorité de santé offers companies support in compiling their file ( pre-submission meetings or meetings early ) which they can then deposit on a dedicated platform;
- Filing procedures on the ministry’s website for an application for registration as a brand name or for attachment to a generic line
- The filing of a medical telemonitoring activity file in the form of a brand or trade name is possible on the EVATECH platform
- The ANS offers a certification window
- Operators can find explanations and route guides on the G-Niux website