In 2021, France approved the principle of rapid exceptional reimbursement of CE-marked digital medical devices ("DMD") for remote medical monitoring or therapeutic purposes (DTx). Entitled PECAN, this scheme only applies to prescribed DMD presumed to be innovative. France is at a crossroads, between, for example, Germany, the market leader and far ahead of the game in legal terms with its DiGA Verzeichnis, and Spain, on the other hand, which does not yet have any regulations but is preparing two texts that will address the issue of DMD in terms of reimbursement.
The framework defined by the French regime is that a DMD operator is entitled to launch its operational deployment, reimbursed on an exceptional basis, while finalizing an application for reimbursement under ordinary law, which must be submitted before the end of the transitional period in order to secure DMD reimbursement. By way of example, the UK has also developed a transitional system via the EVA system used by NICE, unlike the Netherlands, which has no transitional period reimbursement system for its DMDs.
What is changing in France these days is the publication of three new orders, dated October 25, signed by the Ministries of Health and Economy, which complete the pre-existing framework.
The first of the three new orders defines the specific information that prescribers must include on their prescriptions to enable DMD to be reimbursed. This information supplements that which must be provided verbally, notably concerning the anticipated and exceptional nature of the reimbursement.
The second order sets out the amount of financial compensation corresponding to the technical flat-rate tariffs that remunerate the operator, or retail distributor, providing the remote medical monitoring DMD and any associated collection equipment. These tariffs, which are monthly and non-cumulative, are set per patient, and complement those remunerating the operator carrying out the remote medical monitoring activity, defined by a previous order of May 2023, setting the flat-rate amount for the remote medical monitoring activity covered by French health insurance.
The third order allows the first DMD for remote medical monitoring to be reimbursed. In contrast, 55 DMDs are already listed and reimbursed in Germany.
In practice, it is unclear whether practitioners and patients will take advantage of these new DMN, despite these major regulatory changes.
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