The Ministry of Labour, Health and Solidarity publishes the Ordinance of 22 April 2024 fixing the values referred to in Article R. 162-117 of the Social Security Code. of the financial compensation due for the advance assumption of liability by a digital medical device for therapeutic purposes
Article 1
The amount of the financial compensation ensuring the remuneration of the operator or retail distributor who makes the digital medical device available for therapeutic purposes, as provided for in Article R. 162-117 of the Social Security Code, shall be fixed as follows and shall comprise :
an initial lump sum of 435 euros including VAT, billable once for the same patient, for the actual use of the digital medical device for therapeutic purposes. the use of the digital medical device for therapeutic purposes for a period not exceeding 3 months;
a flat-rate fee, consecutive to the aforementioned initial flat-rate fee, which may be adjusted pro rata according to the billing frequency, on a monthly basis of EUR 38.3 including VAT.
The maximum amount of the financial compensation, consisting of the two categories of packages mentioned above, is EUR 780 including VAT per year per patient.
As an example, the calculation methodology is given in the appendix to this order.
Pursuant to Article R. 162-118 of the Social Security Code, the payment by the health insurance company of the financial compensation due for assuming responsibility for a dispensary in advance is subject to the following conditions
Annex
Example of calculation for determining the reimbursement rate for a medical device in application of Article 1 of this Decree. of Article 1 of this Decree:
For a digital medical device intended for therapeutic use, with a medical prescription and subject to the established conditions of use for a period of 6 months, in the event of actual use for the entire period, the total compensation received. period, the total compensation received is calculated as follows
435 + 38.30 + 38.30 = €549.90 INCLUDING VAT.