In its decision no. 2023-860 DC of December 21, 2023, the Constitutional Council ruled on the conformity with the Constitution of the provisions of Social Security Financing Act no. 2023-1250 of December 26, 2023 (LFSS) for 2024. Published in the Journal Officiel on December 27, 2023, the LFSS 2024 came into force on December 28, 2023, unless otherwise provided.
In terms of healthcare products, most of the provisions are not immediately applicable. Indeed, many implementing measures are expected, making the entry into force of the LFSS a real headache.
In order to facilitate the operational implementation of the LFSS 2024 for companies, we publish a timeline of the main measures that concern medical devices (MDs) and acts (see also our timeline of measures concerning pharmaceutical products).
You will find:
- In table 1, measures relating to market access, namely:
- requirement for a certificate of compliance with the Quality Charter for Professional Practices (“Charte de qualité des pratiques professionnelles”) (or a commitment to certification) for all products registered on the List of reimbursable Products and Services (LPP) (including products registered under generic line)
- creation of paybacks for MDs with a negative environmental impact
- introduction of a temporary certificate of compliance for the registration of certain products on the List of Medical Telemonitoring Activities (LATM)
- new restrictions on the reimbursement of MDs with a high public health or financial impact
- acts evaluation: opening the French National Authority for Health (HAS) self-referral to certain operators, and reducing the overall timeframe for acts evaluation
- opening provisional registration of non-innovative acts on the list of acts
- possible reinforced reimbursement of product categories with a single class
- In table 2, measures relating to regulatory, namely:
- dispensing limited to what is necessary for the duration of the treatment
- experimentation with the reprocessing of single-use medical devices (DMUUs)
- simplification of intra-group declarations
- In table 3, measures relating to sector-specific taxes, namely:
- safeguard clause related to medical devices (CS DM): payment schedule, recovery litigation, setting the Z amount 2024, rate of return
Table 1: Measures relating to market access
| Art. | Purpose of the measure | Immediate implementation | Implementing measures to be taken |
| Art. 56 | Certificate or commitment to certify compliance with the Quality Charter for Professional Practicesmandatory for all LPP products[1] (brand name + generic line) | NO | Decree setting the conditions and timeframe for certification commitments |
| Art. 66 | Creation of mandatory paybacks for MDs with negative environmental impact (See our article on this subject) | NO | Ministerial order setting the terms and conditions for paybacks |
| Art. 67 | Introduction of a temporary certificate of compliance for the registration on the LATM of MDs previously registered on the LPP | NO | – Conseil d’Etat decree defining the application of the measure – Decree determining the maximum duration of the temporary certificate |
| Art. 73 | Possibility of making reimbursement of MDs and products with a high impact (public health or financial) subject to a formulary ensuring the relevance of prescriptions | YES | / |
| Art. 74 | Proposal for self-referral of the HAS on the evaluation of an act open to operators of products (i) carrying the therapeutic or diagnostic action of the act and (ii) for collective use | NO | Regulatory text defining the terms and conditions of self-referral proposal |
| Art. 74 | Reduction in the overall timeframe for HAS evaluation of acts (elimination of extensions for complex evaluation) | YES | / |
| Art. 74 | Provisional registration on the list of acts open to non-innovative acts | YES | / |
| Art. 85 | Reinforced reimbursement possible even for product categories with a single class[2] | YES | / |
Table 2: Measures relating to regulatory
| Art. | Purpose of the measure | Immediate implementation | Implementing measures to be taken |
| Art. 53 | Dispensing of MDs and healthcare products limited to the needs for the duration of the treatment | NO | – Conseil d’Etat decree determining the specific terms and conditions – Ministerial order listing the products concerned |
| Art. 66 | 2-year experiment in reprocessing DMUUs | NO | Conseil d’Etat decree setting the date and conditions for implementation of the experiment (by 1 /11/2024 at the latest). |
| Art. 68 | Suppression of reporting obligations for non-manufacturers operators of LPP products when the operator and the manufacturer belong to the same group | Provision declared contrary to the Constitution by the Constitutional Council in its decision no. 2023-860 DC of December 21, 2023 | N/A |
Table 3: Measures relating to sector-specific taxes
| Art. | Purpose of the measure | Immediate implementation | Implementing measures to be taken |
| Art. 28 | Alignment of CS DM payment schedule with CS M in November | YES | / |
| Art. 28 | Application of the general rules of social security litigation to the recovery of CS DM | YES | / |
| Art. 28 | Setting the Z amount 2024 at €2.31 billion | YES | / |
| Art. 30 | Rate of return on CS DM[3] at 90% | YES | / |
[1] An exception is provided for if the pharmaceutical company declares on its honor that it does not carry out the activities covered by the Charter.
[2] The parliamentary activities have shown that the aim of this amendment is to ensure that wheelchairs are fully reimbursed by the health insurance and complementary health insurance, so as to remove any out-of-pocket expenses for people with disabilities.
[3] This concerns the CS DM due for 2024.
GD Avocats advises and supports companies in their market access and regulatory strategies. Contact us by e-mail: contact@gd-associes.com
