PLFSS 2023 - What's new for health technology ?
The Social Security Financing Bill (PLFSS) for 2023 has been recently unveiled. This PLFSS is marked by a context of difficulties in access to care accentuated by the Covid-19 crisis and by the Government's desire to invest more widely in the field of prevention.
Some measures, that may be of interest for health technologies' Market Access, have been identified:
โ Creation of a contribution for high-growth drugs and high sales, extension of the scope of the safeguard clause, introduction of staggered payment for innovative therapies, strengthening of security of supply obligations.
โ Establish the distribution of value (product price, distribution/service margin) by simplifying the pricing methods for products and services on the LPP:
- Product price: bilateral negotiation between the CEPS and the device operator;
- Remuneration for distribution: set by regulation, as in the drug sector, following consultation between the ministers responsible for health and social security and representatives of distributors;
- Case of a service associated with the device: bilateral negotiation between the CEPS and the professional unions;
- Control of commercial discounts (as for drugs) -> transparency of the sector.
โ Improved market transparency: Declaration to CEPS by the operator (when not the manufacturer) of the price at which he buys the device from the manufacturer/wholesaler.
โ Request for reimbursement on the full scope of the CE mark:
- In case of request for reimbursement on a perimeter more restricted than that of the CE marking -> application of compulsory discounts set by ministerial order.
- Objective: to encourage manufacturers to apply for reimbursement on the entire scope of the CE mark.
โ Reinforce the control of devices generic lines :
- Simplification of administrative procedures for operators/distributors by eliminating the declaration to the ANSM.
- Control of compliance with the conditions of PEC of products and services by the CNAM.
- Strengthen the fight against fraud.
โ Improving data collection and conducting post-reimbursement studies: Implement mandatory discounts, indexed on the amount reimbursed for the specialty in case of non transmission of data related to an IPE within the required timeframe.
โ Ensure fair treatment:
In fast track reimbursement (PECT):
- Introduce a legal framework for the registration of the procedure in the CCAM by derogating from the common law procedure.
In Tele-monitoring:
- Payment of a registration fee (644€ to 3,220€).
- Postponement to July 1, 2023 (instead of January 1, 2023) of the changeover from the financing of the ETAPES experiment to common law financing (art. 36 of the LFSS 2022).
- The actor responsible for transmitting the digital solution's utilization data to the health insurance should be both the operator and the operator.
- New formulation of real-life monitoring indicators for these activities.
โ The implementation of prevention appointments at key ages of life, 20-25 years for primary prevention, 40-45 years for the prevention of chronic diseases, 60-65 years for the screening of the first fragilities or loss of autonomy.
โ Access without prescription and free screening for sexually transmitted infections for all and emergency contraception for all women.
โ Creation of an ad hoc status for teleconsultation companies to structure their activities.
โ Allowong the ministers in charge of social security to implement tariff cuts by regulation in the absence of a conventional agreement with the biology sector, allowing for savings of 250 million euros from 2023.