On December 4, 2023, the French National Assembly definitively adopted the Social Security Financing Bill (PLFSS) on final reading without voting.
Article 66 of the Social Security Financing Act (LFSS) 2024 introduces two measures aimed at reducing the environmental impact of MDs, including the introduction of a new mandatory payback mechanism[1].
Devices targeted
This mechanism targets MDs registered in the list of reimbursable products and services (LPP) under brand names:
- which would feature models, references, or packaging unsuitable for their prescription conditions or modes of use (significant volume, packaging in larger packs than the expected consumption, etc.);
- or which generate additional healthcare waste compared to similar products, procedures, or services addressing similar therapeutic objectives (single-use, limited lifespan with electronic components, etc.). This raises the question of what products, procedures, or services could be qualified as “similar” …
This would particularly apply to certain oral clinical nutrition products, ophthalmic solutions, products for continuous negative pressure treatment, or MDs from the “white range” (especially bandages).
However, the Government considers exempting products that have an impact (considering the added expected benefit (ASA) level, for example).
The assessment of negative environmental impact
As part of an application for inclusion, renewal, or modification of inclusion in the LPP, the French National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) would assess the suitability of the packaging and, if applicable, the quantity and type of additional healthcare waste produced.
In parallel with discussions on the PLFSS 2024, the French National Authority for Health (HAS) published on November 28 its Health-Environment Roadmap. For healthcare technologies[2], it notably recommends strengthening the assessment concerning packaging (to avoid waste) and integrating the environmental impact into the medico-economic evaluation.
The consequences on pricing
The French Economic Committee for Healthcare Products (CEPS) would then determine the paybacks owed on the amount reimbursed by health insurance.
From parliamentary work, it emerges that the payback rate would be progressive and could go up to 30%!
The payback rate will be determined based on criteria set by ministerial order. According to the Government, it could vary depending on the observed impact compared to the current reimbursement strategy or the type of additional healthcare waste generated[3].
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[1] By creating a new article L. 165-4-3 in the Social Security Code.
[2]A healthcare technology is an intervention that can be used to promote health, prevent, diagnose, or treat an illness, provide rehabilitation, or offer long-term care.
[3] Electronic, toxic, radioactive.
