Reimbursement Landscape in France
The purpose of this step is to understand the current reimbursement environment in France, relevant for your medical device. To do so, we will:
- Clarify the relevant type of coding systems (CCAM, LPPR, NABM), coverage policies, limitations and guidelines, relevant type of payment mechanisms, national (GHS, CCAM, LPPR or NABM) or by regional health agencies (ARS funding), applicable for the specific device or to any comparable products.
- Locate any specific reimbursement mechanisms that could be utilized by the device, as-is, or recommend on whether new mechanisms will have to be developed and if so, which mechanisms, for example, a new CCAM, LPPR or NABM code, or an application for inclusion in the LPPR extra list (liste en sus).
- Identify the main decision makers, lay out the typical path towards obtaining statutory (AMO) or complementary (AMC) reimbursement, including milestones and typical timelines and provide an initial reimbursement strategy for the device in France.
Reimbursement Planning for French Decision Makers
According to the conclusions in the Reimbursement Landscape, we devise the plan for developing the required evidence for French decision makers, such as the National committee for the evaluation of medical devices and health technologies (CNEDiMTS), the French national authority for health (HAS) or the healthcare products pricing committee (CEPS). This includes the development of:
- Value Story: Puts forward the claims for clinical and economic benefits associated with the use of the new device in the eyes of the relevant decision makers and would serve as the basis for the Economic Model.
- Economic Model: Highlights the economic benefits of the new device from the perspective of French decision makers. May identify specific outcomes data that should be added to future clinical study protocols.
- Clinical Data: Recommendations for adjustments and modifications of any planned clinical studies in order to generate the required reimbursement-related evidence for decision makers.
- Decision Makers' Feedback: Conduct interviews with the identified French decision makers to obtain their feedback regarding the developed value story, the economic model and the reimbursement aspects of the planned clinical study.
Implementation
Depending upon the existence, or the lack of, applicable reimbursement mechanisms (as identified in the Reimbursement Landscape step), we will conduct the following activities:
- Billing Guide: Develop a set of instructions guiding physicians and other healthcare providers how to obtain reimbursement following the use of the new device.
- Reimbursement Applications: Work with the relevant medical societies to apply for new reimbursement mechanisms, such as CCAM, LPPR or NABM codes, funding by regional health agencies (ARSs) or inclusion in the LPPR extra list (liste en sus).
- Pilot Projects: Initiate pilot projects with regional health agencies (ARSs).
- Other Funding Options: Apply for other or interim funding options, such as the separate fund for the missions of general interest and assistance to contracting facilities (Migac) or funding from the general directorate of health care provision (DGOS) through one of its medical innovation support programs.
