4 questions to prepare for reimbursement of your Medical Device*
If your solution is a medical device (MD), its reimbursement by the Health Insurance Fund can be a determining factor in ensuring its proper distribution in France
If your solution is a medical device, CE marking is a prerequisite for you to bring it to market. In addition to this market access requirement for your solution, its reimbursement by the Health Insurance Fund can be a determining factor in ensuring its proper distribution in France.
As early as the development phase of your solution, before obtaining CE marking, anticipating the possible reimbursement options will be decisive in saving time once your solution is ready to be distributed.
Therefore, identifying the possible reimbursement options for your solution is the starting point for knowing:
- How to proceed?
- Who to contact?
- And what will be asked of you?
Four key questions will help you determine your approach
Q1 In what context will my service be used?
There are different ways to cover the cost of medical devices, depending, among other things, on how the device is used:
- In outpatient environments, MDs for individual use used in the patient's home (outside of any hospital setting) can be reimbursed if they are listed on the LPPR, while those linked to a procedure carried out by a health professional are included in the fee for the procedure. When they are used for or during the performance of a professional procedure, MDs used outside any hospital setting are not subject to separate pricing; the procedure includes their fee. Such procedures are registered in the Common Classification of Medical Procedures (CCAM).
- Medical devices used in health care facilities are mainly paid for as a component of homogeneous blocks of stays (GHS), except for certain medical devices paid for above and beyond the GHS (in this case they are included on the list of products and services charged above and beyond hospital services, more commonly known as the "liste en sus").
For more information, two useful guides:
Q2 What is the optimal care organisation to implement my service?
Your digital solution may involve different players for its optimal use. Map the players and their roles with respect to your solution in order to:
- anticipate possible organisational changes relative to current standards of care
- take them into account in your development programme.
For example, your solution may require:
- a procedure by a health professional:
If so, check that the procedure required for its use does exist. Otherwise, you will have to plan for the creation of a new procedure.
This procedure will allow the relevant professionals to be paid.
- a non-medical service (technical service), whether it relates to an installation (at home for example, training in use, technical assistance or maintenance)
In such a case, it will be important to describe this in your reimbursability application when the time comes.
- intra- or inter-professional cooperation:
If so, please describe and anticipate:
- the various interprofessional interactions that may take place between the different players (interprofessional meetings, review of patient files, etc.);
- the coordination methods between the prescriber and the professionals monitoring the patient, if not the same;
- possible delegations of task(s) (specifying the existence of intra- and interprofessional cooperation protocols).
On that note, don't forget other questions to ask in order to cover the necessary usage environment:
- Which "parties" is the CMD intended (or designed) to interact with: other MDs and CMDs, data platforms, patients and their loved ones, health professionals, etc.?
- Is a learning phase necessary?
- Is it interoperable with the information system that has been designed to coordinate the care of health professionals?
It is important to anticipate this care arrangement in order to take it into account in your development and clinical evaluation programme.
Q3 Are there equivalent solutions already supported?
Equivalent solutions may be reimbursed individually via listing on the LPPR. This list is available on the Health Insurance Fund website AMELI.
If the CNEDiMTS, a specialised commission of the HAS, has evaluated it, you will find the opinion available for free on our website.
The reimbursement terms for solutions of the same type already on the market (these may be solutions of the same nature or with the same indication) will enable you to identify:
- the possible reimbursement options
- the terms and conditions for access to reimbursement
Q4 How do I demonstrate the medical value of my solution?
Whatever the medical device you develop, whether it is connected or not, the regulatory evaluation criteria for reimbursement by the Health Insurance Fund are the same. Depending on the purpose of the MD, these criteria take into account the therapeutic, diagnostic or disability-mitigating benefit of the MD, as well as its public health benefit. These benefits are demonstrated through clinical trials.
- To find out more about this issue, please read the CNEDiMTS’ evaluation principles. This document describes the methods and principles according to which the CNEDiMTS, the specialised commission formed by the HAS to evaluate medical devices, implements the evaluation criteria for health products to allow their reimbursement by the French National Health Insurance Fund. This document is regularly updated.
- Another complementary guide dedicated to the evaluation of "connected" medical devices can also be useful when building a clinical development plan best suited to your needs.
With these various documents, the CNEDiMTS has sought to provide you with useful reference points because, in addition to the legal obligation, it is very keen to provide insight into its evaluation principles and thus develop predictability when you go through the reimbursement process.
Two key points to start building your clinical development plan:
- The main challenge is for you to build a clinical development program that is consistent with the purpose behind using your solution, whether or not it is connected. For example, for any individual-use MD, it is necessary to assess its impact in terms of clinical benefit, acceptability or improvement in quality of life for the user; other impacts can also be sought, particularly in terms of the accessibility, quality and arrangement of care.
- The evaluation should focus on the technological solution as a whole, i.e. all the components collecting, processing and transmitting information remotely, if they do so, taking into account the care arrangement in place. In some cases, especially when some components are functional on their own, evaluating the CMD's own effect may be a challenge for the developer.