4 questions to anticipate the reimbursement of my DM*.
If your solution is a medical device (MD), its reimbursement by the French health insurance system can be decisive in ensuring its proper distribution throughout France
.If your solution is a medical device, CE marking is a prerequisite to enable you to market it. Alongside this requirement enabling market access for your solution, its reimbursement by the Assurance maladie can be decisive in ensuring its proper distribution on the national territory.
As early as the development stage of your solution, upstream of obtaining CE marking, your anticipation of possible reimbursement channels will be decisive in saving time when your solution is ready for distribution.
From then on, identifying the possible repayment paths for your solution is the starting point that will enable you to know:
- how to proceed?
- who to contact?
- and what will be asked of you?
Four key questions will help you structure your approach
What will my service be used for?
Different reimbursement methods for medical devices coexist and depend, among other things, on how the device is used:
- In the city, individual-use DMs used in the patient's home (outside any hospitalization context) may be reimbursed thanks to their inclusion on the LPPR, while those linked to a procedure performed by a healthcare professional are included in the fee for service. When used for or during the performance of a professional act, medical devices used outside any hospital context are not priced individually; they are valued on the basis of the act performed. The latter is recorded in the common classification of medical acts (CCAM).
- MDs used in healthcare establishments are mainly financed through homogeneous stay groups (GHS), except for certain DMs financed in addition to the GHS (in this case, they are registered on the list of products and services reimbursed in addition to hospitalization services, more commonly known as "liste en sus").
For more information, 2 useful guides:
What is the optimal care organization for implementing my service?
Your digital solution may involve different players for its optimal use. Map the players and their roles around your solution in order to:
- anticipate possible organizational changes in relation to current standards of care,
- take them into account in your development program.
For example, your solution may require:
- an act by a healthcare professional:
If so, check that the act required for its use exists. If not, you'll need to anticipate the creation of a new act.
This act will enable the professionals concerned to be remunerated.
- a non-medical service (technical service), whether installation (at home for example, user training, technical assistance or maintenance)
In this case, it will be important to describe this in your claim file when the time comes.
- intra- or inter-professional cooperation:
If so, it will be necessary to describe and anticipate:
- the various interprofessional interactions that may take place between the different players (interprofessional meetings, patient file reviews, etc.);
- the coordination arrangements between the prescriber and the professionals providing patient follow-up, if they differ;
- possible delegation of task(s) (specifying the existence of intra- and interprofessional cooperation protocols).
On this topic, don't forget other points of questioning to scan the necessary environment of use:
- With which "interlocutors" is the DMC destined to (or designed to) interact: other DMs and DMCs, data platforms, patients and their entourage, healthcare professionals, etc.?
- Is a learning phase necessary?
- Is it interoperable with the information system designed to coordinate care by healthcare professionals?
It's important to anticipate this organization of care in order to take it into account in your development and clinical evaluation program.
Are equivalent solutions already supported?
Equivalent solutions may be reimbursed individually via a listing on the LPPR. This list can be consulted on the Assurance maladie website AMELI.
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If the CNEDiMTS, a specialized commission of the HAS, has evaluated it, you'll find the opinion available for free consultation on our site internet.
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 route(s)
- the procedures for accessing reimbursement.
How can I demonstrate the medical value of my solution?
Whichever medical device you develop, whether connected or not, the regulatory evaluation criteria for reimbursement by the French health insurance system are the same. Depending on the purpose of the medical device, they take into account its therapeutic, diagnostic or disability compensation benefits, as well as its public health benefits. The demonstration of these interests is based on clinical trials.
- To find out more about this component, consult the CNEDiMTS evaluation principles.This document describes the methods and principles according to which the CNEDiMTS, the HAS specialized commission for the evaluation of medical devices, implements the evaluation criteria for health products with a view to their reimbursement by the Assurance maladie. This document is regularly updated.
- Another complementary guide dedicated to the evaluation of "connected" medical devices may also be useful in building a clinical development plan best suited to your issues.
Through these various documents, the CNEDiMTS has thus wished to provide you with useful benchmarks because, over and above the legal obligation, it is very keen to provide visibility on its evaluation principles and thus develop predictability when you embark on a reimbursement process.
Two key points to get off to a good start in building your clinical development plan:
- The first challenge is for you to build a clinical development program that is consistent with the intended purpose of using your solution, whether or not it is connected. For example, for any DM for individual use, assessment of its impact in terms of clinical benefit, acceptability or improved quality of life for the user is necessary; other impacts may also be sought, notably in terms of access to care, quality of care, and organization of care.
- The assessment must focus a priori on the technological solution as a whole, i.e. all the components collecting, processing and transmitting information remotely if this is the case taking into account the care organization in place. In some cases, particularly when certain components are functional in their own right, assessing the DMC's own effect may be a challenge for the developer.