Article 51 LFSS 2018
Type of financing
Experimentation
Beneficiary
Medical device manufacturer
Context of use
Facility / City
Purpose of the system
Encourage, support and accelerate the deployment of innovative experimental healthcare organizations based on novel financing methods by derogating from many common law rules.
These experiments are applicable in the city as well as in hospital establishments or the medico-social sector, and aim to promote "pathway pricing" approaches and thus help to decompartmentalize the French healthcare system by encouraging cooperation between players.
Issues
Legal framework aimed at experimenting with and financing innovative organizations based on innovative financing methods favoring "route-based pricing" approaches.
Is this scheme right for my project?
Eligible are experiments involving innovation in healthcare pathway coordination, the relevance and quality of healthcare, social or medico-social care, the structuring of ambulatory care and access to care.
It does not allow experimentation with a technological device alone, and does not constitute early access to the market.
Type of financing
- Tarification, pay as you go.
Location of financing
- National (funding via FISS): Fonds pour l'innovation du système de santé, managed by the CNAM and dedicated to the financing of derogatory services for regional and national projects and the engineering of national projects, the evaluation of experiments (carried out by external service providers);
- Regional (financed via the FIR): Fonds d'Intervention Régionale (Regional Intervention Fund), in the hands of the ARS, it covers seed funding and engineering for regional projects Article 51 (These are funds intended to cover non-permanent costs incurred by the "good start" of the experiment, not covered by the derogatory services. Seed funding is used to finance costs relating to the project's ramp-up phase, while engineering funding (CI) is used to finance the additional costs of setting up and managing the project.
Amount of financing
The amount of funding depends on each experimental project, and must be detailed and justified in a financing plan (a financial table showing all the project's financial information). It is carefully studied by the Comité Technique de l'Innovation en Santé (CTIS).
Calendar / periodicity
Projects can be submitted as they come in on the platform of the ARS concerned or on that of the Ministry of Solidarity and Health, depending on the territorial scope.
Carrier type
- Collaborative project.
- The project is open to all players in the healthcare system:
- User associations, healthcare establishments (public or private), federations and unions, healthcare professionals, companies, homecare professionals, complementary organizations or local authorities can be project carriers - no restrictions on the legal status of project carriers.
Conditions to be met
- Receivability (purpose and need for derogation from common law)
- Innovative character
- Feasibility
- Reproducibility for dissemination
- Ratio quality/price (efficiency)
How to apply
- Via the national filing platform for projects concerning several regions.
- Via a regional filing platform for projects concerning a single region.
Consult the list of regional referents.
Find all the information you need to apply on the you have a project page.
Practical guide
All the questions you need to ask yourself, to tackle Article 51 properly.
Who's the right person to talk to?
- Regional contacts
For regional projects, the ARS are the entry point to help you design your experiment and support its implementation. ARS authorizes regional projects.
The primary health insurance funds (CPAM) work closely with the ARS to support you in building your project.
- National contacts
The Ministry of Solidarity and Health, and more specifically the National Support Team, steers the "Article 51" scheme. Each project is assigned a referent within the Ministry's National Support Team, who is the preferred contact for project sponsors and is responsible for monitoring project appraisal and implementation. She interfaces with the various Ministry departments involved in the project. An Article 51 team has been set up within the Caisse Nationale d'Assurance Maladie (Cnam). It monitors the appraisal and implementation of Article 51 projects.
I have an inter-regional project, who can I contact?
Interregional or national projects should be addressed to the national support team.
What steps do I need to take?
The 1st step is to submit a letter of intent (or pre-cahier des charges) to the ARS concerned (see ARS email list) or to the Ministry of Solidarity and Health (RG-ART51@sante.gouv.fr) or via dedicated submission platforms.
The letter of intent offers an initial description of the problem you see and the solution your project proposes. Over the course of exchanges and work, it will be transformed into specifications.
The letter of intent template is available on the Ministry website.
Do you know about Art 51 calls for projects?
Calls for projects (List of calls for projects) and calls for expressions of interest (List of calls for expressions of interest) may be launched.
When calls for projects are issued, players wishing to take part in experimentation, on the basis of defined specifications, complete the application file and forward it to the relevant authorities (most often, the Ministry and the regional health agency - ARS - concerned).
The technical committee and the regional health agencies may launch a call for expressions of interest in order to co-construct with players in the field a draft specification that best responds to concerns and takes into account existing constraints.
The draft specifications are then drawn up by a working group combining administrative staff and players from the healthcare, medico-social and social fields, selected at the end of the procedure.
How do I present my idea?
Check the relevance of your idea:
- Feedback from healthcare professionals
- Analysis of practices in other regions or countries
- Consultation of available literature
- Health care pathways for users, notably via improved coordination of players
- The efficiency of the healthcare system
- Access to care - prevention, healthcare and medico-social
Precisely formulate your problem
- What would you like to improve? What problems or bottlenecks does your experiment address?
- Who are you targeting? Users, healthcare professionals?
- What value proposition do you want to put in place?
How will you go about it?
- How do current care arrangements work? How is this insufficient?
- Who can help you spread the word about your solution?
- What type of prototype can you offer?
- What are your next steps?
What are the key success factors?
- Adopt a collaborative approach
- Propose a funding model that's as comprehensive and precise as possible
- Anticipate project evaluation and expected impacts
- Check eligibility for a waiver