Article 51 LFSS 2018

Type of financing

Experimentation

Beneficiary

Medical device manufacturer

Context of use

Facility / City

Objective

Encourage, support and accelerate the deployment of innovative experimental health organisations based on new financing methods that depart from many of the health care system's standard rules.

These experiments are applicable both for outpatient services as well as in hospitals or the social care sector and are intended to promote "fee-for-value" approaches and thus make it possible to decompartmentalise the French health system by encouraging cooperation between stakeholders.

Go to the Ministry of Health website

Issue

Legal framework for experimenting with and financing innovative organisations based on innovative financing methods that promote "fee-for-value" approaches

Is this scheme suitable for my project?


Experiments involving innovation in the coordination of courses of treatment, the relevance and quality of health, medical, or social care, the structuring of outpatient care and access to care are eligible.

It does not allow for the testing of a technological device alone and does not constitute early market access.

Ce dispositif s'adresse -t-il à mon projet ?

Sont éligibles les expérimentations portant une innovation concernant la coordination du parcours de santé, la pertinence et la qualité des prises en charge sanitaire, sociale ou médico-sociale, la structuration des soins ambulatoires et l’accès aux soins.

Il ne permet pas d’expérimenter un dispositif technologique seul et ne constitue pas un accès précoce au marché.

Type de financement

  • Tarification, versement au fil de l'eau.

Localisation du financement

  • National (financement via le le FISS) : Fonds pour l’innovation du système de santé, géré par la CNAM et dédié au financement des prestations dérogatoires des projets régionaux et nationaux et à l’ingénierie des projets nationaux, à l’évaluation des expérimentations (effectuée par des prestataires externes) ;
  • Régional (financement via le FIR) : Fonds d’Intervention Régionale, à la main des ARS il prend en charge les crédits d'amorçage et d'ingénierie des projets régionaux Article 51 (Il s’agit des crédits destinés à couvrir des frais non pérennes engendrés par le "bon démarrage" de l’expérimentation, non pris en charge par les prestations dérogatoires. Les crédits d’amorçage permettant de financer les coûts relatifs à la phase de montée en charge du projet, les crédits d’ingénierie (CI) permettant de financer les surcoûts relatifs au montage et au pilotage du projet).

Montant du financement

Le montant du financement dépend de chaque projet d'expérimentation et doit être détaillé et justifié dans un plan de financement (tableau financier retraçant l'ensemble des informations financières du projet). Il est étudié attentivement par le Comité Technique de l’Innovation en Santé (CTIS).

Calendrier / périodicité

Les projets peuvent être déposés au fil de l'eau sur la plateforme de l’ARS concernée ou sur celle du ministère des solidarités et de la santé en fonction du champ d’application territorial.

Type of project leader

  • Collaborative project.
  • The system is open to any actor in the health system:
  • Users' associations, health facilities (public or private), federations and unions, health professionals, companies, homecare professionals, complementary organisations or local authorities can be project leaders. There are no restrictions on the legal form of project leaders.

How to apply

  • National filing platform for multi-region projects
  • Regional filing platforms for single-region projects

See the list of regional contacts via this link

Comment se porter candidat ?

  • Via la plateforme de dépôt national pour les projets concernant plusieurs régions.
  • Via une plateformes de dépôt régionaux pour les projets concernant une seule région.

Consultez la liste de référents en région.

Retrouvez toutes les informations pour candidater sur la page vous avez un projet.

Practical guide

All the questions to ask yourself in order to approach Article 51

Who is the right person to contact?

  • Regional contacts

For regional projects, the ARS are the entry point to help you develop your experiment and support its implementation. The ARS authorise regional projects.
The primary health insurance funds (CPAM) work closely with the ARS to support you in building out your project.

  • National contacts

The Ministry of Health, and more specifically the national support team, is piloting the "Article 51" scheme. Each project is assigned a contact person within the Ministry's National Support Team, who is the main contact for project leaders and is responsible for monitoring the project's appraisal and implementation. That person provides the interface with the various Ministry agencies affected by the project.
An Article 51 team has been set up within the Caisse Nationale d'Assurance Maladie (CNAM). It shall monitor the appraisal and implementation of Article 51 projects.

I have an interregional project, who should I contact?

Interregional or national projects should be addressed to the National Support Team

What steps must be followed?

The first step is to submit a letter of intent (or preliminary specifications) to the relevant ARS (see ARS email list) or to the Ministry of Health (RG-ART51@sante.gouv.fr) or via the dedicated submission platforms.

See the platforms’ addresses

The letter of intent provides an initial description of the problem you see and the solution your project is proposing. Over the course of the discussions and the work, it will be translated into specifications.

The template for the letter of intent is available on the Ministry's website

Do you know the Art 51 calls for projects?

Calls for projects (List of calls for projects) and calls for expressions of interest (List of calls for projects) may be launched

During the calls for projects, providers wishing to participate in the trial, on the basis of defined specifications, fill out the application file and send it to the competent authorities; most often, they are the Ministry and the relevant Regional Health Agency (ARS).

The technical committee and the Regional Health Agencies may launch a call for expressions of interest in order to co-construct, with local players, a set of draft specifications that best address the concerns and take account of existing constraints.

The draft specifications are then drawn up by a working group made up of administrative staff and stakeholders from the health, medical, and social care fields, selected at the end of the procedure.

How do I present my idea?

Check the relevance of your idea:

  • Get feedback from health professionals
  • Analyse practices in other regions or countries
  • Read the available literature
  • Users' courses of treatment, in particular through better coordination of those involved
  • The efficiency of the health system
  • Access to care - prevention, health and social care.


State your problem clearly

  • What would you like to improve? What are the problems or bottlenecks that your experiment addresses?
  • Who are you targeting? (Users, health professionals)
  • What value proposition do you want to put in place?

How will you do it?

  • How do current care arrangements work, how are they inadequate?
  • Who can help you distribute 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 is as comprehensive and accurate as possible
  • Anticipate the project’s evaluation and the expected impacts
  • Check eligibility for a special exception

Find out more