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Article 51

Article 51 Agency Consulting firm Experts Specialists Consultancy

The opportunities offered by article 51 of the 2018 French Social Security Financing Law (LFSS) are numerous. Project leaders can offer experimentation with new care pathways (whether or not incorporating new tools), new funding methods, or promote better use of healthcare products. All this with the aim of improving the current healthcare system and providing the best possible support for patients. Thanks to its in-depth knowledge of the system, Alcimed supports its clients in the construction of their projects with a view to the successful submission of their experiment within the framework of Article 51.

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    The challenges related to article 51

    Article 51 offers healthcare players the opportunity to test new approaches by deviating from the usual rules of organization and financing. The aim is to promote innovative organizations that contribute to improving patient care, healthcare system efficiency, access to care and the pertinence of healthcare product prescriptions. This new financing tool necessarily raises a number of questions:

    Within the framework of this article of law 51, there is no restriction on the nature of the project leader. The project leaders can be user associations, public or private healthcare establishments, federations, unions, healthcare professionals, start-ups, home care professionals, complementary organizations or local authorities. In addition, this system is applicable to the public and private sectors, local medical care and hospitals, as well as to the medico-social sector. Although the framework is broad, it is necessary to have a real strategic reflection on the contours of the project, its innovative character, its purpose and its partnership model.

    A great deal of latitude is given on paper: the experiments can be local, regional, interregional or national (although this last option is not often used). The duration of the experiment can vary from a few months to a maximum of 5 years. This therefore requires making choices to build the best model in relation to the identified need.

    Article 51 is based on a Test & Learn approach. First, the experiments are tested, then with the help of an evaluation throughout the experiment, lessons are learned and the model is adjusted accordingly. Levers for optimizing the healthcare system are to be identified with the aim of generalizing the experiment and integrating it into common law. The evaluation is carried out throughout the implementation of the project and at the end of the experiment, with co-piloting by the DREES, the CNAM and the Ministry of Solidarity and Health. It is based on the construction of performance indicators, on qualitative approaches and on comparative methods to assess the impact of the experiment.

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      You have a project and want to discuss it with our explorers, write us!

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      How we support you in your projects related to article 51

      Alcimed supports its clients at all stages of the construction of their projects: to better understand the way in which you can seize the system of Article 51, to reflect on your project and draw its outlines, to identify the partners (including public-private partnerships) and the best strategy to adopt to set up a winning project, or to organize the drafting and submission process of your project in connection with regional and national authorities.

      Examples of recent article 51 projects carried out for our clients

      • Structuring of Article 51 projects with 10 ARS in France as part of a framework agreement

        Alcimed is referenced by 10 ARS to support project leaders in structuring their responses at the regional level.

        Our consortium works with project leaders to help them define the objective of the project, identify partners, formalize the ambition, the objectives or even the project management scope and support the translation of these different elements within the framework of the letter of intent to be produced.

        We can also provide more in-depth support to build the specifications by working on discussions with ARS and CPAM, and in particular by defining the scope for financing and evaluating the experiment until it is authorized.

      • Support for the CNAM's Accelerator 51

        Our team works at the national level within a consortium in charge of piloting and running Accelerator 51, a collaborative innovation system co-supported by Health Insurance and the Ministry of Health aimed at accelerating and developing projects in the form of intensive collective intelligence sessions.

        Our consortium is involved both in the continuous optimization of the operating processes of this Accelerator to guarantee efficient support adapted to the projects that need it, and in the realization of preparatory sessions and workshop sessions aimed at consolidating the projects until their authorization for experimentation.

        We also provide an enlightened view of the overall functioning of the Article 51 system and the innovative projects supported within it.

      • Structuring of various Article 51 projects alongside various project leaders

        We have supported various project leaders (public actors, start-ups, medico-social establishments, industrial players, etc.) in setting up their letter of intent and their specifications on topics as varied as support for the identification and compensation of sensory deficits, the healthcare pathway for caregivers, the fertility pathway, innovation in the assessment of loss of autonomy (AMI ICOPE), improvement of the pathway to access technical aids (AMI EqLAAT) and many other projects!

      • Support in drawing up a detailed application to open hospital-at-home (HAH) beds, with a view to submitting an Article 51 dossier to the Agence Régionale de Santé (ARS)

        Alcimed helped the Oncology Unit of a University Hospital Center (CHU) identify a funding window to launch its project to open home hospitalization (HAD) beds. Article 51 had already been identified as one of the funding windows pre-focused by the project leader.

        Our team began by assessing whether it would be appropriate for the promoter to submit an Article 51 application for his project. To do this, we carried out a benchmark of other HAH bed projects in France, in particular to identify how they had been financed.

        This support enabled the promoter to confirm the relevance of turning to the Article 51 window to finance this project, and to have a very clear argument to submit to the ARS in order to optimize his chances of obtaining funding.

      • Training of the team of a pharmaceutical organization to understand the stakes of an article 51 dossier

        Alcimed trained the staff of a major pharmaceutical group to understand Article 51, both in terms of the dossier’s content and its applicability to the group’s innovation projects.

        To this end, we organized a full day of training. The first part focused on the Article 51 file: legal framework, eligibility criteria, content and conditions for submitting the file, evaluation criteria, financing methods, etc. The second, more operational part enabled the group’s employees to examine real case studies, based on in-house innovative projects, and to assess the eligibility of these projects for an Article 51 file. This training provided our customer with all the theoretical and practical elements needed to make an informed decision on whether or not to submit an Article 51 application for one of the projects worked on during the day’s case studies.

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        To go further

        Founded in 1993, Alcimed is an innovation and new business consulting firm, specializing in innovation driven sectors: life sciences (healthcare, biotech, agrifood), energy, environment, mobility, chemicals, materials, cosmetics, aeronautics, space and defence.

        Our purpose? Helping both private and public decision-makers explore and develop their uncharted territories: new technologies, new offers, new geographies, possible futures, and new ways to innovate.

        Located across eight offices around the world (France, Europe, Singapore and the United States), our team is made up of 220 highly-qualified, multicultural and passionate explorers, with a blended science/technology and business culture.

        Our dream? To build a team of 1,000 explorers, to design tomorrow’s world hand in hand with our clients.

        The 2018 French Social Security Financing Law introduced, in its Article 51, a system allowing testing of new healthcare organizations based on new funding methods. The objective is to promote innovative organizations contributing to improving the patient pathway, the efficiency of the healthcare system, access to care and even the relevance of the prescription of healthcare products.

        Article 51 projects submitted go through an iterative and rigorous selection process, in four main stages:

        • The submission of the project by the project leaders
        • The first selection filter by the General Rapporteur or the Regional Healthcare Agency (ARS)
        • The review by the technical committee made up of all the directors of the Ministry, a Director General of ARS and the director of the National Union of Health Insurance Funds (UNCAM)
        • Authorization by ministerial order or by order of an ARS DG

        Any legal entity can submit an Article 51 application. The profile of project sponsors is very open, and it is not necessary to have a specific legal status to be eligible. Article 51 is equally accessible to :

        • User associations,
        • Healthcare establishments (both public and private),
        • Federations and unions,
        • Healthcare professionals,
        • Startups, Homecare professionals,
        • Healthcare manufacturers,
        • Supplementary organizations and local authorities.