May 20, 2022
The list of products and services (LPP) contains all the products, care and medical procedures that are reimbursed by the French health insurance system . The article L. 165-1 of the Social Security Code states that : "R eimbursement by the health insurance scheme of medical devices for individual use, tissues and cells derived from the human body, whatever the degree of transformation, and their derivatives, health products other than medicines referred to in Article L. 162-17 and associated services and adaptations is subject to their inclusion on a list drawn up after the opinion of a commission of the High Authority for Health referred to in Article L. 161-37 ". Registration on the list of reimbursable products and services (LPPR) provided for in Article L.165-1 of the Social Security Code is the result of a decision by the Minister responsible for Social Security and the Minister responsible for Health, following the opinion of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). In order to obtain registration on the LPP, an application file must be submitted according to a specific procedure (I). In addition, the file must contain elements that will allow the administration to make a decision (II). Finally, the judges have to interpret the legal criteria for the registration on the LOB (III). I) Filing the application for registration The application file to the CNEDiMTS is dematerialized and is done via the SESAME platform. To submit a file, you must first create an access account with the corresponding form, to which a maximum of two people will have access. They will be the account managers. To create this account, you need the company's SIRET number and a certificate signed by its legal representative delegating the persons mentioned to be "account managers". The registration request file must include three parts : Part 1: summary and identification of the application ; Part 2: medico-technical file ; Part 3: economic file Parts 1 and 2, which include the identification of the application and the "medico-technical" file , must be submitted to the CNEDiMTS via the SESAME platform, which will issue an advisory opinion. At the same time, t he entire economic section must be submitted directly to the Comité économique des produits de santé (CEPS), which will set a price and a tariff. A fee of 3220 euros must be paid. II) The content of the registration application A) The documents making up the file 1/ Identification of the application : To identify the application for registration in the LPP, it will be necessary to inform : The applicant : this is the manufacturer, agent or service provider, the single correspondent or the signatory of the agreement with the CEPS. The administrative information such as the CE marking for example. The type of the request , i.e. whether it is a registration, a modification or a renewal. The product or service concerned : if it concerns a product or a product associated with a service. 2/ The medico-technical file : The medico-technical file that is required generally includes: Descriptive information about the product with technical characteristics. A description of the mode of action on the pathology or disability. In case of use of the medical device, a description of the associated acts, services and organizational aspects is required. Identification and selection of available clinical data , i.e. a systematic literature search, but also a post-registration study. A demonstration of the expected and rendered service claimed by the applicant with the interest of the product, the concerned pathology, the therapeutic alternatives or the compensation of the current handicap, an analysis of the available data and the quality of the demonstration, the ongoing studies, the place of the product in the therapeutic strategy. The medico-technical file must also contain : A "public health interest" section , with the transferability of trial results to practice, the potential impact on the health of the population, the foreseeable impact on the organization of care, the foreseeable impact on public health policies and programs. A section on the applicant's proposals on the conditions of prescription and use. A section on the demonstration of the improvement in the expected and rendered service. A "target population" section , which is the population likely to benefit from the product or service. More specifically, a quantitative estimate must be made for each indication. The step-by-step reasoning must be shown : The population corresponding to the targeted pathologies The proportion of patients diagnosed The proportion of patients likely to be managed The proportion of patients likely to be affected by the medical device. In addition to this, a table summarizing material safety data from France and abroad over a period of 5 years is requested, as well as an appendix containing the clinical data on which the argument is based and a summary of the general documents attached to the application. 3/ The economic file : The economic file is composed as follows : For non-generic medical devices : 10 USB sticks and a paper version are required. The content of the files on each USB stick consists of a letter of application for marketing authorization and its amendments, economic file, transparency file, possible annexes and bibliography. For generic medical devices : 8 USB keys and a paper version are required. The content of the files on each USB key contains a marketing authorization application letter and its corrections and a price request form. B) Substantive conditions to be fulfilled The article R165-2 of the Social Security Code states that in order to be included on the list, the expected service of the product or service must be evaluated " according to the following criteria : 1° The interest of the product or service with regard to, on the one hand, its therapeutic, diagnostic or disability compensation effect as well as the undesirable effects or risks associated with its use, and on the other hand, its place in the therapeutic, diagnostic or disability compensation strategy, taking into account other therapies or means of diagnosis or compensation available; 2° Its expected public health interest, including in particular its impact on the health of the population, in terms of mortality, morbidity and quality of life, its capacity to meet a therapeutic, diagnostic or disability compensation need that is not covered, taking into account the seriousness of the pathology or disability, its impact on the health care system and its impact on public health policies and programs. Products or services whose expected service is insufficient to justify registration for reimbursement are not included in the list . " III) The interpretation of the legal criteria by the French High Administrative Court In a ruling dated December 31, 2019 (no. 420255), the High Court indicated that any medical device whose file includes the data that allowed it to obtain the CE mark is not " automatically registered on the list of reimbursable products and services " . In a judgment date d July 24, 2019 (No. 419447) , the High Court ruled with regard to the criterion concerning "public health interest" that " a weak symptomatic effect " of the medical device is not sufficient to justify its registration for reimbursement. Similarly, the High Court ruled that the opinion of the CNEDiMTS, which "considered that the expected service of this device was sufficient for registration on the list of products and services mentioned in Article L.165-1 for three years, while deeming the improvement of the expected service to be minor " does not justify registration on the list of reimbursable products and services. (Ruling of 06/05/2019, n°415410). If you wish to apply for registration for one of your products or services in France , contact our team .