List of products and services (LPP)
Type of financing
Common law
Beneficiary
Medical device manufacturer
Context of use
City
Purpose of the system
Any product or service listed on the list of products and services (LPP) is covered by Assurance Maladie.
This list includes, for example: medical devices intended for the diagnosis and treatment of illnesses and injuries, aids to daily living, dietary foods, external prostheses, implantable medical devices (DM), digital DM, etc. This list does not include medicines.
Issues
Registration on the LPP allows direct reimbursement of the product or service by the Assurance Maladie (otherwise known as common law financing).
Is this scheme right for my project?
Any medical device distributed in the city or hospital that can demonstrate a therapeutic, diagnostic or disability compensation added value. Only mature solutions in terms of clinical evaluation are eligible.
Type of financing
- Price per unit: The LPPR defines a reimbursable amount for each product that makes it up.
Please note: the price of a product on the LPPR may be higher than the amount reimbursed by Health Insurance. The difference is covered by the patient, his or her complementary health insurance (mutuelle) or another organization.
Amount of financing
The HAS evaluates the clinical studies submitted by the manufacturer, and "classifies" DM according to the expected service and the expected improvement in service for the patient.
The reimbursement rate is then set after negotiation with the Comité économique des produits de santé (CEPS). There is no predefined range for these amounts.
Calendar / periodicity
Listings on the LPP are published in the Journal officiel:
- Generic line registration is available for a maximum of 10 years renewable;
- "Brand name" registration is available for a maximum of 5 years renewable.
Carrier type
- The manufacturer, whether French or foreign (established or not on French territory);
- The distributor (importer, reseller or provider of goods and/or services).
Project maturity
Candidate solutions for inclusion on the LPP must be marketable and have clinical studies demonstrating the benefit of the solution.
Conditions to be met
- Be a medical device for individual use
- Be CE marked
- Have added therapeutic, diagnostic or disability compensation value
- Have obtained a certificate of compliance with interoperability and safety guidelines for digital medical devices if my DM integrates digital functions .
How to apply
Registration on the LPP can take place in three distinct formats.
Submission of the registration application triggers the 180-day period covering the entire file review (evaluation by the HAS and price negotiation) until publication of the reimbursement order. Any request for additional information will result in a suspension of the deadline.
Listing as "generic description" or "generic line".
In what cases?
A DM referenced in the LPP has technical characteristics and indications identical to my DM.
How does registration work?
- I'm exempt from evaluation by the Commission nationale d'évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS).
- I must notify Agence nationale de sécurité du médicament et des produits de santé (ANSM) of the use of the existing LPPR code.
- I declare the generic line code.
- I am financed by the Assurance Maladie for the entire duration of coverage of the generic line (maximum 10 years), which may be renewed, modified.
Brand name" or "trade name" registration
In what cases?
My DM does not correspond to any generic line, claims aparticular indication and has a particular interest in terms of efficacy or tolerance that justifies its individualization under a specific code for management.
How does registration work?
- My digital DM is evaluated by the CNEDiMTS according to: its medical purpose, its individual use, its telecommunication function and its filing of my reimbursement file.
- After an advisory opinion from the CNEDiMTS, the Assurance Maladie decides to fund the DM. The maximum reimbursement period is 5 years.
