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 included on the list of products and services (LPP) is covered by health insurance.
This list includes, for example: medical devices for the diagnosis and treatment of illnesses and injuries, equipment to assist with daily living, dietary foods, external prostheses, implantable medical devices (MDs), digital MDs, etc. This list does not include medications.
Challenge
Registration with the LPP allows for direct reimbursement of the product or service by the Health Insurance (otherwise known as common law financing).
Is this program suitable for my project?
Any medical device distributed in cities or hospitals that can demonstrate therapeutic, diagnostic, or disability compensation benefits. Only solutions that are mature in terms of clinical evaluation are eligible.
Type of financing
- Pricing per unit: The LPPR defines a reimbursable amount for each product it covers.
Please note: the price of a product on the LPPR may be higher than the amount reimbursed by the French national health insurance system. The difference is paid by the patient, their supplementary health insurance (mutuelle) or another organization.
Amount of funding
The HAS evaluates the clinical studies submitted by the manufacturer and "classifies" MDs according to the expected service and the expected improvement in service for the patient.
The reimbursement rate is then set after negotiation with the Economic Committee for Health Products (CEPS). There is no predefined range to regulate these amounts.
Schedule / frequency
Registration on the LPP is published in the Official Journal:
- Generic online registration is valid for a maximum of 10 years and is renewable;
- Registration under a "brand name" is available for a maximum period of 5 years, renewable.
Type of carrier
- The manufacturer, whether French or foreign (based in France or elsewhere);
- The distributor (importer, reseller, or provider of goods and/or services).
Project maturity
Solutions eligible for inclusion on the LPP must be marketable and have clinical studies demonstrating their benefits.
Requirements to be met
- Being a medical device for individual use
- Be CE marked
- Have therapeutic, diagnostic, or disability compensation value
- Have obtained a certificate of compliance with the interoperability and safety standards for digital medical devices if my MD incorporates digital functions
How do I apply?
Registration with the LPP can take place in three different formats.
Submission of the registration application triggers a 180-day period covering the entire review of the file (evaluation by the HAS and price negotiation) until the publication of the coverage decision. Any requests for additional information will result in a suspension of the deadline.
Registration as a "generic description" or "generic line"
In what cases?
A medical device that is referenced in the LPP has the same technical characteristics and indications as my medical device.
How does registration work?
- I am exempt from evaluation by the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS).
- I must notify the French National Agency for Medicines and Health Products Safety (ANSM) of the use of the existing LPPR code.
- I declare the generic line code.
- I am funded by the Health Insurance for the entire duration of coverage of the generic line (maximum 10 years), which can be renewed or modified.
Registration as a "trademark" or "trade name"
In what cases?
My medical device does not correspond to any generic line, claims a specific indication, and has a particular advantage in terms of efficacy or tolerance that justifies its individualization under a specific code for reimbursement.
How does registration work?
- My digital medical device is evaluated by the CNEDiMTS according to: its medical purpose, its individual use, its telecommunications function, and my coverage application.
- After receiving the CNEDiMTS's advisory opinion, the French national health insurance system decides whether to fund the medical device. The maximum coverage period is five years.
G_NIUS supports digital health project leaders in understanding the regulatory framework, identifying funding opportunities, and connecting with the ecosystem to accelerate innovation in France.