Basic principles of medical device reimbursement in France
The main feature of the French health care system is the quasi-universal coverage (99% of the population) of the health care by the National Health Insurance, a branch of the National social security system. The general framework of the French National Health Insurance reimbursement is fixed by law.
Patients with chronic severe conditions registered on the Long Duration Disease list (ALD) list benefit from full coverage of their health care by the National Health Insurance. For all remaining cases, the National Insurance reimburses medical devices dispensed to patients in the retail setting at a 60% rate. Private insurance companies can provide additional payment for products and services on top of the amount reimbursed by the National Health Insurance. For some medical devices (e.g., optics, hearing aids, dental prostheses), the reimbursement tariffs of the National Insurance are very low, therefore the major part of costs are covered by complementary private insurance policies.
For being marketed in France, any medical device should have European CE Mark certified by a notified body in Europe.
There are 4 different reimbursement schemes for medical devices in France: generic categories, brand-specific registration, reimbursement within DRG (hospital) or within fee-for-service (FFS) scheme in the retail setting.
- Generic categories: homogeneous groups of medical devices (same indication, same packaging, same technical specifications, same tariff). For this reimbursement scheme, no health technology assessment prior to registration on the positive reimbursement list is required. Manufacturer has to declare each product reimbursed within a generic category to the French Agency of Health Care Products Safety (ANSM, French Drug/Health Products Agency) ; however, no approval is made for access to reimbursement. The choice of the appropriate generic category is under manufacturer’s or distributor’s responsibility. The same generic category can be used by different manufacturers and can include a variety of brands, sizes and items.
- Brand-specific reimbursement: product is registered under its brand name and its own reimbursement code. Medical assessment by the HAS (French health technology assessment body) is required. Brand-specific reimbursement can be granted 1) when there is no generic category allowing for reimbursement of medical device; 2) when the HAS acknowledges, on the basis of clinical evidence provided by manufacturer, an added medical value compared to similar products reimbursed within generic categories. However, some products have been switched from generic to brand-specific categories by decision of the Ministry of Health, this modality allowing for a better traceability of reimbursed volumes, better expenditure control and better follow-up of adverse events.
- DRGs (hospital) and flat fee-for-service (FFS, retail setting). For more information, see Reimbursement of medical device in hospital and Reimbursement of medical device in the retail setting.
Reimbursement tariffs are fixed by the inter ministerial Economic Committee of Health Products (CEPS) within the Ministry of Health and Social Affairs after negotiations with either manufacturer (for brand-specific products), the associations of medical device manufacturers for generic categories, and several distributors’ associations (Home Care providers, Retail Pharmacists, Wholesalers). Any new registration on the positive reimbursement list and the reimbursement tariffs and their changes are published in the Official Journal.
Updated on December 15th, 2016