Reimbursement of medical device in hospital
In order to be used in hospital, any medical device should have the CE mark certified by a notified body in Europe.
Most of medical devices are reimbursed within DRGs (diagnosis-related groups, GHS in French) based on the principle of fixed reimbursement amount paid by the National Health Care Insurance to the hospital for each hospital stay. DRGs are deserved to cover all hospitalization-related costs, with a small supplement to be paid by patient or his complementary private insurance.
DRGs tariff mainly depends on the diagnosis (ICD classification) and the medical procedures provided to patient during the hospital stay. DRGs are assigned by a “grouper” program the PMSI software (Programme de Médicalisation des Systèmes d’Information). The duration of hospital stay has little to no impact on the DRG tariff. The DRGs tariffs are fixed and regularly reviewed by the Ministry of Health and Social Affairs; they are published in the Official Journal.
Prices of medical devices reimbursed in hospital within DRG tariffs are not regulated; they are freely arranged between manufacturer and hospital, hospital group or hospital procurement platform (tenders).
By way of exception from the above rule, some innovative and particularly expensive medical devices registered on the special list (Liste “en sus”) are reimbursed on top of DRG tariff. Registration on this list is under the scope of the Ministry of Health and Social Affairs and represents an additional step in the overall market access process, unless the new product can be reimbursed within a generic category already registered on the list on top of DRG. In other cases, the decision is made with regards to the HAS opinion (CNEDiMTS commission); in general, an added value (ASA) of level I, II or III is required.
Price of medical devices reimbursed on top of DRGs are fixed and regulated by the inter ministerial Economic Committee of Health Products after negotiations with the manufacturers. The list on top of DRG has been created to allow and facilitate access to new innovative technologies. The list is reviewed every year; some products and/or medical device categories are withdrawn from the list and subsequently integrated into DRGs, in order to make place for new innovative health technologies.
Updated on December 15th, 2016