With a Public Notice included in the Official Journal of the French Republic on December the 19th 2015, the French Ministry of Social Affairs, Health and Women’s Rights introduced new possibilities of reimbursement for some invasive medical devices that could not find a proper registration place in the LPPR.
Two main criteria shall be satisfied by the product in order to be included in the new Title 5 “Invasive medical devices, not eligible for registration in the Title 3” of the LPPR. The first criterion is the invasive nature of the device, meaning that the devices at stake are meant to penetrate partially or entirely the body, through a body orifice or through the body surface. The second criterion concerns the implantation modalities of the device, since the products shall only be used by hospital doctors.
Implementation of the new Title did not start yet but many devices are expected to be registered already this year.
The new Title will allow registration of so-called “Expensive consumables”, that is, medical devices whose implantation lasts less than 30 days, with a cost or usage that determines heterogeneity in hospital expenditures. Implants included in Title 5 will be subject to the same evaluation criteria of devices in Title 3 in terms of Expected Benefit (Service Attendu, SA) and improvement of the Expected Benefit (Amélioration du Service Attendu, ASA).