Distribution channels and reimbursement of medical device in the retail setting
Reimbursed medical devices used by patients in retail setting can be prescribed by medical doctors and, for some medical devices categories, by nurses, midwifes, physiotherapists and podiatrists.
Depending on the nature of medical device, it can be supplied to patient by retail pharmacies, home care providers, retail medical material distributors, opticians, prosthetists, hearing aid specialists etc.
For being marketed in France, any medical device should have European CE Mark certified by a notified body in Europe.
There are two reimbursement schemes of prescription medical devices in community: per product reimbursement and flat fee-for-service (FFS).
  • Per product reimbursement: Per product reimbursement: each product prescribed and delivered to patient is reimbursed on the basis of its reimbursement code (generic or brand-specific) registered on the List of Reimbursable Products and Services (LPPR list). Using the LPPR code, the end distributor will charge the medical device dispensed to the patient directly to the National Insurance; in majority of cases there is no out-of-pocket expense for patient (third-party payment system).
    Prescription is often brand-specific, even for products reimbursed within generic categories. Distributors are not allowed to substitute the prescribed product by another one, unless the prescription specifies only a generic description.
  • Fee-for-service (FFS): Fee-for-service (FFS): fixed amount per patient and per time period (week, month) reimbursed for condition-specific home health care. FFS are charged directly by the home care provider to the National Insurance; they are intended to cover cost of medical devices, medical equipment, consumables and associated home care services (delivery, installation, maintenance, technical assistance to health care professionals, patient support etc.). The actual services and the quantities of products provided to the patient don’t affect the reimbursement to the home care provider.
    In general, under FFS reimbursement scheme, home care provider is free to choose the brand of the medical device to supply. FFS do not include pharmaceutical products and interventions of private health care professionals (physicians, nurse) at patient’s home.
    Currently, the FFS reimbursement scheme apply to home health care requiring repeated technical interventions at patient’s home. First introduced for home oxygen care, this reimbursement model has been subsequently extended to other categories, such as sleep apnea treatments, external insulin pumps and infusion medical devices. The classification of FFS and their reimbursement tariffs are registered on the List or Reimbursed Products and Services (LPPR list).
The classification, technical specifications and reimbursement tariffs of products and FFS registered on the LPPR list are regularly reviewed. The official LPPR version is updated every 2 to 3 months.
Updated on December 15th, 2016