Health

#SFHS2611583AFrance adds AXILES BIONICS’ LUNARIS ESSENTIAL ankle-foot prosthesis to the reimbursable products list

🇫🇷France··Other·Medium Impact·View source ↗

AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.

🇬🇧 English

This rule makes AXILES BIONICS’ LUNARIS ESSENTIAL ankle-foot prosthesis eligible for reimbursement in France’s public health system. It applies to patients with lower-limb loss from amputation or congenital absence, especially those who need to walk on uneven ground. For providers, the order sets practical conditions: first-time prescribing must come from a physical medicine and rehabilitation specialist, the reason for choosing the device must be written on the prescription, the prosthesis is limited to the main prosthetic limb and not a backup limb, and fitting must be done by a trained orthoprosthetist. Follow-up maintenance is required at 12, 24, and 36 months. Coverage runs until 1 June 2031.

AI-generated summary. May contain errors. Refer to official sources for legal decisions.

Key Changes

  • Adds LUNARIS ESSENTIAL, an ankle-foot prosthesis from AXILES BIONICS, to France’s reimbursable products list.
  • Limits use to patients with lower-limb loss who need the device for walking, especially on uneven ground.
  • Sets prescription, fitting, and maintenance rules, including specialist prescribing for first use and follow-up maintenance at 12, 24, and 36 months.

Obligations

What this law requires

high

For a first prescription of the LUNARIS ESSENTIAL prosthetic foot, or for renewal when changing the type of foot, the prescription must be issued by a physician specializing in physical medicine and rehabilitation (MPR).

prescribing physiciansprosthetics providers
licensing
high

For a first prescription of the LUNARIS ESSENTIAL ankle-foot prosthesis, or for renewal involving a change of prosthesis type, the prescription must be made by a physician specialist in physical medicine and rehabilitation (MPR).

physicians specializing in physical medicine and rehabilitationprescribing physicians
licensing
medium

When prescribing the LUNARIS ESSENTIAL, the prescriber must specify on the prescription the activities that justify the choice of this system.

prescribing physicians
disclosure
high

When prescribing the LUNARIS ESSENTIAL, the prescriber must state on the prescription the activities or use-case reasons justifying the choice of this device.

prescribing physicians
disclosure
high

The LUNARIS ESSENTIAL may only be used as the main prosthesis and must not be used for a backup/spare prosthesis.

prosthetics providersprescribing physicianspatients
prohibition

Affected Parties

AXILES BIONICSPatients needing lower-limb prosthetic care in France+1 more…

Tags

medical devices,reimbursement,prosthetics