In September 2022, the French National Authority for Health (HAS) published four new opinions, which were based on health technology assessment reports. They are related to neuromodulation and cardiovascular areas. The main goal of these HTA was to support decision-making for the creation of new procedure codes in the Common Classification of Medical Procedures (CCAM) and to update the indications for implantable cardiac defibrillators with endocavitary lead(s) in the Intra-DRG list.
The French National Authority for Health (HAS) published three favorable opinions for the registration of three procedures related to the use of the INSPIRE IV device, upper airway stimulation system, in the CCAM Nomenclature (sufficient actual benefit and level IV of clinical added value) based on the CNEDiMTS assessment “INSPIRE IV Upper Airway Stimulation System” of March 29, 2022:
- Favorable opinion for the procedure of implantation of INSPIRE IV device with the registration of the act “Implantation of a hypoglossal nerve stimulation system” in the CCAM Classification;
- Favorable opinion for the procedure of replacement of INSPIRE IV device with the registration of the act “Replacement of a hypoglossal nerve stimulation system (pulse generator or electrodes)” in the CCAM Classification;
- Favorable opinion for the procedure of removal of INSPIRE IV device with the registration of the act “Removal of a hypoglossal nerve stimulation system (pulse generator or electrodes)” in the CCAM Classification.
The following indications for the use of INSPIRE IV device, upper airway stimulation system, were set out in the CNEDIMTS note: Treatment of moderate to severe obstructive sleep apnea-hypopnea syndrome (OSAHS) (15 ≤ apnea-hypopnea index (AHI) ≤ 50) in patients with a body mass index (BMI) of less than 32 kg/m² and treatment failure (non-responders or non-compliant) by continuous positive airway pressure (CPAP) and by mandibular advancement orthosis (MAO) in the indications defined by the List of Reimbursable Products and Services (LPPR).
Regarding the cardiovascular devices, single, double, and triple chamber implantable automatic cardiac defibrillators with endocavitary lead(s) are currently registered under the generic description on the list of health products so-called Intra-DRG (Intra-GHS) List.
The HAS opinion was based on the health technology assessment report “Reassessment of implantable cardiac defibrillators with endocavitary lead(s)”– the aim was to update the previous report of 2015, specifically, the indications for single, double, and triple chamber ICDs with regard to the recommendations for good practice, the minimum technical specifications of these devices, and their methods of prescription and use. The National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) recommended renewing the conditions for the inclusion of conventional implantable cardiac defibrillators with endocavitary probes (single, double, and triple chamber) on the Intra-DRG list in the form of generic descriptions in accordance with the proposed nomenclature.
See the details in French here (INSPIRE IV device) and here (implantable cardiac defibrillators)
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