Leadless pacemaker

In May 2025, the evaluation phase of the “New Methods” framework was completed for three technologies: leadless pacemaker for cardiac arrhythmias, MR-guided focused ultrasound for essential tremor, and Electrical Field Therapy for glioblastoma treatment. As the recommendations from HTA are now available, the Decision Forum needs to make coverage decisions for these technologies.

In April 2025, the HTA body of Tuscany Regional Healthcare published six rapid HTA reports (five new assessments and one reassessment) of medical devices in the cardiovascular, peripheral vascular, endoscopy, and dermatology fields.

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in April 2024. Eighteen recommendations were published concerning the registration of medical devices or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern cardiovascular, neurovascular, gastrointestinal, interventional radiology, nephrology and urology, neuromodulation, and orthopedic devices, as well as medical aids.

In March 2023, the National Institute for Health and Disability Insurance (INAMI-RIZIV) updated the List of reimbursable devices and Nominative lists to take effect on April 1, 2023. Eight new codes for intracardiac transcatheter pacing systems with the corresponding conditions of reimbursement were added to the List, and two devices (Micra VR and Micra AV) were registered on the list of brands connected to that new codes.

In January-February 2023, Health Technology Wales published sixteen Medtech-related Topic Exploration Reports (TER), including stereotactic radiosurgery, percutaneous implantation of pulmonary artery pressure sensors, ambulatory patch ECG devices, and others; however, Health Technology Wales will not proceed with full appraisals on these topics. No Guidance was released for Medtech in January-February 2023.

In late March 2021, multiple new procedure codes were introduced by the Code Service of the Finnish National Health and Wellbeing Institution (THL), including ten neuromodulation codes, 54 codes in the ophthalmology area, and three codes in the cardiovascular area.

On October 30, 2020, the Swiss Federal Statistics Office (UFS) published the 2021 version of the procedure code (CHOP) nomenclature in French and Italian. The version in the German language was published in July 2020. The most important changes regard cardiovascular and peripheral vascular interventions.

In late September 2020, the Austrian version of the DRG system (LKF) 2021 model with the relevant supplementary documents was published in Austria. For 2021, the main changes include the addition of sixteen new procedure codes and the introduction of two new procedure codes for billing in the day-case settings, update of cases flat rates, and adjustments of the cases daily component calculation.

In October of 2018, the Norwegian Institute of Public Health (NIPH) has published a single technology assessment regarding the external ultrasound stimulation - Exogen™ in the treatment of femoral or tibial non-union. The objective of the assessment was to evaluate the efficacy, safety and health economic documentation for EXOGEN™ compared to surgical treatment for the management of patients with non-union of a fracture. The results have shown that the present documentation does not give evidence to assess the clinical or cost-effectiveness of EXOGEN™ for the treatment of non-union fractures compared to surgery.

In June of 2018, the Norwegian Institute of Public Health (NIPH) has published a single technology assessment regarding the MicraTM Transcatheter Pacing System (Micra TPS) - a leadless pacemaker produced by Medtronic to reduce the rate of complications following pacemaker implantations through design and novel technology. The objective of the assessment was to investigate the clinical efficacy, safety and cost effectiveness of Micra TPS in patients indicated for single chamber ventricular pacemaker implantation. The results have shown that the current evidence is not sufficient to prove that the Micra TPS gives less complications than standard pacemakers, also the use of Micra appeared not to be cost-effective.

Regional guidelines on the use of leadless pacemakers within the region have been released by the technical committee for medical devices in Veneto.