Orthopedic devices

In January 2025, the HTA body of Tuscany Regional Healthcare published four new rapid HTA reports on medical devices used in surgical procedures, ophthalmology, men’s health, and orthopedics.

On December 2, 2024, the Swiss Federal Office of Public Health published the changes that will occur to the Healthcare Benefit Ordinance (KLV/OPre), which determines coverage of medical services in Switzerland. The updates will enter into force on January 1, 2025, and they relate to the list of explicitly evaluated services (Annex 1 of KLV/OPre), outpatient-before-hospital services (Annex 1a), List of Tools and Equipment (Annex 2), and the List of Analyses (Annex 3).

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 20315 of September 9, 2024, Tuscany Regional Healthcare published two new rapid HTA reports of medical devices in the orthopedics and surgical procedures areas.

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 May 2024. Seven 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 neurovascular, neuromodulation, endocrine, ophthalmology, and orthopedic devices, as well as medical aids.

In late March 2024, NHS England released the amended 2023/25 NHS Payment Scheme (NHSPS) to come into force on April 1, 2024. No changes were made to the general payment model. Eight new items were added to the High Cost Devices List, and one new device was added to the MedTech Funding Mandate. New reimbursement codes and tariffs for three types of specialist radiotherapy were introduced. Furthermore, HRG tariffs were uplifted for 2024/25.

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 26990 of December 18, 2023, Tuscany Regional Healthcare has published assessments of three medical devices in the peripheral vascular, orthopedic, and dermatology areas.

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 November 2023. Seven recommendations were published in relation to the registration of medical devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, nephrology and urology, and orthopedic devices, as well as medical aids.

On November 14, 2023, the Institute for the Hospital Remuneration System (InEK) published the DRG catalog (Fallpauschalen-Katalog) with the list of DRGs and additional reimbursement categories (ZEs) for 2024.

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 October 2023. Twelve recommendations were published in relation to the registration of medical devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, e-health, endocrine, gastrointestinal, neurology and neurosurgery, neuromodulation, and orthopedic devices, as well as medical aids.

In October 2023, the FinCCHTA published on its website a Digi-HTA assessment aiming to evaluate Lokomat robot-assisted walking rehabilitation device, as well as Indego – Exoskeleton robot-assisted walking device. The products received a total score of 08 (out of 10), which means the quality but insufficiency of available evidence and safety data. The cost of using the products could be high. There could be minor deficiencies in data security and protection or usability and accessibility.

The updated German Uniform Evaluation Standard (EBM) catalog came into force on October 1, 2023. The EBM catalog (Einheitlicher Bewertungsmaßstab) regulates the reimbursement of services in the public outpatient sector in Germany and is updated once a quarter (four times a year). Among other changes, a new code for “Mawendo” and “Oviva Direkt für Adipositas” health apps were introduced in the catalog.

In October 2023, the Centre for Assessment of Medical Technology in Örebro is working on several HTAs, including evaluations in e-health, ICU/OR, men’s health, orthopedic fields, and other fields.