Medical devices

On January 3, 2023, the Federal Joint Committee (G-BA) initiated the evaluation procedure concerning the method of renal denervation using ultrasound ablation in treatment-resistant hypertension (Paradise-System™ by ReCor Medical) within the framework of the early benefit assessment (in line with § 137h SGB V).

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 24486 of December 7, 2022, Tuscany Regional Healthcare has published assessments of three medical devices in the surgical procedures, neurology and neurosurgery, and extracorporeal treatments areas.

The French National Authority for Health released new recommendations about add-on reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies in November 2022. Twenty recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services. Opinions concern cardiovascular, neurovascular and neuromodulation, endocrine, ENT, endoscopic and dermatological devices, as well as devices for men’s health and medical aids.

In November 2022, Swedish Medical Technologies Product (MTP) Council issued a policy of proven experience for medical technology, which complies profession's assessment of how appropriate medical technology is in specific conditions. The policy provides some examples of how the MTP Council acquires knowledge of proven experience and its impact on the MTP Council's recommendations.

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 21738 of November 4, 2022, Tuscany Regional Healthcare has published assessments of three medical devices in the orthopedics, surgical procedures, and peripheral vascular areas.

In November 2022, NHS England defined a deadline for applications to the High Cost Device List (HCDL) changes to be implemented in the 2024/25 National Tariff Payment System. The completed application form should be submitted via email by May 31, 2023.

The French National Authority for Health 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 in October 2022. Fourteen recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services. Opinions concern cardiovascular, neurovascular, orthopedic, and ENT devices, as well as medical aids.

The French National Authority for Health 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 in September 2022. Thirty-eight recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services. Opinions concern cardiovascular and peripheral vascular, neurovascular and neuromodulation, orthopedic, endocrine, ENT, dermatological, and spine-related devices, as well as digital care and medical aids.

On September 1, 2022, the updated “List of state-paid services and their payment conditions” was published in Latvia. All six newly introduced codes concern the provision of services related to COVID-19 and flu vaccination.

On September 1, 2022, the Institute for Hospital Remuneration Systems (INeK) announced the start of the application process according to §6 (2) KHEntgG (New Examination and Treatment Methods, NUB) for 2023. The deadline for the submission of applications is October 31, 2022.

On June 15, 2022, the National Institute for Health and Care Excellence (NICE) announced a new program called Early Value Assessment for Medtech. The program will offer a rapid assessment of digital products, devices, and diagnostics for clinical effectiveness and value for money where the evidence base is still emerging to inform NHS commissioners. The two pilot assessments for health apps will begin in June 2022 and are expected to be published in October 2022. Further topics are expected in mental health, early cancer diagnosis, and cardiovascular disease.

In early June 2022, NHS England and NHS Improvement updated information about the nationwide purchase and supply system for High Cost Tariff-Excluded Devices, which was introduced in 2016. The name of the program changed to the Specialised Service Devices program (SSDP). The program currently covers 15 categories of devices, and several new categories will be added during the 2022/23 financial year.