Cardiovascular devices

In December 2024, the National Institute for Health and Disability Insurance (INAMI/RIZIV) launched a new agreement (Convention) allowing reimbursement for remote monitoring of patients with chronic heart failure. It will come into force on January 1, 2025. New codes (pseudonomenclature) with fees for packages of care will be used for reimbursement. The packages include monitoring of clinical parameters by patients at home (e.g., blood pressure measurement or pulmonary artery pressure measured by an implanted sensor) and transmission of data via a health app to the remote monitoring team at the hospital.

In Q3 2024, Health Technology Wales completed three full appraisals with the publication of Evidence Appraisal Report and Guidance (AI for whole slide prostate biopsy images, AI-assisted endoscopy for gastrointestinal cancer, and Floseal in the treatment of epistaxis). Furthermore, 24 Med Tech-related Topic Exploration Reports were published concerning cardiovascular, gastrointestinal, gynecology, e-health, in-vitro diagnostics, and other areas.

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 16951 of July 22, 2024, Tuscany Regional Healthcare published five new assessments and two reassessments of medical devices in the cardiovascular, peripheral vascular, surgical procedures, and obstetrics and gynecology areas.

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.

Between mid-January 2024 and mid-February 2024, three more health apps were introduced in the Directory of digital health applications (DiGAs) at the Federal Office for Drugs and Medical Devices (BfArM) and thus became reimbursable. These apps can be prescribed by physicians and psychotherapists and will be reimbursed by health insurers. In total, 56 health apps are currently available in the DiGA Directory, and six health apps were delisted from the Directory.

In December 2023, NHS England launched a consultation regarding proposed changes in the 2023/25 NHS Payment Scheme for the 2024/25 financial year. The key changes concerned the High Cost Device List, top-up payments for specialized services, and payment for radiotherapy. The deadline for submitting comments is January 26, 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 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.

In the fourth quarter of 2023, two new health technology assessments were initiated by the Agency for Health Technology Assessment and Tariff System (AOTMiT). The assessments belong to the cardiovascular and neurovascular technology groups.

On October 26, 2023, the BfArM (Federal Institute for Drugs and Medical Devices) published the final version of the 2024 OPS procedure coding classification. The OPS, together with the ICD-10-GM (International Statistical Classification of Diseases and Related Health Problems, 10th revision, German Modification), forms the basis for the reimbursement systems in outpatient and inpatient care in Germany.

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.

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 August 2023. 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 (LPPR). Opinions concern cardiovascular, peripheral vascular and neurovascular devices, as well as medical aids.

On August 11, 2024, the BfArM (Federal Institute for Drugs and Medical Devices) published the preliminary version of the 2024 OPS procedure coding classification. The OPS, together with the ICD-10-GM (International Statistical Classification of Diseases and Related Health Problems, 10th revision, German Modification), forms the basis for the reimbursement systems in inpatient and outpatient care in Germany.