Cardiovascular devices

The French National Authority for Health (HAS) released new recommendations about transitional coverage of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in July 2022. Four opinions were published, and they concern devices in three technology groups.

On July 15, 2022, the Austrian Institute for HTA (AIHTA) published five decision support documents, which provide recommendations regarding the inclusion of new medical interventions in the catalog of individual medical services of the performance-oriented hospital financing (Leistungsorientierten Krankenanstaltenfinanzierung, LKF) model, as well as four updates to previous decision support documents. The decisions relate mainly to cardiovascular and gastrointestinal technology groups.

The Scottish Health Technologies Group (SHTG) is a national health technology assessment (HTA) agency providing advice to NHSScotland on using new and existing health technologies, likely to significantly impact healthcare. In July 2022, SHTG published three reports (KardiaMobile for detecting atrial fibrillation, complex endovascular aneurysm repair, and Togetherall platform). Currently, the SHTG is working on assessments of technologies in the field of cancer, radiotherapy, musculoskeletal diseases, transplantation, and other topics.

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 July 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 and peripheral vascular, neurovascular and neuromodulation, orthopedic, endocrine, and ENT devices, as well as breast implants and medical aids. Except for this, CNEDiMTS published two positive and two negative opinions concerning transitional coverage of devices.

In July 2022, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (transcatheter tricuspid valve annuloplasty for tricuspid regurgitation, and transcatheter tricuspid valve leaflet repair for tricuspid regurgitation), one new Diagnostic Guidance (PLGF-based testing to help diagnose suspected preterm pre-eclampsia), and four new Medtech Innovation Briefings (ProciseDx point-of-care platform for IBD, RespiraSense for continuously monitoring respiratory rate, Lenus COPD Support Service, and cyanoacrylate glue for hernia mesh fixation). Also, five clinical guidelines were updated.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With regional decree 13241 of July 4, 2022, Tuscany Regional Healthcare has published assessments of three medical devices in the cardiovascular area.

On June 22, 2022, the document "Changes and innovations in the 2022 LKF model" (Änderungen und Neuerungen in den LKF-Modellen 2023) was published. The document summarizes the most significant changes and innovations in the LKF model for inpatient and outpatient care. The newly added procedure codes mainly concern cardiovascular, extracorporeal treatments, and peripheral vascular fields.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With regional decree 10778 of June 01, 2022, Tuscany Regional Healthcare has published assessments of nine medical devices in various therapeutic areas, such as cardiovascular and peripheral vascular areas, surgical procedures, orthopedics, and dermatology.

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 May 2022. Thirty-one 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, diagnostic imaging, interventional radiology, orthopedic, neurovascular and neuromodulation, endocrine and E-health devices, as well as medical aids.

On April 28, 2022, the Dutch Healthcare Authority (NZa) published the first release of the DRG package for 2023 (RZ23a). Nine new DRGs for carotid endarterectomy and aortic surgery with or without neuromonitoring and five supplementary payments for remote monitoring in cardiovascular diseases will be implemented.

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 2022. Thirty 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 and peripheral vascular, orthopedic, neurovascular, and neuromodulation and other devices, as well as medical aids.

On April 11, 2022, the Swedish Medical Technologies Product (MTP) Council released recommendations on devices for diagnosing atrial fibrillation via self-recording of electrocardiogram evaluated within the Orderly Introduction framework since 2020. MTP Council outlined that Coala Heart Monitor and Zenicor ECG could be used in certain types of patients only, whereas KardiaMobile, CardioMem CM 100 XT, and PhysioMem should be refrained from use.