Cardiovascular devices

In November 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (percutaneous implantation of pulmonary artery pressure sensors in chronic heart failure and coronary sinus narrowing device implantation for refractory angina), one new Medical Technologies Guidance (Synergo for non-muscle-invasive bladder cancer), one new Diagnostic Guidance (SeHCAT for diagnosing bile acid diarrhea), and four new Medtech Innovation Briefings (clonoSEQ for minimal residual disease, CerebAir for continuous EEG monitoring, 24/7 EEG SubQ for epilepsy, Paige Prostate for prostate cancer). Also, three new clinical guidelines were published, and six were updated.

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 2021. More than 15 recommendations were published in relation to the registration, modification of registration conditions, renewal of registration of devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, peripheral vascular, neurovascular, dermatological, and endocrine devices, as well as medical aids.

On November 9, 2021, the Belgian Health Care Knowledge Center (KCE) published the health technology assessment report "Remote monitoring of patients with cardiovascular implantable electronic devices (CIED)". Analysis of efficacy and safety of remote monitoring showed an advantage in various aspects. Cost-effectiveness analysis indicates that remote cardiac monitoring of ICDs and PMs is cost-effective compared to monitoring based on in-clinic visits.

In late November 2021, the INeK (Institute for the Hospital Remuneration System) has published the DRG catalog (Fallpauschalen-Katalog) with the list of DRGs and add-on reimbursement categories (ZEs) for 2022. Seven new DRGs and seventeen ZE categories were added to the catalog in 2022.

In early-mid November 2021, the Federal Joint Committee (G-BA) has initiated an evaluation procedure for early benefit assessment for two new cardiovascular technologies (Revivent TC™ by BioVentrix and Trilogy™ Heart Valve System by JenaValve Technology) in heart failure, and aortic valve insufficiency and stenosis, respectively.

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 2021. More than 20 recommendations were published in relation to the registration, modification of registration conditions, renewal of registration of devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, peripheral vascular, neurovascular and neuromodulation, and other groups of devices, as well as medical aids.

In late September 2021, the Austrian version of the DRG system (LKF) 2022 model with the relevant supplementary documents was published in Austria. The document "Changes and innovations in the 2022 LKF model" (Änderungen und Neuerungen in den LKF-Modellen 2022) summarizes the most significant changes and innovations in the LKF model for inpatient and outpatient care. The newly added procedure codes concern mainly the cardiovascular, E-Health, and gastrointestinal area.

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 September 2021. In total, 58 recommendations for registration, modification of registration conditions, and removal of devices from the List of reimbursable products and services (LPPR) were published. Opinions concern cardiovascular, orthopedic, peripheral vascular, and other groups of devices, as well as medical aids.

In September 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (transapical transcatheter mitral valve-in-valve implantation for a failed surgically implanted mitral valve bioprosthesis, transapical transcatheter mitral valve-in-ring (TMVIR) after failed annuloplasty for mitral valve repair, and lateral elbow resurfacing for arthritis), and two new Medtech Innovation Briefings (Carnation Ambulatory Monitor, OrganOx metra for liver transplant). Also, one clinical guideline was updated.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 14763 of August 25, 2021, Tuscany Regional Healthcare has published assessments of thirteen medical devices of various therapeutic areas, including devices belonging to the obstetrics and gynecology field, as well as gastroenterology, urology, cardiovascular, endoscopy, spine, peripheral vascular, and other fields of care.

In mid-August 2021, the Finnish Coordinating Center for Health Technology Assessment announced the release of the four accomplished rapid hospital assessments (HTA) performed by the Helsinki University Hospital. The accomplished rapid HTAs concern the cardiovascular, peripheral vascular, and endoscopy technology groups.

In July 2021, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedure Guidance (inducing and maintaining normothermia using temperature modulation devices to improve outcomes after stroke or subarachnoid hemorrhage) and four new Medtech Innovation Briefings (HealthVCF for detecting vertebral compression fractures on CT scans, trublood-prostate for triaging and diagnosing people with prostate cancer symptoms, AI technologies for detecting diabetic retinopathy, and Acumen IQ sensor for predicting hypotension risk).