Cardiovascular devices

On July 30, 2021, the Swiss Federal Statistics Office (UFS) published the 2022 version of the procedure code (CHOP) nomenclature in the German language. The newly introduced codes concern various technology groups, such as cardiovascular, gastrointestinal, neurology, interventional radiology, orthopedics, gynecology, and others.

In July 2021, the Austrian Institute for Health Technology Assessment (AIHTA) published six new decision support documents and one update to a previous decision support document. The assessed topics included percutaneous left ventricular assist devices, liposuction for surgical therapy of lipoedema, triphasic biomaterial for augmentation of the osteoporotic femoral neck, endoscopic plication therapy in patients with gastroesophageal reflux disease (GERD), allogenic bone screw Shark Screw® in patients with hallux valgus or scaphoid fractures/pseudarthroses, and surgical interventions for the treatment of benign prostatic hyperplasia. The updated decision support document concerned implantable bulking agents for fecal incontinence.

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 June 2021. Recommendations concern cardiovascular and peripheral vascular devices, orthopedic devices, liquid for embolization, and medical aids.

In June 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (laser lithotripsy for difficult-to-treat bile duct stones and percutaneous insertion of a closure device to repair a paravalvular leak around a replaced mitral or aortic valve), one new Medical Technologies Guidance (Plus Sutures for preventing surgical site infection), and four new Medtech Innovation Briefings (RapidAI for analyzing CT/MRI brain scans, WoundExpress, Magtrace and Sentimag, and SYNE-COV). Also, four clinical guidelines were updated, and two new published.

In mid-June 2021, the document "Changes and innovations in the 2022 LKF model" (Änderungen und Neuerungen in den LKF-Modellen 2022) 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 concern mainly the cardiovascular, e-Health, and gastrointestinal area.

In May 2021, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (ex-situ machine perfusion for extracorporeal preservation of lungs for transplant, transvaginal laser therapy for stress urinary incontinence and for urogenital atrophy, electrohydraulic lithotripsy for difficult-to-treat bile duct stones, and permanent His-bundle pacemaker for heart failure), one new Medical Technologies Guidance (UroLift for benign prostatic hyperplasia), and two new Medtech Innovation Briefings (Axonics sacral neuromodulation system for faecal incontinence and KODEX-EPD for cardiac imaging during ablation of arrhythmias). Also, three clinical guidelines and two Medical Technologies Guidance were updated.

The Health Sciences Institute in Aragon (IACS) systematically evaluates healthcare technologies and facilitates the promotion of research, effective innovation, and decision-making in health services through knowledge management. Currently, the IACS is working on assessments of efficacy, effectiveness, and safety of intraoperative radiation therapy in breast cancer, determination of preeclampsia biomarkers SFlt-1 and PlGF, treatment of congenital ventricular septal defect by cardiac catheterization, and others.

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 2021. Recommendations concern orthopedic devices, cardiovascular, peripheral vascular, and neurovascular devices, medical aids, and pulmonary artery pressure sensor.

For the first time in three years, the Institute for Quality and Efficiency in Health Care (IQWiG) received data within the framework of the early benefit assessment of new examination and treatment methods (NUB) with high-risk medical devices according to §137h of Social Code Book (SGB) V. This involves seven invasive therapeutic cardiovascular, pulmonary, neurological, gastrointestinal, and urological procedures.

On May 6, 2021, the Federal Joint Committee (G-BA) announced the start of consultations about the design of three co-funded studies for cardiovascular methods in accordance with §137e SGB V.

The Galician Scientific and Technical Advice Unit in Spain (AVALIA-T) systematically evaluates healthcare technologies and provides decision-makers with critically reviewed information about their efficacy, safety, and effectiveness. Currently, the AVALIA-T is working on assessments of ventricular assist devices in pediatric patients with an indication for permanent destination therapy, bronchial thermoplasty for severe acute asthma, effectiveness and safety of epiduroscopy in the treatment of failed back surgery syndrome, and other topics.

Since 2022, the Dutch Healthcare Authority (NZa) implemented four new DRGs for surgical placement and removal of a heart rhythm monitor for reimbursement of the procedure performed by the cardiopulmonary surgeon.