Ventricular assist devices

The French National Authority for Health (HAS) has released new recommendations about add-on reimbursement of medical devices and medical aids from the January 2025 meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Seventeen favorable opinions were published concerning the registration or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). They relate to cardiovascular, endocrine, e-health, interventional radiology, neurology and neurosurgery, orthopedic devices, and medical aids.

On September 11, 2024, NHS England published an updated work plan for specialized clinical commissioning policies development. One MedTech-related policy was added to the program on long-term left ventricular assist devices (LVAD) for destination therapy in adults with heart failure. No new policies were published.

In August 2024, the National Institute for Health and Care Research (NIHR) in England released eight MedTech-related assessments in its Health Technology Assessment (HTA) Journal, which concerned automated devices for identifying peripheral arterial disease, left ventricular assist devices as destination therapy, cerclage suture type to prevent pregnancy loss, gynecological cancer surveillance in Lynch syndrome, multiparametric MRI in bladder cancer pathway, in-home monitoring for people with glaucoma, real-time ultrasound elastography of thyroid nodules, and AI-based software for analyzing chest X-ray images. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and informs National Institute for Health and Care Excellence (NICE) guidance.

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.

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 HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 13989 of June 29, 2023, Tuscany Regional Healthcare has published assessments of nine medical devices in the cardiovascular, peripheral vascular, diagnostic imaging areas, and surgical procedures.

In January 2022, the Basque Office for Health Technology Assessment (OSTEBA) released an HTA report aiming to assess and compare the efficacy, effectiveness, and safety of the mechanical circulatory support devices most used in the healthcare setting for the treatment and prevention of cardiogenic shock, including Impella® devices, intra-aortic balloon pumps, and extracorporeal membrane oxygenation.

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.

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.

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.

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.