In-vitro diagnostic tests

On November 14, 2024, the State-Regions Conference approved the Decree with the new national LEA tariffs for outpatient specialist care and prosthetic care presented by the Italian Ministry of Health. The effective date of new tariffs is December 30, 2024.

In November 2024, the following ongoing mini-HTA assessments for cardiovascular, diagnostic imaging, e-health, gastrointestinal, in-vitro diagnostics, interventional radiology, men’s health, pulmonary and airways, robotic surgery, and some other fields are evaluated as a part of a framework for the managed introduction of innovations "New Methods" in Norway.

On October 31, 2024, the Swiss Federal Statistics Office (UFS) released the systematic version of the procedure code (CHOP) nomenclature for 2025. The nomenclature is now available in German, Italian, and French languages and will come into force on January 1, 2025. Multiple new procedure codes were introduced in various fields, including endoscopy, extracorporeal treatments, in-vitro diagnostics, interventional radiology, obstetrics and gynecology, orthopedics, and radiotherapy.

In October 2024, the National Institute for Health and Care Research (NIHR) in England released seven Med Tech-related assessments in its HTA Journal, which concerned the Genedrive kit, timing of stoma closure in neonates, interventions in perceptual disorders after stroke, revascularisation strategy for chronic limb ischemia, MRI software and cognitive fusion biopsies in prostate cancer, transperineal prostate biopsy devices, and ultraviolet therapy in severe eczema. 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 NICE guidance.

In late October 2024, the Agency for Health Technology Assessment and Tariff System (AOTMiT) published several recommendations concerning the Prenatal Testing Program, specifically on removing alpha-fetoprotein and estriol testing and qualifying the placental growth factor (PlGF) test and free fetal DNA testing (cffDNA) as part of non-invasive prenatal diagnostics.

On October 10, 2024, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 198 and 094 with changes to be implemented no later than December 5, 2024. Fifty-two new procedure codes related to ENT, gastrointestinal, men’s health, urology, neurology and neurosurgery, gynecology, orthopedics, robotic surgery, and surgical procedures areas, and two new diagnostic codes were introduced.On October 10, 2024, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 198 and 094 with changes to be implemented no later than December 5, 2024. Fifty-two new procedure codes related to ENT, gastrointestinal, men’s health, urology, neurology and neurosurgery, gynecology, orthopedics, robotic surgery, and surgical procedures areas, and two new diagnostic codes were introduced.

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.

On October 9, 2024, the new version of the Nomenclature of Medical Biology Procedures (NABM 93) was released in France. Changes included the introduction of five new codes and wording modifications for several codes.

In September 2024, the National Institute for Health and Care Research (NIHR) in England released three MedTech-related assessments in its Health Technology Assessment (HTA) Journal, which concerned hyperthermic intraoperative peritoneal chemotherapy and cytoreductive surgery in peritoneal metastases, resuscitative endovascular balloon occlusion of the aorta in life-threatening torso hemorrhage, and clopidogrel resistance genotype testing. 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 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 2024. Five recommendations 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). Opinions concern endocrine and spine devices, as well as medical aids.

On September 2, 2024, NHS England published guidance for planning, designing, and implementing Community diagnostic centers (CDCs). The national CDC Program is in its third year and has approved 170 CDC sites across England. The guidance sets the next steps and best practices in developing CDCs, including minimum requirements for core diagnostic tests that CDCs must provide permanently.

On September 23, 2024, the Norwegian Directorate of Health released an updated version of the Norwegian Laboratory Code (NLK) system. Sixty-nine new codes were added, and 209 codes were changed.