Diagnostic imaging

The revised EBM (German Uniform Evaluation Standard) catalog came into force on October 1, 2023. The most significant changes concern the introduction of the new EBM codes for several IVD tests, prostate-specific membrane antigen (PSMA) positron emission tomography, as well as for stereotactic radiosurgery (SRS) in vestibular schwannomas.

In September 2023, the Skåne University Hospital is working on several HTAs, including evaluations in the cardiovascular, diagnostic imaging, men’s health, neurology and neurosurgery fields

On August 11, 2024, the BfArM (Federal Institute for Drugs and Medical Devices) published the preliminary version of the 2024 OPS procedure coding classification. The OPS, together with the ICD-10-GM (International Statistical Classification of Diseases and Related Health Problems, 10th revision, German Modification), forms the basis for the reimbursement systems in inpatient and outpatient care in Germany.

In July 2023, the National Institute for Health and Care Research (NIHR) in England released one MedTech-related report in its Health Technology Assessment (HTA) Journal concerning MRI-based technologies for diagnosing non-alcoholic fatty liver disease. 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 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 June 2023, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (intraoperative electron beam radiotherapy, minimally invasive fusionless posterior-approach surgery to correct idiopathic scoliosis, endoscopic ultrasound-guided gallbladder drainage, radiofrequency denervation for osteoarthritic knee pain, and Botulinum toxin type A injections into the urethral sphincter), two new Diagnostic Guidance (transperineal biopsy for prostate cancer, and FibroScan for liver fibrosis and cirrhosis), and two Medtech Innovation Briefings (MiraQ cardiac TTFM, Proov Confirm; their development started before April 2023). Also, four clinical guidelines were updated.

On June 19, 2023, the Swiss Federal Office of Public Health (FOPH) published the changes that will occur to the Healthcare Benefit Ordinance (KLV/OPre) and its Annexes, which determines coverage of medical services in Switzerland. Key changes relate to introduction of two codes for genetic tests, several extensions of Coverage with Evidence Development, and updates in reimbursement conditions for transcatheter aortic valve implantation. The changes entered into force on July 1, 2023.

In May 2023, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedure Guidance (intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure from high spinal cord injuries), two new Diagnostic Guidance (MRI fusion biopsy systems for diagnosing prostate cancer, automated ankle-brachial pressure index measurement devices to detect peripheral arterial disease), and three new Health Technology Evaluations (Digitally enabled therapies for adults with anxiety disorders / with depression, and point-of-care tests for urinary tract infections). Also, four clinical guidelines were updated.

In March 2023, Health Technology Wales published an Evidence Appraisal Report (EAR) and Guidance on photobiomodulation for the prevention and treatment of oral mucositis. Furthermore, seven Medtech-related Topic Exploration Reports (TER) were published, including single-pulse transcranial magnetic stimulation and AI-assisted ultrasound for deep vein thrombosis; however, Health Technology Wales will proceed with a full appraisal on one topic only - digital wound management tools.

In January-February 2023, Health Technology Wales published sixteen Medtech-related Topic Exploration Reports (TER), including stereotactic radiosurgery, percutaneous implantation of pulmonary artery pressure sensors, ambulatory patch ECG devices, and others; however, Health Technology Wales will not proceed with full appraisals on these topics. No Guidance was released for Medtech in January-February 2023.

On February 1, 2023, the Treatment Council made its first two recommendations based on the major analysis reports regarding handheld focused ultrasound in emergency medicine and artificial intelligence as decision support for colonoscopy. The adoption of these technologies was not recommended.

In February 2023, it was announced that fifty-seven new procedure codes were introduced by the Code Service of the Finnish National Health and Wellbeing Institution (THL). These codes are valid from January 2023. The introduced codes are dedicated to radiology, diagnostic imaging, gastrointestinal, interventional radiology, and some other fields.