In-vitro diagnostic tests

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.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on July 1, 2023. The most significant changes concern introducing the new EBM codes for several IVD tests, as well as for the cryopreservation of the ovarian tissue.

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.

On June 15, 2023, the National Association of Statutory Health Insurance Physicians (KBV) informed that new services for the detection of the adeno-associated virus (AAV) and cytomegalovirus (CMV) will be included in the German Uniform Evaluation Standard (EBM) catalog since July 1, 2023.

In June 2023, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 190 and 086 with changes to be implemented no later than August 4, 2023. Fourteen new procedure codes (concerning cardiovascular, diagnostic imaging, endocrine, endoscopy, gastrointestinal, orthopedic and spine, peripheral vascular, robotic surgery, men's health, and radiotherapy fields) and six new diagnostic codes were introduced.

On June 5, 2023, the updated version of the Laboratory test nomenclature was published by the Finnish Institute for Health and Welfare (THL) to come into force on July 1, 2023. A total of 138 new codes were introduced.

On June 1, 2023, NHS England issued an updated version of the National Genomic Test Directory, which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. Three new codes (test-indication combinations) were introduced in the Test Directory for rare and inherited diseases.

In May 2023, the National Institute for Health and Care Research (NIHR) in England released two MedTech-related reports in its Health Technology Assessment (HTA) Journal, which endoscopic radiofrequency ablation in malignant biliary obstruction and screening for ovarian cancer. 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.

On June 01, 2023, the French National Authority for Health (HAS) announced the start of the application period for the evaluation of procedures and IVD tests to be included in 2024 HAS working program.

n the period of April-May 2023, the Galician Agency for Health Technology Assessment (AVALIA-T) initiated the five health technology assessments referred to IVD, nephrology and urology, obstetrics and gynecology, pulmonary and airways as well as surgical procedures technology groups. The assessments on stereotactic virtual navigation system for percutaneous puncture as well as tumor ablation and invasive telemonitoring of pulmonary pressure in patients with heart failure were released.

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 late May 2023, the Norwegian Directorate of e-Health released an updated version of the Norwegian Laboratory code (NLK) system to be implemented no later than July 1, 2023. A total of 142 new codes were added, 33 codes were terminated, and 122 codes were amended.