In-vitro diagnostic tests

The revised EBM (German Uniform Evaluation Standard) catalog came into force on October 1, 2022. The most significant changes concern introducing the EBM codes for several IVD tests and a new service in artificial insemination.

On September 23, 2022, the Norwegian Directorate of e-Health released an updated version of the National Laboratory code (NLK) system and associated tariffs for state and private laboratories to be implemented no later than November 01, 2022. Twenty-three new codes were added, six codes were changed, and 126 codes were terminated.

On September 5, 2022, it was announced that the Interterritorial Council for the Spanish National Health System (CISNS) approved the distribution of funds to the Autonomous Communities for the fight against cancer. The aim is to boost the screening programs for colorectal and cervical cancer.

On August 25, 2022, the Norwegian Directorate of Health announced the launch of the National screening program for colorectal cancer (Bowel screening program - Tarmscreeningprogrammet). All 55-year-old men and women will be included in the program and offered a test to identify invisible blood in the stool (fecal immunochemical test, FIT) every two years until the age of 65. Colonoscopy will be offered in case of positive FIT.

In August 2022, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (aortic remodeling hybrid stent insertion during surgical repair of aortic dissection, bioresorbable stent implantation to treat coronary artery disease, superficial venous arterialization for chronic limb ischemia, transcutaneous electrical neuromuscular stimulation for urinary incontinence, focal resurfacing implants to treat articular cartilage damage in the knee), and three new Medtech Innovation Briefings (Stockholm3 for prostate cancer screening, contrast-enhanced spectral mammography, differential target multiplexed spinal cord stimulation). Also, two Medical Technologies Guidance and two Medtech-related clinical guidelines were updated.

On August 11, 2022, NHS England and NHS Improvement released an updated National Genomic Test Directory for rare and inherited diseases (version 3.1), which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. No new codes (test-indication combinations) were introduced.

On August 01, 2022, a new version of the Nomenclature of Medical Biology Acts (NABM080) was released. One new code for the detection of the monkeypox virus genome was introduced.

On August 11, 2022, the National Association of Statutory Health Insurance Physicians (KBV) announced that two new services in the in-vitro diagnostics field in lung and colon cancer, respectively, will be reimbursed via the German Uniform Evaluation Standard (EBM).

In July 2022, the French National Authority for Health (HAS) published seven new opinions which were based on health technology assessment reports. These are related to endoscopy, IVD tests, neuromodulation, and primary care settings. The main goal of these HTA reports was to spoort decision-making for the creation of new procedure codes in the Common Classification of Medical Procedures (CCAM) and the Nomenclature of Medical Biology Procedures (NABM).

In July 2022, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (transcatheter tricuspid valve annuloplasty for tricuspid regurgitation, and transcatheter tricuspid valve leaflet repair for tricuspid regurgitation), one new Diagnostic Guidance (PLGF-based testing to help diagnose suspected preterm pre-eclampsia), and four new Medtech Innovation Briefings (ProciseDx point-of-care platform for IBD, RespiraSense for continuously monitoring respiratory rate, Lenus COPD Support Service, and cyanoacrylate glue for hernia mesh fixation). Also, five clinical guidelines were updated.

In July 2022, Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) announced the extension of temporary reimbursement for gene expression profile (GEP) testing for early-stage breast cancer detection until December 31, 2022, and for molecular biology tests by next-generation sequencing (NGS) until June 30, 2023.

On July 1, 2022, the Laboratory Tests Nomenclature (Laboratoriotutkimusnimikkeistö) was updated in Finland. The validity period of seven coronavirus tests was extended until June 30, 2023. Two new codes in the field of physiology were added.