In-vitro diagnostics

15

Sep 2022

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. Read more

13

Sep 2022

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. Read more

06

Sep 2022

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. Read more

31

Aug 2022

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). Read more

24

Aug 2022

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). Read more

10

Aug 2022

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. Read more

05

Aug 2022

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. Read more

25

Jul 2022

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. Read more

22

Jul 2022

The revised EBM (German Uniform Evaluation Standard) catalog came into force on July 1, 2022. The most significant changes concern introducing and updating multiple EBM codes for IVD tests and adjusting tariffs and content of radiotherapy services. Read more

14

Jul 2022

In June 2022, NHS England and NHS Improvement (NHSEI) defined timelines for the evaluation of applications to update the National Genomic Test Directory in 2022/23. Applications can be submitted at any time throughout the year. Applications submitted before August 31, 2022, will be reviewed and considered for inclusion in the April 2023 update to the Test Directory Read more

13

Jul 2022

On June 06, 2022, the Reimbursement Commission of the Social Security Institution (SSI) released an updated version of the Healthcare Implementation Communique (SUT). The main changes relate to the increase in reimbursement fees of genetic tests by approximately 10%. Also, 138 new IVD tests have been added to the SUT. Read more

11

Jul 2022

In June 2022, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 0184 and 0081 with changes to be implemented no later than August 09, 2022. Two new procedure codes for robotic surgery and two new diagnostic codes were introduced. Read more