In-vitro diagnostic tests

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.

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.

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

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.

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.

In mid-June, the Swiss Federal Office for Public Health announced the update of the Annexes of the Services Ordinance (KLV/OPre). Annexes 1, 2, and 3 were updated. The updates related to the endocrine, IVD, and interventional radiology technology groups.