In-vitro diagnostic tests

On July 16, 2024, the French Ministry of Labor, Health and Solidarity published the merged 2024 List of acts outside the nomenclature financed under MERRI G03.

On July 2, 2024, the revised EBM (German Uniform Evaluation Standard) catalog for the third quarter of 2024 was published. The changes introduced mainly concern updating the content of several EBM sections with the respective comments and/or clarifications and introducing the new EBM codes for several companion diagnostics tests, for follow-up and evaluation of the “Kranus Lutera” health app, and for the services provided within the co-funded study on bronchoscopic lung volume reduction in severe pulmonary emphysema using thermal ablation (rp-RL BTVA).

On June 19, 2024, the Order SND/606/2024, of June 13, came into force. This Order, among other things, amends Annexes I, II, III, VI, and VII of Royal Decree 1030/2006, of September 15, which establishes the Common Package of Benefits of the National Health System and the procedure for its update. The changes mostly concern in-vitro diagnostics, ENT, pulmonary and airways, cardiovascular, and some other fields.

On July 1, 2024, the National Institute for Health and Disability Insurance (INAMI/RIZIV) introduced a new agreement (Convention), which allows permanent reimbursement for molecular biology tests by next-generation sequencing (NGS) in oncology and hemato-oncology. The tests were reimbursed temporarily in the context of the pilot Convention from 2019. Fifty-one new pseudo-nomenclature codes with tariffs were introduced. The pseudocode descriptions specify the indication, while certain biomarkers and reimbursement conditions are mentioned as notes to the code.

On June 13, 2024, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 196 and 092 with changes to be implemented no later than August 8, 2024. Five new procedure codes related to endoscopy, ENT, orthopedics, and spine, as well as seven new diagnostic codes were introduced.

On June 18, 2024, France introduced the tariffs of €10-€15 for rapid diagnostic tests performed by pharmacists. This initiative enables pharmacists to swiftly diagnose and manage common conditions, such as Group A Streptococcal pharyngitis and urinary tract infections.

On June 18, 2024, the Swiss Federal Office of Public Health published the changes that will occur to the Services Ordinance (KLV/OPre), which determines coverage of medical services in Switzerland. The updates will enter into force on July 1, 2024, and they relate to the list of explicitly evaluated services (Annex 1 of KLV/OPre), outpatient-before-hospital services (Annex 1a), List of Tools and Equipment (Annex 2), and List of Analyses (Annex 3).

In the first half of June 2024, the French National Authority for Health (HAS) published its positive opinions regarding the reimbursement of several services in France.

On May 23, 2024, the Norwegian Directorate of Health released an updated version of the Norwegian Laboratory Code (NLK) system and associated tariffs to be implemented no later than July 1, 2024. Twenty-two new codes were added, and 49 codes were changed.

In May 2024, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedures Guidance concerning selective internal radiation therapy for liver metastases, endoscopic duodenal mucosal resurfacing in type 2 diabetes, and image-guided percutaneous laser ablation for liver tumours, and one Diagnostics Guidance on tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer.

On May 23, 2024, the 2024 working plan was published by the Spanish Network of HTA Agencies (RedETS). Topics in cardiovascular, diagnostic imaging, e-health, endoscopy, ENT, extracorporeal treatments, ICU/OR, in-vitro diagnostics, interventional radiology, men’s health, neurology and neurosurgery, neuromodulation, obstetrics and gynecology, orthopedics, peripheral vascular, pulmonary and airways, radiology, radiotherapy, robotic surgery, spine, surgical procedures, and some other fields are included in the plan.

On May 17, 2024, the French National Authority for Health (HAS) announced the start of the application period for evaluating procedures and IVD tests to be included in the 2025 HAS working program.