In-vitro diagnostic tests

In February 2024, the Basque Office for Health Technology Assessment (OSTEBA) is working on several HTAs, including evaluations in the cardiovascular, e-health, ENT, IVD, and some other fields.

On January 26, 2024, NHS England announced the third round of the Innovation Open Call, funded by the NHS Cancer Programme. All types of late-stage innovations aimed at early detection and diagnosis of cancer are eligible, including medical devices, in-vitro diagnostics, digital health solutions, and AI. Awarded projects will be 100% funded up to the total value of £4 million to produce and evaluate evidence in a real-world setting, supporting adoption and spread by providers, commissioners, and regulators. The application submission will be open on April 8, 2024.

On January 23, 2024, the Ministry of Health introduced a new national catalog, which guarantees the Spanish population's genetic tests nationwide. Currently, the catalog includes 672 tests in eight disease areas, including adult and pediatric oncohematology, pharmacogenomics, hereditary metabolic and mitochondrial diseases, and others. Twelve more disease areas are expected to be added in 2024.

The LEA catalog was brought in 2017, but the tariffs were approved in 2023. The new tariffs for outpatient specialist care were supposed to enter into force on January 1, 2024, but the adoption of new tariffs was postponed to April 1, 2024, due to the technical inability of the Regions to implement the change in time.

In January 2024, eight NHS Genomic Networks of Excellence were launched within the NHS Genomic Medicine Service (GMS). NHS England is funding these innovative networks to develop the evidence and model of adoption for cutting-edge genomic advances and technology applications and inform commissioning decisions.

In January 2024, NHS England issued an updated version of the National Genomic Test Directory for 2024/2025, which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. Six new codes (test-indication combinations) were introduced in the Test Directory for cancer, and four new codes in the Test Directory for rare and inherited diseases.

In December 2023, the reimbursement scheme for outpatient pathology services was updated for 2024. This scheme has been gradually introduced in Norway since 2022. It comprises fee-for-service reimbursement by the Norwegian Health Economics Administration (Helfo) using Pathology Activity Codes (APAT). Fourteen new reimbursement codes were introduced.

On December 18, 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 January 1, 2024. Sixty new codes were introduced concerning in-vitro diagnostics and functional diagnostic tests in the cardiology, pulmonology, and gastroenterology fields.

In December 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 with changes to be implemented no later than February 12, 2024. Five new procedure codes (concerning endoscopy, gastrointestinal, and spine) and one new in-vitro diagnostic code were introduced.

On December 21, 2023, the revised EBM (German Uniform Evaluation Standard) catalog for the first quarter of 2024 was published. The most significant changes concern the update of Annex 2 of the catalog, the introduction of the new EBM codes for external electrical cardioversion in adult and pediatric patients, follow-up and evaluation of the health app companion patella, as well as a companion diagnostics test for genotyping to determine CYP2C19 metabolism status.

On November 29, 2023, 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 January 1 or 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 November 2023, the Norwegian Directorate of e-Health released an updated version of the Norwegian Laboratory Code (NLK) system and associated tariffs to be implemented no later than January 1, 2024. Eighty-four new codes were added, 77 codes were amended, and 32 codes were terminated.