Molecular diagnostics

In July 2024, the UK National Screening Committee (UK NSC) released an annual report from April 1, 2023 to March 31, 2024. The report provides a summary of the Committee’s ongoing work and accomplishments, including recommendations regarding the introduction of national population screening programs.

On July 12, 2024, the UK National Screening Committee (UK NSC) announced a new task group for multi-cancer detection (MCD) tests. The group will review different methods for the evaluation of MCDs, from which UK NSC is expected to derive a position statement and develop a roadmap for a possible MCD screening program.

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.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on October 1, 2023. The most significant changes concern the introduction of the new EBM codes for several IVD tests, prostate-specific membrane antigen (PSMA) positron emission tomography, as well as for stereotactic radiosurgery (SRS) in vestibular schwannomas.

In late September 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 November 1, 2023. A total of 123 new codes were added, 50 codes were terminated, and 69 codes were amended.

The National Genomic Test Directory lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. It is updated annually. The applications submitted before April 1, 2024, to add new tests or change existing ones will be considered for implementation on April 1, 2025.

In late June 2023, the National Institute for Health and Disability Insurance (INAMI-RIZIV) decided to extend reimbursement for molecular biology tests by next-generation sequencing (NGS) for one year until June 30, 2024. NGS in oncology and hemato-oncology are temporarily reimbursed as a pilot under a specific agreement (Convention) with INAMI-RIZIV from 2019.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on July 1, 2023. The most significant changes concern introducing the new EBM codes for several IVD tests, as well as for the cryopreservation of the ovarian tissue.

On June 5, 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 July 1, 2023. A total of 138 new codes were introduced.

On June 1, 2023, NHS England issued an updated version of the National Genomic Test Directory, which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. Three new codes (test-indication combinations) were introduced in the Test Directory for rare and inherited diseases.

In late May 2023, the Norwegian Directorate of e-Health released an updated version of the Norwegian Laboratory code (NLK) system to be implemented no later than July 1, 2023. A total of 142 new codes were added, 33 codes were terminated, and 122 codes were amended.

On May 17, 2023, NHS England issued an updated version of the National Genomic Test Directory for cancer, which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. Two new codes (test-indication combinations) were introduced.