Genetic tests

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.

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.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on April 1, 2023. The most significant changes concern introducing the new EBM codes for follow-up and evaluation of the “Invirto” health app, high-frequency endometrium ablation, and reducing the tariff for COVID-19 PCR tests.

On March 1, 2023, Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) updated three Articles of the Nomenclature related to in-vitro diagnostics. Twelve new codes concerning clinical biology, molecular biology for infections, and genetics were implemented.

On January 24, 2023, the Swedish National Board of Health and Welfare recommended introducing a national screening program for spinal muscular atrophy (SMA) in newborns. It will identify children with a homozygous deletion in the SMN1 gene and 1–3 copies of the SMN2 gene. SMA testing must be included in the existing newborn screening (so-called PKU test). The launch of the new screening program is expected in the summer of 2023.

On January 23, 2023, the Norwegian Directorate of e-Health released an updated version of the National Laboratory code (NLK) system and associated tariffs for state and private laboratories to be implemented no later than March 1, 2023. Twenty-four new codes were added, 179 codes were changed, and 23 codes were terminated.

In the fourth quarter of 2022, Health Technology Wales published three MedTech-related guidance (Left atrial appendage occlusion in patients with atrial fibrillation, continuous topical oxygen therapy, and virtual reality distraction therapy). Four Topic Exploration Reports were released as well (virtual wards, genetic testing for prostate cancer, autofluorescence imaging, and geniculate artery embolization); however, Health Technology Wales decided not to proceed with complete appraisals on these topics.

In January 2023, the updated Pathology Activity Codes (APAT) of the Norwegian Pathology Code system (NORPAT) came into force. Since 2022, APAT codes have been included in the new reimbursement scheme by Helfo (the Norwegian Health Economics Administration) for outpatient pathology services. Five new classified sample materials for cytology and 22 new additional codes for the method of testing were added to the scheme in 2023.