In-vitro diagnostic tests

In June 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 190 and 086 with changes to be implemented no later than August 4, 2023. Fourteen new procedure codes (concerning cardiovascular, diagnostic imaging, endocrine, endoscopy, gastrointestinal, orthopedic and spine, peripheral vascular, robotic surgery, men's health, and radiotherapy fields) and six new diagnostic codes were introduced.

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.

On April 14, 2023, a repository of innovative acts outside the nomenclature of biology and anatomopathology (RIHN) and a Supplementary list of IVD tests were published. Minor changes were introduced in the 2023 RIHN list.

In April 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 189 and 085 with changes to be implemented no later than June 15, 2023. Eighteen new procedure codes (concerning cardiovascular, endocrine, endoscopy, gastrointestinal, interventional radiology, neuromodulation, peripheral vascular, robotic surgery, men's health, and general surgery fields) and eight new diagnostic codes 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.

In late March 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 May 1, 2023. Twenty-one new codes were added, 122 codes were changed, and one code was terminated.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Horgan et al. completed a survey of the status of Next-Generation Sequencing (NGS) in Europe and globally. Based on the feedback from 62 experts, a framework for implementation of the NGS is proposed along with in-depth discussion about current aspects of demand-and supply-side issues, governance and strategy, clinical standardization, awareness and education, equipment used, reimbursement and funding.

On February 23, 2023, the Innovation Committee at the Federal Joint Committee (G-BA) published the decisions, recommending the transfer to standard care for another three completed projects. The projects relate to preventing the family risk of colorectal carcinoma, shared decision-making in the hospitals, and digitally supported drug therapy management.

In February 2023, the National Institute for Health and Disability Insurance (INAMI-RIZIV) announced the completion of a pilot project for gene expression profiling (GEP) tests in early-stage breast cancer, which ran from 2019. The pilot showed significant benefits, and INAMI-RIZIV launched a reimbursement for certain tests under the specific agreement (GEP convention) with healthcare providers.