Molecular diagnostics

On December 24, 2024, the decision of the National Union of Health Insurance Funds (UNCAM) regarding the update of the CCAM Classification of procedure codes was published in the Official Journal of the French Republic. Changes include registration of three new procedure codes, modification of billing notes for certain procedures, and amendment of modifiers. The updates are expected to come into force on February 1, 2025.

On October 31, 2024, the Swiss Federal Statistics Office (UFS) released the systematic version of the procedure code (CHOP) nomenclature for 2025. The nomenclature is now available in German, Italian, and French languages and will come into force on January 1, 2025. Multiple new procedure codes were introduced in various fields, including endoscopy, extracorporeal treatments, in-vitro diagnostics, interventional radiology, obstetrics and gynecology, orthopedics, and radiotherapy.

On October 10, 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 198 and 094 with changes to be implemented no later than December 5, 2024. Fifty-two new procedure codes related to ENT, gastrointestinal, men’s health, urology, neurology and neurosurgery, gynecology, orthopedics, robotic surgery, and surgical procedures areas, and two new diagnostic codes were introduced.On October 10, 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 198 and 094 with changes to be implemented no later than December 5, 2024. Fifty-two new procedure codes related to ENT, gastrointestinal, men’s health, urology, neurology and neurosurgery, gynecology, orthopedics, robotic surgery, and surgical procedures areas, and two new diagnostic codes were introduced.

On October 01, 2024, the Dutch Healthcare Authority (NZa) published the second release of the 2025 DRG package (RZ25b). Three new procedure codes, four new supplementary payments (OZPs), 18 new diagnosis codes, and two new DRGs will be implemented across gastroenterology, surgery, diagnostic imaging, molecular diagnostics, and other areas.

Molecular gene profile analysis (Oncotype DX) was evaluated within the "New Methods" framework starting in 2021. On August 26, 2024, the Decision Forum for "New Methods" recommended Oncotype DX to be introduced to predict the benefit of chemotherapy in postmenopausal patients with lymph node-positive, estrogen receptor-positive (ER+), human epidermal growth factor receptor-2 negative (HER2-) early-stage invasive breast cancer.

In July 2024, NHS England issued an updated version of the 2024/25 National Genomic Test Directory, which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. A total of 58 new codes (test-indication combinations) were introduced in the Test Directory for cancer, and ten new codes in the Test Directory for rare and inherited diseases.

In July 2024, the National Institute for Health and Care Excellence (NICE) released a report on proposed approaches to the economic evaluation of multi-indication health technologies (MIHTs) developed by the HTA Lab. Examples of MIHTs include circulating tumor DNA tests, polygenic risk scores, and virtual ward platform technologies, which can be used across multiple disease areas or multiple indications. This report proposes approaches that NICE could adopt for future economic evaluations of MIHTs and provides recommendations for implementing the approaches on pilot topics.

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.

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.