Molecular diagnostics

In August 2025, the Common Catalog of Genetic and Genomic Tests of the National Health System in Spain was updated. Two sections with a total of 140 new genetic tests were introduced: one for bone diseases, including craniofacial anomalies, and another for kidney diseases and urogenital disorders. Furthermore, six new tests were added in pediatric oncohematology. Other changes concerned adult oncohaematology, hereditary metabolic, and mitochondrial diseases.

On July 29, 2025, the French National Authority for Health (HAS) issued positive opinions on including targeted next-generation sequencing-based panels in certain clinical indications for patients with aminoacidopathy and acute leukaemia in the NABM Nomenclature for regular reimbursement. Currently, these tests are temporarily reimbursed within the innovative payment scheme (RIHN). These HAS assessments are performed by HAS as a part of the RIHN reform and ‘cleaning up’ the List of temporary covered tests.

On July 17, 2025, the Federal Joint Committee (G-BA) decided that the use of the Oncotype DX Breast Recurrence Score® test as the sole test for deciding for or against adjuvant systemic chemotherapy will be reimbursed for patients with primary hormone receptor-positive, HER2-negative breast cancer involving one to three lymph nodes. Previously, reimbursement was limited to patients without lymph node involvement.

On May 6, 2025, NHS England issued an updated version of the National Genomic Test Directory for 2025/26, which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. One new code (test-indication combination) was introduced in the Test Directory for cancer, and one for rare and inherited diseases.

On May 01, 2025, the Dutch Healthcare Authority (NZa) published the first release of the 2026 DRG package (RZ26a). Three new procedure codes, seven new supplementary payments (OZPs), one new diagnosis code, and two new DRGs will be implemented across in-vitro diagnostics, obstetrics and gynecology, neurology and neurosurgery, cardiovascular and other technology groups.

On April 14, 2025, the National Board of Health and Welfare was tasked to allocate 80 million SEK from the government to support Genomic Medicine Sweden (GMS) project in 2025. Funding will be distributed to several projects, including the development and/or implementation of innovative technologies such as whole genome sequencing based on long DNA reads, gene panels for sensitive detection of residual disease, and precision diagnostics (liquid biopsies for solid tumors, detection of antibiotic resistance).

On April 10, 2025, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 201 and 097 with changes to be implemented no later than June 11, 2025. Ten new procedure codes concerning men’s health, endoscopy, gynecology, orthopedic, and surgical procedures fields and seven new diagnostic codes were introduced.

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 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.