Genetic tests

On August 11, 2022, NHS England and NHS Improvement released an updated National Genomic Test Directory for rare and inherited diseases (version 3.1), which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. No new codes (test-indication combinations) were introduced.

On August 11, 2022, the National Association of Statutory Health Insurance Physicians (KBV) announced that two new services in the in-vitro diagnostics field in lung and colon cancer, respectively, will be reimbursed via the German Uniform Evaluation Standard (EBM).

In July 2022, Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) announced the extension of temporary reimbursement for gene expression profile (GEP) testing for early-stage breast cancer detection until December 31, 2022, and for molecular biology tests by next-generation sequencing (NGS) until June 30, 2023.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on July 1, 2022. The most significant changes concern introducing and updating multiple EBM codes for IVD tests and adjusting tariffs and content of radiotherapy services.

In June 2022, NHS England and NHS Improvement (NHSEI) defined timelines for the evaluation of applications to update the National Genomic Test Directory in 2022/23. Applications can be submitted at any time throughout the year. Applications submitted before August 31, 2022, will be reviewed and considered for inclusion in the April 2023 update to the Test Directory

On June 06, 2022, the Reimbursement Commission of the Social Security Institution (SSI) released an updated version of the Healthcare Implementation Communique (SUT). The main changes relate to the increase in reimbursement fees of genetic tests by approximately 10%. Also, 138 new IVD tests have been added to the SUT.

In June 2022, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 0184 and 0081 with changes to be implemented no later than August 09, 2022. Two new procedure codes for robotic surgery and two new diagnostic codes were introduced.

On May 31, 2022, Regional Cancer Centers collaboration (RCC) updated the national care program for breast cancer. New and updated recommendations concerned genetic testing, molecular diagnostic, de-escalation of surgical treatment for certain patient groups, radiotherapy regimens, and pharmacotherapy. A new chapter was added on breast cancer in men.

On May 30, 2022, NHS England and NHS Improvement updated the 2021/22 National Genomic Test Directory for cancer (version 4), which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. However, no new codes were introduced.

In April 2022, NHS England and NHS Improvement (NHSEI) announced that the timelines for the evaluation of applications to update the National Genomic Test Directory in 2022/23 are currently under review. Previously, NHSEI planned to publish and implement the 2022/23 Test Directory by April 2022. While the timelines are not confirmed, applications can still be submitted.

On April 21, 2022, NHS England and NHS Improvement updated the 2021/22 National Genomic Test Directory (version 3), which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. Forty-two new codes (test-indication combinations) were introduced in the cancer field, and fourteen for rare and inherited diseases.

A new test called Genedrive System to detect babies at risk of gentamycin-related deafness was developed at the University of Manchester, funded by the National Institute for Health and Care Research (NIHR). On April 02, 2022, NHS England and NHS Improvement announced that Genedrive is now fully CE certified to be used in a clinical setting. The test is expected to be implemented in routine care in all NHS Manchester Foundation Trust hospitals within several weeks.