In-vitro diagnostic tests

On August 2, 2024, the HAS published positive opinions on the inclusion of targeted high-throughput sequencing of gene panels in the medical management of lung cancer, gastrointestinal stromal tumors, and chronic lymphocytic leukemia in the NABM Nomenclature. This is a consequence of the efforts to disburden the innovation funding budget and clean the List of IVD tests outside the Nomenclature (Liste des actes hors nomenclatures, AHN, i.e., the merged 2023 RIHN List and the Supplementary List funded outside Statutory Health Insurance via the research and innovation budget).

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.

At the end of July 2024, the French Ministry of Health released a document on the RIHN reform process, including the description on the new RIHN application and evaluation process, but also how the HAS will evaluate tests currently covered in the RIHN Nomenclature, with the purpose of of deciding whether these tests will be granted permanent reimbursement, or will be excluded from coverage within the statutory health insurance. Cleaning the current AHN List will allow for the financing of truly innovative tests patients need.

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in July 2024. Nine recommendations were published concerning the registration of medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern cardiovascular, neurovascular, interventional radiology, nephrology and urology, orthopedic, endocrine devices, and in-vitro diagnostic tests, as well as medical aids.

In July 2024, SBRI (Small Business Research Initiative) Healthcare launched new funding competitions in four priority areas: antimicrobial resistance, women’s health, urgent & emergency care, and stroke. All types of innovations are eligible, including but not limited to medical devices, in-vitro diagnostics, digital health, and AI solutions.

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 16, 2024, the French Ministry of Labor, Health and Solidarity published the merged 2024 List of acts outside the nomenclature financed under MERRI G03.

On July 2, 2024, the revised EBM (German Uniform Evaluation Standard) catalog for the third quarter of 2024 was published. The changes introduced mainly concern updating the content of several EBM sections with the respective comments and/or clarifications and introducing the new EBM codes for several companion diagnostics tests, for follow-up and evaluation of the “Kranus Lutera” health app, and for the services provided within the co-funded study on bronchoscopic lung volume reduction in severe pulmonary emphysema using thermal ablation (rp-RL BTVA).

On June 19, 2024, the Order SND/606/2024, of June 13, came into force. This Order, among other things, amends Annexes I, II, III, VI, and VII of Royal Decree 1030/2006, of September 15, which establishes the Common Package of Benefits of the National Health System and the procedure for its update. The changes mostly concern in-vitro diagnostics, ENT, pulmonary and airways, cardiovascular, and some other fields.

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.

On June 13, 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 196 and 092 with changes to be implemented no later than August 8, 2024. Five new procedure codes related to endoscopy, ENT, orthopedics, and spine, as well as seven new diagnostic codes were introduced.