In-vitro diagnostic tests

On October 9, 2024, the new version of the Nomenclature of Medical Biology Procedures (NABM 93) was released in France. Changes included the introduction of five new codes and wording modifications for several codes.

In September 2024, the National Institute for Health and Care Research (NIHR) in England released three MedTech-related assessments in its Health Technology Assessment (HTA) Journal, which concerned hyperthermic intraoperative peritoneal chemotherapy and cytoreductive surgery in peritoneal metastases, resuscitative endovascular balloon occlusion of the aorta in life-threatening torso hemorrhage, and clopidogrel resistance genotype testing. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and informs National Institute for Health and Care Excellence (NICE) guidance.

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 September 2024. Five recommendations were published concerning the registration or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern endocrine and spine devices, as well as medical aids.

On September 2, 2024, NHS England published guidance for planning, designing, and implementing Community diagnostic centers (CDCs). The national CDC Program is in its third year and has approved 170 CDC sites across England. The guidance sets the next steps and best practices in developing CDCs, including minimum requirements for core diagnostic tests that CDCs must provide permanently.

On September 23, 2024, the Norwegian Directorate of Health released an updated version of the Norwegian Laboratory Code (NLK) system. Sixty-nine new codes were added, and 209 codes were changed.

On September 6, 2024, the new version of the Nomenclature of Medical Biology Acts (NABM 92) was released in France. Various changes were implemented, including the introduction of one new code, modification of the coefficient B rating for a number of codes, and deletion of Article 4 "Minimum quotations" from the general provisions section of the NABM with 18 codes of this section.

On September 2, 2024, the French Ministry of Health released further details on the renewed support for innovation in medical biology and anatomopathology procedures via the Repository of Innovative Services outside the Nomenclature of biology and anatomopathology (RIHN) 2.0 including criteria for application.

In September 2024, the Canary Islands Healthcare Evaluation Service (SESCS) is working on several HTAs, including evaluations in neuromodulation, IVD, and some other fields.

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.

NICE recently introduced a new centralized approach to prioritizing topics for its guidance and a decision-making body - a prioritization board. In July 2024, the decisions of the prioritization board were first published by NICE. Sixteen topics were prioritized, twenty were not prioritized, and one was withdrawn.

On August 8, 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 197 and 093 with changes to be implemented no later than October 4, 2024. Thirteen new procedure codes related to cardiovascular, endoscopy, gastrointestinal, interventional radiology, neurology, gynecology, orthopedics, spine, and robotic surgery areas, and four new diagnostic codes were introduced.

On August 3, 2024, the Ministry of Labor, Health, and Solidarity published an Order in the Official Journal of the French Republic modifying the national neonatal screening program using laboratory examinations. Starting November 1, 2024, all newborns will be screened for sickle cell disease. Other modifications include organizational changes and modifications related to the timing of blood sample collection.