Diagnostics

On January 26, 2024, NHS England announced the third round of the Innovation Open Call, funded by the NHS Cancer Programme. All types of late-stage innovations aimed at early detection and diagnosis of cancer are eligible, including medical devices, in-vitro diagnostics, digital health solutions, and AI. Awarded projects will be 100% funded up to the total value of £4 million to produce and evaluate evidence in a real-world setting, supporting adoption and spread by providers, commissioners, and regulators. The application submission will be open on April 8, 2024.

On December 18, 2023, the updated version of the laboratory test nomenclature was published by the Finnish Institute for Health and Welfare (THL) to come into force on January 1, 2024. Sixty new codes were introduced concerning in-vitro diagnostics and functional diagnostic tests in the cardiology, pulmonology, and gastroenterology fields.

On December 21, 2023, the revised EBM (German Uniform Evaluation Standard) catalog for the first quarter of 2024 was published. The most significant changes concern the update of Annex 2 of the catalog, the introduction of the new EBM codes for external electrical cardioversion in adult and pediatric patients, follow-up and evaluation of the health app companion patella, as well as a companion diagnostics test for genotyping to determine CYP2C19 metabolism status.

On November 16, 2023, the National Association of Statutory Health Insurance Physicians (KBV) informed that Annex 2 of the updated German Uniform Evaluation Standard (EBM) catalog, which is expected to be published on January 1, 2024, will be enriched with an additional 33 interventional procedures.

On October 26, 2023, the BfArM (Federal Institute for Drugs and Medical Devices) published the final version of the 2024 OPS procedure coding classification. The OPS, together with the ICD-10-GM (International Statistical Classification of Diseases and Related Health Problems, 10th revision, German Modification), forms the basis for the reimbursement systems in outpatient and inpatient care in Germany.

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.

On August 11, 2024, the BfArM (Federal Institute for Drugs and Medical Devices) published the preliminary version of the 2024 OPS procedure coding classification. The OPS, together with the ICD-10-GM (International Statistical Classification of Diseases and Related Health Problems, 10th revision, German Modification), forms the basis for the reimbursement systems in inpatient and outpatient care in Germany.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on July 1, 2023. The most significant changes concern introducing the new EBM codes for several IVD tests, as well as for the cryopreservation of the ovarian tissue.

In April 2023, Swedish Medical Technologies Product (MTP) Council recommended that Magtrace and Sentimag be used for locating sentinel lymph nodes in breast cancer. The products were evaluated within the Orderly introduction framework, in which all Swedish regions collaborate to manage the national introduction of innovative medical technologies.

In the middle of April 2023, the French National Authority for Health (HAS) published a decision modifying its internal regulations establishing the “Commission for the Evaluation of Diagnostic, Prognostic, and Predictive Technologies (CEDiag)”. This Commission is responsible for preparing the opinions and decisions of the HAS relating to the evaluation of health technologies for diagnostic, prognostic or predictive purposes.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on April 1, 2023. The most significant changes concern introducing the new EBM codes for follow-up and evaluation of the “Invirto” health app, high-frequency endometrium ablation, and reducing the tariff for COVID-19 PCR tests.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on January 1, 2023. The most significant changes concern introducing the EBM codes for several IVD tests and further promoting outpatient (day case) surgical services.