Diagnostics

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.

In November 2022, the National Institute for Health Research (NIHR) in England released one MedTech-related report in its Health Technology Assessment (HTA) Journal, which concerned SeHCAT (radiopharmaceutical) for the investigation of bile acid diarrhea. 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.

On October 27, 2022, the BfArM (Federal Institute for Drugs and Medical Devices) published the final version of the 2023 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, 2022. The most significant changes concern introducing the EBM codes for several IVD tests and a new service in artificial insemination.

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.

On June 15, 2022, the National Institute for Health and Care Excellence (NICE) announced a new program called Early Value Assessment for Medtech. The program will offer a rapid assessment of digital products, devices, and diagnostics for clinical effectiveness and value for money where the evidence base is still emerging to inform NHS commissioners. The two pilot assessments for health apps will begin in June 2022 and are expected to be published in October 2022. Further topics are expected in mental health, early cancer diagnosis, and cardiovascular disease.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on April 1, 2022. The most significant changes concern the introduction of new additional flat rates for the observation and care of patients who are given certain medications, adjustment of EBM reproductive medicine definitions, and inclusion of several new codes for PET and PET/CT.

Dutch Organization for Health Research and Development, ZonMw awarded eight projects under the "Healthcare Evaluation and Appropriate Use" program, including two projects for geriatric care, two projects for cancer, per one project for cardiovascular, neurovascular, and dermatology care.

In late September 2021, the Austrian version of the DRG system (LKF) 2022 model with the relevant supplementary documents was published in Austria. The document "Changes and innovations in the 2022 LKF model" (Änderungen und Neuerungen in den LKF-Modellen 2022) summarizes the most significant changes and innovations in the LKF model for inpatient and outpatient care. The newly added procedure codes concern mainly the cardiovascular, E-Health, and gastrointestinal area.

In mid-June 2021, the document "Changes and innovations in the 2022 LKF model" (Änderungen und Neuerungen in den LKF-Modellen 2022) was published. The document summarizes the most significant changes and innovations in the LKF model for inpatient and outpatient care. The newly added procedure codes concern mainly the cardiovascular, e-Health, and gastrointestinal area.