In-vitro diagnostic tests

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.

In March 2023, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (percutaneous transluminal renal sympathetic denervation for resistant hypertension, endoluminal gastroplication for gastro-oesophageal reflux disease), three new Health Technology Evaluations via piloted early value assessment approach (CaRi-Heart for predicting cardiac risk in suspected coronary artery disease, ProKnow cloud-based system for radiotherapy data storage, and Genedrive MT-RNR1 ID Kit for detecting a genetic variant), and two new MedTech Innovation Briefings (QBTest and BPMpathway). No new clinical guidelines were published.

In late March 2023, the Norwegian Directorate of e-Health released an updated version of the National Laboratory code (NLK) system and associated tariffs for state and private laboratories to be implemented no later than May 1, 2023. Twenty-one new codes were added, 122 codes were changed, and one code was terminated.

A new preeclampsia screening algorithm has been evaluated within the "New Method" framework since 2021. The algorithm helps to predict the risk of preeclampsia in the first trimester based on several parameters, including ultrasound examination and measurement of the Placenta Growth Factor (PIGF). In March 2023, the Decision Forum for "New Method" was held and commissioned to perform the implementation study of a new screening algorithm at St. Olav's Hospital.

On March 1, 2023, Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) updated three Articles of the Nomenclature related to in-vitro diagnostics. Twelve new codes concerning clinical biology, molecular biology for infections, and genetics were implemented.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Horgan et al. completed a survey of the status of Next-Generation Sequencing (NGS) in Europe and globally. Based on the feedback from 62 experts, a framework for implementation of the NGS is proposed along with in-depth discussion about current aspects of demand-and supply-side issues, governance and strategy, clinical standardization, awareness and education, equipment used, reimbursement and funding.

In February 2023, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (transvenous obliteration for gastric varices, biodegradable spacer to reduce rectal toxicity during radiotherapy for prostate cancer), one new Health Technology Evaluation (guided self-help digital cognitive behavioural therapy), and two new Medtech Innovation Briefings (LIVERFASt, and Ambu aScope 4 RhinoLaryngo). Also, one new clinical guideline was published, and one was updated.

On February 23, 2023, the Innovation Committee at the Federal Joint Committee (G-BA) published the decisions, recommending the transfer to standard care for another three completed projects. The projects relate to preventing the family risk of colorectal carcinoma, shared decision-making in the hospitals, and digitally supported drug therapy management.

In February 2023, the National Institute for Health and Disability Insurance (INAMI-RIZIV) announced the completion of a pilot project for gene expression profiling (GEP) tests in early-stage breast cancer, which ran from 2019. The pilot showed significant benefits, and INAMI-RIZIV launched a reimbursement for certain tests under the specific agreement (GEP convention) with healthcare providers.

In February 2023, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 188 and 084 with changes to be implemented no later than March 23, 2023. Five new procedure codes (concerning interventional radiology, robotic surgery, and radiotherapy) and one new diagnostic code were introduced.

On January 27, 2023, the Swiss Federal Office for Public Health announced the update of Annex 3 of the Health Care Benefit Ordinance (KLV/OPre), which contains the list of reimbursed IVD tests (List of Analyses). Two new tests on Monkeypox virus check will be introduced in March 2023.

In February 2023, it was announced that the Basque Office for Health Technology Assessment (OSTEBA) initiated several HTAs, including evaluations in the e-health, radiology, nephrology and urology, cardiovascular, IVD, obstetrics and gynecology, diagnostic imaging, radiotherapy, neurovascular, ENT, interventional radiology, surgical procedures, and some other fields.