Molecular diagnostics

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.

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.

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.

On January 24, 2023, the Swedish National Board of Health and Welfare recommended introducing a national screening program for spinal muscular atrophy (SMA) in newborns. It will identify children with a homozygous deletion in the SMN1 gene and 1–3 copies of the SMN2 gene. SMA testing must be included in the existing newborn screening (so-called PKU test). The launch of the new screening program is expected in the summer of 2023.

On January 23, 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 March 1, 2023. Twenty-four new codes were added, 179 codes were changed, and 23 codes were terminated.

In January 2023, the National Institute for Health and Care Excellence (NICE) published four new Interventional Procedure Guidance (percutaneous image-guided cryoablation of peripheral neuroma, laparoscopic insertion of a magnetic ring, transcutaneous electrical stimulation of the trigeminal nerve, and trabeculectomy with a biodegradable collagen matrix implant ), two new Diagnostic Guidance (devices for remote monitoring of Parkinson's disease, MRI-based technologies for assessing non-alcoholic fatty liver disease), and three new Medtech Innovation Briefings (PredictSURE IBD, Ambu aScope 4 Broncho, and Aquablation robotic therapy). One MedTech-related clinical guideline was updated.

In January 2023, the updated Pathology Activity Codes (APAT) of the Norwegian Pathology Code system (NORPAT) came into force. Since 2022, APAT codes have been included in the new reimbursement scheme by Helfo (the Norwegian Health Economics Administration) for outpatient pathology services. Five new classified sample materials for cytology and 22 new additional codes for the method of testing were added to the scheme in 2023.

On November 23, 2022, 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 January 1, 2023. Eighty-six new codes were added, 207 codes were changed, and 27 codes were terminated.

On September 22, 2022, the Dutch Healthcare Authority (NZa) published the second release of the DRG package for 2023 (RZ23b). Nineteen new procedure codes, eight new supplementary payments, and seven new DRGs will be implemented. These changes concern remote monitoring, molecular diagnostics, surgical procedures, gynecology and dermatology technology groups.

On August 11, 2022, NHS England and NHS Improvement released an updated National Genomic Test Directory for rare and inherited diseases (version 3.1), which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. No new codes (test-indication combinations) were introduced.

In July 2022, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (transcatheter tricuspid valve annuloplasty for tricuspid regurgitation, and transcatheter tricuspid valve leaflet repair for tricuspid regurgitation), one new Diagnostic Guidance (PLGF-based testing to help diagnose suspected preterm pre-eclampsia), and four new Medtech Innovation Briefings (ProciseDx point-of-care platform for IBD, RespiraSense for continuously monitoring respiratory rate, Lenus COPD Support Service, and cyanoacrylate glue for hernia mesh fixation). Also, five clinical guidelines were updated.