In-vitro diagnostic tests

On January 31, 2023, the Order approving Addendum 11 to the National Convention for Laboratory Directors was published in the Official Journal of the French Republic. The Addendum implements financial measures provided for by the Social Security Financing Act – reduces the reimbursement tariffs for the tests registered in the main reimbursement catalog for IVD tests in France Nomenclature of Medical Biology Acts (NABM).

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 December 2022, the National Institute for Health and Care Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned laser therapy in diabetic macular oedema, EarlyCDT Lung blood test, video-assisted thoracoscopic or open lobectomy, urethral slings for stress urinary incontinence, placental growth factor (PlGF) and sFlt-1 tests, and photobiomodulation in the management of oral mucositis. 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.

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.

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 December 2022, the National Institute for Health and Care Excellence (NICE) published one new Medical Technologies Guidance (Memokath 051 Ureter stent for ureteric obstruction) and one MedTech Innovation Briefing (PromarkerD). Also, two new clinical guidelines were published, and one was updated.

On December 16, 2022, a decision of the National Union of Health Insurance Funds (UNCAM) relating to the update of the NABM Nomenclature for IVD tests was published in the Official Journal of the French Republic. Various changes were introduced, including the inclusion of new codes, modifications of the existing ones, and tariff changes.

On December 16, 2022, a decision of the National Union of Health Insurance Funds (UNCAM) relating to the update of the NABM Nomenclature for IVD tests was published in the Official Journal of the French Republic. Various changes were introduced, including the inclusion of new codes, modifications of the existing ones, and tariff changes.

On December 1, 2022, the Swiss Federal Office of Public Health published the changes that will occur to the Services Ordinance (KLV/OPre), which determines coverage of medical services in Switzerland. The updates will enter into force on January 1, 2023, and they relate to the list of explicitly evaluated services (Annex 1 of KLV/OPre), outpatient-before-hospital services (Annex 1a), List of Tools and Appliances(Annex 2), and List of Analyses (Annex 3).

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.