In-vitro diagnostic tests

In April 2022, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 0183 and 0080 with changes to be implemented no later than June 14, 2022. Eleven new procedure codes and nine new diagnostic codes were introduced.

A new test called Genedrive System to detect babies at risk of gentamycin-related deafness was developed at the University of Manchester, funded by the National Institute for Health and Care Research (NIHR). On April 02, 2022, NHS England and NHS Improvement announced that Genedrive is now fully CE certified to be used in a clinical setting. The test is expected to be implemented in routine care in all NHS Manchester Foundation Trust hospitals within several weeks.

In March 2022, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (endoscopic balloon dilation for subglottic or tracheal stenosis, intramedullary distraction for lower limb lengthening, endoscopic full thickness removal of gastrointestinal stromal tumors of the stomach, percutaneous insertion of a cystic duct stent after cholecystostomy, and liposuction for chronic lipoedema), four new Medical Technologies Guidance (myCOPD, UroShield, Prontosan for wounds, and 3C Patch for diabetic foot ulcers), one new Diagnostic Guidance (terminated assessment of Freelite assays for multiple myeloma), and six new Medtech Innovation Briefings (Genedrive MT-RNR1 ID System, icobrain for multiple sclerosis, Al for analyzing chest X-ray images, and others). Also, three new clinical guidelines were published, and six were updated.

On March 10, 2022, santésuisse announced that the Swiss Federal Department of Home Affairs (FDHA) had decided to reduce the tariffs for laboratory tests, which is a consequence of santésuisse's repeated call for price reductions in the previous years. Santésuisse expects the price reduction to be substantial and to enter into force soon.

In February 2022, the National Institute for Health Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned biomarkers for assessing acute kidney injury, non-invasive testing for neovascular macular degeneration, decision support tool to prevent falls in older people, endometrial scratch, distal radius fracture, and test for group B Streptococcus. 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 March 23, 2022, the Norwegian Directorate of e-Health released an updated version of the National Laboratory code (NLK) system (Norsk laboratoriekodeverk 7280.62) to be implemented no later than May 01, 2022. Thirty-two codes were added, 91 codes have been changed, and one code has been terminated. NLK system has been used for activity-based reimbursement by the Norwegian Health Economics Administration (Helfo) in outpatient settings since 2018.

In February 2022, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (stereotactic radiosurgery for trigeminal neuralgia, and microwave ablation for primary or metastatic cancer in the lung), two new Diagnostic Guidance (EarlyCDT Lung for assessing the risk of lung cancer in solid lung nodules, PredictSURE IBD and IBDX to guide treatment of Crohn's disease), and four new Medtech Innovation Briefings (Insides System for managing intestinal failure, d-Nav insulin management app for type 2 diabetes, GaitSmart for personalized exercise rehabilitation, AposHealth for knee osteoarthritis)

In March 2022, NHS England and NHS Improvement published the MedTech Funding Mandate (MTFM) policy for 2022/23, which will come into force on April 01, 2022. The MTFM launched in 2021 to support NICE-approved and cost-saving devices, diagnostics, and digital products. Commissioners must fund technologies included in MTFM.

In late January 2022, Swedish Medical Technologies Product (MTP) Council issued an updated version of recommendations regarding gene expression analysis for decision-making on the adjuvant breast cancer treatment, initially published in November 2021. The recommendation to the regions remains the same. The changes were only concerned with the clarification of some facts.

On February 22, 2022, a repository of innovative acts outside the nomenclature of biology and anatomopathology (RIHN) and a Supplementary list of IVD tests were published. Minor changes were introduced in the 2022 RIHN list.

On February 21, 2022, it was announced by the Ministry of Health that the public consultation regarding the Draft Order amending the Common Package of Benefits of the National Health System (SNS) was open. The amendments and clarifications are related to the fields of in-vitro diagnostics, ENT, pulmonary and airways, e-health, neurology, dental care, radiology, and enteral nutrition.

In February 2021, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclature for private payers in England, published Bulletins 0182 and 0079 with changes to be implemented no later than April 10, 2022. Three new procedure codes concerned robotic surgery in orthopaedic area, spinal procedures, and ophthalmology, and five new diagnostic codes were introduced.