In-vitro diagnostic tests

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.

On February 08, 2022, the Reimbursement Commission of the Social Security Institution released an updated version of the Healthcare Implementation Communique. The main changes relate to the increase in reimbursement fees of services and medical devices by approximately 35-75%.

The Council for Choices in Health Care in Finland (PALKO) has discontinued the development of recommendations concerning companion diagnostic tests. The respective preparations were completed in November 2021.

On January 24, 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 March 01, 2022. NLK system has been used for activity-based reimbursement by the Norwegian Health Economics Administration (Helfo) in outpatient settings since 2018. Thirty new codes were added medical biochemistry, medical microbiology, immunology and transfusiology, and clinical pharmacology areas.

On February 02, 2022, NHS England updated the 2021/22 National Genomic Test Directory for rare and inherited diseases, initially published in October 2021. No new codes were introduced. Amendments were made in 77 codes, including changing the test method, commissioning category, specialist group.

On January 18, 2022, NHS England and Improvement released guidance on point-of-care testing (POCT) in community pharmacies. It describes the consistent standards and safe environment for the use of POCT equipment and devices for diagnosis, monitoring, and screening in community pharmacy, to guide both commissioners of NHS services and community pharmacies.