In-vitro diagnostic tests

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.

In December 2021, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 0181 and 0078 with changes to be implemented no later than February 01, 2022. Seven new procedure codes and four new diagnostic codes were introduced.

In late December 2021, five new in-vitro diagnostics tests, including one test for COVID-19 spike protein antibodies determination, were added to the Laboratory Test Nomenclature (Laboratoriotutkimusnimikkeistö) in Finland.

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

In 2015, the Federal Office for Public Health launched an HTA program intending to reassess the benefits already reimbursed by compulsory health insurance. The following ongoing re-evaluations are in progress: multigene expression tests in breast cancer, cardiac catheterization for coronary artery disease, invasive procedures for coronary artery disease, removal of osteosynthesis materials, etc.

In November 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (percutaneous implantation of pulmonary artery pressure sensors in chronic heart failure and coronary sinus narrowing device implantation for refractory angina), one new Medical Technologies Guidance (Synergo for non-muscle-invasive bladder cancer), one new Diagnostic Guidance (SeHCAT for diagnosing bile acid diarrhea), and four new Medtech Innovation Briefings (clonoSEQ for minimal residual disease, CerebAir for continuous EEG monitoring, 24/7 EEG SubQ for epilepsy, Paige Prostate for prostate cancer). Also, three new clinical guidelines were published, and six were updated.

On November 23, 2021, 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 01, 2021. 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 in medical biochemistry, immunology and transfusiology, and clinical pharmacology areas.

On November 18, 2021, Swedish Medical Technologies Product (MTP) Council recommended the use of gene expression analysis (Prosigna and OncotypeDX) for decision-making on the adjuvant breast cancer treatment. The technologies have been under evaluation within the Orderly introduction framework since 2020.