In-vitro diagnostic tests

On December 22, 2020, the Swiss Federal Office of Public Health announced the changes that will occur to the Services Ordinance (KLV/OPre). The changes concern the general part of the Services Ordinance (KLV/OPre), and all four of its Annexes, which define the coverage of services (List of explicitly evaluated services, List of Medical Aids and Equipment, List of Analyses, List of Medications with Tariff). The updates will enter into force on January 1, 2021. Updates concern among others bariatric surgery, Autologous Chondrocyte Transplantation, ultrasound focused therapy for neurological indications.

In late November 2020, the Norwegian Directorate of e-Health released an updated version of the National Laboratory code (NLK) system and associated tariffs that will be implemented not later than January 01, 2021. A total of 25 new codes were added in this version of NLK, 201 codes have been changed, and eight codes were inactivated. Six new codes for SARS-related coronavirus antigen and six new codes for SARS-CoV-2 antigen have been established.

In November 2020, the Clinical Coding and Schedule Development (CCSD) group, which develops and maintains procedural and diagnostics nomenclature for private payers in England, has published Bulletins 0173 and 0070 with changes to be implemented not later than February 01, 2021. Three new procedure codes were introduced, related to robotic laparoscopy in gynecology, brachytherapy in prostate tumor, and autologous bone marrow aspirate concentrate (BMAC) for osteochondral defects of the knee. Also, four codes for diagnostic tests were added.

The Department of Health and Social Care announced its new national testing strategy, which aimed to scale up testing programs for COVID-19. To reach the aim, the evaluation process of virus detection and antibody detection tests to place the test kit on the market in the UK was initiated. The call for proposals to supply antibody detection tests has been closed, but proposals for virus detection tests are still ongoing.

On October 30, 2020, the Swiss Federal Statistics Office (UFS) published the 2021 version of the procedure code (CHOP) nomenclature in French and Italian. The version in the German language was published in July 2020. The most important changes regard cardiovascular and peripheral vascular interventions.

The Government of the Russian Federation approved the Order of November 7, 2020, N 2892-r on budget allocations of over 800 million rubles for the provision of subsidies to subordinate institutions of Rospotrebnadzor (Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing) for the procurement of laboratory equipment in order to develop a sustainable system for the prevention, detection, and response to threats to the sanitary and epidemiological well-being of the population.

In late October 2020, the BfArM (Federal Institute for Drugs and Medical Devices) has published the final version of the OPS 2021 (Operation and Procedure Keys) system. The OPS, together with the ICD-10-GM (International Statistical Classification of Diseases and Related Health Problems, 10th revision, German Modification), forms the basis for the reimbursement systems in outpatient and inpatient care.

NHS England has opened a consultation on the proposed approach to updating the National Genomic Test Directory set out in the consultation document. The deadline for comments submission is November 17, 2020.

In mid-October 2020, the Federal Joint Committee (G-BA) has decided that three more biomarker-based tests in breast cancer will be covered by the statutory health insurance. Since January 2020, the "Oncotype DX Breast Recurrence Score" test is already reimbursed in Germany with a tariff of €3,296.50.

The revised EBM (German Uniform Evaluation Standard) catalog for ambulatory reimbursement in Germany came into force on October 1, 2020. MTRC has compiled the selection of the most significant changes, concerning In-vitro diagnostics, telemedicine and vacuum wounds therapy.

In September 2020, Swedish Medical Technologies Product (MTP) Council decided to evaluate gene diagnostics for breast cancer within the Orderly introduction framework. Swedish Dental and Pharmaceutical Benefits Agency (TLV) will perform health economic assessments of these tests, including MammaPrint, Oncotype DX, ProSigna, and EndoPredict

In September 2020, the list of companion diagnostic tests, which are evaluated for reimbursement, was updated. INAMI has a specific reimbursement framework for companion diagnostic tests. INAMI Nomenclature codes from Article 33ter can only be reimbursed in relation to specific biomarker tests and drugs from Chapter VIII of the reimbursable pharmaceutical specialties (Royal Decree of February 1, 2018).