In-vitro diagnostic tests

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).

On August 31, 2020, Decision Forum decided not to introduce blood-based tests in pregnant women with suspected pre-eclampsia that was evaluated within the New Method framework since 2018

The Clinical Coding and Schedule Development (CCSD) group develops and maintains procedural and diagnostics nomenclature for private payers in England. New procedure codes concern planning, insertion, and removal of high/low dose rate radioactive treatment (brachytherapy) into a prostate tumor, open/laparoscopic repair of Spigelian hernia, and others. The codes are introduced with a recommended adoption date being the 1st of August 2020. The document also contains a list of textual changes in codes and unacceptable combinations. There were no changes to the CCSD Schedule of Diagnostic Tests.