In-vitro diagnostic tests

As part of efforts to increase the effectiveness of measures to prevent the spread of coronavirus infection, the Ministry of Health of Russia informed suppliers, manufacturers and executive authorities that, subject to the rules for submitting documents for registration of medical devices intended for the diagnosis of coronavirus infection, their registration will be carried out as soon as possible deadlines.

MTRC has released the new video on the Market Access Insider Youtube channel. Oleg Borisenko spoke to Mr. Andrea Zanella, CEO of DIANAX S.r.l. about market access for in-vitro diagnostic tests in Italy.

On May 7, 2020, the National Association of Statutory Health Insurance Physicians (KBV) announced that antibodies testing for COVID-19 will be reimbursement. The findings of the test must be communicated within 24 hours.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on April 1, 2020. MTRC has compiled the selection of the most significant changes.

On March 4, 2020, the List of Analyses (AL/EA) and the Services Ordinance (KLV/OPre) were updated in Switzerland. On April 1, 2020, the KLV/OPre, the AL/EA, and the List of Medical Aids (MiGel/EMAp) will be updated in Switzerland.

In February 2020, the Andalusian Health Technology Assessment Department published an assessment report on the evaluation of validity, clinical utility, and safety of the next-generation sequencing genomic platform FoundationOne® in non-small cell lung cancer and other solid tumors. It was observed that it is necessary to carry out new studies to confirm the diagnostic results and the clinical usefulness of the test due to the low quality of existing evidence.

Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) has issued an agreement document on March 17, 2020, providing principles for billing and funding the Coronavirus (COVID-19) Detection Tests. Previously in Protocol for Hospitals on March 10, 2020, it was outlined that COVID-19 tests performed outside the National Reference Center for Respiratory Pathogens at UZ Leuven have no specific nomenclature codes, and no reimbursement was provided, therefore, was paid by patients. The new agreement clarifies principles for reimbursement, but the invoicing for the tests still on hold.

On the 1st of February, 2020, the National Association of Statutory Health Insurance Physicians (KBV) and the National Association of Statutory Health Insurance Funds (GKV-SV) have made the agreement for laboratory diagnostic clarification about the novel coronavirus. Afterwards, the statutory health insurance companies will cover the costs of the test for the novel coronavirus (2019-nCoV) if there are justified suspected cases.

The Clinical Coding and Schedule Development (CCSD) group develops and maintains procedural and diagnostics nomenclature for private payers in England. New procedure codes concern repair of femoral hernia requiring removal of previously inserted mesh, transurethral non-ablative radiofrequency of bladder, minimally invasive mitral valve repair, two-stage revision of total hip replacement for infection and others. The codes are introduced with a recommended adoption date being the 1st of May 2020. The document also contains a list of textual changes in codes, unacceptable combinations, and inactivated codes. There were no changes to the CCSD Schedule of Diagnostic Tests.

In January 2020, the Reimbursement Commission made changes to the Healthcare Implementation Communique in Turkey. The main changes relate to the addition of new laboratory test codes, procedure codes, new devices related to the ophthalmology, and price changing of materials related to interventional radiology.

From January 2020, the "Oncotype DX Breast Recurrence Score" test is reimbursed by the health insurance companies at an extra budget of 3,296.50€. This is explicitly the only test that the Federal Joint Committee (G-BA) has included in the contracted medical care.