In-vitro diagnostic tests

The French High Authority for Health (HAS) develops national diagnostic and care protocols whose objective is to guarantee the quality and safety of care delivery within the French setting. In the first half of 2020, national diagnostic and care protocols have been developed for eighteen topics.

The Corona warning app, developed on behalf of the German government, has been available for download in the Google and Apple stores since June 16, 2020. It is intended to help identify and break infection chains at an early stage. Users of the app receive a notification if they have been for a long time in the vicinity of a person who was later found to be infected with the coronavirus.

On 9 May 2020, the Reimbursement Commission made changes to the SUT regarding response to the COVID-19 pandemic and introduced codes for IVD tests for Covid-19 (SARS-CoV-2) reverse transcriptase PCR and detection of Covid-19 antigen, IgG, IgM.

On June 23, 2020, the Swiss Federal Office of Public Health (FOPH) announced several changes in the coverage of benefits that will take place soon. They regard transcatheter aortic valve implantation (TAVI), adjustments in the List of Aids (EMAp/MiGeL) (including reimbursement for CPAP devices and mechanical ventilation at home, and adjustments in the List of Analyses (AL/EA).

The reimbursement for PCR tests for the detection of SARS-CoV-2 will be reduced from €59.00 to €39.40 per test starting from July 1, 2020, and the billing of the examination will be limited to five times in the case of treatment. This decision was made by the extended evaluation committee on June 10, 2020.

According to the German Institute of Medical Documentation and Information (DIMDI) announcement, there will be a new ICD code for the coding of non-curative COVID-19 tests in symptom-free people implemented in ICD-10-GM on June 1, 2020. The implementation in the practice management systems is ongoing.

Public Health England has carried out a number of rapid evaluations of commercial serological tests for their suitability for detecting the production of COVID-19 antibodies. Abbott SARS-CoV-2 IgG assay and the Roche Elecsys Anti-SARS-CoV-2 serology assay were evaluated by Public Health England.

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.