In-vitro diagnostics

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 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.