In-vitro diagnostic tests

On February 5, 2021, the French Ministry of Solidarity and Health published the results of the pre-selection of applications submitted in 2020 for participating in the coverage with evidence development programs. Regarding the Health Economic Research Program (PRME), 20 applications regarding various medical technologies were selected, including high throughput genome sequencing analysis in pediatric diagnostics, robotic thoracic surgery during lobectomy or segmentectomy in lung cancer, robotic gastric bypass for morbid obesity, mechanical thrombectomy techniques in the treatment of ischemic stroke, CAR-T cell therapy in the treatment of diffuse large B-cell lymphomas, creation of arteriovenous accesses for hemodialysis - the surgical technique and the endovascular technique, etc. Regarding the national Hospital Program of Clinical Research (PHRC-N), 205 applications were pre-selected.

In January 2021, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclature for private payers in England, has published Bulletins 0174 and 0071 with changes to be implemented not later than May 01, 2021. Five new procedure codes related to the areas of men's health, robotic surgery, endoscopy, and orthopedics, as well as three new diagnostic codes, were introduced.

On January 25, 2021, the Norwegian Directorate of e-Health released a regular update of the Norwegian Laboratory code (NLK) system (version 7280.54) and associated tariffs for state and private laboratories to be implemented not later than March 01, 2021. In this update, 63 new codes were introduced. On February 02, 2021, an extra update was issued (version 7280.55) to be implemented not later than April 01, 2021. Five new codes for the analyses of mutated SARS-CoV-2 were introduced in this update.

On January 26, 2021, NHS Accelerated Access Collaborative published the MedTech Funding Mandate policy for 2021/22, which will come into force in April 2021. According to the NHS Long Term Plan, introducing a MedTech Funding Mandate will support getting innovative medical devices, diagnostics, and digital products to patients faster. Four technologies will be supported in 2021/22 - HeartFlow FFRCT, gammaCore, SecurAcath, and PIGF-based testing.

On January 11, 2021, a new version of the Nomenclature of Medical Biology Acts (NABM068) was released. One new code for detecting the genome of the influenza A and B viruses by RT-PCR was introduced.

On January 07, 2021, NHS England published an update of the Specialized Services Policy Pipeline (covering the period October 19, 2020 - December 08, 2020). Two new Clinical Commissioning Policies were added to the work program, and six new policies related to radiotherapy, neurosurgery, pulmonology, and in-vitro diagnostics were published.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on January 1, 2021. The most significant changes include the increase of the reimbursement base rate and the introduction of many new surcharge fees in the area of radiotherapy services.

On December 23, 2020, NHS England and NHS Improvement published the final document for updating the National Genomic Test Directory (Test Directory), as well as other documents supporting the application process for amendments. The deadline for applications submission for 2021/22 Test Directory is January 31, 2021.

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.