In-vitro diagnostics

On February 24, 2021, NHS England published an update of the Specialized Services Policy Pipeline (covering period November 10, 2020 - February 10, 2021). Two new Clinical Commissioning Policies were added to the work program, and seven new policies were published, including stereotactic ablative radiotherapy, stereotactic radiosurgery and proton therapy. The status of ongoing policies was updated as well.

In February 2021, the National Institute for Health and Care Excellence (NICE) published one new medical technologies guidance (Leukomed Sorbact for preventing surgical site infection) and seven new Medtech innovation briefings (PROPEL sinus implants, URO17 for detecting bladder cancer, Faecal microbiota transplant, DOAC Dipstick for detecting oral anticoagulants, CytoSorb for reducing the risk of bleeding during cardiac surgery, and others).

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.

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 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 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.

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.

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.