In-vitro diagnostics

04

May 2021

In April 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 0176 and 0073 with changes to be implemented not later than August 01, 2021. Four new procedure codes related to men's health and breast surgery and one new companion diagnostic code were introduced. Read more

22

Apr 2021

The revised EBM (German Uniform Evaluation Standard) catalog came into force on April 1, 2021. Two new EBM codes for IVD tests were introduced, and reimbursement conditions for two IVD tests were amended. Read more

01

Apr 2021

In March 2021, the National Institute for Health Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned sacral nerve stimulation and magnetic sphincter augmentation device for fecal incontinence treatment, patch augmentation surgery for rotator cuff repair, in-vitro diagnostics, and eHealth. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and inform National Institute for Health and Care Excellence (NICE) guidance. Read more

29

Mar 2021

On March 22, 2021, the repository of innovative laboratory tests (RIHN) and the Supplementary list were published. No new codes for IVD tests have been introduced and no codes were removed in the new versions of catalogs. Read more

10

Mar 2021

In the middle of February 2021, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) launched the assessment on the following prognostic platforms for gene diagnostics in breast cancer: Oncotype DX, MammaPrint, ProSigna. The evaluation is planned for the spring of 2021. Read more

09

Mar 2021

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. Read more

05

Mar 2021

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). Read more

22

Feb 2021

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. Read more

09

Feb 2021

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. Read more

02

Feb 2021

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. Read more

13

Jan 2021

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. Read more

28

Dec 2020

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. Read more