Molecular diagnostics

In November 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (percutaneous implantation of pulmonary artery pressure sensors in chronic heart failure and coronary sinus narrowing device implantation for refractory angina), one new Medical Technologies Guidance (Synergo for non-muscle-invasive bladder cancer), one new Diagnostic Guidance (SeHCAT for diagnosing bile acid diarrhea), and four new Medtech Innovation Briefings (clonoSEQ for minimal residual disease, CerebAir for continuous EEG monitoring, 24/7 EEG SubQ for epilepsy, Paige Prostate for prostate cancer). Also, three new clinical guidelines were published, and six were updated.

On November 18, 2021, Swedish Medical Technologies Product (MTP) Council recommended the use of gene expression analysis (Prosigna and OncotypeDX) for decision-making on the adjuvant breast cancer treatment. The technologies have been under evaluation within the Orderly introduction framework since 2020.

In late November 2021, the INeK (Institute for the Hospital Remuneration System) has published the DRG catalog (Fallpauschalen-Katalog) with the list of DRGs and add-on reimbursement categories (ZEs) for 2022. Seven new DRGs and seventeen ZE categories were added to the catalog in 2022.

On July 1, 2021, the updated version of the Swiss Services Ordinance (KLV/OPre) came into force. The changes concern the List of explicitly evaluated services (Annex 1 of KLV/OPre), the List of medical aids (Annex 2 of KLV/OPre), and the List of Analyses (Annex 3 of KLV/OPre).

In mid-May 2021, the Dutch Healthcare Institute (ZIN) published an advice "Molecular Diagnostics: determining the position on molecular diagnostics in oncology," which was developed at the request of the Ministry of Health, Welfare and Sport. The objective of the position is to organize molecular diagnostics within standard regular care and develop a framework for the accessibility and integral implementation of new tests in practice.

In April 2021, the Austrian Institute for Health Technology Assessment (AIHTA) initiated several new research projects. The projects are related to IVD tests for early detection of colon cancer, telemedical care in diabetes field, health apps, screening methods, consequences of coronavirus pandemic, and other topics.

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.

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 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.

On October 14, 2020, the Dutch Healthcare Institute (ZIN) announced the evaluation of personalized medicine and molecular diagnostics for advice on reimbursement under Basic Health Insurance.

NHS England has opened a consultation on the proposed approach to updating the National Genomic Test Directory set out in the consultation document. The deadline for comments submission is November 17, 2020.

New codes for Prostatic Urethral Lift system, CT and MRI examination of the neck, fecal microbiota transplant, testicular sperm extraction, implantable rechargeable and a non-rechargeable pulse generator for deep brain stimulation, as well as PET-CT myocardial perfusion with volume, ejection fraction and flow measurements and molecular diagnostics, were implemented in 2020.