Molecular diagnostics

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.

On the 19th of September 2019, the Federal Joint Committee (G-BA) concluded on the possible applications and limits of non-invasive molecular genetic tests (NIPT) at the expense of the statutory health insurance (SHI). The decision provides that a NIPT can be used in justified individual cases and after medical consultation.

Predictive Analysis for Therapy (PATH) is a major collaborative project to optimize molecular predictive diagnostics in the Netherlands. The project focuses on the molecular analyses that are important for the treatment choice of cancer patients.