Oleg Borisenko will attend the "MedTech Access Leaders Forum" in Berlin 3-5 of December 2019, as well as deliver five presentations with an overview of the reimbursement landscape for medical devices in EU5 during the third day of the meeting (5th of December). Stop by our booth to discuss your reimbursement needs.

We have released the second part of the interview on the Market Access Insider channel on Youtube. Lluis Bohigas, Former General Director of Planning at the Spanish Ministry of Health, Spain.

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in October 2019 concern various types of devices, including orthopedic, cardiovascular devices, and hearing aids. A total of twenty-four decisions were made.

In order to promote the video consultations, the National Association of Statutory Health Insurance Physicians (KBV) and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) have agreed on several new regulations. Thus, a video consultation will also be possible if the patient has not been previously treated by the doctor. For psychotherapies, the video consultations were reopened.

The HTA center of Swedish Västra Götaland region is aimed to work for the continuous development of knowledge-based care in the region and ensure that healthcare is supported by science and evaluation. Currently, Västra Götaland HTA-Centre works on several HTA projects related to medical procedures or devices: alertness therapy, MRI linac, and investigation, and treatment of PANS / PANDAS. After completion of assessments, the final reports would be released on the website of Västra Götaland region.

Outcomes Based Healthcare and My Diabetes My Way have been selected as Health Data Research UK (HDRUK) Sandbox projects.

In September 2019, the Andalusian Health Technology Assessment Department (AETSA) has released an assessment report regarding the evaluation of epigenetic profiling to classify cancer of unknown primary (EPICUP). It was observed that people received empirical therapy without considering the results of EPICUP had a three times higher risk of dying compared to those with specific treatment of the location of the primary tumor, adjusting due to possible confounding factors.

In September 2019, the French High Authority for Health released an assessment report for analysis on DNA chips (ACPA) in different types of oncological conditions to determine its place in comparison with more conventionally used techniques. The ACPA allows to detect a large number of copy number of variations at the whole genome level, ploidy abnormalities, and heterozygosity losses; it is of interest as a cytogenetic technique with some specific advantages among existing technologies.

In early September 2019, the Innovation Committee of the Federal Joint Committee (G-BA) has published an overview of new research projects in the area of health services to be funded by the Innovation Fund in the future.

In Sweden, the Centre for Assessment of Medical Technology (CAMTÖ) leads the development of HTA cooperation in the healthcare region Uppsala-Örebro. In September 2019, CAMTÖ released a systematic review on surgical treatment of abdominal rectus diastasis one year after delivery. The literature search was performed, only one RCT was identified, but as the design of the study was associated with a high risk of bias, no conclusions could be drawn.

The Clinical Coding and Schedule Development (CCSD) group develops and maintains procedural and diagnostics nomenclature for private payers in England. New procedure codes concern scar revision, robotic-assisted thymectomy, prophylactic oophorectomy/ hysterectomy, percutaneous electrical nerve stimulation, delivery of fraction of proton beam therapy for non-ocular adult tumors and diagnostic codes for myriad breast and ovarian cancer panel 101 test, clinical exome sequencing MPLA test, and others. The codes are introduced with a recommended adoption date being the 1st of February 2020. The documents also contain a list of textual changes in codes and inactivated codes.

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.