The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New codes were added for glaucoma surgery, myringoplasty and transforaminal epidural interventions.

CEO of the MTRC, Dr. Oleg Borisenko will be present at the 2nd Annual Medical Devices Sales and Marketing Conference, 28-29 of September in Cologne, Germany. Please, contact us at info@mtrconsult.com if you would like to arrange a meeting to discuss your needs with reimbursement and market access in Europe.

Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) released results of re-evaluation of leadless pacemakers for right ventricular pacing. Due to lack of comparative evidence vs conventional pacemakers, leadless pacemakers were not recommended for inclusion into health benefit catalogue in Austria.

Joint Orders of Ministry of Industry and Trade and Federal Agency for Technical Regulation and Metrology issued a number of standards outlining technical requirements for organizing of state procurement of a number of medical devices, including ventricular assist devices, implantable neurostimulators, means of protection of medical personnel from radiation, and pacemakers.

In the first two weeks of September, the National Institute for Health and Care Excellence published one new (for diagnosis and management of endometriosis) and updated two clinical guidelines (for psoriasis and fertility problems). No health technology assessments were published.

The deadline for submission of proposals for DRG change for year 2019 to the Danish National Board of Health (Sundhedsdatastyrelsen) is November 1, 2017. Different stakeholders can submit a proposal. However, hospitals and individual physicians are the most relevant applicants. Application form for DRG change in Denmark is much simplier compared to other countries.

On 6th of September, the Joint Federal Committee (G-BA) released announcement for manufacturers of OCT equipment to notify about their devices till 4th of October before G-BA makes the final decision about coverage of the procedure in out-patient settings within statutory health insurance. 

All significant innovations in Norway should undergo either national or hospital-based health technology assessment within “New Methods” framework. Guiding criteria for prioritization of topics for assessments were recently formulated by the administration of the program.

In 2016, Joint Federal Committee (G-BA) commissioned Institute for Quality and Efficiency in Health Care (IQWIG) for benefit assessment of telemonitoring systems in patients with implantable cardioverter defibrillators (ICD). In July 2017, IQWIG published a preliminary report. Due to lack of evidence, no benefit statement was made.

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in August 2017. They include different types of stents and stent-grafts for multiple indications (coronary, peripheral vascular), mechanical thrombectomy devices for stroke, medical devices applied for treatment of ulcer of venous origin, remote monitoring for Implantable Cardioverter Defibrillator Systems (ICDS).

Ludwig Boltzmann Institute HTA evaluated EST for GERD and found the current evidence insufficient to recommend its inclusion into health benefit catalogue. Reevaluation is recommended in 2022 when more evidence becomes available.