After successful trial application by a manufacturer (St. Jude Medical, now part of Abbott), the Federal Joint Committee (G-BA) decided to conduct a co-funded study to create evidence about the measurement and monitoring of pulmonary artery pressure using an implanted sensor called “CardioMEMS™ HF System” to optimize therapy in NYHA III heart failure. The G-BA released a trial guideline defining the key points of the planned study, including type and duration of the study, target population and control intervention.

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New codes were added for trans-oral robotic surgery and joint replacement surgery.

A manufacturer (PQ Bypass) requested a consultation by the Joint Federal Committee (G-BA) about the eligibility of their medical device for an early benefit assessment according to §137h of the Social Code Book V (SGB V). The technology (PQ Bypass Stent Graft System) is a fully-percutaneous femoral-popliteal bypass procedure for peripheral arterial disease. The G-BA argued that the method is not based on the use of a high-risk medical device and therefore does not have to undergo a §137h assessment.

Patients should not pay anything other than regulated out-of-pocket payments when they visit general practitioner or other healthcare professional, who have contract with public health authorities.

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New codes were added for nitrogen washout test for lung capacity and fractional flow reserve CT measurement.

The Basque Office for Health Technology Assessment (OSTEBA) published results of assessments of different techniques for biopsy of prostate. In accordance to this report, biopsy with image fusion (MRI and ultrasound) can be considered as a first diagnostic option for prostate biopsy.

An international advisor group of 14 medical and health economic experts proposed 38 measures of how control the increase of healthcare costs in Switzerland. One third of the actions including the strengthening of HTA are already considered. The Swiss Federal Council now wants to develop concrete plans for the implementation of the new measures suggested in the report by the expert group, including global budgets for the outpatient sector, the introduction of medical boards, the encouragement of parallel imports of medical technology and implants and annual review of prices.

The article "Alfapump® system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study" published in the Journal of Hepatology provides valuable insights into efficacy, safety and cost outcomes of the innovative method for managing refractory ascites.

In the second half of October, the National Institute for Health and Care Excellence (NICE) published two new clinical guidelines (for cataracts in adults and cystic fibrosis), and published two new Medtech innovation briefings for radiation dose monitoring software for medical imaging with ionising radiation and Promonitor for monitoring response to biologics in rheumatoid arthritis.

The Belgian Health Care Knowledge Center (KCE) performed assessment of use of static automated external defibrillators (AED) by bystanders for out of hospital cardiac arrest. The aim was to inform government, whether current practice of placing AED for public use should be supported or not. No strict recommendations were given due to insufficient evidence for this device in use by bystanders.

In October, HAS published a set of decisions about add-on reimbursement of medical devices that were assessed by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern orthopedic devices (foot prosthesis, bone graft substitute), TAVI using Sapien valve, liquid embolic system, remote monitoring system, wound dressing and home oxygen system.

Joint Federal Committee (G-BA) evaluated the use of diabetic foot syndrome with hyperbaric oxygen therapy (HBO) as a complementary treatment. Based on studies showing a faster healing process, the G-BA decided to include the method as a benefit in the outpatient sector and expand the indication for the method to a lower severity grade in the inpatient sector.