Germany

In order to decide upon the inclusion of medical benefits into the German statutory health insurance, the Joint Federal Committee (G-BA) can commission the Institute for Quality and Efficiency in Health Care (IQWiG) with the preparation of health technology assessments (HTA). At the turn of the year, IQWiG published its 220th evaluation dossier since its foundation in 2004. G-BA followed IQWiG’s recommendations in 70% of cases.

The German Institute of Medical Documentation and Information (DIMDI) opened the annual application process for procedure codes (OPS) in the inpatient sector. Applications can be submitted by medical societies and other associations within the German healthcare system Deadline for applications is February 28th 2018 and the new codes will be incorporated in the OPS version effective from 2019.

The Institute for Quality and Efficiency in Health Care (IQWiG) has analyzed the applications for approval of clinical trials at the Berlin Ethics Committee. The share of randomized controlled trials (RCTs) had risen to 86% in 2013. This trend is assumed to be an early response to increasing international legal regulations of medical devices requiring manufacturers to present higher standards of evidence.

The Institute for the Hospital Remuneration System (InEK) has opened the proposal procedure for integrating the medical and scientific expertise in the further development of the G-DRG system for the year 2019. Proposals, e.g. add-on payments, DRG re-grouping and changes in coding guidelines or cost calculation can be submitted until March 31st, 2018.

As part of its routine method evaluation, the Federal Joint Committee (G-BA) charged the German Institute for Quality and Efficiency in Health Care (IQWiG) with a benefit assessment of the use of negative pressure wound therapy (NPWT) compared to conventional methods of wound management in the inpatient sector in Germany. Currently, no restrictions exist for the use of NPWT in hospital settings. Based on the new evaluation report, the G-BA will re-assess the reimbursement status in the statutory health insurance.

The German Institute for Quality and Efficiency in Health Care (IQWiG) has published its final plan for the benefit assessment of motor-driven movement splints (CPM) after interventions on the knee joint and on the shoulder joint. IQWiG was commissioned with this task by the Federal Joint Committee (G-BA). Two manufacturers and relevant associations had used the opportunity of commenting on the preliminary project plan.

Shockwave Medical, the manufacturer of the Coronary Lithoplasty® System for the treatment of calcified coronary artery stenosis, requested a consultation by the Joint Federal Committee (G-BA) to find out whether their device requires an early benefit assessment according to §137h of the Social Code Book V (SGB V). The G-BA decided that the technology is highly invasive and innovative and therefore will need to undergo benefit assessment to be granted innovation funding.

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.

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.

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.

Following the request of a patient organization, the Joint Federal Committee (G-BA) evaluated the newborn screening for tyrosinemia type I by tandem mass spectrometry and decided to include the method into the relevant guideline. Before the method can be applied and reimbursed in the statutory health insurance (SHI) in Germany, the Genetic Diagnostics Act requires approval by the Genetic Diagnostics Commission (GEKO).