Market Access,

09.02.2017

Section 137e of the German Social Security Code Volume V for medical devices – many consultations, few trials!

The introduction of Section 137e of the German Social Security Code Volume V in 2012 provided the Federal Joint Committee (G-BA) with an instrument to initiate clinical trials for medical devices with high relevance as part of ongoing method evaluation studies. The Federal Joint Committee reports that so far there has been growing interest in the consultations on the trial regulation held by the Federal Joint Committee, but only few trial procedures to be examined. 2017 (5 years after the introduction of the regulation!) was the first year the trial regulation was applied for the MR-guided high-intensity focused ultrasound treatment for uterine fibroids (MRgFUS-TUF/MR-HIFU).

Read the full article here (in German) or contact us for the article in english and for more information on the early benefit assessment of high risk products.

Reimbursement,

05.10.2017

Mental illness - huge need boosts demand for smart case management!

According to a report by the Federal Statistical Office (Destatis) from 29. September 2017, the healthcare costs for mental and behavioural disorders went up to 44.4 billion Euro, constituting the second biggest share of the total health care expenditure of 338.2 billion Euro. Mental illness has never been such a big issue as it is today. A recent study by the AOK-Bundesverband, which was presented in a press release on 14. September 2017, states that medical certificates (sick leave) due to mental problems have increased by 79.3 percent over the past ten years, resulting in 25.7 days of workplace absence on average. The loss of gross value added due to mental illness was estimated to amount to 16.8 billion in 2015 by the Federal Office for Occupational Safety and Health. Wittchen and Jacobi (2013) from Robert-Koch-Institute in Berlin report that about one third of the population suffers from one or more mental disorders per year.

Read the full article here (in German) or contact us for the article in english and more information about case management programs for mental illness patients. 

Real World Evidence,

09.03.2017

When the statutory health insurance funds give low priority to cost savings...

After Jens Baas, Chairman of the Board of Management of Techniker Krankenkasse (TK), gave an interview to the Sunday newspaper "Frankfurter Allgemeine Sonntagszeitung", discussions about reforming the morbidity‑oriented risk structure compensation scheme have gained momentum.

In 2017, for the first time in six years, the Scientific Advisory Board of the Federal Insurance Office (BVA) will not review whether the selection of 80 diseases for the morbidity‑oriented risk structure compensation scheme (Morbi-RSA) and the associated redistribution of funds is still adequate. This year, the assessment has been suspended for an important reason: due to the discussions about the Morbi-RSA in 2016, the Federal Ministry of Health has commissioned the Scientific Advisory Board to investigate the impact of financial compensation in a special report. This report, which will be prepared until September 30, 2017, will also include an assessment of whether the limitation to 80 diseases can be eliminated.

Read the full article here (in German) or contact us for the article in english and for more information on the morbidity‑oriented risk structure compensation scheme in Germany.