The Joint Federal Committee (G-BA) is in charge of the benefit assessment of treatment methods to be reimbursed by the statutory health insurances.
The benefit assessment in Germany is regulated differently for the in-patient (sec 137c SGB V) and the out-patient sector (sec 135 SGB V).
The recently published draft for a revised benefit assessment process (“Methodenbewertungsverfahrensordnung”, MBVerfV), new regulations for both assessment types are scheduled. The main points are the following:
- Speeding up and reduce the assessment to the key points.
- Regular consideration of low evidence levels in the assessment
- Possibility for third parties to participate at the consultation on request.
“Especially the standard inclusion of lower evidence levels – including non-comparative case series (level IV), single case reports, expert statements and others (level V) – is a remarkable change in the process. This means a fundamental turn away from the demands and standards on high evidence levels in the G-BA assessments”, as Sven Sauermann of Healthcare Heads states.
Correspondingly, the G-BA raises a critical statement on the planned changes. Until now, it is unclear how the final regulations will look like.
Already now it is remarkable that the draft of the new benefit assessment broke through a “invisible wall” which may lead to significant changes on evidence requirements on benefit assessments in the German healthcare system (even outside the G-BA).
The planned changes of the benefit assessment’s process can lead to the influence of not yet considered evidence into the decision process of the G-BA if a method is reimbursed by the statutory health insurances.
We are happy to consult you on the impacts of these changes for your product. Please do not hesitate to contact us for a non-binding first discussion.
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