Background
With the introduction of § 137h to the SGB V, hospitals have to hand in an extensive value dossier comprising information on the current scientific knowledge of the technology to the Federal Joint Committee (G-BA) when applying with high-risk (IIb, III, and actively implantable) medical devices for first-time NUB (Neue Untersuchungs- und Behandlungsmethoden) innovation funding at the Institute for the Hospital Remuneration (InEK) (see Table 1). It is G-BA’s new task to assess in a first step, whether the medical device is based on a new theoretical-scientific concept and, if so, in a second step to evaluate whether the benefit of the method can be considered proven or if it has the potential to be a required treatment alternative.
Presented literature and study registry review of the first applications
The literature reviews of the first applications included case series, case reports, before and after studies, and one RCT. The outcomes in the studies are surrogate and clinical outcome measurements.
The analysis of ongoing studies shows primarily un-blinded and non-randomized studies, except for one on-going RCT with a randomized, double-blind against Sham extension in the planning phase.
Table 1: Overview of initial § 137h applications
Consultations
Prior to handing in the value dossier, manufacturers and hospitals have the opportunity to consult G-BA regarding the eligibility of the § 137h benefit assessment (see Table 2). The primary question is if a method constitutes a new theoretical-scientific concept. In contrast to a § 137e consultation, the process is free of charge, however, submitted documents are public and G-BA’s decision is binding for a later application.
Table 2: Overview of initial § 137h consultations
