8 NUB assessments of high-risk medical devices (§ 137h)

Hospitals can treat patients with novel methods as soon as they become available. The treatment is reimbursed by SHI funds within the DRG. However, often the current DRG codes and associated costs don’t sufficiently cover the new methods yet. Therefore, hospitals can request additional funding, called “Zusatzentgelte”, so they are able to offer these treatments to their patients without a financial loss.

Among these treatments, the G-BA will conduct a benefit assessment for those that are using high-risk medical devices. These so-called NUB assessments are entirely based on the data provided by the hospitals. The legal basis for these NUB assessments of high-risk medical devices is covered in SGB V § 137h.

In 2020, hospitals requested additional funding for eight novel methods using high-risk medical devices. The G-BA now completed the NUB assessments of these methods; however, only one of them was supported by sufficient data to derive a benefit.

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