Since 2005, new treatment and diagnostic methods (NUBs) were reimbursed by individual supplementary fees. The assessment procedure for NUBs is induced by hospitals submitting a request for additional compensation of healthcare treatment to the Institute for the Fee System in the Hospital (InEK). In 2016, the legal norm §137h SGB V was introduced to evaluate medical devices (MD) of high risk classes by the Federal Joint Committee (G-BA). InEK grants a status that is valid for twelve months and impacts additional compensation as well as assessment required by G-BA. The effects of this rating seem to differ between hospitals and Statutory Health Insurance (SHI).

The published InEK decisions on NUBs were analyzed according the decision criteria and possible impact on price negotiations with SHI.

In 2018, 705 NUB requests were assessed by InEK. NUB Status 1, granting negotiation of additional coverage, was assigned to 171 procedures. Status 2 – no additional reimbursement possible - was given in 472 cases, the remaining had not sufficient information. Most NUBs (n = 368) requests did not fall under §137h; however, those with sub-Status “B” (allocated to 12) led to controversies; no participant had requested an evaluation according to §137h for the NUB. Two consultation requests receiving Status 1 B were regarded as not eligible according to § 137h by the G-BA. To avoid price negotiation delays, early consultations according to § 137h are recommended by G-BA during the NUB application.

The NUB process enables hospitals to receive a supplemental payment when using innovative technologies not listed in the existing German healthcare system. The question of which requirements must be fulfilled to guarantee the reimbursement should be asked at an early stage. Consultation requests to the G-BA in due time are strongly recommended. Contact between manufacturers and hospitals are advisable to support the NUB application.