OBJECTIVES: Since 2005, new treatment and diagnostic methods (NUBs) were reimbursed by hospital individual supplementary fees. The assessment procedure for NUBs is triggered by a hospital submitting a request for additional compensation of healthcare services to the Institute for the Fee System in the Hospital (InEK). This was supplemented in 2016 by a legal norm (§137h SGB V) 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 interpretation of this rating seems to differ between hospitals and SHI.

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

RESULTS: 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 (368 NUB) requests were not falling under §137h, however those with sub-Status “B” (allocated to 12 NUBs) lead to controversies: neither manufacturer nor hospitals had requested an evaluation according to §137h for the NUB. The SHI was of the opinion that those cases with sub-status “B” should not be entitled to price negotiations before an evaluation by the G-BA has been performed.

CONCLUSIONS: The NUB process enables participating hospitals to receive full reimbursement for the product and a supplemental payment when using innovative technologies not listed in the existing German healthcare system. The question of what has to be done to guarantee that the new treatments are reimbursed should be asked at an early stage. Contact between Manufacturers and hospitals are advisable to support the NUB application with sufficient information.