OBJECTIVES

The German health care system is characterized by a sectoral division into an outpatient and an inpatient sector with different reimbursement mechanisms. For new examination and treatment methods (German: Neue Untersuchungs- und Behandlungsmethoden, NUB) within the hospital, several reimbursement pathways have been created in recent years, including §§ 137e/h SGB V and NUB payments. The aim of this research is to provide a quantitative overview of success rates for inpatient NUB reimbursement pathways.

METHODS

Decisions publicly available on the website of the Joint Federal Committee (German: Gemeinsamer Bundesausschuss, G-BA) up to May 21th 2019 were analyzed descriptively for all existing § 137h procedures and testing guidelines pursuant to § 137e SGB V. Furthermore, the outcomes of all NUB applications submitted to the Institute for the German Hospital Reimbursement System (InEK) between 2016 and 2018 were evaluated. Evidence was screened and analyzed by two individual reviewers.

RESULTS

Out of 24 procedures for medical devices under § 137h assessment, twelve (50%) met the § 137h requirements. Assessment was completed for eight (66,7%) of the twelve procedures with no benefit attributed to any of them. “Potential” was assigned to two procedures (25%), six (75%) received the rating "no potential". Regarding the § 137e procedures, the G-BA approved six testing guidelines.

Of the NUB applications submitted in 2016, 139 out of 710 (19.6%) received NUB status 1 which enabled them to negotiate a NUB payment. In 2017, 154 (22,4%) of the 686 applications received NUB status 1 and in 2018, 171 (24,3%) of 705. Out of the 171 applications rated with NUB status 1 in 2018, 57 (33.3%) were medical devices.

CONCLUSIONS

The chances of success for NUB reimbursement pathways in the inpatient sector are rather moderate and hold many hurdles for the manufacturer. A well-prepared market access strategy is therefore essential.