Payments for Medical Innovation in Germany: A hospital claims data analysis of utilization and costs from 2013 to 2019

Abstract

Abstract Background: The ability of healthcare systems to allow rapid and broad access to new medical innovations is an essential factor in patient care. A key factor for integration is the reimbursement. Therefore, reimbursement mechanisms have to be evaluated constantly, e.g. to assess the consequences of delays in reimbursement as due to retrospective calculation approaches like in the German Diagnosis Related Groups (DRG) for new examination and treatment methods (NUB). Based on hospital claims data, this study examined the utilization, payment level and pathways for the integration of new medical innovations into the German DRG system for the first time. Methods: Hospital billing data on invoiced NUB from 2013 to 2019 were linked to the information on the application and assessment process. NUB were classified into three groups (drugs, medical devices, medical procedures) depending on the type of innovation. Key process parameters were evaluated over time by NUB type using a mixed ANOVA. Revenue was calculated based on quantity and payment level. Integration into the DRG system was clustered and quantified. Results: Compared to medical devices and medical procedures, drugs were significantly more often assessed positive for reimbursement and invoiced by hospitals to the statutory health insurances (p<0.05). The payment level for NUB decreased slightly over time with no significant differences between the types. The total annual revenue for NUB increased from 74.7 to 232.8 mEUR from 2013 to 2017. Analysis of pathways for a lasting integration into the DRG system showed that the majority of NUB stays in the application process and only for a minor number of innovations a standalone reimbursement was established. Conclusion: The results indicate that the reimbursement of medical innovation by separate payments for NUB gained increasing financial importance in the last years in Germany. Especially new drugs are subject to the NUB process with high success rates as their costs exceed the regular DRG payments. Compared to other European countries the reimbursement process is not directly linked to clinical trials or benefit assessments for all NUB which on the one hand keep the entry threshold low but also impedes nationwide access for all patients.