Market access for medical technologies in Germany

Reimbursement

Reimbursements for hospital procedures are made solely via a German-diagnosis-related group (G-DRG) system. All cases of hospitalization with at least one overnight stay are reimbursed via DRG. Day cases and out-patient care are completely separate from hospital care provisions and are reimbursed via a fee-for-service model (EBM catalog within the statutory health insurance).

The DRG system has the following components:

Diagnosis-related groups

• DRGs are determined by the combination of a procedure code (OPS) and diagnosis code (ICD-10-GM). OPS nomenclature is maintained by the BfArM Cologne Office (ex DIMDI) and released annually
• Most DRGs have a national tariff, which is determined by the administrator of the DRG system, the Institute for the Hospital Remuneration System (InEK)

Add-on reimbursement (Zusatzentgelt, ZE)

• Add-on reimbursement is provided for expensive devices, procedures, and drugs
• ZE might or might not have a national tariff.

The G-DRG system is approved annually.

Innovation funding (NUB) is not formally part of the DRG system. NUB is granted by InEK for a period of less than a year, based on the review of applications made by hospitals. Approved status (status 1) gives hospitals the opportunity to negotiate additional reimbursement with sickness funds. However, it does not guarantee reimbursement, as sickness funds may question the sufficiency of the evidence provided and decide not to pay for the technology.

In out-patient settings, procedures are reimbursed via a fee-for-service mechanism via the EBM Catalog. There are specifics of reimbursement for surgical procedures in day case settings. 

Health technology assessment

HTA is almost exclusively limited to assessments by IQWiG in relation to the creation of out-patient reimbursement codes.