In modern cancer therapy, many treatments require companion diagnostics (CDx) to identify patients with a certain tumor profile who are most likely to benefit from a certain drug. CDx tests are becoming more complex and often require bioinformatics to support interdisciplinary clinical decision making.
In September 2020, a position paper was published and backed by prominent German oncologists including Dr. Gustavo Baretton, Chairman of the German Society for Pathology, pushing for equal reimbursement of CDx in both inpatient and outpatient settings.
Currently, CDx is only officially reimbursable in the outpatient setting in Germany. Inpatient access to CDx is mainly determined by how well a hospital is connected to outpatient care. University hospitals may carry out companion diagnostic examinations via a semi-stationary setting since the hospital's own pathology services can bill these services via the outpatient system (e.g. on the basis of special authorizations). Where this possibility is lacking, hospitals are left with other 'creative' patient management solutions or without modern tumor therapies.
Current reimbursement situation in Germany
Outpatient setting
Patients can access CDx in the outpatient setting. The reimbursement of CDx in the outpatient sector is regulated via the subchapter 19.4 of the Uniform Evaluation Scale (EBM- Einheitlicher Bewertungsmaßstab), available since 2016. (The EBM is a directory based on which outpatient and occupational physician services in the statutory health insurance system are billed).
Inpatient setting
CDx’s are not yet included in diagnosis-related groups (DRGs). However, DRG tariffs can be updated if a sufficient number of hospitals have documented additional costs. But this only happens with a three years delay.
To provide the standard of care, hospitals may apply for additional funding throughout the year via an application for new examination and treatment methods (NUB - Neue Untersuchungs- und Behandlungsmethoden).
Reimbursement of such a method is only granted for one year and the applying hospital. The application is assessed by the institute for payment systems in hospitals (InEK - Institut für Entgeltsystem im Krankenhaus) but InEK is not required to justify their decisions and so far, has declined all applications for CDx reimbursement.
Consequences
For oncology patients treated in the outpatient sector, access to CDx tests is significantly easier since a specific chapter for reimbursement exists in the EBM.
To overcome issues in the inpatient sector, hospitals currently have three options
Patients do not undergo CDx testing in the inpatient setting
CDx tests are performed for selected patients and the additional costs are covered by the hospital
Patients are transferred to the outpatient sector, meaning that they are released from the hospital after the biopsy or blood draw. In this case, molecular analysis is then performed in the outpatient setting
Demand for change
Patient organizations and medical professional societies are requesting that CDx reimbursement in the inpatient setting be equal to the outpatient setting. They are also calling for a transparent decision-making process by NUB and a CDx cost-allocation under the DRG.