The costs for biomarker-based breast cancer testing covered by statutory health insurance in Germany

From January 2020, the "Oncotype DX Breast Recurrence Score" test is reimbursed by the health insurance companies at an extra budget of 3,296.50€. This is explicitly the only test that the Federal Joint Committee (G-BA) has included in the contracted medical care.

The "Oncotype DX Breast Recurrence Score" test is a biomarker-based test aimed to determine the risk of recurrence of a specific form of early breast cancer. The use of this test is intended to support the decision for or against adjuvant systemic chemotherapy. The test can only be used in patients with a primary hormone receptor-positive, HER2-negative, nodal-negative and non-metastatic breast cancer, provided that the recommendation for or against adjuvant systemic chemotherapy for primary breast cancer alone cannot be made based on clinical and pathological criteria.

Several new fee order items (GOP) have been added to the EBM (German Uniform Evaluation Standard) for reimbursement of medical services and the cost-intensive test.

The patient's information about the test and the explanation of the test result after the test can be billed for five minutes in total, up to 25 minutes (65 points / 7.14€- 5 minutes each). The doctor receives up to a maximum of 35.71€ (325 points) in the case of the disease. For this purpose, the GOP 08347 for gynecologists and the GOP 13507 for internists are included in the EBM. Only certain medical specialist groups are allowed to provide information about the test:

• gynecologists specialized in gynecological oncology or with the additional title "medicinal tumor therapy" or with permission to participate in the oncology agreement
• specialists in internal medicine and hematology and oncology
• internists without specialization with permission to participate in the oncology agreement or with the additional title "Medicinal tumor therapy"

The processing of the tissue sample and the forwarding to the gene expression analysis are represented by the GOP 19501 (552 points / 60.65€). This can only be billed by specialists in pathology.

The GOP 19502 reimburses the test costs with 3,296.50€ and is valued in euros. This is explicitly the “Oncotype DX Breast Recurrence Score®” test because this is the only test that the Federal Joint Committee (G-BA) has included in the contracted medical care. So far, other biomarker-based tests are not a contracted medical service but can be used, for example, in outpatient specialist care.

The reimbursement for the new services is extrabudgetary.

The corresponding decision by the G-BA was taken in late June 2019.

The full details in German can be found here.

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