Innovative payment schemes are bilateral or multilateral agreements designed to support medical technologies and procedures that do not align well with, or fail to meet the criteria of, existing reimbursement and funding frameworks.
Germany’s co-funded clinical study framework, regulated under §137e of the Social Code Book V (SGB V) since 2012, represents one of the “Coverage with Evidence Development” schemes, offering a pathway for temporary, conditional reimbursement and structured evidence development for medical devices in Germany.
The Paper explains strategic rationale, legal framework, procedural steps required to launch a co-funded study and data about the utilization of the scheme.
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