Financial influences and the primacy of patient welfare - an empirical and ethical analysis in German cancer medicine.

Abstract

Background: Little is known about how financial influences affect medical decision-making and may challenge the primacy principle of patient welfare. First qualitative results in cancer medicine identified specific decision-making situations that can be influenced by financial considerations and characterized by the type of their financial influence. These qualitative findings provide evidence that these influences are largely shaped by reimbursement strategies. Nevertheless, questions on how reimbursement strategies affect medical decision-making, and what their normative dimension is regarding the primacy principle, remain unclear.

Methods: To address the research questions, we conducted an empirical qualitative content analysis according to Kuckartz and an ethical analysis using Ives' framework of reflexive balancing following the "standards of practice in empirical bioethics research" and the "framework for empirical bioethics research projects".

Results: The empirical analysis identified six financially incentivized actions: to refrain, to reduce, to deflect, to privilege, to prioritize, and to withhold. These were linked to pre-existing definitions from the normative context: rationing, prioritization, deprioritization, and selection. The ethical analysis showed that a lack of transparency about whether reimbursement strategies implement normative priorities or merely regulate costs makes it difficult to assess their compatibility with the primacy of patient welfare.

Conclusions: The empirical and ethical analyses demonstrate that financial influences, as embedded in reimbursement strategies, can challenge the primacy principle by shaping which options appear feasible or appropriate in practice. Greater transparency and clearer justification of the goals embedded in reimbursement systems are required to determine when such influences are ethically acceptable and how they should be governed.

Trial registration: Not applicable, as the empirical part of this study is based on qualitative interview data and does not constitute as a clinical trial.