临床研究中医疗保险基金合规问题分析及管理对策

Analysis of compliance issues and management countermeasures of medical insurance fund in clinical research

目的临床研究在医疗机构内广泛开展,试验研究和常规医疗经费使用有差别,本文旨在分析试验研究中医疗保险基金合规问题,探索试验机构内的管理策略。方法通过查阅文献,问卷及工作实践,分析国内临床试验研究中医疗保险基金合规问题的现状和存在问题,提出有针对性的经费使用的管理措施,规范相应的工作流程。结果本文总结出3种试验相关经费的支付方式,分析目前存在的主要问题为试验要求检查的界定、方案规定的联用药物的支付、医疗器械试验的特殊性、试验中不良事件费用支付、上市后研究以及临床试验的保险。根据法规要求和工作实践,梳理出相应的管理对策,开展试验机构内部应进行项目经费和保险审核,试验研究、医疗保险管理部门、伦理委员会等分工协作共同建立完善合规管理体系,研究团队加强不良事件管理,加强受试者的宣教,利用好共享平台。结论试验研究机构建立规范可行的各项流程,研究团队强化实施管理,利用共享平台有利于确保医疗保险基金合规使用,保护受试者利益。

Objective Clinical research is widely carried out in medical institutions,and there are differences in the use of research and conventional medical funds.This paper aimed to analyze the compliance issues of insurance fund in clinical research and explore the management strategies in the institutions conducting clinical trials or research.Methods By consulting the literature,questionnaire,and work practice,this paper analyzed the current situation and existing problems of the compliance of the medical insurance fund in domestic clinical trials,proposed targeted management measures for the use of funds,and standardizes the corresponding workflow.Results This paper summarized three payment methods of research-related funds and analyzed the main problems at present,including the definition of trial requirements,the payment of combined drugs specified in the protocol,the particularity of medical device trials,the payment of adverse events in clinical trial,the insurance of post-marketing research and clinical trial.According to the regulatory requirements and work practices,the corresponding management countermeasures were sorted out,including that the project funds and insurance audit should be carried out inside the medical institution.Clinical research,medical insurance management departments,ethics committees,and other departments should collaborate on establishing and improving a compliance management system.The research team should strengthen the management of adverse events,strengthen the publicity and education of the participants,and make good use of the sharing platform.Conclusions The research institution should establish standardized and feasible processes,the research team should strengthen the management,and the use of the sharing platform is conducive to ensuring the compliance of the medical insurance fund and protecting the interests of the participants.