住院受试者临床试验费用区隔方法探讨与实践

Exploration and Practice of Cost-segregation Methods for Clinical Trial with Hospitalized Subjects

目的探讨如何通过信息化建设实现住院受试者临床试验费用与普通医疗费用的隔离。方法通过分析当前医疗机构多种区隔临床试验费用的方法及其优缺点,认为在不占用医疗保险(医保)基金的同时保证受试者正常享受医保报销的权益是各种方法应遵循的共同原则。基于住院医生工作站开发一种临床试验费用区隔信息模块。结果通过该模块,受试者可以根据实际医疗情况选择就医身份,研究医生可根据正常医疗或试验需求在医院信息系统(HIS)中开立医嘱,通过增删临床试验标记改变医嘱性质,系统自动拦截临床试验医嘱进行医保报销,其他费用按医保规则正常报销。结论该区隔模块能够降低受试者垫付临床试验费用的经济负担和保障其享受医保报销的权益,提高受试者参加试验的积极性、依从性,可为新备案的机构提供参考。

Objective To explore how to achieve isolation of clinical trial fees and general medical expenses of hospitalized subjects through information technology.Methods This article analyzed various methods for separating clinical trials fees from medical insurance and suggested that all methods need to protect subjects'medical insurance reimbursement rights and ensure that they do not occupy medical insurance funds.Based on this principle,A clinical trial cost segregation information module was developed based on inpatient’s workstation.Results Through this information module,subjects could choose their medical status according to the actual medical situation.Doctors could issue medical orders in hospital information system(HIS)according to normal medical or trail needs,change the nature of the orders by adding or deleting clinical trial tags.The system automatically intercepts the clinical trial orders for reimbursement of medical insurance,while other expenses are reimbursed according to rules of medical insurance.Conclusion The application of this information module has improved the subjects'enthusiasm and compliance to participate in clinical trials,reduced their economic burden,and ensured their rights to enjoy reimbursement of medical insurance,which can be used as a reference example for newly registered clinical trial institution.