Runge V M, Knopp M V
Department of Diagnostic Radiology, University of Kentucky, Lexington, Kentucky 40536, USA.
J Magn Reson Imaging. 1999 Sep;10(3):489-95. doi: 10.1002/(sici)1522-2586(199909)10:3<489::aid-jmri35>3.0.co;2-1.
Use of an approved contrast agent for a clinical purpose not contained in the package insert is not in violation of current U.S. Acts providing that it is in the course of routine medical practice, not part of an investigation into safety or effectiveness and not commercialized through advertising. The Food and Drug Administration does not have the authority to regulate the use of approved contrast media in any manner that radiologists believe, in their professional judgment, would best serve the patient. Moreover, the use of an approved contrast agent for a clinical purpose not explicitly contained in the labeling does not expose the radiologist to malpractice liability. Regarding reimbursement, there is no guarantee that any payer will reimburse a provider for use of a contrast agent outside of package insert indications. The best way to influence reimbursement is to provide the payer with detailed information prior to claim submission.
将已批准的造影剂用于药品说明书中未包含的临床目的，只要是在常规医疗实践过程中进行，不属于安全性或有效性研究的一部分，且未通过广告进行商业化推广，就不违反现行美国法律。食品药品监督管理局无权以放射科医生基于专业判断认为最有利于患者的任何方式来规范已批准造影剂的使用。此外，将已批准的造影剂用于标签中未明确包含的临床目的，不会使放射科医生承担医疗事故责任。关于报销，无法保证任何付款方会为超出药品说明书适应症使用造影剂的情况向医疗机构报销费用。影响报销的最佳方式是在提交报销申请之前向付款方提供详细信息。
