UDI2Claims: Planning a Pilot Project to Transmit Identifiers for Implanted Devices to the Insurance Claim
UDI2Claims: Planning a Pilot Project to Transmit Identifiers for Implanted Devices to the Insurance Claim
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DOI：
10.1097/pts.0000000000000543
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发表时间：
2021-12-01
影响因子：
2.2
通讯作者：
Weissman, Joel S.
中科院分区：
文献类型：
--
作者：
Zerhouni, Yasmin A.;Krupka, Dan C.;Weissman, Joel S.
背景针对当前医疗器械的上市后监控问题，美国食品和药物管理局要求器械贴标机包括唯一的器械识别符(UDI)，该识别符由器械识别符(DI)和生产识别符组成。将DI纳入保险索赔可能是监控植入设备的一种有效方法，但由于利益和操作方面的问题，实施一直滞后。方法将电子健康记录(EHR)植入后90天的不良事件发生率与EHR PLUS声明进行比较，以说明将DIS纳入声明的潜在好处。为了探索操作，我们计划了一个试点项目，将植入设备的DI从护理点传输到两个提供者/付款人对的索赔。结果通过查询索赔和电子病历，估计有潜在不良事件的患者的比率高出3.75倍。对于我们的试点，我们的多方利益相关者团队确定并解决了以下五个挑战：(1)在护理点捕获DI；(2)在索赔表上选择DI的位置；(3)将DI传输到索赔表；(4)分析付款人收到的索赔表；以及(5)验证传输的信息的质量。结论包括DIS在内的索赔可以比EHR数据更完整地捕获植入设备的不良事件的数据。我们克服了将依赖注入传递给索赔的挑战，并注意到规划和多方利益相关者的参与。
Background In response to problems with the current postmarket surveillance of medical devices, the U.S. Food and Drug Administration mandated device labelers to include a unique device identifier (UDI), composed of a device identifier (DI) and production identifier. Including the DI in insurance claims could be a potent method to monitor implanted devices, yet implementation has lagged because of questions of benefit and operational concerns. Methods To illustrate the potential benefit of including DIs in claims, rates of 90-day adverse events after implantation using an electronic health record (EHR) were compared with the EHR plus claims, which capture utilization outside that EHR's health system. To explore operations, we planned a pilot project to transmit the DI of implanted devices from the point of care to the claim at two provider/payer pairs. Results By querying claims plus EHR, estimated rates of patients with potential adverse events were as much as 3.75 times higher. For our pilot, our multistakeholder team identified and resolved the following five challenges: (1) capturing the DI at the point of care; (2) selecting a location for the DI on the claim form; (3) transmitting the DI to the claim form; (4) analyzing the claim forms received by the payer; and (5) verifying the quality of the transmitted information. Conclusions Including DIs on claims could allow more complete data capture of adverse events for implanted devices than the EHR data. We overcame challenges in transmitting the DI to the claim with attention to planning and multistakeholder involvement.