From the Twin Peaks Group, LLC, Lexington, Massachusetts.
Center for Pharmacy Innovation and Outcomes, Geisinger Health, Danville, Pennsylvania.
J Patient Saf. 2021 Apr 1;17(3):223-230. doi: 10.1097/PTS.0000000000000828.
For implanted devices, an effective postmarket surveillance system does not exist. For medications, the Food and Drug Administration's Sentinel Initiative plays that role, relying mainly on drug codes in insurance claims. Unique device identifiers (UDIs) could play an analogous role for implants, but there is no mandate for providers to include UDIs in claims or for payers to record them. Objections have been raised to incorporating UDIs into claims based on a potential burden on providers.
To assess this purported barrier, we modified information systems at 2 provider-payer dyads to allow for the transmission of UDI data from provider to payer. In addition, to illustrate the potential benefit of including device data in claims, we used our data to compare rates of 90-day adverse events after implantation using the electronic health record (EHR) alone with the EHR plus claims.
The software system modifications were modest and performed as designed. Moreover, the level of difficulty of their development and implementation was comparable to that associated with a typical new release of an existing system. In addition, our data demonstrated the ability of claims-based data plus EHR data to reveal a larger percentage of postprocedure adverse events than data from EHRs alone.
Modifying information systems to allow for the transmission of UDI data from providers to payers should not impose a substantial burden on either. Implementation of a postmarket surveillance system based on such data in claims will require, however, the development of a system analogous to Sentinel.
对于植入设备，目前不存在有效的上市后监测系统。对于药物，美国食品和药物管理局的监测倡议（Sentinel Initiative）发挥了这一作用，主要依赖于保险索赔中的药物代码。独特器械标识符（UDI）可以在植入物中发挥类似的作用，但没有要求提供者在索赔中包含 UDI，也没有要求付款人记录它们。有人反对将 UDI 纳入索赔，理由是这可能给提供者带来负担。
为了评估这种所谓的障碍，我们修改了两个提供者-付款人对的信息系统，以允许从提供者向付款人传输 UDI 数据。此外，为了说明在索赔中包含设备数据的潜在好处，我们使用我们的数据来比较仅使用电子健康记录（EHR）和 EHR 加索赔来比较植入后 90 天不良事件的发生率。
软件系统的修改适中且按设计执行。此外，它们的开发和实施难度与现有系统的典型新版本相当。此外，我们的数据表明，基于索赔的加上 EHR 的数据比仅来自 EHR 的数据更能揭示术后不良事件的更大比例。
修改信息系统以允许提供者向付款人传输 UDI 数据不应给双方带来实质性负担。然而，要在索赔中基于此类数据实施上市后监测系统，就需要开发类似于 Sentinel 的系统。
