Yasmin A Zerhouni, Dan C Krupka1, Jove Graham2, Adam Landman, Angela Li3, Deepak L Bhatt4, Louis L Nguyen5, Kevin Capatch2, Kevin Concheri6, Amanda J Reich7, Natalia Wilson8, Joel S Weissman7. 1. Twin Peaks Group, LLC, Lexington, Massachusetts. 2. Care Support Services, Geisinger Health, Danville, Pennsylvania. 3. Blue Cross and Blue Shield of Massachusetts. 4. Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School. 5. Brigham and Women's Hospital. 6. Partners Healthcare, Boston, Massachusetts. 7. From the Center for Surgery and Public Health, Harvard Medical School, Harvard T. Chan School of Public Health, Brigham and Women's Hospital, Boston, Massachusetts. 8. College of Health Solutions, Arizona State University, Phoenix, Arizona.
Abstract
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.
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.
Authors: Guoqian Jiang; Sanket S Dhruva; Jiajing Chen; Wade L Schulz; Amit A Doshi; Peter A Noseworthy; Shumin Zhang; Yue Yu; H Patrick Young; Eric Brandt; Keondae R Ervin; Nilay D Shah; Joseph S Ross; Paul Coplan; Joseph P Drozda Journal: J Am Med Inform Assoc Date: 2021-09-18 Impact factor: 4.497