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FEDERAL | ASPS asks CMS and FDA to Reconsider the Sharing of Unique Device Identifier Information

ASPS joined eleven specialty societies and device manufacturers to pre-emptively notify Food and Drug Administration (FDA) Commissioner Gottlieb and CMS Administrator Seema Verma of their opposition to reporting Unique Device Identifier (UDI) on health insurance claim forms. The group strongly supports the implementation of the UDI through electronic health records (EHRs) and clinical registries, but opposes adding the Device Identifier (DI) portion of a medical device's UDI to health insurance administrative claims forms. While storing this type of data in an EHR could serve as an effective surveillance tool, reporting UDI information on insurance claims would only serve to increase the administrative burden for most providers without a direct benefit to patient safety or the health care system. Mandating reporting via claims would force providers to either update or abandon legacy systems. The cost of upgrades coupled with the possibility of payment delays could lessen the ability of a claims-based system to track implanted devices.

The organizations strongly support inclusion of the full UDI information in a patient's EHR, which when coupled with a more robust data analysis architecture, would facilitate more accurate reporting, as well as review and analysis of medical device performance over time. Unlike the addition of Device Identifier to an administrative claim, including the UDI in the EHR would place the identifier in the context of the clinical information necessary for a complete understanding and evaluation of device performance.

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