ARTICLE SUMMARY:
NCVHS is expected to recommend adding unique device identifiers to insurance claims. Excerpted from Pathways’ Picks April 19: TCET MIA? UDI on Claims? FDA Fact Checks, and More.
Look out for a recommendation soon that could, finally, clear the way for unique device identifiers (UDIs) to appear as a field on insurance claims forms in the US—a long-sought step that experts say could transform evidence collection and surveillance for devices. The National Committee on Vital and Health Statistics (NCVHS) is expected to issue its official recommendations to CMS in the coming weeks on a series of updates, including the UDI addition, to standard claim transaction forms. This would clear the way for the agency to add UDI elements to allow companies, providers, and researchers to better pinpoint devices used to treat individual patients. The issue of device identifiers on claims has been discussed since 2013, when FDA first enacted the UDI regulations mandating companies to label products with UDIs that are linked to detailed information on the agency’s Global UDI Database (GUDID). Several high-profile members of Congress have championed the step, but logistical challenges for hospitals, which have to update their systems to incorporate the change, have stood as a barrier. Medical device data advocates say it is high time to make the move, now that the long phase-in of the UDI requirements has completed and a vast majority of devices have UDIs. Hospitals, however, are still raising questions about whether the claims form update is worth it, particularly now that UDIs are increasingly integrated into patient electronic health records.
