Advisory Group Recommends Adding UDIs on Claims Forms

An advisory group has recommended that the device identifier portion of a unique device identifier (UDI) be included on insurance claims forms for high-risk devices.

The Accredited Standards X12 Committee, which comprises hospital and insurance company bill administrators and develops standards for claims forms, said the UDI data will help the FDA determine the long-term safety of medical devices. However, the Advanced Medical Technology Association condemned the idea as an unnecessary regulatory burden that could cause more problems than it solves, both for manufacturers and consumers.

The committee is accepting comments on the recommendations through May 2, and it then plans to forward them to the Centers for Medicare and Medicaid services for review and adoption.