Shortcomings of Device Claims Data Complicate and Potentially Increase Medicare Costs for Recalled and Prematurely Failed Devices

We determined that Medicare costs related to the replacement of all recalled or prematurely failed medical devices could not be identified and tracked using only Medicare claim data. Such costs cannot be determined using only claim data because, although Medicare claim forms identify the medical procedures performed, they do not contain a field for reporting medical device-specific information. The lack of information on the claim forms prevents the Centers for Medicare & Medicaid Services (CMS) from being able to fully understand and address the Medicare costs related to recalled or prematurely failed medical devices. In addition, the lack of information impedes the Food and Drug Administration and CMS's ability to identify poorly performing devices as early as possible. This diminishes device recipients' chances of receiving timely followup care.