On September 30, 2016, the Department of Health and Human Service’s Office of the Inspector General (OIG) issued an “Early Alert” to the Centers for Medicare & Medicaid Services (CMS) on “Incorporating Medical Device-Specific Information on Claim Forms”. This Early Alert urges CMS to update Medicare claims forms to include the “device identifier” (DI) portion of the “Unique Device Identifier” for implantable medical devices, and to encourage providers to make proper use of an existing two-digit field for reporting “device failures and recalls.”

According to the Early Alert, OIG decided to make this recommendation after it conducted an audit into “the Medicare costs associated with seven cardiac devices from three manufacturers.” Because OIG “could not determine from the claims data alone the specific device implanted and whether the device replacement was due to a recall, a premature failure, or a necessary upgrade,” it “had to establish complex audit procedures and undertake the labor-intensive process of obtaining and reviewing the device recipients’ medical records to identify” Medicare payments it believed were due to “recalls or premature device failures.”

OIG says that “the lack of medical device-specific information in the claims data impedes the ability of CMS to readily identify and effectively track Medicare’s total costs related to the replacement of recalled or defective devices” and that its recommendations will “assist in identifying the costs to Medicare for recalled or defective medical devices, help ensure patient safety, and safeguard Medicare trust funds.”