Benefits to Having Device Identifier on Forms: OIG

The HHS Office of the Inspector General (OIG) says that FDA and the Centers for Medicare and Medicaid Services (CMS) recently took an important step when they co-signed a letter supporting capturing the device identifier (DI) portion of the unique device identifier (UDI) on claim forms for implantable devices. The OIG says that using the device identified along with proper use of the two-digit field could help identify Medicare’s costs related to recalled or failed devices.

An OIG Early Alert gives preliminary results from an ongoing review of the costs Medicare incurred due to recalled or defective medical devices. “Our ongoing review shows that the lack of medical device-specific information in the claims data impedes the ability of the Centers for Medicare and Medicaid Services to readily identify and effectively track Medicare’s total costs related to the replacement or recalled or defective devices,” the alert says. “As described by FDA and CMS, including the DI on claim forms would result in several benefits, which we believe could also help reduce Medicare costs by identifying poorly performing devices, protecting beneficiaries from unnecessary costs, and improving beneficiaries’ chance of receiving appropriate follow-up care more quickly. Including the DI on claim forms could also assist in any related cost-recovery efforts and help prevent fraud and abuse by providing a means to identify unreported manufacturer credits. As the UDI system evolves, we believe that including the production information portion(s) of the UDI on the claim forms could also help identify and track Medicare’s aggregate costs related to recalled or defective devices and would provide patient safety benefits by enabling the identification of specific batches and lots of recalled devices.”