The lack of medical device-specific information in Medicare claims forms wastes time and money when it comes to replacing recalled or defective devices, according to an early alert issued by a federal oversight agency. AAMI says the alert from the Office of the Inspector General (OIG) for the US Department of Health & Human Services is a clear endorsement of the use of the unique device identifier (UDI) system established by FDA.

The UDI system, which is being phased in, calls for medical devices to display a barcode label of sorts that includes product information. The FDA believes the system will help keep track of medical devices and allow for speedier recalls or replacements when there is a problem with a device.

Referring to the device identifier portion of the UDI, the OIG concludes in its alert that ”the inclusion of the DI could assist in identifying the cost to Medicare for recalled or defective medical devices, help ensure patient safety, and safeguard Medicare trust funds.”

There has been some disagreement over the best ways to use UDIs, although support for broader incorporation appears to be growing. The Centers for Medicare & Medicaid Services (CMS) had initially resisted calls to add UDI data to insurance claims forms because of the cost and operational hurdles involved with such a change. This past summer, the head of CMS joined the FDA in writing a letter expressing support for the idea, concluding that such information would strengthen post-market surveillance and allow for value-based reimbursement tied to device performance.

The alert from the OIG is another push to make that happen.

“We believe that this early alert provides important information that policymakers should take into consideration as they contemplate revisions to the claims form,” OIG says.

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