WASHINGTON -- Sen. Chuck Grassley of Iowa and Sen. Elizabeth Warren of Massachusetts have asked top Department of Health and Human Services officials for a progress report on their work to add the unique device identifier (UDI) for medical devices to medical claims forms. The senators noted that Congress has supported establishing the UDI system and integrating device information into the Food and Drug Administration’s (FDA) post-market surveillance system Sentinel. Such a system would improve the post-market surveillance of devices to strengthen patient safety and curb wasteful spending. The senators note that although the Department of Health and Human Services (HHS) and the FDA have supported the inclusion of UDI in claims forms, the Centers for Medicare and Medicaid Services (CMS), has expressed contradictory views on the policy.
“Given the importance of this issue, we hope you will ensure that CMS works collaboratively with FDA and other stakeholders to ensure that the next update of the claims form will incorporate UDIs,” the senators wrote to Health and Human Services Secretary Sylvia Mathews Burwell, Acting CMS Administrator Andy Slavitt and FDA Commissioner Robert Califf.
They also cite a letter from the HHS Office of Inspector General which revealed that recalls of defective products have likely resulted in numerous claims for monitoring, replacement and follow-up care at significant taxpayer expense. Including the UDI in claims would allow for faster identification and recall of poorly performing devices and ensure proper reimbursements for hospitals, device manufacturers and CMS, the senators wrote.
The senators’ letter is available here. The senators’ correspondence with the inspector general is available here and here.
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