Lawmakers Reiterate Call to Integrate UDIs With Insurance Claim Forms
Senate Finance Committee Chairman Chuck Grassley (R-IA) joined Sen. Elizabeth Warren (D-MA) and three representatives to support the integration of the device identifier portion of unique device identifiers (UDIs) with electronic health insurance claims forms.The integration is necessary as currently, when a device fails or is recalled, it can be difficult to identify which patients are affected. And whereas FDA can monitor drugs and vaccines on the market, the agency is limited in its efforts to monitor medical devices because UDIs are not tracked on claims forms.
Grassley and Warren have been trying to establish this type of UDI-claim form integration since at least 2016 (they also sent a similar letter last year). The Department of Health and Human Services (HHS) Inspector General also previously called on the Centers for Medicare and Medicaid Services (CMS) to work with the Accredited Standards Committee X12 to incorporate UDIs for implantable devices into insurance claims forms.
And Grassley and Warren praised the X12 committee in 2017 when it recommended that the device identifier portion of a UDI be included when high-risk devices are implanted or removed. But those changes were not finalized.
Now, according to the latest letters sent to HHS, CMS and the X12 committee, the X12 committee just last month released draft recommendations to incorporate the device identifier portion of the UDI of high-risk implantable medical devices with claims transactions.
“We urge CMS to support the finalization of the recommendation by X12 to enable the addition of device identifiers of medical implants to claims transactions,” the senators and representatives wrote.
In addition, CMS will have to propose and finalize a rule so that both public and private health plans will be able to use this new information because claims transactions are considered standard transactions under the Health Insurance Portability and Accountability Act.
The lawmakers urged CMS to “promptly promulgate regulations to implement this change.”
Device industry group AdvaMed, meanwhile, has resisted such efforts to integrate UDIs and claims forms, saying the move “could generate inaccurate and misleading conclusions about the performance and value of specific technologies.”
Joseph Ross, professor of medicine at the Yale School of Medicine, told Focus via email: "We need the UDI in order to draw any conclusions about device performance before we worry about their being misleading. Right now, without the UDI, we are unable to use existing data to conduct any evaluations to better understand medical device safety or effectiveness."
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