Regulatory Focus™ > News Articles > Grassley and Warren Call for UDIs to be Added to Health Insurance Claims Forms

Grassley and Warren Call for UDIs to be Added to Health Insurance Claims Forms

Posted 31 August 2016 | By Zachary Brennan 

Grassley and Warren Call for UDIs to be Added to Health Insurance Claims Forms

Incorporating unique device identifiers (UDIs) into health insurance claims forms could help improve the postmarket tracking of medical device safety concerns and performance, Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) wrote in a letter earlier this week to the chair of an Accredited Standards Committee.

The Virginia-based committee is tasked with recommending changes to electronic claims forms, with the latest version of standards slated for release 1 December 2016.

“Collecting device identifiers on insurance claims forms would allow device performance and safety concerns to be tracked and evaluated at the model level, enable the collection and analysis of detailed device and patient data, facilitate outcome comparisons across device models, and protect the integrity of the Medicare program by allowing for faster identification of poorly performing and recalled devices and ensuring that proper reimbursements take place with regard to these devices,” Grassley and Warren write, quoting a letter sent from US Food and Drug Administration Commissioner Robert Califf and others to the ASC X12 chair, Gary Beatty.

The letter follows another letter sent in March in which Grassley and Warren questioned the Centers for Medicare and Medicaid Services' (CMS) opposition to incorporating UDIs for devices into insurance claims forms.
The letter followed one from September 2015, in which HHS Inspector General Daniel Levinson wrote to the two senators, saying that "recalls of defective medical devices have likely resulted in millions of Medicare claims for monitoring services and device replacement-related procedures."

While Levinson was unable to come up with exact figures for the number of such claims, or the associated costs, he estimates that, "Medicare, and by extension the taxpayers, has most likely spent several billions of dollars" due to defective devices.

Meanwhile, Pew in April called to incorporate UDIs in electronic health records, registries and health insurance claims, but industry group AdvaMed took issue with including UDIs in claims forms, claiming that doing so would be "costly [and] pose significant operational challenges." Instead, AdvaMed said that including UDIs in EHRs is more practical and should take priority.

The fight over adding UDIs on claims forms continues as FDA issued draft guidance earlier this summer on UDI content and form, and as the agency has pushed back some requirements associated with the UDI Rule.


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