Devices

NCVHS Should Add UDIs to Claims Forms: Article

Researchers from three academic medical centers say the National Committee on Vital and Health Statistics (NCVHS) should approve a proposal to modify health service claims forms to include medical device unique device identifiers (UDIs). Writing in a BMJ opinion piece, the researchers say medical device safety in the U.S. has been restricted because the use of UDIs is disconnected from the rest of the American healthcare system.

The piece says that UDIs were created to solve a core issue for medical device safety — the lack of a standardized way to track how medical devices are used in the real world following authorization by FDA. UDIs are FDA’s flagship initiative to improve postmarket surveillance, it says.

“The American healthcare system is built to facilitate transactions, and the system’s current transaction standards don’t enable tracking of UDIs,” the article says. “This means that the over 3.5 million devices with UDIs today are functionally invisible to the patients that use them, the providers that purchase them, and the payers that reimburse for them.”

For Medicare to begin adding UDIs to claim forms, the researchers say, the proposal has to be ratified by the NCVHS. They stress three points:

they strongly support the proposal to modify claims forms by adding UDIs
NCVHS should incorporate the full UDI, including the production identifier, and not just the device identifier; and
there should be a definitive cutover date for any potential changes to take place rather than a phased transition.

“While progress for device safety has occurred,” the researchers conclude, “the potential for a data-driven postmarket surveillance system remains unrealized.” They say the NCVHS has an opportunity to enable a new era for medical device regulation and patient safety.

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