FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Device Identifiers Would Help CMS Track Defective Products, OIG Says

Oct. 12, 2016

Medicare spent $1.5 billion and patients spent $140 million as a result of just seven recalled or failed cardiac devices, spending that could be better controlled if unique device identifiers (UDIs) were required on CMS claim forms, according to a Sept. 30 report by the HHS Office of Inspector General (OIG).

The next version of the CMS form due to be released for comment on Dec. 1, and if UDI information is not included in this round of updates, device-specific information couldn’t be included until the “end of the next decade,” Inspector General Daniel Levinson said.

The OIG said the Centers for Medicare and Medicaid Services does not receive enough medical device-specific information from claims data to properly identify and track Medicare costs related to the replacement of recalled or defective devices. — Jeff Kinney

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