Recently, the Department of Justice (DOJ) announced a $12 million settlement with Advanced Bionics over allegations that the company misled federal health care programs regarding the radio-frequency emissions generated by its cochlear implant processors.
When submitting pre-market approval applications to the Food and Drug Administration (FDA) for its Neptune and Nadia cochlear implant processors, Advanced Bionics allegedly made false claims regarding the results of its radio-frequency emissions tests. The radio-frequency emissions tests and standards referenced below try to limit the extent to which devices – like cochlear implants – interfere with other devices that use the radio-frequency spectrum, such as telephones, alarms and security systems, and televisions.
The DOJ alleges that Advanced Bionics represented that its processors satisfied an internationally recognized emissions standard when in reality, the company did not comply with the standards. Not only did Advanced Bionics failed to comply with the standards, but the company did not honor the requirements to test processors using “worse case” configurations and allegedly improperly shielded certain emissions-generating system components during emissions testing.
Advanced Bionics then sought reimbursement from Medicare, Medicaid, and other federal healthcare programs for the improperly-tested devices from January 2011 through December 2019. The government alleged that claims made to federal healthcare programs...
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