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 were false, irrespective of whether there were any actual safety issues with the Neptune and Nadia systems as a result of the erroneous testing methods.
Under the settlement, Advanced Bionics will pay $11,361,420.00 to the United States and an additional $1,238,580.00 to participating Medicaid states under one or more separate settlement agreement(s).
The settlement stems from a qui tam suit brought by a former Advanced Bionics engineer. For their role, the relator will receive roughly $1.87 million of the federal settlement amount.
Corporate Integrity Agreement
In addition to the civil settlement agreement, Advanced Bionics entered into a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS OIG). Under the CIA, all activities and processes related to the preparation or submission of Advanced Bionics’ Premarket Approval Applications submitted to the FDA will now have to undergo independent review. Advanced Bionics will also have to implement a compliance program with a risk assessment program under the CIA and certain managers and Board of Directors will also need to obtain compliance certifications.
The CIA does require annual certification by both the Compliance Officer and President that: Advanced Bionics has implemented and is in compliance with the CIA (unless otherwise outlined in the annual report); he or she has reviewed the report, made reasonable inquiry regarding its content, and believes that the report is accurate and truthful; and he or she understands that the certification is being provided to – and relied upon – by the United States.
Comments
“Patients deserve to receive medical devices which are in compliance with all federal standards,” said Special Agent in Charge Maureen R. Dixon of the Department of Health and Human Services (HHS-OIG) Office of the Inspector General. “Manufacturers are required to be truthful in submitting claims for payment to the Medicare and Medicaid Programs. HHS-OIG will continue to work with the Department of Justice and our law enforcement partners to protect the integrity of the Medicare Trust Fund.”