Last month, the Department of Justice (DOJ) announced that Advanced Bionics LLC, a California-based manufacturer of cochlear implant system devices, had agreed to pay more than $12 million to resolve allegations that it violated the False Claims Act (FCA) when it misrepresented to federal health care programs regarding the radio-frequency (RF) emissions generated by some of its cochlear implant processors.
Advanced Bionics allegedly made false claims regarding the results of its RF emissions tests when it submitted pre-market approval applications to the Food and Drug Administration (FDA) for its Neptune and Naida cochlear implant processors. Allegedly, the company purported that its processors satisfied an internationally recognized emissions standard when it, in fact, did not comply with that standard. Particularly, Advanced Bionics allegedly failed “to honor the standard’s requirements to test processors using ‘worst-case’ configurations, and improperly shielded certain emissions-generating system components during emissions testing.” The tests at issue measured the extent to which cochlear implant systems generate RF emissions that can potentially interfere with other devices that use the RF spectrum, such as telephones, security systems, televisions, and radios. This became a False Claims Act investigation because Advanced Bionics sought reimbursement from Medicare, Medicaid, and other federally funded healthcare programs for these devices.
In addition to the civil settlement, Advanced Bionics entered into a five-year Corporate Integrity Agreement (CIA) with HHS-OIG requiring an “independent review of activities and processes relating to the preparation or submission of Premarket Approval Applications (PMAs) to the FDA and performance standards relevant to those PMAs.” The company must also implement its own compliance program.
“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. “The investigation and resolution of this matter illustrates the government’s emphasis on combating healthcare fraud.” The DOJ emphasized in its press release.
The attorneys at Chilivis Grubman represent clients of all types and sizes in connection with False Claims Act litigation and government investigations, both civil and criminal. If you need assistance with such a matter, please contact us today.