Medical device maker to pay $38.7M in FCA allegations
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A medical device manufacturer and a subsidiary have agreed to pay $38.7 million to resolve allegations they violated the False Claims Act by billing, and causing others to bill, the Medicare program for defective testing devices, the U.S. Department of Justice said Thursday.
The settlement resolved allegations that from 2008 to 2016, Alere Inc. and Alere San Diego Inc. knowingly sold rapid point-of-care testing devices, INRatio blood coagulation monitors, used by Medicare beneficiaries taking anticoagulant drugs such as warfarin.
Alere was acquired by Abbott Laboratories in 2017.
Alere allegedly knew since at least 2008 that the software algorithm used in each version of its INRatio monitors contained a material defect, the Justice Department said in its statement.
“Patients and health care providers rely on diagnostic devices to provide reliable health information,” Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division said in a statement.
“The Department of Justice will hold accountable medical device companies that knowingly sell defective products that can harm patients and waste taxpayer dollars.”
An Abbott spokesman could not be reached for comment.
The Justice Department said Tuesday that an air services company and its subsidiary will pay $11.1 million to resolve FCA charges in connection with aircraft maintenance, while the whistleblower who reported the alleged charges will receive $2.2 million.
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