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BioWorld - Thursday, February 12, 2026
Home » False Claims Act

Articles Tagged with ''False Claims Act''

U.S. flag on columned building

Innovasis, two execs hit with $12M fine over FCA allegations

May 31, 2024
By Mark McCarty
The U.S. Department of Justice announced May 29 that Innovasis Inc., of Salt Lake City and two of the company’s executives have agreed to pay $12 million over allegations of payment of kickbacks to surgeons.
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Gavel with whistle

Hospital hit for violating US Medicare rules for TAVR devices

May 20, 2024
By Mark McCarty
U.S. Medicare coverage of transcatheter aortic valve replacement devices requires the use of team medicine for patient selection purposes, which seems to have served as a tripwire for Cape Cod Hospital (CCH) in Hyannis, Mass. Federal agencies forged an agreement with CCH that included a $24 million fine for failure to appropriately screen patients for the procedure, an event that serves as a reminder that non-compliance with Medicare rules can trigger enforcement actions by other agencies.
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U.S. flag on columned building

US circuit court case a bright spot for defendants in FCA cases

March 13, 2024
By Mark McCarty
The news about how the U.S. False Claims Act (FCA) is adjudicated in the courts is typically dismal, but the U.S. Court of Appeals for the Ninth Circuit recently provided an exception.
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US DOJ sets more aggressive course for qui tam activity

March 12, 2024
By Mark McCarty
U.S. deputy attorney general Lisa Monaco recently outlined some new programs related to federal enforcement across the economy, including some novel elements related to artificial intelligence. However, the more important take-away, according to Preston Pugh of Crowell & Moring LLP, is that the Department of Justice (DOJ) continues to work to make the legal environment more friendly to would-be whistleblowers, thus increasing the risk for companies inside and outside the life sciences.
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Gavel and scales

US DOJ sets more aggressive course for enforcement activity

March 11, 2024
By Mark McCarty
U.S. deputy attorney general Lisa Monaco recently outlined some new programs related to federal enforcement across the economy, including some novel elements related to artificial intelligence (AI).
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VC, private equity firms drawing more scrutiny from US DOJ

Feb. 27, 2024
By Mark McCarty
The U.S. Department of Justice (DOJ) has released the metrics for prosecutions under the False Claims Act (FCA) for fiscal year 2023, ringing up recoveries of nearly $2.7 billion, the 15th consecutive year in which recoveries exceeded $2 billion.
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Architectural pillars

US court sees fines levied on Precision Lens as unconstitutional

Feb. 20, 2024
By Mark McCarty
The U.S. Department of Justice (DOJ) announced in May 2023 that it had obtained a judgment of more than $487 million against the parent company of Precision Lens for alleged violations of the False Claims Act (FCA), but the amount of that decision has been overturned. In a Feb. 8 decision, the U.S. District Court for the District of Minnesota decreed that the judgment be reduced to less than $217 million, an outcome which suggests that some of the more excessive fines levied against health care companies will be viewed with more skepticism upon appeal.
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Gavel with whistle

DOJ pursues cardiac PET scan company for induced referrals

Feb. 6, 2024
By Mark McCarty
Fraud on federal health programs often revolves around illicit billings for in vitro diagnostics, but the U.S. Department of Justice (DOJ) has added mobile cardiac positron emission tomography (PET) to the list of technologies that have been used to violate the law.
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Gavel and scales

Device maker convicted for forgery of FDA documents

Jan. 25, 2024
By Mark McCarty
The U.S. Department of Justice (DOJ) has announced a conviction obtained in federal court of an employee of a medical device manufacturer who was charged with forging documents that purported that his employer had obtained clearance for two medical devices. Peter Stoll III, who was employed by Aesculap Inc., of Center Valley, Pa., will serve 12 months in prison and a year of supervised release in one of the most egregious examples of fraudulent med tech behavior in recent memory.
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Architectural pillars

US enforcement in life sciences off to robust start in 2024

Jan. 22, 2024
By Mark McCarty
One of the more significant enforcement actions to date in 2024 is the $13 million hit taken by the owner of a clinical lab in New Jersey for allegations of payment of kickbacks for unnecessary testing, suggesting that this new year will be a robust one for federal fraud enforcement in the U.S.
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