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.
Biotelemetry Inc. and its subsidiary, Lifewatch Services Inc., agreed to pay $14.7 million to settle a whistleblower case alleging overbilling for remote cardiac monitoring. The qui tam case contended that the company’s online portal for its ACT-3L/MCT-3L device and its staff consistently and intentionally forced physicians’ staff to select or themselves selected the most expensive application for the device, despite intent and even written instructions to choose a less expensive service.
The qui tam or whistleblower lawsuit under the U.S. False Claims Act (FCA) has driven a large volume of litigation against life science companies, but three Supreme Court justices expressed misgivings about the constitutionality of the qui tam relator in the Court’s hearing of Polansky. Should a fourth Supreme Court justice harbor similar misgivings, the matter could be ripe for a hearing at the Supreme Court with the possibility that the qui tam relator would then be declared unconstitutional.
The U.S. Supreme Court has heard two cases this year regarding the False Claims Act (FCA), including the Shutte v. Supervalu case, which the court has remanded to the Court of Appeals for the Seventh Circuit. However, even though the case has not come to a close, Jay Stephens of Kirkland & Ellis LLP, believes that the Supreme Court’s handling of Supervalu creates an environment in which the process of discovery will become much more burdensome for all involved.
The U.S. Department of Justice announced that a judgment of more than $487 million has been lodged against Cameron-Ehlen Group Inc., of Bloomington, Minn., for alleged violations of the False Claims Act (FCA) in connection with the company’s distribution of products used in cataract surgeries. That final amount is more than 10 times the amount alleged to have been billed illicitly to federal health programs, a clear signal that inducement of this sort will be met with severe penalties.
The False Claims Act is perhaps the primary vehicle for U.S. federal authorities to extract penalties and fines from life science companies for violations of the law, but a new report by Gibson Dunn & Crutcher LLP suggests a mixed signal. The report notes that the U.S. Department of Justice (DOJ) recovered $2.2 billion via the FCA last year, but while that is not a conspicuous number for the past decade plus, what was conspicuous was that those sums were recovered by the second highest level of FCA actions settlement in the history of the FCA, suggesting that DOJ is keen on enforcement with no regard to the size of the target.
The False Claims Act (FCA) is perhaps the primary vehicle for U.S. federal authorities to extract penalties and fines from life science companies for violations of the law, but a new report by Gibson Dunn & Crutcher LLP suggests a mixed signal. The report notes that the U.S. Department of Justice (DOJ) recovered $2.2 billion via the FCA last year, but while that is not a conspicuous number for the past decade plus, what was conspicuous was that those sums were recovered by the second highest level of FCA actions settlement in the history of the FCA, suggesting that DOJ is keen on enforcement with no regard to the size of the target.
While it continues to deny all kickback allegations raised in a whistleblower suit filed seven years ago, Biogen Inc. agreed Sept. 26 to pay $900 million to resolve claims that it paid doctors in the U.S. to prescribe its multiple sclerosis drugs from 2009 through March 2014.
The U.S. Department of Justice has been intensely focused on illicit billings to federal government agencies, so much so that the agency reclaimed more than $500 million in the first half of calendar year 2022 under the False Claims Act. However, 80% of that amount came from companies in the life sciences, a fact which combines with pending federal and state legislation to amplify the risk for these companies in the coming years, according to a new report by the law firm of Gibson Dunn & Crutcher, LLP.
The U.S. federal government’s crackdown on companies in the health care space shows no signs of slowing down as indicated by an announcement by the Department of Justice (DOJ) that it has achieved a settlement with Opko Health Inc. and Bioreference Health LLC regarding allegations of induced referrals.
