The frequent calls for an expansion of telemedicine have come with relatively hushed advisories about the potential for fraud, concerns that have been borne out by an indictment recently returned by a federal grand jury in New Jersey. A company that presented itself as a provider of telemedicine services has been charged with filing $784 million in false claims for unnecessary durable medical equipment.
For the second time in less than 30 days, a company indirectly acquired by Abbott has settled with the U.S. government over alleged violations of the False Claims Act (FCA). In this instance, the now-defunct Arriva Medical LLC and its parent company Alere Inc. have agreed to pay $160 million to settle allegations that Arriva caused false Medicare claims to be filed for glucometers.
The U.S. Department of Justice (DoJ) has settled with two divisions of Abbott Laboratories of Abbott Park, Ill., over violations of the False Claims Act (FCA) in connection with devices alleged to have been defective. While neither claim recites a specific allegation against corporate executives with St. Jude Medical and Alere, the more conspicuous aspect of these agreements is that they are both directed toward activities that ceased in 2016, making clear that federal attorneys have long memories where problematic devices are concerned.
The Washington Legal Foundation’s (WLF) webinar on False Claims Act (FCA) litigation highlighted several developments in case law, including that non-relator FCA cases were up significantly in fiscal year 2020. However, Jay Stephens, an attorney with Kirkland & Ellis LLP, noted that Sen. Chuck Grassley (R-Iowa) has taken aim yet again at the materiality standard for false claims as spelled out in the Supreme Court’s Escobar, a move which if successful could amplify the federal enforcement focus on life science companies.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: DoJ settles with alleged DME fraudster; GAO: Veteran’s community centers had issues before pandemic.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA formally posts testing advisory after town hall discussion; HHS finalizes regulatory review rule; Lab in California hit for three months of false claims; BVMed calls for German med tech strategy.
False Claims Act (FCA) litigation is one of the more potent weapons used to corral life sciences companies that stray out of legal bounds in the U.S. Jaime Jones, a partner in the Chicago office of Sidley Austin LLP, told BioWorld that Sen. Chuck Grassley (R-Iowa), long a legislative watchdog, has several notions about how the statute might be tweaked.
Drug and medical device manufacturers have several compliance matters to deal with under the False Claims Act (FCA), only one of which is the Anti-Kickback Statute (AKS). Nonetheless, the AKS might be a good area for members of industry to emphasize, given that it accounted for the vast majority of federal enforcement actions in fiscal year (FY) 2019, according to a new report by Gibson, Dunn & Crutcher LLP.
Qui tam litigation holds a dear place in the hearts of U.S. federal prosecutors and whistleblowers alike, but the volume of these cases ebbed as the COVID-19 pandemic swept across the nation. A report by Gibson, Dunn & Crutcher LLP makes clear, however, that despite the pandemic-induced drag, these cases are resuming their historical pace, and makers of drugs and devices are once again the most frequently targeted type of business.
Device makers only can watch when cardiologists grapple with federal agency officials over device utilization. However, cardiologists are punching back hard against a rule used to judge whether a coronary artery stent is appropriately used, thus ensuring these devices won’t suffer a significant drop in utilization.
