In a 32-page decision issued late yesterday, Southern District of New York Judge Mary Kay Vyskocil granted summary judgment for the government in a case where pharmaceutical giant Pfizer challenged an HHS-OIG Advisory Opinion finding that Pfizer could violate the anti-kickback statute (AKS) if it went ahead with a proposal to provide co-pay assistance for . . .
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On September 7, 2021, the U.S. Attorney’s Office in Boston announced a grand jury indictment of medical device company SpineFrontier, Inc., and two of its executives, Kingsley Chin and Aditya Humad, for violating the anti-kickback statute by allegedly paying surgeons bogus “consulting” fees to induce the surgeons to use SpineFrontier products in their surgeries. According to the . . .
In a precedential opinion that likely have a significant impact on several large pending cases, the United States Court of Appeals for the D.C. Circuit today upheld application of the so-called Overpayment Rule, 42 C.F.R. § 422.326, to Medicare Advantage organizations. See UnitedHealthcare Insurance Co. v. Becerra, No. 18-5326 (D.C. Cir. Aug. 13, 2021) (“UHC”). Medicare Advantage . . .
Dr. Sam W. Lee, formerly a Principal Investigator at Harvard Medical School and Massachusetts General Hospital (MGH), has agreed to pay $215,000 to resolve allegations that he submitted false information to get a grant from the National Institutes of Health (NIH) to do research involving “DNA damage response and carcinogenesis.” According to a settlement agreement finalized on . . .
On July 19, 2021, the United States Department of Justice and the California Department of Justice announced that they reached a $37.5 million settlement with a California hospital company, Prime Healthcare Services, its CEO, and a physician to resolve a variety of allegations, including that the hospital company paid kickbacks to the physician to get . . .
On July 8, 2021, the Department of Justice announced that pacemaker manufacturer St. Jude Medical (now owned by Abbott Laboratories) agreed to pay $27 million to resolve a False Claims Act qui tam action alleging that the company sold defective heart devices. Between 2014 and 2016, according to the government, St. Jude knowingly sold four . . .
On May 4, 2021, the Department of Justice announced that Incyte Corporation, a Delaware-based pharmaceutical company, agreed to pay $12.6 million to resolve allegations that it used a foundation, Chronic Disease Fund dba Good Days (“CDF”), to funnel kickbacks to Medicare patients taking its own drug. Incyte sells Jakafi, a drug that, through 2014, was approved only . . .
On April 16, 2021, the Department of Justice announced that a court sentenced six individuals, including a Virginia pharmacy owner and a former sales representative for Kaléo Pharmaceuticals, after they pled guilty to a variety of criminal charges. Mohamed Abdallah, the owner of Medex Health Pharmacy and Royal Care Pharmacy, was sentenced to four years in prison . . .