Medical Devices and DME
This archive displays posts tagged as relevant to medical devices and durable medical equipment. You may also be interested in our pages:
December 16, 2020
Handicare USA, which manufactures and installs patient lift and mobility systems for healthcare facilities, agreed to pay $800,000 to resolve claims that it knowingly provided products to the Veterans Administration that failed to comply with the Trade Agreements Act. A whistleblower tipped the government that Handicare patient lifts installed at VA facilities used parts made in China for the mounting system that secured the patient lift to the ceiling, and took steps to conceal its non-compliance, including by instructing that the products should be installed so that the “Made in China” stamps on metal parts would not be visible. USAO DCDecember 4, 2020
Joint Active Systems, Inc. (JAS), a durable medical equipment manufacturer, and New England Orthotics & Prosthetics, LLP (NEOPS) have agreed to pay $1.59 million and $90,000 respectively to resolve allegations of defrauding multiple federal healthcare programs—including TRICARE, Medicare, and Medicaid programs in Connecticut, Massachusetts, and Rhode Island—through a variety of fraudulent schemes. According to a qui tam suit filed by two former NEOPS employees, JAS allegedly recruited NEOPS to bill Medicare and Medicaid for custom-fabricated orthotics that were not custom-fabricated orthotics, nor medically necessary, and falsely claim that JAS-affiliated sales representatives were properly trained to treat patients during fittings. Additionally, JAS allegedly overcharged the VA for its devices by as much as 300%. For blowing the whistle on these fraud schemes, the whistleblowers will receive a 17% share of the settlement proceeds. USAO MATherakos Settlement Keeps Private Equity in DOJ’s Crosshairs for FCA Liability
Posted 12/4/20
November 19, 2020
Johnson & Johnson (J&J) subsidiary Medical Device Business Services, Inc. (MDBS) has agreed to pay $10 million to settle allegations that a former J&J subsidiary, Therakos, Inc., promoted two medical devices for unapproved uses in pediatric patients. A second entity, The Gores Group (TGG), agreed to pay $1.5 million to settle allegations of continuing to promote the devices for unapproved uses after it acquired Therakos in 2012. According to qui tam relator Brian McCormick of Ross Feller Casey LLP, between 2006 and 2015, Therakos improperly promoted its extracorporeal photopheresis (ECP) systems, used to treat cutaneous T-cell lymphoma, for use in children despite the fact that no ECP devices had been approved for that population. In so doing, Therakos allegedly caused false claims to be submitted to Medicaid, the Federal Employee Health Benefits Program, and TRICARE, in violation of the False Claims Act. USAO EDPAOctober 29, 2020
Medtronic has agreed to pay over $9.2 million to resolve allegations of violating the False Claims Act and CMS’s Open Payments Program by paying kickbacks to a South Dakota-based neurosurgeon, Wilson Asfora, M.D., in order to induce sales of its SynchroMed II implantable intrathecal infusion pumps. According to the government, Medtronic allegedly sponsored nine years’ worth of events at a restaurant owned by Asfora, and to which Asfora would invite his acquaintances, business partners, trusted colleagues, and referral sources. For his role in the kickback scheme, Asfora has been named in a separate FCA lawsuit, which the United States joined last November. USAO SDOctober 14, 2020
Medical device maker Merit Medical Systems Inc. will pay $18 million to resolve claims first brought by a whistleblower under the False Claims Act that the company paid unlawful kickbacks to doctors and hospitals to induce them to use MMSI’s EmboSphere and QuadraSphere devices for embolization procedures. MMSI was alleged to have offered hospitals and providers with millions of dollars in free advertising assistance, “educational” grants, and other services based on the providers’ past sales and to induce future sales. The whistleblower, Charles J. Wolf, M.D., who will receive $2.65 million, was the Chief Compliance Officer for the company; according to DOJ, he repeatedly warned MMSI that its practices violated the Anti-Kickback Statue. DOJ; USAO NJ; NC AGCatch of the Week: 345 Charged in $6 Billion National Health Care Fraud and Opioid Takedown
Posted 10/2/20
