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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:

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December 21, 2020

DME provider Apria Healthcare Group, Inc. and April Healthcare LLC will pay $40.5 million to settle allegations brought in a qui tam action filed by three former Apria employees that they improperly billed government healthcare programs for beneficiary rentals of non-invasive ventilators (“NIVs”) that were not medically necessary or which were provided with improper waivers of patient co-payments.  Medicare pays as much as $1,400 a month for NIVs, and providers are required to monitor patient usage of NIVs and stop billing when the NIVs are no longer being used.  Apria respiratory therapists did not, however, failed to monitor patient NIV usage and even when Apria knew that patients were no longer using the NIVs, Apria often did not take steps to stop seeking payment.  In addition, April sales staff steered doctors and beneficiaries to use NIVs when less-expensive alternatives were available, and routinely waived co-payments for NIV patients without making an assessment of the patient’s financial need.  USAO SDNY

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 DC

December 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 programsincluding TRICARE, Medicare, and Medicaid programs in Connecticut, Massachusetts, and Rhode Islandthrough 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 MA

Therakos Settlement Keeps Private Equity in DOJ’s Crosshairs for FCA Liability

Posted  12/4/20
durable medical equipment fraud whistleblower
On November 19th the United States Department of Justice (“DOJ”) announced an $11.5 million settlement involving the alleged promotion of two drug-device systems for unapproved uses by Therakos, Inc.  The action was initiated by a whistleblower under the qui tam provisions of the False Claims Act. The settling defendants included Johnson & Johnson subsidiary Medical Device Business Services, Inc. and The Gores...

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 EDPA

October 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 SD

October 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 AG

Catch of the Week: 345 Charged in $6 Billion National Health Care Fraud and Opioid Takedown

Posted  10/2/20
Paper Ripped Uncovering Medical Necessity Wording
In the largest health care fraud and opioid enforcement action in the Justice Department’s history, 345 defendants—including more than 100 doctors, nurses, and other medical professionals—face charges for submitting over $6 billion in false or fraudulent claims to federal and private insurers.  Defendants stand accused of submitting $4.5 billion in fraudulent claims linked to telemedicine, $845 million...

September 24, 2020

Transvaginal surgical mesh device manufacturer C.R. Bard, Inc. and its parent company, Becton, Dickinson and Company, have agreed to pay $60 million to 48 states and the District of Columbia to resolve allegations of deceptively marketing the devices.  The company’s surgical mesh—which are permanently implanted to hold up falling organs, and which are extremely difficult or impossible to remove—had life-altering side effects that they failed to disclose, including chronic pain, recurring infections, and shrinking tissue.  Although the devices were taken off the market in 2016, under the terms of the settlement, C.R. Bard and Becton, Dickinson and Company are required to adhere to certain injunctive terms if they choose to reenter the market.  The funds received as part of this settlement will be added to a larger restitution fund that was established after settlement of a similar case with Johnson & Johnson in 2019.  CA AG; FL AG; WA AG

September 10, 2020

Shreveport Prosthetics, Inc. will pay $1.6 million to resolve claims in an action brought by the company’s former office administrator, Kimberly Throgmorton, under the qui tam provisions of the False Claims Act.  The company was alleged to have submitted false bills to Medicare by using the supplier number of a different company after its own supplier number was deactivated, and by routinely waiving patient co-payments.  Ms. Throgmorton will receive over $250,000 as a whistleblower reward.  USAO WD LA
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