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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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P-Stim Fraud: A New DOJ Enforcement Priority?

Posted  04/23/21
The Department of Justice regularly publicizes its fraud prevention and False Claims Act enforcement priorities. These announced priorities typically focus on broad issues that affect the lives of millions of Americans – COVID-19 fraud, the opioid crisis, and the rapid expansion of telehealth.  In addition, we keep an eye on DOJ enforcement actions, and these can reveal emerging trends, often in narrow areas.  One...

April 19, 2021

Maryland physician Njideka Udochi of Millennium Family Practice will pay $660,000 to resolve allegations that she submitted false claims for auricular stimulation, or "P-Stim," devices.  Udochi billed Medicare using a billing code covering the surgical implantation of a type of neurostimulator, but P-Stim devices are not surgically implanted, and are not approved for reimbursement from Medicare.  USAO MD

March 23, 2021

Medical device manufacturer Boston Scientific Corporation has agreed to pay $188.6 million to 47 states and the District of Columbia to resolve allegations concerning its transvaginal surgical mesh, which were found to be deceptively marketed in violation of consumer protection laws and allegedly caused serious complications for thousands of women nationwide.  As part of the settlement, Boston Scientific also agreed to implement various marketing, training, and clinical trial reforms.  Similar settlements were previously reached with other medical device manufacturers, including Johnson & Johnson, which paid $116.9 million in 2019, and C.R. Bard, which paid $60 million in 2020.  CA AG; FL AG; NY AG

March 2, 2021

North Carolina durable medical equipment provider A Perfect Fit for You, Inc. and its owner Margaret Gibson have agreed to pay a total of $24.14 million to resolve civil claims that they falsely billed Medicaid for DME that had never been ordered or delivered, including by using the personally identifying information of Medicaid recipients who had been dead for years.  In addition, to resolve criminal charges of healthcare fraud, the company will pay an additional $2 million fine and $10.1 million in restitution to the North Carolina Medicaid program.  USAO ED NC

February 25, 2021

Following a self-disclosure to the U.S. Department of Health and Human Services in 2018, Bioventus, LLC has agreed to pay more than $3.6 million to resolve allegations of violating the False Claims Act in connection with sales of its Exogen ultrasonic bone growth stimulator device.  According to Bioventus, it discovered that its sales representatives sometimes improperly completed sections of certificates of medical necessity (CMN) that Medicare rules require be completed by treating physicians or physician offices.  USAO MDNC

February 12, 2021

The operator of Georgia-based durable medical equipment company Wilmington Island Medical Inc. has been sentenced to two years in prison and ordered to pay about $550,000 in restitution for paying kickbacks to doctors and nurse practitioners in exchange for signed orders and then billing those orders to Medicare.  The judgment against Patrick Wolfe is part of an ongoing investigation by the Southern District of Georgia to crack down on more than $1.5 billion in losses to Medicare and Medicaid originating from the district.  So far a total of thirty-one individuals and companies have been charged.  USAO SDGA

Operation Brace Yourself Nets $20M Settlement with DME Fraudster

Posted  02/9/21
stethoscope and blood pressure
This week, the Department of Justice announced it had reached a $20.3 million settlement with a Florida businesswoman who pleaded guilty to conspiracy to commit healthcare fraud and filing a false tax return.  The settlement resolved allegations that the woman, Kelly Wolfe, participated in a scheme to defraud Medicare by filling sham prescriptions for Durable Medical Equipment (DME) like back, ankle, knee, and wrist...

February 4, 2021

Durable medical equipment company Regency, Inc., has agreed to a $20.3 million civil settlement to resolve allegations that, together with its principal Kelly Wolfe, it violated the False Claims Act by creating dozens of front companies to submit over $400 million in false claims to government healthcare programs for the sale of DME that was not medically necessary.  Defendants were alleged to have paid unlawful kickbacks to doctors and falsely claimed that those doctors provided telehealth services to the beneficiaries, when in most cases the doctors had no interaction at all with the beneficiaries.  Wolfe also pleaded guilty to conspiracy to commit healthcare fraud and will be sentenced at a later date.  Former Regency employee Condra Albright will receive 23% of the civil recovery as a whistleblower reward.  DOJ; USAO MD FL

December 21, 2020

DME provider Apria Healthcare Group, Inc. and Apria 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 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, Apria 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; CA AG; FL AG

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
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