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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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October 17, 2019

Johnson & Johnson and its subsidiary, Ethicon, Inc., have agreed to pay $116.9 million to 41 states and the District of Columbia for endangering the health of women nationwide by deceptively marketing transvaginal surgical mesh devices and failing to adequately disclose possible serious complications.  A multistate investigation found that both Johnson & Johnson and Ethicon knew of the risks—including chronic pain and inflammation, fistula formation, incontinence, and mesh extrusion and erosion into the body—yet failed to warn consumers or their physicians.  As part of the settlement, the companies must refrain from falsely describing the mesh as “FDA approved,” as well as provide full disclosure of the device’s risks.  DE AG; PA AG; MI AG; NY AG; SC AG; TX AG

September 26, 2019

The Biomedical Research Foundation of Northwest Louisiana, together with related entities and the Board of Supervisors of Louisiana State University and Agricultural and Mechanical College, which operate University Health Hospital in Shreveport, Louisiana, will pay $530,000 to resolve claims that they submitted improper claims for implantable automatic defibrillators.  To be reimbursed for the procedures, Medicare requires providers and hospitals to submit data regarding them to a qualified registry, so that the procedures can be further studied; University Health Hospital failed to make the required data submissions.  The investigation was initiated by a qui tam lawsuit filed by a whistleblower under the False Claims Act.  USAO WD LA

September 17, 2019

Physician Alliance Ltd. (PAL) and its medical director agreed to pay $178,000 to resolve False Claims Act allegations for improperly billing Medicare for providing patients with electric acupuncture medical devices that is affixed behind patients' ears. Since Medicare does not reimburse for acupunctural devices, PAL allegedly billed Medicare for the “implantation of neurostimulator electrodes,” a procedure that requires surgery and for which Medicare reimburses in the thousands of dollars. The case was investigated out of the Eastern District of Pennsylvania. DOJ

September 17, 2019

Physician Alliance Ltd. and Richard Frey, D.O. will pay $178,400 to resolve allegations that they submitted false claims to Medicare.  When defendants provided patients with "P-Stim" devices, which are worn on a patient's ear and marketed as an acupuncture treatment, they billed Medicare for the implantation of neurostimulator electrodes, which is a surgical procedure for which Medicare reimburses thousands of dollars.  By contrast, Medicare does not reimburse for acupuncture or acupuncture devices.  USAO EDPA

September 13, 2019

Medical device manufacturer Avalign Technologies, Inc. and its subsidiary Instrumed International, Inc., will pay $9.5 million to resolve allegations that the companies unlawfully marketed devices not properly approved by the FDA for use in spinal surgeries, circumcisions, and other medical procedures, with knowledge that the devices did not have the required FDA approvals.  The allegations were originally made in False Claims Act action brought by a whistleblower.  USAO SDNY

August 29, 2019

A healthcare executive in Tennessee has been sentenced to 3.5 years in prison and ordered to forfeit nearly $600,000 for her role in a $4.6 million illegal kickback scheme.  In pleading guilty to violating the Anti-Kickback Statute, Brenda Montgomery admitted that she paid the CEO of Comprehensive Pain Specialist (CPS), John Davis, a 60% cut of Medicare reimbursements—amounting to more than $770,000—for arranging the referrals of durable medical equipment.  As a result of the scheme, Montgomery herself received fraudulent reimbursements amounting to as much as $2.9 million.  USAO MDTN

Catch of the Week — Wound Care Device Manufacturer ACell Inc.

Posted  06/14/19
By Edward Baker
Nurse Wrapping a Wound on Mans Wrist
Our Catch of the Week goes to ACell Inc., a Maryland-based medical device manufacturer that pleaded guilty to violating the Federal Food, Drug, and Cosmetic Act (FDCA) by failing to report that it had partially removed its wound-care product, MicroMatrix, from the market because it was contaminated with endotoxins, placing treated patients in danger of serious infection, even death, without informing the FDA that it...

June 11, 2019

A Maryland-based medical device manufacturer facing criminal charges and civil charges under the False Claims Act has agreed to pay $15 million to settle all claims.  According to former employee and whistleblower John Murtaugh, when the company discovered that its MicroMatrix wound dressing powder was contaminated with high levels of endotoxins, it allegedly removed certain MicroMatrix products off the market, but failed to report the removal to the FDA and disclose the reason to doctors, hospitals, and its own sales representatives.  ACell also allegedly caused false claims to be submitted to federal healthcare programs by directing its sales representatives to market the product as safe and effective, providing coding recommendations designed to elicit higher payments from Medicare, and providing improper inducements to encourage use of its product.  As part of the settlement, Murtaugh will receive $2.3 million, and ACell will enter into a 5-year corporate integrity agreement.  DOJ

April 30, 2019

Anna Ramira-Ambriz, the owner of a durable medical equipment (DME) company, pleaded guilty on March 31, 2017, to defrauding Medicare out of more than $3 million. Ramirez-Ambriz owned Compassionate Medical Supplylocated in Edinburg.  From 2007 through 2013, Ramirez-Ambriz billed Texas Medicaid for higher quantities and more costly incontinence supplies than were actually delivered. She will be sentenced to federal prison for over six years, followed by an immediate three years of supervised release. Ramira-Ambriz was also ordered to pay over $3 million in restitution to the Texas Medicaid Program. DOJ

April 24, 2019

Two executives of Arriva Medical, LLC, a mail-order diabetic testing supply company acquired by Alere, Inc. in 2011, will pay a total of $1 million to settle claims that they caused Arriva to submit false claims to Medicare by supplying patients with free or no cost home blood glucose meters, waiving patient copayments, and billing for medically unnecessary home blood glucose meters.  USAO MD TN
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