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Medical Devices and DME

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Catch of the Week: Medical Device Companies to Pay $38.75M Over Defective Coagulation Monitor Allegations Linked to Patient Deaths, Injuries

Posted  07/9/21
tubes of blood
Medical device manufacturers Alere Inc. and Alere San Diego Inc. will pay nearly $40 million to resolve allegations that they knowingly sold defective blood coagulation monitors used by Medicare beneficiaries and falsely billed Medicare for the devices. The monitors are supposed to ensure that patients taking anticoagulant drugs receive a safe dosage to avoid life-threatening consequences from too much or too little...

July 8, 2021

Alere Inc. and Alere San Diego Inc. have agreed to pay nearly $39 million to settle allegations of knowingly selling defective blood coagulation monitors, which are used to determine safe dosages of anticoagulant drugs, to Medicare beneficiaries.  Too much anticoagulant could result in massive bleeding, while too little can result in blood clots and strokes.  By 2008, Alere had allegedly become aware of the fact that the software used in its INRatio monitors contained a material defect that caused some patients to see inaccurate results.  Although the company was also aware of dozens of deaths and hundreds of injuries associated with the devices, it failed to take them off the market and even continued to bill Medicare for them, in violation of the False Claims Act, until the FDA requested a Class I recall in 2016.  USAO NJ

June 11, 2021

Two integrative chiropractic practices in Pennsylvania and their chiropractor owners have agreed to pay over $800,000 to resolve liability under the False Claims Act in connection with an electro-acupuncture device.  The settling parties are Discover Optimal Healthcare, affiliate Weigner Healthcare Management Group, LLC, and owner Jason Weigner (collectively, “Weigner”), and Yucha Medical Pain Management & Chiropractic Rehabilitation, LLC, and owners Randolph Yucha and Rodney Gabel.  Between 2016 and 2017, the parties allegedly billed Medicare and the Federal Employees Health Benefit Program for the surgical implantation of neuro-stimulators, even though the devices involved—ANSiStim—are not reimbursable and can be applied with adhesives.  USAO EDPA

June 10, 2021

Three Texas-based healthcare providers who allegedly billed Medicare for non-reimbursable procedures involving electro-acupuncture devices have agreed to pay over $1 million in settle their liability under the False Claims Act.  For up to two years, each of the providers—Ledger Foot & Ankle, P.A., SPR Medical Group d/b/a Superior Physical Medicine, and Precision Spine and Pain Management—allegedly billed the application of two pain management devices, ANSiStim and STIVAX, as though they were implantable neurostimulators, when in fact their application was non-surgical and non-invasive.  Following a Medicare audit, Superior and Precision self-disclosed improperly billed claims and initiated refund payments to Medicare.  USAO WDTX

June 8, 2021

The chiropractor owner and operator of Texas-based Campbell Medical Group PLLC and Johnson Medical Group PLLC d/b/a Campbell Medical Clinic has agreed to pay $2.6 million to settle claims that she and the entities defrauded Medicare and TRICARE.  As part of the settlement, Suhyun An and her medical entities will be excluded from participating in federal healthcare programs for ten years.  Ms. An and the medical entities allegedly improperly obtained over $3.9 million in reimbursement for unbillable implantations of neurostimulator electrodes.  USAO SDTX

May 25, 2021

Upper Allegheny Health System (UAHS), which operates dental clinics in New York and Pennsylvania, has agreed to pay $2.7 million to resolve whistleblower-brought allegations of submitting false claims to Medicaid in violation of the federal and New York False Claims Acts.  Between 2010 and 2015, UAHS had billed Medicaid for dental services performed using improperly sterilized handpieces, which are considered semi-critical devices and need to be properly heat sterilized between patients.  AG NY; USAO WDNY; USAO WDPA

May 19, 2021

In one of the first settlements to resolve allegations under both the False Claims Act and the Open Payments Program (formerly the “Sunshine Act”), French medical device manufacturer Medicrea International and its American affiliate, Medicrea USA Inc., have agreed to pay $2 million to resolve whistleblower Dory Frain’s allegations that the companies violated the Anti-Kickback Statute while entertaining U.S.-based physicians at a conference in France in 2013.  The settlement also resolves allegations that the companies violated the Open Payments Program by failing to report those expenses to the Centers for Medicare & Medicaid Services.  USAO EDPA; CA AG; FL AG

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
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