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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:

Page 8 of 19

January 30, 2020

Johnson & Johnson has been ordered to pay $344 million to the State of California for misrepresenting the safety of its pelvic mesh implants, which were sold from 2008 to 2014 and have resulted in over 35,000 personal injury lawsuits nationwide.  The State of California brought suit in 2016 after finding the company failed to inform patients and their doctors of possible severe complications, including chronic pain and permanent dysfunctional elimination.  Johnson and Johnson previously settled similar allegations with some 40 other states, for $117 million, in October of last year.  CA AG

Tagged in: Defective Products, Healthcare Fraud, Medical Devices and DME,

Catch of the Week: ResMed Pays $37.5 Million to Settle Five Qui Tam Cases Alleging Kickbacks

Posted  01/16/20
Pizza cut into wedges
Sleep apnea equipment manufacturer ResMed agreed to pay $37.5 million to resolve allegations that it violated the False Claims Act and Anti-Kickback Statute by providing unlawful remuneration to durable medical equipment distributors, sleep labs, doctors, and other healthcare providers.  It seems that ResMed’s kickback schemes struck many people as wrong: the settlement resolves five separate cases brought by...

Tagged in: Anti-Kickback and Stark, Catch of the Week, FCA Federal, Healthcare Fraud, Medical Devices and DME, Multiple Whistleblowers and First-to-File, Whistleblower Case,

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January 15, 2020

ResMed Corp. has agreed to pay $37.5 million to resolve five whistleblower-brought lawsuits alleging that the durable medical equipment (DME) manufacturer paid illegal kickbacks to suppliers, sleep labs, and other health providers, in violation of the Anti-Kickback Statute and False Claims Act.  $6.2 million of the settlement will be split amongst the whistleblowers, who had revealed that ResMed improperly provided or helped provide free or below cost call center services, patient outreach services, medical equipment and installation, and interest-free loans, in exchange for business.  DOJ; USAO EDNY; USAO NC; USAO NDIA; USAO SC; USAO SDCA

Tagged in: Anti-Kickback and Stark, FCA Federal, Healthcare Fraud, Medicaid, Medical Devices and DME, Medicare, Other Government Health Programs, Whistleblower Case, Whistleblower Rewards,

January 15, 2020

TMJ & Orofacial Pain Treatment Centers of Wisconsin has agreed to pay $1 million to settle a qui tam suit alleging submissions of false claims to Medicare and TRICARE.  According to the anonymous whistleblower, who will receive an undisclosed share of the settlement, TMJ billed the government health programs for prosthetic devices as if they had been fabricated by in-house surgeons, when in fact they had been fabricated by an outside laboratory.  USAO EDWI

Tagged in: FCA Federal, Healthcare Fraud, Medical Billing Fraud, Medical Devices and DME, Medicare, Other Government Health Programs, Provider Fraud, Upcoding, Whistleblower Case,

November 7, 2019

Medical device manufacturer Life Spine Inc. has agreed to pay $5.5 million to settle fraud allegations stemming from a qui tam suit, with founder and CEO Michael Butler agreeing pay another $375,000, and VP of business development Richard Greiber agreeing to pay another $115,000.  As part of the settlement, the defendants admitted to paying kickbacks to surgeons and entities between 2012 and 2018 in exchange for their use of Life Spine’s spinal implants, devices, and equipment.  USAO SDNY

Tagged in: Anti-Kickback and Stark, Healthcare Fraud, Medicaid, Medical Devices and DME, Medicare, Whistleblower Case,

October 28, 2019

Sanford Health, Sanford Medical Center, and Sanford Clinic have agreed to pay $20.25 million and enter into a Corporate Integrity Agreement in order to resolve alleged violations of the Anti-Kickback Statute and False Claims Act.  Despite warnings by several physicians that a top neurosurgeon was illegally profiting off his use of implantable medical devices as well as performing medically unnecessary surgeries involving the devices, Sanford did nothing to stop the offender, allowing Medicare and Medicaid to continue being defrauded.  The allegations were raised by Sanford surgeons Drs. Carl Dustin Bechtold and Bryan Wellman, who will share in a $3.4 million cut of the settlement proceeds.  DOJ; USAO SD

Tagged in: Anti-Kickback and Stark, FCA Federal, Healthcare Fraud, Lack of Medical Necessity, Medicaid, Medical Devices and DME, Medicare, Provider Fraud, Whistleblower Case, Whistleblower Rewards,

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

Tagged in: Defective Products, Medical Devices and DME,

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

Tagged in: FCA Federal, Healthcare Fraud, Hospital Fraud, Medical Billing Fraud, Medical Devices and DME, Whistleblower Case,

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

Tagged in: FCA Federal, Healthcare Fraud, Medical Billing Fraud, Medical Devices and DME, Medicare, Provider Fraud,

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

Tagged in: FCA Federal, Healthcare Fraud, Medical Billing Fraud, Medical Devices and DME, Provider Fraud,

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