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September 26, 2022

Biogen Inc. has agreed to pay $900 million to resolve allegations by former employee Michael Bawduniak that the pharmaceutical company paid illegal kickbacks to physicians in order to induce prescriptions of their multiple sclerosis drugs, causing false claims to be submitted to Medicare and Medicaid.  According to Bawduniak, over a five-year period, Biogen paid kickbacks in the form of speaker honoraria, training fees, consulting fees, and free meals.  The vast majority of the settlement proceeds (over $840 million) will go to the federal government, while the remainder will be divided among 15 states.  USAO MA

Tagged in: Anti-Kickback and Stark, FCA Federal, Healthcare Fraud, Medicaid, Medicare, Pharma Fraud, Whistleblower Case,

September 14, 2022

Illinois-based pharmaceutical company Akorn Operating Company LLC has agreed to pay $7.9 million to resolve allegations of violating the False Claims Act by causing Medicare to pay for three generic drugs that stopped being eligible for coverage when their original manufacturers converted the brand name drugs from prescription only to over-the-counter.  According to a whistleblower, the brand name drugs in question were converted in February 2020 and June 2021, but Akorn knowingly failed to seek conversion of their generics until a year later because it knew over-the-counter drugs were non-reimbursable.  USAO MA

Tagged in: FCA Federal, Healthcare Fraud, Part D, Pharma Fraud, Whistleblower Case,

September 14, 2022

New York-Presbyterian/Queens Hospital has agreed to pay over $2.5 million to settle allegations that a former physician repeatedly performed and billed federal healthcare programs for medically unnecessary procedures, at the risk of patient health.  The procedures involved replacing batteries in an implanted pacemaker type device, even though batteries were still functioning normally and did not yet need to be replaced.  USAO EDNY

Tagged in: FCA Federal, Healthcare Fraud, Lack of Medical Necessity, Provider Fraud,

September 2, 2022

Bayer Corporation, together with its subsidiaries, will pay $40 million to settle claims initiated by a whistleblower alleging that the pharmaceutical manufacturer violated the False Claims Act by engaging in off-label marketing, unlawful kickbacks, and misreporting of safety risks with respect to its drugs Trasylol, Avelox, and Baycol.  The whistleblower, former Bayer marketing employee Laurie Simpson, will receive approximately $11 million from the settlement.  DOJ; USAO MN; USAO NJ

Tagged in: Anti-Kickback and Stark, FCA Federal, Healthcare Fraud, Off-Label and Unapproved Use, Pharma Fraud, Whistleblower Case, Whistleblower Rewards,

September 1, 2022

Philips RS North America LLC, formerly known as Respironics, will pay over $24 million to settle claims that it provided unlawful inducements to DME suppliers in the form of physician prescribing data that the DME suppliers could use in their marketing efforts.  The case was initiated by a qui tam complaint filed by former Respironics employee Jeremy Orling, who will receive a whistleblower award of approximately $4.3 million.  DOJ; USAO SC

Tagged in: Anti-Kickback and Stark, FCA Federal, Healthcare Fraud, Medical Devices and DME, Whistleblower Case, Whistleblower Rewards,

August 30, 2022

Medical device manufacturer Philips North America has agreed to pay $4.2 million to resolve allegations that it violated the False Claims Act by falsely certifying that mobile patient monitoring devices it sold to military purchasers met standards for airworthiness and passed safe-to-fly testing required to ensure that medical devices can safely be used in aircraft.  As part of the settlement, Philips admitted that after receiving initial approval in 2008, it made modifications to the device but did not inform government purchasers of those modifications, so that a determination could be made if re-testing was required.  USAO MA

Tagged in: Certifications, FCA Federal, Government Procurement Fraud, Healthcare Fraud, Medical Devices and DME,

August 30, 2022

Vision Quest Industries, Inc., which manufactures knee braces and other durable medical equipment, has agreed to pay $2.25 million to resolve claims that it violated the Anti-Kickback Statute by paying commissions to an independent sales representative based on VQ’s net revenue for each knee brace ordered by a particular purchaser which then, in turn, submitted claims for payment to Medicare.  The settlement with VQ follows earlier settlements in 2020 and 2019.  USAO MN

Tagged in: Anti-Kickback and Stark, FCA Federal, Healthcare Fraud, Medical Devices and DME,

August 23, 2022

Texas-based Cockerell Dermatopathology (CDP) has agreed to pay $3.75 million to resolve allegations of allowing millions of dollars in fraudulent claims to be submitted to TRICARE, in violation of the False Claims Act.  According to a government suit, CDP’s principal physician, Dr. Clay Cockerell, had allowed laboratory management company Progen to use its license to submit false claims for medically unnecessary tests in exchange for a twenty percent cut of the proceeds.  USAO NDTX

Tagged in: FCA Federal, Healthcare Fraud, Laboratory and IDTF, Other Government Health Programs,

August 23, 2022

Essilor International and related subsidiaries, which manufacture, market, and distribute optical lenses and equipment to produce optical lenses—have agreed to pay $22 million to resolve federal and state allegations of defrauding Medicare and Medicaid.  In two separate qui tam suits, former sales managers Laura Thompson and Lisa Brez, and Christie Rudolph alleged that Essilor violated the Anti-Kickback Statute and False Claims Act by paying illegal kickbacks to optometrists and opthalmologists to induce purchases of their products for patients, including patients covered by Medicare and Medicaid.  $5.6 million of the total settlement was allocated between states that were parties to the settlements, and $16.4 million to the federal government. DOJ; USAO EDPA; USAO NDTX; CO; CT; SD (see later CA settlement)

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

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