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Anti-Kickback and Stark

This archive displays posts tagged as relevant to the Anti-Kickback Statute and Stark Law.

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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

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

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 millionDOJ; USAO SC

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 2019USAO MN

August 23, 2022

Essilor International, Essilor of America, Inc., Essilor Laboratories of America, Inc., and Essilor Instruments USA—which manufactures, markets, and distributes optical lenses and equipment to produce optical lenses—have agreed to pay $16.4 million to resolve 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.  USAO EDPA; USAO NDTX

July 27, 2022

ca Glenn Pair and Markuetric Stringfellow will spend 70 and 78 months in prison, respectively, and pay over $5 million each in restitution for defrauding three States’ Medicaid programs of more than $5 million, and for receiving $1.8 million in kickbacks from participating laboratories. The two owned and operated Do-It-4-The Hood Corporation in North Carolina and later expanded to Georgia. They targeted Medicare-eligible children, enrolled them in their programs, and required them to submit urine specimens for drug testing. Drug testing was in turn billed to Medicaid by complicit laboratories, who then paid kickbacks after receiving Medicaid reimbursement. Through their Wrights Care Services LLC franchise in South Carolina, the two filed fraudulent Medicaid claims for mental health counseling, going so far as to host a “note party,” upon learning of a Medicare audit of Wrights Care, to cover up their scheme by creating false billing records to substantiate their fraudulent Medicaid claims. USAO WDNC, USAO SC

July 22, 2022

Medical device manufacturer Biotronik Inc. has agreed to pay nearly $13 million to resolve allegations of paying kickbacks to physicians in order to induce use of their implantable cardiac devices, and causing false claims to be submitted to Medicare and Medicaid.  The alleged violations of the Anti-Kickback Statute and False Claims Act were brought to light in a qui tam suit by Jeffrey Bell and Andrew Schmid, both former sales representatives for Biotronik, who as part of the settlement will receive a $2.1 million relator’s share.  USAO CDCA

July 22, 2022

Metric Lab Services, LLC, Metric Management Services LLC, Spectrum Diagnostic Labs LLC, and two of their owners, Sherman Kennerson and Jeffrey Madison, will pay $5.7 million to resolve allegations of False Claims Act violations. In their genetic testing fraud scheme, Metric and Spectrum paid kickbacks to certain marketers who solicited generic testing samples from Medicare beneficiaries, with false physician attestations that the testing was medically necessary. Kennerson and Madison both pled guilty to one count of conspiracy to defraud the U.S. and are currently awaiting sentencing. DOJ, NJ USAO

July 14, 2022

BioReference Health, LLC, formerly known as BioReference Laboratories, Inc. and OPKO Health, Inc., have agreed to pay nearly $10 million and enter into a five-year Corporate Integrity Agreement to settle a whistleblower-brought case alleging it violated the Anti-Kickback Statute, Stark Law, and False Claims Act.  The alleged misconduct involved making lease payments to healthcare providers that exceeded fair market value, and later failing to report or return any overpayments to federal healthcare programs.  USAO MA

July 7, 2022

A hospital in West Virginia, Weirton Medical Center, has agreed to pay $1.5 million to settle allegations of submitting or causing to be submitted claims to Medicare that resulted from an improper financial relationship.  In violation of the Stark Law, Weirton allegedly paid referring physicians compensation based on volume and that exceeded fair market value.  USAO NDWV
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