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August 9, 2021

The owners of North Carolina compounding pharmacy Wellcare Compouding, David Tsui and Lois Tsui, paid $1.1 million to resolve allegations that they violated the False Claims Act by submitting false claims for payment to the TRICARE program in 2014 and 2015.  The government alleged that Wellcare made improper payments to physicians and “marketers” in violation of the Anti-Kickback Statute and encouraged medically unnecessary prescriptions consisting of high-margin ingredients in order to maximize the pharmacy’s reimbursement. David Tsui had been convicted of healthcare fraud in 2009 and was excluded from participation in federal healthcare programs; the government alleged that his involvement and ownership was intentionally concealed.  USAO MD NC

Tagged in: Anti-Kickback and Stark, Compounding Pharmacy Fraud, FCA Federal, Healthcare Fraud, Improper Medical Personnel, Lack of Medical Necessity, Other Government Health Programs, Pharma Fraud,

July 21, 2021

For their part in creating and fueling the opioid epidemic, three of the nation’s largest drug distributors—McKesson Corporation, Cardinal Health Inc., and AmerisourceBergen Drug Corporation—as well as one of the nation’s largest drug manufacturers, Johnson & Johnson, have agreed to pay $26 billion over the next 18 years to resolve claims from nearly 4,000 lawsuits, including multiple state and local governments.  In addition to the monetary settlement, the companies have signed onto a 10-year injunctive relief agreement that will require them to implement certain data-driven oversight measures and not fund or lobby to promote opioids, among other things.  CA AG; FL AG; MI AG; NY AG; PA AG

Tagged in: Healthcare Fraud, Pharma Fraud,

July 8, 2021

Medical supply company Avanos Medical Inc. entered into a deferred prosecution agreement and will pay $22.2 million to resolve charges that it sold misbranded surgical gowns, labeling the MicroCool gowns as providing the highest level of fluid and virus protection under ANSI/AAMI standards, when the company knew the gowns had never met that standard.  The government also alleged that Avanos obstructed FDA inspection efforts.  ND Tex

Tagged in: Criminal Proceedings, FDA Fraud, Medical Devices and DME,

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

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

June 14, 2021

Centene Corp. will pay a total of $143.8 million to resolve claims by Ohio and Mississippi that it overbilled the states' Medicaid programs in its role as a pharmacy benefit manager.  The states alleged that Centene engaged in practices including "spread pricing," charging more than allowed price caps based on industry standards, inflation of dispensing fees, failure to disclose discounts received, and claiming reimbursement for prescriptions already paid for by third parties.  Ohio will receive $88.3 million, and Mississippi will receive $55.5 million.  OH; MS

Tagged in: Drug and DME Pricing, FCA State, Healthcare Fraud, Medicaid, Pharma Fraud,

May 28, 2021

Erik Santos of Georgia was sentenced to more than 11 years in prison following his guilty plea on healthcare fraud charges.  Santos conspired with Florida compounding pharmacy Patient Care America and others to recruit Tricare beneficiaries to fill prescriptions for expensive, supposedly tailor-made, compounded medications that consisted of little more than common pain or scar creams, but came with price tags as high as $10,000-$15,000 per month.  The beneficiaries did not need the medications, which had little to no therapeutic value, and Santos secured the prescriptions by paying doctors, who had not actually seen the beneficiaries, to approve pre-printed prescriptions for large amounts of these medications.  Santos’s fraudulent referrals caused an actual loss to the Tricare program of approximately $12 million.  PCA pharmacy paid Santos over $7 million in prescription referral kickbacks.  In addition to the prison sentence, the Court imposed restitution in the amount of $11.8 million and entered a forfeiture judgement of approximately $7.6 million.  USAO SD FL

Tagged in: Compounding Pharmacy Fraud, Criminal Proceedings, Healthcare Fraud, Lack of Medical Necessity, Other Government Health Programs, Pharma Fraud,

May 4, 2021

Delaware-based pharmaceutical company Incyte Corporation has agreed to pay $12.6 million to resolve allegations of violating the Anti-Kickback Statute and False Claims Act in connection with its myelofibrosis drug, Jafaki.  Despite federal laws against illegal remuneration to federal healthcare program beneficiaries, Incyte allegedly wielded its influence as the sole donor of a foundation to coerce the foundation into illegally covering the copays of Medicare and TRICARE patients taking Jafaki.  The misconduct continued from 2011 through 2014 before it was revealed in a qui tam suit by former compliance executive turned whistleblower, Justin Dillon.  Dillon will receive approximately $3.59 million for his efforts.  DOJ; USAO EDPA

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

April 29, 2021

Over two dozen defendants who were part of an extensive prescription drug fraud scheme involving Alabama-based Northside Pharmacy d/b/a Global Compounding Pharmacy have been sentenced to prison.  The defendants included company executives and managers, prescribers, billers, and sales representatives who, between 2013 and 2016, billed insurers such as Medicare and TRICARE for massive quantities of medically unnecessary prescription drugs.  In just that short period of time, the defendants caused insurers to pay nearly $50 million in medically unnecessary claims, with more than $13 million arising from improper payments to prescribers, and more than $8.4 million for prescriptions written out to Global employees themselves.  USAO NDAL

Tagged in: Anti-Kickback and Stark, Compounding Pharmacy Fraud, FCA Federal, Healthcare Fraud, Lack of Medical Necessity, Medicare, Other Government Health Programs,

April 1, 2021

Pharma company Bristol-Myers Squibb will pay $75 million to settle a False Claims Act action, filed by a whistleblower, alleging that the company failed to pay amounts it owed under the Medicaid Drug Rebate Program. That program, the MDRP, requires drug manufacturers to report the Average Manufacturer Prices (AMPs) of their Medicaid-covered drugs to the government; the higher the reported AMPs, the greater the rebate owed by the pharma company to the government.  The whistleblower alleged that Bristol-Myers systematically under-reported their AMPs for a number of its drugs, including by reducing service fees it paid to wholesalers and excluding the value of price appreciation provisions in wholesale contracts. Of the total settlement, $41 million will be paid to the federal government, and the remainder to states participating in the settlement.  The government did not intervene, and the action was pursued by the whistleblower, Ronald J. Streck, who will receive an undisclosed share of the settlement.  USAO EDPA

Tagged in: Drug and DME Pricing, FCA Federal, Healthcare Fraud, Medicaid, Pharma Fraud, Whistleblower Case, Whistleblower Rewards,

March 24, 2021

Two men in Mississippi have been sentenced to 7 years in prison and ordered to pay over $16 million in restitution to Medicare, TRICARE, and Express Scripts, as well as forfeiture of close to $1 million, for their roles in a multimillion-dollar healthcare fraud scheme.  Dempsey Bryan Levi and Jeffrey Wayne Rollins, the operators of the Gardens Pharmacy, LLC, had previously admitted to soliciting and incentivizing recruiters to obtain prescriptions for highly reimbursed compounded medications, and soliciting and incentivizing doctors to authorize those prescriptions.  USAO SDMS

Tagged in: Anti-Kickback and Stark, Compounding Pharmacy Fraud, FCA Federal, Healthcare Fraud, Medicare, Other Government Health Programs, Pharma Fraud,

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