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Pharma Fraud

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Catch of the Week: Another Pharma Company, Incyte, Settles FCA Claims For Kickbacks to a Charitable Foundation

Posted  05/7/21
By Edward Baker
pills scattered around
The Department of Justice announced this week that Incyte Corporation, a Delaware pharmaceutical company, has agreed to pay $12.6 million to resolve allegations that it violated the False Claims Act by paying kickbacks to a charitable foundation to increase prescriptions for the drug Jakafi, which is used to treat myelofibrosis, a form of leukemia that causes extensive scarring in bone marrow and leads to severe...

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

Catch of the Week: Dozens of Fraudsters Sentenced in Multimillion Dollar Compounding Pharmacy Fraud

Posted  04/30/21
compounding pharmacy drugs
On Thursday, an Alabama District Court Judge sentenced dozens of defendants to prison for participating in a massive conspiracy to swindle insurers for medically unnecessary compound drugs. The defendants included company executives and managers, a prescriber, billers, and sales representatives associated with Northside Pharmacy, which was doing business as Global Compounding Pharmacy (Global). According to the DOJ...

Bristol-Myers Squibb Settlement Highlights a Common-Sense Law: The Medicaid Drug Rebate Program

Posted  04/2/21
Drug prices are out of control.  They now account for roughly 10% of our healthcare spending and America’s per capita outlay has nearly doubled over the past two decades.  For the least fortunate among us, many of these medications have become out of reach altogether. While new proposals are regularly made, one approach that often gets overlooked is simply enforcing the laws already on the books. That is just...

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

March Madness: AstraZeneca Fudges the Clinical Trial Results for Its COVID-19 Vaccine

Posted  03/26/21
By Edward Baker
basketball hoop in basketball court
In case you haven’t been following the NCAA Men’s Basketball Tournament (or even if you have), you might be surprised to learn that the University of Hartford is poised to win it all this year—except for the fact that it lost in the first round of the tournament to Baylor University, 79-55, and has been eliminated from the competition. Likewise, in case you haven’t been following the results of COVID-19...

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

DOJ Previews False Claims Act Enforcement Priorities for 2021

Posted  03/5/21
Department of Justice Seal on the United States Flag
The False Claims Act is the federal government's primary enforcement tool to combat fraud against the public.  Every year the government recovers billions of dollars under the statute, primarily with the help of whistleblowers.  Under the so-called qui tam provisions of the act, whistleblowers are authorized to act as private attorneys general and bring lawsuits on behalf of the government and recover a portion of...

February 9, 2021

India-based cancer drug manufacturer Fresenius Kabi Oncology Limited (FKOL) has agreed to pay $50 million in fines and forfeiture for failing to provide certain records to FDA investigators.  In violation of the Federal Food, Drug and Cosmetic Act, which helps ensure the purity and potency of drugs sold in the United States, FKOL actively obstructed a 2013 FDA inspection of one of its plants by removing and deleting manufacturing records.  As part of the settlement, FKOL has also agreed to implement a compliance and ethics program to prevent, detect, and correct any further violations of U.S. laws.  DOJ; USAO NV

February 2, 2021

The owner of Mississippi-based Medworx Compounding and Custom Care Pharmacy, Marco Bisa Hawkins Moran, has been sentenced to ten years in prison and ordered to pay $34.3 million in fines and restitution following his guilty plea on charges related to a conspiracy to defraud TRICARE and other healthcare programs.  As part of the scheme, which resulted in the submission of $22.1 million in fraudulent claims, Moran and his co-conspirators adjusted prescription formulas to ensure the highest reimbursement, paid marketers and physicians kickbacks and bribes to obtain prescriptions for high-yield compounded medications without regard to medical necessity, and routinely waived and/or reduced the collection of copayments. USAO SD MS
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