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Pharma Fraud

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November 2, 2020

Hospital system Memorial Health Services will pay a total of $31.5 million after self-disclosing that it overcharged California’s Medicaid program, Medi-Cal, for outpatient prescription drug reimbursements under the 340B Drug Pricing Program.  Memorial Health billed Medi-Cal for outpatient drugs at its usual and customary rate, rather than the lower “actual acquisition costs,” as required under the 340B Drug Pricing Program. California will receive $18.9 million of the settlement, and the federal government will receive $12.6 million.  Cal; CD Cal

Catch of the Week: 345 Charged in $6 Billion National Health Care Fraud and Opioid Takedown

Posted  10/2/20
Paper Ripped Uncovering Medical Necessity Wording
In the largest health care fraud and opioid enforcement action in the Justice Department’s history, 345 defendants—including more than 100 doctors, nurses, and other medical professionals—face charges for submitting over $6 billion in false or fraudulent claims to federal and private insurers.  Defendants stand accused of submitting $4.5 billion in fraudulent claims linked to telemedicine, $845 million...

September 23, 2020

Gilead Sciences, Inc. has agreed to pay $97 million to resolve claims of paying kickbacks to Medicare beneficiaries in connection with its pulmonary arterial hypertension drug, Letairis.  From 2007 to 2010, Gilead enticed beneficiaries to purchase Letairis by allegedly referring the beneficiaries to a foundation, Caring Voice Coalition (CVC), and then making payments to CVC to cover patient copays of Letairis specifically, in violation of the Anti-Kickback Statute and Medicare rules.  Additionally, Gilead routinely obtained data from CVC that it used to inform future payments, including how many CVC clients were on Letairis, how much CVC spent on those clients, and how much CVC expected to spend on them in the future.  DOJ; USAO MA

How Whistleblowers Can Report Fraud Related to Clinical Trials

Posted  09/4/20
Microscope
The COVID-19 pandemic has highlighted the importance of government-funded scientific and medical research, including clinical trials of vaccines, treatments, and more.  We are all potentially at risk if there is fraud and abuse in clinical trials and other research. Individuals with knowledge of fraud and misconduct in federal grants and clinical trials may be able to bring a whistleblower action for that research...

August 24, 2020

Following a whistleblower suit by a former sales representative, DUSA Pharmaceuticals (DUSA), a Massachusetts-based subsidiary of Sun Pharmaceuticals Industries Inc. (Sun Pharma), has agreed to pay $20.75 million to resolve allegations of defrauding Medicare and the Federal Employee Health Benefit Pr­­­ogram.  According to relator Aaron Chung, senior management at DUSA and Sun Pharma allegedly encouraged doctors, via paid speaker programs and discussions, to use shorter incubation periods of 1-3 hours for Levulan Kerastick, a topical prescription medication for treating actinic keratosis (AK) of the face and scalp that had FDA-approved instructions for 14-18 hour incubation periods.  As expected, the significantly reduced incubation periods resulted in significantly reduced AK clearance rates, yet DUSA failed to inform doctors of the lower rates and even actively misinformed them that AK clearance rates were the same regardless of incubation period.  For exposing the fraudulent conduct, Chung will receive approximately $3.5 million of the settlement proceeds.  DOJ; USAO WDWA

August 13, 2020

Advanced Care Scripts, Inc. (ACS) has agreed to pay $3.5 million to resolve allegations of conspiring with Teva Neuroscience, Inc. (Teva) to pay kickbacks to Medicare beneficiaries in order to induce purchases of Teva’s multiple sclerosis drug, Copaxone.  The kickbacks came in the form of effectively covering beneficiaries’ co-pays through correlated payments to the Chronic Disease Foundation (CDF) and The Assistance Fund (TAF).  USAO MA

New Settlement Shows the Power of Whistleblowers to Root out Fraud against Private Insurers

Posted  08/6/20
whistle hanging against a chalkboard
The nation’s biggest insurers, Medicare, Medicaid, and TRICARE already incentivize whistleblowers to report fraud. Because those programs are federally-funded, a whistleblower can bring suit under the False Claims Act and share in 15-30% of the recovery. The FCA is a law that allows private individuals alleging fraud against the government to bring a lawsuit in the name of the United States. The law leads to about...

Catch of the Week: Indivior Agrees to Pay $600 Million to Settle Opioid Fraud Case

Posted  07/31/20
pill container spilled over with pills in the form of a dollar sign
The latest in our Catch of the Week series features Indivior Solutions’ (“Indivior”) agreement to pay $600 million to resolve criminal and civil liability associated with the marketing of the opioid-addiction-treatment drug Suboxone. This is in addition to the $1.4 billion resolution with Indivior’s former parent, Reckitt Benckiser Group PLC (“RB Group”) that was previously announced in 2019. Suboxone is a...

July 28, 2020

A pharmaceutical company accused of paying illegal inducements to physicians has agreed to pay $3.5 million to resolve allegations of violating the False Claims Act.  In order to induce physicians to prescribe its newly-launched local analgesic, EXPAREL, Pacira Pharmaceuticals Inc. allegedly paid doctors kickbacks that were half-heartedly disguised as grant money for research.  In order to receive the so-called research grant, Pacira required EXPAREL to be placed on formulary at the physician’s institution, but did not document why such research was needed or follow up on research results.  The fraud was eventually exposed by a pharmacist in a qui tam suit; the pharmacist will receive $638,000 as part of the settlement.  USAO NJ; AG FL

July 24, 2020

Several divisions of pharmaceutical company Indivior, which marketed of the opioid-addiction drug Suboxone, pleaded guilty to felony healthcare fraud, entered into a five-year Corporate Integrity Agreement, and will pay a total of $600 million in criminal fines, restitution, civil damages, and penalties.  In six separate cases brought by whistleblowers, Indivior was also alleged to have caused false claims to be submitted to government healthcare programs including by promoting the sale of Suboxone to physicians who were prescribing it outside of medically accepted indication, misrepresenting the likelihood of Suboxone being diverted, and taking steps to delay generic competition for Suboxone. Indivior admitted making false statements about the safety of the film version of Suboxone in order to promote its sale.  In addition, the FTC claimed that violated antitrust laws through a deceptive scheme to thwart lower priced generic competition with Suboxone.  The total settlement consists of criminal restitution of $289 million; a civil settlement of $300 million, with $209.3 million paid to resolve claims by the federal government and $90.7 million to participating states; and, $10 million in penalties to the Federal Trade Commission.  The settlement also requires Indivior to take steps including the dissolution of its Suboxone sales force. Indivior was until 2014 a subsidiary of Reckitt Benckiser Group PLC, which previously paid $1.4 billion to resolve claims related to Suboxone marketing.  DOJ; USAO NJ; FTC
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