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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

September 24, 2020

Transvaginal surgical mesh device manufacturer C.R. Bard, Inc. and its parent company, Becton, Dickinson and Company, have agreed to pay $60 million to 48 states and the District of Columbia to resolve allegations of deceptively marketing the devices.  The company’s surgical mesh—which are permanently implanted to hold up falling organs, and which are extremely difficult or impossible to remove—had life-altering side effects that they failed to disclose, including chronic pain, recurring infections, and shrinking tissue.  Although the devices were taken off the market in 2016, under the terms of the settlement, C.R. Bard and Becton, Dickinson and Company are required to adhere to certain injunctive terms if they choose to reenter the market.  The funds received as part of this settlement will be added to a larger restitution fund that was established after settlement of a similar case with Johnson & Johnson in 2019.  CA AG; FL AG; WA AG

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

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

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

July 23, 2020

Two pharmacists who were co-owners of Advantage Pharmacy in Mississippi have been sentenced to over 12 years in prison each and ordered to pay between $9 million and $29 million in civil monetary judgment, and between $185 million and $189 million in restitution for committing healthcare fraud.  According to the press release, Glenn Doyle Beach and Hope Thomley marketed, dispensed, and distributed compounded medications without regard to medical necessity, causing various health benefit programs, including TRICARE, to pay over $200 million in reimbursements.  Thomley’s husband, Randy Thomley, has been sentenced to 8 years in prison and ordered to pay judgment and restitution of $3.6 million each for his role in helping to recruit TRICARE beneficiaries.  USAO SDMS

July 2, 2020

Alexion Pharmaceuticals, Inc. will pay $21 million to resolve SEC charges that it violated the Foreign Corrupt Practices Act.  Alexion subsidiaries in Turkey and Russia were alleged to have made payments to foreign officials in those countries in order to secure favorable regulatory treatment for Alexion’s drug Soliris, and to increase the number of prescriptions for the drug.  The Turkish and Russian subsidiaries, as well as Alexion subsidiaries in Brazil and Colombia, falsified their books and records with respect to improper payments, and Alexion’s internal accounting controls were not adequate to detect or prevent the improper payments and accounting.  SEC

July 1, 2020

Novartis Pharmaceuticals Corporation will pay a total of $678 million to resolve a case brought by a whistleblower, Oswald Bilotta, alleging that between 2002 and 2011 the pharmaceutical company violated the Anti-Kickback Statute and False Claims Act by providing doctors with cash payments and luxury travel and meals to induce them to prescribe Novartis cardiovascular and diabetes drugs reimbursed by federal healthcare programs.  The total settlement consists of $591.4 million as federal FCA damages, $48.2 million as state FCA damages for Medicaid false claims submitted to 28 states and the District of Columbia, and $38.4 million as forfeiture under the Anti-Kickback Statute.  The whistleblower award has not yet been determined.  In addition to the monetary settlement, Novartis entered into a Corporate Integrity Agreement obligating the company to, among other things, significantly reduce its volume and spending on paid speaker programs.  DOJ; USAO SDNY; CA AG; MI AG; NY AG
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