Archive

October 1, 2018

Pharmaceutical distributor AmerisourceBergen Corporation will pay $625 million to the federal government and 43 states to settle claims that between 2001 and 2014 a pre-filled syringe program at one of its subsidiaries, Medical Initiatives, Inc., violated federal law.  Despite lacking the proper licensing and registration, MII opened FDA-approved sterile vials of oncology drugs, and in a non-sterile environment, pooled the medicine and transfered it into non-FDA approved pre-filled syringes which were then sold to oncology practices and physicians.  This practice allowed Amerisource to capture the "overfill" in the original FDA-approved sterile vials and produce a larger number of pre-filled syringes.  AmerisourceBergen also resolved claims that it provided unlawful kickbacks to physicians to induce them to purchase pre-filled syringes rather than vials.  The settlement resolved three qui tam actions initiated by whistleblowers Michael Mullen, Daniel Sypula, Kelly Hodge, and Omni Healthcare, Inc.; a payment of over $93 million will be made to relators. Previously, in September, 2017, AmerisourceBergen Specialty Group pleaded guilty to illegally distributing misbranded drugs and agreed to pay $260 million in criminal fines and forfeitures. USAO E.D.N.Y.;  NY

September 24, 2018

The owner and operator of several Superdrugs pharmacies in Queens, New York, was charged with submitting false claims to Medicare Part D and Medicaid for prescription drugs that were not dispensed, were not prescribed as claimed, or not medically necessary.  The pharmacies allegedly received $7.9 million from Medicare and Medicaid based on the fraudulent claims.  DOJ

September 17, 2018

In the largest healthcare fraud case ever to come out of Mississippi, the co-owner of two Mississippi-based compounding pharmacies, Marco Bisa Hawkins Moran, has pleaded guilty to defrauding TRICARE of more than $22 million. As part of the fraud, Moran and others allegedly paid kickbacks to doctors and marketers to prescribe drugs for beneficiaries covered by TRICARE and other lucrative health benefit programs. Additionally, they allegedly selected formulas meant to maximize profits instead of benefit individuals, and submitted fraudulent reimbursement claims to TRICARE. The case spanned multiple states across the country, including California, Tennessee, Arkansas, and Connecticut, with twelve people charged and nine convicted so far. USAO SDMS

September 13, 2018

One of the owners of an unnamed compounded drug marketing company has pleaded guilty to defrauding a state employee health benefit plan. According to the complaint, over the course of a year, Robert Madonna and others bribed a number of state employees to obtain prescriptions for medically unnecessary but expensive compounded drugs, including vitamins and creams to manage fungus, pain, and scars. The alleged fraud caused more than $2 million in losses to the New Jersey State Health Benefits Plan. Madonna will now pay $2,092,791 in restitution and be sentenced early next year to a possible maximum of 10 years in prison and a $250,000 fine. USAO NJ

September 11, 2018

Through a tip by Connecticut State Comptroller, Kevin Lembo, a Florida-based compounding pharmacy, Assured, Rx, along with multiple individuals—many of them former and current Connecticut state government employees—have been sued by the State of Connecticut for alleged violations of the Connecticut False Claims Act. The pharmacy is accused of paying kickbacks to co-defendants Nicholas and Lisette Maulucci, who then paid other individuals to file reimbursement claims from a state employee health plan for expensive compound drugs manufactured by Assured, Rx. Through their actions, the Mauluccis allegedly received kickbacks totaling upward of $2.6 million, and cost the Connecticut Pharmacy Benefit Plan approximately $10.9 million. CT AG

September 4, 2018

Pharmaceutical company Sanofi has agreed to pay more than $25 million to resolve charges under the FCPA that it made corrupt payments to win business in Kazakhstan and the Middle East. Sanofi was alleged to have made payments to various government officials and healthcare providers to induce them to purchase or prescribe Sanofi's products.  SEC

August 14, 2018

An Illinois pharmacist, Steven Gibson, has pleaded guilty to fraudulently billing Medicare, Medicaid, and private insurance companies for unauthorized and often expensive prescriptions that were never intended to be dispensed to any patient. The reimbursements he received eventually netted him over $630,000—as well as the prospect of a $250,000 fine and ten years in prison. USAO SDIL

August 10, 2018

Trinity Medical Pharmacy, LLP and several members of its leadership have agreed to pay $2,244,270.14 to settle allegations that it violated the False Claims Act by giving illegal kickbacks to patients and providers, billing TRICARE and other government programs for medical reimbursement claims arising from those kickbacks, and failing to disclose information that would have barred it from becoming a provider for Express Scripts, which provides pharmaceutical services for TRICARE. USAO MDFL

August 8, 2018

Dr. Donald Chamberlain and Karen Chamberlain, the owners of a Chattanooga gynecology practice, will pay $428,000 to settle False Claims Act allegations. According to the government, the Chamberlains used foreign-sourced, non-FDA approved, anticancer drugs, and billed Medicare and Tennessee’s Medicaid programs for similar, approved drugs. The drugs the Chamberlains used were cheaper than similar drugs that were approved by the FDA. USAO Eastern District of Tennessee

August 7, 2018

AstraZeneca, the multinational pharmaceutical giant, has agreed to pay Texas $110 million to settle allegations that the company misleadingly marketed two of its drugs, Crestor and Seroquel, in violation of the Texas Medicaid Fraud Prevention Act. The allegations focused on the company’s off-label marketing in 2010, when it was under a corporate integrity agreement. Former employees of AstraZeneca initiated the case under the whistleblower provisions of the Texas Medicaid Fraud Prevention Act. Texas AG