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January 24, 2017

A former Poplar Grove, Illinois woman pleaded guilty in federal court in Rockford, Illinois to mail fraud and aggravated identity theft. According to documents filed with the court, from 2012 through 2014, Shameka Carr, 30, used individuals’ names, social security numbers and dates of birth without their knowledge or consent to file fraudulent income tax returns. Carr directed the fraudulently claimed refunds to prepaid debit cards and refund checks which she had mailed to addresses in Rockford and its surrounding areas. Carr admitted to an intended tax loss of $1,026,284. DOJ

January 19, 2017

Costco Wholesale will pay $11.75 million to settle allegations that its pharmacies violated the Controlled Substances Act when they improperly filled prescriptions for controlled substances. The settlement resolves allegations that Costco pharmacies filled prescriptions that were incomplete, lacked valid Drug Enforcement Administration (DEA) numbers or were for substances beyond various doctors’ scope of practice. Additionally, the settlement resolves allegations that Costco failed to keep and maintain accurate records for controlled substances at its pharmacies and centralized fill locations. In addition to the payment, Costco purchased a new pharmacy management system at a total budgeted five year cost of approximately $127 million. DOJ

January 19, 2017

Nationwide retail pharmacy operator Walgreen Co. agreed to pay $50 million to settle charges it violated the False Claims Act and the Anti-Kickback Statute by enrolling hundreds of thousands of beneficiaries of government healthcare programs in its Prescription Savings Club program by inducing them with discounts and other monetary incentives. According to the government, Walgreens understood that allowing government beneficiaries to participate in the program was a violation of the Anti-Kickback Statute but nevertheless marketed the program to them anyway and paid its employees bonuses for each customer they enrolled in the program, without verifying whether the customers were government beneficiaries. The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act. DOJ (SDNY)

January 17, 2017

McKesson Corporation, one of the country’s largest distributors of pharmaceutical drugs, agreed to pay a record $150 million civil penalty for alleged violations of the Controlled Substances Act. The settlement requires McKesson to suspend sales of controlled substances from distribution centers in Colorado, Ohio, Michigan and Florida for several years and according to the government is among the most severe sanctions ever agreed to by a Drug Enforcement Administration registered distributor. According to the government, McKesson failed to design and implement an effective system to detect and report “suspicious orders” for controlled substances distributed to its independent and small chain pharmacy customers and supplied various U.S. pharmacies an increasing amount of oxycodone and hydrocodone pills, frequently misused products that are part of the current opioid epidemic. DOJ

January 18, 2017

New York announced a joint settlement with four other states and the Federal Trade Commission with Mallinckrodt plc and its U.S. subsidiary, formerly known as Questcor Pharmaceuticals (“Questcor”), a drug manufacturer. The complaint and settlement, filed jointly, alleges that Questcor unlawfully acted to prevent competition for its drug H.P. Acthar Gel, which is typically used as a last resort to treat certain life-threatening diseases, including infantile spasms and multiple sclerosis. In 2001, Questcor bought the rights to Acthar, known as an adrenocorticotropic hormone (ACTH)-based therapeutic drug, which are used to treat certain life-threatening diseases, and is the standard of care for infantile spasms. It is the only such drug sold in the United States. Since then, Questcor has increased the price of Acthar 85,000%, from $40 per vial to over $34,000 per vial. The complaint alleges that Questcor monopolized the market for ACTH drugs by purchasing the rights to Synacthen, which was being sold by Novartis Pharma A.G. in 2012. Synacthen is used to treat patients with the same life-threatening conditions as Acthar, but is sold in Europe and Canada at a fraction of the price. NY, TX

January 13, 2017

Massachusetts-based ambulance company Medstar Ambulance Inc., including four subsidiary companies and its two owners, Nicholas and Gregory Melehov, agreed to pay $12.7 million to resolve allegations that they violated the False Claims Act by submitting false claims to Medicare for ambulance transport services. According to the government, Medstar routinely billed for services that did not qualify for reimbursement because the transports were not medically reasonable and necessary, billed for higher levels of services than were required by patients’ conditions, and billed for higher levels of services than were actually provided. The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by Dale Meehan, a former employee in Medstar’s billing office. Mr. Meehan will receive a whistleblower award of roughly $3.5 million. DOJ

January 12, 2017

Baxter International Inc. subsidiary Baxter Healthcare Corporation agreed to pay roughly $18 million to settle charges of violating the False Claims Act arising from the company's failure to follow current Good Manufacturing Practices when manufacturing sterile drug products in North Carolina. Baxter admitted that it distributed products in interstate commerce that were adulterated in violation of the Federal Food, Drug, and Cosmetic Act FDCA. It will pay a total of $16 million in monetary penalties and forfeiture. It will also pay roughly $2 million to resolve allegations it violated the False Claims Act by submitting false claims to the Department of Veterans Affairs based upon Baxter’s failure to follow cGMPs. The allegations originated in a whistleblower lawsuit under the qui tam provisions of the False Claims Act by Baxter employee Christopher Wall. He will receive a whistleblower award of roughly $432,000 from the proceeds of the government's False Claims Act recovery. DOJ

January 12, 2017

Idia Oriakhi, the administrator of five Houston-area home health agencies, pleaded guilty to conspiring to defraud the State of Texas’ Medicaid-funded Home and Community-Based Service and the Primary Home Care Programs of more than $7.8 million. Oriakhi’s parents owned and operated Aabraham Blessings, LLC; Baptist Home Care Providers, Inc.; Community Wide Home Health, Inc.; Four Seasons Home Healthcare, Inc. and Kis Med Concepts, Inc. and admitted that she, her father Godwin Oriakhi and others obtained patients for her family’s home health agencies by paying illegal kickback payments to patient recruiters and physicians for referring and certifying Medicaid patients for services not medically necessary and often not provided. DOJ

January 12, 2017

Indiana-based manufacturer of orthopedic and dental implant devices Zimmer Biomet Holdings Inc. agreed to pay a $17.4 million criminal penalty in connection with a scheme to pay bribes to government officials in Mexico and for violations of the internal controls provisions of the Foreign Corrupt Practices Act involving the company’s operations in Mexico and Brazil. By failing to require appropriate due diligence and documentation and contracts for payments to third parties, Biomet allowed its Mexican subsidiary Biomet 3i Mexico S.A. de C.V. to pay bribes to Mexican customs officials through customs brokers and sub-agents so 3i Mexico could import contraband dental implants into Mexico. Importing those products into Mexico violated Mexican law because they lacked proper registration or labeling. In related proceedings, the company also agreed to pay the SEC disgorgement of $6.5 million including pre-judgment interest and $6.5 million as a civil penalty. DOJ

January 12, 2017

Connecticut home healthcare provider Family Care Visiting Nurse and Home Care Agency, LLC and its owners David A. Krett and Rita C. Krett agreed to pay roughly $5.25 million to resolve allegations they violated the False Claims Act by billing for services which under Medicaid required a registered nurse when in fact a registered nurse did not provide the services. The government further alleged the company submitted claims to Medicaid for patients who were or may have been dually eligible for Medicare and Medicaid without first following required procedures for submitting claims to Medicare. DOJ (DCT)
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