Medical Devices and DME Archives - Page 17 of 19

February 5, 2015

Minnesota-based medical device manufacturer ev3 Inc. (formerly known as Fox Hollow Technologies Inc.) agreed to pay $1.25M to resolve allegations it violated the False Claims Act by causing certain hospitals to submit false claims to Medicare for unnecessary inpatient admissions related to minimally-invasive atherectomy procedures for removing hardening of the arteries. According to the government, Fox Hollow sold the Silver Hawk Plaque Excision System for these procedures and advised hospitals to bill them as more expensive inpatient procedures, as opposed to less costly outpatient procedures, to artificially increase their Medicare reimbursement claims. The charges originated with a whistleblower lawsuit was filed under the qui tam provisions of the False Claims Act by former Fox Hollow sales representative Amanda Cashi. She will receive a whistleblower award of $250,000. DOJ

Tagged in: FCA Federal, Hospital Fraud, Medical Billing Fraud, Medical Devices and DME, Upcoding, Whistleblower Case, Whistleblower Rewards,

February 3, 2015

Medical device maker Atrium Medical Corporation, Maquet Holding B.V. & Co. KG, Maquet Cardiovascular LLC, and Maquet Cardiopulmonary AG were permanently enjoined from distributing adulterated and misbranded medical devices. According to the government, Atrium — which manufactures medical devices for cardiovascular-related uses, including chest drains, surgical meshes, vascular grafts and stent systems — was not complying with the FDA’s current good manufacturing practice requirements for medical devices which are designed to ensure the devices are safe and effective and otherwise in compliance with the federal Food, Drug and Cosmetic Act. DOJ

Tagged in: CGMP Violation, Defective Products, Medical Devices and DME,

December 17, 2014

Mark Morad and Dr. Divini Luccioni, both of Louisiana, pleaded guilty to their role in a $56M Medicare fraud scheme. According to court documents, Morad directed the scheme through multiple New Orleans-area companies he owned, including Interlink Health Care Services Inc.,Memorial Home Health Inc., Lakeland Health Care Services Inc., Lexmark Health Care LLC, and Med Rite Pharmacy Inc. Morad paid kickbacks to recruiters who canvassed New Orleans neighborhoods for Medicare beneficiary numbers, which Morad then used to bill Medicare for services that were not medically necessary or not provided. Dr. Luccioni admitted that he signed home health referrals and wrote DME prescriptions that were used to support these fraudulent billings. DOJ

Tagged in: Healthcare Fraud, Home Health and Hospice, Lack of Medical Necessity, Medical Billing Fraud, Medical Devices and DME,

December 8, 2014

Medical products manufacturer OtisMed Corp and its former CEO Charlie Chi admitted to intentionally distributing knee replacement surgery cutting guides (called the OtisKnee) after the Food and Drug Administration (FDA) had rejected their application for marketing clearance. OtisMed agreed to pay more than $80M to resolve its related criminal and civil liability for distributing an adulterated medical device in violation of the Food, Drug, and Cosmetic Act (FDCA), and submitting fraudulent claims in violation of the False Claims Act. Whistleblower Insider

Tagged in: FCA Federal, Medical Devices and DME, Off-Label and Unapproved Use,

December 1, 2014

North Atlantic Medical Services Inc., doing business as Regional Home Care Inc., agreed to pay $852,378 to resolve allegations it violated the False Claims Act by submitting claims to Medicare and Medicaid for respiratory therapy services provided by unlicensed personnel. NAMS is a medical device company based in Massachusetts that provides equipment and services for the treatment of respiratory ailments, such as oxygen deficiency and sleep apnea. According to the government, from September 2010 to January 2013, NAMS used unlicensed employees to set up sleep apnea masks and oxygen therapy equipment for patients in Massachusetts. The charges were initiated by former NAMS employees Konstantinos Gakis and Demetri Papageorgiou who filed a whistleblower action under the qui tamprovisions of the False Claims Act. They will receive a whistleblower award of $153,428. DOJ

Tagged in: FCA Federal, Improper Medical Personnel, Medical Devices and DME, Whistleblower Case, Whistleblower Rewards,

November 6, 2014

Medical device maker Biotronik Inc. agreed to pay $4.9M to resolve allegations it violated the False Claims Act by paying kickbacks to induce physicians to use its products. Specifically, the government charged that Biotronik induced electrophysiologists and cardiologists practicing in Nevada and Arizona to use Biotronik pacemakers, defibrillators and cardiac resynchronization therapy devices by paying them in the form of repeated meals at expensive restaurants and inflated payments for membership on a physician advisory board. The allegations first arose in a whistleblower lawsuit filed by a former Biotronik employee, Brian Sant, under the qui tam provisions of the False Claims Act. Sant will receive a whistleblower award of $840,000. DOJ

Tagged in: Anti-Kickback and Stark, FCA Federal, Medical Devices and DME, Whistleblower Case, Whistleblower Rewards,

October 29, 2014

Medical device maker EBI LLC, doing business as Biomet Spine and Bone Healing Technologies and Biomet Inc., agreed to pay $6M to resolve allegations it violated the False Claims Act by paying kickbacks to induce use of its bone growth stimulators, which are used to repair fractures that are slow to heal. Specifically, the government alleged that from 2001 to 2008 EBI paid staff at doctors’ offices (through personal service agreements) to influence doctors to order its bone growth stimulators. The allegations originated in a whistleblower lawsuit filed by former EBI product manager Yu Yue under the qui tam provisions of the False Claims Act, who will receive an undisclosed whistleblower award. DOJ

Tagged in: Anti-Kickback and Stark, FCA Federal, Medical Devices and DME, Whistleblower Case, Whistleblower Rewards,

September 22, 2014

Akinola Afolabi, former owner of Long Beach, California medical supply company Emmanuel Medical Supply was sentenced to serve 30 months in prison and ordered to pay $1.5 million in restitution for his role in a scheme to provide unnecessary power wheelchairs to Medicare patients, resulting in $2.6 million in fraudulent claims to Medicare.DOJ

Tagged in: Lack of Medical Necessity, Medical Devices and DME,

August 29, 2014

Austin, Texas-based Omni Surgical L.P. (doing business as Spine 360), a manufacturer of devices used in spinal surgery, and Dr. Jamie Gottlieb, an Indiana spinal surgeon, agreed to pay $2.6 million to settle allegations that Spine 360 paid illegal kickbacks to Gottlieb to induce him to use the company’s products in violation of the False Claims Act and Anti-Kickback Statute. According to the government, Spine 360 made payments to an entity controlled by Gottlieb which were purportedly made pursuant to a series of intellectual property agreements but in reality were sham payments to compensate Gottlieb for using Spine 360 products in his surgeries. DOJ

Tagged in: Anti-Kickback and Stark, FCA Federal, Medical Devices and DME,

August 15, 2014

Mihran “Mike” Meguerian, former owner of Los Angeles medical clinic management company Med Serve Management pleaded guilty in connection with his role in a scheme to defraud Medicare. Meguerian admitted overseeing medical clinics that wrote prescriptions for medically unnecessary power wheelchairs and other durable medical equipment (DME). Meguerian and his co-conspirators then sold the prescriptions to DME supply companies, knowing that the prescriptions were fraudulent. The DME supply companies then submitted the fraudulent prescriptions to Medicare in close to $3.4M in fraudulent claims. DOJ

Tagged in: Healthcare Fraud, Medical Devices and DME,

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