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Medical Devices and DME

This archive displays posts tagged as relevant to medical devices and durable medical equipment. You may also be interested in our pages:

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June 8, 2016

New Jersey announced that a Burlington County medical device distributor was charged with stealing more than $100,000 in insurance payments intended for two companies that made and marketed a device to clear patients’ airways. Loetta Karen Edwards, 46, owner of Edwards Medical DME, LLC, (Edwards Medical) in Cinnaminson, was indicted on one count of second-degree theft by failure to make required disposition of property received. Edwards was a local distributor of the “Frequencer,” a Canadian-made medical device that helps clear airways in patients with cystic fibrosis and chronic obstructive pulmonary disease. According to prosecutors, Edwards would order the devices on behalf of individuals who paid for them through their insurance companies. Prosecutors say Edwards would then process the insurance claims for the devices and receive the payments. She would then remit a portion of the money to the device manufacturer, Dymedso, Inc., and a portion to Dymedso’s Ohio-based sales representative, Clinical Technology. NJ

May 24, 2016

California filed a lawsuit against Johnson & Johnson (J&J) for false advertising and deceptive marketing of its surgical mesh products for women. The complaint alleges that J&J neglected to inform both patients and doctors of possible severe complications and misrepresented the frequency and severity of risks. California co-led a multistate investigation, including 46 states and the District of Columbia, into J&J’s surgical mesh products for women, and is seeking injunctive relief and monetary penalties to ensure that J&J stops its deceptive practices. The suit further claims that J&J knew about potential risks and side effects prior to the launch of their mesh products, yet omitted that information from educational and marketing materials provided to doctors and patients. CA, WA

May 3, 2016

Virginia-based Agape Health Management, Inc., which operates under the name Agape Adult Day Healthcare Center, agreed to pay $385,917 to settle charges of violating the False Claims Act by submitting false claims for transportation services purportedly provided to Virginia Medicaid recipients that were not present or transported to the Agape facility on the claimed dates of service.  DOJ (EDVA)

April 29, 2016

Hollister Inc., a manufacturer of disposable health care products, and Byram Healthcare Centers Inc., a supplier of medical products, agreed to respectively pay roughly $11.4 million and $9.4 million to resolve allegations they violated the False Claims Act through an illegal kickback scheme.  According to the government, Hollister paid kickbacks to Byram in return for marketing promotions, conversion campaigns and other referrals of patients to Hollister’s ostomy and continence care products.  The government claimed that Byram also received kickbacks from three other manufacturers of ostomy and continence care products, namely Coloplast Corp., Montreal Ostomy and Safe N’ Simple.  The allegations originated in a whistleblower lawsuit filed by two former employees and one current employee of Coloplast under the qui tam provisions of the False Claims Act.  They will receive a yet-to-be-determined whistleblower award from the proceeds of the government's recovery.  DOJ

May 3, 2016

Pennsylvania joined with other states and the federal government in a $306 million civil settlement that resolves allegations that Olympus America, Inc. and some of its subsidiaries paid illegal kickbacks to healthcare providers. The settlement was the result of a whistleblower lawsuit – United States et al., ex rel. John Slowik v. Olympus America, Inc., et al – filed in New Jersey. The lawsuit alleged that Olympus used improper financial incentives to induce doctors and hospital executives to buy a wide ranging array of its endoscopes and other surgical equipment, and to thereby unlawfully increase sales and gain market share. PA, NY

March 23, 2016

Pennsylvania-based Respironics Inc. agreed to pay $34.8 million to resolve charges it violated the False Claims Act and Anti-Kickback Statute by paying kickbacks in the form of free call center services to durable medical equipment (DME) suppliers that bought its masks for patients with sleep apnea.  Respironics allegedly provided DME companies with call center services to meet their patients’ resupply needs at no charge as long as the patients were using masks that Respironics manufactured; otherwise, the DME companies would have to pay a monthly fee based on the number of patients who used masks manufactured by a competitor of Respironics.  The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by Dr. Gibran Ameer, who has worked for different DME companies.  He will receive a whistleblower award of $5.38 million from the proceeds of the government's recovery.  DOJ

March 1, 2016

Ubert Guillermo Rodriguez, president and owner of Florida-based durable equipment provider G.R. Services Equipment & Supplies Inc., pleaded guilty to conspiracy to commit health care fraud.  According to the government, Rodriguez’s company submitted approximately $2.6 million worth of claims to Medicare seeking reimbursement for durable medical equipment, such as wound care supplies, that was not legitimately prescribed by doctors and was not provided to beneficiaries.  DOJ

March 1, 2016

Olympus Corp. of America, the country’s largest distributor of endoscopes and related equipment, agreed to pay $623.2 million to resolve alleged violations of the False Claims Act and Anti-Kickback Statute through a scheme to pay kickbacks to doctors and hospitals.  It is the largest payout ever by a medical device company for violations of the Anti-Kickback Statute.  In addition, Olympus subsidiary Olympus Latin America Inc. also agreed to pay $22.8 million to resolve separate charges relating to violations of the Foreign Corrupt Practices Act.  The allegations originated in a whistleblower lawsuit filed by John Slowik, Olympus’ former chief compliance officer, under the qui tam provisions of the federal and various state False Claims Acts.  He will receive a whistleblower award of roughly $51 million from the proceeds of the government’s recovery.  Whistleblower Insider

DOJ Catch of the Week -- Olympus Corp.

Posted  03/4/16
By the C|C Whistleblower Lawyer Team This week's Department of Justice "Catch of the Week" goes to Olympus Corp. of America, the country's largest distributor of endoscopes and related equipment.  On Tuesday, the company agreed to pay $623.2 million to resolve criminal charges and civil claims for the company's violations of the False Claims Act and Anti-Kickback Statute through a scheme to pay kickbacks to...

February 17, 2016

Fifty-one hospitals in 15 states agreed to pay more than $23 million to settle charges of violating the False Claims Act by implanting cardiac devices in Medicare patients in violation of Medicare coverage requirements.  These settlements represent the final stage of a nationwide investigation into the practices of hundreds of hospitals improperly billing Medicare for these devices, which in total have yielded more than $280 million.  The allegations against most of the current settling hospitals originated in a whistleblower lawsuit brought under the qui tam provisions of the False Claims Act by Leatrice Ford Richards, a cardiac nurse and Thomas Schuhmann, a health care reimbursement consultant.  They will receive a whistleblower reward of more than $3.5 million from the proceeds of the government's recovery from these current settlements.  The settling hospitals and health care companies included Arkansas Heart Hospital (AK); Aurora Health Care (WI); Cleveland Clinic Foundation (OH); Dignity Health (CA); MGH Wind Down (MI); Monongalia County General Hospital (WV); Mount Sinai Medical Center (FL); Nacogdoches Memorial Hospital (TX); Northwell Health (NY); Sentara Healthcare (VA); and Sisters of Charity of Leavenworth Health System (CO).  DOJ
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