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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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February 13, 2023

Spacelabs Healthcare, LLC has agreed to pay $2.5 million to settle claims of violating the False Claims Act by overcharging the Department of Veteran Affairs and Department of Defense between 2014 and 2019.  According to a qui tam suit filed by two former Spacelabs employees, Marci Gebhardt and Christopher Kelley, the company agreed to contract clauses in which they would sell patient monitoring equipment to the government at lower rates.  However, Spacelabs then failed to comply when billing the VA and Defense Logistics Agency.  For their role in bringing a successful enforcement action, Gebhardt and Kelley will share in a $437,500 reward.  DOJ

January 20, 2023

DePuy Synthes, Inc., a subsidiary of Johnson & Johnson that manufactures medical devices, has agreed to pay $9.75 million to resolve allegations of defrauding Medicare and Medicaid.  According to former sales representative Aleksej Gusakovs, DePuy gave a Massachusetts-based orthopedic surgeon thousands of dollars’ worth of free implants and instruments for use in overseas surgeries.  The illegal kickbacks induced the surgeon to use DePuy products in surgeries performed in the United States, and caused false claims to be submitted to Medicare and the Massachusetts Medicaid program.  As the whistleblower in a successful qui tam action, Gusakovs will receive a $1.37 million share of the settlement.  DOJ

December 20, 2022

Cochlear implant manufacturer Advanced Bionics LLC paid $11.4 million to resolve claims brought in a whistleblower action that the company falsely stated that the radio-frequency (RF) emissions generated by some of its cochlear implant processors met international standards when it submitted pre-market approval applications to the FDA.  The company allegedly knew that the devices did not meet standards, and manipulated testing conditions to obtain passing test results.  Whistleblower David Nyberg, a former engineer at Advanced Bionics, will receive a qui tam award of $1.9 million from the federal amount of the settlement.  DOJ; USAO ED PA

December 12, 2022

Medical device manufacturer Coloplast will pay $14.5 million to resolve claims that in its contracts with the Department of Veteran’s Affairs the company overcharged the government and submitted false claims.  Coloplast self-disclosed to the government that in violation of the Trade Agreements Act it misreported country of origin and sold products from non-designated countries, and, in violation of applicable Price Reduction Clauses, failed to provide the government with required discounts.  USAO DC

December 5, 2022

Optical lens manufacturer Essilor Laboratories of America, Inc. will pay $23.8 million to California to resolve allegations that the company violated the state’s Insurance Frauds Prevention Act when it allegedly provided kickbacks and other unlawful incentives to eye care providers in exchange for these providers’ promises to send business to Essilor. The state’s action was initiated by a whistleblower complaint filed by Christie Rudolph, who will receive a whistleblower reward of approximately $11.1 million. (see earlier settlement) CA

November 3, 2022

Titan Medical Compliance, LLC, and its chiropractor owner Timothy Warren, have been ordered to pay over $15 million to resolve claims that they falsely marketed auricular electro-acupuncture devices as FDA-approved and Medicare-reimbursable, when in fact they are not.  The judgment against Warren and Titan is the latest in a federal investigation into the improper billing of these non-surgical devices.  USAO EDPA

October 6, 2022

A man in Missouri who was convicted of committing healthcare fraud through various durable medical equipment companies has been sentenced to 3 years in prison and ordered to repay $7.5 millionJamie McCoy, who owned or operated AE Wellness LLC, Summit Medical Supply, Patriot Medical Supply, and DME Device Co., had worked in conjunction with marketing firms and a telemedicine doctor to cause fraudulent claims derived from illegal kickbacks to be submitted to Medicare and TRICARE.  After the scheme was discovered and McCoy and AE Wellness were suspended from further participation, two of McCoy’s associates opened the other companies to continue the fraud, while concealing McCoy’s role in the operation.  USAO EDMO

September 9, 2022

Daniel Pintado Cazola, the true owner of durable medical equipment company Myers Professional Services, has been sentenced to over 7 years in prison for defrauding Medicare and Medicaid and going to great extents to conceal his connection to the crimes.  Pintado Cazola admitted that he purchased lists of Medicare beneficiaries and directed employees to submit over $2.3 million in fraudulent claims to Medicare and Medicaid for durable medical equipment that was not medically necessary, not prescribed by a doctor, and not supplied to a beneficiary.  USAO SDFL

September 1, 2022

Philips RS North America LLC, formerly known as Respironics, will pay over $24 million to settle claims that it provided unlawful inducements to DME suppliers in the form of physician prescribing data that the DME suppliers could use in their marketing efforts.  The case was initiated by a qui tam complaint filed by former Respironics employee Jeremy Orling, who will receive a whistleblower award of approximately $4.3 millionDOJ; USAO SC
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