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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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August 30, 2022

Vision Quest Industries, Inc., which manufactures knee braces and other durable medical equipment, has agreed to pay $2.25 million to resolve claims that it violated the Anti-Kickback Statute by paying commissions to an independent sales representative based on VQ’s net revenue for each knee brace ordered by a particular purchaser which then, in turn, submitted claims for payment to Medicare.  The settlement with VQ follows earlier settlements in 2020 and 2019USAO MN

August 23, 2022

Essilor International and related subsidiaries, which manufacture, market, and distribute optical lenses and equipment to produce optical lenses—have agreed to pay $22 million to resolve federal and state allegations of defrauding Medicare and Medicaid.  In two separate qui tam suits, former sales managers Laura Thompson and Lisa Brez, and Christie Rudolph alleged that Essilor violated the Anti-Kickback Statute and False Claims Act by paying illegal kickbacks to optometrists and opthalmologists to induce purchases of their products for patients, including patients covered by Medicare and Medicaid.  $5.6 million of the total settlement was allocated between states that were parties to the settlements, and $16.4 million to the federal government. DOJ; USAO EDPA; USAO NDTX; CO; CT; SD (see later CA settlement)

July 22, 2022

Medical device manufacturer Biotronik Inc. has agreed to pay nearly $13 million to resolve allegations of paying kickbacks to physicians in order to induce use of their implantable cardiac devices, and causing false claims to be submitted to Medicare and Medicaid.  The alleged violations of the Anti-Kickback Statute and False Claims Act were brought to light in a qui tam suit by Jeffrey Bell and Andrew Schmid, both former sales representatives for Biotronik, who as part of the settlement will receive a $2.1 million relator’s share.  USAO CDCA

July 1, 2022

Reliance Medical Systems LLC and its owners Bret Berry and Adam Pike will pay $1 million to resolve allegations of False Claims Act violations by paying doctors to use their medical devices in spinal surgeries. Through its physician-owned distributorships (PODs), Reliance paid physicians for referrals, made false statements, and terminated physicians who didn’t refer enough patients, in one instance offering a surgeon a share of profits after he proved his “loyalty” to the POD. DOJ

May 18, 2022

Pat Truglia will spend 120 months in prison, forfeit over $9.4 million, and will pay restitution of $33.7 million for conspiring to defraud Medicare, TRICARE, and CHAMPVA, among others, of approximately $50 million through their fraudulent billing scheme. The scheme involved offering, paying, soliciting, and receiving kickback for durable medical equipment—in this case, braces. Truglia and his conspirators obtained DME orders for Medicare and other federal healthcare program beneficiaries by running multiple call centers, which paid kickbacks and bribes to telemedicine companies, who then paid doctors to write medically unnecessary orders. The orders were filled by Truglia’s companies, who then fraudulently billed the healthcare programs. USAO NJ

April 29, 2022

Eargo Inc., which sells direct-to-consumer hearing aid devices to customers nationwide, has agreed to pay $34.37 million to resolve allegations of defrauding the Federal Employees Health Benefits Program (FEHBP) over a four-year period.  Eargo allegedly submitted or caused to be submitted claims that contained unsupported diagnosis codes, even though an internal review of its billing and coding practices should have detected the error.  DOJ

April 21, 2022

Susan H. Poon, 57, will spend 70 months in federal prison, and will pay nearly $1.4 million in restitution for a scheme spanning over 3 years, and which resulted in approximately $2.2 million in fraudulent billings. Poon submitted prescriptions both with PII obtained at health fairs held by Costco and UPS, and by soliciting information from actual patients about their dependents—dependents whom Poon never saw or treated. Poon used the stolen PII to submit fraudulent durable medical equipment prescriptions to a DME manufacturer, who then unknowingly submitted false claims for reimbursement to a health insurer. In addition to the prison sentence and the owed restitution, Poon’s chiropractic license was revoked in 2019. USAO CDCA

March 24, 2022

A New York woman who defrauded the state out of millions of dollars has been sentenced to 3 to 9 years in prison and ordered to pay more than $4 million in restitution.  According to the Attorney General’s Office, Leslie Montgomery lured low-income New Yorkers to Health Living Community Center under the guise of helping them find housing, then used their information to submit false claims to a Medicaid-funded managed care organization.  The claims for custom-molded back braces were medically unnecessary and not requested by or provided to the intended recipients.  Montgomery then hid the illegal proceeds through multiple shell companies, including LCM Livery P/U, Inc.  NY AG

January 12, 2022

A diabetic shoe company, Foot Care Store, Inc., d/b/a Dia-Foot, and its President and CEO, Robert Gaynor, have agreed to pay $5.5 million to resolve allegations of billing Medicare and Medicaid for custom diabetic shoe inserts when in fact, their inserts were made using generic foot models.  The alleged misconduct occurred between 2013 and 2018 and was revealed in a whistleblower’s 2018 qui tam suit.  In addition to the monetary penalty, Dia-Foot has entered into a three-year Integrity Agreement that requires the company to implement updated policies and procedures and submit to quarterly independent review of its claims to Medicare and Medicaid.  USAO SDFL

Top Ten Healthcare Fraud Recoveries of 2021

Posted  01/11/22
doctor holding stethoscope
Consistent with the trend in prior years, the bulk of the Justice Department’s fraud and false claims recoveries in 2021 stemmed from healthcare fraud matters. Most of the funds recovered arose from cases originated by whistleblowers under the qui tam provisions of the False Claims Act. The majority of the recoveries on this list involve allegations of violations of the Anti-Kickback Statute, a federal law that...
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