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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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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 In addition to the prison sentence and the owed restitution, Poon’s chiropractic license was revoked in 2019.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...

January 5, 2022

Two Florida men, Reinier Gonzalez Caballero and Alexeis Napoles Manresa, have each been sentenced to a little over four years in prison for laundering the ill-gotten proceeds of a $3 million healthcare fraud scheme against Medicare.  Over a couple months in 2019, durable medical equipment company Universal Ortho Supplies, Inc. billed Medicare for orthosis and prosthetics that were never prescribed by physicians, nor provided to patients.  The reimbursements were then turned over to the defendants, who attempted to disguise the source of the funds by setting up shell corporations and opening up fake bank accounts.  Two co-conspirators have already been convicted and sentenced; another two have pleaded guilty and await sentencing.  USAO SDFL

December 8, 2021

The owner and medical director of Georgia’s Milton Hall Surgical Associates, Jeffrey M. Gallups, will pay $3 million, and medical device manufacturer Entellus Medical will pay $1.2 million, to resolve claims that they entered into an unlawful kickback arrangement.  The government alleged that Gallups received cash payments and all-expense paid trips from Entellus in return for directing MHSA physicians to utilize sinuplasty related medical devices exclusively from Entellus and increase the number of sinuplasty procedures performed.  In addition, Gallups was alleged to have received “commissions” from medical testing laboratory NextHealth, in exchange for directing MHSA doctors to order medically unnecessary toxicology and genetic tests from NextHealth.  The settlement resolves a qui tam action initiated by former MHSA physician Myron Jones, M.D., who will receive approximately $614,000 from the settlement.  USAO ND GA

Recent Settlements Show Kickbacks are Always a DOJ Enforcement Priority

Posted  11/15/21
Person Handing Hundred Dollar Bill to Another Person
The Department of Justice regularly highlights the areas of fraudulent conduct it intends to target as enforcement priorities.  These identified enforcement priorities tend to cover burgeoning areas of fraud or particular misbehavior especially ripe or prevalent because of the particular times we live in.  As might be expected, DOJ's current listing of priorities includes fraud related to the pandemic, opioids, the

November 8, 2021

Florida-based medical device company Arthrex Inc. has agreed to pay $16 million and enter into a five-year corporate integrity agreement to resolve allegations of paying kickbacks to a Colorado-based orthopedic surgeon in exchange for the surgeon’s use and recommendation of its products.  According to a qui tam suit by whistleblower Joseph Shea, the kickbacks were disguised as royalty payments for the surgeon’s contributions to Arthrex’s SutureBridge and SpeedBridge products.  For his role in the case, Shea will receive a relator’s share of $2.5 million.  USAO MA
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