Medical Devices and DME

October 6, 2016

Valery Bogomolny, the owner of Los Angeles medical supply company Royal Medical Supply, was sentenced to 60 months in prison for his role in a scheme that fraudulently billed more than $4 million to Medicare.  According to evidence presented at trial, Bogomolny used his company to improperly bill Medicare for power wheelchairs, back braces and knee braces that were medically unnecessary, not provided to beneficiaries or both.  The evidence further showed that Bogomolny created false documentation to support his false billing claims, including creating fake reports of home assessments that never occurred.  DOJ

September 30, 2016

New York announced guilty pleas by Katia Donnelly and her durable medical equipment and supply store, Bennett Surgical Supply, Inc., for submitting thousands of false claims to Medicaid resulting in Medicaid paying them more than two million dollars over a six and a half year period. Donnelly admitted during her plea that she used the Medicaid identification numbers of Bennett Surgical customers to fraudulently bill for items she never purchased or delivered to them. She and her corporation plead guilty to Grand Larceny in the Second Degree, and it is expected that Donnelly will be sentenced to 2 to 6 years in State Prison. NY

September 7, 2016

Medical equipment supply companies U.S. Healthcare Supply LLC and Oxford Diabetic Supply Inc., along with their owners and presidents, agreed to pay more than $12.2 million to resolve allegations that they violated the False Claims Act by making unsolicited calls to Medicare beneficiaries to sell them durable medical equipment.  According to the government, the two companies created a fictitious company called Diabetic Experts Inc., which they used to make the unsolicited calls, and then submitted claims to Medicare for the equipment they sold in violation of the Medicare Anti-Solicitation Statute.  Whistleblower Insider

August 11, 2016

Tracy Richardson Brown, the owner of New Orleans-based medical equipment supply company, Psalms 23 DME LLC was sentenced to 80 months in prison and to pay roughly $2 million in restitution for directing a scheme to defraud Medicare out of more than $3.3 million.  According to the evidence introduced at trial, Brown paid patient recruiters for the names and billing information of Medicare beneficiaries and used it to bill Medicare for power wheelchairs and various knee, elbow and back braces.  However, the vast majority of these patients did not need, and often did not receive or even want, this equipment.  DOJ

July 22, 2016

California-based medical device manufacturer Acclarent Inc., a subsidiary of Johnson & Johnson, agreed to pay $18 million to resolve allegations it violated the False Claims Act by causing health care providers to submit false claims to Medicare and other federal health care programs by marketing and distributing its sinus spacer product known as the Relieva Stratus MicroFlow Spacer (Stratus) for use as a drug delivery device without FDA approval of that use.  The government further alleged that Acclarent marketed the Stratus as a drug delivery device even after the FDA rejected the company’s 2007 request to expand the approved uses for the Stratus.  On July 20, Acclarent’s former CEO William Facteau and former VP of Sales Patrick Fabian were convicted of introducing adulterated and misbranded medical devices into interstate commerce.  The allegations originated in a whistleblower lawsuit filed by Melayna Lokosky under the qui tam provisions of the False Claims Act.  The whistleblower will receive an award of roughly $3.5 million from the proceeds of the government's recovery.  DOJ

July 13, 2016

A Kentucky federal court entered a civil judgment of roughly $4.5 million against Vesta Brue and her medical device companies LifeTechniques, Inc. and Care Team Solutions LLC for violating the False Claims Act by making false statements that allowed them to receive millions of dollars in federal grants from the National Institutes of Health (NIH).  According to the settlement agreement, NIH awarded Brue and her companies five Small Business Innovation Research grants, worth millions of dollars, to support the development of electronic pillboxes customized for specific patient populations, including HIV and pediatric patients.  But Brue and her companies acknowledged that Brue spent the grant money on personal expenses, such as plastic surgery, jewelry, home renovations, and massages, among other expenses.  She also used grant money on business expenses not allowed under the grant regulations, such as costs associated with marketing and promoting her businesses.  DOJ (EDKY)

June 29, 2016

Minneapolis-based Cardiovascular Systems, Inc. (CSI) agreed to pay $8 million to resolve allegations that it violated the False Claims Act by paying illegal kickbacks to induce physicians to use the company’s medical devices.  According to the government, CSI developed and distributed marketing materials to promote physicians using CSI’s devices to referring physicians; coordinated meetings between these physicians and referring physicians; and developed and implemented business expansion plans for the physicians.  The government alleged that CSI engaged in these activities to induce doctors to begin to use or continue to use CSI’s devices.  The allegations originated in whistleblower lawsuit filed by former CSI employee Travis Thams under the qui tam provisions of the False Claims Act.  He will receive a yet-to-be-determined whistleblower award from a share of the government's recovery.  DOJ (WDNC)

June 13, 2016

Ubert Guillermo Rodriguez, former owner of Florida-based durable medical equipment maker G.R. Services Equipment & Supplies Inc., was sentenced to 37 months in prison and to pay $918,402 in restitution for his role in a multimillion-dollar health care fraud scheme in the greater Tampa, Florida, area.  Rodriguez admitted that from May 2013 through July 2013, his company submitted approximately $2.6 million in fraudulent claims to Medicare seeking reimbursement for durable medical equipment not legitimately prescribed by doctors and not provided to beneficiaries.  DOJ

May 27, 2016

Medical device manufacturer Paradigm Spine agreed to pay $585,000 to resolve allegations it violated the False Claims Act by marketing the company’s coflex-F® device for surgical uses that were not approved by the FDA.  The settlement further resolves allegations that Paradigm caused false claims by giving false recommendations on how to code health claims for procedures involving the company’s coflex® device.  The allegations originated in a whistleblower lawsuit filed by Chris Coyle, a former Paradigm Spine sales representative, under the qui tam provisions of the False Claims Act.  Mr. Coyle will receive a whistleblower award of approximately $105,300 from the proceeds of the government's recovery.  DOJ (DMD)