Thursday, March 7, 2024

Former CEO Of Medical Device Company Convicted Of Creating And Selling A Fake Component That Was Implanted Into Patients

 

Damian Williams, the United States Attorney for the Southern District of New York, announced that a jury returned a guilty verdict against LAURA PERRYMAN on two counts of an Indictment charging her with conspiracy to commit health care fraud and wire fraud and substantive health care fraud in connection with her company’s creation and sale of a fake medical device component.  U.S. District Judge Denise L. Cote presided over the 11-day trial. 

U.S. Attorney Damian Williams said: “Laura Perryman brazenly created a dummy medical device component — made entirely out of plastic — to be implanted into patientsShe marketed that dummy component as a means for doctors to bill Medicare and private insurance companies approximately $18,000 for each implantation of the piece of plasticShe did this so that she could entice doctors to buy her device for many thousands of dollarsPerryman recklessly used patients as tools for financial gain, and this jury’s unanimous verdict sends a resounding message that individuals who defraud health care programs will be held criminally accountable.” 

According to the allegations in the Indictment and the evidence at trial:

Stimwave was a medical device company that manufactured and distributed implantable neurostimulation devices.  As the founder and CEO of Stimwave, PERRYMAN oversaw the design of the StimQ PNS System (the “Device”), pictured below, a neurostimulator system designed to treat chronic pain by providing electrical currents to peripheral nerves.  The Device included a component containing electrodes (the “Lead”) and a receiver component that acted as an antenna, transmitting energy from an external power source to the Lead (the “Pink Stylet”).  From at least in or about 2017 up to and including 2020, PERRYMAN, as Stimwave’s CEO, engaged in a multi-year scheme to design, create, manufacture, and market an inert, non-functioning component of the Device — called the “White Stylet.”  The White Stylet was marketed as a receiver of radiofrequency energy, but it was made of plastic and could not function as a receiver.

Photo of the StimQ PNS System (the “Device”)

Stimwave sold the Device to doctors and medical providers for approximately $16,000.  Stimwave instructed health care providers to bill medical insurance providers, including Medicare, for implanting the Device into patients through two separate reimbursement codes.  One code was for implantation of the stimulator portion of the Lead, and a second was for implantation of a receiver.  The billing code for implanting the Lead provided for reimbursement at a rate of between approximately $4,000 and $6,000, while the billing code for implanting a receiver provided for reimbursement at a rate of between approximately $16,000 and $18,000.

Soon after the Device was released, physicians informed Stimwave that they were having trouble implanting the Pink Stylet in certain patients because the Pink Stylet was too long.  Stimwave and PERRYMAN knew that the Pink Stylet could not be cut or trimmed to shorten it without interfering with the functionality of the Pink Stylet as a receiver.  And, without a receiver component for doctors to implant and seek reimbursement for, doctors would incur a substantial financial loss with every purchase of the Device, thereby making it more difficult for Stimwave to sell the Device to doctors and medical providers at the approximately $16,000 price.

However, Stimwave — at the direction of PERRYMAN — did not lower the price of the Device so that its cost to doctors and medical providers could be covered by reimbursement for the implantation of only the Lead.  Nor did PERRYMAN recommend that doctors not implant the Device or its receiver component in cases where the Pink Stylet could not fit comfortably.  Instead, PERRYMAN directed that Stimwave create the White Stylet — a dummy component made entirely of plastic, but which Stimwave misrepresented to doctors as a receiver alternative to the Pink Stylet.  The White Stylet could be cut to size by the doctor for use in smaller anatomical spaces and was created solely so that doctors and medical providers would continue to purchase the Device for use in those scenarios and continue to bill for the implantation of a receiver component.  To perpetuate the lie that the White Stylet was functional, PERRYMAN oversaw training that suggested to doctors that the White Stylet was a “receiver,” when in fact it was made entirely of plastic, contained no copper, and therefore had no conductivity.  In addition, PERRYMAN directed other Stimwave employees to vouch for the efficacy of the White Stylet as a receiver, when she knew that the White Stylet could not function as a receiver.

As a result of these misrepresentations regarding the functionality of the White Stylet, PERRYMAN caused doctors and medical providers to implant the White Stylet into patients and submit reimbursement claims for implantation of the White Stylet to health insurance providers, including Medicare.

PERRYMAN, 55, of Delray Beach, Florida, was convicted of one count of health care fraud and one count of conspiracy to commit health care fraud and wire fraud, which each carry a maximum sentence of 20 years in prison.

The statutory maximum sentences are prescribed by Congress and are provided here for informational purposes only, as any sentencing of the defendant would be determined by the judge.

Mr. Williams praised the outstanding investigative work of the Federal Bureau of Investigation.

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