To maintain the deception that the White Stylet was functional, PERRYMAN oversaw training that implied to doctors that the White Stylet was a legitimate receiver, despite being made entirely of plastic without any conductivity elements like copper.
Damian Williams, the U.S. Attorney for the Southern District of New York, stated that a jury has found LAURA PERRYMAN guilty on two counts from an indictment. The charges include conspiracy to commit health care fraud and wire fraud, as well as substantive health care fraud. These charges are related to her company's production and sale of a counterfeit medical device component. The trial, which lasted 11 days, was overseen by U.S. District Judge Denise L. Cote.
U.S. Attorney Damian Williams said: “Laura Perryman brazenly created a dummy medical device component — made entirely out of plastic — to be implanted into patients. She 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 plastic. She did this so that she could entice doctors to buy her device for many thousands of dollars. Perryman 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.”
The Indictment and trial evidence alleged the following:
Stimwave, a medical device firm, produced and distributed implantable neurostimulation devices. LAURA PERRYMAN, as the founder and CEO of Stimwave, supervised the development of the StimQ PNS System (the “Device”), which is shown below. This neurostimulator system aimed to alleviate chronic pain by delivering electrical currents to peripheral nerves. The Device consisted of a component with electrodes (the “Lead”) and a receiver component that served as an antenna, transmitting energy from an external power source to the Lead (the “Pink Stylet”).
From at least 2017 to 2020, PERRYMAN, in her role as Stimwave’s CEO, allegedly orchestrated a multi-year plan to design, produce, manufacture, and promote an inactive, non-operational component of the Device known as the “White Stylet.” The White Stylet was advertised as a receiver of radiofrequency energy, but it was constructed of plastic and could not function as a receiver.
Stimwave sold the Device to healthcare professionals for about $16,000 each. The company advised healthcare providers to bill medical insurers, including Medicare, for implanting the Device using two separate reimbursement codes. One code was for implanting the stimulator part of the Lead, and the other was for implanting a receiver. The billing code for the Lead's implantation reimbursed at a rate of approximately $4,000 to $6,000, while the code for the receiver reimbursed at a rate of approximately $16,000 to $18,000.
Shortly after the Device's launch, physicians informed Stimwave that they faced difficulties implanting the Pink Stylet in some patients due to its excessive length. Stimwave and PERRYMAN were aware that cutting or trimming the Pink Stylet to shorten it would compromise its function as a receiver.
Without a functional receiver component for doctors to implant and seek reimbursement for, doctors would suffer significant financial losses with each Device purchase. This situation made it more challenging for Stimwave to sell the Device to healthcare professionals at the $16,000 price point.
However, despite these challenges, Stimwave, under PERRYMAN's guidance, chose not to reduce the Device's price so that doctors and medical providers could afford it solely with reimbursement for implanting the Lead. PERRYMAN also did not advise doctors against implanting the Device or its receiver component in cases where the Pink Stylet was too large.
Instead, PERRYMAN instructed Stimwave to develop the White Stylet—a non-functional component made entirely of plastic. Stimwave misrepresented the White Stylet to doctors as an alternative receiver to the Pink Stylet. The White Stylet could be customized by doctors to fit smaller anatomical spaces. It was created solely to ensure that doctors and medical providers would continue purchasing the Device for such scenarios and continue billing for the implantation of a receiver component.
To maintain the deception that the White Stylet was functional, PERRYMAN oversaw training that implied to doctors that the White Stylet was a legitimate receiver, despite being made entirely of plastic without any conductivity elements like copper. Moreover, PERRYMAN instructed other Stimwave employees to affirm the White Stylet's efficacy as a receiver, even though she knew it could not function as one.
Due to these misrepresentations regarding the White Stylet's functionality, PERRYMAN caused doctors and medical providers to implant the White Stylet into patients and submit reimbursement claims for its implantation to health insurance providers, including Medicare.
PERRYMAN, aged 55 and residing in Delray Beach, Florida, was found guilty of one count of health care fraud, which carries a maximum sentence of 10 years in prison, and one count of conspiracy to commit health care fraud and wire fraud, which carries a maximum sentence of 20 years in prison.
It's important to note that these maximum sentences are set by Congress and are provided here for informational purposes only, as the judge would determine the actual sentencing for the defendant.
Mr. Williams commended the exceptional investigative efforts of the Federal Bureau of Investigation.
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