By Several Noses

The United States Court of Appeals for the Fourth Circuit affirmed the conviction on multiple counts of an ear, nose and throat physician

At one time, Jackson was the leading Medicare biller in the nation for a procedure known as balloon sinuplasty surgery, which treats chronic sinusitis. The procedure consists of the doctor inserting a device through the patient’s nose into one or more of the sinuses and inflating a small balloon to widen the cavity. The device Jackson used for this procedure during the relevant timeframe was an Entellus XprESS Multi-Sinus Dilation Tool (“Entellus” or “the device”). The insertable part of this device has a small tip, an inflatable balloon, and a thin hollow metal tube. The balloon slides up and down the tube and is inflated after it is placed in the patient’s sinus cavity. The rest of the Entellus remains outside the patient’s body and consists of the slide mechanism for the balloon, a suction port, and a light fiber that runs through the hollow tube to allow the physician to see into the sinus during the procedure. The device also has small retractable parts that often come into contact with and trap bodily fluids and hair from the patient during the procedure. These parts are fragile and may break easily, particularly if the Entellus is reused. The device was, accordingly, designed for single use and is labeled by the Food and Drug Administration as being approved only for single use.

No accident

Becoming the nation’s leading Medicare biller for sinuplasty surgery was far from happenstance, as Jackson’s employees recounted how she incentivized recruiting Medicare patients to agree to the procedure. For her employees, Jackson tied work hours to surgery-marketing efforts, set surgery quotas for her offices, and paid bonuses related to how many sinuplasty procedures were performed. She encouraged employees to recruit patients throughout the community, targeting rural localities and seeking out individuals likely to have Medicare because it did not require preapproval for the procedure. Employees testified, for example, that they were told to pitch balloon sinuplasty to potential patients at locations like Wal-Mart parking lots, churches, barbershops, and doctor’s offices. In addition, Jackson offered some potential patients financial enticements such as not requiring any front payment or limiting fees to a $50 copayment rather than the higher Medicare-directed copayment amounts. By agreeing to have the sinuplasty procedure, patients could also receive free transportation to Jackson’s office and gift cards to local stores.

The United States Attorney for the Eastern District of North Carolina press release on the conviction

Anita Louise Jackson, 62, was sentenced to 300 months in prison for adulterating surgical devices used in more than 1400 nasal surgeries performed on Medicare patients between 2011 and 2018. Jackson was also ordered to serve 3 years of supervised release and ordered to forfeit 4.7 million dollars.  In January of this year, Jackson was found guilty by a federal jury on 20 criminal counts, including device adulteration, fraud, conspiracy and identity theft.

“This doctor put profit over patients by reusing single-use surgical devices hundreds of times, even though those devices came into contact with blood and other bodily fluids.  In doing so, she risked the contamination of one patient’s sinuses with the bodily fluids of other patients,” said U.S. Attorney Michael Easley.  “Medicare auditors also found that Jackson was the top-biller for balloon sinuplasty surgeries in the country, having billed the program over $46 million.  When auditors began to audit the defendant’s practice, she and her staff falsified medical records and forged patient signatures in an attempt to justify billing the surgeries.”

Evidence presented at the trial demonstrated that Jackson was an Ear, Nose and Throat doctor who operated Greater Carolina Ear, Nose, and Throat (GCENT), with offices in Raleigh, Lumberton and Rockingham.  Jackson, through her employees, marketed balloon sinuplasty, an in-office procedure to treat chronic sinusitis, as a “sinus spa,” and encouraged patients to come to the office for a “free” sinus spa, which was a treatment that they may not have needed.  Jackson falsified medical records to justify the billing of balloon sinuplasty surgeries to Medicare auditors.

“This case is a reminder that health care fraud is not a victimless crime. Jackson stole millions of dollars that are essential to the Medicare program and willfully endangered her patients’ health,” said Special Agent in Charge Tamala E. Miles of the U.S. Department of Health and Human Services Office of Inspector General.  “Our agency, working with our law enforcement partners, will continue to ensure that those who defraud our federal health care programs and needlessly risk harm to patients are held accountable.”

Between 2011 and the end of 2017, Jackson performed 1555 balloon sinuplasty surgeries on 919 Medicare beneficiary patients, using the Food and Drug Administration (FDA)-approved Entellus XprESS device. However, instead of using the device only once and only on one patient, as required by FDA guidelines, Jackson reused the devices on multiple patients. Between 2012 and 2017, Jackson obtained, at most, 36 new Entellus devices, despite being, at times, the top-paid Medicare provider of balloon sinuplasty services in the country and providing more than 1500 surgeries.  In addition, Jackson failed to inform her patients that they were receiving a procedure with an adulterated device.  During the trial, Jackson admitted that she had sufficient money to buy every patient a new device but chose not to do so.

 “U.S. consumers rely on FDA oversight to ensure that medical devices are safe and effective. When healthcare providers disregard safety information, including single-use and single-user designations, resulting in the adulteration of medical devices, they put patients’ health at risk,” said Acting Special Agent in Charge Patrick Whelan, FDA Office of Criminal Investigations, Miami Field Office. “We will continue to investigate and bring to justice providers who jeopardize the public health.”

Jackson billed Medicare more than $46 million dollars for the balloon sinuplasty procedures between 2014 and 2018.  In that time, she netted more than $4.79 million from Medicare for these surgeries.  That amount does not include any sinuplasty surgeries performed on patients with private health care insurance.  The jury ordered Jackson to forfeit these profits.

The final judgment on restitution in this case will not be entered until after 90 days.  During this time period, patient victims will have an opportunity to present any specific claims of loss to the Court arising from the charges. 

From an earlier press release (linked above)

Jackson was an Ear Nose and Throat doctor who operated Greater Carolina Ear, Nose, and Throat (GCENT), with offices in Raleigh, Lumberton and Rockingham.  Between 2011 and the end of 2017, Jackson preformed 1,555 balloon sinuplasty surgeries on 919 Medicare beneficiary patients.

(Mike Frisch)