Physician Found Guilty Of Re-Using Single-Use Medical Device 1400 times: After a three-week federal jury trial, and 5 hours of jury deliberation, Anita Louise Jackson, 59, was found guilty on charges of adulterating medical devices for use on patients with intent to defraud and mislead, fabricating medical and healthcare records, paying illegal renumerations, mail fraud, and conspiracy. Jackson was convicted of using re-used devices to perform more than 1,400 surgeries for Medicare patients between 2011 and the end of 2017. After the verdict, Jackson was taken into custody pending sentencing.
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. Balloon sinuplasty is an in-office surgery to treat chronic sinusitis. The FDA has cleared the Entellus XprESS device to be used in the performance of balloon sinuplasty procedures, but only on one patient, during one surgery. After that, the device must to be discarded. But, 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 United States. The evidence showed that Jackson misled and did not inform her patients that they were receiving a procedure with an adulterated device. The evidence also showed, and the defendant admitted on cross-examination, that she had sufficient money to buy every patient a new device — but chose not to do so.
Jackson billed Medicare more than $46 million dollars for the balloon sinuplasty procedures between 2014 and 2018. She netted more than $4.79 Million from Medicare for these surgeries alone. That amount does not include any sinuplasty surgeries performed on patients with private health care insurance, other than Medicare, and monies received from Medicare prior to that time. The jury ordered forfeiture in the amount of $4,794,039.31.
Jackson was also convicted on 10 counts of illegally inducing her patients to receive the sinuplasty surgery, by failing to collect the portion of the surgery that the patient was required to pay – the co-pay. Jackson, through her employees, marketed the sinuplasty surgery as a “sinus spa.” In doing so, Jackson induced her patients to come to the office for a “free” sinus spa, induced her patients to receive a treatment they may not need, or may not have agreed to, had the full out-of-pocket cost to the patient been disclosed. In an effort to continue obtaining patients for the procedure, Jackson wrote-off, or otherwise hid, the full cost of the procedure on any bills sent to the patient after their visit to GCENT. The patient portion of the sinuplasty surgery could be as high as $1,500 for Medicare beneficiaries, which the jury found was not disclosed to patients.
Jackson was also convicted of three counts of making false statements relating to health care benefits, two counts aggravated identity theft, and three counts of mail fraud. Between 2017 and 2018, Jackson became the subject of three audits by Medicare contractors. The evidence showed, and the jury found, that the defendant fabricated medical records supplied to auditors in an effort to keep more than $1.7 million that had already been paid to her by Medicare. The jury convicted Jackson of fabricating and modifying medical records to justify the billing of balloon sinuplasty surgeries to Medicare auditors. Two aggravated identity theft counts related to the defendant’s knowing use of forged patient signatures on documents in which patients allegedly declared that they received surgeries from the defendant, and that they needed them. The defendant’s Mail Fraud convictions pertained to her fraudulent use of fake medical records to deceive auditors, and to deceive a fellow physician. The defendant was also convicted for tricking a fellow ENT physician into signing a sworn statement that her medical documentation supported her prior balloon sinuplasty surgeries.
The defendant was convicted of conspiring with her staff to commit device adulteration, to pay illegal remunerations, to make false records, and to commit mail fraud.
The federal jury convicted Jackson on all 20 counts in the indictment, which included: Count 1 – Device Adulteration 21 U.S.C. § 331(k), 21 U.S.C. § 333(a)(2) and 21 U.S.C. § 35l(a)(2)(A); Counts 2-11 – Illegal Renumerations 42 U. S. C. § 1320a-7b(b)(2)(B) and 18 U. S. C. § 2; Counts 12-14 – Making False Statements Relating to Health Care Benefits 18 U.S.C. § 1035(a)(2); Counts 15-16 – Aggravated Identity Theft 18 U.S.C. § 102A(a)(1); Counts 17-19 – Mail Fraud 18 U.S.C. § 1341; and Count 20 – Conspiracy 18 U.S.C. § 371.
Jackson faces a maximum term of imprisonment of 20 years for Mail Fraud, 10 years for Paying Illegal Remunerations, and 5 years for Conspiracy and Making False Statements, and three years for Adulteration with the intent to defraud or mislead. Aggravated Identity Theft carries a 2-year mandatory prison sentence, consecutive to any other punishment. Jackson also faces fines exceeding $250,000.
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