Compliance

Physician Found Guilty on All Charges Stemming From Re-Use of Single-Use Medical Devices

February 6, 2023

Although neither you nor I could hear the bars clank closed, Anita Louise Jackson, M.D.’s. current practice address is the cell in which she’s being held pending formal sentencing.

Although indictments are often full of hot air, the January 5, 2022, indictment of Raleigh, North Carolina ENT Anita Louise Jackson, M.D. on multiple counts centering around her re-use, in more than 1,400 cases, of single use balloon sinuplasty devices [see Whether or Not Balloon Sinuplasty Indictment is Hot Air, its Lessons Apply to You] ended up in her January 27, 2023, conviction on all counts in the final indictment:

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 Remunerations 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;

Count 20 – Conspiracy 18 U.S.C. § 371.

At trial, it was shown that between 2011 and the end of 2017, Jackson preformed 1,555 balloon sinuplasty surgeries using the Entellus XprESS device on 99 Medicare beneficiary patients.

The Entellus XprESS device is cleared by the FDA to be used only on one patient, during one surgery. After that, the device must be discarded. However, the evidence showed that between 2012 and 2017, Jackson obtained, at most, 36 new Entellus devices, and that Jackson misled and did not inform her patients that they were receiving a procedure with an adulterated device. Jackson admitted on cross-examination that she had sufficient money to buy every patient a new device but chose not to do so.

Jackson induced patients to come to the office for a “free” sinus spa, and 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 her North Carolina practice, Greater Carolina Ear, Nose, and Throat. 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.

In some cases, she induced patients by not collecting co-pays, and was convicted on 10 counts of that behavior.

Jackson was also convicted of three counts of making false statements relating to health care benefits, two counts of aggravated identity theft, and three counts of mail fraud.

Between 2017 and 2018, Jackson became the subject of three audits by Medicare contractors. The jury found that she 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.

She was also convicted of two counts of 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.

Her mail fraud convictions pertained to her fraudulent use of fake medical records to deceive auditors, and to deceive a fellow ENT physician who was tricked into signing a sworn statement that her medical documentation supported her prior balloon sinuplasty surgeries.

The defendant was also convicted of conspiring with her staff to commit device adulteration, to pay illegal remunerations, to make false records, and to commit mail fraud.

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.

Additionally, the jury ordered forfeiture in the amount of $4,794,039.31.

The Obvious and More Esoteric Lessons For You

1. Don’t adulterate devices or other items and then use or supply them as unadulterated.

2. Don’t subsequently lie about the bona fides of the devices or items.

3. Don’t bill for items that were not provided.

4. Don’t routinely write-off Medicare patient balances or even present Medicare patients with false bills that indicate no or a falsely low co-pay.

5. Don’t use template, or even worse, cloned medical records to support your claims, even if the services were completely, properly, and ethically performed.

6. Don’t falsify records and signatures or the date on which they were obtained.

7. Don’t lie to federal auditors.

And, perhaps the most important, don’t set yourself up to go to prison by thinking you are setting the government up to overpay you.



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