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Seven Things To Know When You Receive A Notice Of Investigation From The Department Of Health

Seven Things To Know When You Receive A Notice Of Investigation From The Department Of Health

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Physician Found Guilty of Re-Using Single-Use Devices During Surgeries

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On January 27, 2023, a North Carolina doctor was found guilty of re-using “unsanitary” medical equipment meant for one-time use on unsuspecting patients during surgeries, the U.S. Department of Justice (DOJ) announced. After a three-week federal jury trial, she was found guilty on 20 counts related to a scheme to re-use single use devices to perform sinus surgeries for Medicare patients.


Putting Profit Ahead of Patients.

According to the DOJ, the defendant, who operated Greater Carolina Ear, Nose, and Throat, used equipment to perform 1,555 balloon sinuplasty surgeries for 919 Medicare patients between 2011 and 2017. For example, she allegedly used a device called the Entellus XprESS which the FDA approved for use on one patient during one surgery, and then it was expected to be discarded. Prosecutors contended, however, that the physician re-used the devices multiple times.

The big catch is that the Medicare reimbursement rate includes reimbursement to the doctor for the purchase of the device.  If the doctor is not paying for a new device, and Medicare is reimbursing the physician for a new device, this contravenes the law.

DOJ alleged that between 2012 and 2017, the doctor obtained, at most, 36 new Entellus devices, despite being, at times, the top-paid Medicare provider of balloon sinuplasty services in the United States, authorities said.  The evidence showed that she misled and did not inform her patients that they were receiving a procedure with an adulterated device.  Additionally, according to the DOJ, the defendant admitted that she had sufficient money to buy every patient a new device but chose not to do so.

Click here to read the press release for more information.

Additional Charges.

The federal jury also convicted her on ten counts of illegally inducing her patients to receive the sinuplasty surgery by failing to collect required co-payments;  three counts of making false statements relating to health care benefits;  two counts aggravated identity theft; and three counts of mail fraud.  She faces a maximum prison term of 20 years for mail fraud, ten years for paying illegal remunerations, five years for conspiracy and making false statements, and three years for adulteration with the intent to defraud or mislead.  Aggravated identity theft carries a two-year mandatory prison sentence, consecutive to any other punishment.

Waiving co-pays and deductibles for Medicare, Tricare, or Medicaid patients has always been a big “No No.”  It is considered to be offering a thing of value to the patient for obtaining the treatment;  in other words, a “kickback.”

The physician now faces fines exceeding $250,000, and the jury ordered a forfeiture in the amount of $4,794,039.31 (to most people, “real money”).  For more information, click here to view the indictment.

Contact Health Law Attorneys Experienced in the Representation of Health Professionals and Providers.

The Health Law Firm and its attorneys have represented physicianspharmacists, nurses, clinics, dentists, pharmacieshealth facilities, and other health care providers in different cases involving allegations of fraud. These include criminal investigations by local police and law enforcement authorities, investigations by the U.S. Drug Enforcement Agency (DEA), U.S. Department of Justice (DOJ), complaints against professional licenses by the Florida Department of Health, investigations, and prosecutions by the Medicaid Fraud Control Units (MFCU), and other types of cases. Having attorneys familiar with the medical standards of care and guidelines for prescribing narcotics and having access to expert medical and pharmacy professionals who can testify as expert witnesses in such cases is also crucial. We have represented professionals in administrative investigations and administrative hearings at both the state and federal levels.

To contact The Health Law Firm, please call (407) 331-6620 or Toll-Free (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

Health News Weekly. “Physician Found Guilty of Re-Using Single Use Devices During Surgeries.” AHLA. (February 3, 2023).

“Raleigh doctor guilty of using ‘unsanitary’ surgical devices, other charges in Medicare fraud case.” ABC 11. (January 27, 2023). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 Toll-Free: (888) 331-6620


Attorney Positions with The Health Law Firm.  The Health Law Firm is always looking for qualified attorneys interested in the practice of health law. Its main office is in the Orlando, Florida, area. If you are a member of The Florida Bar and are interested, forward a cover letter and your resume to: [email protected] or fax to: (407) 331-3030.

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