Northwest ENT Associates, P.C. (“Northwest ENT”), a Marietta, Georgia based professional corporation, has agreed to pay $ 1,195,361 to resolve allegations that it violated the False Claims Act by submitting claims for sinus dilation procedures in which it re-used balloon catheters that were intended for single use only.

“When healthcare providers take shortcuts in order to increase their financial bottom line, their patients are put at risk and federal funds are diverted from legitimate medical procedures,” said U. S. Attorney Byung J. “BJay” Pak. “This settlement demonstrates our commitment to pursuing healthcare providers who put their own financial well-being ahead of the well-being of their patients.”

“The goal of our agency is to protect the health and safety of the American tax payer,” said Derrick L. Jackson, Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services.  “We will continue to work with our law enforcement partners by investigating allegations where the health and safety of Medicare beneficiaries are at risk.”

“American consumers expect and deserve that the devices used by their health care practitioners during medical procedures are not only safe and effective, but also have been held under sanitary conditions,” said Peter Kuehl, Acting Special Agent in Charge, Food and Drug Administration, Office of Criminal Investigations’ Miami Field Office.  “FDA remains fully committed to working with the Department of Justice and our law enforcement partners to hold those who place profits before the health and safety of patients fully accountable.”

 “This settlement demonstrates the Government’s commitment to protect public funds that support the operations of our armed forces healthcare program (TRICARE) from fraud and abuse,” said John F. Khin, Special Agent in Charge, Defense Criminal Investigative Service-Southeast Field Office.  “Every military contractor that submits claims must ensure that its claims are billed appropriately.  DCIS and its partnering agencies will continue to vigorously pursue defense contractors that disregard billing requirements.”

“Federal employees deserve health care providers that meet the highest standards of ethical and professional behavior,” said Bret Mastronardi, Special Agent in Charge for the Office of Personnel Management – Office of the Inspector General.  “Today’s settlement reminds all providers that they must observe those standards, and reflects the OPM-OIG’s commitment to pursuing improper and illegal billings that increase the cost of medical care.”

Northwest ENT has five office locations, operates a single specialty surgery center, and provides services at four hospitals in Georgia.  The physicians at Northwest ENT specialize in the medical field of otolaryngology and are commonly referred to as “ear nose and throat” or “ENT” physicians.

Among the procedures that Northwest ENT performed, is the treatment of sinusitis with a “balloon catheter,” which is inserted into the patient’s sinus and inflated by the physician to enlarge the sinus cavity.  The balloon catheters that Northwest ENT used was cleared by the U.S. Food and Drug Administration as intended for single use only.  Despite this, the physicians at Northwest ENT re-used the devices on their patients, instead of using a new device for each patient.  The civil settlement resolves the government’s investigation into these allegations.

The government alleges that Northwest ENT violated the False Claims Act, 31 U.S.C. § 3729, et seq., by causing the submission of false claims to Medicare, TRICARE and Federal Employee Health Benefit Plans for sinus dilation procedures during the period March 1, 2011 through March 30, 2012, in which the single-use balloon catheters were re-used on their patients.

In addition, pursuant to a Non-Prosecution Agreement with the United States, Northwest ENT has accepted responsibility for its actions.  It has entered into a three-year Integrity Agreement with the Office of the Inspector General of the Department of Health and Human Services.  Under the agreement, an independent organization will review Northwest ENT’s claims quarterly for medical necessity, accurate coding, and safe and appropriate use of medical devices.

This case was investigated by the U.S. Attorney’s Office for the Northern District of Georgia, the U.S. Department of Health and Human Services – Office of Inspector General, the Food and Drug Administration – Office of Criminal Investigations, the Defense Criminal Investigative Service, and the Office of Personnel Management – Office of the Inspector General.

The civil settlement was reached by Assistant U.S. Attorney Neeli Ben-David, Deputy Chief of the Civil Division.  The criminal resolution was reached by Assistant U.S. Attorney Randy Chartash.

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