Georgia ENT Practice to Pay $1.2 Million to Resolve False Claims Act Allegations
Posted on November 28, 2018 by Medtech[y] Staff
We were alerted to a False Claims Act allegation after the story was posted on our forums earlier this week.
According to the FDA press release, the government alleges that Northwest ENT in Georgia 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.
Despite the FDA clearance as a single-use device, 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 and has agreed to pay $1,195,361 to resolve the False Claims Act allegations
“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.”
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.
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