Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
March 21, 2013
United States Attorney's Office
Western District of Kentucky
Contact: Stephanie Collins
LOUISVILLE, Ky. - The owner of Bluegrass Women's Healthcare, located in Elizabethtown, Kentucky was charged, in a 13 count federal grand jury indictment this week, with health care fraud, mail fraud, misbranding and smuggling announced David J. Hale, United States Attorney for the Western District of Kentucky.
Canh Jeff Vo, age 45, of Elizabethtown, Kentucky was the owner, supervising physician, and president at Bluegrass Women's Healthcare between March 2008 and September 2009 when the alleged violations occurred. Vo offered gynecological and obstetric services to women at Bluegrass Women's Healthcare, including providing forms of birth control. According to the federal indictment, between March 2008 and September 2009, Vo, with the intent to defraud or mislead, purchased and inserted into patients, foreign, non-FDA approved Mirenas (levonorgesteral-releasing intrauterine device). These Mirena intrauterine devices or IUDs, were misbranded in that their labeling was not in the English language; and their labeling did not bear adequate directions for use.
Further defendant Vo is charged with health care fraud for submitting false claims for reimbursement from the Medicaid Program. Specifically, Vo is alleged to have billed the Kentucky Medicaid Program and other insurers as if he was administering the FDA-approved version of Mirena, at a greater cost, when he was actually administering a non-FDA approved version of Mirena.
Additionally, Vo is charged with ten counts of mail fraud for utilizing the United States Mail, by receiving payment from the Kentucky Medicaid Program and private insurance companies for Mirena IUDs which were not approved for sale in the United States.
It is also alleged, in the federal indictment, that between March 2008 and September 2009, Vo received, brought, and imported into the United States, Mirena IUDs, knowing that these were misbranded and unlawfully introduced into interstate commerce from various countries, including from Canada.
If convicted at trial, Vo faces a maximum of 233 years in prison, a maximum fine of $3,010,000 and up to 3 years of supervised release.
This case is being prosecuted by Assistant United States Attorney Lettricea Jefferson-Webb, and is being investigated by the United States Food and Drug Administration (FDA) Office of Criminal Investigations, the Federal Bureau of Investigation (FBI), and Kentucky Office of the Attorney General Office of Medicaid Fraud and Abuse Control.
The indictment of a person by a Grand Jury is an accusation only and that person is presumed innocent until and unless proven guilty.