Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Friday, August 13, 2021
Thursday, August 12, 2021
Wednesday, August 11, 2021
Secret of the Islands | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||||
Vaperz Cedar Park | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
Captain's Cloth LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | ||||
Sanit Technologies, LLC dba Durisan | Office of Pharmaceutical Quality Operations, Division II | CGMP/Finished Pharmaceuticals/Adulterated | ||||
Biopolygen Corp. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||||
BBC Group Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded | ||||
Chill6 | Office of Human and Animal Food Operations East – Division 1 | Unapproved New Drugs/Misbranded | ||||
Lepu Medical Technology -Beijing- Co., Ltd. | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||||
3RD Day Nutraceuticals, LLC | Office of Human and Animal Food Operations East – Division 1 | New Drug/Misbranded | ||||
Nuvo Silver Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Former Owners of Hillsborough Compounding Pharmacy Pay $1,082,991.94 to Resolve False Claims Act Allegations
Department of Justice
Former Owners of Hillsborough Compounding Pharmacy Pay $1,082,991.94 to Resolve False Claims Act Allegations
GREENSBORO, N.C. - The owners of a now-closed compounding pharmacy have paid $1,082,991.94 to resolve allegations that they violated the False Claims Act by submitting false claims for payment to the TRICARE program between September 2014 and May 2015.
David and Lois Tsui of Chapel Hill, North Carolina formerly owned Wellcare Compounding, in Hillsborough, North Carolina. David Tsui was previously convicted of health care fraud, and in 2009 was excluded from participation in federal health care programs, including TRICARE. The United States contended that Wellcare intentionally concealed David Tsui’s involvement in and ownership of the pharmacy, including by falsely representing to TRICARE that Lois Tsui was the pharmacy owner. The United States also asserted that Wellcare made improper payments to physicians and “marketers” in exchange for prescriptions or referrals for prescriptions, in violation of the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b). In addition, Wellcare encouraged medically unnecessary prescriptions consisting of high-margin ingredients to maximize the pharmacy’s reimbursement. The United States contended that through these actions, the Tsuis and Wellcare knowingly caused false claims to be presented to the TRICARE program.
“This settlement sends a strong message that individuals who defraud federal health care programs cannot rely on the passage of time or the use of straw owners to conceal their wrongdoing,” said Acting United States Attorney Sandra Hairston. “We will continue to identify those who seek to seek to exploit federal programs for personal gain and will hold them accountable.”
“The results of this investigation highlight another step forward by the Defense Criminal Investigative Service (DCIS) and its law enforcement partners to root out fraud and corruption involving medical professionals who undermine the integrity of the Department of Defense,” said Special Agent in Charge Christopher Dillard, DCIS Mid-Atlantic Field Office. “DCIS will continue to target fraud, waste, and abuse to preserve and recover precious taxpayer dollars for our most vulnerable programs, such as TRICARE.”
This case was handled by the U.S. Attorney’s Office for the Middle District of North Carolina and the Defense Criminal Investigative Service. The United States was represented by Assistant United States Attorney Cassie Crawford.
The claims settled by this agreement are allegations only. The Settlement Agreement is not an admission of liability or wrongdoing by Wellcare or the Tsuis.
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