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, March 19, 2021
Tuesday, March 16, 2021
NOTICE: Board of Pharmacy COVID-19 Emergency Rules
The Georgia Board of Pharmacy continues to monitor this situation closely and has promulgated the emergency rules attached below pursuant to O.C.G.A. 50-13-4(b). These rules, except the veterinarian rule, will expire with the termination of the Public Health State of Emergency. The veterinarian rule will expire 120 days after the termination of the Public Health State of Emergency.
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Former Owners of Telemarketing Company Agree to Pay At Least $4 Million to Resolve False Claims Act Allegations Relating to Compounding Pharmacies
Department of Justice
Former Owners of Telemarketing Company Agree to Pay At Least $4 Million to Resolve False Claims Act Allegations
Two Florida men have agreed collectively to pay at least $4 million to resolve allegations that they violated the False Claims Act by engaging in schemes to generate prescriptions for compounded drugs and refer those prescriptions to pharmacies in exchange for illegal kickbacks. Many of those prescriptions were billed to TRICARE, the federal health care program providing insurance for active duty military personnel, military retirees, and military dependents.
Jack Lee Stapleton, of Gulf Stream, and Jack Hunter Stapleton, of Fort Lauderdale, formerly owned a marketing business in Fort Lauderdale which operated under various names, including CV McDowell LLC, and J&J Tel Marketing LLC (the Stapleton Entities). The United States alleged that the Stapleton Entities, under the Stapletons’ direction, used telemarketing to solicit prospective patients to accept compounded drugs regardless of patient need, procured prescriptions for those patients, and then sent those prescriptions to compounding pharmacies that agreed to pay the Stapleton Entities half of the amount TRICARE reimbursed for each prescription. The Stapletons and Stapleton Entities worked with pharmacies to identify compounded drug formulas that maximized the level of reimbursement for the drugs, regardless of the medical need for the chosen formula. They then sought to procure large volumes of prescriptions for those formulas. In many cases, the Stapleton Entities procured prescriptions by paying telemedicine providers who prescribed expensive compounded drugs without ever seeing the patients or conducting any meaningful medical examination.
“Kickback arrangements undermine confidence in our health care system,” said Acting Assistant Attorney General Brian M. Boynton of the Department of Justice’s Civil Division. “This case demonstrates how kickback schemes often result in the provision of medically unnecessary services at the taxpayer’s expense. The department is committed to holding accountable those who engage in such unlawful conduct.”
“This is another in a long line of this office’s civil and criminal prosecutions of pharmacies, marketers, and prescribers – both individual and corporate – who exploited the TRICARE program for their personal gain and at substantial expense to taxpayers,” said Acting U.S. Attorney Karin Hoppmann for the Middle District of Florida. “We will continue to use all available resources to pursue those who defraud this and other federal healthcare programs and to return monies to those programs.”
“The Defense Criminal Investigative Service (DCIS) protects the integrity of Department of Defense programs, such as TRICARE, by rooting out those who choose to divert into their own pockets American taxpayer dollars intended to support our men and women in uniform,” said Special Agent in Charge Cyndy Bruce of the DCIS Southeast Field Office. “Individuals who unjustly enrich themselves will be held accountable.”
“We are grateful to those who came forward to expose these fraudulent practices and vow to continue our efforts to protect taxpayers from fraudsters siphoning money from the nation’s health care system,” said Special Agent in Charge Michael McPherson of the FBI’s Tampa Division.
As part of the settlement, the Stapletons have agreed to pay additional amounts in the event of certain contingencies.
The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Dwayne Thornton against the Stapletons. Under the qui tam provisions of the False Claims Act, a private party can file an action on behalf of the United States and receive a portion of the settlement if the government takes over the case and reaches a monetary agreement with the defendant. Thornton is a former employee of one of the pharmacies to which the Stapleton Entities referred prescriptions. The share to be awarded from this settlement has not yet been determined. The qui tam case is captioned United States ex rel. Thornton v. National Compounding Co. et al., Case No. 8:15-cv-2647 (M.D. Fla.).
The resolutions obtained in this matter were the result of a coordinated effort between the Civil Division’s Commercial Litigation Branch (Fraud Section), the U.S. Attorney’s Office for the Middle District of Florida, the FBI, and DCIS.
The matter was investigated by Trial Attorney Nathan Green and Assistant U.S. Attorney Charles Harden.
The claims resolved by the settlement are allegations only and there has been no determination of liability.
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