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, January 28, 2022
Wednesday, January 26, 2022
Former South Florida Pharmacy Executive Pleads Guilty to $88 Million Health Care Fraud Conspiracy Targeting Military Health Care Programs
Department of Justice
Former South Florida Pharmacy Executive Pleads Guilty to $88 Million Health Care Fraud Conspiracy Targeting Military Health Care Programs
Miami, Florida – A Palm Beach County, Florida man has pleaded guilty to his role in a multi-million-dollar conspiracy to defraud Tricare and CHAMPVA through a South Florida compounding pharmacy fraud scheme.
As part of his guilty plea, 58-year-old Matthew Smith admitted his role in fraudulently billing Tricare and CHAMPVA for expensive, medically unnecessary compound drugs from a Broward pharmacy. Tricare and CHAMPVA are the health care benefit programs for the United States Department of Defense and Department of Veterans Affairs. In furtherance of the scheme, Smith—then executive vice-president of the pharmacy—and his co-conspirators paid approximately $40 million in kickbacks to patients, patient recruiters and doctors in exchange for their ordering expensive pain creams, scar creams and vitamins without regard to the beneficiaries’ actual medical needs. The drugs were formulated to maximize profit without legitimate therapeutic value. The reimbursement rates sometimes reached $15,000 for a one-month supply. In addition, the pharmacy did not charge beneficiaries the mandatory copayments, something that the co-conspirators concealed. The fraudulent billings caused a loss to the programs of approximately $88 million.
Smith pled guilty to one count of conspiring to commit health care fraud. Sentencing is scheduled for April 5, at 3:00 p.m., in Miami, before U.S. District Judge Roy K. Altman. Smith faces up to 10 years in federal prison.
U.S. Attorney Juan Antonio Gonzalez of the Southern District of Florida; Special Agent in Charge Cynthia A. Bruce, Department of Defense Inspector General’s Defense Criminal Investigative Service (DCIS), Southeast Field Office; Special Agent in Charge David Spilker, Veterans Affairs, Office of Inspector General (VA-OIG), Southeast Field Office; Special Agent in Charge George L. Piro of the FBI Miami; and Special Agent in Charge Justin C. Fielder, FDA Office of Criminal Investigations’ Miami Field Office, made the announcement.
“Fraudsters steal exorbitant amounts of money from our government health programs through prescription medication fraud schemes,” said U.S. Attorney Gonzalez. “Those who use kickback payments and fraudulent billing activities to defraud vital public programs will be held accountable.”
“Compounding pharmacy fraud bilked the Defense Health Agency of over a billion dollars and exploited not only the military, but all citizens,” said DCIS Special Agent in Charge Bruce. “I thank the U.S. Attorney’s Office and our investigative team for their tireless effort to untangle this web of crime, trace the assets, and hold these individuals accountable.”
“The defendant pleaded guilty for his abhorrent conduct in defrauding multiple federal healthcare programs meant to benefit deserving veterans and their families,” said Special Agent in Charge David Spilker of the Department of Veterans Affairs Office of Inspector General’s Southeast Field Office. “The VA OIG is committed to continuing its work with our law enforcement partners to ensure the integrity of VA’s healthcare and benefit programs.”
“Illegal kickbacks undermined the integrity of the Tricare health benefit program by putting profits in front of patient welfare,” said George L. Piro, Special Agent in Charge, FBI Miami. “The investigators who unraveled this scam are to be commended for their diligence and commitment. The FBI and our partners will continue to pursue those individuals who pay kickbacks and fraudulently bill for medical services that are not necessary.”
“Criminals whose schemes cause medically unnecessary prescription drugs to be sent to consumers could put the public health at risk,” said Special Agent in Charge Justin C. Fielder, FDA Office of Criminal Investigations’ Miami Field Office. “We will continue to pursue and bring to justice those who place profits above public health.”
The DCIS, VA-OIG, FBI, and the FDA, investigated the case.
Assistant U.S. Attorney Jon Juenger prosecuted the case. Assistant U.S. Attorney Daren Grove is handling the asset forfeiture component of the case.
Related court documents and information may be found on the website of the District Court for the Southern District of Florida at www.flsd.uscourts.gov or at http://pacer.flsd.uscourts.gov.
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Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter |
---|---|---|---|---|---|
Go Vapor LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
D & J Vapors, LLC-Horse Cave | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
Aurobindo Pharmaceutical Limited | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||
SAS Technologies, Inc d/b/a Save A Smoker | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
Health Plus Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated | |||
Concord Farms, Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | |||
Yuni Wholesale, Inc. d/b/a Blow Disposables | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
Global Vapery LLC and Infinite Vapor LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
Onofrio's Fresh Cut, Inc. | Office of Human and Animal Food Operations - East Division 1 | CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||
CES LLC | Center for Drug Evaluation and Research | CDER | Drug Product/ |
Tuesday, January 25, 2022
Department of Justice
Former Veterinarian Pleads Guilty to Drug Charges
LYNCHBURG, Va. – A Madison Heights, Virginia man and former veterinarian pleaded guilty to a pair of misdemeanor drug charges related to his diversion of hydromorphone, an opioid drug also known under the trade name of “Dilaudid.”
Patrick Gries, 54, pleaded guilty last week to one count of adulteration of a drug held for sale after shipment in interstate commerce and one count of distribution of a controlled substance without a written prescription.
“The U.S. Attorney’s Office is committed to working with our partners at the FDA, and elsewhere, to ensure consumer products are stored and prescribed using the most safe and secure protocols possible,” United States Attorney Christopher R. Kavanaugh said today. “When individuals with access to controlled substances break those safety protocols, even for individual use, they must be held accountable.”
“The FDA oversees the U.S. drug supply to ensure that it is safe and effective, and those who knowingly tamper with medicines put the health of patients (whether they are human or animal) at risk,” said Special Agent in Charge Mark S. McCormack, FDA Office of Criminal Investigations Metro Washington Field Office. “We will continue to protect the public health and bring to justice health care professionals who take advantage of their unique position and compromise their patients’ health and comfort by tampering with needed drugs.”
According to court documents, from 1994 through 2021, Gries practiced as a Doctor of Veterinary Medicine at a veterinary hospital in Amherst County, Virginia. The veterinary hospital held hydromorphone for sale and maintained supplies of hydromorphone for use in treating pain in the hospital’s animal patients following surgeries.
As the hospital’s primary surgeon, Gries had full access to the hospital’s supply of hydromorphone. Beginning in July 2020 and without a valid prescription, Gries diverted hydromorphone for personal use by withdrawing a portion of the hydromorphone from the vial and injecting it into himself. He would then replace the diverted portion of the hydromorphone with another substance, usually either saline or butorphonal, and then return the altered hydromorphone to the supply maintained by the hospital.
The Food and Drug Administration - Office of Criminal Investigations, the Drug Enforcement Administration - Diversion Control Division, and the Virginia State Police investigated the case.