| Amazon.com, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
| Latin Foods Market | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
Wednesday, November 2, 2022
| Walmart Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
| Lupin Limited | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||
| Latin Foods Market | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
| Bakkavor Foods USA Inc. | Office of Human and Animal Food Operations – East Division 3 | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes | |||
| Facema, LLC. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | |||
| Sovereign Pharmaceuticals, LLC | Office of Pharmaceutical Quality Operations, Division II | CGMP/Finished Pharmaceuticals/Adulterated | |||
| McConnell Labs Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated | |||
| ARYZ Trading LLC | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | |||
| Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products | |||
| Minuti Coffee LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
Tuesday, November 1, 2022
|
FDA Warning
FDA continues to warn consumers not to purchase or use Artri and Ortiga products as the agency received adverse event reports, including of liver toxicity and death, associated with the use of Artri King and similarly named products. These products are promoted with unproven claims to treat arthritis and osteoarthritis, restore cartilage, and stop joint deterioration.
FDA analysis revealed hidden drug ingredients, including corticosteroids (diclofenac and dexamethasone). Suddenly stopping corticosteroids after long-term use or high doses can result in a serious withdrawal syndrome that includes fatigue, nausea, low blood pressure, low blood glucose levels, fever, dizziness, muscle and joint pain, and shortness of breath. Medical intervention may be necessary.
In support of public safety, and because some of these products may still be available on the market, FDA issued warning letters on October 28, 2022, to Amazon, Walmart, and Latin Foods Market for distributing various “Artri” and/or “Ortiga” unapproved and misbranded drug products. Walmart and Latin Foods Market already issued voluntary recalls for these products.
Customers with questions about these products should discuss appropriate treatment options with their health care providers.
Learn Mor
Friday, October 28, 2022
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Tuesday, October 25, 2022
Doctor Pleads Guilty to Role in $54 Million Medicare Fraud Scheme
A Texas doctor pleaded guilty today for his role in a $54 million scheme to defraud Medicare by prescribing durable medical equipment and cancer genetic testing without ever seeing, speaking to, or otherwise treating patients.
According to court documents, Daniel R. Canchola, 49, of Flower Mound, agreed to electronically sign orders for durable medical equipment (DME) and cancer genetic testing that he knew were used to submit more than $54 million in false and fraudulent claims to Medicare. From August 2018 through April 2019, Canchola received approximately $30 in exchange for each doctor’s order he signed authorizing DME and cancer genetic test orders that were not legitimately prescribed, not needed, or not used—totaling more than $466,000 in kickbacks. The Medicare beneficiaries for whom Canchola prescribed DME and cancer genetic testing were targeted by telemarketing campaigns and at health fairs and were induced to submit to the cancer genetic testing and to receive the DME regardless of medical necessity.
Canchola pleaded guilty to conspiracy to commit wire fraud. He is scheduled to be sentenced on March 15, 2023, and faces a maximum penalty of 20 years in prison. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.
Assistant Attorney General Kenneth A. Polite, Jr. of the Justice Department’s Criminal Division; U.S. Attorney Chad E. Meacham for the Northern District of Texas; Acting Special Agent in Charge Jason E. Meadows of the Department of Health and Human Services Office of Inspector General (HHS-OIG) Dallas Region; and Chief William Marlowe of the Texas Attorney General’s Medicaid Fraud Control Unit (MFCU) made the announcement.
The HHS-OIG and MFCU investigated the case.
Acting Assistant Chief Brynn Schiess of the Criminal Division’s Fraud Section is prosecuting the case.
The Fraud Section leads the Criminal Division’s efforts to combat health care fraud through the Health Care Fraud Strike Force Program. Since March 2007, this program, comprised of 15 strike forces operating in 24 federal districts, has charged more than 4,200 defendants who collectively have billed the Medicare program for more than $19 billion. In addition, the Centers for Medicare & Medicaid Services, working in conjunction with the Office of the Inspector General for the Department of Health and Human Services, are taking steps to hold providers accountable for their involvement in health care fraud schemes. More information can be found at https://www.justice.gov/criminal-fraud/health-care-fraud-unit.
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Monday, October 17, 2022
Pharmacist Convicted for Health Care Fraud and Black-Market Prescription Drug Diversion Scheme
A federal jury convicted a California woman last Friday, Oct. 14 for a health care fraud and prescription drug diversion scheme involving two Southern California pharmacies.
According to court documents and evidence presented at trial, Irina Sadovsky, 53, of Calabasas, the owner and pharmacist-in-charge of Five Star RX doing business as Five Star Pharmacy (Five Star Pharmacy) and Ultimate Pharmacy Inc. (Ultimate Pharmacy), engaged in a health care fraud and black market prescription drug diversion conspiracy that began in or around September 2016, and continued through in or around April 2017. Sadovsky submitted claims to Medicaid of California (Medi-Cal) and Medicare for prescription drugs that were never dispensed to beneficiaries but rather were provided to co-conspirators to sell on the black market.
Sadovsky’s co-conspirators created fraudulent prescriptions, either by writing the prescriptions themselves or by paying kickbacks to marketers with access to patients and prescribers. Sadovsky recommended the combinations of prescription drugs to be written, checked the eligibility of the patients for reimbursement, and fraudulently submitted claims to Medi-Cal and Medicare.
Sadovsky was convicted of conspiracy to commit health care fraud and conspiracy to engage in the unlicensed wholesale distribution of prescription drugs. She is scheduled to be sentenced on Feb. 3, 2023 and faces a maximum penalty of 10 years in prison for the health care fraud conspiracy, and five years in prison for the unlicensed distribution conspiracy. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.
Assistant Attorney General Kenneth A. Polite, Jr. of the Justice Department’s Criminal Division; U.S. Attorney Martin Estrada for the Central District of California; Assistant Director in Charge Donald Alway of the FBI Los Angeles Field Office; and Special Agent in Charge Timothy B. DeFrancesca of the Department of Health and Human Services, Office of Inspector General (HHS-OIG) made the announcement.
The FBI and HHS-OIG investigated the case, which was brought as part of the Los Angeles Strike Force, supervised by the Criminal Division’s Fraud Section and the U.S. Attorney’s Office for the Central District of California. The California Department of Justice provided valuable assistance.
Assistant Chief Alexis Gregorian and Trial Attorneys Justin Givens and Alex Michael of the Criminal Division’s Fraud Section are prosecuting the case.
The Fraud Section leads the Criminal Division’s efforts to combat health care fraud through the Health Care Fraud Strike Force Program. Since March 2007, this program, comprised of 15 strike forces operating in 24 federal districts, has charged more than 4,200 defendants who collectively have billed the Medicare program for more than $19 billion. In addition, the Centers for Medicare & Medicaid Services, working in conjunction with the Office of the Inspector General for the Department of Health and Human Services, are taking steps to hold providers accountable for their involvement in health care fraud schemes. More information can be found at https://www.justice.gov/criminal-fraud/health-care-fraud-unit.
Compounding pharmacy sales representive admits role in health care fraud and criminal HIPAA schemes
Date: October 20, 2022
Contact: newsroom@ci.irs.gov
Camden, NJ — A former pharmaceutical sales representative admitted his role in two criminal conspiracies involving health care fraud and wrongful obtaining and disclosure of patients' protected personal health information, Attorney for the United States Vikas Khanna announced today.
Keith Ritson, of Bayville, New Jersey, pleaded guilty on Oct. 19, 2022, before U.S. District Judge Robert B. Kugler in Camden to a superseding information charging him with one count of conspiracy to commit health care fraud and one count of conspiring to wrongfully disclose and obtain patients' individually identifiable health information in violation of the criminal provisions of the Health Insurance Portability and Accountability Act (HIPAA).
According to documents filed in this case and statements made in court:
From 2014 to 2016, Ritson was a pharmaceutical sales representative who promoted compound prescription medications and other medications. Compound medications are specialty medications mixed by a pharmacist to meet the specific medical needs of an individual patient. Although not approved by the Food and Drug Administration (FDA), they are properly prescribed when a physician determines that an FDA-approved medication does not meet the health needs of a particular patient, such as if a patient is allergic to a dye or other ingredient.
Ritson and his conspirators discovered that certain insurance plans with pharmacy benefit management services – including plans for state and local government employees and eligible dependents – covered compound medications from a Louisiana pharmacy, Central Rexall Drugs, Inc. (Central Rexall). The pharmacy benefits administrator paid prescription drug claims and then billed the state of New Jersey and other insurance plans for the amounts paid. The conspirators identified that certain compound medication prescriptions would reimburse by insurance for thousands of dollars on a monthly basis. Ritson received a percentage of the amount that Central Rexall received from the pharmacy benefits administrator for the prescriptions he arranged. Ritson recruited individuals with insurance plans that covered the compound medications to receive the medications, regardless of their medical need for them. Ritson himself also received medically unnecessary compound medication prescriptions. Ritson earmarked patients who had insurance plans that covered the compound medications at the medical practices of Dr. Frank Alario.
As a pharmaceutical sales representative not associated with Alario's medical practices, Ritson was not permitted to access and obtain patients' individually identifiable health information and protected health information. As part of the criminal HIPAA scheme, Alario permitted Ritson to have significant access to his medical offices, medical files, and patient information. Ritson was present in the office both during and outside normal business hours and had access to areas of the office restricted to staff, including areas with patient files and office computers. Ritson looked up patients' information in files and on office computers to determine if they had insurance that covered the compound medications. Ritson then would earmark files in advance so that Alario knew to whom to prescribe the medications. Ritson also joined Alario in patient exam rooms during appointments, which gave patients the impression that Ritson was employed by or affiliated with the medical practices. Ritson used patients' confidential information to fill out prescription forms that Alario authorized, and then Ritson received commissions on those prescriptions. Alario pleaded guilty on Oct. 7, 2022, to conspiring to wrongfully disclose patients' individually identifiable health information. He is scheduled to be sentenced Feb. 7, 2023.
Three former executives of Central Rexall – Christopher Kyle Johnston, of Mandeville, Louisiana; Trent Brockmeier, of Pigeon Forge, Tennessee; and Christopher Casseri, of Baton Rouge, Louisiana – were charged on Sept.17, 2020, in a 24-count indictment with health care and wire fraud and other offenses. The charges against them remain pending. A fourth former pharmacy executive, Hayley Taff, of Hammond, Louisiana, pleaded guilty to health care fraud conspiracy on Aug. 12, 2020, and is scheduled to be sentenced March 13, 2023. The charges and allegations contained in the indictment against Johnston, Brockmeier and Casseri are merely accusations, and they are presumed innocent unless and until proven guilty.
Ritson faces a maximum penalty of 10 years in prison and a $250,000 fine on the health care fraud conspiracy count, and a maximum penalty of one year in prison and a $50,000 fine on the criminal HIPAA conspiracy count. Sentencing is scheduled for Feb. 21, 2023.
Attorney for the United States Khanna credited agents of IRS Criminal Investigation, under the direction of Acting Special Agent in Charge Tammy Tomlins in Newark; the FBI's Atlantic City Resident Agency, under the direction of Special Agent in Charge James E. Dennehy in Newark; and the U.S. Department of Labor Office of Inspector General, New York Region, under the direction of Special Agent in Charge Jonathan Mellone, with the investigation leading to the guilty plea.
The government is represented by Assistant U.S. Attorney Christina O. Hud of the Criminal Division; R. David Walk, Jr., Chief of the Opioid Abuse Prevention and Enforcement Unit; Assistant U.S. Attorney Daniel A. Friedman of the Criminal Division; and Assistant U.S. Attorney Barbara Ward, Senior Trial Counsel of the Asset Recovery and Money Laundering Unit.
FDA Warnings on Fraudulent COVID-19 Products
FDA recently issued two warnings letters jointly with the Federal Trade Commission to companies selling unapproved and misbranded products as drugs for use in treating or preventing COVID-19.Consumers concerned about COVID-19 should consult with their health care provider. FDA issued the following:
- Warning letter to Lakpura LLC for selling unapproved and misbranded products as drugs for use in treating or preventing COVID-19.
- Warning Letter to Bespoke Apothecary LLC for selling unapproved and misbranded COVID kit and Post Virus Recovery Herbal Tea products as drugs for use in treating or preventing COVID-19.
FDA is actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims.
Fraudulent COVID-19 Products
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