Thursday, November 30, 2023
The Oklahoma Bureau of Narcotics and Dangerous Drugs (OBN) is currently aware of the ongoing cyberattack regarding Ardent Health Services that is affecting multiple facilities in the state including Hillcrest Health System, Bailey Medical Center, and Utica Park Clinics, among others. We have been in contact with the Oklahoma State Board of Pharmacy regarding the dispensing of medication to patients of Ardent Health providers. The safety of the citizens of our great state, including proper and sufficient medical care, is our primary concern at this time regarding this matter. Our guidance at this time for pharmacies that receive prescriptions for controlled substances from Ardent Health providers is to continue filling the prescriptions received while continuing due diligence in confirming the prescription itself is valid and accurate, regardless of the manner or media received. This is intended to be a short-term, temporary solution to ensure prescribers are able to continue patient care until prescribers are able to obtain OBN prescription pads. All prescribers, if they have not done so already, must place an order for OBN prescription pads to be used in situations such as these. Once received, the prescriber will be able to utilize the prescription pads until the systems become available.
Posted by the Oklahoma Board of Pharmacy
Wednesday, November 29, 2023
Do Not Use Certain Brands of Saline and Sterile Water Medical Products by Nurse Assist Because They May Not Be Sterile: FDA Safety Communication
FDA’s Center for Veterinary Medicine is sharing news of this recall to alert veterinarians who may be using this product.
The U.S. Food and Drug Administration (FDA) is warning consumers, health care providers, and health care facilities not to use recalled saline (0.9% sodium chloride) and sterile water medical products manufactured by Nurse Assist, LLC, and sold under various brands.
On November 6, 2023, Nurse Assist, LLC announced a recall of the following water-based medical products because the products may not be sterile:
- 0.9% Sodium Chloride Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 3.1oz spray can, 7.1oz spray can, 3mL syringes, 5mL syringes, and 10mL syringes);
- Sterile Water for Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 120 mL cups, 10mL syringes, and 30mL syringes).
|Elemental Herbs Inc. d/b/a ALL good||Division of Pharmaceutical Quality Operations IV||CGMP/Finished Pharmaceuticals/Adulterated|
|Raven Route||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|www.directpharmashop.net||Center for Drug Evaluation and Research | CDER||Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet|
|AmLion Toothpaste Mfg. Sdn. Bhd.||Center for Drug Evaluation and Research | CDER||CGMP/Finished Pharmaceuticals/Adulterated|
|Xiamen Wally Bath Manufacture Co., Ltd.||Center for Drug Evaluation and Research | CDER||CGMP/Finished Pharmaceuticals/Adulterated|
|Cerci Kozmetik Ve Otel Ekipmanlari Pazarlama Ic Ve Dis Ticaret Limited Sirketi||Center for Drug Evaluation and Research | CDER||CGMP/Finis|
|Intas Pharmaceuticals Limited||Center for Drug Evaluation and Research | CDER||CGMP/Finished Pharmaceuticals/Adulterated|
|Dr. Berne’s Whole Health Products||Center for Drug Evaluation and Research | CDER||CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug|
|Shenzhen FreeMax Technology Co., Ltd. d/b/a FreeMaxVape||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|Shenzhen IJOY Technology Co., LTD.||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|Brenntag Great Lakes, LLC||Division of Pharmaceutical Quality Operations III||CGMP/Finished Pharmaceuticals/Adulterated|
|Melanie M. Hoppers, M.D./Physicians Quality Care||Center for Drug Evaluation and Research | CDER||Clinical Investigator|
|Wan-Gee Foods, Inc.||Division of Human and Animal Food Operations West II||CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions|
|National Chemical Laboratories||Office of Pharmaceutical Quality Operations||CGMP/Finished Pharmaceuticals/Adulterated|
|Discover Health, LLC d/b/a Discover CBD and Strain Snobs||Center for Drug Evaluation and Research | CDER||Finished Pharmaceuticals/Unapproved New Drugs/Animal Drugs/Human Foods/Animal Foods/Adulterated/Misbranded|
|Cipla Limited||Center for Drug Evaluation and Research | CDER||CGM|
Monday, November 27, 2023
Three Men Sentenced for $54M Fraudulent Compound Medication Prescriptions Scheme Tuesday, November 14, 2023
Three men were sentenced today in connection to a $54 million bribery and kickback scheme involving TRICARE, a federal program that provides health insurance benefits to active duty and retired service members and their families.
David Byron Copeland, 55, of Tallahassee, Florida, was sentenced to four years and three months in prison following his conviction at trial in June for paying and receiving health care kickbacks. James Wesley Moss, 60, of Huntsville, Alabama, and Michael Gordon, 60, of Fort Myers, Florida, were sentenced to two years and three months and one year and six months in prison, respectively, following their guilty pleas to a kickback and fraud conspiracy, among other charges.
According to court documents and evidence presented at trial, Moss was a part-owner and CEO of Florida Pharmacy Solutions (FPS), a Florida-based pharmacy that specialized in compounded prescription drugs. Copeland was also a part-owner and senior sales manager at FPS, and Gordon was a lead sales representative. Moss, Copeland, and Gordon, along with their accomplices, engaged in a practice known as “test billing” to develop the most expensive combination of compounded drugs to maximize reimbursement from TRICARE. Moss, Copeland, Gordon, and their accomplices targeted physicians who treated TRICARE beneficiaries and paid bribes and kickbacks to physicians and salespeople to encourage the referral of prescriptions to FPS. The bribes included lavish hunting trips and expensive dinners. In addition, FPS employees used “blanket letters of authorization” that allowed FPS to modify the prescription components to make them more profitable.
Moss paid Copeland and Gordon millions of dollars in kickbacks based on a percentage of the amount that TRICARE reimbursed for their prescriptions, which provided an incentive to seek prescriptions for the most expensive compounded drugs possible, including pain and scar creams. Copeland facilitated the kickbacks through companies he set up to receive and funnel the payments. From late 2012 through mid-2015, FPS billed TRICARE over $54 million for its compounded pharmaceuticals.
In April, co-defendant Edward Christopher White was sentenced to two years and nine months in prison after pleading guilty for his role in the scheme.
Acting Assistant Attorney Nicole M. Argentieri of the Justice Department’s Criminal Division; U.S. Attorney Roger Handberg for the Middle District of Florida; Special Agent in Charge Darrin K. Jones of the Department of Defense Office of Inspector General (DOD-OIG), Defense Criminal Investigative Service, Southeast Field Office; Acting Special Agent in Charge Stephen Mahmood of the Department of Health and Human Services Office of the Inspector General (HHS-OIG), Miami Regional Office; Special Agent in Charge David Spilker of the Department of Veterans Affairs Office of Inspector General (VA-OIG), Southeast Field Office; Assistant Director Luis Quesada of the FBI’s Criminal Investigative Division; and Special Agent in Charge David Walker of the FBI Tampa Field Office made the announcement.
The DOD-OIG, HHS-OIG, VA-OIG, and FBI investigated the case.
Trial Attorneys Devon Helfmeyer, Clayton Solomon, and Katie Rookard of the Criminal Division’s Fraud Section prosecuted 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, currently comprised of nine strike forces operating in 27 federal districts, has charged more than 5,000 defendants who collectively have billed federal health care programs and private insurers more than $24.7 billion. In addition, the Centers for Medicare & Medicaid Services, working in conjunction with the HHS-OIG, are taking steps to hold providers accountable for their involvement in health care fraud schemes. More information can be found at www.justice.gov/criminal-fraud/health-care-fraud-unit.
Pharmacy Owners and Doctor Convicted for $145M Health Care Fraud, Money Laundering, and Tax Evasion Scheme involving compounded cream drugs/medications Friday, November 17, 2023
A federal jury convicted three Texas men yesterday for a $145 million scheme to defraud the Department of Labor through the submission of fraudulent claims for prescription compound creams.
According to court documents and evidence presented at trial, Dehshid “David” Nourian, 59, of Plano; and Christopher Rydberg, 47, of Fort Worth, and others conspired to pay Dr. Michael Taba, 59, of McKinney, and other doctors to prescribe medically unnecessary compound creams to injured federal workers. Nourian and Rydberg owned and/or operated three pharmacies located in Fort Worth and Arlington. They paid Taba for referring expensive compound medications to be filled by those pharmacies. In less than three years, between May 2014 and March 2017, the pharmacies billed the Department of Labor Office of Workers’ Compensation Programs (DOL-OWCP) and Blue Cross Blue Shield more than $145 million and were paid more than $90 million for unnecessary prescriptions referred by Taba and other providers in exchange for bribes and kickbacks. Nourian, Rydberg, and others then attempted to conceal their ill-gotten gains by laundering the money through purported holding companies and attempted to evade paying federal income taxes on the illicit proceeds.
Nourian, Rydberg, and Taba were convicted of one count of conspiracy to commit health care fraud; and eight (Nourian) and three (Taba) counts of health care fraud, respectively, each count carrying a maximum penalty of 10 years in prison. Nourian and Rydberg were also convicted of one count of conspiracy to launder money and five and six counts of money laundering, respectively, each count carrying a maximum penalty of 20 years in prison, and one count of conspiracy to defraud the United States, which carries a maximum penalty of five years in prison.
All of the defendants are scheduled to be sentenced at a later date. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.
Acting Assistant Attorney General Nicole M. Argentieri of the Justice Department’s Criminal Division; Special Agent in Charge Jonathan Ulrich of the U.S. Postal Service Office of Inspector General (USPS-OIG), Southern Area Field Office; Acting Special Agent in Charge Casey Howard of the Department of Labor Office of the Inspector General (DOL-OIG), Dallas Regional Office; Special Agent in Charge Kris Raper of the Department of Veterans Affairs Office of the Inspector General (VA-OIG), South Central Field Office; and Special Agent in Charge Ramsey Covington of the IRS Criminal Investigation (IRS-CI) Houston Field Office made the announcement.
The USPS-OIG, DOL-OIG, VA-OIG, and IRS-CI investigated the case.
Trial Attorneys Alexander Thor Pogozelski, Ethan Womble, and Edward Emokpae of the Criminal Division’s Fraud Section are prosecuting the case, with significant assistance from Acting Assistant Chief Catherine Wagner.
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, currently comprised of nine strike forces operating in 27 federal districts, has charged more than 5,400 defendants who collectively have billed federal health care programs and private insurers more than $27 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 www.justice.gov/criminal-fraud/health-care-fraud-unit.
Atlantic County Man Sentenced to One Year and One Day in Prison for Health Care Fraud Conspiracy involving compounded medication Friday, November 17, 2023
state health benefits programs out of millions of dollars by submitting fraudulent claims for medically unnecessary prescriptions, Attorney for the United States Vikas Khanna announced today.
Corey Sutor, 42, of Egg Harbor Township, New Jersey, formerly a Ventnor City firefighter, previously pleaded guilty before U.S. District Judge Robert B. Kugler to an information charging him with conspiracy to commit health care fraud. Judge Kugler imposed the sentence on Nov. 13, 2023, in Camden federal court.
According to documents filed in this case and statements made in court:
Compounded medications are supposed to be specialty medications mixed by a pharmacist to meet the specific medical needs of an individual patient. Although compounded drugs are 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.
Sutor was one of the owners of a company formed to market prescription compounded medications. From May 2015 through February 2016, Sutor and others associated with the company persuaded individuals in New Jersey to obtain very expensive and medically unnecessary compounded medications.
The conspirators learned that certain compound medication prescriptions – including pain, scar, and antifungal creams, as well as vitamin combinations – were reimbursed for thousands of dollars for a one-month supply. The conspirators also learned that the New Jersey State Health Benefits Program, which covers qualified state and local government employees, retirees, and eligible dependents, and the School Employees’ Health Benefits Program, which covers qualified local education employees, retirees, and eligible dependents, would cover compound medication prescriptions.
Sutor and his conspirators entered into an agreement in which Sutor’s company would receive a percentage of the amounts paid to compounding pharmacies for prescriptions secured by Sutor and his conspirators. Sutor and his conspirators then recruited public employees, offered them hundreds of dollars per month, and persuaded them to agree to obtain prescription compounded medications they did not need without any physical examination by a medical professional. Sutor would obtain insurance and personal information from the public employees and give that information to conspirators. Sutor’s company then would receive a percentage of the amounts paid on these fraudulent prescriptions, which Sutor and others would divide.
Sutor and his conspirators caused New Jersey to pay more than $2 million in fraudulent claims for compounded medications for public employees.
Sutor received $150,398 in gross proceeds for his role in the scheme.
In addition to the prison term, Judge Kugler sentenced Sutor to two years of supervised release. As part of his plea agreement, Sutor must forfeit his criminal proceeds and pay restitution of at least $2.09 million.
Attorney for the United States Khanna credited special agents of the FBI’s Atlantic City Resident Agency, under the direction of Special Agent in Charge James E. Dennehy in Newark; special agents of IRS – Criminal Investigation, under the direction of Special Agent in Charge Tammy Tomlins 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 sentencing.
The government is represented by R. David Walk Jr., Deputy Chief of the Criminal Division, and Assistant U.S. Attorney Daniel Friedman of the U.S. Attorney’s Office in Camden.