Friday, November 1, 2024

Atlantic County Doctor Sentenced to 15 Months in Prison for Health Care Fraud Conspiracy

 CAMDEN, N.J. – An Atlantic County, New Jersey, doctor was sentenced to 15 months in prison for his role in defrauding New Jersey state and local health benefits programs and other insurers by submitting fraudulent claims for medically unnecessary prescriptions, Attorney for the United States Vikas Khanna announced.

Brian Sokalsky, 46, of Margate, New Jersey, previously pleaded guilty before U.S. District Judge Robert B. Kugler to a superseding information charging him with one count of conspiring to commit health care fraud. U.S. District Judge Edward S. Kiel imposed the sentence on Oct. 29, 2024, in Camden federal court. 

 Sokalsky, pharmaceutical sales representative Vincent Tornari, 50, of Linwood, New Jersey, and former advanced nurse practitioner Ashley Lyons-Valenti, 67, of Swedesboro, New Jersey, were charged in a 33-count indictment in June 2020. Tornari pleaded guilty on March 14, 2023, and Lyons-Valenti pleaded guilty on Feb. 28, 2023, to their respective roles in the conspiracy. Tornari and Lyons-Valenti are both awaiting sentencing.

According to court documents filed in this case and statements made in court:

Compounded medications are 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.

The conspirators learned that certain medications made by compounding pharmacies reimbursed for up to thousands of dollars for an individual’s one-month supply. They learned that certain insurance plans – including insurance plans for state and local government employees and certain other insurance plans – covered these medications.

Sokalsky agreed to authorize prescriptions for former pharmaceutical sales representative Matthew Tedesco, 49, of Linwood, New Jersey, who pleaded guilty to health care fraud conspiracy in June 2017, and others working with Tedesco. In exchange for authorizing those prescriptions, Tedesco referred approximately 30 patients to Sokalsky’s new medical practice.  Sokalsky, in turn, billed insurance for patient visits for those people steered to his practice by Tedesco. Sokalsky also authorized prescriptions for the medications for existing patients of his practice, which he did to financially benefit Tedesco and encourage him to refer more patients to his new practice. Sokalsky authorized medically unnecessary medications, including libido creams for young females and excessive quantities of the medications with the maximum number of refills selected. When insurance stopped covering certain formulations of the medications, Tedesco informed Sokalsky that he needed to authorize new prescriptions.  Sokalsky did so, often without seeing the individual for a follow-up visit or informing the person of the change in medication. In total, insurance paid more than $5 million for fraudulent prescriptions authorized by Sokalsky.

In addition to the prison term, Judge Kiel sentenced Sokalsky to three years of supervised release and ordered restitution of $5.13 million.

Attorney for the United States Khanna credited agents of the FBI’s Atlantic City Resident Agency, under the direction of Acting Special Agent in Charge Nelson I. Delgado in Newark; special agents of IRS - Criminal Investigation, under the direction of Special Agent in Charge Jenifer L. Piovesan 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 A. Friedman of the Camden office.

Updated October 30, 2024

 

Texas Drug Compounder Challenges FDA ‘Clinical Need’ Decision

FDA warns patients and health care professionals not to use compounded drugs from Fullerton Wellness

 [11/1/2024] FDA is warning patients and health care professionals not to use drugs compounded and distributed by Fullerton Wellness LLC, Ontario, Calif., and distributed to patients by medical offices and clinics

Fullerton Wellness is a facility that compounds drugs intended to be sterile, including semaglutide and tirzepatide injections.

Based on conditions observed by FDA and information provided by California regulatory authorities, FDA has concerns about the sterility of drugs distributed by Fullerton Wellness. Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening adverse health consequences including infections and sepsis.

On August 14, 2024, FDA received a complaint from a patient who noticed a black particulate in a vial of semaglutide distributed by Fullerton Wellness. On September 23, 2024, FDA received information from California regulatory authorities as part of ongoing collaboration between FDA and the state noting deficiencies found at Fullerton Wellness during a state inspection. After the state inspection, Fullerton Wellness voluntarily ceased operations.

On October 17, 2024, FDA joined California regulatory authorities at the Fullerton Wellness facility and observed conditions that could cause the drugs produced by the company to become contaminated. Fullerton Wellness used non-sterile ingredients to make these injectable drugs and took no steps to sterilize them which could introduce health risks.

Health care professionals should immediately check their medical supplies, quarantine any drug products from Fullerton Wellness, and not administer them. Patients who have received compounded drugs distributed by Fullerton Wellness should stop using them and contact their health care professional.

FDA is not aware of any adverse reactions associated with the use of compounded drugs from Fullerton Wellness. However, compounders that are not registered with FDA as outsourcing facilities are primarily overseen by state regulators and are not required under federal law to report adverse events to FDA.

Patients and health care professionals should report any adverse reactions to FDA’s MedWatch program:

  • Complete and submit the report online at www.fda.gov/medwatch/report.htm
  • Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178.

 

  1. FDA reminds compounders to use ingredients suitable for sterile …

US FDA warns against California facility making compounded weight-loss drugs Story by Reuters •

 US FDA warns against California facility making compounded weight-loss drugs

Tuesday, October 29, 2024

 

  • On Friday, three individuals in London were sentenced for their role in the international importation and distribution of unapproved drugs. The operation seized over £1M ($1.3M) and 1 million illicit pills. This result is the culmination of numerous law enforcement agencies, including the FDA Office of Criminal Investigations (FDA-OCI), working together from across the world for more than three years. The investigation began in October 2020 when U.S. Customs and Border Protection seized numerous shipments sent from the U.K. found to contain illicit drugs. Information sharing between FDA-OCI and the City of London Police led to the successful execution of warrants in the U.S., where illicit unapproved drugs were found.