uly 2021 ncbop/nabp newsletter - North Carolina Board of ...
6 days ago — pharmacies so that remote medication order processing services can be used by ... understanding (MOU) concerning interstate distribution of compounded drug ...
Thursday, July 15, 2021
Department of Justice
U.S. Attorney’s Office
District of New Jersey
FOR IMMEDIATE RELEASE
Thursday, July 8, 2021
Former Sales Representative Admits Role in $7.89 Million Compounded Prescription Drug Scheme
NEWARK, N.J. – A former sales representative for several compounding pharmacies and marketing companies today admitted his role in a scheme to defraud public and private health benefits programs of $7.89 million for the billing of medically unnecessary compounded prescriptions, Acting U.S. Attorney Rachael A. Honig announced.
Christopher Cuffari, 55, of Little Falls, New Jersey, pleaded guilty by videoconference before U.S. District Judge John Michael Vazquez to an information charging him with conspiracy to commit health care fraud.
According to 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 ingredients in the prescription.
Between November 2014 and September 2017, Cuffari participated in a conspiracy that involved the submission of fraudulent prescriptions for compounded medications to public and private insurance plans. The scheme centered on the discovery that certain insurance plans paid for prescription compounded medications – including scar creams, wound creams, and metabolic supplements/vitamins – at exorbitant reimbursement rates.
Cuffari exploited this opportunity through working as a sales representative for several compounding pharmacies. To profit as a sales representative, Cuffari targeted individuals who had insurance plans that covered compounded medications and then convinced those individuals to obtain prescriptions for compounded medications, regardless of medical necessity, often by providing them with cash payments. To obtain prescriptions for compounded medications for some of the recruited individuals, Cuffari caused payments to be made to a New Jersey-based physician.
Once the prescriptions were written, they were filled by the compounding pharmacies with which Cuffari worked. The compounding pharmacies would then receive reimbursement from the insurance plans and would pay Cuffari a percentage of the reimbursement amount.
As part of his plea agreement, Cuffari must forfeit $995,328 in criminal proceeds he received for his role in the scheme and pay restitution of at least $7.89 million. He faces a statutory maximum of 10 years in prison and a $250,000 fine, or twice the gross gain or loss from the offense. Sentencing is scheduled for Nov. 9, 2021.
Acting U.S. Attorney Honig credited special agents of the FBI, under the direction of Special Agent in Charge George M. Crouch Jr. in Newark, with the investigation leading to today’s guilty plea.
The government is represented by Assistant U.S. Attorney Sean M. Sherman of the U.S. Attorney’s Office, Opioid Abuse Prevention and Enforcement Unit, in Newark.
| Phoenix Nutritionals, Inc. | Office of Human and Animal Food Operations-West Division 5 | New Drug/Misbranded | ||||
| Dream Pharmacy 24/7 Enterprises Limited 2018 | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||||
| Natural Hope Herbals, LLC | Division of Human and Animal Food Operations East II | New Drug/Misbranded | ||||
| Rong Shing Trading NY Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Guangzhou Minghui Cosmetics Co., Ltd. | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||||
| Sobh Import, Inc. | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Biomedical Research Laboratories, LLC | Office of Human and Animal Food Operations –West Division 5 | New Drug/Misbranded | ||||
| Kuiyi International Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Halodine, LLC | Center for Drug Evaluation and Research | Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) | ||||
| BMHshop | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 |
FDA Launches Resource to Increase Awareness of Animal Drug Safety-Related Labeling Changes
Today, the U.S. Food and Drug Administration launched a new resource to improve transparency and communication with veterinarians, animal producers and consumers about safety-related labeling changes made to FDA-approved animal drug products. Awareness of these safety-related changes is essential for the safe use and administration of FDA-approved animal products.
The new resource is in the form of a webpage titled “Animal Drug Safety-Related Labeling Changes,” which provides information on recent safety-related labeling changes and will be updated on a monthly basis when changes to drug labeling are approved by the FDA. Safety-related labeling change information will be available on the webpage for two years after it is first listed. The webpage will only include safety-related labeling changes. For more information about the most current labeling for a particular animal drug, veterinarians should reach out to the drug’s sponsor.
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