https://www.fda.gov/about-fda/fda-memoranda-understanding/compounding-mous
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
Wednesday, July 28, 2021
2021 PacificSource Health Plans Prior Authorization Criteria ...
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7 days ago — Compounded medications will not be covered when an Food and. Drug Administration (FDA) approved, commercially available medication is on the market for ..
When will federal prosecutors and the FDA investigate and indict who came up with the original idea regarding marketing compounded pain medications to the military and others, and who aided and abetted, if anyone, the many compounding pharmacies and pharmacists, doctors, sales reps, etc.(not just a few) with implementing the idea which appears to have created a wheel and spoke conspiracy? Is Interdependence the key factor to examine? Why or why not?
| Visible Vapors, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Sck Zeta Dis Ticaret, Pazarlama Ltd. | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||||
| South Florida Import & Export Corp | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Vapor Amor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Trekker Vapors LLP | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| K&D Vapors | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Jordan’s Crossing Herbal Connections | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
U.S. Sells Unique Wu-Tang Clan Album Owned by Martin Shkreli
The convicted pharmaceutical executive forfeited the one-of-a-kind record after his conviction on securities fraudRead in The Wall Street Journal: https://apple.news/A5NlFHYLbR_
Monday, July 26, 2021
THE GUARDIAN: Dietary supplements causing severe liver injuries in Australians, with some requiring transplants, study shows
Dietary supplements causing severe liver injuries in Australians, with some requiring transplants, study shows
Researchers say cases linked to products claiming to promote muscle growth or weight loss are rising and more rigorous oversight is neededRead in The Guardian: https://apple.news/Ajp4yBDjpSdWigXC70ocJaw
Saturday, July 24, 2021
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Tuesday, July 20, 2021
Mississippi Pharmacist Pleads Guilty to More than $180-Million Health Care Fraud Scheme
A Mississippi pharmacist pleaded guilty today for his role in a multimillion-dollar scheme to defraud TRICARE and private insurance companies by paying kickbacks to distributors for the referral of medically unnecessary compounded prescription medications that were ultimately dispensed by his pharmacies. The conduct allegedly resulted in more than $180 million in fraudulent billings, including more than $50 million paid by federal healthcare programs.
According to court documents, David “Jason” Rutland, 42, of Bolton, a pharmacist and co-owner of various compounding pharmacies, admitted that he participated in a scheme to defraud TRICARE and other health care benefit programs by distributing medically unnecessary compounded medications by, among other things: adjusting prescription formulas to ensure the highest reimbursement without regard to efficacy; soliciting recruiters to procure prescriptions for high-margin compounded medications and paying those recruiters commissions based on the percentage of reimbursements paid by pharmacy benefit managers and health care benefit programs, including commissions on claims reimbursed by TRICARE; and routinely and systematically waiving and/or reducing copayments to be paid by beneficiaries and members, including utilizing a purported copayment assistance program to falsely make it appear as if Rutland’s pharmacy and its affiliate compounding pharmacies had been collecting copayments.
Rutland pleaded guilty to conspiracy to defraud the United States and solicit, receive, offer and pay illegal kickbacks, and faces a maximum penalty of five years in prison. Sentencing has been scheduled for Nov. 30. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors. Rutland must also pay restitution and forfeit all assets traced to the ill-gotten gains.
Acting Assistant Attorney General Nicholas L. McQuaid of the Justice Department’s Criminal Division; Acting U.S. Attorney Darren J. LaMarca for the Southern District of Mississippi; Special Agent in Charge Michelle Sutphin of the FBI’s Jackson Field Office and Special Agent in Charge Cynthia A. Bruce of the Department of Defense Office of Inspector General Defense Criminal Investigative Service (DCIS) Southeast Field Office made the announcement.
The FBI and DCIS are investigating the case.
Trial Attorneys Emily Cohen and Alejandra Arias of the Criminal Division’s Money Laundering and Asset Recovery Section and Assistant U.S. Attorney Kathlyn Van Buskirk of the Southern District of Mississippi are prosecuting the case with assistance from Sara Porter and Dustin Davis from the Criminal Division’s Fraud Section.
Topic(s):
Health Care Fraud
Component(s):
Press Release Number:
21-675
Updated July 20, 2021
Department of Justice
U.S. Attorney’s Office
District of New Jersey
FOR IMMEDIATE RELEASE
Friday, July 23, 2021
Former Pharmaceutical Sales Representative Indicted in Compounded Prescription Drug Scheme
NEWARK, N.J. – A former pharmaceutical sales representative was charged today for his role in a scheme to defraud a telecommunications company’s health care plan by billing for medically unnecessary compounded prescriptions, Acting U.S. Attorney Rachael A. Honig announced.
Carmine A. Mattia Jr. 60, of Cedar Grove, New Jersey, was indicted on one count of conspiracy to commit health care fraud and three counts of health care fraud. He will have his initial appearance on a date to be determined.
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 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.
The scheme centered on Mattia’s work as a sales representative for a marketing company and various compounding pharmacies, for which he sold compounded medications, including pain creams, scar creams, wound creams, and metabolic supplements/vitamins. Mattia was also a full-time employee of the telecommunications company and was a union representative for the company’s employees.
Between April 2016 and July 2016, Mattia participated in a conspiracy to submit fraudulent prescriptions for compounded medications to the telecommunications company’s health care plan. The compounding pharmacies paid Mattia a commission in exchange for each prescription for compounded medication Mattia caused to be billed to the company’s health care plan.
To fraudulently increase his profits as a sales representative, Mattia recruited Individual-1 to receive medically unnecessary compounded medications. Mattia paid Individual-1 to induce Individual-1 to receive these medications. Mattia also secured the signature of a New Jersey doctor, Robert Agresti, on prescription forms for Individual-1. Agresti and Individual-1 did not have a doctor/patient relationship, Agresti did not determine if Individual-1 needed the compounded medications selected, and he did not examine Individual-1. Agresti pleaded guilty on June 26, 2018, to conspiracy to commit healthcare fraud and is awaiting sentencing.
Mattia’s participation in the scheme caused a loss to the telecommunications company’s health care plan of approximately $100,000.
The conspiracy charge and substantive health care fraud charges each carry a statutory maximum of 10 years in prison and a $250,000 fine, or twice the gross gain or loss from the offense, whichever is greatest.
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 indictment.
The government is represented by Assistant U.S. Attorneys Emma Spiro and Sean M. Sherman of the U.S. Attorney’s Office, Opioid Abuse Prevention and Enforcement Unit in Newark.
The charge and allegations contained in the indictment are merely accusations, and the defendant is presumed innocent unless and until proven guilty.
Attachment(s):
Topic(s):
Health Care Fraud
Component(s):
Press Release Number:
21-334
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