Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Thursday, August 16, 2018

FBI: Prescription For Prison Time - Fraudsters Scammed Government, Private Insurance Companies Out Of $100 Million


The FBI released the below information:

A group of Florida scammers who set up pharmacies to bilk the government and insurance companies ended up writing themselves a prescription for prison time.

The eight men owned and/or operated several pharmacies and related businesses—known by names such as A to Z Pharmacy and Havana Pharmacy—whose sole purpose was to help these criminals line their own pockets. Initially, the men bribed medical providers to write unnecessary prescriptions for compounded drugs like pain or scar creams, then billed the patients’ insurance companies large sums for the drugs. And in the making of the prescriptions, they often used unusual ingredients, such as horse tranquilizers, that were not medically necessary for the particular patients.

A compounding pharmacy creates tailored drugs for individual patients who cannot be treated with traditional drugs due to allergies or other special needs. The Food and Drug Administration does not approve compounded drugs. While investigators found no evidence that any of the patients who received compounded drugs in this case suffered any dangerous side effects from them, the FDA warns that unnecessary use of compounded drugs can pose risks for patients.

As the scam evolved, the conspirators bought lists of information on patients with generous private insurance, Medicare, or TRICARE. They then sent their creams and other drugs to those patients with or without the patients’ knowledge or consent and without consulting their physicians.

“The main thing is there was never any patient necessity here,” said Special Agent Kurt McKenzie, who worked the case out of the FBI’s Miami Division. “The patients never asked for it; they didn’t need it. In many cases, the patients would send the creams back and say ‘I never asked for this.’”

The scheme went on for about four years, with the participants using various tactics to avoid detection, including purchasing additional pharmacies to use once an insurance company stopped paying for prescriptions at ones they were already using. The profits were significant—more than $100 million. Nicholas Borgesano, Jr., one of the ringleaders, made an estimated $80 million of that himself. Yet thanks to the investigative work of the FBI, the Department of Health and Human Services’ Office of Inspector General, and the Defense Criminal Investigative Service, the fraudsters were discovered and brought to justice. Traditional investigative techniques like following a complex money trail helped bring down the fraud ring.

All eight men involved in the scheme pleaded guilty to conspiracy to commit health care fraud. In April, Borgesano was sentenced to 15 years in prison. His seven co-conspirators have been sentenced to between one and six years.

“Every paycheck you earn, there is money coming out to fund Medicare and your own health insurance, and the American people are losing cents on the dollar to these fraudsters,” McKenzie said. “They are just reaching out and taking it, so it’s important for the FBI and our partners to target and stop this activity.”  

Borgesano used his millions to buy 16 properties and numerous boats and high-end vehicles that were forfeited as part of his plea. The victims—the insurance plan sponsors and the government—will be able to recoup a small amount of their losses through the asset forfeiture process.

“We can’t let the bad guys keep their ill-gotten gains,” said Special Agent Rolf Gjertsen of the FBI’s Tampa Division, who also worked the case. “It’s probably a drop in the bucket compared to what they lost, but it’s important for the public to know we use the asset forfeiture process to try to make victims whole to the extent we can.”

Special Agent Jennifer McGrath, who also worked on the investigative team out of the Miami Division, said the crime was certainly not a victimless one, in particular for military families.

“TRICARE is the primary insurer for military families,” McGrath explained. “They stole $100 million from TRICARE and other insurers and used it to buy boats and fancy cars. It’s taking that money away from military families and others who use the victim insurance providers.”

McGrath said anyone who suspects insurance fraud—such as unexpectedly receiving medications or equipment not prescribed by your doctor or not being charged a normally required co-payment—should report it to their insurance provider’s fraud prevention department. 

Tuesday, July 7, 2015

DEA: New research Reveals The Trends And Risk Factors Behind America's Growing Heroin Epidemic


The Drug Enforcement Administration (DEA) released the below information:

JULY 7 - (Washington, D.C.) – 

Heroin use has increased across the United States among men and women, most age groups, and all income levels. The greatest increases have occurred in groups with historically lower rates of heroin use, including women and people with private insurance and higher incomes. In addition, nearly all people who use heroin also use multiple other substances, according to the latest Vital Signs report from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). The report also finds the strongest risk factor for a heroin use disorder is a prescription opioid use disorder.
As heroin use increases, more people are dying from heroin overdoses. Heroin-involved overdose deaths nearly doubled between 2011 and 2013; more than 8,200 people died in 2013 alone.
“Heroin use is increasing at an alarming rate in many parts of society, driven by both the prescription opioid epidemic and cheaper, more available heroin,” said CDC Director Tom Frieden, M.D., M.P.H. “To reverse this trend we need an all-of-society response – to improve opioid prescribing practices to prevent addiction, expand access to effective treatment for those who are addicted, increase use of naloxone to reverse overdoses, and work with law enforcement partners like DEA to reduce the supply of heroin.”
For this Vital Signs report, FDA and CDC analyzed data from the 2002-2013 National Survey on Drug Use and Health, sponsored by the Substance Abuse and Mental Health Services Administration and the National Vital Statistics System. Heroin trends among demographic and substance-using groups were compared for 2002- 2004, 2005-2007, 2008-2010, and 2011-2013. Characteristics associated with heroin use disorders were identified through multivariable logistic regression analysis.
Key findings include:
 Nearly all (96 percent) people who reported heroin use also reported using at least one other drug in the past year with more than half (61 percent) using at least three other drugs.
 The people most at-risk of heroin abuse or dependence include non-Hispanic whites, men, 18-to-25 year-olds, people with an annual household income less than $20,000, Medicaid recipients, and the uninsured.
 Significant increases in heroin use were found in groups with historically low rates of heroin use, including women and people with private insurance and higher incomes. The gaps between men and women, low and higher incomes, and people with Medicaid and private insurance have narrowed in the past decade.
 People who abuse or are dependent on:
o prescription opioid painkillers are 40 times more likely to abuse or be dependent on heroin.
o cocaine are 15 times more likely to abuse or be dependent on heroin.
o marijuana are 3 times more likely to abuse or be dependent on heroin.
o alcohol are 2 times more likely to abuse or be dependent on heroin.
 As heroin abuse or dependence has increased so has heroin-related overdose deaths. From 2002 through 2013, the rate of heroin-related overdose deaths nearly quadrupled.
“Approximately 120 people die each day in the United States of a drug overdose,” said DEA Acting Administrator Chuck Rosenberg. “The CDC’s Vital Signs illustrates two significant factors partly fueling that alarming number – the misuse of prescription drugs and a related increase in heroin use. We will continue to target the criminal gangs that supply heroin, and we will work to educate folks about the dangers and to reduce demand. In this way, we hope to complement the crucial efforts of the CDC and our nation’s public health agencies.”
These key findings highlight the need for a comprehensive response that addresses the growing number of demographic groups using heroin along with multiple other drugs and should be considered in the development and implementation of prevention policies.
"We are working with federal, state and local partners to increase access to effective treatment, while reducing overdoses and other consequences of the opioid epidemic, including the spread of Hepatitis C and HIV," said Michael Botticelli, director of National Drug Control Policy. "It is not enough to simply reverse overdoses. We must also connect overdose victims and people struggling with prescription drug and heroin use disorders to treatment facilities and doctors that offer medication-assisted treatment."
States play a central role in addressing and helping to reverse the heroin epidemic; states can:
 Address the strongest risk factor for heroin abuse or dependence: abuse or dependence on prescription opioid painkillers.
o Make prescription drug monitoring programs (electronic databases that track the dispensing of certain drugs) timely and easy to use. Providers can analyze patient prescription-drug history and make informed decisions before prescribing opioid painkillers.
o Look at the data and practices of state Medicaid and worker’s compensation programs to identify and reduce inappropriate prescribing.
 Increase access to substance abuse treatment services, including medication-assisted treatment (MAT) for opioid abuse or dependence.
o Work with Medicaid and other insurance companies to provide coverage for MAT.
o Support adoption of MAT in community settings.
 Expand access to and training for administering naloxone to reduce opioid overdose deaths.
 Ensure that people have access to integrated prevention services, including access to sterile injection equipment from reliable sources, as allowed by local policy.
 Help local jurisdictions to put these effective practices to work in communities where drug abuse or dependence is common.
Health and Human Services Secretary Sylvia M. Burwell has made addressing opioid abuse, dependence, and overdose a priority and work is underway within HHS on this important issue. The evidence-based initiative focuses on three promising areas: informing opioid prescribing practices, increasing the use of naloxone - a drug that reverses symptoms of a drug overdose, and using medication-assisted treatment to slowly move people out of opioid addiction. The Obama administration is also committed to tackling the prescription drug and heroin epidemic by proposing significant investments to intensify efforts to reduce opioid misuse and abuse.
For more information about prescription drug overdose, please visit www.cdc.gov/drugoverdose.
Vital Signs is a CDC report that appears on the first Tuesday of the month as part of the CDC journal Morbidity and Mortality Weekly Report. The report provides the latest data and information on key health indicators. These are cancer prevention, obesity, tobacco use, motor vehicle passenger safety, prescription drug overdose, HIV/AIDS, alcohol use, health care-associated infections, cardiovascular health, teen pregnancy, food safety and viral hepatitis.