https://www.miamiherald.com/news/recalls/article254431553.html
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
Friday, September 24, 2021
"Eleven lots of the compounded intravenous antibiotic Cefazolin have been recalled after manufacturer IntegraDose Compounding Services said there was “a lack of sterility assurance resulting from compounding in a newly installed biologic safety cabinet without completing dynamic smoke study testing.”A recalled antibiotic might not be sterile. That can cause ‘life-threatening’ infections BY DAVID J. NEAL SEPTEMBER 22, 2021 10:15 AM
Monday, September 20, 2021
Friday, September 17, 2021
South Hills Pharmacist Pleads to Health Care Fraud Conspiracy, Fraudulently Obtaining Controlled Substances and Misbranding Drugs
Department of Justice
U.S. Attorney’s Office
Western District of Pennsylvania
FOR IMMEDIATE RELEASE
Friday, September 17, 2021
South Hills Pharmacist Pleads to Health Care Fraud Conspiracy, Fraudulently Obtaining Controlled Substances and Misbranding Drugs
PITTSBURGH, PA - A South Hills pharmacist pleaded guilty in federal court to charges of obtaining controlled substances by fraud, misbranding of drugs, and health care fraud conspiracy, Acting United States Attorney Stephen R. Kaufman announced today.
Timothy W. Forester, 46, of Venetia, PA pleaded guilty to three counts before Senior United States District Judge David S. Cercone.
In connection with the guilty plea, the court was advised that Forester was a licensed pharmacist who owned four pharmacies – Century Square Pharmacy in West Mifflin, PA and Prescription Center Plus with locations in South Park, PA, McMurray, PA and Eight Four, PA. From on or about November 14, 2018, to on or about February 14, 2019, Forester admitted he knowingly, intentionally and unlawfully obtained oxycodone and hydrocodone, Schedule II controlled substances, by misrepresentations, fraud, and deception. Forester admitted he did not place the controlled substances into the inventories of the four pharmacies and did not maintain records to show the controlled substances were dispensed. In addition, Forester admitted he relabeled generic drugs as name brand medications and then sold them as if they were the more expensive drugs. Finally, Forester admitted filling prescriptions with generic drugs, but billing Medicare and Medicaid for the more expensive name brand drugs, thereby committing health care fraud and causing a loss to Medicare and Medicaid of approximately $680,000.
“Timothy Forester ordered opioids without adding them to inventory, mislabeled generic drugs as name-brand medications, and billed Medicare and Medicaid for name-brand drugs when he provided generics, all in violation of federal law,” said Acting U.S. Attorney Kaufman, “We will continue to pursue medical professionals who engage in fraud schemes to enrich themselves at the expense of their patients.”
“U.S. consumers rely on health care professionals to follow FDA requirements pertaining to prescription medications. When they take actions to evade these requirements, they put patient health at risk,” said Special Agent in Charge Mark S. McCormack, FDA Office of Criminal Investigations Metro Washington Field Office. “We will continue to investigate and bring to justice those who threaten the safety of the nation’s drug supply and, ultimately, the patients who take those drugs.”
“Pharmacy professionals who mishandle opioids in an effort to enrich themselves only exacerbate the challenges and devastation families and communities experience as a result of our nation's opioid epidemic," said Maureen R. Dixon, Special Agent in Charge for the Inspector General’s Office of the U.S. Department of Health and Human Services in Philadelphia. “We will continue to work with our law enforcement partners to bring unscrupulous health professionals to justice.”
“Pharmacists such as Forester have an obligation to properly dispense and safeguard controlled substances such as oxycodone and hydrocodone,” said Thomas Hodnett, Acting Special Agent in Charge of the Drug Enforcement Administration’s (DEA) Philadelphia Field Division. “Forester used his position of trust and access to obtain these powerful painkillers for his own use through fraud and deception.”
Judge Cercone scheduled sentencing for February 8, 2020 at 11:30 a.m. As to Count 1, the law provides for a maximum sentence of four years in prison, a fine of $250,000 or both. As to Count 11, the law provides for a maximum sentence of three years in prison, a fine of $250,000 or both. As to Count 12, the law provides for a maximum sentence of 10 years in prison, a fine of $250,000 or both. Under the Federal Sentencing Guidelines, the actual sentence imposed is based upon the seriousness of the offenses and the prior criminal history, if any, of the defendant.
Assistant United States Attorney Robert S. Cessar is prosecuting this case on behalf of the government.
The investigation leading to the filing of charges in this case was conducted by the Western Pennsylvania Opioid Fraud and Abuse Detection Unit, which combines personnel and resources from the following agencies to combat the growing prescription opioid epidemic: Federal Bureau of Investigation, U.S. Health and Human Services – Office of Inspector General, Drug Enforcement Administration, Internal Revenue Service-Criminal Investigations, Pennsylvania Office of Attorney General - Medicaid Fraud Control Unit, United States Postal Inspection Service, U.S. Attorney’s Office – Criminal Division, Civil Division and Asset Forfeiture Unit, Department of Veterans Affairs-Office of Inspector General, Food and Drug Administration-Office of Criminal Investigations and the Pennsylvania Bureau of Licensing.
Topic(s):
Prescription Drugs
Health Care Fraud
Component(s):
A federal grand jury today returned a five-count indictment charging a Gloucester County, New Jersey, man with defrauding his employer’s health insurance plan out of more than $4 million by submitting fraudulent claims for medically unnecessary compounded medications, Acting U.S. Attorney Rachael A. Honig announced today.
Department of Justice
U.S. Attorney’s Office
District of New Jersey
FOR IMMEDIATE RELEASE
Friday, September 17, 2021
Gloucester County Man Charged with Fraud for Role in Healthcare Conspiracy
CAMDEN, N.J. – A federal grand jury today returned a five-count indictment charging a Gloucester County, New Jersey, man with defrauding his employer’s health insurance plan out of more than $4 million by submitting fraudulent claims for medically unnecessary compounded medications, Acting U.S. Attorney Rachael A. Honig announced today.
Christopher Gualtieri, 48, of Franklinville, New Jersey, is charged with conspiracy to commit health care fraud and mail fraud and individual acts of mail fraud. Gualtieri was also charged with making false statements to federal agents during the investigation, as well as preparing and filling fraudulent oxycodone prescriptions. Gualtieri is scheduled to appear today by videoconference before U.S. Magistrate Judge Sharon A. King. The case is assigned to U.S. District Judge Robert B. Kugler in Camden.
According to the indictment:
Compounded medications are specialty medications mixed by a pharmacist to meet the specific medical needs of an individual patient. Compounded drugs can be 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.
Gualtieri and others learned that certain compound medication prescriptions – including vitamins, scar creams, pain creams, and sunscreens – were reimbursed by their health insurance plan for up to thousands of dollars for a one-month supply. Gualtieri recruited co-workers who were covered by their employer’s self-funded health insurance plan to agree to receive medically unnecessary compounded medications for themselves and their family members. Gualtieri and others caused the submission of fraudulent prescriptions to compounding pharmacies, which filled the prescriptions and billed the health insurance plan’s pharmacy benefits administrator. The pharmacy benefits administrator paid the compounding pharmacies more than $4 million for compounded medications arranged by Gualtieri and two conspirators for themselves, their dependents, and other family members. Gualtieri received a portion of the amount paid by the pharmacy benefits administrator to the compounding pharmacies. Gualtieri then paid cash and other remuneration to his conspirators for their participation in the scheme. When questioned by special agents of the FBI, Gualtieri falsely denied recruiting others to receive compounded medications and falsely denied paying cash to others for their participation in the scheme.
During the same time period as the conspiracy involving compounded medications, Gualtieri also prepared and filled fraudulent prescriptions for oxycodone for himself and a family member.
Gualtieri faces a maximum penalty on the conspiracy and mail fraud counts of 20 years in prison, a maximum penalty on the false statements count of five years in prison, and a maximum penalty on the obtaining drugs by fraud count of four years in prison. He also faces a fine on each count of up to $250,000 or twice the gross gain or gross loss from the offense, whichever is greatest.
Acting U.S. Attorney Honig credited agents of the FBI, Philadelphia Field Office, Health Care Fraud Task Force, under the direction of Acting Special Agent in Charge Bradley S. Benavides, and task force members from the Pennsylvania Attorney General’s Office, Department of Health and Human Services – Office of Inspector General, and the Philadelphia Police Department, as well as diversion investigators of the Drug Enforcement Administration, New Jersey Division, Camden Resident Office, under the direction of Special Agent in Charge Susan A. Gibson, with the investigation leading to the indictment. Acting U.S. Attorney Honig also thanked U.S. Postal Service – Office of Inspector General, for their assistance in the investigation.
The government is represented by Assistant U.S. Attorney Jeffrey Bender of the U.S. Attorney’s Office in Camden.
The charges 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:
21-416
Department of Justice
U.S. Attorney’s Office
Southern District of Georgia
FOR IMMEDIATE RELEASE
Friday, September 17, 2021
National healthcare fraud enforcement action results in charges involving more than $1.4 billion in alleged losses
Six defendants, more than $50 million in Southern District of Georgia
Six defendants, more than $50 million in Southern District of Georgia
WASHINGTON: A strategically coordinated, six-week nationwide federal law enforcement action has resulted in criminal charges against 138 defendants, including 42 doctors, nurses, and other licensed medical professionals, in 31 federal districts across the United States for their alleged participation in various healthcare fraud schemes for more than $1.4 billion in alleged losses.
The enforcement action includes criminal charges against six defendants here in the Southern District of Georgia. The charges announced involve some defendants accused of committing a kickback conspiracy involving cancer genomic testing claims, and other defendants accused of illegal distribution of opioids. The Southern District of Georgia’s announced charges account for more than $50 million in collective billings to federal health benefit programs.
Nationwide, the charges target approximately $1.1 billion in fraud committed using telemedicine, more than $29 million in COVID-19 health care fraud, more than $133 million connected to substance abuse treatment facilities, or “sober homes,” and more than $160 million connected to other health care fraud and illegal opioid distribution schemes across the country.
“The vigilance of our law enforcement partners plays a vital role in identifying illegal healthcare activities throughout the nation and the Southern District of Georgia,” said David H. Estes, Acting U.S. Attorney for the Southern District of Georgia. “We will continue to hold accountable those who would seek to gain illicit profit by criminally exploiting our nation’s healthcare safety net.”
“This nationwide enforcement action demonstrates that the Criminal Division is at the forefront of the fight against health care fraud and opioid abuse by prosecuting those who have exploited health care benefit programs and their patients for personal gain,” said Assistant Attorney General Kenneth A. Polite Jr. of the Justice Department’s Criminal Division. “The charges announced today send a clear deterrent message and should leave no doubt about the department’s ongoing commitment to ensuring the safety of patients and the integrity of health care benefit programs, even amid a continued pandemic.”
Today’s enforcement actions were led and coordinated by the Health Care Fraud Unit of the Criminal Division’s Fraud Section, in conjunction with its Health Care Fraud and Appalachian Regional Prescription Opioid (ARPO) Strike Force program, and its core partners, the U.S. Attorneys’ Offices, the Department of Health and Human Services Office of Inspector General (HHS-OIG), FBI, and the Drug Enforcement Administration (DEA), as part of the department’s ongoing efforts to combat the devastating effects of health care fraud and the opioid epidemic. The Southern District of Georgia worked with the Justice Department’s Criminal Division and agents from HHS-OIG, FBI, and DEA in the investigation and prosecution of these cases.
Telemedicine Fraud Cases
The largest amount of alleged fraud loss charged in connection with the cases announced today – more than $1.1 billion in allegedly false and fraudulent claims submitted by 43 criminal defendants in 11 judicial districts nationwide – relates to schemes involving telemedicine: the use of telecommunications technology to provide health care services remotely. In the Southern District of Georgia, two marketers were charged by way of Information relating to their role in a conspiracy that bought and sold cancer genomic (“CGx”) testing for Medicare beneficiaries. Court documents allege that the CGx tests bought in that conspiracy were ultimately billed to Medicare by a series of laboratories for more than $45 million.
The continued focus on prosecuting health care fraud schemes involving telemedicine reflects the success of the nationwide coordinating role of the Fraud Section’s National Rapid Response Strike Force.
“Healthcare crimes hurt every taxpayer and put profits over the care of our nation’s most vulnerable citizens,” said Chris Hacker, Special Agent in Charge of FBI Atlanta. “It puts a tremendous strain on our federally-subsidized health care programs. The FBI and our federal partners will hold accountable anyone who usurps healthcare assistance for their personal greed.”
The focus on telemedicine fraud also builds on the telemedicine component of last year’s national takedown and the impact of the 2019 “Operation Brace Yourself” Telemedicine and Durable Medical Equipment Takedown, which resulted in an estimated cost avoidance of more than $1.9 billion in the amount paid by Medicare for orthotic braces in the 20 months following that takedown. The Southern District of Georgia has played a major role in these nationwide schemes, having charged more than 30 defendants responsible for a collective $1.6 billion in billings across Operation Brace Yourself, Operation Double Helix, and Operation Rubber Stamp. The Southern District of Georgia kickback charges announced today are being prosecuted by Assistant U.S. Attorney Jonathan A. Porter.
Cases Involving the Illegal Prescription and/or Distribution of Opioids and Cases Involving Traditional Health Care Fraud Schemes
The cases announced today involving the illegal prescription and/or distribution of opioids include 19 defendants, including several charges against medical professionals and others who prescribed more than 12 million doses of opioids and other prescription narcotics while submitting more than $14 million in false billings. The cases that fall into more traditional categories of healthcare fraud include charges against more than 60 defendants who allegedly participated in schemes to submit more than $145 million in false and fraudulent claims to Medicare, Medicaid, TRICARE, and private insurance companies for treatments that were medically unnecessary and often never provided.
In the Southern District of Georgia, three South Georgia medical professionals were indicted for illegal distribution of opioids and conspiracy to commit health care fraud. The indictment alleges that the charged physician, nurse practitioner, and physician assistant operated a nominal pain clinic that distributed opioids with no legitimate medical purpose. These charges are being prosecuted by Assistant U.S. Attorneys Matthew A. Josephson and Bradford C. Patrick.
“The public relies on medical professionals to be part of the solution to our nation’s prescription drug abuse epidemic – not to worsen the problem by distributing controlled substances without a legitimate medical purpose," said Special Agent in Charge Derrick L. Jackson of HHS-OIG. “Working closely with our law enforcement partners, we will continue to investigate unscrupulous providers who prey on vulnerable members of the public.”
“Medical practitioners who unlawfully dispense dangerous, addictive and potentially deadly substances do so under the guise of a stethoscope and white coat to hide behind a veil of legitimacy. They commit fraudulent acts and prey on patients who are addicted to prescription opioids and are unfit to administer care to anyone,” said Robert J. Murphy, Special Agent in Charge of the DEA Atlanta Field Division. “DEA and its law enforcement partners stand united and are committed to bringing those to justice who engage in these unlawful acts.”
Prior to the charges announced as part of today’s nationwide enforcement action and since its inception in March 2007, the Health Care Fraud Strike Force, which maintains 15 strike forces operating in 24 districts, has charged more than 4,600 defendants who have collectively billed the Medicare program for approximately $23 billion. In addition to the criminal actions announced today, CMS, working in conjunction with HHS-OIG, announced 28 administrative actions to decrease the presence of fraudulent providers.
The National Rapid Response Strike Force also announced prosecutions across the country today regarding $128 million in COVID-19 fraud, cases and nearly $1 billion in fraud cases involving sober homes.
A complaint, information or indictment is merely an allegation, and all defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.
To view Assistant Attorney General Polite’s remarks, go to: https://www.justice.gov/opa/video/assistant-attorney-general-kenneth-polite-jr-delivers-remarks-health-care-enforcement.
Topic(s):
Health Care Fraud
Component(s):
Contact:
Barry L. Paschal, Public Affairs Officer: 912-652-4422
Press Release Number:
146-21
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