Tuesday, January 25, 2022

 

6 days ago — We write to you today regarding our concerns with the Food and Drug Administration's. (FDA) Guidance for Industry #256, “Compounding Animal Drugs fro

 Department of Justice

U.S. Attorney’s Office
Western District of Virginia

FOR IMMEDIATE RELEASE
Monday, January 24, 2022

Former Veterinarian Pleads Guilty to Drug Charges

LYNCHBURG, Va. – A Madison Heights, Virginia man and former veterinarian pleaded guilty to a pair of misdemeanor drug charges related to his diversion of hydromorphone, an opioid drug also known under the trade name of “Dilaudid.”

Patrick Gries, 54, pleaded guilty last week to one count of adulteration of a drug held for sale after shipment in interstate commerce and one count of distribution of a controlled substance without a written prescription.

“The U.S. Attorney’s Office is committed to working with our partners at the FDA, and elsewhere, to ensure consumer products are stored and prescribed using the most safe and secure protocols possible,” United States Attorney Christopher R. Kavanaugh said today. “When individuals with access to controlled substances break those safety protocols, even for individual use, they must be held accountable.”

“The FDA oversees the U.S. drug supply to ensure that it is safe and effective, and those who knowingly tamper with medicines put the health of patients (whether they are human or animal) at risk,” said Special Agent in Charge Mark S. McCormack, FDA Office of Criminal Investigations Metro Washington Field Office. “We will continue to protect the public health and bring to justice health care professionals who take advantage of their unique position and compromise their patients’ health and comfort by tampering with needed drugs.”

According to court documents, from 1994 through 2021, Gries practiced as a Doctor of Veterinary Medicine at a veterinary hospital in Amherst County, Virginia. The veterinary hospital held hydromorphone for sale and maintained supplies of hydromorphone for use in treating pain in the hospital’s animal patients following surgeries.

As the hospital’s primary surgeon, Gries had full access to the hospital’s supply of hydromorphone. Beginning in July 2020 and without a valid prescription, Gries diverted hydromorphone for personal use by withdrawing a portion of the hydromorphone from the vial and injecting it into himself. He would then replace the diverted portion of the hydromorphone with another substance, usually either saline or butorphonal, and then return the altered hydromorphone to the supply maintained by the hospital.

The Food and Drug Administration - Office of Criminal Investigations, the Drug Enforcement Administration - Diversion Control Division, and the Virginia State Police investigated the case. 

Updated January 24, 2022

 

4 days ago — Drug Compounding. 39. Prescriptions. 40. Expired/Adulterated Drugs. 41. General Record Keeping. 43. Temporary Removal of Drugs. 45. Chemical Capture.

 

7 hours ago — Additionally, all pharmacies that compound drugs must maintain a set of ... For non-patient specific or “office use” of non-sterile compounded drugs, ...

Sunday, January 23, 2022

Mark Cuban's drug company launches online pharmacy

https://www.beckershospitalreview.com/pharmacy/mark-cuban-s-drug-company-launches-online-pharmacy.html 

 Department of Justice

U.S. Attorney’s Office
Southern District of California

FOR IMMEDIATE RELEASE
Thursday, January 20, 2022

San Diego Pharmacy Pays $105,000 Penalty for Illegitimately Dispensing Opioids

SAN DIEGO – San Diego’s Balboa Pharmacy has paid $105,000 to resolve allegations that it illegally dispensed opioids and other dangerous drugs to its patients, according to a settlement agreement signed by Balboa Pharmacy and the United States. The settlement stems from the United States’ continued efforts to combat the opioid epidemic on all fronts, including this investigation of whether Balboa Pharmacy illegally dispensed opioids to its patients in violation of the federal Controlled Substances Act.

The Controlled Substances Act states that pharmacists have a responsibility to only fill prescriptions that are written for a legitimate medical purpose while acting in the usual course of professional practice. The United States alleged that Balboa Pharmacy failed to meet its responsibility when it filled opioid prescriptions without resolving—or often even attempting to resolve—“red flags” that the prescriptions raised. “Red flags” are indications that a prescription may be invalid. According to the settlement agreement, Balboa Pharmacy filled prescriptions without resolving the following commonly known red flags:

  • large quantities of opioids well above guidelines for treating patients, which sometimes exceeded a daily Morphine Milligram Equivalent of 100;
  • dangerous combinations of drugs, including duplicative therapy; opioids and benzodiazepines (e.g., Valium, Xanax); and opioids, benzodiazepines, and muscle relaxants (e.g., Soma), a combination that is colloquially referred to by drug abusers as the “trinity” because of the rapid euphoric effects of this combination of drugs;
  • patients who received prescriptions from multiple prescribers, which sometimes were for the same types of controlled substances or for dangerous combinations of drugs; and
  • filling prescriptions for patients early, which includes filling a patient’s prescription before the patient’s earlier prescription for the same drug ran out.

The investigation exemplifies the Department of Justice’s willingness to investigate pharmacies that may be filling dangerous prescriptions without first confirming the legitimacy of each prescription. Public health experts have long warned health care providers that overdose risk is elevated in patients receiving medically prescribed opioids, particularly those receiving high dosages. Pharmacists should carefully track the potency of opioids dispensed to patients by noting the Morphine Milligram Equivalent (MME, also commonly referred to as Morphine Equivalent Dose or MED) of prescribed opioids. Among other things, tracking MMEs advances better practices for pain management by reinforcing the need to consider alternatives to using high-dosage opioids to treat pain, and to appropriately justify decisions to use opioids at dosages that place patients at high risk of addiction, abuse, and overdose. Furthermore, dispensing high dosages increases the risk that patients will divert opioids.

“Pharmacies are the last line of defense protecting the public from addictive opioids and other controlled substances,” said U.S. Attorney Randy S. Grossman. “This office will pursue pharmacists who carelessly disregard red flags, opting instead to rubberstamp questionable prescriptions. We will continue to use all available tools to combat the serious opioid epidemic.” Grossman thanked the prosecution team and investigators for their excellent work on this case.

In addition to the settlement agreement, the DEA and Balboa Pharmacy entered into a Memorandum of Agreement in October 2021 in which Balboa Pharmacy agreed to, among other things, develop policies and procedures and training that address the identification and resolution of “red flags.”

“This investigation is a reminder that all pharmacies have a responsibility to ensure that prescriptions are issued for a legitimate medical purpose,” said DEA Special Agent in Charge Shelly S. Howe.  “Failure to do so allows prescriptions to become subject to abuse and diversion, fueling the ongoing opioid epidemic.  DEA will continue to hold pharmacies, such as Balboa Pharmacy, accountable.”

To report a tip directly to a DEA representative regarding medical personnel writing suspicious opioid prescriptions and pharmacies dispensing large amounts of opioids, call (571) 324-6499, or visit the DEA’s website (https://www.deadiversion.usdoj.gov/) and click on “Report Illicit Pharmaceutical Activities.”

Assistant U.S. Attorney Dylan M. Aste of the U.S. Attorney’s Office for the Southern District of California handled this matter along with DEA investigators.

The claims resolved by this settlement are allegations only and there has been no determination of liability.

 

Topic(s): 
Opioids
Contact: 
Assistant U. S. Attorney Dylan M. Aste (619) 546-7621
Press Release Number: 
CAS22-0120-Balboa Pharmacy

 Department of Justice

U.S. Attorney’s Office
Southern District of Georgia

FOR IMMEDIATE RELEASE
Thursday, January 20, 2022

Jacksonville pharmacist, pharmacy owner admit to charges related to illegally filling drug prescriptions issued by south Georgia doctor

Both await sentencing in federal court

BRUNSWICK, GA: A pharmacist and a pharmacy owner await sentencing after pleading guilty to charges related to a conspiracy to unlawfully dispense controlled substances.

Gilbert Nelson Weise, Jr., 58, of Jacksonville, Fla., faces up to five years in prison after pleading guilty to a charge of conspiracy to dispense controlled substances without a legitimate medical purpose and not in the usual course of professional practice, said David H. Estes, U.S. Attorney for the Southern District of Georgia. Weise also faces substantial financial penalties and up to three years of supervised release after completion of any prison term. There is no parole in the federal system.

“As demonstrated through this investigation, pill-mill clinics cannot thrive without pharmacists willing to fill their unlawful prescriptions,” said U.S. Attorney Estes. “Pharmacists have an obligation to scrutinize suspicious controlled substances and ensure they are issued for legitimate purpose. In this case, not only did the defendant negligently ignore the presence of red flags, but he also knowingly and intentionally agreed to fill prescriptions that he knew to be unlawful and appropriately is being held to account.”

As described in court documents, from on or about Oct. 9, 2014 to June 13, 2017, in Camden County, in the Southern District of Georgia, in the Middle District of Florida, and elsewhere, Weise and others conspired to dispense hydromorphone, oxycodone, and hydrocodone, among other drugs, for no legitimate medical purpose and outside the usual course of professional practice, in violation of federal law. The prescriptions in question were issued at a nominal pain management clinic known as Coastline Physical Medicine and Rehabilitation, Inc. in St. Mary’s, Ga. The physician at Coastline – who was charged in the indictment but subsequently judged incapable of standing trial – routinely dispensed controlled substances not for a legitimate medical purpose and not in the usual course of professional practice and in so doing generated significant amounts of cash. Between Oct. 9, 2014 and June 13, 2017, drug-seeking customers typically paid approximately $300 cash to Coastline in exchange for prescriptions. To enable more patients to fill their prescriptions, a co-conspirator contacted Weise, Jr., who agreed to fill Coastline’s prescriptions at Weise Prescription Shop located in Jacksonville, Fla.

Given the high volume of Coastline’s prescriptions, a second pharmacy known as Coastal RX Pharmacy also began filing Coastline’s prescriptions. The co-owner of Coastal RX Pharmacy, Amy G. Taylor, 42, of Jacksonville, also awaits sentencing after pleading guilty to an information charging Misprision of Felony. Specifically, Taylor agreed that she had knowledge of and concealed the unlawful conspiracy and did not report that knowledge to a lawful authority, in violation of federal law. This charge carries a statutory maximum sentence of three years in prison, along with substantial financial penalties and a one-year term of supervised release.

“Dispensing addictive prescription pain medication under the guise of a doctor’s care puts greed above an individual’s specific health needs and the trust of the community,” said Robert J. Murphy, the Special Agent in Charge of the DEA Atlanta Field Division. “Individuals like Weise and his associates who are involved in this ‘pill mill’ activity are nothing more than drug dealers who are licensed to wear white coats and fill prescriptions. Thanks to a concerted effort from our law enforcement partners, south Georgia and its surrounding communities are safer today.”

The case was investigated by the DEA and the Southern District of Georgia U.S. Attorney’s Office Investigator Charles Sikes and prosecuted for the United States by Assistant U.S. Attorneys Greg Gilluly, Mathew Josephson and Karl Knoche.

Topic(s): 
Drug Trafficking
Opioids
Prescription Drugs
Contact: 
Barry L. Paschal, Public Affairs Officer: 912-652-4422
Press Release Number: 
12-22

Infusion Pharmacies Call for Investigation, Regulation of Direct Access Infusion Businesses: "These “mobile IV therapy” businesses advertise IV “treatments” for everything from hangovers to migraines to altitude sickness and COVID-19. “

https://www.specialtypharmacycontinuum.com/Online-First/Article/01-22/Infusion-Pharmacies-Call-for-Investigation-Regulation-of-Direct-Access-Infusion-Businesses/65906 

Statement on the Need for State and FDA Review of Direct Access Intravenous Therapy Businesses

https://nhia.org/wp-content/uploads/2022/01/Direct-Access-Infusion-Statement_FINAL.pdf 

Newark Physician and West New York Man Charged with $3.4 Million Health Care and Wire Fraud Conspiracy, Money Laundering, and Making False Statements

 epartment of Justice

U.S. Attorney’s Office
District of New Jersey

FOR IMMEDIATE RELEASE
Thursday, January 20, 2022

Newark Physician and West New York Man Charged with $3.4 Million Health Care and Wire Fraud Conspiracy, Money Laundering, and Making False Statements

CAMDEN, N.J. – A Newark physician and West New York man are scheduled to make their initial appearances today on charges of defrauding New Jersey state and local health benefits programs and other insurers out of more than $3.4 million by submitting fraudulent claims for medically unnecessary prescriptions, U.S. Attorney Philip R. Sellinger announced.

Kaival Patel, 53, of West New York, New Jersey, and Saurabh Patel, M.D., 51, a Woodbridge, New Jersey, resident, are charged in a 12-count indictment with conspiracy to commit health care fraud, and wire fraud and four counts of health care fraud. Kaival Patel is also charged with conspiracy to commit money laundering, substantive counts of money laundering, and making false statements to federal agents. The defendants appeared today by videoconference before U.S. Magistrate Judge Sharon A. King and were released on $250,000 each unsecured bond.

According to the indictment:

Kaival Patel and his wife – referred to in the indictment as “Individual 1” – operated a company called ABC Healthy Living LLC (ABC) to market medical products and services, including compound prescription medications. Saurabh Patel is a medical doctor who owned and operated a clinic – referred to in the indictment as “Medical Practice 1” – in Newark. Saurabh Patel is related to Kaival Patel and Individual 1. Paul Camarda, a pharmaceutical sales representative who is listed as a conspirator, pleaded guilty before Judge Kugler in Camden federal court on July 6, 2021, to health care conspiracy and conspiring to commit money laundering and obstruct justice and is awaiting sentencing.

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.

Kaival Patel, Saurabh Patel, Camarda, and others learned that certain state and local government employees had insurance that would reimburse up to thousands of dollars for a one-month supply of certain compounded medications. The defendants submitted fraudulent insurance claims for prescription compounded medications to a pharmacy benefits administrator, which provided management services for certain insurance plans that covered state and local government employees. The defendants steered individuals recruited to receive medications from the compounding pharmacies to Saurabh Patel’s medical practice, which enabled him to fraudulently receive insurance payments for those patient visits and procedures. The conduct caused the benefits administrator to pay out $3.4 million in fraudulent claims.

The health care fraud and wire fraud conspiracy count carries a maximum potential penalty of 20 years in prison; the health care fraud charges carry a maximum potential penalty of 10 years in prison; the false statement count carries a maximum penalty of five years in prison – all of these counts are also punishable by a fine of $250,000, or twice the gain or loss from the offense, whichever is greatest. The money laundering charges carry a maximum term of 10 years in prison and a fine of $250,000, or twice the gross gain or loss from the offense or not more than twice the amount of the criminally derived property involved in the transactions.

U.S. Attorney Sellinger credited special agents of the IRS - Criminal Investigation, under the direction of Special Agent in Charge Michael Montanez in Newark; special agents of the FBI’s Atlantic City Resident Agency, under the direction of Special Agent in Charge George M. Crouch Jr. 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 indictment.

The government is represented by Assistant U.S. Attorneys Christina O. Hud and R. David Walk Jr. of the Criminal Division in Camden.

The charges and allegations contained in the indictment are merely accusations, and the defendants are presumed innocent unless and until proven guilty.

Topic(s): 
Health Care Fraud
Component(s): 
Press Release Number: 
22-021

 https://deathpenaltyinfo.org/news/investigative-report-idaho-records-reveal-states-efforts-to-conceal-ghost-purchase-of-execution-drugs-and-out-of-state-cash-payment-to-pharmacy-with-dubious-regulatory-history

Wednesday, January 19, 2022

Rx Compounding Pharmacy ordered to pay $4.4 million in restitution for compounding pharmacy scheme

 here

 

 

Tuesday, January 18, 2022

 

4 days ago — Mom-and-pop pharmacies proliferate despite being situated doors down from Walgreens. Agents say — and prosecutions prove — that something suspicious is ...

 

3 days ago — ... guilty to a kickback scheme that defrauded TRICARE out of $42 million.Federal prosecutors say White and three others owned and operated Florida Pharmacy […]

 FOR IMMEDIATE RELEASE

Wednesday, January 12, 2022

Ringleader in prescription drug conspiracy sentenced to federal prison

Defendant forged prescriptions to obtain highly addictive opioid

SAVANNAH, GA:  The leader of a conspiracy that used forged prescriptions to obtain and sell large amounts of highly addictive opioids has been sentenced to federal prison.

Raheem Hardy, 29, of Decatur, Ga., was sentenced to 55 months in prison after pleading guilty to Conspiracy to Possess with Intent to Distribute Oxycodone, said David H. Estes, U.S. Attorney for the Southern District of Georgia. U.S. District Court Judge R. Stan Baker also ordered Hardy to serve three years of supervised release after completion of his prison term. There is no parole in the federal system.

“By forging wholesale numbers of fake prescriptions, Raheem Hardy poured fuel on the raging fires of opioid addiction,” said U.S. Attorney Estes. “The teamwork of our law enforcement partners brought this scheme to an end, and Hardy is being held accountable.”

As described in court documents and testimony, Hardy created forged prescriptions for drugs, including the opioid pain medication Oxycodone, using the names and DEA registration numbers of at least six physicians. He then sold the paper prescriptions to others in the conspiracy who filled the prescriptions and sold the drugs to users.  The scheme crossed Georgia into South Carolina and Alabama, as conspirators filled or attempted to fill prescriptions in those states. The conspiracy resulted in the unlawful acquisition and distribution of more than 4,000 pills.

The case originated in December 2019 in the U.S. Drug Enforcement Administration’s Tactical Diversion Squad in Columbia, S.C., when fraudulent prescriptions were presented to multiple pharmacies in the area.  In April 2020, a pharmacist in Savannah raised an alarm when she questioned the authenticity of a conspirator’s prescription for Oxycodone and contacted the Savannah Police Department and the DEA Savannah Tactical Diversion Squad. A February 2021 indictment alleged Hardy and nine co-conspirators filled at least several dozen fraudulent prescriptions across Georgia to procure thousands of pills.

Six other defendants have pled guilty and been sentenced to incarceration.  Three defendants are awaiting trial and are considered innocent unless and until proven guilty.

“Although these pills came from legitimate pharmacies, the prescriptions were fake,” said Robert J. Murphy, the Special Agent in Charge of the DEA Atlanta Field Division. “Raheem Hardy and his accomplices are not licensed medical professionals, and had no business filling prescriptions for these highly sought after pills. After this sentencing, other criminals have been put on notice that these illicit activities will lead to significant time behind bars.”

The case was investigated by the DEA Tactical Diversion Squads in Savannah and Columbia, S.C.; the Chatham-Savannah Counter Narcotics Team; the Pooler Police Department; and the Savannah Police Department, with assistance from South Carolina Department of Health and Environmental Control, the Columbia County Sheriff’s Office and Richmond County Sheriff’s Office, and prosecuted for the United States by Southern District of Georgia Assistant U.S. Attorneys Matthew A. Josephson and Organized Crime Drug Enforcement Task Force Coordinator Marcela C. Mateo.

Topic(s): 
Drug Trafficking
Opioids
Prescription Drugs
Contact: 
Barry L. Paschal, Public Affairs Officer: 912-652-4422
Press Release Number: 
08-22