Tuesday, December 14, 2021

 

7 hours ago — Some compounded drugs, including those used for HT, have been suspected of contamination and potency issues.5,6 US. FDA surveys conducted in 2001 and 2006, to ...

Monday, December 13, 2021

 

4 hours ago — FDA Plans Rules On 503A Compounding, Product Classification, Tobacco. By Beth Wang / December 13, 2021 at 6:38 PM. Share. FDA plans to issue a handful of ..

Saturday, December 11, 2021

Pharmaceutical Manufacturers Pay Hundreds of Millions to Settle Price-Fixing Charges December 10, 2021 Skylar Kenney, Assistant Editor Pharmacy Times, December 2021, Volume 87, Issue 12

https://www.pharmacytimes.com/view/pharmaceutical-manufacturers-pay-hundreds-of-millions-to-settle-price-fixing-charges 

 

4 hours ago — HOPE MEDICAL ENTERPRISES, INC. V. FAGRON COMPOUNDING SERVICES, No. 21-55165 (9th Cir. 2021) case opinion from the US Court of Appeals for the Ninth Circuit.

Owner of Local Compounding Pharmacies Sentenced to Federal Prison for Tax Evasion and Health Care Fraud

 Department of Justice

U.S. Attorney’s Office
District of Oregon

FOR IMMEDIATE RELEASE
Friday, December 10, 2021

Owner of Local Compounding Pharmacies Sentenced to Federal Prison for Tax Evasion and Health Care Fraud

PORTLAND, Ore.—A Southern California man who owned and operated two local compounding pharmacies was sentenced to federal prison today for evading the payment of approximately $5.5 million in personal income taxes and submitting false reimbursement claims to CVS Caremark, a national pharmacy benefit manager.

Matthew Hogan Peters, 38, was sentenced to three years in federal prison and three years’ supervised release. Peters was also ordered to pay more than $3,441,263 million in restitution to the IRS, in addition to back taxes Peters has already paid.

“Far too often, Matthew Peters bent and skirted the law to pad his pockets and fund a lavish lifestyle. Peters’ crimes, and the illicit actions of others like him, only serve to increase the cost of healthcare and prescription medications for ordinary Americans,” said Scott Erik Asphaug, Acting U.S. Attorney for the District of Oregon. “Healthcare fraud and tax evasion are serious federal crimes and will continue being handled as such by our office.”

“Health care fraud costs insurers and taxpayers tens of billions of dollars a year. Not only do government-funded programs—such as Medicare and Medicaid—take huge hits, but people in our community end up paying higher premiums for coverage. While neighbors and family members struggle to afford prescriptions and basic coverage, people like Mr. Peters are buying exotic homes and funding a lavish lifestyle,” said Kieran L. Ramsey, Special Agent in Charge of the FBI in Oregon.

“Instead of providing honest pharmaceutical services, Mr. Peters instead focused his energies on a scheme designed to benefit only himself at the expense of the most vulnerable people in our communities,” said Special Agent in Charge Bret Kressin, IRS Criminal Investigation (IRS-CI), Seattle Field Office. “Our country’s tax and health care systems are both essential to the well-being of all Americans, and IRS-CI is committed to protecting the integrity of these vital services.”

According to court documents, the U.S. Department of Health and Human Services’ Office of Inspector General, the Oregon Department of Justice’s Medicaid Fraud Unit, and other agencies pursued a multi-year investigation into alleged illegal kickback arrangements at compounding pharmacies owned by Peters and members of his family in several states. Two such pharmacies, Professional Center Pharmacy and Professional Center 205 Pharmacy, were located in Southeast Portland. 

The investigation ultimately revealed that Peters had devised various indirect means of incentivizing healthcare providers to write prescriptions for compounded drugs—custom-mixed medications that generate outsized reimbursements from Medicare, Medicaid, and other healthcare-benefit programs—and to direct those prescriptions to his pharmacies for dispensing. These arrangements proved enormously profitable for Peters’ pharmacies.

Peters’s healthcare fraud conviction stemmed from his requests for reimbursements from CVS Caremark, a major pharmacy benefits manger based in Arizona. Peters sought reimbursements of approximately $3.4 million for medication his pharmacies had purportedly dispensed. In mid-2015, CVS Caremark audited Peters’s reimbursement claims and identified nearly a quarter-million dollars in potentially unwarranted reimbursements. Dozens of the discrepant claims lacked records proving customers’ receipt of medications.

In October 2015, seeking to resolve these discrepancies and avoid possible suspension from CVS Caremark’s network, Peters submitted to CVS Caremark 41 forged patient attestations, purportedly confirming individual patients’ receipt of prescriptions. CVS Caremark auditors saw that the patient attestations all bore the same unique digital code and, after further investigation, suspended Peters’ pharmacies from their network. A subsequent federal investigation confirmed that Peters had used Docu-Sign, an electronic signature application, from his personal computer to sign the attestations.

Peters greatly expanded his criminal liability by attempting to hide his pharmacy profits from the IRS. The IRS’s financial investigation into Peters revealed that he had generated nearly $14 million in gross income between 2014 and 2017. Peters developed several schemes to try and conceal his income and fraudulently decrease his federal income tax liability. Most of these schemes involved spending pharmacy profits on personal expenses and telling his accountant (and the IRS) that they were legitimate business expenses. 

Peters’s purported business expenses included $3.3 million for property and construction in Belize; more than $5 million for personal residences in Laguna Beach and San Carlos, California and Incline Village, Nevada; and millions in cash transfers to straw entities and trust accounts in the names of others for Peters’ personal use. All told, between 2014 and 2017, Peters underreported his income tax liability by more than $5.4 million.

On December 19, 2019, a federal grand jury in Portland returned a two-count indictment charging Peters with healthcare fraud and aggravated identity theft. Later, on July 20, 2020, he was charged by superseding criminal information with healthcare fraud and tax evasion.

On August 4, 2020, Peters waived indictment and pleaded guilty to health care fraud and tax evasion.

Acting U.S. Attorney Scott Erik Asphaug of the District of Oregon made the announcement.

This case was investigated by the FBI, IRS Criminal Investigation, the Offices of Inspectors General for the U.S. Postal Service and the U.S. Departments of Labor and Health and Human Services, the U.S. Postal Inspection Service, and the Defense Criminal Investigative Service. It was prosecuted by Assistant U.S. Attorneys Ryan W. Bounds and Seth D. Uram and Special Assistant U.S. Attorney Elizabeth Ballard Colgrove, for the District of Oregon.

Topic(s): 
Health Care Fraud
Tax
Component(s): 
Updated December 10, 2021

Thursday, December 9, 2021

Centene Corp. reaches another settlement over pharmacy benefit practices, as a shareholder sues

https://www.bizjournals.com/stlouis/news/2021/12/08/centene-corp-reaches-settlement-kansas-pharmacy.html 

 Department of Justice

Office of Public Affairs

FOR IMMEDIATE RELEASE
Friday, December 3, 2021

Federal Jury Convicts Pharmacy Owner for Role in $174 Million Telemedicine Pharmacy Fraud Scheme

On Dec. 2, a federal jury in Greeneville, Tennessee, convicted Peter Bolos, 44, of Tampa, Florida, of 22 counts of mail fraud, conspiracy to commit health care fraud and introduction of a misbranded drug into interstate commerce, following a month-long trial.

According to court documents and evidence presented at trial, Bolos and his co-conspirators, Andrew Assad, Michael Palso, Maikel Bolos, Larry Smith, Scott Roix, HealthRight LLC, Mihir Taneja, Arun Kapoor, and Sterling Knight Pharmaceuticals, as well as various other companies owned by them, deceived pharmacy benefit managers (PBMs), such as Express Scripts and CVS Caremark, regarding tens of thousands of prescriptions. The PBMs processed and approved claims for prescription drugs on behalf of insurance companies. Bolos and his co-conspirators defrauded the PBMs into authorizing claims worth more than $174 million that private insurers such as Blue Cross Blue Shield of Tennessee, and public insurers such as Medicaid and TRICARE, paid to pharmacies controlled by the co-conspirators.

Court documents and evidence at trial established that Bolos, Assad and Palso owned and operated Synergy Pharmacy in Palm Harbor, Florida. Under their direction, Synergy agreed with Scott Roix, a Florida telemarketer operating under the name HealthRight, to generate prescriptions for Synergy and the other pharmacies involved in the scheme. The prescriptions were typically for drugs such as pain creams, scar creams and vitamins. To obtain the prescriptions, evidence showed Roix used HealthRight’s telemarketing platform as a telemedicine service, calling consumers and deceiving them into agreeing to accept the drugs and to provide their personal insurance information. HealthRight then paid doctors to authorize the prescriptions through its telemedicine platform, even though the doctors never communicated directly with the patients and relied solely on the telemarketers’ screening process as the basis for their authorizations. Because this faulty and fraudulent process made the prescriptions invalid, the drugs were misbranded under the Food, Drug and Cosmetic Act. Synergy and the other pharmacies nonetheless dispensed the drugs to consumers as part of the scheme, so that Bolos could submit fraudulent reimbursement claims.

Court documents and evidence at trial established that during the conspiracy, which lasted from May 2015 through April 2018, Bolos paid Roix more than $30 million to buy at least 60,000 invalid prescriptions generated by HealthRight. Evidence showed Bolos selected specific medications for the prescriptions that he could submit for highly profitable reimbursements. In addition, Bolos used illegal means to hide his activity from the PBMs so that he could remain undetected. Evidence showed that Bolos was responsible for at least $89 million out of the total $174 million in fraudulently paid billings.

“The defendants deceived consumers in order to facilitate the distribution of drugs without proper medical oversight, and overbilled insurers for illegal prescriptions,” said Deputy Assistant Attorney General Arun G. Rao of the Justice Department’s Civil Division. “The Department will continue to investigate and prosecute individuals who use telemedicine to advance fraudulent schemes that violate the Food, Drug, and Cosmetic Act.”

“The United States Attorney’s Office for the Eastern District of Tennessee applauds the unwavering efforts of the multiple agencies involved in this collaborative investigation to bring this extensive healthcare fraud and misbranding scheme to justice,” said Acting U.S. Attorney Francis M. Hamilton III for the Eastern District of Tennessee. “The scope and nature of this fraud and misbranding scheme shock the conscience. Patients were given medications that they neither requested nor wanted, and the trial proof demonstrated that the prescriptions were specifically chosen by Bolos to maximize the fraudulent scheme’s profits, rather than for the patients’ healthcare needs. The guilty verdict against Bolos and the guilty pleas obtained from his co-defendants should send a strong message that the Department of Justice will aggressively prosecute fraud against health insurance providers.”

“Healthcare fraud is an egregious crime problem that impacts every American,” said Special Agent in Charge Joseph E. Carrico of the FBI’s Knoxville Field Office. “The guilty verdict was a result of a multi-agency investigation into a complex health care fraud scheme that required substantial investigative resources. Along with its law enforcement partners, the FBI remains committed to investigate these crimes and prosecute all those that are intent in defrauding the American public." 

“Distributing misbranded prescription drugs in the U.S. marketplace places patients’ health at risk,” said Special Agent in Charge Justin C. Fielder of the FDA Office of Criminal Investigations Miami Field Office. “We will continue to pursue and bring to justice those who put profits ahead of public health.”

“Bolos and his co-conspirators used their pharmacies to fraudulently bill insurance companies hundreds of millions of dollars, and that type of health care fraud impacts everyone,” said Special Agent in Charge John Condon of Homeland Security Investigations (HSI) Tampa. “HSI will continue to work with our law enforcement partners at the federal, state and local level to investigate all fraud and bring those responsible to justice.”

“Bolos and his co-conspirators sought to increase their profits by executing a comprehensive health care fraud scheme involving innocent patients,” said Special Agent in Charge Derrick L. Jackson of the U.S. Department of Health and Human Services, Office of Inspector General. “This conviction should serve as a warning to individuals who wish to deceive the government and steal from taxpayers. Alongside our law enforcement partners, we will continue to pursue medical professionals who engage in fraudulent activity.”

“The verdict in this case sends a clear message that these types of schemes will not be tolerated,” said Special Agent in Charge Matthew Modafferi of the U.S. Postal Service Office of Inspector General in the Northeast Area Field Office. “The Special Agents of the U.S. Postal Service Office of Inspector General will continue to work closely with the U.S. Attorney’s Office and our law enforcement partners to bring to justice those who commit these kinds of offenses.”

Roix, Assad, Palso, Smith, Maikel Bolos and various associated business entities previously pleaded guilty to their roles in the conspiracy. Taneja, Kapoor, and Sterling Knight pleaded guilty to felony misbranding in a conspiracy with Bolos. U.S. District Judge J. Ronnie Greer set sentencing for Bolos for May 19, 2022, in the United States District Court for the Eastern District of Tennessee at Greeneville. Sentencings for the other defendants will be set for dates in 2022.

The trial and plea agreements resulted from a multi-year investigation conducted by the U.S. Department of Health & Human Services Office of Inspector General (Nashville); Food and Drug Administration Office of Criminal Investigations (Nashville); U.S. Postal Service, Office of Inspector General (Buffalo); Federal Bureau of Investigation (Knoxville and Johnson City, Tennessee); Office of Personnel Management Office of Inspector General (Atlanta); and the Department of Homeland Security, Homeland Security Investigations (Tampa). The U.S. Marshals Service also assisted in the investigation and the forfeiture of assets.

Assistant U.S. Attorneys TJ Harker and Mac Heavener for the Eastern District of Tennessee and Trial Attorney David Gunn of the Department of Justice Civil Division’s Consumer Protection Branch in Washington, and a former Assistant U.S. Attorney in Knoxville, prosecuted and tried the case. They were assisted by Barbra Pemberton, Bryan Brandenburg and April Denard from the U.S. Attorney’s office. 

Topic(s): 
Consumer Protection
Press Release Number: 
21-1202
Updated December 3, 2021

Tough Pill to Swallow: $174 Million Telemedicine Pharmacy Fraud Scheme Results in Criminal Convictions Thursday, December 9, 2021

https://www.natlawreview.com/article/tough-pill-to-swallow-174-million-telemedicine-pharmacy-fraud-scheme-results 

 Department of Justice

U.S. Attorney’s Office
District of Massachusetts

FOR IMMEDIATE RELEASE
Wednesday, December 8, 2021

Pharmacist and Two Pharmacies Agree to Resolve Allegations of False Claims for Anti-Overdose Drug

BOSTON – A Michigan pharmacist and two pharmacies agreed to pay $1 million to resolve allegations that they submitted false claims to Medicare for a drug used in rapid reversal of opioid overdoses.

Riad “Ray” Zahr, of Dearborn, Mich. and two specialty pharmacies that Zahr formerly owned and operated have agreed to resolve allegations that they submitted false claims for the drug Evzio. Evzio was a naloxone hydrochloride product used for the rapid reversal of an opioid overdose. Evzio was the highest-priced version of naloxone on the market and insurers frequently required the submission of prior authorization requests before they would approve coverage for Evzio.

The United States contends that, between Aug. 1, 2017 and June 30, 2019, Plymouth Towne Care Pharmacy, Inc. d/b/a People’s Drug Store (People’s Drug Store) and Shaska Pharmacy LLC d/b/a Ray’s Drugs (Ray’s Drugs) submitted false claims for Evzio to Medicare. In particular, the government alleges that People’s Drug Store and Ray’s Drugs submitted false and misleading prior authorization requests for Evzio that contained clinical assertions for which the pharmacies lacked any factual basis. At times, Zahr and the pharmacies initiated Evzio prescriptions based on rudimentary patient lists with only basic biographical details. In the prior authorization requests, Zahr and the pharmacies also included assertions about the comparative effectiveness of Evzio purportedly authored by prescribing physicians but that Zahr and the pharmacies actually wrote. The prescribing physicians did not review, sign, or submit the prior authorizations at issue.

The settlement also resolves allegations that Zahr, People’s Drug Store and Ray’s Drugs dispensed Evzio prescriptions to Medicare beneficiaries at times without collecting or attempting to collect co-payment obligations for Evzio, in violation of the Anti-Kickback Statute.

“Taxpayers pay a huge amount of money for federal health care programs, and they expect that money will be spent honestly and effectively – especially when it comes to expensive therapies,” said Acting United States Attorney Nathaniel R. Mendell. “Our job is to find and stop misconduct like this, which hurts those programs and cheats us all.”

“We expect the submission of truthful and non-misleading documentation by all those involved in the delivery of health care goods or services, including pharmacies that submit claims for pharmaceutical products,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “This settlement demonstrates the department’s continuing commitment to preventing fraud in Medicare and other taxpayer-funded health care programs.”

“When healthcare providers put their own financial gain above honest billing of Medicare, they violate the basic trust the public extends to healthcare professionals,” said Phillip M. Coyne, Special Agent in Charge of the U.S. Department of Health and Human Services, Office of the Inspector General. “Our agency, working with our law enforcement partners, will continue to root out all forms of waste, fraud and abuse in our federal health care programs.”

“Pharmacies that take shortcuts to increase their profits by submitting false claims for expensive drugs increase medical costs for all of us,” said Joseph R. Bonavolonta, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division. “Today’s settlement should deter anyone thinking about abusing our federal health care programs that so many rely on for their health care needs.”

Under the terms of the settlement agreement, Zahr, People’s Drug Store, and Ray’s Drugs will pay the government $1 million. The civil settlement includes the resolution of claims brought in a lawsuit filed by a whistleblower under the qui tam provisions of the False Claims Act, which allow private parties, known as relators, to bring suit on behalf of the government and to share in any recovery. 

Acting U.S. Attorney Mendell; AAG Boynton; HHS OIG SAC Coyne; and FBI SAC Bonavolonta made the announcement today. Assistant U.S. Attorneys David J. Derusha and Abraham R. George of Mendell’s office and Trial Attorney Sarah Arni of the Justice Department’s Civil Division handled the matter.

Topic(s): 
Health Care Fraud
Component(s): 
Updated December 8, 2021

 Department of Justice

Office of Public Affairs

FOR IMMEDIATE RELEASE
Wednesday, December 8, 2021

Pharmacist and Two Pharmacies Agree to Pay $1 Million to Resolve Allegations of False Claims for Anti-Overdose Drug

Riad “Ray” Zahr, a pharmacist in Dearborn, Michigan, along with two specialty pharmacies that Zahr formerly owned and operated, have agreed to pay the United States $1 million to resolve allegations that they submitted false claims for the drug Evzio. Evzio was an injectable form of naloxone hydrochloride indicated for use to reverse opioid overdose. Evzio was the highest-priced version of naloxone on the market, and insurers frequently required the submission of prior authorization requests before they would approve coverage for Evzio.

The United States contended that, between Aug. 1, 2017, and June 30, 2019, Plymouth Towne Care Pharmacy dba People’s Drug Store (People’s Drug Store) and Shaska Pharmacy LLC dba Ray’s Drugs (Ray’s Drugs) submitted false claims for Evzio to Medicare. In particular, the government alleged that People’s Drug Store and Ray’s Drugs submitted false and misleading prior authorization requests for Evzio that contained clinical assertions for which the pharmacies lacked any factual basis. At times, Zahr and the pharmacies initiated Evzio prescriptions based on rudimentary patient lists with only basic biographical details. Zahr and the pharmacies also included assertions in Evzio prior authorization requests purportedly authored by prescribing physicians regarding the comparative effectiveness of Evzio that the pharmacies or Zahr actually authored. The prescribing physicians did not review, sign or submit the prior authorizations at issue. The settlement also resolves allegations that Zahr, People’s Drug Store and Ray’s Drugs dispensed Evzio prescriptions to Medicare beneficiaries at times without collecting or attempting to collect co-payment obligations for Evzio, in violation of the Anti-Kickback Statute.

“We expect the submission of truthful and non-misleading documentation by all those involved in the delivery of health care goods or services, including pharmacies that submit claims for pharmaceutical products,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “This settlement demonstrates the department’s continuing commitment to preventing fraud in Medicare and other taxpayer-funded health care programs.”

“Taxpayers pay a huge amount of money for federal health care programs, and they expect that money will be spent honestly and effectively – especially when it comes to expensive therapies,” said Acting U.S. Attorney Nathaniel R. Mendell for the District of Massachusetts. “Our job is to find and stop misconduct like this, which hurts those programs and cheats us all.”

“When health care providers put their own financial gain above honest billing of Medicare, they violate the basic trust the public extends to health care professionals,” said Special Agent in Charge Phillip M. Coyne of the U.S. Department of Health and Human Services, Office of the Inspector General (HHS OIG). “Our agency, working with our law enforcement partners, will continue to root out all forms of waste, fraud and abuse in our federal health care programs.”

“Pharmacies that take shortcuts to increase their profits by submitting false claims for expensive drugs increase medical costs for all of us,” said Special Agent in Charge Joseph R. Bonavolonta of the FBI Boston Division. “Today's settlement should deter anyone thinking about abusing our federal health care programs that so many rely on for their health care needs.”

The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Rebecca Socol, a former employee of kaléo Inc., the manufacturer of Evzio. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. As part of this resolution, Ms. Socol will receive $200,000 of the settlement amount. The qui tam case is captioned United States ex rel. Socol v. Plymouth Towne Care Pharmacy, Inc., 18-cv010050-RGS (D. Mass.) (under seal). On Nov. 9, the department announced that kaléo agreed to pay $12.7 million to resolve allegations that kaléo caused the submission of false claims for Evzio.

The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section and the U.S. Attorney’s Office for the District of Massachusetts, with assistance from HHS OIG; the Department of Defense Criminal Investigative Service; the Office of Personal Management, Office of Inspector General; the FBI; and the U.S. Postal Service Office of Inspector General.

The investigation and resolution of this matter illustrates the government’s emphasis on combating health care fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse and mismanagement can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).

The matter was handled by Trial Attorney Sarah Arni of the Justice Department’s Civil Division and Assistant U.S. Attorneys David Derusha and Abraham George for the District of Massachusetts.

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

Topic(s): 
False Claims Act
Press Release Number: 
21-1219
Updated December 8, 2021