Tag Archives: US Attorney’s Offices

Seven Arrested, Charged with $22 Million Detroit-area Home Health Care Fraud Scheme

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Six Detroit-area residents and one Chicago-area resident were arrested today by federal agents on charges arising from the ongoing investigation into an alleged $22 million home health care fraud scheme.  The indictment was announced by Assistant Attorney General Lanny A. Breuer of the Justice Department’s Criminal Division; U.S. Attorney Barbara L. McQuade of the Eastern District of Michigan; Special Agent in Charge Robert D. Foley III of the FBI’s Detroit Field Office; Special Agent in Charge Lamont Pugh III of the Health and Human Services Office of Inspector General (HHS-OIG) Chicago Regional Office; and Special Agent in Charge Erick Martinez of the Internal Revenue Service Criminal Investigation (IRS-CI) Detroit Field Office.

According to the 18-count indictment returned Jan. 15, 2013, and unsealed today, the seven individuals allegedly participated in a Medicare fraud scheme operating out of four Oakland County, Mich., home health agencies claiming to provide in-home health services: Royal Home Health Care Inc., Prestige Home Health Services Inc., Platinum Home Health Services Inc. and Empirical Home Health Care Inc.  The indictment alleges Medicare paid the agencies approximately $22 million for fraudulently reported services since August 2008.

In addition to the arrests, law enforcement agents suspended Medicare payments to four health care companies associated with the alleged scheme.

Muhammad Aamir, 42; Usman Butt, 39; Hemal Bhagat, 31; Syed Shah, 50; Tariq Tahir, 46; and Raquel Ellington, 56, of the Detroit area; and Tayyab Aziz, 43, from the Chicago area, each are charged with conspiracy to commit health care fraud.  All but Aziz are also charged with health care fraud and with conspiracy to violate the Anti-Kickback Statute.  Butt, Bhagat, Shah and Aziz are additionally charged with conspiracy to commit money laundering.

According to the indictment, Aamir and Butt owned and operated Prestige; Butt, Bhagat and Shah owned and operated Royal; and Aamir owned and operated Platinum and Empirical – all of which allegedly claimed to provide home health therapy services to Medicare beneficiaries that were unnecessary and/or were never performed.  The indictment alleges Tahir and Ellington recruited Medicare beneficiaries, paying them kickbacks for their Medicare information and signatures on documents that detailed physical therapy and/or skilled nursing services that were either never rendered or not medically necessary.  Aamir, Butt, Bhagat, Shah, Tahir and Ellington are also charged with conspiring to pay kickbacks to Tahir and Ellington for their recruiting work.  Butt, Bhagat, Shah and Aziz allegedly conspired to launder the proceeds of the scheme.

The charges of health care fraud conspiracy and health care fraud each carry a maximum potential penalty of 10 years in prison and a $250,000 fine.  The charge of conspiracy to violate the Anti-Kickback Statute carries a maximum potential penalty of five years in prison and a $25,000 fine.  The charge of conspiracy to commit money laundering carries a maximum potential penalty of 20 years in prison and a $500,000 fine.

An indictment is merely a charge and defendants are presumed innocent unless nad until proven guilty.

The case is being prosecuted by Trial Attorney Niall M. O’Donnell of the Criminal Division’s Fraud Section.  The investigation is conducted jointly by the FBI and HHS-OIG, as part of the Medicare Fraud Strike Force, and IRS-CI, supervised by the Criminal Division’s Fraud Section and the U.S. Attorney’s Office for the Eastern District of Michigan.

Since their inception in March 2007, strike force operations in nine locations have charged more than 1,480 defendants who collectively have falsely billed the Medicare program for more than $4.8 billion.  In addition, the HHS Centers for Medicare and Medicaid Services, working in conjunction with the HHS-OIG, are taking steps to increase accountability and decrease the presence of fraudulent providers.

Hudson County, N.J., Pediatrician Charged With Fraudulently Billing Medicaid For Nearly $1 Million

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NEWARK, N.J. – A Hudson County, N.J., pediatrician was arrested at his home this morning for fraudulently billing Medicaid $900,000 for wound-repair treatments on children that were never rendered, U.S. Attorney Paul J. Fishman announced.

Badawy M. Badawy, M.D., 50, of Bayonne, N.J., a licensed pediatrician who owns and operates Sinai Medical Center of Jersey City LLC, a medical practice focusing primarily on pediatrics and family medicine, billed Medicaid thousands of times for nearly $900,000 worth of wound repairs on children and adolescents. He was charged by Complaint with healthcare fraud and is scheduled to make his initial court appearance later today before U.S. Magistrate Judge Cathy L. Waldor in Newark federal court.

According to the Complaint:

From January 2004 through December 2008, Badawy billed Medicaid, through its managed care companies, for certain wound repairs more frequently than any other service provider in the State of New Jersey. His claims for these supposed treatments represented a strong majority of all such claims submitted to Medicaid by all New Jersey medical providers during this time period, including 99.4 percent of all claims for the suturing or stapling of facial wounds larger than 30 centimeters.

Virtually all of these claims, which were submitted for supposed wound repairs on children, were fraudulent. Badawy’s patient charts for a large sample of these children who supposedly received treatment revealed no entry, notation, or other evidence, such as suturing or other closing methods, to support his claims that these procedures were actually performed.

The Complaint also identifies by initials 10 children whom Badawy claimed to have treated for wound repairs on numerous occasions.

∙ From April 2004 through June 2007, Badawy purportedly treated three children on 28 separate occasions for a total of 49 procedures involving some type of wound repair. According to the children’s mother, none of these children has ever had a cut that required stitches or other methods of wound closure.

∙ From March 2006 through February 2007, Badawy submitted eight claims for facial wound repairs, including two 30-centimeter facial wound repairs, on a single teenager during four different visits. According to the teenager, he had never seen Badawy for wounds to his face or other body parts.

∙ From July 2005 through July 2007, Dr. Badawy supposedly performed 15 wound repairs, including six 30-centimeter facial wound repairs, on a boy on eight separate occasions. According to the boy, he was never treated for a cut to his face.

The charge of health care fraud carries a maximum potential penalty of up to 10 years in prison and a maximum fine of $250,000 or twice the gross gain or loss resulting from the crime.

U.S. Attorney Fishman credited special agents of the U.S. Department of Health and Human Services, Office of Inspector General, under the direction of Special Agent in Charge Thomas O’Donnell, and the FBI, under the direction of Acting Special Agent in Charge David Velazquez, with the investigation leading to today’s arrest.
The government is represented by Scott B. McBride of the U.S. Attorney’s Health Care and Government Fraud Unit.

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Defense counsel: Michael J. Keating Esq., Cranford, N.J.

Former FEMA Executive Pleads Guilty to Federal Conflict of Interest Charge Defendant Sought Job From Company That Did Work for FEMA

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WASHINGTON—Timothy W. Cannon, 63, the former director of human resources at the Federal Emergency Management Agency (FEMA), pleaded guilty today to a charge of conflict of interest for negotiating employment with a polling and consulting services company that had a multi-million-dollar contract with FEMA, supervised by Cannon.

The plea occurred before the Honorable Amy Berman Jackson of the U.S. District Court for the District of Columbia. Sentencing is scheduled for April 9, 2013. The charge carries a statutory maximum of five years in prison.

The guilty plea was announced by Ronald C. Machen, Jr., U.S. Attorney for the District of Columbia; Assistant Attorney General Lanny A. Breuer of the U.S. Department of Justice’s Criminal Division; Debra Evans Smith, Acting Assistant Director in Charge of the FBI’s Washington Field Office; Christopher Cherry, Special Agent in Charge of the General Services Administration Office of Inspector General for the National Capital Region; and Mike Dawson, Special Agent in Charge of the U.S. Department of Homeland Security Office of Inspector General’s Washington Field Office.

According to the government’s evidence, from July 2007 through February 2009, Cannon was the director of FEMA’s Human Capital Division. In 2007, Cannon had discussions with a firm, identified in court papers as “Company A,” about FEMA hiring the firm to provide consulting services on human resources matters at FEMA. The work would be done through a project that would eventually be called the “BEST Workforce Initiative.”

In March 2008, the chief executive officer of Company A e-mailed another Company A employee, stating Cannon “said he has done everything to get a job at [Company A] because he believes so much in our products…said he wants to do a real good job at FEMA and that mabye [sic] he would try again….” On April 22, 2008, Company A’s CEO e-mailed another Company A employee that “…if [Cannon] gets us a big deal at FEMA…i [sic] think we should hire him…because he will be a ‘client’ hire…which might be good[.]” Later in the same e-mail chain, Company A’s CEO asked, “[I]s the ink dry yet on our deal with fema [sic] [?]” The Company A employee replied, “[N]o might be mid-May.” Company A’s CEO then stated, “[W]e should wait of course to see if we win a big quality deal here[.]”

On August 12, 2008, Company A was hired to administer the BEST Workforce Initiative at FEMA. The contract was valued at approximately $6 million over five years.

On November 18, 2008, a Company A employee advised Company A’s CEO in an e-mail, “I talked to Tim today. He asked for a job.” Company A’s CEO then stated, “What about ethics…are we okay with all of that…he is a significant client…am sure you know the rules…gee he seems like a winner to me…I don’t think these guys are as expensive as one might think…and he has a military background[.]”

In December 2008 and January 2009, Cannon requested additional funding for the BEST Workforce Initiative. On January 6, 2009, in an e-mail to a Company A employee, Cannon stated, “[A]h yes, I got another 500k put on the contract. Cool huh?”

On January 12, 2009, Cannon had an employment interview with Company A in Washington, D.C. On February 9, 2009, Company A sent an employment offer letter by e-mail to Cannon. The letter offered Cannon “the opportunity to join [Company A] as a Partner with our Government Division in Washington, D.C.” and guaranteed him a minimum annual salary of $175,000 for the first two years of employment. Cannon responded to the e-mail the same day, stating, “I am very excited about joining [Company A] and I look forward to working with you….” Following Cannon’s acceptance of Company A’s employment offer, Cannon continued to oversee and work on the BEST Workforce Initiative at FEMA.

Cannon retired from FEMA effective on February 27, 2009. On his public financial disclosure report, known as Form SF-278, Cannon indicated that he did not have any agreements or arrangements for “future employment” and he specifically did not list his future employment with Company A. On February 27, 2009, Cannon requested that Company A provide him with an offer letter dated after February 27, 2009, so that it would falsely appear that Cannon received Company A’s employment offer after he had resigned from FEMA. On March 2, 2009, Company A sent an updated version of the offer letter, with the new date of March 2, 2009, to Cannon. Cannon signed this updated version of the offer letter on March 3, 2009, and returned it to Company A.

In March 2009, a Company A employee voiced concerns internally about Cannon’s hiring. In addition, on March 25, 2009, a Company A employee stated in an e-mail to another Company A employee, “Well, I just got a call from and am getting more red flags about Tim Cannon. Apparently, word is getting around about his departure and joining [Company A]. There is speculation among is [sic] co-workers that this is improper. They are pretty mad. This may get in the way of future business with FEMA….This, plus the bankruptcy, plus appearance of ethics violations, both on [Company A] and FEMA side. This is not good….I think we are getting too many sign[s], and I do not think this will work.” On March 26, 2009, Company A informed Cannon that Company A’s offer of employment was being withdrawn. Company A told Cannon that he did not meet the background check requirements.

Later, on September 17, 2009, Cannon sent an e-mail to Company A’s CEO advising that Cannon had joined a consulting firm and asking to have lunch. Company A’s CEO forwarded that e-mail to other Company A employees stating, “This is a guy that was our sponsor at FEMA…he is so [Company A] gung ho…when he was applying we broke some of the rules of the U.S. Gov on the ‘how’ we do it…so we had to let him go….”

In announcing the guilty plea, U.S. Attorney Machen, Assistant Attorney General Breuer, Acting Assistant Director in Charge Smith, Special Agent in Charge Cherry, and Special Agent in Charge Dawson commended the outstanding investigative work of agents of the FBI’s Washington Field Office, Assistant Special Agent in Charge Floyd Martinez of the GSA OIG and agents of the DHS OIG, as well as agents and auditors of other federal investigative agencies that assisted with this case. They also praised the efforts of members of the U.S. Attorney’s Office and the Criminal Division Fraud Section, including Paralegal Specialists Diane Hayes and Nicole Wattelet; Legal Assistant Jamasee Lucas; Information Technology Specialist Joshua Ellen; forensic accountants in the Fraud and Public Corruption Section; and Assistant U.S. Attorney David Johnson, Trial Attorney Brian Young, and former Trial Attorney James Graham, who have prosecuted the case.

Former Member of Port Authority Board Sentenced to 57 Months in Prison

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Robert M. Peto, a former member of the Cleveland-Cuyahoga County Port Authority, was sentenced to more than four years in prison today after previously pleading guilty to violating the Hobbs Act, law enforcement officials said today.

Peto, 58, lives in Gates Mills, Ohio. He served as a member of the Port Authority Board between December 2004 through in or around August 2012, according to court documents.

Peto obtained property not due to him or his Port Authority office including free and discounted home improvements and materials, entertainment, and a financial benefit related to a vehicle acquisition, according to court documents.

The property and objects were provided by Michael Forlani and/or Doan Pyramid LLC and Neteam, AVI, companies in which Forlani had an ownership interest, according to court documents.

“This sentence shows the high cost to those who would violate the public’s trust in exchange for personal gain,” said Stephen D. Anthony, Special Agent in Charge of the Federal Bureau of Investigation’s Cleveland Field Office. “Corruption—in this case taking bribes and utilizing his position as a board member for the Port Authority—will not be tolerated.”

The conduct took place between 2004 and October 2, 2007, according to court documents.

The case was prosecuted by Assistant United States Attorneys Antoinette T. Bacon and Nancy L. Kelley following an investigation by the Federal Bureau of Investigation, the Department of Labor, and Internal Revenue Service–Criminal Investigation.

Former Law Firm IT Chief and Contract Employee Vendor Indicted in $4.8 Million Billing Fraud and Kick-back Scheme

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FOR IMMEDIATE RELEASE January 11, 2013

CHICAGO — The former chief information officer of a Chicago-based international law firm who was charged previously, and the president of a company that provided contract technology workers who was charged for the first time and arrested today, were indicted for allegedly engaging in a fraudulent billing and kickback scheme that netted each of them more than $2 million. NICHOLAS DEMARS, the president of NS Mater, a defunct firm that provided contract employees and technology to assist in office automation, web and database development, and general information technology, was arrested today and indicted with DAVID TRESCH, the former law firm officer who supervised the work and billing related to the contract employees.

For the first six years of the scheme that began in 2004, Demars allegedly paid Tresch a portion of the profits that NS Mater made from work its contract employees performed at the victim law firm. During the last two years ending in June 2012, Tresch allegedly received kickbacks totaling nearly all of the false billings that the law firm paid NS Mater for work that was not performed.

Tresch, 51, and Demars, 57, both of Itasca, were each charged with 10 counts of mail fraud in an indictment that was returned by a federal grand jury yesterday and unsealed today after Demars was arrested. Demars was released on bond after appearing this morning before U.S. Magistrate Judge Sidney Schenkier in U.S. District Court. Tresch, who was released on bond after he was arrested in August, will be arraigned at a later date in Federal Court.

The indictment also seeks forfeiture of $4,819,253 representing the combined net proceeds that both men allegedly obtained from the scheme, as well as their respective homes, Demars’ condominium in Chicago, and a residence in Lake Geneva, Wis., and more than $225,000 that was seized from Tresch along with his camping trailer, a van, and a luxury automobile.

The charges were announced by Gary S. Shapiro, Acting United States Attorney for the Northern District of Illinois, and Thomas R. Trautmann, Acting Special Agent-in-Charge of the Chicago Office of the Federal Bureau of Investigation.

According to the initial complaint, the victim law firm, which was not identified by name, reported Tresch’s alleged criminal activity and cooperated in the investigation. The firm, which has offices worldwide, hired Tresch in May 2004 and he held several positions in the information technology department before he was promoted in July 2011 to chief information officer.

The indictment alleges that between November 2004 and March 2011, the law firm issued checks totaling approximately $7.68 million to NS Mater, and Demars, in turn, kicked back $1.14 million to Tresch. In 2004 and 2005, Demars allegedly paid kickbacks directly to Tresch after paying legitimate NS Mater contract employees and payroll administrators for work they had performed for the law firm. Beginning in April 2006, allegedly to conceal the kickbacks, Demars began paying Tresch by issuing checks to Tresch’s wife and treating her as an employee of NS Mater, even though both defendants knew that she was not an employee and had not performed any work, according to the indictment. Tresch’s wife is not a defendant.

Subsequently, in late 2010, Tresch learned that that the law firm would soon stop using NS Mater contract employees, and, in February 2011, the firm directed Tresch to no longer permit NS Mater to provide personnel for the information technology department. Between November 2011 and June 2012, Demars allegedly continued submitting invoices to Tresch totaling more than $1.1 million, falsely representing that NS Mater performed work that both defendants knew was not performed. Tresch submitted the false invoices, which the firm paid, and of the $1.1 million paid during this period, Demars kicked back approximately $970,000 to Tresch, while retaining the remainder for himself, the indictment alleges.

Each count of mail fraud carries a maximum penalty of 20 years in prison and a $250,000 fine, and restitution is mandatory. The Court may impose an alternative fine totaling twice the loss to the victim or twice the gain to the defendant, whichever is greater. If convicted, the Court must impose a reasonable sentence under federal statutes and the advisory United States Sentencing Guidelines.

The government is being represented by Assistant U.S. Attorney Terra Reynolds.

The public is reminded that an indictment is not evidence of guilt. The defendants are presumed innocent and are entitled to a fair trial at which the government has the burden of proving guilt beyond a reasonable doubt.

Georgia Men Plead Guilty to Bribing Official to Secure Government Contracts Defendants Admit to Overcharging Defense Department More Than $900,000

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WASHINGTON – Two men employed by a machine products vendor in Albany, Ga., have pleaded guilty to bribing a public official working for a military organization at the Marine Corps Logistics Base Albany (MCLB-Albany) to secure contracts for machine products, announced Assistant Attorney General Lanny A. Breuer of the Justice Department’s Criminal Division and U.S. Attorney Michael J. Moore for the Middle District of Georgia.

Thomas J. Cole Jr., 43, and Fredrick W. Simon, 55, both of Albany, each pleaded guilty before U.S. District Judge W. Louis Sands in the Middle District of Georgia to one count of bribery of a public official.

During their guilty pleas, Cole, the general manager of an Albany-based machine products vendor, and Simon, an employee responsible for processing sales orders, admitted to participating in a scheme to secure sales order contracts from the Maintenance Center Albany (MCA) at MCLB-Albany by subverting a competitive bid process.  The MCA is responsible for rebuilding and repairing ground combat and combat support equipment, much of which has been utilized in military missions in Afghanistan and Iraq, as well as other parts of the world.  To accomplish the scheme, Cole and Simon bribed a MCA purchase tech responsible for placing machine product orders.  Cole and Simon admitted to participating in the scheme at the purchase tech’s suggestion, after Simon had spoken with the purchase tech about how his company could obtain business from the MCA.  Cole and Simon admitted that, at the purchase tech’s request, they paid the purchase tech a bribe of at least $75 for each of the more than 1,000 sales orders MCA placed with their company.  According to court documents, the purchase tech would transmit sales bids to Simon and then communicate privately to him exactly how much money the company should bid for each particular order.  Cole and Simon admitted that these orders were extremely profitable, often times exceeding the fair market value of the machine products, sometimes by as much as 1,000 percent.

Cole and Simon further admitted that, at the purchase tech’s urging, in 2011 they began routing some orders through a second company, owned by Cole, because the volume of orders MCA placed with the first company was so high.  They also admitted that the purchase tech increased the bribe required for orders as the scheme progressed.  Cole and Simon admitted to paying the purchase tech approximately $161,000 in bribes during the nearly two-year scheme.  Cole admitted to personally receiving approximately $209,000 in proceeds from the scheme; Simon admitted to personally receiving approximately $74,500.  Both admitted that the total loss to the Department of Defense from overcharges associated with the machine product orders placed during the scheme was approximately $907,000.

At sentencing, Cole and Simon each face a maximum penalty of 15 years in prison and a fine of not more than twice the pecuniary loss to the government.  As part of their plea agreements with the United States, Cole and Simon both agreed to forfeit the proceeds they received from the scheme, as well as to pay full restitution to the Department of Defense.  Sentencing has not yet been scheduled.

The case is being prosecuted by Trial Attorneys Richard B. Evans and J.P. Cooney of the Criminal Division’s Public Integrity Section and Assistant U.S. Attorney K. Alan Dasher of the Middle District of Georgia.  The case is being investigated by the Naval Criminal Investigative Service, with assistance from the Dougherty County District Attorney’s Office Economic Crime Unit and the Defense Criminal Investigative Service.

ZACHARY MAN SENTENCED TO PRISON FOR DEFRAUDING BAKER BUSINESS

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BATON ROUGE, LA – United States Attorney Donald J. Cazayoux, Jr., announced that RICHARD GLENN BOYETTE, age 48, of Zachary, Louisiana, was sentenced today by U.S. District Judge James J. Brady to a term of imprisonment of fifty-one (51) months.

BOYETTE had previously pled guilty to mail fraud in connection with a multi-year scheme to defraud Commercial Tire of Louisiana, Inc. (“Commercial Tire”), located in Baker, Louisiana, with offices in Scott and Hammond. While working as the company’s Controller, from 2001 through late 2010, BOYETTE admitted defrauding the company and its employees. To execute the scheme, the defendant (a) created and approved fraudulent payroll checks to himself, which he was not authorized to receive; (b) obtained fraudulent payroll checks and gained control over the funds; (c) created false entries in the company’s accounting records that falsely reflected that the fraudulent payroll checks had actually been issued to other employees; and (d) prepared and distributed fraudulent W-2s that concealed the stolen funds.

At today’s sentencing, the Court found that BOYETTE’s fraudulent scheme caused a loss to Commercial Tire of more than $1.2 million. Accordingly, BOYETTE was ordered to pay restitution in the amount of $1,283,151. BOYETTE was also ordered to forfeit an additional $1,283,151 to the United States as proceeds of his crime. Following his release from imprisonment, BOYETTE will also be required to serve a two-year term of supervised release.

This investigation was conducted by the Federal Bureau of Investigation. The case is being prosecuted by Assistant United States Attorneys Alan A. Stevens and James P. Thompson.

Apple Valley Woman Charged With Defrauding Home Health Care Company, Medica

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FOR IMMEDIATE RELEASE January 10, 2013

MINNEAPOLIS—Yesterday in federal court, an Apple Valley woman was charged with defrauding both her employer and Medica. On January 9, 2012, Lori Jo Mueller, age 48, was charged via an Information with one count of wire fraud and one count of health care fraud.
Allegedly, from June of 2006 through June of 2012, Mueller embezzled approximately $840,000 from Edelweiss Home Health Care and used the funds for her personal use. Mueller began working for Edelweiss, located in Osseo, in 2002, and was promoted to the position of vice president of operations. In that capacity, Mueller was responsible for the review and payment of corporate invoices, bookkeeping, and other financial matters. Mueller allegedly used her access to the corporate checking account to issue payments from corporate accounts to herself. Also, Mueller allegedly concealed her actions from the company owners and made misrepresentations concerning the company’s financial state.
In addition, from March of 2010 through June of 2012, Mueller allegedly defrauded Medica, a health care benefit program. She purportedly submitted claims to various insurers, seeking reimbursement for services provided by Edelweiss nursing staff. In some instances, Mueller double-billed by submitting claims for the same services to multiple insurance providers. For example, Mueller allegedly billed both Minnesota Medicaid and Medica for services provided to one client. The double-billing resulted in a double-payment to Edelweiss with Medicaid being the proper payer and Medica being the overpayer. As a result of this criminal behavior, Mueller obtained for Edelweiss more than $631,000 in fraudulent proceeds. Medica is a non-profit corporation that provides health insurance products to families and individuals.
If convicted in this case, Mueller faces a potential maximum penalty of 30 years in federal prison on the wire fraud count and ten years on the health care fraud count. All sentences will be determined by a federal district court judge.
This case is the result of an investigation by the Federal Bureau of Investigation and the United States Department of Health and Human Services-Office of Inspector General (“DHHS-OIG”). It is being prosecuted by Assistant U.S. Attorney David M. Genrich.
The U.S. Attorney’s Office participates in a task force with the Medicaid Fraud Control Unit at the Minnesota Attorney General’s Office that focuses on home health care fraud trends. The task force includes the DHHS-OIG, the FBI, the Internal Revenue Service, and other federal, state, and local law enforcement partners.
As a result of federal convictions for health care fraud, defendants are excluded from participating in federal health benefit programs, including Medicare and Medicaid. Exclusion determinations are made by the U.S. Department of Health and Human Services. Nationwide, more than 3,000 individuals were excluded from program participation in Fiscal Year 2010 based upon criminal convictions or patient abuse or neglect, license revocations, or other factors.

Clinical Director for Miami-based Health Care Clinic Sentenced to Prison for Role in $50 Million Medicare Fraud Scheme

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 WASHINGTON – A former clinical director for Biscayne Milieu, a Miami-based mental-health clinic, was sentenced today to 100 months in prison for his participation in a Medicare fraud scheme involving the submission of more than $50 million in fraudulent billings to Medicare, announced Assistant Attorney General Lanny A. Breuer of the Justice Department’s Criminal Division; U.S. Attorney Wifredo A. Ferrer of the Southern District of Florida; Michael B. Steinbach, Acting Special Agent in Charge of the FBI’s Miami Field Office; and Special Agent in Charge Christopher B. Dennis of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG), Office of Investigations Miami Office.

Rafael Alalu, 47, of Miami, was sentenced today by U.S. District Judge Robert N. Scola Jr. in the Southern District of Florida.  Alalu was convicted on Aug. 24, 2012, of one count of conspiracy to commit health care fraud and two substantive counts of health care fraud, following a two-month jury trial.  The evidence at trial showed that Alalu participated in treating ineligible patients, concealing that fact by falsifying patient files and writing fraudulent group therapy notes, and instructing others to do the same.  In addition to the prison term, Alalu was ordered to pay more than $5.6 million in restitution, jointly and severally with his co-defendants.

Various owners, doctors, managers, therapists, patient brokers and other employees of Biscayne Milieu have also been charged with various health care fraud, kickback, money laundering and other offenses in two indictments unsealed in September 2011 and May 2012.  Biscayne Milieu, its owners, and more than 25 of the individual defendants charged in these cases have pleaded guilty or have been convicted at trial.  Antonio and Jorge Macli and Sandra Huarte – the owners and operators of Biscayne Milieu – and Dr. Gary Kushner – its medical director – were each convicted at trial of various offenses and are scheduled for sentencing in March 2013.

According to the evidence at trial, the defendants and their co-conspirators caused the submission of over $50 million dollars in false and fraudulent claims to Medicare through Biscayne Milieu, which purportedly operated a partial hospitalization program (PHP) – a form of intensive treatment for severe mental illness.  Instead, the defendants devised a scheme in which they paid patient recruiters to refer ineligible Medicare beneficiaries to Biscayne Milieu for services that were never provided.  Many of the patients admitted to Biscayne Milieu were not eligible for PHP because they were chronic substance abusers, suffered from severe dementia and would not benefit from group therapy, or had no mental health diagnosis but were seeking exemptions for their U.S. citizenship applications.  The evidence at trial showed that once these ineligible patients were admitted to Biscayne Milieu, Alalu and others concealed the fraud by falsifying patients’ group therapy notes to reflect legitimate PHP treatment that was never provided, and directed others to do so.

The case is being prosecuted by Assistant U.S. Attorneys Michael Davis and Marlene Rodriguez of the U.S. Attorney’s Office for the Southern District of Florida, and by Trial Attorney James V. Hayes of the Fraud Section of the Justice Department’s Criminal Division.  The case was investigated by the FBI with the assistance of HHS-OIG, and was brought by the U.S. Attorney’s Office for the Southern District of Florida in coordination with the Medicare Fraud Strike Force, supervised by the Criminal Division’s Fraud Section.

Since its inception in March 2007, the Medicare Fraud Strike Force, now operating in nine cities across the country, has charged more than 1,480 defendants who have collectively billed the Medicare program for more than $4.8 billion. In addition, HHS’s Centers for Medicare and Medicaid Services, working in conjunction with HHS-OIG, is taking steps to increase accountability and decrease the presence of fraudulent providers.

Pfizer Agrees to Pay $55 Million for Illegally Promoting Protonix for Off-Label Use

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FOR IMMEDIATE RELEASE
Wednesday, December 12, 2012
Pfizer Agrees to Pay $55 Million for Illegally Promoting Protonix for Off-Label Use

Pfizer Inc. will pay $55 million plus interest to resolve allegations that Wyeth LLC illegally introduced and caused the introduction into interstate commerce of a misbranded drug, Protonix, between February 2000 and June 2001, the Justice Department announced today.

 

Wyeth manufactured and promoted Protonix tablets. Protonix is a proton pump inhibitor (PPI) that was used by physicians to treat various forms of gastro-esophageal reflux disease (GERD).  Wyeth sought and obtained approval from the Food and Drug Administration (FDA) to promote Protonix for short-term treatment of erosive esophagitis–a condition associated with GERD that can only be diagnosed with an invasive endoscopy. However, the government alleges that Wyeth fully intended to, and did, promote Protonix for all forms of GERD, including symptomatic GERD, which was far more common and could be diagnosed without an endoscopy.

 

Under the Federal Food Drug and Cosmetic Act, manufacturers must obtain FDA approval for any indication for use for which a manufacturer intends to market a drug.   A drug is misbranded if its labeling does not bear adequate directions for use by a layman safely and for the purposes for which it is intended.   A prescription drug must be prescribed by a physician and is only exempt from the adequate directions for use requirement if a number of conditions are met, including that the manufacturer only intended to sell that drug for an FDA-approved use.   A prescription drug marketed for unapproved off-label uses does not qualify for the exemption and is misbranded.

 

As alleged in the government’s complaint, Wyeth’s illegal promotional campaign for Protonix was multi-faceted. Before Wyeth even began promoting Protonix, the FDA warned Wyeth that its proposed promotional materials were misleading because Wyeth had “overstated” its “erosive esophagitis indication” by “suggesting that Protonix is safe and effective in the treatment of patients with . . . GERD. Protonix is not indicated for treatment of GERD symptoms that occur in the absence of esophageal erosions.”   Despite the FDA’s admonishment, the government alleges that Wyeth trained its sales force to promote Protonix for all forms of GERD, beyond its limited erosive esophagitis indication, and that Wyeth sales representatives frequently promoted Protonix to physicians for unapproved uses, such as symptomatic GERD.

 

In addition, Wyeth allegedly promoted Protonix as the “best PPI for nighttime heartburn.” even though there was never any clinical evidence that Protonix was more effective than any other PPI for nighttime heartburn. The allegations in the complaint are that this superiority slogan was formulated at the highest levels of the company. Wyeth retained an outside market research firm, at the cost of tens of thousands of dollars, to ensure that sales representatives delivered that misleading superiority message.

 

Finally, the government alleges that Wyeth used continuing medical education (CME) programs to promote Protonix for unapproved uses. CME programs are sponsored by accredited independent providers, such as universities, nonprofit organizations, or specialty societies. Pharmaceutical companies are permitted to provide financial support for CME programs, but they are not permitted to use CME programs as promotional vehicles for off-label indications.According to the complaint, Wyeth spent millions of dollars providing “unrestricted educational grants” to CME providers, and these grants invariably included promises that Wyeth would not attempt to influence the content of the program in any way. Nevertheless, the government alleges that one of Wyeth’s core marketing tactics for Protonix was to use CME programs to drive off-label use of the drug. According to the complaint, the Protonix “brand team” influenced virtually every aspect of these CME programs:   program topics, speaker selection, organization, and content. In addition, the government alleges that Wyeth even insisted that the CME program materials use the same color and appearance as Protonix promotional materials–a tactic that Wyeth and the vendor called “branducation.”

 

“Today’s settlement once again demonstrates our commitment to making sure drug manufacturers follow the rules,” said Stuart Delery, Principal Deputy Assistant Attorney General of the Department of Justice’s Civil Division.   “Drug manufacturers should not be permitted to profit from misbranding their products; the disgorgement remedy here ensures that this does not happen in this case.”

 

“Wyeth tried to cheat the system by obtaining a limited FDA approval for Protonix, fully intending to promote this drug for additional, unapproved uses,” said U.S. Attorney Carmen M. Ortiz. “Wyeth ignored the FDA’s warning not to promote Protonix off-label, and then went so far as to contaminate CME programs that physicians rely on for unbiased, independent scientific information. Today’s settlement reinforces this office’s historic commitment to holding drug companies responsible for their misconduct.”

 

This case was litigated by Assistant U.S. Attorneys David Schumacher and Susan Winkler of Ortiz’s Health Care Fraud Unit, together with former Trial Attorney Kevin Larsen and Deputy Director Jill Furman in the Department of Justice Consumer Protection Branch.   This case was investigated by the FDA’s Office of Criminal Investigations; the Office of Inspector General of the Department of Health and Human Services, the Department of Veterans’ Affairs, and the FBI.

 

This civil complaint and settlement resolve the United States’ investigation of Wyeth related to the promotion of Protonix for unapproved uses.   The claims settled by this agreement are allegations only, allegations which Pfizer denies; there has been no determination of liability. Pfizer acquired Wyeth in October 2009.   Since August 2009, Pfizer has been under a Corporate Integrity Agreement with the Department of Health and Human Services, which agreement remains in effect.