Wyeth Pharmaceutical Agrees to Pay $490.9 Million for Marketing the Prescription Drug Rapamune for Unapproved Uses

WASHINGTON—Wyeth Pharmaceuticals Inc., a pharmaceutical company acquired by Pfizer Inc. in 2009, has agreed to pay $490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by the U.S. Food and Drug Administration (FDA), the Justice Department announced today. Rapamune is an immunosuppressive drug that prevents the body’s immune system from rejecting a transplanted organ.
“FDA’s drug approval process ensures companies market their products for uses proven safe and effective,” said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department’s Civil Division. “We will hold accountable those who put patients’ health at risk in pursuit of financial gain.”
The Federal Food, Drug, and Cosmetic Act (FDCA) requires a company such as Wyeth to specify the intended uses of a product in its new drug application to the FDA. Once approved, a drug may not be introduced into interstate commerce for unapproved or “off-label” uses until the company receives FDA approval for the new intended uses. In 1999, Wyeth received approval from the FDA for Rapamune use in renal (kidney) transplant patients. However, the information alleges, Wyeth trained its national Rapamune sales force to promote the use of the drug in non-renal transplant patients. Wyeth provided the sales force with training materials regarding non-renal transplant use and trained them on how to use these materials in presentations to transplant physicians. Then, Wyeth encouraged sales force members, through financial incentives, to target all transplant patient populations to increase Rapamune sales.
“The FDA approves drugs for certain uses after lengthy clinical trials,” said Sanford Coats, U.S. Attorney for the Western District of Oklahoma. “Compliance with these approved uses is important to protect patient safety, and drug companies must only market and promote their drugs for FDA-approved uses. The FDA approved Rapamune for limited use in renal transplants and required the label to include a warning against certain uses. Yet, Wyeth trained its sales force to promote Rapamune for off-label uses not approved by the FDA, including ex-renal uses, and even paid bonuses to incentivize those sales. This was a systemic, corporate effort to seek profit over safety. Companies that ignore compliance with FDA regulations will face criminal prosecution and stiff penalties.”
Wyeth has pleaded guilty to a criminal information charging it with a misbranding violation under the FDCA. The resolution includes a criminal fine and forfeiture totaling $233.5 million. Under a plea agreement, which has been accepted by the U.S. District Court in Oklahoma City, Wyeth has agreed to pay a criminal fine of $157.58 million and forfeit assets of $76 million.
The resolution also includes civil settlements with the federal government and the states totaling $257.4 million. Wyeth has agreed to settle its potential civil liability in connection with its off-label marketing of Rapamune. The government alleged that Wyeth violated the False Claims Act, from 1998 through 2009, by promoting Rapamune for unapproved uses, some of which were not medically accepted indications and therefore were not covered by Medicare, Medicaid, and other federal health care programs. These unapproved uses included non-renal transplants, conversion use (switching a patient from another immunosuppressant to Rapamune), and using Rapamune in combination with other immunosuppressive agents not listed on the label. The government alleged that this conduct resulted in the submission of false claims to government health care programs. Of the amounts to resolve the civil claims, Wyeth will pay $230,112,596 to the federal government and $27,287,404 to the states.
“Wyeth’s conduct put profits ahead of the health and safety of a highly vulnerable patient population dependent on life-sustaining therapy,” said Antoinette V. Henry, Special Agent in Charge, Metro-Washington Field Office, FDA Office of Criminal Investigations. “FDA-OCI is committed to working with the Department of Justice and our law enforcement counterparts to protect public health.”
Pfizer is currently subject to a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services’ Office of Inspector General that it entered in connection with another matter in 2009, shortly before acquiring Wyeth. The CIA covers former Wyeth employees who now perform sales and marketing functions at Pfizer. Under the CIA, Pfizer is subject to exclusion from federal health care programs, including Medicare and Medicaid, for a material breach of the CIA, and the company is subject to monetary penalties for less significant breaches.
“We are committed to enforcing the laws protecting public health, taxpayers, and government health programs and to promoting effective compliance programs,” said Daniel R. Levinson, Inspector General, Department of Health and Human Services. “Our integrity agreement with Pfizer, which acquired Wyeth, includes required risk assessments, a confidential disclosure program, and auditing and monitoring to help prospectively identify improper marketing.”
The civil settlement resolves two lawsuits pending in federal court in the Western District of Oklahoma under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the government and share in any recovery. The first action was filed by a former Rapamune sales representative, Marlene Sandler, and a pharmacist, Scott Paris. The second action was filed by a former Rapamune sales representative, Mark Campbell. The whistleblowers’ share of the civil settlement has not been resolved.
"The success obtained in this case is an excellent example of how we address the threats to our nation’s health care system; the importance of the public reporting of fraud, waste, or abuse; and the significant results that can be obtained through multiple agencies cooperating in investigations,” said James E. Finch, Special Agent in Charge of the Oklahoma City Division of the FBI.
The criminal case was handled by the U.S. Attorney’s Office for the Western District of Oklahoma (USAO) and the Justice Department’s Civil Division, Consumer Protection Branch. The civil settlement was handled by USAO and the Justice Department’s Civil Division, Commercial Litigation Branch. The Department of Health and Human Services’ (HHS) Office of Counsel to the Inspector General; the HHS Office of General Counsel, Center for Medicare and Medicaid Services; the FDA’s Office of Chief Counsel; and the National Association of Medicaid Fraud Control Units. These matters were investigated by the FBI; the FDA’s Office of Criminal Investigation; HHS’ Office of Inspector General, Office of Investigations and Office of Audit Services; the Defense Criminal Investigative Service; the Office of Personnel Management’s Office of Inspector General and Office of Audit Services; the Department of Veterans’ Affairs’ Office of Inspector General; and TRICARE Program Integrity.
Except for conduct admitted in connection with the criminal plea, the claims settled by the civil agreement are allegations only, and there has been no determination of civil liability. The civil lawsuits are captioned United States ex rel. Sandler et al v. Wyeth Pharmaceuticals Inc., Case No. 05-6609 (E.D. Pa.) and United States ex rel. Campbell v. Wyeth Inc., Case No. 07-00051 (W.D. Okla.).

Spine Surgeon Arrested on Charges He Performed Unnecessary Surgeries and Billed Health Insurance Programs

CINCINNATI—Federal and state health care fraud investigators arrested Abubakar Atiq Durrani, 44, of Mason, Ohio, today based on a federal complaint alleging that he convinced patients to undergo medically unnecessary spinal surgeries then billed private and public health care benefit programs millions of dollars for the fraudulent services.
Carter M. Stewart, United States Attorney for the Southern District of Ohio; Ohio Attorney General Mike DeWine; Lamont Pugh, III, Special Agent in Charge, U.S. Department of Health and Human Services Office of Inspector General; Kevin R. Cornelius, Special Agent in Charge, Federal Bureau of Investigation Cincinnati Field Office (FBI); Robert Corso, Special Agent in Charge, Drug Enforcement Administration (DEA); and Bret Flinn, Resident Agent in Charge, Defense Criminal Investigation Service (DCIS) announced the arrest.
Durrani owns a private practice called the Center for Advanced Spine Technologies (CAST) with offices in Evendale, Ohio and Florence, Kentucky.
The complaint charges Durrani with one count of health care fraud and one count of making false statements in health care matters. Health care fraud is punishable by up to 20 years in prison. The crime of making false statements in health care matters is punishable by up to five years in prison.
Durrani will appear before U.S. Magistrate Judge Stephanie Bowman in Cincinnati at 1:30 today.
Stewart commended the cooperative investigation by agents and officers of the agencies named above, along with the Ohio Medical Board and Kentucky Medical Board and Assistant U.S. Attorneys Timothy Mangan and Emily Glatfelter, who are representing the United States in the case.
Anyone suspecting health care fraud, waste, or abuse can report it by calling the U.S. Department of Health and Human Services, Office of Inspector General at 800-447-8477. To learn more about health care fraud prevention and enforcement go to www.stopmedicarefraud.gov. Ohioans can report suspected instances of health care fraud to Attorney General DeWine’s office by calling 1-800-282-0515.
A criminal complaint is only a charge and is not evidence of guilt. The defendant is entitled to a fair trial in which it will be the government’s burden to prove guilt beyond a reasonable doubt.

New Jersey Pharmacist Pleads Guilty in Scheme to Illegally Distribute Pharmaceutical Drugs

TRENTON, NJ—Randy Binder, a pharmacist and the former proprietor of Texas Road Pharmacy in Manalapan, New Jersey, admitted today that he conspired to illegally distribute oxycodone to people without a legitimate need for the drug, U.S. Attorney Paul J. Fishman announced.
Binder, 60, of Matawan, New Jersey, pleaded guilty before U.S. District Judge Freda L. Wolfson in Trenton federal court to an information charging him with conspiracy to distribute oxycodone.
According to documents filed in the case and statements made in court:
Binder admitted that he participated in a conspiracy to distribute oxycodone for no legitimate medical purpose and beyond the bounds of medical practice between January 2009 and June 2012.
Oxycodone, the active ingredient in brand name pills such as OxyContin, Roxicodone, and Percocet, is a Schedule II controlled substance—meaning that it has a high potential for abuse. Demand for oxycodone-based prescription pain medication has grown to epidemic proportions in the United States, and dealers profit by selling such medication on the street. Users will often crush and snort the pills or dissolve and inject them to get an immediate high. This abuse can lead to addiction, overdose, and death.
Binder would meet fellow conspirators in the parking lot of Texas Road Pharmacy to provide them with pills or would leave the pills in a car in the parking lot, which conspirators would then pick up. Binder would also accept prescriptions which he knew to be invalid.
The charge to which Binder pleaded guilty carries a maximum potential penalty of 20 years in prison and a $1 million fine. Sentencing is currently scheduled for October 24, 2013.
U.S. Attorney Fishman credited special agents of the DEA, under the direction of Special Agent in Charge Carl J. Kotowski; the FBI, under the direction of Special Agent in Charge Aaron T. Ford; and IRS–Criminal Investigation, under the direction of Special Agent in Charge
Shantelle P. Kitchen for the investigation leading to today’s guilty plea.
The government is represented by Assistant U.S. Attorneys R. Joseph Gribko and Jonathan Romankow of the U.S. Attorney’s Office Criminal Division and Tino Lisella, Trial Attorney with the Department of Justice, Tax Division.

Three Doctors Admit Accepting Bribes for Test Referrals to New Jersey Clinical Laboratory

NEWARK, NJ—Three New Jersey doctors admitted today they accepted tens of thousands of dollars in bribes from Parsippany, New Jersey-based Biodiagnostic Laboratory Services LLC (BLS) as part of a long-running scheme operated by the lab, its president, and numerous associates, U.S. Attorney Paul J. Fishman announced.
Dennis Aponte, 46, of Cedar Grove, New Jersey; Claudio Dicovsky, 51, of Fort Lee, New Jersey; and Franklin Dana Fortunato, 63, of Montville, New Jersey, each pleaded guilty to violating the Federal Travel Act. Fortunato also pleaded guilty to filing a false tax return, admitting that from 2004 to 2008, he failed to disclose and report as income more than $640,000 in bribe money and patient co-pays and failed to pay more than $160,000 in taxes he owed as a result of that unreported income. The defendants entered their guilty pleas today before U.S. District Judge Stanley R. Chesler in Newark federal court.
“Decisions about medical care should not be influenced by doctors and providers who are more interested in lining their pockets than in providing quality health care,” U.S. Attorney Fishman said. “The doctors who pleaded guilty today admitted making decisions about the care they provided based on being paid in return for their referrals. We will continue to seek out and punish those doctors and other medical professionals who put profit before patient care.”
Newark FBI Special Agent in Charge Aaron T. Ford said, “Patients have every right to insist that their physician is making medical referrals based on what is best for the patient. However, these three physicians decided to accept bribes in exchange for referrals. These types of kickback arrangements cripple the health care industry and severely impact patient care. The FBI remains committed to investing its resources to combat these types of schemes.”
“Today’s pleas should send a loud and clear message that kickbacks and unnecessary billing have no place in our federal health care system,” Thomas O’Donnell, Special Agent in Charge of the Office of Inspector General of the U.S. Department of Health and Human Region covering New Jersey, said. “We will aggressively investigate those suspected of defrauding taxpayers and the Medicare program.”
According to documents filed in this and other cases and statements made in court:
On April 9, 2013, federal agents arrested BLS president and part owner, David Nicoll, 39, of Mountain Lakes, New Jersey; Scott Nicoll, 32, of Wayne, New Jersey, a senior BLS employee and David Nicoll’s brother; and Craig Nordman, 34, of Whippany, New Jersey, a BLS employee and the CEO of Advantech Sales LLC—an entity used by BLS to make illegal payments. They were charged by federal complaint with the bribery conspiracy, along with the BLS company and New Jersey physician Frank Santangelo, 43, of Boonton, New Jersey The charges against BLS and Santangelo are pending.
Dicovsky
Dicovsky admitted he agreed with David Nicoll to accept bribes from BLS in exchange for his referral of blood specimens. To disguise those bribes, Dicovsky and BLS entered into a sham lease agreement and a sham service agreement in which the monthly bribe payments of more than $5,000 were characterized as “lease” and “service” payments. While the lease agreement purported to be for 1,000 square feet of space, little or no space was allocated to BLS in Dicovsky’s medical office in Paterson, New Jersey. Between November 2006 and August 2009, Dicovsky received more than $224,000 in bribe payments from BLS, and BLS made more than $800,000 through testing on blood specimens referred by Dicovsky.
Fortunato
On May 2, 2013, two former sales representatives of BLS, Peter Breihof, 42, of Nutley, New Jersey, and William Dailey, 41, of Wall, New Jersey, pleaded guilty to an information charging them with conspiracy to violate the Anti-Kickback Statute and the Federal Travel Act. They admitted using phony lease and service agreements to bribe physicians to send their patients’ blood samples to BLS. Breihof and Dailey also admitted that they paid various physicians a fee per test on behalf of BLS in order to induce those physicians to order more of the blood tests than they otherwise would have.
Fortunato admitted entering into bribe arrangements with BLS through Breihof, with David Nicoll’s knowledge and approval, for the referral of blood specimens of patients of Fortunato’s Montclair, New Jersey practice. Fortunato received more than $100,000 in bribe payments—often more than $5,000 per month—from BLS disguised through sham lease and sham service agreements between 2006 and 2009, and BLS made more than $430,000 through testing on blood specimens referred by Fortunato.
Aponte
Aponte admitted that he and David Nicoll agreed that BLS would pay Aponte bribes to refer to BLS blood specimens from the patients of his West New York, New Jersey medical practice. From October 2012 to March 2013, Nordman, acting at David Nicoll’s direction, paid Aponte approximately $3,000 per month in cash in return for blood specimens referred to BLS. The lab made more than $175,000 through testing on blood specimens referred by Aponte.
The count to which Aponte, Dicovsky, and Fortunato each pleaded guilty is punishable by a maximum potential penalty of five years in prison and a $250,000 fine. Fortunato also faces a maximum potential penalty of five years in prison and a $250,000 fine on the filing a false tax return charge. Sentencing for all three defendants is scheduled for October 22, 2013.
Aponte has agreed to forfeit $235,000, Dicovsky has agreed to forfeit more than $220,000, and Fortunato has agreed to forfeit more than $635,000. The investigation has so far recovered more than $2 million through forfeiture.
On June 10, 2013, David Nicoll, Scott Nicoll, Nordman, and four other associates of BLS pleaded guilty to informations charging them with one count of conspiracy to violate the Anti- Kickback Statute and the Federal Travel Act and one count of money laundering. The charges and allegations against Santangelo and BLS are merely accusations, and the defendants are considered innocent unless and until proven guilty.
U.S. Attorney Fishman credited special agents of the FBI, under the direction of Special Agent in Charge Ford; U.S. Department of Health and Human Services, Office of Inspector General, under the direction of Special Agent in Charge O’Donnell; IRS–Criminal Investigation, under the direction of Special Agent in Charge Shantelle P. Kitchen and the U.S. Postal Inspection Service, under the direction of Inspector in Charge Maria L. Kelokates, with the ongoing investigation leading to today’s guilty pleas.
The government is represented by Senior Litigation Counsel Andrew Leven, Assistant U.S. Attorney Joseph Minish, and Jacob T. Elberg, Chief of the U.S. Attorney’s Office Health Care and Government Fraud Unit in Newark, as well as Assistant U.S. Attorney Barbara Ward of the office’s Asset Forfeiture and Money Laundering Unit.

Former Muscatine Doctor Sentenced for Distributing Controlled Substances Not for Legitimate Medical Purpose and Outside the Scope of Professional Practice

DAVENPORT, IA—On July 18, 2013, David Vincent Gierlus, age 60, formerly an osteopathic doctor in Muscatine, Iowa, was sentenced by United States District Court Judge Stephanie M. Rose to 96 months’ imprisonment and a fine of $400,000 after pleading guilty to distributing hydrocodone to a patient without a legitimate medical purpose and outside the scope of professional practice, announced United States Attorney Nicholas A. Klinefeldt. Gierlus was also ordered to serve five years of supervised release following the imprisonment and to pay $100 towards the Crime Victims Fund.
In August 2012, Gierlus was charged in a criminal complaint with three counts of illegal distribution of drugs to patients. According to the criminal complaint, Gierlus provided prescriptions for controlled substances in exchange for sex. The criminal complaint also alleged that one patient advised that the sexual contact ranged from oral sex, both during medical appointments and outside the office in Gierlus’s vehicle, to intercourse in the examination room during medical appointments. That patient estimated she and Gierlus had sexual contact more than 50 times.
An indictment was filed against Gierlus in January 2013, and on March 1, 2013, Gierlus plead guilty to one of the counts of the indictment. Pursuant to a written sentencing agreement, Gierlus agreed to the 96-month sentence.
Gierlus is no longer licensed to practice medicine and is prohibited from providing any form of health services during the five years he is on supervised release.
This case was investigated by the Federal Bureau of Investigation; the Muscatine, Iowa Police Department; the Muscatine County Sheriff’s Office; and the Muscatine County Drug Task Force. The case was prosecuted by the United States Attorney’s Office for the Southern District of Iowa.

Local Physician, Clinic, and Nurse Practitioner Indicted on Health Care Fraud Charges

ST. LOUIS, MO—Dr. Mel Lucas, Patterson Medical Clinic Inc., and nurse practitioner Robyn Levy were indicted on multiple health care fraud related charges for their alleged false billing for services never rendered and false statements in patients’ medical records.
According to the indictment, from June 2008 to June 2011, the Patterson Medical Clinic Inc. and osteopath Mel E. Lucas billed Medicare, Tricare, and private insurers for more X-rays than were actually taken. The clinic had X-ray equipment in-house. The indictment also alleges that from 2008 to 2011, the clinic and Dr. Lucas billed for Lucas’ services on 573 occasions when he was actually out of town or in Cabo San Lucas, Mexico.
The indictment states that insurers were also billed for Lucas’ services on Fridays, when he did not come into the clinic. Instead, the patients were seen by medical assistants, who took their vital signs and drew their blood or gave them an injection. Lucas reviewed the records when he returned and billed insurers as if he had actually examined the patients.
Finally, the indictment alleges that Patterson, Lucas, and nurse practitioner Robyn Levy also billed insurers for an FDA-approved drug when Lucas had actually bought a non-approved version in Canada for hundreds of dollars less. The patients were not told they were receiving a drug that was not FDA-approved.
Lucas, of Florissant, Missouri, and Patterson Medical Clinic Inc. were indicted by a federal grand jury on eight felony counts of health care fraud and seven felony counts of false statements related to health service. Levy was indicted on two felony counts of health care fraud and three felony counts of false statements related to health service.
If convicted, each count of health care fraud carries a maximum penalty of 10 years in prison and/or fines up to $250,000 and each count of making false statements carries a maximum of five years in prison and/or fines up to $250,000. In determining the actual sentences, a judge is required to consider the U.S. Sentencing Guidelines, which provide recommended sentencing ranges.
Additionally, upon a finding of guilt, the defendants will be subject to forfeiture, which will require them to forfeit to the government all money derived from their illegal activity.
This case was investigated by the Department of Health and Human Services-Office of Inspector General and the FBI. Assistant United States Attorney Dorothy McMurtry is handling the case for the U.S. Attorney’s Office.
As is always the case, charges set forth in an indictment are merely accusations and do not constitute proof of guilt. Every defendant is presumed to be innocent unless and until proven guilty.

United States Intervenes in Health Care Fraud Action and Obtains $4 Million in Settlement

The United States will receive $4 million in the settlement of a lawsuit brought under the False Claims Act against a cardiology practice and a hospital in Jackson, Michigan, United States Attorney Barbara L. McQuade announced today. McQuade was joined in the announcement by Lamont Pugh, III, Special Agent in Charge, Department of Health and Human Services Office of Inspector General (HHS-OIG), and Robert D. Foley, III, Special Agent in Charge, FBI Detroit Field Division.
The lawsuit, alleging medically inappropriate cardiology procedures, was filed by a Michigan cardiologist, Dr. Julie A. Kovach, against Jackson Cardiology Associates and its owner, cardiologist Jashu Patel M.D., and against Allegiance Health, a hospital, all located in Jackson, Michigan. The action was kept under seal while the government investigated. The government thereafter notified the defendants that it intended to intervene and prosecute the action, and the case was unsealed this week.
Dr. Patel and Jackson Cardiology Associates have now settled the case against them for $2.2 million and Allegiance Health, where many of the catheterizations were performed, has settled for $1.8 million. Dr. Kovach will receive a percentage of the recovery.
The complaint alleges that Dr. Patel and cardiologists employed by Jackson Cardiology Associates performed medically inappropriate cardiac procedures, including invasive catheterizations at Allegiance Health. Specifically, the evidence showed that Dr. Patel ordered catheterizations for patients based on findings from nuclear stress tests that he improperly read as positive. The government found that three-quarters of these patients had no significant heart blockages. These catheterizations involve snaking a hollow tube into the heart through an incision in the patient’s groin.
Dr. Kovach also alleged that Patel and Jackson Cardiology Associates performed a variety of other office-based medically unnecessary tests. A portion of the settlement with Allegiance Health also covered medically unnecessary peripheral stents performed on an outpatient basis. Because the unnecessary procedures were paid for by Medicare or Medicaid, the United States is entitled to money damages under the False Claims Act.
“This case is especially important because the defendants unnecessarily subjected patients to invasive and potentially harmful procedures. We urge other health care professionals with knowledge of medically harmful procedures to come forward, either by calling our office and asking to speak to the criminal or civil health care fraud coordinators or through the qui tam whistleblower mechanism,” McQuade said.
The case was handled by Assistant U.S. Attorneys Joan Hartman and Linda Aouate and was investigated by Special Agent John Anderson of HHS-OIG and FBI Special Agent Sean Nicol. In addition to the monetary settlement, the resolution also provides that Jackson Cardiology Associates and Allegiance Health will enter into Integrity Agreements with HHS-OIG.

Jury Convicts Podiatrist, Psychologist, and Pharmacist in Health Care Fraud Case

A podiatrist, a psychologist, and a pharmacist were convicted today in federal court in Detroit, Michigan, for health care fraud and controlled substance distribution, United States Attorney Barbara L. McQuade announced today.
McQuade was joined in the announcement by Special Agent in Charge Robert L. Corso, Drug Enforcement Administration, Detroit Division; Special Agent in Charge Robert D. Foley, III, Federal Bureau of Investigation; and Lamont Pugh, III, Special Agent in Charge, Department of Health and Human Services Office of Inspector General (HHS-OIG).
United States Attorney Barbara L. McQuade stated, “Law enforcement investigators in metro-Detroit are aggressively investigating health care fraud and detecting abuses by doctors and pharmacists. We hope that prosecutions like this one will deter medical professionals from stealing taxpayer funds intended for health care.”
Convicted were podiatrist Anmy Tran, 42, of Clinton Township, psychologist Sanyani Edwards, 34, of Southfield, and pharmacist Mitesh Patel, 39, of Troy. Defendants Tran and Edwards were convicted on all three of the counts with which they were charged, specifically, conspiracies to commit health care fraud, to distribute controlled substances, and to pay or receive health care kickbacks. Defendant Patel was convicted of six of the seven counts with which he was charged, specifically, health care fraud conspiracy, conspiracy to distribute controlled substances, and two substantive counts each of health care fraud and controlled substances distribution.
Defendant Mitesh Patel was acquitted of conspiracy to pay or receive health care kickbacks.
The evidence presented during the three-week trial demonstrated that, from approximately January 2006 through August 2011, Canton Pharmacist Babubhai Patel owned and controlled over 20 pharmacies (termed “the Patel Pharmacies” at trial), which operated in and around Detroit, Michigan. The evidence also showed that Babubhai Patel’s model for turning a profit at his pharmacies was based upon large-scale health care fraud and the diversion of controlled substances. Babubhai Patel paid cash kickbacks and other things of value to physicians in exchange for those physicians writing prescriptions for expensive medications, without regard to medical necessity, that could be billed to Medicare, Medicaid, or a private insurer through one of the Patel Pharmacies. Physicians affiliated with Babubhai Patel would also write prescriptions for controlled substances for their patients, again regardless of medical necessity, which would then be filled at one of the Patel Pharmacies. These controlled substances were distributed to patients and patient recruiters as a kickback in exchange for the patients using a Patel Pharmacy. Pharmacists at the Patel Pharmacies would increase the pharmacies’ profits by billing insurers for medications never actually distributed to patients.
The evidence presented at trial showed that defendant Anmy Tran was one of the physicians to whom Babubhai Patel paid bribes and kickbacks in exchange for referrals of prescriptions. In exchange, Tran wrote numerous prescriptions for expensive medications, without regard to medical necessity, that could be filled at one of the Patel Pharmacies. Evidence presented at trial demonstrated that defendant Mitesh Patel, a pharmacist in Babubhai Patel’s organization, billed Medicare, Medicaid, and private insurers for expensive medications he never dispensed to patients. With respect to Sanyani Edwards, the evidence presented at trial showed that he offered and paid bribes and kickbacks to doctors, nurses, and assisted living facility owners in exchange for referrals of prescriptions to the Patel Pharmacies. Edwards also worked with a corrupt psychiatrist to write fictitious prescriptions for patients, which could then be billed at a Patel Pharmacy.
Defendants Tran, Edwards, and Mitesh Patel were three of 26 individuals who were charged in August 2011 with offenses relating to their involvement with Babubhai Patel’s pharmacy network. All 26 of the original defendants have now been convicted of felonies arising out of their involvement with Babubhai Patel; 17 of those defendants entered guilty pleas, and nine, including the three defendants today, have been convicted after trial. Defendant Babubhai Patel was convicted at a trial in August 2012; he is serving a 17-year prison sentence. A superseding indictment charging 13 additional individuals was unsealed in March 2013; those defendants’ cases remain pending, with a trial date set for January 2014.
The case was prosecuted by Assistant United States Attorneys John K. Neal and Wayne F. Pratt.

Anahit Hovhannisyan and Health Guard Inc. Plead Guilty to Conspiracy to Commit Health Care Fraud Violations

Anahit Hovhannisyan, age 34, of Armenia, pled guilty on Monday, July 1, 2013, to health care fraud. Health Guard Inc., a Louisiana corporation that operated as a medical clinic, also plead guilty to a health care fraud conspiracy. The pleas were entered before U.S. District Court Judge Lance M. Africk, announced U.S. Attorney Dana Boente.
According to the second superseding indictment, the defendants participated in a criminal organization for the purpose of fraudulently billing Medicare and Medicaid. Patients went to Health Guard Inc. for medical tests that were not performed or medically necessary. Patients were moved between other commonly owned health care clinics to Health Guard Inc. to repeatedly perform the same unnecessary tests. Five other clinics and their owners have already been sentenced for the same activity. According to the second superseding indictment, if the patients refused the diagnostic tests at Health Guard Inc., prescriptions for narcotic drugs were withheld. Thereafter, bills for the unnecessary services were submitted to Medicare and Medicaid. Hovhannisyan was the owner of Health Guard Inc. and also an unlicensed and unqualified diagnostic technician, according to the indictment.
The second superseding indictment to which Hovhannisyan pled guilty carries a possible maximum sentence of 10 years’ imprisonment. Sentencing has been scheduled for September 26, 2013.
The investigation was conducted by special agents of the Federal Bureau of Investigation, the U.S. Department of Health and Human Services-Office of Inspector General, and the Louisiana Department of Justice-Medicaid Fraud Control Unit. The case is being prosecuted by Assistant U.S. Attorney Patrice Harris Sullivan.

Los Angeles-Area Doctor and Patient Recruiter Plead Guilty to Participating in a Power Wheelchair Scheme That Defrauded Medicare of More Than $10.1 Million

WASHINGTON—A Los Angeles-area doctor and a patient recruiter pleaded guilty today for their roles in a power wheelchair fraud scheme that defrauded Medicare of over $10.1 million.
The plea was announced by Acting Assistant Attorney General Mythili Raman of the Justice Department’s Criminal Division; U.S. Attorney André Birotte Jr. of the Central District of California; Glenn R. Ferry, Special Agent in Charge for the Los Angeles Region of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG); Steven Martinez, Assistant Director in Charge of the FBI’s Los Angeles Field Office; and Joseph Fendrick, Special Agent in Charge of the California Department of Justice, Bureau of Medi-Cal Fraud and Elder Abuse.
Dr. Emmanuel Ayodele, 65, of Los Angeles, and Alejandro Maciel, 43, of Huntington Park, California, pleaded guilty before U.S. District Judge George Wu in the Central District of California to one count of health care fraud and one count of conspiracy to commit health care fraud, respectively.
Ayodele admitted that he defrauded Medicare by participating in a power wheelchair fraud scheme with the operators of fraudulent durable medical equipment (DME) supply companies. According to court documents, DME suppliers provided Ayodele with patients recruited by street-level patient recruiters or “marketers,” who illegally solicited people with Medicare benefits for power wheelchairs and other DME that the people did not need. In court documents, Maciel admitted that he was one of these marketers.
Maciel admitted that he approached people at their homes, swap meets, grocery stores, and other locations and made various misrepresentations to the people about his true identity and Medicare. Maciel admitted that these misrepresentations allowed him to gain the trust of Medicare beneficiaries and convince them to provide him with their Medicare billing and personal information, which Maciel, Ayodele, and their co-conspirators used to defraud Medicare. Maciel also admitted that, through his misrepresentations, he convinced people to travel with him to fraudulent medical clinics and DME supply companies owned and operated by his co-conspirators. Ayodele admitted that he owned one of these fraudulent medical clinics, Beth Medical Clinic, which he operated in Los Angeles.
Ayodele admitted that, at Beth Medical, he wrote medically unnecessary prescriptions for power wheelchairs and DME. Ayodele admitted he knew that the DME supply companies used the medically unnecessary prescriptions and documents that he wrote to submit claims to Medicare for medically unnecessary power wheelchairs and DME. For example, Ayodele admitted that the operators of fraudulent DME supply company Bonfee Inc., who were indicted with Ayodele and Maciel on Medicare fraud charges, paid Ayodele to write a medically unnecessary power wheelchair prescription for one of Bonfee’s customers and then used that prescription to submit a false power wheelchair claim to Medicare that totaled over $6,000.
Maciel admitted that his profit from the scheme came in the form of illegal kickbacks paid to him for every person whose Medicare billing and personal information his co-conspirators successfully used to bill Medicare for power wheelchairs or other items of DME. According to court documents, once his co-conspirators successfully billed Medicare, Maciel delivered the power wheelchairs and other DME to the people whom he recruited. During these deliveries, Maciel observed that the people could walk and that they did not have a legitimate need for the wheelchairs and other DME.
As a result of their conduct, Ayodele and Maciel admitted that they and the owners and operators of Bonfee, Lutemi Medical Supplies, and other fraudulent DME companies submitted and caused to be submitted over $10,132,178 in false and fraudulent claims to Medicare. Ayodele and Maciel admitted that Medicare paid Bonfee and the other DME supply companies over $5,388,754 on these false and fraudulent claims.
Two of Ayodele and Maciel’s co-defendants, Charles Agbu, a former pastor who owned Bonfee, and Dr. Juan Van Putten, have pleaded guilty to Medicare fraud charges and are scheduled for sentencing on August 15, 2013, and September 26, 2013, respectively. Ayodele and Maciel’s other co-defendants, Obiageli Agbu and Candalaria Estrada, are scheduled for trial on July 9, 2013.
The owner of Lutemi, Olufunke Fadojutimi, a registered nurse, was arrested on May 14, 2013, on Medicare fraud charges. Fadojutimi is scheduled for trial on October 22, 2013. Defendants are presumed innocent unless proven guilty in court.
At sentencing, scheduled for September 30, 2013, Ayodele and Maciel each face a maximum penalty of 10 years in prison and a $250,000 fine.
The case is being prosecuted by Trial Attorneys Jonathan T. Baum, Alexander Porter, William Kanellis and Blanca Quintero of the Criminal Division’s Fraud Section. The case is being investigated by the FBI, HHS-OIG, and the California Department of Justice.
The case was brought as part of the Medicare Fraud Strike Force, supervised by the Criminal Division’s Fraud Section and the U.S. Attorney’s Office for the Central District of California. The Medicare Fraud Strike Force operations are part of the Health Care Fraud Prevention and Enforcement Action Team (HEAT), a joint initiative announced in May 2009 between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country.
Since its inception in March 2007, the Medicare Fraud Strike Force, now operating in nine cities across the country, has charged more than 1,500 defendants who have collectively billed the Medicare program for more than $5 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.
To learn more about the Health Care Fraud Prevention and Enforcement Action Team (HEAT), go to www.stopmedicarefraud.gov.

Los Angeles Medical Supply Company Owner Sentenced to Five Years in Prison in $8.4 Million Medicare Fraud Scheme

WASHINGTON—The owner and operator of a durable medical equipment (DME) supply company was sentenced today to serve five years in prison in connection with a health care fraud scheme involving Latay Medical Services, a DME company based in Gardena, California.
The sentence was announced by Acting Assistant Attorney General Mythili Raman of the Justice Department’s Criminal Division; U.S. Attorney for the Central District of California André Birotte, Jr.; Glenn R. Ferry, Special Agent in Charge for the Los Angeles Region of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG); and Bill L. Lewis, Assistant Director in Charge of the FBI’s Los Angeles Field Office.
Bolademi Adetola, 47, of Harbor City, California, was sentenced today by U.S. District Judge George H. Wu in the Central District of California. In addition to her prison term, Adetola was sentenced to serve three years of supervised release and ordered to pay $4,555,198 in restitution.
On March 1, 2013, Adetola was convicted by a jury in federal court in Los Angeles of one count of conspiracy to commit health care fraud and 12 counts of health care fraud. During trial, the evidence showed that Adetola, as the former owner and operator of Latay, fraudulently billed millions of dollars to Medicare for DME that was either never provided to its Medicare beneficiaries or was not medically necessary.
The trial evidence showed that between January 2005 and October 2009, Adetola paid cash kickbacks for fraudulent prescriptions for DME, such as power wheelchairs and hospital beds. The evidence at trial showed that a co-conspirator physician wrote prescriptions for power wheelchairs and other DME that the Medicare beneficiaries did not need and ultimately never used. The co-conspirator physician testified that Adetola paid him cash kickbacks for every fraudulent prescription that he wrote for the DME and that Adetola used his prescriptions to bill Medicare for the power wheelchairs and other DME. Several Medicare beneficiaries testified that they were lured to medical clinics with the promise of a free recliner sofa, only to receive power wheelchairs that they did not need and did not want. According to the testimony, the beneficiaries were unsuccessful in their attempts to reject delivery of the power wheelchairs from Adetola’s supply company.
In addition, the trial evidence showed that Adetola billed Medicare for DME supposedly provided and delivered to Medicare beneficiaries who were deceased at the time of service. One particular claim submitted by Adetola to Medicare showed that the Medicare beneficiary’s death preceded the date the Medicare beneficiary supposedly signed for the service.
As a result of this fraud scheme, Adetola submitted and caused the submission of over $8.4 million in false and fraudulent claims to Medicare and received over $4.5 million on those claims.
The case is being prosecuted by Assistant Chief Benton Curtis and Trial Attorney Blanca Quintero of the Criminal Division’s Fraud Section. The case is being investigated by the FBI and the Los Angeles Region of HHS-OIG.
The case was brought as part of the Medicare Fraud Strike Force, supervised by the Criminal Division’s Fraud Section and the U.S. Attorney’s Office for the Central District of California. The Medicare Fraud Strike Force operations are part of the Health Care Fraud Prevention and Enforcement Action Team (HEAT), a joint initiative announced in May 2009 between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country.
Since its inception in March 2007, the Medicare Fraud Strike Force, now operating in nine cities across the country, has charged more than 1,500 defendants who have collectively billed the Medicare program for more than $5 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.
To learn more about the Health Care Fraud Prevention and Enforcement Action Team (HEAT), go to www.stopmedicarefraud.gov.