Department of Energy OIG Enforcement under a Trump Administration

The United States Department of Energy (DOE) is a Cabinet-level department of the United States Government. Its responsibilities include the nation’s nuclear weapons program, nuclear reactor production for the United States Navyenergy conservation, energy-related research, radioactive waste disposal, and domestic energy production. It also directs research in genomics; the Human Genome Project originated in an iniative between DOE, NIH and international collaborators.  DOE sponsors more research in the physical sciences than any other U.S. federal agency, the majority of which is conducted through its system of National Laboratories.

Former Governor of Texas Rick Perry has been nominated as the next Secretary of Energy, and a vote is anticipated in the next few weeks.  April Stephenson currently serves as Acting Inspector General United States Secretary of Energy and will continue to head the department,  unless Secretary Perry makes a change. As a practical matter, DOE is unlikely to get a permanent Inspector General installed for many months. This means that its roughly 70 investigative agents in roughly 12 US cities will engage in enforcement that is somewhat skewed by perceptions about what a future Secretary of Energy will want.  For these reasons, I would project that investigative agents will believe they will ultimately receive more overhead support for investigations developed now.

Based on basic familiarity with DOE contracts and DOE-OIG investigative activity in the past as well as reasonable assumptions about how agents will interpret statements made by Trump Administration officials, I see three primary areas where agents will likely focus current efforts to develop cases:

1) Clean-up Sites.

Clean-up sites are viewed as cash cows with poor oversight.  I have lost track of how many there are, but there are  more than half a dozen prime ones including Hanford, Idaho Falls and Savanah River.  The Hanford site is an example of a site that has had longstanding troubles.  CH2MHill took a hit back in 2013 for an $18.5 million qui tam and, just recently, at the same site, BNI and URS agreed to  pay $125 Million for false claims regarding deficient nuclear quality procurements and improper payments to lobby Congress.  Internal conjecture is that there are more false claims being made at these and at other clean-up sites and it would behoove any companies involved at these sites to brush up on compliance and internally investigate around vulnerabilities or weaknesses.

2) Management and Operational (M&O) Contracts

Management Operations Contractors, whether deserved or not, are a source of frustration to enforcers.  These are huge, large dollar volume contracts that are viewed by enforcers as having poor oversight.  Other sources of frustration is that enforcers believe that they have no visibility with indirect contractors.  This feeling is even generally held in regard to direct contractors where transparency is lacking and contractors are perceived as foot dragging.  Because of lack of appetite in some US Attorney’s Offices for these complex investigations, there was less support in the past few years than perhaps there could have been, but I believe this will begin to change as the Trump Administrations enforcement priorities becomes more clear.

3) Green Grants

Although these are smaller dollar volume contracts, legal theories are easier to fashion around bite-sized grants and the story around each is usually more accessible to prosecutors and potential juries.  There is lingering resentment that politics adversely affected investigations that adversely impacted potential prosecutions (see Solyndra as an often cited example in the opinion of some) and there is a view among enforcers that investigations involving more than $2 billion in green grants and associated loans guaranteed by the government were never pursued appropriately.

* * * * * Here for the Rest of the Story * * * * * 

 

Latest GrantFraud.Com post involves a $200 million credit card fraud scheme

Bradford L. Geyer is reading enforcement agency tea leaves and he is seeing signs of enhanced enforcement involving grant fraud and procurement fraud at grantfraud.com.  His latest note regarding an extensive credit card fraud scheme can be found here.

Fourth Individual in NYPA Big-Rigging Scandal Comes Forward, Faces up to Three Years and $250,000

Washington, D.C.-  The New York Power Authority (NYPA) has recently come under multilateral investigation over allegations of bid rigging, tax fraud, and market fixture.  The DOJ, IRS, and New York Inspector General are all working jointly in this case and have subsequently made their fourth indivdual charge.  John Simonlacaj (White Plains, NY) has confessed to aiding the NYPA in filing false tax returns and now faces up to three years in prison and a $250,000 fine.

The original article is reproduced below with its link following.

 

Fourth Individual Charged in Ongoing New York Power Authority Procurement Fraud Investigation

The Department of Justice, the Internal Revenue Service (IRS) and the New York State Inspector General, which are all conducting a joint federal and state investigation into bid-rigging, fraud and tax-related offenses in the award of contracts at the New York Power Authority (NYPA), announced today that a Westchester County, New York, resident pleaded guilty today to aiding and assisting in the filing of a false tax return.

According to the one-count felony charge filed in the U.S. District Court for the Southern District of New York, in White Plains, New York, John Simonlacaj caused another individual to file a Form 1040 for the tax year 2010 that substantially understated that individual’s taxable income.  Simonlacaj pleaded guilty to aiding and assisting in the filing of a false tax return, which carries a maximum penalty of three years in prison and a $250,000 fine.

“Our investigation into bid rigging and fraud by companies supplying the New York Power Authority has uncovered a variety of criminal activity,” said Principal Deputy Assistant Attorney General Renata Hesse, head of the Justice Department’s Antitrust Division.  “Filing a false tax return is a serious offense and we are pleased to have worked with our partners in law enforcement to prosecute the criminal violation.”

“We say many times the FBI won’t stop until we find everyone responsible for their roles in a criminal investigation,” said Assistant Director in Charge Diego Rodriguez of the FBI’s New York Field Office.  “These charges prove our tenacity in digging until we hit the bottom of the pile and uncover anyone who had a part in criminal wrongdoing.”

“Today’s plea marks yet another defendant admitting guilt following a bid rigging investigation that began at the state level. My office and those of my federal law enforcement partners, will continue to follow the evidence wherever it may lead,” said New York State Inspector General Catherine Leahy Scott.

“Mr. Simonlacaj is now held accountable for his role in filing a false tax return,” said Special Agent in Charge Shantelle P. Kitchen of the IRS Criminal Investigation New York Field Office.  “Towards pursuing its goal of ensuring that that everyone pays their fair share of taxes, IRS Criminal Investigation remains committed to this ongoing investigation.”

The investigation is being conducted by the Antitrust Division’s New York Office with the assistance of the FBI, IRS Criminal Investigation and the New York State Office of the Inspector General.  NYPA is cooperating with the investigation.  Anyone with information on bid rigging or other anticompetitive conducted related to the award or performance of municipal and state contracts should contact the Antitrust Division’s Citizen Complaint Center at 888-647-3258 or visit http://www.just

Original Link

 

Medtronic to Pay $4.41 Million in USDOJ-CIV Case

The Justice Department announced today that Medtronic plc and affiliated Medtronic companies, Medtronic Inc., Medtronic USA Inc., and Medtronic Sofamor Danek USA Inc., have agreed to pay $4.41 million to the United States to resolve allegations that they violated the False Claims Act by making false statements to the U.S. Department of Veterans Affairs (VA) and the U.S. Department of Defense (DoD) regarding the country of origin of certain Medtronic products sold to the United States.

“Today’s settlement demonstrates our commitment to ensure that our service members and our veterans receive medical products that are manufactured in the United States and other countries that trade fairly with us,” said Acting Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division.  “The Justice Department will take action to hold medical device companies to the terms of their government contracts.”

“Domestic manufacture is a required component of many military and Veterans Administration contracts,” said U.S. Attorney Andrew M. Luger of the District of Minnesota.  “Congress has mandated that the United States use its purchasing power to buy goods made in the United States or in designated countries.  We take that mandate seriously and will not hesitate to take appropriate legal action to ensure compliance.”

According to the settlement agreement, between 2007 and 2014, Medtronic sold to the VA and DoD products it certified would be made in the United States or other designated countries.  The Trade Agreements Act of 1979 (TAA) generally requires companies selling products to the United States to manufacture them in the United States or in another designated country.  The United States alleged that Medtronic sold to the United States products manufactured in China and Malaysia, which are prohibited countries under the TAA.

The specific Medtronic products at issue included anchoring sleeves sold with cardiac leads and used to secure the leads to patients, certain instruments and devices used in spine surgeries, and a handheld patient assistant used with a wireless cardiac device.  The agreement covers the period from Jan. 1, 2007, to Dec. 31, 2013, and for one device (the handheld patient assistant), the period from Jan. 1, 2014, to Sept. 30, 2014.

The settlement resolves allegations originally brought in a lawsuit filed by three whistleblowers under the qui tam provisions of the False Claims Act, which allow private parties to bring suit on behalf of the government and share in any recovery. The relators will receive a total of $749,700 of the recovered funds.

This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by the Attorney General and the Secretary of Health and Human Services.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in this effort is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $23.9 billion through False Claims Act cases, with more than $15.2 billion of that amount recovered in cases involving fraud against federal health care programs.

The case was handled by the U.S. Attorney’s Office of the District of Minnesota with assistance from the Civil Division, DoD, Defense Logistics Agency and Defense Criminal Investigative Service and the VA’s Office of General Counsel.

The underlying case is United States of America ex rel. Samuel Adam Cox, III, Meayna Phanthavong, and Sonia Adams v. Medtronic, Inc., Medtronic USA, Inc., and Medtronic Sofamor Danek USA, Inc., Civil No. 12-cv-2562 (PAM/JSM).

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

Mexican Businessman Arrested

WASHINGTON, Feb. 3, 2015 /PRNewswire-USNewswire/ — The Office of Inspector General (OIG) for the Export-Import Bank of the United States (Ex-Im Bank) announced today that Fernando Pascual-Jimenez, age 44, was arrested on January 30, 2015, on charges that he conspired to commit wire fraud in connection with Ex-Im Bank loans resulting in loan defaults and claims paid by ExIm Bank of approximately $5 million.

On January 30, 2015, U.S. Customs and Border Protection and Homeland Security Investigations (HSI) agents in Las Vegas, Nevada, arrested Pascual as he arrived on an international flight from Mexico. Pascual was arrested based on an indictment and arrest warrant obtained by Special Agents from the Ex-Im Bank OIG charging him with violations of 18 U.S.C. § 1349 (conspiracy to commit wire fraud).

According to the indictment, Pascual owned and operated CEMEC Commercial, S.A. de C.V. (CEMEC), a company located inQueretaro, Mexico. According to the allegations in the indictment, from in or around July 2005 through July 2010, Pascual conspired with others to obtain an Ex-Im Bank guaranteed loan for exporting U.S. goods overseas. The indictment alleges that Pascual and others conspired to create false documents and did not use the loan proceeds for the purchase and shipment of the goods guaranteed by Ex-Im Bank.

This case is being prosecuted by the U.S. Attorney’s Office, Southern District of Florida. The case is being investigated by Ex-Im Bank OIG, Homeland Security Investigations – El Paso, TX; and the FBI – Washington, D.C.

An arrest based on an indictment is merely a charge and should not be considered as evidence of guilt. The defendant is presumed innocent until proven guilty in a court of law.

Ex-Im Bank is an independent federal agency that helps create and maintain U.S. jobs by filling gaps in private export financing. Ex-Im Bank provides a variety of financing mechanisms to help foreign buyers purchase U.S. goods and services.

Ex-Im Bank OIG is an independent office within Ex-Im Bank. The OIG receives and investigates complaints and information concerning violations of law, rules or regulations, fraud against Ex-Im Bank, mismanagement, waste of funds, and abuse of authority connected with Ex-Im Bank’s programs and operations. Additional information about the OIG can be found at www.exim.gov/oig. Complaints and reports of waste, fraud, and abuse related to Ex-Im Bank programs and operations can be reported to the OIG hotline at 888-OIG-EXIM (888-644-3946) or via email at IGhotline@exim.gov.

SOURCE Office of Inspector General for the Export-Import Bank of the United States

Omnicare to Pay Government $4.19 Million to Resolve False Claims Act Allegations of Kickbacks

Omnicare Inc., an Ohio-based long-term care pharmacy, has agreed to pay the government $4.19 million to settle allegations that it engaged in a kickback scheme in violation of the False Claims Act, the Justice Department announced today.  Omnicare provides pharmaceuticals and services to long-term care facilities and residents and other senior populations.

The settlement resolves allegations that Omnicare solicited and received kickbacks from the drug manufacturer Amgen Inc. in return for implementing “therapeutic interchange” programs that were designed to switch Medicaid beneficiaries from a competitor drug to Amgen’s product Aranesp.  The government alleged that the kickbacks took the form of performance-based rebates that were tied to market-share or volume thresholds, as well as grants, speaker fees, consulting services, data fees, dinners and travel.

“Kickbacks are designed to influence decisions by health care providers, such as which drugs to prescribe,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery.  “Americans who rely on federal health care programs, particularly vulnerable patients in skilled nursing facilities, are entitled to feel confident that decisions about their medical care are not tainted by improper financial arrangements.”

“The District of South Carolina has devoted significant resources over the last three years to pursuing claims under the False Claims Act, and this settlement is the latest example of this office’s successful efforts,” said U.S. Attorney for the District of South Carolina William Nettles.  “I am very proud of the work this office has done in this area.”

This civil settlement resolves a lawsuit filed under the qui tam, or whistleblower, provision of the False Claims Act, which allows private citizens with knowledge of false claims to bring civil actions on behalf of the government and to share in any recovery.  The relator’s share in this case is $397,925.

“Kickbacks corrode our federal health care programs,” said Derrick L. Jackson, Special Agent in Charge of the Office of Inspector General, U.S. Department of Health and Human Services in the region covering South Carolina.  “OIG is committed to unveiling these illegal reciprocal relationships, and companies making or receiving such payments can expect serious consequences.”

The settlement with Omnicare Inc. was the result of a coordinated effort among the Civil Division, the U.S. Attorney’s Office for the District of South Carolina and the U.S. Department of Health and Human Services Office of Inspector General.

This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Secretary of Health and Human Services Kathleen Sebelius.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in this effort is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $19 billion through False Claims Act cases, with more than $13.4 billion of that amount recovered in cases involving fraud against federal health care programs.

The claims settled by this agreement are allegations only; there has been no determination of liability.

The False Claims Act lawsuit was filed in the U.S. District Court for the District of South Carolina and is captioned United States ex rel. Kurnik v. Amgen Inc., et al.

US Government Intervenes in False Claims Lawsuit Against United States Investigations Services for Failing to Perform Required Quality Reviews of Background Investigations

The government has intervened in a lawsuit filed under the False Claims Act against United States Investigations Services LLC (USIS) in the U.S. District Court for the Middle District of Alabama, the Department of Justice announced today.  The lawsuit alleges that USIS, located in Falls Church, Va., failed to perform quality control reviews in connection with its background investigations for the U.S. Office of Personnel Management (OPM).

The lawsuit was filed by a former employee of USIS, Blake Percival, under the qui tam or whistleblower provisions of the False Claims Act, which permit private parties, known as relators, to sue on behalf of the government when they believe false claims for government funds have been submitted.  The private party is entitled to receive a share of any funds recovered through the lawsuit.  The False Claims Act also permits the government to investigate the allegations made in the relator’s complaint and to decide whether to intervene in the lawsuit, and to recover three times its damages plus civil penalties.  The government is intervening now based on the results of its investigation of the relator’s allegations and has requested that the court give it until Jan. 22, 2014, to file its own complaint.

“We will not tolerate shortcuts taken by companies that we have entrusted with vetting individuals to be given access to our country’s sensitive and secret information,”  said Stuart F. Delery, Assistant Attorney General for the Justice Department’s Civil Division.  “The Justice Department will take action against those who charge the taxpayers for services they failed to provide, especially when their non-performance could place our country’s security at risk.”

Since 1996, USIS has contracted with OPM to perform background investigations on individuals seeking employment with various federal agencies.  Executed in 2006, the contract at issue in the lawsuit required USIS to conduct the investigatory fieldwork on each prospective applicant.  It also required that a trained USIS Reviewer perform a full review of each background investigation to ensure it conformed to OPM standards before sending the file back to OPM for processing.

According to the relator’s complaint, starting in 2008, USIS engaged in a  practice known at USIS as “dumping.”  Specifically, USIS used a proprietary computer software program to automatically release to OPM background investigations that had not gone through the full review process and thus were not complete.  USIS allegedly would dump cases to meet revenue targets and maximize its profits.  The lawsuit alleges that USIS concealed this practice from OPM and improperly  billed OPM for background investigations it knew were not performed in accordance with the contract.

“Thorough, appropriate and accurate background checks are essential in the employment of government personnel,” said George L. Beck Jr., U.S. Attorney for the Middle District of Alabama.  “The increase in foreign and domestic terrorism places an increased responsibility on our government to ensure that unsuitable individuals are prohibited from government employment.”

“This is a clarion call for accountability,” said Patrick E. McFarland, Inspector General of OPM.    “As recent events have shown, it is vital for the safety and security of Americans to have these background investigations performed in a thorough and accurate manner.  We can accept no less.  Those responsible for any malfeasance that compromises the integrity of the background investigations process must be held accountable.”

“OPM does not tolerate fraud or falsification,” said Elaine Kaplan, Acting Director of OPM.  “We work hard to prevent and detect both through a variety of means including a robust integrity assurance program, multiple levels of review and workforce education and training.  We also work hand in hand with our Inspector General and the Department of Justice when we discover fraud so that bad actors are held accountable to the fullest extent of the law.”

This matter was handled by the Commercial Litigation Branch of the Justice Department’s Civil Division and the U.S. Attorney’s Office for the Middle District of Alabama in conjunction with OPM’s Office of Inspector General and Federal Investigative Service.

The claims asserted against USIS are allegations only, and there has been no determination of liability.

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FORMER PROJECT MANAGER CONVICTED FOR ROLE IN CONSPIRACY SCHEMES INVOLVING TWO EPA SUPERFUND SITES IN NEW JERSEY

WASHINGTON — A New Jersey jury convicted a former project manager for his  central role in conspiracies that spanned seven years and involved kickbacks in  excess of $1.5 million at two Environmental Protection Agency (EPA) Superfund  sites in New Jersey, the Department of Justice announced today.  The jury returned guilty verdicts on 10  counts charged in the indictment against Gordon D. McDonald, which was filed on  Aug. 31, 2009.

In addition to today’s conviction,  to date, eight individuals and three companies have pleaded guilty to charges  arising out of this investigation.

After a two-week trial, McDonald, a former project manager for a prime contractor, was convicted  of engaging in separate bid-rigging, kickback and/or fraud conspiracies with  three subcontractors at two New Jersey Superfund sites – Federal Creosote in  Manville, N.J., and Diamond Alkali in Newark, N.J.  He was also convicted of engaging in an  international money laundering scheme, major fraud against the United States,  accepting illegal kickbacks, committing two tax violations and obstruction of  justice. The various conspiracies took  place at different time periods from approximately December 2000 until approximately April 2007.  McDonald was acquitted on counts eight and nine involving certain fraud and kickback charges.

“Today’s guilty verdict sends a clear message that  corrupt purchasing officials will be held accountable for engaging in  fraudulent schemes designed to undermine the government’s competitive  contracting practices,” said Bill Baer, Assistant Attorney General in charge of  the Department of Justice’s Antitrust Division.   “The Antitrust Division is committed to ensuring there is fair play and competition  in our markets.”

As part of  the conspiracies, McDonald and co-conspirators at his former company accepted  kickbacks from sub-contractors in exchange for the award of sub-contracts at  Federal Creosote.  McDonald provided  co-conspirators at Bennett Environmental Inc., a Canadian-based company that  treats and disposes of contaminated soil, with bid prices of their competitors,  which allowed them to submit higher bid prices and still be awarded the  sub-contracts.  In exchange for  McDonald’s assistance, Bennett Environmental, Inc. provided him with over $1.5  million in kickback payments.

According to court documents, McDonald also  accepted kickbacks in exchange for the award of sub-contracts at the Federal  Creosote and Diamond Alkali sites from the owner of JMJ Environmental Inc., a  wastewater treatment and chemical supply company, and the co-owner of National  Industrial Supply LLC, an industrial pipes supplier.  He participated in a conspiracy with the  owner of JMJ and co-conspirators to rig bids and allocate sub-contracts at  inflated prices for wastewater treatment supplies and services at Federal Creosote.

The cleanup at Federal Creosote was  primarily funded by the EPA.  An  interagency agreement between the EPA and the U.S. Army Corps of Engineers designated that the U.S. Army Corps of Engineers hire the prime contractors at Federal Creosote.  According to a settlement with the EPA and  the New Jersey Department of Environmental Protection, Tierra Solutions was  required to fund remedial action and maintenance of Diamond Alkali.  Tierra Solutions hired the prime contractor  for the remedial action and maintenance of Diamond Alkali.

Sentencing is  scheduled for Jan. 6, 2014, before Judge Susan D. Wigenton.  To date, more than $6 million in criminal  fines and restitution have been imposed, and five individuals have been  sentenced to serve more than 10 years in total prison time.

Today’s  conviction is the result of an ongoing federal antitrust investigation being  conducted by the Antitrust Division’s New York Office, the EPA Office of  Inspector General and the Internal Revenue Service-Criminal Investigation.  Anyone with information concerning bid  rigging, kickbacks, tax offenses or fraud relating to subcontracts awarded at  the Federal Creosote Superfund site or Diamond Alkali Superfund site should  contact the Antitrust Division’s New York Office at 212-335-8000

Shands Healthcare to Pay $26 Million to Resolve Allegations Related to Inpatient Stays at Six Florida Hospitals

Shands Teaching Hospital & Clinics Inc., Shands Jacksonville Medical Center Inc. and Shands Jacksonville Healthcare Inc. (collectively, Shands Healthcare), which operates a network of health care providers in Florida, will pay the government and the state of Florida a total of $26 million to settle allegations that six of its health care facilities submitted false claims to Medicare, Medicaid and other federal health care programs for inpatient procedures that should have been billed as outpatient services, the Justice Department announced today.  The six Florida hospitals are:  Shands at Jacksonville; Shands at Gainesville, also known as Shands at the University of Florida; Shands Alachua General Hospital; Shands at Lakeshore; Shands Starke and Shands Live Oak.

“The Department of Justice is committed to ensuring that Medicare funds are expended appropriately, based on the medical needs of patients rather than the desire of health care providers to maximize profits,” said Stuart F. Delery, Assistant Attorney General for the Civil Division.  “Hospitals participating in Medicare must bill for their services accurately and honestly.”

Allegedly, from 2003 through 2008, the six hospitals knowingly submitted inpatient claims to Medicare, Medicaid and TRICARE for certain services and procedures that Shands Healthcare knew were correctly billable only as outpatient services or procedures.

“The public expects its medical professionals to operate with a high degree of integrity,” said A. Lee Bentley III, Acting U.S. Attorney for the Middle District of Florida.  “When health care providers seek higher profits at the expense of their professional judgment, the public trust in the medical system is compromised.”

“Regardless of the complexity of these schemes to siphon off crucial health care dollars,” said Daniel R. Levinson, Inspector General of the U.S. Department of Health and Human Services, “our law enforcement officials will work tirelessly to seek justice.”

The six Florida hospitals were named as defendants in a qui tam, or whistleblower, lawsuit brought under the False Claims Act, which permits private citizens to sue on behalf of the government and receive a portion of the proceeds of any settlement or judgment awarded against a defendant.  The lawsuit was filed in federal district court in Jacksonville, Fla., by Terry Myers, the president of a healthcare consulting firm, YPRO Corp.  Of the $26 million settlement, $25,170,400 will go to Medicare and other federal health care payors.  The settlement also resolved allegations under the Florida False Claims Act; the state of Florida will receive $829,600.  Myers’ portion of these recoveries has yet to be determined.

This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in this effort is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $14.8 billion through False Claims Act cases, with more than $10.8 billion of that amount recovered in cases involving fraud against federal health care programs.

The settlement was the result of a coordinated effort among the U.S. Attorney’s Office for the Middle District of Florida, the Commercial Litigation Branch of the Justice Department’s Civil Division, the Department of Health and Human Services’ Office of Inspector General and Office of Counsel to the Inspector General, and the Florida Attorney General’s Office.

The claims resolved by these settlements are allegations only, and there has been no determination of liability.   The lawsuit is captioned United States of America and the State of Florida ex rel. Terry L. Myers v. Shands Healthcare et al., Civil Action No. 3:08-cv-441-J-16HTS (M.D. Fla.).

North Carolina-Based Trans1 to Pay U.S. $6 Million to Settle False Claims Act Allegations

Medical device manufacturer TranS1 Inc., now known as Baxano Surgical Inc., has agreed to pay the United States $6 million to resolve allegations under the False Claims Act that the company caused health care providers to submit false claims to Medicare and other federal health care programs for minimally-invasive spine surgeries, the Justice Department announced today.
“The Justice Department is committed to ensuring that medical device manufacturers follow the law when providing devices to beneficiaries of federal health care programs,” said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department’s Civil Division.  “It is critical that health care providers bill federal health care programs accurately and honestly for the work they perform, and it is imperative that they base their selection of medical devices on the best interests of their patients.”
The United States alleged that TranS1 knowingly caused health care providers to submit claims with incorrect diagnosis or procedure codes for minimally-invasive spine fusion surgeries using Trans1’s AxiaLIF System.  That device was developed as alternative to invasive spine fusion surgeries.  The United States alleges that TranS1 improperly counseled physicians and hospitals to bill for the AxiaLIF System by using incorrect and inaccurate codes intended for more invasive spine fusion surgeries.  The United States alleged that, as a result, health care providers received greater reimbursement than they were entitled to for performing the minimally-invasive AxiaLIF procedures.
The United States further alleged that TranS1 knowingly paid illegal remuneration to certain physicians for participating in speaker programs and consultant meetings intended to induce them to use TranS1 products, in violation of the Federal Anti-Kickback Statute, 42 U.S.C.  § 1320a-7b(b), and thereby caused false claims to be submitted to federal health care programs.  The Anti-Kickback Statute prohibits offering or paying remuneration to induce referrals of items or services covered by federally-funded programs and is intended to ensure that a physician’s medical judgments are not compromised by improper financial incentives and are based solely on the best interests of the patient.
In addition, the United States alleged that TranS1 promoted the sale and use of its AxiaLIF System for uses that were not approved or cleared by the U.S. Food and Drug Administration, including use in certain procedures to treat complex spine deformity, and which were thus not covered by federal health care programs.     

               
“A medical device manufacturer violates the law when it advises physicians and hospitals to report the wrong codes to federal health insurance programs in order to increase reimbursement rates,” said Rod J. Rosenstein, U.S. Attorney for the District of Maryland.  “Health care providers are required to bill federal health care programs truthfully for the work they perform.”
As part of the settlement, TranS1 has agreed to enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.  That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter.
“Using kickbacks to encourage health providers to make false payment claims will not be tolerated,” said Daniel R. Levinson, Inspector General of the U.S. Department of Health and Human Services.  “TranS1’s agreement to now comply with government health laws is an important step.”
The civil settlement resolves a lawsuit filed under the whistleblower provision of the False Claims Act, which permits private parties to file suit on behalf of the United States for false claims and obtain a portion of the government’s recovery.  The civil lawsuit was filed in the District of Maryland and is captioned United States ex rel. Kevin Ryan v. TranS1, Inc.  As part of today’s resolution, Mr. Ryan will receive $1,020,000 from the settlement.
This resolution is part of the government’s emphasis on combating health care fraud and another step for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced by Attorney General Eric Holder and Kathleen Sebelius, Secretary of the Department of Health and Human Services in May 2009.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover more than $10.7 billion since January 2009 in cases involving fraud against federal health care programs.  The Justice Department’s total recoveries in False Claims Act cases since January 2009 are over $14.7 billion.
The settlement with TranS1 was the result of a coordinated effort among the U.S. Attorney’s Office for the District of Maryland; the Commercial Litigation Branch of the Justice Department’s Civil Division; the Department of Health and Human Services’ Office of Inspector General; the Department of Defense, Office of the Inspector General; and the Office of Personnel Management, Office of Inspector General.

 

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