Category Archives: Office of Inspector General (OIG)

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

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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

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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

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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

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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

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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.