CALL US TOLL FREE FOR HELP: 1-800-632-1404

We are attorneys that investigate False Claims Act cases nationwide, including in the state of New Jersey for Medicare fraud, tax fraud, contractor fraud and more against a range of employers including healthcare providers, medical device companies, defense contractors, and pharmaceutical companies. We stand ready to provide a free case evaluation to you; please call us today.

False Claims Act Attorney Discusses Case Filed in Texas on Improperly Accepting Money for Housing Grants

As False Claims lawyers we wanted to bring your attention to a Qui Tam whistle blower suit that is currently pending in the United States District Court for the Northern District of Texas in Dallas.  The facts of that case are as follows:

During the false claims period, the City of Dallas applied for and received over $238,000,000 in federal housing and community development funds from the government.  Congress expressly conditioned receipt of these federal funds on a city certification that each “grant will be conducted and administered in conformity with the Civil Rights Act of 1964 and the Federal Housing Act, the grantee will affirmatively further their housing”.  See 42 U.S.C. § 5304(d)(2).

Congress conditioned receipt of these funds on compliance with the Civil Rights Certifications and in particular further their housing in order to leverage the funds to further racial national origin, integration and jurisdictions like Dallas and others.  The benefit of the bargain sought by the federal government who agreed to pay these funds is to ensure that the city uses them to provide for greater housing choices for people included in the housing acts protected classes.  The city of Dallas, however, is alleged to have not kept up with its end of the bargain.   It is alleged to have repeatedly made false certifications that it was in compliance with its civil rights obligations and in order to keep the falsehood of federal housing and community development funds running while knowingly shrinking its civil rights obligations.  It is alleged that the city of Dallas, Texas failed to conduct even basic evaluations of fair housing and segregation as is required by its duty to the AFFH, and that it has concealed impediments in federal housing choice and actually taken actions that further segregation in Dallas, Texas.  It is alleged that the city knowingly filed false certifications of civil rights compliance in order to receive federal housing and community development funds.

The plaintiff relators allege that each year during the false claims period the city was required to certify its AFFH compliance meaning that promised the government that it identified impediments to fair housing choices and took actions to address those impediments.

 

However, it is alleged that the city in fact failed to consider the AFFH impact of many of its own housing programs.  In the complaint filed the relators allege in detail how the defendant’s policies in fair housing primarily occupied by minority individuals into segregated, low opportunity neighborhoods.  In fact, the lawsuit alleges that city officials confirmed that low income housing available to minorities is not welcome in certain areas of Dallas, Texas.  The city went so far as to misrepresent the HUD to the extent to which it protects minority citizens.  It is also alleged that the city failed to adequately assess the scope of actual impediments to fair housing faced by African Americans and Latinos or to analyze the impact of policies on housing choice for the populations.

The complaint also alleges that the City of Dallas knew of its obligations to the AFFH and knew of the historic import of raising national origin, discrimination and segregation in Dallas, but in the face of an affirmative obligations identify and analyze these areas, the city knowingly concealed evidence that its programs perpetuated racial and national origin segregation and reduced housing choices all the while certifying to HUD that it was complying with its AFF obligations.

If you are an employee of a city or state and know of similar conduct, we invite you to contact us for a confidential brief case evaluation.  We stand ready to discuss the specific facts of your case with you concerning a false claims act case.

THE SCOPE OF FRAUD

Amazingly, some estimates have suggested that approximately 10% of the entire annual United States budget is lost to companies or individuals who are defrauding the government. The United States Federal budget for 2010 was $3.456 billion, meaning around $345.6 million was wrongfully wasted on fraud.

The entities defrauding the government do so in a variety of ways: Medicare or Medicaid fraud whereby they bill the government for services which they never provided or overbill for services that were provided; SEC Trading; Tax Fraud; TARP Fraud; Military/Defense contract fraud; Pharmaceutical Manufacturing;contract fraud involving any number of large government spending programs; or other types public benefit fraud.

HELPING THE PUBLIC.

As a whistleblower attorney, we are interested in speaking with persons willing to make known the truth about company practices and are willing to file a qui tam or whistleblower action. One area in particular we are interested in discussing are lawsuits involving medical device companies where the company is alleged to have overcharged, engaged in kickback programs, and the like. We will nevertheless investigate claims in a variety of areas.

Workers and persons all across the country witness actions at their work that may be unlawful or even corrupt. Unfortunately, some employees and workers feel that they will be fired, terminated, harrassed or punished if they report an unlawful or corrupt action. These reporters, however, are protected by the law as a Whistleblower and can receive compensation because of the False Claims Act or the Medicaid False Claims Act. If you have reported actions that may be fraudulent, then you should talk to a Whistleblower or qui tam lawyer about your facts.

Whistleblowers help the government to get back billions of dollars each year with the help of the False Claims Act. In fact, fraudulent Medicaid claims are also caught by whistleblowers having the Medicaid False Claims Act on their side. If you report a false claim or fraudulent action to the government, then the government will give you, the whistleblower, a part of the money that gets recovered. This is because of qui tam requirements. Qui Tam means that a person files a lawsuit for the king and also for him or herself. The phrase is qui tam pro domino rege quam pro se ipso in hac parte sequitur, or, “he who sues for the king as well for himself.”

These requirements and lawsuits were made popular during the Civil War when many people were getting away with fraudulent actions against the government. In 1986, the False Claims Act was amended to raise the total compensation given to people who reported fraudulent actions, or whistleblowers. If a whistleblower works with a lawyer then it may be possible for them to get three times the amount the government would get in damages and also get additional compensation for general fines.

TYPES OF CASES

The most common situations that could form the basis of a Qui Tam action include:

• Submitting a false or fraudulent record, bill or statement to the government in order to fraudulently obtain money such as reporting a medical service that was never performed for Medicare or Medicad;
• Conspiring with a third party to submit or present have a false or fraudulent claim to the government;
• Withholding property of the government with the intent to defraud or conceal the property from the government;
• Fraudulently buying property of the government from someone not authorized to sell that property; and
• Making a false statement to fraudulently avoid paying money to the government or to avoid delivering property to the government.

FOR HELP, PLEASE CONTACT US.

We help whistleblowers on a contingency basis, meaning there is no fee charged for our work unless there is a recovery. We also front any and all expenses. No matter where you are located — we will represent you. We will come to you, you will not have to come to us.

Attorneys in our firm and attorneys that we work with on Whistleblower, Qui Tam, False Claims Act cases have represented a host of persons making claims, for violations of federal tax law, Medicare law and more.

For more information, please contact our team of whitsleblower and qui tam attorneys today.

CALL 1-800-632-1404

or fill out this form below for a free initial consultation.

CALL US TOLL FREE FOR HELP: 1-800-632-1404

We are attorneys that investigate False Claims Act cases nationwide, including in the state of New Jersey for Medicare fraud, tax fraud, contractor fraud and more against a range of employers including healthcare providers, medical device companies, defense contractors, and pharmaceutical companies. We stand ready to provide a free case evaluation to you; please call us today.

False Claims Act Attorney Discusses Improper Prescription Drugs and Medicare

As attorneys under the False Claims Act, we wanted to advise you of a recent ruling where a Qui Tam suit alleging fraud against one of the nation’s largest private contractors for the multi-billion dollar Medicare Part D prescription drug program survived a motion to dismiss.  U. S. District Judge Ronald Buckwalter of the Eastern District of Pennsylvania allowed every claim to proceed ahead including three claims made under the False Claims Act against CVS Caremark.  Among the claims allowed, the U.S. District Court held that the request for reimbursement for drugs dispensed to Medicare Part D Beneficiaries from the Government qualify as claims subject to enforcement by the False Claims Act.  This is the first case that marks the decision that goes to the heart of the Part D program which has been in effect for six years.

In 2007, a Puerto Rican Health Insurance Company called Medical Card System hired Spay, a former pharmacist, to audit the Part D claims process by its subcontractor, Caremark.  Caremark merged with CVS to become CVS Caremark in early 2007, the largest prescription provider in the country.  Based on his findings from that audit, Spay filed a whistle blower suit against CVS Caremark alleging it had engaged in a year’s long scheme to defraud the government filing false claims under Part D, which resulted in the payment of administrative and dispensing fees as well as pharmacy charges for the company.

The opinion held that the PDE’s that CVS Caremark submitted to the Centers for Medicare and Medicaid services, or CMS are clearly request to collect money from the government for the prescriptions dispensed to Part D patients.  Mr. Spay will be allowed to proceed ahead with claims against CVS Caremark nationally even though the audit in which he participated was only in Puerto Rico.  The Court found a strong inference that CVS Caremark submitted false claims nationwide indicated by the sheer number of claims identified by plaintiff in at least three states and Puerto Rico.

It should be noted that the United States government declined to intervene in the case at this point in time and that Spay’s lawyers are proceeding ahead at this time on their own.

THE SCOPE OF FRAUD

Amazingly, some estimates have suggested that approximately 10% of the entire annual United States budget is lost to companies or individuals who are defrauding the government. The United States Federal budget for 2010 was $3.456 billion, meaning around $345.6 million was wrongfully wasted on fraud.

The entities defrauding the government do so in a variety of ways: Medicare or Medicaid fraud whereby they bill the government for services which they never provided or overbill for services that were provided; SEC Trading; Tax Fraud; TARP Fraud; Military/Defense contract fraud; Pharmaceutical Manufacturing;contract fraud involving any number of large government spending programs; or other types public benefit fraud.

HELPING THE PUBLIC.

As a whistleblower attorney, we are interested in speaking with persons willing to make known the truth about company practices and are willing to file a qui tam or whistleblower action. One area in particular we are interested in discussing are lawsuits involving medical device companies where the company is alleged to have overcharged, engaged in kickback programs, and the like. We will nevertheless investigate claims in a variety of areas.

Workers and persons all across the country witness actions at their work that may be unlawful or even corrupt. Unfortunately, some employees and workers feel that they will be fired, terminated, harrassed or punished if they report an unlawful or corrupt action. These reporters, however, are protected by the law as a Whistleblower and can receive compensation because of the False Claims Act or the Medicaid False Claims Act. If you have reported actions that may be fraudulent, then you should talk to a Whistleblower or qui tam lawyer about your facts.

Whistleblowers help the government to get back billions of dollars each year with the help of the False Claims Act. In fact, fraudulent Medicaid claims are also caught by whistleblowers having the Medicaid False Claims Act on their side. If you report a false claim or fraudulent action to the government, then the government will give you, the whistleblower, a part of the money that gets recovered. This is because of qui tam requirements. Qui Tam means that a person files a lawsuit for the king and also for him or herself. The phrase is qui tam pro domino rege quam pro se ipso in hac parte sequitur, or, “he who sues for the king as well for himself.”

These requirements and lawsuits were made popular during the Civil War when many people were getting away with fraudulent actions against the government. In 1986, the False Claims Act was amended to raise the total compensation given to people who reported fraudulent actions, or whistleblowers. If a whistleblower works with a lawyer then it may be possible for them to get three times the amount the government would get in damages and also get additional compensation for general fines.

TYPES OF CASES

The most common situations that could form the basis of a Qui Tam action include:

• Submitting a false or fraudulent record, bill or statement to the government in order to fraudulently obtain money such as reporting a medical service that was never performed for Medicare or Medicad;
• Conspiring with a third party to submit or present have a false or fraudulent claim to the government;
• Withholding property of the government with the intent to defraud or conceal the property from the government;
• Fraudulently buying property of the government from someone not authorized to sell that property; and
• Making a false statement to fraudulently avoid paying money to the government or to avoid delivering property to the government.

FOR HELP, PLEASE CONTACT US.

We help whistleblowers on a contingency basis, meaning there is no fee charged for our work unless there is a recovery. We also front any and all expenses. No matter where you are located — we will represent you. We will come to you, you will not have to come to us.

Attorneys in our firm and attorneys that we work with on Whistleblower, Qui Tam, False Claims Act cases have represented a host of persons making claims, for violations of federal tax law, Medicare law and more.

For more information, please contact our team of whitsleblower and qui tam attorneys today.

CALL 1-800-632-1404

or fill out this form below for a free initial consultation.

CALL US TOLL FREE FOR HELP: 1-800-632-1404

We are attorneys that investigate False Claims Act cases nationwide, including in the state of New Jersey for Medicare fraud, tax fraud, contractor fraud and more against a range of employers including healthcare providers, medical device companies, defense contractors, and pharmaceutical companies. We stand ready to provide a free case evaluation to you; please call us today.

False Claims Act Attorney Discusses Pending Case

Medicare was enacted in 1965 as Title XVIII of the Social Security Act, and is federally run health insurance program benefitting those who are age 65 and older and disabled.  42 U.S.C. § 1395cj et seq.

Medicare Part B primarily pays for out-patient care; does not pay for Durable Medical Equipment (DME) provided to patients in Skilled Nursing Facilities (SNF).  Medicare Part B pays for DME only when it is used in a patient’s home or in a facility used as the patient’s home such a custodial care facility.  See 42 CFR § 4.10.38.  Medicare Part B defines a DME as equipment that withstands repeated use, is primarily and customarily used to serve a medical purpose, generally is not useful to an individual in the absence of an illness or injury, and is appropriate for use in the home.  2 CFR Part 414.202.

“A home” can include a custodial care facility, a facility that provides, generally on a long-term basis, room, board and other personal assistance that does not include a medical component.  However, a home specifically does not include a hospital or skilled nursing facility as defined under 42 U.S.C. § 1395i-3(a).  Section 1395i-3(a)(1) defines a skilled nursing facility as an institution or distinct part of an institution which is primarily engaged in providing to residents skilled nursing care and related services for residents who require medical or nursing care or rehabilitation services or the rehabilitation of injured disabled or sick persons.  42 U.S.C. § 1395i-3(a)(1).  A skilled service is one that is “so inherently complex that it can be safely and effectively performed only by, or under the supervision of, professional or technical personnel.”  42 CFR § 409.32(a).

Skilled nursing facilities charge a daily rate per patient that includes the cost of durable medical equipment used by its patients.  The daily rate is often paid for by Medicare Part A, Medicare’s in-patient benefit, or by Medicaid).  Thus, any separate additional durable medical equipment payment to a DME provider for SNF patients under Medicare Part B is duplicative.  The DME provider must bill the Skilled Nursing Facility for durable medical equipment provide it to its patients and the skilled nursing facility can pay the provider out of its daily rate; the durable medical equipment provider may not bill Medicare part B.  This is true regardless of the source of payment of the skilled nursing facility’s daily rate and even if the patient’s Part A benefits are exhausted.

To receive payments under Medicare Part A, a skilled nursing facility must be Medicare certified.  To obtain Medicare certification, the facility must be “primarily engaged” in providing skilled nursing or rehabilitative care in accordance with 42 U.S.C. § 1395i-3(a)(1) without regard to the type of care that a particular resident may be receiving.

Although facilities typically obtain Medicare certification for their entire facility, Medicare allows facilities to obtain Medicare certification for only a section of its facility.  If the certified section is a distinct part of the facility and the remaining section of the facility does not provide skilled care, the remaining section may be qualified as a “home” and Part B payment may be available.  Approximately 95% of all nursing facilities nationwide by Medicare certified which means only 5% of the nursing facility beds are unskilled.  To qualify as a distinct part skilled nursing facility, that facility must be physically distinguishable from the larger institution or institutionally complex that houses it and must meet the applicable statutory requirements for skilled nursing facilities under 42 U.S.C. 1395i-3.  A distinct part skilled nursing facility may be comprised of one or more buildings or designated parts of buildings that are wings, wards or floors.  A distinct part must include all of the beds within the designated area and cannot consist of a random collection of individual rooms or beds that are scattered throughout the physical plant.  42 CFR § 483.5(b).  The manual that describes the Medicare certification process for skilled nursing homes provides a somewhat more detailed definition of a distinct part.  “A distinct part must be physically distinguishable from the larger institution and physically separate for cost reporting purposes. . . the distinct part must consist of all beds within the designated area.  The distinct part can be a wing, separate building, a floor, a hallway or one side of a corridor. The beds in the certified distinct part area must be physically separate from (that is, not commingled with) the beds of the institution or institutional complex in which it is located.  However, the distinct part need not be confined to a single location within the institution or institutional complex’s physical plant.  It may, for example, consist of several floors or wards in a single building or floors or wards that are located throughout several different buildings within the institutional complex.  In each case, however, all residents of the distinct part would have to be located in units that are physically separate from those units housing other patients of the institution or institutional complex.”  CMS State Operations Manual (SOM) § 2762 Chapter 2.

The physical and fiscal separation of the Medicare Certified Part for the remainder of the facility makes the survey and certification of SNF’s much less burdensome and complicated.  If skilled patients were scattered about the facility, it would mean that the certifying agency would be applying Medicare survey and certification rules to residents or beds rather than to facilities.  Medicare survey and certification requirements apply to facilities, not beds or residents.  Medicare’s policies regarding Part D, Durable Medical Equipment and Skilled Nursing Facilities have been communicated to Durable Medical Equipment providers and nursing facilities throughout the statutes, regulations and policy manuals.  It is common knowledge in the durable medical equipment industry that  durable medical equipment provided does not bill Medicare Part B or the Durable Medical Equipment provided to patients in Medicare Certified Skilled Nursing Facilities.

One recent lawsuit has been filed against Dynasplint Systems, Inc.  In or around 2009, data showed that approximately one-half of Dynasplint’s Medicare billings to Durable Medical Equipment and Medicare Administrative Contractors in Region 8 were for patients Dynasplint represented were in “custodial care” facilities.  However, during the same time period, looking at other ME suppliers in Region B, less than 0.1% had billed Medicare Part B for patients in custodial care.  From at least 2004 to the present it is alleged that Dynasplint engaged in a pattern and practice of knowingly submitting false claims for payment or causing false claims for payment to be submitted to Medicare.  The claims falsely represented that Dynasplint provided DME to patients who were in their home or a custodial care facility when in fact the patients were in skilled nursing facilities.  Dynasplint also caused facilities to make false statements that patients were in a distinct part of the facility that did not provide skilled care and used these false statements to get a false or fraudulent claim paid.

In January 1994, CMS issued a ruling that Dynasplint devices were considered Durable Medical Equipment.  It was at this point in time that Defendant knew or should have known that its devices were not covered by Medicare Part B in skilled nursing facilities.  At that point in time, Dynasplint electronically submitted claims for payment of Dynasplint Durable Medical Equipment to Medicare Part B for patients who were in skilled nursing facilities.  The claims falsely represented the place of service, the place where the patient would primarily use the device, and that the skilled nursing facilities were actually custodial care facilities, or in their homes, not skilled nursing facilities.

One tactic that Dynasplint allegedly used was collecting qualification forms over the years that varied in scope.  These forms generally contained a certification from a facility employee on the date the patient was fitted with the Dynasplint device that the patient was not receiving Part A benefits, or was in a distinct part of the facility that does not provide skilled care.  Dynasplint would use these “forms” to collect its claims under the False Claims Act which are alleged to be fraudulent.  It is alleged that Dynasplint relied upon the facility’s self interest in promoting this scheme.  If the facility signed the qualification form, its patient would receive the Dynasplint Durable Medical Equipment and the facility would not have to pay for it.  The facility would not have to pay out of its Medicare Part A funds.  Frequently, these forms are signed by physical therapists or nurses, who unlike a facility administrator, would have no reason to know whether the facility had an unskilled distinct part.  When facility’s question the forms, Dynasplint would advise them that they need not be concerned because Dynasplint “assumes the responsibility for correct billing.”

Mr. George Hepburn was an officer with Dynasplint and issued a memo to sales representatives in 2009 about problem skilled nursing facilities stating that for “practical purposes” a “distinct part” can be a single patient room where no other skill is provided.  He asserted that contrary to the guidance provided to him by CMS that this interpretation is based upon Medicare’s definition of a distinct part as a separate unit consisting of all beds in a particular building, floor, wing, or ward.  He claimed that according to Webster’s definition a “ward” can be interpreted to mean a single room.  A ward is not a single patient room, however, according to CMS.  A ward consists of a multi-patient room that houses multiple beds.

The case at issue is United States of America Ex Rel Meredith Monahan Dean v. Dynasplint Systems, Inc. and George Hepburn, pending in the United States District Court for the Eastern District of Louisiana.

THE SCOPE OF FRAUD

Amazingly, some estimates have suggested that approximately 10% of the entire annual United States budget is lost to companies or individuals who are defrauding the government. The United States Federal budget for 2010 was $3.456 billion, meaning around $345.6 million was wrongfully wasted on fraud.

The entities defrauding the government do so in a variety of ways: Medicare or Medicaid fraud whereby they bill the government for services which they never provided or overbill for services that were provided; SEC Trading; Tax Fraud; TARP Fraud; Military/Defense contract fraud; Pharmaceutical Manufacturing;contract fraud involving any number of large government spending programs; or other types public benefit fraud.

HELPING THE PUBLIC.

As a whistleblower attorney, we are interested in speaking with persons willing to make known the truth about company practices and are willing to file a qui tam or whistleblower action. One area in particular we are interested in discussing are lawsuits involving medical device companies where the company is alleged to have overcharged, engaged in kickback programs, and the like. We will nevertheless investigate claims in a variety of areas.

Workers and persons all across the country witness actions at their work that may be unlawful or even corrupt. Unfortunately, some employees and workers feel that they will be fired, terminated, harrassed or punished if they report an unlawful or corrupt action. These reporters, however, are protected by the law as a Whistleblower and can receive compensation because of the False Claims Act or the Medicaid False Claims Act. If you have reported actions that may be fraudulent, then you should talk to a Whistleblower or qui tam lawyer about your facts.

Whistleblowers help the government to get back billions of dollars each year with the help of the False Claims Act. In fact, fraudulent Medicaid claims are also caught by whistleblowers having the Medicaid False Claims Act on their side. If you report a false claim or fraudulent action to the government, then the government will give you, the whistleblower, a part of the money that gets recovered. This is because of qui tam requirements. Qui Tam means that a person files a lawsuit for the king and also for him or herself. The phrase is qui tam pro domino rege quam pro se ipso in hac parte sequitur, or, “he who sues for the king as well for himself.”

These requirements and lawsuits were made popular during the Civil War when many people were getting away with fraudulent actions against the government. In 1986, the False Claims Act was amended to raise the total compensation given to people who reported fraudulent actions, or whistleblowers. If a whistleblower works with a lawyer then it may be possible for them to get three times the amount the government would get in damages and also get additional compensation for general fines.

TYPES OF CASES

The most common situations that could form the basis of a Qui Tam action include:

• Submitting a false or fraudulent record, bill or statement to the government in order to fraudulently obtain money such as reporting a medical service that was never performed for Medicare or Medicad;
• Conspiring with a third party to submit or present have a false or fraudulent claim to the government;
• Withholding property of the government with the intent to defraud or conceal the property from the government;
• Fraudulently buying property of the government from someone not authorized to sell that property; and
• Making a false statement to fraudulently avoid paying money to the government or to avoid delivering property to the government.

FOR HELP, PLEASE CONTACT US.

We help whistleblowers on a contingency basis, meaning there is no fee charged for our work unless there is a recovery. We also front any and all expenses. No matter where you are located — we will represent you. We will come to you, you will not have to come to us.

Attorneys in our firm and attorneys that we work with on Whistleblower, Qui Tam, False Claims Act cases have represented a host of persons making claims, for violations of federal tax law, Medicare law and more.

For more information, please contact our team of whitsleblower and qui tam attorneys today.

CALL 1-800-632-1404

or fill out this form below for a free initial consultation.

CALL US TOLL FREE FOR HELP: 1-800-632-1404

We are attorneys that investigate False Claims Act cases nationwide for Medicare fraud, IRS tax fraud, contractor fraud and more against a range of employers including but in no way limited to healthcare providers, medical device companies, defense contractors, and pharmaceutical companies. We stand ready to provide a free case evaluation to you; please call us today.

As False Claims Act attorneys, and especially attorneys who represent clients that have the courage to blow the whistle on fraud against the federal government, we are pleased to see that a Sanofi has agreed to pay more than $100 million dollars to settle claims that it violated the False Claims Act by giving physicians free units of Hylagan, a knee injection, in violation of the Anti-Kickback Act.

Sanofi-Aventis U.S. Inc. and Sanofi-Aventis U.S. LLC, subsidiaries of international drug manufacturer Sanofi (collectively, Sanofi US), have agreed to pay $109 million to resolve allegations that Sanofi US violated the False Claims Act by giving physicians free units of Hyalgan, a knee injection, in violation of the Anti-Kickback Statute, to induce them to purchase and prescribe the product. The settlement also resolves allegations that Sanofi US submitted false average sales price (ASP) reports for Hyalgan that failed to account for free units distributed contingent on Hyalgan purchases. The government alleges that the false ASP reports, which were used to set reimbursement rates, caused government programs to pay inflated amounts for Hyalgan and a competing product.

The United States contends that, facing pressure from a lower-priced competitor, Sanofi US provided its sales representatives with thousands of free “sample” Hyalgan units and trained its sales representatives to market the “value add” of these units to physicians. In practice, the United States alleges, Sanofi US sales representatives often entered into illegal sampling arrangements with physicians, using the free units as kickbacks and promising to provide negotiated numbers of them in order to lower Hyalgan’s effective price. The government contends that there were numerous such arrangements, including:

• A Southern California-based Sanofi US sales representative who allegedly provided 25 Hyalgan samples to a physician practice for every 100 Hyalgan units purchased, and who supplemented these kickbacks by regularly treating the entire practice to lavish dinners at Sanofi US’s expense and with Sanofi US’s approval.
• A New York-based Sanofi US sales representative who allegedly provided 12 Hyalgan samples to a physician practice for every 50 Hyalgan units purchased, and whose manager supplemented these kickbacks by treating the practice, along with friends and family members, to a lavish dinner in Manhattan at Sanofi US’s expense and with Sanofi US’s approval.

·         A Central Texas-based Sanofi US sales representative who allegedly promised a physician practice 125 free Hyalgan syringes in exchange for a purchase of 500 Hyalgan units and was lauded by Sanofi US’s Texas sales team for “[u]tiliz[ing] samples to provide value for the office.”

The United States contends that price was important to physicians because Hyalgan and its direct competitor were reimbursed at the same, fixed rate by Medicare and other insurers. Thus, the less expensive option afforded a greater reimbursement “spread,” or profit, to physicians’ practices. According to the government’s allegations, Sanofi US chose not to compete by lowering the actual invoiced price of Hyalgan, for fear of setting off a price war with its competitor that would lead to a “downward spiral” in prices and reimbursements. Instead, the government alleges, Sanofi US surreptitiously lowered the effective price of Hyalgan by promising the free units to doctors who agreed to purchase the product. The government alleges that Medicare and other federal health care programs paid millions of dollars in kickback-tainted claims for Hyalgan.

“Kickback schemes subvert the health care marketplace and undermine the integrity of public health care programs,” said Principal Deputy Assistant Attorney General for the Civil Division Stuart Delery. “We will continue to hold accountable those who we allege are providing illegal incentives to influence the decision making of health care providers in federal health care programs.”

“The government’s allegations describe a situation where a drug manufacturer used valuable free units of a drug to subvert Medicare’s drug reimbursement system for physicians,” said Carmen M. Ortiz, United States Attorney for the District of Massachusetts. “This is not the first time that this Office has brought action against a manufacturer who engaged in such an illegal scheme, and the government will remain vigilant in policing such conduct.”

“Patients expect their health providers to be concerned solely with their best medical interests” said Daniel R. Levinson, Inspector General for the U.S. Department of Health. “Kickbacks undermine that all-important patient trust, and taxpayers’ expectation that government health dollars be put only to the wisest of uses.”

Today’s settlement with the France-based pharmaceutical manufacturer resolves a lawsuit filed by former sales representative Mark Giddarie under the qui tam, or whistleblower provisions, of the False Claims Act. Under the False Claims Act, private citizens can bring suit on behalf of the United States and share in any recovery. Giddarie will receive $18.5 million as his share of the government’s recovery.

This settlement was the result of a coordinated effort by the Department of Justice, Civil Division, Commercial Litigation Branch; the U.S. Attorney’s Office for the District of Massachusetts; the FBI; and the Offices of the Inspectors General of the U.S. Department of Health and Human Services, the U.S. Postal Service, and the Office of Personnel Management.

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 $10.1 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 $13.9 billion.

This case is docketed as United States ex rel. Giddarie v. sanofi-aventis U.S., Inc., No. 10-CV-10070 (D. Mass.). Sanofi-Aventis U.S. Inc. and Sanofi-Aventis U.S. LLC, subsidiaries of international drug manufacturer Sanofi (collectively, Sanofi US), have agreed to pay $109 million to resolve allegations that Sanofi US violated the False Claims Act by giving physicians free units of Hyalgan, a knee injection, in violation of the Anti-Kickback Statute, to induce them to purchase and prescribe the product. The settlement also resolves allegations that Sanofi US submitted false average sales price (ASP) reports for Hyalgan that failed to account for free units distributed contingent on Hyalgan purchases. The government alleges that the false ASP reports, which were used to set reimbursement rates, caused government programs to pay inflated amounts for Hyalgan and a competing product.

The United States contends that, facing pressure from a lower-priced competitor, Sanofi US provided its sales representatives with thousands of free “sample” Hyalgan units and trained its sales representatives to market the “value add” of these units to physicians. In practice, the United States alleges, Sanofi US sales representatives often entered into illegal sampling arrangements with physicians, using the free units as kickbacks and promising to provide negotiated numbers of them in order to lower Hyalgan’s effective price. The government contends that there were numerous such arrangements, including:

• A Southern California-based Sanofi US sales representative who allegedly provided 25 Hyalgan samples to a physician practice for every 100 Hyalgan units purchased, and who supplemented these kickbacks by regularly treating the entire practice to lavish dinners at Sanofi US’s expense and with Sanofi US’s approval.
• A New York-based Sanofi US sales representative who allegedly provided 12 Hyalgan samples to a physician practice for every 50 Hyalgan units purchased, and whose manager supplemented these kickbacks by treating the practice, along with friends and family members, to a lavish dinner in Manhattan at Sanofi US’s expense and with Sanofi US’s approval.
• A Central Texas-based Sanofi US sales representative who allegedly promised a physician practice 125 free Hyalgan syringes in exchange for a purchase of 500 Hyalgan units and was lauded by Sanofi US’s Texas sales team for “[u]tiliz[ing] samples to provide value for the office.”

The United States contends that price was important to physicians because Hyalgan and its direct competitor were reimbursed at the same, fixed rate by Medicare and other insurers. Thus, the less expensive option afforded a greater reimbursement “spread,” or profit, to physicians’ practices. According to the government’s allegations, Sanofi US chose not to compete by lowering the actual invoiced price of Hyalgan, for fear of setting off a price war with its competitor that would lead to a “downward spiral” in prices and reimbursements. Instead, the government alleges, Sanofi US surreptitiously lowered the effective price of Hyalgan by promising the free units to doctors who agreed to purchase the product. The government alleges that Medicare and other federal health care programs paid millions of dollars in kickback-tainted claims for Hyalgan. 


“Kickback schemes subvert the health care marketplace and undermine the integrity of public health care programs,” said Principal Deputy Assistant Attorney General for the Civil Division Stuart Delery. “We will continue to hold accountable those who we allege are providing illegal incentives to influence the decision making of health care providers in federal health care programs.”

“The government’s allegations describe a situation where a drug manufacturer used valuable free units of a drug to subvert Medicare’s drug reimbursement system for physicians,” said Carmen M. Ortiz, United States Attorney for the District of Massachusetts. “This is not the first time that this Office has brought action against a manufacturer who engaged in such an illegal scheme, and the government will remain vigilant in policing such conduct.”

“Patients expect their health providers to be concerned solely with their best medical interests” said Daniel R. Levinson, Inspector General for the U.S. Department of Health. “Kickbacks undermine that all-important patient trust, and taxpayers’ expectation that government health dollars be put only to the wisest of uses.”

Today’s settlement with the France-based pharmaceutical manufacturer resolves a lawsuit filed by former sales representative Mark Giddarie under the qui tam, or whistleblower provisions, of the False Claims Act. Under the False Claims Act, private citizens can bring suit on behalf of the United States and share in any recovery. Giddarie will receive $18.5 million as his share of the government’s recovery.

This settlement was the result of a coordinated effort by the Department of Justice, Civil Division, Commercial Litigation Branch; the U.S. Attorney’s Office for the District of Massachusetts; the FBI; and the Offices of the Inspectors General of the U.S. Department of Health and Human Services, the U.S. Postal Service, and the Office of Personnel Management.

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 $10.1 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 $13.9 billion.

This case is docketed as United States ex rel. Giddarie v. sanofi-aventis U.S., Inc., No. 10-CV-10070 (D. Mass.).

If you have information about any alleged fraud against the government, please contact us immediately.

THE SCOPE OF FRAUD

Amazingly, some estimates have suggested that approximately 10% of the entire annual United States budget is lost to companies or individuals who are defrauding the government. The United States Federal budget for 2010 was $3.456 billion, meaning around $345.6 million was wrongfully wasted on fraud.

The entities defrauding the government do so in a variety of ways: Medicare or Medicaid fraud whereby they bill the government for services which they never provided or overbill for services that were provided; SEC Trading; Tax Fraud; TARP Fraud; Military/Defense contract fraud; Pharmaceutical Manufacturing;contract fraud involving any number of large government spending programs; or other types public benefit fraud.

HELPING THE PUBLIC.

As a whistleblower attorney, we are interested in speaking with persons willing to make known the truth about company practices and are willing to file a qui tam or whistleblower action. One area in particular we are interested in discussing are lawsuits involving medical device companies where the company is alleged to have overcharged, engaged in kickback programs, and the like. We will nevertheless investigate claims in a variety of areas.

Workers and persons all across the country witness actions at their work that may be unlawful or even corrupt. Unfortunately, some employees and workers feel that they will be fired, terminated, harrassed or punished if they report an unlawful or corrupt action. These reporters, however, are protected by the law as a Whistleblower and can receive compensation because of the False Claims Act or the Medicaid False Claims Act. If you have reported actions that may be fraudulent, then you should talk to a Whistleblower or qui tam lawyer about your facts.

Whistleblowers help the government to get back billions of dollars each year with the help of the False Claims Act. In fact, fraudulent Medicaid claims are also caught by whistleblowers having the Medicaid False Claims Act on their side. If you report a false claim or fraudulent action to the government, then the government will give you, the whistleblower, a part of the money that gets recovered. This is because of qui tam requirements. Qui Tam means that a person files a lawsuit for the king and also for him or herself. The phrase is qui tam pro domino rege quam pro se ipso in hac parte sequitur, or, “he who sues for the king as well for himself.”

These requirements and lawsuits were made popular during the Civil War when many people were getting away with fraudulent actions against the government. In 1986, the False Claims Act was amended to raise the total compensation given to people who reported fraudulent actions, or whistleblowers. If a whistleblower works with a lawyer then it may be possible for them to get three times the amount the government would get in damages and also get additional compensation for general fines.

TYPES OF CASES

The most common situations that could form the basis of a Qui Tam action include:

• Submitting a false or fraudulent record, bill or statement to the government in order to fraudulently obtain money such as reporting a medical service that was never performed for Medicare or Medicad;
• Conspiring with a third party to submit or present have a false or fraudulent claim to the government;
• Withholding property of the government with the intent to defraud or conceal the property from the government;
• Fraudulently buying property of the government from someone not authorized to sell that property; and
• Making a false statement to fraudulently avoid paying money to the government or to avoid delivering property to the government.

FOR HELP, PLEASE CONTACT US.

We help whistleblowers on a contingency basis, meaning there is no fee charged for our work unless there is a recovery. We also front any and all expenses. No matter where you are located — we will represent you. We will come to you, you will not have to come to us.

Attorneys in our firm and attorneys that we work with on Whistleblower, Qui Tam, False Claims Act cases have represented a host of persons making claims, for violations of federal tax law, Medicare law and more.

For more information, please contact our team of whitsleblower and qui tam attorneys today.

CALL 1-800-632-1404

or fill out this form below for a free initial consultation.

CALL US TOLL FREE FOR HELP: 1-800-632-1404

We are attorneys that investigate False Claims Act cases nationwide for Medicare fraud, IRS tax fraud, contractor fraud and more against a range of employers including but in no way limited to healthcare providers, medical device companies, defense contractors, and pharmaceutical companies. We stand ready to provide a free case evaluation to you; please call us today.

As False Claims Act attorneys, and especially attorneys who represent clients that have the courage to blow the whistle on fraud against the federal government, we are pleased to see that a federal judge in New York has approved a settlement involving the improper false claims and use of Aransep.  The following will give a summary of this development which totals to $762 Million Dollars.

Bloomberg News (12/20, Smythe, 1M) reports, “A federal judge accepted Amgen Inc.’s plea agreement on a charge that it misbranded its anemia drug Aranesp, putting to rest a five-year probe of the company’s marketing practices.” US District Judge Sterling Johnson in Brooklyn, NY, signed off Wednesday “on the agreement with prosecutors, which will cost the company $150 million in criminal penalties. Amgen will also pay $612 million to settle civil claims by states and whistle-blowers alleging the company also illegally marketed other drugs. The company’s guilty plea and resolution of civil cases ‘demonstrate our vigilance in protecting American’s health-care consumers and pursuing any corporation that seeks to profit by violating U.S. Law,’ Marshall L. Miller, head of the criminal division for the Brooklyn U.S. Attorney’s office, said in a statement.”

MarketWatch (12/20, Spain) reports, “The plea is part of a settlement the company has made to avoid further criminal and civil liability and is the largest ever of its kind to involve a biotechnology firm. Amgen owned up to the charge of illegally pushing its Aranesp drug for ‘off-label’ uses in order to boost sales ‘and reap the resulting profits,’ the DOJ said. Under terms of the deal Amgen will pay a criminal fine of $136 million and forfeit another $14 million. It will also pay $587.2 million to the federal government and $24.8 million to individual states to resolve claims of Medicare, Medicaid and other government insurance fraud.”

The Danbury (CT) News Times (12/19, Varnon, 18K) reports, “New York Attorney General Eric T. Schneiderman said Wednesday, pharmaceutical maker Amgen has agreed to a $612 million national settlement of allegations it illegally marketed some drugs for use to treat kidney disease and cancer for a decade. The company also pleaded guilty to a misdemeanor in federal court that will require [it] to pay a $150 million fine.” The Times continues, “The agreement, reached with the 50 states and the District of Columbia, also settles allegations that Amgen fixed drug prices and paid kickbacks to health care professionals, which included the filing of false claims for Medicare reimbursement by doctors.”

The New York Times (12/20, Pollack, Subscription Publication, 1.68M) reports, “Jill Osiecki, a longtime sales representative at Amgen,” cooperated with the Department of Health and Human Services by wearing a recording device under her clothes and recording an Amgen manager who “boasted of how she had given a $10,000 unrestricted grant to a pet project of a doctor who was an adviser to the local Medicare contractor. In turn, she said, the doctor would help persuade the contractor to provide reimbursement for an unapproved use of Amgen’s anemia drug, Aranesp.” Ms. Osiecki, along with other whistle-blowers, provided the evidence that the government needed to secure the settlement.

MORE ON THE ARANSEP SETTLEMENT

Earlier today, at the federal courthouse in Brooklyn, New York, U.S. District Judge Sterling Johnson, Jr. accepted a guilty plea by American biotechnology giant Amgen Inc. (Amgen) for illegally introducing a misbranded drug into interstate commerce. The plea is part of a global settlement with the United States in which Amgen agreed to pay $762 million to resolve criminal and civil liability arising from its sale and promotion of certain drugs. The settlement represents the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history.

The announcement was made by Stuart F. Delery, Principal Deputy Assistant Attorney General for the Justice Department’s Civil Division; Marshall L. Miller, Acting U.S. Attorney for the Eastern District of New York; Jenny A. Durkan, U.S. Attorney, Western District of Washington; Carmen M. Ortiz, U.S. Attorney for the District of Massachusetts; Thomas O’Donnell, Special Agent in Charge, U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG), New York Regional Office; John Roth, Director, U.S. Food and Drug Administration (FDA), Office of Criminal Investigations; Eric Schneiderman, New York State Attorney General; and George Venizelos, Assistant Director in Charge of the FBI’s New York Field Office; along with numerous law enforcement and regulatory partners.

As part of the plea agreement and criminal settlement, Amgen entered a guilty plea yesterday before U.S. District Judge Sterling Johnson of the Eastern District of New York to a criminal information charging the company with illegally introducing a misbranded drug, Aranesp, into interstate commerce. Under the Food, Drug and Cosmetic Act, it is illegal for drug companies to introduce into the marketplace drugs that the company intends will be used “off-label,” i.e., for uses or at doses not approved by the FDA. Aranesp is an erythropoiesis-stimulating agent (ESA) that was approved by the FDA at calibrated doses for particular patient populations suffering from anemia. In order to increase sales of Aranesp and reap the resulting profits, Amgen illegally sold the drug with the intention that it be used at off-label doses that the FDA had specifically considered and rejected, and for an off-label treatment that the FDA had never approved. Under the terms of the criminal plea agreement, Amgen will pay a criminal fine of $136 million and criminal forfeiture in the amount of $14 million.

As part of the civil settlement, Amgen has agreed to pay $612 million ($587.2 million to the United States and $24.8 million to the states) to resolve claims that it caused false claims to be submitted to Medicare, Medicaid and other government insurance programs. The federal civil settlement agreement encompasses allegations that Amgen: (1) promoted Aranesp and two other drugs that it manufactured, Enbrel and Neulasta, for off-label uses and doses that were not approved by the FDA and not properly reimbursable by federal insurance programs; (2) offered illegal kickbacks to a wide range of entities in an effort to influence health care providers to select its products for use, regardless of whether they were reimbursable by federal health care programs or were medically necessary; and (3) engaged in false price reporting practices involving several of its drugs. As part of the global settlement, Amgen has also agreed to enter into a Corporate Integrity Agreement (CIA) with HHS-OIG that will govern its conduct, and ensure careful oversight of its branding and marketing practices.

“Today’s resolution reinforces the Department of Justice’s commitment to cracking down on unlawful conduct by pharmaceutical companies,” said Civil Division Principal Deputy Assistant Attorney General Delery. “When drug companies improperly misbrand their products, they not only could put individual patients at risk, but they also undermine the federal health care system that protects all of us.”

“Instead of working to extend and enhance human lives, Amgen illegally pursued corporate profits while jeopardizing the safety of vulnerable consumers suffering from disease. Americans expect – and the law requires – much more. Today’s settlement demonstrates our vigilance in protecting America’s healthcare consumers and pursuing any corporation that seeks to profit by violating U.S. law,” said Acting U.S. Attorney of the Eastern District of New York Miller. “To all who might consider introducing misbranded drugs into the marketplace, you are on notice: we remain steadfastly committed to prosecuting such violations of law.” Mr. Miller also expressed his appreciation to the Offices of Inspector General for the Department of Defense, the Office of Personnel Management and the Veterans Administration for their assistance.

“The public has been well served by this investigation and the FDA commends the efforts of the U.S. Attorney’s Office in the Eastern District of New York, the Department of Justice and the other law enforcement agencies that worked with us to vigorously pursue this matter,” said John Roth, Director of the FDA’s Office of Criminal Investigations in the FDA’s Office of Regulatory Affairs. “Today’s settlement demonstrates our continued scrutiny of any illegal practices used by pharmaceutical and biotechnology companies.”

“Promoting drugs for unapproved purposes is beyond wrong; it jeopardizes the health and safety of the public,” said FBI Assistant Director Venizelos. “Preserving the integrity of the pharmaceutical industry is important work, and the FBI will continue working with our colleagues in law enforcement to investigate and charge those who inappropriately market drugs for scurrilous profits.”

“This sends a powerful message to pharma companies: you must not put profits ahead of patients’ health and doctors’ trust. Drugs should be prescribed because they make people better, not because they make companies money,” said Western District of Washington U.S. Attorney Durkan. “The coordination by our office, the U.S. Attorney’s Offices in the Eastern District of New York and Massachusetts and Main Justice also shows that there is no corner of the country where these actors can hide.”

“Today’s resolution is a testament to coordination and cooperation throughout the Department of Justice to ensure drug manufacturers are held to account and fraud is properly addressed,” said Massachusetts U.S. Attorney Ortiz. “The District of Massachusetts is proud to have played a role in the resolution of this matter, and in ensuring that drug manufacturers’ claims regarding their products are truthful and properly supported.”

“There are no excuses for illegally marketing off label drugs, offering kickbacks to health care professionals and ripping off the taxpayers by defrauding Medicaid and other programs,” said New York State Attorney General Schneiderman. “With this settlement the message we are sending is clear: biotechnology giants are not above the law, and my office will continue to ensure that prescriptions be written based on medical judgment – not profit motive.”

If you have information about any alleged fraud against the government, please contact us immediately.

THE SCOPE OF FRAUD

Amazingly, some estimates have suggested that approximately 10% of the entire annual United States budget is lost to companies or individuals who are defrauding the government. The United States Federal budget for 2010 was $3.456 billion, meaning around $345.6 million was wrongfully wasted on fraud.

The entities defrauding the government do so in a variety of ways: Medicare or Medicaid fraud whereby they bill the government for services which they never provided or overbill for services that were provided; SEC Trading; Tax Fraud; TARP Fraud; Military/Defense contract fraud; Pharmaceutical Manufacturing;contract fraud involving any number of large government spending programs; or other types public benefit fraud.

HELPING THE PUBLIC.

As a whistleblower attorney, we are interested in speaking with persons willing to make known the truth about company practices and are willing to file a qui tam or whistleblower action. One area in particular we are interested in discussing are lawsuits involving medical device companies where the company is alleged to have overcharged, engaged in kickback programs, and the like. We will nevertheless investigate claims in a variety of areas.

Workers and persons all across the country witness actions at their work that may be unlawful or even corrupt. Unfortunately, some employees and workers feel that they will be fired, terminated, harrassed or punished if they report an unlawful or corrupt action. These reporters, however, are protected by the law as a Whistleblower and can receive compensation because of the False Claims Act or the Medicaid False Claims Act. If you have reported actions that may be fraudulent, then you should talk to a Whistleblower or qui tam lawyer about your facts.

Whistleblowers help the government to get back billions of dollars each year with the help of the False Claims Act. In fact, fraudulent Medicaid claims are also caught by whistleblowers having the Medicaid False Claims Act on their side. If you report a false claim or fraudulent action to the government, then the government will give you, the whistleblower, a part of the money that gets recovered. This is because of qui tam requirements. Qui Tam means that a person files a lawsuit for the king and also for him or herself. The phrase is qui tam pro domino rege quam pro se ipso in hac parte sequitur, or, “he who sues for the king as well for himself.”

These requirements and lawsuits were made popular during the Civil War when many people were getting away with fraudulent actions against the government. In 1986, the False Claims Act was amended to raise the total compensation given to people who reported fraudulent actions, or whistleblowers. If a whistleblower works with a lawyer then it may be possible for them to get three times the amount the government would get in damages and also get additional compensation for general fines.

TYPES OF CASES

The most common situations that could form the basis of a Qui Tam action include:

• Submitting a false or fraudulent record, bill or statement to the government in order to fraudulently obtain money such as reporting a medical service that was never performed for Medicare or Medicad;
• Conspiring with a third party to submit or present have a false or fraudulent claim to the government;
• Withholding property of the government with the intent to defraud or conceal the property from the government;
• Fraudulently buying property of the government from someone not authorized to sell that property; and
• Making a false statement to fraudulently avoid paying money to the government or to avoid delivering property to the government.

FOR HELP, PLEASE CONTACT US.

We help whistleblowers on a contingency basis, meaning there is no fee charged for our work unless there is a recovery. We also front any and all expenses. No matter where you are located — we will represent you. We will come to you, you will not have to come to us.

Attorneys in our firm and attorneys that we work with on Whistleblower, Qui Tam, False Claims Act cases have represented a host of persons making claims, for violations of federal tax law, Medicare law and more.

For more information, please contact our team of whitsleblower and qui tam attorneys today.

CALL 1-800-632-1404

or fill out this form below for a free initial consultation.