Showing posts with label department of justice. Show all posts
Showing posts with label department of justice. Show all posts
Saturday, July 2, 2011
Psychiatrist Pleads Guilty Role in $200 Million Medicare Fraud Scheme
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Thursday, June 30, 2011
WASHINGTON - A Miami-area psychiatrist pleaded guilty today in U.S. District Court in Miami for his part in a fraud scheme that resulted in the submission of more than $200 million in fraudulent claims to Medicare, the Department of Justice, FBI and Department of Health and Human Services (HHS)announced.
Dr. Alan Gumer, 64, of Tamarac, Fla., pleaded guilty to one count of conspiracy to commit health care fraud. Gumer was charged on Feb. 15, 2011, with one count of conspiracy to commit health care fraud and four counts of health care fraud.
According to court documents, Gumer was a psychiatrist at American Therapeutic Corporation (ATC), a Florida corporation headquartered in Miami. ATC purported to operate partial hospitalization programs (PHPs) in seven different locations throughout South Florida and Orlando. A PHP is a form of intensive treatment for severe mental illness.
Gumer admitted that he signed evaluations, notes and other documents in medical files for patients who did not need the treatment for which ATC billed Medicare. Specifically, as a psychiatrist, Gumer knew that the patients attending ATC did not need intensive mental health treatment, and that the treatments offered by ATC were not the type of intensive treatments a PHP should provide. Gumer admitted that he signed these files without examining the patients, or writing and reading the statements he was signing. Gumer also admitted to writing prescriptions for psychiatric medications for patients who did not need them in order to make it appear to Medicare that the patients qualified for PHP treatment. According to court documents, Gumer also referred hundreds of ATC patients to a related company, the American Sleep Institute (ASI), for unnecessary diagnostic sleep disorder testing.
According to court filings, Gumer’s co-defendants and ATC’s owners and operators paid kickbacks to owners and operators of assisted living facilities (ALFs) and halfway houses and to patient brokers in exchange for delivering ineligible patients to ATC and ASI. In some cases, the patients received a portion of those kickbacks. Throughout the course of the ATC and ASI conspiracy, millions of dollars in kickbacks were paid in exchange for Medicare beneficiaries, who did not qualify for PHP services, to attend treatment programs that were not legitimate PHP programs so that ATC and ASI could bill Medicare for more than $200 million in medically unnecessary services.
According to the plea agreement, Gumer’s participation in the fraud resulted in $19.3 million in fraudulent billing to the Medicare program. Sentencing for Gumer is scheduled for Jan 19, 2012. Gumer faces a maximum of 10 years in prison and a $250,000 fine.
ATC, its management company Medlink Professional Management Group Inc., and the owners and lead manager of ATC, Medlink and ASI, were charged with various health care fraud, money laundering and other offenses in a separate superseding indictment unsealed on Feb. 15, 2011. Two of the three owners and the lead manager, as well as both ATC and Medlink, have pleaded guilty and have admitted to the fraudulent scheme and that more than $200 million in billings were submitted to the Medicare program as a part of the scheme. They are scheduled for sentencing on Sept. 14, 2011, by U.S. District Court Judge James Lawrence King. The trial of the third owner charged in the separate superseding indictment is scheduled to begin on Aug. 15, 2011.
The remaining 17 co-defendants named in the indictment in which Gumer was charged are scheduled to stand trial on Nov. 7, 2011, before U.S. District Judge Patricia A. Seitz.
An indictment is merely an accusation and defendants are presumed innocent unless and until proven guilty in a court of law.
Today’s guilty plea was announced by Assistant Attorney General Lanny A. Breuer of the Justice Department’s Criminal Division; U.S. Attorney Wifredo A. Ferrer of the Southern District of Florida; John V. Gillies, Special Agent-in-Charge of the FBI’s Miami field office; and Special Agent-in-Charge Christopher Dennis of the HHS Office of Inspector General (HHS-OIG), Office of Investigations Miami office.
The criminal case is being prosecuted by Trial Attorney Jennifer L. Saulino of the Criminal Division’s Fraud Section. The case was investigated by the FBI and HHS-OIG and was brought as part of the Medicare Fraud Strike Force, supervised by the Criminal Division’s Fraud Section and the U.S. Attorney’s Office for the Southern District of Florida.
Since its inception in March 2007, the Medicare Fraud Strike Force operations in nine locations have charged more than 1,000 defendants that collectively have billed the Medicare program for more than $2.3 billion. In addition, HHS’s Centers for Medicare and Medicaid Services, working in conjunction with the HHS-OIG are taking steps to increase accountability and decrease the presence of fraudulent providers.
Thursday, February 10, 2011
Getting Rich Exposing Pharma Fraud
Eamon Javers of CNBC reported recently that A Florida Company called Ven-A-Care has become a profitable whistle blower against Pharmaceutical fraud.
Javers reported that in one case Ven-A-Care found that there appears to be a pattern of overbilling by some Pharmaceutical companies. These pharma firms are selling drugs to patients (mainly elderly) for a set amount and the pharmaceutical company would bill the US Government via Medicare and Medicaid 500 to 2000% markup.
In Dec. 2010 the US Justice Department announced that Dey Inc. Dey Pharma L.P. and Dey L.P. Inc. had agreed to pay $280 million to settle False Claims Act allegations, the Department of Justice disclosed via their website. The United States alleged that Dey reported false prices for the following drugs Albuterol Sulfate, Albuterol MDI, Cromolyn Sodium and Ipratropium Bromide. The Justice department indicated that the Dey Pharma inflated government payments where they charge the Medicare and Medicaid a higher amount over actual price paid by health care providers. This discovery was related by Ven-A-Care.
The Los Angeles times reports that a Texas jury ordered two subsidiaries of Icelandic pharmaceuticals company Actavis to pay $170 million for overcharging the Texas Medicaid program. This was also relayed by Ven-A-Care and they will be rewarded as a “relator”
Ven-A-Care filed whistleblower suits against drug companies in 18 cases thus far since 2001 with settlements to date according to the Los Angeles Times are at least $2.2 billion for state and federal governments and at least $380 million in whistle blower fees for the four partners involved in Ven-A-Care's litigation. Some other big named pharmaceutical companies have settled or were fined such as Bayer Inc., Abbott Laboratories Inc., B. Braun Medical Inc., Roxane Laboratories Inc.,and GlaxoSmithKline to name a few.
These are the kinds of wiki leaks the government likes as all injured benefit, especially the taxpayer and government. It also shows a pattern of immoral and unethical behavior of the pharmaceutical industry by overbilling, overprescribing, and erroneous positive tests of their drugs against placebos.
Tuesday, October 26, 2010
Almost $Billion Fine in DOJ GlaxoSmithKline Fraud Case, Whistle Blower Gets $96 Million
Bloomberg News By Justin Blum, David Voreacos and Andrew Harris Oct 26,2010
This is the complete Bloomberg article
GlaxoSmithKline Plc agreed to pay $750 million to settle a U.S. government false-claims lawsuit over the sale of defective drugs.
Glaxo, the U.K.’s largest drugmaker, and the U.S. Justice Department announced the accord today, resolving a lawsuit first filed in 2004 by Cheryl D. Eckard, a former global quality assurance manager for the London-based company.
“This is not something I wanted to do, but because of patient safety it was necessary,” Eckard, 51, told reporters following a Justice Department press conference in Boston. As a whistleblower, she will receive $96 million from the settlement money.
Glaxo was accused in court papers of selling tainted drugs under false pretenses. The medicines, made at a Glaxo plant in Cidra, Puerto Rico, were misidentified as a result of product mix-ups, according to papers filed in federal court in Boston. The affected drugs included the antidepressant Paxil CR and the diabetes treatment Avandamet.
The settlement includes a criminal fine and forfeiture totaling $150 million and a $600 million civil settlement under the False Claims Act and related state claims, the Justice Department said in a statement.
“We will not tolerate corporate attempts to profit at the expense of the ill and needy in our society -- or those who cut corners that result in potentially dangerous consequences to consumers,” Carmen M. Ortiz, the U.S. Attorney in Boston, said at today’s news conference.
Guilty Plea
SB Pharmco Puerto Rico Inc., a Glaxo unit, agreed to plead guilty to charges relating to the manufacture and distribution of adulterated drugs made at the now-shuttered plant, the Justice Department said. Glaxo said in July it had agreed in principle with the U.S. to pay 500 million pounds ($791 million) to resolve the investigation.
“We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice requirements and with GSK’s commitment to manufacturing quality,” PD Villarreal, a Glaxo senior vice president, said in an e-mailed statement.
Eckard’s take is the largest ever for a single whistleblower, said Patrick Burns, spokesman for Taxpayers Against Fraud, a nonprofit Washington group that publicizes the use of legal means to combat fraud against the U.S. The federal government will receive $436.4 million from the settlement and participating states will split as much as $163.6 million, the Justice Department said.
‘Serious Deficiencies’
Other drugs made at the plant include Kytril, an anti- nausea medication, and Bactroban, an ointment used to treat skin infections, the Justice Department said.
“The false claims arose out of chronic, serious deficiencies in the quality assurance function at the Cidra plant and the defendants’ ongoing serious violations of the laws and regulations designed to ensure the fitness of drug products for use,” the government said in court papers.
The U.S. Food and Drug Administration in 2005 seized some Paxil CR lots after it was discovered that the pills sometimes split inappropriately, according to court papers. Some of the pills lacked an active ingredient.
“We did not uncover any evidence that patients were harmed from these adulterated batches,” Ortiz said today. “It is critical we keep pressure on companies to follow FDA standards and play by the rules.”
Eckard’s complaint was joined by the states of California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Nevada, New Hampshire, New Mexico, New York, Tennessee, Texas and Virginia, as well as the District of Columbia, Chicago and New York City.
The case is U.S. v. SmithKline Beecham Corp., 04-10375, U.S. District Court for Massachusetts (Boston)
To contact the reporters on this story: Justin Blum in Washington at jblum4@bloomberg.net; Andrew M. Harris in Chicago at aharris16@bloomberg.net; David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net.
Friday, August 13, 2010
DOJ Targets Pharmaceutical Companies Globally in Corruption Probe
Financial Times FT.com
By Stephanie Kirchgaessner
August 12, 2010
The US Department of Justice is scrutinising payments by leading pharmaceuticals companies for hospitality, consultants, licensing agreements and charitable donations in markets around the world as part of a wide-ranging corruption probe.
GlaxoSmithKline, Pfizer, Bristol-Myers Squibb and Eli Lilly, among others, have disclosed being contacted by the DoJ and Securities and Exchange Commission in connection with the investigation. Merck, the US drugs group, announced last week that it had also been contacted and was co-operating with investigators.
An industry attorney familiar with the probe said that the DoJ was looking at whether pharma companies had ignored a “systematic risk” inherent in the global drugs business and ignored obligations under local and US anti-bribery law.
The highly regulated nature of the business, combined with the fact that healthcare officials in many non-US markets were government funded, made the industry a natural target for such a probe, the person added.
The investigation is at a relatively early stage but is considered a priority for the DoJ.
While hospitality – including meals and all expenses-paid travel for conferences – has long been considered a potential risk for pharma groups, the DoJ’s probe is looking at all aspects of companies’ dealings in non-US markets, people familiar with the matter say. That includes the recruitment of physicians for clinical trials. In some markets, the same physicians may serve on regulatory boards that approve or deny drugs.
The DoJ declined to comment. But last November, Lanny Breuer, head of the DoJ’s criminal division, announced that investigators would be focusing on international corruption in the pharmaceuticals industry for “years”.
Mr Breuer warned a conference of pharmaceutical industry lawyers that prosecutors were gearing up for an investigation of international corruption in the sector. The drugs companies took notice.
That threat has now become a reality. Merck, AstraZeneca, Eli Lilly, Baxter, SciClone, and Bristol-Myers Squibb have in recent months received inquiries from the DoJ and the Securities and Exchange Commission in connection with an industry-wide bribery investigation.
GlaxoSmithKline, the UK drugmaker, told the Financial Times on Thursday that it too had received “inquiries” from US authorities, but that it disclosed the issue “reactively” only to selected reporters in April.
Pfizer, the world’s largest pharmaceutical group, said in February that it had voluntarily provided the DoJ and SEC with information concerning potentially improper payments outside the US and was exploring resolution of the matter.
There is perhaps no industry that is as vulnerable to violations of US anti-bribery laws as the pharmaceutical industry. In markets round the world, the companies deal, sometimes thousands of times in a single day, with doctors, clinicians, hospital operators and regulators who are considered under US law to be government officials, because they are employed by state-owned facilities.
Under the Foreign Corrupt Practices Act, the US anti-bribery law, companies may not offer items of value to foreign government officials for profit. One industry lawyer involved in the matter said global pharmaceutical companies operating in countries with state-run medical institutions deal with government officials at every turn of their business: whether it is seeking the go-ahead for a manufacturing site; obtaining drug licences; conducting clinical trials; importing drugs; selling and marketing drugs to physicians; or getting a product on to a hospital’s approved list.
“What most companies will find is that all of these areas are risky and, if they don’t train and educate their people, they are going to find themselves with issues. For example, if you have hired customs brokers, how do you know they aren’t bribing officials?” the attorney said.
According to the law firm Arnold & Porter, the DoJ is particularly interested in corrupt payments that may have influenced the reliability or integrity of data in clinical trials performed outside the US. A recent report by the Department of Health and Human Services found 80 per cent of marketing applications for drugs approved by the Food and Drug Administration in the US had relied on at least one foreign trial.
“Companies may find themselves facing critical legal issues if approval of products rested on the results of studies the DoJ deems corrupt,” Arnold & Porter said in an advisory letter to clients last month.
A person familiar with the investigation confirmed that clinical trials were one of several areas the DoJ was examining.
Alexandra Wrage, the president of Trace, a non-profit organisation that helps companies establish anti-corruption practices, said that alleged wrongdoing at pharmaceutical companies could often centre on inappropriately lavish hospitality, such as wining and dining doctors from state-run hospitals at conferences in Bali or Monaco.
Copy and paste link here (free FT.com Reg.):http://www.ft.com/cms/s/0/9a8e8f90-a63e-11df-8767-00144feabdc0.html
By Stephanie Kirchgaessner
August 12, 2010
The US Department of Justice is scrutinising payments by leading pharmaceuticals companies for hospitality, consultants, licensing agreements and charitable donations in markets around the world as part of a wide-ranging corruption probe.
GlaxoSmithKline, Pfizer, Bristol-Myers Squibb and Eli Lilly, among others, have disclosed being contacted by the DoJ and Securities and Exchange Commission in connection with the investigation. Merck, the US drugs group, announced last week that it had also been contacted and was co-operating with investigators.
An industry attorney familiar with the probe said that the DoJ was looking at whether pharma companies had ignored a “systematic risk” inherent in the global drugs business and ignored obligations under local and US anti-bribery law.
The highly regulated nature of the business, combined with the fact that healthcare officials in many non-US markets were government funded, made the industry a natural target for such a probe, the person added.
The investigation is at a relatively early stage but is considered a priority for the DoJ.
While hospitality – including meals and all expenses-paid travel for conferences – has long been considered a potential risk for pharma groups, the DoJ’s probe is looking at all aspects of companies’ dealings in non-US markets, people familiar with the matter say. That includes the recruitment of physicians for clinical trials. In some markets, the same physicians may serve on regulatory boards that approve or deny drugs.
The DoJ declined to comment. But last November, Lanny Breuer, head of the DoJ’s criminal division, announced that investigators would be focusing on international corruption in the pharmaceuticals industry for “years”.
Mr Breuer warned a conference of pharmaceutical industry lawyers that prosecutors were gearing up for an investigation of international corruption in the sector. The drugs companies took notice.
That threat has now become a reality. Merck, AstraZeneca, Eli Lilly, Baxter, SciClone, and Bristol-Myers Squibb have in recent months received inquiries from the DoJ and the Securities and Exchange Commission in connection with an industry-wide bribery investigation.
GlaxoSmithKline, the UK drugmaker, told the Financial Times on Thursday that it too had received “inquiries” from US authorities, but that it disclosed the issue “reactively” only to selected reporters in April.
Pfizer, the world’s largest pharmaceutical group, said in February that it had voluntarily provided the DoJ and SEC with information concerning potentially improper payments outside the US and was exploring resolution of the matter.
There is perhaps no industry that is as vulnerable to violations of US anti-bribery laws as the pharmaceutical industry. In markets round the world, the companies deal, sometimes thousands of times in a single day, with doctors, clinicians, hospital operators and regulators who are considered under US law to be government officials, because they are employed by state-owned facilities.
Under the Foreign Corrupt Practices Act, the US anti-bribery law, companies may not offer items of value to foreign government officials for profit. One industry lawyer involved in the matter said global pharmaceutical companies operating in countries with state-run medical institutions deal with government officials at every turn of their business: whether it is seeking the go-ahead for a manufacturing site; obtaining drug licences; conducting clinical trials; importing drugs; selling and marketing drugs to physicians; or getting a product on to a hospital’s approved list.
“What most companies will find is that all of these areas are risky and, if they don’t train and educate their people, they are going to find themselves with issues. For example, if you have hired customs brokers, how do you know they aren’t bribing officials?” the attorney said.
According to the law firm Arnold & Porter, the DoJ is particularly interested in corrupt payments that may have influenced the reliability or integrity of data in clinical trials performed outside the US. A recent report by the Department of Health and Human Services found 80 per cent of marketing applications for drugs approved by the Food and Drug Administration in the US had relied on at least one foreign trial.
“Companies may find themselves facing critical legal issues if approval of products rested on the results of studies the DoJ deems corrupt,” Arnold & Porter said in an advisory letter to clients last month.
A person familiar with the investigation confirmed that clinical trials were one of several areas the DoJ was examining.
Alexandra Wrage, the president of Trace, a non-profit organisation that helps companies establish anti-corruption practices, said that alleged wrongdoing at pharmaceutical companies could often centre on inappropriately lavish hospitality, such as wining and dining doctors from state-run hospitals at conferences in Bali or Monaco.
Copy and paste link here (free FT.com Reg.):http://www.ft.com/cms/s/0/9a8e8f90-a63e-11df-8767-00144feabdc0.html
Wednesday, September 23, 2009
Anti-Smoking Drugs Can Create Suicidal Thoughts and Aggressive Behavior
In January of this year, David Collins killed himself with a shotgun just three months after he began taking Chantix (varenicline) a smoking cessation drug made by Pfizer. Linda Collins who is David Collins widow has filed a lawsuit in Indianapolis against Pfizer over Chantix (Champix in other countries) its side effects and its possible failure to provide warnings to users. Mr. Collins had no prior history of mental illness, but before his suicide Mr. Collins exhibited aggression and strange behavior. More details will be divulged once the lawsuit progresses and apparently increases in size (chantixsuicidelawsuits.com). The FDA had reported thirty nine suicides and nearly five hundred cases of suicide behavior or thoughts of suicide from the use of Chantix. These suicide behaviors regarding Chantix are similar to the black box warnings that all drug companies are compelled to divulge on their antidepressant labels. Just two months ago, the FDA required Chantix (varenicline) and Zyban to carry a black box warning due to side effects including depression, suicidal thoughts, and suicidal actions.
Zyban made by GlaxoSmithKline involves bupropion an antidepressant drug which acts as a norepinephrine and dopamine reuptake inhibitor and nicotinic antagonist. This drug is cross marketed as an antidepressant and smoking cessation drug. To our knowledge Chantix is not cross marketed as an antidepressant. But apparently Pfizer likes to cross market drugs legally or not. This week Pfizer settled with the Department of Justice for $2.3 billion, the largest health care fraud settlement in the history of the DOJ. It resolved their criminal and civil liability arising from the illegal promotion of certain pharmaceutical products. Pfizer “off labeled” drugs for uses the FDA didn’t previously approve of. $1 billion was allocated to resolve allegations under the civil False Claims Act that Pfizer illegally promoted the drugs Bextra, Geodon an anti-psychotic drug, Zyvox, an antibiotic, and Lyrica, an anti-epileptic drug. What is worse is that Pfizer is a habitual criminal company since they have been found guilty before in a similar case.
Tony West the DOJ Assistant Attorney General for the Civil Division was quoted by news releases, “Illegal conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by health care providers, and costs the government billions of dollars”. Perhaps this massive fine will curtail Pfizer to some degree, but they will likely need at least three strikes. We think this is the beginning of more and more lawsuits against pharmaceutical companies for cross labeling, inadequate tests and warnings, and drugs that create suicidal thoughts, and aggressive behavior. Consumers need to fully perform their due diligence before taking drugs which have clear controversial effects. Chantix and Zyban have a new warning that the drug can produce suicidal thoughts and behavior. Do you want to stop smoking or stop life?
Zyban made by GlaxoSmithKline involves bupropion an antidepressant drug which acts as a norepinephrine and dopamine reuptake inhibitor and nicotinic antagonist. This drug is cross marketed as an antidepressant and smoking cessation drug. To our knowledge Chantix is not cross marketed as an antidepressant. But apparently Pfizer likes to cross market drugs legally or not. This week Pfizer settled with the Department of Justice for $2.3 billion, the largest health care fraud settlement in the history of the DOJ. It resolved their criminal and civil liability arising from the illegal promotion of certain pharmaceutical products. Pfizer “off labeled” drugs for uses the FDA didn’t previously approve of. $1 billion was allocated to resolve allegations under the civil False Claims Act that Pfizer illegally promoted the drugs Bextra, Geodon an anti-psychotic drug, Zyvox, an antibiotic, and Lyrica, an anti-epileptic drug. What is worse is that Pfizer is a habitual criminal company since they have been found guilty before in a similar case.
Tony West the DOJ Assistant Attorney General for the Civil Division was quoted by news releases, “Illegal conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by health care providers, and costs the government billions of dollars”. Perhaps this massive fine will curtail Pfizer to some degree, but they will likely need at least three strikes. We think this is the beginning of more and more lawsuits against pharmaceutical companies for cross labeling, inadequate tests and warnings, and drugs that create suicidal thoughts, and aggressive behavior. Consumers need to fully perform their due diligence before taking drugs which have clear controversial effects. Chantix and Zyban have a new warning that the drug can produce suicidal thoughts and behavior. Do you want to stop smoking or stop life?
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