Whistleblower for Urgent PC

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200 pharma whistleblowers in line for court
November 6, 2009 — 12:20pm ET | By Tracy Staton

Think Big Pharma has been plagued by whistleblower lawsuits lately? You ain't seen nothin' yet, legal eagles say. Yes, 2009 appears to be the year of the False Claims Act, that federal law that allows whistleblowers to sue--and collect a share of any eventual settlement. After all, the government has announced settlements of more than $4 billion in off-label drug marketing claims, and another trial is already underway.

But there are hundreds more pharma whistleblowers waiting in the wings. There's a backlog of 1,000 cases at the Department of Justice, and drugmakers are involved in 200 of them. "The seeds for these cases were planted a number of years ago, and they're finally coming to fruition," Reuben Guttman, a Washington lawyer who specializes in whistleblower cases, told Gannett.

And if history is any guide to the outcome of those cases, pharma could be in for trouble. Of the top 20 False Claims Act cases in terms of money recovered, 12 included settlements or judgments against drug companies.

PhRMA, the drugmakers' trade group, tried to put a brave face on things in a statement to Gannett: "It's not completely unexpected that the cases would be filed in waves as the government wraps up a group of investigations. And publicity in one case can spawn others." No doubt, especially when some whistleblowers have personally walked away with millions. In any case, we can expect more of this kind of news as the backlogged suits make their way into the light of day.

Read more: http://www.fiercepharma.com/story/200-pharma-whistleblowers-line-court/2009-11-06#ixzz0WS31YGGD
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Are there any whistleblowers for Urgent PC?

How long are you going to tell physicians to use 64555 or "contact your carrier for information" but you are not going to get paid if you use 64999? Do you really think your physicians are going to back YOU or their Administration manager when Medicare comes calling to reclaim their money? Who do you think Uroplasty is going to back?
 






Anonymous said:
200 pharma whistleblowers in line for court
November 6, 2009 — 12:20pm ET | By Tracy Staton

Think Big Pharma has been plagued by whistleblower lawsuits lately? You ain't seen nothin' yet, legal eagles say. Yes, 2009 appears to be the year of the False Claims Act, that federal law that allows whistleblowers to sue--and collect a share of any eventual settlement. After all, the government has announced settlements of more than $4 billion in off-label drug marketing claims, and another trial is already underway.

But there are hundreds more pharma whistleblowers waiting in the wings. There's a backlog of 1,000 cases at the Department of Justice, and drugmakers are involved in 200 of them. "The seeds for these cases were planted a number of years ago, and they're finally coming to fruition," Reuben Guttman, a Washington lawyer who specializes in whistleblower cases, told Gannett.

And if history is any guide to the outcome of those cases, pharma could be in for trouble. Of the top 20 False Claims Act cases in terms of money recovered, 12 included settlements or judgments against drug companies.

PhRMA, the drugmakers' trade group, tried to put a brave face on things in a statement to Gannett: "It's not completely unexpected that the cases would be filed in waves as the government wraps up a group of investigations. And publicity in one case can spawn others." No doubt, especially when some whistleblowers have personally walked away with millions. In any case, we can expect more of this kind of news as the backlogged suits make their way into the light of day.

Read more: http://www.fiercepharma.com/story/200-pharma-whistleblowers-line-court/2009-11-06#ixzz0WS31YGGD
------------
Are there any whistleblowers for Urgent PC?

How long are you going to tell physicians to use 64555 or "contact your carrier for information" but you are not going to get paid if you use 64999? Do you really think your physicians are going to back YOU or their Administration manager when Medicare comes calling to reclaim their money? Who do you think Uroplasty is going to back?
Click to expand...

The company is always going to back their rep!
 












Biotech Can Sue Consultant Over Whistleblower Loss
24 Comments
By Ed Silverman // November 19th, 2009 // 7:55 am

This may add a whole new wrinkle to whistleblower lawsuits. A federal appeals court ruled that Cell Therapeutics can pursue a claim for nearly $23 million against a former consultant, the Associated Press reports. And the 9th U.S. Circuit Court of Appeals ruling creates a new interpretation of law surrounding fraud cases brought on behalf of the government (the ruling).

The case concerns Trisenox, a leukemia drug developed by Cell Therapeutics, which claims it marketed the med off-label on the advice of a consultant, formerly known as Documedics Acquisition and now called Lash Group, the AP writes. As a result, docs billed Medicare for unapproved uses. After a former employee filed a whistleblower lawsuit, Cell Therapeutics agreed to settle $10.5 million without admitting liability.

Cell Therapeutics believes the mistake was not its fault and sued Lash Group, hoping to recover the $10.5 million plus $12.3 million in attorneys fees and damages, including loss of reputation, the AP continues. There’s the twist. As the AP notes, historically, courts have not allowed defendants in whistleblower suits to try to recover fines or settlements by suing others.

But the appeals court noted the biotech never admitted liability. So was wrongdoing committed? The court sent the case back to US District Court in Seattle. “For the first time here, the 9th Circuit has now swept away the rationale for all of that law,” Dan Dunne, who represented the biotech, tells the AP. “That’s a very important development. With hundreds of billions of dollars of stimulus money being sprinkled across the country, you can expect qui tam lawsuits to be a growth industry.”


It’s not clear if Lash Group will appeal, the AP writes, adding that Cell Therapeutics sold Trisenox to Cephalon in 2005.
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Does this mean that physician can sue Uroplasty for telling them the wrong codes (64555 and the programming code) to use with Medicare?
 






Anonymous said:
Biotech Can Sue Consultant Over Whistleblower Loss
24 Comments
By Ed Silverman // November 19th, 2009 // 7:55 am

This may add a whole new wrinkle to whistleblower lawsuits. A federal appeals court ruled that Cell Therapeutics can pursue a claim for nearly $23 million against a former consultant, the Associated Press reports. And the 9th U.S. Circuit Court of Appeals ruling creates a new interpretation of law surrounding fraud cases brought on behalf of the government (the ruling).

The case concerns Trisenox, a leukemia drug developed by Cell Therapeutics, which claims it marketed the med off-label on the advice of a consultant, formerly known as Documedics Acquisition and now called Lash Group, the AP writes. As a result, docs billed Medicare for unapproved uses. After a former employee filed a whistleblower lawsuit, Cell Therapeutics agreed to settle $10.5 million without admitting liability.

Cell Therapeutics believes the mistake was not its fault and sued Lash Group, hoping to recover the $10.5 million plus $12.3 million in attorneys fees and damages, including loss of reputation, the AP continues. There’s the twist. As the AP notes, historically, courts have not allowed defendants in whistleblower suits to try to recover fines or settlements by suing others.

But the appeals court noted the biotech never admitted liability. So was wrongdoing committed? The court sent the case back to US District Court in Seattle. “For the first time here, the 9th Circuit has now swept away the rationale for all of that law,” Dan Dunne, who represented the biotech, tells the AP. “That’s a very important development. With hundreds of billions of dollars of stimulus money being sprinkled across the country, you can expect qui tam lawsuits to be a growth industry.”


It’s not clear if Lash Group will appeal, the AP writes, adding that Cell Therapeutics sold Trisenox to Cephalon in 2005.
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Does this mean that physician can sue Uroplasty for telling them the wrong codes (64555 and the programming code) to use with Medicare?
Click to expand...

Probably.
 






























Anonymous said:
200 pharma whistleblowers in line for court
November 6, 2009 — 12:20pm ET | By Tracy Staton

Think Big Pharma has been plagued by whistleblower lawsuits lately? You ain't seen nothin' yet, legal eagles say. Yes, 2009 appears to be the year of the False Claims Act, that federal law that allows whistleblowers to sue--and collect a share of any eventual settlement. After all, the government has announced settlements of more than $4 billion in off-label drug marketing claims, and another trial is already underway.

But there are hundreds more pharma whistleblowers waiting in the wings. There's a backlog of 1,000 cases at the Department of Justice, and drugmakers are involved in 200 of them. "The seeds for these cases were planted a number of years ago, and they're finally coming to fruition," Reuben Guttman, a Washington lawyer who specializes in whistleblower cases, told Gannett.

And if history is any guide to the outcome of those cases, pharma could be in for trouble. Of the top 20 False Claims Act cases in terms of money recovered, 12 included settlements or judgments against drug companies.

PhRMA, the drugmakers' trade group, tried to put a brave face on things in a statement to Gannett: "It's not completely unexpected that the cases would be filed in waves as the government wraps up a group of investigations. And publicity in one case can spawn others." No doubt, especially when some whistleblowers have personally walked away with millions. In any case, we can expect more of this kind of news as the backlogged suits make their way into the light of day.

Read more: http://www.fiercepharma.com/story/200-pharma-whistleblowers-line-court/2009-11-06#ixzz0WS31YGGD
------------
Are there any whistleblowers for Urgent PC?

How long are you going to tell physicians to use 64555 or "contact your carrier for information" but you are not going to get paid if you use 64999? Do you really think your physicians are going to back YOU or their Administration manager when Medicare comes calling to reclaim their money? Who do you think Uroplasty is going to back?
Click to expand...

Is it true that a former rep filed a lawsuit in NY regarding this?
 






FDA takes aim at corporate executives to reign in pharma abuses
Mar 29, 2011
By: From staff reports
Drug Topics E-News



FDA has a new target in its continuing efforts to clean up pharmaceutical industry abuses: individual corporate officials. The most recent targets are the vice president of quality and the vice president of operations for OTC Products at McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson. The two are named as defendants in a consent decree of permanent injunction for failing to comply with current good manufacturing practice requirements at plants in Pennsylvania and Puerto Rico that resulted in massive product recalls.

The tactic of going after individuals is no surprise to industry insiders. FDA warned last November that it was resurrecting a 1970s legal doctrine to bring criminal charges against top executives. The goal, said Eric Blumberg, FDA deputy chief counsel for litigation, was to “change the corporate culture” at firms that have shrugged at billion dollar penalties.

“It is clear that fines are not working here,” Blumberg told a Food and Drug Law Institute meeting in Philadelphia. “We need to put something else on the scale to make people think twice, three times.”

Blumberg was talking about illegal drug marketing. Eli Lilly paid $1.4 billion in 2009 for crossing the line in marketing Zyprexa (olanzapine) and Pfizer paid $2.3 billion for illegal marketing of Bextra (valdecoxib).

FDA’s weapon of choice is the Park Doctrine, based on a 1975 case against Acme Markets President John Park. FDA charged Park personally with sanitation violations following multiple warning notices. The U.S. Supreme Court agreed that Park, as company president, was ultimately responsible for ensuring compliance.

In 2007, 3 executives of Purdue Frederick Company pled guilty to charges of misbranding OxyContin (oxycodone). The trio paid $634.5 million to the Virginia Medicaid Fraud Unit and were barred from federal healthcare programs for 12 years.

In 2010, 4 executives of Synthes pled guilty for off-label promotion of a bone cement. The 4 face fines of up to $10,000 each and a year in federal prison.

Other recent targets include former GlaxoSmithKline Vice President Lauren Stevens, indicted for making false statements and obstructing an FDA investigation into illegal marketing of Wellbutrin SR (bupropion sustained release) and former KV Pharmaceutical CEO and Chairman of the Board Marc Hamerlin, barred from participating in federal healthcare programs for 20 years.

“This is the topic of a lot of discussions and concerns among executives across the pharmaceutical industry,” said Victor Kleinman, executive vice president, Global Life Sciences, for the executive search firm DHR International. “There are companies where these kinds of issues keep the CEO up at night.”
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uh oh Dave and Larry.
 






Do you think this will happen to Dave K. when the BOD and investors find out he lied regarding PTNS coverage and that he knowingly allowed reps to sell using the old code?
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InterMune ex-CEO Harkonen sentenced in Actimmune drug scandal

San Francisco Business Times - by Ron Leuty
Date: Friday, April 15, 2011, 10:43am PDT

Former InterMune Inc. CEO Scott Harkonen was fined $20,000 and sentenced to six months of home confinement in connection to a misleading 2002 company press release about the drug Actimmune.

Harkonen was convicted of wire fraud in September 2009 after Brisbane-based InterMune distributed an Aug. 28, 2002, press release that claimed that Actimmune in a Phase III trial reduced deaths by 70 percent in patients with mild to moderate idiopathic pulmonary fibrosis.

Actimmune, a $50,000-a-year drug approved to treat severe osteopetrosis and chronic granulomatous disease, was not approved for IPF, a fatal lung-scarring disease for which there are no approved treatments in the United States.

Doctors can use drugs off-label — for uses other than those for which they are approved — but drug companies are prohibited from promoting off-label use.

In a seven-week trial in U.S. District Court for Northern California that led to Harkonen’s conviction, the Justice Department said the executive directed the press release to boost InterMune’s revenue and profit. But even as prosecutors sought a 10-year prison sentence, Judge Marilyn Hall Patel found that the government had “no evidence whatsoever that the press release had caused any loss or any harm to anyone,” Harkonen’s attorney, Mark Haddad, told Bloomberg.

InterMune (NASDAQ: ITMN) in October 2006 entered a deferred prosecution agreement, which included a payment of $36.9 million, that settled criminal charges and civil liability claims that Actimmune was illegally marketed and caused false claims for reimbursement from government health programs.

Harkonen left InterMune at the end of June 2003.
 






Medicare and Medicaid Fraud

Violations of laws and regulations governing the Medicare and Medicaid programs may also constitute violations of Federal and State False Claims Acts. Hospitals, nursing homes, doctors, home health care agencies, durable goods providers, pharmacies, and laboratories that seek and receive reimbursement for Medicare and Medicaid funds are Government contractors subject to the False Claims Acts. To the extent that these entities receive money from TRICARE, the military’s health insurance program, the Federal False Claim Act is also implicated. In addition, wrongful conduct that defrauds the state of dollars used to insure the health care of public employees may implicate violations of state False Claims Acts.

Healthcare workers and families of nursing home or hospital patients should pay particular attention to the services provided. Not only can this improve the healthcare for patients and loved ones, but it also helps ensure that public monies are properly spent in accordance with law and prudent medical practice.

Billing for services not rendered, misrepresenting the type of goods or services rendered, or misrepresenting the nature of the patient’s illness can trigger liability under the False Claims Act. Likewise, failing to provide correct data on annual hospital or nursing home cost reports that must be provided to the Government may violate the law.

In addition, hospitals and nursing homes that provide substandard care may also violate False Claims Acts.

The following types of conduct should trigger a red flag:
1.Partially filling prescriptions, but charging as if a full prescription was provided.
2.Providing kickbacks to a medical provider in order to induce the provider to prescribe certain drugs or use certain products.
3.Prescribing medications, drugs, or treatment that are not a medically necessary.
4.Charging Medicare or Medicaid patients a higher rate than others for the same prescription.
5.Knowingly providing defective products or services.
6.Falsely diagnosing a more severe ailment than the one the patient actually has, known as “upcoding” a diagnosis, thereby justifying a more expensive drug therapy or other treatment than that which the patient’s health requires.
7.Inappropriate changes in patients’ prescriptions from one drug to another as a result of kickbacks or for other improper reasons.
8.Falsely reporting drug research grant information to government agencies.
9.Changing a diagnosis or treatment code to secure a higher reimbursement from a government program.
 






Anonymous said:
Do you think this will happen to Dave K. when the BOD and investors find out he lied regarding PTNS coverage and that he knowingly allowed reps to sell using the old code?
-----------------------------

InterMune ex-CEO Harkonen sentenced in Actimmune drug scandal

San Francisco Business Times - by Ron Leuty
Date: Friday, April 15, 2011, 10:43am PDT

Former InterMune Inc. CEO Scott Harkonen was fined $20,000 and sentenced to six months of home confinement in connection to a misleading 2002 company press release about the drug Actimmune.

Harkonen was convicted of wire fraud in September 2009 after Brisbane-based InterMune distributed an Aug. 28, 2002, press release that claimed that Actimmune in a Phase III trial reduced deaths by 70 percent in patients with mild to moderate idiopathic pulmonary fibrosis.

Actimmune, a $50,000-a-year drug approved to treat severe osteopetrosis and chronic granulomatous disease, was not approved for IPF, a fatal lung-scarring disease for which there are no approved treatments in the United States.

Doctors can use drugs off-label — for uses other than those for which they are approved — but drug companies are prohibited from promoting off-label use.

In a seven-week trial in U.S. District Court for Northern California that led to Harkonen’s conviction, the Justice Department said the executive directed the press release to boost InterMune’s revenue and profit. But even as prosecutors sought a 10-year prison sentence, Judge Marilyn Hall Patel found that the government had “no evidence whatsoever that the press release had caused any loss or any harm to anyone,” Harkonen’s attorney, Mark Haddad, told Bloomberg.

InterMune (NASDAQ: ITMN) in October 2006 entered a deferred prosecution agreement, which included a payment of $36.9 million, that settled criminal charges and civil liability claims that Actimmune was illegally marketed and caused false claims for reimbursement from government health programs.

Harkonen left InterMune at the end of June 2003.
Click to expand...

Thank goodness they gave us those pricing sheets to show physicians how much money they would make using PTNS. It's too bad the company doesn't focus on selling PTNS on its efficacy.
 






Inspector General Puts Forest CEO in the Crosshairs

By Ben Comer | Published: April 15, 2011


Forest Laboratories’ CEO Howard Solomon was no doubt surprised to receive a form letter from the Office of Inspector General (OIG) on April 8, which, if acted upon, would exclude him from doing business with federal healthcare plans, including Medicare and Medicaid.

Solomon has 30 days to explain to the OIG why he should not be punished for illegal activities conducted by Forest Pharmaceuticals, a subsidiary, which pled guilty to a felony obstruction of justice charge, two misdemeanors related to distribution of an unapproved drug – Levothroid – and the off-label promotion of two anti-depressants, Lexapro and Celexa, last September. Forest settled those charges – criminal and civil – by coughing up over $313 million.

It’s not the first time a CEO has been taken to task by the OIG – three executives including the CEO of Purdue Pharma were banned from Medicare and Medicaid in 2007, and lost their jobs as a result – but with Purdue, those executives pled guilty to misdemeanor charges. Eighty-three-year-old Solomon, however, was not named in the criminal or civil proceedings of the Forest case and eventual settlement.

“One of the things that is different about this notice of intent to exclude, is that it’s an action taken against an individual who was not charged by the Justice Department,” said Ginny Gibson, partner at the law firm Hogan Lovells. “In the other cases, the Justice Department has taken action against the person or entity that the Inspector General is acting against. This is an exclusion of someone who did not commit a felony, so there’s no mandatory exclusion, and he did not plead guilty to a Park Doctrine misdemeanor.”
 












Anonymous said:
Medicare and Medicaid Fraud

Violations of laws and regulations governing the Medicare and Medicaid programs may also constitute violations of Federal and State False Claims Acts. Hospitals, nursing homes, doctors, home health care agencies, durable goods providers, pharmacies, and laboratories that seek and receive reimbursement for Medicare and Medicaid funds are Government contractors subject to the False Claims Acts. To the extent that these entities receive money from TRICARE, the military’s health insurance program, the Federal False Claim Act is also implicated. In addition, wrongful conduct that defrauds the state of dollars used to insure the health care of public employees may implicate violations of state False Claims Acts.

Healthcare workers and families of nursing home or hospital patients should pay particular attention to the services provided. Not only can this improve the healthcare for patients and loved ones, but it also helps ensure that public monies are properly spent in accordance with law and prudent medical practice.

Billing for services not rendered, misrepresenting the type of goods or services rendered, or misrepresenting the nature of the patient’s illness can trigger liability under the False Claims Act. Likewise, failing to provide correct data on annual hospital or nursing home cost reports that must be provided to the Government may violate the law.

In addition, hospitals and nursing homes that provide substandard care may also violate False Claims Acts.

The following types of conduct should trigger a red flag:
1.Partially filling prescriptions, but charging as if a full prescription was provided.
2.Providing kickbacks to a medical provider in order to induce the provider to prescribe certain drugs or use certain products.
3.Prescribing medications, drugs, or treatment that are not a medically necessary.
4.Charging Medicare or Medicaid patients a higher rate than others for the same prescription.
5.Knowingly providing defective products or services.
6.Falsely diagnosing a more severe ailment than the one the patient actually has, known as “upcoding” a diagnosis, thereby justifying a more expensive drug therapy or other treatment than that which the patient’s health requires.
7.Inappropriate changes in patients’ prescriptions from one drug to another as a result of kickbacks or for other improper reasons.
8.Falsely reporting drug research grant information to government agencies.
9.Changing a diagnosis or treatment code to secure a higher reimbursement from a government program.
Click to expand...

I wonder what the deadline is for filing a compliant?
 






15. Compliance Procedures

We must all work to ensure prompt and consistent action against violations of this Code. However, in some situations it is difficult to know if a violation has occurred. Since we cannot anticipate every situation that will arise, it is important that we have a way to approach a new question or problem. All employees should keep the following steps in mind when evaluating a possible violation of the Code:
•Make sure you have all the facts. In order to reach the right solutions, we must be as fully informed as possible.
•Ask yourself: What specifically am I being asked to do? Does it seem unethical or improper? This question will enable you to focus on the specific situation you are faced with and the alternatives you may have. Use your judgment and common sense; if something seems unethical or improper, it probably is.
•Clarify your responsibility and role. In most situations, there is shared responsibility. Are your colleagues informed? If so, it may help to get others involved and discuss the problem.
•Discuss the problem with your supervisor. This recommendation is basic guidance for all situations. In many cases, your supervisor will be more knowledgeable about the question, and will appreciate being brought into the decision-making process. Remember that it is your supervisor's responsibility to help solve problems.
•Seek help from Uroplasty resources. In the rare case where it may not be appropriate to discuss an issue with your supervisor, or in situations where you do not feel comfortable approaching your supervisor with your question, please discuss the issue with our Chief Financial Officer.

You may report the ethical violations in confidence and without fear of retaliation. If your situation requires that your identity be kept secret, we will take steps to ensure your anonymity will be protected. We do not permit retaliation of any kind against employees for good faith reports of ethical violations.
 






14. Reporting Fraud or any other Illegal or Unethical Behavior

All employees are responsible for reporting fraud, falsification of records or reports, misappropriation of funds or other assets of Uroplasty and other irregularities. Managers should become familiar with the types of irregularities that might occur in their area of responsibility. Fraud applies to any irregularity or suspected irregularity related to our business and involving employees, vendors, or persons that provide service or materials.

Employees, officers and directors are encouraged to talk to supervisors, managers or other appropriate personnel about observed fraudulent, illegal or unethical behavior and, when in doubt, about the best course of action in a particular situation. If you suspect fraud, do not discuss the matter with any of the individuals involved and do not attempt to investigate or determine facts on your own. To report fraudulent, illegal or unethical behavior, or if you have a question regarding the appropriate course of action, follow the guidelines described in Section 15 of this Code. It is our policy not to allow retaliation for reports of misconduct by others made in good faith by employees. We expect employees to cooperate in internal investigations of misconduct. Our Chief Financial Officer will investigate any reported violations and will oversee an appropriate response, including corrective action and preventative measures.

Employees must read our Employee Complaint Procedures for Accounting and Auditing Matters below (Section 17), which describes our procedures for the receipt, retention and treatment of complaints that we receive regarding accounting, internal accounting controls or auditing matters. Any employee may submit a good faith concern regarding questionable accounting or auditing matters without fear of dismissal or retaliation of any kind.
 






Report a ConcernFollow Up on a Reported Concern


https://uroplasty.alertline.com/gcs/welcome



Uroplasty


Welcome to the Uroplasty page hosted by Global Compliance, Inc! The management team and Board of Directors of the company have established this system to enhance communication in the company and provide employees with a means to anonymously communicate with Uroplasty management. Uroplasty is also committed to complying with the Sarbanes-Oxley Act of 2002 by providing this confidential reporting system for our employees. We respect and value each of your opinions, and hope you will feel comfortable using the AlertLine website to communicate problems, concerns, or suggestions.

This tool will allow all company employees to provide valuable feedback, comments, suggestions and alerts. The level of success of improving communication and efficiency within our organization directly corresponds with how effective and how often you utilize this powerful tool. Please respect our intentions of establishing an anonymous feedback system by not abusing it. This website is not meant to be a complaint line or "get back at my boss" line.

We encourage all of you to feel comfortable using AlertLine. You can feel assured that you will remain completely anonymous, if you select that option. Once again, your comments, suggestions and valuable feedback will have a direct result to the success of our organization.

Sincerely,

Dave Kaysen
President and CEO

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