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SEC May Let Whistle-blowers Bypass Internal Complaint Systems
By Jesse Hamilton - May 25, 2011 9:30 AM ET

The U.S. Securities and Exchange Commission may let corporate whistle-blowers collect as much as 30 percent of penalties for reporting financial wrongdoing even when they bypass companies’ internal complaint systems.

SEC commissioners are scheduled to take a final vote on the measure, part of the agency’s rulemaking under the Dodd-Frank Act, at a meeting in Washington today.

Companies had asked the SEC to require whistle-blowers to report problems though internal compliance programs before going to the agency. While rejecting that approach, the SEC increased incentives for using internal systems by permitting bounties for people whose tips are passed on to the agency and expanding the time window in which employees can maintain their place in line at the SEC while reporting to the company first.

“The door is opening for a new chapter in corporate compliance,” Thomas Borgers, a managing director of Mesirow Financial Consulting, said in an interview. “The more they listen to their employees and respond to the needs of the employees, I think they’ll do very well.”

The Dodd-Frank Act called for the SEC to establish the bounty system, which has been active since the regulatory overhaul was enacted in July. The commission, which proposed the rule in a unanimous vote on Nov. 3, was directed to overhaul the rules after being faulted for fumbling tips about Bernard Madoff’s multibillion-dollar fraud.
 






Feds hold execs accountable for health fraud
May 31, 2011 — 12:05pm ET | By Karen Cheung

To the dismay of the corporate C-suite, federal enforcers are tackling healthcare fraud by targeting the top executives of healthcare enterprises, nursing homes, drug companies and medical device manufactures.

To prevent repeat offenses, the federal government, including the Food and Drug Administration and the Justice Department, is laying down the law and increasing penalties. In addition to the standard fines normally associated with settling fraud, corporate executives are facing criminal charges and exclusions from government health programs, according to the Associated Press.

"When you look at the history of healthcare enforcement, we've seen a number of Fortune 500 companies that have been caught not once, not twice, but sometimes three times violating the trust of the American people, submitting false claims, paying kickbacks to doctors, marketing drugs which have not been tested for safety and efficacy," said Lewis Morris, chief counsel for the inspector general of the Health and Human Services Department.

The idea of targeting select individuals for wrongs committed by an organization is based on the Park Doctrine, a 1975 Supreme Court ruling in which a company president was held accountable for corporate noncompliance.

Medicare fraud costs taxpayers $60 billion each year, according to the AP.

Read more: Feds hold execs accountable for health fraud - FierceHealthcare http://www.fiercehealthcare.com/sto...untable-health-fraud/2011-05-31#ixzz1Nxh0QUyf
Subscribe: http://www.fiercehealthcare.com/signup?sourceform=Viral-Tynt-FierceHealthcare-FierceHealthcare
 






Federal law enforcers aim their scopes at top health care executives
May 31, 2011 by MassDevice staff

The FDA targets executives when corporations get caught behaving badly.

MASSDEVICE ON CALL — Corporate heads at medical device manufacturers and other major health care enterprises are at increasing risk of criminal prosecution when corporations that work with Medicare and Medicaid get caught breaking the rules.

It used to be that corporations were held solely responsible in cases of health care fraud, such as submitting false claims, paying kickbacks to doctors, or marketing drugs not cleared for safety and efficacy. The company paid a hefty fine and everyone moved on.

In a growing trend, health care executives could face criminal charges and may be banned from doing business with government health programs, a potential a career-killer.

The feds say they are using tools that were already in the books but never used, taking action against repeat offenders that are costing taxpayers billions, the Washington Post reported. Health care fraud costs taxpayers $60 billion per year by some estimates, according to the Post.

Some worry that the new measures take too heavy a hand, handing down radical punishments to individuals whose guilt isn't clear, according to the Post.

“Life sciences and medical devices have become a minefield with regard to regulation and prosecution by the FDA,” said civil liberties attorney Harvey Silverglate at a Massachusetts Institute of Technology discussion about federal prosecution of health care executives in April. “It’s an extraordinarily dangerous environment that you can’t believe until they come knocking at your door.”

Silverglate cautioned executives to keep all electronic communications, maintain detailed records of actions and intentions during all stages of product development, and never talk to federal investigators without a lawyer present.

Medical data breaches leave many concerned

More than 300 hospitals, doctors and insurance companies have reported significant breaches of medical privacy in just the last couple years, the New York Times reported, a problem that could impede President Obama's efforts to shift medical records to electronic form.

The breaches amount to at least 7.8 million individual records improperly exposed.

In one case 1.7 million records belonging to patients, staff members, contractors and suppliers in Bronx hospitals and clinics operated by the Health and Hospitals Corp. were stolen from an unlocked van, according to the Times.

"The health care industry is not as vigilant as they should be about protecting private information in a patient's medical records," Rep. Joe Barton (R-Texas) told the Times. Barton is co-chairman of the Bipartisan Privacy Caucus in the House.

Barton's personal records were among those reported missing alongside thousands others from a research project at the National Institutes of Health after a disk containing the information was stolen from the trunk of a car.

Electronic prescriptions display mixed results in 12-month study

Federal incentives have health care providers rushing to switch to new electronic health care systems, but a new study found that certain types of prescribing errors became more frequent during the transition, the Wall Street Journal's Health Blog reported.

Researchers followed 17 physicians at an outpatient clinic as it switched to a new system for electronic medical records. Prescribing errors decreased overall, dropping from 35.7 errors per 100 prescriptions to 12.2 errors after one year. But errors such as mistakes in directions and frequency were higher at 12 weeks than before the system was put in place, and some errors occurred even more frequently after a year, the Health Blog reported.

The study appears in the Journal of General Internal Medicine.

Contrary to accepted wisdom, Medicare beneficiaries who spend more on medical treatment have better health outcomes, according to a new study from George Mason University and the Urban Institute. Researchers analyzed data from more than 17 thousand Medicare recipients and found that those who spent 10 percent more on medical care scored 1.9 percent higher on patient health scores and had a 1.5 percent greater survival probability.
 






Anonymous said:
Federal law enforcers aim their scopes at top health care executives
May 31, 2011 by MassDevice staff

The FDA targets executives when corporations get caught behaving badly.

MASSDEVICE ON CALL — Corporate heads at medical device manufacturers and other major health care enterprises are at increasing risk of criminal prosecution when corporations that work with Medicare and Medicaid get caught breaking the rules.

It used to be that corporations were held solely responsible in cases of health care fraud, such as submitting false claims, paying kickbacks to doctors, or marketing drugs not cleared for safety and efficacy. The company paid a hefty fine and everyone moved on.

In a growing trend, health care executives could face criminal charges and may be banned from doing business with government health programs, a potential a career-killer.

The feds say they are using tools that were already in the books but never used, taking action against repeat offenders that are costing taxpayers billions, the Washington Post reported. Health care fraud costs taxpayers $60 billion per year by some estimates, according to the Post.

Some worry that the new measures take too heavy a hand, handing down radical punishments to individuals whose guilt isn't clear, according to the Post.

“Life sciences and medical devices have become a minefield with regard to regulation and prosecution by the FDA,” said civil liberties attorney Harvey Silverglate at a Massachusetts Institute of Technology discussion about federal prosecution of health care executives in April. “It’s an extraordinarily dangerous environment that you can’t believe until they come knocking at your door.”

Silverglate cautioned executives to keep all electronic communications, maintain detailed records of actions and intentions during all stages of product development, and never talk to federal investigators without a lawyer present.

Medical data breaches leave many concerned

More than 300 hospitals, doctors and insurance companies have reported significant breaches of medical privacy in just the last couple years, the New York Times reported, a problem that could impede President Obama's efforts to shift medical records to electronic form.

The breaches amount to at least 7.8 million individual records improperly exposed.

In one case 1.7 million records belonging to patients, staff members, contractors and suppliers in Bronx hospitals and clinics operated by the Health and Hospitals Corp. were stolen from an unlocked van, according to the Times.

"The health care industry is not as vigilant as they should be about protecting private information in a patient's medical records," Rep. Joe Barton (R-Texas) told the Times. Barton is co-chairman of the Bipartisan Privacy Caucus in the House.

Barton's personal records were among those reported missing alongside thousands others from a research project at the National Institutes of Health after a disk containing the information was stolen from the trunk of a car.

Electronic prescriptions display mixed results in 12-month study

Federal incentives have health care providers rushing to switch to new electronic health care systems, but a new study found that certain types of prescribing errors became more frequent during the transition, the Wall Street Journal's Health Blog reported.

Researchers followed 17 physicians at an outpatient clinic as it switched to a new system for electronic medical records. Prescribing errors decreased overall, dropping from 35.7 errors per 100 prescriptions to 12.2 errors after one year. But errors such as mistakes in directions and frequency were higher at 12 weeks than before the system was put in place, and some errors occurred even more frequently after a year, the Health Blog reported.

The study appears in the Journal of General Internal Medicine.

Contrary to accepted wisdom, Medicare beneficiaries who spend more on medical treatment have better health outcomes, according to a new study from George Mason University and the Urban Institute. Researchers analyzed data from more than 17 thousand Medicare recipients and found that those who spent 10 percent more on medical care scored 1.9 percent higher on patient health scores and had a 1.5 percent greater survival probability.
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Look out DK.
 






AstraZeneca Pays $250K For Sex Discrimination

AstraZeneca will pay $250,000 to 124 women who were subjected to pay discrimination while working at an office in Wayne, Pennsylvania, according to the US Department of Labor, which filed a lawsuit last year alleging the drugmaker discriminated against female sales reps by paying them salaries that were, on average, $1,700 less than their male counterparts.

The department’s Office of Federal Contract Compliance Programs conducted a scheduled compliance review of the business center in 2002 and found that AstraZeneca had violated Executive Order 11246 by failing to meet its obligations as a federal contractor to ensure employees were paid fairly without regard to sex, race, color, religion and national origin (read the lawsuit). AstraZeneca holds a contract valued at more than $2 billion with the US Department of Veterans Affairs to provide drugs to hospitals nationwide.

“Forty-eight years after President Kennedy signed the Equal Pay Act, women are still fighting for fundamental fairness when it comes to how we are paid,” OFCCP director Patricia Shiu, a member of President Obama’s National Equal Pay Enforcement Task Force, says in a statement. “I am glad AstraZeneca finally has agreed to pay its employees what they’ve earned. More importantly, we look forward to working with the company’s management to make sure this does not happen again to anyone who works for AstraZeneca.”

Under a consent decree, the drugmaker also agreed to conduct a statistical analysis of the base pay of 415 individuals employed full time as “primary care” and “specialty care” level III sales specialists in Alabama, Delaware, Indiana, Kentucky, Maryland, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Tennessee, Virginia, West Virginia and the District of Columbia. If the analysis concludes that female employees continue to be underpaid, salaries will be adjusted, DOL states (you can read the consent decree and order here).

Finally, AstraZeneca has agreed to develop and annually update its affirmative action plan and keep all supporting documentation as required by law. If the company fails to comply with the consent decree, it may be subject to sanctions, including cancellation of its current federal contract and debarment from acquiring future ones.

An AstraZeneca spokesman sends us this statement: “We reached this agreement to resolve the matter without further legal proceedings. We are confident that our compensation practices then and now are fair and non-discriminatory – and this settlement supports our position.”
 












Anonymous said:
SEC May Let Whistle-blowers Bypass Internal Complaint Systems
By Jesse Hamilton - May 25, 2011 9:30 AM ET

The U.S. Securities and Exchange Commission may let corporate whistle-blowers collect as much as 30 percent of penalties for reporting financial wrongdoing even when they bypass companies’ internal complaint systems.

SEC commissioners are scheduled to take a final vote on the measure, part of the agency’s rulemaking under the Dodd-Frank Act, at a meeting in Washington today.

Companies had asked the SEC to require whistle-blowers to report problems though internal compliance programs before going to the agency. While rejecting that approach, the SEC increased incentives for using internal systems by permitting bounties for people whose tips are passed on to the agency and expanding the time window in which employees can maintain their place in line at the SEC while reporting to the company first.

“The door is opening for a new chapter in corporate compliance,” Thomas Borgers, a managing director of Mesirow Financial Consulting, said in an interview. “The more they listen to their employees and respond to the needs of the employees, I think they’ll do very well.”

The Dodd-Frank Act called for the SEC to establish the bounty system, which has been active since the regulatory overhaul was enacted in July. The commission, which proposed the rule in a unanimous vote on Nov. 3, was directed to overhaul the rules after being faulted for fumbling tips about Bernard Madoff’s multibillion-dollar fraud.
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Did it pass?
 






How to encourage the right kind of whistleblowers

June 15, 2011: 12:15 PM ET


Dodd-Frank critics argue that offering larger payouts for whistleblowers will cause an uptick in financially-motivated tips, but the concerns are misguided.

By Eleanor Bloxham, contributor


SEC headquarters in Washington, D.C.

FORTUNE -- Following in the footsteps of other agencies with successful bounty programs like the IRS, the Dodd-Frank Act has required the SEC to implement protections for whistleblowers and payments of what could be large sums for valuable information related to corporate fraud. While the SEC has been offering these protections and rewards since the Dodd-Frank Act's passage, on May 25, the SEC established rules that will govern these procedures going forward.

Today, most companies have internal mechanisms that allow employees to blow the whistle. For these systems to work, however, companies need to understand what motivates employees to report wrongdoing internally. And because of the SEC's new whistle blower program, this is needed now more than ever before.

In response to the new whistleblower requirements, the Greek chorus of Dodd-Frank naysayers stepped forward to lament, "The sky is falling," as is so often the case with each new Dodd-Frank rule requirement.

"Employees will go for the money" the chorus says. "The bounties provide too much of an incentive. Instead of using corporate whistle blower programs, they'll go to the SEC. Employees should be forced to use internal channels first."

Responding to these concerns, the SEC's new procedures will offer individuals even greater sums if they go through internal corporate channels first and lesser sums if they do not, providing added encouragement for internal reporting as a first step.

But is the Greek chorus right? Has the offer of large payouts lead to a big uptick in reports to the SEC?

Since Dodd-Frank's passage, John Nester, SEC spokesperson says the rate of new tips hasn't increased from "the 100 a day the SEC has always received." The quality of the information SEC is receiving, however, has changed for the better, Nester says.

Higher quality information could mean that tips may be coming from individuals with more access to the details of potential wrongdoing, and perhaps people in higher positions of authority within a given company.

Is money the motive? While the Greek chorus may be correct that bounties have an impact, a closer look reveals that this motivation does not apply equally to all whistleblowers.

Recent research by University of San Diego law professor Orly Lobel shows that protections to the whistleblower can be just as, if not more, important than monetary rewards to some employees. Lobel says that, on average, women are more likely to the blow the whistle than men, and for women, small monetary payments will actually "crowd out" their desire to report wrongdoing.

What women do care about (and more than men) are protections if they do decide to blow the whistle; they seek social support, Lobel says. In addition, women prefer to not confront the offender or offenders directly. In other words, safety is an important factor for women considering whether and how to blow the whistle.

For corporations reassessing their internal programs with an eye to making them the first-choice destination for those with relevant information, it is important to understand the range of motivations in detail rather than make blanket assumptions about the impact of monetary rewards.

The new procedures for the whistle blowing program provide a number of assists in encouraging employees to choose internal whistle blowing first, in addition to the added monetary benefits. "The whistleblower who had first reported internally will be considered the first whistleblower who came to the Commission," as long as they subsequently report to the SEC within 120 days, the new rules state. By reporting internally, whistleblowers increase their odds of receiving an award.

All of this is a real win for corporations who want employees to use internal mechanisms to report wrongdoing.

Still, corporations and boards will need to consider the impact of lack of job mobility and worker dissatisfaction in addressing this complex issue.

Regarding SEC matters, the more boards can establish a culture of accountability, particularly at the top, the less employees will view reporting to the SEC as their only alternative to correct the wrongs. (Corporate fraud, the purview of the SEC, often involves actions by individuals at the very top of organizations.)

If there is real, ongoing concern at corporations, watch and see what innovations companies and boards will be making in their corporate cultures from top to bottom. If this is an issue of real concern, corporations will be renewing efforts to do all they can to prevent situations that require whistle blowing in the first place. And they'll be taking actions to ensure that, should a real problem arise, that they know first, can move quickly to address issues, and can self-report to the SEC rather than create incentives for employees to report solely to the SEC instead.

If the Greek chorus' lament is simply talk, expect no action at all.
 
























Anonymous said:
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

What would you like to do?

►

Report a Concern


►

Follow Up on a Reported Concern

This website is operated by Global Compliance, a third-party provider. This is not an emergency service.
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HOw long does it take to get an answer from them?
 






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?
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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.
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I don't know how DK would look in an orange jumpsuit.
 






Boston Scientific to Pay $9.25 Million in Whistleblower Case
...
Boston Scientific Corp. (BSX)’s Guidant LLC unit will pay $9.25 million to settle a whistleblower’s claim that the company over-billed the U.S. and private hospitals for heart pacemakers and defibrillators.

The U.S. Justice Department said today that the accord ends a lawsuit filed against Guidant by a former sales agent, Robert A. Fry, in federal court in Nashville, Tennessee. He will receive more than $2.3 million from the settlement.

Guidant allegedly reneged on credits owed to the U.S. Department of Veterans Affairs for replacement of units still under warranty and is accused of over-charging hospitals for the devices, causing them to over-bill Medicare, according to an e-mailed statement from the Justice Department.

“Overcharging for lifesaving medical devices wastes taxpayer dollars,” Assistant U.S. Attorney General Tony West said in the statement.

Fry worked for Guidant in Tennessee and Kentucky from 1981 to 1997 according to a revised complaint filed with the court in 2006. His lawsuit was filed under the federal False Claims Act.

“Boston Scientific has denied the allegations but is pleased this settlement resolves all claims in the case,” Denise Kaigler, a senior vice president and spokeswoman for the Natick, Massachusetts-based company, said in an e-mailed statement.

The case is U.S. ex rel. Fry v. Guidant Corp., 03-cv-842, U.S. District Court, Middle District of Tennessee (Nashville).
 






Anonymous said:
Boston Scientific to Pay $9.25 Million in Whistleblower Case
...
Boston Scientific Corp. (BSX)’s Guidant LLC unit will pay $9.25 million to settle a whistleblower’s claim that the company over-billed the U.S. and private hospitals for heart pacemakers and defibrillators.

The U.S. Justice Department said today that the accord ends a lawsuit filed against Guidant by a former sales agent, Robert A. Fry, in federal court in Nashville, Tennessee. He will receive more than $2.3 million from the settlement.

Guidant allegedly reneged on credits owed to the U.S. Department of Veterans Affairs for replacement of units still under warranty and is accused of over-charging hospitals for the devices, causing them to over-bill Medicare, according to an e-mailed statement from the Justice Department.

“Overcharging for lifesaving medical devices wastes taxpayer dollars,” Assistant U.S. Attorney General Tony West said in the statement.

Fry worked for Guidant in Tennessee and Kentucky from 1981 to 1997 according to a revised complaint filed with the court in 2006. His lawsuit was filed under the federal False Claims Act.

“Boston Scientific has denied the allegations but is pleased this settlement resolves all claims in the case,” Denise Kaigler, a senior vice president and spokeswoman for the Natick, Massachusetts-based company, said in an e-mailed statement.

The case is U.S. ex rel. Fry v. Guidant Corp., 03-cv-842, U.S. District Court, Middle District of Tennessee (Nashville).
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How much did the UPI rep make?
 






























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