Princess Health and New York Hospital Settles Fraud Charges Twice in Six Years. Princessiccia

Princess Health and New York Hospital Settles Fraud Charges Twice in Six Years. Princessiccia

fraud Staten Island University Hospital

Gusty 11:57 Add Comment

From the NY Times, Staten Island University Hospital has agreed to pay $76.5 million to settle claims that it fraudulantly billed the state's Medicaid program. This is the second time the hospital has been charged with over-billing Medicaid. In 1999, it paid Medicaid $45 million and agreed to provide free care worth $39 million to settle previous claims. New York Attorney General Elliot Spitzer also issued a criminal complaint against the hospital, but dismissed it in response to the settlement. Spitzer noted "the magnitude and depth of this fraud, and the willingness of the leadership there to tolerate it, was unusual."
The hospital was charged with billing Medicaid for clinic services at a higher rate allowed for clinics that are open only part-time, while it ran the clinics full-time. It was also charged with lying on state financial reports. The investigation found that the hospital had real-estate contracts with a doctor who was allegedly an associate of the Gambino crime family.
Hospital executives who were warned by their lawyer and the Department of Health, CEO Americo Varone, Executive Vice President Joseph Pisani, and Senior Vice President James Walsh, have left the hospital.
The hospital released a statement that "we deeply regret and are embarassed by the misconduct carried out by former executives of the hospital that led to this settlement."
This is just a reminder that pharmaceutical companies are hardly the only health care organizations accused of misconduct, nor are they necessarily responsible for the worst misconduct in health care.

Princess Health and New York Hospital Settles Fraud Charges Twice in Six Years.Princessiccia

Princess Health and New York Hospital Settles Fraud Charges Twice in Six Years.Princessiccia

fraud Staten Island University Hospital

Gusty 11:57 Add Comment

From the NY Times, Staten Island University Hospital has agreed to pay $76.5 million to settle claims that it fraudulantly billed the state's Medicaid program. This is the second time the hospital has been charged with over-billing Medicaid. In 1999, it paid Medicaid $45 million and agreed to provide free care worth $39 million to settle previous claims. New York Attorney General Elliot Spitzer also issued a criminal complaint against the hospital, but dismissed it in response to the settlement. Spitzer noted "the magnitude and depth of this fraud, and the willingness of the leadership there to tolerate it, was unusual."
The hospital was charged with billing Medicaid for clinic services at a higher rate allowed for clinics that are open only part-time, while it ran the clinics full-time. It was also charged with lying on state financial reports. The investigation found that the hospital had real-estate contracts with a doctor who was allegedly an associate of the Gambino crime family.
Hospital executives who were warned by their lawyer and the Department of Health, CEO Americo Varone, Executive Vice President Joseph Pisani, and Senior Vice President James Walsh, have left the hospital.
The hospital released a statement that "we deeply regret and are embarassed by the misconduct carried out by former executives of the hospital that led to this settlement."
This is just a reminder that pharmaceutical companies are hardly the only health care organizations accused of misconduct, nor are they necessarily responsible for the worst misconduct in health care.

Princess Health and "Medical Journal Are an Extension of the Marketing Arm of Pharmaceutical Companies". Princessiccia

Princess Health and "Medical Journal Are an Extension of the Marketing Arm of Pharmaceutical Companies". Princessiccia

manipulating clinical research

Gusty 11:06 Add Comment

In the latest PLoS Medicine is an article by Richard Smith, former editor of the British Medical Journal, with a title which expresses his main point, "Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies."
Smith charged that pharmaceutical companies use publication of randomized controlled trial as a marketing tool. His most important contention is that they do so not by publishing poor quality trials or false data, but by designing trials so they are particularly likely to produce results favorable for the companies' products. Each article may be "one piece of a gigantic and clever marketing jigsaw." He listed the following tactics that pharmaceutical companies may use to increase the likelihood that each trial produces favorable results:

• Conduct a trial versus a treatment known to be inferior
• Use a dosage of the comparison drug that is too low (so it won't work), or too high (so it will have side effects)
• Keep the trial too small to have enough power to show the comparison drug is better
• Use multiple endpoints in the trial, but pick the one that shows a favorable result
• Do multi-center trials, but use only results from the centers with favorable outcomes for the product
• Do multiple sub-group analysis, but only publish those with favorable results
• Frame results for maximum effect, e.g., present relative, not absolute risk

Smith acknowledged that pharmaceutical companies rarely have resorted to suppressing research, but that this is rarely "necessary" since it is usually easy to assure favorable results with the tactics above. Also note that this article was apparently written before the deceptive practice of ghost-writing received more attention (as we noted here.)
His proposed solutions included public funding of trials, especially of the most prominent treatments available for a particular condition. Furthermore, he suggests publishing trials not in journals, but on "regulated" web sites.
My comments:

• Smith's list of tactics to improve the likelihood of favorable trial results is an important summation. But if these are the only tactics we must combat, the solution does not seem so difficult. A reviewer well-trained in the precepts of evidence-based medicine should be able to detect most of these tactics. Pushing for more stringent peer review by better trained reviewers might be enough to solve this problem. Underlying this could be a wider effort to train physicians and researchers in EBM.
• However, I fear that there is more outright dishonesty out there than Smith acknowledged. Some was of the sort demonstrated in the recent ghost-writing stories. (See our posts here, here, here, here and here.) (Also, see a BMJ article which Smith cited that cataloged similar deceptive tactics used by pharmaceutical companies when marketing drugs in Australia.) Combating such dishonesty will require a more active approach.
• Furthermore, one can draw further parallels between dishonest marketing tactics used by pharmaceutical companies and dishonest or unethical practics that have been springing up all over the health care spectrum. Scrolling throught the Health Care Renewal archives ought to show that leaders of all sorts of health care organizations, hospitals and health care systems; managed care organizations and insurers; medical schools and universities; government agencies; not-for-profits; etc., etc., etc have been caught acting unethically or dishonestly. This suggests that improving health care will require a more broadly based effort directed at all kinds of health care organizations and their leadership.
• Finally, marketing can be defined in a rather neutral was as "the process or technique of promoting, selling, and distributing a product or service" (by Webster's Collegiate Dictionary). Yet Smith's article (and some of his quotes from books by Angell and Kassirer) suggest that the word as acquired a more malev0lent tinge, especially in the pharmaceutical context. This suggests we ought to question why this has happened.

Princess Health and "Medical Journal Are an Extension of the Marketing Arm of Pharmaceutical Companies".Princessiccia

Princess Health and "Medical Journal Are an Extension of the Marketing Arm of Pharmaceutical Companies".Princessiccia

manipulating clinical research

Gusty 11:06 Add Comment

In the latest PLoS Medicine is an article by Richard Smith, former editor of the British Medical Journal, with a title which expresses his main point, "Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies."
Smith charged that pharmaceutical companies use publication of randomized controlled trial as a marketing tool. His most important contention is that they do so not by publishing poor quality trials or false data, but by designing trials so they are particularly likely to produce results favorable for the companies' products. Each article may be "one piece of a gigantic and clever marketing jigsaw." He listed the following tactics that pharmaceutical companies may use to increase the likelihood that each trial produces favorable results:

• Conduct a trial versus a treatment known to be inferior
• Use a dosage of the comparison drug that is too low (so it won't work), or too high (so it will have side effects)
• Keep the trial too small to have enough power to show the comparison drug is better
• Use multiple endpoints in the trial, but pick the one that shows a favorable result
• Do multi-center trials, but use only results from the centers with favorable outcomes for the product
• Do multiple sub-group analysis, but only publish those with favorable results
• Frame results for maximum effect, e.g., present relative, not absolute risk

Smith acknowledged that pharmaceutical companies rarely have resorted to suppressing research, but that this is rarely "necessary" since it is usually easy to assure favorable results with the tactics above. Also note that this article was apparently written before the deceptive practice of ghost-writing received more attention (as we noted here.)
His proposed solutions included public funding of trials, especially of the most prominent treatments available for a particular condition. Furthermore, he suggests publishing trials not in journals, but on "regulated" web sites.
My comments:

• Smith's list of tactics to improve the likelihood of favorable trial results is an important summation. But if these are the only tactics we must combat, the solution does not seem so difficult. A reviewer well-trained in the precepts of evidence-based medicine should be able to detect most of these tactics. Pushing for more stringent peer review by better trained reviewers might be enough to solve this problem. Underlying this could be a wider effort to train physicians and researchers in EBM.
• However, I fear that there is more outright dishonesty out there than Smith acknowledged. Some was of the sort demonstrated in the recent ghost-writing stories. (See our posts here, here, here, here and here.) (Also, see a BMJ article which Smith cited that cataloged similar deceptive tactics used by pharmaceutical companies when marketing drugs in Australia.) Combating such dishonesty will require a more active approach.
• Furthermore, one can draw further parallels between dishonest marketing tactics used by pharmaceutical companies and dishonest or unethical practics that have been springing up all over the health care spectrum. Scrolling throught the Health Care Renewal archives ought to show that leaders of all sorts of health care organizations, hospitals and health care systems; managed care organizations and insurers; medical schools and universities; government agencies; not-for-profits; etc., etc., etc have been caught acting unethically or dishonestly. This suggests that improving health care will require a more broadly based effort directed at all kinds of health care organizations and their leadership.
• Finally, marketing can be defined in a rather neutral was as "the process or technique of promoting, selling, and distributing a product or service" (by Webster's Collegiate Dictionary). Yet Smith's article (and some of his quotes from books by Angell and Kassirer) suggest that the word as acquired a more malev0lent tinge, especially in the pharmaceutical context. This suggests we ought to question why this has happened.

Princess Health and FBI Can't Account for its Budget to Fight Health Care Fraud. Princessiccia

Princess Health and FBI Can't Account for its Budget to Fight Health Care Fraud. Princessiccia

Gusty 11:59 Add Comment

The NY Times reports that the US Federal Bureau of Investigation (FBI) has been unable to account how it spent money allocated to investigate health care fraud. A 1996 law set aside money for the agency to address fraud against Medicare, Medicaid, and other federal health programs. But in response to a request from Sen. Charles E. Grassley (R-Iowa), the Government Accountability Office found that the FBI "had no effective mechanism in place" to ensure its own compliance with the 1996 law. It also claimed that FBI agents were shifted from addressing health care fraud to counter-terrorism after Sept. 11, 2001. Grassley responded, "It's inexcusable that the government cannot account for millions of dollars set aside to fight health care fraud."
It's sadly ironic that a program meant to fight white-collar financial crime cannot account for its own financing of this effort.
This does seem to fit the disturbing pattern we have noted again and again on Health Care Renewal. "The anechoic effect" is the label Russ Maulitz gave to the silence and indifference with which the mismanagement, or even outright corruption of health care organizations is greeted.
At least the FBI seemed a bit sheepish about how it has been dealing with health care fraud. Its chief financial officer claimed that it is now "one of its top white-collar criminal investigative priorities." We look forward to the echoes.

Princess Health and FBI Can't Account for its Budget to Fight Health Care Fraud.Princessiccia

Princess Health and FBI Can't Account for its Budget to Fight Health Care Fraud.Princessiccia

Gusty 11:59 Add Comment

The NY Times reports that the US Federal Bureau of Investigation (FBI) has been unable to account how it spent money allocated to investigate health care fraud. A 1996 law set aside money for the agency to address fraud against Medicare, Medicaid, and other federal health programs. But in response to a request from Sen. Charles E. Grassley (R-Iowa), the Government Accountability Office found that the FBI "had no effective mechanism in place" to ensure its own compliance with the 1996 law. It also claimed that FBI agents were shifted from addressing health care fraud to counter-terrorism after Sept. 11, 2001. Grassley responded, "It's inexcusable that the government cannot account for millions of dollars set aside to fight health care fraud."
It's sadly ironic that a program meant to fight white-collar financial crime cannot account for its own financing of this effort.
This does seem to fit the disturbing pattern we have noted again and again on Health Care Renewal. "The anechoic effect" is the label Russ Maulitz gave to the silence and indifference with which the mismanagement, or even outright corruption of health care organizations is greeted.
At least the FBI seemed a bit sheepish about how it has been dealing with health care fraud. Its chief financial officer claimed that it is now "one of its top white-collar criminal investigative priorities." We look forward to the echoes.

Princess Health and A Scathing Commentary on California's New Institute for Regenerative Medicine. Princessiccia

Princess Health and A Scathing Commentary on California's New Institute for Regenerative Medicine. Princessiccia

California Institute for Regenerative Medicine ill-informed management

Gusty 11:40 Add Comment

The Los Angeles Times included a scathing commentary on California's new stem cell research agency. Author Michael Hitzik charged that "the California Institute for Regenerative Medicine has behaved not like the state agency it is, but with the arrogance of a private corporation that happens to be playing with the taxpayers' cash." Hitzik charged that the agency has not yet developed ethical rules or financial disclosure requirements, but it has hired a private lobbying firm, "perhaps the only state agency that pays an outside lobbyist to battle the Legistlature." In addition, Hitzik alleged that the chairman of the agency, "Bay Area real estate developer Robert Klein II.... often seems to assume that anyone who criticizes himself of his agency must be fanatically hostile to embryonic stem cell research, or worse." Furthermore, in challenging lawsuits filed against the agency, Klein claimed that "over half of all California families ... have a member who might benefit from stem cell research." Since no one yet knows what the practical outcomes of stem cell research will be, this claim about how many people will benefit from it is obviously unsubstantiated, and thus is not the sort of claim that should be made by the head of a biomedical research organization. Finally, Hitzik claimed that the Institute "seems determined to start issuing grants within the next few months, possibly before it has in place an operational budget, a full sheaf of ethical standards and conflict-of-interest rules, or, indeed, bond money."
This appears not to be an auspicious start for the leadership of this Institute.