Legal Settlements Have Become So Common that They are Barely News

Legal settlements by big health care organizations have become so common that those of less than blockbuster size barely seem to qualify as news.  They have become "dog bites man" stories.  For example, the following stories barely got noticed in the media (presented chronologically).

Novartis Settles Price Misrepresentation Suit for $150 Million

This story was mentioned as an aside in a a news story covering a settlement by Watson Pharmaceuticals in September.  In slightly more detail, it has only appeared in PharmaLot in November.  In a very small nutshell,

the Sandoz unit of Novartis earlier this week agreed to pay $150 million to settle lawsuits filed by the states of Florida and California, as well as a whistleblower, to settle charges that it deliberately misreported pricing information in order to hike reimbursements from Medicaid.

By the way, per the settlement document, the allegations were that Novartis' subsidiary knowingly maintained, set or reported "false, fraudulent, and/or inflated Reported Prices," yet, as is typical of nearly all settlements, the settlement "shall not constitute or be construed as an admission of fault, liability, or unlawful conduct."

Roche Settles Off-Label Promotion, Physician Kickback Suit for $20 Million

This story was reported briefly in some blogs, including again PharmaLot, and in the most detail in the San Francisco Business Times. The basics of it were:

Genentech Inc. will pay $20 million to settle a whistleblower lawsuit around off-label marketing of the cancer-fighting drug Rituxan.

It only took eight years since a whistle-blower raised the issue:

John Underwood, ... was a senior manager of sales development from the start of Genentech’s oncology franchise in 1997.

When Underwood filed the suit in July 2003 in U.S. District Court for the Eastern District of Pennsylvania, he was a senior hospital systems specialist for Genentech.

This suit is actually of particular interest because it was not just about off-label promotion,

Genentech, the suit claimed, retained doctors to act as independent speakers on behalf of Rituxan and its off-label uses, paid kickbacks to doctors that were disguised as consulting payments, 'exerted significant pressure' on sales reps to increase off-label uses of Rituxan, and devised and conducted 'selling skills workshops' for sales reps devoted to non-label uses,

What’s more, the suit claimed, Genentech invited doctors to attend “medical education seminars” at 'luxurious locations' and gave financial incentives to sales reps to get doctors who sold the most Rituxan to attend the events.

These were serious allegations, involving allegedly direct efforts by the company to subvert physicians' ethics by tying their decisions for individual patients to payments for prescribing specific products whatever the benefits and risks of those products for those patients.  The allegations suggested that "consulting payments" to physicians may be nothing more than disguised bribes, and that the companies making these payments may be quite conscious of this. 

Nonetheless, as usual,

Genentech, the South San Francisco-based U.S. subsidiary of Swiss drug giant Roche, did not admit wrongdoing....

So, as in the famous recent Citigroup case (see this post), the settlement obfuscates the crucial question, did the corporation involved commit illegal acts? It seems likely that what they did was in some sense unethical, since they were willing to pay millions not make the matter go away.

By the way, one member of the Executive Committee of Genentech at the time these events were allegedly occurring is now the Chancellor of the University of California - San Francisco (See our post here). Maybe concerned students or faculty might ask her what really went on.

CVS Caremark Settles Fraud Suit for about $20 Million

As reported briefly in the Los Angeles Times,

Pharmacy and prescription drug management company CVS Caremark Corp. has agreed to pay nearly $20 million to settle three lawsuits involving allegations that the company defrauded pension systems in three states, including California’s giant pension fund, attorneys said.

The whistleblower lawsuits, filed by two former CVS Caremark pharmacists, accused the company of reselling returned drugs, changing prescription orders to make them more expensive and submitting false reports about how long it took to fill prescriptions.

Not the least bit surprisingly, the company did not admit liability in the settlement, and had no comment for the Times. Ho, hum, another big company paying millions to make allegations of fraud go away... nothing to see here, so we will just move on.

Merck Settles Fraud Suit for $24 Million

This story was picked up by AP, so a very brief version of it did appear in a variety of locations. A longer version was published by the Boston Globe,

At this point, it should be no surprise that it took a long time to get to this settlement, eight years in fact, just as in the case above,

Merck & Co. has agreed to pay $24 million to the state Medicaid program to settle long-running civil charges that it charged too much for some drugs, in the largest single-case Medicaid fraud settlement in Massachusetts history.

The agreement, unveiled yesterday by Attorney General Martha Coakley’s office, closes out a 2003 lawsuit....

Again, the allegations were of fraud,

Coakley said her office’s Medicaid fraud division wanted to hold accountable drug companies that defraud taxpayers.

Again, "hold accountable" did not translate into establish the allegations as true,

Ron Rogers, a spokesman at Merck corporate headquarters, said the drug company did not admit liability or wrongdoing in the settlement. He said Merck agreed to resolve the claims to put the matter behind it.

Nothing more to see here, so we will move on again.
Summary

Every month, it seems that more settlements are announced of cases alleging all sorts of wrongdoing by major health care organizations. Very often, the allegations are of wrongdoing that appears serious to the uninitiated. For example, most of the above cases involved allegations of fraud, and one involved allegations of kickbacks, that is, bribes to doctors.

Yet, in every one of these cases -
- The monetary penalties were barely more than pocket change for the corporations involved.
- The payments were made by the organization as a whole, and hence would disadvantage many people who were not involved in and did not benefit from the specific actions alleged. Such de facto victims of the settlement included company shareholders, employees, and probably patients (who may have paid prices raised to pay for settlements), and the public (who may have indirectly paid these higher prices through insurance premiums or taxes.)
- The organization did not have to admit any facts, leaving the record foggy, and clouding the chances for any people who might have been hurt by the actions to take legal action.
- No people who actually authorized, directed, or implemented the apparent bad behavior suffered any negative consequences.

Thus, these settlements, like many others we have discussed, did not appear to be any major deterrent of future bad behavior.

These settlements do provide a public, if largely ignored, record that suggests how a miasma of sleazy behavior, if not outright corruption has settled over health care. These settlements do provide the context for many pithy questions that could be asked of health care organizational leaders, if anyone dared to do so. The settlements do suggest a need for wholesale, real health care reform that would make health care leaders accountable for what their organizations do, particularly when these organizations misbehave.

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Medtronic Settles, Yet Again

And the march of legal settlements continues... Circling around the block and coming in front of the viewing stand again is device manufacturer Medtronic. 

The Latest Medtronic Settlement

As Bloomberg reported:

Medtronic (MDT) Inc., the world’s biggest maker of heart rhythm devices, agreed to pay $23.5 million to settle claims it paid kickbacks to doctors who implanted its pacemakers and defibrillators in patients, the U.S. Justice Department said in a statement.

Medtronic agreed yesterday to settle two lawsuits filed in federal courts in California and Minnesota accusing the company of violating the federal False Claims Act by paying physicians $1,000 to $2,000 for each patient who was implanted with one of the company’s devices, according to the Justice Department.

'Patients who rely on their health-care providers to implant vital medical devices expect that those decisions will be made with the patients’ best interests in mind,' Tony West, assistant attorney general for the Justice Department’s Civil Division, said in an e-mailed statement. 'Kickbacks, like those alleged here, distort sound medical judgments with financial incentives paid for by the taxpayers.'

As usual, Medtronic did not admit doing anything wrong:

Medtronic said in an e-mailed statement that it makes no admissions that the studies were 'improper or unlawful.' The company also said it established a reserve for the anticipated payment in the fourth quarter of fiscal year 2011.

'We are happy that the investigation is behind us, so we can continue designing and executing clinical trials that generate evidence to improve patient care, outcomes and cost effectiveness,' Marshall Stanton, vice president of clinical research and reimbursement for the cardiac and vascular group....

Previous Legal Settlements by Medtronic
Note that this is not the first time Medtronic has been accused of paying doctors (kickbacks, this time, which seem to be the ethical equivalent of bribes) to use its products. The Bloomberg report also noted:

In 2006, Medtronic agreed to pay $40 million to settle allegations that its Sofamor Danek unit violated state laws and the False Claims Act by paying sham consulting fees and providing lavish trips to doctors who used its products from 1998 to 2003.

Perusing the Medtronic file on Health Care Renewal also showed that Medtronic has had to settle other lawsuits alleging misconduct:

- In 2008, Medtronic subsidiary Kyphon settled a suit for $75 million and signed a corporate integrity agreement for allegations that it defrauded Medicare through a scheme that lead to excessive hospitalization for patients who received the company's spine surgery device (link here)
- In 2010, Medtronic settled multiple civil lawsuits for $268 million for allegations that it marketed an implantable cardiac defibrillator with faulty leads whose failures lead to 13 deaths (link here)

Cases of Apparent Conflicts of Interest Generated by Medtronics' Payments
In fact, paging through the Medtronic file on Health Care Renewal, we also found these cases of apparent conflicts of interest that Medtronic caused by making payments to or otherwise creating financial relationships with:

- FDA advisory board members (2007 link here),
- health care professionals who appeared on public television programs about heart disease and treatments of it (2007 link here),
- members of a non-profit organization which was supposed to guide the FDA regarding drug development  (2007 link here),
- prominent academic orthopedic surgeons who were in positions to influence other physicians' choices of orthopedic devices (2008 link here and 2009 links here, here and here),
- a military surgeon who wrote questionable articles about the supposed virtues of a Medtronic bone growth product (2009 link here),
- a top leader of US Veterans Affairs Department who objected to the appointment of an industry critic as US Surgeon General (2010 link here),
- spine surgeons apparently who could promote Medtronics' spine surgery products in (2010 link here) and who did not disclose all such payments when writing ostensibly scholarly articles on the subject (2010 link here)

So prior to the current settlement for "alleged" kickbacks, Medtronic had a long history of allegations that it had financial relationships with physicians who were in a position to promote the use of its products or its policy interests.

Why the Bad Behavior Continues

The latest settlement by Medtronic illustrates why the anemic approach by US government agencies to health care corporate misbehavior does not deter bad behavior.

- The punishment was a fine not large enough to have any effect on the finances of the corporation.. Such a relatively small financial penalty might just be seen as a cost of doing business by company executives.  (See these comments on the current case by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.)
-  The punishment was not a result of any specific bad behavior.  In this case, like many others, the corporation did not have to admit to anything.  This leads to the paradox of a punishment meted out for apparently nothing other than "alleged" actions, making it appear that the actual punishment was just a payment by the company to allow it to continue the sorts of actions that were alleged with impunity.  (Such punishments without clear crimes happen all the time in cases affecting the finance sector.  See a federal judge's condemnation of this practice here.) 
-  The punishment seems unrelated to the corporation's historic behavior.  In this case, there was no reference to the company's previous settlements, or the other allegations of questionable payments to physicians and health care decision makers in other circumstances listed above.  (Keep in mind that Health Care Renewal strives to present interesting cases, but does not have the resources to report on every single case of bad behavior by health care organizations.  Hence the list above of apparent bad behavior may not be complete.)
-  The punishment applied to the corporation as a whole, and hence may disadvantage many people, stockholders and corporate employees in particular, who had nothing to do with the alleged bad behavior.  On the other hand, those who authorized, directed, or implemented the bad behavior were not subject to any negative consequences. 

So why on earth would corporate leaders cease bad behavior which could increase revenues short-term and hence increase their compensation (e.g., in 2011, the Medtronic CEO received $9,624,709 according to the 2011 proxy statement), when the likelihood of any negative consequences for them appears to be near zero? 

This would be bad enough if the bad behavior only causes financial disadvantage for stockholders or corporate employees.

However, the bad behavior in question seems to repeatedly involve paying physicians and other health care decision makers in ways likely to influence their decisions in favor of Medtronics' products and corporate well-being.  Making decisions this way, however, is unlikely to be good for patients' and the public's health, as it is likely to lead to excess use of expensive tests and treatments that may have adverse effects, sometimes severe.  Thus patients may suffer unnecessary morbidity and mortality, and the public at large may pay far too much for medical care.

So will we see in our lifetimes honest, tough policing of health care corporate behavior?  Will the punishments start to fit the crime, and will they be significant enough to deter future misbehavior?  Why do we continue to accept government actions that seem more solicitous of the executives of big corporations than the public for whose benefit government is supposed to be run?  Where is the outrage?   

So, once more, with feeling.... in my humble opinion, until the people responsible for the bad behavior experience negative consequences from that behavior, they will continue to perform, direct, and condone bad behavior. We will not achieve real health care reform in the US until we effectively deter unethical, self-serving behavior by leaders of health care organizations.

ADDENDUM (15 December, 2011) - On the GoozNews blog, Merrill Goozner called Medtronic's actions "a crime against science."

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Abbott Laboratories to Settle for $1.3 Billion Allegations Including Giving Doctors Kick-Backs and Training Them to Make False Diagnoses

It looks like the march of billion dollar legal settlements by health care organizations is on its way again. 

The Proposed Abbott Laboratories Settlement

Last month Bloomberg reported:

Abbott Laboratories (ABT) agreed to pay at least $1.3 billion to settle claims by the U.S. government and 24 states alleging the company illegally marketed its Depakote epilepsy drug, people familiar with the accords said.

Abbott executives, federal prosecutors and state officials reached a tentative agreement calling for the drugmaker to pay about $800 million to resolve civil claims over Depakote and about $500 million in criminal penalties for marketing the epilepsy medicine for unapproved uses, said three people familiar with the settlement who declined to be identified because the agreement hasn’t been made public. Abbott said earlier this week it was reserving $1.5 billion to cover costs of the potential settlement.

A billion here, and billion there, it begins to add up:

The settlement would be the third-largest illegal pharmaceutical marketing accord in U.S. history, behind the $2.3 billion Pfizer paid in 2009 over the marketing of its Bextra painkiller and other drugs and the $1.4 billion Eli Lilly & Co. paid the same year over sales of its Zyprexa anti-psychotic medicine.

Encouraging Dishonesty, Giving Kick-Backs

The Bloomberg report only briefly discussed the behavior by Abbott that lead to the settlement:

In February, the government joined cases brought by former Abbott employees alleging the company engaged in so-called off-label marketing starting in the late 1990s. The suits contend the illegal sales practices resulted in false claims being submitted to government health programs.

The whistle-blowers claim the drugmaker marketed Depakote for unapproved uses including agitation and aggression in patients with dementia, autism, sexual compulsion and other disorders.

However, an article published last week in the Chicago Tribune further described the allegations made by the whistle-blowers. In summary,

The lawsuits against Abbott allege that the company encouraged and trained sales reps to market Depakote off-label to nursing home directors, geriatric doctors and other long-term care facilities. The company also gave doctors illegal kickbacks to talk about off-label uses of the drug in an effort to boost sales, according to the lawsuits, which were filed in federal courts in Virginia, Illinois and the District of Columbia.

The FDA approved Depakote in 1983 to treat certain seizures in adults and children over 10. Since then, the drug has received approval for the treatment of other types of seizures, manic episodes of bipolar disorder and the prevention of migraine headaches.

However, Depakote was never approved to treat Alzheimer's disease or other types of dementia or for general treatment of bipolar disorder.

According to the whistle-blower lawsuits, though, Abbott sales reps specifically marketed Depakote to treat agitation and aggression associated with dementia.

One whistle-blower alleged that Abbott encouraged doctors to make false diagnoses that would enable the government to pay for the use of Depakote:

During a nationwide conference call in 2007, an Abbott trainer allegedly coached sales reps on how to explain to doctors that they could miscode a patient's illness in order to bypass federal regulations. For example, a physician could code a patient as having 'late onset of bipolar' or 'underlying seizure disorder' instead of 'agitation associated with dementia,' according to her complaint.

Abbott held training sessions focused on off-label promotion but brought in outside consultants and held the training away from its North Chicago headquarters.

At one training event, McCoyd and another sales representative allegedly were asked to share their techniques for off-label marketing but were forbidden from preparing or distributing any written materials about the topic.

Upper-level management who attended the sales training purposely left the room when the off-label training sessions began, according to the complaint.

The whistle-blowers also alleged that Abbott gave kick-backs (presumably the same idea as bribes) to doctors for prescribing Depakote:

The complaints also allege that doctors were given kickbacks to talk about off-label uses of Depakote.


According to McCoyd's filing, Abbott salespeople were given about $20,000 to $30,000 each year to 'educate' physicians and other heath care providers about off-label use of Depakote.

Abbott paid doctors who promoted the drug between $500 and $2000 per speech, the complaint states. The money allegedly was funneled through intermediaries and associations, including the Alzheimer's Association, although the association told the Tribune it has 'no knowledge' of such activities.

Using the organizations to pay doctors was done to 'disguise the direct payments to doctors and Abbott's substantial and direct involvement' in the events, the complaint alleges.

Summary

So it appears that Abbott is about to settle a case involving some very serious allegations, including training physicians to make false diagnoses, and giving physicians kick-backs. These sort of actions seriously subvert physicians' core values (and any physicians who made such false diagnoses or accepted such kick-backs would have seriously violated core ethical principles.)

These actions also may have directly harmed patients. There appears to be no good evidence that Depakote has benefits that exceed its harms for patients with dementia, autism, etc. So encouraging doctors to prescribe the medicine for these patients was likely to have subjected some patients to side-effects without providing them any benefit. That would contradict the physicians' obligations to put the interests of individual patients first, and to avoid harming them. As the Tribune article noted,

[Dr Adriane} Fugh-Berman, with PharmedOut, said companies put patients at risk when they promote drugs that haven't gone through the FDA's regulatory process.

'These drugs are being promoted for conditions they have not been shown to be effective, and they might be dangerous,' she said.

So a $1.3 billion penalty would actually be a cheap price to pay for such ethical offenses. Note that the Bloomberg report did mention "criminal penalties," so this may be one of the infrequent cases in which a big health care organization actually would plead guilty to some crime.

Note however that neither article mentioned anything about any individual who authorized, directed, or implemented the conduct in question suffering any negative consequence or paying any penalty. These reports are preliminary, so it may be that such penalties are part of the final settlement. But it is also possible that this settlement becomes another, and particularly flagrant example of health care corporate executive impunity.

If no one turns out to have to pay a penalty for training physicians to lie to the government, and giving them kick-backs to prescribe a possibly useless and likely harmful medicine, what will deter other executives from authorizing and directing such actions again to make more money? Note in the Bloomberg article:

Sales of Depakote 'rocketed to over $1.4 billion per year' as a result of improper marketing, according to a complaint filed in February by ex-Abbott sales representative Meredith McCoyd. 'Compensation for senior executives soared as well.'

Furthermore, if no one turns out to have to pay a penalty for these actions, this case will just contribute to the ongoing demoralization of health care professionals. It will be another example of how insiders take advantage of the system for their personal gain, to the disadvantage of patients, and at further cost to an already overly expensive health care system that fails to provide adequate access and quality care.

So I repeat, repeat, repeat... to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

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"Prepare Them to Die" - For-Profit Hospices as the Real Death Panels

A Bloomberg news investigative report illustrated the adverse effects of having for-profit corporations taking care of patients.

Hospice as a Social Movement

The corporations in question this time are for-profit hospices. Hospices in general gained a good reputation for improving the quality of life for patients near life's end:

Hospice got its start in the 1960s as a social movement. Volunteers, often meeting in schools and church basements, organized care so patients could die at home with loved ones, instead of at the hospital laced with tubes. Dame Cicely Saunders, the pioneering English physician who opened St. Christopher’s Hospice in London in 1967, fought traditional methods of unconditional resistance to death, and brought the concept to U.S. shores.

Hospices Become Commercial

Subsequently, in the US, every part of health care has become commercialized, including hospices:

hospice care has evolved from its charitable roots into a $14 billion business run mostly for profit,

In addition,

Of the hospices with two- thirds or more of their patients in nursing homes, 72 percent are for-profits.

Commercial Hospices Expand Their Markets: "Stop All the Live Discharges"

Hospices were originally meant to care for patients near death, however commercial hospices sought to expand their markets:

Providers have been accused of boosting their revenues with patients who aren’t near death and not eligible for hospice -- people healthy enough to live a long time with traditional medical care.

In particular,

Two-thirds of patients in hospices run for profit have general diagnoses like 'failure to thrive' and 'debility' compared to half in non-profits, which cater more to faster- killing conditions like cancer, a Harvard University study found earlier this year. Patients stay an average of 98 days in for- profit hospices versus 68 days at non-profits, which have a 0.2 percent profit margin, according to Medicare. The margin at for- profits is 50 times higher at 10 percent.

My comment is that "failure to thrive," and "debility" are not real diagnoses. At best, they are merely general descriptions of patients' conditions. Physicians have a hard enough time predicting the life span of patients with chronic, ultimately terminal, well-defined diseases, like specific types of metastatic cancer. How anyone can accurately predict the survival of patients who fail to thrive or exhibit debility is beyond me (and I have spent many years assessing the accuracy of physicians' predictions of a variety of outcomes, including the survival of critically ill patients, references provided on request).

So,

To be eligible for Medicare hospice coverage, a person must have a prognosis of six months or less to live, certified by two doctors. Yet 20 percent of hospice patients live beyond that term, with their providers receiving government checks via recertifications that can go on indefinitely.

One case cited by the Bloomberg article includes allegations that a for-profit hospice held on to patients even though it had become clear they were not at the end of life.

An executive of a hospice owned by Harden Healthcare LLC emailed managers in 2008 urging them to 'stop all these live discharges' of patients to keep enrollments high, according to a civil fraud complaint by the Justice Department in federal court in Kansas City, Kansas. Company spokeswoman Meg Meo said the alleged events occurred before Austin, Texas-based Harden owned the hospice.

A whistleblower lawsuit brought by a former social worker for hospices run by Atlanta-based Gentiva Health Services Inc. (GTIV) said her job was to talk people who weren’t dying into believing that they were. The allegations predated Gentiva’s ownership of the chain, spokesman Scott Cianciulli said.

Gentiva’s Odyssey hospice unit faces investigations by HHS’s Office of Inspector General and the state of Georgia, according to regulatory filings. The company, which is the second-largest hospice provider, is cooperating with investigators, Cianciulli said.

Furthermore,

Enrolling patients, retaining them as long as possible, and controlling costs are the top priorities at for-profit hospices, according to former and current employees interviewed by Bloomberg News. To increase revenues, hospices tie employee bonuses to enrollment, pay kickbacks to patients and referral sources, and use false diagnoses to admit ineligible patients, according to whistleblower, or qui tam, suits against three chains filed under the False Claims Act, which allows plaintiffs to share in any financial recovery for the government.

The Bloomberg report contained an even more chilling case:

One of the suits was filed by Misty Wall, a former social worker at Gentiva’s VistaCare hospice unit who said she was fired in 2005. Wall was assigned to convince people who weren’t dying that they were, she said in an interview.

Wall, now an assistant professor of social work at Boise State University in Idaho, said one woman broke down in tears when Wall suggested her father was dying from renal failure. The man’s own doctor had declined to recommend hospice, prescribing dialysis instead. Wall said VistaCare sent her to the daughter to change the family’s mind.

'I gave her this huge emotional blow, then sat there and soothed her,' Wall said. 'Of course she signed.'

Wall’s lawyer, Loren Jacobson, said, 'It wasn’t her idea. She did it because that was what was expected of her as part of her job, and when she refused to do it anymore and complained, she was fired.' Jacobsen called her client 'an extremely good soul stuck in a bad situation.'

Wall’s lawsuit, filed in federal court in Dallas, accuses VistaCare of paying illegal kickbacks to patients and nursing- home employees who referred residents to hospice. It also accuses VistaCare of doctor shopping to get patients certified.

As part of its sales pitch, the hospice told prospects, 'The VistaCare Foundation is here to make all your dreams come true,' Wall said. 'We used it as a selling feature.'

This case is particularly disturbing because patients with kidney failure actually may have quite a long life expectancy if they do not have serious co-morbid disease. Patients can be sustained on dialysis, and may be eligible for kidney transplants.

Note also that in 2009 we discussed a case of SouthernCare, a for-profit hospice company which settled (for $24.7 million) a case alleging that it had enrolled patients who were not likely to die in six months to increase its revenue, further suggesting that this is a widespread problem among for-profit hospices.

Limiting Care: "Prepare Them to Die" 

So I am actually surprised that only 20% of hospice patients survived more than six months.

However, putting patients who were not already near the end of life in hospice may mean denying potentially life saving care to patients who had the potential to live for at least a while:

Providers have been accused of boosting their revenues with patients who aren’t near death and not eligible for hospice -- people healthy enough to live a long time with traditional medical care. In hospices, patients give up their rights to 'curative' measures because they are presumed to be futile.

'By admitting these folks to hospice, they are denied access to routine medical and rehabilitative care that they need to extend and improve their lives,' said Cristen Krebs, executive director of Catholic Hospice of Pittsburgh, a non- profit. 'A vulnerable and voiceless population is preyed upon for money.'

So if "curative" measures are not used for patients who started with relatively favorable prognoses, but have developed new problems, guess what may happen?

The Bloomberg article opened with another distressing case:

With his mother wheezing and losing consciousness in a California nursing home, Robert Rogers wanted her moved to a hospital. Vitas Healthcare, her hospice provider, said that wasn’t in the plan.

'Our job is not to prepare them to live,' a Vitas nurse told Rogers on the phone, according to a deposition he gave in April. 'Our job is to prepare them to die.'

Rogers called 911. At the hospital, an emergency-room doctor removed 11 maggots from an open wound on his mother’s big toe. Five days later, in September 2008, 91-year-old Thelma Covington died of a sepsis infection brought on by gangrene in her toe and poor circulation, her death certificate said.

Rogers is suing Vitas, a unit of Cincinnati-based Chemed Corp. (CHE), in a California court for alleged elder abuse and wrongful death. Vitas, the biggest company in hospice care, has denied negligence and said that Covington and Rogers knew the risk involved in entering hospice.

The article elaborated on Ms Covington's initial condition, and how she was enrolled in hospice despite of it:

Vitas admitted Thelma Covington to hospice in November 2007, taking over her medical care at Willow Pass Healthcare Center in Concord, California. Her son, Robert Rogers, who had Covington’s power of attorney, said a Vitas salesperson called him and offered help so he wouldn’t have to be there so much.

Rogers said he didn’t know he was giving up rights to curative care when he signed his mother up for hospice, and wouldn’t have done so if he did. He said he 'didn’t read the fine print' and gave his consent because he was told there would be more people looking after her, taking a load off him.

He described her as alert on his visits, doing crossword puzzles, discussing movies and enjoying the Kentucky Fried Chicken he brought her.

The Vitas admission assessment for Covington said she was terminally ill with 'debility, unspecified' and had various other conditions, including dementia, congestive heart failure and diabetes. Two doctors certified that she had less than six months to live.

'She didn’t have no dementia,' Rogers said.

No one said anything about his mother’s life expectancy, according to Rogers, 75, a retired longshoreman and Covington’s only child. For 10 months, Medicare paid Vitas $199 a day to provide palliative care for her at Willow Pass, bills show.

Obviously, Ms Covington had more than 10 months to live. There is a major question whether she had anything resembling dementia. As noted earlier, "debility" is not a real diagnosis and does not imply a specific life-span.

The details of how the hospice allegedly failed to treat a new condition which was eventually fatal for Ms Covington are gut-wrenching:

On July 9, 2008, two months before her death, a Vitas doctor ordered a two-week cleansing and ointment treatment for an open wound on Covington’s toe, medical records show. The treatment was never carried out because the plan wasn’t placed in the 'treatment administrative record' that the nursing home used to implement orders, according to a deposition by Jennifer Bernal, one of Covington’s Willow Pass nurses. She called it 'a serious nursing error.'

Nevertheless, Vitas 'discontinued' the toe treatment on July 28, according to notes written by one of its nurses, who added 'course complete.'

Two days later, Covington was in agony from the wound; a Vitas nurse assessed her pain at level 10 on a 10-point severity index, records show. She was given morphine and a sedative.

On Aug. 25, a nursing home employee noted in a 'skin condition report' that the toe was scabrous, swollen, contained pus and had developed black 'eschar' -- dead tissue that’s a sign of gangrene. 'Hospice notified,' the report said.

Vitas’s notes on the toe for Aug. 25 and Aug. 27 again said 'interventions effective, continue plan.' On Sept. 5, a Vitas nurse described 'soft black eschar' on the toe. By then, Covington was in such pain from the wound that she lay moaning, 'Lo[r]d have mercy,' a Vitas nurse noted.

On the morning of Sept. 7, a Vitas nurse discovered the gangrene and maggots, conferred with a Vitas doctor, washed the toe and wrapped it in plastic, according to nursing notes.

Rogers said in his deposition that he learned of the maggots later that day from the emergency-room doctor.

Summary

There has been a lot of blather from politicians in the US about "death panels" in debates about health care reform. Many such politicians seem worried that the US government has or will have death panels under the new health care reform legislation. We have criticized that legislation for not addressing many important health care problems. No one, however, has convingly demonstrated how its provisions would convene "death panels."

Wendell Potter argued in his book, Deadly Spin, (see this post) that for-profit insurance companies had their own "death panels." The Bloomberg article strongly suggests that for-profit hospices may also act like death panels. In search of more revenue, for-profit hospices may enroll patients who are not at the end of life, but then provide them only "comfort care," so that if they develop new conditions that are treatable, they are likely to die in the absence of treatment.

I am waiting for the politicians who so enthusiatically condemned the supposed "death panels" to be found in health care reform legislation to condemn for-profit hospices for behaving like death panels. 

In my humble opinion, the cases discussed above are the strongest argument yet that we need to reconsider our headlong rush to turn health care, particularly the direct care of patients, over to relatively unregulated, for-profit corporations. The cases above suggest that the pursuit of revenue ahead of patients' welfare by such organizations may lead to sick and dead patients.

I cannot see how for-profit direct patient care can be made safe for patients without intense government regulation. If any of those vocal advocates of "free market" health care (in the absence of any good explanation of how health care can ever be an ideal free market, see this post) can explain to me how for-profit hospices can be made safe for patients without such regulation, I would welcome their attempts.

Meanwhile, this just calls out for legislative and legal investigation, and urgent policy changes.

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Quest Diagnostics Settles, Version 2

And the latest entrant in the parade of legal settlements is a medical laboratory company, as reported by the Los Angeles Times:

Quest Diagnostics Inc., the biggest provider of medical lab services in California, has agreed to pay $241 million to settle a whistle-blower's lawsuit that accused it of overcharging the state Medi-Cal program.

This was not only about financial misbehavior, but about paying physicians and health care providers to influence their decisions in favor of the payer, but not necessarily their patients:

The lawsuit also alleged that the Madison, N.J., company paid illegal kickbacks to doctors, hospitals and clinics that sent patients their way.

As usual, despite the allegations above, the company issued the de rigeur denials:

Quest acknowledged the settlement in a statement but denied any wrongdoing.

'Our laboratory testing services for Medi-Cal were priced appropriately, and we deny all allegations in the complaint,' said Michael E. Prevoznik, Quest's senior vice president and general counsel.

Quest said it settled 'to put the lawsuit behind us.'

Of course, lawyers are expensive. But it is awfully hard to believe a trial would cost more than a small fraction of the amount paid out. So it is very hard to believe that the company paid nearly a quarter of a billion dollars just to avoid the expense and inconvenience of going to court.

That the company paid so much to avoid contesting an action that alleged such kickbacks seems at odds with the company's earnest "corporate citizenship" statement:

Honesty and integrity are the cornerstones of our corporate philosophy. We strive to do the right thing when it comes to caring for our patients, dealing with our business partners and working alongside our fellow employees. We never forget that we’re in the business of caring for people. Every day, we work hard to earn your trust and maintain our reputation for providing unsurpassed diagnostic insights and innovation.

What does not contesting allegations about kickbacks to doctors and hospitals have to do with "honesty and integrity," doing "the right thing," or "earn[ing] your trust?"

That would be a particularly good question to put to certain members of the Quest Diagnostics board of directors who have roles that ought to suggest they might have a certain level of discomfort with not  contesting allegations of giving kickbacks to physicians and hospitals, e.g.:

• John C Baldwin MD, the surgeon who is "Senior Advisor for Health Affairs to the Texas Tech University System,"
• Jenne K. Britell, Ph.D.,"a trustee of the Fox Chase Cancer Center,"
• Rosanne Haggerty, "the founder and President of Common Ground Community, a not-for-profit organization that develops strategies to end homelessness,"
• Surya N. Mohapatra, Ph.D., CEO and Chairman of the Board, also "a Trustee of Rockefeller University," and
• Gail Wilensky Ph.D., a well-known health policy expert who has been vocal in health care reform discussions, and is "a Senior Fellow at Project HOPE."

Of course, as the parade of legal settlements continues, it has been markedly unusual for any of the board members of the organizations involved, no matter how distinguished their credentials in the health arena, to have anything to say about them.

Also, as is tediously usual in such cases, I could find nothing to suggest any negative consequences for any individual who might have authorized, directed, or implemented the bad behavior, and specifically, that might have had anything to do with the kickbacks that were alleged to have occurred.

The continuing march of legal settlements now seems to have included most of the previously well reputed commercial health care firms in the US. The length of this march is an indication of how pervasive is bad behavior by such health care organizations, especially when the marchers were accused of behavior that appeared clinically, not just financially unethical.

I assert again that pervasive bad behavior by large health care organizations has got to be a major cause of our ongoing health care dysfunction.

As we have said repeatedly, even large monetary penalties paid by corporations are unlikely to do anything other than somewhat increase their costs of doing business.  (Note that this is the second settlement by Quest Diagnostics we have discussed on Health Care Renewal.  The first settlement, for over $300 million, was in 2009 and involved felony misbranding charges by a Quest subsidiary.  In that case too no actual persons suffered any negative consequences.)

So, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable.    As long as they are not, expect the bad behavior to continue. 

(We said that in 2009 about the first Quest Diagnostics settlement, and now it seems to have been a good prediction.  You heard it here first on Health Care Renewal.)

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Merck KGaA Settles, Again

They just keep marching along, legal settlements, that is.  The latest entry in the parade is Merck KGaA (of Switzerland, not to be confused with the American Merck and Co, Inc), as per the AP, via ABC News:

The Department of Justice said Wednesday that multinational drugmaker Merck Serono SA has agreed to pay $44.3 million to settle allegations that it illegally promoted one of its drugs using kickbacks to doctors.

Federal prosecutors said that Merck Serono and EMD Serono allegedly made inappropriate payments to hundreds of doctors for prescribing its multiple sclerosis drug, Rebif, between 2002 and 2009. Merck Serono paid to send doctors to various training meetings and conferences at upscale resorts and other locations, according to the Department of Justice.

Of course, while agreeing to pay out the money, the company denies everything:

The company pointed out in a statement: 'the settlement contains no claims that unnecessary prescriptions for Rebif were written, no allegations of patient harm and no admission of fault by the company.'

One wonders whether $44 million is now such a trivial amount to a large health care corporation that companies are willing to pay so much just to avoid the inconvenience of a trial? Or did perhaps the company leadership worry it might lose this trial?

Note that regardless of the above company statement, the US Department of Justice asserted that the company made "improper payments" to physicians "For prescribing its drugs." So, unlike some of the many settlements we have discussed which involved only financial improprieties, this one allegedly involved actions that corrupted physicians.

As we have noted previously, Transparency International defines corruption as "abuse of entrusted power for private gain." Physicians are entrusted to make decisions for individual patients for the patients' good. Accepting payments from a drug company to prescribe a particular good appear to be an abuse of such entrusted power, obviously for private gain. So the sorts of behavior that allegedly resulted in this settlement are particularly pernicious for medical professionalism, as well as for the good of patients.

Nonetheless, despite protestations that they are going to get tough, US law enforcement seems unwilling to hold any individual accountable for this sort of behavior. Granting individual impunity, though, seems to provide no deterrent against future bad behavior. 

For example, as we noted here, Merck KGaA had to pay a settlement last year of claims that its previous subsidiary, Mylan, reported falsely inflated claims.  That legal action also imposed no negative consequences on individuals.  This legal action had been in the works since at least 2007, but as noted above, the actions that lead to the current settlement continued through 2009. 

So, to repeat, repeat, repeat: we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

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St Jude Medical Settles Again

Here we go again to kick off the week, legal settlements, cardiac devices, alleged kickbacks, manipulated research, as reported by Bloomberg:

Another Legal Settlement by St Jude Medical

St. Jude Medical Inc. agreed to pay $16 million to settle a U.S. government probe of claims the company paid kickbacks to doctors who implanted its heart devices in patients.

The accord resolves a five-year investigation of St. Jude’s marketing practices for defibrillators and pacemakers.

This was not even the first recent settlement by this particular company:

In June, St. Jude agreed to pay the federal government $3.7 million to resolve a separate whistleblower case over claims that it made illegal payments to hospitals in Kentucky and Ohio that used the company’s heart devices.

Our relevant post about that previous settlement was here.

Kickbacks, Manipulated Research

The $16 million settlement stemmed from a case filed by Charles Donigian, a former St. Jude technician from St. Louis, who accused the company of using kickbacks to market products.

The kickbacks, which ranged as high as $2,000 per patient, came in the form of 'sham fees' for phony clinical-research studies on the devices, Donigian said in his suit.

There was slightly more detail in a report in TheHeart.org:

According to the DoJ, the company used postmarketing studies and a registry as vehicles to reward physicians participating in those studies to implant the devices. 'In each case, St Jude paid each participating physician a fee that ranged up to $2000 per patient,' a statement from US Attorney Carmen M Ortiz notes. 'The United States alleges that St Jude solicited physicians for the studies in order to retain their business and/or convert their business from a competitor's product.'

The statement also observes: 'Although St Jude collected data and information from participating physicians, it knowingly and intentionally used the studies and registry as a means of increasing its device sales by paying certain physicians to select St Jude pacemakers and ICDs for their patients.'

Summary

It all is getting so old, isn't it? Yet another pharmaceutical, biotechnology or device company settles a case alleging payments to physicians to induce them to use its products. The twist here is that the form of the payment allegedly also manipulated the clinical research process.

There have been other cases of manipulation or suppression of research about cardiac devices. For example, see our recent post about how Guidant, now a subsidiary of Boston Scientific, was put on probation for its actions in another such case.

The allegations amounted to serious external threats to physicians' professionalism: payments to promote use of health care products whether or not their implantation was in patients' best interests, and manipulation of clinical research that could have further corrupted the clinical evidence base, and presumably could have broken the trust of clinical research subjects. Left unsaid in the brief articles is how willingly the physicians gave in to these threats to their professionalism for the dollars involved.

Yet despite the apparently corrosive quality of the bad behavior, the penalties to the company were trivial. Per St Jude Medical's most recent financial profile, its yearly revenue was over $4.5 billion.  Two settlements totaling less than $20 million amount to a relatively small cost of doing business.  And note that St Jude Medical is not admitting it did anything wrong.  Per TheHeart.org, its statement was:

We are pleased to have reached a settlement agreement with the DoJ that fully resolves the postmarket-study matter in Boston. The company maintains that its postmarket studies and registries are legitimate clinical studies designed to gather important scientific data, and St Jude Medical does not admit liability or wrongdoing by entering into this agreement. The company entered into a settlement agreement to avoid the potential costs and risks associated with litigation. This settlement brings the previously reported postmarket-study investigation to a close.

So it all gets so tiresome. The continuing march of legal settlements like this do provide evidence of how professionalism and evidence-based medical practice are under threat. However, as we have said ad infinitum, such settlements are likely to do nothing to alleviate that threat.

To repeat the conclusion of our last post about St Jude Medical, the usual sorts of legal settlements we have described do not seem to be an effective way to deter future unethical behavior. Even large fines (and the one described above would be peanuts to a large health care corporation) can be regarded just as a cost of doing business. Furthermore, the fine's impact may be diffused over the whole company, and ultimately comes out of the pockets of stockholders, employees, and customers alike. It provides no negative incentives for those who authorized, directed, or implemented the behavior in question. My refrain has been: we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

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Elan, Eisai Settle for Related Reasons

The parade of legal settlements of bad behavior by major health care organizations marches on. The latest to shuffle by are Elan Corp, based in Ireland, and Eisai Inc, based in Japan, for actions taken in the US.  According to Bloomberg:

Elan Corp. will pay $203 million and a U.S. unit of the Irish drugmaker will plead guilty to a misdemeanor charge to resolve an investigation of its marketing of the epilepsy medicine Zonegran.

Elan will pay $102.9 million to resolve civil claims and $100 million in criminal fines and forfeitures, according to the U.S. Justice Department. Japanese drugmaker Eisai Inc., which bought the drug from Elan in 2004 for $128.5 million, also will pay $11 million to settle civil claims.

The Elan Pharmaceuticals unit will plead guilty in federal court in Boston to a charge of misbranding Zonegran, which was approved by U.S. regulators for treatment of epileptic seizures in adults over age 16, the Justice Department said yesterday in a statement. Dublin-based Elan promoted Zonegran for uses including mood stabilization, bipolar disorder, migraine headaches, weight loss and seizures in children.

'Elan’s off-label marketing efforts targeted non-epilepsy prescribers and the company paid illegal kickbacks to physicians in an effort to persuade them to prescribe Zonegran for these off-label uses,' according to the statement.

The details were:

In 2002, EPI [Elan Pharmaceuticals Inc] 'came under significant financial pressure' because of an investigation of its financial practices by the U.S. Securities and Exchange Commission that caused shares to drop to $2 from $65 in six months, according to the criminal charge. In evaluating its options, EPI 'decided to retain Zonegran because of its large potential for growth, particularly in unapproved areas,' prosecutors said.

EPI then trained its sales staff to promote Zonegran for off-label uses, including for children, pain, psychiatric disorders, migraines and movement disorders, prosecutors said. Letters sent to pediatricians described how to administer Zonegran to a child by putting a capsule’s contents into applesauce, according to the document, which EPI will admit to in its guilty plea.

Doctors with the potential to write many prescriptions were invited on expense-paid trips to Bermuda, Key Largo, Florida, Banff in Alberta and Tucson, Arizona, to hear speeches on off- label uses, according to the charge. Sales 'increased dramatically,' rising 80 percent from August 2001 to August 2002, while 2003 revenue increased 87 percent over the previous year, prosecutors said.

So here we ago again, another week, another multi-hundred million dollar settlement. Once again, the settlement is of charges of deceptive marketing practices and kick-backs to physicians. Once again, the settlement involves criminal charges and a corporate integrity agreement, but does not involve any negative consequences for any individual who authorized, directed, or implemented the unethical practices.

We have noted recent cases, one in which a corporate executive was banned from doing business with the federal government, another in which a corporate executive was indicted, but not yet tried on criminal charges.  However, in most cases, the parade of legal settlements made by health care organizations has just marched on, sometimes including guilty pleas to criminal charges, often involving charges of kickbacks, fraud, conspiracy, and other colorful offenses. Most of these settlements entailed fines or other payments by the organizations that may seem huge, but were fractions of the amounts made by the practices that lead to the charges that were settled.  With the few exceptions above, (plus one other known exception, the disbarment from federal business of three former executives of Purdue Pharma, story here), almost never have the cases involved penalties for any individuals who authorized, directed, or implemented the misbehavior.  We have also been saying (seemingly endlessly, but most recently here) that such settlements may be viewed by organizations as merely the costs of doing business, and so until the actual people who were involved in the bad behavior suffer some negative incentive or penalty, expect the behavior to continue. 

Health care costs keep rising, access keeps declining, quality gets worse. We moan and wring our hands, but as long as we allow the rot to worsen, and the muck to grow, expect these trends to continue until the whole smelly mess collapses of its own weight (with all those rich executives escaping to their mansions.)

If we really want high quality accessible, reasonably priced health care, we need true health care reform that reduces concentration of power in large organizations, and makes health care organizations' leadership accountable, ethical, and transparent. That will not be easy.
(FULL DISCLOSURE - I own 3200 shares of Elan.  This is the only health care stock I own.  I have held it a long time, not bothering to sell since the shares have been worth little for years.  This has provided a lesson about how the share-holders of big health care corporations rarely profit from the executives' risk taking.) 

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Wright Medical Settles, ... But Wait, There is Less

Everyone loves a parade, and so the parade of legal settlements by prominent health care organizations continues.  The latest to march into view is Wright Medical Group, as reported by Bloomberg:

Wright Medical Technology Inc. agreed to pay $7.9 million to resolve U.S. criminal and civil investigations into whether it paid kickbacks to induce doctors to use its hip and knee devices.

Prosecutors in Newark, New Jersey, today charged Wright with conspiring to violate a federal anti-kickback statue through consulting contracts with orthopedic surgeons. The U.S. agreed to drop the case in 12 months if a monitor agrees that Wright has reformed the way it hires consultants.

Wright, based in Arlington, Tennessee, also agreed to a $7.9 million civil settlement with the Justice Department and inspector general of the Health and Human Services Department to resolve fraudulent-marketing claims. The company entered into a five-year corporate integrity agreement.

Here we go again. A company is accused of giving kickbacks, aka bribes, to individual doctors, in this case orthopedic surgeons, to get them to use the company's products. Such payments clearly violate medical ethics (especially doctors' obligations to put the interests of patients ahead of their personal financial interests), leading to decision making not in the best interests of the patients. However, the penalty to the company itself is minuscule, only a fraction of the company's revenue, according to Google Finance, in 2009, just under $500 million. As we have noted endlessly before, financial penalties to corporations are diffused among all shareholders and employees, and possibly customers and patients.

Do we really expect that this penalty will change anything, or deter future bad behavior by this or any other company?

But our government continues to treat the corporate employees who authorize, direct, or implement bad behavior like this as essentially above the law. In this case, like in many others we have discussed previously, no one who authorized, directed or implemented the bad behavior will have to pay any sort of penalty or suffer any sort of negative consequences.  Does anyone in their right mind believe that Wright Medical really is

pleased to announce these agreements and look[ing] forward to working with the independent monitor as we continue our commitment to the highest standards of ethical and legal conduct

That was a quote from Wright Medical CEO Gary D Henley. He may be pleased to announce the agreements, since they really amount to such a tiny pinprick of a penalty. After all, Mr Henley will be able to to continue to use Wright Medical's revenues, virtually unaffected by this penalty, to justify his compensation (per the 2009 proxy statement, $2,036,517 in 2009, and his continuing accumulation of wealth, e.g., 436,601 shares of stock, currently valued at $13.86/ share according to Google Financial.)

I leave an assessment of what the company's previous commitment to "the highest standard of ethical and legal conduct" was to our dear readers.

We will not have true health care reform until we end the unholy alliance between big government and big health care organizations, that is, health care corporatism. Then, maybe, we can make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

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Novartis Settles..., But Wait, There's More

Back in January, 2010, we posted about Novartis' settlement of charges that it promoted its anti-seizure drug, Trileptal, (Oxcarbazepine) for off-label uses, agreeing to plead guilty to one charge of violating the US Food, Drug and Cosmetic Act.  This week, the full story of the settlement just came out, and yes, but wait, there's more.  Per the New York Times article by Duff Wilson, the story is not only about Trileptal:

The Swiss drug giant Novartis is paying $422.5 million to settle criminal and civil investigations into the marketing of the antiseizure medicine Trileptal and five other drugs, federal officials said on Thursday.

The other drugs were:

Diovan, a hypertension drug that is the company’s top-selling product, at $6 billion last year; Sandostatin, a drug to treat a growth hormone disorder that had worldwide sales of $1.2 billion last year; Exforge, a hypertension drug that sold $671 million; Tekturna, a blood pressure medicine that sold $290 million; and Zelnorm, a medicine for irritable bowel syndrome and constipation that was later withdrawn from the United States market.

And the issue was not solely off-label marketing:

Federal prosecutors accused Novartis of paying illegal kickbacks to health care professionals through speaker programs, advisory boards, entertainment, travel and meals. But aside from pleading guilty to one misdemeanor charge of mislabeling in an agreement that Novartis announced in February, the company denied wrongdoing.

While the allegations were much more broad than those originally announced, the penalties were the usual suspects:

The settlement includes a $170 million criminal fine and $15 million in criminal forfeiture by Novartis Pharmaceuticals, its United States subsidiary.

Also,

Novartis settled the investigation into the other drugs for $237.5 million.

However,

Prosecutors said top management at Novartis had approved illegal marketing from July 2000 to June 2004. No individual, however, was named or charged.

Back in June, we posted about how US law enforcement was supposedly going to start getting tougher with the people who authorized, directed or implemented wrong doing by health care organizations. Back then, federal officials said that executives would be held accountable, and forced to leave their jobs or even be disbarred from working in the industry.

However, here we are, four months later, and even a case that mushroomed from involving allegations of off-label promotion of one drug to off-label promotion of six drugs, allegations of kickbacks to physicians, and allegations that top management knew about what was going on results in no negative consequences to any individuals.

So it still seems that if misdeeds, such as promotion of drugs for off-label uses, and giving kickbacks to doctors disguised as honoraria for talks, consulting fees, and meals and travel payments, are done under the auspices of a large health care organization, no one is ultimately responsible for them.  The organization may have to pay what appears to be a big fine, but one that pales against the profits to be made from the misdeeds.

So, if an ordinary person commits fraud, he or she is likely to have to pay a big fine and go to jail.  If a physician commits fraud, he or she is likely to have to pay a big fine and go to jail, and incidentally to lose his or her medical license.  But if a corporate executive authorizes a fraudulant practice, he or she is likely not to pay any penalty (but may well have already collected a big bonus).

We have repeated endlessly that by limiting penalties to only modest increases in the costs of doing business for organizational malfeasance in health care, we just encourage more bad behavior.  But with each new example like this, I agree more that the fundamental problem has become corporatism, (or Corpocracy, as Robert A G Monks put it).  Government and corporate leaders find that they have more in common with each other than with the little people.  Or as Barry Ritholtz just blogged:

The new dynamic, however, has moved past the old Left Right paradigm. We now live in an era defined by increasing Corporate influence and authority over the individual. These two 'interest groups' – I can barely suppress snorting derisively over that phrase – have been on a headlong collision course for decades, which came to a head with the financial collapse and bailouts. Where there is massive concentrations of wealth and influence, there will be abuse of power. The Individual has been supplanted in the political process nearly entirely by corporate money, legislative influence, campaign contributions, even free speech rights.

This may not be a brilliant insight, but it is surely an overlooked one. It is now an Individual vs. Corporate debate – and the Humans are losing.

Furthermore,

There is some pushback already taking place against the concentration of corporate power: Mainstream corporate media has been increasingly replaced with user created content – YouTube and Blogs are increasingly important to news consumers (especially younger users). Independent voters are an increasingly larger share of the US electorate. And I suspect that much of the pushback against the Elizabeth Warren’s concept of a Financial Consumer Protection Agency plays directly into this Corporate vs. Individual fight.

But the battle lines between the two groups have barely been drawn. I expect this fight will define American politics over the next decade.

Keynes vs Hayek? Friedman vs Krugman? Those are the wrong intellectual debates. Its you vs. Tony Hayward, BP CEO, You vs. Lloyd Blankfein, Goldman Sachs CEO. And you are losing . . .

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