Thursday, July 28, 2011

Executives Get Rich Despite Ethical and Legal Questions about For-Profit Hospices

We recently posted about some shocking allegations suggesting that the for-profit corporations that now dominate hospice care may prey on vulnerable patients to increase their revenues, and may specifically recruit patients who are not terminally ill for hospice, and then neglect to attend to their treatable medical problems.  The post was based on a Bloomberg investigative report.

The Bloomberg report focused on two large for-profit hospice providers, Vitas, a subsidiary of Chemed, and VistaCare, a subsidiary of Gentiva. We have repeatedly seen a pattern in numerous other health care organizations, non-profit as well as for-profit: despite questionable corporate behavior that appears to violate the values of health care professionals, executives receive rich compensation overseen by complacent corporate stewards. So, using publicly available information, I compared and contrasted the two for-profit hospice corporations' health care missions, behavior with respect to core values, executive compensation, and board composition.

Stated Mission

Chemed (including Vitas Hospice Care)

Vitas Mission and Values
VITAS Values
Patients and families come first.
We take care of each other.
I’ll do my best today and do even better tomorrow.
I am proud to make a difference.

VITAS Mission
We are a growing family of hospices providing the highest quality human services, products and case management to terminally ill and other appropriate patients and their families with measurable advantages for the patient, the family, the medical community, the employee and the stockholder.

Gentiva (including VistaCare, part of Odyssey Healthcare)

Gentiva's "about us" web page declares:
We are committed to clinical excellence and determined to continually raise the bar in home healthcare by setting new industry standards for quality care and personalized service. That’s why thousands of patients every day choose us for their home healthcare needs.

Gentiva's hospice website declares:
Our hospice services allow patients to make the most of each day, at home surrounded by friends and family in a familiar, comfortable environment. Because at Gentiva, we believe that every moment matters.

So both organizations affirmed "warm and fuzzy" commitments to put patients first and to quality of care.



The Bloomberg article noted that the Vitas subsidiary of Chemed is being sued for elder abuse and wrongful death based on allegations that the company put a patient who did not appear to be terminally ill in hospice care, and then failed to adequately treat the infection that appeared to eventually cause her death.

In addition, the 2010 Chemed Annual Report noted that the company is now the subject of two ongoing investigations.

The first involves:
In May 2009, VITAS received an administrative subpoena from the U.S. Department of Justice requesting VITAS deliver to the OIG documents, patient records, and policy and procedure manuals for headquarters and its Texas programs concerning hospice services provided for the period January 1, 2003 to the date of the letter.

In addition,
In February 2010, VITAS received a companion civil investigative demand ('CID') from the state of Texas Attorney General’s Office, seeking related documents. In September 2010, it received a second CID and a second administrative subpoena seeking related documents.

The second involves:
In April 2005, the Office of Inspector General ('OIG') for the Department of Health and Human Services served VITAS with civil subpoenas relating to VITAS’ alleged failure to appropriately bill Medicare and Medicaid for hospice services.

This is still active,
In March 2009, we received a letter from the government reiterating the basis of their investigation.


The Bloomberg article noted that VistaCare, part of Odyssey Healthcare, which is a Gentiva subsidiary, is being sued by a former employee who alleged that her job was to entice patients who did not have terminal conditions into hospice, and that the company used other unethical tactics to enroll more patients.

Also, according to the 2010 Gentiva Annual Report, the company's Odyssey subsidiary is currently operating under a corporate integrity agreement:
On July 6, 2006, Odyssey entered into a five-year Corporate Integrity Agreement (“CIA”) with the Office of Inspector General of Health and Human Services. The CIA imposes certain auditing, self-reporting and training requirements that Odyssey must comply with. If Odyssey fails to comply with the terms of its CIA, it could subject us to substantial monetary penalties and/or suspension or termination from participation in the Medicare and Medicaid programs.

There are also numerous ongoing investigations and regulatory actions ongoing, including:
On February 14, 2008, Odyssey received a letter from the Medicaid Fraud Control Unit of the Texas Attorney General’s office notifying Odyssey that the Texas Attorney General was conducting an investigation concerning Medicaid hospice services provided by Odyssey, including its practices with respect to patient admission and retention, and requesting medical records of approximately 50 patients served by its programs in the State of Texas.

On May 5, 2008, Odyssey received a letter from the DOJ notifying Odyssey that the DOJ was conducting an investigation of VistaCare, Inc. ('VistaCare') and requesting that Odyssey provide certain information and documents related to the DOJ’s investigation of claims submitted by VistaCare to Medicare, Medicaid and TRICARE, from January 1, 2003 through March 6, 2008, the date Odyssey completed the acquisition of VistaCare. Odyssey has been informed by the DOJ and the Medicaid Fraud Control Unit of the Texas Attorney General’s Office that they are reviewing allegations that VistaCare may have billed the federal Medicare, Medicaid and TRICARE programs for hospice services that were not reasonably or medically necessary or performed as claimed. The basis of the investigation is a qui tam lawsuit filed in the United States District Court for the Northern District of Texas by a former employee of VistaCare. The lawsuit was unsealed on October 5, 2009 and served on Odyssey on January 28, 2010. In connection with the unsealing of the complaint, the DOJ filed a notice with the court declining to intervene in the qui tam action at this time. The Texas Attorney General also filed a notice of non-intervention with the court. These actions should not be viewed as a final assessment by the DOJ or the Texas Attorney General of the merits of this qui tam action.

On January 5, 2009, Odyssey received a letter from the Georgia State Health Care Fraud Control Unit notifying Odyssey that the Georgia State Health Care Fraud Control Unit was conducting an investigation concerning Medicaid hospice services provided by VistaCare from 2003 through 2007 and requesting certain documents

On February 2, 2009, Odyssey received a subpoena from the OIG requesting certain documents related to Odyssey’s provision of continuous care services from January 1, 2004 through February 2, 2009. On September 9, 2009, Odyssey received a second subpoena from the OIG requesting medical records for certain patients who had been provided continuous care services by Odyssey during the same time period.

On February 23, 2010, Odyssey received a subpoena from the OIG requesting various documents and certain patient records of one of Odyssey’s hospice programs relating to services performed from January 1, 2006 through December 31, 2009.

In April 2003, the Company received a subpoena from the OIG. The subpoena sought information regarding the Company’s implementation of settlements and corporate integrity agreements entered into with the government, as well as the Company’s treatment on cost reports of employees engaged in sales and marketing efforts. In February 2004, the Company received a subpoena from the U.S. Department of Justice ('DOJ') seeking additional information related to the matters covered by the OIG subpoena. In early May 2010, the Company reached an agreement in principle, subject to final approvals, with the government to resolve this matter. Under the agreement, the Company will pay the government $12.5 million, of which $9.5 million was recorded as a charge in 2010 with the remaining $3 million covered by a previously-recorded reserve.

On July 13, 2010, the SEC informed the Company that the SEC had commenced an investigation relating to the Company’s participation in the Medicare Home Health Prospective Payment System, and, on July 16, 2010, the Company received a subpoena from the SEC requesting certain documents in connection with its investigation. Similar to the Senate Finance Committee request, the SEC subpoena, among other things, focused on issues related to the number of and reimbursement received for therapy visits before and after changes in the Medicare reimbursement system, relationships with physicians, compliance efforts including compliance with fraud and abuse laws, and certain documents sent to the Senate Finance Committee.
In addition to the allegations detailed by the Bloomberg article, there are an impressive number of investigations going on.  In addition, Gentiva has already recently settled apparently two different legal actions.  Thus, many questions have been raised about the companies' ethics, and the extent that they really uphold the warm and fuzzy values portrayed by their marketing.

Executive Compensation and Board Composition


Based on the 2011 Chemed proxy statement, the company CEO, K J McNamara, got $5,848,230 total compensation in 2010. The four other most highly paid executives got from just over $1 million to over $2.5 million. Mr McNamara's compensation included over $150,000 for use of company aircraft. Other executives had use of the aircraft, of a company apartment, and of a company car, and company paid golf club memberships, and one got over $64,000 in housing costs. None apparently has any background in direct health care.

Of the "independent" directors, one, Andrea R Lindell, is now the retired Dean and Professor of the College of Nursing at the University of Cincinnati, and retired Associate Senior Vice President of the Medical Center. She retired in 2011, but has been director of Chemed since 2008. None of other directors apparently has any direct health care background. They include five who are currently or were formerly in financial services, and one attorney. The majority hold or held executive positions at least at the Senior Vice President level for a variety of organizations.The independent directors generally got somewhat over $100,000 in compensation in 2010.


Based on the 2011 Gentiva proxy statement, the company CEO, Tony Strange, got $5,472,327 in total compensation in 2010.  Three senior vice presidents and "C" level officers got over $1.3, $2.1, and $3.1 million respectively.  One, the Chief Clinical Officer, has a nursing diploma and nursing experience (see management biographies here.)  No others have apparent experience in direct clinical care.

Of the "independent" directors, one, Dr Sheldon M Retchin, is a physician, and is now CEO of the Virginia Commonwealth University Health System and Vice-President for Health Sciences at Virginia Commonwealth University.  None of other independent directors apparently has any direct health care background. The majority hold or held chief executive positions at a variety of different kinds of firms. The independent directors generally got somewhat over $145,000 in compensation in 2010.

Thus, despite the fact that the two companies provide direct clinical care to the most vulnerable of patients, their top leadership has very little background in direct patient care.  Only two directors, one of each company, are involved in health care, but their involvement may involved conflicts of interest.  Despite the apparent contrast between the companies' high-minded missions and the ethical questions besetting them, their top executives are compensated at a level sufficient to make them quite wealthy.


The pattern repeats again.  Not only has the compensation given to health care leaders got so large that it is per se a cause of increased health spending, but also, and more importantly, such compensation often provides perverse incentives that perpetuate mismanagement, raising costs and lowering quality. This situation appears to be enabled by governance by individuals who are often fellow members of the CEOs' club, and hence who may feel more sympathy with the executives they are supposed to supervise than the stockholders whose financial interests they are supposed to protect, or the public whom the companies' products and services are supposed to benefit. Moreover, these individuals often have conflicts of interest which may mitigate against objective scrutiny of the executives they are supposed to oversee. Finally, these individuals often may come from corporate cultures which do not espouse the values that we in health care are supposed to uphold. (See this post and its links for other examples of the sorts of people who are supposed to provide stewardship to health care organizations.)

So to reiterate-

I strongly believe that there needs to be much more investigation, academic, journalistic, and perhaps legal, of the identity, nature, and culture of the leaders of health care, and their relationships. A few bloggers cannot do it all. Obviously, the anechoic effect mitigates against medical and health care academics looking into their own leaders. However, failing to understand who is leading our march to the brink of health care failure ought not to be something such academics would want on their conscience.

Finally, and obviously, health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research.

If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

Tuesday, July 26, 2011

"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).

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.

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.

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.

Monday, July 25, 2011

On Penalties for Alteration of Electronic Health Records

I am increasingly hearing stories of alleged alterations occurring in electronic medical records.

Since there is no permanent paper record in an increasing number of facilities, some might believe digital alterations might be easier to get away with.

Not so, according to S. Sandy Sanbar, MD, PhD, JD, FCLM in a book chapter partly on advantages and disadvantage of electronic records (PDF) from the American Board of Legal Medicine,

Alteration, Destruction, or Loss of Medical Records

... no entry in the medical record should ever be altered or backdated.

In the law of evidence, the loss, destruction, or significant alteration of evidence is termed “spoliation of evidence.” Thus, when medical records that have been altered, or had portions removed, or cases in which the record cannot be found come before the court, the evidentiary concept of spoliation of evidence is invoked. The common law evidentiary inference concept or remedy for spoliation is explained by Wigmore as an indication that the spoiler’s case is weak, and “operates, indefinitely though strongly, against the whole mass of alleged facts constituting his cause” (2 Wigmore
(3d ed. 1940) §278 p. 120 (emphasis added). [25]

Therefore, alterations to records can prove to be disastrous. Records with alterations are absolutely deadly in court. Document examination is now a sophisticated science. With skill and uncanny accuracy, experts may be able to determine the time that entries were made in medical records and who made them. [26] [Electronic records can greatly facilitate this process, and there are specialty companies with the forensic expertise to analyze EMR data for tampering - ed.]

Courts reason that destroying or altering records in anticipation of or in response to a discovery request falls under the umbrella of misuse of discovery. Discovery rules provide a broad range of sanctions for the misuse of discovery. Sanctions can include monetary fines, contempt charges, establishing or precluding the facts at issue, striking pleadings, dismissing all or parts of the action, and even granting a default judgment against the offending party. In addition to these evidence and discovery sanctions, many penal codes include criminal penalties for perjury and spoliation. [27] In several jurisdictions, spoliation of evidence itself is a cause of action in tort. [28]

Therefore, tampering with medical records may make malpractice cases impossible to defend. Further, providers who falsify a patient’s record may be found civilly and criminally liable. Proof of such charges will result in loss of hospital privileges and even loss of license to practice [29].

As I look for new avenues to explore regarding the legal EHR, which is an interest of mine (having supervised a Johns Hopkins postdoc's thesis on that topic), gaining expertise in EHR alteration detection is a prime area for me.

Another good source of information on this topic is a new book "Basics of e-Discovery", PA Bar Institute, PBI number 2010-6139. Unfortunately, the book is not free, but is available in law libraries such as the library at my university, Drexel:

SUBJECT Civil and appellate procedure.
TITLE Basics of e-Discovery.
IMPRINT [Mechanicsburg, Pa.] (5080 Ritter Rd., Mechanicsburg 17055-6903) : Pennsylvania Bar Institute, c2010.
DESCRIPT xii, 160 p. : ill. ; 28 cm.
SERIES PBI ; no. 2010-6139.
CALL NO. KFP537.5 .E4 B38 2010
LOCATION Legal Research Center Pennsylvania Collection

It is my belief that EHR alteration, facilitated (or seemingly so) through the elimination of a permanent paper record, needs to uniformly carry very serious consequences, including permanent loss of involvement in clinical affairs, and incarceration.

-- SS

Sunday, July 24, 2011 and "The National Database of EHR Errors Being Called For" - Where's the Beef?

At my Nov. 2011 posts on a new entity called "" that is supposed to be a health IT industry watchdog, I expressed various forms of skepticism. See my Nov. 2010 posts at the following HC Renewal links:

November 15, 2010
: Web Site to Collect EHR Safety Reports

November 16, 2010: EHRevent: survey amateurism, bias, or something else?

November 17, 2010: Some answers about new site "" for health IT and drug adverse event reporting

November 22, 2010: CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error?

Now, approximately eight months later, I read this in the July 2011 EHREvent newsletter at this link, written by Michael Victoroff, MD, Editor in Chief:

... The media has drawn our attention to the case of Genesis Burkett, a newborn who recently died in a Chicago hospital when an order for intravenous fluids was incorrectly transcribed by a pharmacy technician. Some journalists have characterized this a “computer error” because the ordering physician entered the order (correctly) into an electronic system, and the pharmacy tech re-entered the order (incorrectly) into an automated compounding machine. [If so, perhaps one should wonder how mission hostile - see link - the user experience of that compounding machine might have been, which could have contributed to or caused the error - ed.]

Moreover, a decision support system that should have alerted at the mistake had been disabled. [Disabled by whom, exactly, and why? Perhaps because it, too, was ill conceived and user hostile? - ed.]

This case has been invoked as a warning about hazards of automation. Calls have been made for “mandatory reporting of adverse events related to HIT to a national database.”

Uh, hello? is exactly the “national database” being called for. It is a fully accredited, federal Patient Safety Organization and part of an AHRQ network of error-reporting entities. Reports to are fully confidential, and data that is collected is reportable only in de-identified or collective form.

("Uh, hello?" he writes?)

Uh, hello, Dr. Victoroff ... As in the old Wendy's commercial:

Where's the beef?

Where's the beef???

A search of the website shows no accessible, searchable database that I can find.

If someone knows of such a publicly accessible database at least remotely similar to the FDA's MAUDE (Manufacturer and User Facility Device Experience) database at this link, please let me know.

The best I can find on a Google search on "EHRevent database" is a page of legalese containing these statements:

2.1 PDR Secure will develop a Patient Safety Evaluation System (“PSES”) for the collection, management, and analysis of information received from and/or reported to participating providers, to be accessed through a PDR Secure web portal [but, apparently, not public dissemination, and based on this language it seems dubious that even "participating providers" will get a complete, searchable corpus of reports - ed.]

... 2.4 PDR Secure will assemble a knowledgeable workforce, and in collaboration with its workforce (which may consist of employees, contractors, volunteers, representatives of participating providers and other Patient Safety Organizations, and other individuals as appropriate to the involved Patient Safety Activity), will develop and conduct Patient Safety Activities, including but not limited to data collection, appropriate studies, evaluative activities, reports, and recommendations, including, where feasible, “best practices” recommendations; and will offer the results to participating providers. [In other words, we disseminate what we think is relevant - ed.]

Examples of what the public can find - for free and at will - on the FDA MAUDE site are at the posts here:

January 21, 2011: HC Renewal - MAUDE and HIT Risks: What in God's Name is Going on Here?

Drexel Health IT website
Real-World, Though Limited, Examples of Healthcare IT Malfunction From the FDA MAUDE Database

Drexel Health IT website
FDA MAUDE DATABASE: Patient outcome = death

Unless I am missing some MAUDE analog at, a claim that " is exactly the national database [on EHR medical device problems, dangers, harms etc. - ed.] being called for" raises some questions:

  • Called for by whom: patients and their advocates, or, an industry interested in secrecy and turf protection?
  • If the public does not have unfettered, searchable access to the set of de-identified case reports being submitted to EHRevent, as they do to FDA's MAUDE and other public databases, how can the public know their publications are complete, unbiased, and not selectively preferential towards certain HIT vendors and/or user organizations?
  • Is EHRevent's model based on the watchdog's opinions of what's important for the public to know, or will it allow the public to make its own informed choices?
  • Will EHRevent publicly demand the recall of EHR medical devices repeatedly reported to them to be harmful, as would the FDA or other governmental regulators regarding dangerous products?
At present, the answers to these questions raise little confidence in me that is "the national database" being called for by true watchdogs, e.g., those truly interested in ensuring the safest, most effective EHR medical devices, and the weeding out of dangerous and deficient EHR medical devices.

I'm going to go a step further.

I am making the following request: that make available online, in a de-identified (as to people and organization) and searchable format the event reports about the EHR medical devices they receive.

Finally, regarding infant mortality related to health IT, perhaps Dr. Victoroff should read cases #2 and #3 at the post "Babies' deaths spotlight safety risks linked to computerized systems" at this link.

-- SS

ePrescribing: Assuming Like This Makes An Ass (And Maybe a Corpse) Out Of You And Me

No surprise here to anyone with engineering sense (e.g., in my case, arising from my decades of experience in amateur radio, operating many different brands and types of extremely complex radio equipment):

American Medical News (American Medical Association)
Upgrading e-prescribing system can bump up error risk

Some of those risks can put patients in jeopardy in the first few weeks of implementation, a study finds.

By PAMELA LEWIS DOLAN, amednews staff. Posted June 13, 2011.

Switching to new or upgraded electronic-prescribing systems may pose patient safety risks during the transition period, despite the advanced clinical decision support tools offered by the newly implemented technology.

Let me translate this euphemism: "Patient safety risks" = risks that patients will be maimed or killed.

Many hospitals and physician practices are upgrading or switching their ePrescribing systems to meet meaningful use incentive requirements.

The collateral damage and/or roadkill on the way to "meaningful use" might be you or your loved one...

Physicians from Weill Cornell Medical College and New York-Presbyterian Hospital, both in New York, authored a report published online April 16 in the Journal of General Internal Medicine that identified challenges associated with switching to new e-prescribing technology. Some of those issues may pose safety threats during the first few weeks after implementation, the study found.

This is accurate, if you consider three months to a year of increased medical error risk "a few weeks":

Researchers examined prescribing errors that occurred from February 2008 through August 2009 at an academic-affiliated ambulatory clinic that switched from an older electronic medical record system to a new one with advanced clinical decision support for ePrescribing. They measured errors that occurred with the old system prior to implementing the new system, 12 weeks post-implementation of the new system and errors that took place one year later.

The report showed that the largest number of errors occurred before implementation, when the old system was still in use. The number of overall errors dropped from 36% to 12% one year later. [12% = more than one in ten. Why not near zero a.k.a. six-sigma for the billions of dollars spent? - ed.]

The most common errors, those caused by improper abbreviations, fell from 24% to 6% in one year. But the number of non-abbreviation errors, such as those associated with directions, frequency and dosage mistakes [just minor "issues" - ed], increased in the first 12 weeks of implementation of the new system.

[Remember, though. Three months = "just a few weeks" - ed.]

Experimental technology-related injury and roadkill figures were apparently not included.

Now for the assumption:

Study co-author Rainu Kaushal, MD, MPH, chief of the Division of Quality and Medical Informatics at Weill Cornell Medical College, said she knew the transition from paper to electronic was difficult for most physicians. She was surprised to learn that even for experienced e-prescribers, the move to a new system can be challenging. Dr. Kaushal, who was involved in the transition studied for the report, said she found the experience to be "exceedingly difficult."

"We thought it would be more of a seamless transition because people were already accustomed to sitting in front of a computer, entering in orders and so on, so they didn't have to get used to that piece," she said.

Where do foolhardy assumptions such as "We thought it would be more of a seamless transition because people were already accustomed to sitting in front of a computer, entering in orders and so" come from?

Do these 'experts' have absolutely no engineering sense, e.g., that when you have learned to use one complex machine (virtual in the case of an EMR), using another that has many differences is not 'automagically' a piece of cake?

By that flaw in logic, a Cessna pilot should have no problems rapidly learning to fly a 747 - or the Space Shuttle.

"But each electronic system has its nuances and learning how to utilize it and optimize the physician-computer interaction takes time. Every time a switch is made there are important issues that arise."

"Important issues" is a rather kind euphemism. Let me state the same concept via a dysphemism::

"Each electronic system has its nuances and learning how to utilize it and optimize the physician-computer interaction takes time. Every time a switch is made there are important clinical mistakes these changes cause clinicians to make. But mistakes never, ever, ever cause patients to be maimed or killed - at least not that we're going to admit publicly. Besides, these adverse outcomes are justified anyway, because we have the right to play God with peoples' lives through IT experimentation, using unregulated, unvetted medical devices without informed consent (link), for the greater good that will necessarily follow via technological determinism."

I think this is a more honest way to state the nature of the "issues" here.

Also see my June 2011 post "
Electronic medication prescribing: The Magic Bullet Theory of IT-Enabled Transformation once again bites the dust in the real world of medicine" for more on ePrescribing, and more on the change of health IT from clinician adviser to clinician governor. From that post:

As many as 12 percent of the drug prescriptions sent electronically to pharmacies contain errors, a rate that matches handwritten orders for medicine from physicians, researchers said.

-- SS

Thursday, July 21, 2011

Blood Money at the Border - The Red Cross and a Local Blood Bank Fight Over Donors

Writing in our local Providence Journal, Felice Freyer reported on a story that becomes less bewildering when viewed in the context of how nominally not-for-profit health care organizations are now run. 

The Border Dispute

It seems that two such non-profits are having a border dispute:
Two local charities are fighting for your blood.

The Rhode Island Blood Center, long the sole blood-collection agency in the state, is objecting to incursions by the American Red Cross of Eastern Massachusetts, which recently started holding blood drives here.

A war of words has resulted, with the blood center accusing the Red Cross of a 'campaign of misinformation,' and the Red Cross calling the blood center 'hypocritical.' The Hospital Association of Rhode Island entered the fray with a letter to blood donors urging loyalty to the Rhode Island center.

The dispute might seem inconsequential to the typical blood donor, who is just trying to do a good deed and may not care or notice who collects the blood.

But the Rhode Island Blood Center argues that it matters a great deal. The competition, blood center officials say, is threatening a carefully calibrated system that ensures a steady, predictable supply of blood. The hospitals in Rhode Island all rely on the blood center for 100 percent of their blood supply.

The Red Cross says it just wants to give Rhode Islanders another way to support its mission. 'We are a humanitarian organization, a symbol of trust,' said spokeswoman Donna M. Morrissey.

The Red Cross’ Rhode Island chapter does not collect blood. A chapter based in Dedham, Mass., started collecting blood here last fall. Since then, the Red Cross has collected 138 units of blood in Rhode Island — a drop in the bucket compared with the 90,000 units of whole blood that the Rhode Island Blood Center collects each year.
High-Toned Missions

On its surface, the whole thing is bewildering. Here are two non-profit organizations ostensibly dedicated to providing worthwhile health services for people in need.

The American Red Cross' mission is to:
provide relief to victims of disaster and help people prevent, prepare for, and respond to emergencies.

The Rhode Island Blood Center's mission is:
to provide a safe, adequate and cost-effective blood supply for the patients and the hospitals we serve.

Why can't we all just get along? Why should these organizations be fighting, especially over what amounts to market share? Wouldn't they be able to better support their missions by cooperating? 

Where Does the Money Go?

I cannot give a definitive answer to those questions. However, there are some clues.

Let us look at the latest available (2008) US Internal Revenue Service form 990 from the Rhode Island Blood Center, and the latest available (2009) form 990 from the American National Red Cross, the parent of the eastern Massachusetts chapter.

The ProJo article stated that the RI Blood Center collected some 90,000 units of blood last year. The most recent form 990 for that organization revealed that the RIBC had $33,043,096 in program service revenue from sale of blood or blood components for its 2008 tax year. Assuming that its blood collections were the same then as the ProJo reported, that means it got $367 in revenue per unit of blood it supplied. Note further that program service revenue accounted for about 88% of its total $37,478,357 revenue in 2008, revenue sufficient to create a $558,169 surplus

So the sale of blood is lucrative. That may come as a big surprise to blood donors, who are unpaid, (and do not even get a tax-deduction for a charitable donation in the US).

Now of course it may not be cheap to collect, test, store and distribute blood, that is, the core functions of the RIBC. But note further that in 2008, it was also lucrative to be an executive for RIBC. That year, Lawrence F Smith, the CEO, got $430,650 in total compensation; Scott J Asadorian, the COO, got $331,736, and Carolyn T Young, the CMO, got $273,052. Six other managers got more than $100,000. That seems to be very good pay for managers of a relatively small, regional non-profit whose revenues depend on voluntary donations of bodily fluids.

There are parallels with the American Red Cross, parent organization of the local Massachusetts chapter. It got a whopping $2,219,161,636 in program service revenue from "biomedical products & services" in 2009, which was about two-thirds of its total revenue of $3,587,775,430, and which generated a $233,597,985 surplus.

Being an executive of the American Red Cross was much more lucrative. In 2009, then CEO Gail McGovern received over a million in total compensation, $1,032,022 to be exact. Its President for Biomedical Services got $850,489. Its Executive VP for Biomedical Services got $596,309. Twelve other executives got more than $250,000. Of those, ten got more than $350,000.


This is all too reminiscent of a dispute we noted briefly here, which involved threatened litigation by the large Susan G Komen For the Cure foundation against other charities that dared to use the word "cure" in their own campaigns to fight cancer.

The current example does seem a bit more tawdry because the organizations in question depend for their revenue and to support their executives' posh pay on voluntary donations, not just of money, but of blood.  (And it is not the first example we have found that raises questions about non-profit blood banks, look here.)

We have gone on at great length about how health care organizations have been infected by the prevailing "greed is good" culture of US (and world) businesses. Some of the worst examples have come from for-profit companies, but nominally non-profit companies (NGOs, outside of the US) have become part of the epidemic. Instead of cooperating to do good works, some have taking to fighting over market share. We have shown numerous examples in which the leaders of health care non-profits got incentives unrelated to the degree they uphold their institutions' high-toned missions, (here is a recent example) and seem happy to do what it takes to keep their compensation high.

So, once more with feeling.... health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior.

What Is to Be Done?

Based on our ever enlarging file of cases on compensation of the top hired managers of non-profit health care organizations, let me make some concrete suggestions, based on my humble opinion.

A step forward would be to make the finances and compensation arrangements of health care non-profit organizations at least as transparent as those of large public for-profit organizations. So my big idea is:

Non-profit health care organizations above a reasonable threshold size should provide prompt, public, annual reports analogous and very similar to the reports required by the US Securities and Exchange Commission of public, for-profit companies.

These reports should include, at a minimum, a summary of financial and operational status, an audited financial report, an explanation and accounting for any for-profit subsidiaries and any interlocking non-profit organizations, the compensation given to the CEO and some minimum number of the top-paid officers and employees, a detailed explanation and rationale for the pay of these individuals, and a listing of other affiliations and all conflicts of interest affecting them.

If the need to supply such information causes non-profit health care organizations' hired executives and boards of trustees some cognitive dissonance, that would be a good thing.

Wednesday, July 20, 2011

BLOGSCAN - Bleeding Heart Prosecutors in the Thrall of "Economism"?

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody further analyzed the case of the soft-hearted prosecutors, which we discussed here.  He suggested that the systematically increasing leniency that the US government is displaying towards corporate wrong-doing is due to "economism," his tern for a "free-market" ideology that is inherently self-contradictory. 

Tuesday, July 19, 2011

Health Care for the Very Rich is Different from That for You and Me - the Case of the CEO's Six-Figure Hip Replacement

Another glimpse of health care for the very rich comes by way of a BNet post by Jim Edwards about the beleaguered CEO of Forest Laboratories.

The background is that:
The CEO is fighting to retain his place atop the company against both investor Carl Icahn, who wants his own directors on Forest’s board, and the Department of Health & Human Services, which wants to exclude Solomon from the drug business as a punishment for the company settling a $313 million investigation by the Department of Justice over its illegal marketing of Levothroid and other drugs.

We had posted about the government threat to disbar him from government business after his company here.

Edwards noted that despite these setbacks, Solomon's total compensation actually increased:
Forest Labs (FRX) reported that CEO Howard Solomon earned $8.9 million in fiscal 2011, 7 percent more than last year,...

This is par for the course for executive compensation in health care. We have discussed numerous instances in which such pay defies gravity, rising even when serious questions have been raised about the performance of the executives and the organizations they lead. We most recently belabored this issue here.

However, Edwards also wrote
The company also spent $316,638 on medical expenses for the 83-year-old CEO, up from $56,571 in 2010. The company’s proxy disclosure did not say what was wrong with Solomon. UPDATE: A spokesperson for the company said:

Mr. Solomon is in excellent health and has no ongoing medical conditions that would impair his ability to continue functioning as the Company’s CEO. A good portion of last year’s expense was related to hip replacement following a fall when he was playing tennis – which he has now reluctantly discontinued.

Later, he summarized the amounts the company paid for Mr Solomon's medical care in previous years:
Here’s how Solomon’s medical bills have increased over the last few years.

2011: $316,638
2010: $56,571
2009: $28,000
2008: $25,000

Mr Solomon is 83 years old, and therefore qualified years ago for Medicare, the US single payer health insurance system for the elderly and disabled. Medicare serves as the primary health insurance for many elderly people, and it covers hip replacements for quite a few of them. A publication by Zimmer, one of the larger manufacturers of prosthetic hips, noted that Medicare payment rates in 2009 for hip replacement were up to about $25,000 for hospitals, and up to about $1500 for surgical fees.

Yet Forest Laboratories increased its payments to Mr Solomon for health care by about $250,000 due to his hip replacement. This amount is obviously an order of magnitude bigger than the usual Medicare payments for hip replacements, and presumably was paid in addition to the amounts Medicare paid for this surgery.

Nothing in Mr Edwards' post, or in the proxy statement from which the numbers came explains the use to which the $250,000 was put. The size of the amount does suggest that Mr Solomon received some sort of health care much more expensive than that available to the general public.

We have previously noted a few instances (e.g. here)  suggesting that the amounts large corporations pay for their top executives' health care are far larger than even the high prices charged by commercial health insurers.  Information from litigation suggested that one retired corporate CEO was entitled to payments for all sorts of amenities, such as first-class transportation, services of personal aides and trainers, cosmetic procedures, etc in conjunction with his health care (see post here).  The case of the Forest Laboratories CEO provides more evidence that top corporate leaders receive health care in what amounts to a system separate from and in a tier above what even supposedly well-insured "regular people" can access. 

The existence of this separate health care system for very rich corporate executives may provide yet another explanation of why real health care reform is so difficult.  We have frequently suggested that those who have become rich from the current health care system are likely to strongly resist any changes to that system that might threaten their continued accumulation of wealth.  These peoples' riches provide them with the resources to fight such changes, e.g., through stealth policy advocacy (see posts here and here).  Furthermore, these peoples' access to a separate health care system for the very rich makes it extremely unlikely that they or their families will ever experience the problems that drive many common folk to despair about our current health care dysfunction.

Perhaps some intrepid investigative reporter will write a Pulitzer prize-worthy story about the parallel health care system for the very rich.  Perhaps some honest health services researcher will study how the existence of such a system affects policy-makers.

At the least, we deserve health care policy informed by how the health care affects real people, and not made solely by those who are sheltered from he vicissitudes of the real, and currently dysfunctional health care system.

Tuesday, July 12, 2011

Would You Like Fries With That? - The Fast Food Model for the Corporate Physician

Allegations that suggest the continuing degradation of the professionalism of employed physicians just appeared in the Palm Beach (FL) Post.  A former physician employee of Solantic Urgent Care, a for-profit chain of urgent care clinics, described to state investigators the life of employed physicians there.

Putting Revenue First

Physicians answered to managers who put revenue first:
Thirty-something business graduates lacking in any medical training supervised the clinics' doctors and were encouraged to maintain an adversarial relationship with them, Prokes said.

Those clinic managers' raises and bonuses depended on their achieving ambitious goals for patient visits, labor and overhead costs, per-patient revenues and customer satisfaction.

Prokes said clinic manager turnover was high, and a succession of managers wrote him up for a variety of infractions: arriving five minutes late, failing to suggest Solantic's pharmacy at three points of contact and suggesting a patient might want to return later, when there would be less of a wait.

As is common elsewhere, there was pressure to see as many patients as possible:
Prokes told state investigators that he found the atmosphere increasingly untenable, as he was pressed to see 70 to 90 patients each day.

'They actually told us not to sit down for 14-hour shifts,' Prokes told state investigators. '[Former Solantic CEO Rick] (Scott) does not care about the quality of medicine. They care about how fast you see people.'

A Business Model from the Fast-Food Industry

A former Solantic executive admitted that the business model came straight from the fast-food industry:
[Former Solantic Chief Operating Officer Shaun] Ginter said the retail concept that he, Scott, and then-CEO Karen Bowling created drew on lessons from the fast food and other retail industries. Counters were built at standing height, for example, because it speeded workflow, he said.

'The culture, the workflow, were all streamlined for a more efficient delivery, a more efficient method of care,' said Ginter, who had previously managed drug stores with small clinics within. 'The name of the game is keeping your costs tight, and Rick, Karen and myself were very focused on keeping costs down.'

Up-Selling Unneeded Services

Just as in the fast food industry, the help was expected to up-sell. In particular, Dr Prokes charged that physicians were strongly pushed to suggest services patients did not need, but that brought in more revenue:
Doctors were monitored with cameras in the clinics' common areas, [Dr Randy] Prokes told investigators. Staff were expected to suggest extras, including vitamins and probiotics, and a colon cancer screening test considered unreliable and outdated by CDC officials.

The Background: Rick Scott, Columbia/HCA, and the State of Florida

Note that Rick Scott just sold Solantic LLC to private equity group Welsh, Carson, Anderson & Stowe, per the Jacksonville (FL) Business Journal. Note further that Scott was the former CEO of Columbia/ HCA, which ultimately paid a huge fine for fraudulant practices:
John Schilling was working as reimbursement supervisor for Columbia/HCA's Southwest Florida division, where he oversaw Medicare and Medicaid compliance and the cost reporting.

'Before HCA, when it was just Columbia, the CEOs of the hospitals were making up to 100 percent of their salaries as a bonus; the CFOs made 50 percent. Even some of the directors were making 25 percent bonuses,' Schilling said.

It drove a do-anything-to-make-the-numbers mentality, he said. Schilling now runs a firm called Ethics Solutions, where he helps potential whistleblowers.

'There were no incentives for being in compliance with Medicare and Medicaid rules,' Schilling said. 'It was about, how are we going to make it profitable, and if we meet our goals, it means we get our bonuses.'

He found that the hospitals in his area kept two sets of books. The one for Medicare auditors showed inflated costs, so that hospitals could justify higher reimbursement rates to take advantage of a funding formula that has since changed.

The hospitals also kept 'real' books with different numbers. The discovery put him in an ethical bind, he said. When he took his concerns to a supervisor, he was told not to rock the boat. Ultimately, his whistleblower lawsuit proved among the most damaging to his employer, which eventually paid $1.7 billion to the federal government to settle criminal fraud and abuse charges.

Scott, who wanted to fight the charges rather than settle, was never charged, and said he was unaware of what his managers had been doing.

After Scott left Columbia / HCA, he used the riches he acquired as its hired executive to help fund an ultimately successful campaign for the governorship of Florida, his current office. (See posts here and here.)


We have previously posted, most recently here, about how physicians are increasingly becoming employees of for-profit corporations. We have discussed other instances in which such corporations are appearing to pressure physicians to provide "care" to patients in such a manner as to increase corporate revenue, whether or not it is good for patients. We noted that when insurance companies hire physicians, they are likely to push them into providing less care across the board, since the insurers are paid per patient, not for what is done to each patient. When hospitals, hospital systems, and other entities that directly provide care hire physicians, they are likely to push them into channeling patients to get tests, drugs, and procedures for which the corporations are most highly paid.

In this current case, the allegations fit the latter pattern. Furthermore, At least one former executive admitted that "the name of your game is keeping your costs tight," not providing the best patient care.

There is more and more evidence that doctors who provide direct patient care as employees of for-profit corporations, and possibly other large organizations, are being increasingly pushed to put corporate revenue ahead of their patients' best interests. It should be obvious that this is unethical. Doctors swear oaths to put their patients' interests first.

Patients should be extremely wary of the care provided by doctors who are employed by large organizations. Doctors should be extremely wary of working for such organizations to provide direct patient care.

Below, I have repeated my humble suggestions from last week, with some additions, for

What Is to Be Done?

- Find out if their physicians are employed, and if so, by whom.
- Find out what incentives their physicians have, if employed, to recommend more or less care of certain types.
- Find out whether other aspects of the physicians' employment arrangements, e.g., contractual confidentiality clauses, could affect his or her relationships with patients
- Avoid doctors employed by for-profit companies who have incentives to provide more or less care than what may be best for the patient

- Do not accept any employment offer or contract which has incentives to provide more or less care than is best for individual patients
- Who are already employed disclose to their patients such employment, and any incentives it may provide to provide more or less care
- Urge professional societies, and certifying and accrediting organizations to further investigate threats to physicians' professionalism arising from employment, and develop strategies to mitigate such threats

- Rapidly investigate the extent that for-profit companies whose revenues depend on physicians' decisions are hiring physicians to take care of patients, and the incentives and influences that these companies use to affect physicians' decisions
- Develop regulations that force disclosure of all such employment and relevant incentives and influences
- Consider further regulation of organizations that so employ physicians
- Consider whether such "commercial practice of medicine" ought to be once again banned.

ADDENDUM (12 July, 2011) -  See also this related post on KevinMD.

Monday, July 11, 2011

The Case of the Bleeding Heart Prosecutors - How the Justice Department Became Lenient with Corporate Wrong-Doing

We have frequently posted, some may say tiresomely, about the lack of consequences or negative incentives for health care organizational leaders involved in wrong-doing.  For example, see the numerous cases against health care organizations that resulted in legal settlements, almost never requiring any penalties against individuals who authorized, directed, or implemented the behavior in question.

Now a major article in the New York Times by Gretchen Morgenson and Louise Story explains some of the history behind this aspect of the decreasing accountability of corporate leadership.  Their article focused on financial corporate leadership, but clearly is generalizable to health care corporate leadership.

Banks Asked to Report Their Own Misbehavior

The Times article documents how the US Department of Justice deliberately became more lenient in the 1990s, supposedly to conserve scarce investigational resources:
dating to the mid-1990s ... banks were asked to regularly report suspicious activities to the Treasury Department, an effort that aimed at relieving regulators of some of their enforcement loads.

The Effect of the Arthur Andersen Case

Around the beginning of the 21st century there had been some vigorous prosecution of corporate financial wrong-doing:
The names have become synonymous with corporate wrongdoing — and forceful prosecution: Not just Enron, but also WorldCom, Tyco, Adelphia, Rite Aid and ImClone. In the early part of the last decade, senior executives at all these companies were convicted and imprisoned.

However, for reasons that were not explained, a single unsuccessful case caused reconsideration of this approach:
The department began pulling back from a more aggressive pursuit of white-collar crime around 2005, say defense lawyers and former prosecutors, after the Supreme Court overturned a conviction it won against the accounting firm Arthur Andersen. That ended an era of brass-knuckle prosecutions related to fraud at companies like Enron.

Sympathy for the Targets of Investigation

The pullback was rationalized for a sudden sympathy for the objects of investigation:
But by 2005, a debate was growing over aggressive prosecutions, as some business leaders had been criticizing the approach as perhaps too zealous.

That May, Justice Department officials met ahead of a session with a cross-agency group called the Corporate Fraud Task Force. It was weeks after Justice Department lawyers had presented to the Supreme Court their case against Arthur Andersen, which was seeking — successfully, it would turn out — to overturn its criminal fraud conviction in a prominent case.

In the meeting, the deputy attorney general at the time, James B. Comey, posed questions that surprised some attendees, according to two people there who asked to remain anonymous because they were not supposed to discuss private meetings.

Was American business being hurt by the Justice Department’s investigations?, Mr. Comey asked, according to these two people, who said they thought the message had come from others. He cautioned colleagues to be responsible. 'It was a total retrenchment,' one of the people said. 'It was like we were going backwards.'

Mr. Comey said recently that he did not recall this conversation.

Around the same time, the Justice Department was developing instructions on dealing with companies under investigation — particularly companies that work with the government. It issued a memo in 2003 that gave companies more credit for cooperating than in the past. That message was reinforced in another memo in 2006.

As the first memo put it, 'it is entirely proper in many investigations for a prosecutor to consider the corporation’s pre-indictment conduct, e.g., voluntary disclosure, cooperation, remediation or restitution, in determining whether to seek an indictment.'

During this period, the Justice Department increased the use of deferred prosecutions or even nonprosecution agreements.

Many well-known companies have benefited. In 2004, the American International Group, the giant insurer, paid $126 million when it entered a deferred prosecution agreement to settle investigations into claims that it had helped clients improperly burnish financial statements.

Deals over accounting improprieties also were struck that year by Computer Associates International, a technology company, and in 2005 by Bristol- Myers Squibb, a pharmaceutical concern. Prudential Financial entered into a deferred prosecution in 2006 over improper mutual fund trading.

Note that while the emphasis of this article was on the financial services industry, big health care organizations were also benefiting from more lenient treatment.  Note also that one firm given lenient treatment, AIG, went on to threaten collapse, a collapse that was feared could take down the entire world financial system, and hence was given a very generous government bail-out, which has not be paid back to this day. 

Formalized Leniency

In 2008, the approach was formalized:
As the financial storm brewed in the summer of 2008 and institutions feared for their survival, a bit of good news bubbled through large banks and the law firms that defend them.

Federal prosecutors officially adopted new guidelines about charging corporations with crimes — a softer approach that, longtime white-collar lawyers and former federal prosecutors say, helps explain the dearth of criminal cases despite a raft of inquiries into the financial crisis.

Though little noticed outside legal circles, the guidelines were welcomed by firms representing banks. The Justice Department’s directive, involving a process known as deferred prosecutions, signaled 'an important step away from the more aggressive prosecutorial practices seen in some cases under their predecessors,' Sullivan & Cromwell, a prominent Wall Street law firm, told clients in a memo that September.

The guidelines left open a possibility other than guilty or not guilty, giving leniency often if companies investigated and reported their own wrongdoing. In return, the government could enter into agreements to delay or cancel the prosecution if the companies promised to change their behavior.

Less Deterrence

The NY Times article documented a number of opinions that increasing leniency was resulting in less deterrence of bad behavior:
'If you do not punish crimes, there’s really no reason they won’t happen again,' said Mary Ramirez, a professor at Washburn University School of Law and a former assistant United States attorney. 'I worry and so do a lot of economists that we have created no disincentives for committing fraud or white-collar crime, in particular in the financial space.'

Why So Much Sympathy from Prosecutors?

What was not really clear from the article is why US federal prosecutors seemed to go from their stereotypically tough on crime personas to bleeding hearts for corporate criminals. The one rationale the article provided from the Department of Justice was:
Defending the department’s approach, Alisa Finelli, a spokeswoman, said deferred prosecution agreements require that corporations pay penalties and restitution, correct criminal conduct and 'achieve these results without causing the loss of jobs, the loss of pensions and other significant negative consequences to innocent parties who played no role in the criminal conduct, were unaware of it or were unable to prevent it.'

This, however, makes no sense. Well directed prosecutions of the people who apparently authorized, directed or implemented the wrong-doing ought to have very little effect on "innocent parties." The only jobs and pensions that should be lost should be those of the accused.


This seems to be the most recently documented example of important but overlooked, or concealed changes in government policies that have enabled the health care system to become more unethical, dishonest and corrupt, and hence more dysfunctional.

Here we discussed a Supreme Court decision interpreting US anti-trust law that has been used to prevent medical societies from enforcing ethical rules, and hence helped medicine to become increasingly commercialized, and to increasingly put money ahead of patient care.

Here we discussed little discussed legislation from 1945 that allowed US insurance companies/ managed care organizations to avoid federal anti-trust investigation and enforcement, and hence to increased market power.

Here we discussed failure of the executive branch, and especially the Department of Justice to use existing legal doctrine, the Responsible Corporate Officer Doctrine, available since 1943, to make corporate leaders responsible for their companies' bad behaviors, leading to their increasing lack of accountability and less deterrence of malfeasance.

Now we have seen a deliberate turn away from even direct penalties on corporations which have misbehaved, in return basically for a promise that "we won't do it again."

The first two examples may be of unintended consequences.

The last two seem to signal an increased coziness between some in government and corporations. The origins of this coziness just beg for investigation.

Meanwhile, there seems to be no evidence that the government's new leniency has protected innocent people who would have been harmed by the previous tougher approach. Instead, there seems to be a growing tide of bad behavior by health care organizations, exemplified by the nature of some of the bad behavior that lead to the march of legal settlements, and to the deferred prosecution agreements and corporate integrity agreements generated in response to the new policies.

What Is to Be Done?

- There clearly needs to be investigation, both by journalists and at a congressional level, of Department of Justice policies that have been increasingly lenient to and cozy with large corporations, including health care corporations.

- Current Department of Justice officials need to be reminded that their clients are the US people, not corporate executives, no matter how hearty and well-met.

ADDENDUM (12 July, 2011) -  See this related post on the Naked Capitalism blog.

ADDENDUM (19 July, 2011) - See related post by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

Friday, July 08, 2011

Guest Blog: Health Care in Dangerous Times

Health Care Renewal presents another guest blog by Steve Lucas, a retired businessman who formerly worked in real estate and construction who has a long standing interest in business ethics, and has long observed the health care scene.

Health Care Renewal has often covered the disconnect between the stated goals of companies and the realities of their day to day operations. This raised the following question: Has medicine moved from being dysfunctional to being dangerous?

There is certainly no lack of material to support this question as in the last two weeks we can find examples of pharma/biotech/device companies all engaged in questionable behavior.

Medtronic and Manipulation of Study Data

In the print media, The Wall Street Journal, a pro-business newspaper regularly highlights stories questioning the actions of companies.

In the June 29 story titled "Medtronic Surgeons Held Back, Study Says" by John Carreyrou and Tom McGinty we find doctors being paid by Medtronic held back information regarding negative out comes of a bone growth product.
'Medtronic paid millions to doctors and those same doctors, oddly enough, published the 'science' Medtronic needed to sell a product,' says Paul Thacker, a former aide to Sen. Charles Grassely…'

Chantix's Cardiac Adverse Effects

In the July 5 story, "Pfizer Drug Tied To Heart Risk" by Thomas M. Burton covers the increased cardiovascular problems with Chantix that only now seemingly have become evident.

However, J. Taylor Hays, a Mayo Clinic doctor who has received funding from Pfizer for research on Chantix, responded in a commentary, 'The risk for serious cardiovascular events is low and is greatly outweighed by the benefits of diminishing the truly 'heartbreaking' of smoking.'
The article then continues:
'Some people have had changes in behavior, hostility, agitation, depressing mood, suicidal thoughts or actions while using Chantix to help them quit smoking,' Pfizer says in safety information.

Overuse of Cardiac Stents

In the July 6 article, "Heart Treatment Overused" by Ron Winslow and John Carreyrou we find the over use of stents and the profit potential for doctors and hospitals.

Outside of heart attacks, doctors are often quick to use a common $20,000 procedure to treat patients suffering from coronary artery disease, a new study suggest.

Untested Imported Drug Ingredients

In the July 6 Op-ed, "Beware the Risk of Generic Drugs" by Roger Bate reinforces a point made often on Health Care Renewal when he covers the importation of untested or tainted product used in our pharmaceuticals.
China is now the largest supplier of pharmaceutical chemicals – hundreds of tons annually – to the world. And pharmaceutical companies that buy these chemicals do not test them.

Moving on to widely read blogs,

Ghost Writing and Risperdal

1BoringOldMan in his post on bipolar kids and the doctors involved in the Harvard debacle discussed an article favorable to the drug ostensibly written by Harvard Professor Josephy Biederman:

This covers the reworking of a previously done study to promote the use of drugs in children with this printed at the bottom of the first page:

“"Printed in the USA. Reproduction in whole or part is not permitted. Copyright © 2006 Excerpta Medica, Inc."

1BoringOldMan continues with this post that since we have identified children as bipolar we are free to ignore other factors and simply medicate them to death.

As reported by '60 Minutes' in September of last year, Rebecca Riley died on December 13, 2006, at her home in Hull, Massachusetts, due to an overdose of psychiatric drugs. The drugs — Depakote (divalproex; Abbott), Seroquel (quetiapine; AstraZeneca), and clonazepam — were prescribed by Tufts psychiatrist Kayoko Kifuji for the child’s bipolar disorder, which was diagnosed at the age of 2 years.
This covers the death of a child, a child, using the above ghost written drug information.

Bayer's Use of Social Media to Market Drugs

Pharma does adjust to the times and market, if it is not explicitly forbidden then it is fair game.

Per a post in Pharmalot entitled, "To Tweet or not to Tweet"

'To Tweet or not to Tweet?' That is a question that Bayer Healthcare will be pondering for some time. The drugmaker was upbraided by the UK’s Prescription Medicines Code of Practice Authority for recently Tweeting about two medicines, which was deemed to be a cause for concern since the information went directly to the public.

Much like shooting a gun into a crowd and then claiming they had no way of knowing they would injure someone, a tweet is sent with the full knowledge the first thing everybody will do is hit the forward to all button.

Pharma's Public Relations People Infiltrate Patient Support Groups

Per a post on the HealthReviewNews Blog we have one of the most frightening posts possible since it shows pharma following individuals and a willingness to intrude into their personal lives.

Marilyn Mann is approached on her Facebook page set up to support parents of children with lipid disorders by a drug PR person to promote a drug.

Hi Marilyn,

A few months ago, I had emailed you about some research I was doing about a new treatment for FH. I am now working with a pharmaceutical company, and the company currently has a drug in development to help treat people with severe FH that may not be responding to current therapies.

In the comment section we find this:

I'm a communications consultant to many big pharma firms and I'm not sure the PR person in this case did anything wrong. She was upfront and polite about her role, and asked if any patients would do what many have done, and be interviewed to raise the profile of FH.
The owner of the group politely declined as was her right.
It would have been a different case if there had been any subterfuge involved, but there wasn't.
I think on this occasion you have aimed at the wrong target.
Good luck with future postings.

What do all of these references have in common? Senior executives, and health care academics, removed from the day to day work of helping people being able to claim they are not responsible while making ever larger incomes.

Natrecor Shown Not to Work

The corporate culture of medicine has become so perverse that even selling a drug that has no benefit becomes acceptable.

Per this item in the Heart Health Center Health Day News:

Study Finds Heart Failure Drug Ineffective

Billions wasted on Natrecor in decade it took to find out it doesn't work, expert says.

By Steven Reinberg, HealthDay News

WEDNESDAY, July 6 (HealthDay News) — The heart failure drug Natrecor (nesiritide) is ineffective and linked to increased rates of potentially dangerous low blood pressure, a new study finds.

Summary: The Most Dangerous Game

So, back to my original question: Has medicine become dysfunctional or dangerous? I would contend dangerous. There is nothing magical about the above listed articles or posts. I am not a professional medical person, nor an academic, only someone concerned by the continued decline of medicine and medical care due to a corporate culture that promotes profit above all else.

When I meet doctors socially they all speak of being small businessmen. Time and time again we see hospital administrators of all types speaking about being the CEO’s of multi-billion dollar organizations.

Drug companies speak of blockbuster drugs as being those with sales of over one billion dollars and fines become the cost of doing business.

Today we have a small, but vocal group of people who feel all drugs should be offered to the public and it is up to them to decide if they are appropriate. They also want the government and insurance companies to pay for this return to the pre-FDA days.

How will the FDA itself withstand the onslaught of new technologies given out current Federal budget concerns? Tweets and Facebook represent only the beginning of a whole new wave of ways to communicate.

My personal opinion is this is a very dangerous time for doctors and patients. Doctors are being pushed into corporate practices where financial gain is the main driver, not health care. Information given to doctors can be so tainted by commercial interest as to be of no value.

Patients have no way of knowing where the doctor’s loyalty lies, with them or the practice? DTC ads are full of half truths and fear mongering. Patients need to bring even more information and skepticism to the doctor/patient relationship.

I fear we do live in dangerous times. The word “good” has left much of medicine.

Steven Lucas MBA