Health Care Renewal

KevinMD: How algorithm driven medicine can affect (make more dangerous, actually) patient care

2012-02-02T13:00:00.006-05:00

Reposted from KevinMD blog on another aspect of the health IT mission hostile user experience. Emphases and comments in [red italics] are mine:

How algorithm driven medicine can affect patient care
by Jeffrey Parks, MD

Whenever someone is scheduled for an operation, the assigned nurse is required to fill out a “pre-op checklist” to ensure that all safety and quality metrics are being adhered to. Before the patient is allowed to be wheeled into the OR we make sure the surgical site is marked, the consents are signed, all necessary equipment is available, etc. One of the most important metrics involves the peri-operative administration of IV antibiotics. SCIP guidelines mandate that the prophylactic antibiotic is given within an hour of incision time to optimize outcomes. This has been drilled into the heads of physicians, health care providers, and ancillary staff to such an extent that it occasionally causes total brain shutdown.
Let me explain. For most elective surgeries I give a single dose of antibiotics just before I cut. For elective colon surgery, the antibiotics are continued for 24 hours post-op. This is accepted standard of care. You don’t want to give antibiotics inappropriately or continue them indefinitely.
But what about a patient with gangrenous cholecystitis or acute appendicitis? What if, in my clinical judgment, I want to start the patient on antibiotics right away (i.e. several hours before anticipated incision time) and then continue them for greater than 24 hours post-op, depending on what the clinical status warrants? I should be able to do that right? [No - wrong - the idiots who designed your system forgot that robotic medicine is bad medicine - ed.]
Well, you’d be surprised. [No, actually, I'm not. I'd have been more surprised to see a system not impeding critical medical decisions tailored to the individual patient - ed.]
You see, at two different, unaffiliated hospitals I cover, the surgeons have seen that decision-making capability removed from their power. If a young patient comes in with acute appendicitis and I feel that it would be prudent to continue the Zosyn an extra couple of days, an automatic stop order is triggered in the department of pharmacy and the antibiotic is stopped after 24 hours, no matter what. Unless the surgeon specifically writes “please do not stop this antibiotic after 24 hours; it is being administered for therapeutic purposes, not prophylaxis [that sounds a bit like begging - ed.] ,” the antibiotic will not be sent to the patient’s floor for administration. As a result, patients end up being treated sub-optimally, and potentially harmed, due to an over-emphasis on “protocol” and “quality care metrics.”
Similarly, the 60-minute timeline for pre-operative antibiotic administration can be problematic. I have had patients come into the ER with appendicitis or cholecystitis and, in my pre-op orders, write for Zosyn or whatever, to be started ASAP, no matter what time the operation is scheduled. Not too long ago, I admitted a gallbladder over the phone at 2am. I gave the nurse admitting orders which included one for a broad spectrum antibiotic.
When I saw the patient in the morning, I added her on to the OR schedule. By the time a room opened up, it was about 10:30am. The OR nurse asked me if I wanted to give an antibiotic for the case. I told her that the patient was already on antibiotics as part of her admit orders for treatment. The nurse shook her hand. It had never been given; the floor nurse held it so that it wasn’t administered until 60 minutes before the scheduled OR time, just like the algorithm dictates — despite the fact it had been ordered nearly 8 hours prior to the case, not for peri-op prophylaxis, but for treatment of an established pathology. [This is how EHR-induced malpractice occurs, readers. Guess who bears liability? - ed.]
And there it was, the cefotetan, hanging on her IV stand. Now nothing bad happened [this time, due to luck - ed.], but here you have a situation where health care providers are so terrified of violating Quality Assurance Protocol that they end up withholding necessary treatment. It’s just astounding. [It's astounding the surgeons don't simply use a scalpel on the computer terminal network and power cables to protect their patients - ed.]
As surgeons, we have bitched and moaned. You would think that these issues would be quickly rectified. But no. It is the responsibility of the surgeon to write qualifying statements [a workaround to a 'feature' that turns medical judgment on its head - ed.] for therapeutic antibiotics because the default mode is to override a licensed physician’s clinical judgment. [Not mentioned is who is overriding that judgment through cybernetic proxy - ed.]
This is what I’m talking about when I say that blind allegiance to a top-down, systems analysis-driven algorithm can turn everyone involved in health care into a bunch of mindless drones.
Jeffrey Parks is a general surgeon who blogs at Buckeye Surgeon.

I will simply add that these issues are one of poor design and implementation, with IT getting in a physician's way regarding tailoring of care to the individual patient.

An inviolable rule in health IT is - or needs to be -

"You should not have to work around something that is not in the way."

There is nothing to debate or discuss on this issue.

-- SS

EHR Workstation Designed by Amateurs

2012-02-01T13:15:00.012-05:00

Below is an actual workstation, in an ICU, to permit interaction with an already mission-hostile EHR system:

How many things are wrong here? (Click to enlarge)

I can charitably say this workstation, in this recent picture, was designed by amateurs. Less charitably, I would use the words 'morons.'

How many things are wrong here? For starters (commenters are welcome to suggest additions to the list):

Small square (4x3) monitor, when large 16x9 monitors are available quite cheaply at retail;

Monitor in front of window so on sunny days, glare causes eye strain;

Monitor forces user to look away from the patient, with their back facing the patient behind them;

Standard keyboard and mouse to help spread infection, not medical-specialty devices such as membrane-based or membrane-covered keyboards and easily cleanable trackpads;

Very slow, small, toy-ish nettop computer, to facilitate responsiveness delays;

Height of ledge with keyboard/mouse and of elevated monitor on ledge does not facilitate comfortable ergonomics when sitting, note chair in background (or standing as is intended, either, although I don't recall ever making entries in the permanent paper chart on my feet). It seems nobody ever heard of an appropriate moveable workstation desk;

Tangle of wires behind setup facilitates "accidents."

There are probably a few more "issues" I'm missing.

There is nothing to argue here and nothing to debate. Combined with the mission hostile virtual user interfaces presented by health IT software itself, this is inexcusable.

Apart from designers, any physicians and nurses who would accept such poor choices - and the cause of this workstation's problems were, in fact, deliberate choices - are either weak-kneed morons themselves, or enjoy EHR-induced medical errors (and lawsuits).

The workstations are poorly designed like this all throughout this hospital, including the ED.

This is not the first time I've observed this type of amateurism in hospitals. I observed similar issues in another ICU - over a decade ago. Hospitals are truly an IT backwater.

-- SS

What is Life is Really Like in Pharma? - These xtranormal Video Cartoons Come Close.

2012-02-01T01:35:00.011-05:00

Sadly, the 'xtranormal' video cartoons at the following URL capture all too well what life is like in the pharmaceutical industry - buzzwords, neologisms, nouns turned into verbs, new paradigms, team players - and per the site, endless inane "initiatives" and related threats to sanity.

I've been there; while a parody, these videos are uncomfortably close to reality.

http://www.youtube.com/user/ZombieSymmetry/feed

"I'll have to ideate on that for awhile, Mike"

Even sadder are managers who believe their own babble.

-- SS

How the Anechoic Effect Is Institutionalized - A Hospital Policy Against Unsupervised Discussion with the Media

2012-01-31T14:58:00.000-05:00

In a single sentence, a short, obscure article in the Worcester (MA) Business Journal on life at a community hospital after a for-profit corporate take-over:

Several Nashoba employees, who didn't want their names used because it's against hospital policy to talk to the media without authorization, said they're happy with the new insurance plan.

We have often discussed the anechoic effect, how cases involving or discussions of the topics we address on Health Care Renewal, the concentration and abuse of power in health care, fail to produce any responses, or echoes. It was almost an aside, but the sentence above provides evidence of the existence of apparently blanket hospital policies against unsupervised discussion with the media. Here is an example of the institutionalization of the anechoic effect.

This example raises three immediate questions. How prevalent is this? How long has it been going on? What is it meant to hide?

Prevalence

This article is only about a single hospital. However, the context of the article is the take-over of Nashoba Hospital by Steward Health Care. Steward Health Care is a for-profit health care corporation that grew out of the take-over of the formerly not-for-profit Caritas Christi health system by the private equity firm Cerberus Capital Management. Steward Health Care now comprises eight hospitals, and also owns physician practices (apparently including over 2000 doctors based on a quick search using its "doctor finder" function.) Thus it is likely that the policy at Nashoba Hospital that prevents unsupervised discussion with the media also applies at seven other hospitals, and perhaps to the practices of over 2000 doctors. Thus it is very likely that this hospital gag policy is not unique, and may be widespread. However, recursively, the existence of such gag policies will make it hard to determine their own prevalence.

Note that we have posted a few times about confidentiality clauses mainly within physicians' contracts here.

Duration

This policy is likely relatively new, since the take-over of Caritas Christi by Cerberus occurred in 2010. My guess is that the rise of such policies may parallel the resurgence of for-profit hospitals and hospital systems, and perhaps the new involvement of private equity firms in such organizations.

In my humble experience, gag policies and confidentiality clauses at least within non-profit teaching hospitals were virtually unheard of from the time I began medical school (1974) to when I left my last full-time academic medical position (2005).

Note that we recently found out (because of investigative journalism about presidential candidate Mitt Romney's previous involvement with private equity firm Bain Capital) that such firms are generally rebranded leveraged buy-out firms. They have become known for their secretiveness. Therefore, maybe it should not be surprising that they have imposed such secretiveness on hospitals and health care professionals.

Rationale

The big question is why should hospital employees not be allowed to talk to the media without management supervision? I can only speculate.

In this case, perhaps such secretiveness is just the habit of the private equity executives who now run the hospital system. Even if this is the reason, they ought to reconsider. Hospitals and health care professionals due have a solemn obligation to keep confidential their patients' medical information. However, otherwise health care organizations and health care professionals ought to be as transparent as possible.

Maintaining such a level of secrecy could lead to some suspicions, for example, that the generic managers of the organization distrust the professionals they hire who actually provide patient care; worse, that the managers fear discussion that might question their actions or abilities; worse, that the managers want to silence whistle-blowers; or even worse, that the managers have something unethical or illegal to hide. That is all speculation, of course.

On the other hand, we have discussed again and again how the anechoic effect has stifled discussion of what is wrong with health care, and hence prevented meaningful health care reform. Gagging hospital employees is an obvious extension and institutionalization of the anechoic effect. It should not be done, because we need honest discussion of what is really wrong with health care so we can come up with some real solutions.

Can You Sue the Government? FDA Whistleblowers Sue Over Surveillance of Personal e-Mail

2012-01-30T13:26:00.012-05:00

From the Washington Post:

FDA staffers sue agency over surveillance of personal e-mail
Ellen Nakashima and Lisa Rein
January 29, 2012

The Food and Drug Administration secretly monitored the personal e-mail of a group of its own scientists and doctors after they [the scientists - ed.] warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients, government documents show.

The surveillance — detailed in e-mails and memos unearthed by six of the scientists and doctors, who filed a lawsuit against the FDA in U.S. District Court in Washington last week — took place over two years as the plaintiffs accessed their personal Gmail accounts from government computers.

While accessing Gmail from government computers was not a wise idea, since all traffic over an institutional PC and network can be monitored, these Gmails were apparently to members of Congress.

Copies of the e-mails show that, starting in January 2009, the FDA intercepted communications with congressional staffers and draft versions of whistleblower complaints complete with editing notes in the margins. The agency also took electronic snapshots of the computer desktops of the FDA employees and reviewed documents they saved on the hard drives of their government computers.

See sample emails at link above.

Information garnered this way eventually contributed to the harassment or dismissal of all six of the FDA employees, the suit alleges. All had worked in an office responsible for reviewing devices for cancer screening and other purposes.

That's very unfortunate.

It will be far more unfortunate if the warnings of the six, as in this whistleblower case, went unheeded, and patients are injured or die as a result. In that case, FDA bureaucrats might have been accessories to those injuries or deaths.

“Who would have thought that they would have the nerve to be monitoring my communications to Congress?” said Robert C. Smith, one of the plaintiffs in the suit, a former radiology professor at Yale and Cornell universities who worked as a device reviewer at the FDA until his contract was not renewed in July 2010. “How dare they?”

I, on the other hand, would have expected it. It would have been far more prudent to send such emails from a private home computer and ISP.

The scientists and doctors denied sharing information improperly. The HHS inspector general’s office, which oversees FDA operations, declined to pursue an investigation, finding no evidence of criminal conduct. It also said that the doctors and scientists had a legal right to air their concerns to Congress or journalists.
FDA officials sought a second time that year to initiate action against the scientists and doctors. “We have obtained new information confirming the existence of information disclosures that undermine the integrity and mission of the FDA and, we believe, may be prohibited by law,” wrote Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, on June 28, 2010.
The inspector general, after consulting with federal prosecutors, declined the second request, as well.

The IG office seemed to find the behavior legal, but FDA bureaucrats apparently did not like non-team players.

The FDA scientists and doctors, all of whom worked for the agency’s Office of Device Evaluation, said they first made internal complaints beginning in 2007 that the agency had approved or was on the verge of approving at least a dozen radiological devices whose effectiveness was not proven and that posed risks to millions of patients. Frustrated, they also brought their concerns to Congress, the White House and the HHS inspector general.
Three of the devices risked missing signs of breast cancer, the scientists and doctors warned, according to documents and interviews. Another risked falsely diagnosing osteoporosis, leading to unnecessary treatments; one ultrasound device could malfunction while monitoring pregnant women in labor, risking harm to the fetus; and several devices for colon cancer screening used such heavy doses of radiation that they risked causing cancer in otherwise healthy people, the FDA scientists and doctors said.

Permit me to wonder if regulatory capture played a role in these decisions.

One might also wonder if complaints about electronic health records or other clinical IT, admitted by FDA to be a medical device "political hot potato" they elected to not regulate, were also involved.

... The first documented FDA interception was of an e-mail dated Jan. 29, 2009, shortly after the letter from Ferry. In it, device reviewer Paul T. Hardy asked a congressional aide, Joanne Royce, for assurances that “it is not a crime to provide information to the Congress about potential misconduct by another Agency employee.”
Royce replied: “[Y]ou and your colleagues have committed no crime. . . . you guys didn’t even provide confidential business information to Congress.”

The only 'crime' was apparently not being a 'team player', which on Healthcare Renewal has been defined as someone who is silent, or silenced, or a co-conspirator regarding managerial mediocrity, malfeasance, or madness.

Hardy, who is among the six employees who filed the suit, was fired in November after a negative performance review; an internal FDA letter obtained in separate litigation quoted managers saying they did not “trust” him. Of the other five scientists and doctors, the suit says two did not have their contracts renewed, two suffered harassment and werepassed over for promotions, and one was fired.

Trust him to do - what, I ask?

Read the whole WaPo article.

Plaintiff's lawyers need to be aware of this event, and I intend to make them aware.

-- SS

Elephants We Can Notice But Cannot Name

2012-01-27T15:30:00.001-05:00

We have often discussed the anechoic effect, how cases involving or discussions of the topics we address on Health Care Renewal, the concentration and abuse of power in health care, fail to produce any responses, or echoes.

Last month, an article with the provocative title, "Elephants in Academic Medicine," by Souba et al addressed the anechoic effect, but was unable to discuss what people in academic medicine cannot discuss.(1)

"Organizational Silence"

In summary, the authors surveyed chairs of departments of medicine and surgery at all accredited US medical schools to ask about the "elephants in their living rooms." By this they meant the problems which people are unwilling to discuss at their medical schools. Their goal was to assess "organizational silence" in academic medicine, as they discussed in their introduction:

Morrison and Milliken popularized the term 'organizational silence,' which refers to the collective-level phenomenon of doing or saying very little about the problems facing an organization. Organizational silence derives both from people's fears of negative feedback and from a set of behavioral cues adopted by supervisors that lead to structures, procedures, and processes that discourage speaking up. Two common structural features of organizations that foster organizational silence are centralized decision making and a lack of formal feedback mechanisms.

Some organizations face an apparent dilemma in which employees know the truth about specific problems within the organization yet dare not speak that truth to their superiors. A key factor that fosters the creation of a climate of organizational silence is senior leaders' fears of receiving criticism, especially from subordinates. The unwritten message from the top is 'No bad or unpleasant news.' Fearing retaliation or the label 'not a team player' if they speak their minds, subordinates become silent; even if they do speak up, they may discover that their feedback is disregarded. A culture of silence becomes ingrained.

Methods

The investigators sought to learn from these academic leaders:

(1) What are the major elephants in your AHC [academic health center]? (2) What do you believe to be the most prevalent reasons people do not speak up? and (3) What are the consequences of remaining silent?

The survey response rate was 55%. The major elephants, in the order that they were ranked by the participants, were
- misalignment between goals and available resources
- ignoring information that clearly indicates a performance problem
- unwillingness to give up on a failed strategy
- unwillingness to speak up about inequities (e.g., pay, space, favoritism, special deals)
- failure to deal with disruptive behavior

The wording of these items were chosen by the investigators. The survey allowed for respondents to write in additional items, but the paper did not discuss any such responses. Its discussion of the results did not further define the nature of any elephants.

In addition, survey results suggested that more open discussion is unlikely to be in the offing.

- The majority of respondents thought that the elephants were someone else's problem:

Both chairs of surgery and of medicine believed that elephants are more commonly ignored by deans and hospital leaders than by other department chairs or themselves. Surgery chairs were more likely to say that hospital leaders ignore elephants, whereas medicine chairs were more likely to say that deans disregard elephants.

- The majority thought that other leaders did not encourage discussion of elephants:

Only 52 of the chairs (37%) said that elephants are usually discussed in an appropriate venue, whereas 87 (63%) said that elephants are discussed in less constructive venues or not discussed at all. Less than a quarter of the chairs (32; 23%) reported that the top leaders at their institutions actually encourage people to call out and deal with elephants. More commonly, the chairs (77; 55%) reported that the top leaders of their institutions say they want people to be frank about elephants, but their actions or nonverbal cues indicate otherwise. A higher percentage of medicine chairs than of surgery chairs (16 of 53 [30%] versus 16 of 86 [19%]), said that top leaders pretend that elephants do not exist.

- An important minority did not think the elephants were a problem at all:

nearly a fifth (26 of 139; 19%) agreed that, indeed, some issues are best left undiscussed.

- While the majority favored discussing elephants, they did not think it would be easy to do so:

two-thirds (92 of 137; 67%) felt that creating a culture in which elephants are openly discussed would be very or moderately difficult.

Their and Our Discussion

It was particularly striking that an article about elephants in the living room did not more fully describe what sorts of elephants they were. The descriptions of elephants above, taken verbatim from the survey instrument, were vague. They were not clarified in the discussion section of the article.

Particularly lacking were the sort of nasty elephants described by Pololi et al in a qualitative study of barriers to the advancement of primary care faculty.(2) As we summarized in our letter,(3) these elephants included academic leaders who put revenues ahead of patient care, teaching, and research; and who allegedly used deception for personal gain. Also lacking were nasty elephants we have discussed on Health Care Renewal. We have discussed examples of self-interested, conflicted, and corrupt leadership of health care organizations, including academic medical institutions.

I am glad that Souba et al brought up the topic of elephants in academic medicine's living room. However, I am disappointed that these elephants were never clearly identified. It seems that while we are getting to the point of being able to say there are things we cannot say, we are not yet at the point of saying what those things are. The strength of the anechoic effect is demonstrated by cases in which we cannot talk about what we cannot talk about.

Souba et al concluded:

We believe that AHCs are designed, often subconsciously, to keep the range of conversation limited to a few voices, usually the voices of those in power. The powerful silence the voices of others because they consider others' views to be either contrary to the status quo or of limited value.

We would add that those in power often may value the status quo not merely because of philosophical conservatism, but because maintaining the status quo supports their self interest. In particular, it has become increasingly lucrative to be in a leadership position in a health care organization, even in a non-profit academic institution. Executive compensation at these institutions has been rising inexorably, driven by increasing institutional relationships with corporate health care. Individuals in leadership positions in academic medicine frequently have their own, increasingly lucrative financial relationships with the health care industry. (A study by Campbell et al showed that the majority of department chairs, like those who answered the survey above, have such relationships.[4]) Ever increasing hunger for institutional and personal revenue may lead to a variety of practices that are hostile to the academic and professional mission. Discussing any of these aspects of the status quo may offend and threaten those who are profiting from it.

However, as long as we cannot even talk about such problems, the problems will only get worse.

References

1. Souba W, Way D, Lucey C, Sedmak D, Notestine M. Acad Medicine 2011; 86: 1492-1499. Link here.
2. Pololi L, Kern DE, Carr P, Conrad P, Knight S. The culture of academic medicine: faculty perceptions of the lack of alignment between individual and institutional values. J Gen Intern Med 2009; 24: 1289-95. Link here.
3. Poses RM, Smith WR. Faculty values. J Gen Intern Med 2010; 25: 646. Link here.
4. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786, link here.]

Wikipedia page on EHR's: ==Disadvantages== material seems to keep disappearing

2012-01-27T12:42:00.043-05:00

It's interesting how most of the information below seems to have a hard time "staying put" on the Wikipedia page for "Electronic Health Record" at http://en.wikipedia.org/wiki/Electronic_health_record

The information is presented in a neutral fashion from impeccable sources. Yet several Wikipedia "editors" take issue with it and, rather then editing it or refuting it (and stating their rationale and sources!), they keep deleting it. (The most recent edit history comments follow this "disappearing" information, at the bottom of this post):

==Disadvantages==

===Software quality and usability deficiencies===
EHR software is unregulated, unlike computer systems used both in the development and production of, and as a part of pharmaceutical products, medical devices, food, blood establishments, tissue establishments, and clinical trials.http://en.wikipedia.org/wiki/Validation_%28drug_manufacture%29 Other life-critical industries also have strict software validation and testing standards, e.g., Federal Aviation Administration, NASA.http://www.faa.gov/regulations_policies/advisory_circulars/index.cfm/go/document.information/documentID/1019261http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf.

As a result, EHR software quality and usability is often suboptimal. For example, in "A study of an Enterprise Health information System", March 2011, a Medical Informatics researcher at [[University of Sydney]] in Australia found that a major EHR system for Emergency Departments slated for deployment in the public hospitals of [[New South Wales]] has serious deficiencies in software architecture and fit with clinician workflow. These deficiencies make it difficult to use and unreliable in terms of data integrity and loss, in one of the most demanding of clinical environments .http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146

The [[Healthcare Information and Management Systems Society]] (HIMSS), a very large U.S. healthcare IT industry trade group, observed that EHR adoption rates "have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available."http://www.himss.org/content/files/HIMSS_DefiningandTestingEMRUsability.pdf

Serious reliability and usability problems with the U.S. Department of Defense’s [[AHLTA]] EHR system have been reported to the Congress.http://www.usmedicine.com/articles/electronic-records-system-unreliable-difficult-to-use-service-officials-tell-congress.html

The U.S. [[National Institute of Standards and Technology]] (NIST) issued a Sept. 2011 report on deficient usability of current EHR systems, with recommendations for usability evaluation, testing and validation.http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf

===Unintended adverse consequences===
EHRs can introduce new unintended consequences, compared to paper records, and adverse outcomes, including patient injury and death, according to regualtory and governmental agencies, researchers, and others; for example, in an internal 2009 FDA memorandumhttp://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf of Feb. 23, 2010 obtained and released by the Huffington Post Investigative Fundhttp://web.archive.org/web/20110425002322/http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight, EHR-related medical errors are categorized as: errors of commission (EOC), errors of omission or transmission (EOT), errors in data analysis (EDA), and incompatibility between multi-vendor software applications or systems (ISMA).

The [[National Health Service]] (NHS) in the UK reports specific examples of EHR-caused patient harms in a 2009 document on guidance on the management of clinical risk relating to the deployment and use of health software, Annex A "Examples of potential harm presented by health software."http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009/0160182009specification.pdf.

Also, in "Research in Ambulatory Patient Safety 2000–2010: A 10-year review", Dec. 2011http://www.ama-assn.org/resources/doc/ethics/research-ambulatory-patient-safety.pdf, the American Medical Association reports:

:While health IT may confer benefits, some research has also suggested that health IT systems can create new issues or exacerbate existing problems. Wachter noted that, “[i]n both professional and lay publications, concerns have been raised that today’s electronic health records promote the copying and pasting of clinical information, instead of its thoughtful analysis; foster a focus on completing computerized checklists and templates rather than detailed probing of the patient’s history, and support less thoughtful diagnostic reasoning and more automatic behavior on the part of caregivers." Research indicates that a great deal depends on the design of the health information technology system, with poorly designed systems contributing to instances of errors (Ash et al). Where user interface designs are cumbersome to use and do not fit into the clinician’s natural work context, some have noted the potential for “cognitive overload,” among other reactions, and ultimately the possibility of increasing errors in data entry and retrieval as well as errors in the process of communication and coordination (Ash et al, Singh et al).

In the U.S., FDA's MAUDE (Manufacturer and User Facility Device Experience) databasehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFMreveals many reported EHR problems, some of which could result in patient injury or death http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html. Both FDA (in the 2010 memo referenced above) and the [[Institute of Medicine]] of the National Academies in a 2011 study http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF reveal that EHR-related injuries and deaths are real, but the true extent is likely understated, they report, due to numerous factors impeding diffusion of knowledge such as contractual gag and hold harmless clauseshttp://jama.ama-assn.org/content/301/12/1276.extract and lack of familiarity by users of where to report EHR-related adverse events (per aforementioned 2009 FDA internal memo). A Medical Informatics researcher in the U.S. has compiled a well-referenced teaching site that covers unintended consequences of EHRs, health IT project difficulties and failure and related issues{{cite web | last=Silverstein| first=Scot| year=2012 | url=http://www.ischool.drexel.edu/faculty/ssilverstein/cases/ | title=Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties| publisher=Drexel University |accessdate=2012-01-26}}.

The literature is conflicting on benefits and harms of EHRs http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html, and as in the Jan. 2009 U.S. National Academies study "COMPUTATIONAL TECHNOLOGY FOR EFFECTIVE HEALTH CARE: IMMEDIATE STEPS AND STRATEGIC DIRECTIONS", EHR's ultimate success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering.http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572

===Regulatory controversy===
FDA's Jeffrey Shuren, MD JD, Director of the [[Center for Devices and Radiological Health]] (CDRH), has explicitly declared EHRs are a medical device.http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_11673_910717_0_0_18/3Shuren_Testimony022510.pdf So has the [[Medical Products Agency (Sweden)]]; Swedish law for medical devices is based on EU Directives.http://www.lakemedelsverket.se/upload/foretag/medicinteknik/en/Medical-Information-Systems-Report_2009-06-18.pdf. In medicine, legal and ethical standards such as the NIH Guidelines for Conduct of Research Involving Human Subjectshttp://ohsr.od.nih.gov/guidelines/index.html and the World Medical Association Declaration Of Helsinkihttp://ohsr.od.nih.gov/guidelines/helsinki.html restrict introduction of new drugs and medical devices without informed consent, and without extensive preclinical and clinical testing and post-marketing surveillance, especially when risks of the technology are unknown. As in the 2011 U.S. [[Institute of Medicine]] study "Health IT and Patient Safety: Building Safer Systems for Better Care"http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF, there are calls for formal governmental regulation of the technology.

The edit-history comments are quite interesting, where a poster who uses the ID "Barek" keeps deleting all or most of the information on EHR disadvantages, despite indications the material is impeccably sourced and does not draw its own conclusions. Read from bottom to top:

17:29, 27 January 2012‎ Ohnoitsjamie (talk | contribs)‎ (67,826 bytes) (please discuss on talk page, as you are approaching WP:3RR)

17:28, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,232 bytes) (clarifying that information comes from the cited sources.)

17:26, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,137 bytes) (→Unintended adverse consequences)

17:24, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,151 bytes) (If you have factual disageements, let them be known and document the source of your information.)

17:23, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,137 bytes) (If you have factual disageements, let them be known and document the source of your information.)

17:18, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,122 bytes) (Undid revision 473542684 by Barek (talk). Barek may have a conflict of interest regarding exposure of health IT difficulties.)

17:14, 27 January 2012‎ Barek (talk | contribs)‎ m (67,826 bytes) (Reverted edits by InformaticsMD (talk) to last version by Barek)

17:14, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,122 bytes) (→Regulatory controversy)

17:12, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,217 bytes) (The added information is factual, well-referenced from impeccable sources, and does not draw conclusions.)

17:08, 27 January 2012‎ Barek (talk | contribs)‎ (67,826 bytes) (→Disadvantages: restore some content after purging WP:SYNTH material)

17:06, 27 January 2012‎ Ohnoitsjamie (talk | contribs)‎ (65,826 bytes) (rv per WP:SYNTH)

17:01, 27 January 2012‎ 108.16.62.235 (talk)‎ (76,341 bytes) (Undid revision 473539844 by Barek (talk))

16:57, 27 January 2012‎ Barek (talk | contribs)‎ (65,826 bytes) (rv - some of that content is usable - but most is pure WP:SYNTH, attempting to draw conclusions rather than simply stating what's in the sources - requires a total re-write to be encyclopedic)

... 20:22, 26 January 2012‎ SarekOfVulcan (talk | contribs)‎ (65,058 bytes) (→Unintended Adverse Consequences: actually, remove whole section - BAD HANDWRITING can result in patient injury and death)

20:21, 26 January 2012‎ SarekOfVulcan (talk | contribs)‎ (65,860 bytes) (→Unintended Adverse Consequences: If it's unknown, we don't need to report it. If it's not a RS, we don't need to report its conclusions. And "a researcher says" isn't notable enough to mention without establishing authority in the subject) (undo)

I note that the logically fallacious "Bad handwriting can cause patient injury and death, so remove whole EHR Unintended Adverse Consequences section" and "if it's unknown, we don't need to report it" [regarding the referenced FDA and IOM observations that the true extent of EHR adverse consequences is unknown -- which is on its face a matter critical to public health and policy - ed.], coming from an editor who ironically calls him/herself "Sarek of Vulcan", offers a prime example of how the utopian concept of tapping "community wisdom" can fall flat on its face.

WP:SYNTH is Wikipedia-talk for "Synthesis of published material that advances a position", i.e., "drawing conclusions." Apparently, when it comes to EHR, citing the work of governmental regulatory and healthcare agencies, expert researchers, etc. is "drawing conclusions."

Wikipedia is essentially open to all, including the HIT industry and its pundits.

It is possible that the Wikipedia editors who keep deleting the material could have some sort of conflict of interest. COI could cause them to find easily-verifiable information from impeccable sources on the Wikipedia EHR page (viewed 22924 times in the last 30 days as of this morning) that refutes common cybernetic legends to be "inconvenient." We've certainly seen that type of person before (link).

This affair may also be another example of the "anechoic effect", the notion we discuss often on this blog that certain topics in medicine and health care 'just aren't talked about', in action.

The 'disadvantages' material, revised, will be re-posted again soon, after my being blocked (for 'reverting', i.e., restoring the material three times in 24 hrs.) expires tomorrow. It will be revised to have as neutral a tone as possible, with exact page numbers where possible, in accordance with written Wikipedia examples. If the additions still disappear, that will be revelatory.

-- SS

Unequal Justice Under Law - Comparing Cases of Alleged Misbehavior by Large Health Care Organizations and Individuals

2012-01-25T15:05:00.000-05:00

How the wealthy and powerful have become able to play by a different set of rules than those affecting ordinary people may be the defining issue of our time. Yesterday, President Obama's State of the Union message asked for an economy in which "everyone plays by the same set of rule." We posted about how this issue, which got national attention due to the Occupy movement, affects health care here.

We have previously posted again and again about how the penalties for misbehavior by large US health care organizations seem to be so minimal as to be incapable of deterring future bad behavior (e.g., see posts about legal settlements). At most, corporations often pay fines that are no more than a cost of doing business. They rarely have to admit guilt, and when they do, it is usually to a relatively trivial charge. The people who authorized, directed, or implemented the bad behavior almost never suffer any negative consequences. Thus, the leaders of large US health care organizations seem to have impunity.

Similar complaints have been made about the lack of accountability of the leaders of the finance firms that lead us into the global financial crisis, or great recession.

However, while I have reviewed now hundreds of stories about such minimal organizational punishments, I have also seen hundreds of stories discovered by my automatic news searches of much more severe penalties paid by individuals who have been accused of similar misbehavior. I have never previously made an explicit comparison of how health care corporate and individual misbehavior are handled.

A recent set of examples of organizational misbehavior invites such a comparison. Here they are, in chronological order.

KV Pharmaceutical

On December 6, 2011, the St Louis Post Dispatch reported:

KV Pharmaceutical Co. has agreed to pay $17 million to federal and state authorities to settle Justice Department allegations that it defrauded federal health care programs.

The settlement resolves allegations that KV, as the Bridgeton-based parent company of now-defunct Ethex Corp., misrepresented the regulatory status of two of its drugs that did not qualify for coverage under federal health care programs, the Justice Department said today.

The Justice Department alleges that Ethex submitted false quarterly reports to the federal Centers for Medicare and Medicaid Services related to the two drugs: nitroglycerin extended release capsules and hyoscyamine sulfate extended release capsules.

Company leadership made the usual sort of comment. CEO Greg Divis said:

The closure of this matter is another step forward as KV moves ahead as a women's healthcare focused branded specialty pharmaceutical company.

Corporate leaders seem to love putting such unpleasantness in the past and moving on, especially when they personally are not held accountable for the previous misbehvior.

Note that this is just the latest settlement for KV Pharmaceutical:

KV shut down Ethex after the subsidiary pleaded guilty in March 2010 to two felony counts of criminal fraud for failing to report to the Food and Drug Administration that it was making oversize drugs - and drew $27.6 million in fines and restitution.

Catholic Healthcare West, Sutter Health

On December 8, the Sacramento Bee reported:

Two of Sacramento's biggest health care players paid a combined $2.3 million to the federal government to settle allegations that 61 of their hospitals double-billed Medicare for therapies and services, U.S. Department of Justice officials announced Wednesday.

Catholic Healthcare West paid more than $875,000 and Sutter Health nearly twice that – more than $1.43 million – for alleged duplicate charges for infusion therapies and treatments to break up kidney and bladder stones, in what Lauren Horwood, a spokeswoman in the Sacramento U.S. attorney's office, called 'a significant settlement.'

As usual,

Officials at the two health networks admitted no wrongdoing in agreeing to the settlement, Horwood said. No charges will be filed.

Again, however, this was not the first such issue to affect these large non-profit organizations:

In 2006, Sutter Health agreed to grant discounts and refunds to uninsured patients the network was accused of overcharging, stemming from a 2004 class-action lawsuit.

Blue Shield (California)

On December 29, 2011, the Los Angeles Times reported:

More than a year after the healthcare reform law sought to prevent sick patients from losing medical coverage, insurers are still paying for their alleged abuses.

Blue Shield has agreed to pay $2 million to resolve accusations that the company improperly dropped policyholders after they got sick and needed expensive treatment.

The settlement, announced Wednesday by Los Angeles City Atty. Carmen Trutanich, ends an investigation into more than 1,000 so-called rescissions by Blue Shield, a San Francisco-based not-for-profit company.

As usual, there was no admission of guilt, and a company spokesperson claimed that while the company decided to pay out the money in response to the allegations, it, of course, was blameless:

Blue Shield spokesman Steve Shivinsky said the firm settled to avoid litigation.

'Our process meets or exceeds all legal and regulatory requirements,' Shivinsky said in a statement. 'In every instance, we provide immediate notice, ensure multiple layers of review, involve a medical director in the decision, give members an opportunity to provide additional information before we take any action, and follow the guidance of an independent third party review.'

Note that rescission is now against US federal law:

President Obama made rescission a central theme in his push for a healthcare overhaul. In September 2010, a ban on rescissions for unintentional application errors became one of the first pieces of the healthcare law to take effect.

GE Healthcare

On December 29, 2011, the Detroit Free Press reported (via USA Today):

Pharmaceutical giant GE Healthcare will pay $30 million to the U.S. Department of Justice to settle claims in a case filed by a Michigan salesman, alleging one of its companies marketed a diagnostic drug used in cardiology tests as one that could be diluted and stretched to more patients than intended.

Not surprisingly,

GE admitted no wrongdoing in the settlement.

This was despite the fact that the actions alleged may have harmed patients as well as defrauding the government:

For patients, the diluted product resulted in more false positives during cardiology tests and exposed them to additional and unnecessary testing....

We have posted previously about some previous questionable behavior by GE in the health care sphere.
Actavis

On January 3, 2012, Bloomberg reported:

Two units of Actavis Group Hf will pay $84 million to settle a lawsuit over drug pricing, Texas officials said, less than half the amount an Austin jury said the company should pay.

The state accused Actavis Mid-Atlantic LLC and Actavis Elizabeth LLC, subsidiaries of the Iceland-based company’s U.S. division, of inflating billings to the Texas Medicaid program by falsely reporting drug prices. The state court jury in February ordered the units to pay the state $170 million.

The settlement resolves that litigation, Texas Attorney General Greg Abbott said today in a statement.

Note that Medicaid is a joint federal-state insurance program for the poor.

The company's statement had a familiar ring to it:

'Actavis denies any and all wrongdoing, and denies that it has any liability relating to the Texas judgment,' the company and the state said in the settlement agreement. The parties reached a settlement 'to avoid the delay, uncertainty, inconvenience and expense of continuing the litigation.'

Nothing to see here, just move along.

Denver Health Medical Center

On January 5, 2012, the Denver Post reported:

Denver Health Medical Center will pay $6.3 million to federal and state officials for overbilling Medicare and Medicaid, state and U.S. attorneys said.

After investigating a whistleblower's lawsuit, government officials said Denver Health was classifying patients with an "inpatient" status when it should have been listing them as 'outpatient' or under 'observation' status, which paid less under government rules.

Oops, missing from this story was the pro forma denial of blame, wrongdoing, misconduct by organizational leadership. However, the Denver Business Journal was able to add that:

Denver Health, in a statement, said it and the government agreed to the settlement to avoid 'protracted litigation' over the allegations. It did not admit guilt in agreeing to the settlement.

Of course, again despite having to pay millions, the organization asserted that it is fine and upstanding:

'Denver Health has, and will continue to, strive to ensure that its billing systems are accurate,' the hospital said in a statement, adding that the hospital has implemented a system to correct and improve billing accuracy.

Whoever wrote the statement seemed to overlook the implication that flowed from the need to "correct" the system.

CVS Caremark

On January 12, 2012, the Baltimore Sun reported:

The Federal Trade Commission announced that CVS Caremark Corp. agreed to pay $5 million to settle a complaint that it misinformed seniors about the price of certain Medicare Part D prescription drugs sold through CVS and Walgreens pharmacies.

The action by the company, according to the FTC, caused seniors and consumers with disabilities to pay significantly more for drugs. It also pushed them more quickly into the so-called 'doughnut hole,' in which drug costs aren’t covered by the federal program.

Despite its multimillion dollar payment, the company admitted no guilt, of course, and asserted its exemplary corporate citizenship:

CVS Caremark released a statement:

'During the course of this two year investigation, our company cooperated fully with the FTC and provided to the government millions of documents as well as access to numerous members of our management team who participated in voluntary interviews and depositions,' said Douglas A. Sgarro, Executive Vice President and Chief Legal Officer of CVS Caremark.

He also took comfort from the fact that there were not even more charges:

It is important to note that, at the conclusion of this comprehensive investigation, the FTC made no allegations of antitrust law violations or anti-competitive behavior associated with any of our business practices, products or service offerings.

Stryker Corp

On January 18, 2012, Bloomberg reported:

A Stryker Corp. (SYK) unit agreed to plead guilty and pay a $15 million fine while the medical-device maker was on trial on charges it marketed an unapproved mixture of products for strengthening human bone growth.

The unit, Stryker Biotech, and three Stryker sales representatives were on trial in federal court in Boston on a 13-count criminal indictment claiming conspiracy and wire fraud. The trial began Jan. 9 with jury selection.

Stryker Biotech agreed to plead to one misdemeanor count of misbranding a medical device, according to a letter dated yesterday from the U.S. Attorney’s Office in Boston and filed with the federal court.

This did involve an admission of guilt, but to what amounts to a financial violation when there were allegations that patients may have been harmed:

The U.S. had charged Stryker Biotech with misbranding and its sales force with conspiring to defraud surgeons into combining the company’s OP-1 and OP-1 Putty with the bone filler Calstrux. Some patients suffered adverse side effects and required more surgery, the U.S. said.

'That mixture was never studied clinically,' Assistant U.S. Attorney Susan Winkler told the jury in her opening statement on Jan. 12. 'They did not know if it worked. They did not know if it was safe, and they marketed it to doctors anyway.'

Interval Summary

We have presented eight cases in which major US health care organizations settled cases involving allegations of financial gain under false pretenses. Nearly all involved US federal charges, and the others included alleged misbehavior that affected a federal program or that now would be illegal under federal law. All the cases were resolved with fines over $1 million. However, while these fines may seem big to most people, they were trivial compared to the revenues of the organizations. None of the settlements involved any penalties to actual people who authorized, directed, or implemented the misbehavior. No individuals at any of the involved organizations admitted any mistakes, much less wrong doing.

While the volume of such settlements indicates the prevalence of misbehavior by large health care organizations, it is not clear that their results, which amount to slaps on corporate wrists, have any deterrent effect.

In comparison, see what happens when little people obtain money from the government under false pretenses. I found a convenience sample of such cases reported in the last month through a Google search.

Vasquez

On January 9, the San Francisco Chronicle reported:

A Los Angeles woman who pleaded guilty to committing $6.2 million in Medicare fraud has been sentenced to 5 years in prison.

Federal Health and Human Services officials say 47-year-old Carolyn Ann Vasquez has also been ordered to pay $6.2 million in restitution.

Vasquez admitted to conspiring with others to use a series of fraudulent Los Angeles-area medical clinics to defraud the federal health care insurance program for people over age 65 and the disabled.

Between 2007 and 2008, Vasquez obtained a physician's personal information and Medicare provider number and used it to print prescription pads.

She then had a physician's assistant, David Garrison, write fraudulent prescriptions for pricey medical equipment.

Curtis

On January 7, 2012, the [Jacksonville] Florida Times-Union reported:

A federal judge sentenced the would-be owner of a Brunswick prosthetic business to three years and six months in prison for his organization and leadership of a scheme that defrauded Medicare of more than $250,000.

Also,

In addition to prison, Wood sentenced Curtis to repay $254,750.94 to Health and Human Services and serve three years’ probation. She dismissed eight other counts as part of his plea agreement.

In stark contrast to the stories above about cases of fraud involving large health care organizations:

Samuel Curtis III, who had submitted false claims from Preferred Prosthetics and Orthotics in Brunswick and Team Orthotics and Prosthetics of Houston, had pleaded guilty in July to conspiring to commit health care fraud.

Curtis, 38, apologized and asked U.S. District Judge Lisa Godbey Wood for leniency during his sentencing hearing Friday.

Popov

On January 12, 2012, the Sacramento Bee reported:

A Los Angeles physician who assumed the role as co-owner of a Sacramento medical clinic has been sentenced to federal prison for his participation in a Medicare fraud scam.

Alexander Popov, 47, was sentenced today by U.S. District Judge Morrison C.England Jr. to eight years and one month in prison for committing health care fraud and conspiring to commit health care fraud, according to a federal Department of Justice news release. He was found guilty by a jury in July.

In sentencing, Judge England found that Popov was responsible for more than a million dollars in fraudulent billings submitted to Medicare and more than $600,000 in payments made on false claims.

Evidence at trial showed that Popov gave false testimony and manufactured evidence at trial, amounting to an obstruction of justice, officials said.

Also,

Vardges Egiazarian previously pleaded guilty in the case and is serving 78 months in prison.

Applebaum

On January 20, 2012, Medscape reported:

A former Idaho psychiatrist was ordered to pay nearly $95,000 in a legal judgment this week, adding to a prison sentence of up to 5 years, which he received in November for obstruction and falsifying records relating to Medicaid fraud.

The judgment, obtained by the US Attorney's Office against Michael Applebaum, MD, of Nampa, Idaho, involved a civil lawsuit in which he was accused of submitting false Medicare and Medicaid claims for undocumented and ineligible services from 2004 through 2009.

Prosecutors claimed Dr. Applebaum failed to properly document services for approximately 502 claims, including falsifying service dates on 49 claims to make them appear eligible for reimbursement under Medicaid's rule of submitting claims within 12 months of the date of service.

Summary

As we noted above, if a large organization, such as a hospital system, pharmaceutical company, or health insurance company is accused of fraud against the government, the outcome is likely to be a large fine that is nonetheless small compared with the organization's revenue, no admission of guilt or responsibility, and no penalties for any individuals who authorized, directed or implemented the misbehavior. However, if an individual or small business is accused of such fraud, the results are likely to include fines sufficient to bankrupt either, admissions of guilt, and years of jail time.

Yet such actions by large organizations are likely to be more harmful to individuals and society than those of individuals or small businesses.

This seems like a glaring, stark example of unequal justice in health care. If an individual does something bad in a health care context, the punishment is likely to be severe and life altering. If an individual who is a leader of a large health care organization does something equally bad, he or she is likely to receive no punishment at all.

This is an example that ought to unite the left and the right, liberals and libertarians in outrage. Liberals are supposed to believe in the rights of the individual and economic justice. Libertarians are supposed to believe in economic freedom and the economic rights of the individual. In this example, the government and large corporations seem to have gotten together to let corporate leaders play by different rules than individuals. Corporate leaders seem to be above the law, the same law that can ruin individuals who violate it.

If we really want to reform health care, we need to make sure that its rules apply equally to all individuals, whether humble or rich, whether they are individual professionals of corporate CEOs. As long as the rich and powerful can play by different rules, we only fuel cynicism and anger. Down that road lies disaster.

London Ambulance Service: Would You Like Some Death And Mayhem With Your American Healthcare IT?

2012-01-25T10:56:00.027-05:00

It seems American companies are good at producing really noisome commercial healthcare IT and foisting it on other countries, such as outlined at "Is clinical IT mayhem good for [the IT] business? UK CfH leader Richard Granger speaks out" and at "Cerner's Blitzkrieg on London: Where's the RAF?".

Yet another example: Software for the London Ambulance Service (LAS). From Wikipedia:

The London Ambulance Service NHS Trust (LAS) is the largest "free at the point of contact" emergency ambulance service in the world. It responds to medical emergencies in Greater London, England, with its ambulances and other response vehicles and over 5,000 staff at its disposal.

Thanks to the U.S., the inhabitants of London are now the unconsenting subjects of an American IT beta-testing experiment that could cost them their lives.

From E-Health Insider.com:

LAS plans for IT go-live and failure
E-Health Insider.com
25 January 2012
Shanna Crispin

London Ambulance Service NHS Trust may terminate its contract with American supplier Northrop Grumman if a second attempt to go-live with a new dispatch system fails.

The trust initially attempted to launch the CommandPoint computer aided dispatch system in early June last year.

However, the technical switch-over to the new system had disastrous effects; with the system failing, staff having to use pen and paper, and then finally aborting the go-live by reverting to the old CTAK dispatch system.

Health IT can kill you ever before you ever reach the hospital...

An investigation into the incident has found the response to calls was delayed by more than three hours in some cases. One patient has lodged a legal claim for the delay he experienced, and the service has received four additional complaints.

A patient died in one of the calls affected. However, a separate investigation concluded that it could not be determined whether they would have survived if the response had been faster.

In other words, the patient very well might have survived without long delays for the ambulance to arrive.

Board papers drawn up for a board meeting next week say an investigation into the 8 June go-live attempt concluded that critical configuration issues were not identified during the testing phase.

It also found there were no operational procedures in place in the event of a critical system failure and that the product failed to deliver the system, technical and operational functionality expected.

At least in this case an absolution for the software itself was not made. One wonder if the vendor was "held harmless" contractually for this somber outcome.

The trust has since been working to further test the system, and is planning to go-live again on 28 March.

However, the trust’s director of information management and technology, Peter Suter, said if that go-live failed then “the contract with Northrop Grumman would need to be reconsidered.”

That will make two chances to get it right. In life-critical IT, I would only have given one.

A defective first-responder system is, on first principles, a public health menace. There is nothing to argue here, nothing to discuss on that point.

I note that disrupting the first-responder system in London would be the envy of terrorists, especially at the time of the London 2012 Olympic Games. However, who needs them when you have U.S. IT personnel who create a system as described?

The trust completed testing the software prior to Christmas, when it began training staff. Leading up the March go-live, the software will be subjected to four separate live runs, with the system staying live for progressively longer periods of time.

If the system fails to go live in March, the trust will abandon any further attempts to go-live before the Olympics in July.

That's still very tight timing to discover all the bugs in an IT system, in preparation for expected increased need during the Olympics...

Instead, it will keep operating the current CTAK system. However, the trust decided to procure a new system in 2007 because CTAK was deemed ‘unstable’ and in need of replacement.

An analysis of the CTAK system has now determined it is stable enough to handle the increased pressure during the Olympics, which is estimated to be an increase of 5.6% to 8.9% on top of the usual volume for this time of year.

One wonders if the "new system" was not needed at all, but was instead sold as vaporware by impressively attired, good-haired, shiny-toothed, fast-talking salespeople to hapless decision-makers with all sorts of promises of cybernetic and financial miracles.

(I've been in that game before from both sides - as a potential customer, and as part of a health IT sales team.)

One also wonders if, should the system be dismantled due to a second failure, the British taxpayers who paid for it will get their tax dollars refunded.

-- SS

"Conspiracy Theory" Proven - Taking UCSF Private

2012-01-22T23:49:00.001-05:00

Students and faculty at the University of California have come up with a vivid, and prescient example of how the hired executives and bureaucrats have taken over higher and health care education.

"Run in the Interests of the Administration"

Two weeks ago, the Orange County Register reported:

Over the past few months, the University of California has raised undergraduate tuition by 18 percent, awarded raises of as much as 23 percent to a dozen high-ranking administrators and announced a possible 81 percent tuition increase over the next three years.

Students haven't taken the news well.

At campus rallies across the state, thousands of students and their faculty supporters have decried the actions, staging raucous rallies and 'Occupy'-style sit-ins that in some cases have ended in clashes with law enforcement. They've also descended en masse on UC regents' meetings, disrupting proceedings and even forcing officials to retreat to a private room.

Behind the angry chanting and acts of civil disobedience is a growing sense that the 10-campus UC system is no longer a public institution accessible to the middle class, but rather a sprawling bureaucracy of hospitals and auxiliary research institutions buffeted by an ever-expanding roster of administrators.

The problem, as the student activists see it, is that none of these functions translates directly into expanded course offerings or improved student-to-faculty ratios, even as their tuition dollars help sustain the system.

'The university is now being run in the interest of the administration,' said UC Irvine student activist Anne Kelly, a Ph.D. candidate in earth system science. 'They're promoting their own internal growth, asking us to sacrifice with higher tuition – but administrators have had raises.'

In higher education, as well as in health care education and in health care in general, the pattern is the same: rising costs without any obvious increase in quality or quantity of services. As in health care, however, the pain never seems to extend to administrators/ managers/ bureaucrats/ executives. Worse, as their numbers grow, these insiders seem to run organizations more for their own benefit, and less for the mission.

One Manager Per Faculty Member

Furthermore, UC faculty have data:

The students' growing frustration is fueled by UC employment data that show that almost three-fourths of UC's 152,500 employees last year were designated 'non-academic personnel,' according to an annual UC employment report.

In the report, UC characterizes the growth in its non-academic staff as the inevitable byproduct of 'an increasingly complex university system that 'requires greater professionalization of its staff, who must meet higher technical and competency standards.' Non-academic personnel includes everyone from custodians and food-service workers to accountants and plant operators. [The question begged is whether it was the managers and executives that caused this complexity - Ed.]

UC Davis horticulture researcher Richard Evans, who has independently analyzed UC personnel data, offered a different take on the data, publishing a tongue-in-cheek piece for UC faculty in 2010 entitled 'Soon every faculty member will have a personal senior manager: Is this a good way to spend money?'

'Data available from the UC Office of the President shows that there were 2.5 faculty members for each senior manager in the UC system in 1993,' Evans wrote in his piece. 'Now there are as many senior managers as faculty. Just think: Each professor could have his or her personal senior manager.'

In his analysis, Evans compared the number of UC employees classified as either 'senior management' or 'managers and senior professionals' with the number of tenure-track UC faculty members.

As of spring 2011, UC employed 8,144 senior managers, managers and senior professionals, and 8,521 tenure-track faculty members, according to the latest available UC data.

This pattern is similar to that seen in some data we discussed a long time ago about the ever rising numbers of administrators/ managers/ bureaucrats/ executives in health care. In 1988, Alain Enthoven advocated in Theory and Practice of Managed Competition in Health Care Finance, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post here). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post here). Health care went from being controlled by clinicians to controlled by a growing volume of managers. Most of these managers were generic, in that they had little if any knowledge of, experience in, or sympathy to the values of health care. These generic managers have used the same techniques advocated for the management of supermarkets or automobile manufacturers to manage health care organizations, despite all the obvious differences in context, goals, values, and people involved.

A "Conspiracy Theory" About the Privatization of the University

At the University of California, the Register reported that there is a "conspiracy theory" about the next step to increase the domination of the managers:

The salaries and size of UC's administrative staff, in particular, have fueled conspiracy theories among students and faculty that the system has deliberately sought to 'privatize' itself – in other words, to compete with private universities on all fronts, from the scope of its non-instructional programs to executive compensation to the amount of tuition that students pay.

Three years ago, the head of a UC faculty group advanced the privatization theory in a multi-part series called 'They Pledged Your Tuition.'

Of course, the administrators denied, sort of, anything so far-fetched:

For its part, UC denies all such allegations, saying that while the university has arguably become privatized, outside influences beyond its control are entirely to blame.

"It is not something we advocate, not something we want,' Klein said. But, 'he added, 'times have changed; the economic model has changed.'

Not Just a "Conspiracy Theory" - UCSF Chancellor Advocates Privatization

It only took two weeks, however, for the notion of administrators taking the university private to go from "conspiracy theory" to official plan. Yesterday, the San Francisco Chronicle reported,

UCSF Chancellor Susan Desmond-Hellmann told the regents, delicately, that she wants out.

Under her proposal, UCSF's medical school, hospital, clinics and research facilities would remain a public university connected to UC, the chancellor assured the regents. But the tendrils connecting the two entities should be thinner than they are today.

Desmond-Hellmann said she envisions a relationship like those of UC Hastings College of the Law, Lawrence Livermore National Laboratory and Lawrence Berkeley National Laboratory, which contract with UC for health and pension services. While ultimately accountable to the regents, they are autonomous with their own boards of directors.

Referring to 'alternative governance models' and 'examining UCSF's financial relationship with UC,' the chancellor and campus executives talked of their ambition to become the world's leading innovator in the health field - a goal better achieved, they hinted, without the rest of the university weighing it down.

To Health Care Renewal readers, that UCSF would be proposed as the first part of the University of California to privatize should not come as a shock. After all, Chancellor Desmond Hellmann came not from academia, but from the world of for-profit biotechnology. She was a former president for drug development for Genentech.

Two and one half years ago I suggested that "hiring a lavishly compensated top executive from a biotech firm known for its high drug prices to run a public health sciences university does considerably blur the line between academic medicine and the health care industry." Furthermore, three months ago I noted that Dr Desmond Hellmann seemed be advocating that the university's focus turn to product development, so that it would start to emulate a contract research organization. Now it appears that Dr Desmond Hellmann wants to traverse the line between government and the private sector, so that the organization could "make a ton of money," and "focus on spinning innovations into business deals," according to the San Francisco Chronicle.

What any of this has to do with the university's fundamental mission to discover and disseminate knowledge, and with this health care university's mission to take the best possible care of its patients is not clear.

Summary

Turning UCSF into a private, quasi contract research organization might conceivably yield some good research and drug development. Why a formerly academic organization would be better at this than a purpose-built CRO is hardly proven. Whether UCSF recast as a CRO would yield better research, leading to better patient outcomes than would have resulted if it continued as a state government sponsored health care university is also hardly proven.

Turning UCSF into a quasi CRO, however, would likely be very much in the self-interest of its administrators/ managers/ bureaucrats/ executives who would be freed from any constraints on their incomes, and the disclosure of same that were previously obligated by the messy representative democracy to which they formerly had to answer.

On the other hand, it is hard to conceive of how such a privatization would be good for students or patients. In fact, it is not the least bit clear why a medical, nursing, or other health professional student would want to study within what would basically be a contract research organization. It is also unclear whether patients seeking care from such an organization could trust it to put their interests, rather than the organization's revenue and the self-interest of its administrators/ managers/ bureaucrats/ executives first.

We are now a good 30+ years into our ill-fated American experiment about the effects of turning medicine commercial and making health care a commodity. So far, it has yielded the highest costs in the world, but declining access, mediocre quality, and demoralized professionals. Turning one of our once proud and prestigious state government sponsored academic medical institutions into a private contract research organization would be a powerful symbol of our final national health care decline.

Let us hope that the students and faculty whose "conspiracy theory" about privatization proved true will now mount a more effective protest before UCSF falls into the muck.

Hospital IT Department Attitudes on Clinicians

2012-01-20T17:37:00.008-05:00

A quasi-satirical but actually quite serious post:

As exemplified by my posts at my 12-year-old HIT difficulties site at this link, and much feedback from clinicians, informaticists, and others, the picture below speaks for itself about the apparent attitudes of health IT vendor and hospital IT departments towards clinicians. (And, by implication, towards patients - you - and patient safety):

(Click to enlarge)

Enough said.

-- SS

A Letter to the Joint Commission on Their EHR-Related Investigations

2012-01-20T16:02:00.023-05:00

After a U.S. Joint Commission (JC) evaluation of a complaint involving an EHR-related mishap that affected a relative of mine, I sent the following letter to Mark Chassin, MD, President of the Joint Commission; and the same letter, personalized, to Paul Schyve, MD, Senior Advisor, Healthcare Improvement, to Anita Giuntoli, Director, and to Shirley Legaspi, RN, MSN, Patient Safety Specialist, JC Office of Quality Monitoring.

Joint Commission hospital accreditation is advertised to consumers by the JC itself and by accredited hospitals and other healthcare organizations as an assurance of quality and safety.

For example, prominently displayed on the JC website here is the following:

An independent, not-for-profit organization, The Joint Commission accredits and certifies more than 19,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards.

Our Mission: To continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value.

Vision Statement: All people always experience the safest, highest quality, best-value health care across all settings.

And here:

What's the Word on Accreditation
"Joint Commission accreditation puts us ahead of the curve when it comes to quality and safety. We are confident, based on how we operate our business, that we are Joint Commission-ready at all times."

Dee Weigel, R.N., B.S. - Quality Assurance and Risk Manager Algonquin Road Surgery Center, L.L.C.

The letter below should help prevent future public misunderstandings of the Joint Commission's stance on faulty electronic medical records and related clinical IT systems, or on policies or procedures surrounding use of same.

Scot M. Silverstein, MD
Medical Informatics Specialist
Plaintiff’s Expert Witness in EHR-Related Medical Malpractice
[address redacted]
[phone redacted]
[email redacted]

January 20, 2012

Mark R. Chassin, M.D., F.A.C.P., M.P.P., M.P.H.
President, the Joint Commission
One Renaissance Blvd.
Oakbrook Terrace, IL 60181
Via email and postal mail

Dear Dr. Chassin,

This letter is to put on the record facts about the Joint Commission’s (JC) evaluation activities of complaint/ incident #XXXX-YYYY-ZZ [actual code redacted].

The information transmitted to the JC included, but was not limited to documentary proof of:

• A warning letter I submitted to the CEO and CMO of the hospital system that was the subject of the complaint evaluation activities, warning about EHR deficiencies that could cause patient harm a month prior to actual harm occurring;
• Evidence an EHR permitted an RN to discontinue at triage a longstanding critical cardiac medication the patient had been on for approximately 8 years;
• A failure of mechanisms, both cybernetic and human, for clinical staff in the continuum of care (ED/ICU/specialty floor), including those explicitly informed of the medication by the patient’s relative, himself a physician and family member, to be aware of or alerted to this discontinuation;
• Resultant severe, debilitating patient harm that ultimately led to death;
• A medication reconciliation H&P ICU page (handwritten) that was left blank;
• A non-dated, non-timed chart alteration adding the missing medication as if to appear contemporaneous with the H&P;
• A finding by Medicare’s state QIO after their investigation that the care provided did not meet accepted professional standards of healthcare, and that the deviations led to the patient harm and subsequent complications.

In response to the above materials and documentation, and despite hearing my opinion (which, in fact, is supported by reports and research from the Joint Commission itself, the National Research Council, the Institute of Medicine, the National Institute of Standards and Technology, the American Medical Informatics Association, the ECRI Institute, and others) that such deficiencies pose a risk to the public of further EHR-related near-misses and actual patient injuries and deaths, the JC decided that:

• "The standards areas in which requirements for improvement were issued as a result of complaint evaluation activities" was "None.”

In effect, the Joint Commission’s officers and investigative personnel, who have a fiduciary responsibility to the public to assure hospital operational safety, believe hospitals with deficient EHRs and other clinical IT systems and policies and procedures that can create scenarios such as this are in compliance with all JC standards, and can advertise to the public they are JC accredited for safe operations.

Sincerely,

Scot Silverstein, MD

The Joint Commission's Dec. 11, 2008 Sentinel Events Alert on Health Information Technologies is at this link (PDF): http://www.jointcommission.org/assets/1/18/SEA_42.PDF

In that Alert it states (emphases mine):

As health information technology (HIT) and “converging technologies”—the interrelationship between medical devices and HIT—are increasingly adopted by health care organizations, users must be mindful of the safety risks and preventable adverse events that these implementations can create or perpetuate. Technology-related adverse events can be associated with all components of a comprehensive technology system and may involve errors of either commission or omission.

These unintended adverse events typically stem from human-machine interfaces or organization/system design. The overall safety and effectiveness of technology in health care ultimately depend on its human users, ideally working in close concert with properly designed and installed electronic systems. Any form of technology may adversely affect the quality and safety of care if it is designed or implemented improperly or is misinterpreted. Not only must the technology or device be designed to be safe, it must also be operated safely within a safe workflow process.

-- SS

The Very Latest Health IT "Glitch" - Britsh MP Says No to Cerner

2012-01-19T16:24:00.012-05:00

It's just a glitch:

Bacon calls for halt on Millennium
e-Health Insider.com
19 January 2012

Conservative MP Richard Bacon has called for a halt to all Cerner Millennium deployments following appointment problems and delays at the latest trusts to go-live with the system - North Bristol and Oxford.

Bacon, who has followed the progress of the National Programme for IT in the NHS [NPfIT - ed.] for many years, said the two hospitals had been “brought to their knees” by the implementation of the new electronic patient record system.

“These deployments need to be stopped until we are sure that they can be managed safely,” he said; adding that the system should be "switched off" if it was not working for patients.

North Bristol NHS Trust and Oxford University Hospitals NHS Trust said they are working through some deployment issues, but denied that patient safety has been compromised.

[There's that 'safety has not been compromised by major IT system disruptions' line again - see here - ed.]

However, Oxford University Hospitals told eHealth Insider that it has had to bring in extra staff to help it overcome some “temporary problems while the new system beds in.”

Bacon said local news reports indicated that the trust was having serious difficulties booking patients in for treatment.

The Oxford Mail has reported that problems were so bad before Christmas that the trust had to suspend its parking charges as clinics over-ran by hours.

... Bacon, who was instrumental in triggering last year’s National Audit Office and Commons’ public accounts committee inquiries into the programme, said the NHS should never have been locked into buying software that was “unreliable” and “unreasonably expensive."

“Effective, affordable and robust IT systems are vital to the future of the NHS, but it is clear that the fiasco that is the national programme cannot deliver them,” he said this morning.

He called for “a halt” to new Cerner Millennium deployments, including that at Imperial College Healthcare NHS Trust, which is being undertaken by BT as the local service provider for London, and that at Royal Berkshire NHS Foundation Trust, which went outside the national programme more than two years ago.

[More typical hospital executive-style excuses and spin control follow]

Readers, I won't bore you with the rest of the excuses, pleadings for special accommodation, etc. You've heard them all already on this blog.

However you can read them at the link above if you so desire.

-- SS

Harvard Psychiatry Fails Again

2012-01-19T00:09:00.000-05:00

HARVARD PSYCHIATRY FAILS AGAIN

About a year ago I remarked upon the ethical tone deafness that characterizes Harvard psychiatry. It is bad enough that Harvard-MGH is the home of Joseph Biederman, MD, with whom Senator Grassley had so much fun a while back. Biederman is still in the news. It is also the home of Andrew Nierenberg, MD, who was rash enough to take on Marcia Angell in the New York Review over her well founded criticisms of the hyping and misuse of psychiatric drugs. In response, Dr. Angell handed Dr. Nierenberg his head.

Biederman and Nierenberg are not the only ones. When I called one of the senior Harvard professors, Carl Salzman, MD, to task for signing up a pair of compromised key opinion leaders as speakers in his annual Psychopharmacology Master Class last spring, I hoped the ensuing negative publicity would persuade him to go in a different direction next time.

No such luck! Today I saw the flyer for the 2012 Harvard Psychopharmacology Master Class. The list of speakers is virtually unchanged from a year ago. There is Charles Nemeroff. There is Alan Schatzberg. Both were outed by Senator Grassley’s investigation in 2008, and both were subjected to major administrative sanctions, by Emory University and by Stanford University. Other people now occupy the departmental leadership chairs they held in 2008. There also is a group of other key opinion leaders who appear content to endure the taint of sharing the podium with the compromised Nemeroff and the compromised Schatzberg. What are they thinking?

For that matter, what is the course director Carl Salzman thinking? A year back he said Nemeroff and Schatzberg would give great talks and that he would ensure they were objective and impartial. That’s not the point. The point is that they brought dishonor on our field, and for Harvard Medical School to give them this platform amounts to compartmentalizing information in service of their public rehabilitation. To repeat what I said a year ago, Adolph Hitler also gave a lot of speeches that received rave reviews, and compartmentalized information was widespread in the nation of Germany between 1928 and 1945. The best one can say about the upcoming course is that Biederman and Nierenberg are not on the program.

The Augean stables of psychiatry, at Harvard and nationwide, will not be flushed clean by the Carl Salzmans of our field, quibbling over legal technicalities while failing to see the ethical elephant in the living room.

For how long will the grownups at Harvard Medical School allow this farce to continue?

EHR Lowers Costs By 33% ... Oh ... Wait A Minute ... We Retract That Statement

2012-01-18T18:12:00.008-05:00

There's this:

Blue Cross Blue Shield of RI Pilot Lowered Monthly Costs By Up to 33% Through EHRs
December 13, 2011
Becker's Hospital Review.com
Sabrina Rodak

Health plan members that received care from physician practices using electronic health records had an average of 17-33 percent lower monthly healthcare costs compared to members receiving care at non-EHR physician practices, according to a news release by Blue Cross & Blue Shield of Rhode Island.

BCBSRI conducted a three-year pilot program that partially funded 79 primary care physicians to purchase and use EHRs.

Then, there's this:

Blue Cross backtracks on claim that EHRs lower care costs
December 22, 2011
FierceEMR.com
Dan Bowman

A week after reporting that use of electronic health records lowered the cost of care for its customers between 17 and 33 percent, Blue Cross Blue Shield of Rhode Island has backtracked on those claims. In an email sent to FierceEMR, BCBS/RI says that while the program significantly improved healthcare quality, its cost data had not been risk adjusted and did not include costs related to infrastructure spending. "At this time we are unable to accurately ascertain the cost implications of the pilot and are retracting the news release," the email reads. BCBSRI updated its announcement, which can be found here.

I note the following:

Healthcare organizations, HIT pundits and vendors seem happy to promote EHR's as saving a great deal of money. I do not believe they ever will. (I have company, such as at Wharton.)

One can only wonder what led to the retraction of a press release based on a curbstone data analysis, as cited above. Internal dissent, perhaps?

Healthcare IT, as in this pilot study, can improve healthcare quality metrics (outcomes is another matter as yet undecided as illustrated by this reading list) - but only if done well, a remarkably complex undertaking. That undertaking starts at conception and design, to production, to implementation, to customization, to maintenance of software and hardware during the system lifecycle. See this report by the U.S. National Research Council.

When healthcare IT is done poorly, it will neither reduce costs, nor improve outcomes, and will increase risk to patients.

The current ecosystem of commercial health IT and its lack of true regulatory framework for these experimental devices can be counted upon to "do health IT poorly."

-- SS

"Barbarians at the Gate" - Making Private Equity Less Private, and Understanding Its Effects on Health Care

2012-01-18T14:23:00.001-05:00

One good byproduct of the tumultuous everlasting 2012 campaign for the US presidency has been to shed light on a number of political and economic issues that had previously been ignored, especially those relating to the global financial crisis or great recession. In turn, many of these issues may be relevant to our understanding of our ongoing health care dysfunction.

The latest issue to achieve prominence was the nature of private equity firms. Current presidential contender Mitt Romney used to work for Bain Capital, a private equity group. As we discussed here, Bain Capital owned a variety of companies, including some important health care corporations. More importantly, attacks on Mr Romney's record at Bain by other candidates have lead to a broader discussion of the nature of private equity. This discussion is very relevant to health care, since private equity firms have taken over a number of important health care corporations, and more recently, have begun to take over formerly non-profit health care organizations.

Therefore, we will summarize what has become known about private equity, and then consider its implications for health care.

Understanding Private Equity as Re-Branded Leveraged Buy-Out Firms

- Private Equity Firms are Just Re-Branded Leveraged Buyout Firms

The first good statement to this effect I found was by Merrill Goozner in the Fiscal Times(1):

Private equity is actually a misnomer, since the modus operandi of those investors is no different than the leveraged buyout firms that pioneered junk-bond financing in the 1980s.

As reported by the Los Angeles Times(2):

'Being known as a leveraged-buyout-deal shop wasn't the most attractive label out there,' said Colin Blaydon, director of the Center for Private Equity and Entrepreneurship at Dartmouth's Tuck School of Business. 'Private equity has a much nicer ring to it.'

In fact, according to Forbes columnist Robert Lenzer,(3) the famed investor Warren Buffet called this re-branding

'Orwellian': Buffett wrote that 'private equity' is a 'name that turns facts upside-down: A purchase of a business by these firms almost invariably results in dramatic reductions in the equity portion of the acquiree’s capital structure compared to that previously existing.'

I must admit I always thought private equity firms simply collected large amounts of capital from investors, then used the pooled capital to buy out troubled firms. I assumed that because these investors therefore had a large personal stake in these firms, they would want to increase at least their financial value. I also thought that leveraged buy-out firms ceased to exist after all the bad press they got in the 1980s. It turns out I was wrong on all counts. Probably, a lot of other peoples' beliefs about private equity were similarly wrong.

Once the equation of private equity and leveraged buyout firms is made, understanding what they do and its implications are easier.

- Leveraging the Buy-Out

The modus operandi of leveraged buyout firms is to make their purchases of troubled corporations mainly with borrowed money. As Merrill Goozner put it(1),

Private equity firms generally finance anywhere from 60 to 90 percent of their purchases with borrowed cash.

Note that,

Interest payments on those debts are treated just like any other expense, and are therefore deductible from earnings.

- Then Leveraging the Acquired Company

If this leveraging were the only leveraging done in a leveraged buy-out, the implications might not be that big, except for the acquiring firm. After all, when the leveraged buy-out firm borrows the money, it then becomes obligated to pay it back. However, then comes the tricks.

One important trick was described in the following example by economist Dean Baker on the Beat the Press blog(4),

To take a simple example, suppose a public company (let's call it Gingrich Inc.), has $1 billion a year in profits. If Gingrich Inc. paid taxes at the full 35 percent rate (fat chance), it would have $650 million [thanks Robert] a year to either keep as retained earnings or to pay out as dividends to its shareholders.

Now suppose that a PE company (we'll call it Romney Capital) steps in. The current price to earnings ratio in the stock market is around 14, so Gingrich Inc. would have a pre-takeover market value of approximately $9.2 billion (14*$650 million). Romney Capital then arranges for Gingrich Inc. to borrow $6 billion which it pays out as a dividend to itself. This means that the Romney Capital has just gotten back almost two-thirds of its investment.

A somewhat less vivid description of the process appeared in a post by Robert K Lifton on the Huffington Post(5):

Most often, in order to increase the return on capital invested by the fund, the fund will borrow a significant portion of the purchase price of the business. And sometimes, if it can, the fund will take back as a distribution immediately upon closing the purchase of the business, a portion of its investment in the purchase price, reducing its own investment and enhancing its return on the investment left in the business. This distribution may come from the company's existing cashable assets or from money that the company is caused to borrow.

Thus, it appears that while the leveraged buy-out (or private equity) firm borrowed money to finance the purchase of a company, it can almost immediately get out of its obligation to pay off that loan, by making the acquired company its own loan, and using proceeds from that to end the LBO firm's debt. The leverage, and the obligation to pay back a debt has almost magically been transferred from the LBO or private equity firm to the acquired company. That has big implications, as Lifton wrote(5):

This additional leverage also creates additional risk; if things don't go right the business will not be able to pay the carrying costs of the debt, the lender will take over the business and the fund will lose its investment. Sometimes, that results in the acquired company placed in bankruptcy proceedings either to liquidate its assets to pay off the debt or to restructure, a process Bain also experienced.

- Selling Assets to Further Reduce the Private Equity Firm's Debt

LBO firms have another trick up their collective sleeves. As Dean Baker continued his example(4),

Now suppose that the Romney Capital arranges to sell off some of Gingrich Inc.'s assets, such as real estate or a highly profitable subsidiary, and then uses the proceeds to make a payment to the Romney Capital rather than leaving the money under the control of Gingrich Inc. Such sales may allow Romney Capital to recoup the rest of its investment and possibly more.

Of course, the result is

Gingrich Inc. is then left as a highly indebted company with few assets.

In this story, Romney Capital may have earned a substantial profit on a limited investment (it recouped most of its money almost immediately when it loaded Gingrich Inc. with debt), without doing anything to improve the operation of Gingrich Inc. If Gingrich Inc. manages to stay in business and generate profits, then this will increase the return. Romney Capital may be able to resell the company and treat the whole sale price as profit.

On the other hand, if Gingrich Inc. goes bankrupt, this will primarily be a problem for creditors, since Romney Capital has already gotten its investment back. In effect, Romney Capital might have secured large gains entirely by financial engineering, while creating no value whatsoever.

Let me underscore that. The LBO model (now also the private equity model) enables the acquiring LBO firm to avoid any losses, by shifting all the risk and obligations to the acquired firms. This puts these firms at considerable jeopardy.

- Tactics to Prepare Acquired Firms for Sale

Of course, LBO/ private equity firms want to do more than not lose money. To make real money, they must be able to sell off the firms they acquire. To do so, they must make these firms, or their components, seem attractive, at least in the short term. To do this, they employ a standard set of tactics out of the generic management playbook.

So, per the LA Times(2),

layoffs are part of the playbook that elite investment firms use to squeeze cash out of struggling companies.

Also, per Lifton(5),

To increase the profits of the acquired company, the fund may reduce the number of employees, reduce pay levels or curtail work time.

In addition, per Josh Barro writing for the Forbe blog(6), other tactics can include

downsizing, increased automation, offshoring, and the like.

- The Private Equity/ Leveraged Buy-Out Version of the Anechoic Effect

It is striking that while Mitt Romney worked at Bain Capital in the last century, and private equity has been around, if not growing, since then, the current presidential campaign seems to be the first occasion which prompted any real public discussion about the nature of private equity, and its significance for the larger political economy. Thus private equity/ LBO seem to have been anechoic for a very long time (like much about how our current health care system operates seems to be anechoic.)

This version of the anechoic effect seems to have been deliberately created by the private equity/ LBO firms.

A Washington Post commentary(7) quoted Mitt Romney,

You know I think it's fine to talk about those things in quiet rooms,...

As a New York Times story(8) put it, these firms are lead by

a group of Wall Street executives who prefer to operate out of the spotlight

A story in Politico(9) called private equity/ leveraged buy-out firms

one of the most secretive redoubts of the American economy

The article went on to suggest that these firms may well have something to hide:

Josh Kosman, author of 'The Buyout of America: How Private Equity Is Destroying Jobs and Killing the American Economy.' [said] 'Most private equity firms are because once you look behind the numbers, there is much they don’t want you to see.'

Furthermore,

Private equity companies often tend to have confidentiality agreements with their investors (Bain would not comment on what agreements it has). Several equity experts interviewed for this story thought any disclosures from Bain were likely to spook its investors.

The private equity business model is based on taking companies out of the public markets, where reporting requirements are strict and investors punishing, making changes that will hopefully make them more profitable and then selling them or taking them public through an IPO.

The part that happens behind the curtain is not always pretty, and private equity firms have learned over the years that it’s hard to tell a complicated story in the media. The goal of private equity is to keep things private.

'It’s had very little consciousness in the political realm until Romney came along because these guys are smart enough not to try to become Treasury secretaries,' said Bill Cohan, a former Wall Street banker-turned-investigative journalist who wrote 'Money and Power: How Goldman Sachs Came To Rule The World.'

In addition, Dean Baker suggested that the confidentiality is used to hide how private equity/ leveraged buy-out firms remove capital from acquired companies(4),

The sort of asset stripping described here, which harms creditors by taking away potential collateral for their loans, violates the law. However it is extremely difficult to prevent, especially with private equity companies that have to make few public disclosures.

Thus secrecy/ confidentiality/ deception should be regarded as one of the main tactics used by private equity/ leveraged buy-out firms.

Implications for Health Care

Mitt Romney's candidacy has generated a surprising amount of discussion about the effects of private equity/ leveraged buy-out firms on the political economy. Many are worried that despite his claims, such firms cause more job loss than job creation. In the Huffington Post(10), Robert Creamer wrote that private equity/ LBOs have contributed to the sense that ordinary people who play by the rules suffer while well-connected insiders prosper:

It just doesn't make sense to them that a relatively tiny number of people -- who don't build a product or create a service -- can make massive amounts of money, while ordinary people who work hard and play by the rules see their incomes flat-line.

Their view is simple. They create cars, or food, or houses or computers -- or they provide police protection, or care for sick people, or teach our kids. Why should they be asked to sacrifice when guys who basically gamble for a living -- as Wall Street speculators -- make incomprehensibly large sums of money?

There seems to be a good argument that the tactics used by private equity/ leveraged buy-out firms might be bad for the general political economy.

Moreover, these firms often take over health care corporations, drug and device companies, health care information technology companies, health insurance companies, for-profit hospital chains, etc. There is reason to think that their standard tactics used on such targets are likely to be particularly bad for health care.

Many health care corporations depend on a long-term view to be successes. To develop new products, drug, device, and health care IT companies must pursue research and development projects that take years. All health care companies depend on highly trained, specialized workers and professionals. To sustain these sorts of employees requires a long-term attention to their development. So private equity/ leveraged buy-out firms' short-term focus, transfer of debt and risk to the acquired companies, and emphasis on short-term generic management cutting costs techniques including lay-offs, outsourcing, etc clash with the sophisticated long-term focus these companies require.

These health care organizations often require the complex interplay of many components. Private equity/ leveraged buy-out firms' efforts to sequester and sell particular assets may disturb this complex system.

Health care quality, and successful research and development require transparency. Extreme emphasis on secrecy by private equity/ leveraged buy-out firms threatens such transparency.

Even more pointed concerns may arise when private equity/ leveraged buy-out firms endeavor to take over non-profit health care organizations. We plan to discuss these in a subsequent post.

The NY Times(g) noted that in the 1980s, leveraged buy-out firms

were branded as 'barbarians at the gate' - the title of a book [by Burrough and Helyar, link here] about the takeover of RJR Nabisco by Kohlberg Kravis Roberts.

Now 30 years later we are finally having a conversation about the role of these firms in the greater political economy. We in health care should be having a parallel discusion about their role in our sphere. I submit that their role was not likely productive. Since health care should not merely be looked upon as a means to make money, but as a public good, we ought to be talking about how to restrain private equity/ leveraged buy-out firms from doing it more damage.

References

1. Goozner M. Private equity's edge: buy now, deduct taxes later. Fiscal Times, Jan 9, 2012. Link here.
2, Hamilton W. Private equity industry: a bad rep, but is it deserved. Los Angeles Times, Jan 12, 2012. Link here.
3. Lenzer R. Why Warren Buffet disdains the private equity crowd. Forbes, Jan 14, 2012. Link here.
4. Baker D. NPR does fluff piece for private equity. Beat the Press, Jan 13, 2012. Link here.
5. Lifton RK. Mitt Romney and Bain Capital: understanding the reality. Huffington Post, Jan 13, 2012. Link here.
6. Barro J. The discussion we should be having about Bain. Forbes, Jan 12, 2012. Link here.
7, Robinson E. Reexamining the myth of no-fault capitalism. Washington Post, Jan 16, 2012. Link here.
8. Lattman P, Lowrey A. As Romney advances, private equity becomes part of the debate. New York Times, Jan 10, 2012. Link here.
9. Hagey K. Mitt Romney's Bain Capital days: a black box. Politico, Jan 11, 2012. Link here.
10 Creamer R. Why the Bain Capital controversy is so damaging to GOP chances this fall. Huffington Post, Jan 16, 2012. Link here.

An "Anecdotal Complaint" About An ICU EHR

2012-01-15T11:18:00.028-05:00

An "anecdotal complaint" (see health IT-specific definition of 'anecdotal' at this link) from a practicing medical informaticist on an EMR system being rapidly rolled out - in a neonatal ICU, where a single slip is an ended life or lifelong crippling injury, and a multimillion dollar lawsuit, in the making:

... Having just exited a 4 week “Night call” rotation of q3 nights (16 hours in house) or weekend days (16-26 hour shift in house) call / attesting/checking and signaturing horror show, my first with our “New” {#$@#**%%$@!*&!!*} charting and attesting, etc system [symbolic praise in the original - ed.], I can 100% attest that everything [another colleague -ed.] said is exactly why I’m scared to death of all the UCs [unintended consequences - ed.] of this current effort, when adult outpatient systems hit quaternary NICUs of 50-60 patients, with untested crash [i.e., artificially rushed - ed.] rollouts.

Dozens and dozens>>>>thousands of examples of each and every comment [made by the other colleague on EHR problems - ed.], plus more is exactly what I’m personally suffering. The more is bilateral horrible carpel tunnel flare ups (7-10 clicks and scrolls to get an “overview” of anything) so right now both my hands are numb.

Plus, one to two minute logons, is a lifetime when a baby is suddenly crashing. This is a “coding horror” and a safety nightmare. I live in constant fear of somebody screwing up something important, and perhaps uncorrectable. We do our work in real-time, most of the time. Where is the FDA when you need them? [Scared of hot potatoes as I wrote here - ed.]

And we do still talk to each other – but even that doesn’t always “work out”, because we’ve lost our operational minds (collectively) – the shared-by-all compact, visually all data in one place, and temporally arranged – i.e., the shared nurse/doc/resp flowsheet [traditionally in an ICU, a long tabular scroll of paper for "at a glance" patient status overview - ed.] – where everybody was looking at the same page, which we no longer are – as the team is slowly discovering.

And which required no logon for sign-over bedside rounding (~40 minutes for 20-30 babies was the allotted time). The flowsheet needed only a 10-15 second glance to spot developing problems; “the computer” is effectively inaccessible in the time allotted for the twice daily sign-n-out “rounds”.

A traditional ICU flowsheet (click to enlarge)

One wonders how often this scenario - what I now call a "But ... patient safety is not compromised" scenario in the words of the typical hospital administrator - is being repeated around the country.

Of course, the problem just can't be the software (as in the post at this link). It's those dullard clinicians and hospital IT staff who have misconfigured the cybernetic miracle.

This is certainly an example where the customs, traditions and methodologies of business IT (e.g., implement on-time and on-budget, at all costs, according to a strict timeline with benchmarks) are highly ill-suited for medicine. That assumes that there are not kickbacks or other financial 'incentives' or COI's in play, of course.

In fact, it would not surprise me if the IT vendor, a major company, has insulated itself from liability through a "hold harmless " clause. If so, as I have written in 2009 in JAMA at this link in response to an article by Koppel and Kreda [1], and at my Drexel Univ. health IT difficulties site at this link, having signed such a clause would represent a breach of hospital governance's fiduciary responsibilities to their clinical employees and agents (in effect, laying the liability for EHR-induced malpractice solely on them), and to patients.

I advised this doctor to 'be safe', as I would not want to have to be expert witness for a plaintiff whose child they injured or killed due to EHR-mediated obstacles to accepted professional standards of healthcare.

Finally, if this doctor were to resign, perhaps a case could be made for constructive discharge.

-- SS

[1] Health Care Information Technology Vendors' “Hold Harmless” Clause Implications for Patients and Clinicians. Koppel R, Kreda B. JAMA. 2009;301(12):1276-1278. doi:10.1001/jama.2009.398

2011 Closes on a Note of Electronic Medical Record Privacy Breach Shame

2012-01-14T11:20:00.006-05:00

At my Oct. 2011 post "Still More Electronic Medical Data Chaos, Pandemonium, Bedlam, Tumult and Maelstrom: But Don't Worry, Your Data is Secure" and others in this query link on medical record privacy, http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy I wrote:

"Don't worry, your medical data's safe."

Joseph Conn of ModernHealthcare.com apparently disagrees (with my sarcasm, that is) and states the obvious outright. I post his story with few comments and several emphases which are mine:

Year closes on a note of breach shame
Modern Healthcare
Dec. 2012

Three-eighty. Three-eighty. Do I hear four hundred?

With 2011 winding down, there are now 380 major data breaches involving 500 or more patients' records listed on the "wall of shame" website kept by HHS' Office for Civil Rights.

So far, from the first wall postings in September 2009 through the latest on Dec. 8 this year, there have been 18,059,831 "individuals affected," and even that massive number is an undercount of the breach problem.

First, the civil rights office hasn't yet released the records of tens of thousands of breaches it has received under a federal reporting mandate on breaches affecting fewer than 500 patients per incident. I've been asking for electronic copies of those records since June. I hope to hear soon on an appeal of a decision last fall by HHS, claiming that the civil rights office can hide those reports while it "investigates" an estimated 30,000 or more breaches they describe.

Second, even the OCR's posted numbers are low.

A Nov. 4 public notice on a breach reported by the UCLA Health System states that "some personal information on 16,288 patients" was stolen, but the wall of shame lists the "individuals affected" in the UCLA incident as 2,761.

UCLA spokeswoman Dale Tate said in an e-mail that the nearly six-times-larger number in its notice "represents the number of individuals who had some information on the hard drive," while the 2,761 figure sent to the OCR "represents the number of people that met the specific criteria" under the federal breach notification rule.

Under the federal rule, Tate says, "the information for these individuals could possibly cause more than a minimal amount of financial, reputational or other harm." Information on the rest of the individuals, Tate said, did not meet the criteria.

Not to get too harpy, but this breach stuff is long past being ridiculous.

The lawyers are already all over it, and maybe that's what it will take for the industry to finally start addressing the problem. Brian Kabateck, a California lawyer, thinks so.

In the past three months, his Los Angeles law firm has filed a pair class-action breach suits against two of the most highly regarded healthcare systems in the state, University of California, Los Angeles and Stanford, as well as one of the latter's business associates, Multi-Specialty Collection Services.

"I think this is a short blip on the radar," Kabateck said. As the settlement costs pile up, he said, "I think big institutions are going to learn—five years from now, these lawsuits are going to be obsolete."

Class-action lawsuits are needed as much for health IT risk and safety issues causing near-misses, injuries and death as for security breaches, I note.

I think five years is highly overoptimistic as well on the breach issue, considering the degree of "institutional learning" that's occurred on how to do health IT "right" over the past ~ three decades, and considering that the breaches that are increasing, not decreasing, in intensity and severity across all industry sectors. That includes industry sectors far better equipped to manage IT security than hospitals.

Right now, though, Kabateck says, "This is not to the level of being an epidemic, but it's close."

I think it is epidemic.

Rather than being a miracle that will revolutionize medicine, health IT is like any other information and communication technology (ICT): it has unintended consequences (UC's) that can dilute or even negate its advantages. The issue of damaged medical record privacy, confidentiality and security is but one UC of health IT.

-- SS

North Bristol Hits Appointment Problems: Another "Our Lousy IT Systems Screwed Up, But Patient Safety Was Never Compromised" Story

2012-01-14T09:56:00.036-05:00

At my Dec. 2011 post "IT Malpractice? Yet Another "Glitch" Affecting Thousands of Patients. Of Course, As Always, Patient Care Was "Not Compromised" referencing prior posts, I wrote:

... At my Nov. 2011 post "Lifespan (Rhode Island): Yet another health IT glitch affecting thousands - that, of course, caused no patient harm that they know of - yet" I wrote:

There's been yet another health IT "glitch" that, of course, caused no patients to be harmed. See other "glitches" here, here, here and at other posts which can be found by searching this blog on the banal term 'glitch'.

Another "our clinical IT crapped out , BUT ... patient care/safety was never compromised" story just arose:

North Bristol hits appointment problems
E-Health Insider
11 January 2012
Rebecca Todd

Clinicians working at North Bristol NHS Trust have expressed concern about disruption to patient care, which they say is caused by appointment problems following the go-live of a new Cerner Millennium electronic patient record system.

I would have entitled the article "North Bristol hit by IT-created appointment problems."

Reported problems include patients being booked into non-existent clinic appointments or not being told about scheduled operations, resulting in some operations being cancelled.

No patient care compromise possible there. Who, after all, needs a timely operation? It frees up a lot of money for IT golf tournaments to let those of no value to society (i.e., the old, and those who will not admit computers in healthcare with deterministically revolutionize medicine because, well, they're magic) simply die due to delayed or cancelled surgery...

Ehealth Insider understands that some of the problems relate to the way the trust configured the EPR system; including setting up dummy clinics for which appointment letters were subsequently sent out.

It's never the software or computer's fault.

As a matter of fact, I have not seen any official response to the work of Dr. Jon Patrick at U. Sydney on the many software engineering flaws of another product of the same company. His work is entitled "A study of an Enterprise Health information System" and is at this link: http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146. Do they have Class Action lawsuits in Australia?

In a regional BBC news report, aired on Monday evening, anonymous hospital clinicians called the implementation a “complete shambles” and said it represented a “potential danger” to patients.

According to the BBC report, the problems meant patients were being booked for impossible appointment times, such as 12.05 am, and quoted correspondence saying staff and the system were both on the “verge of meltdown."

The clinician comments are anonymous since non-anonymous reporting would get the clinicians declared health IT apostates, and then excommunicated. Non-anonymous 'whistleblowers' could also fear being sued due to possible gag clauses - the kind of clause hospital executives sign in violation of their fiduciary responsibilities to their staff and to patients. (See my 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards"at this link and the much-expanded essay on the same themes "Health Care Information Technology Vendors' Hold Harmless and Keep Defects Secret Clauses" at this link.)

Martin Bell, director of IM&T at the trust, confirmed to EHI that North Bristol had experienced some “unexpected problems” in the past few weeks with some of the outpatient appointments and theatre lists.

Bell stressed, however, that patient safety had not been compromised and that this continued to be the top priority.

There's that line again. Perhaps it's part of some hospital administrator JournoList-recommended catchphrase for describing how safety was not compromised during a major workflow disruption?

He said the problems were not down to the software itself, but due to “implementation and data migration difficulties in some clinics."

Right. Quite credible.

“Our information management and technology team, supported by our suppliers BT and Cerner, have been working very hard to sort out any initial issues as quickly as possible and we are already seeing improvements,” he said.

Congratulations are due. They are seeing "improvements" in dangerous clinical IT malfunctions that should never have to have been seen in the first place, if the statement is true.

“Many wards, our two minor injuries units and the Emergency Department, are successfully using the new system." The trust is one of the largest in the South of England, with more than 1,000 beds.

Just give them time.

EHI understands that as part of the Millennium implementation, dummy clinics were set up. Patients were then sent appointment letters for these clinics in error.

EHI also understands that some patients had also not turned up for scheduled operations because they had not been informed about the booking.

Bell apologised to patients who had been “inconvenienced during this transition period” and said staff had shown real dedication to continue to deliver patient care.

What if someone had been inconvenienced into their grave, or ends up there as a result of delays? On what wavelength will the apology be transmitted?

“We firmly believe that the new system, once fully implemented, will improve services for our patients and provide real value,” he said.

That seems to be the mantra, but delivery on such promises are rare. See "Pessimism, Computer Failure, and Information Systems Development in the Public Sector" as here, Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand. The article is a cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT.

A £69m contract for BT to deliver Cerner Millennium to three new, or ‘greenfield’ sites in the South of England was agreed in April 2010, under the auspices of the National Programme for IT in the NHS.

That would not be the failed National Programme for IT in the NHS, the NPfIT what went PfffT, would it?

North Bristol was the last of these three sites to go-live with the system in December last year.

It followed Oxford University Hospitals NHS Trust, which went live a week earlier, and Royal United Hospital Bath NHS Trust, which was the first to go-live in July.

Cerner said it was working closely with North Bristol and BT on the recent implementation of Millennium.

“In complex and large deployments, especially when migrating from two different systems, it is always anticipated that it would take time for the new system to bed-in,” it said in a statement.

The patients are given full informed consent on this issue, right? Right?

“Across much of the trust, the deployment has worked well. However, this is a major change management project and there have been some difficulties with outpatient appointments.

“Although this is not a problem with the software, Cerner is working in partnership with BT and trust staff to resolve any issue as quickly as possible.”

Link: BBC News

Right. Perhaps this software and claim needs testing - in a court of law.

The only thing missing is the word "glitch", though I am including that term in this posting's index, since I consider it another story in the ever-growing health IT "glitch" series.

-- SS

Addendum:

A reader sent me this comment:

How can anyone claim the problems at N. Bristol are unexpected. they are EXACTLY the same problems encountered in Taunton five years ago.

The Somerset Trust had sixteen cancelled go live dates and when Cerner 'Millennium" (note: they never defined which Millennium...) was switched on the whole hospital went into slow-motion.

Appointments could not be made at out-patient reception desks while patients waited and therefore had to be posted on. Twenty-four whole time equivalent clerks had to be employed to manage the back-up of appointment requests. So much for enhanced efficiency and cost savings.

The only possible response to this news is again to remind people of Einstein's famous definition of insanity: "repeating the same thing again and again and expecting a different result."

As for other Trusts, why no news of transformed performance by Cerner's systems at other Cerner implemented sites, Berkshire, Newcastle, Kingston, Oxford etc. The only 'good' news we get is that the system has been switched on.

If any of this expensive activity had really produced data, efficiency or cost gains, we would be drowning in Cerner press releases, the silence can only mean one thing, that their system is performing as poorly at other sites as it has in the South West.

Contrast this with the output and data produced openly by Birmingham University Hospital from its in-house created IT system.

Unfortunately one can only draw one serious conclusion about the whole Cerner/ NHS debacle - to paraphrase Mr. Clinton - "It's the (imho substandard) software, stupid!

This story needs serious investigation ... Recently US news items have started to discount the supposed efficiency gains for e-Health implementations and started to emphasize data capture and patient safety as the imperative for switch on. Unfortunately for Cerner supporters (and other vendors) the US Institute of Medicine's recent report stated unequivocally that there was (to everyone's apparent surprise) no quality evidence that e-Health improved patient safety.

I would contend no drug, therapeutic equipment or operation would or could be implemented in secondary care in the absence of critical and peer reviewed evidence of benefit [emphasis mine - ed.] that has characterized the rush to switch-on substandard IT solutions in English NHS hospitals.

I note that critical, peer-reviewed evidence, especially based on prospective randomized clinical trials as opposed to anecdotal, weak retrospective observational studies, have been deemed unnecessary in health IT.

Yet serious case reports of risk and injury from credible sources are deemed the true "anecdotes" and discounted. As I've written before, the science of medicine is nearly entirely lacking in the domain of health IT.

To put it in the words of James Le Fanu (channeling Sherlock Holmes) in his very apropos essay entitled "The Case of the Missing Data: The Dog That Didn't Bark", details on contrary strands of evidence that could reasonably have been expected to appear in evidential text are absent.

-- SS

Three Golden Parachutes and Some Unexpected Sequels

2012-01-12T14:11:00.002-05:00

Golden parachutes are an always fascinating aspect of executive compensation in health care. I have collected three relatively recently revealed stories about golden parachutes given to government and non-profit hospital system CEOs, at least two of which involve unexpected, and also fascinating sequels. They will appear in order of the apparent size of the parachutes.

Santa Clara Valley Health and Hospital System

Santa Clara Health and Hospital System is a county (government) system of moderate size in California. Last week, the compensation given its outgoing CEO in 2010 was revealed by the San Jose Business Journal:

Former Santa Clara Valley Health and Hospital System CEO Kim Roberts walked away with an impressive chunk of change when she abruptly left the job in February 2010.

According to a city and county salary report released from the State Controllers Office, the position earned a little over $1 million that year.

A county spokeswoman confirmed that the total included accrued vacation, sick leave and other payments Roberts was entitled to.

The salary was the highest in the Bay Area for public employees in 2010.

Note that

Roberts was hired as CEO in March 2007 with a five-year contract. The agreement included a starting salary of $285,744 with annual salary adjustments, severance and other benefits.

The issue here is that Ms Roberts was the CEO of a local government run health system. Traditionally, the pay given to people in such positions is closely scrutinized by politicians and tax payers, and hence is usually less than that given out by private, non-profit hospital systems, much less for-profit ones. Nonetheless, while it appears that Ms Roberts got something more than $700,000 worth of compensation beyond her usual salary in her last year, the nature of this compensation, and the justification for it is unclear.

Erlanger Health System

The story that got my attention appeared two days ago in the Chattanooga Times-Free Press:

After more than a month of negotiations, Erlanger trustees reversed a previous vote and approved a controversial $728,000 severance package for outgoing CEO Jim Brexler.

Trustees voted 4-4 against the same severance package in December but voted 5-4 to approve it during a 30-minute meeting Monday morning.

More detail about the package:

The approved agreement provides 15 months of severance for Brexler, worth about $713,000. He also keeps his Erlanger health coverage for 18 months, paying his employee portion, a benefit worth about $15,000.

This story is actually a complex sequel. We discussed CEO compensation at Erlanger Health System, an academic medical center affiliated with the University of Tennesse, a year ago. At that time, we noted that a substantial bonus given to then CEO Jim Brexler was based on favorable financial results in the previous year, but did not apparently take into account the more recent decline in the system's finances. That bonus was justified by the typical paean to the leadership's "real expertise in health care" by one member of its board.

By last month, however, Erlanger's finances had deteriorated dramatically. A Free Press article then stated,

Erlanger hospital employees have been asked to take 12 days off in the next two months, consider voluntary buyouts and face possible layoffs as Chattanooga's only public hospital bleeds money.

The hospital has lost more $6 million in the last five months, half of that in November.

The reason for this accelerating misfortune deterioration remain unexplained. Apparently, CEO Brexler had decided to depart, for also unclear reasons, two months earlier:

In October, the hospital announced CEO Jim Brexler would retire at the end of the year.

At that time, the board had voted to give him the severance package described above, but then suddenly began to reconsider after how bad things were became clear:

The board voted earlier this month not to give Brexler a more than $700,000 severance package, but the issue may be brought back up, board members have said.

It was unclear whether the decline in Erlanger's finances had to do with its relationship with another troubled hospital, Hutcheson Medical Center, as described in another Free Press article:

Despite a new board, new management and the infusion of a $20 million line of credit, a struggling North Georgia public hospital continues to lose money.

Erlanger at Hutcheson, formerly known as Hutcheson Medical Center, lost more than $9 million in the first five months of the 2012 fiscal year, which began in July. It lost the most -- $2.7 million -- in September.

Hutcheson board Chairman Corky Jewell could not be reached for comment last week.

The hospital's administrator, Debbie Reeves, and other management personnel were not in the office the week between Christmas and New Year's, according to spokeswoman Haley Johnson.

The publicly funded hospital in Fort Oglethorpe had been losing about $1 million a month, defaulted on a $35 million bond and laid off 75 employees in fiscal year 2011.

In May, Erlanger Health System took over management of the hospital and extended up to $20 million in credit to it.

Apparently inflated compensation to Hutcheson's CEO was also a subject of one of our posts from about a year ago. At that time, we wrote, "despite a major financial loss, lay-offs and service discontinuations, and a bond default," the CEO got "bonus and incentive compensation" in 2009.

So, to summarize, despite major financial problems, Hutcheson Medical Center's CEO got a bonus and incentive compensation in 2009. As its situation got worse, it was taken over in some sense by Erlanger Health System, whose CEO also got a bonus despite increasing financial problems in 2010. Thereafter, the finances of Erlanger really declined, its CEO announced his retirement, and still will collect a golden parachute.

Thus Erlanger Health System's golden parachute for its outgoing CEO symbolizes the anti-gravitational powers of executive compensation. While lavish executive pay is often justified by short-term financial results, health care executives seem to be able to just keep collecting more and more until they have to flee. Health care seems to more and more be run for the benefit of self-interested insiders.

Also, this case demonstrates how skeptical we ought to be of the breathless praise for health care executives and managers and the uncritical touting of their latest advances and initiatives. (By the way, we posted here, just before it became apparent how badly Erlanger's finances were collapsing, about its breathless advertisement of a "new service excellence program" for Erlanger employees run by the Ritz-Carlton hotel chain. One wonders whether the attention to the peripheral ahead of core responsibilities this denoted could have been one reason for the system's decline.)

And we are just working our way up to our big case....

University of Chicago Medical Center

This story actually dates back to 2009, but was first revealed briefly in late 2011, in Becker's Hospital Review,

The other three highest-paid hospital CEOs in Chicago in 2010 include the following:
• James Madara, MD, and Ken Sharigian, University of Chicago Medical Center: $7.9 million
Note: This includes severance for Dr. Madara, who resigned in Oct. 2009. Mr. Sharigian served as the interim in 2010.

A little more detail came out in a side-bar to a story on executive compensation in higher education by the Chronicle of Higher Education:

James L. Madara, dean of the school of medicine and chief executive of the medical center, U. of Chicago
Total compensation: $7,038,944
Mr. Madara’s base salary was $1.3-million, and he received $2.5-million in severance pay.

There was also a hint of why this was so interesting:

Mr. [sic] Madara stepped down after seven years as dean and three as chief executive to return to the faculty. He resigned amid controversy over his management decisions, such as a plan to redirect medical-center patients to neighboring hospitals, according to local news reports.

A little digging shows there was more to it than that. Recall our recent post that discussed the "Urban Health Initiative," a program ostensibly meant to direct some patients, allegedly mainly poor patients, to more appropriate health care venues, allegedly away from the Emergency Department of the university medical center, and again allegedly to make room for patients who need and whose insurance can pay for more lucrative services.

By February, 2009, the Wall Street Journal reported that

In February, two high-ranking doctors quit their administrative posts to protest the plan, saying it could lengthen already long waiting times for patients who visit the ER.

In particular,

The two doctors who gave up their administrative posts in Chicago were Dr. Vanden Hoek, who stepped down as interim chief of emergency medicine, and pulmonology researcher Joe G.N. Garcia, who had been chairman of medicine. The doctors still can practice medicine at the hospital.

About a dozen other doctors from the emergency room and other departments had signed a letter of protest over the hospital administration's plan to reduce the number of beds available to emergency patients in the ER and other units.

Three months later, as reported by Chicago Business,

Some University of Chicago Medical Center faculty members are accusing CEO James Madara of putting hospital finances ahead of research and teaching.

A letter delivered to Dr. Madaar last month and signed by 76 faculty members asserts that, since adding the hospital CEO title in 2006, Dr. Madara has lost focus on his role as a dean of the Hyde Park medical center's vaunted research and academic enterprise. A preocccupation with hospital profits and an 'insular management style' have 'disenfranchised' the faculty, the letter says.

By that month, according to the Wall Street Journal,

More than 190 doctors at the University of Chicago Medical Center signed a letter to trustees protesting plans to reduce the number of beds available to emergency patients as 'unnecessarily risky' and a threat to patient safety.

The plan was put on hold by the university president a few days later. Dr Madara resigned in August.

So, somewhat like the case above, this involved a hospital system CEO who got a very large golden parachute after leaving under fire, not for declining revenue, but for his role in overseeing a program of questionable ethics, one possibly bad for patients, and having lost the confidence of some important proportion of his medical faculty.

He did not, however, go off quietly into the night. His next stop was Leavitt Partners (as noted in this AMA press release), founded by former President George W Bush administration Secretary for Health and Human Services James Leavitt.

As we noted here, Leavitt Partners advertises that it "advises clients that invest in health care and food safety." It does not publicize its client list, but that list apparently includes Alliance Health Networks, whose press release noted that Leavitt Partners "will help it expand its presence in the US health industry and beyond "(look here); and Connextions, Inc, whose press release noted that it would work with Leavitt Partners to " refine existing health insurance exchange models for federal and state governments, as well as private sector organizations that are navigating health care reform law," (look here.) Mr Leavitt joined the board of Medtronic last year (look here).

Then, however, he got back into the CEO business. While still maintaining a role at Leavitt, in 2011, per the AMA release,

The American Medical Association (AMA) today named James L. Madara, M.D., as its new Executive Vice President and Chief Executive Officer. Dr. Madara will assume leadership of the nation’s oldest and largest physician group on July 1.

That news release noted his past positions,

the Thompson Distinguished Service Professorship and deanship at the University of Chicago Pritzker School of Medicine, where he was the longest serving Pritzker dean in the last 35 years. Subsequently, he added the responsibility of CEO of the University of Chicago Medical Center, bringing together the university’s biomedical research, teaching and clinical activities.

Perhaps not surprisingly, it did not mention the controversies at the medical center that preceded his resignation, nor his sizable golden parachute, nor his ongoing role at Leavitt Partners.

So, the American Medical Association claims to represent all US physicians and their values. It turns out that its current Executive Vice President and CEO is a former hospital system CEO who departed under fire with a golden parachute beyond any severance package a practicing or academic physician would dream about. He also is a former and current consultant with a firm lead by one of our better recent examples of beneficiaries of the revolving door. We have come a long, and the wrong way since the AMA asserted, "the practice of medicine should not be commercialized, nor treated as a commodity in trade." (See this post.)

This story is not just about the ridiculous compensation given to health care executives, and how this provides perverse incentives and suggests that many health care leaders have become insiders who put their self-interest ahead of the health care mission. This story is also about the connectedness of these insiders, and how they appear to control nearly every part of health care.

The Moral of the Stories

Maybe if I write this often enough, it will get some notice.... 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.

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.

US Presidential Candidates' Financial Relationships with Health Care Organizations

2012-01-09T17:06:00.000-05:00

As the leadership of the large field of Republican candidates for the US Presidency shifts, different candidates come in for increased media scrutiny. Recently, reporting about former Pennsylvania Senator Rick Santorum focused on his financial relationships with a health care organization. Senator Santorum, however, is only the candidate with ties to health care organizations to come into the spotlight most recently. We will review the report on Santorum, and then summarize the publicly known relationships of the other candidates.

Republican Former Pennsylvania Senator Rick Santorum and Universal Health Services

The relationship was first revealed by Bloomberg,

Santorum’s greatest financial gain came from $395,414 in director fees and stock options he listed in a recent financial disclosure.

The fees and options came from King of Prussia-based Universal Health Services Inc., a publicly traded health-care management company....

Senator Santorum started on his board service in 2006. He resigned in June, 2011, when he started his campaign for the presidency.

Note that while Santorum served on the board, the company was accused of ethical missteps:

The Justice Department accused the company in a 2010 lawsuit of submitting fraudulent reimbursement claims under the Medicaid health-care program for the poor. The government said the company falsely claimed to have provided inpatient psychiatric services to children at a detention facility in Marion, Virginia. Pantaleoni said the case has been settled.

The company has also risked losing certification to receive Medicare reimbursement for medical centers that it owns.

According to a release on the UHS website, the Rancho Springs Medical Center and Inland Valley Regional Medical Center in Riverside County regained their certification in November after the Centers for Medicare and Medicaid Services threatened to terminate their provider agreement in June 2010. The state of California had also threatened to revoke the group’s hospital license.

It wasn’t the first time UHS risked losing certification for one of its facilities. In late September 2008, CMS terminated participation in Medicare for the Two Rivers Psychiatric Hospital in Kansas City. It’s a decision that led to a court appeal and settlement requiring Two Rivers to retain an outside monitor for six months.

Thus, Senator Santorum was on the board of a for-profit hospital corporation until just before he became a presidential candidate. While he was on the board, the company allegedly committed unethical actions.

Republican Former Georgia Congressman Newton Leroy "Newt" Gingrich and the Center for Health Transformation and its Numerous Corporate Sponsors

A few weeks ago, we posted about Congressman Gingrich's operation of a health care consulting firm, the Center for Health Transformation. It had relationships with a long list of major health care organizations, including Allscripts, the American Hospital Association, AstraZeneca, Blue Cross Blue Shield, GE Healthcare, Gundersen Lutheran Health System, Johnson and Johnson, Pfizer, Pharmaceutical Research and Manufacturers' of America, Siemens, and WellPoint. At a minimum, the Center helped some of these organizations try to influence health care policy to favor their vested interests in the guise of promoting health policy solutions.

The juxtaposition of the stories about Senator Santorum's and Congressman Gingrich's financial ties to health care organizations suggested we review whether other current candidates also had such ties. Some quick searching revealed that some others did. We will review the other current major candidates below, starting with the other Republicans, in alphabetical order.

Republican Former Utah Governor Jonathan Huntsman Jr

I could not find any publicly reported relevant relationships.

Republican Texas Congressman Dr Ronald E Paul

Dr Paul is a physician, an obstetrics-gynecology specialist. According to Wikipedia, he apparently practiced until his current stint in the Congress began in 1996. I could not find any publicly reported relevant relationships.

Republican Texas Governor James Richard "Rick" Perry and Merck

In September, 2011, Governor Perry's prominence in the campaign caused a reconsideration of his relationship to Merck. As MSNBC reported,

On the campaign trail, Perry had recently apologized for the executive order-which would have made Texas the first state in the country to mandate that all teenage girls, starting with 12-year-old sixth graders, be vaccinated with Gardasil.

Gardisil is made by Merck. Then candidate Representative Michele Bachmann noted that Governor Perry had received campaign contributions from Merck. As the Los Angeles Times reported,

In fact, Merck PAC — the company’s Washington, D.C.-based political action committee — has given Perry $28,500 since 2001, according to Texas Ethics Commission filings.

The bulk of that money came before 2007, when the governor signed an executive order mandating all sixth-grade girls in the state to receive the Gardasil vaccine against HPV.

However, Governor Perry had another tie to Merck, as noted by MSNBC,

Perry's order came after the drug company that manufactured the vaccine hired Mike Toomey, his former chief of staff, as one of the firm's top lobbyists in Austin.

Toomey, who is now running the main 'super pac' backing Perry's candidacy, was retained by pharmaceutical giant Merck & Co., maker of the Gardasil vaccine, which is designed to prevent the human papillomavirus, or HPV, an infection linked to cervical cancer in women.

His hiring was part of an aggressive lobbying push in Texas by the drug company, which also donated $16,000 to Perry's gubernatorial campaigns in the two and a half years prior to the executive order. Merck paid Toomey between $260,000 and $535,000 in lobbying fees between 2005 and 2010, according to state lobbying records.

Although Perry's GOP foes never brought up the connection during the debate, Democratic political operatives and a public watchdog group said Thursday his association with Merck is likely to be emerge as a prime example of Perry's 'crony capitalism,' should he win the GOP nomination.

Although there were no reports that Governor Perry personally financially benefited from a relationship with Merck, the company paid substantial amounts to his campaign and to an organization he ran, and to his former chief of staff. There seems to be at least a reason to think that these relationships had something to do with a decision he made that lead to increased sales of a Merck product, and which he now regrets.

Republican Former Massachusetts Governor Willard Mitt Romney and Bain Capital and Numerous Health Care Corporations

Today's Wall Street Journal summarized the investments made by Bain Capital, a venture capital and private equity firm lead by Governor Romney,

The Wall Street Journal, aiming for a comprehensive assessment, examined 77 businesses Bain invested in while Mr. Romney led the firm from its 1984 start until early 1999, to see how they fared during Bain's involvement and shortly afterward.

Among the findings: 22% either filed for bankruptcy reorganization or closed their doors by the end of the eighth year after Bain first invested, sometimes with substantial job losses. An additional 8% ran into so much trouble that all of the money Bain invested was lost.

Of the 10 firms that produced the biggest returns for Bain, four were involved in health care, PhysioControl, Waters, Dade, and Wesley Jessen VisionCare. Dade, a medical diagnostics company, went bankrupt in 2002.

Furthermore, in 2007, the Boston Globe (via the Deseret News) reported on Governor Romney's private equity career, including his involvement with a company that had its ethical challenge,

Bain Capital's 1989 purchase of Damon Corp., a Needham medical testing firm that later pleaded guilty to defrauding the federal government of $25 million and paid a record $119 million fine.

Romney sat on Damon's board. During Romney's tenure, Damon executives submitted bills to the government for millions of unnecessary blood tests. Romney and other board members were never implicated.

More than a decade later, when Romney was in pursuit of the Massachusetts governorship, his Democratic opponent Shannon O'Brien accused him of lax oversight at Damon and failing to report the fraud.

Romney replied that he had helped uncover the illegal activity at Damon, asking the board's lawyers to investigate. As a result, he said, the board took 'corrective action' before selling the company in 1993 to Corning Inc.

But court records suggest that the Damon executives' scheme continued throughout Bain's ownership, and prosecutors credited Corning, not Romney, with cleaning up the situation. Bain, meanwhile, tripled its investment.

Romney personally reaped $473,000.

Thus, Governor Romney was on the board of a device company, albeit many years prior to when he became a presidential candidate. While he was on the board, the company allegedly committed unethical actions.

Democratic President Barack Obama, Michelle Obama, and the University of Chicago Medical Center

The issue of then Democratic Senator Barack Obama's wife's role at the Medical Center was first discussed in 2008, with some follow up in 2009. As the Washington Post reported in 2008,

Shortly after Barack Obama joined the U.S. Senate in 2005, the medical center promoted Michelle Obama to vice president of community and external relations, and more than doubled her salary. She is now on leave from the $317,000-a-year post, in which she sought to bridge the gap between the wealthy institution and its poorer neighbors. The hospital declined to discuss the budget for her program or her input into budgetary decisions.

She was particularly involved in one program that became controversial,

A few years ago, executives at the prestigious University of Chicago Medical Center were concerned that an increasing number of patients were arriving at their emergency room with what the executives considered to be non-urgent complaints. The visits were costly to the hospital, and many of the patients, coming from the surrounding South Side neighborhood, were poor and uninsured.

Michelle Obama, an executive at the medical center, launched an innovative program to steer the patients to existing neighborhood clinics to deal with their health needs.

That effort, in time, inspired a broader program the hospital now calls its Urban Health Initiative.

The Post noted,

The medical center markets its initiative as an effort to improve patient health for the poor and at the same time free its resources for emergencies and complicated procedures. The Urban Health Initiative also could save the hospital substantial amounts of money, by removing the nonpaying poor patients from its emergency room.

However, after Senator Obama became President, his wife became the First Lady and quit her job at the medical center, the program became even more controversial. In March, 2009, the Chicago Weekly reported on the extensions of the Urban Health Initiative

or UHI, which has garnered a lot of criticism recently, such as accusations that it comes 'dangerously close' to the illegal practice of 'patient dumping.' Additionally, the emergency room structure that it will leave in its wake will likely result in a decline in the quality of care provided to Medicaid, Medicare, and uninsured patients.

Ultimately, the Wall Street Journal reported that:

More than 190 doctors at the University of Chicago Medical Center signed a letter to trustees protesting plans to reduce the number of beds available to emergency patients as 'unnecessarily risky' and a threat to patient safety.

At that time, this admission appeared,

Dr. Madara, the hospital's chief executive, said in an interview last week that the hospital is seeking to admit more patients to its 'programs of distinction' such as oncology and advanced surgery, and treat fewer in the ER, and that these moves will mean more privately insured patients at the hospital.

Note that "programs of distinction" may also mean programs that provide the most revenue. Ultimately, the Chicago Tribune reported that the plan was halted by the university president, and a few months later, Dr Madara, the CEO resigned (again per the Tribune).

Thus, while he was a Senator, current President Obama's wife earned a substantial salary from a non-profit academic medical center and hospital system. A program she ran was then and later alleged to have compromised patient safety and perhaps acted unethically.

Summary

We have frequently discussed how large health care organizations seek to influence discussions of health policy to further their vested interests. At times, they have organized stealth health policy advocacy initiatives to comprehensively push their aims. For example, we discussed how commercial health insurance companies have tried, often succesfully, to influence health policy as recounted by former CIGNA public relations leader Wendell Potter in his book Deadly Spin.

It appears that the more one looks, the more one finds evidence of the web of influence of large health care organizations. Pulling together a variety of journalistic efforts over more than three years, it now appears that the majority of the current credible contenders for the presidency of the US have or had financial relationships with health care organizations.

Often these relationships appear significant enough to be called conflicts of interest were the people who had them communicating about health policy in a venue that requires conflict of interest disclosure, like a major medical journal. One candidate until very recently was on the board of directors of a for-profit hospital corporation, and hence had a fiduciary duty to that company and its stock-holders. One candidate until very recently ran a health care consulting company whose clients included major drug, device, and insurance companies. One candidate previously was on the board of a medical device company. One candidate's spouse previously was a top executive of a academic medical center and hospital system.

While the current candidates may now now be writing articles for medical or health care policy journals, by virtue of their candidacies they now receive enormous attention. Anything they say about health care policy is likely to be influential. Yet there is reason to be concerned that many of their views on health policy were influenced by their financial relationships. In particular, would a candidate who at one time got a major part of his or his family's livelihood from a big health care organization be likely to strongly challenge the status quo that allowed that organization to prosper?

In my humble opinion, there needs to be complete reconsideration of how health care policy is made. In particular, we must define how much of the discussion is driven by vested economic interests, and make sure such interests and their relationship to those in the discussion becomes clear. It is just as important for health policy analysts, pundits, and decision-makers to disclose in detail their conflicts of interest as it is for clinical researchers and educators. Maybe the Institute of Medicine would be willing to take up this issue as they took up conflicts of interest affecting research and education.

The Corporate Psychopaths Theory of Health Care Dysfunction

2012-01-04T17:57:00.000-05:00

A new article in the Journal of Business Ethics suggested that the global financial crisis, or great recession, was primarily due to a fundamental flaw in the leadership of financial organizations, one that has important implications for health care organizations.

The article, Boddy CR. The corporate psychopaths theory of the global financial crisis. J Bus Ethics 2011; 102: 255-259 is here. Its premise was:

The Corporate Psychopaths Theory of the Global Financial Crisis is that Corporate Psychopaths, rising to key senior positions within modern financial corporations, where they are able to influence the moral climate of the whole organisation and yield considerable power, have largely caused the crisis.

Note that in 2004 we first posted about the possibility that a proportion of corporate managers, including those in health care, could be psychopaths, raised then by two experts on psychopathy, Paul Babiak and Robert Hare. In 2006, they published Snakes in Suits, about the dangers of psychopaths as executives and managers (see post here). However, the issue got scant attention in those days of letting the good times roll.

Defining Corporate Psychopaths

Boddy described psychopaths as:

the 1% of people who have no conscience or empathy and who do not care for anyone other than themselves. Some psychopaths are violent and end up in jail, others forge careers in corporations. The latter group who forge successful corporate careers is called Corporate Psychopaths.

Corporate Psychopaths as Leaders

Such people do not make good leaders:

Although they may look smooth, charming, sophisticated, and successful, Corporate Psychopaths should theoretically be almost wholly destructive to the organizations that they work for. The probable mal-effects of the presence of psychopaths in the workplace have been hypothesized about in recent times by a number of leading experts and commentators on psychopathy.

Researchers report that such malevolent leaders are callously disregarding of the needs and wishes of others, prepared to lie, bully and cheat and to disregard or cause harm to the welfare of others. Corporate Psychopaths are also poorly organized managers who adversely affect productivity and have a negative impact on many different areas of organizational effectiveness.

How Corporate Psychopaths Could Have Become Prevalent
Despite the dangers posed by such leadership, corporate psychopaths may rise quickly in management:

Psychologists have argued that Corporate Psychopaths within organizations may be singled out for rapid promotion because of their polish, charm, and cool decisiveness. Expert ccommentators on the rise of Corporate Psychopaths within modern corporations have also hypothesized that they are more likely to be found at the top of current organisations than at the bottom.

The nature of current corporate culture may facilitate the rise of corporate psychopaths:

These Corporate Psychopaths are charming individuals who have been able to enter modern corporations and other organisations and rise quickly and relatively unnoticed within them because of the relatively chaotic nature of the modern corporation. This corporate nature is characterized by rapid change, constant renewal and quite a rapid turnover of key personnel. These changing conditions make Corporate Psychopaths hard to spot because constant movement makes their behaviour invisible and combined with their extroverted personal charisma and charm, this makes them appear normal and even to be ideal leaders.

The destabilization of modern corporations likely lead to the ascendancy of the corporate psychopath:

However, once corporate takeovers and mergers started to become commonplace and the resultant corporate changes started to accelerate, exacerbated by both globalisation and a rapidly changing technological environment, then corporate stability began to disintegrate. Jobs for life disappeared and not surprisingly employees’ commitment to their employers also lessened accordingly. Job switching first became acceptable and then even became common and employees increasingly found themselves working for unfamiliar organisations and with other people that they did not really know very well.

Rapid movements in key personnel between corporations compared to the relatively slower movements in organisational productivity and success made it increasingly difficult to identify corporate success with any particular manager. Failures were not noticed until too late and the offending managers had already moved on to better positions elsewhere. Successes could equally be claimed by those who had nothing to do with them. Success could thus be claimed by those with the loudest voice, the most influence and the best political skills. Corporate Psychopaths have these skills in abundance and use them with ruthless and calculated efficiency. In this way, the whole corporate and employment environment changed from one that would hold the Corporate Psychopath in check to one where they could flourish and advance relatively unopposed.

The Harms Caused by Corporate Psychopaths as Executives

Thus, Boddy hypothesized the rise of management by corporate psychopaths lead directly to the global financial crisis or great recession:

As evidence of this, senior level remuneration and reward started to increase more and more rapidly and beyond all proportion to shop floor incomes and a culture of greed unfettered by conscience developed.

Corporate Psychopaths are ideally situated to prey on such an environment and corporate fraud, financial misrepresentation, greed and misbehaviour went through the roof, bringing down huge companies and culminating in the Global Financial Crisis that we are now in.

Writing in 2005, this author commentating on Corporate Psychopaths predicted that the rise of Corporate Psychopaths was a recipe for corporate and societal disaster. This disaster has now happened and is still happening.

What Could be Next

Worse, if this hypothesis is true, as long as it is not addressed, things will get worse:

The very same Corporate Psychopaths, who probably caused the crisis by their self-seeking greed and avarice, are now advising governments on how to get out of the crisis. That this involves paying themselves vast bonuses in the midst of financial hardship for many millions of others, is symptomatic of the problem. Further, if the Corporate Psychopaths Theory of the Global Financial Crisis is correct then we are now far from the end of the crisis. Indeed, it is only the end of the beginning.

Some Agreement

The plausible theory that corporate psychopaths ascending to top management positions in finance caused the global financial crisis has been noticed by a few prominent financial pundits. Writing in Bloomberg, William D Cohan agreed with Boddy's suggestion that "anyone who makes decisions that affect significant numbers of other people, concerning issues of corporate social responsibility or toxic waste, for example, or concerning mass financial markets or mass employment, should be screened to make sure that they are, at the very least, not psychopaths and at most are actually people who care about others."

Brian Besham, writing in the Independent, suggested that Richard Fuld, former CEO of Lehman Brothers, whose bankruptcy kicked off public awareness of the global financial collapse, saying he wanted to eat the hearts of those selling his company's stock short (see this post), was a "terrifying" example of corporate executive psychopathy. Worse, Besham noted that he had discovered an case of an investment bank which "psychometric testing to recruit social psychopaths because their characteristics exactly suited them to senior corporate finance roles." It may be that corporate psychopaths are actively recruiting their fellows.

Implications for Health Care

This is chilling. It also unfortunately is highly relevant to health care. As we noted, most recently here, leaders of big finance firms, including those whose failures were most spectacular, now often sit on boards of trustees of hospitals, academic medical centers, medical schools, and their parent universities. Thus, the likelihood that a good proportion of the stewardship of our most prominent not-for-profit health care organizations may be in the hands of psychopaths is not negligible.

Furthermore, health care organizations have become as unstable and chaotic, in the way these terms were used by Boddy, as finance firms. This would suggest that their current nature would make it as easy for psychopaths to rise to positions of power in them as they may have in financial firms. In health care we certainly have seen the consequences he suggested were due to psychopathic managers, including

- intimidation (per Boddy, corporate psychopaths are "prepared to lie, bully and cheat and to disregard or cause harm to the welfare of others");
- self-interest ("pursuit of self-enrichment and self-aggrandizement") leading to outrageous executive compensation ("senior level remuneration and reward started to increase more and more rapidly and beyond all proportion to shop floor incomes")
- fraud and other crime ("corporate fraud, financial misrepresentation, greed and misbehaviour went through the roof,... ")

So as we noted in 2006, "a high prevalence of psychopathic managers could explain the prevalence of mismanagement, conflicts of interest, and corruption in the leadership of health care organizations that we have often discussed on Health Care Renewal."

Boddy's first suggestion to deal with the problem in finance was:

Measures exist to identify Corporate Psychopaths. Perhaps it is time to use them.

However, it is as hard to imagine top health care leaders willingly and honestly submitting to the use of instruments designed to identify psychopaths as it is to imagine finance leaders doing so. Furthermore, it is easy to imagine how corporate psychopaths in positions of leadership would ruthlessly deploy their legions of public relations personnel and lawyers to quash any challenge should the notion that they are so dominant gain any credibility.

However, if there is any significant prevalence of corporate psychopaths among the leaders of health care, woe will be unto us until we identify and remove them.

Just Say "No" to the Term "Anecdotes"; and HIT as a Medical Metadevice

2012-01-04T12:26:00.028-05:00

A New Year's thought: there needs to be a push in healthcare for dropping of the word "anecdote" to describe case reports of health IT-related errors.

This word even appears in the late 2011 IOM report on HIT safety (PDF), e.g., the preface:

... We found that specific types of health IT can improve patient safety under the right conditions, but those conditions cannot be replicated easily and require continual effort to achieve. We tried to balance the findings in the literature with anecdotes from the field but came to the realization that the information needed for an objective analysis and assessment of the safety of health IT and its use was not available.

The "A" word needs to be dropped from the healthcare IT lexicon, since such reports from reliable sources are in fact incident reports purposed for risk management activities.

Incident reports do not need peer review for consideration for that purpose.

Of note, I do not believe the incident reports filed in hospitals when something awry occurs are labelled "anecdotes", either.

See the Aug. 2011 post "From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things" for more on this topic.

And on another vein, the issue of HIT being a medical device:

As the good State Rep. Marino of my home state of Pennsylvania and others oddly proffer - that 'certification' of health IT, having nothing to do with safety or usability, relieves HIT from being a device [1] - and as the IOM itself debates exactly what to call HIT and under what guidelines to regulate it, another term/category for HIT devices is needed.

In the spirit of the naming of the UMLS Metathesaurus, and in consideration of HIT's informational governance/orchestration of other medical devices and personnel (including the 'carbon units' known as clinicians and patients) -- I suggest the term "metadevice" for HIT.

Healthcare metadevices need their own specific regulation, apart from traditional medical devices.

-- SS

Note:

[1] As in line 21- 24 on page 6 of the "Safeguarding Access For Every Medicare Patient Act" Bill (PDF) that I wrote about here. The Bill states: "CLARIFICATION OF AUTHORITY. Certified EHR’s shall not be considered a device for purposes of the Federal Food, Drug, and Cosmetic Act."

(This proposal, of course, raises the question of whether Rep. Marino believes non-certified HIT shall be considered a medical device, a topic for another time.)

SELF INFLICTED DAMAGE

2012-01-04T11:59:00.000-05:00

SELF INFLICTED DAMAGE

The American Psychiatric Association (APA) is in the news again for bad public relations: worse than bad, actually – appalling. Locked in a bunker mentality, they have moved to stifle advance criticism of their flagship initiative, DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition), which is a work in progress. Lawyers for the APA have threatened the owner of a UK blog that served as a discussion forum for issues affected by DSM-5 and other, international psychiatric classifications. The blog, named dsm5watch was considered authoritative and accurate. If you go to this site now you will find that it has been deleted.

As recounted this week by Allen Frances, MD, the editor of the last published DSM edition, the blog’s owner, Suzy Chapman, told him, ”On December 22, I was stunned to receive two emails from the Licensing and Permissions department of American Psychiatric Publishing, claiming that the domain name my site operates under was infringing upon the DSM 5 trademark in violation of United States Trademark Law and that my unauthorized actions may subject me to contributory infringement liability including increased damages for willful infringement. I was told to cease and desist immediately all use of the DSM 5 mark and to provide documentation within ten days confirming I had done so."

"Given my limited resources compared with APA's deep pockets, I had no choice but to comply and was forced to change my site's domain name to dxrevisionwatch. Hits to the new site have plummeted dramatically and it will take months for traffic to recover - just at the time when crucial DSM 5 decisions are being made."

In effect, the APA, acting not through its medical or scientific officers but through its wholly owned publishing house, has attempted a SLAPP maneuver. SLAPP is the acronym for strategic lawsuit against public participation. What kind of leadership does this signal in a major professional organization?

The normal remit of professional medical societies is stewardship of professional values and ethics. That is why these societies are accorded deference and respect on matters of clinical guidelines, health policy and public education. Even when, like the Institute of Medicine of the National Academy of Sciences, they tolerate compromised members, they can generally hope to retain the public trust.

One reason for this assurance is that they are expected as a matter of professional duty to avoid conflicts of interest – personal and financial. The APA, however, has an enormous conflict in this case: it counts on millions of dollars in revenue from sales of the DSM volumes and it is under siege currently for perceived scientific and clinical weaknesses of the DSM-5 that is due to be released next year. Professional criticism is running so high that over 10,000 interested parties have signed a petition for the APA to reconsider planned changes. There is even talk of abandoning DSM-5 in favor of the ICD system (International Classification of Diseases), which is a WHO initiative.

The APA doesn’t own psychiatric classification and diagnostic criteria. When the field allows the APA to take the initiative for revisions of the DSM, it is with the understanding that the work will be conducted in the public interest rather than in the commercial interest of the APA itself, which is said to derive over $5 million annually in profits from DSM sales. The public interest and the public trust are served by transparency and open discussion, not by contrived SLAPP threats.

It is bad enough that the APA resorts to this legal artifice to stifle public discussion. When they do it through their lawyers and business entities rather than through their medical and scientific officers, they sink to a lower level yet. The parallels with corporate sleaze that we have discussed so often on this blog are obvious. For shame.

New York - Presbyterian Hospital Trustee Advocated Novel Cardiac Procedure - "Reach In, Rip Out Their Heart, and Eat It Before They Die"

2012-01-03T14:50:00.000-05:00

The dominant theme of Health Care Renewal has been how problems with the leadership of health care organizations have lead to our current state of health care dysfunction. We have discussed examples of ill-informed, mission-hostile leadership rewarded with excess compensation, exhibiting impunity in the face of alleged misbehavior, and at times descending into corruption. The cause of these problems is doubtless multi factorial. However, one possible cause is that rather than exercise stewardship and hold leadership accountable, those in charge of governance of health care organizations, that is, boards of directors or trustees, have instead infected the organizations with the amoral culture now dominant in much of the business world, especially finance. We have discussed, most recently here and here, how the boards of health care corporations often include heavy representation of leaders of finance, including many of those who seemed responsible for the global financial collapse, great recession, or whatever we will end up calling it.

I recently stumbled upon a particularly graphic example of the sort of predatory culture that now exists on the boards of health care organizations. (More on how I did so later.) Below is an embedded YouTube video of a speech made by a current Trustee of New York - Presbyterian Hospital (who has been on the board since 2007). He is Richard Fuld, the former CEO of Lehman Brothers, whose continuing role on the hospital board, despite his failed leadership of one of the financial firms whose bankruptcy ushered in the global financial collapse, we discussed first here.

Just to underline it once more, Mr Fuld, referring to short sellers of his company's stock, said he "what I really want to do is I want to reach in, rip out their heart, and eat it before they die."

Can there be a more stark reminder of what has gone wrong with the governance of health care? Can anyone watch this video and argue that Mr Fuld ought to be on the board of a hospital system? Why is he still on the board in January, 2012, when this video was released in October, 2011?

While I suspect not many other hospital system board members have been videographed displaying equally brutal sentiments, there are likely others with similarly barbaric tendencies.

So, on a more positive note.... The boards of hospitals, hospital systems, medical schools, and their parent universities ought to be populated with people who take their stewardship roles seriously. They ought to be people who understand, agree with, and support the organizations' mission, and their dedication to patient care and teaching. They ought to understand what good leadership of health care organizations entail. Needless to say, they ought to be of good character and above any ethical reproach. In short, they ought to be the opposite of the sort of person displayed in the video above.

It should now be obvious that grievous problems with the leadership and governance of health care organizations are principle causes of the dysfunction in our health care system. True health care reform will require wholesale changes in health care leadership and governance.

PS - In case the video above seems too short on context, see the one below:

They Think We are "Imbeciles," and They Run Health Care Organizations

2011-12-29T15:32:00.000-05:00

Arrogance seems to fuel many of the problems with health care leadership that we discuss, particularly hostility to the mission, often driven by self-interest; a sense of entitlement to lavish compensation out of proportion to any measure of performance; and a lack of accountability shading into impunity. Some recent stories hint at some of the origins of such arrogance.

The Occupy Wall Street movement drew attention to the plight of the poor and middle class, who had lost income, retirement benefits, jobs, houses, and access to health care while the richest, especially corporate executives, got richer. The less fortunate's anger was not directed indiscriminately at the successful or the rich, but those who got wealthy by gaming the system, or flaunting the rules that lesser mortals had to obey. Perhaps not surprisingly, some of those most vulnerable to such criticism have responded with contempt.

Anonymous or Indirect Defenses of the One Percent

The initial defense of the plutocrats came from some of their political supporters, who denounced their "demonization" (see this opinion piece by Barbara Ehrenreich in September, 2011) or decried the rise of "mob rule" (see this by Paul Krugman in October). Then several articles documented the anonymous complaints of finance insiders about:

a bunch of whiny people who are lazy and incompetent and have nothing to do with their time

from a Reuters article in October.

a ragtag group looking for sex, drugs and rock 'n' roll

from a NY Times article in October.

The Plutocrats Strike Back

However, increasingly those in the one percent are willing to be open. In late December a Bloomberg article documented the sentiments of a number of finance and other corporate leaders.

- Jamie Dimon, CEO of JP Morgan Chase, complained:

Acting like everyone who's been successful is bad and because you're rich you're bad, I don't understand it.

- Bernard Marcus, founder of Home Depot:

Who gives a crap about some imbecile? Are you kidding me?

- John A Allison IV, Chairman of BB&T:

'Instead of an attack on the 1 percent, let’s call it an attack on the very productive,' Allison said. 'This attack is destructive.'

- Stephen Schwarzman, CEO of the Blackstone Group:

'You have to have skin in the game,' said Schwarzman, 64. 'I’m not saying how much people should do. But we should all be part of the system.'

- John Paulson, President of hedge fund Paulson & Co:

has also said the rich benefit society.

'The top 1 percent of New Yorkers pay over 40 percent of all income taxes,...'

- Tom Galisano, founder of Paychex Inc:

If I hear a politician use the term ‘paying your fair share’ one more time, I’m going to vomit

- Ken Langone, founder of Home Depot:

I am a fat cat, I’m not ashamed

Considering how Paul Krugman explained the generation of the global financial collapse by

people who got rich by peddling complex financial schemes that, far from delivering clear benefits to the American people, helped push us into a crisis whose aftereffects continue to blight the lives of tens of millions of their fellow citizens.

Yet they have paid no price. Their institutions were bailed out by taxpayers, with few strings attached. They continue to benefit from explicit and implicit federal guarantees — basically, they’re still in a game of heads they win, tails taxpayers lose. And they benefit from tax loopholes that in many cases have people with multimillion-dollar incomes paying lower rates than middle-class families.

Thus the responses by the very rich above only represent some or more arrogance.

The Plutocrats as Health Care Leaders

One wonders how much this arrogance carried over into health care. We have noted previously how the leadership of finance has increasingly overlapped the leadership of health care, and how top executives increasingly seem to identify more with each other than with their employees, customers, or other stakeholders. Therefore, it should be no surprise that all but one of the group above also had or have leadership roles in health care organizations.

- Jamie Dimon is on the board of trustees of the New York University Langone Medical Center.

- Bernard Marcus formerly served as the chair of the board of the CDC Foundation.

- John A Allison IV is a member of the board of visitors of Wake Forest University Baptist Medical Center, per his BB&T Corp official biography.

- Stephen Schwarzman's Blackstone Group includes the Blackstone Healthcare Group, which invests in various health care corporations (as of 2010, Nycomed, Gerresheimer, Stiefel Laboratories, and Catalant per this press release), and all of whose members serve on one or more boards of directors of health care corporations (per the press release, Arthur Higgins serves on the boards of Zimmer, Eco Labs, and Resverlogix Corp; Lodewijk J R de Vink serves on the board of Roche; Doug Rogers serves on the boards of Codevax, Charles River Laboratories, and Computerized Medical Systems.)

- John Paulson is on the board of trustees of New York University,

- Kenneth G Langone, is vice chair again of the board of trustees of New York University, and chair of the board of trustees of the NYU Langone Medical Center.

I submit that linking their sentiments above to their leadership roles in health care should be highly disconcerting. Do we want people running medical centers who are proud to be "fat cats?" Do we want people running medical centers who do not understand why people who have lost income, retirement funds, jobs or their homes might be upset? Do we want people running health care corporations who do not think the poor and middle-class have any skin in the economic game? Do we want people running health care foundations who think that those who complain about the current economic situation are "imbeciles?"

Summary

The problems of health care increasingly seem to be a part of the larger problems with the global political economy. The problems we have been discussing that affect health care leadership seem to have come out of the culture of what now many are calling the larger plutocracy.

So it now seems that true health care reform will require a larger reform of the political economy. However, we still need leaders who understand the health care context, uphold health care professionals' values, and put patients first. We do not need leaders who are ill-informed, incompetent, self-interested, conflicted, or corrupt. We need governance that is accountable, honest, transparent, ethical, and again puts patients first.

IT Malpractice? Yet Another "Glitch" Affecting Thousands of Patients. Of Course, As Always, Patient Care Was "Not Compromised."

2011-12-28T13:14:00.105-05:00

At my Nov. 2011 post "Lifespan (Rhode Island): Yet another health IT glitch affecting thousands - that, of course, caused no patient harm that they know of - yet" I wrote:

There's been yet another health IT "glitch" that, of course, caused no patients to be harmed. See other "glitches" here, here, here and at other posts which can be found by searching this blog on the banal term 'glitch'.

Add another case to the health IT glitch file, under the "do we feel lucky today?" patient risk category.
From the Pittsburgh Post-Gazette (I am quoted):

Computer outage at UPMC called 'rare' Systemwide disruption potentially dangerous, expert warns Saturday, December 24, 2011 By Jonathan D. Silver, Pittsburgh Post-Gazette

UPMC's electronic medical records system for inpatients went offline for more than 14 hours at nearly all its hospitals in the region, marking what the health system called a "rare" outage, but one that it claims did not harm patients.

First, as my aforementioned Nov. 2011 post and its contained links point out, these events are not as "rare" as they should be. (The asteroid colliding with Earth that caused the extinction of the dinosaurs - now that's a "rare" event.)

Second, as multiple posts on this blog have pointed out, the claims that "no patients were harmed" is both misleading and irrelevant:

Such claims of 'massive EHR outage benevolence' are misleading, in that medical errors due to electronic outages might not appear for days or weeks after the outage, depending on what information was corrupted/lost/misindentified/or otherwise mishandled after it is 'backloaded' once the system is up. All it takes is one med lost to cause misery and death. (I can speak about that from unfortunate personal experience.)

Claims of 'massive EHR outage benevolence' are also irrelevant in that, even if there was no catastrophe directly coincident with the outage, their was greatly elevated risk. Sooner or later, such outages will maim and kill.

The outage affected a system designed by Cerner Corp., a global electronic records company, and customized by UPMC that doctors and nurses rely on for communication about patient records, medical orders and prescriptions.

It was unavailable from about 8:45 p.m. Thursday to 11 a.m. Friday at almost all of UPMC's hospitals except for Children's and UPMC Hamot in Erie, spokeswoman Wendy Zellner said.

"This is rare. This kind of widespread, extensive downtime would be rare," Ms. Zellner said.

Doctors and nurses continued to have access to patients' electronic records through backup systems, she said. They also had to resort to using old-fashioned paper records for documentation and orders.

"These things happen. They have really well spelled-out procedures for what to do when something goes down," Ms. Zellner said.

She acknowledged that doctors and nurses faced some challenges.

Faced 'some challenges?' In other words, care was compromised by the outage and the 'challenges' were to avoid medical error (and, of course, to make sure billing was unaffected):

Compromised -

a. To expose or make liable to danger, suspicion, or disrepute

b. To reduce in quality, value, or degree; weaken or lower.

Thousands of patients were affected, again reinforcing my point about how IT can and does greatly amplify the risks of paper -- as in my Rhode Island post -- such as errors and confidentiality breaches.

I cannot, for example, think of a single instance where thousands of paper records went unavailable simultaneously (unless, that is, someone lost the key to the Medical Records department), were made available to identity thieves en masse, or where thousands of medical orders were scrambled or truncated in a relatively short period of time as in Rhode Island.

These amplified risks could wipe out any advantages of EHR's over paper in a microsecond.

A partial list of facilities apparently affected in this latest episode of EHR mayhem, from this list:

Magee-Womens Hospital of UPMC
UPMC Bedford Memorial
UPMC East
UPMC Horizon
UPMC McKeesport
UPMC Mercy
UPMC Montefiore
UPMC Northwest
UPMC Passavant
UPMC Presbyterian
UPMC Shadyside
UPMC St. Margaret
Western Psychiatric Institute and Clinic of UPMC

That accounts for several thousand active patients, I am sure.

(12/28 Addendum: Bed counts of PA hospitals are here. Searching on "University of Pittsburgh Medical Center", it can be seen that thousands of beds were indeed involved.)

"Whenever people aren't working in their native system and workflow I have to believe that is more cumbersome for the clinicians, but these folks are well-trained in what to do when these things happen."

This seems at best an insensitive and perhaps even inhumane bit of P.R. More "cumbersome" for the clinicians? What about the poor patients? How would Ms. Zellner feel, I wonder, if it were her mother, child or significant other on the Operating Room table or having an acute MI when the EHR/CPOE systems went down?

Ms. Zellner said UPMC's public relations staff was unaware of the outage until contacted by a reporter.

It appears P.R. is not very high on the list for receiving information when a crisis arises. I may have known of the outage before they did.

The outage was caused by a "bug" or glitch in software designed by a vendor affiliated with Cerner, Ms. Zellner said. She refused to identify the company.

"We're not trying to point fingers at different vendors. It's a database bug, that's all I can tell you."

(That is, it's not our fault, it's the fault of the database vendor. Hospitals, I regret to inform you - you are responsible for unapproved medical devices used in your facilities, no matter what the source.)

And there's that word "glitch" again, accompanied by the equally banal "bug."

It's just a "bug." Cute little critter!

Me again in the Post-Gazette:

Scot M. Silverstein, a doctor and assistant professor Healthcare Informatics at Drexel University in Philadelphia, disagreed with the use of the terms "bug" and "glitch."

"What occurred here was a disruptive, potentially dangerous major malfunction of a life-critical enterprise medical device," he said.

Somehow, when a clinician makes a mistake, the terms "bug" and "glitch" are never used. In fact, when clinicians fail to meet accepted professional standards of healthcare practice, it is called "malpractice."

I think we can all agree that a major near-full-day outage of an enterprise EHR affecting multiple hospitals and thousands of patients does not meet accepted professionals standard of life-critical computing practice. Yet, all this merits is the word "glitch." It seems to me that if patients are harmed by, in reality, what is (on its face) IT malpractice during such events, not only the clinicians affected should be held liable.

Ms. Zellner said the problem was not a "crash" of the system because there were alternate methods used to cope that prevented patient care from being compromised.

The usual refrain. Let me repeat my definition of "compromised:"

Compromised -

a. To expose or make liable to danger, suspicion, or disrepute

b. To reduce in quality, value, or degree; weaken or lower.

A simple question - if extended EHR outages like this never seem to "compromise" care, then why not eliminate health IT entirely and spend the hundreds of millions saved on patient care?

"This is not a crash of Cerner either," Ms. Zellner said. "I think a crash is, 'Oh my God, the sky is falling,' nobody can get anything."

I leave it to the readers to ascertain the computer expertise levels and reasonableness of what Ms. Zellner thinks a "crash" is.

Technicians from UPMC, Cerner and the third company [the 'mystery' database company? - ed.] worked together on-site to identify and fix the problem. Ms. Zellner said she did not know why it took 14 hours to fix and the underlying cause was still unclear.

"They know what the problem is and I believe it's been fixed, but we really don't know what triggered it," Ms. Zellner said. "I think the next step would be some actual software upgrades."

They "don't know what triggered the 'problem'" - is a proper translation that they have no idea what went wrong?

In fact, regarding another Cerner EHR system which was extensively studied (see "A Study of an Enterprise Information System" at this link), Dr. Jon Patrick came to the conclusion that one of the sources of catastrophic failures is poor software engineering that has made the behavior of the studied system "non-deterministic." Further, software upgrades are not protected from incremental changes made by maintenance and customization staff, and may introduce even more instability.

A software upgrade without clearly understanding "what triggered the problem" is simply asking for more trouble. (My bet, however, is that they attempt it anyway.)

A Cerner representative could not be reached for comment.

What's to say?

How about this:

Dr. Silverstein said based on what he was told about the computer outage, it means that hospital medical staff would have been unable to update patient charts and probably would not have been able to issue any orders through the system during the time it was off line.

He also questioned how up-to-date the hospital's redundant records were.

Repeating UMPC's statement from the article that appeared after I gave my quotes to the reporters: "Doctors and nurses continued to have access to patients' electronic records through backup systems, [the UPMC spokesperson] said. They also had to resort to using old-fashioned paper records for documentation and orders."

My stated fears of disruption and increased risk due to compromised care seem well-grounded.

In May, Allegheny General Hospital had to shut its electronic medical records computer system down because of problems with the vendor's hardware.

The hospital used backup procedures to continue care for patients, including using paper orders and record-keeping.

Wait ... I thought I'd heard these events were "rare." Two in the same city within six months?

---------------------------

Truth be told:

The primary rule in computing is:

Either you are in control of your information systems, or they are in control of you.

Clearly the latter was the case here.

The following questions arise:

Was the software containing the "bug" properly vetted before being used on live patients? This is not just the vendor's obligation.
If it was not vetted properly, why not?
Was it an "upgrade" or patch? (If so, the same vetting rules apply.)

Further, the soft-selling of these incidents must end. The use of terms such as "bug" and "glitch" must also end. What occurred here, echoing my newspaper quote, was a disruptive, potentially catastrophic major malfunction of a life-critical enterprise medical device.

System-wide EHR crashes are not merely ‘glitches’ or ‘bugs.’ They need to be considered, as in medicine itself, as 'never events.' From AHRQ:

The term "Never Event" was first introduced in 2001 by Ken Kizer, MD, former CEO of the National Quality Forum (NQF), in reference to particularly shocking medical errors (such as wrong-site surgery) that should never occur. Over time, the list has been expanded to signify adverse events that are unambiguous (clearly identifiable and measurable), serious (resulting in death or significant disability), and usually preventable.

Further, re: "patient care was never compromised." How do they know that? In fact, this is 'spin' and word games on its face. By definition, if CPOE and chart updating was unavailable, patient care was compromised, where "compromised" means "increased levels of risk for error were created, requiring workarounds."

Further, as mentioned earlier, harms might not show up for some time. Lost orders, corrupted data, errors of omission or commission transcribing backup paper records into the computer ("backloading"), etc. can take their toll later. Post-outage vigilance is essential, putting even more stress on clinicians that increases likelihood of further error and that they certainly do not need. Clinicians are stressed enough already.

Finally:

IT personnel have not only deliberately inserted themselves into clinical affairs (e.g, via the HITECH Act of 2009), they have also done so with a stunning arrogance and unproven braggadocio about their systems "revolutionizing" medicine (whatever that means).

Indeed, they need to accept the medical responsibility and obligations this territorial intrusion entails.

On its face, this massive outage was the result of issues that did not meet accepted professional standards of IT practice for life-critical environments. Res ipsa loquitur.

Something was not vetted properly, there was a lack of redundancy, the IT personnel were NOT in control of their systems.

Just as when physicians don't provide care that meets accepted professional standards of healthcare, this incident and others like it are, by definition, a result of IT malpractice.

If patients are harmed, IT personnel and their management (often non-IT C-level officers) involved in this system need to be held accountable.

If they can't take the clinical heat (as clinicians do daily since the time they enter medical or nursing school), then they need to get out of the clinical kitchen.

-- SS

Note: see this take on these matters at the HIStalk blog:

UPMC’s Cerner systems go down for 14 hours at most campuses last Thursday and Friday, forcing them to go back to paper. The PR person blamed “a database bug,” which makes the above Oracle press release from this past summer a particularly fun read. Cerner and UPMC have an atypical vendor-customer relationship since they’ve invested big money together in innovation projects and UPMC runs a Cerner implementation business overseas.

Now we know who the unnamed "mystery database vendor" is...

-- SS

Dec. 29, 2011 Addendum:

Was UPMC acting as a "proving ground" for some Oracle-Cerner-UPMC experimental health IT technology that resulted in the crash? The claim of being an IT "proving ground" has been made in the past:

Pittsburgh Tribune
May 2, 2006
UPMC partners with technology provider

The University of Pittsburgh Medical Center is taking another step in a quest to commercialize new medical technology.

UPMC on Monday signed a three-year deal with health care information technology provider Cerner Corp. to develop and market medicine-related technological advances. Both parties will contribute $10 million in cash, services and intellectual property to the effort.

The deal is a smaller version of an April 2005 deal between UPMC and information technology behemoth IBM.

As is the case in the IBM deal, UPMC will serve as a built-in proving ground for jointly developed technologies and products, with Cerner marketing the products and UPMC awarded a share of profits.

As I wrote at "Proving Ground for IT Tests On Children: Pioneers in Health IT, or Pioneers in Ignoring the Past?":

"A hospital and patients are not a learning lab for HIT vendors. The appropriate "proving ground" for new medical technology is the controlled clinical trial where participants (in this case, patients and healthcare professionals alike) have freedom of choice whether or not to participate, and a chance to give (or deny) consent after being fully informed of potential risk."

This is a fundamental human rights issue.

-- SS

Legal Settlements Have Become So Common that They are Barely News

2011-12-28T12:06:00.000-05:00

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.

More Tales of the Hospital CEO Compensation Bubble

2011-12-26T23:00:00.003-05:00

The hospital CEO compensation bubble continues to grow. As the year draws to a close, I have found another set of stories about outsized payments to health care executives. While their repetitive features suggest the magnitude of the issue, they featured some twists on the usual justifications given for large compensation packages. Presented in order of the size of the compensation package.....

Maxis Health System, Pennsylvania

The Scanton Times-Tribune reported:

Mary Theresa Vautrinot, president and CEO of parent company Maxis Health System, earned a little more than $464,000 in salary and other compensation, according to 2010 tax forms filed by the hospital.

These days, compensation under a half a million dollars may not seem like all that much, but it should be viewed in context. Maxis Health Systems actually actually owns only one hospital, Marian Community Hospital. In 2010, that hospital, already small, shrunk further,

In January 2010, the 70-bed hospital scaled back operations to just 35 beds. For the past six months, Marian Community Hospital has had about 20 inpatients each day.

Now it will close:

Last Monday, parent company Maxis Health System announced the Carbondale hospital's impending closure, citing ongoing financial pressures and a dwindling patient population

$464,000 seems like a lot of money to run a tiny hospital under "ongoing financial pressure" into bankruptcy. This seems like another example of pay for poor performance.

Summa Health System, Akron Children's Hospital, Akron General Health System, Ohio

In a survey of local hospital CEO compensation, the Akron Beacon-Journal noted,

Children’s President and Chief Executive William Considine received compensation and other benefits totaling $1,560,659 in 2010.

Thomas J. Strauss, president and chief executive of Summa Health System, received a total compensation and bonus package worth $1,408,062 last year.

For Akron General, 2010 was a year of leadership transition, with a former, interim and current leader all receiving executive pay.

Alan J. Bleyer, who retired as the hospital’s leader in 2009, received $677,267 in compensation. Michael Rindler, a national health-care consultant who was interim chief executive and continued in a consulting role through the year, made $983,744.

Vincent J. McCorkle, who took over as president and chief executive on July 1, 2010, received $568,605 in total compensation last year.

Lest anyone think that these hospitals were paying their CEOs a lot of money,

Nonprofit hospital executives could make substantially more if they worked in for-profit industries, [Ohio Hospitals Association spokesperson Mary] Yost said.

'A million dollars certainly is a decent package, but it’s not the highest thing that these people could command,' she said. 'We’re blessed that there are people who want to work for a nonprofit that has the mission of serving its community and they’re not just in it for the money.'

Only within the protected world of top executives would $1 million a year seem only a "decent package." The stock defense of lavish executive pay is an appeal to common practice, i.e., the pay is justified because so many organizations pay their executives similar amounts. This version of the defense lacked even the common accompanying assertions that the particular executives are so brilliant and hard-working that they would be assured of a high market price.

Furthermore, let us consider another comparison. Consider the following data,

Summa’s revenue exceeded expenses by $31.7 million, for an operating margin of about 3 percent.

Akron General Medical Center’s revenue exceeded expenses by about $8 million, resulting in an operating margin of 1.7 percent.

Parent company Akron General Health System posted a loss of about $1 million on revenue of $854,207, according to IRS filings. The health system's filings reflect investment income and the costs of providing health screenings to the public, not hospital operations, Akron General spokesman Jim Gosky said.

Revenue at Children’s exceeded expenses by about $35.3 million for a 7.4 percent operating margin.

These data implied that the CEOs of Summa and Childrens' each received compensation equal to about 5% of their organization's total operating margins. The two people who acted as CEO at Akron General received together an amount that was larger than their system's operating loss, so had they been paid $1 million less, their system would have broken even. In this case, the newspaper found no one to quote who would assert that the former CEOs' performance was so good as to command that much of the hospital's excees, or the latter CEO's performance was so good as to be worth putting the hospital system into a deficit.

Mercy Health Systems, Wisconsin

The Janesville, Wisconsin Gazette published a story about one CEOs response to previous reporting of his compensation,

Javon Bea saw the August article in a Madison newspaper that questioned the salaries of area health care leaders.

Bea, the president and chief executive officer of Janesville-based Mercy Health System, was singled out for receiving considerably more than hospital executives in Madison.

The article was based on 2009 tax filings, which show that Mercy paid Bea $3.6 million in total compensation. That included compensation of nearly $2 million and deferred pension payments of just more than $1.6 million.

The newspaper reported that the national average was $630,000 and included base salaries, bonuses, pensions and other benefits.

Many stories of executive pay have shown leaders who make many times other employees' compensation. In this case, however, a CEO tried to assert that he did many times other employees' work. Bea defended his salary by arguing he did the work of at least three, perhaps six people:

Bea said the Madison newspaper story compared executives at individual operations to him, an executive of a system that has three hospitals and 61 other facilities in 24 communities in southern Wisconsin and northern Illinois.

'To equal the job description of the CEO of Mercy Health System, you'd have to (add together) the salary of the CEO of DeanCare insurance, the salary of the CEO of Dean Clinic and the salary of the CEO of St. Mary's Hospital,' Bea said. 'And then you'd better throw in the chief operating officers at all three.'

Bea said Mercy doesn't have COOs and that he does that work.

Mr Bea did not explain how he found enough time in a 24 hour day to do the work of three to six people. This seems to be a particularly hyperbolic version of argument that the executive is so brilliant and hard-working as to command such a high market price. Perhaps Mercy does not have CEOs or COOs of individual hospitals, but its 2010 Form 990 (from Guidestar here) documents that it has ten vice-presidents who each make approximately $200,000 to over $375,000 a year. Why Mr Bea would need to do the work of three or six people when he has so many other well-executives around to help was not clear.

Furthermore, Mr Bea came up with an apparently unique justification for his high pay, that its source was some sort of magic money that did not add to health care costs,

Bea said his salary has no effect on health care costs or the premiums MercyCare subscribers pay each year. He likened his salary to capital costs, which he also said don't affect what patients are charged.

John Cook, Mercy's chief financial officer, said Medicare, Medicaid and private insurance companies don't pay providers based on the costs of capital improvements or salaries, which in Bea's case is determined by a board of directors that works with national consultants and attorneys.

'My salary isn't going to affect your health care cost,' Bea said.

Maybe Mr Bea needs a second opinion from another CFO. His compensation appears to come from the hospital system's budget, per its 990 form, so it affects hospital costs as much as any other expense of the same amount. Furthermore, it is well known that hospital systems negotiate payment rates with private insurers, and that larger systems with more market power may negotiate higher rates. Finally, it is also well known that different hospitals collect different amounts from government insurance programs for patients with apparently similar problems. Thus, the notion that executive pay has no effect on health care costs, and the implication that it somehow comes from a magical place outside of the budget, seems to be an entirely new rationale for huge executive compensation. From a psychological standpoint, it appears to be based on wishful or magical thinking. Another way to look at it is as a logical fallacy, a special pleading, an assertion without a clear basis that the usual rules or principles do not apply.

Montefiore Medical Center, New York-Presbyterian Medical Center, and Others, New York, New York

A brief article in the New York Post focused on the bonuses given to some local CEOs,

Dr. Kenneth Davis, the head of Mount Sinai hospital and medical school, raked in a $1.2 million bonus in 2010, and Michael Dowling, the CEO of the North Shore-LIJ Health System, got $1 million. Louis Shapiro, president of the Hospital for Special Surgery, got a $1.5 million bonus and $992,215 salary.

Some CEOs also got a housing allowance, car and driver, and first- or business-class air travel.

Montefiore Medical Center in The Bronx paid CEO Steven Safyer $1.4 million plus a $359,845 bonus. The hospital also put $2.2 million into Safyer’s retirement fund, which he can take only when he leaves.

In addition,

The highest total compensation — $4.3 million — went to Dr. Herbert Pardes, the retiring head of New York-Presbyterian Hospital, who got $1.7 million in salary, a $1.9 million bonus and $648,686 as “other” compensation.

The Post found someone to provide the usual rationale,

Brian Conway, a spokesman for the Greater New York Hospital Association, defended the packages.

'Hospital CEO compensation reflects their myriad responsibilities, the complexity of running a medical center, and the national market for their talents,' he said.

That was a quick one-sentence summation of the "market" and "brilliant, hard-working" arguments. Note that, as usual, no justification of why the particular people involved should be considered particularly brilliant or hard-working, and no comparison of their dedication or brilliance to that of lesser paid hospital employees was supplied. Note also that CEO compensation is usually determined not by the market, but by a biased benchmarking process, see post here. Note further that this process almost never includes comparisons with employees who are not CEOs, nor includes explicit comparison of particular CEOs dedication, brilliance, etc with either that of other CEOs or other employees.

Premier Health Partners, and Others, Cincinnati, Ohio

The Middletown (Ohio) Journal reported,

Jim Pancoast, president and CEO of Premier Health Partners, the parent organization of Atrium Medical Center in Middletown, had the highest pay in 2010 of information available to date from that year. Pancoast collected about $4.6 million in 2010, most of which is a lump sum paid out through a supplemental executive retirement program.

The year before saw someone get even richer compensation,

Kettering Health Network’s former Chief Executive Officer Frank Perez and UC Health’s former CEO Kenneth Hanover topped the list in 2009, with each receiving more than $2.6 million.

Frank Perez’ total reportable pay in 2009 of more than $5.5 million included a more than $4.5 million lump-sum, taxable retirement payment.

Ron Seifert, executive compensation practice leader for the health care practice at Hay Group, supplied the usual rationale,

'No one, including the boards of these organizations, denies this is a lot of money. But what they’ll tell you is this takes a special leader,' he said. 'They come with a price tag.'

As is also usual, why the particular leader should be considered so special, particularly in comparison to other lesser paid hospital employees, was not specified..

Northwestern Memorial Healthcare System, Chicago, Illinois

Last but not least, we address the compensation given Dean M Harrison, the CEO of Northwestern Memorial Healthcare System, as discussed in an editorial in FierceHealthFinance, entitled, "The problem of 8-figure hospital paychecks and near-poor patients." In summary,

Harrison was paid an astonishing $10.2 million in 2010, the result of a $7.5 supplemental retirement fund payout.

The ire this generated, so unlike the tone in the typical news article about executive compensation, is worth quoting:

There are hundreds of nonprofit hospital CEOs like Harrison, compensated with millions of dollars while their institutions throw a few bread crumbs to the poor living in their service areas. Many these institutions spend more on CEO pay than charity care.

Alan Sager, a professor of health policy and management at Boston University, recently told Crain's Chicago Business what a lot of healthcare pay and governance experts dare not say: 'There's an enormous sense of self-entitlement among CEOs. It started in the for-profit corporate sector, but it has sloshed over into the non-profit hospital world.'

I worked up some talking points for Northwestern Chief Financial Officer Peter J. McCanna that he can bring to the next board meeting, although I'm guessing he won't do so. For those CFOs actually willing to rock the boat, these bullet points work for practically any large urban hospital in the country:

• Dean Harrison's 2010 compensation was approximately 170 times that of a charge nurse on their feet 12 hours a day. Does Dean Harrison work 170 times harder?

• Dean Harrison's compensation was approximately 20 times that of a cardiac surgeon performing 300 to 400 high-revenue procedures a year. Does Dean Harrison provide 20 times the benefit?

• Dean Harrison's compensation could be used to cover the first 10,000 uninsured patients who come through the emergency room each year. Which would provide a greater benefit to the hospital and community?

• The purpose of a supplemental retirement plan is to ensure its recipient maintains a reasonable standard of living past their working years. Given the tens of millions of dollars Dean Harrison has already received during his career and the six-figure pension and high five-figure Social Security income he is guaranteed upon retirement, will the $7.5 million payout actually accomplish its goal? Or will it merely be gravy for his heirs?

He concluded,

Meanwhile, if your hospital has a single patient who works hard, will be bankrupted by the bill they receive, and no one on your staff has walked them through every step of a charity care claim, that is where some imagination and original thought is sorely needed.

Too much money in some places, and not enough in others. Someone needs to announce that the buck stops here. And start moving around all the other bucks.

Summary

In a health care system with ever rising costs, declining access, and stagnant quality, we no longer can tolerate the perverse incentives generated by unaccoutanably high compensation to top executives. As long as top executives continue their sense of "self-entitlement," and can continue their current management practices reinforced by ever rising pay checks, expect poor leadership to undermine any attempts to improve health care. Tired repititions of the usual rationales, that the CEOs are brilliant and hard-working, and that their compensation is mandated by the market do not make these rationales true.
We need health care leadership that has compassion for the increasing hardships that their patients have to endure, and that puts doing the right thing for patients' and the public's health ahead of self-interest.

David Pogue: "The Year of C.E.O. Failures Explained" and Why IT is so Bad

2011-12-20T22:35:00.009-05:00

David Pogue is a prolific writer on IT, having written some of the most popular books on MacIntosh, e.g., the Mac Secrets series.

In an article in the Dec. 15, 2011 New York Times on "CEO's idiotic blunders" as he calls them, he reveals why IT generally, HIT included, may be so poorly done:

The Latest in Technology from David Pogue
The Year of CEO Failures Explained
New York Times
Dec. 15, 2011

... But it doesn’t seem like you’d need a business degree to appreciate that these [decisions by CEO's on making major changes to businesses] would be bad decisions. Whenever I see a company shooting itself in the foot like that, I always wonder: how could anyone be so stupid? When do people become so stupid?

Last spring, I taught a class at the Columbia Business School called “What Makes a Hit a Hit—and a Flop a Flop.” I focused on consumer-tech success stories and disasters.

I distinctly remember the day I focused on products that were rushed to market when they were full of bugs — and the company knew it (can you say “BlackBerry Storm?”). I sagely told my class full of twentysomethings that I was proud to talk to them now, when they were young and impressionable — that I hoped I could instill some sense of Doing What’s Right before they became corrupted by the corporate world.

But it was too late.

To my astonishment, hands shot up all over the room. These budding chief executives wound up telling me, politely, that I was wrong. That there’s a solid business case for shipping half-finished software. “You get the revenue flowing,” one young lady told me. “You don’t want to let your investors down, right? You can always fix the software later.”

You can always fix the software later. Wow.

That’s right. Use your customers as beta testers. Don’t worry about burning them. Don’t worry about souring them on your company name forever. There will always be more customers where those came from, right?

In health IT, beta-testing unregulated, experimental software medical devices on patients is commonplace. And patients do get burned. Literally.

That “ignore the customer” approach hasn’t worked out so well for Hewlett-Packard, Netflix and Cisco. All three suffered enormous public black eyes. All three looked like they had no idea what they were doing.

Maybe all of those M.B.A.’s pouring into the workplace know something we don’t. Maybe there’s actually a shrewd master plan that the common folk can’t even fathom.

Actually, no. If anything, IMO the MBA's suffer the Dunning-Kruger effect.

But maybe, too, there’s a solid business case to be made for factoring public reaction and the customer’s interest into big business decisions. And maybe, just maybe, that idea will become other C.E.O.s’ 2012 New Year’s resolution.

I doubt it.

In healthcare IT, it will take a few more years - and much more litigation - before the frankly immoral and nihilistic attitude of "we can fix the software later" becomes taboo.

It may also take some of those sage MBA's realizing that their loved ones have no "reset button" when they've been "burned" by faulty health IT, and that their loved ones - unlike software - cannot be "fixed later."

-- SS

Health Care Policy of the Insiders, by the Insiders, for the Insiders - the Newt Gingrich Case Files

2011-12-20T16:07:00.002-05:00

Newt Gingrich's rise to the top of the pack of Republican contenders for the US presidency has earned him increased scrutiny. The resulting investigative reporting has provided a revealing set of case studies showing how insiders have come to dominate US health care policy.

Below I have reorganized the information presented in a series of news articles from mid-November to mid-December, 2011.

Mr Gingrich's Consulting Empire

A general description of Mr Gingrich's health care "think tank" appeared in the Washington Post.(1)

A think tank founded by GOP presidential candidate Newt Gingrich collected at least $37 million over the past eight years from major health-care companies and industry groups, offering special access to the former House speaker and other perks, according to records and interviews.

The Center for Health Transformation, which opened in 2003, brought in dues of as much as $200,000 per year from insurers and other health-care firms, offering some of them 'access to Newt Gingrich' and 'direct Newt interaction,' according to promotional materials.

Despite its name, the CHT was for-profit. Much of its actual workings are confidential, per the Post,(1)

Susan Meyers, a center spokeswoman, declined to comment on the think tank’s income or staffing levels because it is a private-sector organization.

Despite its pretentious name, the CHT was apparently a vehicle for its wealthy corporate clients to influence health policy to favor their business interests. A NY Times article(2) reported that:

His consultancy practice was centered around his ability to help big corporate interests speak the language of Republicans and navigate the corridors of Capitol Hill on issues vital to their businesses.

According to a Bloomberg article(3), the work was quite lucrative:

Two companies founded by Newt Gingrich announced yesterday that they had grossed $55 million between 2001 and 2010, part of an effort to quiet questions about how the former U.S. House speaker earned millions since he resigned from Congress in 1999.

That revenue supports the Center for Health Transformation and The Gingrich Group LLC, which have a staff of as many as 30 people, stage health-care policy events, and provide advice to clients, Nancy Desmond, the chairman and chief executive officer of the firms, said in a written statement.

The CHT was linked to a small corporate empire, as described by the Washington Post,(4)

Former House speaker Newt Gingrich transfigured himself from a political flameout into a thriving business conglomerate. The power of the Gingrich brand fueled a for-profit collection of enterprises that generated close to $100 million in revenue over the past decade, said his longtime attorney Randy Evans.

Among Gingrich’s moneymaking ventures: a health-care think tank financed by six-figure dues from corporations; a consulting business; a communications firm that handled his speeches of up to $60,000 a pop, media appearances and books; a historical documentary production company; a separate operation to administer the royalties for the historical fiction that Gingrich writes with two co-authors; even an in-house literary agency that has counted among its clients a presidential campaign rival, former senator Rick Santorum (R-Pa.).

Separate from all of that was his nonprofit political operation, American Solutions for Winning the Future.

Relationships with Big Health Care Corporations

The Center for Health Transformation was largely funded by big health care corporations. The Post first noted,(1)

The biggest funders, ... [included] firms such as AstraZeneca, Blue Cross Blue Shield and Novo Nordisk,...

Also,(1)

The center has listed scores of firms and industry groups as members over the years, amounting to a Who’s Who of the medical field, from GE Healthcare to the American Hospital Association to Wellpoint, the nation’s largest health insurer.

Other clients were listed in a Bloomberg article,(5)

Among the member companies were drugmaker Johnson & Johnson (JNJ) and health insurer Blue Cross and Blue Shield Association....

Also,(5)

Pfizer Inc. (PFE), the world’s largest drugmaker, had consulting contracts with Gingrich, according to two people familiar with the arrangements. Pfizer spokesman Ray Kerins didn’t respond to requests for comment.

The Pharmaceutical Research and Manufacturers of America, the industry’s trade group, was also a client. His firm 'was retained by the PhRMA general counsel’s office at one time to provide advice on a positioning project,' the group said.

In addition, as noted below, clients included important firms in the health care information technology (IT) sector, including GE, IBM, Microsoft, Allscripts, and Siemens.

Below, we present several cases in which Mr Gingrich apparently intervened on behalf of his clients to promote their business interests in the guise of promoting his views on health policy solutions. In some cases, the views he promoted did not fit with what is generally regarded as his political philosophy, suggesting that the interests of his paying clients overrode his political views.

Case: End of Life Care

The New York Times reported,(2)

Writing on the Web site of the Washington Post, Mr Gingrich praised Gundersen Lutheran Health System of LaCrosse, Wis., for its successful efforts to persuade most patients to have 'advance directives,' saying if Medicare had followed Gundersen's lead on end-of-life care and other practices, it would 'save more than $33 billion a year.'

Note that

Gundersen was one of the paying clients of Mr. Gingrich's Center for Health Transformation....

However,

within weeks, Mr. Gingrich would find himself on the wrong end of what some Republicans labeled the 'death panel' issue.

At that point, Mr Gingrich abruptly changed his tune,

As it happens, shortly after Mr. Gingrich wrote his article praising Gundersen, he joined the conservative critics of the provision. 'You are asking us to trust turning power over to the government,' Mr Gingrich told George Stephanopoulos of ABC News that August 'when there are clearly people in America who believe in establishing euthanasia, including selective standards.'

This suggested that Mr Gingrich took up the cause of end-of-life decision making not be cause he deeply believed in it, but because it was expeditious given the wishes of his clients, despite the assertion made by his spokesperson,(2)

Mr. Hammond said that Mr. Gingrich did not take policy positions for pay; rather, he said, clients sought him out because of the views he already held and his expertise in communicating ideas.

Case: Medicare Prescription Coverage Sans Negotiations about Drug Prices

As reported by Bloomberg,(5)

When U.S. House Republican leaders in 2003 were short of votes to pass a $395 billion Medicare prescription drug benefit, they recruited former House Speaker Newt Gingrich for help.

In a hushed room on Capitol Hill, Gingrich told his former Republican colleagues that if he could endorse the measure, they should be comfortable with it, too, said two former senior House aides who attended the closed-door session.

Two days later, after a vote was held open for three hours as leaders corralled the final ayes, the measure passed and was eventually signed into law by President George W. Bush.

What Gingrich didn’t mention during the Republican caucus meeting was that he was also building a for-profit, health-care research company and seeking financing from drugmakers, which were investing $128.6 million in lobbying for passage of the new benefit for seniors.

Note that the legislation that provided Medicare drug coverage forbade the government from negotiating prices with drugmakers. This was unprecedented, because drug coverage from the US Veterans Administration and Medicaid did not come with the obligation to pay whatever the drug-makers charged. The inability of Medicare to negotiate the prices it paid for drugs certainly helped the companies' revenues while driving up the costs of Medicare, the federal deficit and the costs of health care in general.

Case: Promoting Expensive Diabetes Care

The Washington Post reported,(4)

Novo Nordisk, a Denmark-based drug firm that specializes in diabetes treatments.... paid a total of $1.2 million to Gingrich’s foundation over six years as a 'founding charter member.'

'It was strictly a business, nonpolitical relationship,' Novo Nordisk spokesman Ken Inchausti said. 'We admired his leadership on issues related to health-care delivery systems. We thought the CHT brought something to the table to us in terms of finding ways to help people prevent diabetes.'

Gingrich loaned his celebrity to causes that, whatever their other merits, could also be good for Novo Nordisk’s bottom line. For instance, he was the keynote speaker at Novo Nordisk’s 'diabetes summit' in 2005 and joined the company in issuing a 'call to action' to fight diabetes in Texas and Georgia.

One wonders how many of the widely promoted "summits" and other star-studded conferences on health care featuring corporate and political leaders as speakers are just stealth health policy advocacy or stealth marketing.

Case: Irrational Exuberance for Electronic Health Records

My fellow Health Care Renewal blogger has often discussed the "irrational exuberance" for electronic health records (EHRs) despite scant information about their benefits, and increasing data suggesting their harms. It now appears that Mr Gingrich, sponsored by copious funds from the health care IT sector, has been a major source of such exuberance.

Mr Gingrich had a complex relationship with the health care information technology (IT) industry. It began to come out first in a NY Times story,(6)

When the center [for Health Transformation] sponsored a 'health transformation summit' at the Florida State Capitol in March 2006, lawmakers who attended Mr. Gingrich's keynote speech inside the House chamber received a booklet promoting not just ideas but also the specific services of two dozen of his clients. Executives from some of those companies sat on panels for discussions that lawmakers were encouraged to attend after Mr. Gingrich's address.

Gerard White, president of Clearwave, which paid about $50,000 to become a center member, used the occasion to pitch his company's system for managing patient data.

This had all began earlier,

Two years before the Florida 'summit,' Mr. Gingrich made a presentation to Republican lawmakers in Georgia, promoting the work of his member companies by citing specific benefits if they were hired. For example, 'VitalSpring could save the State Employee Program over $20 million a year.'

Minutes of the members-only conference call from March 2004 said the center had 'arranged joint meetings' for members to present their work on electronic health records to top federal officials, noting that Mr. Gingrich 'reported very positive feedback overall from these meetings.'

He also pressed for passage of a federal bill to increase the use of electronic health records, collaborating with one of its co-sponsors, Representative Patrick J. Kennedy of Rhode Island, and Senator Hillary Rodham Clinton of New York, both Democrats.

Furthermore,

Many of the ideas he has pushed involve the increased use of information technology, and companies specializing in that are well represented in the center's roster. They also figured prominently in an early center initiative, teaming up in 2003 with the conservative Georgia Public Policy Foundation to promote changes in health care in Mr. Gingrich's home state.

At his discussion with Georgia House Republicans in 2004, Mr. Gingrich gave examples of companies whose services could 'both improve health and start saving money,' according to the center's summary of his presentation.

And there is more,

In Washington, Mr. Gingrich's push for electronic health records illustrated how his own policy advocacy and ties to former Congressional colleagues made him a sought-out consultant for companies like Astra Zeneca and Siemens. Mr. Gingrich hailed HealthTrio, one of the center's 'founding charter members,' during a hearing held in 2003 by Senator Larry Craig, Republican of Ohio. Telling the senator that HealthTrio's chief executive had helped design the electronic records program in the United Kingdon, Mr. Gingrich said the company 'estimates we could have an electronic health record for American for about 10 cents per month, per person.'

The center later arranged for HealthTrio and I.B.M to meet with senior federal health officials and congressional leaders 'to review the U.K. approach and how it might be applied in the U.S.,' according to center records.

Some of the ideas promoted by the center found their way into the electronic health records legislation proposed by Mr. Kennedy, which was prepared with input from Mr. Gingrich.

This is especially ironic, given that the UK NHS electronic health record initiative has become a crashing failure (for example, see this post).

Even more involvement with the push for electronic health records (EHRs) appeared in a Boston Globe article,(7)

Newt Gingrich seized the TV airwaves in 2009 to bash President Obama’s stimulus package, calling it 'entirely a pork-barrel bill' that would do little to solve the recession.

Later, in a separate web video, the former House speaker stepped back from his blanket criticism. He explained that he strongly supported spending $27 billion of stimulus funds to encourage doctors and hospitals to create electronic medical records for their patients. Left unsaid was that the Gingrich Group, his consulting business in Washington, received large payments from medical technology companies that stand to profit from the federal money.

In particular,

The stimulus infusion Gingrich supported is expected to benefit health care technology companies, including those who have been clients such as GE Healthcare and Allscripts.

GE Healthcare said it pays Gingrich’s center to act as a 'collaborator and facilitator' among a diverse group of health care interests.

'We work with the Center for Health Transformation in an effort to improve the effectiveness of the health system through the use of information technology,' said GE Healthcare spokesman Corey Miller.

Allscripts spokeswoman Ariana Nikitas said the company ended its relationship with Gingrich’s center two years ago but considered the venture 'a think-tank to advance health care efforts.'

It does not stop there. Per the NY Times,(8)

Mr. Gingrich was cheering a $19 billion part of the [Obama stimulus] package that promoted the use of electronic health records, something that benefited clients of his consulting business. 'I am delighted that President Obama has picked this as a key part of the stimulus package,' he told health care executives in a January 2009 conference call.

After the bill was passed a month later, Mr. Gingrich's consultancy, the Center for Health Transformation, joined two of his clients, Allscripts and Microsoft, in an 'Electronic Health Records Stimulus Tour' that traveled the country, encouraging doctors and hospitals to buy their products with billions in federal subsidies.

We, particularly InformaticsMD, have frequently commented on how health care information technology has been promoted not just by enthusiasts in the field, and by companies that manufacture such devices, but by the government. The bandwagon has gone down the road despite little clinical evidence that such technology is beneficial, and increasing evidence of its harms. Now it appears that an important reason for this ruch to promote expensive, but unproven devices comes from the sort of stealth health care policy advocacy on behalf of corporate vested interests described above.
Summary

So Newt Gingrich parlayed his political track record into a lucrative "consultancy" which enthusiastically promoted the health policy objectives of its clients, who included some of the biggest US health care corporations. Some of the policy positions the consultancy promoted seemed to run counter to Mr Gingrich's political record. Worse, some of the initiative he successfully promoted seem to have contributed to US health care dysfunction.

These stories, some of which are many years old, only came out after Mr Gingrich became the front runner for the Republican nomination for US President. Had he not chosen to re-enter politics, it is not clear when reporters would have had time to due the required investigations. One wonders how many similar stories have not been made public because they do not involve prominent presidential candidates.

The bottom line seems to be that there are myriad ways corporate and political insiders push health policy agendas because of self-interest, regardless of their effects on patients' and the public's health. Health policy in the US has become an insiders' game. Unless it is redirected to reflect patients' and the public's health, facilitated by the knowledge of unbiased clinical and policy experts rather than corporate public relations, expect our efforts at health care reform to just increase health care dysfunction.

Physicians, public health advocates, whatever unbiased health policy experts remain must educate the public about how health policy has been turned into a corporate sandbox. We must try to somehow activate the public to call for health care policy of the people, by the people, and for the people.

References

1. Eggen D. Gingrich think tank collected millions from health-care industry. Washington Post. November 17, 2011. Link here.
2. Rutenberg J. Gingrich faces more scrutiny over corporate clients. NY Times, November, 17, 2011. Link here.
3. Benson C, Lerer L. Gingrich health center and group paid $55M. Bloomberg, November 22, 2011. Link here.
4. Tumulty K, Eggen D. Newt Gingrich Inc.: how the GOP hopeful went from political flameout to fortune. Washington Post, November 26, 2011. Link here.
5. Davis JH, Jensen K. Gingrich campaigning as change agent profited as an insider. Bloomberg, November 18, 2011. Link here.
6. McIntire M, Rutenberg J. Gingrich gave push to clients, not just ideas. NY Times, November 29, 2011. Link here.
7. Rowland C. Newt Gingrich supported $27 billion of President Obama's stimulus for electronic medical records, helping his consulting clients. Boston Globe, December 16, 2011. Link here.
8. Rutenberg J, McIntire M. Gingrich push on health care appears at odds with G.O.P. NY Times, December 16, 2011. Link here.

Hospital Executives - What Will They Think of Next?

2011-12-19T17:25:00.000-05:00

Health care organizations are now most often run by people with management, not clinical backgrounds. It seems like business schools have taught managers to sign on to whatever the latest management fashions are. So what are the latest fashions in hospital management? Here are a few hot items.

Retreading Pharmaceutical Representatives

My jaundiced reading of the business news suggests that most executives think that marketing is the most important part of their organizations, and that clever marketing can sell any product or service. For example, the pharmaceutical industry spends about twice as much on marketing as it does on research and development (despite pharma executives' protestations that they run research driven businesses) (see this post). So it should be no surprise that now hospitals are using "hospital representatives" to market referrals to their institutions to doctors.

From last week's USA Today:

n northwest Indiana, Carrie Sota visits five or six doctors' offices every workday as part of her new sales job.

But Sota isn't selling the physicians on a prescription drug or a medical device. She's promoting her hospital — the University of Chicago Medical Center.

Sota, 30, is one of four employees the academic medical center has hired in recent months to make 'sales calls' on physicians in the hope that they will send more patients to the hospital. 'We are trying to build meaningful relationships,' said Sota, who was previously a saleswoman for a small medical device company.

The University of Chicago Medical Center is one of a growing number of hospitals nationwide hiring former drug and device sales reps to visit doctors' offices to persuade them to use their services over competing facilities.

Rather than handing out samples of prescription drugs, the sales reps call on doctors armed with the latest information on how their facility is reducing hospital-acquired infections and improving patient-satisfaction scores.

In visits that can last five to 20 minutes, reps try to win doctors' loyalty by helping them get better times on operating room schedules or easier patient referrals to hospital-based specialists. The sales reps can also carry messages back to the hospital, such as a doctor's request for a new medical device to be available in surgery.

The article suggested a few problems with this approach. First, the point of the marketing is not to improve the match between patients' needs and the services the hospital provides. Rather, it is to generate referrals that have the potential to provide the maximum revenue:

While hospitals have always tried to woo doctors to refer patients to them, the institutions are growing more direct in their efforts. The hospitals mine data to see which doctors have the most profitable, well-insured patients, and then they assign those doctors to a sales rep.

So in particular,

Many of the physician liaisons focus on specialists, who bring in patients for services with the highest profit margins, including orthopedics, cardiac care and cancer care, [Duke University Health System physician liaison manager Christine] Perry said.

Second, the hospital reps have incentives based on revenue, not on value to the patient:

About two-thirds of Tenet's liaisons are former drug and device sales reps, and they can make tens of thousands of dollars in bonuses if doctors increase their referrals to the hospitals.

Third, across the system, the revenues generated may be much less than the costs incurred, since most of the marketing will only succeed in moving patients from one hospital to another:

Paul Ginsburg, president of the non-partisan Center for Studying Health System Change, said, 'When you look at the health system, this is a waste of resources. It's a zero-sum game.'

He added: 'The net results of changing physician-referral patterns is that one hospital gains at a cost of others, and all the hospitals burn resources to pay (sales)people who take up the doctor's time.'

Of course, the reps could succeed in persuading doctors to refer patients to specific hospitals for services the doctors originally did not think the patients needed. That would be good were the patients to need those services, but bad if they were not.
Fourth, we have discussed (for example, here and here) how pharmaceutical representatives use sophisticated psychological and emotional manipulation, despite claims that all they do is provide unbiased information and educational, to influence physicians to prescribe drugs. Again, this may result in patients getting drugs whose benefits do not outweigh their harms. It is possible that hospital representatives will do something similar:

'These people are really good and really assertive and very sophisticated,' said Stephen Newman, Tenet's chief operating officer.

Unbundling Payments

The airlines decided a while ago that they could make more money by charging passengers for each checked bag, and even for those little meals on plastic trays. It looks like hospital executives have discovered a new way to unbundle.

As reported last month by the St Louis Post-Dispatch, hospitals have begun charging often hefty "facility fees" for patients seen as outpatients in hospital clinics or hospital owned practices, even for very minor procedures or just office visits, and even for Medicare patients. (Private physicians who see patients in their own offices cannot charge such fees to Medicare patients, and most private insurance companies will not cover such fees.):

A few weeks after Allison Zaromb took her 4-year-old son Meir to see a dermatologist in an outpatient office at the SSM Cardinal Glennon Children's Medical Center campus, she received separate bills from the doctor and the hospital.

The cost for a 3-minute procedure to treat Meir's warts totaled $538, which included a $220 bill for physician services - and a separate bill for a $318 hospital 'facility fee.'

Zaromb, a periodontist who lives in University City, is now suing SSM Health Care Corp. and Cardinal Glennon Children's Medical Center in a proposed class action lawsuit on behalf of other patients

More generally,

With the proliferation of hospital-owned outpatient centers and hospital-owned physician practices, hospital 'facility fees' have become increasingly common. Such hospital facility fees often involve greater dollar amounts than the fees charged by physicians.

Technically, it all appears to be legal:

Under federal regulations, health systems are permitted to charge a hospital facility fee for an outpatient service if it's done in a clinic that is 'hospital-based' - meaning that the clinic is owned and operated as part of a hospital or health system, regardless of whether the clinic is physically located on the hospital grounds.

This technique does seem to be a way to increase revenue. But one person's revenue is another person's cost, so it also seems to be a great way to further increase the already high cost of US health care. It is not obvious, however, that these increased costs will lead to increased quality of care or value for the patient:

'From a consumer's perspective, when you go see your doctor, you go see your doctor - whether it's in an office inside a larger hospital complex or right across the street,' [Zaromb's lawyer John] Phillips said. 'The doctor's practice remains the same. ... They're making the doctor's office a ‘hospital-based' clinic for one reason: to make money by charging a facility fee, not to improve consumer service.'

Negotiating the Costs of Medical Devices

One of the favorite topics on Health Care Renewal, at least before we found even more outrageous subjects, was the stratospheric cost of medical devices. For example, look at posts from 2005 here, here, here, and here. So last month we found out that hospital executives have come up with a revolutionary idea to combat the high cost of devices. They will actually try to see what prices the device companies charge other hospitals, and then negotiate the prices down, as Reuters reported as big news in late November:

Implantable devices make up a sizable chunk of typical hospital budgets, and administrators are devising new ways to limit that cost as they brace for cuts to government reimbursement and treat more patients who can't pay for care.

That means methodically working through each category of device, from heart valve replacements and stents to spinal products, to see where they can negotiate lower prices. It also means creating databases of shared information on pricing between hospitals.

Imagine that! Of course, the notion that buyers ought to bargain with sellers to get the best price goes back a few years. However, only in 2011 did it apparently occur to hospital executives that they ought to negotiate the prices of one their most expensive purchases. This suggests that there has been something profoundly wrong with the basic assumptions underlying the commonly accepted wisdom that making the health care system more of a market will lead to more financially efficient care.

Summary

In 1988, Alain Enthoven advocated in Theory and Practice of Managed Competition in Health Care Finance, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post here). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post here). Health care went from being controlled by clinicians to controlled by a growing volume of managers. Most of these managers were generic, in that they had little if any knowledge of, experience in, or sympathy to the values of health care. These generic managers have used the same techniques advocated for the management of supermarkets or automobile manufacturers to manage health care organizations, despite all the obvious differences in context, goals, values, and people involved.

So these generic managers have brought us such "innovations" as the "hospital (marketing) representative," and the "facility fee" for outpatient visits, but only thought to negotiate device prices in 2011. But that is why we pay them the big bucks.

How many more arguments do we need that health care organizations ought to be lead by people who understand the health care context, share its core values, and are accountable for how these organizations affect patients' and the public's health?

EHR: "The Dangerous Decade"

2011-12-18T09:47:00.049-05:00

A new perspective piece has appeared in the Journal of the American Medical Informatics Association. Although it is not freely available, I thought posting the abstract and the opening would be of interest:

The dangerous decade
JAMIA
Published Online First 24 November 2011
Enrico Coiera, Jos Aarts, Casimir Kulikowski

Abstract

Over the next 10 years, more information and communication technology (ICT) will be deployed in the health system than in its entire previous history. Systems will be larger in scope, more complex, and move from regional to national and supranational scale. Yet we are at roughly the same place the aviation industry was in the 1950s with respect to system safety. Even if ICT harm rates do not increase, increased ICT use will increase the absolute number of ICT related harms. Factors that could diminish ICT harm include adoption of common standards, technology maturity, better system development, testing, implementation and end user training. Factors that will increase harm rates include complexity and heterogeneity of systems and their interfaces, rapid implementation and poor training of users. Mitigating these harms will not be easy, as organizational inertia is likely to generate a hysteresis-like lag, where the paths to increase and decrease harm are not identical.

The perspective piece then opens with this:

There is a paradox in the relationship between information and communication technology (ICT) and patient safety. ICT can improve the quality, safety and effectiveness of clinical services and patient outcomes,1 although the evidence base for this is sometimes weak.2 As a consequence, the rapid deployment of ICT on a national scale is a priority for many nations faced with a diminishing clinical workforce, increasing workloads, and resource constraints. 3 4

However, ICT use can also lead to patient harm.5 Many commentators have raised concerns that ICT has yet to deliver on its promises,6 or that the rapid adoption of ICT is a risk.7 7a Errors persist in clinical practice even after ICT is introduced,8 because manual processes co-exist with the automated, and the interfaces between the two are seldom perfect. Others counter that such overemphasis on ICT-related harm only delays the implementation of a crucial technology that will save lives.9

It appears that we are caught in a bind. The demands for health system reform are now so compelling that there appears no choice but to implement complex ICT on a large, often national, scale. Yet these ICT systems appear less mature than we would like and our understanding about how to implement and use them safely remains in its infancy. As such, we are faced with a pressing policy challenge on both the national and international stages.10

They raise these rhetorical questions:

... Where is the ‘kill switch’ in our health ICT systems when large-scale privacy breaches are occurring, or large volumes of critical patient data are being corrupted? Who is authorized to activate such a switch?

The answers to these questions are, quite frankly: nowhere, and nobody. What we have instead is an environment of 'irrational exuberance' -- as well as 'rational exuberance', i.e., opportunism, often of a pecuniary nature.

To the authors' other observations I would add that:

1) "Organizational inertia" is probably too narrow a concern. I would broaden it to "cultural inertia", especially since the health IT "ecosystem" is grossly lacking of a culture of safety and accountability;

2) The authors note that "Predicting the actual harm rate and total patient harms that we will see through the use of ICT in healthcare over the next decade is currently not possible."

While I agree, and agree this inability needs to be remediated, extrapolations can be performed to achieve estimates. Regarding increased ICT use increasing the absolute number of related harms, that number could already be quite substantial as I wrote in an April 16, 2010 thought experiment at "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers."

Ironically and tragically, that post was written just five days before I wrote a confidential warning letter to a hospital about EHR deficiencies I'd noted in my mother's care there (part 1 here), and just one month before she was severely injured at that hospital by an EHR-related error of a nature as identified in the letter. Thus, the numbers in the thought experiment should be incremented accordingly;

3) I would say regarding safety that the health IT sector is roughly in the same place as aviation was in the 1920's (e.g., unregulated, experimental technology abounding), not the 1950's, and as the maritime passenger service was in ca. 1912 (April to be precise); and

4) The authors observe that "There is however caution in the [2011 IOM] report [on health IT safety here, PDF] that safety regulations would impede industry innovation, an argument which would literally not fly in the aviation industry ... the caution toward recommending regulation may however be misplaced. Simply put, if healthcare wants the benefits of ICT then it must actively manage its risks."

I strongly agree that the IOM's cautions on regulation are misplaced, as I wrote here. Robust regulation could diminish ICT harm as in pharmaceuticals and medical devices (and aviation).

Innovation will not be harmed, and the IT industry needs to -- and can afford to -- accept the responsibilities and obligations of being involved in healthcare. See for example "No More Soft Landings For Software: Liability for Defects in an Industry That Has Come of Age" (PDF), Zollers, McMullin et al., Santa Clara Computer & High Technology Law Journal, Vol. 21 No. 4, 2005.

-- SS

As U.S. Presidential Campaign Ramps Up, Newt Gingrich Plays Down Support for Health IT

2011-12-17T18:36:00.031-05:00

Presidential candidate Newt Gingrich, who I recall hearing in person as an an invited speaker at a health IT meeting some years ago (AMIA, I believe), has been pushing health IT rather uncritically in recent years.

However, he seems to have backed off that position at the election cycle heats up:

As Campaign Ramps Up, Gingrich Plays Down Support for Health IT
iHealthbeat.org
Friday, December 16, 2011
Now that he is a frontrunner in the race for the Republican presidential nomination, former House Speaker Newt Gingrich (R-Ga.) is downplaying his previous support for health IT adoption, The Hill's "Healthwatch" reports (Pecquet, "Healthwatch," The Hill, 12/15).
History of Supporting Health IT
During the George W. Bush administration, Gingrich worked with former CMS administrator Mark McClellan and former National Coordinator for Health IT David Brailer on federal efforts to promote health IT, according to the New York Times (Rutenberg/McIntire, New York Times, 12/16).
Gingrich also worked with former Senate Majority Leader Tom Daschle (D-S.D.) to co-author the forward of a book titled, "Paper Kills 2.0," which gives examples of how federal funds for health IT could be used in pilot projects to improve health care (Rowland, Boston Globe, 12/16).
Shortly before the passage of the 2009 federal economic stimulus package, Gingrich criticized the legislation as a "big politician, big bureaucracy, pork-laden bill." However, at the same time, Gingrich praised a provision of the stimulus package that allocated $19 billion to promote the use of health IT. He said, "I am delighted that President Obama has picked this as a key part of the stimulus package."

His views have apparently changed somewhat:

... Campaign Plays Down Health IT Support

On Wednesday, Gingrich unveiled a new brain science initiative that does not include any mention of EHRs, even though the technology was a major component of the brain science proposals he discussed over the summer.

Politics aside (it is probably not too far from the truth to say that all politicians hold out their fingers to see what direction the wind is blowing, although Mr. Gingrich is probably becoming more aware of HIT downsides thanks to lobbying of both sides of the aisle by people such as myself and like-minded experts [1]), I cannot disagree with this:

In August, Gingrich said he aimed to bolster brain science research in part by modernizing FDA through the use of EHRs. Gingrich said EHRs would allow for "much faster [FDA] approval times because you can monitor in real time everyone who uses the drug. And if you start getting inappropriate responses, you can change within weeks" ("Healthwatch," The Hill, 12/15).

In fact, I was championing exactly this idea ca. 2001 when I was employed at Merck Research Labs in the Research Information Systems division. Unfortunately, the answer from more senior personnel was that doing so would be "impossible" due to inability to blind, to control the data quality, etc., responses I considered unreasonable at the time but did not argue with to avoid getting on the Short List early in my employment there.

I also tried to present the idea to Merck as a former employee in Nov. 2006, at an invited presentation to the Clinical Risk Management & Safety Surveillance department of MRL entitled “Medical Informatics Perspectives on Leveraging the EMR in Pharma" (PPT). Also see my 2007 paper "A Medical Informatics Grand Challenge: the EMR and Post-Marketing Drug Surveillance" where I address a number of issues related to using EHR's in this fashion (PDF).

Using EHR's (e.g., with special screens and training) for well-defined Phase IV post-marketing surveillance studies would be one of the best uses for the technology [2].

Finally, I note that we need post-marketing surveillance of EHR's, CPOE's and other clinical IT systems themselves, not just drugs. Information technology cannot improve healthcare until it itself is improved significantly regarding its current deficiencies (see "reading list" here for illustrations).

-- SS

Notes:

[1] Health IT risks are a non-partisan issue.

[2] I should note that while I believe EHR's could facilitate postmarketing surveillance of drugs and devices, I take a dim view of more grandiose proposed uses of EMR's such as for comparative effectiveness research (CER). See my essay in the Journal of the American Association of Physicians and Surgeons (AAPS) entitled "The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry?" here (PDF).

A comment posted to the website "Doctors Helping Doctors Transform Healthcare", Peter Basch, William Bria et al.

2011-12-17T17:30:00.066-05:00

A new website has appeared that purports to be:

A collaborative effort led primarily by doctors for doctors to provide a "trusted resource" for physicians as they work to transform health care - initially through the use of health IT.

The site is entitled "Doctors Helping Doctors Transform Health Care" and is at this link. (I note that when one encounters such platitudinous and potentially highly ideological titles, one should ask "transform how, and into what, exactly?" I presume "transform" means, in part, to reduce risk and improve safety and outcomes - while protecting patient and physician rights.)

The site has a significant number of people on their advisory board (link), but no information on compensation. I note there are industry people involved, representing a potential conflict of interest.

According to one of the principals, Peter Basch, MD, Medical Director, Ambulatory EHR and Health Information Technology Policy, MedStar Health, Washington, DC, on funding:

A Few Words About Our Supporters

It takes resources to create and maintain this site, to make the work of Doctors Helping Doctors possible. We have solicited unrestricted contributions from individuals and organizations who believe in our mission and are able to support its work. In particular, we wish to thank Patrick Soon-Shiong of the Chan Soon-Shiong Family Foundation, John Glaser of Siemens Health Services; and Andy Slavitt of Optum’s Institute for Sustainable Health.

To my knowledge, I've never met Dr. Basch, but at meetings I have met one of the other principals of the new website, William Bria, III, MD, Chief Medical Information Officer, Shriners Hospitals for Children; President and Co-Founder, Association of Medical Directors of Information Systems (AMDIS), St. Petersburg, FL.

Dr. Basch's writing has appeared at Healthcare Renewal before, such as at the Jan. 2009 post "Throwing The National Research Council Report On Health IT Under The Bus, Part 1: MedStar Health."

In the new site, Dr. Basch states that:

As early adopters, EHR implementers, and practicing physicians, we have seen the “bad and the ugly” as well as the promise of health IT. We understand how health IT can and should be used to make care better, safer, and more value-laden. As such, we believe that unnecessarily harsh criticism of Meaningful Use—which we have heard from some quarters—and uncritical cheerleading—which we have also heard—are equally unhelpful.

We see physician “extremism” essentially marginalizing what is needed now more than ever—a clear and constructive physician voice, articulating not for compliance with Meaningful Use, but rather leveraging the opportunity that Meaningful Use presents, and consistently inserting the highest ideals that led us all to choose a career in medicine.

While on the surface this is not an unreasonable position, I fear the word "extremism" is used as a metaphor for those who express genuinely critical appraisals of the state of health IT as it now exists, on issues regarding safety, efficacy, usability, need for regulation, vendor, buyer and user liability, and other "unpleasant" topics.

I do note precious little on the site about educating physicians on the considerable downsides of health IT as it currently exists, nor on the scientific literature expressing doubts about its safety, efficacy, usability, ROI and other issues (such as here).

There is, it would seem obvious, no ethical excuse for introducing medical devices and other technology of unknown benefit and of unknown risk magnitude (as recently reported by the IOM, see this post), that is unregulated, into life-critical domains such as medicine without explicit acknowledgement of experimentation. Human subjects experimentation requires, of course, explicit informed consent under the many guidelines formulated as a result of past systemic abuses. Also, users need to be fully aware of the risks.

Such informed consent cannot be accomplished, and awareness attained by physicians regarding the dangers of use of health IT in its present form, through simple "best practices" protagonism.

For instance, health IT can be inherently defective and/or mission hostile (worse, the industry is unregulated), and can injure or kill. Several illustrative examples just off the top of my head are at:

"FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death";

"Lifespan (Rhode Island): Yet another health IT 'glitch' affecting thousands";

"FDA MAUDE Database: Patient Outcome - Death" and "FDA Manufacturer and User Facility Device Experience (MAUDE) database - case reports of EHR defects";

"ECRI: Healthcare IT In Top Ten Health Technology Threats to Patient Safety";

"Bad Health Informatics Can Kill" [European Federation for Medical Informatics];

"A Study of an Enterprise Health information System" [Australia - severe deficiencies in software engineering noted in major U.S. vendor ED EHR system that cause user confusion as well as data corruption/loss];

"Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software" [ISO/UK NHS - with an accounting of EHR-related medical errors in Annex A];

and a personal account "A Diary of EHR-Initiated Tragedy."

Not even including privacy and confidentiality issues (see this query link on those issues), should physicians, nurses, patients and other stakeholders not be explicitly educated on the issues of risk, that can be greatly replicated/amplified across hundreds or thousands of patients by EHRs as opposed to paper, and on actual injuries and deaths that have occured? If not, why not?

Are not these issues and the issue of the lack of a culture of safety in the health IT field at least as important, if not more important for clinicians, patients, healthcare executives and other stakeholders to be strongly aware of than "best practices" and "meaningful use?"

(I note that the "negative reports are mere anecdotes" argument commonly used by health IT pundits only shows, as in the Aug. 2011 essay by a senior clinician in Australia "From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things", that those making that argument need to attend revision courses in research methodology and risk management.)

In consideration of the "Doctors Helping Doctors" site's seemingly uncritical pro-HIT advocacy, I have posted the following note at the end of Dr. Basch's introductory essay. The comment appears at this link and is awaiting moderation.

The comment's remaining online would be a sign that the site is not another attempt to "control the channel", and is truly serious about being "trusted." It would be a sign of a site truly concerned with "physicians helping physicians transform health care" while not sacrificing patients as unconsenting test subjects of unregulated, experimental software-based medical devices in the process.

S Silverstein MD says:
December 17, 2011 at 10:29 pm

Doctors,

One way to help doctors transform healthcare would be to educate them on the downsides of information technology in healthcare, how to avoid them, and the conflicting literature on benefits (e.g., as at http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist).

I do not see such information here yet.

I do expect some such information will follow.

Sincerely,

Scot Silverstein

---------------------------------------------------
Scot M. Silverstein, MD
Consultant/Plaintiff's Expert Witness in Healthcare Informatics (May 2010-present)
Adjunct faculty in Healthcare Informatics and IT (Sept. 2007-present)
Assistant Professor of Healthcare Informatics and IT, and Director, Institute for Healthcare Informatics (2005-7)

Drexel University
College of Information Science and Technology
3141 Chestnut St., Philadelphia, PA 19104-2875

Email: sms88 AT drexel DOT e-d-u
Bio: http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm
Common Examples of Healthcare IT Difficulties: http://www.ischool.drexel.edu/faculty/ssilverstein/cases/

Note: I am cross-posting this comment on Healthcare Renewal blog under the title "A comment posted to the website 'Doctors Helping Doctors Transform Healthcare, Peter Basch, William Bria et al.'"

It is my hope the comment stays, and receives a reasoned reply.

-- SS

Dec. 23, 2011 addendum:

My comment appears to have disappeared. I leave it to the reader to determine what that means about the site "Doctors Helping Doctors Transform Healthcare."

-- SS

Medtronic Settles, Yet Again

2011-12-15T14:40:00.001-05:00

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."