Former KV Pharmaceutical CEO and Chairman Banned from Government Business

Early this year we noted that a subsidiary of KV Pharmaceutical, Ethex, pleaded guilty to two felony counts, and paid a fine in response to charges "stemming from its failure to make and submit to the U.S. Food and Drug Administration a report on its discovery of undistributed pills that 'failed to meet product specifications,' ...."   At the time, we noted that this was yet another marcher in the parade of legal settlements affecting health care organizations.  In this case, as in many others, despite the acknowledgement that unethical actions, worse, crimes were committed, no person appeared to suffer any penalty or negative incentive.  As usual, we argued that settlements like this would be perceived by unscrupulous leaders as mere costs of doing business, and would not deter future bad behavior.

That was then, and this is now.  Bloomberg just reported:

KV Pharmaceutical Co. said Marc Hermelin resigned as a director and will sell his controlling interest after being banned from doing business with the U.S. government for two decades. KV rose in New York trading.

Hermelin left the board on Nov. 10 and will sell his shares, said Catherine Biffignani, vice president of investor relations, in a telephone interview today. Hermelin, 68, had been fired as chairman and chief executive officer of Bridgeton, Missouri-based KV in December 2008. He held about a 52 percent voting stake, either in his own name or through trusts, according to a company filing on May 7. KV didn’t specify the timing of the stock sales.

The ban takes effect tomorrow.

This was really news. As the article noted:

Hermelin will become the first drug-company owner or executive barred from doing business with the government in an antifraud push involving Medicare, the insurance program for seniors and the disabled, and Medicaid, the health program for the poor, according to the Health and Human Services Office of Inspector General’s website.

We just discussed an indictment of a former GlaxoSmithKline executive. Now we have a KV Pharmaceutical executive banned from doing business with the government. So all of a sudden, it looks like the US government has realized that when health care organizations violate the law, their executives do not have complete impunity.

Of course, things immediately became more complicated. The St Louis Post-Dispatch just reported:

In yet another major shakeup, KV Pharmaceutical's board chairman, a member of its audit committee and its chief financial officer quit this week.

The chairman and audit committee member charged that KV's newly elected board can't provide the independent oversight the company needs. The new board had been elected last Thursday.

The CFO, John Stamp, quit on Monday and has not been replaced, the company said in a regulatory filing released Wednesday afternoon.

KV also revealed that the new board had terminated interim CEO David A. Van Vliet. The company last week announced that Van Vliet had been replaced but gave no details.

What seems to be going on here is resistance to the continued control of the company by the family of the now banned former CEO:

In their resignation letters, board chairman Terry Hatfield and audit committee member John Sampson said they had 'serious concerns regarding the ability of the newly constituted board and senior management to provide the required independent oversight of KVs business during this critical time in the company's history.'

They noted that only three of the board's seven nominees for board seats were elected at KV's annual meeting last Thursday. The remaining elected members were candidates proposed by shareholders.

The family of the firm's founder, Victor Hermelin, retains 52 percent of the Class B shares, which have super voting rights, according to the company proxy issued in May.

Among those re-elected to the board was Marc Hermelin, son of the founder, who was ousted as CEO in 2008. Also re-elected was David Hermelin, the son of Marc Hermelin and a former director of corporate strategy who retained his seat on the board.

David Hermelin was among the board's nominees. Marc Hermelin was not.

As soon as the government appears to get somewhat serious about imposing negative consequences for bad behavior in health care, one can expect that the leaders of organizations who have personally profited from bad behavior in the past will try to come up with work-arounds.

Nonetheless, it may be that if health care leaders realize they do not have complete impunity, and they may be held responsible for the bad behavior of the organizations they lead, they may behave better. One can hope.

One can also hope that increasing evidence about the bad behavior of leaders of health care organizations will lead to increased unwillingness by health care professionals to go along with, or at least ignore such bad behavior that compromises their own professional values.

Insurers Test Data Profiles to Identify Risky Clients

Stories like this one today at the WSJ disturb me.

“Insurers Test Data Profiles to Identify Risky Clients”
Wall Street Journal
Nov. 19, 2010

From that story:

Life insurers are testing an intensely personal new use for the vast dossiers of data being amassed about Americans: predicting people’s longevity.

Insurers have long used blood and urine tests to assess people’s health—a costly process. Today, however, data-gathering companies have such extensive files on most U.S. consumers—online shopping details, catalog purchases, magazine subscriptions, leisure activities and information from social-networking sites—that some insurers are exploring whether data can reveal nearly as much about a person as a lab analysis of their bodily fluids.

In one of the biggest tests, the U.S. arm of British insurer Aviva PLC looked at 60,000 recent insurance applicants. It found that a new, “predictive modeling” system, based partly on consumer-marketing data, was “persuasive” in its ability to mimic traditional techniques.

The research heralds a remarkable [alarming? -ed.] expansion of the use of consumer-marketing data, which is traditionally used for advertising purposes.

Read the entire article.

The reason I find this article disturbing is that it can and probably should be looked at as another example of technophiles and opportunists with no knowledge of (or lack of caring about) Social Informatics, a decades-old discipline with a focus on studying the unintended consequences of new information and communications technologies (ICT's), enabling our society to move one step closer to centralized control.

Social Informatics (SI) refers to the body of research and study that examines social aspects of computerization, including the roles of information technology in social and organizational change, the uses of information technologies in social contexts, and the ways that the social organization of information technologies is influenced by social forces and social practices.

Stories such as the above WSJ story, and others in their running series on Internet privacy, also dampen my enthusiasm about the possibility that electronic medical information will be kept private, confidential and secure.

-- SS

GAO report: - Health Care Delivery: Features of Integrated Systems Support Patient Care Strategies and Access to Care (such as HIT)

A new GAO report has appeared entitled "Health Care Delivery: Features of Integrated Systems Support Patient Care Strategies and Access to Care, but Systems Face Challenges." (Hat tip: saw this in story by Inga at HerTALK).

The report is available at these links:

GAO-11-49 November 16, 2010
Highlights Page (PDF) Full Report (PDF, 33 pages) Accessible Text

One of those strategies, of course, is healthcare IT:

IDSs in GAO's sample reported that using electronic health records (EHR), operating health insurance plans, and employing physicians all support strategies to improve patient care. An EHR contains patient and care information, such as progress notes and medications. Some IDSs said that using EHRs supports their patient care strategies such as care coordination, disease management, and use of care protocols by increasing the availability of individual patient and patient population data and by improving communication among providers.

Some might take this report as "proof" that healthcare IT is ready for national rollout.

However, the following passage lends doubt to that interpretation, in the form of a significant "however" (a common word seen in reports about healthcare IT, along with terms such as "but", "except", "in some cases", "in the next release", the ever-valuable term "glitches", and other similar hedge terms).

… However, the information we present is from the perspective of the IDSs in our sample. We relied on data obtained through the Web-based data collection instrument, interviews with system representatives, and published studies and did not conduct independent analyses of the effectiveness of strategies.

This report suffers a serious flaw: potential (or might I say likely) self-reporting bias.

Caveat emptor.

-- SS

Avatar fails. (No, not the Cameron movie, but yet another lousy EMR system implemented by amateurs.)

A story "Designed for Efficiency, New Computer Software at Health Dept. Misfires" by The Bay Citizen senior writer Katharine Mieszkowski appeared in the New York Times today regarding San Francisco's Dept. of Public Health.

"Misfires?"

That's a mild term indeed. In the realm of incendiary comments in the interest of patient care:

In this story, mental health and social workers, and the disadvantaged people suffering mental illness, drug addiction, etc. that these professionals attempt to raise up from misery one difficult step at a time, are being used as unconsenting experimental subjects and free software debuggers and beta testers:

This story follows a script very familiar to Medical Informatics professionals:

• Poorly designed and implemented healthcare IT causes clinical and other chaos;
• Vendor and implementation leaders claims "glitches" and "teething pains" and blame the users for inexperience and/or incompetence;
• Vendor promises relief in the "next version";
• These principals hope it all "goes away" until the system implodes on itself and needs replacement, starting the cycle anew, and/or-
• The principals hope newspapers stop paying attention to the chaos caused by the IT and the users simply surrender, and let the information systems control them, rather than the other way around.

Considering the patient population involved here, one might wonder if the project leaders have any more compassion than the machines they proffer:

New York Times
Designed for Efficiency, New Computer Software at Health Dept. Misfires
By KATHARINE MIESZKOWSKI
November 18, 2010 (from the Bay Citizen)

In July, the San Francisco Department of Public Health started using an $11.2 million electronic medical records system, Avatar, that was designed to streamline billing and improve care for tens of thousands of clients. Thus far, however, it has brought administrative chaos to the mental health and substance abuse services in the city.

Documents obtained by The Bay Citizen under a California Public Records Act request show that shortly after installing Avatar, providers struggled to use the new software, causing health officials to lose track of millions of dollars of services.

Officials are scrambling to fill in the missing data to meet deadlines to qualify for reimbursement from the state.

In addition to mere financial chaos:

... Problems related to the conversion to Avatar delayed for months the payment of about $450,000 to individual therapists, Anne Okubo, the health department’s deputy financial officer, told the San Francisco Health Commission on Tuesday night. The department was forced to use a third party to make the payments, which are still incomplete.

In addition, some therapists and social workers report that the demands of the new software have cut into the time they spend with patients, eroding the quality of care.

In an Aug. 19 e-mail headed “problems with Avatar,” Steven Schreibman, a social worker at Sunset Mental Health, a city-run clinic, wrote that the software required “excessive time charting and performing data entry” and had led to “shorter sessions with clients” and “delays in our capacity to accept new clients.” [This is not news to anyone familiar with poorly designed, mission hostile healthcare IT - ed.]

The customary excuses were presented. Growing pains, ignorant users:

Senior health department officials and Netsmart Technologies, Avatar’s developer, said the problems were glitches that were to be expected as the city made the transition to a more efficient record-keeping system.

“We knew it was going to be rough initially, because there is a learning curve,” said Jo Robinson, who heads the Community Health Behavioral Services division, where Avatar was introduced.

Kevin Scalia, a Netsmart Technologies executive vice president, said that he does not see this as a big problem. “From our point of view,” he said, “everything is going swimmingly.” [Translation - they're making good money - ed.]

Here's the key passage:

Department managers told the Health Commission that Avatar would lead to “improved client care” and had “positive fiscal impacts,” but they acknowledged there had been problems.

In September, the department compared the cost of mental health and substance services reported by the hospital, clinics and organizations in March, before the software was put into use, to those reported in July using the new system.

The data showed that the mental health services reported had plunged 55 percent. Substance abuse services reported fell 32 percent. The large discrepancies caused alarm because they indicated that providers were having problems using the software, according to documents and interviews. [I can also predict they've had problems _providing_ those services under the time duress added by the software - ed.]

As someone who was once a Medical Review Officer for drug testing in the public transit industry, and a colleague of the company's Employee Assistance Program liaison, I can assure readers that implementation of health IT will not effect a one-third reduction in drug abuse problems and recidivism.

After a month of use:

A month later, as more providers gained access and proficiency with the software, the picture improved, but significant discrepancies remained.

Some data modeling issues are apparent:

But some organizations worry that the services they are providing will not be fully reflected in the new system.

Here's a reverse twist on HIT vendor "Hold Harmless" clauses:

At the Health Commission meeting, Estela Garcia, executive director of the Instituto Familiar de la Raza, a community organization that provides mental health services, asked the commission to protect organizations like hers from any financial liability related to Avatar.

“I want a hold-harmless policy until the system is fully up and running,” Ms. Garcia said.

How long that will take is unclear. One mental health program director, who would not allow his name to be used because it could jeopardize his relationship with the department, said his staff had gone to repeated training sessions to try to get up to speed.

“Avatar turns out to be a total disaster,” the program director said. “What is going to happen to contracted agencies if their billing is short at the end of the fiscal year as compared to the terms of their contract, because they can’t master Avatar?”

As in typical in health IT, system users are afraid to speak candidly:

A psychologist who works with a community organization under contract to the city, who spoke on the condition of anonymity because he was afraid of losing his job, said he used to do all his charting and billing on paper and was told that the new system would be more efficient. So far, that has not proved to be the case, he said.

“We are seeing the same number of patients,” he said, “but we are providing substantially less service to them, because the time we are now spending just to do the billing alone, not to mention the record keeping, it’s become the majority of our time.”

Labor unions are taking a look:

Greg Cross, a field representative for Service Employees International Union Local 1021, which represents hundreds of social workers, psychologists and counselors who work for the city, said he had met with officials to discuss Avatar’s impact on workload as well as performance expectations.

I invite SEIU Local 1021 and national SEIU leaders to read this blog, and review my academic site on HIT failure here, to better understand why these debacles repeatedly occur.

At the Health Commission meeting, Fred McGregor, the health department’s senior information technology manager for community programs, said that the department was aware that providers find the demands of Avatar “a little onerous” and that it was working on a redesign to make clinical assessment more efficient.

A "little onerous"?

"Working on a redesign to make clinical assessment more efficient"?

What about getting it right the first time, based on the significant amount of literature that exists on proper IT design?

I, for one, am tired of hearing this corporate mumbo-jumbo every time another health IT system impairs users.

What is needed here is a full scale investigation and evaluation of the competence and expertise of the project leaders, designers, and implementers to be experimenting in the complex field of healthcare information technology.

Mr. Schreibman, the social worker, made it clear in his August e-mail that change was needed quickly.

“The kind and amount of work skill involved using this software represents a change in our job description,” he wrote. “This is not the job we accepted when we chose to do clinical work for the city.”

In other words, they did not accept a job as data entry clerks and directors of workarounds to the mission hostile user experience presented by poorly designed healthcare information systems.

I note that missing in this story are the human tragedies (such as pain & suffering, injury, death) these IT "glitches" may have caused.

Until the memes of complete health IT beneficence and "anyone can do it" are soundly pounded into the ground and out of the heads of hapless politicians, healthcare leaders, and IT personnel, this type of mishap will continue.

Sadly, health IT mishaps are likely to be occurring on a national scale, soon, in a neighborhood near you, thanks to the timelines and penalties expounded in the HITECH act. HITECH was an integral part of the legislation known as the ARRA (American Recovery and Reinvestment Act of 2009).

-- SS

Who You Gonna Call? - How Should a Young Academic Respond to a Proffered Conflict of Interest?

To prepare a workshop on conflicts of interest in health care, I wrote a case of a faculty member offered a proposition that might provide a conflict of interest:

Consider a health care researcher called by a commercial health care corporation's marketing department. The department representative proposes paying the researcher as a consultant to write a scholarly article on a specific policy topic of interest to the company. The implication is that the article should be favorable to the interests of the corporation in this arena. The corporation would be delighted to give the researcher editorial and staff assistance in writing the article and getting it published.

Who you gonna call?

The researcher is concerned that getting this consultancy might be a conflict of interest. What organization (e.g., appropriate professional society, unit within his or her academic institution, other academic unit, independent not-for-profit organization or NGO, or government agency) should the researcher contact for support and help? Please give at least one specific example, (preferably including a URL), with a brief justification of why that organization might be helpful.

I sent the case to a few hundred people on our combined mailing list, to see how they might answer.  Responses came from medical academics, with a sprinkling of practitioners, a journalist, and a well-informed lay-person.

Sources of Information: Is It a Conflict of Interest?

Nearly everyone thought it would be unethical for a young academic to be paid as a consultant to write a health policy review policy by a company with a vested interest in the subject, and with editorial and staff support coming from the company.

I implied (but did not make clear) that the faculty member felt uncomfortable with the situation, was looking either for advice and information, or actual support not to accept a conflict of interest that he or she might have felt pressured to take on.

People suggested some sources of information. Most appeared to be useful, but most also were specialized (by clinical specialty, directed at journal editors, directed only at conflicts related to pharmaceuticals, etc)  Those particularly worthy of mention include:
- The Prescription Project's site on medical school conflict of interest policies
- The World Association of Medical Editor's (WAME) site on conflict of interest in scholarly publication
- The PharmedOut.org general resource site
My personal preference for a single source of general information on COIs is the 2009 US Institute of Medicine report on same.  (I will add all these links to our side-bar, and note that there are some other relevant links there.)

The IOM definition of conflict of interest is:

Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.

Primary interest include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients.

So the offer in the above case clearly seemed to present a conflict. The situation presented in my case seemed to present the potential to violate the report's recommendations 5.1 that bans scientific publications "that are controlled by industry," or that "contain substantial portions written by someone who is not identified as an author...."

Note, however, that even the IOM report seems not to question the idea that "collaborations between physicians or medical researchers and pharmaceutical, medical device, and biotechnology companies can benefit society — most notably by promoting the discovery and development of new medications and medical devices that improve individual and public health."  It has never been clear to me that collaboration requires payment by one party to the other, or that academic medical institutions ought to be developing drugs and devices (as opposed to discovering knowledge that commercial firms might later use to do so.) Furthermore, the IOM report, while it is moderately tough and comprehensive, did not recommend that detailed public disclosure of all relevant conflicts by all parties to them, or an outright ban on all of the sorts of conflicts that many might think are objectionable.

Support to Resist the Proffered Conflict

Suggested sources of help resisting pressure to assume an unwanted conflict of interest included local sources: mentors, grants and contracts offices, local conflict of interest/ ethics committees, compliance departments, and research officers. Some people thought their local versions of the above might be helpful. No person seemed sure that any of these options would clearly lead to support if the academic was being pressured by his or her academic superiors.

However, I have big concerns about the availability of even these sorts of local support.  We know COIs are very prevalent among individual academics.  About 60% of all academics, and of department chairs have important conflicts according to two articles by Campbell et al.(1-2)  So it might be hard for the young academic to find a mentor or university officer who was not already conflicted.

We also know that medical schools and academic medical centers see commercializing their discoveries as taking precedence over their traditional mission of seeking and disseminating knowledge, and providing and improving patient care and public health.  For example, in 2000, a Vice President of the American Association of Medical Colleges(3) wrote that research universities must respond to "societal demands that they become engines of economic development…."[caps added for emphasis] Furthermore,

Academic medicine… finds itself struggling to create a precarious equipoise between the world and values of commerce and those of traditional public service….

Also

In our capitalistic economy the pathway by which research invention becomes beneficial application is often totally dependent on venture capital, the availability of which commonly demands the active participation of academic inventors in the commercial venture; put simply, no participation, no money. It is this demand … that has driven the dramatic increase in medical faculty entrepreneurship.

I have seen university conflict of interest policies that include such verbiage in their introductions. The impression is that most academic medical institutions now think that is their mission, maybe their overriding mission, to develop and commercialize drugs and devices.

So it might also be hard for the young academic to find a local academic unit that is not affected by institutional conflicts of interest. Indeed, none of the people on our list was sure that their institutions had local authorities or units that could help the young academic in the case above avoid the proffered conflict of interest.

A few people suggested external sources of support: e.g., a small medical society, an association of journal editors, a bioethics center. But they too were ambivalent about how helpful they might be. The small medical society would only be helpful for its few members, and the person who mentioned it doubted it could provide more help that citing its own COI policy. The journal editors and their organizations might only be helpful about how the proffered conflict might affect the ability of the faculty member to get the resulting study published. The bioethics center appeared to have heavy institutional conflicts of interest of its own. No one could suggest an independent organization likely to provide effective support to resist COIs to a wide spectrum of academics (or other health care professionals, etc)

Summary

So this exercise did reinforce one of the assumptions I made when writing the case. Young academics at most US (at least) institutions may have little local support for resisting the extant pressure to become conflicted. There are NO generally useful and effective external sources of such support.

I would point out that with all its limitations, the IOM report still called on academic institutions to develop clear guidelines for COIs (3.1, 3.2); ban people with COIs from research on humans (that is, from all clinical research) (4.1); develop educational programs on COIs (5.2); participate in developing continuing medical education that is free of industry influence (5.3); set up a committee on COIs at the board of trustees level (8.1). It also called on the US government to promote research about COIs (9.2).

As far as I can tell, that was all pretty much wishful thinking. Despite the prestige of the IOM, almost none of these recommendations have been implemented. (I have heard so far of one university that seems to have implemented watered down versions of some of the IOM recommendations in their own policy. I would love to be told there are more extensive implementations of these recommendations. If there are, please show me the specifics.)

Furthermore, there seems to be no effective support for the reduction of COIs from accrediting organizations, professional societies, or foundations that fund health care initiatives. (Again, I would love to be told I am wrong, but if I am, show me the specifics.)  Of course, it appears that most professional societies get extensive support from commercial sources, particularly drug, device, and biotechnology companies, and their leadership often have their own financial relationships with for-profit health care corporations.  Foundations that support health care and medicine may have leaders with similar relationships, and may have endowments disproportionately invested in health care corporations.   

Given the pervasive nature of personal and institutional COIs throughout health care, which we have documented on Health Care Renewal , I was saddened, but not surprised by the responses to my query. So many people and so many institutions are making so much money from their industry payments. They will nearly all have excuses so that they can keep accepting the money. Young faculty are unlikely to be able to resist the prevailing culture, especially when it affects so many of their colleagues and supervisors.

I know that the people on our email lists are more aware of this than most. But we all should be saddened and ashamed that so little progress is being made.

Will academic medical institutions ever again put seeking and disseminating new knowledge, and providing and improving patient care and for the public health ahead of trying to be ersatz drug and device companies?

Will professional societies ever again put put their members' core values ahead of pleasing their corporate funders?

Will health care foundations ever again put rescuing health care's core values ahead of bland projects meant not to offend health care corporate leaders?

References


1. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. (link here)
2. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786. (link here)
3. Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-2237. (link here)

NEJM: Medical Malpractice Liability in the Age of Electronic Health Records

As I wrote on Nov. 11 at Report of an AMIA special task force on challenges in ethics, safety, best practices, and oversight regarding HIT :

This report may be part of a trend ... It appears that the views on healthcare IT safety, ethics, management practices, etc. appearing on the Healthcare Renewal blog and on my once-controversial academic health IT website "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" (started in 1999) are now becoming mainstream.

Notable "events" continue to occur rapidly in the literature on clinical IT. Another example of the trend I noted appeared today, this time in the New England Journal of Medicine:

Medical Malpractice Liability in the Age of Electronic Health Records
Sandeep S. Mangalmurti, M.D., J.D., Lindsey Murtagh, J.D., M.P.H., and Michelle M. Mello, J.D., Ph.D.
N Engl J Med 2010; 363:2060-2067 (Nov. 18, 2010)

From the Department of Medicine, New York University Medical Center, New York (S.S.M.); and the Department of Health Policy and Management, Harvard School of Public Health, Boston (L.M., M.M.M.).

The above hyperlink takes you, as of this writing, to full text and an available PDF.

My comments on this article are that:

I am happy to see it appear -- as it shows that critical thinking about HIT has reached the top echelons of the medical literature.

However, the new paper itself appears to wander a bit, and seems to add little to the much more comprehensive article:

"E-Health Hazards: Provider Liability and Electronic Health Record Systems." Sharona Hoffman and Andy Podgurski. Berkeley Technology Law Journal (2010).
Available at: http://www.btlj.org/data/articles/24_4/1523_Hoffman.pdf

(Sharona Hoffman JD is Professor of Law and Bioethics, Co-Director of Law-Medicine Center, Case Western Reserve University School of Law, and Andy Podgurski PhD is Professor of Electrical Engineering and Computer Science, Case Western Reserve University.)

The new article does reference the Hoffman/Posgurski article once at [32].

The new NEJM article also seems to display biases. For instance, it states:

EHR users overwhelmingly report improvement in the quality of care they provide. [29]

Reference [29] is this article:

29. DesRoches CM, Campbell EG, Rao SR, et al. Electronic health records in ambulatory care — a national survey of physicians. N Engl J Med 2008;359:50-60.

From that article:

In late 2007 and early 2008, we conducted a national survey of 2758 [ambulatory care] physicians, which represented a response rate of 62%. Using a definition for electronic health records that was based on expert consensus, we determined the proportion of physicians who were using such records in an office setting and the relationship between adoption and the characteristics of individual physicians and their practices.

... Four percent of physicians reported having an extensive, fully functional electronic records system, and 13% reported having a basic system ... Physicians reported positive effects of these systems on several dimensions of quality of care and high levels of satisfaction ... Physicians who use electronic health records believe such systems improve the quality of care and are generally satisfied with the systems. However, as of early 2008, electronic systems had been adopted by only a small minority of U.S. physicians, who may differ from later adopters of these systems.

I would therefore relate that the blanket statement that "EHR users overwhelmingly report improvement in the quality of care they provide" is overstated.

It might have been more appropriate to write that:

"In one study of ambulatory care physicians, a minority of which at present were using EMR's at various levels of sophistication, users reported improved care."

Also, other literature refuting the premise that physicians report improved care could (should) have been considered, such as (in just one example) the 2008 survey reported upon by the American Association of Physicians and Surgeons (AAPS):

PHYSICIAN ATTITUDES & ADOPTION OF HEALTH INFORMATION TECHNOLOGY (PDF)

I wrote about that survey at this link. (I note that the AAPS is a conservative group; NYU and Harvard tend strongly towards the left; one wonders if the NEJM authors would have considered mentioning the AAPS survey, even if they did know of it.)

More potential biases appear in the conclusion of the new NEJM paper:

... In evaluating whether to invest in EHR technologies, provider organizations must weigh the substantial up-front cost and possible risks against the potentially sizeable, but uncertain, long-run benefits.[55]

[55] DesRoches CM, Campbell EG, Vogeli C, et al. "Electronic health records’ limited successes suggest more targeted uses." Health Aff (Millwood) 2010;29:639-46.

From [55]:

... We examined electronic health record adoption in U.S. hospitals and the relationship to quality and efficiency. Across a large number of metrics examined, the relationships were modest at best and generally lacked statistical or clinical significance. However, the presence of clinical decision support was associated with small quality gains. Our findings suggest that to drive substantial gains in quality and efficiency, simply adopting electronic health records is likely to be insufficient. Instead, policies are needed that encourage the use of electronic health records in ways that will lead to improvements in care.

Using [55] as an example of "potentially sizable but uncertain long-run benefits" is not how I would have interpreted the Health Affairs Millwood article.

The NEJM paper authors then write in their conclusion:

... The malpractice implications of EHRs should be included in future discussions of risks and benefits. [Agreed - ed.] Although there is currently little research quantifying the risks and benefits with respect to liability, we are optimistic that they will ultimately weigh in favor of the implementation of EHRs.

They do not state how or why they are optimistic, nor provide corroborating references for that opinion.

Is it revealing of bias and probably not a good practice, as far as I am concerned, to put what appears as wishful thinking -- especially where one states that there is little research supporting the optimism -- in the conclusion of a scientific paper.

In summary, while I feel the paper has a number of flaws, I am glad to see the topic of potential healthcare IT malpractice liability addressed in one of the top journals in medicine.

-- SS

Some answers about new site "EHRevent.org" for health IT and drug adverse event reporting - and a note on incendiaries

Some answers to the questions I raised here and here about a new site EHRevent.org, for reporting of healthcare IT and drug problems, can be found in a blog post at the site of Occam Practice Management at this link: http://www.occampm.com/blog/general/ehr-event-reporting/.

Its author, Michelle R. Wood, had noted this HC Renewal post. She researched some of the questions and wrote up her findings.

It is well worth a read.

I do have a small bone to pick with her post at Occam. She wrote:

"While HC Renewal occasionally borders on the incendiary side of things, Dr Silverstein posed some valid questions about a website that seem to have caught everyone by surprise..."

I maintain that the true incendiaries are fired by those we write about, those whose pronouncements and acts are "threats to health care's core values, especially those stemming from concentration and abuse of power."

Those 'incendiary' pronouncements and acts can indeed maim and kill (for example, as my own mother is now experiencing thanks to an ill done commercial EMR).

I may be more accurate to say we don't restrict ourselves to the confines of 'political correctness', that is, stunted discourse conventions that generally favor maintenance of the status quo.

As I wrote on that issue last year here in my series on mission hostile healthcare IT:

... Some have complained I am being "politically incorrect." At a time when our banks, major industries, investments, lifestyle and retirements have been seriously eroded by a combination of secrecy, incompetence, and criminal behavior on an unprecedented scale, I think such people need to get their priorities in order.

In his mantra "Critical thinking always, or your patient's dead", cardiothoracic surgeon Victor P. Satinsky, mentioned in earlier posts as my earliest medical mentor, did not include "but be polite about it" as part of the lesson.

On those pesky EMR curmudegons ... (click to enlarge)

-- SS

Addendum 11/17/10:

At the above Occam link Ms. Wood published my brief comment on this issue, and a thoughtful response. See the comment thread of her EHRevent essay.

-- SS

EHRevent: survey amateurism, bias, or something else?

At my post EHRevent.org: Web Site to Collect EHR Safety Reports, I wrote of my questions about a new organization, EHRevent.com, that seems to supercede or compete with the FDA's MAUDE and Medwatch medical device and medication adverse events reporting and analysis services.

Reviewing the EHRevent report form on this day (archived here, PDF), I note the following multiple choice question on page 7 (emphasis mine):

Notwithstanding the event you are reporting, has the adoption and use of an EHR by your practice added to patient safety, improved care or improved documentation? Select one option.

o Yes, definitely

o Likely

o Not sure

o No impact

A bias and/or survey amateurism is clearly evident in this question. And perhaps something more?

Missing is this option:

o None of the above; EHR adoption did not "add to"; rather, it subtracted, as worsening occurred

A fundamental rule of surveys is that the choices should not artificially limit the survey taker's ability to provide critical or relevant information.

As Ross Koppel, PhD, a sociologist studying healthcare IT at the University of Pennsylvania stated at the Feb. 25, 2010 HHS Certification/Adoption Workgroup Meeting on Health IT Safety (minutes of that meeting are archived at this link, PDF):

... Like everyone else, I want HIT to increase patient safety, care efficiency, treatment quality, savings, and drug ordering guidance. I want HIT to provide coherent structures for test results and other data, and I wanted to provide better visualization of complex clinical data.

Unlike many of my colleagues here who are HIT scholars and advocates, however, because of my training perhaps, I‘ve studied the surveys that have been used to guide and explain the current HIT strategy.

These surveys explored why doctors and hospitals have not embraced HIT‘s benefits. The findings pointed to the cost of HIT, to the physicians‘ resistance. They called them technophobic, hide bound, and perhaps most gruesome, too old. It also talked about overwhelmed hospital IT staff and other user pathologies or user inadequacies.

Now the years of research on HIT suggested that those answers could not be complete. They weren‘t right. The reasons the surveys found this, I‘ve been investigated, was I looked at the questions that were asked of the doctors and hospitals. And the only answer options dealt with the problems of hospitals and doctors. In other words, they found only the questions that they asked about physician difficulties, doctor difficulties. They didn‘t look for any other options, and they didn‘t even give other option answers to talk about the following issues.

So they could have asked, does HIT slow or speed your clinical work? Are EHR data presented in helpful ways, or do they generate unnecessary cognitive burdens because, for example, the data that should be contiguous are in five separate screens, where you‘re scrolling across vast wastelands of rows and columns looking for the needed information. How many information displays are understandable or are disarticulated, confusing, or missing key data? Does HIT distract from your patient care or improve it? And the last one I‘ll ask, although I have about 50 others, how responsive are HIT vendors to acknowledging and repairing defects? How quickly are these defects repaired?

The absence of the relevant questions divert us from understanding the actual HIT needs of clinicians and patients. Now I‘m certain that the people who asked these questions, designed these surveys, were not intentionally deceptive. Well, I‘m certain most were not intentionally deceptive. But the restricted options reflects a series of assumptions or … that says HIT is intrinsically beneficial. Anything that encourages HIT is good for patient safety. Anything that discourages it or retards it is bad by definition.

The creators of the EHRevent survey apparently were not present, or not listening, during Dr. Koppel's presentation.

I have not yet reviewed in depth the other survey questions for similar issues, but this one stood out like a sore thumb.



I cannot imagine an objective, competent scientist committing such an error.

-- SS

EHRevent.org: Web Site to Collect EHR Safety Reports

At "Cart before the horse, again" I observed the irrationality of creating "meaningful use" rules for health IT before usability issues (i.e., poor usability) had been robustly addressed, and the further irrationality of the IOM studying HIT safety after HIT became slated for national rollout in the next few years.

The horse seems to be starting to catch up to the cart (or is it the other way around?):

HDM Breaking News, November 15, 2010

The iHealth Alliance, a coalition of industry stakeholders, has launched an electronic health record safety reporting Web site, called EHRevent.org.

The site is designed to be a national system where providers can report safety issues related to the use of EHRs. Reported events will be confidential but used as the basis to generate other reports that medical societies, malpractice insurers and government agencies can use "to help educate providers on the potential challenges that EHR systems may bring," according to the alliance. The Food and Drug Administration will use data collected on the site to assist in evaluating safety issues that may arise during the forthcoming widespread implementation of EHRs.

Initial supporters of EHRevent.org include the American Medical Association and some state medical societies, American Cancer Society, National Patient Safety Foundation, American Pharmacists Association, CentrEast Regional Extension Center in Texas, and EHR vendor eMDs Inc.The PDR Network, which distributes drug labeling information, FDA-issued product safety alerts and other services such as the Physicians' Desk Reference, will operate the network. Participating insurers, medical societies, EHR vendors and other entities will have links to EHRevent.org on their own Web sites. A similar site to report adverse medication events, RxEvent.org, will launch in 30 to 60 days. [Is the FDA outsourcing MedWatch? - ed.]

Federal agency supporters include the Agency for Healthcare Research and Quality, and the Food and Drug Administration. Malpractice carrier supporters include COPIC Insurance Company and The Doctors Company.

From the homepage at http://www.ehrevent.org/:

The EHR Safety Event Reporting Service is a service of PDR Secure™, a Patient Safety Organization (“PSO”).

I have several concerns with this development:

• The site page on Privacy and Security states that "PDR Secure™, a certified Patient Safety Organization, receives oversight and governance from the iHealth Alliance, a not-for-profit organization whose mission is to protect the interests of patients and providers, as healthcare increasingly moves online." However, who's paying for the EHR Safety Event Reporting Service and the salaries of the people involved?
  

• How is it that these watchdog organizations seem to spring out of nowhere, with no opportunity for public comment or involvement before they "hatch?"

• Did Congress or other elected representatives have a role in this development?
  

• Will competitors also "hatch?"
  

• Why doesn't the FDA take on this role instead of simply "using data collected on the site to assist in evaluating safety issues that may arise during the forthcoming widespread implementation of EHRs?" They have the infrastructure and experience (e.g., the Medwatch and MAUDE reporting facilities).

• Will actual reports, de-identified as the the reporter, be available to the public in a searchable database as they are in, say, FDA's MAUDE database? (See posts on MAUDE here and here.) From the EHRevent site:
  

The Privacy and Security page states that "PDR Secure™ ... will collect, analyze and report back to healthcare providers and others on trends, recent new developments, and other information designed to reduce the risk of harm in the delivery of health care." The FAQ page states "PDR Secure will ... analyze and make available reports on the type of events, frequency of events, and other statistics as well as recommendations and best practices for using EHR systems. "

Will the actual report text itself be unavailable to the public?

• Re: "A similar site to report adverse medication events, RxEvent.org, will launch in 30 to 60 days." Is FDA abandoning its role in collecting drug AE reports?

Further, from the site's own language:

• What, exactly, will be done with the information? They state: "Reporting EHR events can help improve EHRs, support patient safety, reduce professional liability and help liability carriers and others properly educate physicians on safe use of EHRs." How?

• Is the reporting process really protected? Again, from the site itself:

How broad is the legal protection in this PSO?

Patient Safety Work Product - the information you provide in the reporting form, once it becomes part of the PSO environment - is entitled to greater protection from disclosure in legal matters as part of a new statutory and regulatory framework. PDR Secure™, as a certified and listed Patient Safety Organization under Federal law/regulations, has been designed to afford a reporter with the protections under this law. However, it is important to know that PSOs are relatively new entities that have not been tested in the courts of every jurisdiction. Each person or entity who submits information to PDR Secure™ should make their own independent evaluation as to the risks involved in submitting information and what particular information to submit.

Can I submit a report without identifying myself?

You need to provide your identity, which will become part of the PSO database. You can select whether your identity can be shared or is to be kept confidential under the regulations governing the PSO, and PDR Secure’s policies and procedures.

• Will the "contract" one has to agree with, a 16-page document studded with legalese (download here, .doc format), inhibit voluntary EMR-related problem reporting?
  

Even with those questions in mind, I think this may be a net positive development. It would at the very least seem to lay to rest the deterministic notion (and/or marketing message) that this technology is harmless and entirely beneficent.

Will it be an effective way to help reform the health IT industry? Time will tell.

-- SS

Addendum 11/16/10:
See my initial concerns with the EMRevent report form at my followup post here.

Addendum 11/17/10:
Some answers to these questions can be found in a blog post at the site of Occam Practice Management at this link: http://www.occampm.com/blog/general/ehr-event-reporting/, whose author noted this HC Renewal post. My comments are at a post here.

"Living High Life on Money to Treat the Poor"

Here is another story that has developed over the last week about questionable goings on at a not-for-profit health care organization.  The organization in question this time was the not-for-profit, but state government supported Medicaid managed care organization/ health insurer for the Louisville, Kentucky region.  The details came from a Louisville (Kentucky) Courier-Journal article about a state auditor's report on the Passport Health Plan:

The organization providing Medicaid services in Jefferson and surrounding counties has spent lavishly on such things as travel, meals, salaries, bonuses and lobbying in recent years, the state auditor’s office said in a report released Tuesday.

The scathing report, which Gov. Steve Beshear described as 'disheartening,' said two Passport Health Plan officials — Executive Vice President Shannon Turner and Associate Vice President Nici Gaines — were paid well, ate well and traveled extensively.

'Lodgings were often luxury spas and resorts,' the report said. 'The executives used limousine services and dined at expensive restaurants. While these types of expenditures may be routine for many private, for-profit companies, they should not be typical in nonprofit, health care organizations.'

The report also said Passport made extraordinary efforts to burnish its public image and gain political support by spending $1 million since 2007 on lobbying and public relations, as well as $423,000 in donations and sponsorships.

Many of the donations had no connection with health care, the report said — including $600 to sponsor a reception for the Senate Republican majority in 2009, $10,000 to sponsor an 'inflatable character' for the Kentucky Derby Festival's Pegasus Parade, and contributions to the Boy Scouts, Kentucky Opera, Volunteers of America and others.

Here are some more specifics about amounts spent:

Travel: Passport spent $106,722 on more than 36 trips including trips to conferences at resorts in New Orleans, Key West, Las Vegas, Seattle, Philadelphia, Tucson, Washington and Coeur d'Alene, Idaho.
Meals: Spent $72,994 on 753 meals for groups large and small. These were mostly at Louisville restaurants but included tabs at some famous restaurants outside Kentucky, such as Emeril's and Commander's Palace in New Orleans.
Limo services: Five uses of limos totaling $3,996.
Lobbying and public relations: Spent $1 million.
Donations and sponsorships: Spent $423,000, some with no connection to health care, including $10,000 to be an “Inflatable Character Sponsor” for the Kentucky Derby Festival.
Gifts: Spent $9,311 for 95 gifts, which included flowers and Christmas gifts.
Salaries: Paid salary and bonuses of $303,750 to Executive Vice President Shannon Turner and $156, 000 to Associate Vice President Nici Gaines in most recent year.

Here are more specifics about conflicts of interest:

Conflicts of interest: Both Turner and Gaines received additional compensation in contracts with subcontractor they were overseeing, AmeriHealth Mercy. Also, Larry Cook, Passport's chairman and CEO, had divided loyalties because he serves as an executive vice president of U of L. He also was reimbursed $1,717 by AmeriHealth for expenses for a trip to Ireland in 2007.
Grants: Many grants were made by Passport to groups with ties to staff and/or board members

The organization also was charged with distributing additional funds to area health providers based on their initial investment in the not-for-profit managed care organization, but not on the amount of care they were providing to Medicaid patients:

[State Senator Tim] Shaughnessy was particularly concerned about distributions of $10 million in excess funds in late 2008 and again in and 2009 to the large Jefferson County health-care providers that formed Passport.

These distributions were reported to the Kentucky Department of Insurance as grants to cover indigent care costs incurred by Passport's provider partners — University Medical Center, University Physician Associates, Norton Healthcare, Jewish Hospital and St. Mary's Healthcare, and the Louisville/Jefferson County Primary Care Association.

But the auditor’s report said the money was distributed based on the percentage of the providers' initial investments to create Passport — not the amount of indigent care they provided. And the report said this money was placed in the general funds of these providers 'rather than specifically set aside for uncompensated indigent care.'

Finally, it appears that Passport tried to block disclosure of important information, including the compensation of its executives, even though it is a not-for-profit organization entirely funded by the government:

Early this year The Courier-Journal filed a request under the state open records law seeking Passport records on compensation of its executives and minutes of its board meetings. But Passport refused to release them, claiming that the law did not apply.

The attorney general's office disagreed, saying that Passport is 100 percent publicly funded and must release the records. But Passport again refused and took the matter to Jefferson Circuit Court, where it is pending.

So again we have the same tiresome features of leaders who apparently regard their organization as their own personal sandbox: lavish compensation, given the context, luxuries supplied the leadership out of organizational funds, conflicts of interest that apparently increased further the leaders' personal gains, and attempts to keep the whole thing secret. As a Lexington (Kentucky) Herald-Leader editorial ("Living High Life on Money to Treat the Poor") noted, given the mission of the organization, this sort of sleaze is particularly unfortunate:

In one way, though, Passport's profligacy deserves special condemnation. Every dollar Passport executives spent on their own pleasurable pursuits, on lobbying to insure tax money kept flowing their way, on buying goodwill in the Louisville area or on any other unnecessary expense was a dollar taken away from providing Medicaid services to the most vulnerable, needy members of society.

This case resembles one we discussed previously, that of the non-profit community health agency in Florida whose leaders again seemed to regard their job as an opportunity for personal enrichment.  It seems that even leaders of non-profit organizations whose mission is to help the needy may seem to put their own needs before those of their disadvantaged constituents.  Of course, given they may have seen leaders of not-for-profit universities and hospital systems making millions, and leaders of for-profit pharmaceutical, device, and especially managed care organizations/ health insurers making tens of millions, and conclude that their six-figure salaries and occasional luxuries were barely adequate compensation.

As we have noted before, the "executives take all" mentality of an era economically dominated by financiers as aristocrats seems to have infected health care.  Somehow we have to restore the idea that executives and managers  like doctors and nurses, should regard their work as calling meant to put the needs of patients and public health first, rather than a quick way to get rich. 

About to be Bought-Out Non-Profit Hospital System Tries to Hide Executives' Golden Parachutes

A report from FloridaToday (in Brevard County) about the sale of a not-for-profit Florida hospital system to a for-profit corporation raises some interesting questions. The background is that the non-profit Wuesthoff Health System was bought by for-profit Health Management Associates (HMA):

HMA, a for-profit hospital management company in Naples, bought the not-for-profit Wuesthoff Oct. 1 for $145 million. Wuesthoff lawyer William Kopit has said it was forced to sell because the hospital system lacked the capital to compete.

The question is about the conditions of the sale:

A foundation formed to manage the proceeds of the sale and continue providing indigent health care has refused to disclose the executive packages to the state, claiming it constitutes a trade-secret exemption under Florida law.

This was despite the state Attorney General's authority to oversee sales of charitable non-profit organizations to for-profit entities:

Under its statutory obligation to oversee charities registered in the state, the Attorney General's Office requested the executive pay information from Wuesthoff, Wiggins said. Wuesthoff's lawyers submitted 40 pages of heavily redacted material. Negotiations led to Wuesthoff agreeing to redact only the names and compensation details of the executives.

The materials submitted suggested a lot of executives getting golden parachutes, but not the amounts or conditions involved:

The unredacted portions show as many as eight former executives receiving three years of salary paid out over 12 months, a pay-to-stay retention bonus for continuing to work for the company during sale discussions, a senior executive retirement package and regular retirement pay and extended health benefits. Based on Wuesthoff's tax returns, those payouts will be in the millions.

So, legal action will ensue:

'Therefore we will look to the court for guidance and abide by any judicial ruling on the public record and trade secret issues,' said Ryan Wiggins, communications director for the attorney general.

The notion that how much a for-profit corporation will pay in golden parachutes to former executives of a not-for-profit hospital system is a "trade secret" just boggles the mind.  What could a competitor possibly gain from this information that could lead to specific action that would disadvantage Wuesthoff?

On the other hand, it might be that the size of these golden parachutes, if revealed, would lead to some raised eyebrows, or worse.  Consider first the contrast between payments made and to be made to fortunate executives and the performance of the health care system. 

Note that what is available on the public record (via the hospital system's latest available, that is, 2008 form 990 disclosures to the US Internal Revenue Service) suggests that in the past, Wuesthoff executives were already quite well-paid. On that form we found the following total compensation reported:
Emil Miller, President: $927,543 ($523,069. compensation; $342,130, benefits; $62,344, benefits)
Brian Bodi, Controller: $184,789
George Fayer, CFO: $439,580
Johnette Gindling, Senior Vice President: $236,975
Marchita Marino, Senior Vice President: $264,529

Nearly a million dollars was a lot of compensation for the CEO of a small, non-profit hospital system in 2007.  Although there is no easily publicly available information about executive compensation since 2007 (the year covered by the 2008 report noted above), these high rates of compensation were paid by a hospital system that now apparently has so little capital that it no longer can "compete" without being bought by a for-profit corporation.   Now the executives who could not amass a competitive amount of capital will amass quite a sizable amount of personal riches.

Consider second the contrast between the extraordinary assertion that these golden parachutes should remain secret, and the hospital system's stated interest in "transparency," or its stated devotion to "five core values that drive our hospital and its mission: integrity, courtesy, compassion, competence and stewardship." It seems that preventing embarrassment about executive enrichment may trump transparency and integrity.

Health care, probably infected by the finance industry that brought us the global financial collapse, aka "great recession," seems to have been overcome by "compensation madness."  A central value of many health care organizations seems to be enriching their top leaders/ managers/ executives, no matter what the financial condition of the organization, or the performance of the leaders in terms of fulfilling the organization's mission.  From these perverse incentives, the perverse incentives favoring short-term financial performance over patient care seem to have sprung.  As Prof Mintzberg wrote, "All this compensation madness is not about markets or talents or incentives, but rather about insiders hijacking established institutions for their personal benefit."

If we truly want health reform that addresses spiraling costs, declining access, and threatened quality of care, we need to give health care practitioners and leaders positive incentives for being caring, competent, well-informed, and honest, not for clever financial manipulation and short-term profits, or just for managing to show up for work.

ADDENDUM (2 December, 2010) - 4 days after the above post, Florida Today reported that details about the golden parachutes were released:

[Emil] Miller, who ran Wuesthoff for more than a decade, received $6.25 million total. Of that, $2.2 million was severance pay and $3.2 million was retirement pay. The balance was the cost of his employee benefits.

Former CFO George Fayer has the next highest exit pay at $973,000, which includes a $171,000 for staying through the sale and transition. Fayer is a consultant to the foundation, Gindling said.

Chantal LeConte, who ran the Rockledge hospital, received the third highest payout, $553,000. LeConte's package included about $138,000 for staying through the transition.

Given that the health system was merged out of existence because it supposedly no longer had enough capital to "compete," now we see why system leaders were so reluctant to reveal the amounts.