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Health IT Ddulites and Disregard for the Rights of Others

At my Feb. 8, 2012 post "<a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-irrational.html">Health IT: Ddulites and Irrational Exuberance</a> " I defined a "Ddulite" (Luddite with the first four characters reversed) as the opposite of a Luddite, specifically: <blockquote>Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures. </blockquote> An astute reader points out that "opposite" may be an incomplete description, as the <a href="http://en.wikipedia.org/wiki/Luddite">Luddites</a>: <blockquote>"were a social movement of 19th-century English textile artisans who protested – often by destroying mechanized looms – against the changes produced by the Industrial Revolution, which they felt were leaving them without work and changing their way of life. The movement was named after General Ned Ludd or King Ludd, a mythical figure who, like Robin Hood, was reputed to live in Sherwood Forest."</blockquote> In other words, they were merely trying to save their jobs, and their actions did not cause life-threatening adverse events, such as death by freezing due to lack of warm garments. Ddulites, on the other hand, ignore the downsides (patient harms) of health IT. This is despite being already aware of, or informed of patient harms, even by reputable sources such as <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">FDA</a> (Internal FDA memo on H-IT risks), <a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html">The Joint Commission</a> (Sentinel Events Alert on health IT), the <a href="http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009/0160182009specification.pdf">NHS</a> (Examples of potential harm presented by health software - Annex A starting at p. 38), and the <a href="http://hcrenewal.blogspot.com/2010/12/ecri-healthcare-it-in-top-ten-health.html">ECRI Institute</a> (Top ten healthcare technology risks), to name just a <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">few</a>. In fact, the hyper-enthusiastic health IT technophiles will go out of their way to incorrectly dismiss risk management-valuable case reports as "anecdotes" not worthy of consideration (see "Anecdotes and medicine" essay <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">at this link</a>). They will also make unsubstantiated, often hysterical-sounding claims that health IT systems are necessary to, or simply will "transform" (into what, exactly, is usually left a mystery) or even "revolutionize" medicine (whatever that means). This is despite the fact that many of this mindset are medical and/or Medical Informatics professionals who know better. They also ignore the draining waste of resources of failed or ineffectual IT ("<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">bad health IT</a>"), potentially depriving patients of the best healthcare possible. Thus, as the reader pointed out, there could be an element of <a href="http://en.wikipedia.org/wiki/Psychopathy">psychopathy</a> or, at best,<a href="http://definitions.uslegal.com/c/conduct-in-reckless-disregard/"></a> reckless disregard for rights of others in their thinking. <blockquote><a href="http://law.yourdictionary.com/reckless-disregard">Reckless disregard</a>: An act of proceeding to do something with a conscious awareness of danger, while ignoring any potential consequences of so doing. Reckless disregard, while not necessarily suggesting an intent to cause harm, is a harsher condition than ordinary negligence.</blockquote> In my opinion, at a time of mass funding and pressure for rapid rollout of health IT in its present state of experimental development, this is not an observation that should be casually dismissed. -- SS

Health IT Ddulites and Disregard for the Rights of Others

At my Feb. 8, 2012 post " Health IT: Ddulites and Irrational Exuberance " I defined a "Ddulite" (Luddite with the first...

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A Camel Through the Eye of a Needle - at Non-Profit Health Insurers

It is time to drag out that well-worn phrase,...  sometimes you just cannot make this stuff up.  Recently, the New York Post <a href="http://www.nypost.com/p/news/local/nonprofit_execs_healthy_wealthy_UhdbNKvMXTqbBIhLjrZ4yO">reported</a> about executive compensation at some non-profit health maintenance organizations/ health insurance companies in New York.  To wit, FidelisCare <blockquote>At one Catholic-run health insurer for the needy, charity starts in the executive suite. Mark Lane, the CEO of the Fidelis Care/New York State Catholic Health Plan, receives a $1.1 million salary plus another $864,000 in retirement pension and other benefits, The Post has learned. His total compensation comes to nearly $2 million. Fidelis is a tax-exempt, not-for-profit HMO serving 750,000 patients throughout the city and state who mostly qualify for Medicaid, the public insurance program for the needy. That means nearly all of Fidelis’ revenues come from taxpayers. Meanwhile Fidelis’ executive vice president and chief operating officer, the Rev. Patrick Frawley, an ordained Catholic priest, is paid $587,249. Frawley received more than $900,000 in other retirement and deferred benefits — raising his total compensation to $1.54 million, according to IRS filings. That’s a lot of pennies from heaven. 'It’s shocking to me,' said a source familiar with Catholic health charities.</blockquote>Amazingly, the justification that was trotted out in this case was just of the "our CEO is brilliant" variety, but in this case, provided by a Bishop: <blockquote>Fidelis defended the salaries of its top officers, who oversee a $3 billion operation. Bishop Joseph Sullivan, a member of Fidelis’ board of trustees who formerly served as chairman, called the compensation 'generous but fair.' He said the goal is for salaries to be at the '75th percentile' of rivals. “Our ability to continue to grow is based on the quality of leadership. You get what you pay for. Lane and Father Frawley are worth every penny,” Sullivan said. Fidelis also issued a statement explaining that Frawley, after serving in pastoral roles for 25 years, was granted release from his priestly assignment to pursue a career in health care.</blockquote> So much for a vow of poverty, even at a non-profit providing health care mainly to the poor. EmblemHealth On the other hand, executives of secular, but still non-profit health insurers do even better, <blockquote>Anthony Watson, CEO of EmblemHealth, gets a compensation package of $8.5 million — about half in salary and bonuses and the rest in retirement and deferred benefits, according to IRS filings. Two other EmblemHealth executives also snagged multimillion-dollar compensation packages.</blockquote>Summary We have <a href="http://hcrenewal.blogspot.com/2011/10/peer-benchmarking-lake-wobegone-effect.html">noted before </a>how the "peer benchmarking process," setting executive (but not necessarily other) compensation based on a comparison with compensation at other, often highly selected organizations, coupled with the "Lake Wobegone Effect," the belief that one's own executives are always above average, will lead to inexorable rises in executive pay, regardless of performance, or whatever else is going on in the world. The Bishop's assertion that Fidelis' executive compensation should be at the seventy-fifth percentile, because of the "quality of leadership," not further described, is a perfect example of these phenomena. It is striking to see these phenomena at a non-profit organization whose <a href="http://www.fideliscare.org/aboutus/index.aspx">mission</a> is: <blockquote>to ensure that every resident, regardless of income, age, religion, gender, or ethnic background, has access to quality health care, provided with dignity and respect.</blockquote> So, ad infinitum, I repeat.... 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.

A Camel Through the Eye of a Needle - at Non-Profit Health Insurers

It is time to drag out that well-worn phrase,... sometimes you just cannot make this stuff up. Recently, the New York Post reported about...

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The Bloat Continues: More Tales of Non-Profit Hospital Executive Compensation

While unemployment remains high, and mortgage foreclosures continue in the US, nothing seems to stop the rise of health care costs, lead by compensation for top health care leaders. So, it is time once again for a round-up of inflated executive compensation at non-profit and government hospital systems.  We will describe the bloat in order of the appearance of the information in public. Cincinnati The December, 2011, the Cincinnati Business Courier <a href="http://www.bizjournals.com/cincinnati/feature/datacenter-hospital-executive.html">tabulated </a>the pay of the best compensated hospital employees, and discussed the results in an <a href="http://www.bizjournals.com/cincinnati/blog/2011/12/in-hospitals-its-not-just-ceos.html">accompanying article</a>.  By my count, 19 local hospital employees made more than $1 million in 2010.  These included 6 system CEO, 4 division CEOs, 5 chief level executives or vice presidents, 1 clinical department chair, and 3 doctors.  The top compensation went to Kenneth Hanover, CEO of Health Alliance/ UC Health, $2,799,338. Three others made more than $2 million. Western New York In January, 2012, Buffalo Business First <a href="http://www.bizjournals.com/buffalo/news/2012/01/23/four-hospital-execs-earn-more-than-1.html">reported</a>: <blockquote>The top hospital administrators in Western New York took home more than $53 million in compensation during 2010, with four executives earning $1 million-plus paydays. Hospital presidents and chief executives at the region’s two largest health systems were among the top earners, with James Kaskie, president and CEO of Kaleida Health , earning $2.36 million; and Joseph McDonald, president and CEO at Catholic Health , earning nearly $1.1 million. Kaskie’s compensation, as well as Kaleida executives Connie Vari, Robert Nolan and Margaret Paroski, included a deferred retirement plan payout. All four were among the top five earners for 2010, the most recent year for which complete data is available.</blockquote> The life of a top hospital executive near Buffalo was not quite as plush as in Cincinnati. Only 4 made more than $1 million, including the CEO, Chief Medical Officer/ Executive Vice President, and Chief Operating Officer of Kaleida Health, and the CEO of Catholic Health System. Eleven more executives got more than $500,000. North Carolina It was a very good year for executives from some of the state's biggest health care systems, per a February, 2012 <a href="http://www.charlotteobserver.com/2012/02/01/2974848/chs-paid-its-ceo-42m.html">article in the Charlotte Observer</a>. <blockquote>Carolinas HealthCare System paid its CEO $4.2 million in 2011, $523,000 more than the year before, as the system celebrated a profitable year and met all of its systemwide goals, according to hospital officials. Chief Executive Officer Michael Tarwater, 58, who has led the $6 billion public hospital system for 10 years, received a base salary of about $1 million, two bonuses totaling $2.5 million, and other compensation, including retirement and health benefits, of about $700,000. That represents a 9 percent increase in base salary and a 14 percent overall increase compared to 2010, when Tarwater's salary was $986,172 and total compensation was $3.7 million.</blockquote> Meanwhile, at Novant Health, <blockquote>The most recent compensation figures for Novant executives are from 2010. In that year, Novant's CEO Paul Wiles, 64, received total compensation of $3.2 million, including his salary of $1 million, a bonus of about $837,000, and $1.37 million in other income, including retirement and health benefits. Wiles retired at the end of 2011 and was succeeded by Carl Armato, who was previously chief operating officer for Novant.</blockquote> A data table within the article showed that there were 10 employees, all executives, at Carolinas Healthcare System in 2011, and 6, again all executives, at Novant Health in 2010, who got more than $1 million in compensation. Why did the Carolinas CEO warrant a multi-million dollar pay package? One of his employees endeavored to explain, <blockquote>'We've had extremely good performance,' said Debra Plousha Moore, the system's chief of human resources. 'All performance goals this year were either met or exceeded.'</blockquote>Why the credit for that performance should not be spread amongst more hospital employees, especially those who actually took care of patients, she did not explain. Northern New York City Suburbs In February, 2012, LoHud.com <a href="http://www.lohud.com/article/20120212/NEWS02/302120060/Business-Medicine-Part-2-Eight-local-hospital-officials-got-1M-2010">reported</a>: <blockquote>Eight executives from 15 Lower Hudson Valley hospitals received more than $1 million in salary, bonuses, benefits and other pay in 2010 at a time when the state struggled to control health-care costs.</blockquote> The details included: <blockquote>Three executives received more in total compensation than Westchester Medical Center CEO Michael Israel, who earned $1.3 million and oversees a hospital that’s more than twice the size of other facilities in the region.</blockquote> Also, <blockquote>The highest-paid hospital employees include White Plains Hospital CEO Jon Schandler with $1.6 million in total compensation, Dr. Edward Lundy at Good Samaritan Hospital in Suffern with $1.48 million and Edward Dinan, CEO of Lawrence Hospital in Bronxville, with $1.41 million. Others in the million-dollar range include John Federspiel, president of Hudson Valley Hospital Center in Cortlandt; Joel Seligman, CEO of Northern Westchester Hospital in Mount Kisco; and Keith Safian, CEO of Phelps Memorial Hospital Center in Sleepy Hollow. A year earlier, Federspiel received a compensation package of nearly $2 million due partly to an $800,000 deferred compensation payout. The average CEO compensation rose 13 percent from 2009, to $939,751. Ten hospitals paid $7.7 million in bonuses to top executives, an increase of 15 percent over 2009. White Plains Hospital alone distributed $2.1 million in bonuses, including $650,000 to Dr. Jesus Jaile-Marti, chief of neonatology, and $575,000 to Schandler.</blockquote> This article highlighted the contrast between compensation for executives and for employees who provide front line care: <blockquote>The high salaries also come as hospitals pressure many employees for wage freezes, rising insurance costs and watered-down pensions, said Deborah Elliott, a nurse and deputy executive officer of the New York State Nurses Association, a statewide union representing nurses at Sound Shore, Mount Vernon, St. John’s Riverside, St. Joseph’s and Nyack hospitals as well as Westchester Medical Center. 'It never ceases to amaze me that we sit at the bargaining table with these executives who are making $1 million and they give us such a hard time about a half-percent increase for a nurse who is making $63,000,' Elliott said. 'It’s galling.'</blockquote>Again, contrast that one half percent with the average chief executive increase of 13%. While it is a rare hospital that would disparage the performance of its dedicated nurses and physicians, somehow executive talent seems to matter more. For example, here is how Hudson Valley Hospital Center president John Federspiel's compensation was justified by his board chair: <blockquote>Edward B. MacDonald Jr., chairman of Hudson Valley Hospital Center’s board of directors, said Federspiel deserves his paycheck. The hospital has earned a profit for 22 of the 25 years that Federspiel has been at the helm and has expanded both its services and payroll in that time, he said. 'He’s the best administrator, planner and motivator I have ever had the privilege to work with,' MacDonald said. 'I wish I could pay him more.'</blockquote>Again, why the CEO, but not the nurses and doctors deserves the credit for the hospital's performance was not stated. Summary It all gets so tedious, doesn't it? CEOs of all but the smallest non-profit hospitals now seem entitled to at least $1 million a year. At larger systems, multiple executives per system seem entitled to that level of compensation, and CEOs may get multiple millions a year. Yet these are ostensibly non-profit organizations dedicated or providing care to their communities, and often to serving the poor. Thus the health care bubble continues to inflate, and executives are ever more distracted by money, and seem less focused on mission. Note that reporting of this ever rising compensation seems to be becoming more perfunctory as the results seem more routine (and tedious). Two of the four articles noted above did not provide any justifications for the high pay, while two only trotted out brief versions of the "our CEO is so brilliant" meme. As I <a href="http://hcrenewal.blogspot.com/2011/12/more-tales-of-hospital-ceo-compensation.html">said in December</a>, in a health care system with ever rising costs, declining access, and stagnant quality, we no longer can tolerate the perverse incentives generated by unaccountably 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 repetitions 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.

The Bloat Continues: More Tales of Non-Profit Hospital Executive Compensation

While unemployment remains high, and mortgage foreclosures continue in the US, nothing seems to stop the rise of health care costs, lead by ...

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Generic Leadership Fine for EHR Implementation in High Acuity, High Risk Areas Such as an Emergency Department?

At my Feb. 16, 2012 post "<a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html">Hospitals and Doctors Use Health IT at Their Own Risk - Even if 'Certified'</a>" I established that buyers and users of EHR systems do so at their own risk with regard to implementation problems or outright defects resulting in patient harm. As I've also written at my April 2011 post "<a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">FDA Decides Regulating Implantable Defibrillator Medical Devices a Political Hot Potato; Demurs</a>", FDA has admitted health IT is a medical device that they shy away from regulating because it's politically expedient not to do so. (The area is a "hot potato" per the Director of FDA's <a href="http://www.fda.gov/MedicalDevices/default.htm">CDRH</a>, the Center for Devices and Radiological Health, so FDA stays away.) Yet FDA knows of the stakes. As I observed at my Aug. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks</a>" and elsewhere, patient harm is occurring due to these devices and FDA is aware. Due to admitted impediments to information diffusion, however, even FDA, IOM, The Joint Commission (due to a "dearth of data" as in their 2008 <a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html">Sentinel Events Alert On Healthcare IT</a>) and others do not know the true magnitude of the problem. From the FDA internal memo at the preceding FDA memorandum link: <blockquote> Limitations of the MAUDE [<a style="font-weight: bold;" href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM">Manufacturer and User Facility Device Experience database</a>] search and final subset of Medical Device Reports (MDRs) include the following: 1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including ... (a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues; ... (b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue; ... (c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports. 2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events. 3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device. 4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports. 5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting. ... The results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs and impedes a more comprehensive understanding of the actual problems and implications. </blockquote> Finally, as I pointed out in my Dec. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html">ONC Defines a Taxonomy of Robust Healthcare IT Leadership</a>", the Office of the National Coordinator for Health IT at HHS (ONC) had published the following with regard to the qualification of those who could "lead the successful deployment and use of health IT to achieve transformational improvement in the quality, safety, outcomes, and thus in the value, of health services in the United States": <blockquote>Clinician/Public Health Leader: By combining formal clinical or public health training with training in health IT, individuals in this role will be able to lead the successful deployment and use of health IT to achieve transformational improvement in the quality, safety, outcomes, and thus in the value, of health services in the United States. In the health care provider settings, this role may be currently expressed through job titles such as Chief Medical Information Officer (CMIO), Chief Nursing Informatics Officer (CNIO). In public health agencies, this role may be currently expressed through job titles such as Chief Information or Chief Informatics Officer. Training appropriate to this role will require at least one year of study leading to a university-issued certificate or master’s degree in health informatics or health IT, as a complement to the individual’s prior clinical or public health academic training. For this role, the entering trainees may be physicians or other clinical professionals (e.g. advanced-practice nurses, physician assistants) or hold a master’s or doctoral degree(s) in public health or related health field. Individuals could also enter this training while enrolled in programs leading directly to degrees qualifying them to practice as physicians or other clinical professionals, or to master’s or doctoral degrees in public health or related fields (such as epidemiology). Thus, individuals could be supported for training if they already hold or if they are currently enrolled in courses of study leading to physician, other clinical professional, or public-health professional degrees.</blockquote> Here, though, is a more typical reality in today's hospitals, the background of an EHR deployment leader in one of the most risk-prone and difficult environments in healthcare, the Emergency Department (ED) in a large hospital of which I am aware: <div dir="ltr"></div><blockquote><div style="font-weight: bold;" dir="ltr">Clinical Systems Analyst </div> <div style="font-weight: bold;" dir="ltr">January 2004 – Present</div> <div dir="ltr">Project manager for implementation of an ED EHR [vendor name redacted] Responsible for all aspects of implementation including build and process design, report build, testing, training, and go-live support. Extensive knowledge ADT processes, HL7, and CPOE. Manage software patches and upgrades. Experience in HTML, SQL and SAP. </div> <div dir="ltr"> </div> <div dir="ltr">Financial Systems Analyst November 2001 – January 2004 </div> <div dir="ltr">Project Team Lead for implementation of Patient Accounting system. Responsible for system development and system build, training, testing, and reporting. </div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> Education </div> <div dir="ltr"> [Regional university in the lower 50% of US News rankings in the region, name redacted] B.S., Management Information Systems 2000 – 2003 </div> <div dir="ltr"> </div> <div dir="ltr"> [Name redacted] Community College </div> <div dir="ltr">Associates Degree, Business Administration</div> </blockquote><div dir="ltr"></div> <div dir="ltr"> So, ED physicians (with many years of doctoral and post-doctoral training and experience, boards testing their competence, etc.) may be placing the lives of patients and their careers in the hands of: <ul><li> An experimental medical device, </li><li>unregulated by anyone, </li><li>in a field whose qualifications for leadership are unregulated by anyone, </li><li>devices known to be risky, </li><li>but without anyone knowing the magnitude of that risk, </li><li>whose implementation is led by a generic 'clinical' systems analyst "responsible for all aspects of implementation" with a Bachelor's degree in MIS from a second-tier institution, an Associates degree from a community college, and no medical or Medical Informatics education or experience whatsoever.</li></ul> Further, that project lead jumped from financial systems analyst to 'clinical' analyst/leader of an ED EHR implementation. One should also ask <ul><li>Who was the hiring manager who hired such a person and put them in the role?</li><li>On what credentials and experience was the decision based? </li><li>What were the hiring manager's own credentials? </li></ul> I leave it to the reader to decide if this is an appropriate arrangement, and if they would place their trust in an ED whose activities center around a cybernetic system implemented in this manner. -- SS Feb. 17, 2012 Addendum: At least in this case the person has degrees. Per several prominent healthcare IT recruiters in the past in the article "Who's Growing CIO's" in the journal Healthcare Informatics, as mentioned at my Sept. 2009 post "<a href="http://hcrenewal.blogspot.com/2008/09/correcting-historical-misinformation.html">Correcting historical information from the recruiter component of the Health IT Ecosystem</a>", the School of Hard Knocks was plenty good for health IT leadership roles: <blockquote>I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman.</blockquote> -- SS </div>

Generic Leadership Fine for EHR Implementation in High Acuity, High Risk Areas Such as an Emergency Department?

At my Feb. 16, 2012 post " Hospitals and Doctors Use Health IT at Their Own Risk - Even if 'Certified' " I established tha...

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Hospitals and Doctors Use Health IT at Their Own Risk - Even if "Certified"

Due to my observations of confusion about health IT certification [1], and due to vague or incomplete seller language that could be misinterpreted by buyers (perhaps by design), I recently asked several ONC-ATCBs (HHS's Office of the National Coordinator for Health IT-Authorized Testing and Certification Bodies) the following. I sent this question via email to their "questions" email addresses: <blockquote>"Is EHR certification by an ATCB a certification of EHR safety, effectiveness, and a legal indemnification, i.e., certifying freedom from liability for EHR use of clinical users or organizations? Or does it signify less than that?"</blockquote> One ONC-ATCB provided the following in response to my request for information. <div style="margin-left: 40px;">From: Trivedi, Amit V (ICSA Labs) Sent: Thursday, February 16, 2012 11:22 AM To: Scot Silverstein Subject: RE: Form submission from: Contact Us Hello Scot, Thanks for your email. Certification by an ATCB signifies that the product or system tested has the capabilities to meet specific criteria published by NIST and approved by the Office of the National Coordinator. In this case the criteria are designed to support providers and hospitals achieve "Meaningful Use." A subset of the criteria deal with the security and patient privacy capabilities of the system. Here is a list of the specific criteria involved in our testing: <a href="http://healthcare.nist.gov/use_testing/effective_requirements.html" target="_blank">http://healthcare.nist.gov/use_testing/effective_requirements.html</a> In a nutshell, ONC-ATCB Certification deals with testing the capabilities of a system, some of them relate to patient safety, privacy and security functions (audit logging, encryption, emergency access, etc.). What was suggested in the email below (freedom from liability for users of the system, etc.) would be out of scope for ONC-ATCB testing based on the given criteria. [I.e., certification criteria - ed.] I hope that helps to answer your question. Thanks, Amit Amit Trivedi Program Manager - Healthcare ICSA Labs, an Independent Division of Verizon Business</div> Mar. 5, 2012 Addendum:  I also received a response from another ONC-ATCB, the Drummond Group: <blockquote>From: Joani Hughes (Drummond Group) Sent: Monday, March 05, 2012 1:06 PM To: Scot Silverstein Subject: RE: EHR certification question Per our testing team: It is less than that. It does not address indemnification although a certification could be used as a conditional part of some other form of indemnification function, such as a waiver or TOA, but that is ultimately out of the scope of the certification itself. Certification in this sense is an assurance that the EHR functions in way that could enable an eligible provider or eligible hospital to meet the CMS requirements of Meaningful Use Stage 1. Or to restate it more directly, CMS is expecting eligible providers or eligible hospitals to use their EHR in “meaningful way” quantified by various quantitative measure metrics and eligible providers or eligible hospitals can only be assured they can do this if they obtain a certified EHR technology. Please let me know if you have any questions. Thank you, Joani. Joani Hughes Client Services Coordinator Drummond Group Inc.</blockquote> These are direct and clear statements. My question was certainly answered. ONC cerification is not a safety validation, such as in a document from NASA on aerospace software safety certification, "<a href="http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf">Certification Processes for Safety-Critical and Mission-Critical Aerospace Software</a>" (PDF) which specifies at pg. 6-7: <blockquote>In order to meet most regulatory guidelines, developers must build a safety case as a means of documenting the safety justification of a system. The safety case is a record of all safety activities associated with a system throughout its life. Items contained in a safety case include the following: • Description of the system/software • Evidence of competence of personnel involved in development of safety-critical software and any safety activity • Specification of safety requirements • Results of hazard and risk analysis • Details of risk reduction techniques employed • Results of design analysis showing that the system design meets all required safety targets • Verification and validation strategy • Results of all verification and validation activities • Records of safety reviews • Records of any incidents which occur throughout the life of the system • Records of all changes to the system and justification of its continued safety </blockquote> Health IT testing conspicuously lacks attention to most of the aerospace software safety points above. I note that there appears to be no reasonable excuse for such omissions. IOM has recently studied the issue of HIT safety. IOM states in a Nov. 2011 report that HIT safety and safety testing is unsatisfactory, and has recommended HHS study it as well. IOM recommends HHS annually re-evaluate whether regulation is needed to improve safety, although IOM favors industry self-policing [2]. Thus, buyers and users of even "ONC certified" health IT are not indemnified from liability due to medical errors or problems caused by the health IT. Sellers who exaggerate the value of certification or imply its meaning is akin to FDA device approval, likewise, could be faulted for making false representations about their products. It would appear the sellers could potentially be sued for doing so by purchasers/users who themselves get into legal hot water due to EHR defects or other problems. -- SS Note: [1] I believe confusion about EHR "certification" is in part due to the term itself. I raised objections to this term when it was first proposed based on my experience in pharma, suggesting what I felt was the more accurate expression "features qualification" instead. [2] "Health IT and Patient Safety: Building Safer Systems for Better Care", Institute of Medicine of the National Academies, Nov. 2011, <a href="http://www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx">http://www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx</a>

Hospitals and Doctors Use Health IT at Their Own Risk - Even if "Certified"

Due to my observations of confusion about health IT certification [1] , and due to vague or incomplete seller language that could be misint...

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Logical Fallacies in Defense of Conflicts of Interest Employed by a Leader of Academic Medicine

We have repeatedly discussed the adverse effects of conflicts of interest on health care.  Recently, I <a href="http://hcrenewal.blogspot.com/2012/02/texas-tmap-trials-as-illustration-of.html">argued</a> that the most pernicious are conflicts of interest created as an incentive for trusted health care leaders, usually respected health care professionals or academics, to promote the vested interests of those who pay them, in the guise of the leaders' professional roles.  In this capacity, the leaders are often dubbed "key opinion leaders" by those who employ them, but may be regarded as mere "salesmen" by the corporate personnel who recruit them. (See posts <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">here</a>)  These relationships may be hidden, often behind confidentiality agreements, unless revealed by litigation.  Documents revealed by discovery in legal actions showed how companies planned other organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">here</a> about marketing of Lexapro, and <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a> about Neurontin). However, defenses of conflicts of interest continue to appear regularly.  The latest example, which incorporates an important twist, appeared <a href="http://online.wsj.com/article/SB10001424052970203686204577116374283814362.html">in yesterday's Wall Street Journal</a>.  It was in the form of a "Boss Talk"  interview with a leader of a major health care organization (whose identity we will discuss later.) The title of the interview indicated that the interviewee was not "worried about industry ties" of academia or of health care professionals.  Conflicts of interest were clearly its main focus.  For example, it began, <blockquote>Many universities are wringing their hands over the increasing coziness of medical schools and their corporate partners.</blockquote> Then it stated that the interviewee: <blockquote>has no such qualms.</blockquote> The defense of this lack of qualms was heavily based on logical fallacies. Biased Sample or Hasty Generalization The main reason for this lack of concern appeared to be complete disregard of the more serious kinds of conflict of interest briefly described above. The interviewer asked: <blockquote>What are the trickiest conflicts of interest to navigate?</blockquote> The answer was: <blockquote>Surgery is particularly challenging. Let's say you're a physician and you come up with a new hip replacement. You invented it so you're going to make a lot of money. But if you're going to do my surgery, I want you to put in the device you think is best. How do you separate that, when the person is the inventor and the great technician?</blockquote>This may be tricky, but is arguably not the most tricky kind of conflict of interest. The trickier example of the key opinion leader hired as a salesman was not raised by the interviewer or the interviewee. Such a case was graphically revealed by testimony of the aborted TMAP trial which implicated the former state mental health director as hired by Johnson and Johnson subsidiary Janssen to "promote Risperdal as a safe and effective medication." (See <a href="http://hcrenewal.blogspot.com/2012/02/texas-tmap-trials-as-illustration-of.html">this post</a>.) Industry spokespeople and key opinion leaders themselves tout KOLs as clinical, educational, and/or scientific experts chosen for their expertise to advance medicine, science and public health.  There have been  documented instances (e.g., see posts <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">here</a>) in which defectors from marketing departments of commercial health care corporations described KOLs as salespeople who could be more influential hidden within their professional or academic cloaks.  Even some physicians paid to be speakers on behalf of pharmaceutical corporations have acknowledged their role as salespeople in fancy dress (see post <a href="http://hcrenewal.blogspot.com/2010/11/of-drug-talks-deception-and-denial.html">here</a>).  There are cases of documents revealed by discovery in legal actions that show how companies planned organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">here</a> about marketing of Lexapro, and <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a> about Neurontin). Perhaps the interviewee was unaware of these issues.  Whether due to ignorance or deliberate avoidance, failing to consider the full spectrum of conflicts of interest, and specifically ignoring those with the greatest likelihood of adverse effects, appears to be a logical fallacy in this instance.  If deliberate, it appears to be reasoning from an (intentionally) <a href="http://www.nizkor.org/features/fallacies/biased-sample.html">biased sample</a>, if not, it appears to be a <a href="http://www.nizkor.org/features/fallacies/hasty-generalization.html">hasty generalization</a>. The interview also included a few other choice logical fallacies that went unchallenged by the interviewer. False Dilemma The interviewer asked: <blockquote>What do you tell professors who won't work with drug or biotech companies?</blockquote> The response was: <blockquote>I think that's a huge mistake. If you're a professor now, and you want to get your discovery to society, you either need to start a company or work with a company to commercialize a product.</blockquote> Of course, in the "good old days," academic researchers got their "discoveries to society" simply by publishing them. Developing and marketing products based on their discoveries, while worthwhile undertakings in their own rights, were not considered part of the academic mission. Professors could still do this, if their goal was not to get rich. Yet the Bayh-Dole act allowed academic institutions to make money from their professors' discoveries, and the rush to commercialize the university has been on ever since. So while professors and academic institutions who are motivated mainly by money might not consider just putting the knowledge they discover in the public domain, that course remains possible, just not so lucrative. The assertion that the only way to get a "discovery to society" is to start or work with a company is simply false, and using this assertion in an argument appears to be an example of a <a href="http://www.nizkor.org/features/fallacies/false-dilemma.html">false dilemma</a>. Straw Man The interviewee worked another argument into the same paragraph: <blockquote>When professors have told me they won't work with companies anymore because they feel they'll have this scarlet letter, I think: 'Wouldn't that be sad if all the best scientists and clinicians won't work with companies because the public has said they're evil?'</blockquote> I doubt that any of even the most vociferous critics of the conflicts of interest that now befog health care have claimed that those involved are evil, much less that they are have successfully convinced the whole public at large that anyone who "works with companies" is evil. Implying that this would be the result of criticism of conflicts of interest does not appear to be supported by evidence, and is probably flat wrong. Asserting it here appears to be an example of the <a href="http://www.nizkor.org/features/fallacies/straw-man.html">straw man fallacy</a>. Summary So the Wall Street Journal has added to our collection of defenses of conflicts of interest that seem mainly to be based on logical fallacies.  We have noted that logical fallacies are increasingly deployed to defend the status quo in health care, and particularly to defend the interests of those who are profiting the most from the current dysfunctional system.  We have noted that several defenses of the conflicts of interest generated by financial relationships between physicians and medical academics on one hand and commercial health care firms on the other, were based on logical fallacies.  (See examples <a href="http://hcrenewal.blogspot.com/2011/03/once-more-with-feeling-another-defense.html">here</a>, <a href="http://hcrenewal.blogspot.com/2010/11/there-you-go-again-richard-epstein-says.html">here</a>,  <a href="http://hcrenewal.blogspot.com/2009/09/latest-version-of-argument-that-we-are.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2011/09/using-logical-fallacies-to-scold.html">here</a>.)  I have yet to see a coherent, logical, fact-based argument that the benefits for patients' and the public's health of physicians and medical academics working part-time as consultants, advisers, speakers, and directors of health care corporations outweigh the obvious risks of biasing medical decision making, education and research in favor of vested interests. In 2011, I <a href="http://hcrenewal.blogspot.com/2011/09/using-logical-fallacies-to-scold.html">noted</a>, "I have also yet to see an argument in favor of conflicts of interest made by anyone who does not have such conflicts."At least, however, up to that point I had not noted any such arguments made by people who had much power to enforce their views, as opposed to the ability to just express them.  The interview discussed above, however, was a person who has such power. The interview was with Dr Susan Desmond-Hellmann, the relatively new Chancellor of the University of California- San Francisco, who was just <a href="http://www.fiercebiotech.com/special-reports/25-most-influential-people-biopharma-today/susan-desmond-hellmann-25-most-influentia">named</a> one of the "25 most influential people in biopharma."  She has recently been advocating a change of direction towards commercialization for her campus, one of the most prestigious health care oriented universities/ academic medical centers in the country.  She previously justified this redirection again using logical fallacies (look <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">here</a>).  She also appears to yet another advocate for conflicts of interest who has her own conflicts.  As we noted <a href="http://hcrenewal.blogspot.com/2009/05/bio-tech-u.html">here</a>, Dr Desmond-Hellmann had little academic experience before she became Chancellor, but had worked her way up in the corporate pharmaceutical world, leaving her position as President for drug development at Genentech after it was taken over by Roche.  As we <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">noted previously</a>, even after that, Dr Desmond-Hellmann apparently has not completely left the corporate world. - A <a href="http://www.athletepromotions.com/celebrity/Susan-Desmond-Hellmann-appearance-booking-agent.php">web-site</a> for a speakers' bureau in which she apparently still participates lists her as a current "Advisor of Genentech since April 2009." - In 2010, Dr Desmond-Hellmann joined the board of directors of Procter and Gamble, a company which makes many health related products, although it sold its global pharmaceutical business. Last year, the company made an agreement with Teva to market over-the counter medications (see<a href="http://www.reuters.com/article/2011/11/03/teva-pg-idUSN1E7A20BZ20111103"> this Reuters article</a>). Note that she got this position despite apparently not having any prior personal investment in P&G stock. However, per the company's <a href="http://www.pg.com/en_US/downloads/investors/annual_reports/2011/PG_2011_Proxy.pdf">2011 proxy statement</a>, she appears to be in line to collect over $250,000 a year in compensation for this position. It does not seem impossible that these ongoing commercial interests may influence how she acts in her role as Chancellor.  Yet while it may be unsurprising, it is very disappointing that conflicts of interest are now being uncritically and illogically publicly defended by people in positions to exert so much influence on health care. The noted cognitive psychologists George Loewenstein, Sunita Sah, and Daylian Cain just asserted in JAMA [Loewenstein G, Sah S, Cain DM. The unintended consequences of conflict of interest disclosure. JAMA 2012; 307: 669-670. Link <a href="http://jama.ama-assn.org/cgi/content/extract/307/7/669?etoc">here</a>.] <blockquote>Conflicts of interest, including fee-for-service arrangements, are at the heart of the astronomical increases in health care costs in the United States, and transparency is not substitute for more substantive reform.</blockquote> True health care reform requires such substantive reform of the financial arrangements among corporations that sell health care services or products and health care professionals and others who make decisions about patients' or the public's health. To decide how to accomplish such reform, we need a better discussion informed by logic and evidence, sans logical fallacies. Those who lead health care ought to be able to participate in this discussion under these conditions.

Logical Fallacies in Defense of Conflicts of Interest Employed by a Leader of Academic Medicine

We have repeatedly discussed the adverse effects of conflicts of interest on health care. Recently, I argued that the most pernicious are ...

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Congressman Darrell Issa: FDA's email monitoring of "whistleblowers" communicating with Congress was illegal

In followup to my post of Jan. 30, 2012 "<a href="http://hcrenewal.blogspot.com/2012/01/can-you-sue-government-fda.html">Can You Sue the Government? FDA Whistleblowers Sue Over Surveillance of Personal e-Mail</a>" I provide a link to a probing letter from Darrell Issa, Chairman, US House of Representatives Committee on Oversight and Government Reform to Margaret Hamburg MD, Commissioner of the FDA. The letter raises the issue that FDA's email monitoring of "whistleblowers" communicating with Congress was illegal ("unlawful, and will not be tolerated"), and the illegality was further compounded by harassment and retaliation against the "whistleblowers." Many probing "who? why? when?" questions are asked of FDA. I do not have free text of this letter, just a link to images of the letter. I cannot post the text (no access to OCR of a PDF at the moment), but the letter images are here: <a href="http://www.whistleblowers.org/storage/whistleblowers/documents/FDAComplaint/issaletter.fdaspying.pdf">http://www.whistleblowers.org/storage/whistleblowers/documents/FDAComplaint/issaletter.fdaspying.pdf</a> Worth reading in its entirety. -- SS

Congressman Darrell Issa: FDA's email monitoring of "whistleblowers" communicating with Congress was illegal

In followup to my post of Jan. 30, 2012 " Can You Sue the Government? FDA Whistleblowers Sue Over Surveillance of Personal e-Mail ...

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