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EHRevent.org and "The National Database of EHR Errors Being Called For" - Where's the Beef?

At my Nov. 2011 posts on a new entity called "EHRevent.org" that is supposed to be a health IT industry watchdog, I expressed various forms of skepticism. See my Nov. 2010 posts at the following HC Renewal links: <blockquote> November 15, 2010: <a name="5203906860886106791"></a><a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2010/11/ehreventorg-web-site-to-collect-ehr_15.html">EHRevent.org: Web Site to Collect EHR Safety Reports </a> November 16, 2010: <a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2010/11/emrevent-survey-amateurism-bias-or.html">EHRevent: survey amateurism, bias, or something else?</a> November 17, 2010: <a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2010/11/some-answers-about-ehreventorg-for.html">Some answers about new site "EHRevent.org" for health IT and drug adverse event reporting</a> November 22, 2010: <a href="http://hcrenewal.blogspot.com/2010/11/ehreventorg-ceo-edward-fotsch-md-real.html">EHRevent.org CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error? </a></blockquote> Now, approximately eight months later, I read this in the July 2011 EHREvent newsletter <a href="http://hosted.verticalresponse.com/250140/435a3185f3/1244020649/669c663396/">at this link</a>, written by Michael Victoroff, MD, Editor in Chief: <blockquote>... The media has drawn our attention to the case of Genesis Burkett, a newborn who recently died in a Chicago hospital when an order for intravenous fluids was incorrectly transcribed by a pharmacy technician. Some journalists have characterized this a “computer error” because the ordering physician entered the order (correctly) into an electronic system, and the pharmacy tech re-entered the order (incorrectly) into an automated compounding machine. [If so, perhaps one should wonder how <a href="http://www.tinyurl.com/hostileuserexper">mission hostile</a> - see link - the user experience of that compounding machine might have been, which could have contributed to or caused the error - ed.] Moreover, a decision support system that should have alerted at the mistake had been disabled. [Disabled by whom, exactly, and why? Perhaps because it, too, was ill conceived and user hostile? - ed.] This case has been invoked as a warning about hazards of automation. Calls have been made for “mandatory reporting of adverse events related to HIT to a national database.” Uh, hello?<a style="font-weight: bold;" href="http://cts.vresp.com/c/?PDRNetwork/435a3185f3/669c663396/955ea94392"> www.EHRevent.org</a> is exactly the “national database” being called for. It is a fully accredited, federal Patient Safety Organization and part of an AHRQ network of error-reporting entities. Reports to EHRevent.org are fully confidential, and data that is collected is reportable only in de-identified or collective form.</blockquote> ("Uh, hello?" he writes?) Uh, hello, Dr. Victoroff ... As in the old Wendy's commercial: Where's the beef? <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg74CijUKvONDDLFQOJ4TFpt2imtbXTcYlF-kSuZFje2PWOzR456-4btIEpB7XH0YbZ1nDbJH8-dr1yjPjIX92KPGCer-mHzai828RmO6i9gteHOlUJs5G76jv9uPHa6pkgiI4WQx2mmJkD/s1600/0528_wendys-wheres-the-beef-tagline_280x340.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5633046759014964418" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg74CijUKvONDDLFQOJ4TFpt2imtbXTcYlF-kSuZFje2PWOzR456-4btIEpB7XH0YbZ1nDbJH8-dr1yjPjIX92KPGCer-mHzai828RmO6i9gteHOlUJs5G76jv9uPHa6pkgiI4WQx2mmJkD/s320/0528_wendys-wheres-the-beef-tagline_280x340.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 172px; height: 209px;" /></a> <div style="text-align: center;">Where's the beef??? </div>A search of the <a href="http://www.ehrevent.org/">http://www.ehrevent.org/</a> website shows no accessible, searchable database that I can find. If someone knows of such a publicly accessible database at least remotely similar to the FDA's MAUDE (Manufacturer and User Facility Device Experience) database <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm">at this link</a>, please let me know. The best I can find on a Google search on "EHRevent database" is a page of legalese containing <a href="http://www.ehrevent.org/Tos.html">these statements</a>: <blockquote>2.1 PDR Secure will develop a Patient Safety Evaluation System (“PSES”) for the collection, management, and analysis of information received from and/or reported to participating providers, to be accessed through a PDR Secure web portal [but, apparently, not public dissemination, and based on this language it seems dubious that even "participating providers" will get a complete, searchable corpus of reports - ed.] ... 2.4 PDR Secure will assemble a knowledgeable workforce, and in collaboration with its workforce (which may consist of employees, contractors, volunteers, representatives of participating providers and other Patient Safety Organizations, and other individuals as appropriate to the involved Patient Safety Activity), will develop and conduct Patient Safety Activities, including but not limited to data collection, appropriate studies, evaluative activities, reports, and recommendations, including, where feasible, “best practices” recommendations; and will offer the results to participating providers. [In other words, we disseminate what we think is relevant - ed.] </blockquote> Examples of what the public can find - for free and at will - on the FDA MAUDE site are at the posts here: <blockquote>January 21, 2011: HC Renewal - <a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">MAUDE and HIT Risks: What in God's Name is Going on Here? </a> Drexel Health IT website Real-World, Though Limited, Examples of Healthcare IT Malfunction From the FDA MAUDE Database <a style="font-weight: bold;" href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=MAUDE">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=MAUDE</a> Drexel Health IT website FDA MAUDE DATABASE: Patient outcome = death <a style="font-weight: bold;" href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=maude_death">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=maude_death</a> </blockquote> Unless I am missing some MAUDE analog at EHRevent.org, a claim that "<a style="font-weight: bold;" href="http://cts.vresp.com/c/?PDRNetwork/435a3185f3/669c663396/955ea94392">EHRevent.org</a> is exactly the national database [on EHR medical device problems, dangers, harms etc. - ed.] being called for" raises some questions: <ul><li>Called for by whom: patients and their advocates, or, an industry interested in secrecy and turf protection?</li><li>If the public does not have unfettered, searchable access to the set of de-identified case reports being submitted to EHRevent, as they do to FDA's MAUDE and other public databases, how can the public know their publications are complete, unbiased, and not selectively preferential towards certain HIT vendors and/or user organizations?</li><li>Is EHRevent's model based on the watchdog's opinions of what's important for the public to know, or will it allow the public to make its own informed choices?</li><li>Will EHRevent publicly demand the recall of EHR medical devices repeatedly reported to them to be harmful, as would the FDA or other governmental regulators regarding dangerous products? </li></ul>At present, the answers to these questions raise little confidence in me that EHRevent.org is "the national database" being called for by true watchdogs, e.g., those truly interested in ensuring the safest, most effective EHR medical devices, and the weeding out of dangerous and deficient EHR medical devices. I'm going to go a step further. I am making the following request: that EHRevent.org make available online, in a de-identified (as to people and organization) and searchable format the event reports about the EHR medical devices they receive. Finally, regarding infant mortality related to health IT, perhaps Dr. Victoroff should read cases #2 and #3 at the post "Babies' deaths spotlight safety risks linked to computerized systems" <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">at this link</a>. -- SS

EHRevent.org and "The National Database of EHR Errors Being Called For" - Where's the Beef?

At my Nov. 2011 posts on a new entity called " EHRevent.org " that is supposed to be a health IT industry watchdog, I expressed va...

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

No surprise here to anyone with engineering sense (e.g., in my case, arising from my decades of experience in amateur radio, operating many different brands and types of extremely complex radio equipment): <blockquote style="font-family:arial;">American Medical News (American Medical Association) <a style="font-weight: bold;" href="http://www.ama-assn.org/amednews/2011/06/13/bisb0613.htm">Upgrading e-prescribing system can bump up error risk</a> Some of those risks can put patients in jeopardy in the first few weeks of implementation, a study finds. By PAMELA LEWIS DOLAN, amednews staff. Posted June 13, 2011. Switching to new or upgraded electronic-prescribing systems may pose patient safety risks during the transition period, despite the advanced clinical decision support tools offered by the newly implemented technology.</blockquote> Let me translate this euphemism: "Patient safety risks" = risks that patients will be maimed or killed. <blockquote style="font-family:arial;">Many hospitals and physician practices are upgrading or switching their ePrescribing systems to meet meaningful use incentive requirements. </blockquote> The collateral damage and/or roadkill on the way to "meaningful use" might be you or your loved one... <blockquote style="font-family:arial;">Physicians from Weill Cornell Medical College and New York-Presbyterian Hospital, both in New York, authored a report published online April 16 in the Journal of General Internal Medicine that identified challenges associated with switching to new e-prescribing technology. Some of those issues may pose safety threats during the first few weeks after implementation, the study found. </blockquote>This is accurate, if you consider three months to a year of increased medical error risk "a few weeks": <blockquote style="font-family:arial;">Researchers examined prescribing errors that occurred from February 2008 through August 2009 at an academic-affiliated ambulatory clinic that switched from an older electronic medical record system to a new one with advanced clinical decision support for ePrescribing. They measured errors that occurred with the old system prior to implementing the new system, 12 weeks post-implementation of the new system and errors that took place one year later. The report showed that the largest number of errors occurred before implementation, when the old system was still in use. The number of overall errors dropped from 36% to 12% one year later. [12% = more than one in ten. Why not near zero a.k.a. six-sigma for the billions of dollars spent? - ed.] The most common errors, those caused by improper abbreviations, fell from 24% to 6% in one year. But the number of non-abbreviation errors, such as those associated with directions, frequency and dosage mistakes [just minor "issues" - ed], increased in the first 12 weeks of implementation of the new system. [Remember, though. Three months = "just a few weeks" - ed.] </blockquote> Experimental technology-related injury and roadkill figures were apparently not included. Now for the assumption: <blockquote style="font-family:arial;">Study co-author Rainu Kaushal, MD, MPH, chief of the Division of Quality and Medical Informatics at Weill Cornell Medical College, said she knew the transition from paper to electronic was difficult for most physicians. She was surprised to learn that even for experienced e-prescribers, the move to a new system can be challenging. Dr. Kaushal, who was involved in the transition studied for the report, said she found the experience to be "exceedingly difficult." "We thought it would be more of a seamless transition because people were already accustomed to sitting in front of a computer, entering in orders and so on, so they didn't have to get used to that piece," she said. </blockquote> Where do foolhardy assumptions such as "We thought it would be more of a seamless transition because people were already accustomed to sitting in front of a computer, entering in orders and so" come from? Do these 'experts' have absolutely no engineering sense, e.g., that when you have learned to use one complex machine (virtual in the case of an EMR), using another that has many differences is not 'automagically' a piece of cake? By that flaw in logic, a Cessna pilot should have no problems rapidly learning to fly a 747 - or the Space Shuttle. <blockquote face="arial">"But each electronic system has its nuances and learning how to utilize it and optimize the physician-computer interaction takes time. Every time a switch is made there are important issues that arise." </blockquote> "Important issues" is a rather kind euphemism. Let me state the same concept via a <a href="http://www.merriam-webster.com/dictionary/dysphemism">dysphemism:</a>: <blockquote style="font-family: arial;"> "Each electronic system has its nuances and learning how to utilize it and optimize the physician-computer interaction takes time. Every time a switch is made there are important clinical mistakes these changes cause clinicians to make. But mistakes never, ever, ever cause patients to be maimed or killed - at least not that we're going to admit publicly. Besides, these adverse outcomes are justified anyway, because we have the right to play God with peoples' lives through IT experimentation, using unregulated, unvetted medical devices without informed consent (<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">link</a>), for the greater good that will necessarily follow via technological determinism." </blockquote>I think this is a more honest way to state the nature of the "issues" here. Also see my June 2011 post "<a href="http://hcrenewal.blogspot.com/2011/06/electronic-medication-prescribing-magic.html">Electronic medication prescribing: The Magic Bullet Theory of IT-Enabled Transformation once again bites the dust in the real world of medicine</a>" for more on ePrescribing, and more on the change of health IT from clinician adviser to clinician governor. From that post: <blockquote> As many as 12 percent of the drug prescriptions sent electronically to pharmacies contain errors, a rate that matches handwritten orders for medicine from physicians, researchers said.</blockquote> -- SS

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

No surprise here to anyone with engineering sense (e.g., in my case, arising from my decades of experience in amateur radio, operating many ...

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

Writing in our local Providence Journal, Felice Freyer <a href="http://www.projo.com/news/content/BLOOD_COLLECTION_DISPUTE_07-21-11_T5P9VUQ_v19.4357c.html">reported</a> on a story that becomes less bewildering when viewed in the context of how nominally not-for-profit health care organizations are now run.  The Border Dispute It seems that two such non-profits are having a border dispute: <blockquote>Two local charities are fighting for your blood. The Rhode Island Blood Center, long the sole blood-collection agency in the state, is objecting to incursions by the American Red Cross of Eastern Massachusetts, which recently started holding blood drives here. A war of words has resulted, with the blood center accusing the Red Cross of a 'campaign of misinformation,' and the Red Cross calling the blood center 'hypocritical.' The Hospital Association of Rhode Island entered the fray with a letter to blood donors urging loyalty to the Rhode Island center. The dispute might seem inconsequential to the typical blood donor, who is just trying to do a good deed and may not care or notice who collects the blood. But the Rhode Island Blood Center argues that it matters a great deal. The competition, blood center officials say, is threatening a carefully calibrated system that ensures a steady, predictable supply of blood. The hospitals in Rhode Island all rely on the blood center for 100 percent of their blood supply. The Red Cross says it just wants to give Rhode Islanders another way to support its mission. 'We are a humanitarian organization, a symbol of trust,' said spokeswoman Donna M. Morrissey. The Red Cross’ Rhode Island chapter does not collect blood. A chapter based in Dedham, Mass., started collecting blood here last fall. Since then, the Red Cross has collected 138 units of blood in Rhode Island — a drop in the bucket compared with the 90,000 units of whole blood that the Rhode Island Blood Center collects each year.</blockquote>High-Toned Missions On its surface, the whole thing is bewildering. Here are two non-profit organizations ostensibly dedicated to providing worthwhile health services for people in need. The American Red Cross' <a href="http://www.redcross.org/portal/site/en/menuitem.d229a5f06620c6052b1ecfbf43181aa0/?vgnextoid=f5195032f953e110VgnVCM10000089f0870aRCRD">mission</a> is to: <blockquote>provide relief to victims of disaster and help people prevent, prepare for, and respond to emergencies.</blockquote> The Rhode Island Blood Center's <a href="http://www.ribc.org/full/inner/annualReports.shtml">mission</a> is: <blockquote>to provide a safe, adequate and cost-effective blood supply for the patients and the hospitals we serve. </blockquote> Why can't we all just get along? Why should these organizations be fighting, especially over what amounts to market share? Wouldn't they be able to better support their missions by cooperating?  Where Does the Money Go? I cannot give a definitive answer to those questions. However, there are some clues. Let us look at the latest available (2008) US Internal Revenue Service <a href="http://www.guidestar.org/FinDocuments/2009/050/317/2009-050317817-066c6dad-9.pdf">form 990</a> from the Rhode Island Blood Center, and the latest available (2009) <a href="http://www.redcross.org/www-files/Documents/pdf/corppubs/ARC_990_2010.pdf">form 990</a> from the American National Red Cross, the parent of the eastern Massachusetts chapter. The ProJo article stated that the RI Blood Center collected some 90,000 units of blood last year. The most recent form 990 for that organization revealed that the RIBC had $33,043,096 in program service revenue from sale of blood or blood components for its 2008 tax year. Assuming that its blood collections were the same then as the ProJo reported, that means it got $367 in revenue per unit of blood it supplied. Note further that program service revenue accounted for about 88% of its total $37,478,357 revenue in 2008, revenue sufficient to create a $558,169 surplus So the sale of blood is lucrative. That may come as a big surprise to blood donors, who are unpaid, (and do not even get a tax-deduction for a charitable donation in the US). Now of course it may not be cheap to collect, test, store and distribute blood, that is, the core functions of the RIBC. But note further that in 2008, it was also lucrative to be an executive for RIBC. That year, Lawrence F Smith, the CEO, got $430,650 in total compensation; Scott J Asadorian, the COO, got $331,736, and Carolyn T Young, the CMO, got $273,052. Six other managers got more than $100,000. That seems to be very good pay for managers of a relatively small, regional non-profit whose revenues depend on voluntary donations of bodily fluids. There are parallels with the American Red Cross, parent organization of the local Massachusetts chapter. It got a whopping $2,219,161,636 in program service revenue from "biomedical products & services" in 2009, which was about two-thirds of its total revenue of $3,587,775,430, and which generated a $233,597,985 surplus. Being an executive of the American Red Cross was much more lucrative. In 2009, then CEO Gail McGovern received over a million in total compensation, $1,032,022 to be exact. Its President for Biomedical Services got $850,489. Its Executive VP for Biomedical Services got $596,309. Twelve other executives got more than $250,000. Of those, ten got more than $350,000. Summary This is all too reminiscent of a dispute we noted briefly <a href="http://hcrenewal.blogspot.com/2011/06/blogscan-another-health-care-foundation.html">here</a>, which involved threatened litigation by the large Susan G Komen For the Cure foundation against other charities that dared to use the word "cure" in their own campaigns to fight cancer. The current example does seem a bit more tawdry because the organizations in question depend for their revenue and to support their executives' posh pay on voluntary donations, not just of money, but of blood.  (And it is not the first example we have found that raises questions about non-profit blood banks, look<a href="http://hcrenewal.blogspot.com/2010/01/why-are-health-care-organizations.html"> here</a>.) We have gone on at great length about how health care organizations have been infected by the prevailing "greed is good" culture of US (and world) businesses. Some of the worst examples have come from for-profit companies, but nominally non-profit companies (NGOs, outside of the US) have become part of the epidemic. Instead of cooperating to do good works, some have taking to fighting over market share. We have shown numerous examples in which the leaders of health care non-profits got <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">incentives unrelated</a> to the degree they uphold their institutions' high-toned missions, (<a href="http://hcrenewal.blogspot.com/2011/07/being-non-profit-hospital-ceo-means.html">here</a> is a recent example) and seem happy to do what it takes to keep their compensation high. So, once more with feeling.... health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior. What Is to Be Done? Based on our ever enlarging file of cases on compensation of the top hired managers of non-profit health care organizations, let me make some concrete suggestions, based on my humble opinion. A step forward would be to make the finances and compensation arrangements of health care non-profit organizations at least as transparent as those of large public for-profit organizations. So my big idea is: Non-profit health care organizations above a reasonable threshold size should provide prompt, public, annual reports analogous and very similar to the reports required by the US Securities and Exchange Commission of public, for-profit companies. These reports should include, at a minimum, a summary of financial and operational status, an audited financial report, an explanation and accounting for any for-profit subsidiaries and any interlocking non-profit organizations, the compensation given to the CEO and some minimum number of the top-paid officers and employees, a detailed explanation and rationale for the pay of these individuals, and a listing of other affiliations and all conflicts of interest affecting them. If the need to supply such information causes non-profit health care organizations' hired executives and boards of trustees some cognitive dissonance, that would be a good thing.

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

Writing in our local Providence Journal, Felice Freyer reported on a story that becomes less bewildering when viewed in the context of how ...

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

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

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody further analyzed the case of the soft-hearted prosecutors, which we discus...

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

Another glimpse of health care for the very rich comes by way of a BNet <a href="http://www.bnet.com/blog/drug-business/whats-wrong-with-solomon-forest-labs-spent-316k-on-ceos-medical-bills/9014">post</a> by Jim Edwards about the beleaguered CEO of Forest Laboratories. The background is that: <blockquote>The CEO is fighting to retain his place atop the company against both investor Carl Icahn, who wants his own directors on Forest’s board, and the Department of Health & Human Services, which wants to exclude Solomon from the drug business as a punishment for the company settling a $313 million investigation by the Department of Justice over its illegal marketing of Levothroid and other drugs.</blockquote> We had posted about the government threat to disbar him from government business after his company <a href="http://hcrenewal.blogspot.com/2011/05/logical-fallacies-to-defend-ceos-from.html">here</a>. Edwards noted that despite these setbacks, Solomon's total compensation actually increased: <blockquote>Forest Labs (FRX) reported that CEO Howard Solomon earned $8.9 million in fiscal 2011, 7 percent more than last year,...</blockquote> This is par for the course for <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">executive compensation</a> in health care. We have discussed numerous instances in which such pay defies gravity, rising even when serious questions have been raised about the performance of the executives and the organizations they lead. We most recently belabored this issue <a href="http://hcrenewal.blogspot.com/2011/07/being-non-profit-hospital-ceo-means.html">here</a>. However, Edwards also wrote <blockquote>The company also spent $316,638 on medical expenses for the 83-year-old CEO, up from $56,571 in 2010. The company’s proxy disclosure did not say what was wrong with Solomon. UPDATE: A spokesperson for the company said: Mr. Solomon is in excellent health and has no ongoing medical conditions that would impair his ability to continue functioning as the Company’s CEO. A good portion of last year’s expense was related to hip replacement following a fall when he was playing tennis – which he has now reluctantly discontinued.</blockquote> Later, he summarized the amounts the company paid for Mr Solomon's medical care in previous years: <blockquote>Here’s how Solomon’s medical bills have increased over the last few years. 2011: $316,638 2010: $56,571 2009: $28,000 2008: $25,000 </blockquote> Mr Solomon is 83 years old, and therefore qualified years ago for Medicare, the US single payer health insurance system for the elderly and disabled. Medicare serves as the primary health insurance for many elderly people, and it covers hip replacements for quite a few of them. A <a href="http://www.zimmer.com/web/enUS/pdf/Hip_Coding_Guide_Revised_121108.pdf">publication</a> by Zimmer, one of the larger manufacturers of prosthetic hips, noted that Medicare payment rates in 2009 for hip replacement were up to about $25,000 for hospitals, and up to about $1500 for surgical fees. Yet Forest Laboratories increased its payments to Mr Solomon for health care by about $250,000 due to his hip replacement. This amount is obviously an order of magnitude bigger than the usual Medicare payments for hip replacements, and presumably was paid in addition to the amounts Medicare paid for this surgery. Nothing in Mr Edwards' post, or in the proxy statement from which the numbers came explains the use to which the $250,000 was put. The size of the amount does suggest that Mr Solomon received some sort of health care much more expensive than that available to the general public. We have previously noted a few instances (e.g. <a href="http://hcrenewal.blogspot.com/2009/07/are-health-plans-of-very-rich-different.html">here</a>)  suggesting that the amounts large corporations pay for their top executives' health care are far larger than even the high prices charged by commercial health insurers.  Information from litigation suggested that one retired corporate CEO was entitled to payments for all sorts of amenities, such as first-class transportation, services of personal aides and trainers, cosmetic procedures, etc in conjunction with his health care (see post <a href="http://hcrenewal.blogspot.com/2010/07/not-your-average-joes-health-plan.html">here</a>).  The case of the Forest Laboratories CEO provides more evidence that top corporate leaders receive health care in what amounts to a system separate from and in a tier above what even supposedly well-insured "regular people" can access.  The existence of this separate health care system for very rich corporate executives may provide yet another explanation of why real health care reform is so difficult.  We have frequently suggested that those who have become rich from the current health care system are likely to strongly resist any changes to that system that might threaten their continued accumulation of wealth.  These peoples' riches provide them with the resources to fight such changes, e.g., through stealth policy advocacy (see posts <a href="http://hcrenewal.blogspot.com/2011/02/health-care-corporate-disinformation.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/02/wendell-potters-deadly-spin.html">here</a>).  Furthermore, these peoples' access to a separate health care system for the very rich makes it extremely unlikely that they or their families will ever experience the problems that drive many common folk to despair about our current health care dysfunction. Perhaps some intrepid investigative reporter will write a Pulitzer prize-worthy story about the parallel health care system for the very rich.  Perhaps some honest health services researcher will study how the existence of such a system affects policy-makers. At the least, we deserve health care policy informed by how the health care affects real people, and not made solely by those who are sheltered from he vicissitudes of the real, and currently dysfunctional health care system.

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

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

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

Allegations that suggest the continuing degradation of the professionalism of employed physicians just <a href="http://www.palmbeachpost.com/news/state/ex-solantic-doctor-tells-of-intense-pressure-on-1596934.html">appeared</a> in the Palm Beach (FL) Post.  A former physician employee of Solantic Urgent Care, a for-profit chain of urgent care clinics, described to state investigators the life of employed physicians there. Putting Revenue First Physicians answered to managers who put revenue first: <blockquote>Thirty-something business graduates lacking in any medical training supervised the clinics' doctors and were encouraged to maintain an adversarial relationship with them, Prokes said. Those clinic managers' raises and bonuses depended on their achieving ambitious goals for patient visits, labor and overhead costs, per-patient revenues and customer satisfaction. Prokes said clinic manager turnover was high, and a succession of managers wrote him up for a variety of infractions: arriving five minutes late, failing to suggest Solantic's pharmacy at three points of contact and suggesting a patient might want to return later, when there would be less of a wait.</blockquote> As is common elsewhere, there was pressure to see as many patients as possible: <blockquote>Prokes told state investigators that he found the atmosphere increasingly untenable, as he was pressed to see 70 to 90 patients each day. 'They actually told us not to sit down for 14-hour shifts,' Prokes told state investigators. '[Former Solantic CEO Rick] (Scott) does not care about the quality of medicine. They care about how fast you see people.'</blockquote> A Business Model from the Fast-Food Industry A former Solantic executive admitted that the business model came straight from the fast-food industry: <blockquote>[Former Solantic Chief Operating Officer Shaun] Ginter said the retail concept that he, Scott, and then-CEO Karen Bowling created drew on lessons from the fast food and other retail industries. Counters were built at standing height, for example, because it speeded workflow, he said. 'The culture, the workflow, were all streamlined for a more efficient delivery, a more efficient method of care,' said Ginter, who had previously managed drug stores with small clinics within. 'The name of the game is keeping your costs tight, and Rick, Karen and myself were very focused on keeping costs down.'</blockquote> Up-Selling Unneeded Services Just as in the fast food industry, the help was expected to up-sell. In particular, Dr Prokes charged that physicians were strongly pushed to suggest services patients did not need, but that brought in more revenue: <blockquote>Doctors were monitored with cameras in the clinics' common areas, [Dr Randy] Prokes told investigators. Staff were expected to suggest extras, including vitamins and probiotics, and a colon cancer screening test considered unreliable and outdated by CDC officials.</blockquote> The Background: Rick Scott, Columbia/HCA, and the State of Florida Note that Rick Scott just sold Solantic LLC to private equity group Welsh, Carson, Anderson & Stowe, <a href="http://www.bizjournals.com/jacksonville/news/2011/06/29/investor-group-buys-out-solantic.html">per</a> the Jacksonville (FL) Business Journal. Note further that Scott was the former CEO of Columbia/ HCA, which ultimately paid a huge fine for fraudulant practices: <blockquote>John Schilling was working as reimbursement supervisor for Columbia/HCA's Southwest Florida division, where he oversaw Medicare and Medicaid compliance and the cost reporting. 'Before HCA, when it was just Columbia, the CEOs of the hospitals were making up to 100 percent of their salaries as a bonus; the CFOs made 50 percent. Even some of the directors were making 25 percent bonuses,' Schilling said. It drove a do-anything-to-make-the-numbers mentality, he said. Schilling now runs a firm called Ethics Solutions, where he helps potential whistleblowers. 'There were no incentives for being in compliance with Medicare and Medicaid rules,' Schilling said. 'It was about, how are we going to make it profitable, and if we meet our goals, it means we get our bonuses.' He found that the hospitals in his area kept two sets of books. The one for Medicare auditors showed inflated costs, so that hospitals could justify higher reimbursement rates to take advantage of a funding formula that has since changed. The hospitals also kept 'real' books with different numbers. The discovery put him in an ethical bind, he said. When he took his concerns to a supervisor, he was told not to rock the boat. Ultimately, his whistleblower lawsuit proved among the most damaging to his employer, which eventually paid $1.7 billion to the federal government to settle criminal fraud and abuse charges. Scott, who wanted to fight the charges rather than settle, was never charged, and said he was unaware of what his managers had been doing.</blockquote> After Scott left Columbia / HCA, he used the riches he acquired as its hired executive to help fund an ultimately successful campaign for the governorship of Florida, his current office. (See posts <a href="http://hcrenewal.blogspot.com/2011/03/conflicts-of-interest-government.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/05/how-did-ceo-who-presided-over-company.html">here</a>.) Summary We have previously posted, most recently <a href="http://hcrenewal.blogspot.com/2011/07/here-comes-your-new-doctor-brought-to.html">here</a>, about how physicians are increasingly becoming <a href="http://hcrenewal.blogspot.com/search/label/corporate%20physician">employees of for-profit corporations</a>. We have discussed other instances in which such corporations are appearing to pressure physicians to provide "care" to patients in such a manner as to increase corporate revenue, whether or not it is good for patients. We noted that when insurance companies hire physicians, they are likely to push them into providing less care across the board, since the insurers are paid per patient, not for what is done to each patient. When hospitals, hospital systems, and other entities that directly provide care hire physicians, they are likely to push them into channeling patients to get tests, drugs, and procedures for which the corporations are most highly paid. In this current case, the allegations fit the latter pattern. Furthermore, At least one former executive admitted that "the name of your game is keeping your costs tight," not providing the best patient care. There is more and more evidence that doctors who provide direct patient care as employees of for-profit corporations, and possibly other large organizations, are being increasingly pushed to put corporate revenue ahead of their patients' best interests. It should be obvious that this is unethical. Doctors swear oaths to put their patients' interests first. Patients should be extremely wary of the care provided by doctors who are employed by large organizations. Doctors should be extremely wary of working for such organizations to provide direct patient care. Below, I have repeated my humble suggestions from last week, with some additions, for What Is to Be Done? Patients: - Find out if their physicians are employed, and if so, by whom. - Find out what incentives their physicians have, if employed, to recommend more or less care of certain types. - Find out whether other aspects of the physicians' employment arrangements, e.g., contractual confidentiality clauses, could affect his or her relationships with patients - Avoid doctors employed by for-profit companies who have incentives to provide more or less care than what may be best for the patient Physicians: - Do not accept any employment offer or contract which has incentives to provide more or less care than is best for individual patients - Who are already employed disclose to their patients such employment, and any incentives it may provide to provide more or less care - Urge professional societies, and certifying and accrediting organizations to further investigate threats to physicians' professionalism arising from employment, and develop strategies to mitigate such threats Policy-makers: - Rapidly investigate the extent that for-profit companies whose revenues depend on physicians' decisions are hiring physicians to take care of patients, and the incentives and influences that these companies use to affect physicians' decisions - Develop regulations that force disclosure of all such employment and relevant incentives and influences - Consider further regulation of organizations that so employ physicians - Consider whether such "commercial practice of medicine" ought to be once again banned. ADDENDUM (12 July, 2011) -  See also this related <a href="http://www.kevinmd.com/blog/2011/07/professional-status-physicians-risk.html">post</a> on KevinMD.

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

Allegations that suggest the continuing degradation of the professionalism of employed physicians just appeared in the Palm Beach (FL) Post...

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

We have frequently posted, some may say tiresomely, about the lack of consequences or negative incentives for health care organizational leaders involved in wrong-doing.  For example, see the numerous cases against health care organizations that resulted in <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a>, almost never requiring any penalties against individuals who authorized, directed, or implemented the behavior in question. Now a <a href="http://www.nytimes.com/2011/07/08/business/in-shift-federal-prosecutors-are-lenient-as-companies-break-the-law.html">major article</a> in the New York Times by Gretchen Morgenson and Louise Story explains some of the history behind this aspect of the decreasing accountability of corporate leadership.  Their article focused on financial corporate leadership, but clearly is generalizable to health care corporate leadership. Banks Asked to Report Their Own Misbehavior The Times article documents how the US Department of Justice deliberately became more lenient in the 1990s, supposedly to conserve scarce investigational resources: <blockquote>dating to the mid-1990s ... banks were asked to regularly report suspicious activities to the Treasury Department, an effort that aimed at relieving regulators of some of their enforcement loads.</blockquote> The Effect of the Arthur Andersen Case Around the beginning of the 21st century there had been some vigorous prosecution of corporate financial wrong-doing: <blockquote>The names have become synonymous with corporate wrongdoing — and forceful prosecution: Not just Enron, but also WorldCom, Tyco, Adelphia, Rite Aid and ImClone. In the early part of the last decade, senior executives at all these companies were convicted and imprisoned. </blockquote> However, for reasons that were not explained, a single unsuccessful case caused reconsideration of this approach: <blockquote>The department began pulling back from a more aggressive pursuit of white-collar crime around 2005, say defense lawyers and former prosecutors, after the Supreme Court overturned a conviction it won against the accounting firm Arthur Andersen. That ended an era of brass-knuckle prosecutions related to fraud at companies like Enron. </blockquote> Sympathy for the Targets of Investigation The pullback was rationalized for a sudden sympathy for the objects of investigation: <blockquote>But by 2005, a debate was growing over aggressive prosecutions, as some business leaders had been criticizing the approach as perhaps too zealous. That May, Justice Department officials met ahead of a session with a cross-agency group called the Corporate Fraud Task Force. It was weeks after Justice Department lawyers had presented to the Supreme Court their case against Arthur Andersen, which was seeking — successfully, it would turn out — to overturn its criminal fraud conviction in a prominent case. In the meeting, the deputy attorney general at the time, James B. Comey, posed questions that surprised some attendees, according to two people there who asked to remain anonymous because they were not supposed to discuss private meetings. Was American business being hurt by the Justice Department’s investigations?, Mr. Comey asked, according to these two people, who said they thought the message had come from others. He cautioned colleagues to be responsible. 'It was a total retrenchment,' one of the people said. 'It was like we were going backwards.' Mr. Comey said recently that he did not recall this conversation. Around the same time, the Justice Department was developing instructions on dealing with companies under investigation — particularly companies that work with the government. It issued a memo in 2003 that gave companies more credit for cooperating than in the past. That message was reinforced in another memo in 2006. As the first memo put it, 'it is entirely proper in many investigations for a prosecutor to consider the corporation’s pre-indictment conduct, e.g., voluntary disclosure, cooperation, remediation or restitution, in determining whether to seek an indictment.' During this period, the Justice Department increased the use of deferred prosecutions or even nonprosecution agreements. Many well-known companies have benefited. In 2004, the American International Group, the giant insurer, paid $126 million when it entered a deferred prosecution agreement to settle investigations into claims that it had helped clients improperly burnish financial statements. Deals over accounting improprieties also were struck that year by Computer Associates International, a technology company, and in 2005 by Bristol- Myers Squibb, a pharmaceutical concern. Prudential Financial entered into a deferred prosecution in 2006 over improper mutual fund trading. </blockquote> Note that while the emphasis of this article was on the financial services industry, big health care organizations were also benefiting from more lenient treatment.  Note also that one firm given lenient treatment, AIG, went on to threaten collapse, a collapse that was feared could take down the entire world financial system, and hence was given a very generous government bail-out, which has not be paid back to this day.  Formalized Leniency In 2008, the approach was formalized: <blockquote>As the financial storm brewed in the summer of 2008 and institutions feared for their survival, a bit of good news bubbled through large banks and the law firms that defend them. Federal prosecutors officially adopted new guidelines about charging corporations with crimes — a softer approach that, longtime white-collar lawyers and former federal prosecutors say, helps explain the dearth of criminal cases despite a raft of inquiries into the financial crisis. Though little noticed outside legal circles, the guidelines were welcomed by firms representing banks. The Justice Department’s directive, involving a process known as deferred prosecutions, signaled 'an important step away from the more aggressive prosecutorial practices seen in some cases under their predecessors,' Sullivan & Cromwell, a prominent Wall Street law firm, told clients in a memo that September. The guidelines left open a possibility other than guilty or not guilty, giving leniency often if companies investigated and reported their own wrongdoing. In return, the government could enter into agreements to delay or cancel the prosecution if the companies promised to change their behavior. </blockquote> Less Deterrence The NY Times article documented a number of opinions that increasing leniency was resulting in less deterrence of bad behavior: <blockquote>'If you do not punish crimes, there’s really no reason they won’t happen again,' said Mary Ramirez, a professor at Washburn University School of Law and a former assistant United States attorney. 'I worry and so do a lot of economists that we have created no disincentives for committing fraud or white-collar crime, in particular in the financial space.' </blockquote> Why So Much Sympathy from Prosecutors? What was not really clear from the article is why US federal prosecutors seemed to go from their stereotypically tough on crime personas to bleeding hearts for corporate criminals. The one rationale the article provided from the Department of Justice was: <blockquote>Defending the department’s approach, Alisa Finelli, a spokeswoman, said deferred prosecution agreements require that corporations pay penalties and restitution, correct criminal conduct and 'achieve these results without causing the loss of jobs, the loss of pensions and other significant negative consequences to innocent parties who played no role in the criminal conduct, were unaware of it or were unable to prevent it.' </blockquote> This, however, makes no sense. Well directed prosecutions of the people who apparently authorized, directed or implemented the wrong-doing ought to have very little effect on "innocent parties." The only jobs and pensions that should be lost should be those of the accused. Conclusions This seems to be the most recently documented example of important but overlooked, or concealed changes in government policies that have enabled the health care system to become more unethical, dishonest and corrupt, and hence more dysfunctional. <a href="http://hcrenewal.blogspot.com/2009/06/why-did-us-physicians-give-up-their.html">Here</a> we discussed a Supreme Court decision interpreting US anti-trust law that has been used to prevent medical societies from enforcing ethical rules, and hence helped medicine to become increasingly commercialized, and to increasingly put money ahead of patient care. <a href="http://hcrenewal.blogspot.com/2009/06/why-did-us-physicians-give-up-their.html">Here</a> we discussed little discussed legislation from 1945 that allowed US insurance companies/ managed care organizations to avoid federal anti-trust investigation and enforcement, and hence to increased market power. <a href="http://hcrenewal.blogspot.com/2010/06/attempt-to-hold-health-care-leaders.html">Here</a> we discussed failure of the executive branch, and especially the Department of Justice to use existing legal doctrine, the Responsible Corporate Officer Doctrine, available since 1943, to make corporate leaders responsible for their companies' bad behaviors, leading to their increasing lack of accountability and less deterrence of malfeasance. Now we have seen a deliberate turn away from even direct penalties on corporations which have misbehaved, in return basically for a promise that "we won't do it again." The first two examples may be of unintended consequences. The last two seem to signal an increased coziness between some in government and corporations. The origins of this coziness just beg for investigation. Meanwhile, there seems to be no evidence that the government's new leniency has protected innocent people who would have been harmed by the previous tougher approach. Instead, there seems to be a growing tide of bad behavior by health care organizations, exemplified by the nature of some of the bad behavior that lead to the march of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a>, and to the <a href="http://hcrenewal.blogspot.com/search/label/deferred%20prosecution%20agreement">deferred prosecution agreements</a> and <a href="http://hcrenewal.blogspot.com/search/label/corporate%20integrity%20agreement">corporate integrity agreements</a> generated in response to the new policies. What Is to Be Done? - There clearly needs to be investigation, both by journalists and at a congressional level, of Department of Justice policies that have been increasingly lenient to and cozy with large corporations, including health care corporations. - Current Department of Justice officials need to be reminded that their clients are the US people, not corporate executives, no matter how hearty and well-met. ADDENDUM (12 July, 2011) -  See this related <a href="http://www.nakedcapitalism.com/2011/07/defining-deviancy-away-how-the-justice-department-adopted-see-no-evil-approach-to-corporate-crime.html">post</a> on the Naked Capitalism blog. ADDENDUM (19 July, 2011) - See related <a href="http://brodyhooked.blogspot.com/2011/07/kid-gloves-on-corporate-crime-different.html">post</a> by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

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

We have frequently posted, some may say tiresomely, about the lack of consequences or negative incentives for health care organizational lea...

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