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Is the Meaningful Use Stage 2 Final Rule invalid?

Here are a few reasonable questions I decided to elevate as a post of its own. In the face of the discovery of industry influence over comments submitted to ONC regarding Meaningful Use Stage 2, as I documented at my post earlier today "<a href="http://hcrenewal.blogspot.com/2012/08/health-it-vendor-epic-uses-clients-as.html">Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?</a>" (<a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing" target="_blank">ghost writing</a>, in effect, by those with obvious conflicts of interest): <ul><li> Is the MU Stage 2 Final Rule invalid due to the influence the industry had on the submitted "public" comments and opinions, supposedly by and of the submitters, which are now demonstrably tainted?</li><li> Should an investigation be opened?</li></ul> After all, as I pointed out on Aug. 29 in "<a href="http://hcrenewal.blogspot.com/2012/08/the-scientific-justification-for.html" target="_blank">The Scientific Justification for Meaningul Use, Stage 2: The NWB Methodology</a>", not only is MU2 based on an admitted "nevertheless, we believe" justification (that is, lack of scientific rigor), but now it appears the legislation is based on stealth lobbying and resultant regulatory capture, ONC in essence doing the seller's bidding. Tens of billions of taxpayer dollars are at issue here. -- SS

Is the Meaningful Use Stage 2 Final Rule invalid?

Here are a few reasonable questions I decided to elevate as a post of its own. In the face of the discovery of industry influence over comme...

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Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?

<div style="text-align: left;">Note: Also see the followup Sept. 5, 2012 post "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?" at <a href="http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html">http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html</a>.</div> ----------------------- From the Histalk blog in the 8/31/12 news <a href="http://histalk2.com/2012/08/30/news-83112/" target="_blank">at this link</a>: <blockquote class="tr_bq">Epic not only submitted MU Stage 2 comments to ONC, it even helpfully distributed them to their customers so they could submit the same comments under their own names. <a href="http://dclunie.blogspot.com/2012/08/why-onc-whimped-out-annotated.html" target="_blank">David Clunie</a> noticed this and lists the hospitals who sent in the boilerplate, including University of Miami, which submitted the same comments five times without noticing the “Remove Before Submitting” headline that prefaced Epic’s explanation of why its customers should share its opinions with Uncle Sam.</blockquote> From the primary source linked in the Histalk note: <blockquote class="tr_bq"><a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0147" target="_blank">Epic via University of Michigan Health System Meaningful Use Workgroup</a> also the <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0241" target="_blank">same Epic comments from University of Miami</a> (who liked them so much they <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0241" target="_blank">submitted it twice</a> and then a <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0326" target="_blank">third time</a> and then a <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0313" target="_blank">fourth</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0299" target="_blank">fifth</a> time) and again from the <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0123" target="_blank">Martin Health System</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0137" target="_blank">Metro Health Hospital</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0306" target="_blank">The Methodist Hospitals</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0404" target="_blank">Fairview Health Services</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0358" target="_blank">Sutter Health</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0338" target="_blank">Parkview Health System</a> and the <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0284" target="_blank">Everett Clinic</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0255" target="_blank">Dayton Childrens'</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0254" target="_blank">UMDNJ</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0243" target="_blank">NYU Langone Medical Center</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0142" target="_blank">Hawaii Pacific Health</a> and finally as submitted by <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0285" target="_blank">Epic themselves</a> - others like the <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0158" target="_blank">Community Health Network</a> just stated they had read and agreed with Epic's comments - Imaging - concur that DICOM is not needed for that objective and PACS images do not need to be duplicated - concerned about single sign on if two systems - View, Download and Transmit to 3rd Party - images are not in the EHR but the PACS - patients would need DICOM viewers - size of the images is a problem - disks are better (also if you look at some copies of this, there are some pretty funny "remove before submitting to ONC" notes that say things like which versions support what and how much it would cost to retrofit, etc.; how embarrassing, both for Epic and their lackeys at these institutions)</blockquote> I certainly admire David Clunie's endurance at being able to slog through all of that and appreciate his shedding some sunlight on the "remove before submitting" notes, but - I don't think it's funny at all. Among other things, it represents taint of the submissions via <a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing" target="_blank">ghostwriters</a> (unattributed authors) with obvious <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest" target="_blank">conflicts of interests</a>, topics often addressed at HC Renewal. Here's an example I verified, the submission to the government from Dayton Children's Hospital: <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEirxuPSNKvfNLmw5qDGu4JlMVP-MPi6cFKz36m3M_3lZOGY90p1U3Tw36P-mHfyXcyEVGviytPAI6tSdBcvjEgKryW9vAZbve_nooHA5H5vj4Fhdgt7Zn83CBGGrHw6qAX9nedacFQbfZxS/s1600/remove_before_submitting.bmp" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="348" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEirxuPSNKvfNLmw5qDGu4JlMVP-MPi6cFKz36m3M_3lZOGY90p1U3Tw36P-mHfyXcyEVGviytPAI6tSdBcvjEgKryW9vAZbve_nooHA5H5vj4Fhdgt7Zn83CBGGrHw6qAX9nedacFQbfZxS/s400/remove_before_submitting.bmp" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">"Informational Comments for Organizations Using EPIC (remove before submitting to ONC)" - click to enlarge.  At least here they say they are "in total agreement" with EPIC's concerns and recommendations.  </td><td class="tr-caption" style="text-align: center;"> </td><td class="tr-caption" style="text-align: center;"> </td><td class="tr-caption" style="text-align: center;"> </td><td class="tr-caption" style="text-align: center;"> </td><td class="tr-caption" style="text-align: center;"> </td></tr></tbody></table> Another example - University of Miami: <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgOJPENnCLi6R2iGZR_GWK9akDzTBYxtYsy5YZi0rONJsZqF8FSCNxjVeO1MUYeGQLEHOqG8vndOhgb2rUn9OWCSMUNLLXGrtAjJAE9CNRdd4WLijC4RFOjLwEvXwoV4B2pF_awkyAzyTLl/s1600/miami.bmp" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="392" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgOJPENnCLi6R2iGZR_GWK9akDzTBYxtYsy5YZi0rONJsZqF8FSCNxjVeO1MUYeGQLEHOqG8vndOhgb2rUn9OWCSMUNLLXGrtAjJAE9CNRdd4WLijC4RFOjLwEvXwoV4B2pF_awkyAzyTLl/s400/miami.bmp" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">A danger of dealing with incompetents:  they neglect to tidy up for you - click to enlarge.  (Corollary question: note the line "Our [Epic's - ed.] comments stem from the fact the we believe ..."  So - what opinions belong to the 'public commenting organization', and which to the company?  Likely the whole thing belongs to the latter's ghostwriters, but can anyone really tell?  That's the problem with tainted submissions.)</td></tr></tbody></table> Others is the links above I checked such as Martin and Methodist have the same boilerplate about the "chart search feature."  Some retain the "reminder" to remove; in others it has been erased.  However, the boilerplate remains. I actually find the "advice" from EPIC in the latter document stunning regarding a "chart search feature" (e.g., search note text, and probably also ad hoc clinical searches such as 'find my patients whose blood sugars have been > 100 in the past month').  These are "features" critical to quality care that should have been present decades ago ** [see note below].  Emphasis mine: <blockquote class="tr_bq">... Focus certification on the minimum floor set of capabilities required to complete meaningful use objectives. </blockquote> Is this a tacit admission "certification" is a sham?  Is this in patients' best interests? and <blockquote class="tr_bq">Informational Comments for Organizations Using Epic (remove before submitting to ONC) We’ve heard your requests for a chart search feature, and our desire to see this certification criterion removed does not mean we don’t want to develop such a feature. In a future version of Epic, we want to develop the best possible chart search feature based on your input. However, if this criterion stays in the Final Rule, we worry we’ll have to divert attention from future chart search features you’ve requested to focus on a simplified, less valuable version of the feature to meet certification. </blockquote> In my opinion, this translates to: "we are already overextended, so help us stymie the experts' and government's efforts to make it a criteria for certification, and to hell with your doctors and nurses who need a search feature right now." Can you imagine in 2012 a word processor, database or operating system without a search feature?  That's the kind of antediluvian IT the clinicians have to put up with.  And this industry speaks of "innovation?" It would come as no surprise - to me, at least - if other health IT sellers were engaged in similar activities. I am unable to judge whether stealth lobbying by sellers using their clients, which enables the sellers to then line their pockets through favorable government legislation based on echoed comments of clients, is legal or ethical.  My belief, however,  is that it is at best a questionable practice.  It is certainly inherently unfair e.g., anti-competitive in regard to smaller health IT companies who might be able to meet more stringent MU2 certification criteria, and unfair to private citizens who have no such captive mouthpieces at their beck and call.  While perhaps not as bad as possible 'Combination in Restraint of Trade' as in my April 2010 post "Healthcare IT Corporate Ethics 101" (<a href="http://hcrenewal.blogspot.com/2010/04/healthcare-it-corporate-ethics-101.html" target="_blank">link</a>), this situation should probably be brought to the attention of health IT watchdogs such as Sen. Grassley. This May 2012 post might also be of interest:  <a href="http://hcrenewal.blogspot.com/2010/05/did-epic-ceo-judy-faulkner-of-epic.html" target="_blank">Did EPIC CEO Judy Faulkner of Epic declare that 'healthcare IT usability would be part of certification over her dead body'?</a>  ONC never responded to the questions I raised in the post. Another question:  why did ONC apparently turn a blind eye towards these "accidental inclusions"?  Yet another question:  is the MU2 Final Rule invalid due to the influence the industry clearly had on the submitted "public" comments, which can now reasonably be viewed as tainted? -- SS Addendum: I've informed the Senator via his email and staff voicemail lines.  I've also created a short URL to more conveniently access this post:  <a href="http://www.tinyurl.com/epic-stealth">http://www.tinyurl.com/epic-stealth</a> Also see the followup Sept. 5, 2012 post "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?" at <a href="http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html">http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html</a>. -- SS Note: ** For instance, I had  implemented a robust search feature of clinical notes, all comment fields and the comprehensive clinical, genetic and genealogical dataset in the Yale-Saudi Clinical Genetics EHR - in 1995.

Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?

Note: Also see the followup Sept. 5, 2012 post " Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule? " at ...

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Duchess of WellPoint Abdicates, Likely to Escape with Much Loot

A change in the leadership of one of the biggest health care organizations reveals a little more about how such leadership has become our new corporate royalty and nobility. The Departure of WellPoint CEO Angela Braly The basics of the story, as <a href="http://online.wsj.com/article/SB10000872396390444327204577617943525945430.html">reported</a> by the Anna Wilde Matthews in the Wall Street Journal, <blockquote>Under pressure from investors unhappy with the health insurer's performance and direction, WellPoint Inc. Chief Executive Angela Braly resigned Tuesday, and the company's board said it would begin a search for a permanent replacement. The abrupt shift came as the board's leadership had been meeting with major investors in the wake of a disappointing second-quarter earnings report that sharpened concerns about Ms. Braly and the company's strategy</blockquote> Note that while this change was seemingly dramatic, <blockquote>In its statement, the board signaled that WellPoint's direction might not change dramatically. Ms. Ward said that the board 'continues to believe that time will prove the wisdom of potentially transformative actions taken under Angela's leadership…But now is the right time for a leadership change.' She also said the board believes 'the remaining executive team is dynamic and strong, with great potential to drive WellPoint's future success.'</blockquote> In addition, the Indianapolis Star <a href="http://www.indystar.com/article/20120828/BUSINESS/120828060/WellPoint-investors-force-CEO-Angela-Braly-to-step-down">suggested</a> that Ms Braly would be richly rewarded for her departure: <blockquote>Details about her exit package were not released Tuesday, but under her contract, she is entitled to at least $7.7 million if terminated without cause.</blockquote> Furthermore, recall how much the board apparently thought of Ms Braly's leadership in the immediate past, as evidenced by the compensation she received. In 2011, her total compensation was a mere $13.2 million (see <a href="http://www.indystar.com/article/20120405/BUSINESS/204050363/WellPoint-s-CEO-saw-drop-compensation">this article </a>in the Indianapolis Star), just slightly less than that in 2010, $13.4 million (see this <a href="http://hcrenewal.blogspot.com/2011/03/millions-to-health-insurance-ceos-but.html">post</a>). Such compensation, of course is gargantuan compared to that received by mere mortals such as primary care physicians (actually, conservatively it is at least 66, and probably more like 100 times that of primary care physician, and over 250 times the median US family income) Such compensation, and the likelihood of a rich severance package, suggests that either the board applauded Ms Braly's leadership right up until now, or perhaps that Ms Braly, despite being a hired employee, actually had more power than the board, sufficient to virtually set her own pay. Was Financialization the Reason She Had to Go? So why get rid of her now? Aside from references to recent issues with only short-term revenue, there were few hints in the media. The WSJ article did note <blockquote>a series of stumbles over the past few years, including an unexpected earnings hit last year tied largely to problems with a Medicare plan in California. In 2010, the company scaled back a proposed rate increase in California that had become a lightning rod in the policy debate over a health overhaul, leading to a loss. </blockquote> A Forbes <a href="http://www.forbes.com/sites/brucejapsen/2012/08/30/wellpoints-braly-broke-glass-ceiling-then-shards-of-obamacare-knocked-her-down/">post</a> suggested that one problem was Ms Braly supported President Obama's health care reform legislation, the Patient Protection and Affordable Care Act (PPACA, or ACA): <blockquote>Many blame Braly and her team for putting The Affordable Care Act over the top in Congress after Wellpoint’s Anthem Blue Cross plan in California two years ago raised rates nearly 40 percent on individual policyholders before the increase was tamed. Many at the time say that provided President Obama and Sebelius political momentum and ammunition to tell the story of excessive rate increases by the loathed insurance industry.</blockquote> However, no media report so far has raised the issue of the ethics of past WellPoint behavior. In fact, as we have discussed, (most recently <a href="http://hcrenewal.blogspot.com/2012/06/huge-insurance-company-wellpoint.html">here</a>), the company has made a lengthy series of ethical missteps, to put it kindly. (The complete list appears in an appendix at the end of this post.) These problems have been going on for quite a while, and if they were not a concern before, there is no hint that they became a concern within the company recently. So, one explanation for the sudden leadership change is the dominance of financialization of for-profit health care insurance (and likely of all health care organizations.) The notion, pushed by a few economists in the 1980s, that the only thing that should matter to corporate leadership is short-term financial results may be that powerful (see this <a href="http://hcrenewal.blogspot.com/2012/04/health-care-dysfunction-explained-by.html">post</a>). Of course, that is profoundly troubling for health care organizations, since it dismisses the importance of any long-term results, especially of results that affect patients' and the public's health, and the importance of values like honesty. Corporate Leadership as Our New Royalty and Nobility Another explanation, which need not contradict the one above, was suggested by Charles Ferguson in <a href="http://www.randomhouse.com/book/213722/predator-nation-by-charles-h-ferguson">Predator Nation</a>. He wrote that the leadership of big financial corporations, which became the dominant organizations in the US and, indeed, in the world, <blockquote>became corporate royalty, with all the absurd arrogance, disconnections from reality, ego poisoning, and cults of personality thereby implied.</blockquote> If the leadership of big financial firms became royalty, then the leadership of big health care organizations became nobility. The issues above only would affect nobility slightly less. In that sense, the departure of Ms Braly likely resulted from personal and political battles among royalty. The good thing is that in this somewhat more enlightened age, the results are merely abdication, probably with a huge severance payment. In the old days, the results would likely have been imprisonment in the castle dungeon, if not beheading. Nonetheless, the notion that top corporate leaders, including leaders of for-profit and non-profit health care corporations, are becoming the new royalty and nobility should be profoundly disturbing in the US, which was founded after a revolution against royalty's excess power.  They should be no less disturbing in other countries which have overthrown their former royal leaders, or instituted constitutional monarchies in which the royals and nobles have little political or real power.  Obviously, the growing power and decreasing accountability of hired managers of large health care organizations has become a major reason, if not the major reason for health care dysfunction.  True health care reform would decrease the size and scope of health care organizations, and make their leaders accountable to ownership, when appropriate, and to the community at large for patients' and the public health.  Appendix: WellPoint's Ethical Misadventures <ul><li>settled a RICO (racketeer influenced corrupt organization) law-suit in California over its alleged systematic attempts to withhold payments from physicians (see 2005 post <a href="http://hcrenewal.blogspot.com/2005/07/wellpoint-settles-rico-law-suit.html">here</a>).</li><li>subsidiary New York Empire Blue Cross and Blue Shield misplaced a computer disc containing confidential information on 75,000 policy-holders (see 2007 story <a href="http://www.nytimes.com/2007/03/14/business/14insure.html">here</a>).</li><li>California Anthem Blue Cross subsidiary cancelled individual insurance policies after their owners made large claims (a practices sometimes called rescission).  The company was ordered to pay a million dollar fine in early 2007 for this (see post <a href="http://hcrenewal.blogspot.com/2007/03/wellpoint-fined-1-million-for-canceling.html">here</a>).  A state agency charged that some of these cancellations by another WellPoint subsidiary were improper (see post <a href="http://hcrenewal.blogspot.com/2007/07/more-than-half-of-wellpoints-policy.html">here</a>).  WellPoint was alleged to have pushed physicians to look for patients' medical problems that would allow rescission (see post <a href="http://hcrenewal.blogspot.com/2008/02/wellpoint-halts-attempts-to-have.html">here</a>).  It turned out that California never collected the 2007 fine noted above, allegedly because the state agency feared that WellPoint had become too powerful to take on (see post <a href="http://hcrenewal.blogspot.com/2008/07/wellpoint-settles-but-has-it-become-too.html">here</a>). But in 2008, WellPoint agreed to pay more fines for its rescission practices (see post <a href="http://hcrenewal.blogspot.com/2008/07/fines-re-statements-and-more-fines-just.html">here</a>).  In 2009, WellPoint executives were defiant about their continued intention to make rescission in hearings before the US congress (see post <a href="http://hcrenewal.blogspot.com/2009/06/managed-care-executives-will-not-limit.html">here</a>).</li><li>California Blue Cross subsidiary allegedly attempted to get physicians to sign contracts whose confidentiality provisions would have prevented them from consulting lawyers about the contracts (see 2007 post <a href="http://hcrenewal.blogspot.com/2007/11/physicians-and-contracts-cautionary.html">here</a>).</li><li>formerly acclaimed CFO was fired for unclear reasons, and then allegations from numerous women of what now might be called Tiger Woods-like activities surfaced (see post <a href="http://hcrenewal.blogspot.com/2008/01/more-managed-care-management-mumbo.html">here</a>).</li><li>announced that its investment portfolio was hardly immune from the losses prevalent in late 2008 (see post <a href="http://hcrenewal.blogspot.com/2008/10/if-this-is-how-wellpoint-has-managed.html">here</a>).</li><li>was sanctioned by the US government in early 2009 for erroneously denying coverage to senior patients who subscribed to its Medicare drug plans (see 2009 post <a href="http://hcrenewal.blogspot.com/2009/01/wellpoint-sanctioned.html">here</a>).</li><li>settled charges that it had used a questionable data-base (built by Ingenix, a subsidiary of ostensible WellPoint competitor UnitedHealth) to determine fees paid to physicians for out-of-network care (see 2009 post <a href="http://hcrenewal.blogspot.com/2009/02/wellpoint-settles.html">here</a>).  </li><li>violated state law more than 700 times over a three-year period by failing to pay medical claims on time and misrepresenting policy provisions to customers, according to the California health insurance commissioner (see 2010 post <a href="http://hcrenewal.blogspot.com/2010/02/argument-over-insurance-rate-hikes.html">here</a>). </li><li>exposed confidential data from about 470,000 patients (see 2010 post <a href="http://hcrenewal.blogspot.com/2010/06/wellpoint-dont-know-much-about-computer.html">here</a>) and settled the resulting lawsuit in 2011 (see post <a href="http://hcrenewal.blogspot.com/2011/10/still-more-ehr-chaos-pandemonium-bedlam.html">here</a>).</li><li>fired a top executive who publicly apologized for the company's excessively high charges (see 2010 post here).</li><li>California Anthem subsidiary was fined for systematically failing to make fair and timely payments to doctors and hospitals (see 2010 post <a href="http://hcrenewal.blogspot.com/2010/12/health-insurers-sanctioned-fined.html">here</a>).</li><li>management was accused of hiding the company's political contributions from the company's own stock-holders (see 2012 posts <a href="http://hcrenewal.blogspot.com/2012/04/some-of-wellpoints-owners-stockholders.html">here</a> and <a href="http://hcrenewal.blogspot.com/2012/05/wall-street-journal-defends-hired.html">here</a>).</li><li>settled charges that its Anthem subsidiary cheated former policy-holders out of money owed when that company was converted from a mutual insurance company (see 2012 post <a href="http://hcrenewal.blogspot.com/2012/06/huge-insurance-company-wellpoint.html">here</a>)</li></ul>

Duchess of WellPoint Abdicates, Likely to Escape with Much Loot

A change in the leadership of one of the biggest health care organizations reveals a little more about how such leadership has become our ne...

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Clinicians: How to Document the EHR Screens You Encounter That Cause Concern

Healthcare IT "<a href="http://hcrenewal.blogspot.com/search/label/glitch" target="_blank">glitches</a>" as reported on this blog should make any clinician - and patient - wary of the technology in its present state. In the past, when camera film was the only image recording medium, it was often difficult to get high quality photographs of TV screens.  No longer. Clinicians, here's a hint: it's now easy to photograph computer screens, either old CRT-based or newer flat panels, with a cellphone or other digital camera. When you see something you are concerned about...you have the tools to document and share as necessary with the appropriate authorities, and to protect yourself. Further, hospitals often claim they cannot show data as clinicians see it on-screen because of "print page" restrictions or due to the "oppressive burden" of someone having to do multiple screen dumps to a printer. That excuse is no longer valid: <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEig7-LsWln5LvZp3YMl-Uo7PCrMei-dVWFE9gqhTVRuBsMywT5PwUxKvkshjMf_o1tSrPkUri5YA4CO7y8_127GArLx5rA1IHWsDFM6c4_7ZicO5lpnKPL8alcPdXuKkFpc7s15fXMreTbT/s1600/0830121054-00.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="253" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEig7-LsWln5LvZp3YMl-Uo7PCrMei-dVWFE9gqhTVRuBsMywT5PwUxKvkshjMf_o1tSrPkUri5YA4CO7y8_127GArLx5rA1IHWsDFM6c4_7ZicO5lpnKPL8alcPdXuKkFpc7s15fXMreTbT/s400/0830121054-00.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">A screen shot of the very screen used to create this post, taken with an old 2 megapixel cellphone, default settings, no flash, ambient (dim) light, unremarkable flat screen monitor.  The same can be done for EHR, CPOE, etc.  Click to enlarge.</td></tr></tbody></table> This example blows that Discovery-impairing excuse out of the water. "Glitches" should be reported, and in a manner as I wrote at <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">this post</a>, reproduced below: (Disclaimer:  The IT sellers and hospital corporate officials are likely to invoke IP rights regarding EHR screens and HIPAA regulations in the attempt to limit transparency about problems, for which I take no responsibility.  Use this technique with appropriate precautions with regard to information sharing.) <blockquote class="tr_bq">... When a physician or other clinician observes health IT problems, defects, malfunctions, <a href="http://www.tinyurl.com/hostileuserexper">mission hostility</a> (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting): <ul><li>Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "<a href="http://www.jpands.org/vol9no3/huntoon.pdf">disruptive physician</a>" and/or or being subjected to sham peer review (<a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/">link</a>).</li></ul><ul><li>Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal"> at this link</a>. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger <a href="http://hcrenewal.blogspot.com/search/label/Dr.%20Scott%20Monteith">Dr. Scott Monteith</a> in a comment to me about this post.)</li></ul><ul><li>Inform the Joint Commission (or similar national accreditor of hospital safety if not in the U.S.) via their complaint site at <a href="http://www.jointcommission.org/report_a_complaint.aspx">http://www.jointcommission.org/report_a_complaint.aspx</a> . Also consider writing the JC senior officers (<a href="http://www.jointcommission.org/about_us/joint_commission_officers.aspx">link to officer's list</a>), whose awareness of HIT issues I can personally attest to via our correspondences.</li></ul><ul><li>Inform the FDA (or similar healthcare regulator if not in the U.S.) via the FDA Medwatch Form 3500 reporting site at <a href="https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm">https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm</a>. An example of such an adverse event report I filed myself (when the involved hospital refused) is <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1729552">at this link</a> in the FDA MAUDE (Manufacturer and User Facility Device Experience) database.</li></ul><ul><li>Inform the State Medical Society and local Medical Society of your locale.</li></ul><ul><li>Inform the appropriate Board of Health for your locale.</li></ul><ul><li>If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "<a href="http://www.qipa.org/Home.aspx">Quality Insights of PA</a>."</li></ul><ul><li>Inform a personal attorney.</li></ul><ul><li>Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.</li></ul><ul><li>As clinicians are often forced to use health IT, at their own risk even when "certified" (<a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html">link</a>), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:</li></ul><blockquote>"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.] We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients. We assume responsibility for any such malpractice. With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at <a href="http://www.jointcommission.org/assets/1/18/SEA_42.PDF" style="font-style: italic;">http://www.jointcommission.org/assets/1/18/SEA_42.PDF</a>, the IOM report on HIT safety at <a href="http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF" style="font-style: italic;">http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF</a>, and the FDA Internal Memorandum on H-IT Safety Issues at <a href="http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology" style="font-style: italic;">http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology</a>. CMO __________ (date, time) CIO ___________ (date, time) CMIO _________ (date, time) General Counsel ___________ (date, time) etc."</blockquote><ul><li>If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.</li></ul>As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.</blockquote> Physicians can create health IT transparency; waiting for the industry or HHS to do so is, in my view, futile and not a patient advocacy stance. -- SS Aug. 31, 2012 Addendum: I tried this method on a 20 year old, cathode ray tube-based Fisher 13" (appx.) color TV set.  Of course, this TV set is limited to a few hundred lines of resolution, and is <a href="http://en.wikipedia.org/wiki/Interlaced_video" target="_blank">interlaced</a> (unlike most computer monitors after the early 1990's). Here's what I got.  Note that the picture was moving: <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjx2ZEkNyP2839R-IMJWuJBgmdXHYbUeSgHaWcxZB3UAaJZnlbzUEXh22yEKIb8pqvbafn3-FC_pHjrkASi8NsOp_smYDb5zweyZI7wemKvbVts3XdqwGhGIsLIb6ZshSKpvOCZs_qALbjO/s1600/fox1.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="233" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjx2ZEkNyP2839R-IMJWuJBgmdXHYbUeSgHaWcxZB3UAaJZnlbzUEXh22yEKIb8pqvbafn3-FC_pHjrkASi8NsOp_smYDb5zweyZI7wemKvbVts3XdqwGhGIsLIb6ZshSKpvOCZs_qALbjO/s400/fox1.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Old TV, old 2 MP cellphone, default settings.  Click to enlarge.</td></tr></tbody></table> Again, old 2 MP cellphone, ambient background, default settings.  I tried several shots, and all were of similar quality. -- SS

Clinicians: How to Document the EHR Screens You Encounter That Cause Concern

Healthcare IT " glitches " as reported on this blog should make any clinician - and patient - wary of the technology in its presen...

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A Tacit Admission That National Health IT is a Gargantuan Experiment

In my post yesterday "<a href="http://hcrenewal.blogspot.com/2012/08/the-scientific-justification-for.html" target="_blank">The Scientific Justification for Meaningul Use, Stage 2</a>" I wrote: <blockquote class="tr_bq">There's no truly robust evidence of generalizable benefit, no randomized trials, there's <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">significant evidence to the contrary</a>, there's risk to safety that this disruptive technology causes in its present state (but the magnitude is unknown, see quotes from 2012 IOM study <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">here</a>) that MU and "certification" <a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html" target="_blank">do not address</a>, there's a plethora of <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">hair-raising defect reports</a> from the only seller that reports such things, but CMS justifies the program [starting at p. 18 in the Final Rule for Meaningful Use Stage 2 at <a href="http://www.ofr.gov/OFRUpload/OFRData/2012-21050_PI.pdf" target="_blank">this link</a> - ed.] with the line: <blockquote class="tr_bq">"Evidence [on benefits] is limited ... Nonetheless, we believe there are substantial benefits that can be obtained by eligible hospitals and EPs ... There is evidence to support the cost-saving benefits anticipated from wider adoption of EHRs."</blockquote> I am deeply impressed by the level of rigorous science here.  We are truly in a golden age of science.  [That is obviously satirical - ed.]</blockquote> The Final Rule for MU Stage 2, via the admissions made by it regarding limited evidence, is in fact a tacit admission that the whole national health IT enterprise is a huge experiment (involving human subjects, obviously).  It is likely the most forthright admission we will get from this government on that issue. With neither explicit patient informed consent nor a formal regulatory process to validate safety, but merely based on a "we believe" justification from the government, hospitals and practices are leaving themselves wide open to liability in the situation of patient injury or death caused by, or promoted by, this technology. (Parenthetically, I note that I've already seen a claim in a legal brief that "certification" implies safety and a legal indemnification, and that the federal HITECH act - that as in this report merely provides statutory authority to the incentive program - pre-empts common-law i.e., state litigation over health IT.  The judge dismissed the claims.) -- SS Aug. 30, 2012 addendum: A commenter pointed out that experiments on minors without consent might constitute an even more egregious action, subject to even more stringent laws (and perhaps penalties, I add) than on adults.   I cannot confirm that, but it is an interesting observation.  If you are an attorney, please comment, anonymously or otherwise. -- SS

A Tacit Admission That National Health IT is a Gargantuan Experiment

In my post yesterday " The Scientific Justification for Meaningul Use, Stage 2 " I wrote: There's no truly robust evidence of ...

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The Scientific Justification for Meaningul Use, Stage 2: The NWB Methodology

The Final Rule for Meaningful Use Stage 2 has been released.  It is at <a href="http://www.ofr.gov/OFRUpload/OFRData/2012-21050_PI.pdf" target="_blank">this link</a> (PDF).  It is a mere 672 pages in length, a quick read during one's evenings of leisure. Here is, from page 18 verbatim, the scientific justification for the program.  The finest scientific methods were used to achieve these criteria in justification of spending of $15 billion of taxpayer money in "incentives" (probably a low estimate), not counting the additional hundreds of billions the buyers themselves will spend that is diverted from your healthcare to the IT sector: <blockquote class="tr_bq">3. Summary of Costs and Benefits This final rule is anticipated to have an annual effect on the economy of $100 million or more, making it an economically significant rule under the Executive Order and a major rule under the Congressional Review Act. Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the final rule. The total Federal cost of the Medicare and Medicaid EHR Incentive Programs between 2014 and 2019 is estimated to be $15.4 billion (these estimates include net payment adjustments for Medicare providers who do not achieve meaningful use in 2015 and subsequent years in the amount of $2.1 billion). In this final rule we have not quantified the overall benefits to the industry, nor to EPs, eligible hospitals, or CAHs participating in the Medicare and Medicaid EHR Incentive Programs. Information on the costs and benefits of adopting systems specifically meeting the requirements for the EHR Incentive Programs has not yet been collected and information on costs and benefits overall is limited.  Nonetheless, we believe there are substantial benefits that can be obtained by eligible hospitals and EPs, including reductions in medical recordkeeping costs, reductions in repeat tests, decreases in length of stay, increased patient safety, and reduced medical errors. There is evidence to support the cost-saving benefits anticipated from wider adoption of EHRs.</blockquote> There's no truly robust evidence of generalizable benefit, no randomized trials, there's <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">significant evidence to the contrary</a> (that, incidentally, is deliberately being ignored), there's risk to safety that this disruptive technology causes in its present state (but the magnitude is unknown, see quotes from 2012 IOM study <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">here</a>) that MU and "certification" <a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html" target="_blank">do not address</a>, there's a plethora of <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">hair-raising defect reports</a> from the only seller that reports such things, but CMS justifies the program with the line: <blockquote class="tr_bq">"Evidence [on benefits] is limited ... Nonetheless, we believe there are substantial benefits that can be obtained by eligible hospitals and EPs ... There is evidence to support the cost-saving benefits anticipated from wider adoption of EHRs."</blockquote> I am deeply impressed by the level of rigorous science here.  We are truly in a golden age of science. I recommend NIH, NSF, FDA and all other research and regulatory agencies immediately adopt this rigorous HHS methodology (called the "NWB" methodology for "nonetheless we believe") in their professional pursuits and research grant approval processes. -- SS

The Scientific Justification for Meaningul Use, Stage 2: The NWB Methodology

The Final Rule for Meaningful Use Stage 2 has been released. It is at this link (PDF). It is a mere 672 pages in length, a quick read dur...

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Parallels Between the Anechoic Effect in Finance and in Health Care: Predator Nation by Charles Ferguson

What has gone wrong with health care now seems to be the same as what has gone wrong with finance, and society at large.  This was not always obvious to those of us toiling in medicine, probably because we were so focused on medicine that we paid too little attention to the larger world around us.  The people I interviewed in preparation for writing A Cautionary Tale, [Poses MD. A cautionary tale: the dysfunction of American health care.  Eur J Int Med 2003; 14: 123-130.  Link <a href="http://www.ejinme.com/article/S0953-6205%2803%2900029-3/abstract">here</a>.] identified broad issues that helped characterize American health care dysfunction.  Neither they nor I, however, initially thought that these problems were tied to the broader society.  In fact, I often wondered back then why health care, and it seemed particularly academic medicine, was so uniquely cursed. Now it seems obvious in retrospect that health care, finance, politics, and society are circling the same drain.  Now there has been enough time since the beginning of the great recession/ global financial collapse for some people to describe the larger problems. The Anechoic Effect We have frequently discussed what we called the "<a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>" in health care.  In short, this meant that discussing the big problems in health care, particularly those involving leadership and governance, was simply not done, particularly by the academics who could have addressed the problem.  Lots of examples of the anechoic effect are <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">here</a>.  We have postulated that this has to do with fear of offending the rich and powerful who now lead and govern health care organizations, and the benefits, which may be produced by conflicts of interest, of maintaining good relationships with these rich and powerful. Charles Ferguson in Predator Nation on the Anechoic Effect Meanwhile, the anechoic effect was a big reason that finance became such a big mess.  Charles Ferguson, as we have previously discussed, has been one of the most insightful commentators on the great recession/ global financial collapse, starting with his Academy Award winning documentary <a href="http://www.sonyclassics.com/insidejob/">Inside Job</a>. <iframe allowfullscreen="allowfullscreen" frameborder="0" height="315" src="http://www.youtube.com/embed/FzrBurlJUNk" width="560"></iframe> This year he published <a href="http://www.amazon.com/Predator-Nation-Corporate-Corruption-ebook/dp/B005DXOQMC">Predator Nation</a> (Ferguson C. Predator Nation: Corporate Criminals, Political Corruption, and the Hijacking of America. New York: Crown Business, 2012.) a more complete account of our financial disaster.  It has a section on what we on Health Care Renewal would call the anechoic effect, and how it is driven by perverse incentives (pp 81-82) : <blockquote>You see a horrific train wreck in the making, with all your coworkers contributing to it. But they are all making a fortune, and their manager - who is your boss too - is making even more money by keeping it going. Quite obviously, they're going to keep doing it whether you participate or not; so even if you refuse to participate, the firm will be dead anyway. You can try to stop it by going over your boss's head to the CEO; but your boss won't like that at all, and he and the entire department will tell the CEO whatever they need to tell him in order to keep it going. And if - speaking purely hypothetically - your CEO is an oblivious, selfish, obnoxious egomaniac nearing retirement age, heavily focused on his golf game and art collection, with a few hundred million in cash already stashed away, scheduled to rake in another $50 million this year, whose contract guarantees him another $100 million if he loses his job - well, then he probably won't be very sympathetic to you either. You could try going to the board of directors, but even if you could reach them, it will turn out that they are old pals of the CEO, often stunningly clueless, picked largely so that they won't rock the boat. So if you try to stop the party, you'll probably get marginalized or fired, as happened to a number of serious, ethical people who tried to warn their management and curtail unethical and illegal conduct in Merrill Lynch, Lehman, Citigroup, AIG and elsewhere. So you'd gain nothing by acting ethically - quite the contrary, you'd ostracize yourself and lose your chance to build (or rather, transfer to yourself) some real personal wealth - possibly once-in-a-lifetime opportunity.</blockquote> Summary: the Application to Health Care, and What Must be Done to Change Things So consider how much of this might apply to a) serious, ethical employees of large health care corporations, and b) health care professionals who are employees of large health care non-profits, and/or have major financial relationships (conflicts of interest) with large health care corporations.  Regarding the latter, think of the health care professionals who worked at the <a href="http://hcrenewal.blogspot.com/search/label/AHERF">Allegheny Health Education and Research Foundation</a> (AHEF) back in the 1990s, and who were told by their multi-millionaire CEO,  <a href="http://www.post-gazette.com/aherf/part6.asp">"Don’t cross me or you will live to regret it."</a>  How inclined would they have been to blow the whistle on his supposedly "visionary" leadership?  On Health Care Renewal, we have posted lots of relevant newer examples of bad behavior by wealthy leaders of drug, device, biotechnology, health care information technology, and health insurance companies.  We have also posted lots of relevant newer examples of bad behavior within hospital systems and academic medical centers.  Yet most of these generated little resistance from within the organizations at the time they were occurring, and those who did try to blow the whistle often did not fare very well.  The biggest issue is clearly that if you are in a system which may hugely award clueless, or bad behavior (i.e., that has perverse incentives), then those who might protest will be effectively silenced by those who are profiting from the status quo. Combating this would require serious outside regulation to discourage perverse incentives and conflicts of interest, serious law enforcement to prosecute any resulting fraud, bribery, etc, and serious protection of whistleblowers, just for a start. All are currently lacking in finance, and in health care. But if we do not put such measures in place, the downward spirals in health care and finance will just continue. Do not expect to see much discussion of these issues in health care or finance in the current political debate, unless those currently outside of the debate break the anechoic effect and inject them into the debate.

Parallels Between the Anechoic Effect in Finance and in Health Care: Predator Nation by Charles Ferguson

What has gone wrong with health care now seems to be the same as what has gone wrong with finance, and society at large. This was not alway...

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