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Putting Finance Executives in Charge of Health Care? - What Could Possibly Go Wrong?

A US News and World Report <a href="http://health.usnews.com/health-news/hospital-of-tomorrow/articles/2014/01/28/wanted-hospital-ceos-without-health-care-experience">article</a> affirms what we have <a href="http://hcrenewal.blogspot.com/2013/12/health-care-experience-hospital-ceos.html">previously written</a>, that those charged with the stewardship of US hospitals are even more inclined now to hire top managers with little or no health care experience or credentials.  Putting Finance Managers in Charge They particularly seem to favor executives drawn from the world of finance. Just to make it really clear, the exposition started with the article title, <blockquote class="tr_bq">Wanted: Hospital CEOs Without Health Care Experience </blockquote> The article drew on some of the figures about executive hiring which we <a href="http://hcrenewal.blogspot.com/2013/12/health-care-experience-hospital-ceos.html">discussed</a> in December, 2013, <blockquote class="tr_bq">It’s expected that two-thirds of hospital CEOs hired this year will have little to no health care experience, according to Black Book Rankings, which last year conducted a poll of 1,404 human resource officers and board members of health care organizations</blockquote> However, the new article profiled some examples, <blockquote class="tr_bq">.When Carlos Migoya was hired in May 2011 to run Jackson Health System, Miami-Dade County’s safety net hospital system, he had no health care experience. A career banker, Migoya took over.....</blockquote> Also, <blockquote class="tr_bq">Mike Keating, CEO of Christ Hospital in Cincinnati, previously was an investment banker.;Robert Meyer, president and CEO of Phoenix Children's Hospital, came from the consulting world;... </blockquote> The article stressed that hospital boards think a background in finance is particularly valuable. <blockquote class="tr_bq">Hospital board and HR directors are looking for non-industry productivity, business development and financial management experts with heavy technological expertise. </blockquote> Also, <blockquote class="tr_bq">[executive vice president and managing principle at Cejka Executive Search. Paul]  Esselman  notes that boards increasingly 'are looking at leaders from managed care, the payer side or from finance or banking.'</blockquote> Why Hospital Boards Favor Finance Executives <blockquote class="tr_bq">banking, like health care, is heavily regulated and that two decades ago banking went through significant consolidation, which hospitals today face.</blockquote> So, <blockquote class="tr_bq">[ managing partner of Black Book Rankings Doug] Brown says leaders that come from productivity-focused fields and sectors that have endured consolidation are particularly suited for running hospitals today. Those in financial services may prove useful in today’s climate, as 'there are a lot of troubled hospitals,' he says.</blockquote> As we <a href="http://hcrenewal.blogspot.com/2013/12/health-care-experience-hospital-ceos.html">noted before</a>, the article suggested that those who hire hospital executives think their most important challenges s included  - <blockquote class="tr_bq">'Communication is now more important than ever,; says Paul Esselman</blockquote> <blockquote class="tr_bq">the opportunities come in delivering its service or business lines to ever-expanding distribution channels.</blockquote> <blockquote class="tr_bq">says [former investment banker Mike] Keating. 'The key in health care is how you go about executing and executing well.'</blockquote> <blockquote class="tr_bq">[former banker Carlos] Migoya put in place operational reforms, including bringing in 'a lot of people with for-profit experience' to maintain expense controls, monitor operations, collect payments more quickly and pay its own bills sooner to gain prompt-payment discounts. Then, 'we realigned procurement,' he says, adding 'we motivate our procurement department with incentives,' which 'dramatically improved' Jackson Health’s process, time and costs. Meanwhile, the system outsourced pharmaceutical management, saving $15 million a year.... </blockquote> Note that these examples are all about management process and financial outcomes, NOT about clinical processes, quality of care, or patient outcomes.  (The only mention of anything close to clinical management was a plan to outsource same.) Left unsaid is that the boards charged with the stewardship of hospitals are now mainly composed of business executives, often heavily weighted with those in finance.  Summary - What Could Go Wrong? Of course, former bankers, and others from the world of <a href="http://hcrenewal.blogspot.com/search/label/finance">finance </a>may not really know much about clinical work, quality of care, or patient outcomes.  They may not have been picked because they care about such issues, nor socialized with the "patient first" mantra which health professionals are supposed to support.  Worse, it seems that those who choose hospital executives may not be thinking about the recent history of finance.  True, it shares with health care the presence of regulation and increasing consolidation.  However, as we all started to realize in 2008, the leaders of finance helped bring on the worst financial crisis since the great depression.  More than five years since the beginning of this new great recession, US median income is dropping adjusted for inflation, while income inequality has tremendously increased.  Finance executives have been prime proponents of <a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a>, the theory that increasing shareholder value, which really seems to translate into increasing organizational short term income and increasing executive compensation are more important than any other outcomes.  Thus seems to correspond to the discussion above about financial and management objectives sans any notion of what is good for patients. Even more disturbing is all the anecdotal evidence that business management, particularly in finance, has been gripped by overarching greed.  Pope Francis called it the "idolatry of money."  (look <a href="http://www.washingtonpost.com/business/economy/pope-francis-denounces-trickle-down-economic-theories-in-critique-of-inequality/2013/11/26/e17ffe4e-56b6-11e3-8304-caf30787c0a9_story.html">here</a>). In his graphic <a href="http://www.nytimes.com/2014/01/19/opinion/sunday/for-the-love-of-money.html">memoir</a> of his days as a successful Wall Street trader, Sam Polk called it wealth addiction, .  <blockquote class="tr_bq">I noticed the vitriol that traders directed at the government for limiting bonuses after the crash. I heard the fury in their voices at the mention of higher taxes. These traders despised anything or anyone that threatened their bonuses. Ever see what a drug addict is like when he’s used up his junk? He’ll do anything — walk 20 miles in the snow, rob a grandma — to get a fix. Wall Street was like that. In the months before bonuses were handed out, the trading floor started to feel like a neighborhood in 'The Wire' when the heroin runs out.</blockquote> He was not the first to describe wealth addiction: <blockquote class="tr_bq"> Wealth addiction was described by the late sociologist and playwright Philip Slater in a 1980 book, but addiction researchers have paid the concept little attention. Like alcoholics driving drunk, wealth addiction imperils everyone. Wealth addicts are, more than anybody, specifically responsible for the ever widening rift that is tearing apart our once great country. Wealth addicts are responsible for the vast and toxic disparity between the rich and the poor and the annihilation of the middle class. Only a wealth addict would feel justified in receiving $14 million in compensation — including an $8.5 million bonus — as the McDonald’s C.E.O., Don Thompson, did in 2012, while his company then published a brochure for its work force on how to survive on their low wages. Only a wealth addict would earn hundreds of millions as a hedge-fund manager, and then lobby to maintain a tax loophole that gave him a lower tax rate than his secretary.</blockquote> Physicians swear oaths to put patient care ahead of all else.  While we may be far from perfect in our adherence to these oaths, I would like to think that when health care organizations were lead by health professionals, many tried to put patient care first  Yet professional managers, not health care professionals now lead health care. .In 1988, Alain Enthoven advocated in <a href="http://www.amazon.com/gp/product/0444703594/102-6581115-0444916?n=283155">Theory and Practice of Managed Competition in Health Care Finance</a>, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post <a href="http://hcrenewal.blogspot.com/2006/03/consequences-of-breaking-physicians.html">here</a>). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post <a href="http://hcrenewal.blogspot.com/2005/04/growing-proliferation-of-managers.html">here</a>). As we noted <a href="http://hcrenewal.blogspot.com/2013/09/a-plague-of-bureaucrats-now-10-per.html">here</a>, the growth continued, so there are now 10 managers for every US physician. The managers who first took over health care may have had some health care background.  Now it seems that health care managers are decreasingly likely to have any health care background, and increasingly likely to be from the world of finance.  Can anyone seriously believe that finance managers taught to put short-term revenue first, and who may often be wealth addicts who practice the idolatry of money in charge of health care is going to improve anything other than those same managers' wealth? As I have said before,  true health care reform would put in place leadership that understands the health care context, upholds health care professionals' values, and puts patients' and the public's health ahead of extraneous, particularly short-term financial concerns. We need health care governance that holds health care leaders accountable, and ensures their transparency, integrity and honesty. But this sort of reform would challenge the interests of managers who are getting very rich off the current system.  So I am afraid the US may end up going far down this final common pathway before enough people manifest enough strength to make real changes.

Putting Finance Executives in Charge of Health Care? - What Could Possibly Go Wrong?

A US News and World Report article affirms what we have previously written , that those charged with the stewardship of US hospitals are ev...

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The CareFusion/ Denham/ NQF Case - the Plot Thickens

The story about CareFusion, its financial relationships with Dr Charles Denham, and his alleged role in promoting a CareFusion product through standards produced by the National Quality Forum has gotten even more complicated.  This means that the tasks faced  by National Quality Forum leaders who asserted their intent to improve their conflicts of interest policy in response to this case just got more complex. Background As we most recently discussed <a href="http://hcrenewal.blogspot.com/2014/01/putting-in-ski-lifts-national-quality.html">here</a>, the basics of the case were: -  The case became public with an apparently routine legal settlement between CareFusion and the US Department of Justice  -  the CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote <a href="http://www.carefusion.com/medical-products/carefusion-brands/chloraprep/">ChloraPrep</a>, a solution meant for preoperative and other health care skin cleaning -  the Department of Justice <a href="http://www.justice.gov/opa/pr/2014/January/14-civ-021.html">news release</a> also alleged that payments were made to a corporation called Health Care Concepts to conceal kickbacks made to its owner, Dr Charles Denham -  the implication was that Dr Denham was supposed to influence a standard writing committee run by the National Quality Forum, a well known organization that promotes quality improvement, issues authoritative practice standards, a form of clinical practice guidelines, and has contracts with the US government for quality of care activities -  the draft of the standard written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision -  NQF leaders asserted that after hearing of the case from the DOJ, the organization severed ties with Dr Denham and the non-profit organization he runs,  established a policy not to accept money from funding organizations whose leaders are on its committees, reviewed all the standards set by the committee of which Dr Denham was co-chair, and twice revised its conflict of interest policy. I opined that the NQF response to this case was more open and pro-active than responses by many other organizations to cases involving conflicts of interest, although there was still room for the NQF to further strengthen its conflict of interest policies. The Plot Thickens Since last week, three more articles on the case have appeared, in <a href="http://www.modernhealthcare.com/article/20140125/MAGAZINE/301259961">Modern Healthcare</a>, the <a href="http://commonhealth.wbur.org/2014/01/patient-safety-scandal-carefusion">WBUR CommonHealth blog</a>, and on <a href="http://www.propublica.org/article/hidden-financial-ties-rattle-top-health-quality-group">ProPublica</a>.  These pointed out additional disturbing aspects of the case. Dr Denham's and CareFusion's Relationships with the NQF Were Even More Complex than Heretofore Revealed According to ProPublica, <blockquote class="tr_bq">in response to questions from ProPublica, the Quality Forum divulged that Denham’s nonprofit was one of its contributors, and that in 2007 and 2008 it received $485,000 in donations from a foundation affiliated with Cardinal Health, a company that spun off CareFusion in 2009.</blockquote> Also, <blockquote class="tr_bq">Between 2006 and 2009, Denham’s nonprofit donated $725,000 to the Quality Forum. The group and Denham had a five-year contract, but the Quality Forum declined to provide a copy or explain the terms, saying only that <a href="http://www.qualityforum.org/News_And_Resources/Press_Releases/2014/NQF_Statement_on_Department_of_Justice_Settlement.aspx">it was ended three years early</a>, in 2010, after concerns about Denham emerged. </blockquote> Not only did the non-profit help fund the NQF, it was directly involved in relevant NQF activities, <blockquote class="tr_bq">According to [Dr Denham's attorney Lawrence] Gondelman, Denham’s nonprofit was obligated to provide financial and staff support for Quality Forum projects, including evidence-based medicine reviews, hosting webinars and creating multimedia presentations about the safe practice recommendations. </blockquote>  Furthermore, while the NQF asks committee members to disclose conflicts of interest verbally at the start of each meeting, again according to ProPublica, <blockquote class="tr_bq">Both [Dr Patrick] Romano and Dr. Peter Pronovost, who leads a patient safety institute at Johns Hopkins Medicine, said they had been unaware of Denham’s financial ties with CareFusion. Quality Forum officials said Denham never reported them, nor did he mention them during the 2009 meeting when members were asked to disclose their financial relationships, the transcript shows. 'He clearly lied,' Dr. Christine Cassel, the Quality Forum’s president and CEO told ProPublica. 'He just didn’t say anything about any of his business relationships.'</blockquote> The Clinical Evidence in Support of the CareFusion Product Denham Touted was Dubious According to ProPublica's review of a transcript of the meeting about the NQF standards that Denham co-chaired, <blockquote class="tr_bq">At the safe practices committee session on Aug. 19, 2009, Denham twice appears to reference the New England Journal of Medicine study, the meeting transcript shows. Although he did not cite the study or ChloraPrep by name, Denham remarked that research to be published soon in a 'major journal' would show the effectiveness of the 2 percent chlorhexidine antiseptic. CareFusion's ChloraPrep is apparently the only well known 2 percent chlorhexidine antiseptic. However, the same article pointed out that the study too was affected by conflicts of interest. Its authors "all reported ties to Cardinal Health,' the company from which CareFusion was spun off.  Furthermore, ProPublica charged that Dr Denhams company was involved with the financing of that study.</blockquote> Also, per an interview with Brian Johnson, publisher of MassDevice.com, WBUR reported: <blockquote class="tr_bq">the government says there are several ways this study did not use accepted protocols. For example, a member of the company’s sales and marketing staff reviewed the data from the clinical trial and edited the final study. Prosecutors also say the company failed to 'review, evaluate and report safety information' and failed to obtain and maintain accurate records showing all financial transactions from CareFusion to Dr. Rabih Darouiche, the lead investigator on the study.</blockquote> Thus, it appears that this study may have been <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulated</a> (in particular, by a company marketer's editing) to make its sponsor's product look more favorable (in this case, particularly by ignoring data about safety and adverse effects)  NQF Went Farther to Endorse CareFusion's ChloraPrep than Was Heretofore Appreciated  According to the WBUR interview, <blockquote class="tr_bq">The NQF didn’t adopt a recommendation of Chloraprep but Denham hosted webinars with Dairouche under the NQF brand for hospital staffers that absolutely endorsed Chloraprep. So while it didn’t end up in the official financial recommendations, there certainly was influence. </blockquote> However, according to ProPublica things were even more complicated.  Denham promoted ChloraPrep in not one, but two instances, <blockquote class="tr_bq">At the safe practices committee session on Aug. 19, 2009, Denham twice appears to reference the New England Journal of Medicine study, the meeting transcript shows. Although he did not cite the study or ChloraPrep by name, Denham remarked that research to be published soon in a 'major journal' would show the effectiveness of the 2 percent chlorhexidine antiseptic. [Dr Peter] Pronovost said it wasn’t necessary to actually identify ChloraPrep because it was well known as the product with the 2 percent chlorhexidine formulation. The committee members agreed that chlorhexidine was an effective antiseptic – guidelines by the Centers for Disease Control and Prevention (CDC) say so as well. But studies show it also works in other concentrations and combinations. Discussion turned to recommendations for preventing infections caused by central lines, the thin tubes inserted into a vein to deliver fluids or medications. Dr. Gregg Meyer of Massachusetts General Hospital in Boston, the co-chair of the committee with Denham, brought up the forthcoming study. 'Chuck (Denham) made me aware of it,' Meyer said. He then asked Pronovost, a leading expert on preventing central-line infections, what he thought</blockquote> The final report did delete the specific reference to ChloraPrep as the preferred method for preparing surgical sites, <blockquote class="tr_bq">.After the meeting, when the committee’s draft report was published in late 2009, a recommendation for preparing surgical sites to prevent infection did not name ChloraPrep but did specify its telltale formula – a 2 percent chlorhexadine and alcohol antiseptic. That draft recommendation was challenged by 3M, a company that makes a competing product. A scientific review of the evidence by a Quality Forum ad hoc committee found a lack of clear evidence to support one skin prep product over another. As a result, the recommendation to use the ChloraPrep formulation on surgical sites didn’t make it into the final 2010 safe practices report. </blockquote> However, the final report did appear to endorse ChloraPrep for reduction of central line infections, <blockquote class="tr_bq"> On the separate issue of reducing central-line infections, the 2009 draft report endorsed a chlorhexidine antiseptic but did not specify any one concentration – just as the committee decided. Yet the final 2010 report does call for a 2 percent chlorhexidine and alcohol antiseptic like ChloraPrep. </blockquote> Also, again per ProPublica, the NQF seemed to have been roped into other efforts run by Dr Denham to promote ChloraPrep, <blockquote class="tr_bq">Although Quality Forum officials seemed surprised to learn this last week from ProPublica, the group is listed as a co-host, with Denham’s nonprofit, of a webinar where the 2010 safe practices guidelines for central-line and surgical site infections are presented. The presentation, <a href="http://www.safetyleaders.org/downloads/WebinarNQFSafePractices_PanelistSlides_Feb_18_2010_Handout.pdf">posted on the website</a> of Denham’s nonprofit, states that the Quality Forum recommends the ChloraPrep formulation to protect against both central-line and surgical site infections.     CareFusion also cites the Quality Forum’s endorsement in at least one brochure <a href="http://www.carefusion.com/pdf/Interventional_Specialties/Thora-Para_catheter_drainage_system_brochure-IS2391.pdf">on its website</a>.</blockquote> Summary: a Longer Row to Hoe It looks like NQF will have to deal with even more specifics if it wants to prevent future compromises of its standards due to conflicts of interest and manipulation of the clinical research evidence base. It will have to consider: -  Whether individual disclosures of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> can be trusted -  Whether it is prepared to deal with the apparently nearly infinite variety of conflicts that creative minds can produce to promote vested interersts -  How to be appropriately skeptical of clinical evidence used to devise standards when such evidence is now so susceptible to <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> and/or <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> to further vested interests -  How to better recognize the various kinds of machinations that the conflicted may endeavor to promote their interests Again, my question is whether it may just be better to ban individuals with conflicts of interest from roles in which they may influence standards in favor of vested interests, rather than continuing to try to "manage" the complex web of conflicts and the actions they may produce generated by an increasingly commercialized and simultaneously poorly regulated health care system. By the way, if anyone in other organizations is sitting back thinking this is just an NQF problem, they ought to think again.  As we have discussed, the web of conflicts of interest, both individual and <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional</a>, is vast, and the extent of manipulation and suppression of the clinical research base is equally vast.  Every health care decision maker, health policy decision maker, and health care organization is confronted by similar problems which may differ only in the details. Again, I applaud the NQF for trying to deal with these issues upfront, and hope that others will learn from the lessons this case provides.

The CareFusion/ Denham/ NQF Case - the Plot Thickens

The story about CareFusion, its financial relationships with Dr Charles Denham, and his alleged role in promoting a CareFusion product throu...

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Martin Health System, Florida: Our EHRs were out for two days, but patient care has not been compromised, sayeth Pinocchio

This is yet another post in my ever-growing "our EHRs went out due to IT incompetence, and chaos ensued, but patient care has not been compromised" series (see query link: <a href="http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised">http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised</a>): <div class="fontStyle4 storyFontResize"><div class="story last"> <blockquote class="tr_bq">Martin Health System looking into network outage that slowed hospital operations Posted: 01/24/2014 By: Meghan McRoberts <a href="http://www.wptv.com/dpp/news/region_martin_county/martin-health-system-looking-into-network-outage-that-slowed-hospital-operations">http://www.wptv.com/dpp/news/region_martin_county/martin-health-system-looking-into-network-outage-that-slowed-hospital-operations</a> MARTIN COUNTY, Fla.-- Martin Health System is looking into what caused some computer hardware to fail Wednesday, leading to network outage in all of the Martin Health System hospitals. Things were back to normal Friday morning, according to hospital spokesperson, Scott Samples. </blockquote> Translation: for two days there was a complete network outage, with no EHRs, email, CPOE etc. <blockquote class="tr_bq">But since Wednesday night patients say the atmosphere around the hospital was chaotic.</blockquote> Patients likely noted doctors and nurses running like headless chickens.  I note that chaos and safe medical care are not good bedfellows. <blockquote class="tr_bq">Hospital staff, doctors and nurses access the computer system to read patient charts and medical information. Without it, they were left digging into paper documents.</blockquote> The paper documents left laying around would have best had scanty, sparse patient information, since the computer in computerized hospitals has become the primary source of truth.  (One might think such a system, including the network, would be hardened against failure, but a two-day outage, as per other outages at the query link above, show this is often not the case.) <blockquote class="tr_bq">Samples says this led to some minor inconveniences around the hospitals, where some patients received their meals later than normal. Some outpatient appointments could not be scheduled, and extra nurses and administrative staff were brought in to help with the increased work load. No medication or treatment was jeopardized.</blockquote> There we have it.  In Pinocchio-like fashion we hear the obligatory "we lost all our information systems, which are our central nervous system for patient care, but patient care has not been compromised" statement from hospital PR.  This statement is questionable on its face.  The risk of accident was significantly increased on its face. <blockquote class="tr_bq">New patients information was taken down on paper, and put into the system on Friday. Samples says there was a back up computer for data from former patients.</blockquote> The future will be in question depending on the quality, or lack thereof, of this "backload" of patient information that was collected during what patients themselves described as "chaos." Of course, according to the IT pundits paper itself, even under ideal circumstances, is so risky that tens or hundreds of millions of dollars per hospital has been spent to replace it.  Someone is not being truthful. <blockquote class="tr_bq">The hospitals that experienced the outage were Martin Medical Center, Martin Hospital South, and Tradition Medical Center.</blockquote> But patient safety risk was not compromised at any of them, so sayeth the figure below. <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/AVvXsEijzbyCRlWSocm_NxvqQwFGt3O9mxxjuSB3JRvq8pGtmEXlJvFwuCpQUINhi6ytR9f43tEIvHDKYNM0BIvvoMEfHnmmIlBzNkAq_yNGg7JYQx2M3b2TR_ViEXeUXiQEEg29GDSf72wQfK3i/s1600/Pinnochio.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEijzbyCRlWSocm_NxvqQwFGt3O9mxxjuSB3JRvq8pGtmEXlJvFwuCpQUINhi6ytR9f43tEIvHDKYNM0BIvvoMEfHnmmIlBzNkAq_yNGg7JYQx2M3b2TR_ViEXeUXiQEEg29GDSf72wQfK3i/s1600/Pinnochio.jpg" width="152" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">All our EHRs and other clinical IT were unavailable for two days ... patients reported chaos ... we had to delay or cancel appointments and bring in extra clinical staff to maintain order ... but patient safety was not compromised, except for some late lunches!</td></tr></tbody></table> Pinocchio must be working at a lot of hospitals. When EHRs are out, patient safety is compromised. This is not open for debate, it is an "on its face" issue. These systems need hardening so as to be up and available 100%. Period. People responsible for outages need to be held accountable, including in a court of law if patients are injured or die as a result. Period. Finally I note that, with the corporatization of healthcare and with population of executive offices by lightweights with unquestioning faith in "cybernetic miracles", the credo of my early 1970's medical mentor, cardiothoracic surgery pioneer and educator Victor P. Satinsky, MD (<a href="http://articles.philly.com/1997-09-13/news/25550525_1_cardiovascular-institute-cardiovascular-surgery-programs-for-young-people">link</a>) - "Critical thinking, always, or your patient's dead" - is more valuable than ever. -- SS <div><div class="fontStyle10" id="copyrightStoryModule"> </div></div></div></div>

Martin Health System, Florida: Our EHRs were out for two days, but patient care has not been compromised, sayeth Pinocchio

This is yet another post in my ever-growing "our EHRs went out due to IT incompetence, and chaos ensued, but patient care has not been ...

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WINDY CITY BLUES

<div class="MsoNormal">WINDY CITY BLUES<o:p></o:p></div><div class="MsoNormal"> </div><div class="MsoNormal">There is an academic ethics mess brewing in the windy city… at The University of Chicago. It involves a start-up Chicago corporation, a star statistician in the medical school, seed money in the form of NIH research grants, the American Psychiatric Association, and the chairman of the APA’s DSM-5 Task Force. It involves the appearance of self-interested bias in the DSM-5 process. It involves a recidivist pattern of failure to disclose material conflict of interest. And it involves academic journal editors (JAMA and JAMA Psychiatry) who did not do the right thing when the perps were outed.<o:p></o:p></div><div class="MsoNormal"> </div><div class="MsoNormal">I broke the story <a href="http://hcrenewal.blogspot.com/2013/11/when-is-disclosure-not-disclosure.html">on this site</a> back in November, right after a <a href="http://archpsyc.jamanetwork.com/article.aspx?articleID=1780020">confession</a> appeared on-line in JAMA Psychiatry by the gang of five perps (Robert Gibbons, Ellen Frank, David Kupfer, Paul Pilkonis, and David Weiss) . Indeed, it was I who had alerted the journal. Others have since weighed in <a href="http://1boringoldman.com/index.php/2013/12/29/insider-trading/">here</a> and <a href="http://www.behaviorismandmentalhealth.com/2013/12/23/dsm-5-dimensional-diagnoses-more-conflicts-of-interest/">here</a> and <a href="http://www.psychologytoday.com/blog/saving-normal/201401/holding-psychiatry-much-higher-ethical-standard">here</a>, for instance. The definitive summary and Timeline were the work of Dr. John M. (Mickey) Nardo <a href="http://1boringoldman.com/index.php/2014/01/21/open-letter-to-the-apa/">here</a>. Of course, readers of JAMA Psychiatry would never know that the authors were outed. The editors (Howard Bauchner for JAMA and Joseph Coyle for JAMA Psychiatry) allowed the authors to make it seem like they were making a spontaneous admission of nondisclosure, and they acquiesced in the withholding of key information that I had given to the journal.<o:p></o:p></div><div class="MsoNormal"> </div><div class="MsoNormal">It gets worse. We now know that the chair of the DSM-5 Task Force (Dr. David Kupfer) failed to disclose his financial conflict of interest on at least 4 occasions (#s 13, 15, 16, 19 in the Nardo <a href="http://1boringoldman.com/index.php/2014/01/21/open-letter-to-the-apa/">Timeline</a>). On two of those occasions he was representing the DSM-5 team and the APA! These lapses undermine his repeated assurances that COI issues were under control in DSM-5. If the chairman of the DSM-5 Task Force does not have his own act together concerning COI disclosures, then what are his assurances worth? Nevertheless, the APA released a <a href="http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=3&ved=0CDgQFjAC&url=http%3A%2F%2Fwww.psych.org%2FFile%2520Library%2FAdvocacy%2520and%2520Newsroom%2FLetter-to-Assembly-20140114.pdf&ei=8ZTaUoLaGfSrsQSJ14GgDQ&usg=AFQjCNE--psrRvauH2Ow3Xu9VKYfv9AItQ&sig2=WFYXTx1QYMMKjrS0DfMANQ&bvm=bv.59568121,d.cWc">statement</a> that tried to whitewash Dr. Kupfer’s nondisclosures. They need to recalibrate their ethical compass.<o:p></o:p></div><div class="MsoNormal"> </div><div class="MsoNormal">The methods adopted in this affair are classic: Peddle unproven psychiatric screening scales backed up by black box statistics (a distressing specialty of Dr. Gibbons); publish a glowing report in JAMA Psychiatry, which you have infiltrated (Ellen Frank and Robert Gibbons are on the editorial board); get your corporate people inside the DSM-5 process (David Kupfer, Robert Gibbons, Paul Pilkonis); slant the DSM-5 process to endorse, however weakly, the kind of products you intend to market; start a corporation without telling anybody and establish a <a href="http://www.adaptivetestingtechnologies.com/">website </a> with advance marketing that touts your new academic publication in JAMA Psychiatry while <a href="http://www.adaptivetestingtechnologies.com/our-people.html">highlighting</a>Dr. Kupfer’s key role in DSM-5; loudly <a href="http://www.cmeinstitute.com/psychs-talk/#top">proclaim</a> (see page 4) the advent of population-wide screening but before doing any serious field trials or acknowledging that most positive screens will be false positives. This is the usual dodgy hand waving of wannabe entrepreneurs, whose vision is obscured by dollar signs. Oh, and did I mention regulatory capture of NIMH for <a href="http://1boringoldman.com/index.php/2014/01/19/what-2/">over $11 million</a> in funding while not producing a product worth a tinker’s damn? <o:p></o:p></div><div class="MsoNormal"> </div><div class="MsoNormal">In response to all this adverse commentary, the authors and the journal editors have gone to radio silence. They must be hoping it will blow over.  If anything, their silence has provoked even more searchlight questions that focus on what is happening at The University of Chicago. <o:p></o:p></div><div class="MsoNormal"> </div><div class="MsoNormal">For instance, who is bankrolling this start-up corporation? Last summer they brought on board an executive named Yehuda Cohen who is a mover and shaker in Chicago business circles. I am sure he doesn’t work for peanuts. He set up a <a href="http://www.adaptivetestingtechnologies.com/">website</a> that must be staffed to respond to queries from consumers and professionals. Plus, the corporate office appears to be located in prime commercial space at 217 N Jefferson #600, Chicago IL 60661; phone 312-878-6490. E-mail: <a href="mailto:info@adaptivetestingtechnologies.com">info@adaptivetestingtechnologies.com</a>(from the website: you can find a picture of the neighborhood on Google). So, they are racking up significant operating expenses already. Heaven forfend that these expenses might be covered directly or indirectly by their NIMH funding! Are the responsible administrators at NIMH and at The University of Chicago looking and auditing?<o:p></o:p></div><div class="MsoNormal"> </div><div class="MsoNormal">It is also unclear whether they have a sound or even a legal business plan. Where will the high powered computing needed for their expansive applications be conducted? Do they have a computing facility at the corporate office? Or do they intend to perform the commercial computing through the NIH-supported Center for Health Statistics at The University of Chicago, which Dr. Gibbons personally directs? If so, did the University sign off on that plan? Is NIH aware of the plan?<o:p></o:p></div><div class="MsoNormal"> </div><div class="MsoNormal">In late November I asked NIH about the ownership of the data bases and algorithms on which the corporation relies for the business plan. I received a reply from NIH outlining the applicable federal policy and stating “We understand that the data are deposited and made available to the community per request through the Center for Health Statistics.” That had to be what Dr. Gibbons told them. Notice that no mention was made of the algorithms. I have replied to NIH, asking them to clarify the status of the algorithms, without which the data bases alone are of little use. I also pointed out to NIH that there is no mention of this public access option in any of the publications from these authors or on the corporate website. This situation is typical of the dissembling style we have seen before from Dr. Gibbons and Dr. Kupfer – lacking in candor and transparency.</div> <div class="MsoNormal">The more one looks, the more questions arise. Is The University of Chicago being taken for a ride? Is NIMH being taken for a ride? Are we all being taken for a ride? Can we please have some transparency here? Can we please have some psychometric standards here? Will the APA step up to the plate? Will NIH step up to the plate? Will The University of Chicago step up to the plate?<o:p></o:p></div>

WINDY CITY BLUES

WINDY CITY BLUES There is an academic ethics mess brewing in the windy city… at The University of Chicago. It involves a start-up Chicago co...

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Physician whose mother had heart surgery reflects on sane EHR use

The following from a physician I know, an ED physician, on the care their mother received at a major academic medical center's teaching hospital using EHR. Emphases mine: <blockquote class="tr_bq">Mom just had aortic valve at hospital [name redacted] associated with [redacted] Medical School.  EHR used was [major EHR vendor name redacted] but it clearly had been pushed into the background...... 1) Every ICU patient also had a printed chart in a notebook (paper) medical record book kept at the nursing station.  Just like the old days. It was the most commonly used source of info to the residents and staff. 2) Not once did I see an EHR physically come between a patient and a staff member (as opposed to nearly every encounter where I work). 3) Mom's (and every ICU patients) plan for the day was outlined in magic marker directly on the glass doors and windows and updated during rounds....available for immediate reference, not buried in an EHR. 4) Her clinical info was accurate....... it was dictated and not fabricated from pick lists or dot phrases. 5) Clerks put in the data and Dr's orders......apparently they long ago figured out the nonsense called CPOE and let the clerks do it. I suspect many major University hospitals have worked around the workflow barriers and most egregious documentation sins.  The doctors there (at least in that Cardiothoracic ICU) have enough clout that they can just say HELL NO.  Those of us working for less astute/ non cutting edge community hospitals run by "also ran" healthcare corps are left to bear the crosses ONCHIT and the EHR industry have dumped upon us. I am grateful to the folks at [hospital] for an excellent job on my mom and demonstrating that efficient healthcare pushes the EHR (as currently sold and configured) to the back burner. Oh, [EHR name redacted] still is loaded with those prefilled templates and copy/ paste pull forward geared for upcoding.....but these "top of the food chain" docs just didn't waste their time with them.</blockquote> Having had to gut and remediate really, really terrible health IT for invasive cardiology and cardiac surgery years ago (<a href="http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story">http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story</a>), and revise workflows to relieve busy clinicians with critically-ill patients from the stupidity and time-sink of fiddling with balky computers with poorly-designed software, I identify with this physician's observations and beliefs. As I've stated in previous posts, most clinicians need to be relieved of clerical tasks associated with computers, especially data entry and ordering, not just surgeons. If the data is really that valuable, hiring clericals to do clerical work should remain a true bargain, with massive return on investment. If that is not the case, then the data is really not that valuable. -- SS

Physician whose mother had heart surgery reflects on sane EHR use

The following from a physician I know, an ED physician, on the care their mother received at a major academic medical center's teaching ...

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Putting in the Ski Lifts - National Quality Forum Leaders Improve Conflict of Interest Policies in Response to CareFusion Case

The complex case that came to light with reports of a legal settlement by CareFusion of allegations that it paid kickbacks to promote its ChloraPrep product just got even more complex, but now also a bit more hopeful, and hence much more hopeful than most of the cases we discuss.. Background As we <a href="http://hcrenewal.blogspot.com/2014/01/our-man-in-nqf-carefusion-settles.html">noted yesterday</a>, the CareFusion settlement seemed routine when it was first briefly reported in the media.  Then Modern Healthcare published a series of articles about its ramifications, the <a href="http://www.modernhealthcare.com/article/20140123/NEWS/301239944">latest appearing today</a>. In summary prior to the latest article, -  the CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote <a href="http://www.carefusion.com/medical-products/carefusion-brands/chloraprep/">ChloraPrep</a>, a solution meant for preoperative skin cleaning -  the Department of Justice <a href="http://www.justice.gov/opa/pr/2014/January/14-civ-021.html">news release</a> also alleged that payments were made to a corporation called Health Care Concepts to conceal kickbacks made to its owner, Dr Charles Denham -  the implication was that Dr Denham was supposed to influence a standard writing committee run by the National Quality Forum, a well known organization that promotes quality improvement, issues authoritative practice standards, a form of clinical practice guidelines, and has contracts with the US government for quality of care activities -  the draft of the standard written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision We noted that the NQF policy on conflicts of interest for its standard writing committees seemed somewhat weak.  The <a href="http://www.qualityforum.org/docs/CDP_Conflict_of_Interest_Policy.aspx">current (October, 2013) policy</a> asks members to internally disclose conflicts and recuse themselves from " discussion of the applicable measure or measures, and in some instances competing and related measures."  However it does not ban members with conflicts, nor require public disclosure of conflicts.  We also noted that NQF has several board members who have full-time leadership positions with health care corporations, financial firms that invest in health care, or health care trade associations, and NQF received funding from pharmaceutical companies and their in-house foundations.  Thus NQF appears to have its own institutional conflicts of interest.  So we thought that the case raised questions about how well NQF standards are protected from the influence of conflicts of interest, and whether they should remain so influential in the absence of stronger protections? NQF Clarifies its Conflicts of Interest Policies As <a href="http://www.modernhealthcare.com/article/20140123/NEWS/301239944">reported</a> by Modern Healthcare, it took only a day for the NQF to issue yet <a href="http://www.qualityforum.org/News_And_Resources/Press_Releases/2014/NQF_Statement_on_Department_of_Justice_Settlement.aspx">another press release</a> to clarify its conflict of interest polcies.  In particular, <blockquote class="tr_bq">I n response to concerns that the community raised about the evidence base underlying Safe Practice #22 and Dr. Denham’s inordinate interest in this particular Safe Practice, NQF took the following steps in early 2010: <ul><li>Severed its relationship with Dr. Denham who has not been involved in any other NQF work since March 2010;</li><li>Made a decision to refuse offers for financial support from Dr. Denham’s foundation, discontinuing a 2008 - 2013 grant agreement that had more than three years remaining ;</li><li>Determined that it would not enter into grant agreements where the funder is on the endorsement committee, even as a non-voting member;</li><li>Reviewed committee reports that Dr. Denham was involved in to be certain that he did not influence their outcome; NQF staff believe that he did not; and </li><li>Updated and enhanced its conflict of interest policy – in 2010 and again in 2013;</li></ul></blockquote> So NQF appeared to react ad hoc to concerns that Dr Denham was too avid about the use of a particular product.  Its response included strengthening its COI policy and banning one particular type of conflict, receiving funding from an organization controlled by a member of a standard writing committee.  However, as we noted above, the 2013 policy still has its weaknesses.   Furthermore, an NQF executive volunteered to inform me that while the current written COI policy does not require public disclosure, in practice the organization requires public verbal disclosure of conflicts at the beginning of each committee meeting, and that the transcripts of these disclosures are available on the organization's website.  However, how to reach these disclosures is not obvious, and I so far have not been able to find the transcript that supposedly contains the disclosures for the meeting which Dr Denham co-chaired Summary and a Few Optimistic Thoughts (Rare as They are for Us) What I must say is now most unusual in the CareFusion/ Dr Denham/ NQF case is that NQF leadership, rather than  hunkering down in a defensive posture we have seen many other leaders adapt, seems to be trying to take steps toward addressing problems posed by conflicts of interest affecting its standard setting, guideline development, and quality assurance.  First, it is clear that NQF leaders did react to concerns about Dr Denham, and did somewhat tighten up their conflict of interest policies in response to them.  Second, it is clear that they are willing to listen to public questions and criticism, and at least consider further change in response to them.  They thus appear far more open than do leaders of many other organizations. IMHO, NQF leadership is to be congratulated for this more transparent approach.  If only the leaders of other health care organizations would do as much.  Since they do seem open to criticism and change, in the spirit of constructive criticism, I do hope that NQF leaders might also consider: -  further strengthening their conflict of interest policy for standard setting committees, particularly by minimizing the number of committee members with conflicts, and banning individuals with conflicts from chairing committees, as per the <a href="http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx">IOM report on standards for trustworthy clinical practice guideline development</a> -  increasing transparency about conflicts of interest, particularly by making disclosures for all projects available without complex web searching -  decreasing institutional conflicts of interest by refusing funding from health care corporations whose revenues might be affected by the content of standards and guidelines, and reducing conflicts affecting NQF board members and executives Health care leaders who see transparency and reduction of conflicts of interest as important goals show us that true health care reform might actually be possible. ADDENDUM (24 January, 2014 - I was told that many people may need an explanation of the title.  "Putting in the ski lifts" is a shortened version of an old college saying.  The location for the ski lifts was a place that is traditionally very hot, think fire and brimstone.  The phrase refers to an extremely improbably event.  Sorry about any confusion.

Putting in the Ski Lifts - National Quality Forum Leaders Improve Conflict of Interest Policies in Response to CareFusion Case

The complex case that came to light with reports of a legal settlement by CareFusion of allegations that it paid kickbacks to promote its Ch...

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Our Man in the NQF? - CareFusion Settles Kickback Allegations for $40.1 Million and Government Alleges They Meant to Manipulate National Quality Forum Standards

What appeared to be yet another entry in the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a> turns out to be more interesting than it first appeared. The Basic Story: Off-Label Marketing  The story was initially briefly reported in the media.  A <a href="http://blog.seattlepi.com/boomerconsumer/2014/01/09/company-to-pay-40-1-million-to-settle-medicaid-fraud-kickback-charges/">report</a> in the Seattle Post-Intelligencer on 9 January, 2014, was perhaps the most complete, <blockquote class="tr_bq">CareFusion, a manufacturer of medical and surgical supplies and medical devices, has agreed to settle charges of illegal marketing practices and kickback payments for promoting sales of the company’s surgical preparation solution, Chloraprep. Under the terms of the settlement with Washington, other states, and the federal government, CareFusion will pay a total of $40.1 million.</blockquote> In particular,   <blockquote class="tr_bq">When the FDA approves a surgical solution such as Chloraprep as safe and effective, its manufacturer can’t market or promote it for an 'off-label' use – any use not approved by the FDA. Chloraprep was approved for specific inpatient hospital procedures, including the preparation of a patient’s skin prior to surgery or an injection. The FDA rejected its use for prepping the skin prior to inserting catheters into veins for administering medications, or cleaning the skin as part of closing wounds. The lawsuit alleges that from Sept. 1, 2009 to Aug. 31, 2011, CareFusion promoted Chloraprep for improper uses. CareFusion also allegedly publicized unverified information about Chloraprep during the same time period, Ferguson said.</blockquote> So this follows a template we have seen before, most recently <a href="http://hcrenewal.blogspot.com/2014/01/more-pharmaceutical-misadventures.html">here</a>.  A company promotes a drug or device for "off-label" uses.  While physicians are legally allowed to prescribe a drug or use a device for reasons other than its official indications, companies are not legally allowed to promote such uses.  Sometimes it turns out that the drug has benefits that outweigh its harms when used off-label, in which case the violation could be considered technical.  In other cases, the drug might turn out to be useless or even net harmful when used off-label, so the violation indicates putting revenue ahead of patients' welfare.   The reporting on the CareFusion Chloraprep settlement did not clearly suggest that the off-label use was harmful to patients. Allegations of Kickbacks to Promote Off-Label Use, but How? It gets more interesting.  The Post-Intelligencer also noted, <blockquote class="tr_bq">The states also contend that in 2008 CareFusion’s predecessor corporation entered into agreements that CareFusion assumed legal and financial responsibility for. This included payments to Health Care Concepts Inc., payments that were allegedly made to hide kickbacks to the physician-owner of HCC for promoting and influencing providers to use Chloraprep, he said. This violates federal and state anti-kickback laws.</blockquote> Now the allegations also include kickbacks to the "physician-owner" of a company to facilitate off-label promotion.  So the issue goes beyond a technical violation of the law.  The Post-Intelligence report, however, did not make clear what Health Care Concepts Inc actually did to contribute to off-label promotion. A quick attempt to find out more about this company via the web was not fruitful.  There are lots of companies/ organizations called Health Care Concepts or some variant.  The most relevant may be<a href="http://www.hcc1.com/"> this one</a>, which lists CareFusion as a "partner" on its main web-page.  What this company actually does is a bit unclear.  Its business model is <a href="http://www.hcc1.com/node/3">described</a> as "a private incubator of early products, services, and technologies, as well as an accelerator of mature solutions that will be taken to scale." What that has to do with off-label promotion of a product of a big established company like CareFusion is not clear.  How this company could have influenced providers is not clear, given that it is not an advertising firm, public relations firm, or medical education and communication company (MECC). So what is going on here?   Allegations of a $11.6 Million Payment to Manipulate the National Quality Forum Standards Yesterday, 21 January, 2014, Modern Healthcare began to <a href="http://www.modernhealthcare.com/article/20140120/NEWS/301209952/nqf-committee-member-paid-11-6m-by-carefusion-to-influence-panels">explain</a> the mystery.    <blockquote class="tr_bq">Many healthcare companies have been accused of paying kickbacks to influence physicians' medical decisions, but one major supplier allegedly tried to steer an entire industry by influencing the recommendations of the National Quality Forum The NQF, which reviews medical evidence and makes recommendations for improving healthcare, acknowledges that a well-known patient safety advocate is alleged to have received millions of dollars to promote a surgical sterilization product while co-chairing an NQF committee that suggested hospitals use that product.  Federal officials say Dr. Charles Denham, co-chair of NQF's Safe Practices Committee in 2010, received $11.6 million from San Diego-based CareFusion to promote the company's ChloraPrep line of skin-preparation products. Denham's committee at the NQF also recommended surgeons use ChloraPrep products to prevent surgical infections, the NQF said. </blockquote> The allegations about the role of Dr Denham in the NQF also did appear in the the official US Department of Justice <a href="http://www.justice.gov/opa/pr/2014/January/14-civ-021.html">press release</a>. Allegations of Bogus Contracts, and Non-Denial Denials The allegations produced some <a href="http://en.wikipedia.org/wiki/Non-denial_denial">non-denial denials</a> (in the phrase found in All the President's Men). Dr Denham responded, but through a lawyer: <blockquote class="tr_bq">A statement from Denham's attorney, Larry Gondelman of Powers Pyles Sutter & Verville in Washington, said reports that the underlying lawsuit involved Dr. Denham were 'blatantly false.' Denham was not accused of wrong-doing in the whistleblower lawsuit, and Gondelman said Denham has and continues to cooperate with investigators in the case.</blockquote> Note that while the attorney denied that Dr Denham was named in the underlying lawsuit, he did not apparently specifically deny the allegations. The NQF also reponded, <blockquote class="tr_bq"> An NQF review committee removed the reference to the specific product before final publication of '<a href="http://www.qualityforum.org/Publications/2010/04/Safe_Practices_for_Better_Healthcare_%E2%80%93_2010_Update.aspx">Safe Practices for Better Healthcare</a>' in 2010. 'An NQF ad hoc review did not find sufficient evidence to support one skin preparation over another,' <a href="http://www.qualityforum.org/News_And_Resources/Press_Releases/2014/NQF_Statement_on_Department_of_Justice_Settlement.aspx">a statement from the organization said</a>. 'The ad hoc review effectively served its role of rapidly responding when a potential issue is identified.'</blockquote> Note that the <a href="http://www.qualityforum.org/News_And_Resources/Press_Releases/2014/NQF_Statement_on_Department_of_Justice_Settlement.aspx">NQF press release</a> did not deny that the CareFusion money was given to Dr Denham's organization, nor that the NQF report might have promoted the use of a class of products in which CareFusion's Chloraprep resides. A <a href="http://www.modernhealthcare.com/article/20140121/NEWS/301219952/nqf-panel-member-admits-he-got-11m-from-carefusion-but-calls">follow-up story</a> in Modern Healthcare noted that Dr Denham confirmed the payment of the money to his company, but not its purpose, <blockquote class="tr_bq"> Renowned quality expert Dr. Charles Denham confirms that CareFusion paid his company more than $11 million, but Denham says he was surprised to see the U.S. Justice Department describe the money as kickbacks intended to influence national quality-of-care guidelines published by the National Quality Forum.</blockquote> Dr Denham's lawyer confirmed the payment, but did not further explain it: <blockquote class="tr_bq">Denham's lawyer, Larry Gondelman of Powers Pyles Sutter & Verville in Washington, acknowledged that CareFusion did pay Denham's company under two contracts. </blockquote> And, <blockquote class="tr_bq">Gondelman said the $11.6 million paid to Denham's company covered 'an array of services' and that he could not elaborate.</blockquote> Again, note that Mr Gondelman did not specifically deny that the money served as a kickback. Meanwhile, the Department of Justice alleged something more elaborate, and nefarious,  <blockquote class="tr_bq">The Justice Department, though, says the contracts were written to look as though CareFusion was buying consulting, software development and strategic marketing services, as well as the completion of three unnamed projects. The value of the deals, the government alleges, far exceeded the fair-market costs of those services, and that one of the actual purposes of the deals was to conceal kickbacks to Denham while he served on the National Quality Forum.</blockquote> Interval Summary So what is clear so far is that: -  CareFusion agreed to a $40.1 million settlement of allegations that it provided kickbacks to promote off-label use of its product. -  CareFusion paid $11.6 million to Health Care Concepts -  Health Care Concepts is run (and possibly owned) by Dr Charles Denham, who chaired a National Quality Forum committee that recommended use of CareFusion's product ChloraPrep in a performance standard and the final version of the NQF standard recommended use of a group of products including ChloraPrep We have frequently discussed how health care corporations may promote goods, particularly drugs and devices and services through <a href="http://hcrenewal.blogspot.com/search/label/deception">deceptive</a> and unethical practices, including inducements ranging form creation of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> to outright <a href="http://hcrenewal.blogspot.com/search/label/bribery">bribes </a>and <a href="http://hcrenewal.blogspot.com/search/label/kickbacks">kickbacks</a>.   We have also discussed the influence of individual and <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional conflicts of interest</a> on <a href="http://hcrenewal.blogspot.com/search/label/guidelines">clinical practice guidelines</a>.  This has become an important enough problem for the US Institute of Medicine to weigh in with <a href="http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx">standards for trustworthy guidelines</a> that markedly limit such conflicts of interest.  This case seems notable because it may link the problems of <a href="http://hcrenewal.blogspot.com/search/label/deception">deceptive</a> and unethical promotion with the influencing of clinical practice guidelines.  It is particularly notable because the organization generating the guidelines in question, the National Quality Forum, has become large, influential, and authoritative.  Re the latter point, the latest Modern Healthcare article affirmed, <blockquote class="tr_bq">The NQF is a standards-setting organization for the healthcare provider industry. It holds the exclusive contract to provide Medicare and Medicaid with recommendations on a national quality-of-care strategy and the measures used to gauge improvements.</blockquote> In fact, while the NQF performance standards can function as guidelines, they also may be bases for <a href="http://hcrenewal.blogspot.com/search/label/pay%20for%20performance">pay for performance</a> schemes that attach real incentives to guidelines, which could become <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse</a> if the guidelines have been manipulated. Can the NQF Defend Against Conflicts, and If Not, Should it Remain So Authoritative? So the big question is whether the NQF, given its unique influence, has any meaningful approach to prevent its standards from being influenced by conflicts of interest? The NQF does have a <a href="http://www.qualityforum.org/docs/CDP_Conflict_of_Interest_Policy.aspx">recent conflicts of interest policy</a>. However, according to my reading, it neither bans committee members with conflicts of interest, nor even requires public disclosure of conflicts of interest.  All it seems to require is that committee members disclose conflicts internally and <strike>voluntarily</strike> recuse themselves from deliberations which may be affected by them.  Although the policy states that conflicts of interest may be made public, I could find nothing in the <a href="http://www.qualityforum.org/Publications/2010/04/Safe_Practices_for_Better_Healthcare_%E2%80%93_2010_Update.aspx">report</a> which Dr Denham co-authored about conflicts of interest or competing interests affecting any of the authors, including Dr Denham Furthermore, a very quick look at information publicly available on the NQF web-site suggests the organization itself may have major institutional conflicts of interest.  The NQF is one of those "public-private partnerships" that have become all the rage.  Several members of its <a href="http://www.qualityforum.org/About_NQF/Board/Board_of_Directors_Roster.aspx">board of directors</a> have leadership positions in large health corporations, financial firms with large health care interests, or trade associations for large health care corporations:  <a href="http://www.qualityforum.org/About_NQF/Board/Elizabeth_Fowler.aspx">- Elizabeth J. Fowler</a>, PhD, JD, is Vice President, Global Health Policy, in the Government Affairs & Policy group at Johnson & Johnson. - <a href="http://www.qualityforum.org/About_NQF/Board/Robert_Galvin.aspx">Robert Galvin</a>, MD, is Chief Executive Officer, Equity Healthcare, at The Blackstone Group.  - <a href="http://www.qualityforum.org/About_NQF/Board/Karen_Ignagni.aspx">Karen Ignagni</a>, President and Chief Executive Officer of America’s Health Insurance Plans (AHIP), is the voice of health insurance plans.... - <a href="http://usa.healthcare.siemens.com/infrastructure-it/healthcare-it/about-health-services/leadership-profile-healthcare-it">J Mark Overhage</a> MD, PhD,  Chief Medical Informatics Officer, Health Services, Siemens Healthcare Thus it is conceivable that they could personally profit, and that their organizations could institutionally profit from standards that favor their organizations' interests.   Furthermore, NQF receives <a href="http://www.qualityforum.org/About_NQF/Funding.aspx">funding</a> from the US government and private foundations, but also from pharmaceutical companies and their in-house foundations: <blockquote class="tr_bq">the Bristol-Myers Squibb Foundation, the Cardinal Health Foundation, Pfizer Inc., Sanofi-aventis,...</blockquote> Unless the current case leads to big changes in the prevalence of conflicts of interest among the NQF board, the continuation of its institutional conflicts of interest generated by its sources of funding, and its weak policy on conflicts affecting committee members, the question becomes whether it should continue to have such an authoritative role? As we have said over and over, pervasive conflicts of interest affect health care decision-makers and policy makers and the organizations within which they function.  Such conflicts threaten to put various private interests way ahead of patients' and the public's health.  If we really want health care that will put patients' and the public's health first, we need to end such arrangements that favor private gain.    Roy M. Poses MD on Health Care Renewal ADDENDUM (23 January, 2014) - A closer re-reading of the NQF conflict of interest policy made it clear that recusal is not voluntary, and that conflicts of interest may be revealed publicly, but that such disclosure is not mandatory.  The paragraph above dealing with these issues was revised accordingly.

Our Man in the NQF? - CareFusion Settles Kickback Allegations for $40.1 Million and Government Alleges They Meant to Manipulate National Quality Forum Standards

What appeared to be yet another entry in the march of legal settlements turns out to be more interesting than it first appeared. The Basic ...

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