tag:blogger.com,1999:blog-28241174499937417672024-02-07T00:54:39.293-08:00Health Care & MedicalAnonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comBlogger499125tag:blogger.com,1999:blog-2824117449993741767.post-41409097076374505192013-06-05T15:23:00.000-07:002013-06-07T11:46:38.430-07:00Long After the Start of the "War on Terror," a Conflict of Interest about an Anthrax Scare Comes to LightIn May, David Willman writing for the Los Angeles Times broke a <a href="http://www.latimes.com/news/nationworld/nation/la-na-anthrax-resistant-20130519-dto,0,3192936.htmlstory">story</a> of a somewhat new variant on the conflict of interest theme, one that has not gotten a lot of attention, but should.<br /><br />The issue was medical, with a twist, - how to best treat a bioterror attack with anthrax engineered to be resistant to multiple drugs, an event that luckily is not known to ever have occurred. The story came from the bad old days of the "war on terror," but only has now come to light years later. <br /><br /><b>The Alarm Raiser</b><br /><br />The story opened thus,<br /><br /><blockquote class="tr_bq">Over the last decade, <i>former Navy Secretary Richard J. Danzig, a prominent lawyer, presidential advisor and biowarfare consultant to the Pentagon and the Department of Homeland Security, has urged the government to counter what he called a major threat to national security. </i><br /><br /><i>Terrorists, he warned, could easily engineer a devastating killer germ: a form of anthrax resistant to common antibiotics.</i></blockquote><br />In particular,<br /><br /><br /><blockquote class="tr_bq">Danzig began warning about antibiotic-resistant anthrax after the terrorist attacks of Sept. 11, 2001, and the mailings of anthrax-laced letters that fall.<br /><br />The powdered anthrax in the letters killed five people but was not resistant to common antibiotics. Asked what gave rise to his <i>concern about resistant strains,</i> Danzig cited conversations with 'people whose technical skills exceed mine.' One of them, Dr. Robert P. Kadlec, a bioterrorism advisor in the Bush White House, said he and others were concerned that terrorists could develop such a weapon.<br /><br />Danzig has s<i>ounded the alarm in published papers and in private briefings and seminars for biodefense and intelligence officials.</i><br /><br />In a 2003 report funded by the Pentagon, "<a href="http://documents.latimes.com/catastrophic-bioterrorism-what-be-done/" target="_blank">Catastrophic Bioterrorism — What Is To Be Done?</a>" he wrote that it would be '<i>quite easy' for terrorists to produce antibiotic-resistant anthrax.</i> He has expanded on that theme over the years, including in a 2009 paper for the Pentagon.<br /><br />In the 2003 report, published while raxi [raxibacumab, an anthrax anti-toxin] was in development at Human Genome, Danzig said<i> a drug to combat resistant strains of anthrax should be produced 'as soon as possible' and that stockpiling such a treatment, 'even if expensive and in limited supply' would deter an attack</i>.<br /><br />John Vitko Jr., a top Homeland Security official during the Bush and Obama administrations, said he turned frequently to Danzig for advice on biodefense matters — and<i> read and 'paid attention to' his 'Catastrophic Bioterrorism' report.</i></blockquote><br />Note that while Danzig is a lawyer, and certainly not a physician or biomedical researcher, he had major credibility in the defense field, particularly in anti-terrorism, so his recommendations had great influence.<br /><br /><blockquote class="tr_bq">He served as a Pentagon appointee during the Carter administration and as undersecretary and then secretary of the Navy under President Clinton. He has a long-standing interest in biowarfare.<br /><br />During the 2008 presidential campaign, Danzig advised then-Sen. Barack Obama on national security and bioterrorism. After Obama's election, Danzig was named to the Pentagon's Defense Policy Board and the President's Intelligence Advisory Board, in addition to his consulting positions with the Defense Department and Homeland Security.</blockquote><br />So apparently at least partly due to Mr Danzig's persistent warnings, the government took action,<br /><br /><blockquote class="tr_bq"> In 2004, President Bush signed into law Project BioShield, which provided billions of dollars for biodefense drugs.<br /><br />The contracts are administered by the Department of Health and Human Services, based on advice from federal agencies and consultants. Homeland Security must certify the need for a drug before the government can buy it.<br /><br /> <i>Danzig, through his seminars, writings and consulting duties, has helped frame the discussion over whether a given biological threat is 'material' </i>and whether the government should stockpile medicines to defend against it.</blockquote><br />Also,<br /><br /><br /><blockquote class="tr_bq">Speaking of Danzig's broader role as a government advisor, Vitko said:<i> 'Richard's got incredible insights into this and I think has made major contributions'</i><br /><br />He called Danzig one of '<i>the major bio player'</i> and said his views had informed a range of policy considerations, including 'how many countermeasures do you need, of what kind.'<br /><br />It was in response to advice from Vitko and his staff that Homeland Security Secretary Tom Ridge in 2004 <i>declared anthrax a 'material threat,'</i> the certification required for the government to buy drugs to fight it.<br /><br /><i>The drug the government bought was raxibacumab, or raxi, an anthrax anti-toxin made by Human Genome Sciences Inc. </i><br /><i><br /></i><i>In 2006, the Department of Health and Human Services finalized its first order of raxi — 20,000 doses at a cost of $174 million.</i><br /><br />That year, Ridge's successor, Michael Chertoff, signed a second, more specific declaration, <i>adding 'multi-drug-resistant' anthrax to the government's list of material threats.</i><br /><br />Asked the basis for the second declaration, Vitko said: 'I think the concern was more forward-looking, and saying, 'How could the threat evolve, and are we prepared for that?''<br /><br />Since 2009, the Obama administration has ordered an additional 45,000 doses of raxi for $160 million.</blockquote><br />There was just one catch.<br /><br /><b>The Undisclosed Conflict</b><br /><br />Mr Danzig had a largely undisclosed conflict of interest. He was on the board of directors of Human Genome Sciences Inc, the company whose drug his constant warnings and exhortations lead the government to buy.<br /><br /><blockquote class="tr_bq">When <i>Human Genome named Danzig to its board on May 24, 2001,</i> the company's chief executive said his high-level federal experience would 'serve us well.'</blockquote><br />He thus was on the board on September 11, 2001, and later when the events on that day and soon after apparently induced him to start sounding the alarm about resistant anthrax, and he stayed on the board as he continued sounding alarms, and after the government started buying his company's drug.<br /><br /><br /><blockquote class="tr_bq">During his 11-year tenure on the board, which ended in August, <i>Danzig collected at least $1,054,255 in director's fees and by cashing in grants of Human Genome stock and stock options,</i> according to Fred Whittlesey of Compensation Venture Group, who reviewed the company's Securities and Exchange Commission filings for The Times.<br /><br />Nearly half of Danzig's compensation came from the stock options, of which he had been granted 184,000 by the end of 2011, Whittlesey said.</blockquote><br />Danzig did not seem to think that serving on the board of the company which made the primary drug directed at the perhaps hypothetical disease about which Danzig was sounding the warning constituted any sort of conflict of interest.<br /><br /><br /><blockquote class="tr_bq">Danzig said in an interview that he believed his position at Human Genome<i> posed no conflict.</i><br /><br />He said he had tried to improve policymakers' understanding of biodefense issues, including the threat of antibiotic-resistant anthrax, but <i>never lobbied the government to purchase raxi.</i><br /><br />'My view was I'm not going to get involved in selling that,' Danzig said. 'But at the same time now, should I not say what I think is right in the government circles with regard to this? And my answer was, 'If I have occasion to comment on this, it ought to be<i> in general, as a policy matter, not as a particular procurement.'</i><br /><br />'I feel that I've acted very properly with regard to this'' he said.</blockquote><br />He also apparently did not feel he needed to disclose his board membership to most of the people he was trying to persuade to be alarmed about resistant anthrax, and to pursue a treatment, such as that made by the company on whose board he sat.<br /><br /><blockquote class="tr_bq"> A number of senior federal officials whom Danzig advised on the threat of bioterrorism and what to do about it said they were unaware of his role at Human Genome.<br /><br />Dr. Philip K. Russell, a biodefense official in the George W. Bush administration who attended invitation-only seminars on bioterrorism led by Danzig, said<i> he did not know about Danzig's tie to the biotech company until The Times asked him about it.</i></blockquote><br />Also,<br /><br /><blockquote class="tr_bq"> <i>Vitko said he knew nothing of Danzig's involvement with Human Genome until a Times reporter asked him about it.</i><br /><br />'I'm surprised I didn't,' Vitko said. 'I'm not aware of it.'<br /><br />Five other present or former biodefense officials who conferred with Danzig said they, too, had been unaware of his position with the company. Danzig, they said, made no mention of it in their presence during group discussions he led or in smaller meetings.</blockquote><br />Furthermore,<br /><br /><br /><blockquote class="tr_bq">A Times search found seven papers Danzig had written on bioterrorism since 2001. <i>In only one of those did he disclose his tie to Human Genome.</i><br /><br />As an advisor to the federal government, Danzig is required to file confidential forms annually, revealing any outside affiliations but not his related compensation. Danzig said he had noted his position with the biotech firm on the forms.<br /><br />Asked whether he mentioned his corporate role during contacts with government officials, Danzig replied: 'If I thought any of it posed a potential conflict that might cause somebody who knew about it to discount my views, I would tell them.'</blockquote><br />Some people disagreed with Danzig's failure to perceive a conflict of interest<br /><br /><blockquote class="tr_bq"><i> 'Holy smoke—that was a horrible conflict of interest,' </i>said Russell, a physician and retired Army major general who helped lead the government's efforts to prepare for biological attacks.</blockquote><br /><br /><b>The Take-Over by a Familiar Corporation</b><br /><br />By the way, Human Genome Science was eventually bought out by a bigger company which has had its own sets of issues regarding conflicts of interest, GlaxoSmithKline,<br /><br /><blockquote class="tr_bq"> Human Genome was acquired by GlaxoSmithKline in August [presumably 2012] for $3.6 billion.</blockquote><br />It may yet stand to make even more money from raxi,<br /><br /><blockquote class="tr_bq"> Because raxi loses its potency after three years in storage, the government's supply will expire as of 2015, according to federal documents and people familiar with the matter. </blockquote><br /><b>Summary</b><br /><br />This appears to be a variant on the "key opinion leader" (KOL) theme writ large. Mr Danzig clearly functioned as a very major key opinion leader about bioterrorism. Like many KOLs we have previously discussed, he had financial interests that favored the company whose drugs his key opinion leadership seemed to be favoring. His influence seems to have lead to huge purchases of these drugs. Like many KOLs who are physicians or health care academics, Mr Danzig seems utterly blind to the possibility that his multiple efforts to emphasize the importance of the supposed disease for which his company made a drug could somehow be viewed as a conflict of interest, or to why failure to tell his audiences about his major relationship to this company might have appeared just a small bit dishonest. We have seen many medical/ health care KOLs who deny that somehow their opinions could have been influenced by their financial relationships, or that their audiences deserved at least to be aware of these relationships. Yet, of course, Mr Danzig is not a doctor, and he was trying to influence government purchasers of drugs, not physician prescribers of it.<br /><br />It does seem that the leadership of health care organizations, particularly but certainly not limited to pharmaceutical and biotechnology companies, have no lack of imagination about how to construct financial relationships with influential people who could help sell their products, whether or not they acknowledge what amounts to their marketing roles. <br /><br />Given that this story involved influencing the government, it will be interesting to see at this late date whether it results in any legal action. After all, as David Willman pointed out,<br /><br /><blockquote class="tr_bq"> Federal law bars U.S. officials, including consultants, from giving advice on matters in which they or a company on whose board they serve have 'a financial interest.'</blockquote>It will also be interesting to see if it gets any more attention. Only a few blogs have noted it, but at least they included <a href="http://www.the-scientist.com/?articles.view/articleNo/35639/title/Selling-an-Anthrax-Scare-/">The Scientist</a>.<br /><br /><br />Yet our country has an unfortunately very long history of corporate leaders getting close to political leaders who then may overlook the legal niceties when their friends' interests are at stake. Nonetheless, true health care reform would require all those who have decision making power over patients, health policy, or the public health to be completely transparent about their conflicts of interest, and would ban the more serious variants of conflicts of interest, even if that might cost some already rich people a bit of money. I am not holding my breath, however, about when this might happen.<br /><br />Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-8336755276163347212013-06-03T05:32:00.000-07:002013-06-07T11:46:38.438-07:00Want to help a hospital go bankrupt? Get a bad EHR - Westchester hospitals' sale price over $54 million, Hospitals' debt about $200M<div style="text-align: center;">- Posted at the Healthcare Renewal Blog on June 3, 2013 - </div><br /><a href="http://www.ssmc.org/homepagess.cfm">Sound Shore Medical Center</a> (New Rochelle, NY) is filing for bankruptcy protection:<br /><br /><blockquote class="tr_bq">Montefiore Medical Center is offering to buy Sound Shore Health System for $54 million plus furniture and equipment, according to the latter’s bankruptcy filing — which also reveals just how far the troubled Westchester health network had fallen into the red. <br /><br />Sound Shore Medical Center in New Rochelle, Mount Vernon Hospital and five related entities have about $200 million in debts owed to more than 3,000 creditors, while possessing only $159.6 million in assets, the U.S. Bankruptcy Court documents show. <b>Sound Shore filed for Chapter 11 bankruptcy protection Wednesday as the first step in discharging its debts and selling itself to the Montefiore system.</b></blockquote><br />Why were they in the red?<br /><br />You can read the full article "<b>Westchester hospitals' sale price over $54 million; Hospitals' debt about $200M</b>" in The Journal News for yourself at this link: <a href="http://www.lohud.com/article/20130530/NEWS/305300081/Westchester-hospitals-sale-price-over-54-million?odyssey=tab|topnews|text|News&gcheck=1">http://www.lohud.com/article/20130530/NEWS/305300081/Westchester-hospitals-sale-price-over-54-million?odyssey=tab|topnews|text|News&gcheck=1</a>, but there's this interesting passage:<br /><br /><blockquote class="tr_bq">... Beginning in 2006, the hospitals saw falling patient volume and a change in their case mix. That led to “significant” losses in recent years, negative cash book balances and bills paid more than 225 days late. <b>A 2011 electronic medical record and billing system conversion caused major delays in billing and cash collection that still haven’t been fully solved. </b></blockquote><br />(This passage has a familiar ring to it; e.g., see SEC Count 9 at "<b>Florida Hospital gets an 'F' on Informatics</b>" at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=miami">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=miami</a>.)<br /><br />A 2011 EHR and billing conversion? It's now 2013.<br /><br />How many hospital IT personnel does it take to <strike>screw in</strike> implement a <strike>light bulb</strike> new EHR?<br /><br />-- SS<br /><br />Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-60742436002159649902013-05-31T13:10:00.000-07:002013-06-07T11:46:38.444-07:00Is the Patient Centered Outcomes Research Institute Really More Industry-Centered?One of the biggest reasons our health care system seems so dysfunctional is that clinicians and patients have great difficulty determining what might be the appropriate management of particular clinical problems. Due to endless and sometimes <a href="http://hcrenewal.blogspot.com/search/label/deception">deceptive</a> marketing,<a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest"> conflicts of interest</a> affecting health care professionals and academics, and <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> and <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression </a>of clinical research, making truly evidence based decisions that put individual patients interests first has become very difficult. Instead, we may end up using excessively expensive, relatively ineffective, and more dangerous than anticipated drugs, devices, and diagnostic and therapeutic strategies, thus leading to poor patient outcomes and high costs.<br /><br /><b>Background - the Patient-Centered Outcomes Research Institute (PCORI)</b><br /><br />One lingering hope has been that better clinical research, particularly focusing on the outcomes that are most important to patients (patient-centered outcomes), and comparing clinical strategies that may be widely used but poorly evaluated (<a href="http://hcrenewal.blogspot.com/search/label/comparative%20effectiveness%20research">comparative effectiveness research</a>) would help dissipate the fog. An attempt to promote such research in the US appeared in our recent health reform legislation, the Affordable Care Act. It authorized the creation of the <a href="http://www.pcori.org/">Patient Centered Outcomes Research Institute </a>(PCORI).<br /><br />However, as we <a href="http://hcrenewal.blogspot.com/2010/03/health-care-reform-bill-and-health-care.html">observed</a>, how good a solution this would be would depend on the details. Our concerns were that PCORI, which is an independent although government sponsored institute, not a government agency, might be too beholden to "stake-holders" including the large organizations, device and pharmaceutical companies, insurance companies, hospital systems, etc, that already dominate health care and may promote their and particularly their executives' interests ahead of patients.<br /><br />Recently, Merrill Goozner, the editor of Modern Healthcare, <a href="http://www.modernhealthcare.com/article/20130427/MAGAZINE/304279990">raised similar concerns</a>,<br /><br /><blockquote class="tr_bq">there is the law's requirement for stakeholder boards to set PCORI research priorities. They must include representatives of researchers, clinicians, patients, providers, insurers, employers and industry. <i>The interests of those groups are not the same. Priority-setting by stakeholder boards could turn into a prescription for steering clear of the most controversial, and therefore most significant, questions.</i></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />So,</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq">There is no shortage of drug and device firms, specialty hospitals and medical specialty societies with a vested interest in leaving certain questions unasked or muddying the waters with methodological quibbles. <i>They shouldn't be allowed to hijack or soften the agenda.</i></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div></div><br />PCORI is now in operation, but has seemingly not gotten a lot of scrutiny. What scrutiny it has received as not allayed these concerns.<br /><br /><b>The PCORI Advisory Panels</b><br /><br />Recently, the publication of the membership of four key advisory panels for PCORI got the attention of Michael Millenson, <a href="http://thehealthcareblog.com/blog/2013/04/05/why-the-pcori-picks-matter/">blogging on</a> the Health Care Blog. He noted that initially the members of the panels were identified only by name and city of residence, without any information on their other affiliations or characteristics. He suggested,<br /><br /><blockquote class="tr_bq"> PCORI isn’t a church, where all are created equal in the eyes of God, but <i>a politically created, politically governed, controversial dispenser of a very large amount of money that a host of interest groups would like to control.</i> PCORI staff chose the panel members in part by looking at their affiliations, and those connections (or lack of them) should be an immediate part of the public record when the appointments are announced. <i>By being vague, PCORI obfuscates political and power relationships and makes it more difficult for the public and industry stakeholders to either approve of or criticize those choices.</i></blockquote><br />Eventually, PCORI did release somewhat more information on membership of these panels, on <a href="http://www.pcori.org/get-involved/pcori-advisory-panels/advisory-panel-on-addressing-disparities/">Addressing Disparities</a>, <a href="http://www.pcori.org/get-involved/pcori-advisory-panels/advisory-panel-on-assessment-of-prevention-diagnosis-and-treatment-options/">Assessment of Prevention, Diagnosis, and Treatment Options</a>, <a href="http://www.pcori.org/get-involved/pcori-advisory-panels/advisory-panel-on-improving-healthcare-systems/">Improving Healthcare Systems</a>, and <a href="http://www.pcori.org/get-involved/pcori-advisory-panels/advisory-panel-on-patient-engagement/">Patient Engagement</a>. Mr Millenson was able to review the membership of one panel, and noted some strange anomalies in a comment to his original blog post. <br /><br />One panel member who supposedly represents "patients, caregivers, and patient advocates" had a full time position with a pharmaceutical company. Another worked for a big consumer organization which is heavily funded by the pharmaceutical industry. <br /><br />This raised concerns that PCORI may get guidance from people whose interests are actually different from those they are supposed to represent. <br /><br />Therefore, I attempted to review the stated affiliations of all PCORI advisory panels.<br /><br />Review of the what was made public about the membership of the advisory panels revealed several additional important anomalies. Members said to be representing "patients, caregivers, and patient advocates" appeared to have positions working for organizations who might have their own, and different interests from the group they were supposed to be representing. <br /><br />Let me summarize the apparent anomalies by advisory panel. In each case, in alphabetical order by panel, I will list the panelists name, supposed representation, and affiliation, with my comments. <br /><br /><u>Addressing Disparities</u><br /><br />Monique Carter MS - Dallas, TX<br />representing: patients, caregivers, and patient advocates<br />affiliation: <i>Senior Research Scientist, AROG Pharmaceuticals Inc</i><br /><br />So this person would appear to be more of an industry (pharmaceuticals) representative.<br /><br />Venus Gines, MA, P/CHWI - Manvel, TX<br />representing: patients, caregiver, and patient advocates<br />affiliation: <i>Instructor, Chronic Disease Prevention and Control Research Center, Department of Medicine, Baylor College of Medicine</i><br /><br />So this person appears to be more of a clinician, or health system representative<br /><br />Doriane C Miller MD - Chicago, IL<br />representing: patients, caregivers, and patient advocates<br />affiliation: <i>Director, Center for Community Health and Vitality, University of Chicago Medical Center</i><br /><br />So this person also appears to be more of a clinician, or health system representative.<br /><br />Carmen E Reyes, MA - Whittier, CA<br />representing: patients, caregivers, and patient advocates<br />affiliation: <i>Center and Community Relations Manager, Los Angeles Community Academic Partnership in Research in Again, UCLA</i><br /><br />So this person appears to be more of a health system representative.<br /><br />Mary Ann Sander, MHA, MBA, NHA - Pittsuburgh, PA<br />representing: patients, caregivers, and patient advocates<br />affiliation: <i>Vice President, Aging and Disability Services, UPMC Community Provider Services</i><br /><br />So this person appears to be more of a health system representative<br /><br />Deborah Steward, MD, MBA - Jacksonville, FL<br />representing: clinicians<br />affiliation: <i>Florida Blue</i><br /><br />So in summary, this panel included five people who ostensibly represent patients, caregivers, and patient advocates but who actually work for large academic medical centers or health systems, and one who was there to ostensibly represent patients, caregivers, and patient advocates who works for a pharmaceutical firm. (In addition, one person supposedly representing clinicians apparently works full time for a health insurance company.)<br /><br /><u>Assessment of Prevention, Diagnosis, and Treatment Options</u><br /><br />Karen Chesbrough, MPH - Annandale, VA<br />representing: patients, caregivers, and patient advocates<br />affiliation: <i>Scientific Program Administrator, Foundation for Physical Therapy.</i><br /><br />Note that the <a href="http://foundation4pt.org/get-involved/about/">stated mission</a> of the Foundation for Physical Therapy is that it "supp<span style="font-size: small;"><span>orts the physical therapy profession’s research needs," and the foundation is funded in part by companies that make physical therapy devices and supplies (look <a href="http://foundation4pt.org/get-involved/partners/">here</a>). Therefore, this person appears to be more of a representative of clinicians, or perhaps industry (devices).</span></span><br /><br /><span style="font-size: small;"><span>Bettye Green RN - South Bend, IN</span></span><br /><span style="font-size: small;"><span>representing: patients, caregivers, and patient advocates</span></span><br /><span style="font-size: small;"><span>affiliation: <i>Community Outreach Nurse and Associate Director of Advocacy, Alliance for Clinical Trials in Oncology, Saint Joseph Regional Medical Center</i></span></span><br /><br /><span style="font-size: small;"><span>So this person appears to be more of a health system representative.</span></span><br /><br /><span style="font-size: small;"><span>Debra Madden - Newtown, CT</span></span><br /><span style="font-size: small;"><span>representing: patients, caregivers, and patient advocates</span></span><br /><span style="font-size: small;"><span>affiliation:<i> Clinical Applications Systems Analyst, Associated Neurologists</i></span></span><br /><br /><span style="font-size: small;"><span>So this person appears to be more of a clinician representative.</span></span><br /><br /><span style="font-size: small;"><span>Daniel Wall - Spencer, WI</span></span><br /><span style="font-size: small;"><span>representing: patients, caregivers, and patient advocates</span></span><br /><span style="font-size: small;"><span>affiliation: <i>Analyst, Biomedical Informatics Research Center, Marshfield Clinic Foundation</i></span></span><br /><br /><span style="font-size: small;"><span>So this person appears to be more of a clinician or health system representative</span></span><br /><br /><span style="font-size: small;"><span>So in summary, this panel included four people who ostensibly represent patients, caregivers, and patient advocates but who actually work for health systems or clinician organizations, and one of the latter organizations appears to be heavily funded by the medical device and supplies industry.</span></span><br /><br /><span style="font-size: small;"><u><span>Improving Healthcare Systems</span></u></span><br /><br /><span style="font-size: small;"><span>Susan Diaz MPAS, PA-C - Jacksonville, FL</span></span><br /><span style="font-size: small;"><span>representing patients, caregivers, and patient advocates</span></span><br /><span style="font-size: small;"><span>affiliation: <i>Physician Assistant in Liver Transplant, Mayo Clinic in Florida</i></span></span><br /><br /><span style="font-size: small;"><span>So this person appears to be more of a clinician, or health system representative.</span></span><br /><br /><span style="font-size: small;"><span>Anne Sales PhD- Ann Arbor, MI</span></span><br /><span style="font-size: small;"><span>representing: patients, caregivers, and patient advocates</span></span><br /><span style="font-size: small;"><span>affiliation: <i>Professor, School of Nursing, University of Michigan</i></span></span><br /><br /><span style="font-size: small;"><span>So this person appears to be more of a clinician, or health system representative.</span></span><br /><br /><span style="font-size: small;"><span>Jamie Sullivan MPH - Silver Spring, MD</span></span><br /><span style="font-size: small;"><span>representing: patients, caregivers, and patient advocates</span></span><br /><span style="font-size: small;"><span>affiliation: <i>Director of Public Policy, COPD Foundation.</i></span></span><br /><br /><span style="font-size: small;"><span>Note that the COPD Foundation receives support at least from "</span>Boehringer-Ingelheim/Pfizer Inc. and Grifols" (look <a href="http://www.copdfoundation.org/Home/AboutUs/PartnersSponsors.aspx">here</a>). .</span><br /><br /><span style="font-size: small;">So this person appears to be at least somewhat an industry (pharmaceutical) representative. </span><br /><br /><span style="font-size: small;">So in summary, this panel includes three people who ostensibly represent patients, caregivers, and patient advocates, two of whom actually work for large health system, and one who works for a foundation with significant pharmaceutical industry support. </span><br /><br /><span style="font-size: small;"><u>Patient Engagement</u></span><br /><br /><span style="font-size: small;">Stephen Arcona MA PhD - East Hanover, NJ</span><br /><span style="font-size: small;">representing patients, caregivers, and patient advocates</span><br /><span style="font-size: small;">affiliation:<i> Executive Director, Outcomes Research Methods & Analytics, Department of Health Economics and Outcomes Research, Novartis Pharmaceuticals Corporation</i></span><br /><br /><span style="font-size: small;">So this person appears to be more of a researcher, and industry (pharmaceutical) representative. </span><br /><span style="font-size: small;"><br /></span><span style="font-size: small;">Marc Boutin JD - Washington, DC</span><br /><span style="font-size: small;">representing patients, caregivers, and patient advocates</span><br /><span style="font-size: small;">affiliation: <i>Executive Vice President and Chief Operating Officer, National Health Council </i></span><br /><span style="font-size: small;"><br /></span><span style="font-size: small;">Note that while the National Health Council <a href="http://www.nationalhealthcouncil.org/pages/page-content.php?pageid=53">claims</a> to be an advocate for people with chronic disease and disability, its core membership includes "<span><span style="font-family: Verdana;"><span style="font-family: Times,"Times New Roman",serif;">major pharmaceutical, medical device, health insurance, and biotechnology companies</span>." </span></span>and it receives considerable industry support. For example, it <a href="http://www.nationalhealthcouncil.org/pages/corporate-partners.php">disclosed</a> contributions in the $100,000 - $300,000 range from Amgen, Astra-Zeneca, Eli Lilly, Novartis, Pfizer, and the Pharmaceutical Research and Manufacturers of America (PhRMA), and smaller but still significant contributions from other pharmaceutical companies and other industry associations. So this person appears to be at least somewhat of an industry (pharmaceutical) representative.</span><br /><span style="font-size: small;"><br /></span><span style="font-size: small;">Charlotte W Collins JD - Elkridge, MD</span><br /><span style="font-size: small;">representing patients, caregivers, and patient adovcates</span><br /><span style="font-size: small;">affiliation: <i>Vice President of Policy and Programs, Asthma and Allergy Foundation of America</i></span><br /><span style="font-size: small;"><br /></span><span style="font-size: small;">Note that while the Asthma and Allergy Foundation of America claims to be a patient advocacy organization, it <a href="http://www.aafa.org/display.cfm?id=10&sub=27&cont=250">disclosed</a> financial support from many pharmaceutical, device, and health insurance companies, and from major health care systems</span><br /><span style="font-size: small;"><br /></span><span style="font-size: small;">So this person appears to be at least somewhat an industry, health insurance, and/or health system representative.</span><br /><span style="font-size: small;"><br /></span><span style="font-size: small;">Amy Gibson, RN MS - Washington, DC</span><br /><span style="font-size: small;">representing patients, caregivers, and patient advocates</span><br /><span style="font-size: small;">affiliation: <i>Chief Operating Officer, Patient-Centered Primary Care Collaborative (PCPCC)</i></span><br /><span style="font-size: small;"><br /></span><span style="font-size: small;">Note that the PCPCC has an <a href="http://www.pcpcc.net/executive-members">executive committee</a> that includes multiple pharmaceutical, device, and health insurance companies, and health systems. So this person appears to be at least somewhat an industry, health insurance, and/or health system representative.</span><br /><span style="font-size: small;"><br /></span><span style="font-size: small;">Julie Ginn Moretz - Augusta, GA</span><br /><span style="font-size: small;">representing patients, caregivers, and patient advocates</span><br /><span style="font-size: small;">affiliation: <i>Associate Vice Chancellor, Patient- and Family-Centered Care, University of Arkansas for Medical Sciences</i></span><br /><span style="font-size: small;"><br /></span><span style="font-size: small;">So this person appears to be more of health system representative.</span><br /><span style="font-size: small;"><br /></span><span style="font-size: small;">Sara Triagle van Geertruyden - Washington, DC</span><br /><span style="font-size: small;">representing patients, caregivers, and patient advocates</span><br /><span style="font-size: small;">affiliation: <i>Executive Director, Partnership to Improve Patient Care (PIPC)</i></span><br /><span style="font-size: small;">(Note: this affiliation appears incomplete. Sara van Geertruyden is <a href="http://thornrun.com/contact">listed</a> as <i>a <a href="http://thornrun.com/sara-van-geertruyden">current partner </a>of Thorn Run Partners,</i> a <a href="http://thornrun.com/">lobbying firm</a>, with a major <a href="http://thornrun.com/practice-areas">practice area</a> in health care, boasting, "Thorn Run Partners offers one of Washington, DC’s most comprehensive, competent and effective health policy practices."</span><br /><br /><br /><span style="font-size: small;">Note also that PIPC has <a href="http://www.improvepatientcare.org/pipc-member-list-0">membership</a> that includes many specialty physician societies, and a <a href="http://www.improvepatientcare.org/steering-committee">steering committee</a> that includes the Biotechnology Industry Organization, and PhRMA. </span><br /><span style="font-size: small;"><br /></span><span style="font-size: small;"><span>So this person appears to be more of an industry (pharmaceutical and biotechnology) representative.</span></span><br /><br /><span style="font-size: small;"><span>So in summary this panel includes six members who ostensibly represent patients, caregivers, and patient advocates, but who work for either patient advocacy organizations that get considerable industry support, or a health system, or a pharmaceutical company. One person whose affiliation was listed as a patient advocacy organization also somehow appears to be a full-time lobbyist. </span></span><br /><br /><span style="font-size: small;"><span><b>Summary </b></span></span><br /><span style="font-size: small;"><span><br /></span></span><span style="font-size: small;"><span>While PCORI has set up advisory panels that seem to strongly emphasize representation of patients, caregivers, and patient advocates, a substantial fraction of the people who are supposed to provide this representation seem to work for patient advocacy groups with considerable industry support, or directly for industry or health care systems. Some of them may work as clinicians or researchers, but many appear to have high level executive positions with these organizations. One appears to be a full-time lobbyist at a firm that has a strong health care practice. </span></span><br /><span style="font-size: small;"><span><br /></span></span><span style="font-size: small;"><span>Thus it appears that PCORI advisory panels actually may be as much about the interests of big health care organizations, including pharmaceutical and device companies, health insurance companies, and large hospital systems, as they are about patients, caregivers, or patient advocates. </span></span><br /><span style="font-size: small;"><span><br /></span></span><span style="font-size: small;"><span>I am afraid my and Merrill Goozner's original fears that PCORI may end up being more about industry-centered interests than patient-centered outcomes may not be paranoid. I do hope that PCORI leadership manages to put improving patients' and the public's health ahead of making industry executives happy. </span></span><br /><span style="font-size: small;"><span><br /></span></span><span style="font-size: x-small;"><span style="font-size: small;">by Roy M. Poses MD, for Health Care Renewal</span></span>Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-60323497901570255062013-05-30T04:37:00.000-07:002013-06-07T11:46:38.452-07:00Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients .. CEO Cites Defective HHS Paper and Red Herrings As Excuse Why He Knowingly Allows This To Continue<div style="text-align: center;">- Posted at the Healthcare Renewal Blog on May 30, 2013 - </div><br />The following appeared in the Marin County Independent Journal about an EHR system so bad the nurses at Marin General Hospital were publicly complaining, putting their careers at risk (see my May 17, 2013 post "<a href="http://hcrenewal.blogspot.com/2013/05/marin-general-hospital-nurses-warn-that.html">Marin General Hospital nurses warn that new computer system is causing errors, call for time out</a>"):<br /><br /><blockquote class="tr_bq"><b>National critic of health care information technology says Marin General should heed nurses' advice</b><br /><div class="articleByline" id="articleByline"><a class="articleByline" href="mailto:rhalstead@marinij.com?subject=Marin%20Independent%20Journal:"><span class="author vcard"><span class="fn"></span></span></a><br /><div class="Byline"><a class="articleByline" href="mailto:rhalstead@marinij.com?subject=Marin%20Independent%20Journal:">By Richard Halstead<br />Marin Independent Journal<span class="source-org vcard"></span></a></div></div><div class="articleDate" id="articleDate">Posted: 05/27/2013 04:03:00 PM PDT</div></blockquote><br />The critic is me. I spoke to the reporter but did not know he would publish:<br /><blockquote class="tr_bq"><span id="rds_global"></span><br /><div class="bodytext">A nationally known critic of electronic health records has harshly criticized managers at Marin General Hospital for their response to a plea by nurses to hold off on a new computer system to prevent potentially dangerous errors.</div><br />"The executives at the hospital should be taking out extra insurance policies because they're setting themselves up for a massive corporate negligence lawsuit," said Dr. Scot Silverstein, an adjunct professor of health care informatics at Drexel University in Philadelphia.<br /><br />Silverstein, who contacted the Independent Journal after reading about the Marin General situation, doesn't dispute the potential of digital records; but he believes implementation has been rushed. He thinks electronic health records should be regulated by the federal Food and Drug Administration, much like medical hardware or pharmaceuticals. </blockquote><br />Or regulated by someone with experience in similar mission critical software, and with regulatory teeth. Paper tigers and bad health IT are a very poor mix where patients' rights are concerned IMO.<br /><br /><blockquote class="tr_bq"><span id="rds_global"></span><br />At issue is a new computerized physician order entry system, known as CPOE; doctors place medication orders for patients directly into the system.<br /><br />At a meeting of the Marin Healthcare District board on May 14, a group of Marin General <b>nurses told the board problems with the new computer system were diverting them from their patients and causing errors, such as sending orders to the wrong patients. One nurse reported that a patient had received a medication to which he was allergic. </b></blockquote><br />That is a very direct calling out of the potential for harm and death by front line clinical personnel. To ignore it is grossly if not criminally negligent.<br /><br /><span id="rds_global"></span><br /><table border="0" cellpadding="0" cellspacing="0" style="width: 100%px;"><tbody><tr><td class="articleBox" style="width: 100%;"><a href="https://www.blogger.com/null" name="top"></a><span class="articleFooterLinks"></span></td></tr></tbody></table><blockquote class="tr_bq"><span id="rds_global">Lee Domanico, who serves as the CEO of both Marin General and the Marin Healthcare District, assured the board <b>that </b></span><span id="rds_global"><b>the hospital was safe, despite "glitches" in the new system. </b>Domanico said he was working to fix the problem.</span></blockquote><br /><span id="rds_global">Glitches = safe? The Board must be highly gullible if they believe this See </span><a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> for more on "safe" glitches.<br /><br /><blockquote class="tr_bq">Silverstein said, "Glitches are a euphemism for life-threatening electronic health record malfunctions and defects."<br /><br /><span id="rds_global"></span><br />"What they need to do is exactly what the nurses are asking for," Silverstein said. "They need to turn the system off and put it through rigorous testing and confirm the thing is going to work properly with no glitches before they use it on patients."</blockquote><br />That's not rocket science - its common sense - unless they think their own nurses are lying.<br /><br />Of course, as computers have more rights than patients, and bonuses might be affected, the system will likely continue in full operation, with patients as guinea pigs, and the nurses punished for informing the public that perhaps they should consider other hospitals while the "glitches" in this enterprise clinician command-and-control system are worked out.<br /><blockquote class="tr_bq"><br /><span id="rds_global"></span><br />Two days after the Marin Healthcare District meeting, Domanico issued a press release stating, "We have not received any medication error incident reports resulting from the implementation of computerized physician order entry."<br /><br />On Friday, however, Barbara Ryan, a Marin General registered nurse who serves as the California Nurses Association/National Nurses United representative, said, <b>"I can't understand why that statement was made."</b><br /><br />Ryan said <b>nurses have told her of errors, and information about errors appears in "Assignment Despite Objection" forms that nurses have filed since implementation of the computerized order system began on May 7. Nurses file the forms to document formal objections to an unsafe, or potentially unsafe, patient care assignment. </b></blockquote><br /><span id="rds_global">The statement's reason and purpose seems fairly obvious. </span><br /><br /><blockquote class="tr_bq"><span id="rds_global"><span id="rds_global">Ryan said Marin General nurses have filed close to <b>50 such forms so far this month; she said typically 10 to 20 such forms are filed per month at the hospital.</b><br /><br />"There are still problems with the system," she said. "There are still mistakes being made." Ryan <b>said the hospital needs to boost nurse staffing ratios during the implementation.</b></span></span></blockquote><br /><span id="rds_global">That would increase costs (and probably decrease the pool of money for bonuses).</span><br /><br /><blockquote class="tr_bq"><span id="rds_global"><span id="rds_global">Jon Friedenberg, Marin General's chief fund and business development officer, said the hospital is in the process of upgrading computer servers and adding memory to work stations to increase the speed of the new computerized order system.<br /><br />"<b>We completed an upgrade of memory to 200 of the work stations</b>, and 120 of the work stations have been replaced," Friedenberg said.</span></span></blockquote><br /><span id="rds_global">This reminds me of a similar IT fiasco I faced some years ago, when the brilliance of IT personnel really shone through regarding an ICU monitoring system that crashed regularly. Their solution? Add more RAM. (See "<b>Serious clinical computing problems in the worst of places: an ICU</b>" at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU</a>).</span><br /><br /><blockquote class="tr_bq"><span id="rds_global">... Silverstein earned a medical degree from Boston University and subsequently completed a two-year fellowship in medical informatics at Yale University School of Medicine. He served as Merck Research Laboratories' director of scientific information in the early 2000s before serving for a time as a full-time professor at Drexel University. Today, in addition to teaching part-time, Silverstein works on <span style="color: red;"><i><b>[EHR-related - ed.] </b></i></span>medical liability cases for plaintiff attorneys. <span style="color: red;"><i><b>[And the defense too</b></i></span></span><span style="color: red;"><i><b>, when asked; I'd rather advise on how to prevent mistakes, in fact, than get involved after the fact when someone's been injured or killed - ed.] </b></i></span></blockquote><span id="rds_global"></span><br /><br />What was not mentioned was that I was a CMIO in a major hospital in the mid to late 1990s.<br /><br />But of course, I - and similarly trained Medical Informatics experts - "don't have enough experience" to lead (as opposed to being an 'internal consultant') health IT projects, a refrain I've often heard from hospital executives.<br /><br /><br /><blockquote class="tr_bq"><span id="rds_global">Silverstein said he started assisting on the liability cases after his mother died as the result of an electronic health care record error that resulted in her not being given the proper heart medicine. Silverstein said his mother's case was not an anomaly. </span></blockquote><blockquote><span id="rds_global"><span id="rds_global">For example, he pointed to the results of a recent Emergency Care Research Institute study of 36 hospitals conducted over a nine-week period. Asked to report electronic record problems on a volunteer basis, Silverstein said the hospitals reported <b>170 malfunctions, including eight incidents that resulted in patient harm, three of which may have contributed to patients' deaths. </b> </span></span><span id="rds_global"><span id="rds_global"><span id="rds_global">Although the federal Food and Drug Administration does not regulate health care information technology, some manufacturers have voluntarily supplied data to the FDA. In February 2010, the F<b>DA reported it had been notified of 260 problem events involving health care information technology in the previous two years that were linked with 44 injuries and six deaths.</b></span></span> </span></blockquote><br /><span id="rds_global">See my Feb. 28, 2013 post "</span><b>Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI Deep Dive Study of Health IT Events</b>" at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>. Also see my Aug. 5, 2010 post "<b>Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun? I report, you decide</b>" at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a>. I merely report what ECRI, AMA and FDA have reported.<br /><br />Finally:<br /><br /><blockquote class="tr_bq"><span id="rds_global">In his press release, however, [CEO] Domanico stated that "more than 150 studies conducted since 2007 have confirmed that organizations using health information technology, like CPOE, have seen positive outcomes."</span> </blockquote><br />I believe he's referring to a highly biased and scientifically defective ONC paper of 154 selected studies: "<b>The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results</b>."<br /><br />What an unbelievably cavalier attitude.<br /><br />My colleagues and I refuted (dare I say trashed) that paper pretty thoroughly here: <br /><a href="http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html" rel="nofollow nofollow" target="_blank">http://<wbr></wbr>hcrenewal.blogspot.com/<wbr></wbr>2011/03/<wbr></wbr>benefits-of-health-informat<wbr></wbr>ion.html.</a><br /><br />Even worse, the mention of that paper, or EHR benefits in general, is a diversion, an in-your-face <b>red herring</b> (at best; an inability to reason logically at worst), steering away from the real issue: an EHR implementation about which nurses are complaining ... in the now.<br /><br /><blockquote class="tr_bq"><span style="font-family: Arial Black; font-size: medium;"><span style="font-family: arial; font-size: small;"><a href="http://www.nizkor.org/features/fallacies/red-herring.html">http://www.nizkor.org/features/fallacies/red-herring.html</a>: A Red Herring is a fallacy in which an irrelevant topic is presented in order to divert attention from the original issue. </span></span></blockquote><span id="rds_global"><br /></span><span id="rds_global">That a CEO of a major hospital relies on one defective paper - one that he most likely lacks the experience and expertise to understand, let alone critically evaluate - and red herrings is a poster example of why medical and medical informatics amateurs should not be running hospitals or clinical IT projects.</span><br /><span id="rds_global"><br /></span><span id="rds_global">-- SS</span>Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-91794679702605551212013-05-28T12:15:00.000-07:002013-06-07T11:46:38.460-07:00Ghosts in the Criminal Machine - How a Drug Company Can Plead Guilty to Federal Fraud, Yet No One is Held ResponsibleWe have often discussed how leaders of health care organizations have become increasingly unaccountable for their actions. A recent, slightly obscure story shows how a corporate admission of guilt to a felony can be used to prevent anyone, including anyone in corporate management, from being held responsible for that fraud.<br /><br /><b>Basics of the Settlement</b><br /><br />The case was that of ISTA Pharmaceuticals. The basics appeared in brief wire service articles, like <a href="http://www.foxbusiness.com/industries/2013/05/24/bausch-lomb-ista-admits-to-kickbacks/">this one</a> from Rueters (via Fox News):<br /><br /><br /><blockquote class="tr_bq"><i>Ista Pharmaceuticals pleaded guilty on Friday to charges it used kickbacks and improper marketing to boost sales of a drug </i>meant to treat eye pain and agreed to<i> pay $33.5 million to settle criminal and civil liability</i>, the U.S. Department of Justice said.<br /><br /> The unit of eye care company Bausch & Lomb <i>pleaded guilty to conspiracy to offer kickbacks to induce physicians to prescribe Xibrom,</i> a drug meant to treat pain after cataract surgery, and <i>conspiracy to promote that drug for unapproved uses</i>, including after Lasik and glaucoma surgeries.<br /><br /> Ista agreed as part of a criminal settlement to a $16.63 million fine and an $1.85 million asset forfeiture. It also agreed to a $15 million civil settlement to resolve allegations that its marketing of Xibrom caused false claims to be submitted to government health care programs.</blockquote><br /><b>Kickbacks Disguised as Honoraria and Consulting Fees </b><br /><br />Note that unlike many such legal settlements involving large health care organizations, this one involved admissions of guilt to felonious criminal offenses. The severity of the charges apparently arose out of the egregious conduct of company executives. Colorful details were <a href="http://www.buffalonews.com/apps/pbcs.dll/article?AID=/20130524/CITYANDREGION/130529545/1005">supplied</a> by the Buffalo (NY) News:<br /><br /><blockquote class="tr_bq">ISTA, which is based in California, <i>admitted using kickbacks to doctors and an illegal marketing campaign </i>as part of an elaborate scheme to increase its sales of Xibrom.<br /><br />The scheme, outlined in detail in newly released court papers, ranged from company-provided instruction sheets for doctors to continuing medical education programs to promote the drug.<br /><br />In many cases, <i>ISTA employees were told not to leave printed materials behind in doctors’ offices or to keep records of their meetings with doctors in order to avoid detection </i>by others.<br /><br />The company went so far as to <i>offer speaking engagements and consulting appearances to doctors in hopes that they might use Xibrom</i> for non-authorized treatments.<br /><br />Doctors can legally prescribe drugs for non-FDA approved treatments, but drugmakers are prohibited from promoting their products for those uses.<br /><br />'Essentially <i>they entered into consulting arrangements to induce physicians to prescribe their drug</i>,' said Jeffrey I. Steger, a lawyer in the Consumer Protection Branch of the U.S. Department of Justice.<br /><br />When [US District Judge Richard J] Arcara asked if money was the doctors’ motivation, Steger said yes.<br /><br />'Thousands of dollars,' he told the judge. </blockquote><br />So here we have a company admitting that it bribed doctors to prescribe its drug, and its techniques of administering bribes included paying the doctors honoraria to give talks, and paying the doctors as consultants. As an aside, note that many defenders of "collaboration" among doctors and industry sign the praises of doctors "consulting" for industry, and often see nothing wrong with industry paying doctors for "educational" speeches. Yet here is more evidence that such paid talks and consulting assignments may be nothing more than marketing, and at times are merely disguised bribery. <br /><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><b>An Apparently Tough Penalty</b></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">An unusual feature of this settlement was that (per Reuters):</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq">As part of the settlement, <i>Ista will be barred from participating in Medicare and Medicaid,</i>...</blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div></div><br /><br />That would appear to be the death knell for the company, as reported by Reuters, <br /><br /><blockquote class="tr_bq">Bausch & Lomb, which is based in Rochester, New York, said it was pleased to settle the matter, which involved conduct between January 2006 and March 2011, and that it knew of the government probe well before it purchased Ista.<br /><br /> That purchase closed in June 2012 and Bausch and Lomb <i>plans to wind down the Ista corporate entity by year end.</i></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div>So Bausch and Lomb bought a company that turned out to be valueless? But wait,... there's a trick. <br /><br />As <a href="http://www.fiercepharma.com/story/ista-excluded-medicare-335m-label-settlement/2013-05-28">detailed</a> in FiercePharma,<br /><br /><blockquote class="tr_bq"> ISTA will be barred from doing business with Medicare, Medicaid, et al, for 15 years. Luckily for Bausch + Lomb, however, it bought ISTA in June 2012, late enough in the game to actually escape the ramifications of exclusion. <i>The exclusion won't begin until 6 months after the settlement date, giving Bausch + Lomb time to transfer ISTA's products out of that subsidiary and shift the drugs over to the Bausch + Lomb label.</i></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /><b>A Crime Committed by... No One?</b></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">So Bausch and Lomb gets ISTA's drugs, and essentially can resolve the company's felony convictions by relatively small fines, and through management sleight of hand, can finesse ISTA's disbarment from federal programs.. This will occur despite admissions that someone within ISTA, presumably within ISTA management, perhaps high up in ISTA management, per FiercePharma, </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq"><i>instructed reps to avoid leaving a paper trail of their off-label discussions with doctors. </i>Prosecutors had enough evidence of this to <i>persuade ISTA to plead guilty to a felony fraud charge.</i> 'These instructions were given in order to avoid having their conduct relating to unapproved new uses being detected by others, the Justice Department said. 'ISTA agreed that this conduct represented an intent to defraud under the law.'</blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />So felony fraud was committed, but no person apparently committed it. It was as if a ghost committed the crime.</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Not only was a crime committed, but apparently by nobody, the corporation within which the crime was committed also becomes obscure. ISTA became responsible, but by being bought out by Bausch and Lomb, the more severe penalty directed against ISTA will be meaningless. </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Should Bausch and Lomb be responsible? Of course, they claim they should not. As <a href="http://www.bloomberg.com/news/2013-05-24/bausch-lomb-unit-pays-33-5-million-in-misbranding-case.html">reporte</a>d by Bloomberg, </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><blockquote class="tr_bq"><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> Rochester, New York-based Bausch & Lomb said the actions occurred 'well before' it acquired Ista in 2012. </div></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote><br />'Bausch & Lomb is committed to earning trust in everything that we do and is pleased to have resolved this pre-acquisition issue,' Bob Bailey, a Bausch & Lomb spokesman, said in a statement. </blockquote><br />In fact, The Hill<a href="http://thehill.com/blogs/regwatch/healthcare/301949-drug-company-pleads-guilty-to-felony-kickback-scheme-pays-335m"> reported</a> that the bad behavior took place from 2005 to 2010: <br /><br />But consider that while ISTA recently became part of Bausch and Lomb, since 2007, Bausch and Lomb has been wholly owned by private equity firm Warburg Pincus. In fact, as we <a href="http://hcrenewal.blogspot.com/2009/06/was-private-equity-takeover-of-bausch.html">discussed</a> in in 2009, some people suspected that this maneuver would have allowed Baush and Lomb to settle multiple suits alleging that its products were faulty and dangerous out of the public eye. So while ISTA is now really Bausch and Lomb is now really Warburg Pincus, no one in the management of ISTA, Bausch and Lomb, or Warburg Pincus apparently will be held responsible for criminal fraud and kickbacks to doctors, even though guilty pleas for these felonies have been made. So somehow we have admissions that crimes were committed, crimes that compromised the integrity of doctors, and exposed patients to needless side effects, yet these crimes were apparently committed by ... nobody, by a ghost, and even the machine that ghost was in - was it ISTA, Bausch and Lomb, or Warburg Pincus? - becomes a mystery. Where is Sherlock Holmes when we need him most?.<br /><br /><b>Summary</b><br /><br />This case thus becomes a really striking example of the impunity of health care corporate managers. They can commit crimes, even felonies, yet the company, but no human beings, is held responsible. But the company being a company, it cannot go to jail. And through the magic of obfuscatory corporate take-overs, which company is guilty is not even apparent. <br /><br />As we have said ad infinitum, <br /><br /> We will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich. </div></div>Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-21711997949600154222013-05-23T12:26:00.000-07:002013-06-07T11:46:38.467-07:00The Best Governance for Medicines ... is in Thailand<b>The Best Health Care System in the World? </b><br /><br />Here in the US, a lot of people have been convinced that we have the best health care system in the world. For example, during the 2012 US presidential campaign, Politi-Fact <a href="http://www.politifact.com/truth-o-meter/statements/2012/jul/05/john-boehner/john-boehner-says-us-health-care-system-best-world/">reported</a>,<br /><br /><br /><blockquote class="tr_bq">House Speaker John Boehner, R-Ohio, says the health care law signed by President Barack Obama -- and upheld by the U.S. Supreme Court -- imperiled the nation’s health care system.<br /><br />'Gov. Romney understands that Obamacare will bankrupt our country and <i>ruin the best health care delivery system in the world,</i>' Boehner said, during the July 1, 2012, edition of <a href="http://www.cbsnews.com/8301-3460_162-57464563/face-the-nation-transcripts-july-1-2012-speaker-boehner-senators-schumer-and-coburn-governors-walker-and-omalley/?pageNum=2&tag=contentMain;contentBody">CBS’ <i>Face the Nation</i></a>.<br /><br />Boehner wasn’t the only one making that claim on the Sunday talk-show circuit. On <i><a href="http://www.foxnews.com/on-air/fox-news-sunday/2012/07/02/white-house-ready-move-and-implement-health-care-law-mcconnell-we-can-defeat-obamacare-no?page=4">Fox News Sunday</a></i>, Senate Minority Leader Mitch McConnell, R-Ky., added that the U.S. has '<i>the finest health care system in the world</i>.'</blockquote><br />More recently, as the Huffington Post<a href="http://maddowblog.msnbc.com/_news/2013/03/25/17455963-the-greatest-health-care-system-the-world-has-ever-known?"> reported</a>,<br /><br /><br /><blockquote class="tr_bq">Sen. Jeff Sessions (R-Ala.) charged Thursday that Obamacare is destroying the '<i>greatest health care system the world has ever known</i>' and that it was 'horrible' for anyone to suggest Americans receive anything less than the best care, even though they die younger on average than people in many other countries.<br /><br />'This is just one example of what happens in this country when people in Washington take on the arrogant view that they know how to fix the health care system -- one of <i>the most massive, complex, marvelous systems the world has ever known</i>,' Sessions said on the Senate floor.</blockquote><br />One would expect that the greatest health care system in the world would have the greatest pharmaceutical industry in the world too. In fact, as noted by Politi-Fact, that is pretty much what Congressman Boehner asserted,<br /><br /><blockquote class="tr_bq"> Boehner’s office also noted that wealthy foreigners flock to the U.S. to receive care because of its cutting-edge facilities, and that the U.S. is <i>among the leaders, if not No. 1, in medical research and pharmaceutical development.</i></blockquote><br /><b>Not the Best Governance for Medicines in the World </b><br /><br />A recent <a href="http://www.bernama.com.my/bernama/v7/wn/newsworld.php?id=951522">article</a> from the National News Agency of Malaysia will probably not get a lot of attention in the US, or other developed countries, but it does suggest another reason to be very skeptical about shouts of "USA Number 1" at least applied to health care. The article's main point was:<br /><br /><blockquote class="tr_bq">The World Health Organisation (WHO) has <i>praised Thailand for the world's best governance for medicine</i>, Thai News Agency (TNA) reported.<br /><br />Public Health Minister Dr. Pradit Sintawanarong, who is attending the 66th World Health Assembly in Geneva, Switzerland, from May 20-28, told journalists on Wednesday that the <i>WHO has asked Thailand to co-organise a meeting on good governance for medicine, as the Thai Kingdom is considered the world's most advance in governance for medicine and should be a good example for other countries.</i><br /><br />Dr. Pradit, who was invited by the WHO to open a meeting on Thailand's governance for medicine and health systems, held as part of the 66th World Health Assembly, acknowledged that the WHO has also asked Thailand to share experiences in another side meeting on 'Good Governance in the Pharmaceutical Sector:The Case of Thailand and Malawi'.</blockquote><br /><br />Again, a lot of people think of the US health care system as a model of the rest of the world. Here is one little bit of data that maybe it should not be the model for "governance for medicine." Of course, that phrase itself is almost never used here. Its definition, however, should be instructive.<br /><br />The World Health Organization has had a small "Good Governance for Medicines" program since 2004. We first discussed it <a href="http://hcrenewal.blogspot.com/2008/12/two-important-resources.html">here</a> in 2008 On the <a href="http://www.who.int/medicines/ggm/en/">program web-site</a>, its goal is defined: <br /><br /><blockquote class="tr_bq">contributing to <i>health systems strengthening and preventing corruption</i> by promoting good governance in the pharmaceutical sector.<br /><br />Specifically the programme aims:<br />-To <i>raise awareness on the impact of corruption in the pharmaceutical sector and bring this to the national health policy agenda</i><br />- To <i>increase transparency and accountability in medicine regulatory and supply management systems </i> - To promote <i>individual and institutional integrity</i> in the pharmaceutical sector<br />- To<i> institutionalize good governance in pharmaceutical systems</i> by building national capacity and leadership. </blockquote><br />So if Thailand received recognition for having the best governance for medicines, the implication is that the US does not.<br /><br />In fact, we and other dissidents have documented a host of problems with individual and institutional integrity in the pharmaceutical sector, lack of transparency and accountability in medicine regulatory and supply management systems, and actual corruption in the pharmaceutical sector. Some of the most recent big examples on Health Care Renewal since December, 2012, include:<br />- the CEO of drug and biotechnology company Amgen collected tens of millions of dollars while his company settled lawsuits alleging it gave kickbacks to doctors, pharmacists and others to use potentially dangerous medicines (post <a href="http://hcrenewal.blogspot.com/2013/05/amgen-ceos-prosper-despite-or-because.html">here</a>)<br />- Pfizer's 14 legal settlements since 2000, including settlements of allegations of fraud, illegal promotion of hazardous drugs, kickbacks given to physicians, bribery of foreign officials, etc. The biggest was for $2.3 billion. In one case, the company was convicted of being a racketeering influenced corrupt organization (RICO) (post <a href="http://hcrenewal.blogspot.com/2013/01/pfizers-pfourteenth-settlement-small.html">here</a>).<br />- Three settlements in the US by GlaxoSmithKline in 2012, of allegations including deceptive marketing to hide drugs' adverse effects, improperly preventing generic competition, and a $3 billion settlement for deceptive marketing and improper promotion of multiple drugs (post <a href="http://hcrenewal.blogspot.com/2012/12/tis-season-for-legal-settlements.html">here</a>). <br />- Eli Lilly settled allegations that it bribed foreign officials. (In 2009 it pleaded guilty to criminal charges arising from deceptive marketing of Zyprexa) (post <a href="http://hcrenewal.blogspot.com/2012/12/tis-season-for-legal-settlements.html">here</a>)<br />- After making two settlements of overcharging the US government in 2007 and 2009, Sanofi settled US allegations of giving kickbacks to doctors (post <a href="http://hcrenewal.blogspot.com/2012/12/tis-season-for-legal-settlements.html">here</a>)..<br />- The pharmaceutical paid "key opinion leader" who was most influential in promoting widespread use, and probably overuse of opiates, admitted it was all "misinformation" (post <a href="http://hcrenewal.blogspot.com/2012/12/the-king-of-pain-recants-pharmaceutical.html">here</a>).<br /><br />See also our posts on <a href="http://hcrenewal.blogspot.com/search/label/bribery">bribery</a>, <a href="http://hcrenewal.blogspot.com/search/label/kickbacks">kickbacks</a>, <a href="http://hcrenewal.blogspot.com/search/label/fraud">fraud</a>, <a href="http://hcrenewal.blogspot.com/search/label/crime">crime</a>, and <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">corruption</a>, not to mention <a href="http://hcrenewal.blogspot.com/search/label/deception">deception</a>, <a href="http://hcrenewal.blogspot.com/search/label/stealth%20marketing">stealth marketing</a>, <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a>, <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional conflicts of interest</a>, etc. <br /><br /><b>Participatory Democracy in Health Care </b><br /><br /><br />So good for the Thais for apparently doing much better with far fewer resources. One reason seems to be that the government has made good governance for medicines, defined as above, a big priority:<br /><br /><blockquote class="tr_bq">According to the public health minister, the <i>Thai government and his ministry have adhered great importance to good governance for medicine (GGM) and health systems</i> and Thailand has also joined the WHO's campaigns on the GGM from the first stage, concerning the assessment of the situation and the installation of relevant systems.</blockquote><br /><br />I can also speculate that one reason they have done better is their conscious effort to enlist the public at large in discussing and setting the direction of their health care system. For example, as we <a href="http://hcrenewal.blogspot.com/2009/09/making-health-care-more-representative.html">discussed</a> in 2009, Thailand has set up by law a National Health Assembly, with its <a href="http://en.nationalhealth.or.th/Health_Assembly">stated goal</a> to be:<br /><br /><blockquote class="tr_bq"><span style="font-family: Times,"Times New Roman",serif;"><span style="font-size: small;"><span style="color: #333333;">an instrument as well as a learning process to develop <i>participatory public polices on health and pushing for practicability.</i></span></span></span></blockquote><br />Assemblies have been held yearly since 2008. A detailed report on the 2008 assembly is <a href="http://www.who.int/sdhconference/resources/rasanathan_healthexpectations.pdf">here</a>. [Rasanathan K, Posayanonda T, Birminghan M et al. Innovation and participation in the first National Health Assembly in Thailand. Health Expectations 2012; 15: 87-96]. The most recent was in December, 2012 (look <a href="http://en.nationalhealth.or.th/nha2012">here</a>.) <br /><br />Such a mechanism for broad public input into health care does not obviously occur in the US. Instead, we have corporations spending billions on <a href="http://hcrenewal.blogspot.com/search/label/stealth%20lobbying">lobbying</a>, <a href="http://hcrenewal.blogspot.com/search/label/public%20relations">public relations</a>, <a href="http://hcrenewal.blogspot.com/search/label/stealth%20health%20policy%20advocacy">stealth advocacy</a>, and campaign contributions. We have the constant interchange of top government and corporate health care leaders via the <a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">revolving door</a>.<br /><br />We do not have any significant public discussion of good governance for medicines, or anything like it. (The few, rare exceptions about which I know are the recent Healthy Skepticism meeting on <a href="http://sellingsickness.com/">Selling Sickness</a>, and the now yearly meetings organized by <a href="http://pharmedout.org/">PharmedOut.org</a>) Discussion of deception, conflicts of interest, crime and corruption affecting large health care organizations is muted and <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>. I know of precisely one course on health care corruption in any US medical, public health, or health administration school (look<a href="http://hcrenewal.blogspot.com/2009/12/how-to-give-course-on-corruption-in.html"> here</a>, and its focus is on developing countries.)<br /><br />Time to head to Bangkok?.... But if we all cannot... <br /><br />In the US, we will not have a chance of meaningfully improving our health care system until we start listening to unbiased health care professionals and academics (in particular, who have not been paid off by vested interests), civil society organizations, and people and patients at large, and stop getting all our insight from corporate executives, their cronies, and their paid experts. We will not have a chance until we allow discussion of all the problems, including bad leadership and governance, dishonest and deceptive practices, conflicts of interests, and outright crime and corruption. We will not have a chance until we put our priority on patients' and the public's health, not the vested interests of those who have gotten rich off the current dysfunctional system. <br /><br /><br />.Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-12408246019984792022013-05-21T09:25:00.000-07:002013-06-07T11:46:38.474-07:00Executive Compensation as "Legal Corruption" - and the Continuing Example of the Troubles of Wake Forest Baptist"Legal corruption" was the description of current <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">executive compensation</a> practices <a href="http://online.wsj.com/article/SB10001424052970203922804578080670062571256.html">appearing</a>, of all places, in the Wall Street Journal. The arguments, by Henry Mintzer of the Desautels Faculty of Management at McGill University, apply to health care, and provide a counterpoint to the usual talking points that are trotted out whenever a top health care manager, or his cronies, feels the need to justify his or her compensation. <br /><br /><b>A Rigged Game with Other Peoples' Money </b><br /><br />Prof Mintzer's arguments start with the assertion that executive bonuses are hopelessly rigged in favor of the managers who receive them. In particular:<br /><ul><li> They represent gambling with "other people's money," in this case, "the stockholders [of large public corporations] not to mention the livelihoods of their employees and the sustainability of their institutions"</li></ul><ul><li>Bonuses are given just based on the appearance of winning, for example, when a company's stock goes up short term, regardless of long-term results.</li></ul><ul><li>Bonuses are given even when the company may lose, for example, the "golden parachute," or severance package that even executives forced to resign or retire may receive.</li></ul><ul><li>Bonuses are given for actions that at best only provide potential gains for the company, for example prior to a merger, but before it is known that the merger will be successful</li></ul><ul><li>Bonuses are given just for showing up, that is, "retention bonuses."</li></ul><br />Thus he contended that bonuses inspire executives to be gamblers in a game rigged in their favor.<br /><br /><b>Based on False Assumptions </b><br /><br />Furthermore, he argued that the current system of executive compensation is based on false assumptions. These include:<br /><br /><u>"A company's health is represented by its financial measures alone - even better, the price of its stock."</u> <br /><br />However, as Prof Mintzer noted:<br /><br /><blockquote class="tr_bq">Companies are a lot more complicated than that. Their health is significantly represented by what accountants call goodwill, which in its basic sense means a company's intrinsic value beyond its tangible assets: the quality of its brands, its overall reputation in the marketplace, the depth of its culture, the commitment of its people, and so on. </blockquote><br />I would note that this applies especially in health care, and more especially to organizations that provide direct patient care. No hospital system, for example, could function at all without a corps of dedicated health professionals, physicians, nurses, therapists, etc. <br /><br />Furthermore, Prof Mintzer wrote,<br /><br /><blockquote class="tr_bq">All too often, financial measures are a convenient substitute used by disconnected executives who don't know what else to do—including how to manage more deeply. Or worse, <i>such measures encourage abuse from impatient CEOs</i>, who can have a field day cashing in that goodwill by cutting back on maintenance and customer service, 'downsizing' experienced employees while others are left to 'burn out,' trashing valued brands, and so on. Quickly the measured costs are reduced while slowly the institution deteriorates </blockquote><br />This is obviously particularly pernicious in health care, a field in which institutions are complicated, and dependent on the efforts of some very highly trained and specialized people well beyond the management suite. <br /><br /><u>"Performance measures, whether short or long term, represent the true strength of the company."</u> <br /><br />Prof Mintzer pointed out the lack of accurate measures of the overall performance of a company or organization. <br /><br /><br /><u>"The CEO, with a few other senior executives, is primarily responsible for the company's performance." </u><br /><br />Prof Mintzer asked,<br /><br /><blockquote class="tr_bq">In something as complex as the contemporary large corporation, <i>how can success over three or even 10 years possibly be attributed to a single individual?</i> Where is teamwork and all that talk about people being 'our most important asset?' <br /><br />More important, should any company even try to attribute success to one person? <i>A robust enterprise is not a collection of 'human resources'; it's a community of human beings. </i>All kinds of people are responsible for its performance. <i>Focusing on a few—indeed, only one, who may have parachuted into the most senior post from the outside—just discourages everyone else in the company.</i></blockquote><br />Again, this is obviously particularly the case in health care organizations, especially those that provide direct patient care. <br /><br /><b>Leading to the Worst Possible Leaders and Leadership</b><br /><br />Finally, Prof Mintzer argued that the current system is designed to promote the worst possible leadership, leading likely to the worst possible outcomes. He opened with<br /><br /><blockquote class="tr_bq"> Executive bonuses—especially in the form of stock and option grants—represent<i> the most prominent form of <b>legal corruption</b> that has been undermining our large corporations and bringing down the global economy. </i></blockquote><br />Our argument has been that the current leadership of health care is similarly bringing down our health care system.<br /><br />He later noted that current compensation practices mainly function to select out the worst possible leaders:<br /><br /><blockquote class="tr_bq"> executive compensation these days <i>reinforces a class structure within the enterprise that is antithetical to its effective functioning</i>. Because of its symbolic nature, executive compensation as currently practiced sends out the worst possible signal to everyone in the enterprise.</blockquote><br />Furthermore,<br /><br /><blockquote class="tr_bq">bonuses can serve one purpose. It has been claimed that if you don't pay them, you don't get the right person in the CEO chair. I believe that <i>if you do pay bonuses, you get the wrong person in that chair. At the worst, you get a self-centered narcissist</i>. [Or even a full-fledged, if non-violent, psychopath, as noted <a href="http://hcrenewal.blogspot.com/2012/01/corporate-psychopaths-theory-of-health.html">here</a> - Ed] At the best, you get someone who is willing to be singled out from everyone else by virtue of the compensation plan. Is this any way to build community within an enterprise, even to foster the very sense of enterprise that is so fundamental to economic strength?<br /><br />Accordingly, executive bonuses provide the perfect tool to screen candidates for the CEO job. <i>Anyone who insists on them should be dismissed out of hand</i>, because he or she has demonstrated an absence of the leadership attitude required for a sustainable enterprise.<br /> <br />Of course, this might thin the roster of candidates. Good. Most need to be thinned, in order to be refilled with <i>people who don't allow their own needs to take precedence over those of the community they wish to lead.</i></blockquote><br />It will be interesting to see if anyone attempts a logical refutation of Prof Mintzer's arguments. My guess is that we will see little response, based on the usual public relations dictum that it is best not to acknowledge one's detractors, even if they are right. Furthermore, I predict that what responses there are will partake heavily of logical fallacies. <br /><br />Finally, it is worthwhile to think about Prof Mintzer's points when assessing the arguments made in favor of particular executives' outsized remuneration. <br /><br /><b>An Example - Continued Riches for Wake Forest Baptist Executives</b><br /><br /><u>Outsize Executive Compensation Continues </u><br /><br />A few weeks ago, we <a href="http://hcrenewal.blogspot.com/2013/05/clouded-visionary-leadership-wake.html">noted</a> that the leaders of this large medical center, while previously proclaimed as visionaries, and enjoying enlarging compensation, seemed to have lead the institution to a financial crisis due to difficulties with a poorly chosen or implemented electronic health record system. <br /><br />One follow up story updated compensation information and provided the official management rationale for the ongoing largess. The redoubtable Richard Craver <a href="http://www.journalnow.com/business/business_news/local/article_5da8b354-bda0-11e2-b691-001a4bcf6878.html">wrote</a> in the Winston-Salem Journal,<br /><br /><span class="paragraph-0"> </span><br /><blockquote class="tr_bq"><span class="paragraph-0">Wake Forest Baptist Medical Center provided its top executive, Dr. John McConnell, an 11.9 percent raise in salary during 2011 to $983,777, although his total compensation dropped 18 percent, the center reported Wednesday as part of an annual regulatory filing.<br /><br /> </span> <span class="paragraph-1"> <i>McConnell was paid <b>$2.04 million</b> in total compensation,</i> compared with almost $2.5 million for 2010. Although Wake Forest Baptist operates on fiscal years that end on June 30, the pay for its top executives is required to be listed on a calendar-year basis.<br /><br /> </span> </blockquote><blockquote>The main difference between the 2010 and 2011 compensation totals for McConnell was $461,575 he received as a one-time payment that replaced the retirement benefits he forfeited upon leaving the University of Texas Southwestern Medical Center in Dallas. McConnell was required to work at Wake Forest Baptist for two years to receive the one-time payment.</blockquote><br />Keep in mind that in 2008-9x, Dr McConnell made a total of just over $700,000, so his compensation in 2011 was about three times that.<br /><br />The benevolent board of the medical center saw to it that Dr McConnell got money for all sorts of reasons:<br /><br /><blockquote class="tr_bq">McConnell received <i>$384,203 in bonus and incentives</i> in fiscal 2010-11. The center said the amount reflects the achievement of clinical quality, academic and financial goals set by the board of directors. The bonus was down $115,797 from fiscal 2009-10 primarily because the center reduced the potential percentage of the incentive compensation from 75 percent of his base salary to 53 percent.<br /><br /> McConnell received $38,511 in other reportable compensation, which the center listed: as <i>$8,797 in annual dues for Forsyth Country Club and Rotary Club membership</i>, defined as for business purposes; $16,500 qualified deferred compensation; $3,612 in after-tax life-insurance deduction; and <i>$9,602 in an automobile allowance.</i><br /><br /> He also received<i> $619,002 in contributions to retirement plans,</i> including a supplemental executive retirement plan solely for McConnell’s benefit.</blockquote><br />One wonders why, given his salary and bonus, Dr McConnell could not afford to pay dues to the country club and rotary on his own, or for his own car expenses, or to provide for his own retirement, for that matter?<br /><br />Other executives also continued to do very well:<br /><br /><blockquote class="tr_bq">Donny Lambeth, former president of N.C. Baptist Hospital, <i>received <b>$2.47 million</b> in total compensation.</i> Lambeth served as president of Davie County Hospital and Lexington Medical Center before retiring last year. He is now serving as an N.C. House representative.<br /><br /> Lambeth’s $495,595 in base salary represented an 8 percent decrease related to his reduced job responsibilities. His bonus and incentive compensation was down 2 percent to $181,988. The bulk of Lambeth’s compensation was $1.62 million related to a fully vested deferred compensation upon his retirement.<br /><br /> Dr. Thomas Sibert, president of Wake Forest Baptist Health and chief operating officer, received a 14 percent increase in <i>total compensation to <b>$1.13 million</b></i>, including $631,297 in salary (up 15.7 percent) and $234,540 in bonus and incentive compensation (up 41.3 percent). Sibert took over his role in September 2010.<br /><br /> Edward Chadwick, chief financial officer, received a less than 1 percent increase in <i>total compensation to <b>$979,420</b></i>. His salary rose 4.6 percent to $527,216, while his bonus and incentive compensation fell 5 percent to $189,929.<br /><br /> Russell Howerton, chief medical officer, was paid $295,714 in salary, $300,786 in bonus and incentive compensation and<i> <b>$657,025</b> in total compensation</i>. Doug Edgeton, former president of Piedmont Triad Research Park (recently renamed as Wake Forest Innovation Quarter), received $490,485 in salary, $162,367 in bonus and incentive compensation and <i><b>$710,729</b> in total compensation</i>.</blockquote><br /><b>The Chief Information Quietly Departs, with Some More Money </b><br /><br />Meanwhile, Mr Craver also <a href="http://www.journalnow.com/business/business_news/local/article_de6ed88a-bf47-11e2-b05e-0019bb30f31a.html">reported</a> the quiet departure of the executive who presided over the troubled implementation of the EHR,<br /><br /><span class="paragraph-0"> </span><br /><blockquote class="tr_bq"><span class="paragraph-0">The chief information officer for Wake Forest Baptist Medical Center is stepping down, effective May 31, the center confirmed Friday.<br /><br /> </span> <span class="paragraph-1"> Sheila Sanders has served in that role, as well as vice president of information technology, since being hired in 2009 to direct the center’s overhaul of its IT system.<br /> </span></blockquote><blockquote><div class="p402_hide"><div id="in-story"> </div></div><br />She is leaving at a time when the center is struggling financially and operationally with implementing the Epic electronic health records system — one of the largest overall projects Wake Forest Baptist and most health care systems have undertaken in recent years.</blockquote><br />Note that Ms Sanders was well rewarded for her questionable efforts,<br /><br /><br /><blockquote class="tr_bq">Sanders was paid $333,961 in salary, $89,145 in bonus and incentive compensation and <i><b>$464,543</b> in total compensation in 2011</i>, according to a regulatory filing that Wake Forest Baptist made public Wednesday. The center’s executive-compensation data typically is about 18 months old when released.<br /><br /> In terms of salary, Sanders <i>ranked sixth among the center’s 27 listed management officials.</i> </blockquote><br />It was clear that Ms Sanders ought to have been directly responsible for the EHR implementation,<br /><br /><blockquote class="tr_bq"> The center said Sanders’ duties included clinical information, administrative, business, academic and research support systems, as well as core IT functions that include a central IT help desk, email, computer desktop support, IT security and telecommunications.</blockquote><br />Nonetheless, the extremely well-paid top leadership did not seem to have hard feelings.<br /><br /><br /><blockquote class="tr_bq">Dr. John McConnell, the center’s chief executive, said in a statement that Sanders decided in January to <i>take 'a brief career break' </i>after completing major portions of the overhaul. He said Sanders is relocating to Florida to spend more time with her family.<br /><br /> Wake Forest Baptist spokesman Chad Campbell stressed it was Sanders’ decision to leave her positions, and it was not related to Epic, which went live in September on the center’s main campus.</blockquote><br />Also,<br /><br /><blockquote class="tr_bq">'We are deeply grateful to Sheila for her numerous contributions that will serve the medical center for years to come,' McConnell said. McConnell said senior IT officials will manage day-to-day IT operations with his oversight while the center conducts a national search for her replacement.</blockquote><br />But to reiterate,<br /><br /><blockquote class="tr_bq"> The center said May 2 it had launched another round of 'multi-million dollar' cost-cutting measures that will last through at least June 30, the end of its 2012-13 fiscal year, related to fixing Epic revenue issues.</blockquote><br /> Perhaps any attempt to saddle the chief information officer with responsibility would point out the lack of responsibility imposed on even higher level and better paid executives for apparently approving and authorizing her previous work.<br /><br /><u>The Usual Talking Points </u><br /><br />Instead, the official statement from hospital system management about top <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">executives' compensation</a> trotted out the usual talking points in defense of all this lavish pay,<br /><br /><blockquote class="tr_bq">Wake Forest Baptist said in a statement explaining its executive compensation packages that as an academic medical center, it requires management with '<i>a special set of skills and experience</i> to manage relationships with physicians and researchers, the university, its patients and community. … It takes <i>proven talents</i> possessed by a small group of health care executives.'<br /><br /> 'Compensating executives, as we do all of our employees, <i>competitively and appropriately</i>, is crucial to the success of Wake Forest Baptist and to Northwest North Carolina.'</blockquote><br />In addition,<br /><br /><blockquote class="tr_bq"> Baptist said its executive compensation is based<i> primarily on comparisons </i>with 32 academic medical centers, including Duke University Hospital and UNC Hospitals. </blockquote><br />With regard to Dr McConnell's special retirement plan,<br /><br /><blockquote class="tr_bq">'This is a common benefit for executives at academic medical centers and health systems to <i>encourage retention and provide competitive retirement benefits</i>,' the center said in its statement.</blockquote><br />We first listed the talking points <a href="http://hcrenewal.blogspot.com/2011/09/talking-points-sans-original-thought-to.html">here</a>, and then provided additional examples of their use <a href="http://hcrenewal.blogspot.com/2011/09/more-repeats-of-talking-points.html">here</a>, <a href="http://hcrenewal.blogspot.com/2012/03/example-of-how-complex-takes-control.html">here</a> and <a href="http://hcrenewal.blogspot.com/2012/12/health-care-hired-managers-not-playing.html">here</a>. The official administration discussion above does seem to include: <br />- We have to pay competitive rates<br />- We have to pay enough to retain at least competent executives, given how hard it is to be an executive<br />- Our executives are not merely competitive, but brilliant.<br /><br />Left out was any evidence about the executives' performance, much less their degree of responsibility for their institution's performance. Why the few top paid executives should continue to get credit for the institutions' supposed, but unspecified successes, while escaping any accountability for its failures (including the looming problems with its commercial health care information technology) was of course not mentioned. <br /><br />So here is a great, current example of how top health care executives are gambling with other peoples' money, in a game rigged so that they always win. As long as we continue such perverse incentives in health care, they will continue to inspire leaders to line their own pockets at the expense of our health care institutions, and ultimately to the detriment of patients' and the public's health. <br /><br /><b>Conclusion </b><br /><br />So let me conclude with Prof Mintzer's conclusion,<br /><br /><blockquote class="tr_bq">All this compensation madness is not about markets or talents or incentives, but rather about <i>insiders hijacking established institutions for their personal benefit.</i><br /><br />Too many large corporations today are starved for leadership—true leadership, meaning engaged leadership embedded in concerned management. And the global economy desperately needs renewed enterprise, embedded in the belief that companies are communities. Getting rid of executive bonuses, and the gambling games that accompany them, is the place to start.</blockquote><br /><br />Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-87077778976318115592013-05-17T09:08:00.000-07:002013-06-07T11:46:38.482-07:00Marin General Hospital nurses warn that new computer system is causing errors, call for time out<div style="text-align: center;">- Posted on the Healthcare Renewal Blog May 17, 2013 -</div><br />Of course, the ever-present euphemism for life-threatening EHR malfunctions and defects, i.e., "<b>glitches</b>" are the cause (<a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>):<br /><a href="http://www.marinij.com/rosskentfieldgreenbrae/ci_23251638/marin-general-hospital-nurses-warn-that-new-computer"><br /></a><br /><blockquote class="tr_bq"><a href="http://www.marinij.com/rosskentfieldgreenbrae/ci_23251638/marin-general-hospital-nurses-warn-that-new-computer">Marin General Hospital nurses warn that new computer system is causing errors, call for time out</a><br /><br />By Richard Halstead<br />Marin Independent Journal<br />Posted: 05/15/2013 04:07:49 PM PDT<br /><br />Nurses at Marin General Hospital have asked administrators to put implementation of a new computerized physician order entry system on hold until <b>glitches </b>can be worked out and more training provided to nurses and doctors who use it.<br /><br />Nearly a dozen nurses attended the regularly scheduled meeting of the Marin Healthcare District board Tuesday night at Marin General to voice their concerns. The district board oversees Marin General, but it does not involve itself in the hospital's day-to-day operations.<br /><b><br />"Orders are being inadvertently passed to the wrong patients</b>. <b>People have gotten meds when they've been allergic to them</b>. This is dangerous," said Barbara Ryan, a Marin General registered nurse, who works in pediatrics and the intensive care nursery. "We're not asking you to get rid of it. We're asking you to place it on hold."</blockquote><br /><br />Orders passed to wrong patients? No problem, just a glitch! Meds people are allergic to? Just a glitch. Dangerous? No way. It's just a glitch!<br /><br /><blockquote class="tr_bq">But Lee Domanico, who serves as the CEO of both Marin General and the Marin Healthcare District, said, "I'm confident that in spite of the implementation issues,<b> we have a system today that is safer for patients than our old paper system</b>, and it will get even safer as we gain experience with it and work to fix some of the glitches we've experienced."</blockquote><br />Where's the data backing up that assertion, I ask? The actual risks of paper records don't seem to be robustly documented anywhere.<br /><blockquote class="tr_bq"><br />Ryan, who serves as the California Nurses Association/National Nurses United representative, was one of four Marin General nurses who spoke during the public comment portion of the meeting. Ryan said the <b>nurses warned in advance </b>of the system's roll-out on May 7 that nurses and doctors had insufficient knowledge of the system. Ryan said due to problems with the software <b>nurses had been unable to open the program at home to practice using it.</b></blockquote><br />And yet the rollout happened anyway? That seems to me to be reckless indifference to the concerns of clinicians.<br /><br /><blockquote class="tr_bq">"Lo and behold the problems that we were worried about have happened," Ryan said. "We're looking at <b>two-hour preps for surgery and two- to three-hour discharges; </b>skilled nursing facilities calling back saying, this really doesn't make sense; <b>the wrong meds ordered on the wrong patients </b>and then given to the wrong patients; the inability for nurses to be able to see what the doctor ordered and double-check it."</blockquote><br />Of course, I might add, patient safety was not compromised, the other common refrain of EHR glitch-excusers ... see below.<br /><br /><blockquote class="tr_bq">Ryan said nurses have and will continue to file "assignment despite objection" forms due to the system. Nurses file the forms to document formal objections to what they consider an unsafe, or potentially unsafe, patient care assignment.<br /><br />"We will take patients but we will object to the assignment because it is unsafe," Ryan said. "This system is making it unsafe."</blockquote><br />These will be exceptionally helpful in court to any patients injured or killed as a result of these "glitches" and EHR rollout that occurred despite direct warnings from clinical experts.<br /><br /><blockquote class="tr_bq">Marin General nurse Susan Degan said, <b>"This is not about resistance to change</b>. It's about accountability. My most important role is that of patient advocate. I am held accountable when errors are made."<br /><br />Domanico acknowledged there have been some technical problems with the Paragon system, including making it possible for nurses to open from home. <b>And he said the software is not faster than the old paper system.</b> <span style="color: red;"><i><b>[Considering it's acknowledged all the way up to the highest levels of HHS that current EHR's slow physicians down, one wonders if anyone in this organization thought an EHR would actually increase speed? - ed.]</b></i></span></blockquote><br />About the "resistance to change" canard, see my essay "<b>Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality"</b> at <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html">http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html</a> .<br /><blockquote class="tr_bq"><br />"So yes," Domanico said, "it is causing stress for nurses who have heavy workloads, who are learning how to use it, particularly in areas where we need to speed up the computer."</blockquote><br />What? <b>"Speed up the computer?" </b> They've spent tens if not hundreds of millions for an EHR, and the computer's too slow?<br /><br />Actually, I think what this CEO in an obvious display of health IT ignorance is trying to say is that we have to do something about the system's poor usability, which sort of mimics what the Board Chair of the American Medical Assocation just said (<a href="http://hcrenewal.blogspot.com/2013/05/ama-finally-on-board-with-ehr-views.html">http://hcrenewal.blogspot.com/2013/05/ama-finally-on-board-with-ehr-views.html</a>).<br /><br />Also - clinician stress promotes error.<br /><br /><blockquote class="tr_bq">But Domanico challenged the suggestion that patient safety at Marin General had been compromised.</blockquote><br /><b>In fact, there is no way the issues described above cannot be compromising patient safety, on its face. </b>(<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>)<b>.</b><br /><br /><blockquote class="tr_bq">"I would have no hesitation about entering this hospital tonight," he said.</blockquote><br />As a VIP, of course, this CEO would get special treatment. Thanks a lot.<br /><br />I would NOT want to be a patient there under these conditions, unless perhaps I had a 24x7 medically-skilled advocate/bodyguard.<br /><br /><blockquote class="tr_bq">Board member Ann Sparkman, who previously served as in-house counsel at Kaiser Permanente, said nurses at Kaiser struggled at first when a new computer system was introduced there.<br /><br />Sparkman said, <b>"It's just to be expected."</b></blockquote><br />This seems a rather bizarre appeal to common practice (<a href="http://www.nizkor.org/features/fallacies/appeal-to-common-practice.html">http://www.nizkor.org/features/fallacies/appeal-to-common-practice.html</a>).<br /><br />The stunning ignorance of this board member about proper mission-critical IT safety testing and implementation, such as performed in pharma, aerospace, etc. is, quite frankly, shocking.<br /><br />Further, an attitude that life-threatening "glitches" are "just to be expected" by a member of the Board of Directors, with fiduciary responsibilities regarding hospital operations, is grossly negligent in my opinion, and completely ignores patient's rights.<br /><br />Unbelievable. <br /><br />One wonders if any formally-trained medical informatics experts were in leadership roles in this project. <br /><br />-- SSAnonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-65237228877157867252013-05-17T06:10:00.000-07:002013-06-07T11:46:38.488-07:00American Medical Association finally on board with EHR views expressed on this blog since 2004<div style="text-align: center;">- Posted on the Healthcare Renewal Blog May 17, 2013 -</div><br />It seems to have taken awhile, but organized medicine seems to finally be recognizing that today's commercial health IT is not quite the revolutionizing, transformative, plug-and-play panacea to healthcare's ills it is often touted as:<br /><br /><blockquote class="tr_bq"><b>AMA Wire</b><br /><b>May 15, 2013 </b><br /><b><a href="http://www.ama-assn.org/ams/pub/amawire/2013-may-15/2013-may-15-general_news1.shtml">AMA board chair: HHS should address EHR usability issues immediately</a></b><br /><br />The government needs to act quickly to remedy the impaired usability of electronic health records (EHR) if the technology's touted benefits are to be realized, AMA Board of Trustees Chair Steven J. Stack, MD (left), told officials during a federal hearing last week.<br /><br /><b>"The AMA and most physicians believe that, done well, EHRs have the potential to improve patient care,"</b> Dr. Stack, an emergency physician in Lexington, Ky., said during his 30-minute <a class="pdf" href="http://www.ama-assn.org/resources/doc/washington/ehr-meaningful-use-testimony-03may2013.pdf" target="_blank">testimony</a>. "At present, however, these EHRs <b>present substantial challenges</b> to the physicians and other clinicians now required to use them."<br /><br />He emphasized that many of today's EHR systems require <b>significant changes</b> before they can deliver the promised outcomes. Referring to Medicare's meaningful use program, he pointed to <b>undesired consequences of pushing EHR systems on physicians before the technology was completely ready for prime time.</b></blockquote><br />"Immediately" is strong language. <br /><br />I note that the phrase <b>"health IT done well"</b> is a term I've been using since 1998 at my now-Drexel-based health IT teaching website at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases">http://www.ischool.drexel.edu/faculty/ssilverstein/cases</a>, as well as at this blog.<br /><br />Penned by me at my aforementioned Drexel graduate teaching site, originally housed on AOL, in 1998 and still appearing in its main essay:<br /><br /><blockquote class="tr_bq"><div class="MsoNormal"><span style="font-size: small;"><span style="font-family: Arial;">... While clinical IT is now potentially capable of achieving many of the benefits long claimed for it such as improved medical quality and efficiency, reduced costs, better medical research and drugs, earlier disease detection, and so forth, there is a major caveat and essential precondition<b>:</b> the benefits will be realized only if clinical IT is <b><i>done well</i></b>. For if clinical IT is <b>not</b> done well, as often occurs in today’s environment of medical quick fixes and seemingly unquestioning exuberance about IT, the technology can be injurious to medical practice and biomedical R&D, and highly wasteful of scarce healthcare capital and resources. </span></span></div><div class="MsoNormal"><br /></div><span style="font-size: small;"><span style="font-family: Arial;">Those two short words “<b><i>done well</i></b>” mask an underlying, profound, and, as yet, largely unrecognized (or ignored) complexity. This website is about the meaning of "<i>done well</i>" in the context of clinical computing, a computing subspecialty with issues and required expertise quite distinct from traditional MIS (management information systems, or business-related) computing.</span></span></blockquote><br />(I have more recently switched to the easier-to-parse terminology of "good health IT" vs. "bad health IT" after discussions with Dr Jon Patrick at U. Sydney during my visit Down Under last summer, <a href="http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html">http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html</a>.)<br /><br />I've also heard "<i>not ready for prime time</i>" before. It is a phrase I used in speaking with a New York Times reporter that then appeared in the Oct. 8, 2012 NYT article <b>"The Ups and Downs of Electronic Medical Records"</b> (<a href="http://www.nytimes.com/2012/10/09/health/the-ups-and-downs-of-electronic-medical-records-the-digital-doctor.html?pagewanted=2">http://www.nytimes.com/2012/10/09/health/the-ups-and-downs-of-electronic-medical-records-the-digital-doctor.html?pagewanted=2</a>) by Milt Freudenheim, October 8, 2012, where I am quoted and this blog cited:<br /><br /><blockquote class="tr_bq">... <b>Critics are deeply skeptical that electronic records are ready for prime time. </b>“The technology is being pushed, with no good scientific basis,” said Dr. Scot M. Silverstein, a health I.T. expert at Drexel University who reports on medical records problems on the blog <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>. He says testing these systems on patients without their consent “raises ethical questions.” </blockquote><br />The AMA Board chair went on to opine:<br /><br /><blockquote class="tr_bq">"Attempting to transform the entire health system in such a rapid and proscriptive manner has compelled providers to purchase tools not yet optimized to the end-user's needs and that often impeded, rather than enable, efficient clinical care," he said.<br /><br />He noted that physicians are "prolific technology adopters" but that adoption of EHR systems has required federal incentives because t<b>he technology still is "at an immature stage of development."</b></blockquote><br />My near-exact terminology has been that the technology is still experimental.<br /><br /><blockquote class="tr_bq">"EHRs have been and largely remain <b>clunky, confusing and complex</b>," he said.</blockquote><br />Perhaps he read my ten-part series on the health IT mission hostile user experience at this blog, at <a href="http://www.tinyurl.com/hostileuserexper">http://www.tinyurl.com/hostileuserexper</a>.<br /><br /><blockquote class="tr_bq">According to a <a class="external" href="http://www.americanehr.com/blog/2013/03/himss13-ehr-satisfaction-diminishing/" target="_blank">recent survey</a> by AmericanEHR Partners, physician dissatisfaction with EHR systems has increased. Nearly one-third of those surveyed in 2012 said they were "very dissatisfied" with their system, and 39 percent said they would not recommend their EHR system to a colleague—up from 24 percent in 2010.</blockquote><br />A survey I posted about in Jan. 2010 is here: "<b>An Honest Physician Survey on EHR's</b>", <a href="http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html">http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html</a><br /><br /><blockquote class="tr_bq">Dr. Stack spoke at a "listening session" hosted by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), a division of the U.S. Department of Health and Human Services (HHS). The agencies coordinated the session to examine how a marked increase in code levels billed for some Medicare services might be tied to the increased use of EHRs.<br /><br />Dr. Stack noted that some Medicare carriers have begun denying payment for charts that are too similar to other records.<br /><br />"In this instance, even when clinicians are appropriately using the EHR, a tool with which they are frustrated and the use of which the federal government has<b> mandated under threat of financial penalty</b>, they are now being accused of inappropriate behavior, being economically penalized, and being instructed ‘de facto' to re‐engineer non‐value‐added variation into their clinical notes," he said. "This is an appalling Catch‐22 for physicians."</blockquote><br /><i>"Mandated under threat of financial penalty</i>" has been one of my stated "cart before the horse" issues with HITECH (e.g., <a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html</a>). <br /><br /><blockquote class="tr_bq">Dr. Stack advised officials that three key actions are necessary to rectify these issues with EHR systems:<br /><ul type="disc"><li>The <b>ONC promptly should address EHR usability concerns raised by physicians and add usability criteria to the EHR certification process.</b></li><li>CMS should provide clear and direct guidance to physicians concerning use of EHRs for documentation, coding and billing. </li><li>Stage 2 of the meaningful use program should allow more flexibility for physicians to meet requirements as EHR systems are improved. </li></ul>The AMA will continue to work with federal agencies to improve EHR systems and the Medicare meaningful use program.</blockquote><br />I've been calling for usability evaluation to be added to the certification process, including in comments during public comment periods to HHS, for some time.<br /><br />What the AMA Board Chair is apparently missing, though, is <b>health IT safety</b>. They should perhaps read my post on the recent ECRI Institute Deep Dive Study on health IT risk - itself based on a report in their own <span style="font-size: small;">AMNews (<a href="http://amednews.com/" target="_blank">amednews.com)</a> </span>publication ("<b>Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI Deep Dive Study of Health IT Events</b>", <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>).<br /><br />I don't think any prudent person would consider a 9-week study of 36 hospitals with volunteered reports of 171 health information technology-related problems, where eight of the incidents reported involved patient harm and three may have contributed to patient deaths, information to ignore.<br /><br />-- SSAnonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-78246392251883402572013-05-16T09:28:00.000-07:002013-06-07T11:46:38.495-07:00C R Bard Settles Allegations of Kickbacks to Promote Radiation Treatment for Prostate CancerScreening for and aggressive treatment of prostate cancer has become an enormously lucrative business, if not necessarily a life-saving medical strategy. The minimal media coverage of a recent settlement suggests that at least to some degree, it has been fueled by some questionable practices.<br /><br /><b>The CR Bard Settlement</b><br /><br />As <a href="http://www.ajc.com/news/business/bard-agrees-to-48-million-whistle-blower-settlemen/">reported</a> by the Atlanta Journal Constitution,<br /><br /><br /><blockquote class="tr_bq">A medical device company on Monday agreed to<i> pay a $48.2 million settlement to resolve claims by a Georgia employee that it paid kickbacks to doctors and customers who bought radiation treatment for prostate cancer.</i><br /><br />C.R. Bard Inc., which is headquartered in New Jersey and has offices in Covington, resolved a whistle-blower suit filed by the employee in 2006. The suit <i>alleged that the company paid off doctors and hospitals to induce them to prescribe brachytherapy seeds, which are implanted in the prostate and deliver a dose of radiation to cancer cells.</i></blockquote><br />Another <a href="http://www.macon.com/2013/05/14/2478611/medical-company-agrees-to-pay.html">brief report</a> in the Macon (GA) Telegraph gave a tiny bit more detail about what was given to physicians to get them to use Bard's radiation therapy products,<br /><br /><blockquote class="tr_bq"> Customers could order the seeds, used in brachytherapy to deliver a prescribed dose of radiation directly to cancer cells, from multiple companies. But <i>Bard allegedly offered doctors grant money, rebates, free medical equipment and advertising campaigns to entice them to buy their product at inflated prices,</i> according to a news release issued by [whistle-blower Julie] Darity’s legal team....</blockquote><b>The Usual Elements of Legal Settlements of Allegations of Health Care Corporate Bad Behavior </b><br /><br />The story, briefly told as it was, included many of the usual elements of stories of legal settlements of wrong-doing by large health care corporations. <br /><br /><u>Slow Justice </u><br /><br />The settlement, hence justice, as it were, took a long time, about 7 years since the most recent behavior, and 15 years since its start. Per the AJC,<br /><br /><blockquote class="tr_bq"> Bard employed its kickback scheme from 1998 to 2006, federal prosecutors said.</blockquote> <u>Penalties Not as Big as They Appeared</u><br /><br />The penalties were not as big as they seemed. There was the seemingly large fine, $48.2 million dollars. However, that should be compared to the company's net sales of over $2.95 billion and net income of $530 million in 2012, according to the company's <a href="http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9MTc1OTY0fENoaWxkSUQ9LTF8VHlwZT0z&t=1">annual report</a>. It should also be compared to the total compensation of the company's chairman and CEO in 2012, over $8.7 million, and to that of its president and chief operating officer, over $6.0 million, according to the company's <a href="http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9MTc3OTA0fENoaWxkSUQ9LTF8VHlwZT0z&t=1">2012 proxy statement</a>. Apparently, the fine came out of the company's treasury, so its impact was diffused among all shareholders, employees, customers, and patients, not directed to those who may have authorized, directed or implemented the kickbacks to physicians. <br /><br /><u>No Penalties for Individuals, No Acknowledgement of Wrong-Doing </u><br /><br />The settlement did not involve any sort of direct penalties to those who authorized, directed, or implemented the kickbacks.<br /><br />The corporation did not even acknowledge any bad behavior. As per the AJC,<br /><br /><br /><blockquote class="tr_bq">Bard is pleased to settle the claims, Scott Lowry, a company spokesman, said in a statement.<br /><br />'This resolution allows the company to put this matter behind it and continue to focus on delivering life-enhancing medical devices and technologies to patients around the world,' he said. 'We remain committed to continuously enhancing and improving our compliance programs in accordance with industry standards.'</blockquote><b>Suppression of Whistle-Blowing </b><br /><br />It may not be part of all such settlements, but note that in this case there seemed to be an attempt to shut up the whistle-blower. So, there is reason to think that justice, such as it was, was delayed because the company seemingly tried to punish the whistle-blower, rather than listen to what she had to say. Per the Macon Telegraph,<br /><br /><blockquote class="tr_bq"> Darity, 56, said she first reported what she suspected as questionable activities to her supervisors.<br /><br />'I did exactly what was outlined in the company ethics policy,' she said. 'I wanted to think things were being corrected.'<br />In time, she realized nothing had changed. She filed an internal whistle-blower complaint.<br /><br />Her job was eliminated in November 2005, soon after an investigation was launched into her whistle-blower complaint, she said.<br /><br />Darity had worked for Bard, which has an office in Covington, for more than 18 years. When her job was eliminated, she was a manager in the Brachytherapy Contracts Administration division.<br /><br />Out of a job, Darity filed the lawsuit in U.S. District Court for the Northern District of Georgia in January 2006.</blockquote><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.macon.com/2013/05/14/2478611/medical-company-agrees-to-pay.html#storylink=cpy</div><br />Nonetheless, the government seemingly trusted C R Bard to fix its own behavior going forward, <a href="http://online.wsj.com/article/SB10001424127887323716304578482953550885568.html">per the Wall Street Journal</a>,<br /><br /><blockquote class="tr_bq"> As part of a non-prosecution agreement, C.R. Bard agreed to pay an additional $2.2 million and take remedial steps to enhance compliance. The company had said in a regulatory filing last year that it expected the settlement to include a corporate integrity agreement, which typically require companies to obey restrictions on their sales and marketing practices, but no such agreement was announced Monday. </blockquote>Note that <a href="http://hcrenewal.blogspot.com/2012/06/administrators-at-pepper-spray-u-found.html">here</a> we discussed a case in which an academic medical institution seemingly tried to punish faculty members who questioned that organization's overly enthusiastic approach to prostate cancer. <br /><br /><b>Summary - the Profitable but Unsubstantiated Aggressive Approach to Prostate Cancer </b><br /><br />So its just another day at the office. This was a typical <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">settlement</a> of allegations of unethical behavior by a large health care organization. A large health care company allegedly bribed doctors to use its products. It seemingly tried to shut up a whistle-blower. Seven years later, the company got a financial slap on the wrist, but no one directly involved in the alleged kickbacks, and no one whose compensation may have been enlarged due to such apparently unethical activity paid a price. Never mind that the alleged kickbacks may have induced doctors to use treatments that provided no overall benefit, but could have harmed patients. <br /><br />Before ending with our usual fulmination, I should note that this case appears to be one small piece in the puzzle of our national infatuation with an aggressive approach to prostate cancer, despite a lack of essentially any good evidence that this approach does any good. Brachytherapy, the treatment pushed allegedly by kickbacks, is one kind of aggressive treatment for prostate cancer. Yet there is no good evidence from randomized controlled trials that is prolongs life. In fact, a recent (and the only major) randomized controlled trial of aggressive treatment of prostate cancer on initial diagnosis failed to show any overall survival benefit.(1) There has been a huge push to screen all men of a certain age for prostate cancer. Yet now two new trials also failed to show any overall survival benefit from screening.(2,3) <br /><br />But the prostate cancer business is very lucrative. On the Reforming Health blog, <a href="http://reforminghealth.org/2012/04/25/on-prostate-cancer-screening-warren-buffet-and-ignoring-science/">a post</a> summarized a lecture given by Dr Otis Brawley, chief medical officer of the American Cancer Society in which Dr Brawley described the financial scheme underlying the aggressive approach to prostate cancer,<br /><br /><br /><blockquote class="tr_bq">Brawley recounts an experience he had on a site visit to a hospital in 1998 while an Assistant Director at the National Cancer Institute. During the visit a marketing executive explains to Brawley the publicity value and financial rewards of a free prostate screening program offered by the hospital at a local mall. The plan is to screen the first 1,000 men over 50 who come to the mall for testing. I’ve transcribed Brawley’s recollections from the video and they provide a great explanation for the profit-driven practices that continue to occur today, 14 years later:<br /><br /> <em>'If they screen 1,000 men they’re going to have 145 abnormals. They’re going to charge about $3,000 to figure out what is abnormal about these abnormals, that’s how they pay for the free screening. About 10 of the 145 won’t come to this hospital so that’s business for their competitors, but they’ll get 135 times $3,500 on average. Of the 135, 45 are going to die of prostate cancer and the other percentage are going to get radical prostatectomy at about $30-40,000 a case; there’s a percentage that’s going to get seeds at about $30,000 a case; a percentage were going to get radiation therapy that (at the time) was about $60,000. Then [the marketing executive’s] business plan goes further, he knows how many guys are going to have so much incontinence that diapers aren’t going to do it so he had in his business plan how many artificial sphincters urologists were going to implant. And then he was a little apologetic because there was this new thing called Viagra that screwed up his estimates for how many penile implants he was going to sell because guys were upset about impotence related to prostate cancer treatment.'</em><br /> <br /><em>Brawley says, 'this is 1998, I ask him, if you screen 1,000 people how many lives are you going to save? He took off his glasses and looked at me like I was some kind of fool and said, ‘Don’t you know, nobody’s ever shown that prostate cancer screening saves lives, I can’t give you an estimate on that.’'</em></blockquote><br />Presumably because he was a marketing executive, the manager whom Brawley quoted did not have to feel doubt about all the men subjected to needless procedures, and who would be at risk of serious and unpleasant adverse effects of these procedures, all to make money but not to prolong their lives. Of course, not only the hospitals make money, but also quite obviously the companies that sell them the drugs and devices needed for all this medical aggression make money, as do the doctors who go along with it all. <br /><br />Now we suspect that one small reason the doctors have gone along with it is that they may have gotten inducements from those companies.<br /><br />Time to fulminate,...<br /><br />We will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich. <br /><br /><b>References</b><br /><br />1. Wilt TJ, Brewer MK, Jones KM et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med 2012; 367: 203-13. [Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1113162">here</a>]<br />2. Andriole GL, Crawford ED, Grubb RL et al. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med 2009; 360: 1310-9. [Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa0810696">here</a>]<br />3. Schroder FH, Gugosson J, Roobl MJ et al. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med 2009: 360: 1320-8.[Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa0810084">here</a>]<br /><br /><br /><br /><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.macon.com/2013/05/14/2478611/medical-company-agrees-to-pay.html#storylink=cp</div><br />Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-83645409625548984072013-05-14T11:40:00.000-07:002013-06-07T11:46:38.502-07:00Six Years Later, Ranbaxy - Oops, Daiichi Sankyo - Pleads Guilty to Adulteration, Pays $500 MillionIt only took until 2013, but the US Food and Drug Administration finally secured guilty pleas and fines. The basics are in an Associated Press story (<a href="http://www.washingtonpost.com/business/subsidiary-of-indian-drug-maker-agrees-to-pay-record-500-million-us-penalty-for-impure-drugs/2013/05/13/2d586104-bc33-11e2-b537-ab47f0325f7c_story.html">via the Washington Post</a>):<br /><br /><blockquote class="tr_bq"> A subsidiary of India’s largest pharmaceutical company has <i>agreed to pay a record $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators</i> in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S.<br /><br />Federal prosecutors say the guilty plea by Ranbaxy USA Inc. represents the <i>largest financial penalty against a generic drug company for violations of the Federal Food, Drug and Cosmetic Act, which prohibits the sale of impure drugs.</i></blockquote><br />Note that the company pleaded guilty to criminal charges. <br /><br /><blockquote class="tr_bq"> The subsidiary of Ranbaxy Laboratories Limited <i>pleaded guilty to federal criminal charges </i>and the company separately agreed to resolve civil claims with all 50 states and the District of Columbia. The company had earlier set aside $500 million to cover potential criminal and civil liability stemming from the Justice Department investigation.<br /><br />It admitted as part of the deal that it sold adulterated batches of drugs — including an antibiotic and generic versions of medications used to treat severe acne, epilepsy and nerve pain — that were developed at two manufacturing sites in India. </blockquote><br /><b>Ironies</b><br /><br />Note that this resolution has certain ironies.<br /><br /><u>Lateness</u><br /><br />There is a saying that justice delayed is justice denied. Note that it took six years to obtain the guilty pleas. As noted by the AP,<br /><br /><blockquote class="tr_bq"> The problems were largely<i> revealed by a whistleblower in a federal lawsuit filed in Maryland in 2007.</i> </blockquote><br /><u>Ambiguities about Responsibility</u><br /><br />First, note that while all the headlines are about Ranbaxy, Ranbaxy is not really an independent company. As<a href="http://www.reuters.com/article/2013/05/13/us-ranbaxy-settlement-idUSBRE94C0PT20130513"> reported</a> by Reuters (and only by Reuters so far as I can tell at this time),<br /><br /><blockquote class="tr_bq"><i>Ranbaxy ... [is] majority-owned by Japan's Daiichi Sankyo.</i></blockquote><br />Second, as per the AP, see the comment made by the Ranbaxy CEO,<br /><br /><blockquote class="tr_bq">'While <i>we are disappointed by the conduct of the past </i>that led to this investigation, we strongly believe that settling this matter now is in the best interest of all of Ranbaxy’s stakeholders; the conclusion of the DOJ investigation does not materially impact our current financial situation or performance,' Ranbaxy CEO and managing director Arun Sawhney said in a statement.</blockquote><br />Maybe there was something lost in translation, but the CEO certainly spoke as if someone else was responsible for the "conduct of the past." Incidentally, it does not appear that so far any journalist has even sought comment from the people really in charge, at Daiichi Sankyo.<br /><br />Third, just like many other cases we have reported before, no individual, especially anyone who authorized, directed, or implemented the bad behavior, was held legally responsible. The cost of the fines will no doubt be spread among the corporate structures involved. Since a company pleaded guilty, no individual pays a fine, much less goes to jail. <br /><br />It does appear that when the settlement was first announced in 2011, a cut in compensation for top executives of Daiichi Sankyo was announced, but the cuts were temporary, and apparently in response to the immediate financial consequences of the settlement, not any larger implications. See Bloomberg's <a href="http://www.bloomberg.com/news/2011-12-21/daiichi-sankyo-lowers-executive-pay-after-500-million-ranbaxy-settlement.html">report</a>:<br /><br /><blockquote class="tr_bq"> Chief Executive Officer Joji Nakayama and board members will receive <i>5 percent to 30 percent less compensation for six months</i> in response to the cut in the earnings forecast, Daiichi Sankyo said today. The company has lost about half its market value since agreeing to buy a majority stake in Ranbaxy, India's largest drugmaker, in June 2008. </blockquote><br /> <u>The Contrast with the Case of the Adulterated Heparin</u><br /><br />Note that in this case, there have been no allegations that patients were harmed by the admitted adulteration, Per the AP:<br /><br /><blockquote class="tr_bq"> It’s not known whether the problems with the drugs led to any health issues.... The government’s allegations against the company make no claims that the drugs, whose strength, purity or quality differed from the specifications, harmed anyone.</blockquote><br /><br />In 2008, we <a href="http://hcrenewal.blogspot.com/2008/02/heparin-made-out-of-pigs-from-elsewhere.html">began </a>blogging about how US patients started to get sick and die after being infused with heparin, the common anti-coagulant drug. As we have discussed repeatedly (look <a href="http://hcrenewal.blogspot.com/search/label/heparin">here</a>, and see the summary at the end of the post), Baxter International was selling contaminated heparin under its label which was made in unregulated workshops in China, and then transmitted through a complex chain of Chinese and US companies. <br /><br />The AP article stated,<br /><br /><blockquote class="tr_bq"> The case comes as federal regulators and prosecutors focus attention on the quality of ingredients of generics and other drugs manufactured overseas, said Allan Coukell, an expert on drug safety at The Pew Charitable Trusts. He said the <i>2008 deaths linked to tainted batches of the blood-thinner heparin that were imported from China </i>served as a 'wake up call' about just how much of the nation’s drug supply comes from overseas.</blockquote><br />So perhaps this wake up call helped propel the current case against Ranbaxy, that is, Daiichi Sankyo. However, since 2008, if there has been a criminal investigation of the tainted heparin, which appears to have been much more consequential, sometimes fatally so, to patients, the results have not been made public. A cynic might note that the contaminated heparin was sold by a US based manufacturer of branded pharmaceuticals, not a foreign based manufacturer of generic drugs. <br /><br /><b>Summary </b><br /><br />The most fundamental obligation of a drug company is to produce pure, unadulterated drugs. The first attempts to regulate the drug industry in the US were meant to ensure that these companies fulfilled this obligation. Yet now there is increasing evidence that the contemporary pharmaceutical industry has trouble with this most basic responsibility. <br /><br />As we discussed <a href="http://hcrenewal.blogspot.com/2012/09/who-really-makes-brand-name.html">here</a>, the managers of pharmaceutical companies have been swept up in a dominant business management fad, <a href="http://hcrenewal.blogspot.com/search/label/outsourcing">outsourcing</a>, as a means to cut costs to the bone. (It seems that most health care managers are also caught up in the larger rage for <a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a>, to emphasize short term revenue over all other concerns, including patients' and the public's health.) As the New York Times <a href="http://www.nytimes.com/2013/05/14/business/global/ranbaxy-in-500-million-settlement-of-generic-drug-case.html">reported </a>re the Ranbaxy case,<br /><br /><br /><blockquote class="tr_bq"><div itemprop="articleBody">Others say the company’s problems highlight how <i>little oversight federal drug safety officials have of overseas plants.</i> Studies that have shown the F.D.A. inspects foreign generic manufacturing plants about <a href="http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm310992.htm" title="The F.D.A.’s statement on the issue.">once every seven to 13 years</a>, compared with once every two years for domestic manufacturers. A law passed last year will eventually require the F.D.A. to apply the same standards when inspecting all manufacturing plants, regardless of location. But some worry that <a class="meta-classifier" href="http://topics.nytimes.com/top/reference/timestopics/subjects/f/federal_budget_us/index.html?inline=nyt-classifier" title="Recent and archival news about the federal budget.">federal budget</a> cuts are <i>slowing the adoption of that law. </i></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">'They just happened to stumble across the Ranbaxy problem at those two plants in India,' said Joe Graedon, a pharmacologist who runs a consumer Web site, <a href="http://www.peoplespharmacy.com/" title="The Web site.">the People’s Pharmacy</a>, which has raised questions about the safety of generic drugs. 'Ranbaxy was the biggest and one of the best in India. What about all the smaller ones? What does that say about them?' </div></blockquote><br /><a href="http://hcrenewal.blogspot.com/2012/09/who-really-makes-brand-name.html">Again,</a> all pharmaceutical companies, not just generic drug manufacturers, have seen fit to outsource much, if not most of their production.<br /><br />In our rush to market fundamentalism, we seem to have deregulated, at least de facto, most aspects of health care. We now cannot trust the drugs we take to have been made by the companies whose labels they bear, or to be pure. We now cannot trust that regulators will find that out, or having found that out, will do anything about it in a timely manner. <br /><br />To repeatedly reiterate, as long as the leaders of health care organizations are not held accountable for the results of their decisions on health care quality, cost, and access (even in such extreme quality violations as those resulting in multiple patient deaths), we can expect continuing decisions that sacrifice quality, increase costs, and worsen access, but that are in the self-interest of the people making them.<br /> <br />To really reform health care, we must hold health care organizations and their leaders accountable (and not blame all the problems on doctors, other health care professionals, patients, and society at large).<br /><br />- Roy M. Poses MD for Health Care Renewal <br /><br /><br /><span style="color: blue; font-size: xx-small;">Appendix - Heparin Case Summary</span><br /><br /><span style="color: blue; font-size: xx-small;">- We have posted several times, recently <a href="http://hcrenewal.blogspot.com/2011/06/first-contaminated-heparin-case-verdict.html">here</a></span><span style="color: blue; font-size: xx-small;"> about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late in 2007, hundreds of such reactions, and 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.</span><br /><br /><span style="color: blue; font-size: xx-small;">- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. (See posts <a href="http://hcrenewal.blogspot.com/2008/02/in-middle-of-all-those-pigs-in-china.html">here</a> and <a href="http://hcrenewal.blogspot.com/2008/03/heparin-in-era-of-hogwash.html">here</a>.)</span><br /><br /><span style="color: blue; font-size: xx-small;">- We found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post </span><a href="http://hcrenewal.blogspot.com/2008/03/fake-heparin-then-sick-and-dead.html"><span style="color: blue; font-size: xx-small;">here</span></a><span style="color: blue; font-size: xx-small;">.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post </span><a href="http://hcrenewal.blogspot.com/2008/03/who-was-responsible-for-purity-of.html"><span style="color: blue; font-size: xx-small;">here</span></a><span style="color: blue; font-size: xx-small;">.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.</span><br /><br /><span style="color: blue; font-size: xx-small;">- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."</span><br /><span style="font-size: xx-small;"><br /><span style="color: blue;"></span></span> <span style="color: blue; font-size: xx-small;">- Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post </span><a href="http://hcrenewal.blogspot.com/2008/05/blaming-some-dude-for-contaminated.html"><span style="color: blue; font-size: xx-small;">here</span></a><span style="color: blue; font-size: xx-small;">.) Note that SPL was recently bought out and taken private, making its current leadership even less transparent (see post </span><a href="http://hcrenewal.blogspot.com/2010/10/more-contaminated-heparin-but-who-leads.html"><span style="color: blue; font-size: xx-small;">here</span></a><span style="color: blue; font-size: xx-small;">). A 2010 inspection of an SPL facility by the FDA revealed ongoing manufacturing problems (see post </span><a href="http://hcrenewal.blogspot.com/2011/02/fda-to-scientific-protein-laboratories.html"><span style="color: blue; font-size: xx-small;">here</span></a><span style="color: blue; font-size: xx-small;">).</span><br /><br /><span style="color: blue; font-size: xx-small;">- Researchers (who turned out to have financial ties to a company which is developing an anti-coagulant drug that could compete with the heparin made by Baxter International) investigated the biological mechanisms by which the contamination of the heparin lead to adverse effects, but no one investigated further how the contamination occurred, or who was responsible. (See post </span><a href="http://hcrenewal.blogspot.com/2009/08/who-investigated-case-of-deadly.html"><span style="color: blue; font-size: xx-small;">here</span></a><span style="color: blue; font-size: xx-small;">.)</span><br /><br /><span style="color: blue; font-size: xx-small;">- Hundreds of lawsuits against Baxter have now been filed, so far without resolution. (See post </span><a href="http://hcrenewal.blogspot.com/2010/01/blog-post.html"><span style="color: blue; font-size: xx-small;">here</span></a><span style="color: blue; font-size: xx-small;">.) Efforts to make documents to be used in these cases public so far have not succeeded (see post </span><a href="http://hcrenewal.blogspot.com/2010/08/proprietary-information-confidentiality.html"><span style="color: blue; font-size: xx-small;">here</span></a><span style="color: blue; font-size: xx-small;">).</span><br /><br /><span style="color: blue; font-size: xx-small;">- A government report which attracted little attention warned of the dangers of pharmaceutical ingredients made in China and subject to virtually no oversight. (See post </span><a href="http://hcrenewal.blogspot.com/2010/04/another-echo-of-case-of-deadly-heparin.html"><span style="color: blue; font-size: xx-small;">here</span></a><span style="color: blue; font-size: xx-small;">.)</span><br /><br /><span style="color: blue; font-size: xx-small;">- Despite requests from the US, the Chinese government did not investigate the production of the heparin that lead to the deaths (see post </span><a href="http://hcrenewal.blogspot.com/2010/07/more-about-what-we-dont-know-about.html"><span style="color: blue; font-size: xx-small;">here</span></a><span style="color: blue; font-size: xx-small;">.)</span><br /><br /><span style="color: blue; font-size: xx-small;">- In February, 2011, a congressional investigation of the case was announced, but results are so far unavailable (see post <a href="http://hcrenewal.blogspot.com/2011/02/three-years-later-congressional.html">here</a>.)</span><br /><br /><span style="color: blue; font-size: xx-small;">- In June, 2011, a jury returned the first verdict in a civil case about the contaminated heparin, awarding money from Baxter International and Scientific Protein Laboratories to the estate of a man who apparently died due to tainted heparin (see post <a href="http://hcrenewal.blogspot.com/2011/06/first-contaminated-heparin-case-verdict.html">here</a>).</span><br /><br /><span style="color: blue; font-size: xx-small;">- If there was a criminal investigation of the case, its results have not yet appeared. </span>Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-37423269789020588122013-05-10T13:53:00.000-07:002013-06-07T11:46:38.600-07:00Clouded "Visionary" Leadership - Wake Forest Baptist Medical Center's EPIC "Business Cycle Disruptions" A typical excuse for the multi-million dollar compensation now enjoyed by many leaders of health care organizations is these leaders' supposed brilliance.<br /><br />For example, in 2011 we <a href="http://hcrenewal.blogspot.com/2011/05/million-dollar-plus-hospital-ceo.html">noted </a>that the total compensation of Dr John McConnell, the CEO of Wake Forest Baptist Medical Center, a non-profit teaching hospital, rose from over <b><i>$700,000</i></b> in 2008-2009 to over <b><i>$1.6 million</i></b> in 2009-2010. Other top executives in the system made nearly one million a piece. An official statement from the hospital system claimed that this level of compensation was needed to "retain skilled executives and <b><i>visionary leaders</i></b> for the medical center." Furthermore, in 2012 we <a href="http://hcrenewal.blogspot.com/2012/05/more-rising-compensation-for-executives.html">noted </a>that in 2010-2011 Dr McConnell's compensation had grown to nearly <b><i>$2.5 million</i></b>, while other top executives received from over $900,000 to over $1.1 million. <br /><br />Recent events, however, suggest that the "visionaries" may need new glasses.<br /><br /><b>An EPIC Challenge </b><br /><br />Last month, the Winston-Salem Journal <a href="http://www.journalnow.com/business/business_news/local/article_c2801866-9e0c-11e2-bf84-0019bb30f31a.html">reported</a> that Wake Forest Baptist Medical Center is facing some unexpected fiscal challenges, especially from its new electronic health record (EHR):<br /><br /><span class="paragraph-0"></span><br /><blockquote class="tr_bq">Wake Forest Baptist Medical Center’s <i>struggles to implement its <a href="http://hcrenewal.blogspot.com/search/label/EPIC">Epic electronic records system</a></i> <i>contributed to additional costs and lost revenue</i> during the first half of its fiscal year 2012-13.<br /><span class="paragraph-1"> <br />The center provided the information in a second-quarter financial report submitted to bond agencies in which it also reported <i>a $49.6 million operational loss</i> and a gain of $7.4 million in overall excess revenue.<br /> </span></blockquote><br />That is interesting. There have been many criticisms of EHRs, particularly for how they may <a href="http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20difficulties">impede</a>, rather than help health professionals, and more importantly for their risks of causing <a href="http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20dangers">adverse effects</a> affecting patients, in the absence of clear data from controlled clinical trials that they provide benefits that outweigh their potential harms to patients. Some of these problems may stem from design and implementation that prioritizes benefits to managers and institutional finances over effects on patients and doctors. As InformaticsMD <a href="http://hcrenewal.blogspot.com/2013/05/ama-says-ehrs-create-appalling-catch-22.html">noted</a>, even the AMA now admits that<br /><br /><blockquote class="tr_bq"> As the healthcare industry moves to EHRs, t<b>he medical record has essentially been reduced to a tool for billing, compliance, and litigation that also has a sustained negative impact on doctors' productivity,</b> according to Steven J. Stack, MD, chair of the American Medical Association’s board of trustees. </blockquote><br />Yet in this case, a well known commercial EHR did not even help out the hospital system's finances.<br /><br />Furthermore,<br /><br /><blockquote class="tr_bq">Wake Forest Baptist said it spent as of Dec. 31 about $13.3 million directly on the Epic electronic-record system, which went live in September.</blockquote><br />And,<br /><br /><blockquote class="tr_bq"> The center also cited $8 million in 'other Epic-related implementation expense' that it listed among '<i>business-cycle disruptions (that) have had a greater-than-anticipated impact on volumes and productivity</i>.' Also listed was $26.6 million in lost margin <i>'due to interim volume disruptions during initial go-live and post go-live optimization</i>.'</blockquote><br />Note that InformaticsMD frequently criticizes proponents of commercial health care information technology for glossing over potentially bad effects on patients and practice with management-speak (e.g., as "glitches," or "hiccups."). Here is a great example of an attempt to gloss over bad effects on finance with management-speak. <br /><br /><b>Bond Downgrades and Furloughs, Wage Reductions, Hiring Freezes, Retirement Contribution Reductions, and Bonus Eliminations</b><br /><br />As a consequence,<br /><br /><blockquote class="tr_bq"> On March 20, <i>Moody’s Investors Service downgraded the center’s long-term debt rating below the lowest level of high-grade investment quality.</i> The downgrade to A1 from Aa3 affects $597.2 million of rated debt outstanding.</blockquote><br />The rationale was clear,<br /><br /><blockquote class="tr_bq"> Moody’s said the A1 rating 'reflects the unexpected decline in financial performance through the first half of fiscal 2013, largely due to the installation of a new information technology platform (Epic), encompassing 95 percent of all revenue components of the enterprise.'</blockquote>You know when you see bond downgrade by rating agencies that financial matters are really going badly. <br /><br />By May, 2013, month, the problems were evidently still not solved, and the hospital was forced to take more drastic measures. As again <a href="http://www.journalnow.com/business/business_news/local/article_0cb3b3a8-b33d-11e2-a80f-0019bb30f31a.html">reported</a> by Richard Carver writing for the Winston-Salem Journal, <br /><br /><span class="paragraph-0"> </span><br /><blockquote class="tr_bq">The workforce at Wake Forest Baptist Medical Center is <i>paying a paycheck price to make up for the financial shortcomings to date of its Epic electronic records system</i>.<br /><br /><span class="paragraph-1"> The center said in a statement Thursday it has begun <i>another round of cost-cutting measures</i> that will last through at least June 30, the end of its 2012-13 fiscal year.<br /> </span> <br /><br />The measures include attempts at <i>volunteer employee furloughs and hour-and-wage reductions, a hiring freeze, a reduction in employer retirement contributions, and elimination of executive incentive bonuses for 2013.</i></blockquote><br /><br />Management made clear that the cuts were in response to the Epic debacle,<br /><br /><br /><blockquote class="tr_bq">Even though management said Thursday the center is making progress with fixing the Epic revenue issues, it acknowledged it 'will not meet projected financial targets for the current fiscal year.'<br /><br />'Wake Forest Baptist has identified immediate multimillion-dollar savings with a series of short-term measures that impact personnel,' according to the statement.</blockquote><br />To give credit where it is due, at least the cuts will apparently not affect line clinical employees:<br /><br /><blockquote class="tr_bq"> Those primarily affected by the volunteer furloughs and hour-and-wage reduction requests are nonclinical full-time employees, including administrative staff. They can volunteer to work as few as 30 hours a week with no loss of health or dental benefits for May and June. In the memo, management said employees can volunteer to continue the reduced-hour work week into fiscal year 2013-14.</blockquote><br />However, it seems likely that they will affect many employees, including some proportion who likely had not responsibility for the problems with Epic.<br /><br /><b>When in Doubt, Lobby the Government </b><br /><br />What the hospital system did not seem to be cutting was lobbying and public relations. Perhaps this was a response to its unexpected inability to manage its own commercial health care information technology? What bad management can lose, maybe government can supplant. Once again Richard Carver had <a href="http://www.journalnow.com/news/state_region/article_1aee766e-b5e1-11e2-bba7-001a4bcf6878.html">the story</a> for the Journal:<br /><br /><span class="paragraph-0"> </span><br /><blockquote class="tr_bq">Stung by a series of unusual setbacks at the General Assembly, the North Carolina hospital industry is <i>launching a public relations campaign</i> aimed, in part, at protecting revenues and staving off competition from lower cost surgery centers.<br /><br /><span class="paragraph-1"> In a social media initiative targeted at lawmakers and their constituents, the N.C. Hospital Association says hospitals are 'fighting for their economic survival.' [It was not said whether they were fighting in part because they had already managed to shoot themselves in their economic feet - Ed]<br /><br /> </span> <br />The association and some of the state’s bigger hospitals also are hiring more GOP lobbyists to make inroads with the Republicans who control the state House, Senate and governor’s mansion.<br /><br />The hospital association recently began promoting a new website — <a href="http://www.healthyhospitalsnc.org/">www.healthyhospitalsnc.org</a> — that describes an array of financial threats.</blockquote><br />Wake Forest Baptist is a big part of this initiative:<br /><br /><blockquote class="tr_bq">When asked about its lobbying efforts, Wake Forest Baptist spokeswoman Paula Faria said last week that the center’s Office of Government Relations monitors proposed legislation and regulations at both the federal and state levels.<br /><br />'It informs North Carolina’s congressional delegation, members of the General Assembly and their staff about how proposed language could impact the day-to-day operations of the medical center.'</blockquote><br />Maybe they should be first worrying about the impact of badly chosen, designed, or implemented commercial health care information technology on "day-to-day operations of the medical center" first. <br /><br /><b> Summary</b><br /><br />So the top executives of Wake Forest Baptist Medical Center have seen compensation rising at a rate greater than inflation and than the general public's income over the last few years. In particular, the CEO has seen his compensation go up three and one-half times in three years! The hospital system administration has justified this extraordinary increase by referring to supposedly "visionary" leadership. Yet over this time frame these "visionaries" decided to implement an EHR whose first effects were to lose the hospital system a lot of money. Based on previous anecdotes about the Epic system, it is quite possible it had other adverse effects. For example, InformaticsMD <a href="http://hcrenewal.blogspot.com/2012/09/in-addition-to-nurses-doctors-now-air.html">discussed</a> a case in which an EPIC system apparently lead to a large disruption in patient workflow and hence large increases in waits for acute care, and <a href="http://hcrenewal.blogspot.com/2012/08/contra-costas-45-million-computer.html">lead to errors</a> that could have adversely affected patients. So this underscores some important lessons:<br /><br />So beware that "visionary" behind the curtain. As we have noted repeatedly, top health care managers can now easily make themselves rich. They, their boards of directors (who may be their cronies), and their public relations flacks often justify their exorbitant compensation by their supposed brilliance, if not visionary status. Such claims are rarely further explained, and mostly seem be be humbug, for want of a better term. It seems that most top leaders of health care organizations have participated in the managers' coup d'etat, and become at least manager nobility, if not manager-kings At least, the public should know that their compensation is what they can grab, and its justification is often nonsense. <br /><br />Note that contrary to a red herring argument often made, outrageous compensation is important not so much because of how much money it drains out of health care, although that can be large in the aggregate. It is important because it reflects a system that is no longer accountable, and leaders who follow perverse incentives.<br /><br />Such management compensation is almost never revisited to determine whether it turned out to be justified. Instead, the public, watchdog organizations, health care professionals, and even politicians ought to demand accountability of health care management, good justification for their compensation, and rationality for the incentives they are provided. True health care reform would encourage well-informed, competent, mission-focused, honest, responsible, accountable and transparent management, leading organizations of manageable size. But as long as things stay the same, expect the craziness to continue. <br /><br /><br />Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-38630724142140760622013-05-09T14:40:00.000-07:002013-06-07T11:46:38.700-07:00Guest Post: A Physician Rebels Against Micromanagement by "'Leadership-Trained' Management Extenders"<span style="color: blue;"><i>Health Care Renewal presents a guest post by <a href="http://imh.utmb.edu/about-us/faculty/howard-brody">Dr Howard Brody,</a> John P McGovern Centennial Chair of Family Medicine, Director of the Institute for Medical Humanities at University of Texas - Medical Branch at Galveston, and blogger at <a href="http://brodyhooked.blogspot.com/">Hooked: Ethics, Medicine and Pharma</a>. </i></span><br /><br /><!--[if gte mso 9]><xml> <w:WordDocument> <w:View>Normal</w:View> <w:Zoom>0</w:Zoom> <w:PunctuationKerning/> <w:ValidateAgainstSchemas/> <w:SaveIfXMLInvalid>false</w:SaveIfXMLInvalid> <w:IgnoreMixedContent>false</w:IgnoreMixedContent> <w:AlwaysShowPlaceholderText>false</w:AlwaysShowPlaceholderText> <w:Compatibility> <w:BreakWrappedTables/> <w:SnapToGridInCell/> <w:WrapTextWithPunct/> <w:UseAsianBreakRules/> <w:DontGrowAutofit/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> </w:WordDocument></xml><![endif]--><br /><!--[if gte mso 9]><xml> <w:LatentStyles DefLockedState="false" LatentStyleCount="156"> </w:LatentStyles></xml><![endif]--><!--[if gte mso 10]><style> /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman"; mso-ansi-language:#0400; mso-fareast-language:#0400; mso-bidi-language:#0400;} </style><![endif]--> <br /><div class="MsoNormal">I recently heard from a physician whom I knew well in an earlier stage of her training—I’ll call her Pauline. She completed her training at one of the top children’s hospitals in the US, and served in several capacities in academic medical centers before her most recent job with a physician-owned for-profit practice. She called me to express her frustrations and to ask if the right course for her was to quit doing clinical medicine.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">Pauline had become skilled in her earlier jobs in providing primary care for children with severe chronic conditions. Her reputation was such that when she was settled in her current post, pediatric subspecialists started to refer their difficult cases to her for follow-up. This patient mix did not suit her current employer for two reasons. First, these children were hard to take care of and even though they could have their visits “up-coded” to reflect their complexity, the practice much preferred to see healthy children with colds and earaches that could be moved through quickly and who did not demand much staff time and attention. Second, most of these children with special needs were on state insurance, which did not pay as well (even after up-coding) as the private insurance the practice coveted.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">Pauline found herself constantly struggling with her co-workers and superiors in order to deliver all of her patients—not just the special-needs kids—the quality of care she had been trained to demand. As far as the practice was concerned, it was Pauline, and the medically complex kids she was attracting into the practice, who were the problem.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">One recent incident had especially concerned Pauline. She had set up a visit to see a new medically complex patient and had blocked off 40 minutes, the amount of time she felt she needed to do a good job. The child had a complex genetic disorder, cerebral palsy, and heart, lung, and kidney problems.<span style="mso-spacerun: yes;"> </span>Both the cardiologist and the nephrologist had called asking her to take this patient.<span style="mso-spacerun: yes;"> </span>She agreed.<span style="mso-spacerun: yes;"> </span>After she had scheduled the visit, a manager called her and told her that she was being allowed only 15 minutes to see that patient. After some fruitless discussion with him, Pauline finally said, “Okay, I guess that means that you’ll be seeing the patient instead of me, right?” The shocked voice at the other end of the phone line replied, “What do you mean? I don’t know how to take care of patients.” “That’s exactly my point,” Pauline put in. </div><div class="MsoNormal"><br /></div><div class="MsoNormal">Pauline explained that this manager assigned to her office is not even a college graduate. Physicians cannot access the schedule electronically and have no control over scheduling. These functions are controlled by the office manager and (amazingly) by some of the medical assistants who have received some “leadership” training. These medical assistants are even allowed to evaluate the clinical competency and skills of the physicians.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">Now, at this stage, I can imagine a response from a management-trained person. Pauline is obviously one of those starry-eyed idealist physicians who believe that money grows on trees and that costs should never be a factor in caring for patients. Somebody who actually knows what it means to make a payroll and keep the lights on has to step in and rein in these physicians. There has to be somebody in the system someplace with a head for business, who can recognize the stark realities of what today’s practice demands from all parties. Physicians should get off their high horses and stop imagining that they can give orders to everyone else.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">So let me add a further nugget about Pauline’s background. In one of her previous jobs, she was made the manager of a pediatric outpatient center within a county hospital caring for a largely indigent population. This center had been running in the red for a good while. Pauline took over and within 28 months she’d streamlined the place and had them running well in the black, while still administering a quality of care that Pauline and her colleagues could be proud of. In short, Pauline could probably tell the managers of her current practice a thing or two about how to optimize patient scheduling without compromising care or cost —if they’d listen.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">Pauline probably has a nearly-unique skill set in her community and has put in a lot of years of training and experience to get there. Due to the present state of American medicine, and those who want to run it as if it were an industrial operation to make a profit, Pauline is thinking about leaving clinical practice altogether despite her relatively young age – and she has several colleagues, who trained in the same way that she did, who are considering this option.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">Fortunately, Pauline has at least for now postponed any final decision about leaving clinical medicine entirely. Here’s what she last told me:</div><div class="MsoNormal"><br /></div><br /><blockquote class="tr_bq"><div class="yiv528586260msonormal" style="background: white; margin-bottom: 12.0pt;"><i>I am leaving the organization - I cannot remain in an organization where profit comes ahead of quality - and as a former medical director who had financial accountability/responsibilities, I know it does not HAVE to be a choice. I do not know what my next steps will be from here. For me, working with integrity, compassion and a desire for excellence is not negotiable.</i></div><div class="yiv528586260msonormal" style="background: white; margin-bottom: 12.0pt;"><i>Physicians MUST become better advocates for our profession. For too long, we have been asleep at the wheel while insurance companies and corporations shaped the environment in which we practice. We cannot allow this to continue. We are professionals, not vocationally educated medical automatons<span style="mso-spacerun: yes;"> </span>who need every moment of work day micromanaged by 'leadership-trained' management extenders who have no idea what it means to take responsibility for patients. </i></div></blockquote><br /><div class="MsoNormal">Dr Howard Brody</div>Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-74146017479687528682013-05-08T12:00:00.000-07:002013-06-07T11:46:38.797-07:00Tales of the Wayfaring Generic Manager - from Ritz Carlton Hotels to Henry Ford West Bloomfield Hospital to Cancer Treatment Centers of AmericaIn 2006, we <a href="http://hcrenewal.blogspot.com/2006/03/putting-on-ritz.html">wondered</a> what a former hotel manager, Mr Gerard van Grinsven, admittedly known for putting the "wow" back in the Detroit Ritz-Carlton, would be doing as a hospital CEO. This seemed at the time like a real "wow" example of how <a href="http://hcrenewal.blogspot.com/search/label/generic%20managers">generic managers </a>were taking over health care. Mr Grinsven had extensive experience in the hospitality field, but no known background in health care. <br /><br /><b>Organic Local Produce, "Wellbeing Centers," Gourmet Dining, Wedding Receptions, and Corporate Functions</b><br /><br />Over the next few years, Mr van Grinsven's Henry Ford West Bloomfield hospital did make a name for itself. In 2009, Becker's Hospital Review <a href="http://www.beckershospitalreview.com/news-analysis/ceo-gerard-van-grinsven-explains-how-henry-ford-west-bloomfield-hospital-reinvents-the-community-hospital.html">reported</a> on some of Mr Van Grinsven's innovations. <br /><br />First, he lead an apparent change in the hospital's mission from acute care to recreating:<br /><br /><blockquote class="tr_bq">the hospital experience into one<i> focused on promoting wellbeing and healthy living</i>. The hospital has already begun to realize its mission statement, which reads '<i>to take health and healing beyond the boundaries of imagination</i>.'</blockquote><br />The new hospital apparently was designed to look like a luxury hotel:<br /><br /><blockquote class="tr_bq">The hospital is located on 160 acres of woodlands and is designed to resemble a Northern Michigan lodge. The facility also features a retail 'main street' which looks like an actual main street in a Northern Michigan town and includes stores focused on sleep, pregnancy, organic food and healthy cooking as well as a pharmacy.</blockquote><br />Apparently it is now a favored site for weddings:<br /><br /><blockquote class="tr_bq">The hospital also holds free concerts for the community and has already received <i>nine wedding inquiries. </i></blockquote><br />It had a "wellness center"<br /><br /><blockquote class="tr_bq">Henry Ford West Bloomfield also features a <i>unique, integrated wellness center called Vita. Vita offers acupuncture, therapeutic message, yoga and relaxation classes, an aqua therapy suite, a spa and health coaches who provide lifestyle and exercise consultations</i>. In addition to offering one-time services, the hospital offers memberships to community members to encourage frequent use of the center. </blockquote><br />What really stood out was its food service:<br /><br /><blockquote class="tr_bq">Henry Ford brought in top Michigan chef Matt Prentice to transform traditional hospital food service. The hospital features 24-hour room service for patients, all of which is served by the hospital's <i>on-site gourmet, organic restaurant</i>, Henry's. All food served in the hospital is <i>organic, promotes sustainable agriculture and, in many cases, is procured from local farmers</i>.</blockquote><br />A 2011 <a href="http://management.fortune.cnn.com/2011/03/02/what-hospitals-can-learn-from-the-ritz/">article</a> in Fortune noted that<br /><br /><blockquote class="tr_bq">the hospital is on track to <i>generate millions of dollars a year hosting and catering functions</i> for companies and community groups.</blockquote><br />It all sounds great, if it were describing a luxury hotel.<br /><br />The Fortune article ended with the gushing summation:<br /><br /><blockquote class="tr_bq">While it will be years before anyone can say whether this model works, there's no question that it <i>captures a spirit of innovation </i>that just might be a cure for what ails so many organizations. We are living today through the <i>age of disruption.</i> You can't do big things if you're content with just doing things a little better than everyone else or a little differently from how you've done them in the past. In an era of intense competition and non-stop reinvention, <i>the only way to stand out from the crowd is to stand for something special.</i> Originality has become the acid test of strategy.</blockquote><br />Neither it nor the Becker's rather uncritical discussions dealt with what any of this had to do with the fundamental mission of a hospital, to care for the sick, what it has to particularly do with quality of care, especially care of severely acutely or chronically ill patients, traditionally those whom hospitals were meant to serve. Would a patient desperately sick from a myocardial infarction (heart attack), stroke, sepsis (bacterial blood stream infection) or the other major ills that bring people to hospitals really care that if he or she were to survive without major sequelae, organic, locally grown food would be served in the hospital's fancy restaurant? Is there any evidence that provision of any of these fancy hotel amenities would affect important clinical outcomes for such patients? Could the funds needed for all these fancy hotel services be better spent to improve patients' the the population's health?<br /><br /><b>On to a More Ethically Challenged Environment </b><br /><br />We may never know. But what we do know is that Mr van Grinsven, having brought "wellness" centers and organic, locally grown, gourmet food to an acute care hospital, is now moving on.<br /><br />Crain's Detroit Business just <a href="http://www.crainsdetroit.com/article/20130426/NEWS/130429902/henry-ford-west-bloomfield-hospitals-van-grinsven-resigns-as-ceo">reported</a>:<br /><br /><br /><blockquote class="tr_bq">Henry Ford West Bloomfield Hospital President and CEO Gerard van Grinsven has resigned from the position effective June 1, according to an internal email sent Friday to employees from Henry Ford Health System President and COO Bob Riney.<br /><br />Van Grinsven is leaving the hospital to <i>become the president and CEO of Chicago-based Cancer Treatment Centers of America,</i> Riney said in the email. He will oversee the CTCA's five hospitals and medical centers in Illinois, Pennsylvania, Oklahoma, Arizona and Georgia. The CTCA is expected to announce van Grinsven's new position later today.</blockquote><br />Henry Ford Health System CEO Bob Riney saluted van Grinsven thus,<br /><br /><blockquote class="tr_bq">'Gerard's leadership talents and his tremendous global experience made<i> the transformation of this innovation and distinctive vision a reality</i>,' Riney told employees in the email.</blockquote><br />He did not apparently mention anything about the quality of care for acutely and chronically ill patients. The <a href="http://www.prnewswire.com/news-releases/stephen-b-bonner-assumes-new-role-as-ctca-executive-chairman-gerard-van-grinsven-succeeds-as-president--ceo-204883721.html">press release</a> from CTCA proclaimed <br /><br /><blockquote class="tr_bq">'Gerard's arrival is an exciting and dramatic step in the evolution of our leadership that will <i>herald new opportunities for all of our talented Stakeholders</i> and the thousands of patients we serve,' said [executive chairman and former CEO Stephen B] Bonner. 'Our expertise in <i>Patient Empowerment Medicine<span>®</span> and track record implementing change</i> is unparalleled. Nothing we do today is the same as we did two years ago. Gerard is uniquely qualified to provide the leadership required to advance our commitment to patient-centered care in all we do,' concluded Bonner.</blockquote><br />Of course, there was nothing about how van Grinsven's expertise in wellness centers and organic produce would be useful to an organization supposedly devoted to cancer patients, whose care may involve risky treatment choices and who may become desperately ill. <br /><br />There was also nothing about how van Grinsven's background would help CTCA to avoid new ethical misadventures. Earlier this year, we <a href="http://hcrenewal.blogspot.com/2013/03/the-dangers-of-big-corporate-health.html">posted</a> about issues involving CTCA making unsubstantiated survival claims; promoting "integrative" treatments that are unsupported by evidence; and manipulating survival statistics, in part by turning away patients with poor prognoses. Of course, it is not clear that given van Grinsven's background he would even understand why such behavior is unethical. <br /><br /><b>Summary</b><br /><br />As a physician, it is hard not to laugh at all this, at least to keep from crying. As we have noted frequently, health care has been taken over by generic hired managers. At best, while well meaning, many of them seem clueless about the nature and context of health care, and health care professionals' values. At worst, the <a href="http://hcrenewal.blogspot.com/search/label/managers%27%20coup%20d%27etat">manager's coup d'etat</a> has turned managers into manager-kings, queens and nobles, while driving up health care costs, and sacrificing the health of patients and the public. The depth of this phenomenon is demonstrated by the absolute lack of skepticism about the worthiness of a former Ritz-Carlton executive to run either a community hospital or a system of cancer treatment centers. <br /><br />I say once again that 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. <br /><br /><br />Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-91571549004088430102013-05-07T08:40:00.000-07:002013-06-07T11:46:38.896-07:00BLOGSCAN - An Ex-Pharmaceutical Company CEO to Run the American College of Cardiology?<span style="color: #274e13;">Marilyn Mann's blog <a href="http://marilynmann.wordpress.com/2013/04/28/should-a-former-drug-company-executive-be-ceo-of-the-american-college-of-cardiology/">discussed</a> the appointment of a former pharmaceutical company executive, most recently at Actelion, and previously at Hoffman La Roche, Abbott Canada, Nordic Labs and Marion Merrill Dow (now known as Aventis), as president of the American College of Cardiology. Although Mr Jacobovitz, who boasts a bachelor's degree in biology but no obvious experience in direct health care or biomedical science, was <a href="http://www.cardiosource.org/News-Media/Publications/Cardiology-Magazine/2013/04/CEO-Announcement.aspx">touted </a>by the ACC as having "developed a strong patient- and customer-centered corporate strategy," Ms Mann provided documentation that his trajectory at Actelion seemed more money- than patient-centered. </span><br /><br /><span style="color: #274e13;">During his watch, Actelion was cited for not reporting 3500 deaths of patients taking two of its drugs to the US Food an Drug Administration (FDA). Actelion blocked availability of samples of one of its drugs to generic drug companies, an action that the US Federal Trade Commission (FTC) alleged violated anti-trust laws. Actelion purchased a company that was working on a drug that could have become a competitor to Actelion's most remunerative product, and then shut down development, possibly preventing a drug that might help patients from reaching them. Finally, Acetelion's marketing practices seem to be currently under investigation by a US Attorney. </span><br /><span style="color: #274e13;"><br /></span><span style="color: #274e13;">One wonders why cardiologists would want such an individual representing them as leader of their premier organization? </span><br /><span style="color: #274e13;"><br /></span><span style="color: #274e13;">(Dr Wes<a href="http://drwes.blogspot.com/2013/04/the-american-college-of-cardiology-gets.html"> wondered</a> as well.)</span>Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-65503431745133626152013-05-05T16:11:00.000-07:002013-06-07T11:46:38.994-07:00AMA says EHRs create 'appalling Catch-22' for docs - And just how many experts does it take to screw in a light bulb, anyway?(NOTE: this post, being about minor matters like death and financial mayhem, is particularly and unusually [even for me] biting and lacking in euphemisms and political correctness. If you are easily offended and want the latter, and/or believe we all need to be 'nice' about banal issues like patient injury and death, fraud, and other minor matters, click here: <b><a href="http://www.disney.com/">http://www.disney.com</a></b> and skip the post below.) <br /><br />You were warned.<br /><br />--------------------------------------- <br /><br />At some point, so-called EHR "experts" and pundits need to stop being accommodated for their having ignored years of warnings, complaints, "anecdotes" -a particularly egregious term that comes from those who don't understand risk management, especially academics of the echo chamber-egghead subspecies (<a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">link</a>) - and other signs that health IT is not a beneficent, omniscient gift from the <a href="http://en.wikipedia.org/wiki/Lords_of_Kobol">Lords of Kobol.</a> (The latter is a pun on the business-IT programming language Cobol, of course.)<br /><br />Instead, they simply need to be ridiculed for being stupid.<br /><br />I will do so: folks, you have been, and remain, stupid:<br /><br /><br /><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/AVvXsEic3sYZg6l77567lvpSU9AZgc5DZr4nzy3Y1MmczJ-aHpsNQdFhPWD5XjJqehmsVv4mhuhYuSfsWvyqtwwDFUtwqSc653Go-3CcL_HRFkHSTFHSQFUwqNRP7eQEuALvmAmvEI77E3VAtPr1/s1600/cow3.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="150" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEic3sYZg6l77567lvpSU9AZgc5DZr4nzy3Y1MmczJ-aHpsNQdFhPWD5XjJqehmsVv4mhuhYuSfsWvyqtwwDFUtwqSc653Go-3CcL_HRFkHSTFHSQFUwqNRP7eQEuALvmAmvEI77E3VAtPr1/s200/cow3.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">The Bovine Stare of Incomprehension (click to enlarge)</td></tr></tbody></table><br />The Bovine Stare of Incomprehension describes the reactions I've gotten over the years to many warnings about health IT. It was like talking to a cow.<br /><br />So now there's this: <br /><br /><blockquote class="tr_bq"><a href="http://www.govhealthit.com/news/ama-says-ehrs-create-appalling-catch-22-docs">AMA says EHRs create 'appalling Catch-22' for docs</a><br />May 03, 2013 | Tom Sullivan, Editor<br /><br />As the healthcare industry moves to EHRs, t<b>he medical record has essentially been reduced to a tool for billing, compliance, and litigation that also has a sustained negative impact on doctors' productivity,</b> according to Steven J. Stack, MD, chair of the American Medical Association’s board of trustees. </blockquote><br />Gee, they're only realizing and complaining about that <b>- now?</b> <b>In 2013?</b><br /><br /><blockquote class="tr_bq">“Documenting a full clinical encounter in an EHR is <b>pure tormen</b>t,” Stack said during the CMS Listening Session: Billing and Coding with Electronic Health Records on Friday. </blockquote><br />(What, the "pure torment" in such a mission-critical function only started with the most recent patches installed last month on the nation's EHRs? EHRs were just dandy until then?)<br /><br />It's nice to know in May 2013 that “documenting a full clinical encounter <span style="color: red;"><i><b>[essential to avoid injurious and even lethal mistakes, I anecdotally note - ed.]</b></i></span> in an EHR is <b>"pure torment”</b>, several years into an accelerated "National Program for HIT in the HHS" costing hundreds of billions of dollars.<br /><br />I guess sites like this blog, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">this site</a> extant since 1998, and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">other materials</a> written over the years by backwards stubborn health IT iconoclast fear-mongering Luddites were beyond the comprehension level of - t<i>hose now proffering the exact same pronouncements.</i><br /><br /><blockquote class="tr_bq">EHRs are also driving the industry toward charts that look remarkably similar because they’re based on templates created by the technology vendors — that includes often using the same words. <b>And that threatens to make doctors appear to be committing fraud by the practice of record cloning, or cutting and pasting from one record to another, when they are not, in fact, acting fraudulently</b>. </blockquote><br />I guess putting patients in mortal danger from note cloning (and to those too stupid to understand why that is, get off your rear end and look it up, I'm not going to spoon-feed you) is a step better than acting fraudulently...<br /><br /><blockquote class="tr_bq">Alongside the federal mandate to implement an EHR under threat of a monetary fine, that creates what Stack called “an appalling Catch-22 for physicians.”<br /><br />Put another way: The government mandates that doctors use an EHR, the EHR vendors’ templates can <b>sometimes create an appearance of fraud</b> and that, in turn, opens the door for payers to decline reimbursement or, even worse, the government to prosecute doctors for the crime.</blockquote><br />I guess actual fraud is just anecdotal.<br /><br /><blockquote class="tr_bq">As dire as that sounds, it's an exception that belies the unproven perception that EHRs perpetuate fraud. “<b>Upcoding does not necessarily equate to fraud and abuse,”</b> said Sue Bowman, AHIMA’s senior director of coding and compliance at the same event<b>. “This is an area where more study is needed. We really need to know the causes</b>. Further research is needed on the fraud risk of using EHRs.”</blockquote><br />Sure, let's study while rolling this stuff out as frantically as we can. We'll fix it later -- and Jesus, I guess, will heal and reanimate any patients actually harmed by the technology (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">link</a> to <b>ECRI Institute Deep Dive Study</b>: 36 hospitals! Nine weeks! 171 health information technology-related problems voluntarily reported! Eight injuries! Three possible deaths! <b>All mere "anecdotes", of course</b>).<br /><br /><blockquote class="tr_bq">Indeed, Jacob Reider, MD, CMO of ONC, explained that the government and industry d<b>o not have good data right now proving whether or not EHRs trigger fraud and abuse</b>.</blockquote><br />Per the IOM, the same industry does not have good data on harms levels. (The previous link to a recent small ECRI "Deep Dive" study's probably the most robust we've got on that score, and the figures are not encouraging).<br /><br />So - let's review -<br /><ul><li>poor data on harms, </li><li>poor data on benefits, </li><li>poor data on fraud and abuse.</li></ul><br /><b> The logical, ethical course of action thus is:</b><br /><b><br /><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/AVvXsEh0TnWQdQ5eRPtY0WAfaa2wEwZmGrGFrpcPFGDP0qZ32mLxMkYdBrhidGEMwTlGOgVWOrtc5Mhx4nU7HUlvUWkN0StkSmVVCR29ApJApFz8SiC61Zvmgh2IOufdVNH5X0dNSDKbRqhzYjFC/s1600/homer-simpson.gif" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh0TnWQdQ5eRPtY0WAfaa2wEwZmGrGFrpcPFGDP0qZ32mLxMkYdBrhidGEMwTlGOgVWOrtc5Mhx4nU7HUlvUWkN0StkSmVVCR29ApJApFz8SiC61Zvmgh2IOufdVNH5X0dNSDKbRqhzYjFC/s200/homer-simpson.gif" width="165" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><b>D'OH! LET'S ROLL THE TECHNOLOGY OUT AS FAST AS WE CAN, AND PENALIZE NON-ADOPTERS BESIDES!</b></td></tr></tbody></table></b><br /><br /><br />See how simple logic, ethics and clear thinking can be?<br /><br /><blockquote class="tr_bq">“There is concern that some doctors are using the EHR to obtain payments to which they are not entitled,” said Mickey McGlynn of Siemens Medical Solutions and HIMSS EHR Association. <b>“Any fraud is an important issue and we, as the vendor community, take that very seriously.”</b></blockquote><br />Only after independent whistleblower investigations by <a href="http://www.publicintegrity.org/health/medicare/cracking-codes">Fred Schulte of the Center for Public Integrity ("Cracking the Codes")</a>, and by <a href="http://www.nytimes.com/2012/09/22/business/medicare-billing-rises-at-hospitals-with-electronic-records.html?_r=0">New York Times reporters Reed Abelson and Julie Creswell</a>, that is...<br /><blockquote class="tr_bq"><br />AMA’s Stack offered a triptych of suggestions to CMS and ONC: address EHR usability concerns, provide guidance on EHR use for coding and billing, and make meaningful use stage 2 more flexible for providers.<br /><br /><b>“My purpose is not to denigrate EHRs</b>,” Stack said, explaining that he believes CMS and ONC are genuinely trying to better the current situation.</blockquote><br />Nice to have <a href="http://en.wikipedia.org/wiki/Caspar_Milquetoast">Caspar Milquetoast </a> on the side of EHR criticism.<br /><br />Knock knock, anyone home, McFly? <br /><br /><br /><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/AVvXsEhzt8h4QMuPFwEez3QOVc2XvBRxCFCfb7Hd3irqBG8jN0XHfdfdM5NfVcY2ckiG5FgH3Zv6MM5oyLcEdhLhyphenhyphenFUg_fyNT573aNr-muVfeYTp6XmK7fK7zbL2dVaxI0LOhRQMGDTfVv2NeBbu/s1600/hello-mcfly1.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="177" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhzt8h4QMuPFwEez3QOVc2XvBRxCFCfb7Hd3irqBG8jN0XHfdfdM5NfVcY2ckiG5FgH3Zv6MM5oyLcEdhLhyphenhyphenFUg_fyNT573aNr-muVfeYTp6XmK7fK7zbL2dVaxI0LOhRQMGDTfVv2NeBbu/s320/hello-mcfly1.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Knock knock, anyone home, McFly?</td></tr></tbody></table><br /><br />Today's EHR systems, for the aforementioned reasons above and more, <b>deserve denigration for patients' sake.</b><br /><blockquote class="tr_bq"><br />There are efforts underway, within the government and industry, <b>to more comprehensively understand the unintended consequences of EHR implementation.</b></blockquote><br />But let's keep rollin' em out, anyway. Wheeee! What fun!<br /><br />Class action attorneys, are you listening?<br /><br />-- SS<br /><br />Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-91540265697367839952013-05-04T16:24:00.000-07:002013-06-07T11:46:39.092-07:00Financial woes at Maine Medical Center: Reading this blog might have saved them millions of dollars, and prevented massive "cost saving initiatives"In this article, the euphemistic and almost endearing term <b>"hiccup"</b> is used instead of the more traditional "<a href="http://hcrenewal.blogspot.com/search/label/glitch">glitch</a>" to describe obvious major information technology malfunctions. It is likely the knowledge at this blog and at my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">health IT dysfunction teaching site</a> could have helped prevent most of these problems:<br /><br /><blockquote class="tr_bq"><b><a href="http://www.healthcarefinancenews.com/news/financial-woes-maine-medical?topic=03,22">Financial woes at Maine Medical Center</a></b><br />New England health system facing $13 million loss, initiates plan to save $15 million<br />NEW GLOUCESTER, ME | May 2, 2013 <br /><br />In a memo to its employees last week, one of Maine’s largest health systems said it has suffered an operating loss of $13.4 million in the first half of its fiscal year.<br /><br />“Through March (six months of our fiscal year), Maine Medical Center <b>experienced a negative financial position that it has not witnessed in recent memory</b>,” Richard Petersen, president and CEO of the medical center, wrote in the memo to employees. A copy of the memo was sent to MedTech Media, publisher of Healthcare Finance News.</blockquote><br /><b>A "negative financial position" </b>(translation: we lost big money)<b> that it has not witnessed in recent memory</b>? What are the reasons?<br /><br /><blockquote class="tr_bq">In order to bring the medical center to breakeven by year’s end, the health system’s leadership has determined $15 million needs to be saved.<br /><br />In the memo, Petersen said the operating loss is due to declines in inpatient and outpatient volumes because of the hospital’s efforts to reduce readmissions and infections;<b> “unintended financial consequences” due to the roll out of the health system’s Epic electronic health record and problems associated with being unable to accurately charge for services provided</b>; an increase in free care and bad debt cases; and continued declining reimbursement from Medicare and MaineCare, the state’s Medicaid program.</blockquote><br />That rings a familiar tune - from the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Insufficient%20IT%20management">mid 1990's</a> at Yale, as well as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/DUCOM_EMR_Complaint.pdf">more recently</a>.<br /><br /><blockquote class="tr_bq">Many of the reasons for Maine Medical’s financial woes are similar to those hospitals across the country are facing.<br /><br />A recovering national economy, continued budget restrictions and restraint and the realization that, while electronic health records may have efficiencies and cost savings over time, <b>the costly transition to EHRs may take years to recoup.</b></blockquote><br /><br />Especially when not done well.<br /><br /><blockquote class="tr_bq">In his memo to employees, Petersen said the hospital has <b>identified many of the hiccups contributing to the charge capture problems</b> and a team of hospital employees and Epic technicians are working to resolve those issues. In the meantime, the <b>remaining roll out of the Epic EHR to the rest of the health system is on hold.</b></blockquote><br />Hiccups? Health IT has a euphemistic language all its own. Only apostates would dare to call the "hiccups" for what they really are, in medical parlance: <b>IT malpractice.</b><br /><blockquote class="tr_bq"><br />To save $15 million by year’s end, Maine Medical is immediately instituting a number of cost-saving initiatives including selective travel and <b>hiring freezes</b>, putting the <b>operating contingency budget on hold</b> and <b>reducing overtime. </b>Petersen appealed to employees to curb discretionary spending and contact management with any cost-saving ideas.</blockquote><br />All, of course, will have no impact on patient care....<br /><blockquote class="tr_bq"><br />“I’m confident that we’ll confront this <b>test,</b> beat back the issues we face, and reverse this negative financial picture,” Petersen wrote in the conclusion to the memo.</blockquote><br />Test? Test of what, IT competence?<br /><br />Of course, "C" officers would never write that "I'm <b>not </b>confident we'll confront our <b>screwups</b>."<br /><br /><blockquote class="tr_bq">Maine Medical did not reply to an interview request by deadline. The Maine Hospital Association declined to comment for this story. </blockquote><br />Silence is golden.<br /><br />A newspaper letter from Stuart Smith, Selectman, Town of Edgecomb, St. Andrews Regional Task Force (a software developer himself) tells more:<br /><br /><blockquote class="tr_bq"><b><a href="http://www.boothbayregister.com/affiliate-post/stuart-smiths-letter-register/13586">STUART SMITH'S LETTER TO THE REGISTER</a></b><br />Wednesday, May 1, 2013 - 7:30pm<br /><b>Save St. Andrews Hospital</b><br /><br />As the Boothbay Peninsula moves forward with the effects of a MaineHealth/Lincoln County HealthCare decision <b>to close St. Andrews Hospital</b>, I have served on the 4 Town Regional Task Force. This has been an unprecedented cooperation between 4 towns in this region that has generated many continuing activities that will benefit all towns in our region.</blockquote><br />Apparently an entire hospital is closing as a result of these debacles.<br /><br /><i><b>[May 8, 2013 addendum: a family physician in Lincoln County where St. Andrews hospital is located and a member of the Board of Trustees, </b></i><i><b>Dan Friedland, M.D., writes me that the EHR had nothing to do with the hospital closing - ed.] </b></i><br /><br /><blockquote class="tr_bq">But let me get back to the MH/LCH decision. <b>We are told that MaineHealth has spent over $150 million on an Electronic Medical Records (EMR)</b> system that helps all of its “subsidiaries.” I can appreciate this because my work is in software development.<br /><br /><b>I do question the $150 million figure. I think it is extremely high and Portland has had a real failure in its implementation. </b>So much so that it looks like LCH will not have a real integrated EMR until 2015 and financial software problems exemplify a major failure of MH to create any real benefit to the State. Millions of dollars have been charged to member hospitals and staff time (salaries and mileage) over the past 2-3 years with no benefit.</blockquote><br />I'd questioned the high cost of these commercial EHR systems as far back as 2006 ("<a href="http://msnbc.msn.com/id/11693923/">Yet another clinical IT controversy: UC Davis</a>" and "<a href="http://hcrenewal.blogspot.com/2007/06/oversight-needed-for-hospital-emr.html">External oversight needed for hospital EMR implementation?</a>" - Lancaster General Hospital and "<a href="http://hcrenewal.blogspot.com/2006/10/70-million-for-electronic-medical.html">$70 million for an Electronic Medical Records system [quasi endpoint]?</a>- Geisinger).<br /><br />One might think healthcare systems have money to burn ...<br /><blockquote class="tr_bq"><br />The system failure also <b>adds operational costs going forward that were not planned for</b> and regional consolidation of finance will now be delayed. The cost to Maine Health Center is huge in improper service and supply charges. <b>Information Technology leadership has been fired</b>, but MH administration is truly accountable.</blockquote><br />For once, someone in IT leadership did not get a a <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story">promotion for failure</a>. It is true that MH administration is accountable, however - they had the fiduciary responsibility to hire the best talent, and to oversee that talent as needed to assure success. If "C" leadership didn't understand IT, that's their failure as well. In my view in 2013 everyone in a position of organizational responsibility should have a good understanding of IT, which is now, after all, a commodity.<br /><br />I'm hopeful EPIC, with its apparently <a href="http://hcrenewal.blogspot.com/2010/08/epics-outrageous-recommendations-on.html">revolutionary hiring practices</a> akin to the hiring of physicians, will have the "hiccups" fixed in no time. From <a href="http://histalk2.com/2010/08/14/monday-morning-update-81610/">this link</a> at the "Histalk" site on staffing of health IT projects, Aug. 16, 2010. Emphases mine:<br /><br /><blockquote class="tr_bq">Epic Staffing Guide<br /><br />A reader sent over a copy of the staffing guide that Epic provides to its customers. I thought it was interesting, first and foremost in that Epic is so specific in its implementation plan that it sends customers an 18-page document on how staff their part of the project.<br /><br />Epic emphasizes that many hospitals can staff their projects internally, choosing people who know the organization. However, they emphasize choosing the best and brightest, not those with time to spare. <b>Epic advocates the same approach it takes in its own hiring: don’t worry about relevant experience, choose people with the right traits, qualities, and skills, they say.</b> The guide <b>suggests hiring recent college graduates for analyst roles</b>. Ability is <b>more important than experience,</b> it says. That includes reviewing a candidate’s college GPA and <b>standardized test scores.</b></blockquote><span style="color: black; font-size: 100%;"><br /></span> <br />I am forwarding links to this post, blog, my teaching site (begun in 1998) and additional material to Selectman Smith.<br /><br />I'd offer to help, but the management of the organization would likely find, as did <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=leadership">management at this one</a> (a major denominational chain), that I have too much experience for the organization. <br /><br />-- SS<br /><br /><span style="font-family: arial, helvetica, sans-serif; font-size: small;"></span>Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-50059472525949409522013-05-04T12:02:00.000-07:002013-06-07T11:46:39.191-07:00Health Information Technology: Blessings, Disasters, and Recommendations: An Interview with Scot M. Silverstein, MDI was recently interviewed by <a href="http://asp.cumc.columbia.edu/facdb/profile_list.asp?uni=eas2150&DepAffil=Psychiatry"><span style="color: #21197b;">Dr. </span></a><span style="color: #21197b;"><a href="http://asp.cumc.columbia.edu/facdb/profile_list.asp?uni=eas2150&DepAffil=Psychiatry">Elizabeth Saenger</a> for <a href="http://www.coalitionny.org/the_center/">The Center for Rehabilitation and Recovery</a> regarding use of healthcare information technology in provision of mental health services. </span><br /><br /><span style="color: #21197b;">The Center, part of the <a href="http://www.coalitionny.org/">Coalition of Behavorial Health Agencies Inc.</a>, provides assistance to the New York City mental health provider community through expert trainings, focused technical assistance, evaluation, information dissemination and special projects.</span><br /><br /><span style="color: #21197b;">The interview is here:</span><br /><br /><span style="color: #21197b;"><a href="http://coalitionny.org/the_center/recovere-works/RECOVERe-worksApril2013.html#DrSilverstein">http://coalitionny.org/the_center/recovere-works/RECOVERe-worksApril2013.html#DrSilverstein </a></span><br /><span style="color: #21197b;"><br /></span><span style="color: #21197b;">The themes I discussed will be familiar to readers of this blog. </span><br /><br /><span style="color: #21197b;">-- SS</span>Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-49382627838868241552013-05-04T10:59:00.000-07:002013-06-07T11:46:39.288-07:00Repost: Health IT Ten Commandments (1970) v. Health IT Truisms (2012) I believe this Oct. 2012 post bears repeating, especially in view of the recent <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">ECRI Deep Dive study</a> of health IT risk (36 hospitals/9 weeks/volunteer reporting/171 health IT-related problems/8 incidents of harm/3 possible deaths):<br /><br /><span style="font-family: inherit;">In 1970, health IT pioneer Dr. Octo Barnett at Harvard/MGH wrote his "<b>Health IT Ten Commandments</b>" <span style="font-size: 85%;"><span style="font-size: 100%;"></span></span><span style="font-size: 85%;"><span style="font-size: 100%;">(from Collen's "<a href="http://www.amazon.com/History-Medical-Informatics-United-States/dp/0964774305">A history of Medical Informatics in the United States, 1950-1990</a>"):</span></span></span><span style="font-size: 100%;"> </span><br /><br /><br /><blockquote class="tr_bq"><span style="font-size: 100%;">1. Thou shall know what you want to do</span><br /><span style="font-size: 100%;"><br />2. Thou shall construct modular systems - given chaotic nature of hospitals</span><br /><span style="font-size: 100%;"><br />3. Thou shall build a computer system that can evolve in a graceful fashion</span><br /><span style="font-size: 100%;"><br />4. Thou shall build a system that allows easy and rapid programming development and modification</span><br /><span style="font-size: 100%;"><br />5. Thou shall build a system that has consistently rapid response time and is easy for the non-computernik to use</span><br /><span style="font-size: 100%;"><br />6. Thou shall have duplicate hardware systems</span><br /><span style="font-size: 100%;"><br />7. Thou shall build and implement your system in a joint effort with real users in a real situation with real problems</span><br /><span style="font-size: 100%;"><br />8. Thou shall be concerned with realities of the cost and projected benefit of the computer system</span><br /><span style="font-size: 100%;"><br />9. Innovation in computer technology is not enough; there must be a commitment to the potentials of radical change in other aspects of healthcare delivery, particularly those having to do with organization and manpower utilization</span><br /><span style="font-size: 100%;"><br />10. Be optimistic about the future, supportive of good work that is being done, passionate in your commitment, but always guided by a fundamental skepticism.</span></blockquote><br />Four decades later, I write the following 2012 "<b>Health IT Truisms</b>" (perhaps more to follow). Many of the points summarized here can be found in the past 8 years of my writing on this blog:<br /><br /><blockquote class="tr_bq">1. Health IT in 2012 remains experimental, not proven effective or safe, with actual results conflicting. <br /><br />2. Health IT is costly, not money-saving, diverting scarce healthcare resources away from actual healthcare provision to the IT industry.<br /><br />3. "EHR" is an anachronistic term (that disarms the uninformed, who "see" an innocuous file system) for what is now an enterprise medical resource and workflow control system.<br /><br />4. The proper framework in which to view "resistance" to health IT is not Luddite clinicians vs. IT modernists. It's pragmatist clinicians (with ethical and legal obligations and responsibilities), vs. IT hyper-enthusiasts who ignore or are blinded to the ethical considerations and downsides, and whose actions are based not on science, but on faith in technology and self interest.<br /><br />5. HIT can be partitioned into good health IT (GHIT) and bad HIT (BHIT) - see definitions at the introduction to <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases">http://www.ischool.drexel.edu/faculty/ssilverstein/cases</a>. <br /><br />6. BHIT prevails due to its being far cheaper to produce than GHIT and due to lack of meaningful industry regulation of quality, usability and safety.<br /><br />7. The lack of HIT regulation, post-market surveillance, formal validation and accountability is a special accommodation that is unprecedented in modern medicine.<br /><br />8. Underlying HITECH and "Meaningful use" is the assumption that all HIT is good HIT.<br /><br />9. A good or even average paper system is better for patients than a bad health IT system. <br /><br />10. The incentives and coercive aspects of HITECH would not be needed if GHIT prevailed.<br /><br />11. The coercive force of government should have been directed not at users, but at sellers, to produce GHIT and to abolish BHIT.<br /><br />12. The term "meaningful use" is political rhetoric whose criteria were decided by committee and industry influence; nobody knows if meeting the criteria will prove truly "meaningful" or not. (That medical informaticists placidly accepted the term is a disgrace to a field that strives for terminological precision; "good faith use" would have been precise.)<br /><br />13. Human research protections are given the blind eye with respect to commercial health IT.<br /><br />14. Health IT being used safely is currently by happenstance and via compensation for flaws by clinicians who improvise (which itself introduces risk and is stressful), not by design.<br /><br />15. Business IT a/k/a MIS personnel have far too narrow an education and experience to make pronouncements about health IT "transforming" medicine.<br /><br />16. IT personnel should be part of the medical team, including liability for IT-related failure.<br /><br />17. The commercial health IT sector is not an evidence-based domain.<br /><br />18. A cybernetic "Libby Zion" catastrophe is unavoidable, and probably the only way to "transform" the health IT industry into an evidence-based industry - essential before that industry can even begin to "transform" (i.e., facilitate improvement of) medicine.</blockquote><br />Had Dr. Barnett's Ten Commandments not been disobeyed in favor of cybernetic idolatry, the Health IT Truisms in 2012 would appear far different.<br /><br />-- SSAnonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-54243179847460063382013-05-03T12:47:00.000-07:002013-06-07T11:46:39.386-07:00UnitedHealth CEO Continues to Prosper While His Company's Behavior Appears to Contradict its Mission StatementTis spring, the season in the US for legal settlements, government findings, and proxy statements revealing executive compensation. Therefore, maybe there should be no surprise that we are seeing a series of cases in which health care corporate leaders continue to enrich themselves while their organizations' behavior raises ethical questions.<br /><br />Following on the <a href="http://hcrenewal.blogspot.com/2013/05/amgen-ceos-prosper-despite-or-because.html">Amgen example</a>, we now present the latest UnitedHealth example (in a post organized similarly.)<br /><br /><b>The CEO Gets Richer</b><br /><br />Last week, the Associated Press (<a href="http://articles.washingtonpost.com/2013-04-25/business/38810785_1_medicare-advantage-insurer-compensation">via the Washington Post</a>) summarized UnitedHealth CEO Stephen J Hemsley's growing pile of money:<br /><br /><blockquote class="tr_bq"><div class="mod-washingtonpostarticletext mod-tribunearticletextimpl mod-articletext" id="mod-a-body-first-para">UnitedHealth Group Inc. kept CEO Stephen J. Hemsley’s salary stable in 2012 but <i>bumped up his total compensation</i> for a year in which the nation’s largest health insurer grew earnings and enrollment and launched a major acquisition.<br /><br />The Minnetonka, Minn., insurer gave its top executive <i>a compensation package valued at about <b>$13.9 million</b> last year</i>, according to the company’s proxy statement filed with the Securities and Exchange Commission. That’s <i>up 4 percent from the $13.4 million total he received last year.</i><br /><br />Hemsley, 60, received <i>a $1.3 million annual salary </i>in 2012, like he has the past several years. He also <i>received $7 million in stock awards</i>, which is the same total as 2011. But his <i>performance-based bonus climbed 7 percent to $5.3 million, and he received $287,443 in other compensation, up from $154,804 in 2011.</i><br /><br />Other compensation included savings plan contributions and a $125,000 Hart-Scott-Rodino Antitrust Improvement Act filing fee payment UnitedHealth made on behalf of the CEO so he could maintain and increase his stock ownership in the company.</div></blockquote><br />At the same time, Hemsley continued to cash in stock options which also added to his riches:<br /> <br /><blockquote class="tr_bq">Outside AP’s calculation of his 2012 total compensation, Hemsley also <i>acquired 284,836 shares that had vested with a value of $15.3 million.</i> He also <i>exercised options to acquire 600,000 shares and realized a value of $12.5 million</i>. Those options and stock awards had been previously given to the executive.<br /><br />The proxy said Hemsley <i>directly owned UnitedHealth shares valued at about $140 million</i>, as of March 1.</blockquote><br /><b>The Mission Promises Much but the Company Delivers Less</b><br /><br />On one hand, the rate of rise of Hemsley's compensation at least seemed comparable to the company's financial performance:<br /><br /><blockquote class="tr_bq">Overall, UnitedHealth shares climbed 7 percent to close 2012 at $54.24, a smaller gain than the 13.4 percent advance from the Standard & Poor’s 500 index.</blockquote><br />On the other hand, the largess given to the CEO ought to be contrasted with the how UnitedHealth failed to deliver what its mission promised. <br /><br />Most recently, a jury found the company failed to live up to its legal obligation (in the state of Nevada) to review the quality of the clinicians on its panel. As <a href="http://www.bloomberg.com/news/2013-04-04/unitedhealth-units-told-to-pay-24-million-over-hepatitis-doctor.html">reported</a> by Bloomberg,<br /><br /><br /><blockquote class="tr_bq"><i>Two UnitedHealth Group Inc (UNH) units must pay $24 million in damages for failing to properly monitor a doctor who gave two colonoscopy patients hepatitis C by employing substandard medical practices</i>, a Nevada jury ruled. <br /><br />Jurors in state court in Las Vegas deliberated about five hours over two days before finding officials of Health Plan of Nevada and Sierra Health Services were negligent in their oversight of Dipek Desai. The former gastroenterologist has been <i>blamed for infecting patients with hepatitis C by reusing vials of the anesthetic Propofol and failing to sterilize equipment.</i><br /><br />The panel ordered the two UnitedHealth units to pay $15 million in compensatory damages to Bonnie Brunson and her husband and $9 million to Helen Meyer. The two women contend they got hepatitis during colonoscopy procedures at Desai’s clinic. Their lawyers said earlier in the case they may ask the jury to award more than $1 billion in punitive damages.<br /><br />The verdict reflects 'what’s wrong with health insurance companies in the U.S.' Robert Eglet, Brunson’s lawyer, said in an interview after the verdict was announced. 'They put profit before patient safety.'</blockquote><br />Note that the state of Nevada does explicitly hold managed care organizations accountable for the clinical quality of its health care professionals' practice,<br /><br /> <br /><blockquote class="tr_bq">Meyer and Brunson sued under a Nevada law <i>requiring HMOs to file annual reports showing officials reviewed the quality of health services provided to their members.</i><br /><br />The women’s lawyers <i>argued officials of the UnitedHealth units knew Desai had a reputation for sloppy practice before giving him a contract to handle colonoscopies and then didn’t check the quality of his work</i>. At one point, Desai was a member of Nevada's Board of Medical Examiners, which oversees the licensing of doctors in the state.<br /><br />The plaintiffs<i> contend the insurer didn’t properly monitor Desai’s practices and procedures even though they received complaints about his practices. </i><br /><br />During the trial, witnesses said Desai adopted a cavalier attitude toward patient safety, speeding through procedures so he could see as many as 20 patients in a three-hour period.<br /><br />The women’s lawyers argued the insurers’ executives had an obligation to insure Desai was providing quality care to their HMO members and were required to vet his practices before hiring him.</blockquote><br />Also note that managed care organizations and other health insurers often boast about the quality of their provider panels. <br />For example, see the UnitedHealth <a href="http://www.unitedhealthgroup.com/About/MissionValues.aspx">mission statement</a>:<br /><br /><blockquote class="tr_bq">- Our mission is to help people live healthier lives. <i>Our role is to help make health care work for everyone.</i><br /> - <i>We seek to enhance the performance of the health system and improve the overall health and well-being of the people we serve and their communities.</i><br />- <i>We work with health care professionals and other key partners to expand access to quality health care</i> so people get the care they need at an affordable price. <br />- We support the physician/patient relationship and empower people with the information, guidance and tools they need to make personal health choices and decisions. </blockquote><br />It seems reasonable to interpret the italicized parts above as a statement of accountability for the quality of care provided by the health care professionals within the United network.<br /><br />To reinforce that accountability, a subsequent Bloomberg <a href="http://www.bloomberg.com/news/2013-04-09/unitedhealth-to-pay-500-million-over-hepatitis-doctor.html">story </a>added,<br /><br /><blockquote class="tr_bq">Two UnitedHealth Group Inc (UNH) units must <i>pay $500 million in punitive damages for failing to oversee a doctor blamed for giving colonoscopy patients hepatitis C through shoddy medical practices</i>, a Nevada jury found.<br /><br />Jurors in state court in Las Vegas deliberated more than six hours yesterday before handing down the punitive-damages award against Health Plan of Nevada and Sierra Health Services for turning a blind eye to Dipak Desai's actions. </blockquote><br />Furthermore, the lofty UnitedHealth mission statement should be compared to two recent government findings.<br /><br />In the state of California, as<a href="http://articles.latimes.com/2013/may/01/business/la-fi-unitedhealth-rates-20130502"> reported</a> by the Los Angeles Times,<br /><br /><blockquote class="tr_bq"><i>California Insurance Commissioner Dave Jones said the nation's largest health insurer, UnitedHealth Group Inc., is imposing unreasonable rate hikes on about 5,000 small businesses. </i><br /><br />Jones said Wednesday that <i>UnitedHealth couldn't justify the average annual increase of nearly 8%</i>, which reflects both higher premiums and a reduction in benefits. He said the rate hike, which went into effect Wednesday, affects up to 45,000 small-business employees and dependents and represents $12.5 million in higher costs.<br /><br />'At a time when small businesses are struggling to survive, UnitedHealthcare's rate increase is just one more unwarranted economic burden on California's small business owners and their employees,' Jones said. </blockquote><br />Such behavior seems to contradict the mission statement's assurance that the company will seek to provide health care at "an affordable price."<br /><br />Meanwhile, Bloomberg just published a <a href="http://www.bloomberg.com/news/2013-05-03/pentagon-blames-unitedhealth-for-failures-under-contract.html">story</a> about how UnitedHealth has been running an insurance program for US military families.<br /><br /><blockquote class="tr_bq"><i>The Pentagon rebuked UnitedHealth (UNH) Group Inc, the nation’s largest insurer, after military families began experiencing long delays getting medical-care referrals from the company. </i><br /><br /><i>The backlogs occurred almost as soon as Minnetonka, Minnesota-based UnitedHealth took over a contract</i>, valued as much as $20.5 billion, from TriWest Healthcare Alliance Corp. It assumed responsibility on April 1 for the western region of the military’s health-care system, known as Tricare.<br /><br /><i>UnitedHealth’s 'failure to meet contractor requirements' has prevented a large number of beneficiaries in one Tricare health plan from obtaining timely access to specialty care, Jonathan Woodson, assistant secretary of defense for health affairs, said</i> in a memo yesterday to other military leaders.<br /><br />Woodson, <i>calling the situation 'extraordinary,</i>' said the Pentagon stepped in to grant a temporary waiver so the plan’s members in the western region could get specialty care without UnitedHealth’s authorization and not incur penalties.. </blockquote><br />This behavior seemed to contradict the mission statement's assurance that the company seeks to "expand access to quality health care."<br /><br /><b>The Song Remains the Same </b><br /><br />Of course, UnitedHealth actually has a very long record of preaching about its aspirational mission, while paying its top hired managers extraordinary amounts and contradicting that mission, and at times ethical norms. Our posts on UnitedHealth are here. Recently we wrote,<br /><br /> UnitedHealth would be the company whose CEO once was worth over a billion dollars due to back dated stock options, some of which he had to give back, but despite all the resulting legal actions, was still the ninth best paid CEO in the US for the first decade of the 21st century (look <a href="http://hcrenewal.blogspot.com/2010/08/despite-scandal-former-unitedhealth-ceo.html">here</a>). UnitedHealth would be the company whose then CEO made a cool $106 million in 2009 (look <a href="http://hcrenewal.blogspot.com/2010/08/can-1-billion-group-of-babies-provide.html">here</a>).<br /><br />Moreover, UnitedHealth would also be the company known for a string of ethical lapses:<br />- as <a href="http://www.courant.com/business/hc-natbizdigbrf0530.art2may30,0,109447.story">reported</a> by the Hartford Courant, "UnitedHealth Group Inc., the largest U.S. health insurer, will refund $50 million to small businesses that New York state officials said were overcharged in 2006."<br />- UnitedHalth promised its investors it would continue to raise premiums, even if that priced increasing numbers of people out of its policies (see post <a href="http://hcrenewal.blogspot.com/2008/05/commercial-managed-care-organizations.html">here</a>);<br />- UnitedHealth's acquisition of Pacificare in California allegedly lead to a "meltdown" of its claims paying mechanisms (see post <a href="http://hcrenewal.blogspot.com/2008/01/bungled-not-brilliant-results-of.html">here</a>);<br />- UnitedHealth's acquisition of Sierra Health Services allegedly gave it a monopoly in Utah, while the company allegedly was transferring much of its revenue out of the state of Rhode Island, rather than using it to pay claims (see post <a href="http://hcrenewal.blogspot.com/2007/03/unitedhealth-declares-health-care.html">here</a>)<br />- UnitedHealth frequently violated Nebraska insurance laws (see post <a href="http://hcrenewal.blogspot.com/2007/01/on-performance-on-one-supposedly.html">here</a>);<br />- UnitedHealth settled charges that its Ingenix subsidiaries manipulation of data lead to underpaying patients who received out-of-network care (see post <a href="http://hcrenewal.blogspot.com/2009/01/unitedhealth-and-ingenix-settles.html">here</a>).<br />- UnitedHealth was accused of hiding the fact that the physicians it is now employing through its Optum subsidiary in fact work for a for-profit company, not directly for their patients (see post <a href="http://hcrenewal.blogspot.com/2011/07/here-comes-your-new-doctor-brought-to.html">here</a>).<br /><br /><b>Summary</b><br /><br />The US dysfunctional health care system has produced a long string of big corporations that promise warm and fuzzy health care yet deliver something less, all the while mightily enriching their top hired managers. Given the deadly serious nature of the health care system, these companies' promises, marketing, public relations and mission statements cannot be dismissed as fluff and puffery. Market fundamentalists and executive apologists have touted our system as market based. If patients must act as consumers, they cannot make good consuming decisions if they are awash with deceptive marketing and advertising. It is one thing for Hollywood to advertise blockbuster movies that are duds. It is another for health care corporations to advertise quality care and deliver bad care.<br /><br />As we have said far too many times, we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich. Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-92091409871679993732013-05-02T08:31:00.000-07:002013-06-07T11:46:39.484-07:00Amgen CEOs Prosper Despite (or Because of) Continuing Ethical QuestionsThis is becoming a familiar narrative on<a href="http://hcrenewal.blogspot.com/"> Health Care Renewal</a>: top health care leaders continue to enrich themselves while their organizations' behavior continues to raise ethical questions.<br /><br />For our latest example we return to the ongoing adventures of biotechnology giant <a href="http://hcrenewal.blogspot.com/search/label/Amgen">Amgen</a>.<br /><br /><b>CEOs Get Richer </b><br /><br />An AP story (<a href="http://www.latimes.com/business/la-fi-amgen-ceo-20130408,0,1832506.story">via the LA Times</a>) documented the continuing enrichment of its current CEO:<br /><br /><blockquote class="tr_bq">Amgen Inc's new chief executive, Robert A. Bradway, <i>received total compensation of <b>$13.6 million</b></i> in 2012, more than his predecessor, according to an analysis of a company regulatory filing.<br /><br />Bradway, who was promoted from chief operating officer to chief executive May 23, saw his compensation nearly double from $7.1 million in 2011.<br /><br />Last year Bradway, 50, was paid <i>a salary of $1.26 million and received stock awards worth $8.57 million, incentive payments of $3.32 million and miscellaneous compensation totaling $420,059. That included nearly $314,000 in retirement plan contributions, $65,000 for personal use of company aircraft, more than $20,000 for his personal expenses and those of guests during business travel, and $15,000 for financial planning services.</i></blockquote><br /><br />The former CEO also did very well in his final year in office.<br /><br /><blockquote class="tr_bq">Former CEO Kevin W. Sharer, who stepped down from his seat on Amgen's board when he retired Dec. 31, <i> received compensation totaling <b>$9.13 million</b> last year.</i><br /><br />Sharer was paid a 2012 <i>salary of $1.81 million and received stock awards worth $3.66 million, incentive payments of $2.31 million and miscellaneous compensation totaling $1.36 million. That included $801,000 in retirement plan contributions, nearly $262,000 for personal use of company aircraft, more than $38,000 for his personal expenses and those of guests during business travel, $15,000 for financial planning services and more than $255,000 for secretarial, information technology and travel support. </i>Much of that support runs through 2017.</blockquote><br />You would think they could both afford financial planning on their own.<br /><br /><b>Legal Settlements Pile Up </b><br /><br />Keep in mind that as we discussed in <a href="http://hcrenewal.blogspot.com/2012/12/amgen-settles-pleads-guilty-to.html">late 2012</a> and <a href="http://hcrenewal.blogspot.com/2013/01/how-revolving-door-and-other-aspects-of.html">early 2013</a>, Amgen pleaded guilty to a charge of misbranding for promoting its epoetin drug Aranesp for unapproved indications, and settled allegations of giving kickbacks to physicians to increase the drug's use, among other charges, for a total of $762 million.<br /><br />Furthermore, soon after the CEOs' compensation was announced, tiny articles in local media announced two more settlements by Amgen. <br /><br />A small AP story (again <a href="http://www.latimes.com/business/la-fi-amgen-20130416,0,4959804.story">via the LA Times</a>) noted another settlement regarding allegations of unethical promotion of Aranesp:<br /><br /><br /><blockquote class="tr_bq">The US Department of Justice<a class="taxInlineTagLink" href="http://www.latimes.com/topic/crime-law-justice/u.s.-department-of-justice-ORGOV0000160.topic" id="ORGOV0000160" title="U.S. Department of Justice"></a> said Tuesday that biotech drug maker Amgen Inc. will pay $24.9 million to resolve claims it paid kickbacks to increase sales of its anemia<a class="taxInlineTagLink" href="http://www.latimes.com/topic/health/physical-conditions/anemia-HEPHC0000047.topic" id="HEPHC0000047" title="Anemia"></a> drug Aranesp.<br /><br />The Justice Department said Amgen paid kickbacks to Omnicare Inc<a class="taxInlineTagLink" href="http://www.latimes.com/topic/economy-business-finance/omnicare-incorporated-ORCRP011399.topic" id="ORCRP011399" title="Omnicare Incorporated">.</a> and PharMerica Corp., which sell drugs to long-term care providers such as nursing<a class="taxInlineTagLink" href="http://www.latimes.com/topic/health/medical-specialization/nursing-HEMSP000015.topic" id="HEMSP000015" title="Nursing"></a> homes and hospitals, and Kindred Healthcare Inc., which runs long-term acute-care hospitals and nursing and rehabilitation centers.<br /><br />Amgen wanted the companies to switch Medicare and Medicaid beneficiaries to Aranesp from competing drugs and tried to get consultant pharmacists and nursing home staffers to encourage the use of Aranesp in patients who didn't have anemia associated with kidney failure, the Justice Department said.<br /><br />The Thousand Oaks company made payments based on the sales volume or market share of Aranesp, the agency said.</blockquote><br />Then a few days ago, a <a href="http://www.sfvbj.com/news/2013/apr/29/amgen-reaches-11-million-settlement-over-medicaid-/">story</a> in the San Fernando Valley Business Journal described yet another Amgen settlement:<br /> <br /><blockquote class="tr_bq">Thousand Oaks biotech Amgen Inc. has reached an $11 million settlement with 36 states over charges it inflated pricing data and caused Medicaid to overpay for six of its drugs, the New York State Attorney General said Monday.<br /><br />The charges allege Amgen inflated cost benchmarks for drugs used to treat kidney disease and cancer patients. The drugs involved were Aranesp, Enbrel, Epogen, Neulasta, Neupogen and Sensipar. Those benchmarks are used to set pharmacy reimbursement rates for drugs dispensed to state Medicaid beneficiaries.</blockquote><br />Keep in mind that all these recent settlements involved allegations of efforts made to oversell Aranesp. As we noted previously, this drug carries a "black box" warning about serious and potentially fatal side effects. The <a href="http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173_103951Orig1s5258lbl.pdf">official Aranesp label</a> states (in a black box warning, in capital letters):<br /><br /><br /><blockquote class="tr_bq"> ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE</blockquote><br /><br /><br />So the overselling of Aranesp not only appeared unethical, it seemed to put short term revenue ahead of patient safety, and could conceivably have lead to patients dying so that the company could make more money. <br /><br /><b>Summary</b><br /><br />So while the evidence mounts that health care organizations, and in this case, Amgen, continue to aggressively pursue short-term revenue even is their means of doing so endangers patients. However, <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal efforts</a> to challenge such reckless practices continue to fail to impose any negative consequences on those who personally profited from this behavior, and particularly those corporate executives who authorized and directed the bad behavior. Moreover, while such evidence mounts, the top leaders of these organizations continue to pile up riches. It seems that CEOs of health care organizations continue to prosper despite, or perhaps because of their organizations' continuing unethical and dangerous behavior. <br /><br />As we have said far too many times, we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-86304978816812609602013-04-25T14:36:00.000-07:002013-06-07T11:46:39.581-07:00The Myth of the Tough Prosecutor as a Distraction from Health Care Corporate Executives' ImpunityThe tragic case of the Boston Marathon bombing illustrates how myth making about tough law enforcement obscures the impunity enjoyed by top health care executives.<br /><br /><b>A "Tough to a Fault" Prosecutor</b><br /><br />A recent Reuters<a href="http://www.reuters.com/article/2013/04/22/us-usa-explosions-prosecutor-idUSBRE93L00X20130422"> article</a> touted the toughness of the prosecutor who will take on the case of the surviving accused Boston terrorist:<br /><br /><blockquote class="tr_bq"><span id="articleText"><span class="focusParagraph">As the top federal law enforcer in Massachusetts, U.S. Attorney Carmen Ortiz has<i> taken heat for being tough to a fault and coming down too hard on some defendants.</i><br /><br /> </span><span id="midArticle_1"></span>But as she builds a possible death penalty case against suspected Boston Marathon bomber Dzhokhar Tsarnaev, 19, the <i>unflinching approach </i>that earned her opponents in the past could become a legal asset for the biggest case of her career, said attorneys who have faced off against her.<br /><span id="midArticle_2"></span><br />'The criticism lately has been that they've<i> over-charged some people and been overly harsh</i>,' said Peter Elikann, a Boston defense attorney.'I don't think that's relevant for Tsarnaev because no one is going to accuse any prosecutor of making too big a deal out of this case.'</span></blockquote><span id="articleText"></span><br /><br />Similarly, an<a href="http://www.businessweek.com/news/2013-04-23/marathon-bomb-prosecutor-seen-as-ready-for-marquee-case"> article</a> in Bloomberg included this:<br /><br /><br /><blockquote class="tr_bq">Ortiz’s former bosses insist that she’s ready for her moment on the big stage. <br /><br />'She’s<i> tough-minded</i> and exceptionally professional,' [former Massachusetts Attorney General Scott] Harshbarger said. </blockquote><br />One of the cases cited as an example of Ms Ortiz's toughness was her prosecution of electronic information freedom activist Aaron Swart. As Rueters noted,<br /><br /><blockquote class="tr_bq"><span id="articleText">One of Ortiz's best-known cases to date was her prosecution of Aaron Swartz on wire fraud and hacking allegations for downloading millions of articles from an academic database.<br /><br /><span id="midArticle_10"></span>Swartz, a 26-year-old computer prodigy, hanged himself in his Brooklyn, New York, apartment in January, prompting friends and family to partly blame Ortiz's prosecution for his death.</span></blockquote><br /><span id="articleText"></span><br />At the time, Ms Ortiz was criticized for being unreasonably harsh, but then as now toughness was touted as her style.<br /><br /><b>Not So Tough on Corporate Crime </b><br /><br />However, as we <a href="http://hcrenewal.blogspot.com/2013/01/the-tragic-case-of-aaron-swartz-unequal.html">pointed out then</a>, while Ms Ortiz was noted for being tough on individuals accused of various offenses, she was notably not so tough on individuals involved in alleged corporate health care wrong doing.<br /><br />In particular, as we wrote before, Ms Ortiz was involved in three settlements of notably bad behavior by large health care corporations, none of which involved prosecution of, or any penalties for the individuals at the corporations who authorized, directed or implemented the bad behavior.<br /><br /><span style="background-color: #f3f3f3;"><u>Forest Pharmaceuticals </u></span><span style="background-color: #f3f3f3;"><br />In September, 2010, how Ms Ortiz led the pursuit of a settlement with Forest Pharmaceuticals became apparent (look <a href="http://hcrenewal.blogspot.com/2010/09/forest-pharmaceuticals-pleads-guilty-to.html">here</a>). The company was accused of promoting its anti-depressant Celexa for use in adolescents and children. Such drugs have since been shown to increase the risk of suicide by such young patients, and this drug was only approved for adults. At the time, Ms Ortiz said, "Forest Pharmaceuticals deliberately chose to pursue corporate profits over its obligations to the F.D.A. and the American public." Although the offense may have lead to use of the drug by many adolescents and children, and hence may have lead to some of them attempting or committing suicide, the case was settled only with fines. As is usual in such legal settlements, no individual corporate executive who authorized or lead the off-label and potentially dangerous marketing of the drug was arrested, or accused, and none suffered any negative consequences.</span><span style="background-color: #f3f3f3;"><br /></span><span style="background-color: #f3f3f3;"><u>GlaxoSmithKline </u></span><span style="background-color: #f3f3f3;"><br />In October, 2010, how Ms Ortiz led the pursuit of a settlement with GlaxoSmithKline became apparent (look <a href="http://hcrenewal.blogspot.com/2010/10/glaxosmithkline-subsidiary-pleads.html">here</a>.) The company was accused of selling drugs that were not what they appeared to be, apparently because the wrong drugs were put in labelled containers. Obviously, taking one drug, like Paxil, GSK's anti-depressant which has a number of known adverse effects, including suicide risk for adolescents and children as noted above, when a patient is supposed to be taking a wholly different drug could lead to patient harm. At that time, Ms Ortiz said, "We will not tolerate corporate attempts to profit at the expense of the ill and needy in our society -- or those who cut corners that result in potentially dangerous consequences to consumers." Again, while the settlement involved a guilty plea by a GSK subsidiary, again no individual corporate executive who had authority over the drug manufacturing was arrested or accused, much less suffered any negative consequences.</span><span style="background-color: #f3f3f3;"><br /></span><span style="background-color: #f3f3f3;"><u>St Jude Medical </u></span><span style="background-color: #f3f3f3;"><br />In January, 2011, Ms Ortiz led the pursuit of a settlement with St Jude Medical (look <a href="http://hcrenewal.blogspot.com/2011/01/st-jude-medical-settles-again.html">here</a>). The company was accused of paying kickbacks to doctors to implant its cardiac defibrillators (ICDs) and pacemakers. Obviously, providing kickbacks to doctors may have lead them to plant devices in patients who did not really need them, yet the devices and the implantation procedures can have adverse effects. At that time, Ms Ortiz said, "The United States alleges that St Jude solicited physicians for the studies in order to retain their business and/or convert their business from a competitor's product." Again, as is usual, the settlement did not require any executive who authorized or directed the activities leading to the kickbacks suffered any negative consequences.</span><br /><br /><br />Despite this, note that Bloomberg in its recent coverage of the Tsarnaev prosecution even tried to make Ms Ortiz failure to hold any individuals accountable for this health care corporate misbehavior seem like tough prosecution.<br /><br /><br /><blockquote class="tr_bq"><span id="articleText">The office has been a <i>leader in health-care fraud prosecutions</i>, securing $4 billion in civil and health-care recoveries in 2012. Those included a $3 billion payment from GlaxoSmithKline Plc (GSK), which pleaded guilty to charges that it illegally promoted prescription drugs. </span></blockquote><span id="articleText"></span><br />Again, note that apparently being a "leader" in health care fraud prosecution involved pushing for big fines to be paid by the corporations involved in actions that may have harmed many patients, but no punishment for the individuals who may have authorized, directed or implemented the bad behavior, but being "tough" on Aaron Swartz involved pushing for a long imprisonment of someone whose alleged crime was not violent, and did not result in anyone being hurt.<br /><br /><br /><b>Summary </b><br /><br />As we have noted again and again and again, leaders of large health care organizations, particularly the largest health care corporations, seem to enjoy virtual impunity. No matter how bad the behavior of the corporations which they are supposed to be leading, and no matter whether such behavior might have harmed patients, they almost never have to face any negative consequences, especially not fines they must pay themselves, much less prison time. We have <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">documented many legal settlements</a> of often egregiously bad alleged behavior that did not involve any penalties for top corporate leaders. <br /><br />One way corporate leaders thus escape accountability seems to be the cultivation of myths that distract the public from what is going on. One such urban legend seems to be the toughness of government prosecutors. If prosecutors are believed to be uniformly tough and uncompromising, then the public may be lead to believe either that they are tough and uncompromising on corporate crime <br /><br />As we have said repeatedly, true health care reform would require making the leaders of health care organizations accountable, especially for the effects of their actions on patients' and the public's health.<br /><br />Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-80407079443984450712013-04-24T07:02:00.000-07:002013-06-07T11:46:39.678-07:00Johns Hopkins: Thanks to EHRs, time with patients seems “squeezed out” of medical training, investigator says Question: Who would have thought it? That there is yet another potentially deadly unintended consequence of <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">bad health IT</a> and health IT <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html">hyper-enthusiasm</a>?<br /><br />Suggested answer: anyone who truly understands the issues at the intersection of medicine, information science, information technology, and <a href="http://en.wikipedia.org/wiki/Social_informatics">Social Informatics</a> - which probably excludes 95% of the health IT "experts", pundits and opportunists.<br /><br />Which only goes to show how dense such people can be - as the medical trainees of today will be treating them, their families, and their children in the future:<br /><blockquote class="tr_bq"><br /><div class="Boxed" id="detailInteriorDate"><div class="Copy"><b>Johns Hopkins Medicine</b></div><div class="Copy"><b>Release Date: 04/23/2013 </b></div></div><b> </b><br /><div class="Boxed" id="detailInteriorSubTitle"><div class="Copy"><b><a href="http://www.hopkinsmedicine.org/news/media/releases/doctors_in_training_spend_very_little_time_at_patient_bedside_study_finds">Time with patients seems “squeezed out” of training, investigator says </a></b></div><div class="Copy"></div></div>Medical interns spend just 12 percent of their time examining and talking with patients, and more than 40 percent of their time behind a computer, according to a new Johns Hopkins study that closely followed first-year residents at Baltimore’s two large academic medical centers. Indeed, the study found, interns spent nearly as much time walking (7 percent) as they did caring for patients at the bedside.</blockquote><br />I can honestly say much if not most of my time in training, several decades ago, was spent at the bedside.<br /><br /><blockquote class="tr_bq">Compared with similar time-tracking studies done before 2003, when hospitals were first required to limit the number of consecutive working hours for trainees, the researchers found that interns since then spend significantly less time in direct contact with patients. Changes to the 2003 rules limited interns to no more than 30 consecutive hours on duty, and further restrictions in 2011 allow them to work only 16 hours in a row.<br /><br />“One of the most important learning opportunities in residency is direct interaction with patients,” says <a href="http://www.hopkinsmedicine.org/gim/fellowship/current_fellows.html">Lauren Block</a>, M.D., M.P.H., a clinical fellow in the <a href="http://www.hopkinsmedicine.org/gim/index.html">Division of General Internal Medicine</a> at the Johns Hopkins University School of Medicine and leader of the study published online in the Journal of General Internal Medicine. <b>“Spending an average of eight minutes a day with each patient just doesn’t seem like enough time to me.”</b></blockquote><br />An understatement, as most critical information comes from the H&P and ongoing patient interaction - not from cybernetics. Further, that's probably all the time a butcher spends processing a slab of meat...<br /><br /><blockquote class="tr_bq">“Most of us went into medicine because we love spending time with the patients. Our systems have squeezed this out of medical training,” says <a href="http://www.hopkinsmedicine.org/doctors/results/directory/profile/0019344/leonard-feldman">Leonard Feldman</a>, M.D., the study’s senior author and a hospitalist at The Johns Hopkins Hospital (JHH).<br /><br />For the study, trained observers followed 29 internal medicine interns — doctors in their first year out of medical school — at JHH and the University of Maryland Medical Center for three weeks during January 2012, for a total of 873 hours. The observers used an iPod Touch app to mark down what the interns were doing at every minute of their shifts. If they were multi-tasking, the observers were told to count the activity most closely related to direct patient care.<br /><br />The researchers found that interns spent 12 percent of their time talking with and examining patients; <b>64 percent on indirect patient care, such as placing orders, researching patient history and filling out electronic paperwork</b>; 15 percent on educational activities, such as medical rounds; and 9 percent on miscellaneous activities. </blockquote><br />Researching the history is made more complex by today's low-usability EHR systems, so much so that I personally know of cases (through my legal work) where trainees and even attendings did not know the patient's history. In the past, this would have been considered a severe medical<i> faux pas</i>.<br /><br /><blockquote class="tr_bq">The researchers acknowledge that it’s unclear what proportion of time spent at the bedside is ideal, or whether the interns they studied in the first year of a three-year internal medicine training program make up the time lost with patients later in residency. <b>But 12 percent, Feldman says, “seems shockingly low at face value. Interns spend almost four more times as long reviewing charts than directly engaging patients.”</b></blockquote><br />Not to be critical of the Hopkins piece, it is excellent - but academics often use disclaimers and softeners in their conclusions as a custom and tradition. At a blog I can be more direct: 12% <b>is </b>shockingly low. No "<i>seems</i>" is actually necessary.<br /><br /><blockquote class="tr_bq">Feldman says questions raised by his study aren’t just about whether the patients are getting enough time with their doctors, but whether the time spent with patients is enough to give interns the experience they need to practice excellent medicine. </blockquote><br />Personally, I would really be nervous under the care of graduates who'd only spent a tenth of their clinical hours actually seeing, speaking to and examining patients, and a majority of their time frittering around with computers.<br /><br /><blockquote class="tr_bq">With fewer hours spent in the hospital, protocols need to be put in place to ensure that vital parts of training aren’t lost, the researchers say.<br /><br />“As residency changes, we need to find ways to preserve the patient-doctor relationship,” Block says. “<b>Getting to know patients better can improve diagnoses and care and reduce medical errors</b>.” </blockquote><br />As opposed to getting to know the (needlessly complex and confusing) EHR better, which adds little. <br /><blockquote class="tr_bq"><br />The researchers say <b>better electronic medical records may help reduce time spent combing through patient histories on the computer.</b> </blockquote><br />After several decades of the health IT industry being in business, it's sad that an organization of the (deserved) stature of Johns Hopkins has to provide remedial education 101 to that industry in 2013.<br /><br />Perhaps that's the most important finding of all in this study.<br /><br /><br /><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/AVvXsEiPCB5VwpuCwKR6KZ_fQWshnUSWN7CgcgcSZovwsFrWYaHKHBpy23nfwh90iltoIi9G9NqnjFcZgq8cUFVxz46BCqjbJV7SpPTr5Pio1ZJRjYi7KTUdsQg5cBGHznHf1u4hY-P7LjE9hd76/s1600/wizard_of_id.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="146" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiPCB5VwpuCwKR6KZ_fQWshnUSWN7CgcgcSZovwsFrWYaHKHBpy23nfwh90iltoIi9G9NqnjFcZgq8cUFVxz46BCqjbJV7SpPTr5Pio1ZJRjYi7KTUdsQg5cBGHznHf1u4hY-P7LjE9hd76/s400/wizard_of_id.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">There's some wisdom in this comic strip. Click to enlarge.</td></tr></tbody></table><br /><br />-- SS<br /> Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-81684578871122906512013-04-23T09:29:00.000-07:002013-06-07T11:46:39.784-07:00WellPoint's Former Manager-Queen Got $20.6 Million and Its Nobility Got MillionsScore another for our new would be royalty, that is, for the hired managers who run big corporations. Early this month a few scattered reports came out showing just how much even apparently failed executives of big health care organizations can make on their way out the door. <br /><br /><b>A New Fortune for the Abdicating Queen of WellPoint </b><br /><br />Last year we <a href="http://hcrenewal.blogspot.com/2012/08/duchess-of-wellpoint-abdicates-likely.html">discussed</a> the abdication of Angela Braly, the former queen of giant insurance company WellPoint. We then speculated about how much she might abscond with. Now the Associated Press has <a href="http://bigstory.ap.org/article/outgoing-wellpoint-ceo-made-over-20m-last-year">reported</a>:<br /><br /><blockquote class="tr_bq"> The compensation paid to outgoing Wellpoint Inc. CEO Angela Braly last year <i>rose 56 percent</i>, even as the company's <i>shares slid </i>on lower enrollment in its Blue Cross Blue Shield health plans.<br /><br /><i>Braly, who resigned in August, received 2012 compensation valued at <b>$20.6 million</b>,</i> according to an Associated Press analysis of the company's annual proxy statement. Most of the increase came from stock options.<br /><br /> Braly, 51, became CEO in 2007. She received a<i> $1.2 million salary</i> last year, up slightly from $1.1 million in 2011. Her compensation included a <i>performance-related bonus of nearly $1.4 million.</i> More than 85 percent of Braly's compensation came from <i>stock options and awards, which totaled $17.8 million.</i> That total was up from about $10 million the year before.<br /><br /> She also received <i>$179,618 in other compensation, including $3,700 spent on security measures for her and her family due to concerns about her safety 'as a result of the national health care debate,'</i> according to the proxy, which was filed Tuesday with the Securities and Exchange Commission.</blockquote><br /><b>Despite Bad Financial Performance and Investors' Losses </b><br /><br />Remember, though, that Braly was asked to leave:<br /><br /><blockquote class="tr_bq"> investors had grown frustrated with the company's performance, leading Braly to resign last August. </blockquote><br />In particular, in terms of financial performance<br /><br /><blockquote class="tr_bq"><i>shares fell 8 percent last year</i> to close 2012 at $60.92, while the Standard & Poor's 500 index rose more than 13 percent. <br /><br />WellPoint's 2012 <i>earnings were nearly flat </i>compared to 2011. The insurer earned $2.65 billion, or $8.18 per share, last year, as total revenue climbed 1.6 percent to $61.71 billion.</blockquote><br />A slightly different <a href="http://www.ibj.com/wellpoint-brass-given-doule-digit-pay-bumps-while-stock-price-falls/PARAMS/article/40583">analysis</a> by the Indianapolis Business Journal came up with similar results,<br /><br /><blockquote class="tr_bq"> WellPoint’s membership growth came mainly from its acquisition <a href="http://www.ibj.com/wellpoint-buying-1-800-contacts-for-about--900m/PARAMS/article/34779" target="_blank"><span style="color: blue;"></span></a>of Virginia-based Amerigroup Corp., which operates Medicaid managed care plans for states. The rest of WellPoint’s existing business lost customers during 2012.<br /> <br /> And while WellPoint has boosted earnings per share by continuing to buy back shares, overall profit was unchanged last year compared with about $2.6 billion in 2011.<br /> <br /> WellPoint raised its dividend in 2012 and acquired 1-800-Contacts Inc. But its stock price fell 8 percent to close the year at $60.92 per share.<i> Even taking into account dividends, WellPoint shares<b> lost 6.3 percent of their value</b> during the year.</i></blockquote><br />So while the nominal owners of the company, the investors, lost money on their investments, the CEO who presided over this loss left with a huge pile of cash.<br /><br /><b>The Royal Court of WellPoint Also Prospered </b><br /><br />Incidentally, the Indianapolis Business Journal also showed that WellPoint executives who did not leave generally got big increases in their compensation, again while the company owners to whom they ostensibly report lost money,<br /><br /><br /><blockquote class="tr_bq"> <i>WellPoint Inc.’s top brass all enjoyed double-digit bumps in 2012 compensation</i>, according to a proxy released April 2, even though the stock price fell and the company admittedly did not meet its financial goals.<br /> <br /> The Indianapolis-based health insurer’s board of directors approved higher salaries and larger potential stock awards heading into 2012 after most of its top executives saw their pay hold steady or decline in 2011.<br /> <br /> The company’s performance merited its executives receiving only 83 percent of their target stock awards. But because the board had already established larger pools of stock to award to executives, the value of those awards still rose over previous years. Bonus amounts fell in 2012 compared with the previous year.<br /><br /> The extra cash and stock <i>drove up Chief Financial Officer Wayne DeVeydt's overall pay 11.9 percent to nearly <b>$4.4 million</b>.</i><br /> <br /> Ken Goulet, executive vice president of WellPoint's commercial insurance business, saw <i>his total compensation rise 18.2 percent to nearly <b>$4.4 million</b>.</i><br /> <br /> And Lori Beer, executive vice president of information technology, enjoyed <i>a 17.9-percent boost. She earned <b>$3.2 million</b>, </i>although that was still below the nearly $4.5 million she received in 2010.<br /> <br /> John Cannon, the general counsel, saw his <i>compensation more than double to nearly <b>$6.5 million</b></i>. But that was partly because WellPoint hiked his salary by $350,000 and gave him a $500,000 bonus for agreeing to serve as interim CEO after the August resignation of former CEO Angela Braly.</blockquote><br /><b>Despite Angry Policy-Holders and Ethical Missteps </b><br /><br />So the compensation given the outgoing CEO and some of the remaining top hired managers seemed wildly out of proportion to the company's financial results. Could the generosity they received be based on how well the company performed in other dimensions? That, of course, seems equally improbable. <br /><br />The Los Angeles Times <a href="http://www.latimes.com/business/money/la-fi-mo-wellpoint-ceo-pay-20130403,0,6503087.story">noted</a>,<br /><br /><blockquote class="tr_bq"> <i>Braly had also caught the ire of consumers and even President Obama</i><a class="taxInlineTagLink" href="http://www.latimes.com/topic/politics/government/barack-obama-PEPLT007408.topic" id="PEPLT007408" title="Barack Obama"></a> in 2010 for trying to raise rates by up to 39% in California. The national outrage that ensued helped Obama win approval for his healthcare overhaul in Congress.</blockquote><br />Furthermore, as we have discussed again and again, most recently <a href="http://hcrenewal.blogspot.com/2012/08/duchess-of-wellpoint-abdicates-likely.html">here</a>, WellPoint has a very sorry record of ethical misadventures. (The updated list is at the end of this post.) So one could certainly not justify the huge payments given WellPoint hired managers by their upstanding ethical leadership.<br /><br /><b>Summary</b><br /><br />In a new book just published by Robert A G Monks, entitled <a href="http://www.governmentcapture.com/citizens-disunited/"><i>Citizens Disunited</i></a>, the author describes one of the biggest problems affecting the US economy and society as the rise of "manager-kings." Clearly, Angela Braly could be called the former "manager-queen" of WellPoint. The company seemed to be run primarily for the benefit of the queen and her court, while its investors lost money, its customers became outraged, and it stumbled from one ethical quandary to another.<br /><br />In the eighteenth century, British colonial subjects in North America succeeded in a revolution that lead them out from under the rule of a British King. How many examples do we have to have before there is action to repudiate the rule of our new manager-kings and queens? And to turn health care back into a calling meant to put patients' and the public's health first, rather than a feudal society meant to benefit its nobility?<br /><br />As we have said again, again, again,...<br /><br />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. <br /><br /><br /><br /><strong>Appendix: WellPoint's Ethical Misadventures</strong><br /><br /><ul><li><em>settled a RICO (racketeer influenced corrupt organization) law-suit</em> 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<em> misplaced a computer disc containing confidential information </em>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 <em>cancelled individual insurance policies after their owners made large claims</em> (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 <em>get physicians to sign contracts whose confidentiality provisions would have prevented them from consulting lawyers</em> 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 <em>CFO was fired</em> for unclear reasons, and then <em>allegations from numerous women of what now might be called Tiger Woods-like activities surfaced</em> (see post <a href="http://hcrenewal.blogspot.com/2008/01/more-managed-care-management-mumbo.html">here</a>).</li><li>announced that its <em>investment portfolio was hardly immune from the losses</em> 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 <em>erroneously denying coverage</em> 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><em>settled charges that it had used a questionable data-base</em> (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><em>violated state law more than 700 times over a three-year period</em> 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><em>exposed confidential data from about 470,000 patients</em> (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><em>fired a top executive who publicly apologized for the company's excessively high charges</em> (see 2010 post <em>here</em>).</li><li>California Anthem subsidiary was fined for <em>systematically failing to make fair and timely payments</em> 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 <em>hiding the company's political contributions from the company's own stock-holders</em> (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 <em>cheated former policy-holders</em> 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><br /><br />Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.comtag:blogger.com,1999:blog-2824117449993741767.post-35741274161703079972013-04-19T07:14:00.000-07:002013-06-07T11:46:39.882-07:00Healthcare computing 'glitch' time again: 15 patients possibly given wrong antibiotic after lab error at Regina General Hospital Just another computer "<a href="http://hcrenewal.blogspot.com/search/label/glitch">glitch</a>", that innocuous euphemism for a catastrophe-promoting IT defect, this time causing patients to receive the wrong antibiotics:<br /><br /><blockquote class="tr_bq">Regina Leader-Post<br />April 17, 2013 <br /><br /><b><a href="http://www.leaderpost.com/patients+possibly+given+wrong+antibiotic+after+error+Regina+General+Hospital/8252890/story.html#ixzz2QsfL7BoJ">15 patients possibly given wrong antibiotic after lab error at Regina General Hospital</a> </b><br /><br />Fifteen patients in southern Saskatchewan were potentially treated with the wrong antibiotic stemming from a lab error at Regina General Hospital, the Regina Qu'Appelle Health Region announced Tuesday.<br /><br />According to the RQHR, lab reports between late January and late March erroneously deemed Clindamycin would effectively treat the patients' infections <b>when those bugs were actually resistant to the drug. <span style="color: red;"><i>[The biological bugs, not the cybernetic bugs, that is - ed.]</i></span></b><br /><br />Only one of the 15 patients suffered adverse effects. The 15th patient, an adult male, experienced short-term negative effects but has since been switched to another antibiotic. Citing patient confidentiality, the health region would not elaborate on the man's condition.<br /><br />Dr. Jessica Minion, a medical microbiologist in the General Hospital's laboratory, said a <b>computer glitch </b>caused the faulty reports between Jan. 23 and March 28. </blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />Need I add that this "glitch" could very easily have killed people?<br /><br /><blockquote class="tr_bq">Minion added she and other medical staff will now cross-check lab reports against lab tests after a change has been made within the computer system.</blockquote><br />Wait - if the "glitch" is fixed, why is cross-checking still needed? Doesn't sound like there's much confidence in this computing system...<br /><br /><blockquote class="tr_bq">The lab became aware of the problem on March 28 when the doctor treating the man who experienced problems notified the hospital, Minion said. Lab staff then sifted through records and determined a total of 15 people had been prescribed Clindamycin since the erroneous reports began Jan. 23. </blockquote><br />Clindamycin itself is not an innocuous drug, with many potential serious <a href="http://www.drugs.com/sfx/clindamycin-side-effects.html">side effects</a>.<br /><br /><blockquote class="tr_bq">"It was a very identifiable mistake that was being made in the computer system, and there is a very clear trail of who exactly it affected," she said. <b>"So we are quite confident that we have identified everybody that would have been affected."</b></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />Only by the grace of God, none of those affected are six feet (2 meters) under, either due to their primary infections or drug adverse events from a drug they should never have been given.<br /><br />At least this time the oft-heard refrain "<a href="http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised">but patient safety was not compromised</a>" was not proffered. </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">-- SS</div></div>Anonymoushttp://www.blogger.com/profile/07960721329930567119noreply@blogger.com