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Six Years Later, Ranbaxy - Oops, Daiichi Sankyo - Pleads Guilty to Adulteration, Pays $500 Million

It 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>): <blockquote class="tr_bq"> A subsidiary of India’s largest pharmaceutical company has agreed to pay a record $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S. Federal prosecutors say the guilty plea by Ranbaxy USA Inc. represents the 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.</blockquote> Note that the company pleaded guilty to criminal charges. <blockquote class="tr_bq"> The subsidiary of Ranbaxy Laboratories Limited pleaded guilty to federal criminal charges 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. 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> Ironies Note that this resolution has certain ironies. Lateness 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, <blockquote class="tr_bq"> The problems were largely revealed by a whistleblower in a federal lawsuit filed in Maryland in 2007. </blockquote> Ambiguities about Responsibility 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), <blockquote class="tr_bq">Ranbaxy ... [is] majority-owned by Japan's Daiichi Sankyo.</blockquote> Second, as per the AP, see the comment made by the Ranbaxy CEO, <blockquote class="tr_bq">'While we are disappointed by the conduct of the past 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> 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. 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. 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>: <blockquote class="tr_bq"> Chief Executive Officer Joji Nakayama and board members will receive 5 percent to 30 percent less compensation for six months 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>  The Contrast with the Case of the Adulterated Heparin Note that in this case, there have been no allegations that patients were harmed by the admitted adulteration,  Per the AP: <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> 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. The AP article stated, <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 2008 deaths linked to tainted batches of the blood-thinner heparin that were imported from China served as a 'wake up call' about just how much of the nation’s drug supply comes from overseas.</blockquote> 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. Summary 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.  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, <blockquote class="tr_bq"><div itemprop="articleBody">Others say the company’s problems highlight how little oversight federal drug safety officials have of overseas plants. 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 slowing the adoption of that law. </div><div itemprop="articleBody"> </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> <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. 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.  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. 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). - Roy M. Poses MD for Health Care Renewal  Appendix - Heparin Case Summary - We have posted several times, recently <a href="http://hcrenewal.blogspot.com/2011/06/first-contaminated-heparin-case-verdict.html">here</a> 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. - 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>.) - 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 <a href="http://hcrenewal.blogspot.com/2008/03/fake-heparin-then-sick-and-dead.html">here</a>.) 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 <a href="http://hcrenewal.blogspot.com/2008/03/who-was-responsible-for-purity-of.html">here</a>.) 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. - 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." - 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 <a href="http://hcrenewal.blogspot.com/2008/05/blaming-some-dude-for-contaminated.html">here</a>.)  Note that SPL was recently bought out and taken private, making its current leadership even less transparent (see post <a href="http://hcrenewal.blogspot.com/2010/10/more-contaminated-heparin-but-who-leads.html">here</a>).  A 2010 inspection of an SPL facility by the FDA revealed ongoing manufacturing problems (see post <a href="http://hcrenewal.blogspot.com/2011/02/fda-to-scientific-protein-laboratories.html">here</a>). - 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 <a href="http://hcrenewal.blogspot.com/2009/08/who-investigated-case-of-deadly.html">here</a>.) - Hundreds of lawsuits against Baxter have now been filed, so far without resolution. (See post <a href="http://hcrenewal.blogspot.com/2010/01/blog-post.html">here</a>.)  Efforts to make documents to be used in these cases public so far have not succeeded (see post <a href="http://hcrenewal.blogspot.com/2010/08/proprietary-information-confidentiality.html">here</a>). - 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 <a href="http://hcrenewal.blogspot.com/2010/04/another-echo-of-case-of-deadly-heparin.html">here</a>.) -  Despite requests from the US, the Chinese government did not investigate the production of the heparin that lead to the deaths (see post <a href="http://hcrenewal.blogspot.com/2010/07/more-about-what-we-dont-know-about.html">here</a>.) -  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>.) -  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>). -  If there was a criminal investigation of the case, its results have not yet appeared.

Six Years Later, Ranbaxy - Oops, Daiichi Sankyo - Pleads Guilty to Adulteration, Pays $500 Million

It only took until 2013, but the US Food and Drug Administration finally secured guilty pleas and fines. The basics are in an Associated Pr...

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Clouded "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. 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 $700,000 in 2008-2009 to over $1.6 million 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 visionary leaders 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 $2.5 million, while other top executives received from over $900,000 to over $1.1 million.  Recent events, however, suggest that the "visionaries" may need new glasses. An EPIC Challenge 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): <blockquote class="tr_bq">Wake Forest Baptist Medical Center’s struggles to implement its <a href="http://hcrenewal.blogspot.com/search/label/EPIC">Epic electronic records system</a> contributed to additional costs and lost revenue during the first half of its fiscal year 2012-13. The center provided the information in a second-quarter financial report submitted to bond agencies in which it also reported a $49.6 million operational loss and a gain of $7.4 million in overall excess revenue. </blockquote> 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 <blockquote class="tr_bq"> As the healthcare industry moves to EHRs, the medical record has essentially been reduced to a tool for billing, compliance, and litigation that also has a sustained negative impact on doctors' productivity, according to Steven J. Stack, MD, chair of the American Medical Association’s board of trustees. </blockquote> Yet in this case, a well known commercial EHR did not even help out the hospital system's finances. Furthermore, <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> And, <blockquote class="tr_bq"> The center also cited $8 million in 'other Epic-related implementation expense' that it listed among 'business-cycle disruptions (that) have had a greater-than-anticipated impact on volumes and productivity.' Also listed was $26.6 million in lost margin 'due to interim volume disruptions during initial go-live and post go-live optimization.'</blockquote> 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. Bond Downgrades and Furloughs, Wage Reductions, Hiring Freezes, Retirement Contribution Reductions, and Bonus Eliminations As a consequence, <blockquote class="tr_bq"> On March 20, Moody’s Investors Service downgraded the center’s long-term debt rating below the lowest level of high-grade investment quality. The downgrade to A1 from Aa3 affects $597.2 million of rated debt outstanding.</blockquote> The rationale was clear, <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.   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, <blockquote class="tr_bq">The workforce at Wake Forest Baptist Medical Center is paying a paycheck price to make up for the financial shortcomings to date of its Epic electronic records system. The center said in a statement Thursday it has begun another round of cost-cutting measures that will last through at least June 30, the end of its 2012-13 fiscal year. The measures include attempts at 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.</blockquote> Management made clear that the cuts were in response to the Epic debacle, <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.' 'Wake Forest Baptist has identified immediate multimillion-dollar savings with a series of short-term measures that impact personnel,' according to the statement.</blockquote> To give credit where it is due, at least the cuts will apparently not affect line clinical employees: <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> However, it seems likely that they will affect many employees, including some proportion who likely had not responsibility for the problems with Epic. When in Doubt, Lobby the Government 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: <blockquote class="tr_bq">Stung by a series of unusual setbacks at the General Assembly, the North Carolina hospital industry is launching a public relations campaign aimed, in part, at protecting revenues and staving off competition from lower cost surgery centers. 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] 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. 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> Wake Forest Baptist is a big part of this initiative: <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. '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> 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.  Summary 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: 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.  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. 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.

Clouded "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' su...

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Guest Post: A Physician Rebels Against Micromanagement by "'Leadership-Trained' Management Extenders"

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>.   <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"> </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"> </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"> </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.  Both the cardiologist and the nephrologist had called asking her to take this patient.  She agreed.  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"> </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"> </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"> </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"> </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"> </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"> </div> <blockquote class="tr_bq"><div class="yiv528586260msonormal" style="background: white; margin-bottom: 12.0pt;">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.</div><div class="yiv528586260msonormal" style="background: white; margin-bottom: 12.0pt;">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  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.  </div></blockquote> <div class="MsoNormal">Dr Howard Brody</div>

Guest Post: A Physician Rebels Against Micromanagement by "'Leadership-Trained' Management Extenders"

Health Care Renewal presents a guest post by Dr Howard Brody, John P McGovern Centennial Chair of Family Medicine, Director of the Institut...

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Tales of the Wayfaring Generic Manager - from Ritz Carlton Hotels to Henry Ford West Bloomfield Hospital to Cancer Treatment Centers of America

In 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.  Organic Local Produce, "Wellbeing Centers," Gourmet Dining, Wedding Receptions, and Corporate Functions 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.  First, he lead an apparent change in the hospital's mission from acute care to recreating: <blockquote class="tr_bq">the hospital experience into one focused on promoting wellbeing and healthy living. The hospital has already begun to realize its mission statement, which reads 'to take health and healing beyond the boundaries of imagination.'</blockquote> The new hospital apparently was designed to look like a luxury hotel: <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> Apparently it is now a favored site for weddings: <blockquote class="tr_bq">The hospital also holds free concerts for the community and has already received nine wedding inquiries. </blockquote> It had a "wellness center" <blockquote class="tr_bq">Henry Ford West Bloomfield also features a 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. In addition to offering one-time services, the hospital offers memberships to community members to encourage frequent use of the center. </blockquote> What really stood out was its food service: <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 on-site gourmet, organic restaurant, Henry's. All food served in the hospital is organic, promotes sustainable agriculture and, in many cases, is procured from local farmers.</blockquote> 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 <blockquote class="tr_bq">the hospital is on track to generate millions of dollars a year hosting and catering functions for companies and community groups.</blockquote> It all sounds great, if it were describing a luxury hotel. The Fortune article ended with the gushing summation: <blockquote class="tr_bq">While it will be years before anyone can say whether this model works, there's no question that it captures a spirit of innovation that just might be a cure for what ails so many organizations. We are living today through the age of disruption. 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, the only way to stand out from the crowd is to stand for something special. Originality has become the acid test of strategy.</blockquote> 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? On to a More Ethically Challenged Environment 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. 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>: <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. Van Grinsven is leaving the hospital to become the president and CEO of Chicago-based Cancer Treatment Centers of America, 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> Henry Ford Health System CEO Bob Riney saluted van Grinsven thus, <blockquote class="tr_bq">'Gerard's leadership talents and his tremendous global experience made the transformation of this innovation and distinctive vision a reality,' Riney told employees in the email.</blockquote> 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 <blockquote class="tr_bq">'Gerard's arrival is an exciting and dramatic step in the evolution of our leadership that will herald new opportunities for all of our talented Stakeholders and the thousands of patients we serve,' said [executive chairman and former CEO Stephen B] Bonner. 'Our expertise in Patient Empowerment Medicine® and track record implementing change 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> 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. 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.  Summary 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. 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.

Tales of the Wayfaring Generic Manager - from Ritz Carlton Hotels to Henry Ford West Bloomfield Hospital to Cancer Treatment Centers of America

In 2006, we wondered what a former hotel manager, Mr Gerard van Grinsven, admittedly known for putting the "wow" back in the Detr...

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BLOGSCAN - An Ex-Pharmaceutical Company CEO to Run the American College of Cardiology?

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.   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.    One wonders why cardiologists would want such an individual representing them as leader of their premier organization?  (Dr Wes<a href="http://drwes.blogspot.com/2013/04/the-american-college-of-cardiology-gets.html"> wondered</a> as well.)

BLOGSCAN - An Ex-Pharmaceutical Company CEO to Run the American College of Cardiology?

Marilyn Mann's blog discussed the appointment of a former pharmaceutical company executive, most recently at Actelion, and previously a...

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AMA 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:  <a href="http://www.disney.com/">http://www.disney.com</a> and skip the post below.) You were warned. --------------------------------------- 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.) Instead, they simply need to be ridiculed for being stupid. I will do so:  folks, you have been, and remain, stupid: <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/AVvXsEhZE95zecrMVRB1bq9q2g01AUsab2c67jIhlE-ARIcXChO_6KSU5IP-c2sQpFyO-MiKOXWOOrpyAZAeWR-1L3VIpsiYWG_2dldo8bUN1af4BuG8p24xo2u2V_pTviw9_w3ZMLvXbAvwG9Zo/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/AVvXsEhZE95zecrMVRB1bq9q2g01AUsab2c67jIhlE-ARIcXChO_6KSU5IP-c2sQpFyO-MiKOXWOOrpyAZAeWR-1L3VIpsiYWG_2dldo8bUN1af4BuG8p24xo2u2V_pTviw9_w3ZMLvXbAvwG9Zo/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> 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. So now there's this: <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> May 03, 2013 | Tom Sullivan, Editor As the healthcare industry moves to EHRs, the medical record has essentially been reduced to a tool for billing, compliance, and litigation that also has a sustained negative impact on doctors' productivity, according to Steven J. Stack, MD, chair of the American Medical Association’s board of trustees. </blockquote> Gee, they're only realizing and complaining about that - now?  In 2013? <blockquote class="tr_bq">“Documenting a full clinical encounter in an EHR is pure torment,” Stack said during the CMS Listening Session: Billing and Coding with Electronic Health Records on Friday. </blockquote> (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?) It's nice to know in May 2013 that “documenting a full clinical encounter [essential to avoid injurious and even lethal mistakes, I anecdotally note - ed.] in an EHR is "pure torment”, several years into an accelerated "National Program for HIT in the HHS" costing hundreds of billions of dollars. 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 - those now proffering the exact same pronouncements. <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. 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. </blockquote> 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... <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.” Put another way: The government mandates that doctors use an EHR, the EHR vendors’ templates can sometimes create an appearance of fraud and that, in turn, opens the door for payers to decline reimbursement or, even worse, the government to prosecute doctors for the crime.</blockquote> I guess actual fraud is just anecdotal. <blockquote class="tr_bq">As dire as that sounds, it's an exception that belies the unproven perception that EHRs perpetuate fraud. “Upcoding does not necessarily equate to fraud and abuse,” said Sue Bowman, AHIMA’s senior director of coding and compliance at the same event. “This is an area where more study is needed. We really need to know the causes. Further research is needed on the fraud risk of using EHRs.”</blockquote> 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 ECRI Institute Deep Dive Study: 36 hospitals!  Nine weeks!  171 health information technology-related problems voluntarily reported!  Eight injuries!  Three possible deaths!  All mere "anecdotes", of course). <blockquote class="tr_bq">Indeed, Jacob Reider, MD, CMO of ONC, explained that the government and industry do not have good data right now proving whether or not EHRs trigger fraud and abuse.</blockquote> 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). So - let's review - <ul><li>poor data on harms, </li><li>poor data on benefits, </li><li>poor data on fraud and abuse.</li></ul>  The logical, ethical course of action thus is: <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/AVvXsEgzFC_WsPusjorZPhSFY5JNJs4lrt-V5x8PZiENWJVqP7gPQUwxbtq0bhjwtsjUvHuXdwrMUrEOAhghWrHjEV5pRduQIHRcyj9uMkKL4OC1x87NkSBUQTkZ2MFlroX8uK0YIz8pxcKCC1jP/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/AVvXsEgzFC_WsPusjorZPhSFY5JNJs4lrt-V5x8PZiENWJVqP7gPQUwxbtq0bhjwtsjUvHuXdwrMUrEOAhghWrHjEV5pRduQIHRcyj9uMkKL4OC1x87NkSBUQTkZ2MFlroX8uK0YIz8pxcKCC1jP/s200/homer-simpson.gif" width="165" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">D'OH!  LET'S ROLL THE TECHNOLOGY OUT AS FAST AS WE CAN, AND PENALIZE NON-ADOPTERS BESIDES!</td></tr></tbody></table> See how simple logic, ethics and clear thinking can be? <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. “Any fraud is an important issue and we, as the vendor community, take that very seriously.”</blockquote> 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... <blockquote class="tr_bq"> 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. “My purpose is not to denigrate EHRs,” Stack said, explaining that he believes CMS and ONC are genuinely trying to better the current situation.</blockquote> Nice to have <a href="http://en.wikipedia.org/wiki/Caspar_Milquetoast">Caspar Milquetoast </a> on the side of EHR criticism. Knock knock, anyone home, McFly? <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/AVvXsEhtRtjpOxhXTclN2k84gzTCHH0QfGVK4EArboCbP3IGByDNyfeuK8KnsHHBwxufCjhZMfBaX_fi2c3IJcMZ0Ld8LH_e9O9fNum3CO4Vrr-U1ZhuGyPRyBVFK3qZ_kYUNFkVGqyPAHOgcBZO/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/AVvXsEhtRtjpOxhXTclN2k84gzTCHH0QfGVK4EArboCbP3IGByDNyfeuK8KnsHHBwxufCjhZMfBaX_fi2c3IJcMZ0Ld8LH_e9O9fNum3CO4Vrr-U1ZhuGyPRyBVFK3qZ_kYUNFkVGqyPAHOgcBZO/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> Today's EHR systems, for the aforementioned reasons above and more, deserve denigration for patients' sake. <blockquote class="tr_bq"> There are efforts underway, within the government and industry, to more comprehensively understand the unintended consequences of EHR implementation.</blockquote> But let's keep rollin' em out, anyway.  Wheeee!  What fun! Class action attorneys, are you listening? -- SS

AMA 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...

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Financial 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 "hiccup" 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: <blockquote class="tr_bq"><a href="http://www.healthcarefinancenews.com/news/financial-woes-maine-medical?topic=03,22">Financial woes at Maine Medical Center</a> New England health system facing $13 million loss, initiates plan to save $15 million NEW GLOUCESTER, ME | May 2, 2013 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. “Through March (six months of our fiscal year), Maine Medical Center experienced a negative financial position that it has not witnessed in recent memory,” 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> A "negative financial position" (translation: we lost big money) that it has not witnessed in recent memory?  What are the reasons? <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. 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; “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; an increase in free care and bad debt cases; and continued declining reimbursement from Medicare and MaineCare, the state’s Medicaid program.</blockquote> 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>. <blockquote class="tr_bq">Many of the reasons for Maine Medical’s financial woes are similar to those hospitals across the country are facing. 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, the costly transition to EHRs may take years to recoup.</blockquote> Especially when not done well. <blockquote class="tr_bq">In his memo to employees, Petersen said the hospital has identified many of the hiccups contributing to the charge capture problems and a team of hospital employees and Epic technicians are working to resolve those issues. In the meantime, the remaining roll out of the Epic EHR to the rest of the health system is on hold.</blockquote> 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:  IT malpractice. <blockquote class="tr_bq"> To save $15 million by year’s end, Maine Medical is immediately instituting a number of cost-saving initiatives including selective travel and hiring freezes, putting the operating contingency budget on hold and reducing overtime. Petersen appealed to employees to curb discretionary spending and contact management with any cost-saving ideas.</blockquote> All, of course, will have no impact on patient care.... <blockquote class="tr_bq"> “I’m confident that we’ll confront this test, beat back the issues we face, and reverse this negative financial picture,” Petersen wrote in the conclusion to the memo.</blockquote> Test?  Test of what, IT competence? Of course, "C" officers would never write that "I'm not confident we'll confront our screwups." <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> Silence is golden. A newspaper letter from Stuart Smith, Selectman, Town of Edgecomb, St. Andrews Regional Task Force (a software developer himself) tells more: <blockquote class="tr_bq"><a href="http://www.boothbayregister.com/affiliate-post/stuart-smiths-letter-register/13586">STUART SMITH'S LETTER TO THE REGISTER</a> Wednesday, May 1, 2013 - 7:30pm Save St. Andrews Hospital As the Boothbay Peninsula moves forward with the effects of a MaineHealth/Lincoln County HealthCare decision to close St. Andrews Hospital, 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> Apparently an entire hospital is closing as a result of these debacles. [May 8, 2013 addendum: a family physician in Lincoln County where St. Andrews hospital is located and a member of the Board of Trustees, Dan Friedland, M.D., writes me that the EHR had nothing to do with the hospital closing - ed.] <blockquote class="tr_bq">But let me get back to the MH/LCH decision. We are told that MaineHealth has spent over $150 million on an Electronic Medical Records (EMR) system that helps all of its “subsidiaries.” I can appreciate this because my work is in software development. I do question the $150 million figure. I think it is extremely high and Portland has had a real failure in its implementation. 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> 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). One might think healthcare systems have money to burn ... <blockquote class="tr_bq"> The system failure also adds operational costs going forward that were not planned for and regional consolidation of finance will now be delayed. The cost to Maine Health Center is huge in improper service and supply charges. Information Technology leadership has been fired, but MH administration is truly accountable.</blockquote> 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. 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: <blockquote class="tr_bq">Epic Staffing Guide 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. 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. 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.  The guide suggests hiring recent college graduates for analyst roles. Ability is more important than experience, it says. That includes reviewing a candidate’s college GPA and standardized test scores.</blockquote> I am forwarding links to this post, blog, my teaching site (begun in 1998) and additional material to Selectman Smith. 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. -- SS

Financial 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 "hiccup" is used instead of the more traditional " glitch " ...

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