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BLOGSCAN: Forensic Statistics

Several interesting points are raised in the newsletter of the <a href="http://www.aapsonline.org/">American Association of Physicians and Surgeons</a> (AAPS) in a post entitled "Forensic Statistics" in their <a href="http://www.aapsonline.org/index.php/site/article/aaps_news_july_2011_-_numbers/">July 2011 newsletter</a> headlined "Numbers." Healthcare Renewal is cited: <blockquote>Forensic Statistics While claims from RCTs fail to replicate about 20% of the time, the problem with epidemiology is so bad as to constitute a crisis, writes S. Stanley Young (“<a href="http://nisla05.niss.org/talks/Young_Safety_June_2008.pdf" target="_blank" style="color: rgb(128, 0, 0); text-decoration: underline; font-weight: normal;">Everything Is Dangerous: a Controversy</a>,” National Institute of Statistical Sciences, June 2008, <a href="http://www.niss.org/" target="_blank" style="color: rgb(128, 0, 0); text-decoration: underline; font-weight: normal;">www.niss.org</a>). Fewer than 20% of nonrandomized trials [e.g., observational studies - ed.] replicate; i.e. 80%-90% of epidemiologists’ claims are false. More than $1 billion in grant/tax money flows to institutions with reproducibility problems, Young states. A fundamental flaw in their methodology is to ask multiple, often hundreds to thousands of questions, of the same data set. It’s like playing “maverick solitaire”: given 25 randomly selected cards from a deck of 52 playing cards, the probability of being able to arrange them into 5 “pat hands” (e.g. a full house) is 98%. Since data miners are good at concealing their footsteps, critics need full access to the raw data and the code used for the statistical analysis—often not forthcoming. The EHR software that is supposed to support all this “research” and to guide medical treatment also needs a forensic evaluation, writes Scot Silverstein, M.D., of Drexel University (see <a href="http://hcrenewal.blogspot.com/2011/03/on-emr-forensic-evaluation-from-down.html" target="_blank" style="color: rgb(128, 0, 0); text-decoration: underline; font-weight: normal;">http://hcrenewal.blogspot.com</a>). He cites such an evaluation of the Cerner FirstNet system used in New South Wales, Australia, done by Prof. Jon Patrick. The authoritarian implementation processes of the governmental HIT “support” staff were familiar to Silverstein, such as disenfranchising the clinical staff and failing to acknowledge the validity of complaints. “Healthcare reform” demands acceptance because it claims to be based on science. But then, so did Communism.</blockquote> The "maverick solitaire" data mining issues (to be used, no doubt, in future "comparative effectiveness research" based on EHR data) are a additional concern to those I raised in an essay "<a href="http://www.jpands.org/vol14no2/silverstein.pdf">The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry?</a>" in the AAPS journal several years ago (PDF). I can also add: where are the RCT's of EHR/CPOE systems? -- SS

BLOGSCAN: Forensic Statistics

Several interesting points are raised in the newsletter of the American Association of Physicians and Surgeons (AAPS) in a post entitled ...

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The Restless Shade of AHERF and the Return of Merger Mania: Highmark Tries to Buy Another Insurance Company, a Hospital System, a Medical School, and Physicians' Practices

Starting in the 1990s, as US health care became more commercialized, a wave of mergers lead to super-sized hospital systems, insurance companies, and pharmaceutical companies.  Not all those mergers, especially involving hospitals, prospered.  Although the mergers were justified as drivers of increased efficiency, health care has become decreasingly accessible, increasingly expensive, and of no better quality.  However, now a whole new wave of mergers seems to be upon us.  The Proposed Highmark Blue Cross/ West Penn Allegheny Health System Merger The latest example to get national attention is the proposed combination of already large non-profit health insurer Highmark Inc, a Blue Cross Blue Shield plan, and non-profit hospital system Allegheny Health System.  The national attention was in a Wall Street Journal <a href="http://online.wsj.com/article/SB10001424052702303627104576413580875856442.html">article</a> by Anna Wilde Matthews, which described the proposed transaction: <blockquote>Pittsburgh insurer Highmark Inc. struck a deal to acquire the second-largest hospital chain in its region, an ambitious, controversial step that would further blur the lines between those who pay for medical care and those who provide it. Under the tentative plan, nonprofit Highmark will pump as much as $475 million into the five-hospital West Penn Allegheny Health System, which has been operating in the red for the past five years. If state and federal regulators sign off on the plan, Highmark officials say the deal will allow them to move away from traditional fee models that reward providers for providing unnecessary procedures and services. Instead they would pay salaries to doctors, offering them incentives to achieve quality and efficiency goals. The integrated model would also rely on primary-care doctors to coordinate patients' care and focus on preventive efforts. Highmark officials said the deal is the best way to keep West Penn in business. 'It brings our expertise as an insurance company into the provider system,' said Kenneth R. Melani, Highmark's chief executive. </blockquote> This deal is unusual because it would unite a health care insurance company/ managed care organization with a hospital system. The Context: An Already Concentrated Health Care Environment The deal appears in the context of and may be in response to an already concentrated health care environment.  Per the WSJ: <blockquote>The newly combined Highmark-West Penn will face off against the University of Pittsburgh Medical Center, which is officially known by its acronym, UPMC. The prestigious $8 billion,19-hospital network employs 2,881 doctors and has about 56% of the inpatient market share in Allegheny County. It also owns a health plan with about 1.6 million members. UPMC's current contract with Highmark runs out next June. Paul Wood, the hospital system's vice president for public relations, said the network won't sign a new one after the acquisition. 'In effect, Highmark expects UPMC to subsidize our competitor,' he said.</blockquote>UPMC has had its issues, too, as discussed in posts <a href="http://hcrenewal.blogspot.com/search/label/UPMC">here</a>.  The deal is also more extraordinary because it was accompanied by several other proposed deals that would create quite a sprawling health care entity. The Extended Scope of the Merger First, and as noted in the WSJ article, the proposed deal would involve physicians' practices: <blockquote>Highmark may also buy or invest in other providers, including doctor practices, Dr. Melani said.</blockquote>However not noted in the WSJ article, or in a contemporaneous Pittsburgh Post-Gazette <a href="http://www.post-gazette.com/pg/11179/1156765-100.stm">article</a>, was that since 2010 there has also been a proposal on the table for Highmark to merge with a non-profit Blue Cross Blue plan in neighboring Delaware. The latest discussion of this deal can be <a href="http://www.delawareonline.com/article/20110626/BUSINESS/106260317/Layoffs-would-pay-top-execs-well">found on </a>DelawareOnline, and was just noted in a Philadephia Inquirer <a href="http://www.philly.com/philly/insights/in_money/124837394.html">commentary</a>. <blockquote>In Delaware, a bill that would remove a major obstacle to Highmark's proposed affiliation with Blue Cross Blue Shield of Delaware sailed through the legislature, passing the Senate unanimously Tuesday and the House, 34-5, Wednesday.</blockquote> That is not all. It seems that while pursuing the merger with Highmark, West Penn Allegheny Health was also pursuing an arrangement with Temple University to set up a branch of its medical school in Western Pennsylvania. As<a href="http://www.pittsburghlive.com/x/pittsburghtrib/news/health/s_741530.html"> noted </a>by the Pittsburgh Tribune Review: <blockquote>West Penn Allegheny Health System leaders expressed optimism on Friday about their partnership prospects with Highmark Inc. as they announced plans with Temple University to establish a four-year medical school campus in the North Side.</blockquote>So it appears that lined up against the UPMC behemoth could be another behemoth combining a large Pennsylvania insurance company, a Delaware insurance company, a good-sized hospital system, physicians' practices, and a branch of a medical school.  So we see a new effort to divide the health care supposed "market" among a few large, vertically-integrated health care systems. The Eerie Shadow of AHERF Maybe all these simultaneous deals, which would apparently create a conglomerate of Highmark Blue Cross, Delaware Blue Cross Blue Shield, West Penn Allegheny Health System, Temple University Medical School, and possibly a large group of doctors' practices, were all being discussed separately because of how they could be seen as a strange shadow of the spectacularly failed Allegheny Health Education and Research Foundation (AHERF) of the late 1990s. As discussed <a href="http://hcrenewal.blogspot.com/2008/07/10-years-later-eerie-echo-of-fall-of.html">here</a>, AHERF was a large integrated health care system formed out of multiple mergers.  AHERF which went bankrupt in 1998, leading to massive layoffs, hospital closures, and the near dissolution of a medical school (which ended up taken over by Drexel University). The former AHREF CEO, whose high compensation (for the time) was accompanied by an autocratic management style, ended up in the local jail on a plea bargain. Note that West Penn Allegheny Health System was formed from some of the pieces of the failed AHERF, and seems to have never fully recovered from its previous troubles. Despite the fact that the AHERF bankruptcy was the second largest US bankruptcy up to its time, this vivid case was notably <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>. The lack of echoes it originally produced made it prototypical of the anechoic effect. The link to AHERF was briefly noted in the Post-Gazette <a href="http://www.post-gazette.com/pg/11179/1156765-100.stm">article</a>: <blockquote>'They are well-capitalized, and we're not,' said David L. McClenahan, WPAHS board chairman, speaking of Highmark. 'That's putting it mildly.' In the decade since the collapse of the Allegheny Health Education and Research Foundation, whose bankruptcy eventually bore the West Penn Allegheny Health System, WPAHS has been persistently starved for capital, he said.</blockquote>So far, however, the ominous implications of that previous debacle have not been publicly discussed. How Some Executives Would Gain Perhaps the executives rushing to make a deal are being distracted by the potential for personal gain. The DelawareOnline article noted that current executives of Delaware Blue Cross Blue Shield may be able to pull the ripcords of their golden parachutes if its proposed merger with Highmark goes through: <blockquote>Seven executives at Blue Cross Blue Shield of Delaware, for example, are due a combined $6 million in severance pay -- equal to about three years of salary -- if they lose their jobs. Details of Blue Cross severance payout packages have attracted attention recently because top executives at Delaware's largest health insurer are busy pressing for a merger with Pittsburgh-based insurer Highmark Inc., which could mean the elimination of some top positions. Highmark has pledged that Blue Cross President and CEO Tim Constantine will keep his job after the merger's closing, if the deal is approved by state regulators. But Constantine, who has an annual salary of $420,000, would be due a $1.6 million payment if he were to lose his job. Six other top executives, who earn between $245,000 and $330,000 annually, have potential payouts equal to about $4.3 million. Highmark has not discussed the fate of those officers, who range in position from the company's general counsel to its chief medical and financial officers.</blockquote> That article further noted: <blockquote>Some observers worry that the prospect of large severance payments could cloud the judgments of executives working to close the deal. Considering the size of the Blue Cross payouts in relation to annual salaries, the payout promises deserve attention, said Ethan Rome, executive director of Health Care for America Now, a Washington consumer advocacy group. Severance agreements are typically in place to provide a cushion between jobs, he said. 'Three years is a long time,' Rome said. 'Three years is not a severance. It's a substantial payout.'</blockquote> One wonders which other executives involved in these potential deals may also have prospects for either larger compensation or golden parachutes. This could include executives in particular current executives of West Penn Allegheny.  One also wonders whether the creation of this new conglomerate will produce rationales for big raises for the current executives of all the organizations involved who get to work for the new merged entity.  Perhaps someone should ask them. Further Implications Of course the various mergers were touted as productive of new efficiencies, as attempts to obtain increased market power usually are. As reported by the Post-Gazette: <blockquote>While the short-term goal of this partnership is to preserve a 'fragile' Pittsburgh hospital system, the long term goal, said Highmark CEO and President Kenneth Melani, is the creation of a new model of health care, one that is outcomes based, with an integrated delivery and financing system. ;Health care services are becoming less affordable,' he said. 'It's important to have choice. It's important to have a second system.'</blockquote> And, as we discussed <a href="http://hcrenewal.blogspot.com/2008/07/10-years-later-eerie-echo-of-fall-of.html">here</a>, the former CEO of AHERF pledged "new forms of organization that are more flexible, more adaptive, and more agile than ever before." But common sense and history suggests that increasing market domination will be good mainly for the market dominators, not their customers, or in this case, their patients, clients and students. As Dr Westby Fisher <a href="http://www.medcitynews.com/2011/06/highmarks-hospital-acquisition-a-lose-lose-for-doctors-and-patients/">asserted</a> about how the new conglomerate will likely own physicians' practices: <blockquote>So doctors lose more professional independence and autonomy and have even more chance that clinical decisions will be compromised by bureaucratic dictates. Yet ask patients who they want steering the boat when they get sick: their doctor. It continues to be clear who the winners and losers are as health care reform unfolds. But when doctors lose autonomy, patients lose autonomy. It’s that simple. To argue that the only way to control the health care dollar is to bloat the bureaucratic levels of our system is a fool’s game. However, bureaucrats promote bureaucrats – it’s always been this way. Until doctors and the public speak up, there’s simply nothing to stop this train.</blockquote> So I wonder if this complex merger will get more scrutiny than the many mergers that have preceded it in the last 30 years. Someone who is more likely to get answers than I am should be asking: - What evidence is there that this merger will lead to any benefits to individual patients or to the public health? - How will any efficiencies achieved benefit anyone other than the organizations' current and future managers? - What sorts of management layers will the complexity of the multiple mergers proposed necessitate between current Highmark executives and current management of its new acquisitions? - If the current problem is existing market concentration, why will these mergers be a better solution than a direct approach to that concentration? - How will the current leaders of all the organizations involve personally benefit from this merger? Meanwhile, increasing concentration of power in health care continues to benefit the leaders of the enlarging health care organizations, while reducing the choice of individual patients and the autonomy of health care professionals.

The Restless Shade of AHERF and the Return of Merger Mania: Highmark Tries to Buy Another Insurance Company, a Hospital System, a Medical School, and Physicians' Practices

Starting in the 1990s, as US health care became more commercialized, a wave of mergers lead to super-sized hospital systems, insurance compa...

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Hospital system has major computer breakdown with "resultant chaos"; patients not adversely affected (of course)

As mentioned on this blog numerous times. Healthcare IT outages never, but never, adversely affect patients in any manner whatsoever: <blockquote>Traverse City Record-Eagle [Michigan - ed.] June 30, 2011 <a href="http://record-eagle.com/local/x981128298/Munson-has-4-hour-communications-failure/print">Munson has 4-hour communications failure</a> By Bill O'Brien bobrien@record-eagle.com TRAVERSE CITY — Munson Healthcare officials are trying to figure out how to avoid a repeat of a four-plus-hour data systems crash and "resultant chaos" that gripped local hospitals and clinics this week. A system failure Tuesday morning shut down computers, telephones, pagers and other telecommunications systems at Munson Medical Center and its Munson Healthcare affiliates in Frankfort and Kalkaska, an incident that administrators described as "unacceptable." [That sounds about right - ed.] Munson officials still aren't sure why a back-up fiber optic circuit failed during a planned outage that started Tuesday at 7:30 a.m. "You can rest assured we're looking very carefully at that," Munson Medical Center CEO Kathleen McManus said. "Of course, we need to know what happened." McManus said no patients were adversely affected during the outage. Even with the "resultant chaos" that gripped the local hospitals and clinics, no patients were adversely affected.</blockquote> Amazing. There must be a cybernetic angel department in heaven that prevents patients from harm - i.e., from missed or delayed treatments or treatment mistakes - during the "resultant chaos" of major systems outages. I'm sure insurers and risk managers have full confidence in Providence when these mishaps occur. -- SS July 1, 2011 update: The Traverse City Record Eagle has <a href="http://record-eagle.com/latest/x357283355/Munson-memo-explains-systems-failure">published a memo</a> explaining the outage: <blockquote> Munson Healthcare officials distributed a memo on Wednesday that explained Tuesday’s systems failure that affected Munson Medical Center, Paul Oliver Memorial Hospital and Kalkaska Memorial Health Center and various clinics. The following memo is attributed to Chris Podges, Munson’s vice president of information systems. “As you are all aware, we experienced an unplanned network downtime (Tuesday) that had widespread operational and clinical implications. Briefly, here is what happened: Munson’s data centers’ connectivity to the outside world runs primarily on two redundant high speed fiber optic circuits administered by Traverse City Light and Power. We were informed by them that they needed to take one of the circuits off-line in order for them to do maintenance. This would leave us operating on one circuit for the duration of their planned, 12-hour downtime. This shouldn’t have been any problem for us and is precisely why we have parallel, redundant technology on our most important systems and infrastructure. We have frequently tested for an event like this (losing one of the circuits) by manually “switching off” a fiber circuit. In our testing, the remaining circuit took on all the traffic, just as it was architected to do; no hiccups, no instability, no impact on users, no downtime. And that is what we fully expected yesterday morning when one of the circuits was taken off line.</blockquote> In medicine, or in any complex domain, one must expect the unexpected... <blockquote>Unfortunately, that isn’t what happened. The core switch of the remaining circuit became confused, couldn’t take over the role as the primary switch (a transition which is measured in milliseconds) and ultimately shut down. Once down, everything running on the network – applications, paging systems, wireless devices, IP phones, etc., went down with it.</blockquote> (I hear Kate Winslet humming in the background...) Anthropomorphism aside, it seems to me that switches and other inanimate objects don't become "confused." The engineers/programmers who designed them just didn't anticipate the event that sinks the Titanic. But let's roll the technology out nationally, now, rush...rush...rush...before it's too late. Computer bits get stale after awhile, after all.... Re: "Unplanned network downtimes." In the long running TV series <a href="http://stargate.mgm.com/">Stargate SG-1</a> there's a character, <a href="http://en.wikipedia.org/wiki/Walter_Harriman_%28Stargate%29#Walter_Harriman">Walter Harriman</a>, who runs the command console. Just about the only line he gets to say over the base PA system over 10 seasons is ... <blockquote>"UNSCHEDULED OFF-WORLD ACTIVATION!"</blockquote> ... when some person or alien attempts to come through from another Stargate somewhere in our galaxy or others nearby. Perhaps hospitals can use him as a role model to announce "unscheduled down time"... <blockquote>... During the downtime, we assembled a small army working on three objectives: 1. Make sure the hospitals and clinics could operate - especially as to the provision of patient care – on downtime procedures 2. Communicate as comprehensively and as often as we could 3. Fix the technical issues</blockquote> Aside from the fact that these "objectives" are obvious, now hospitals need "small armies" to protect patients when a network switch gets "confused." Pen and paper offer no analogous bellicose hostilities. <blockquote>While the reports are that all hospitals and clinics did a fantastic job surviving the down-time, we fully understand that it was very difficult to manage the resultant chaos and that downtimes like this are unacceptable.</blockquote> But no patient was hurt (as they never are when the IT goes down). <blockquote>Thursday morning at 2 a.m. we are going to re-introduce the second fiber optic circuit into our network architecture. While we expect no issues, we’re planning otherwise. This afternoon your organizations will receive specific instructions on how to prepare for the event of another network outage; What to print in advance of 2 a.m., what resources are available to you during the downtime, how to get needed clinical information without the use of computers, who to call for help, etc.</blockquote> Thank god. <blockquote>Again, we do not expect any downtime tomorrow morning, but we did re-learn some valuable lessons yesterday and the safety of our patients is the number one objective should the network experience another issue. We’ll be ready at 2 a.m. and we want your organizations to be ready, too.</blockquote> Why do such "lessons" need to be "re-learned" - EVER? <blockquote>We are working diligently to understand what happened yesterday and will share with you what we learn and our plans to remedy whatever may need attention.</blockquote> In effect, they really don't understand what caused the outage. This is similar to other cases of outages written about at Healthcare Renewal. There's never certainty, because these IT systems have become so complex and the support relatively diffused (via outsourcing, consultants, etc.) This is a fertile ground for patient injury and death when luck runs out. As stories like "Failures in care alleged after premature birth - $1,000,000 Settlement" from the Virginia Lawyer's Weekly I referenced <a href="http://hcrenewal.blogspot.com/2011/03/thanks-to-wonders-of-ehr-this-premature.html">here</a> imply, the cost of ownership of HIT will likely go way up once the multimillion dollar lawsuits start adding up. Considering the track record of health IT as it is in 2011 regarding reliability, risk/benefit and <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">security</a>, spending hundreds of billions of dollars to put patients at risk of life and limb, and risk of potentially career-ending or bankrupting loss of privacy, en masse nationally, is increasingly brainsick. -- SS

Hospital system has major computer breakdown with "resultant chaos"; patients not adversely affected (of course)

As mentioned on this blog numerous times. Healthcare IT outages never, but never , adversely affect patients in any manner whatsoever: Trave...

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Electronic medication prescribing: The Magic Bullet Theory of IT-Enabled Transformation once again bites the dust in the real world of medicine

Computers once again are proving not to be the plug-and-play-panacea they've been made out to be in the complex world of medicine. The Magic Bullet Theory of IT-Enabled Transformation once again bites the dust in the real world of medicine: <a style="font-family: arial;" href="http://www.bloomberg.com/news/print/2011-06-29/errors-occur-in-12-of-electronic-drug-prescriptions-matching-handwritten.html"> </a><blockquote style="font-family:arial;"><a style="font-weight: bold;" href="http://www.bloomberg.com/news/print/2011-06-29/errors-occur-in-12-of-electronic-drug-prescriptions-matching-handwritten.html">Errors Occur in 12% of Electronic Drug Prescriptions Matching Handwritten</a> Bloomberg By Michelle Fay Cortez Jun 29, 2011 As many as 12 percent of the drug prescriptions sent electronically to pharmacies contain errors, a rate that matches handwritten orders for medicine from physicians, researchers said. An analysis of 3,850 computer-generated prescriptions written over a four-week period found 452 contained errors, including 163 that could harm the patient, according to a report published today in the Journal of the American Medical Informatics Association. The rate was consistent with past studies reviewing the risk of errors when a doctor writes a prescription and hands it to the patient, the researchers said.</blockquote> Pens and prescription pads are orders of magnitude less expensive than multimillion dollar computer systems, I might add. <blockquote style="font-family:arial;"> The results undermine the expected safety benefits from computer-generated prescriptions, said the study authors led by Karen Nanji of Massachusetts General Hospital’s anesthesia, critical care and pain department. The U.S. paid more than $158.3 million to doctors and hospitals in the first half of 2011 to encourage adoption of electronic health records, which President Barack Obama has advocated as a way to lower health- care costs and reduce medical errors.</blockquote> "Expected benefits?" Expected under what assumptions? [The assumptions that computers are a 'magic bullet' of some sort for complex real-world problems, and that technological determinism applies, are my best guesses as to the major ones - ed.] <blockquote style="font-family:arial;">“Providers appear to be rapidly adopting electronic health records and computerized prescribing, and one of the major anticipated benefits is expected to be through medication-error reduction,” the researchers wrote. “Many of these benefits will not be realized if the electronic prescribing applications are not mature and either do not catch or even cause new medication errors.”</blockquote> If health IT are indeed medical devices (as per CDRH Director Shuren, see <a style="font-family: arial;" href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">this link</a>) but they are "not mature", then why are they on the market without pre-marketing validation, post-marketing surveillance and other regulatory requirements faced by other medical devices? <blockquote face="arial">“With more than 3 billon prescriptions written annually in the U.S. alone, this could amount to 385 million errors each year, with 128 million of them having the potential to cause patient harm, said researcher Jeffrey Rothschild, from the center for patient safety research and practice at Brigham and Women’s Hospital in Boston.</blockquote> If the technology is this unreliable at this time, then perhaps investing hundreds of billions of dollars in it in 2011 is premature? Feeling a bit like Harry Markopolos once again, I offer what I am going to call Healthcare Renewal's Rule #1 of Cybernetic Common Sense in Medicine: <blockquote style="font-family: arial;">"Computers can only solve problems amenable to be being solved by computers, and only when all steps in their design and implementation are led by bona fide, domain-experienced, competent problem solvers." </blockquote><div style="font-family:arial;">This will not happen in the Wild-West <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=ecosystem">health IT ecosystem</a> that currently exists. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiygWhNyymv7S077RDs6uFVTyEMZK45avJkH4z9ekC0lagcNOtmDMj46HcmIk8lmNuAfalGoJGCrGCIbIWZiQuvm_FSkI-eAe0YEiIO7xdNIviOHYFYmsduokyPSF0uBamMqlzTpN147JfC/s1600/magic+bullet.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5624076346912619874" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiygWhNyymv7S077RDs6uFVTyEMZK45avJkH4z9ekC0lagcNOtmDMj46HcmIk8lmNuAfalGoJGCrGCIbIWZiQuvm_FSkI-eAe0YEiIO7xdNIviOHYFYmsduokyPSF0uBamMqlzTpN147JfC/s320/magic+bullet.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 194px; height: 147px;" /></a>USB-equipped Magic Bullets. Click to enlarge. </div> I have been asked what is needed for this industry to mature. Conceptually, the first step is: regulatory consistency. </div> <div style="font-family:arial;"> </div> <div style="font-family:arial;">As previously mentioned, Jeff Shuren MD JD of FDA's Center for Device & Radiological Health (CDRH), a physician and a lawyer, called health IT a "medical device". On Feb. 25 2010 he stated: </div> <div style="font-family:arial;"> </div> <blockquote style="margin-right: 0px;font-family:arial;" dir="ltr"> <div>... Under the <a href="http://www.blogger.com/redir.aspx?C=04b1666d8cac42bb98c48a047c663742&URL=http%3a%2f%2fwww.fda.gov%2fregulatoryinformation%2flegislation%2ffederalfooddrugandcosmeticactfdcact%2fdefault.htm" target="_blank">Federal, Food, Drug, and Cosmetic Act</a>, [that regulates all drug, medical devices, etc. in the United States -ed.] HIT software is a medical device. Currently, the FDA mandates that manufacturers of other types of software devices comply with the laws and regulations that apply to more traditional medical device firms. These products include devices that contain one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor patient activity), as well as devices that are composed solely of software (such as laboratory information management systems). </div></blockquote> <div style="font-family: arial;"> </div> <div face="arial">See links to his quotes at my post at <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html" target="_blank">http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html</a> </div> <div dir="ltr" style="font-family:arial;"> </div> <div style="direction: ltr;font-family:arial;" id="divRpF334264"> Treating "HIT software" as such - as a medical device - with all that implies, would be a first step. Instead - for whatever political reasons - HIT is given special accommodation.</div> <div style="direction: ltr;font-family:arial;"> </div> <div style="direction: ltr;font-family:arial;"> We could do the reverse to achieve regulatory consistency as well. What about de-regulating other medical devices and drugs? Might that not work out well? One might also ask, if that's a ridiculous option, then why does HIT, even more potentially dangerous than a drug, stent or defibrillator get a pass?</div> <div style="direction: ltr;font-family:arial;"> </div> <div style="direction: ltr;font-family:arial;"> Why is HIT even more potentially dangerous than a drug, stent or defibrillator? There's a critical, infrequently addressed issue that arises as IT capabilities advance. HIT is much more than a medical device like a stent or defibrillator, since it increasingly acts as a "coach" in the sports meaning of the term, or a "conductor" of clinicians in the sense of, say, a Herbert von Karajan or Eugene Ormandy as conductor of musicians.</div> <div style="direction: ltr;font-family:arial;"> </div> <div style="direction: ltr;font-family:arial;"> The computer increasingly calls the shots, so it in effect is increasingly a cybernetic intermediary or "proxy" between doctor and patient. (In essence, the "learned intermediary" metaphor is obsolete; for instance when a doctor fired up some expert system, posed a question about what antibiotic to best use, and then either used or ignored the outputs. The computer is now between doctor and patient.) </div> <div style="direction: ltr;font-family:arial;"> </div> <div style="direction: ltr;font-family:arial;">Here are tragic, if accurate, allegations of a computer in control of clinicians: the child death lawsuit complaint #2 at my post "Babies' deaths spotlight safety risks linked to computerized systems" at <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html" target="_blank">http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html</a> : </div> <div style="direction: ltr;font-family:arial;"> </div> <blockquote style="margin-right: 0px;font-family:arial;" dir="ltr"> <div style="direction: ltr;">Count 42: Defendants told Plaintiffs that the incorrect date on the image caused the x-ray not to be read by a radiologist in the night the image was taken, and that if the image had been correctly dated February 27, 2010, it would have been reviewed by a radiologist immediately, who would have alerted Defendants that the PICC line was improperly positioned and had to be moved back to a safe position. However, since the film was incorrectly dated February 23, 2010, the film was classified as “old” [BY THE COMPUTER PROGRAM - ed.] and was not put in line for immediate review [BY THE COMPUTER PROGRAM - ed.], and was not reviewed in time to prevent injury to Plaintiffs Decedent. </div> <div style="direction: ltr;"> </div> <div style="direction: ltr;">Count 45: Defendants told Plaintiff that the x-ray from the 27th, which was mislabeled as being from the 23rd, would have been reviewed by the neonatologist on duty on the morning of the 28th, but this did not happen because the computer which places films in line to be reviewed would have ignored such an “old” film. [That is, the computer cybernetically made the decision that the radiologists need not read the film, and in doing so exerted deadly interference with the clinicians' work - ed.]</div></blockquote> <div style="direction: ltr;font-family:arial;"> If a machine is to be given this kind of authority, i.e., as a conductor or governor of clinicians, its competence to do so needs to be extensively and robustly validated.</div> <div style="direction: ltr;font-family:arial;"> </div> <div style="direction: ltr;font-family:arial;"> </div> <div style="direction: ltr;font-family:arial;"> A neurosurgeon doesn't cut into someone's head before their skills in that regard have been extensively validated. Why do cybernetic intermediaries get special regulatory accommodation, especially when <a style="font-weight: normal;" href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">evidence is increasingly mounting</a> that, as of 2011, they are often deficient? -- SS </div>

Electronic medication prescribing: The Magic Bullet Theory of IT-Enabled Transformation once again bites the dust in the real world of medicine

Computers once again are proving not to be the plug-and-play-panacea they've been made out to be in the complex world of medicine. The...

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More Revelations About How Top Managers Prosper While Care-Giving Employees are Laid Off This Time Leads to Labor Strife

Last month, we <a href="http://hcrenewal.blogspot.com/2011/05/severance-package-to-un-severed-ceo.html">discussed</a> the contrast between executive compensation at Salinas Valley Memorial Healthcare System (SVMH), a small California public hospital system, and the treatment of employees in the trenches. While the hospital had laid off workers ostensibly because of the poor economic climate, the local newspaper revealed that its CEO was leaving with a multi-million dollar retirement package, and that some of his supposed severance pay had been given him before he was severed. This month, amidst growing labor unrest partially driven by the disparate treatment of the hired top manager and the more lowly employees who actually take care of patients, a new report revealed further contrasts between how hired executives and "regular" employees are treated. Let me give a blow by blow summary in chronological order. The Employees Strike This month, the hospital system suffered its first strike ever, partially in response to the discrepancy between executive compensation and how lesser employees were treated.  <a href="http://latimesblogs.latimes.com/lanow/2011/06/workers-strike-at-hospital-where-ceo-got-5-million-retirement-plan.html">According to</a> the Los Angeles Times: <blockquote>About 850 workers at a Salinas public hospital went on strike Tuesday, about two months after revelations of a multimillion-dollar pension awarded to the hospital's CEO. Caregivers at Salinas Valley Memorial Hospital walked off their jobs at 6 a.m., according to representatives of the National Union of Healthcare Workers. The workers are protesting proposed layoffs and cuts to their retirement benefits as well as pay given to hospital executives and consultants. The Times reported in April on the retirement package granted the hospital's outgoing chief executive, Samuel Downing, which included about $5 million in supplemental payments along with a $150,000 annual benefit. Hospital officials and board members have defended the package, saying that Downing was a successful leader throughout his 27 years as CEO. The hospital workers' union has been negotiating with administrators since January and indicated its plan to strike earlier this month, according to union vice president John Borsos. 'There's a sense of disbelief here that the hospital can come up with millions of dollars for Downing's retirement and millions for their consultants, but when it comes to caregivers by the bedside, they say they can't find the money,' he said.</blockquote> The Management's Lock-Out Then, hospital managers' responses to the strike provoked more anger from union members, and one state agency affirmed their complaints, <a href="http://www.thecalifornian.com/article/20110623/NEWS01/106230317">according to</a> The Californian: <blockquote>The California Public Employment Relations Board issued a five-page complaint against Salinas Valley Memorial Healthcare Systems, alleging that the public hospital district violated several sections of state labor law when it barred striking workers from returning to their posts Wednesday. Prompted by charges brought by the National Union of Healthcare Workers, PERB Regional Attorney Katharine Nyman charged SVMH with committing unfair labor practices and with violating PERB regulations in the way it blocked workers from going back to work after Tuesday's one-day labor walk-out.</blockquote>Strikers Picket a Board Member Then, the union escalated its protest by picketing the house of the hospital board treasurer, <a href="http://www.kionrightnow.com/story/14963052/state-files-complaint-against-svmh">according to </a>television station KION: <blockquote>Thursday morning, some union members took their demonstration from the front entrance of SVMH directly to the home of Harry Wardwell, Treasurer of the SVMH Board of Directors and President of Rabobank. 129 employees were still unable to go back on the job, replaced by temporary workers for one more day. Wardwell is one of five publicly elected members of Salinas Valley Memorial Healthcare System's Board of Directors. 'We have to draw the Salinas community and everybody in the hospital district. Every resident in this neighborhood votes and they need to know that Harry Wardwell is making these cuts,' said Marilyn Benson, an NUHW member.</blockquote> How Executive Pay Rose Faster than Inflation While Employees Were Laid Off Just after that protest ended, The California published <a href="http://www.thecalifornian.com/article/20110624/NEWS01/106240321/SVMH-execs-took-large-raises?odyssey=nav|head">a new article </a>about executive compensation: <blockquote>At the same time it laid off hundreds of rank and file employees, the Salinas Valley Memorial Healthcare System steadily provided generous increases to the salary and benefits packages of its senior executive team, records show. SVMH vice presidents Bev Ranzenberger, John Fletcher, Dr. David Perrott, Elizabeth Lorenzi, Irene Neumeister and James Griffith all received double-digit increases in their total compensation packages during the years of 2005 through 2010 according to an SVMH document obtained by The Californian on Thursday. And while not all of the vice presidents received salary increases every year during that time period, they all received percentageincreases in total salary and benefits of 29.4 percent to 153.8 percent, which translates to annual average increases of between 5.9 percent and 30.8 percent. By comparison, for the12 months that ended in May, the national rate of inflation rose just 3.6 percent, based on the Consumer Price Index. News of the increases incensed National Union of Healthcare Workers leaders whose members went on a one-day strike Tuesday after declaring an impasse with health care district management over wage and benefit issues and over how many more employees will be laid off as SVMH continues to struggle with reducing costs. 'How could a majority of the board approve of the outrageous salary increases while claiming that the hospital had to lay off hundreds of caregivers out of financial necessity?' asked union vice president John Borsos. 'It's not just hypocritical, but it demonstrates that the hospital has more than enough money to keep caregivers at the bedside.'</blockquote> Note that the SVMH leadership's defense of the pay given top executives was typical of explanations of outsize pay given to other health care leaders: <blockquote>But according to SVMH spokeswoman Adrienne Laurent, the executives' salaries are in keeping with industry standards and have been reviewed by an outside consulting agency for appropriateness. "Compensation for our hospital executives is not taken lightly, and that's why our [Board of Directors] engaged an outside, third party to assist us in this process. An important goal set forth by our board is that all of our employees, including our executives, receive compensation that is comparable to our competitors. In order for us to successfully recruit and retain the best people, it is critical that we remain competitive with not only other public district hospitals, but also private companies," Laurent wrote in an email to The Californian. In her email, however, Laurent did not address the seeming disparity of the institution increasing executive salaries while at the same laying-off employees. Laurent also added that the six SVMH vice presidents do not enjoy some of the standard perquisites offered to executives at other health care institutions such as bonuses and car and cellphone allowances.</blockquote>It must be tough having to pay for a cell-phone package when one's salary is only somewhat in excess of a quarter-million dollars a year. Note that the irony of defending high pay to recruit "the best people" to executive positions while health care professionals are being laid off seemed to escape Ms Laurent. Summary Once again we see how the notion that "top management are different from you and me" plays out throughout the health care system. Even at a small public community hospital system, the top hired managers seem to feel entitled to be treated differently, and much better than other employees, even those who directly care for patients.  Top hired managers do not flinch at the doublethink necessary to use poor financial results as a rationale for laying-off line employees, but simultaneously for hiking the pay of top hired managers. Again, we see how top hired managers of all sorts of health care organizations, big and small, for-profit, not-for-profit and government, delivering direct care, and manufacturing products used in care, have become accountable only to themselves. This situation, of course, produces health care done first for the benefit of its new overlords. The case of Salinas Valley Memorial Healthcare, however, also now demonstrates that this situation is starting to produce reactions.  It now seems that the ordinary employees of health care organizations are not continuing to welcome their new overlords. SVMH endured its first strike ever mainly in response to the disparity between how top hired managers treated other employees and treated themselves. Angry employees publicly identified the board of trustees that seemed to exert no functional oversight over top management as part of the problem. I suspect that if current trends continue, we will see more labor unrest, and that unrest will be directed at hired managers and those who are supposed to oversee them. This may eventually yield major changes in how health care is lead, but if the confrontations continue, these changes may be very messy, and continued strife may end up being bad for everyone. Instead, we should consider real, peaceful health care reform. As I have repeated endlessly,... health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior. If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

More Revelations About How Top Managers Prosper While Care-Giving Employees are Laid Off This Time Leads to Labor Strife

Last month, we discussed the contrast between executive compensation at Salinas Valley Memorial Healthcare System (SVMH), a small Californi...

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CEO Compensation: Nothing to See Here, Just Move Along

An <a href="http://www.washingtonpost.com/business/economy/business-group-public-companies-shouldnt-have-to-compare-ceo-and-worker-pay/2011/06/23/AGGMcFjH_story.html">article</a> in the Washington Post showed how uncomfortable executives of big corporations, including health corporations, are about making their outsize compensation transparent.  <blockquote>Here’s one financial figure some big U.S. companies would rather keep secret: how much more their chief executive makes than the typical worker. Now a group backed by 81 major companies — including McDonald’s, Lowe’s, General Dynamics, American Airlines, IBM and General Mills — is lobbying against new rules that would force disclosure of that comparison. The lobbying effort began more than a year ago. It involved some of the biggest names in corporate America and meetings with members of both parties on the House Financial Services Committee and Senate banking committee. The companies and their Republican allies in Congress call comparisons between the chief and everyone else in the company 'useless.'</blockquote> It's not just useless, they also claimed: <blockquote>Disclosing such comparisons 'can mislead or confuse investors,' said Rep. Nan A.S. Hayworth (R-N.Y.), who filed the bill to repeal the disclosure. 'It creates heat but sheds no light.' She also said the calculation of the ratio would be a burden for companies, especially those with global operations.</blockquote> One apparent reason for their discomfort is that the pay of top hired executives has been skyrocketing while the pay of most other employees stagnates: <blockquote>'The real reason House Republicans want to keep the typical worker’s pay secret is that it may embarrass some companies to reveal that they pay their CEO in the range of 400 times what they pay their typical worker,' said Sen. Robert Menendez (D-N.J.), who added the requirement to the financial regulatory overhaul bill that passed last year. Executive compensation at the nation’s largest firms has more than quadrupled in real terms since the 1970s, according to research by Carola Frydman of MIT’s Sloan School of Management and Raven E. Molloy of the Federal Reserve, even as pay for 90 percent of American earners has stalled. In 1970, average executive pay at the nation’s top companies was 28 times the average worker income, according to the Frydman-Molloy data and numbers provided by Emmanuel Saez at the University of California at Berkeley. By 2005, executive pay had jumped to 158 times that of the average worker.</blockquote> Behind the repeal effort are some of the largest US companies: <blockquote>The Center on Executive Compensation has led the criticism of the provision. The group is part of the HR Policy Association, which represents the human resources executives at 325 large companies. The thrust of the group’s criticism is that the information would have little value for investors comparing firms, because companies have workforces that differ in skills and expected pay. Wages also vary across regions and industries. Current rules already require disclosure of executive compensation; the new requirement calls for the additional disclosure of median worker pay. Critics say that would add little to what is already known. 'You can already tell where a CEO falls relative to his peers,' said Tim Bartl, senior vice president and general counsel for the Center on Executive Compensation. 'You can already tell where he falls relative to the average worker in the industry. What is this number going to tell us?' Last year, the HR Policy Association paid Bartl’s law firm, McGuiness & Yager, more than $1.5 million for lobbying, according to OpenSecrets.org.</blockquote> The HR Policy Association's <a href="http://www.hrpolicy.org/about_governance.aspx?w=board">board of directors</a> includes executives from some of the biggest health care corporations, including pharmaceutical and device firms (Amgen, Johnson and Johnson, and Merck), commercial health insurance companies and managed care organizations (Aetna, CIGNA, and Humana), and other firms with major health care interests (General Electric, Procter and Gamble). Note that Mr Bartl's concession that calculation of the ratio would be simple seemed to contradict Rep Hayworth's claim that the calculation would be burdensome. Summary It certainly appears that top hired managers of big corporations are not happy about the common people seeing how huge their pay is compared to that of other workers. They seem particularly unhappy to have their own stockholders, the common people who actually own their companies and to whom they theoretically report see how much they are making. Perhaps they fear the realization that they may be running their companies more for their personal advantage than in the interests of their supposed owners, much less the other, lesser employees, much less their customers, clients and patients, much less the public at large. The ability of small cabals of top executives at big corporations to set their own pay independent of the wishes and interests of the corporations' owners would seem to be the fundamental threat to the capitalistic and free market ideal. After all, in my humble and perhaps naive opinion, private ownership is central to capitalism, and the apparent managers' coup d'etat seems to be a existential challenge to private ownership. (For much more informed commentary on how executives have wrested control from owners, see the blog <a href="http://www.nakedcapitalism.com/">Naked Capitalism</a> and Robert A G Monks' <a href="http://www.ragm.com/">website</a>.) One wonders why so few of the many vocal supposed supporters of capitalism and free markets fail to see this as a problem. Even though it is increasingly informative to see what has happened to health care within the context of the larger political economy, Health Care Renewal, however, is about health care issues first. So to put this in health care terms.... First, we see again how top leaders of health care organizations prefer opacity to transparency, especially when that opacity increases their ability to put self-enrichment ahead of their organizations' missions and ultimately individuals' and the public's health. They embrace opacity when it protects the perverse incentives that likely are the major cause of increasing health care costs, declining access, and worsening quality. To repeat, and repeat, and repeat.... to reform health care, we must reverse the managers' coup d'etat, and restore leadership of health care organizations that puts the mission, and the health of patients and the population first, and is accountable to corporate owners (when applicable) and to patients and the public.  But that will mean now going up against those who have made themselves the richest and most powerful people in the country and the world, who will not lightly give up their oligarchy.

CEO Compensation: Nothing to See Here, Just Move Along

An article in the Washington Post showed how uncomfortable executives of big corporations, including health corporations, are about making ...

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Google is shutting down its cloud-based Google Health, a Personal Health Record service

Google is <a href="http://www.examiner.com/web-2-0-in-tampa-bay/google-retires-powermeter-and-health-services-controversy-ensues">shutting down its cloud-based Google Health</a>, a Personal Health Record service, by the end of the year. I wrote: <blockquote>"<a href="http://hcrenewal.blogspot.com/2007/07/personal-health-record-project-with.html">Who'da thunk it? -- Personal Health Record project with big corporate sponsors not working out so well ...</a>" </blockquote> and <blockquote>"<a href="http://hcrenewal.blogspot.com/2007/05/label-me-skeptical-personal-health.html">Label me skeptical: Personal Health Records as healthcare panacea?</a>" </blockquote> both in 2007. Considering the education and expertise one needs to really manage (and comprehend) health records robustly, let me state that I consider the entire concept of the "personal heath record" inane. You heard it here first. -- SS

Google is shutting down its cloud-based Google Health, a Personal Health Record service

Google is shutting down its cloud-based Google Health , a Personal Health Record service, by the end of the year. I wrote: " Who'da...

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