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Health IT and 'High Regulatory Standards': Criminal Negligence for Implementing Defective Systems That Put Data in the Wrong Charts?

Over at the <a href="http://www.histalk.com/">HIStalk</a> blog (a blog whose owner remains anonymous, and who uses an ISP that does not reveal information that could be used to identify him, apparently out of fear of retaliation for controversial stories he posts), the following appeared: <blockquote><a href="http://histalk2.com/2010/07/10/monday-morning-update-71210/" rel="bookmark" title="Article about: Monday Morning Update 7/12/10">Monday Morning Update 7/12/10</a> From Holy Smoke: “Re: Cerner. Misidentification incidents have been reported with Cerner PowerChart and Millenium in hospitals in Indiana, Michigan, and others after a Cerner upgrade. Entries are placed in the wrong electronic chart and reviewed data is for the wrong patient.” Unverified. I saw nothing in the FDA’s <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm" target="_blank">Maude database</a>, so if it’s happening, customers should file an experience report. </blockquote> While the reports are "unverified", I can add that the FDA MAUDE database would not show any data if this problem were recent, as I believe MAUDE contributions are reviewed by FDA before posting. (7/21/10 addendum: various sources confirm this occurred at a religious-denomination hospital chain headquartered in the Great Lakes region of the U.S.) However, as I wrote in Oct. 2009 at <a href="http://hcrenewal.blogspot.com/2009/10/out-policy-is-to-always-have-unabashed.html">"Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault</a>", the MAUDE database does contain some error reports from this vendor (one of the very few HIT vendors who actually file such reports) such as: <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=64345"></a><blockquote><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=64345">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=64345</a> Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities. Defects in the Auto Launch functionality make it possible for a mismatch of patient data. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=946706">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=946706</a> Patient care delay. The issue involves functionality in cerner millennium powerchart office and powerchart core and affects users that utilize the powerchart inbox and message center inbox. In results to endorse or sign and review, if the user clicks ok and next multiple times in quick succession while attempting to sign a result or a document, the display could lag behind the system's processing of the action, and multiple results or documents could be signed without the user's review. In message center, when clicking ok and next or accept and next, or when deleting or completing messages and moving to the next task, a document could be signed or a message could be deleted without the user's review. Results could be endorsed or documents could be signed without physician review, which could impact patient care. Cerner received communication that a patient's follow-up care was delayed as a result of this issue. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=753029">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=753029</a> Microbiology set up a program within the cerner computer system to automate the reporting system for hsv (herpes simplex virus)testing. The system was tested with the assistance of cerner and found to be working appropriately. The new system was operational for approximately 3 weeks when it was determined that the first word of the sentence, "no" was inappropriately dropping off of the following sentence: "no herpes simplex virus type 1 or herpes simplex virus type 2 detected by dna amplification. " as such, two of five patients were incorrectly informed that they had hsv before the error was detected. One had started an antiviral creme treatment. The other three did not have follow-up visits until after the correct results were determined. Cerner has looked at the program and has not provided an answer for the system issue. In the interim, the previous manual review and entry process is being used. </blockquote> Assuming the current reports from anonymous whistleblower "Holy Smoke" are true, I note the following. My observations apply to any vendor and/or healthcare organization that puts defective HIT into use in patient care-- At my April 2010 post "<a href="http://hcrenewal.blogspot.com/2010/04/healthcare-it-corporate-ethics-101.html">Healthcare IT Corporate Ethics 101: 'A Strategy for Cerner Corporation to Address the HIT Stimulus Plan'</a>", I'd written: <blockquote>A profoundly disappointing lesson in the ethics of the healthcare IT sector (and the B-schools as well) can be gleaned from the following, a paper written by a Cerner employee and two health industry colleagues for a <a href="http://www.fuqua.duke.edu/">Duke Fuqua School of Business</a> course. The course is "Health Economics & Strategy (<a href="http://www.fuqua.duke.edu/admin/stuserv/courseinfo/hlthmgmt326.html">HLTHMGMT 326</a>), Distance Executive MBA" (syllabus <a href="http://faculty.fuqua.duke.edu/%7Edbr1/teaching/syllabusWEMBA.pdf">here</a> in PDF) ... The paper is entitled "A STRATEGY FOR CERNER CORPORATION TO ADDRESS THE HIT STIMULUS PLAN." </blockquote>The paper was scrubbed from the Duke Fuqua School of Business Site on or around April 16, 2010 but a cached copy is <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Aycock-Prasad-Stiber-Cerner-2009.pdf">available here</a>. In that paper what I believe is a <a href="http://www.answers.com/topic/combination-in-restraint-of-trade-2">combination in restraint of trade</a> was suggested: <blockquote>This paper seeks to clarify these implications [of the the economic 'stimulus' package - ed.], understand the strengths and weaknesses of various players in the industry and recommend a strategy for Cerner Corporation to maximize its profit from the stimulus package and thereby secure a dominant position in the HIT industry. ... We recommend that Cerner collaborate with other incumbent vendors to establish high regulatory standards, effectively creating a barrier to new firm entry.</blockquote> High standards? I have some suggestions regarding "high regulatory standards." I agree that high, in fact, the highest regulatory standards should be upheld. I think I can safely state that a common regulatory standard in healthcare is that those involved in patient care, even peripherally, act with sound judgment and with patient well being as a foremost concern. Those acting recklessly and dangerously might be found negligent in a civil sense, or if acting recklessly in a willful and knowing manner, might be found criminally negligent. Two descriptions of criminal negligence: <blockquote><a href="http://www.thefreedictionary.com/criminal+negligence">Criminal negligence</a> - (law) recklessly acting without reasonable caution and putting another person at risk of injury or death (or failing to do something with the same consequences). <a href="http://definitions.uslegal.com/c/criminal-negligence/">Criminal negligence</a> is conduct which is such a departure from what would be that of an ordinary prudent or careful person in the same circumstance as to be incompatible with a proper regard for human life or an indifference to consequences. Criminal negligence is negligence that is aggravated, culpable or gross.(PDF). </blockquote> It is damn well clear that electronic medical records systems must function without unpredictable data errors that put data into the wrong persons' charts, thus producing two errors and two possibilities for patient harm: an erroneous absence of appropriate data in one patient's chart, and an erroneous presence of inappropriate data in another's. This is not a theoretical argument open to debate, and this is not a drill. A recent IT-related data error involving one single medication nearly killed my relative. In addition, the "<a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">learned intermediary</a>" excuse used to punt liability onto physicians and other clinicians for patient harm due to IT errors does not apply here, and this is also not open to debate. Physicians, even the most learned, are not clairvoyant; they should not be expected to know which chambers are empty and which chambers are loaded in a game of cybernetic <a href="http://en.wikipedia.org/wiki/Russian_roulette">Russian Roulette</a> with the data on their patients. Having an EMR maintain fundamental relational integrity, i.e., not place clinical data entered in good faith by trusting clinicians in another patients' chart, is not rocket science. Those who design, those who implement, and those who put into production (i.e., for use by physicians, nurses and other clinicians in the care of patients) any health IT "upgrade" without the extensive testing, testing and more testing necessary to prove proper operation on such a fundamental point as maintenance of relational integrity (i.e., correct patient identity in data storage and retrieval) knew, should have known, or should have made it their business to know that doing so puts patients at risk of injury or death. Putting an "upgraded" software application with such fundamental defects into actual use in real, live patients care environments - for whatever reason, e.g., finances, vendor marketing pressures, meeting planned objectives and numbers, obtaining a bonus, etc. - reflects in my view: <blockquote>"... a departure from what would be that of an ordinary prudent or careful person in the same circumstance as to be incompatible with a proper regard for human life or an indifference to consequences."</blockquote> Thus: In upholding the highest regulatory standards, if patients are harmed or die as a result of this type of HIT snafu, criminal charges against the responsible IT, clinical and administrative personnel would be an appropriate remedy to this type of negligence. As I wrote at "<a href="http://hcrenewal.blogspot.com/2010/07/4-billion-military-emr-ahlta-to-be-put.html">$4 Billion Military EMR "AHLTA" to be Put Out of Its Misery?</a>", in my view as of 2010 legal actions are the only way that the domain of healthcare IT can be returned to a field "of, by and for" clinicians, instead of "of, by and for" those who live off the hard work of clinicians and their patients. -- SS

Health IT and 'High Regulatory Standards': Criminal Negligence for Implementing Defective Systems That Put Data in the Wrong Charts?

Over at the HIStalk blog (a blog whose owner remains anonymous, and who uses an ISP that does not reveal information that could be used to...

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Hospitals' Star-Crossed Financial Engineering

And speaking of the costs of <a href="http://hcrenewal.blogspot.com/2010/07/failure-of-success-healthcare-when.html">financial maneuvering by hospitals</a>, the Wall Street Journal just reported on <a href="http://online.wsj.com/article/SB10001424052748704545004575353190698790172.html">"Hospitals' Wall Street Wounds,"</a> <blockquote>Hospitals nationwide are tangling with Wall Street to get out of disastrous wagers that have complicated their financial problems. Some hospitals are paying millions of dollars in penalties to get out of derivatives contracts, after betting incorrectly that interest rates would rise. Other hospitals are paying higher interest rates. At many, these ill-fated financial bets have contributed to layoffs and scuttled projects. More than 500 nonprofit hospitals—at least one in six—bought interest-rate "swaps" in a bid to lower their borrowing costs, estimates Municipal Market Advisors, a Concord, Mass., consulting firm. The swaps allowed hospitals to act much like homeowners switching from a floating-rate mortgage to fixed-rate one, betting on rising interest rates. For a fee, the hospitals received a fixed rate to sell bonds, lower than the municipal-bond market at the time. These bets backfired when the Federal Reserve cut interest rates to nearly zero from more than 5% in 2007. Hospitals also issued auction-rate securities—which reset bond prices weekly or monthly through auctions—that represented about a third of the $330 billion market for these derivatives. Hospitals paid Wall Street firms more than $120 million in fees for the securities between 2005 and 2007, said data firm Thomson Reuters. That market dried in the 2008 financial panic, leaving hospitals with higher interest rates.</blockquote> The article included a few pointed examples, e.g., <blockquote>In April 2007, Smith Barney brokers pitched Tri-City Medical Center in Oceanside, Calif., on ways to save money on interest rates. In a presentation, the brokers argued that the hospital could save tens of millions of dollars by refinancing its debt with derivatives from parent Citigroup, according to a lawsuit filed in April 2010 against Citigroup and Smith Barney, now co-owned by Morgan Stanley. 'Historically low' interest rates created an 'optimal environment,' according to Citigroup documents reviewed by The Wall Street Journal. 'Citigroup can mitigate the primary risks,' according to a slide presentation. Persuaded that it could cut its interest rate—5.7% at the time—on $67 million in outstanding bonds, the hospital issued auction-rate securities and added interest-rate swaps, according to the lawsuit and Daniel Callahan, an attorney for the hospital. Soon, the auction-rate market collapsed. Investors stopped bidding on these securities and the banks that sold them stopped acting as a buyer of last resort as they had in the past. This forced many hospitals and other issuers to pay a maximum penalty rate—sometimes up to 20%—that kicks in if there aren't buyers. As a result, rates shot up to 17%, costing Tri-City some $16 million more than it would have paid under its old rates, according to the lawsuit, filed in California Superior Court in Orange County. The hospital board replaced many top officials and paid Citigroup more than $6 million to get out of the auction-rate securities and the interest-rate swaps, Mr. Callahan said. The loss 'continues to impact Tri-City's ability to meet the needs of the entire community,' Mr. Callahan said, delaying the expansion of services and capital improvements. Auction-rate securities 'were an engineered, artificial market supported by the activities of the investment bankers designed to postpone a collapse,' the hospital alleges in the lawsuit.</blockquote> At least one financial expert agreed: <blockquote>'Financial engineering by Wall Street has been a huge part of hospital's financial problems and has even translated into a lack of hospital beds,' said Brian McGough, a managing director of health-care investments at Bank of Montreal Capital Markets in Chicago.</blockquote>This is another example of how health care organizations, including respected not-for-profit institutions, jumped headlong into the transactions first economy of the last 20 plus years.  The were lured by the prospect of making easy money from financial transactions.  However, it looked like those who really made money were the middle men who sold everyone on the magic of derivatives. You would have thought that the highly compensated financial wizards that hospitals and other health care not-for-profits chose for their leaders in the last 20 plus years would have been able to see through such nonsense.  Why were they paid so much, if not for expertise in this area?  But I would suspect that they too became distracted by all the money floating their way to think about how it might end.  We have often decried the problems of<a href="http://hcrenewal.blogspot.com/search/label/ill-informed%20management"> ill-informed health care leaders</a> who do not have direct experience in actually providing health care, or much sympathy for the values of health care professionals.  <a href="http://hcrenewal.blogspot.com/2006/03/consequences-of-breaking-physicians.html">Breaking the medical "guild,"</a> and putting professional managers in charge of health care was once touted as a way to control costs.  It is ironic that after  health care organizations became sold on the uncanny abilities of managers with business, usually finance or marketing training, these geniuses turned out to be as gullible about the wonders of Wall Street as everyone else.

Hospitals' Star-Crossed Financial Engineering

And speaking of the costs of financial maneuvering by hospitals , the Wall Street Journal just reported on "Hospitals' Wall Street ...

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The Failure of "Success Healthcare" - When Financial Maneuvering Takes Precedence Over the Health Care Mission

In the last few years, it seems that the whole world got tangled up in a web of complex financial dealings that mostly benefited those moving the money and paper, but often harmed everyone else.  So it should be no surprise that health care was similarly affected.  A <a href="http://www.stltoday.com/news/local/metro/article_03dce44e-8359-5bce-98f5-404949282a1b.html">story</a> from the St. Louis Post-Dispatch provided an illustrative case.  The news article began discussing the current difficulties of two local St Louis hospitals, then provided an explanation in what amounted to a series of flashbacks. Let me re sequence it a bit, starting with the background of two local hospitals that got caught up in web. Background <blockquote>For several decades, Forest Park Hospital — founded in 1889 as Deaconess Central Hospital — was one of the city’s leading community hospitals, serving a broad spectrum of patients including many African-American residents from north St. Louis. But in recent years, the hospital’s revenues and its number of patient visits had waned because, in part, of the emergence of major hospitals in west St. Louis County and its decision in 2006 to discontinue obstetric services. As the hospital struggled, it continued to be passed along from one owner to the next. In 2004, it was acquired by Argilla Healthcare Inc. Argilla merged with Doctors Community Healthcare Corp. of Scottsdale, Ariz., which became Envision Hospital Corp. Former board member Buford said Forest Park’s downfall began several years ago when Envision executives made the decision to use the hospital’s profits to help prop up a faltering hospital that Envision owned in Washington. In 2005, Envision sold the buildings and land of Forest Park Hospital and St. Alexius Hospital to Medline Industries, the Illinois manufacturer of surgical supplies.</blockquote> How the Hospitals were Sold to Success Healthcare LLC To address its financial problems, Envision decided to sell its accounts receivable to a firm in Florida. Here is the rationale: <blockquote>Less successful hospitals operate on razor-thin profit margins, waiting for slow-paying state and federal agencies to provide Medicaid and Medicare reimbursements. Such hospitals have difficulty obtaining financing and lack dependable cash flow. To provide support to a distressed hospital, the Florida partners would purchase its accounts receivables at a discount. For instance, if the government, a health insurer or patient owed a hospital for services, the partners would purchase that invoice for less money. The hospital, in turn, would have cash in hand.</blockquote>Note that "hospitals tend to avoid such cash-flow companies, because some of them use heavy-handed collection tactics." However, <blockquote>For struggling Forest Park and St. Alexius, selling their accounts receivables was an alluring option. </blockquote>So, <blockquote>Forest Park also was dogged by creditors and having difficulty making its payroll and paying utility bills. That’s when Envision began doing business with one of the Florida partners’ firms, Sun Capital Healthcare Inc., which purchased $61 million in receivables from Forest Park and St. Alexius. When Envision defaulted on its sales agreement in September 2008, the Florida partners formed Success [Healthcare LLC] to purchase the two hospitals for $39.5 million.</blockquote> The Promise of a Turn Around To the public and the struggling hospitals, the purchase by Success Healthcare LLC seemed a promise of deliverance: <blockquote>Eighteen months ago, the new buyers of Forest Park Hospital vowed to revive the beleaguered institution. They voiced optimism that the once-thriving, 450-bed medical center could be saved by fresh capital and determined leadership. They seemed equally enthusiastic about their other acquisition — St. Alexius Hospital in south St. Louis. Even the name of their company — Success Healthcare LLC — evoked the sense that better days were ahead.</blockquote> Also, <blockquote>When Success Healthcare bought Forest Park Hospital in December 2008, company officials spoke of transitions, not cutbacks. In a statement, the company called Forest Park and St. Alexius hospitals important community assets, saying that it planned to enact a 'turnaround plan and financial strategy' in the next six months “that will support the immediate and long-term objectives for the hospitals.'</blockquote>The Actual Results Better days were not ahead.  Instead, as summarized by the Post-Dispatch article, <blockquote>But the three partners from South Florida were ill-prepared to make good on their words. In reality, they were already deep in a financial scandal that involved the potential loss of more than $500 million in investor funds, the suicide of an investment manager in Bermuda, and allegations of fraud and self-dealing.</blockquote> The mess resulted from the involvement of what became Success Healthcare LLC and an off-shore financier. First, here is some information on the history of the ironically named Success Healthcare LLC: <blockquote>In recent years, [Peter] Baronoff, [Howard] Koslow and [Lawrence] Leder had built a small empire of health-related companies, whose holdings include at least 18 hospitals, and two finance firms. The firms share an office building at 999 Yamato Road in Boca Raton, Fla. Baronoff, a former deputy mayor of Boca Raton, had worked as a wine and spirits importer. Koslow had experience in financial services and real estate. Leder, an accountant, was a former supervisory auditor for the U.S. General Accounting Office. The partners marketed themselves as 'rescuing health care clients in financial emergencies,' including providers that file for bankruptcy protection or are considering such a filing.</blockquote> Then enter the off-shore financier: <blockquote>Court records indicate that the Florida partners approached [William] Gunlicks in 1999 to invest in the health care receivables business. Two of the partners — Koslow and Baronoff — formed a Bermuda-based venture with Gunlicks in December 2009 called Stewards & Partners Ltd. to attract offshore investors.</blockquote> But between 1999 and December, 2009, things had had gone bad, <blockquote>The first sign of serious problems appeared in April 2009, when the Securities and Exchange Commission filed a case against money manager William Gunlicks, a former Chicago banker whose investment funds provided hundreds of millions of dollars to the Florida partners to help finance their ventures. The SEC accused Gunlicks of placing at risk about $550 million in investor funds, including $5 million invested by the archdiocese of New Orleans. Soon after, Gunlicks’ fund manager in Bermuda killed himself with an overdose of pills, upset that he had lured investors to the troubled fund, according to media reports. Gunlicks, who declined to comment, settled the SEC case — agreeing not to operate another investment fund. In July 2009, a receiver appointed by a federal judge — whose mission is to recover Gunlicks’ investor’s money — sued the Florida partners’ finance companies for allegedly defaulting on loan payments to Gunlicks. The receiver accused the partners of fraudulently transferring hundreds of millions of dollars to purchase or prop up distressed hospitals that they owned. Investors also have sued the Florida partners.</blockquote> The troubles afflicting Success Healthcare LLC quickly affected the hospitals they had promised to save: <blockquote>There are conflicting accounts about the financial strength of the Florida partners, but this is clear: They do not appear to have the wherewithal to operate Forest Park as a full-service hospital, and their financial troubles could also negatively affect St. Alexius, which reported in 2008 a bare-bones profit margin of 1.38 percent. Daniel Newman, the court-appointed receiver, has asserted that the Florida partners’ finance firms 'had long been insolvent ... and had been losing money.' He has accused them of overstating their revenues and assets to conceal at least $50 million in losses in recent years.</blockquote> The results on local health care were not good: <blockquote>By April of this year, Forest Park Hospital had laid off about three-quarters of its staff and reduced its operations to a small emergency department, 20-bed psychiatric ward, laboratory and pharmacy. 'It’s a very dire situation,' said Dr. James Buford, president of the Urban League and a former member of the Forest Park Hospital’s board. 'It wouldn’t surprise me if the hospital went under. There hasn’t been a necessary infusion of capital to make it work.' Today, Forest Park Hospital is an almost empty landmark that overlooks the renovated Highway 40 (Interstate 64). The hospital is trying to use only one of its six floors and staffs a few dozen patient beds. Meanwhile, St. Alexius Hospital continues to offer a range of patient services, though it staffs only about one-third of its 456 licensed beds.</blockquote> Summary First, I must admit that it is possible that the two St Louis hospitals could not have been maintained in their original configurations by even the most knowledgeable, dedicated, and visionary leadership. It may be that there location was untenable, given the growth of powerful competitors. However, it is hard to believe that the complex financial maneuvers in which they were caught up provided any benefits to patients, health care, or health professionals. Instead, it is likely that these maneuvers provided considerable personal gains to the people behind them (although these were not investigated in the St Louis Post Dispatch story). The big lesson: be very skeptical of glorious promises, especially those that come from new health care leaders who turn out to have no knowledge or background in health care. (Note that the leaders of Success Healthcare had no apparent background in actually providing health care, and no apparent commitment to the values health care professionals ought to support.) When you meet the new boss, assume at best he or she will be "same as the old boss," (to the lyrics of "Won't Get Fooled Again.")  We seem to be caught up in a business culture in which every new leader and fashionable management strategy is hyped and spun, and somehow people believe it all, forgetting how badly the previously hyped leaders and strategies crashed. How many times have we health professionals been told the new CEO, the new corporation taking over, the new business strategy will make everything better? How often has that been true? Health care desperately needs leadership that understand the context, and believes in the values.  The quick buck artists have been making themselves rich, while health care on the ground becomes poor.  How much money goes into the pocket of the clever leaders for their fancy financial maneuvers, rather than to provide patient care?  The answer might explain why US health care is the most expensive in the world, while primary care, and in this case, basic hospital acute care becomes less available.

The Failure of "Success Healthcare" - When Financial Maneuvering Takes Precedence Over the Health Care Mission

In the last few years, it seems that the whole world got tangled up in a web of complex financial dealings that mostly benefited those movin...

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Sanofi-Funded Society of Hospital Medicine Stands Up for Lovenox

Here is another case to raise questions about the true goal of some medical societies.  As <a href="http://online.wsj.com/article/SB20001424052748703900004575325023225623274.html">reported</a> by Alicia Mundy in the Wall Street Journal in late June, <blockquote>A medical researcher and two medical groups with financial ties to Sanofi-Aventis SA have asked federal regulators to hold off on approving generic forms of a Sanofi blood-thinner.... Citing potential patient safety issues, the head of the Society of Hospital Medicine and a medical researcher at Duke University last month sent letters to the Food and Drug Administration contending that Lovenox is too complex for any generic maker to copy fully. Earlier this year, another Sanofi-sponsored medical group, the North American Thrombosis Forum, sent two letters in favor of Sanofi's position opposing generic Lovenox. None of the letters mentions the signer's financial support from Sanofi. Two small drug companies, Amphastar Pharmaceuticals Inc. and Momenta Pharmaceuticals Inc., filed applications to the FDA in 2003 and 2005 respectively seeking to sell generic Lovenox, called enoxaparin.</blockquote> Of course, the two medical societies involved denied that there was any relationship between their support from Sanofi-Aventis and their concerns about the safety of biogeneric medications that might compete with a Sanofi-Aventis product (which, as the WSJ article noted, "had global sales of $4.57 billion in 2009"). <blockquote>Laurence Wellikson, chief executive of The Society of Hospital Medicine, which represents doctors who coordinate patient care, said his letter to the agency 'was based entirely on the best evidence-based medicine available and the collective experience of SHM's senior hospitalists.'</blockquote>Also <blockquote>Ilene Sussman, executive director of the North American Thrombosis Forum, said the group's doctors are concerned about generic Lovenox, and its letter was independent of Sanofi.</blockquote> The CEO of the SHM denied even a responsibility to disclose the Society's support from Sanofi-Aventis: <blockquote>Dr. Wellikson said it wasn't necessary to disclose that the group receives financial support from Sanofi because its letter 'focused on providing the best, most effective care to the hospitalized patient.'</blockquote> In fact, the SHM web-site includes a <a href="http://www.hospitalmedicine.org/Files/PDF/cmss/Industry_Support_Disclosure.pdf">"disclosure of organizational support" page</a> which suggests Sanofi-Aventis provided somewhere between $200,000 to $800,000 for three projects of the Society's projects, "pharmacoeconomics," "improving glycemic control," and "preventing VTE." The latter presumably could have something to do with anti-coagulants such as Lovenox. (The numbers are vague because the statement only discloses the amount of support provided in broad ranges.) Thus, support by Sanofi-Aventis could provide as little as 2.7% or as much as 11.1% of the Society's total income, which was noted to be $7,203,596 in its <a href="http://www.guidestar.org/FinDocuments/2009/233/057/2009-233057353-05ac90cc-9.pdf">2009 Form 990 </a>filed with the IRS, and publicly available via Guidestar. Given the broad <a href="http://www.hospitalmedicine.org/Content/NavigationMenu/AboutSHM/GeneralInformation/General_Information.htm">mission of the SHM</a> <blockquote>SHM is dedicated to promoting the highest quality care for all hospitalized patients. SHM is committed to promoting excellence in the practice of hospital medicine through education, advocacy and research.</blockquote>one wonders why it would want to get officially entangled in the approval process for specific biogeneric drugs.  If the leadership of the Society is so concerned about the safety of anti-coagulants, one wonders why they did not speak up about the case of the lethal contaminated heparin, about which we have blogged extensively, most recently <a href="http://hcrenewal.blogspot.com/2010/05/more-questions-no-answers-about-case-of.html">here</a>.  (I can find nothing on the web to suggest the Society, or Dr Wellikson, ever noted any concerns about this issue.)  Of course, that case involved heparin sold by Baxter International, whose production was out-sourced to a questionable supply chain.  SHM also receives support, amounting to something between 0 and $100,000, according to its "disclosure of organizational support" page, from Baxter International.  Thus it appears that the leadership of SHM was very concerned about the safety of an anti-coagulant manufactured by a competitor of Sanofi-Aventis which could threaten that company's revenues from the drug, while Sanofi-Aventis is one of the Society's major financial supporters.  On the other hand, the leadership seemed unconcerned about the safety of an anti-coagulant sold under the Baxter International label, while Baxter-International is also one of the Society's major financial supporters.  So it is hard to tell whether the leadership is more concerned about the safety of anti-coagulants, or the financial interests of the drug companies that support it.  The problem with the funding of health care professional societies by health care corporations that sell products or services that doctors can prescribe or order is that it raises the suspicion that such societies may use their considerable influence to serve the corporations', not patients' interests, and so undermine the professional values of the societies' members.  For this reason, Rothman et al suggested that such societies sever most of their financial ties to such corporations.(1)  (See our blog post <a href="http://hcrenewal.blogspot.com/2009/07/again-logical-fallacies-in-defense-of.html">here</a>.)  As long as the SHM chooses to accept support from drug and device companies, questions will be asked about the effects of such support on how the Society uses its influence.  Furthermore, assertions that such support is so irrelevant that the Society need not even disclose it will only fuel more suspicion. If ostensibly mission-driven not-for-profit health care organizations, like health care professional societies, but also including medical schools, academic medical centers, and patient advocacy groups, want the public and health care professionals to believe that they really are mission-driven, they need to spurn funding from organizations with vested interests whose service might distort these missions. Hat tip to Steve Lucas for his comment <a href="https://www.blogger.com/comment.g?blogID=9551150&postID=7625518709680137413&isPopup=true">here</a>. References 1. Rothman DJ, McDonald WJ, Berkowitz CD et al. Professional medical associations and their relationships with industry. JAMA 2009; 301: 1367-1372. (Link <a href="http://jama.ama-assn.org/cgi/content/full/301/13/1367">here</a>.)

Sanofi-Funded Society of Hospital Medicine Stands Up for Lovenox

Here is another case to raise questions about the true goal of some medical societies. As reported by Alicia Mundy in the Wall Street Jour...

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Jurassic Attitudes about Medical Informatics: in the U.S. Navy?

Jurassic Attitudes about Medical Informatics: in the U.S. Navy?

The message below to a listserv for Chief Medical Informatics Officers and related positions was recently forwarded to me by a colleague. ...

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Wellcare Settles Again, but Wait, There is More...

We posted several times, most recently in 2009 (<a href="http://hcrenewal.blogspot.com/2009/05/wellcare-settles-accepts-deferred.html">here</a> and <a href="http://hcrenewal.blogspot.com/2009/08/wellcare-did-not-contest-that-its.html">here</a>), about misbehavior by the health insurance company/ managed care organization Wellcare.  That year, the company settled criminal charges that it defrauded the Florida state Medicaid program by paying a fine and accepting a deferred prosecution agreement.  Previously, the state of Connecticut had canceled its arrangement with Wellcare to run a Medicaid program in that state after the company refused to provide the state with requested data.  Then the company signed a consent order with the Florida Elections Commission in which it admitted making "questionable" political contributions. Then this year, it was announced that the company would settle additional civil charges, as <a href="http://www.tampabay.com/news/health/wellcare-health-plans-strikes-1375-million-settlement-challenged-by-new/1104947">per the St. Petersburg (FL) Times</a>, <blockquote>Tampa-based WellCare Health Plans Inc. has agreed to pay $137.5 million to the U.S. Department of Justice and other federal agencies to settle civil lawsuits accusing the company of overcharging for its Medicaid and Medicare programs.</blockquote> Also, <blockquote>Under the tentative deal, which must be approved in court, WellCare would have three years to make payments to the Justice Department's civil division, the U.S. Attorney's Office for the Middle District of Florida and the U.S. Attorney's Office for Connecticut. WellCare said the payments will include the approximately $23 million owed to the Florida Agency for Health Care Administration for overpayments received by the company in 2005. The civil settlement is separate from a deal struck last year on the criminal front. In that case, WellCare agreed to pay $80 million to settle a charge of conspiracy to defraud the Florida Medicaid program and the Florida Healthy Kids Corp. It also previously agreed to a $10 million civil penalty settling an informal inquiry by the Securities and Exchange Commission that regulatory filings reflected more than $40 million in profits that WellCare failed to return to the Florida agencies from 2003 to 2007. WellCare, which is Florida's largest Medicaid plan operator, has acknowledged that it overcharged Florida and Illinois health programs by about $46.5 million.</blockquote> But wait, there is more. No sooner than this settlement been announced than it was challenged. While considering the settlement, the judge involved unsealed a set of complaints by whistle-blowers about Wellcare. First, <a href="http://www.miamiherald.com/2010/06/28/1704842/wellcare-whistleblower-complaint.html">as reported by the Miami Herald</a>, <blockquote>The complaint, filed by former WellCare financial analyst Sean J. Hellein, portrays a company so ethically challenged that it rewarded employees who dumped hundreds of sick newborns and terminally ill patients from the membership rolls, thereby pumping up profits by millions of dollars. It describes a company that embraced fraudulent accounting as a business model, eventually stealing between $400 million and $600 million from Medicare and Medicaid programs in several states, perhaps most of it from Florida.</blockquote> See these specifics: <blockquote>Hellein, who wore a wire for more than a year to gather evidence for federal agents, says in the complaint that: - WellCare moved money between accounts to make it appear that patients' treatment cost much more than it actually did. In some cases, the company made payments years in advance to jack up the apparent cost of care to fool states into increasing Medicaid premiums. It worked, he said. - When states made overpayment errors, WellCare didn't pay the money back, as its contract requires. Florida Medicaid made a series of overpayment blunders that fattened WellCare's bottom line by many millions; those who made the errors included both state officials and contractors. - Sometimes hospitals and physician groups helped WellCare hide its true spending from Medicaid programs by accepting payments through one account for expenses incurred by another. Sometimes they allowed WellCare to pay for future years' expenses to make it appear spending for the current year was higher than it actually was. Hellein named two hospital systems - one in Illinois and one in Florida - that he said participated in the sham arrangement, but he said it was common. WellCare pushed expenses into certain programs - behavioral health programs in Florida and Illinois and the Healthy Kids program in Florida, a program for uninsured children of families with modest incomes - because they required repayment if the cost of treatment fell below a certain threshold. Florida public officials were repeatedly duped by WellCare. The director of the Florida Medicaid program from 2004 to 2007, while much of the alleged fraud was going on, was Tom Arnold. He currently is Secretary of the Agency for Health Care Administration. Another agency that fell for WellCare's line was the Office of Insurance Regulation, where an actuary found nothing wrong with a WellCare subsidiary in the Cayman Islands acting as the company's reinsurer. The reinsurance arrangement enabled WellCare to bank $5 for each insured while making it appear that the cost was just 11 cents, the complaint says. After Wall Street analysts raised questions about the legality of the reinsurance arrangement in 2007, some thought it might be reviewed by Chief Financial Officer Alex Sink. But nothing ever came of it. WellCare conducted a study to figure out which Medicaid recipients were profitable and which were not so that it could engage in "cherry-picking," a term for enrolling only the profitable members. The study found that disenrolling a baby born with health problems saved the company an average of $20,000; each terminally ill patient saved $11,500. Those who were persuaded to resign from WellCare went into the general Medicaid or Medicare fee-for-service programs. WellCare also restructured its benefit package to discourage the least-profitable Medicaid recipients from enrolling and encouraging those who were more profitable to sign up. Low-income mothers and children yielded a net of only about 10 percent, while the physically and mentally disabled paid for by Medicare yielded a net of 30 percent, the complaint says. The complaint names about 20 employees of WellCare who knew about the fraudulent activities. Only one, Gregory West, has been charged. He pleaded guilty in December 2007 but sentencing has been postponed several times. No charges have been brought against three former executives of the company named in the complaint as orchestrating the fraud: President, CEO and Chairman Todd Farha, CFO Paul Behrens and General Counsel Thaddeus Bereday. They all resigned in January of 2008, three months after the FBI and other law-enforcement agents raided the Tampa campus of WellCare and carted off computers and files.</blockquote> The the St. Petersburg Times <a href="http://www.tampabay.com/news/business/more-lawsuits-against-tampa-company-wellcare-made-public/1105716">reported</a> about two more complaints that were unsealed: <blockquote>Clark J. Bolton, a former supervisor of special investigations at WellCare, said the insurer encouraged overbilling and refused to audit claims for fraud in order to curry favor with doctors and hospitals and build market share. The result was millions in excessive and illegal expenses passed through to federal Medicare and state Medicaid programs, Bolton said. Eugene Gonzalez, a referral coordinator for seven years, claimed WellCare met government customer service standards only because it had employees create backdated documents and make bogus calls to the company's phone lines. Failure to meet these standards would have resulted in the loss of billions of dollars worth of Medicare and Medicaid contracts.</blockquote> As we have before, we see a striking contrast between the scope of the allegations and the response by the government agencies that are supposed to regulate insurers, insure that public money is spent wisely, and investigate and seek punishment for illegal activities. As the latter St. Petersburg Times article noted, <blockquote>U.S. Rep. Kathy Castor criticized the proposed settlement as wholly inadequate in a letter this week to Attorney General Eric Holder. 'Where is the penalty and punishment for such egregious actions?' she wrote. 'It appears that companies such as these simply build such payments into the 'cost of doing business.' We cannot allow this to continue.'</blockquote> This notion should be familiar to readers of Health Care Renewal. The Wellcare case fits right into the parade of<a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements"> legal settlements</a> we have discussed. As we have said again and again, the usual sorts of legal settlements we have described do not seem to be an effective way to deter future unethical behavior by health care organizations. Even large fines can be regarded just as a cost of doing business. Furthermore, the fine's impact may be diffused over the whole company, and ultimately comes out of the pockets of stockholders, employees, and customers alike. It provides no negative incentives for those who authorized, directed, or implemented the behavior in question. My refrain has been: we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich. Also note that the case of Wellcare remains relatively <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>. Despite the severity of allegations, and the national scope of the company, the case has only been mentioned in news stories, mainly in Florida where the company has its headquarters, and in a few health care trade publications. It, like many of the cases we discuss on Health Care Renewal, has not been mentioned in the medical/ health care research/ health care policy literature. If we cannot even speak about the sort of very bad management that afflicted Wellcare as a cause of many of the ills of our health care system, how do we really expect to constructively reform that system?

Wellcare Settles Again, but Wait, There is More...

We posted several times, most recently in 2009 ( here and here ), about misbehavior by the health insurance company/ managed care organizat...

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Quackwatch being sued by "Doctor's Data", a laboratory that caters to chelation therapists

<a href="http://www.quackwatch.org/">Quackwatch</a> is being sued by "Doctor's Data", a laboratory that caters to chelation therapists. See the post "Why Doctor's Data Is Trying to Shut Me Up" by Stephen Barrett, MD at <a href="http://www.quackwatch.org/14Legal/dd_suit.html">this link</a>. (I have no connections to either Quackwatch or "Doctor's Data", and do not know Dr. Barrett. However, this case caught my eye.) From a law firm, <a href="http://www.augustinekernandlevens.com/index.htm">Augustine, Kern and Levens, Ltd.</a> of Chicago: <blockquote>Dear Dr. Barrett: It has recently come to the attention of our client, Doctor's Data, Inc., an Illinois corporation, that you have, on a continuing basis, harmed Doctor's Data by transmitting false, fraudulent and defamatory information about this company in a variety of ways, including on the internet and in other publications. Doctor's Data is shocked that you would intentionally try to harm its business and its relationship not only with doctors but also with the public. Doctor's Data has also learned that you have apparently conspired with and encouraged individuals to seek litigation against it, and have filed false complaints at various government and regulatory agencies against Doctor's Data. "It is never libelous," you have said, "to criticize an idea." However, you have gone way beyond the idea stage, and our client will not tolerate it. You apparently have carried on this conduct in an intentional manner and with the assistance of others. It is clear that you have a specific intent to harm Doctor's Data, and this conduct must stop immediately. We demand that you cease and desist any and all comments regarding Doctor's Data, which have been and are false, fraudulent, defamatory or otherwise not truthful, and make a complete and full retraction of all statements you have made in the past, including those which have led in some instances to litigation. Such comments include, but are not limited to, those made in your article entitled, "<a href="http://www.quackwatch.org/t">How the 'Urine Toxic Metals' Test Is Used to Defraud Patients,</a>" which you authored and posted on Quackwatch.com. "The best evidence for reckless disregard," you have written, "is failure to modify where notified." Consider this notice to you that if you do not make these full and complete retractions within 10 days of the date of this letter, in each and every place in which you have made false and fraudulent, untruthful or otherwise defamatory statements, Doctor's Data will proceed with litigation against you and any organizations, entities and individuals acting in common cause or concert with you, to the full extent of the law, and will seek injunctive relief and monetary damages, both compensatory and punitive. Doctor's Data is a CLlA-certified company in full compliance with all state and federal regulatory and CLlA standards, and your false, fraudulent, defamatory and otherwise untruthful comments have been made to intentionally damage Doctor's Data, Inc. This conduct will no longer be tolerated and if the retractions are not made as written above, the lawsuit shall be filed imminently. Very truly yours, Algis Augustine</blockquote> Dr. Barrett of Quackwatch replied: <blockquote>Dear Mr. Augustine: Thank you for your letter of June 4th in which you accuse me of "transmitting false, fraudulent and defamatory information" about Doctor's Data. Your letter asks me to: <blockquote> Cease and desist any and all comments regarding Doctor's Data, which have been and are false, fraudulent, defamatory or otherwise not truthful. and make a complete and full retraction of all statements you have made in the past. Make . . . full and complete retractions within 10 days of the date of this letter, in each and every place in which you have made false and fraudulent, untruthful or otherwise defamatory statements. </blockquote> I take great pride in being accurate and carefully consider complaints about what I write. However, your letter does not identify a single statement by me that you believe is inaccurate or "fraudulent." The only thing you mention is my article about how the urine toxic metals test is used to defraud patients: (<a href="http://www.quackwatch.org/t">http://www.quackwatch.org/t</a>). The article's title reflects my opinion, the basis of which the article explains in detail. If you want me to consider modifying the article, please identify every sentence to which you object and explain why you believe it is not correct. If you want me to consider statements other than those in the article, please send me a complete list of such statements and the people to whom you believe they were made. Thank you, Stephen Barrett, MD</blockquote> To which the response was predictable, resulting in this: <blockquote>On June 18th, Doctor's Data filed suit against me [Barrett], the National Council Against Health Fraud, Inc., Quackwatch, Inc., and Consumer Health Digest, accusing us of restraint of trade; trademark dilution; business libel; tortious interference with existing and potential business relationships; fraud or intentional misrepresetation; and violating federal and state laws against deceptive trade practices. (On June 29th, Consumer Health Digest was dropped as a defendant.) The complaint asks for more than $10 million in compensatory and punitive damages. The suit objects to seven articles on my Web sites: <ul><li><a href="http://www.quackwatch.org/01QuackeryRelatedTopics/Tests/urine_toxic.html">How the Urine Toxic Metals Test Is Used to Defraud Patients</a></li><li><a href="http://www.casewatch.org/civil/stemp/petition.shtml">CARE Clinics, Doctor's Data, Sued for Fraud</a></li><li><a href="http://www.autism-watch.org/reports/casd/overview.shtml">Be Wary of CARE Clinics and the Center for Autistic Spectrum Disorders (CASD)</a></li><li>Three brief articles in Consumer Health Digest: <ul><li><a href="http://www.ncahf.org/digest09/09-14.html">Slate article blasts the urine toxic metals test</a></li><li><a href="http://www.ncahf.org/digest09/09-29.html">Shady clinic and lab under legal assault</a></li><li><a href="http://www.ncahf.org/digest10/10-09.html">"Autism specialists" sued</a></li></ul> </li><li><a href="http://www.quackwatch.org/01QuackeryRelatedTopics/Tests/nonstandard.html">Laboratories Doing Nonstandard Laboratory Tests</a></li></ul></blockquote><a href="http://www.quackwatch.org/01QuackeryRelatedTopics/Tests/nonstandard.html"></a> <div style="text-align: center;"><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiRll541Zy_LthaNlT-Yb-jnUPLFmwEhaMQs6U0fiOL5quhW5_VpFCHgr-zrW8Z9DrKUJ0hiPMCsEboxHmMWoDawfOK_XajZlQ-EjCWDvrRAnKFhPUfoW7oXKNDWJlLHLCGIEU11B4SI4z3/s1600/QUACK10cm.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5489278547564377698" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiRll541Zy_LthaNlT-Yb-jnUPLFmwEhaMQs6U0fiOL5quhW5_VpFCHgr-zrW8Z9DrKUJ0hiPMCsEboxHmMWoDawfOK_XajZlQ-EjCWDvrRAnKFhPUfoW7oXKNDWJlLHLCGIEU11B4SI4z3/s320/QUACK10cm.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 276px; height: 168px;" /></a>My personal opinion of "offbeat practitioners" </div> Barrett also writes: <blockquote>Very few people provide the type of information I do. One reason for this is the fear of being sued. Knowledgeable observers believe that Doctor's Data is trying to intimidate me and perhaps to discourage others from making similar criticisms. However, I have a right to express well-reasoned opinions and will continue to do so. If you would like to help with the cost of my defense, <a href="http://www.quackwatch.org/00AboutQuackwatch/donations.html">please follow the instructions on our donations page</a>.</blockquote> This seems like a case of legal intimidation and may be a case for Senator Grassley's whistleblower hotline (whistleblower@finance-rep.senate.gov). Finally, as a Medical Informatics specialist once called "Doctor Data", I find the company name "Doctor's Data" for a company in this business ironic indeed. -- SS

Quackwatch being sued by "Doctor's Data", a laboratory that caters to chelation therapists

Quackwatch is being sued by "Doctor's Data", a laboratory that caters to chelation therapists. See the post " Why Doctor...

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