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Arguments with Pavlov's Dogs: Health IT Regulation Will "Harm Innovation"? How, exactly?

Health IT hyper-enthusiasts, when faced with the prospect of government regulations, react like <a href="http://en.wikipedia.org/wiki/Classical_conditioning" target="_blank">Pavlov's dogs</a> with the response "regulation of health IT will harm innovation." Here's a soliloquy of critical questions that need be asked: ----------------------- Now, Mr. (or Dr.)  Hyper-Enthusiast, you state HIT regulation will harm innovation. What aspects of regulation, specifically, will harm innovation? Good manufacturing processes (GMPs)? Building a safety case for review and inspection? Pre-market safety/fitness/quality/reliability testing? Post-marketing surveillance? What? Innovations happen before regulatory evaluation, do they not? What, exactly, are your objections to safety and quality testing of innovations? Don't innovations need to be tested for safety and quality? If innovations are not safe, should they not be used on live patients? How can the industry with its conflicts of interest effectively regulate HIT? Even if it could, again, how would additional regulatory oversight harm innovation? -----------------------  And perhaps this needs to be asked as well: <ul><li>Don't you really mean regulation would harm the bottom line? </li></ul> -- SS

Arguments with Pavlov's Dogs: Health IT Regulation Will "Harm Innovation"? How, exactly?

Health IT hyper-enthusiasts, when faced with the prospect of government regulations, react like Pavlov's dogs with the response " ...

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Hospital Retaliation Against Outspoken Physician Reaches New Levels - La Cosa Nostra Levels, That Is

Physicians, take note: <blockquote class="tr_bq">The Advisory Board Company Feb. 14, 2013   <a href="http://www.advisory.com/Daily-Briefing/2013/02/15/Jury-Hospital-CEO-framed-physician-by-planting-gun" target="_blank">Hospital Framed Physician; Planted a Gun </a> A jury has ordered a California hospital chain to pay physician Michael Fitzgibbons $5.7 million after its former CEO allegedly framed him by planting a gun in his car. In 2006, Fitzgibbons—an infectious disease specialist and former chief of staff at Western Medical Center—was arrested in the hospital parking lot after police found a pair of black gloves and a handgun in his car. Police questioned Fitzgibbons and searched his car after an anonymous 9-1-1 call claimed that the doctor had brandished the gun in traffic. DNA evidence from the gloves and gun exonerated Fitzgibbons, and he was never charged. However, the arrest followed a series of disagreements between Fitzgibbons and the leadership of Integrated Healthcare Holdings Incorporated (IHHI), which owned the Santa Ana hospital. Fitzgibbons and his attorney—Ted Mathews—alleged that IHHI's then-CEO, Bruce Mogel, had framed Fitzgibbons in an effort to silence him. Specifically, Mathews said that the frame was part of Mogel's attempt to "humble" Fitzgibbons after the doctor won a legal victory over IHHI in June 2006. During the trial, former IHHI President Larry Anderson testified that Mogel had instructed him to create a $10,000 contract for a "scary guy" named Mikey Delgado immediately after Fitzgibbon's legal victory. The contract was for unnecessary work on the health system's website. In his testimony, Anderson said he realized after Fitzgibbons was arrested that the contract was actually for the frame. Mathews told the jury that the $10,000 was used to "[get] Dr. Fitz set up." IHHI's board learned of the $10,000 contract during Anderson's deposition in 2008. Instead of firing Mogel, the board awarded him an eight-month consultancy worth $43,750 per month, Mathews says. This showed that IHHI board "knew what Mogel did to Dr. Fitzgibbons," Mathews told the jury, adding, "They ratified it, and they gave him a golden handshake goodbye.</blockquote> The article notes Board acquiescence. Two questions come to mind: 1.  Have the involved people been permanently removed from positions of authority in healthcaree? 2.  Have the persons involved been charges criminally? <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEilmYlDXF0wtZWXy1i_Qce5WGtXzfJhnM2jwPUoB_AD06s_waEqlZyWng7l078AfCON-jrqQwmzZ-npxbJ3w66ZsTv53A1dbmrREys3idjEO9K6iBwgPffmubMHGPIwfO81GDQVOGmlFo3d/s1600/goldfinger-54.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEilmYlDXF0wtZWXy1i_Qce5WGtXzfJhnM2jwPUoB_AD06s_waEqlZyWng7l078AfCON-jrqQwmzZ-npxbJ3w66ZsTv53A1dbmrREys3idjEO9K6iBwgPffmubMHGPIwfO81GDQVOGmlFo3d/s320/goldfinger-54.png" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><a href="http://www.youtube.com/watch?v=QtkFmufS6k8" target="_blank">Shocking.  Positively shocking.</a></td></tr></tbody></table> -- SS

Hospital Retaliation Against Outspoken Physician Reaches New Levels - La Cosa Nostra Levels, That Is

Physicians, take note: The Advisory Board Company Feb. 14, 2013 Hospital Framed Physician; Planted a Gun A jury has ordered a California h...

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Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI "Deep Dive" Study of Health IT "Events"

FDA's <a href="http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/default.htm" target="_blank">Center for Devices and Radiological Health</a> director Jeffrey Shuren MD JD voiced the opinion a few years ago that what FDA knows about health IT risks is the "tip of the iceberg" due to systematic impediments to knowledge gathering and diffusion.   See links to source <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html" target="_blank">here</a> and to the FDA Internal Memo on HIT risk - labeled "internal document not intended for public use" and unearthed by investigative reporter <a href="http://www.publicintegrity.org/authors/fred-schulte" target="_blank">Fred Schulte</a> several years ago - <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf" target="_blank">here</a> (PDF). At my Feb. 9, 2013 post "<a href="http://hcrenewal.blogspot.com/2013/02/ecri-institute-pso-uncovers-health.html" target="_blank">A New ECRI Institute Study On Health Information Technology-Related Events</a>" I opined that a new ECRI study was beginning to peer beneath the waterline of Jeff Shuren's iceberg tip, at what may reside underneath that waterline.  Iceberg tips, needless to say, are usually tiny compared to the iceberg's overall size. Reporter Kevin O'Reilly at AMNews (<a href="http://amednews.com/" target="_blank">amednews.com)</a> has now written about that ECRI report. The results of the report are concerning: <blockquote class="tr_bq"> <a href="http://www.ama-assn.org/amednews/2013/02/25/prsa0225.htm" target="_blank">Ways EHRs can lead to unintended safety problems</a> Wrong records and failures in data transfer impede physicians and harm patients, according to an analysis of health technology incidents. By Kevin B. O'Reilly, amednews staff, posted Feb. 25, 2013. In spring 2012, a surgeon tried to electronically access a patient’s radiology study in the operating room but the computer would show only a blue screen. The patient’s time under anesthesia was extended while OR staff struggled to get the display to function properly. That is just one example of 171 health information technology-related problems reported during a nine-week period to the ECRI Institute PSO, a patient safety organization in Plymouth Meeting, Pa., that works with health systems and hospital associations in Kentucky, Michigan, Ohio, Tennessee and elsewhere to analyze and prevent adverse events. Eight of the incidents reported involved patient harm, and three may have contributed to patient deaths, said the institute’s 48-page report, first made privately available to the PSO’s members and partners in December 2012. The report, shared with American Medical News in February, highlights how the health IT systems meant to make care safer and more efficient can sometimes expose patients to harm.</blockquote>  Mar. 1, 2013 addendum.  From ECRI, the denominator is this: <blockquote class="tr_bq"><div class="MsoNormal">Participating facilities submitted health IT related events during the nine-week period starting April 16, 2012, and ending June 19, 2012. ECRI Institute PSO pulled additional health IT events that were submitted by facilities during the same nine-week period as part of their routine process of submitting event reports to ECRI Institute PSO’s reporting program. The PSO Deep Dive analysis consisted of 171 health IT-related events submitted by 36 healthcare facilities, primarily hospitals.   [I note that's 36 of 5,724 hospital in the U.S. per data from the American Hospital Association (<a href="http://www.aha.org/research/rc/stat-studies/fast-facts.shtml" target="_blank">link</a>), or appx. 0.6 %.  A very crude correction factor in extrapolation would be about x 159 on the hospital count issue alone, not including the effects of the voluntary nature of the study, of non-hospital EHR users, etc.  Extrapolating from 9 week to a year, the figure becomes about x 1000.  Accounting for the voluntary nature of the reporting (5% of cases per Koppel), the corrective figure approaches x20,000.  Extrapolation of course would be less crude if # total beds, degree of participant EHR implementation/use, and numerous other factors were known, but the present reported numbers are a cause for concern - ed.] </div></blockquote> Sept. 2013 addendum:  Health Leaders Media has more on the ECRI Deep Dive study at <a href="http://www.healthleadersmedia.com/print/TEC-290834/HIT-Errors-Tip-of-the-Iceberg-Says-ECRI">http://www.healthleadersmedia.com/print/TEC-290834/HIT-Errors-Tip-of-the-Iceberg-Says-ECRI</a>: <blockquote class="tr_bq">HIT Errors 'Tip of the Iceberg,' Says ECRI Cheryl Clark, for HealthLeaders Media , April 5, 2013 Healthcare systems' transitions from paper records to electronic ones are causing harm and in so many serious ways, providers are only now beginning to understand the scope. Computer programs truncated dosage fields, leading to morphine-caused respiratory arrest; lab test and transplant surgery records didn't talk to each other, leading to organ rejection and patient death; and an electronic systems' misinterpretation of the time "midnight" meant an infant received antibiotics one dangerous day too late. These are among the 171 health information technology malfunctions and disconnects that caused or could have caused patient harm in a report to the <a href="https://www.ecri.org/Pages/default.aspx" target="_blank">ECRI</a> Institute's Patient Safety Organization. ... The 36 hospitals that participated in the ECRI IT project are among the hospitals around the country for which ECRI serves as a Patient Safety Organization, or PSO. The 171 events documented, break down like this: <ul><li>53% involved a medication management system. <ul><li>25% involved a computerized order entry system</li><li>15% involved an electronic medication administration record</li><li>11% involved pharmacy systems</li><li>2% involved automated dispensing systems</li></ul></li><li>17% were caused by clinical documentation systems</li><li>13% were caused by Lab information systems</li><li>9% were caused by computers not functioning</li><li>8%. Were caused by radiology or diagnostic imaging systems, including PACS</li><li>1% were caused by clinical decision support systems</li></ul> Karen Zimmer, MD, medical director of the institute, says the reports of so many types of errors and harm got the staff's attention in part because the program captured so many serious errors within just a nine-week project last spring.  The volume of errors in the voluntary reports was she says, "an awareness raiser." "If we're seeing this much under a voluntary reporting program, we know this is just the tip of the iceberg; we know these events are very much underreported."</blockquote> As at the opening of this post, "tip of the iceberg" is a phrase also used by FDA CDRH director Jeffrey Shuren MD JD regarding safety issues with EHRs and other health IT. Along those lines, at my April 2010 post "<a href="http://hcrenewal.blogspot.com/2010/04/if-benefits-of-hit-can-be-guesstimated.html" target="_blank">If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers</a>" I proposed a "thought experiment" to theoretically extrapolate limited data on health IT risk to a national audience, taking into account factors that limited transparency and thus reduced known injury and fatality counts. The results were undesirable, to say the least - but it was a thought experiment only. Using the current data, coming from a limited, voluntary set of information over 9 weeks, I opine that the results of an extrapolation to a national (or worldwide) level, in an environment of rapidly increasing adopters (many of whom are new to the technology), on an annual basis, not a mere 9 weeks - would not look pretty. <blockquote class="tr_bq">The institute’s report did not rate whether electronic systems were any less safe than the paper records they replaced. The report is intended to alert hospitals and health systems to the unintended consequences of electronic health records. </blockquote> Ethically, this is really not relevant towards national rollout, especially with penalties beginning to accrue to non-adopters of HHS "Certified" technology in a few years. As I've written on this blog, medical ethics generally do not condone experimentation without informed consent, especially when the experimental devices are of unknown risk. Not knowing the risks of IT, it really doesn't matter, ethically, what the safety of paper is.  "Hope" is not a valid reason for medical experimentation.  (See below for what a PubMed search reveals about risks of paper records.) The unspoken truth prevalent in healthcare today seems to be this:  the sacrifice of individual patients to a technology of unknown risk is OK, as long as - we hope -  it advances the greater good.    Perhaps that should be explicitly admitted by the HIT industry's <a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-disregard-for.html" target="_blank">hyper-enthusiast proponents</a> who ignore the downsides, so the spin can be dropped and there can be clarity? <blockquote class="tr_bq">The leading cause of problems was general malfunctions [also known by the benign-sounding euphemism "<a href="http://hcrenewal.blogspot.com/search/label/glitch" target="_blank">glitches</a>" - ed.]  responsible for 29% of incidents. For example, following a consultation about a patient’s wounds, a nurse at one hospital tried to enter instructions in the electronic record, but the system would not allow the nurse to type more than five characters in the comment field. Other times, medication label scanning functions failed, or an error message was incorrectly displayed every time a particular drug was ordered. One system failed to issue an alert when a pregnancy test was ordered for a male patient. [These 'general malfunctions' are thus not just computer bugs undetected due to inadequate pre-rollout testing, but also examples of design flaws due to designer-programmer-seller-buyer-implementer lack of due diligence, i.e.,  negligence - ed.] A quarter of incidents were related to data output problems, such as retrieving the wrong patient record because the system does not ask the user to validate the patient identity before proceeding. This kind of problem led to incorrect medication orders and in one case an unnecessary chest x-ray. Twenty-four percent of incidents were linked to data-input mistakes. For example, one nurse recorded blood glucose results for the wrong patient due to typing the incorrect patient identification number to access the record.  [Many of these are likely due to what NIST has termed "<a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html" target="_blank">use error</a>" - user interface designs that will engender users to make errors of commission or omission - as opposed to "user error" i.e., carelessness - ed.] Most of remaining event reports were related to data-transfer failures, such as a case where a physician’s order to stop anticoagulant medication did not properly transfer to the pharmacy system. The patient received eight extra doses of the medication before it was stopped. [Due to outright software, hardware and/or network problems and defects - ed.]</blockquote> I've been writing about such issues since 1998, not because I imagined them.  As a CMIO I saw them firsthand; as teacher and mentor I heard about them from colleagues; as a writer I heard about them via (usually unsolicited) emails from concerned clinicians; as an independent expert witness on health IT harms I've heard about them from Plaintiff's attorneys, but not from the Defense side of the Bar as yet.  Of course the reasons for that are understandable -  albeit disappointing. In fact, robust studies of a serious issue - the actual risks of paper towards harm causation - and further, whether any of the issues are remediable without spending hundreds of billions of dollars on IT - seem scarce.  I've asked the PA Patient Safety Authority about the possibility of using data in the Pennsylvania Patient Safety Reporting System (PA-PSRS) database, just as they did for EHR-related medical events, to determine incidence of paper-related medical events.  They are pondering the issue. As an aside, I note that it would be ironic if the relative risks of both IT and paper were not really robustly known.  (I note that in a PubMed search on "<a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=risks+of+paper+medical+records" target="_blank">risks of paper medical records</a>", not much jumps out.)  IT hyper-enthusiasts will not even debate the issue of studying whether a good paper system might be safer for patients in some clinical environments than bad health IT. Considering the tremendous cost and unknown risk of today's health IT (and perhaps the unknown risk of paper, too), would it not make more sense, and be consistent with the medical Oath, to leave paper in place where it is currently used - and perhaps improve its performance - until we "get the IT right" in controlled, sequestered environments, prior to national rollout? In other words, as I've asked before on these pages, should we not slow down the IT push and adhere to traditional (and hard-learned) cautions on medical research? Even asking such questions brings forth logical fallacies such as straw arguments (e.g., UCSF's <a href="http://community.the-hospitalist.org/" target="_blank">Bob Wachter</a> in a recent discussion I initiated with several investigative reporters: "...where we part ways is your defense of paper and pencil. I understand advocacy, and you have every right to bang this particular drum"), ad hominem attacks, etc. <blockquote class="tr_bq">... It is not enough for physicians and other health care leaders to shop carefully for IT systems, the report said. Ensuring that systems such as computerized physician order entry and electronic health records work safely has to be a continuing concern, said Karen P. Zimmer, MD, MPH, medical director of the ECRI Institute PSO. “Minimizing the unintended consequences of health IT systems and maximizing the potential of health IT to improve patient safety should be an ongoing focus of every health care organization,” she said.</blockquote> I recommended that clinicians take matters into their own hands if their leaders do not, as at the bottom of my post <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">here</a>.  This advice bears repeating: <blockquote class="tr_bq">... When a physician or other clinician observes health IT problems, defects, malfunctions, <a href="http://www.tinyurl.com/hostileuserexper">mission hostility</a> (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting): (DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.) <ul><li>Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "<a href="http://www.jpands.org/vol9no3/huntoon.pdf">disruptive physician</a>" and/or or being subjected to sham peer review (<a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/">link</a>).</li></ul><ul><li>Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal"> at this link</a>. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger <a href="http://hcrenewal.blogspot.com/search/label/Dr.%20Scott%20Monteith">Dr. Scott Monteith</a> in a comment to me about this post.)</li></ul><ul><li>Inform the Joint Commission (or similar national accreditor of hospital safety if not in the U.S.) via their complaint site at <a href="http://www.jointcommission.org/report_a_complaint.aspx">http://www.jointcommission.org/report_a_complaint.aspx</a> . Also consider writing the JC senior officers (<a href="http://www.jointcommission.org/about_us/joint_commission_officers.aspx">link to officer's list</a>), whose awareness of HIT issues I can personally attest to via our correspondences.</li></ul><ul><li>Inform the FDA (or similar healthcare regulator if not in the U.S.) via the FDA Medwatch Form 3500 reporting site at <a href="https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm">https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm</a>. An example of such an adverse event report I filed myself (when the involved hospital refused) is <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1729552">at this link</a> in the FDA MAUDE (Manufacturer and User Facility Device Experience) database.</li></ul><ul><li>Inform the State Medical Society and local Medical Society of your locale.</li></ul><ul><li>Inform the appropriate Board of Health for your locale.</li></ul><ul><li>If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "<a href="http://www.qipa.org/Home.aspx">Quality Insights of PA</a>."</li></ul><ul><li>Inform a personal attorney.</li></ul><ul><li>Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.</li></ul><ul><li>As clinicians are often forced to use health IT, at their own risk even when "certified" (<a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html">link</a>), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:</li></ul><blockquote>"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.] We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients. We assume responsibility for any such malpractice. With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at <a href="http://www.jointcommission.org/assets/1/18/SEA_42.PDF" style="font-style: italic;">http://www.jointcommission.org/assets/1/18/SEA_42.PDF</a>, the IOM report on HIT safety at <a href="http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF" style="font-style: italic;">http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF</a>, and the FDA Internal Memorandum on H-IT Safety Issues at <a href="http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology" style="font-style: italic;">http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology</a>. CMO __________ (date, time) CIO ___________ (date, time) CMIO _________ (date, time) General Counsel ___________ (date, time) etc."</blockquote><ul><li>If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.</li></ul><ul><li>As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.</li></ul></blockquote> These recommendations still stand, although after this recent story, my caution about retaliation should be re-emphasized: <blockquote class="tr_bq">The Advisory Board Company Feb. 14, 2013 <a href="http://www.advisory.com/Daily-Briefing/2013/02/15/Jury-Hospital-CEO-framed-physician-by-planting-gun" target="_blank">Hospital Framed Physician; Planted a Gun </a></blockquote> -- SS

Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI "Deep Dive" Study of Health IT "Events"

FDA's Center for Devices and Radiological Health director Jeffrey Shuren MD JD voiced the opinion a few years ago that what FDA knows a...

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Another Reason for Hope? - Concern about Excessive Executive Pay in Health Care Goes Mainstream

Another recent case suggested that the problem of excess, disproportionate <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">compensation of health care executives</a> is becoming more of a mainstream concern.  The Case of Eastern Connecticut Health Network The case appeared in the Manchester (CT) Journal-Inquirer (<a href="http://www.journalinquirer.com/articles/2013/02/22/politics_and_government/doc51263d0334cdf093796210.txt">link</a> requires subscription).  Here are the basics: <blockquote class="tr_bq">ECHN Inc., which owns Mancester Memorial and Rockville General hospitals, reported to the IRS last year that the company paid its president and CEO, Peter J Karl, a total of $1,042,200 in salary and fringe benefits.  That's a 30.7 percent increase over Karl's compensation reported in the previous year,.... ECHN also reported that six other top executives were paid between $254,640 and $591,090, representing increases of as much as 20.6 percent. </blockquote> ECHN is yet another relatively small non-profit hospital system with a million dollar plus CEO. For comment on this, I turn back to the Journal-Inquirer article.  One person the reporter interviewed <blockquote class="tr_bq">says the big salaries and bonuses paid to top officials at Eastern Connecticut Health Network are part of a national scandal over executive compensation propelled by the 'pursuit of talent for short-term gains.' 'The hospital industry is emblematic of what's happened in executive compensation in the United States, where the multiple of the lowest- paid employee to get to the salary of the highest-paid employee has just exploded over the last 30 years,'....</blockquote> Furthermore, the person interviewed noted that hospital executives were bemoaning decreases in payments to their institutions by state government "while making 10 to 20 times as much money as" the state governor makes.  In this case, the CEO, Mr Karl's "compensation package was 6.9 times [Governor Daniel P] Malloy's salary of $150,000." A second person interviewed said <blockquote class="tr_bq">Salaries have gotten to the point where they have skyrocketed and are out of control.</blockquote> He also raised an issue about conflicts of interest affecting the ECHN board <blockquote class="tr_bq">he agreed with state health care advocate, Victoria Veltri, who told the Journal Inquirer last week that nearly $1 million in business deals between ECHN and five members of its board of trustees require further scrutiny</blockquote>Criticism from the Mainstream I have been coy about who the commentators were, but bear with me. So we see in this one somewhat obscure newspaper article about one small regional hospital system points that we have been raising for years about the perverse incentives generated by excess executive compensation in health care.  We have frequently discussed how such compensation is often completely untethered to the organizations' financial results, much less its positive effects on patients' and the public's health.  Compensation often rises faster than inflation, faster than revenue (and sometimes when revenue declines and deficits loom), and even when the organization is facing financial, clinical, or ethical challenges.  Thus it often seems that the primary goal of the organization has become enriching top executives (look <a href="http://hcrenewal.blogspot.com/2013/02/non-profit-hospital-executive-salaries.html">here</a> for a recent example).  As the first commentator noted above, this seems to arise out of the business school dogma that puts short-term revenue ahead of all other goals (which we discussed <a href="http://hcrenewal.blogspot.com/2012/04/health-care-dysfunction-explained-by.html">here,</a> and can be termed <a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a>.) But our concerns do seem to be getting more mainstream.  The first commentator above was actually the Governor of Connecticut, Dannel P Malloy, himself.  The second commenter was Connecticut state Senator Steve Cassano.  So prominent politicians are beginning to see the perversity of excess executive compensation in health care at a time of still burgeoning health care costs and still threatened health care access and quality.  So maybe some more people will listen this time when we repeat....  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.

Another Reason for Hope? - Concern about Excessive Executive Pay in Health Care Goes Mainstream

Another recent case suggested that the problem of excess, disproportionate compensation of health care executives is becoming more of a mai...

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Reason for Hope? - Novartis Rescinds Vasella's Golden Parachute

Enormous compensation of hired health care executives, out of all proportion, if related at all to whether their work had any positive effect on patients' or the public's health, has long been a <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">concern</a> on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>.  For example, back in 2006, we posted repeatedly (look <a href="http://hcrenewal.blogspot.com/2006/10/another-really-big-one-bites-dust-ceo.html">here</a> for links) about the billion dollar plus fortune amassed by the then CEO of UnitedHealthcare which vividly contrasted with the company's avowal to "make health care more affordable." We have posted many such stories.  Yet maybe there is a whiff of change in the air.  For the first time that I can recall, a gigantic pay package to a top health care executives has been rescinded after public protest. Novartis' Golden Parachute for Vasella This is how the New York Times <a href="http://www.nytimes.com/2013/02/19/business/global/for-daniel-vasella-of-novartis-78-million-to-keep-secrets.html">described</a> the huge golden parachute that was initially proposed: <blockquote class="tr_bq">A plan by Novartis<a class="meta-org" href="http://topics.nytimes.com/top/news/business/companies/novartis_ag/index.html?inline=nyt-org" title="More information about Novartis A.G"></a>, one of Switzerland’s biggest drug makers, to pay its departing chairman $78 million to keep him from sharing his knowledge with competitors has added fuel to an already heated debate about executive pay. <div itemprop="articleBody">The announcement of the payment to the chairman, Daniel Vasella, was made last Friday, just two weeks before a Swiss referendum to give shareholders more power to determine executive compensation. Mr. Vasella, who had previously said that he would step down as chairman at Novartis’s annual shareholder meeting on Friday, is to receive the sum, 72 million Swiss francs, over six years. </div><div itemprop="articleBody"> </div>In a statement, Mr. Vasella said that 'it has been very important to Novartis that I refrain from making my knowledge and know-how available to competitors and to take advantage of my experience with the company.'</blockquote> Unprecedented Resistance by Shareholders, Politicians and the Public The plan to provide this "golden parachute" met stunning resistance from Swiss citizens and company shareholders.  As the Times reported, <blockquote class="tr_bq"><div itemprop="articleBody">Swiss lawmakers and shareholder activists criticized the company over the weekend for not making the amount public earlier. They also contended that the planned payment was just the latest of several bad decisions by Novartis on executive pay. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Ethos, a Swiss group of investors, on Monday called on Novartis to immediately cancel the contract with Mr. Vasella and take back any money already paid. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Christophe Darbellay, president of the Christian Democratic People’s Party, told a Swiss newspaper, SonntagsZeitung, that Mr. Vasella’s compensation was 'beyond evil.' Simonetta Sommaruga, the Swiss federal justice minister, told another newspaper, SonntagsBlick, that the payment was an 'enormous blow for the social cohesion of our country' and that such 'help-yourself mentality' was damaging confidence in the economy. </div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">Even Swiss identified as pro-business or right-wing joined in the criticism.  As <a href="http://www.swissinfo.ch/eng/swiss_news/Vasella_s_extra_pay_stirs_up_emotions.html?cid=35006618">reported</a> by the Swiss Broadcasting Company, </div><div itemprop="articleBody"> </div><blockquote class="tr_bq"><div itemprop="articleBody">Philipp Müller, president of the centre-right Radical Party which traditionally has close links with the business community, is quoted as saying Vasella was 'taking liberal Switzerland to the henchman'. Other politicians described the latest figure as 'disgusting' and denounced the recklessness of top managers. The director of the Swiss Business Federation, which has been leading the fight against the initiative, said he was surprised by the 'dimension of the payment' to Vasella.</div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">A Golden Parachute Despite a Past Record of Misadventures </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Maybe there would have been even more outrage if those in Switzerland had known about Novartis' track record of misadventures, at least in the US, while Vasella had been leading it.  In particular,</div><div itemprop="articleBody">-  In 2011, as we noted <a href="http://hcrenewal.blogspot.com/2011/12/legal-settlements-have-become-so-common.html">here</a>, a company subsidiary paid $150 million to settle charges by several US states that it had misrepresented pricing information</div><div itemprop="articleBody">-  In 2010, as we noted <a href="http://hcrenewal.blogspot.com/2010/10/novartis-settles-but-wait-theres-more.html">here</a>, the company settled US federal civil and criminal charges in connection with its marketing of multiple drugs for $422.5 million.  The charges included giving kickbacks to physicians disguised as speakers' honorariums and fees for serving on advisory boards.  </div><div itemprop="articleBody">-  In 2010, as we noted <a href="http://hcrenewal.blogspot.com/2010/05/novartis-settles-again.html">here</a>, the company settled separate US charges that it made false claims to support off-label marketing of its drug tobramycin for cystic fibrosis for $72.5 million.  </div><div itemprop="articleBody">- In 2008, as we noted <a href="http://hcrenewal.blogspot.com/2008/07/bad-week-in-court-for-us-health-care.html">here</a>, the company settled charges in the US state of Alabama that it defrauded Medicaid for $33.7 million. However, these legal escapades were not mentioned in the recent media coverage of the proffered and then withdrawn parachute.  </div><div itemprop="articleBody"> </div><div itemprop="articleBody"> </div><div itemprop="articleBody">The Company Backs Down. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Nonetheless, what was really surprising was that the outrage made the company back down.  <a href="http://online.wsj.com/article/SB10001424127887323495104578313670408396876.html">Per</a> the Wall Street Journal, </div><div itemprop="articleBody"> </div><blockquote class="tr_bq"><div itemprop="articleBody">Novartis AG on Tuesday abandoned a 72-million-Swiss-franc ($78 million) exit package for its chairman, bowing to pressure from shareholders and Swiss politicians after four days of increasing criticism.</div><div itemprop="articleBody"> </div>The Swiss drug maker said its board and Chairman Daniel Vasella<a class="topicLink" href="http://topics.wsj.com/person/V/Daniel-Vasella/4329"></a> agreed to cancel a six-year noncompete and related-compensation agreement designed to prevent him from joining or advising rivals and which would have paid him 12 million francs a year. The agreement was scheduled to take effect on Friday, when Dr. Vasella, 59 years old, is planning to leave the Basel-based company at its annual shareholder meeting</blockquote> Furthermore, <blockquote class="tr_bq">In the Novartis statement on Tuesday, Dr. Vasella acknowledged that his offer hadn't soothed public opinion: 'I have understood that many people in Switzerland find the amount of the compensation linked to the noncompete agreement unreasonably high,' he said. </blockquote> In addition, as Reuters noted, Vasella actually admitted he made "mistakes," <blockquote class="tr_bq">'The fierce reaction and reproaches that were made as a consequence of the many-sided discussions about my compensation did leave its mark on me,' 59-year-old Vasella said in his opening address to 2,688 shareholders gathered at Novartis's annual general meeting in Basel. 'I made two avoidable mistakes: the first was to even negotiate this contract. And the second to believe that giving up this individual payment to charities would be considered as something positive by society.'</blockquote> Of course, it is hard to believe that Novartis had previously paid him as lavishly as it did  - the New York Times had reported that his pay just prior to resignation was 12.4 million francs, "about $13.4 million a year" -  without securing an agreement to protect trade secrets.  Many businesses routinely add confidentiality clauses, trade secret protection, and non-compete clauses to contracts of many employees.  Thus adding a $78 million golden parachute ostensibly just to protect trade secrets and defection to the competition seems like impossibly gilding the lily.  Furthermore, if Novartis really thought that Vasella was likely to run to another firm at the drop of a hat, it would have made no sense to entrust someone thought to be at risk of such disloyalty with top leadership positions. Reason for Hope At least Chairman Vasella admitted "mistakes," and at least the ridiculous pay package was rescinded. This incident does show that it is possible for public and shareholder outrage over gargantuan payments to executives to have some effect.  That seems like real progress, and a reason to hope.  Of course, executives of public for-profit corporations are supposed to be working for shareholders.  Thus their general impunity from shareholders' control up to now remains inexplicable.  Furthermore, executives of pharmaceutical companies and other health care corporations seemingly should be responsible for putting patients' and the public's health ahead of their own enrichment.  Thus their ability up to now to ignore public concern about their companies' actions, and to avoid personal responsibility for their companies' bad actions also remains inexplicable. But progress may now be possible.  In and outside of Switzerland, shareholders of publicly-held for-profit health care corporations should demand accountability from the executives who are supposed to be working for them.  In and outside of Switzerland, health care professionals, policymakers, and the public at large should demand accountability from leaders of health care organizations for the effects of their organizations on patients' and the public's health.

Reason for Hope? - Novartis Rescinds Vasella's Golden Parachute

Enormous compensation of hired health care executives, out of all proportion, if related at all to whether their work had any positive effec...

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From another happy EHR user: automatic data "corrections" that alter the past

From another happy EHR user: <blockquote class="tr_bq">One of my patients was married in late 2012.   <div> </div>Her name changed from XXXX to YYYY. <div> </div><div>Today I incidentally reviewed this patient's chart.</div><div> </div><div>Can you guess what name appears on all progress notes (on the LCD screen and in printed form)…going back to early 2007?</div><div> </div><div>You guessed it…YYYY…even though her name was XXXX until late 2012.</div><div> </div><div>I've also seen this happen with providers.  Example:  an RN received her NP.  When they updated her prof designation in the EHR, ALL of her notes were changed to NP…even though about 10 of those years she was an RN.</div><div> </div><div>That's data integrity if I've ever seen it!</div></blockquote> These "features" could create injurious clinical confusion, and credentialing issues in litigation as well. Thus are the risks of having merchant computing "experts", with little understanding of how clinical and medicolegal issues differ from selling doggie biscuits, shove their bad health IT down clinician's throats. (Or, perhaps the better metaphor would involve the distal end of the GI tract.) -- SS

From another happy EHR user: automatic data "corrections" that alter the past

From another happy EHR user: One of my patients was married in late 2012. Her name changed from XXXX to YYYY. Today I incidentally reviewe...

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EHRs and "Meaningful Use": Begging the Question in the New England Journal of Medicine

I used to have great respect for the New England Journal of Medicine. No more. That respect was reduced significantly in 2010 when I saw the following passage (as I wrote in my July 2010 post "<a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html" target="_blank">Science or Politics? The New England Journal and The 'Meaningful Use Regulation for Electronic Health Records</a>"):  <blockquote class="tr_bq"><div class="MsoNormal">... In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available <a href="http://healthcarereform.nejm.org/?p=3732&query=home">at this link</a>, the opening statement is (emphases mine):</div><div class="MsoNormal"> </div><div class="MsoNormal"> </div><div class="MsoNormal" style="margin-left: .5in;">The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.</div><div class="MsoNormal"> </div><div class="MsoNormal">I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals.</div><div class="MsoNormal"> Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced. I note the lack of footnotes showing the source(s) of these statements.</div><div class="MsoNormal"> </div><div class="MsoNormal">I also note the lack of mention of literature refuting or potentially refuting these statements of certainty. I can think of more than a few examples of the latter just off the top of my head [ref. 1-15 below, certainly not a comprehensive list but merely skimming the surface].</div><div class="MsoNormal"> </div><div class="MsoNormal">... So, did the NEJM publish fact, or political platitude?</div><div class="MsoNormal"> </div><div class="MsoNormal">Can someone provide a list of peer reviewed, rigorous studies that back the assertions of certainty in 10.1056/NEJMp1006114, and override the body of literature that could cast doubt on these assertions of certainty?</div></blockquote> The negative if not bitter reader comments to yesterday's New York Times article on the health IT lobby (<a href="http://hcrenewal.blogspot.com/2013/02/nyt-digital-shift-on-health-data-swells.html" target="_blank">link</a>) certainly cast some doubt. My respect has dropped several more notches in 2013. The NEJM has served as a PR journal for health IT once again. In a correspondence piece "<a href="http://www.nejm.org/doi/full/10.1056/NEJMc1213481" target="_blank">Early Results of the Meaningful Use Program for Electronic Health Records</a>", N Engl J Med 2013; 368:779-780,  February 21, 2013 by Adam Wright, Ph.D., Stanislav Henkin, B.A., Joshua Feblowitz, M.S., Allison B. McCoy, Ph.D., David W. Bates, M.D. and Dean F. Sittig, Ph.D., the following statement is published (emphases mine): <blockquote class="tr_bq">... The downstream effects of meaningful use on quality, safety, and efficiency are not yet known, and further increases in EHR adoption, functionality for clinical decision support systems, and research are needed to ensure the effectiveness of the meaningful use program </blockquote> I note that <a href="http://www.nizkor.org/features/fallacies/begging-the-question.html" target="_blank">B</a><a href="http://www.nizkor.org/features/fallacies/begging-the-question.html" target="_blank">egging the Question</a> is a fallacy in which the premises include the claim that the conclusion is true or (directly or indirectly) assume that the conclusion is true. Further, I made the following points in my Jan. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/01/meaningfully-experimental-protocols-and.html" target="_blank">Meaningfully Experimental Protocols and Interfaces to Nowhere? Nagging Questions On Healthcare IT Remain</a>": <blockquote class="tr_bq">... there is a major problem with the term "meaningful use" itself: <blockquote> This [term "meaningful use"] is an example of putting the cart before the horse, and is a semantically-based, self contained logical fallacy of sorts. If a health IT system is harmful, the term "meaningful use" is itself Orwellian. If we don't know if HIT is beneficial, or have doubts, then such as term presupposes that health IT is inherently beneficial. A better term would have been "good faith use" - use based on the faith or hope that health IT will have an overall positive effect. The term "meaningful use" jumps the gun and is more a political slogan than a "meaningful term."</blockquote> I go further. Use of a term that a priori assumes some outcome reflects the antithesis of science. The term "meaningful use" in the domain of technology implies that those following the recipe for use of some technology, as well as their subjects, will experience meaningful outcomes. A parallel is in the logical fallacy of <a href="http://www.logicalfallacies.info/presumption/begging-the-question/">begging the question or circular argument</a>, where the conclusion of an argument is among its premises.</blockquote> In this current NEJM passage, the "question" of MU effectiveness is shamelessly begged like a hungry puppy begging for a <a href="http://snausages.com/" target="_blank">Snausage doggie snack</a>. <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgPmkXt5cm0oa6UEcuITsYQ0L1LBsHyz_Vk6_adzOsPcKEDK0ycg56RxordM-mcHKEyeuWFUabhhYvKD8xgrsURwRH48HHquDOG2J9_Yhx9RJlX9licuN8HOxhgEvOcXK5Q3dtt7_ze5hTo/s1600/Snausages-.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgPmkXt5cm0oa6UEcuITsYQ0L1LBsHyz_Vk6_adzOsPcKEDK0ycg56RxordM-mcHKEyeuWFUabhhYvKD8xgrsURwRH48HHquDOG2J9_Yhx9RJlX9licuN8HOxhgEvOcXK5Q3dtt7_ze5hTo/s200/Snausages-.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"> </td></tr></tbody></table> "Ensure the effectiveness?"  The inherent assumption is that MU (developed by consensus committee without supporting rigorous evidence of effectiveness), whose 'downstream effects' are admittedly unknown, WILL be effective - if only we spend MORE billions of dollars on the technology. At best, the appropriate statement to have been made is this: <blockquote class="tr_bq">... The downstream effects of meaningful use on quality, safety, and efficiency are not yet known, and further increases in EHR adoption, functionality for clinical decision support systems, and research are needed to determine if meaningful use will have any positive impact on healthcare quality, safety and efficiency."</blockquote> <div style="right: auto;">From a physician commenter overseas who excels in demolishing health IT propaganda:  <blockquote class="tr_bq">Seriously, did they proof read the last paragraph? How did the NEJM editors let that get printed?  Given the recent food scandal in the UK, it is like the PM saying we are not quite sure that there's horsemeat in the Burgers and Lasagna so we are going to need to import a lot more of this muck from France, Poland & Romania before drawing any conclusions... </blockquote></div><div style="right: auto;"></div> Shame on the New England Journal.  My respect for them is even lower than after the 2010 health IT advert as above.  This current letter's conclusion is a high school-level <a href="http://www.thefreedictionary.com/faux+pas" target="_blank">faux pas</a> and, in my opinion, should not have been published in its present form. -- SS Addendum:  Let's see if they publish my Letter to the Editor on this matter, submitted today. Second addendum:  a reader opined that MU could have a negative impact on quality, safety and efficiency (cf. yesterday's NYT article and reader comments, <a href="http://hcrenewal.blogspot.com/2013/02/nyt-digital-shift-on-health-data-swells.html" target="_blank">link</a>).  While less likely, we just don't know. Addendum Mar. 18, 2013.  I received this today from the NEJM: <blockquote class="tr_bq">Your letter referring to the Wright article of 21-Feb-2013  has been received.  Because of the limited availability of space, we can publish only a fraction of the letters we receive.  Although we will not be able to print yours, we have forwarded a copy to the authors in case they wish to reply directly to you. </blockquote>  This is why I blog. -- SS

EHRs and "Meaningful Use": Begging the Question in the New England Journal of Medicine

I used to have great respect for the New England Journal of Medicine. No more. That respect was reduced significantly in 2010 when I saw the...

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