The Pervasiveness of Health Care Corruption as Shown by Another Roundup of Legal Settlements

Legal settlements are one way to document unethical and even corrupt behavior by large health care organizations, even if they may not deter bad behavior in the future.  It is time for another roundup of settlements by large pharmaceutical and device companies, presented in alphabetical order<br /><br /><b>Abbott Laboratories</b><br /><br />This one goes back to late December, 2013.  As <a href="http://www.chattanoogan.com/2013/12/27/266328/Abbott-Laboratories-To-Pay-5.475.aspx">described</a> in the Chattanoogan (from Tennessee):<br /><br /><blockquote class="tr_bq">Abbott Laboratories, a global healthcare company, has agreed to pay $5.475 million to settle alleged violations of the False Claims Act, and other federal laws and regulations in connection with the operation of its medical device business which manufactures, markets and supplies carotid, biliary, and peripheral vascular products.</blockquote><br />The US Justice Department accused Abbott of kickbacks to physicians,<br /><br /><blockquote class="tr_bq"> As alleged in the settlement agreement, between 2005 and 2010, through its employees and a third party continuing medical education providers, <i>Abbott offered physicians paid teaching and training assignments, consulting arrangements, speaking engagements, and/or sponsorship grants for physician conferences, for the purpose of inducing physicians to arrange for or recommend that the hospitals with which they were affiliated purchase or order Abbott’s carotid, biliary and peripheral vascular products.</i></blockquote><br />Note in particular that the kickbacks were disguised as payments for consulting or speaking. <br /><br />As is usual in such cases, no individual seems to have paid any penalty or been subject to any punishment.  Because this was a legal settlement, the company did not admit wrongdoing.<br /><br />Abbott's previous issues are discussed <a href="http://hcrenewal.blogspot.com/search/label/Abbott">here</a>, including a <a href="http://hcrenewal.blogspot.com/2012/05/abbott-pleads-guilty-settles-for-16.html">$1.6 billion settlement in 2012</a>.  <br /><br /><b>Baxter International</b><br /><br />This was <a href="http://www.modernhealthcare.com/article/20140421/INFO/304219992">reported</a> in April, 2014 by Modern Healthcare,<br /><br /><blockquote class="tr_bq"> Baxter International agreed to pay $64 million to settle a class-action lawsuit that alleged the Deerfield, Ill.-based company and some of its competitors <i>colluded to raise prices</i> of plasma-based therapies.</blockquote><br />Unlike the other cases above and below, this seemed to be a purely financial misadventure, although one that clearly increased health care costs,<br /><br /><blockquote class="tr_bq">Hospitals and drug distributors, saying they bought the plasma products at inflated prices, sued in 2009 Baxter; Victoria, Australia-based CSL; and the Plasma Protein Therapeutics Association, an Annapolis, Md.-based trade group.</blockquote><br />Once more, the company admitted no wrongdoing, and no individuals seemed to be subject to any negative consequences.   <br /><br />Baxter International's previous misadventures are <a href="http://hcrenewal.blogspot.com/search/label/Baxter">here</a>, including the <a href="http://hcrenewal.blogspot.com/2011/08/jama-article-begs-key-questions-about.html">striking case</a> of its marketing of contaminated and sometimes deadly heparin made from Chinese pigs.  <br /><br /><b>Endo Health Solutions</b><br /><br />This one is from February, 2014, as<a href="http://www.bloomberg.com/news/2014-02-21/endo-to-pay-193-million-in-lidoderm-marketing-probe.html"> reported</a> by Bloomberg<br /><br /><blockquote class="tr_bq">Endo Health Solutions entered a deferred-prosecution agreement and will pay $193 million to settle whistle-blower claims that it <i>marketed the shingles drug Lidoderm for unapproved purposes</i>, the U.S. said. <br />Endo will pay $20.8 million in forfeitures and $171.9 million in civil false claims settlements with the states and the U.S. government, the Justice Department said today in a statement. </blockquote><br />This one was all about marketing for uses not approved by the US Food an Drug Administration,<br /><br /><blockquote class="tr_bq">Between 2002 and 2006, Endo sales managers instructed some representatives on how to<i> expand 'sales conversations' with doctors beyond the treatment of shingles-related pain</i>, the U.S. said. Under the deferred-prosecution agreement, Endo admitted that it intended Lidoderm to be used for uses not approved by the U.S. Food and Drug Administration, the Justice Department said. </blockquote><br />Note that this case involves false claims, that is, fraud, because it is illegal to bill government programs for unapproved uses.<br /><br />Again, no individual suffered any consequences, and the company offered the usual kind of statement that admitted neither responsibility nor guilt,<br /><br /><blockquote class="tr_bq">'We are pleased to resolve this matter and are confident that we have robust programs in place to assist us in satisfying our legal and regulatory agreements,' Endo Chief Executive Officer Rajiv De Silva said in a statement.  </blockquote><br />One wonders, as usual, why a company would pay so much merely to avoid the legal expenses of a trial, unless of course the lawyers suspected the trail would not go well?<br /><br /><b>Hospira</b><br /><br />This one was about hiding quality problems due to cost-cutting from investors, as<a href="http://www.reuters.com/article/2014/03/27/hospira-lawsuit-idUSL1N0MO2BS20140327"> reported</a> by Reuters in March, 2014.   <br /><br /><blockquote class="tr_bq">Hospira Inc <span id="articleText"><span class="focusParagraph">has agreed to pay $60 million to resolve a class action lawsuit accusing the drug maker of misleading investors about <i>quality control problems that undermined an initiative to improve the company's margins and operations.</i></span></span></blockquote><br /><span id="articleText"><span class="focusParagraph">The details included,</span></span><br /><br /><blockquote class="tr_bq"><span id="articleText">As Hospira was promising to address issues raised by the U.S. Food and Drug Administration following inspections, the plaintiffs said the company was '<i>making the problems worse by gutting quality control efforts through cost cutting aimed at boosting short-term profitability</i>.'<br /><br /><span id="midArticle_7"></span>The lawsuit said those cost-cutting moves stemmed from a March 2009<i> initiative called 'Project Fuel' intended to increase shareholder value by eliminating underperforming and duplicative units and reducing its global workforce.</i><br /><br /><span id="midArticle_8"></span>Plaintiffs contended the <i>cuts in the budget and workforce hurt Hospira's quality control </i>efforts, particularly at Rocky Mount, the company's largest facility.<br /><br /><span id="midArticle_9"></span>An FDA inspection in January 2010 of the Rocky Mount facility found a number of <i>problems with the company's quality control and drug validation processes</i>, the lawsuit said, and the agency issued a warning letter that April.</span></blockquote><span id="articleText"></span><br /><br />Note that this involved quality control problems presumably in drug or device production, possibly leading to safety risks for patients.  Yet it was investors who brought the lawsuit.<br /><br />Note also that this seemed to be a clear case in which cost-cutting measures meant to improve short-term corporate revenue lead to problems that could have caused such risks.   <br /><br />One interesting feature of this case was that company executives were named as defendant (presumably again because it was investors, not patients or law-enforcement officials who initiated the suit.)<br /><br /><br /><blockquote class="tr_bq"><span id="articleText"><span id="articleText">The lawsuit ... also named executives including Chief Executive Officer Michael Ball as defendants,...</span></span></blockquote><span id="articleText"></span><br /><br /><span id="articleText">I cannot find any information about whether these executives were personally liable for any payments, however.   </span><br /><span id="articleText"><br /></span><b><span id="articleText">Pfizer</span></b><br /><span id="articleText"><br /></span><span id="articleText">This is yet another settlement involving the marketing of Neurontin, as <a href="http://www.bloomberg.com/news/2014-04-22/pfizer-agrees-to-pay-190-million-to-settle-neurontin-case-1-.html">reported</a> by Bloomberg in April, 2014,</span><br /><span id="articleText"><br /></span><br /><blockquote class="tr_bq"><span id="articleText"><span id="articleText">Pfizer Inc </span>the world’s biggest drugmaker, agreed to pay $190 million to end a lawsuit claiming it <i>violated federal antitrust laws by delaying generic versions of its Neurontin epilepsy drug. </i><br /></span></blockquote><blockquote>Pfizer agreed to settle the class-action litigation pending in federal court in Newark, New Jersey, according to a filing today. U.S. District Judge Faith Hochberg must approve the accord, which would cover purchasers of Neurontin from December 2002 to August 2008. </blockquote><br />Note that this settlement, like many others, is of matter from a long time ago.  When it comes to bad behavior by big health care corporations, any form of justice is not swift. <br /><br />Note also that this is only the latest chapter in the long saga of Neurontin, for whose mis-marketing Pfizer has already shelled out a lot of money (see<a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html"> this post</a> to start, and <a href="http://hcrenewal.blogspot.com/search/label/Neurontin">here</a> for the collection).  Pfizer has an amazing record of bad behavior on view <a href="http://hcrenewal.blogspot.com/search/label/Pfizer">here</a>.  In fact, it has had a conviction as a Racketeering Influenced Corrupt Organization (RICO) on the basis of its previous marketing of Neurontin (look <a href="http://hcrenewal.blogspot.com/2013/12/blogscan-us-supreme-court-turns-down.html">here</a>). <br /><br />This particular bad behavior involved included,<br /><br /><blockquote class="tr_bq"> improperly listing certain patents with the U.S. Food and Drug Administration, engaging in <i>illegal promotion</i> and sales of Neurontin for unapproved uses, filing and maintaining sham litigations with respect to certain patents, and making misrepresentations to the patent courts,</blockquote><br />Note that while much of this was legalistic, illegal marketing was in there too.<br /><br />Once more, I found nothing about any negative consequences for individuals who authorized, directed, or implemented questionable actions.<br /><br /><b>Summary</b><br /><br />So it is all drearily familiar.  Big health care organizations seem to repeatedly engage in deceptive marketing, providing kickbacks to health professionals, fraudulent billing, anti-competitive practices, etc, etc.  These practices increase health care costs, and may risk patients' health and safety.  Many of these practices are corrupt, at least according to the Transparency International definition of corruption, "abuse of entrusted power for private gain."  Drug and device companies, for example, are entrusted to provide safe and effective products.  Deceptive marketing, kickbacks to health professionals to encourage overuse, and cutting quality control to cut costs all seem to be examples of abuse of this entrusted power.  The private gain obviously goes to any managers and executives who score bigger bonuses due to the increases in revenue that result.  <br /><br />Yet there are very few examples of any individuals who gained ever being subject to any negative consequences.  Given that lack, and the lack of any requirement for corporate leaders to admit responsibility, much less guilt, is it any surprise that these practices go on and on.  The failure of current limp legal efforts against such corruption is evident by how many corporations have become ethical repeat offenders.   (Note that in fact, as noted above, one of the pharmaceutical companies above actually was convicted of being a RICO, racketeering influenced corrupt organization, yet that conviction seemed to have no real negative consequences for the organization or any of the people involved.) <br /><br />As I have said again and again, pervasive bad behavior by large health care organizations has got to be a major cause of our ongoing health care dysfunction.<br /><br />So, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue. <br />

The Pervasiveness of Health Care Corruption as Shown by Another Roundup of Legal Settlements

Legal settlements are one way to document unethical and even corrupt behavior by large health care organizations, even if they may not deter...

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From a physician and former USAF air traffic controller/pilot on the state of healthcare IT

From a colleague, a physician and blogger and fellow AMIA member with an eclectic background, on the state of healthcare information technology.  Reposted with his permission.<br /><br />Emphases in bold are mine:<br /><br /><div id="divRpF835024" style="direction: ltr;"><span style="color: black; font-family: Tahoma; font-size: x-small;"></span></div><blockquote class="tr_bq">To restate the old joke, the nice things about medical informatics standards, are their are so many of them too chose from… don’t think we necessarily need to invest even more time and energy on ever more sophisticated data models or ever more exhaustive standards (which are then largely ignored).  <br /><div><br /></div><div>The fact of the matter is that the EMR remains in the United States a tool for maximization of reimbursement and as such is <b>not a  technological destination but rather a technological dead end</b>. The driver for proliferation of this ‘dead end’ is the government being willing to fund its expansion with their fervent hope that it will be their magic bullet for finding the cheats and cheaters of Medicare. </div><div><br /></div><div>When I was in the USAF, I was trained to be a software and systems engineer at their great expense and at my great pleasure. Additionally, I was for several years prior to my medical school career <b>a USAF Air Traffic Controller</b> and so I was intimately familiar with perhaps the most perfect of all known systems engineering efforts the Worldwide Air Traffic Control System, <b>and most remarkably (from the wellsprings of my fading memories) I have 50 hours of stick time in the F-16. </b></div><div><br /></div><div>The flying environment of the F-16 which is ‘eyes outside the cockpit’ was made possible by <b>advanced human engineering efforts</b> that resulted in Heads Up Displays of both intense rational and aesthetic beauty that made the machine a joy to fly. </div><div><br /></div><div>Fast forward 20 years and what am I given as a clinician to work with…. to keep my head out of the cockpit…… spreadsheets…… designed by engineers who like spreadsheets and think in spread sheets…..  <b>and who don’t even take the 30 minutes it takes to articulate the logic of presentation of clinical data</b>, i.e., present the serum salts together with the BUN/Creatinine, present the RDW with the RBC indices and the hematocrit and hemoglobin … present the last 3 d’s worth of data together aggregated by type rather than alphabetized and homogenized and distributed in clinically illogical boxes. </div><div><br /></div><div><b>The F-16 was designed by engineers, but pilots oversaw its development and the display of its information systems were always the results of intense end user interaction with the design teams. </b>This type of intense physician interaction and <b>veto power of poor information design efforts does not exist in [the health IT] industry. </b>Their goal is feature proliferation and uniqueness (not commonality) of function as a market differentiation tool and to avoid suits for ‘look and feel’ viz a viz the Apple vs Microsoft suits of the 80’s. </div><div><br /></div><div>The reality is the train has left, those of us addicted to patient care <b>watch in dismayed horror as our productivity plunges and we struggle to restructure not our workflows but our clinical thought processes to badly designed, logically flawed, and obscenely overpriced documentation tools that distract the expert clinician from a high quality clinical encounter. </b></div><div><br /></div><div>Quite honestly gentleman and gentlewomen of the jury, I don’t give a ‘rats a**’ about superior documentation, I am obsessed with superior outcomes, and as somebody who actually has to work with this junk, it all sucks………. and will continue to suck <b>until such time as real world clinicians have veto power over the efforts of systems design teams with respect to their information design efforts</b>…. What information design efforts?  My point precisely……. </div><div><br /></div><div>As always Acerbically Yours, </div><div><br /></div><div><br /></div><div>frnk m (Frank Meissner)</div><div><br /></div><div>“I am not a pessimist, I am an optimist who has not arrived’ </div><div>                                                                      Mark Twain</div></blockquote><br />My reply back was:<br /><br /><blockquote class="tr_bq">Frank, on a related note, I was at a fleamarket yesterday looking for radio & electronics stuff (my hobby) and came across a man selling copies of "Aviation Week" from 1960.  He had the entire year's set.<br /><br />I looked through them and was STUNNED.<br /><br />The engineering prowess described in not just the articles but in the advertisements as well - bearings, servos, instrumentation, etc. for aircraft and spacecraft was stunning.  There was even an ad for a desktop computer, a Packard Bell PB-250 with "microsecond add time, 350 transistors and 46 (or so) instructions" for a mere $30,000.<br /><br />What you are describing - and what I have been trying to describe for over a decade and a half - is <b>an intellectually impoverished industry that ignores our specialty [Medical Informatics] and good engineering practices in general.</b><br /><br />That AMIA has made itself appear comfortable with that status quo has been a disappointment to say the least.  What you just wrote should have come from the leadership, and years ago, not from the grass roots.<br /><br />If physicians could refuse use of clinical IT without sanction, I believe in 2014 that most would walk away.<br /><br />The fact that this technology is now forced on clinicians is not what the pioneers in informatics intended, I am confident; our medical leadership, furthermore, should be ashamed of this set of affairs. As a former medical manager for the Southeastern PA Transportation Authority, even bus drivers and porters in public transit had more rights to determine what equipment they would or would not use in their work, and its configuration, than physicians have in theirs.</blockquote><br />-- SS

From a physician and former USAF air traffic controller/pilot on the state of healthcare IT

From a colleague, a physician and blogger and fellow AMIA member with an eclectic background, on the state of healthcare information technol...

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In ECRI Institute's new 2014 "Top 10 Patient Safety Concerns for Healthcare Organizations", Healthcare IT is #1. (FDA: E-cigarettes are REALLY dangerous.)

The ECRI Institute in Pennsylvania (<a href="https://www.ecri.org/About/Pages/default.aspx">https://www.ecri.org/About/Pages/default.aspx</a>) has had health IT as among the "Top Ten Healthcare Technology Risks" for several years running.  Search this blog on "ECRI" for mention of those reports.<br /><br />Just off the press, though, is ECRI's <b>"Top Ten patient safety concerns for 2014"</b>.  The PDF report is available at <a href="https://www.ecri.org/EmailResources/PSRQ/Top10/Top10PSRQ.pdf">https://www.ecri.org/EmailResources/PSRQ/Top10/Top10PSRQ.pdf</a>.<br /><br />Health IT is number one, perhaps as a result of the ECRI Deep Dive study of Health IT risk with its hair-raising numbers of 171 "IT incidents", 8 resultant injuries, and 3 possible deaths in 36 hospitals in just 9 weeks (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>).<br /><br />From the new report: <br /><br /><span style="font-family: arial,helvetica,sans-serif;">CONCERN #1: <b>Data integrity failures with health information technology systems</b></span><br /><br /><div><span style="font-family: arial,helvetica,sans-serif;">At page 7:</span></div><div><span style="font-family: arial,helvetica,sans-serif;"><br /> </span><br /><div style="font-family: serif; margin-left: 40px;"><span style="font-family: inherit;"><span style="font-size: small;">With the federal government offering financial incentives for hospitals and physician</span></span><span style="font-family: inherit;"><span style="font-size: small;"> practices to adopt EHR systems, use of these systems more than tripled from 2009 </span></span><span style="font-family: inherit;"><span style="font-size: small;">through 2012. “Health IT systems are very complex,” says James P. Keller, M.S., vice </span></span><span style="font-family: inherit;"><span style="font-size: small;">president, technology evaluation and safety, ECRI Institute. <b>“They are <u>managing a lot of</u></b><b><u> information</u>, and it’s easy to get something wrong” if the systems are not designed and </b><b>implemented well.</b> While appropriately designed and implemented systems can provide complete, current, and accurate patient care information so that the clinician can make appropriate treatment decisions,<b> the presence of incorrect data can lead to incorrect</b><b> treatment, potentially leading to patient harm.</b></span></span></div><span style="font-family: inherit;"></span><br /><div style="font-family: serif; margin-left: 40px;"><span style="font-family: inherit;"><span style="font-size: small;">For example, the integrity of data in health IT systems can be compromised from any of the following:<b> </b>data entry errors, missing data or delayed data delivery, inappropriate</span></span><span style="font-family: inherit;"><span style="font-size: small;"> use of default values, copying and pasting older information into a new report, use of </span></span><span style="font-family: inherit;"><span style="font-size: small;">both paper and electronic systems for patient care, and patient/data association errors (i.e., patient data from a medical device is mistakenly associated with another patient’s record). Key steps in safeguarding the integrity of electronic patient data include the </span></span><span style="font-family: inherit;"><span style="font-size: small;">following:</span></span></div><div dir="ltr" style="font-family: serif; font-size: 16.6667px;"><span style="font-family: inherit;"><span style="font-size: small;"> </span></span><br /><div style="font-family: serif; margin-left: 40px;"><span style="font-family: inherit;"><span style="font-size: small;"><br /></span></span></div><div style="font-family: serif; margin-left: 40px;"><span style="font-family: inherit;"><span style="font-size: small;"><b>x  </b>Assessing the clinical workflow to understand how the data is, or will be, used by frontline staff  <br /> <b>x  </b>Testing the system and the associated interfaces, preferably in a simulated setting, to verify that the system is functioning as intended<br /><b>x  </b>Providing sufficient user training and support<br /><b>x  </b>Establishing a mechanism for users to report problems as they are discovered</span></span><br /><br /></div></div></div>In the Bizarro world in which we find ourselves in 2014, however:<br /><br /><ul><li>FDA has decided that healthcare information technology systems <b>"</b><b><b><u>for health information and data management</u></b>" </b>(I quote) are of <b>"sufficiently low risk"</b>, even if they "meet the statutory requirements as medical devices" and thus fall under the Food, Drug & Cosmetic Act, to not require FDA oversight, and even though FDA admits they really do not and cannot know the true level of risks (<a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>).  </li></ul><i>(Got that?)</i><br /><br />While:<br /><ul><li>Regulation of <b>E-cigarettes</b> is a National Priority of the Highest Importance due to Their Possible Deadly Dangers (<a href="http://hcrenewal.blogspot.com/2014/04/hypocrisy-at-fda-lets-regulate.html">http://hcrenewal.blogspot.com/2014/04/hypocrisy-at-fda-lets-regulate.html</a>).</li></ul>The E-cigarette focus is <i>For The Children</i>, no doubt.<br /><ul><li>Except for <i>children such as these</i>, one might conclude:  <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html</a>.</li></ul><br /><ul> </ul><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh0BV8P-O5io5HPCOYJHdjddYwVGrOt4Fj_vfeeLDGHu1cvrn3-1iryc-KRA_e-toY6ak2nFKFtijMIOvXB0W2PE8xMQe8IX6Pbbs42QmR4cTSR9swsk-IG3i371ljixE3-GSUn7QbQXzqZ/s1600/bizzaroworld.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh0BV8P-O5io5HPCOYJHdjddYwVGrOt4Fj_vfeeLDGHu1cvrn3-1iryc-KRA_e-toY6ak2nFKFtijMIOvXB0W2PE8xMQe8IX6Pbbs42QmR4cTSR9swsk-IG3i371ljixE3-GSUn7QbQXzqZ/s1600/bizzaroworld.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Bizarro World (<a href="http://en.wikipedia.org/wiki/Bizarro_World">http://en.wikipedia.org/wiki/Bizarro_World</a>).</td></tr></tbody></table><br /><br />Note that ECRI Concerns #2 and #3 also may involve electronic medical records systems.<br /><br /><span style="font-family: arial,helvetica,sans-serif;">CONCERN #2:<b> </b></span><b>Poor Care Coordination with Patient’s Next Level of Care</b> (page 8):<br /><br /><blockquote>... Electronic health records (EHRs) can facilitate communication about a patient’s care among providers, but organizations must establish procedures that address accessing, reviewing, and acting on the findings in those records. For example, what happens if a provider who is viewing a patient’s record discovers that results of tests ordered by another provider have not been acted upon? <b>EHRs could become a barrier “if physicians are second-guessing one another</b>,” says Possanza. Organizations might find it helpful to develop a policy specifying procedures <b>for a provider who finds an abnormal laboratory or pathology result with no indication that the abnormal result was acted upon.</b></blockquote><ul></ul><br /><span style="font-family: arial,helvetica,sans-serif;">CONCERN #3</span>: <b>Test Results Reporting Errors</b> (page 10):<br /><br /><blockquote class="tr_bq">... Callahan observes that breakdowns in test results reporting, particularly in physician practices, typically have one of three causes or a combination of them: (1) <b>technology limitations, such as an inadequate interface between an EHR system and a laboratory system that provides the results electronically</b>; (2) provider-to-provider communication gaps, such as those that occur when no backup plan is in place to designate a provider to review test results for another provider who is unavailable or on vacation; and (3) staffing and training failures, <b>such as requiring a staff member to periodically check an EHR system for test results but not informing the person of what to expect in terms of the volume of test results</b> typically reported to the practice.<br /><br />As more healthcare organizations adopt EHR systems, Callahan<b> warns against being lulled into thinking the systems are a panacea </b>and can prevent test reporting failures. “It’s another tool,” she says. “It won’t improve test results reporting if it’s not used correctly.”</blockquote><br />I was involved as consultant in a related scenario, in a case that settled out of court, where an ordered lab test was never performed (probably due to an EHR-lab interface failure!) and automatically "expired" in the EHR after a year.  However, no subsequent provider acted upon the expired order, with disastrous results.<br /><br />-- SS

In ECRI Institute's new 2014 "Top 10 Patient Safety Concerns for Healthcare Organizations", Healthcare IT is #1. (FDA: E-cigarettes are REALLY dangerous.)

The ECRI Institute in Pennsylvania ( https://www.ecri.org/About/Pages/default.aspx ) has had health IT as among the "Top Ten Healthcare...

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Followup to "CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives"

At my April 16, 2014 post "<b>CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives</b>" (<a href="http://hcrenewal.blogspot.com/2014/04/cms-does-not-have-any-information-that.html">http://hcrenewal.blogspot.com/2014/04/cms-does-not-have-any-information-that.html</a>) I noted that the American Association of Physicians and Surgeons (AAPS) had received a reply from CMS to a FOIA request that:<br /><br /><blockquote class="tr_bq"><i>"We [CMS] do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."</i> </blockquote><br />Put another way, the country is embarking on a $1 trillion healthcare experiment, and blindly.<br /><br />I mentioned I'd post the letter when received from AAPS.  That just occurred.<br /><br />The letter is below (click to enlarge):<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhXyGzY3biU0IcibR_jpNBb18X__sIeFWVd7E3T1MoAa300RBg2N_3-t_UMmx2bhlwk3KnobEgycCWCVmwWTy13uQVLGi3VBPFpgdzCHBu_0Qq5-fDamfZIWx-WeLaeYztcEayTGeCU7JIC/s1600/CMS_Letter.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhXyGzY3biU0IcibR_jpNBb18X__sIeFWVd7E3T1MoAa300RBg2N_3-t_UMmx2bhlwk3KnobEgycCWCVmwWTy13uQVLGi3VBPFpgdzCHBu_0Qq5-fDamfZIWx-WeLaeYztcEayTGeCU7JIC/s1600/CMS_Letter.jpg" width="308" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  Click to enlarge.<b><br /></b></td></tr></tbody></table><br />I've added it as an addendum to the original post, but thought it worthwhile to call out the letter in a post of its own to those who might not revisit the original.<br /><b><br /></b><b><u>An additional thought</u>:</b><br /><br />While CMS may "not have any information that supports or refutes claims that a broader adoption of EHRs can save lives", they <b>do have</b> (or should have made it their business to have) information <b><u>that EHRs cause harm and take lives</u></b> (e.g., via FDA at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a> , ECRI at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a> and others).<br /><br />-- SS

Followup to "CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives"

At my April 16, 2014 post " CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save ...

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Hypocrisy at the FDA: Let's regulate E-cigarettes ... E-medical records, E-medical ordering and related Bad Health IT? They get a gentleman's pass.

Bad health IT is defined at my Medical Informatics academic site (<a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a>) as follows:<br /><br /><blockquote class="tr_bq"><span style="color: black; font-family: Arial; mso-bidi-font-weight: bold;"><b>Bad Health IT</b> ("BHIT") is health IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.<span style="mso-spacerun: yes;"> </span></span></blockquote><br />Health IT is unregulated, and Bad Health IT <i>results in patient injuries and deaths</i>.   This is unarguable from the data cited in this post and related posts I've linked to.  The levels of harm are unknown.<br /><br />At my April 9, 2014 post "<b>FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it</b>" (<a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>) I observed how the FDA bent over backwards to avoid regulating Electronic Medical Records systems and other healthcare IT systems:<br /><br />To recap that post:<br /><br />Out of one side of their mouth FDA wrote this:<br /><br /><blockquote class="tr_bq">... products with health management heath IT functions, <b>includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.</b><br /><br />Products with health management health IT functions are of<b> sufficiently low risk</b> and thus, [even] if they <b><u>meet the statutory definition of a medical device</u>, FDA does not intend to focus its oversight on them.</b></blockquote><br />While out of the side of their mouth that was not intended for public viewing, discovered by investigative reporter Fred Schulte, they wrote this:<br /><br /><div style="margin-left: 40px;"><span style="font-family: inherit;"><span style="font-size: 100%;">...In summary, the <b>results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology</b>. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. <b>The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs [device reports] and <u> impedes a more comprehensive understanding of the actual problems and implications</u>.</b></span></span><br /><span style="font-family: inherit;"><span style="font-size: 100%;"><b> </b></span></span> </div>FDA is thus claiming "we know what we non-publicly concluded it is not possible to know, and Health IT is not worth regulating ... even in face of dangers we do know" (e.g., see the alarming ECRI Institute data at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>).<br /><br /><b>Note that everyone who needs medical care</b> (which is. essentially, <i><u>everyone</u></i>) is increasingly exposed to these electronic products with health management heath IT functions, against their will and without any informed consent processes.  The only people exposed to E-cigarettes are <u><i>those who willingly buy and consume them</i></u>.<br /><br />With E-cigarettes, however:<span class="source"> </span><br /><br /><blockquote class="tr_bq"><span class="source">CBS/AP</span>  April 24, 2014<b> </b><br /><b>FDA: Ban sales of electronic cigarettes to minors </b><br /><br /><a href="http://www.cbsnews.com/news/fda-ban-sales-of-electronic-cigarettes-to-minors/">http://www.cbsnews.com/news/fda-ban-sales-of-electronic-cigarettes-to-minors/</a><br /><br /><b>WASHINGTON --</b> The federal government wants to ban sales of electronic cigarettes to minors and require health warning labels and approval for new products under regulations being proposed by the Food and Drug Administration. </blockquote><br />Wonderful.  How thoughtful.  (E-cigarettes are plastic or metal tubes, usually the size of a cigarette, that heat a liquid nicotine solution instead of burning tobacco. That creates vapor that users inhale.)<br /><blockquote class="tr_bq"><br />While the proposal being issued Thursday won't immediately mean changes for the popular devices, the move is aimed at eventually taming the fast-growing e-cigarette industry.<br /><br />The agency said the proposal sets a foundation for regulating the products but the rules don't immediately ban the wide array of flavors of e-cigarettes, curb marketing in places like TV or set product standards.<br /><br />Any further rules "will have to be grounded in our growing body of knowledge and understanding about the use of e-cigarettes and their potential health risks or public health benefits," Commissioner Dr. Margaret Hamburg said.</blockquote><div dir="LTR" id="article-entry"><br />(Perhaps the E-cigarette industry hasn't figured out who to pay off yet?)<br /><br /><blockquote class="tr_bq">... "By being able to regulate e-cigarettes, we'll get a lot more information about what's in them, how they're made and we're already studying e-cigarettes in terms of how they're being used and what are their implications for health," Hamburg told CBS News.<br /><br />"At the present time, when we can't regulate cigarettes, <b>it's like they wild, wild West"</b> she said. <b>"Companies can do anything they want. They can market in ways that they want</b>. ... Unless they make a therapeutic claim that it is a product for actual cessation of nicotine use, we can't regulate them. If they make a therapeutic claim, we can regulate them as a medical product."</blockquote><br />The "Wild, wild west" is a perfect descriptor of the health IT market.  And claims of benefits?  How about some <b>'Words that Work?'  </b>(<a href="http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html">http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html</a>) <br /><br /><blockquote>Hamburg stressed to CBS News that, "Until we have the authority to regulate e-cigarettes, we cannot provide the information that the American public wants about the relative risk and safety of these products. ... <b>We cannot put in place certain restrictions that might be appropriate with respect to how the products are made, the kind of flavorings, the kind of marketing, etc. </b>So we see this as really a crucial first step."</blockquote><br />The health IT industry has special accommodations in that regard that the E-cigarette company lawyers need to closely examine.<br /><blockquote class="tr_bq">Smokers like e-cigarettes because the nicotine-infused vapor looks like smoke but doesn't contain the thousands of chemicals, tar or odor of regular cigarettes. Some smokers use e-cigarettes as a way to quit smoking tobacco, or to cut down. However, there's not much scientific evidence showing e-cigarettes help smokers quit or smoke less, and it's unclear how safe they are.</blockquote><br />It's undeniably unclear how safe clinical IT devices are, either.  The ECRI Institute, for instance, found 171 mishaps in 9 weeks at 36 hospitals voluntarily reported, leaving 8 patients harmed and possibly three of them dead.   (A likely far more than serous problem than GM cars with defective ignitions that killed ~13 in a decade...)   The FDA found many injuries and several deaths in their own self-admitted limited dataset as well.  (See <b>FDA Internal Memo on HIT risk</b> at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a>).<br /><br /><blockquote class="tr_bq">... Companies also will be required to submit applications for premarket review within two years. As long as an e-cigarette maker has submitted the application, the FDA said it will allow the products to stay on the market while they are being reviewed. That would mean companies would have to submit an application for all e-cigarettes now being sold.</blockquote></div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">There is no premarket review of clinical IT of the types categorized by FDA as "with health management heath IT functions" as above, even if those devices meet the statutory requirements as a medical device that falls under the Food, Drug & Cosmetic Act.  These systems increasingly mediate and regulate every transaction of healthcare.</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">E-cigarettes, however, are a major concern that are being reviewed in earnest?</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">Unbelievable.</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">-- SS<br /><br /><span style="font-size: x-small;">DISCLAIMER:  I neither use tobacco products in any form nor E-cigarettes, never did, and have no conflicts of interest of any kind with either the tobacco or E-cigarette industries.</span></div>

Hypocrisy at the FDA: Let's regulate E-cigarettes ... E-medical records, E-medical ordering and related Bad Health IT? They get a gentleman's pass.

Bad health IT is defined at my Medical Informatics academic site ( http://cci.drexel.edu/faculty/ssilverstein/cases/ ) as follows: Bad Healt...

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Innumeracy at the Centers for Medicare & Medicaid Services (CMS)

<div class="MsoNormal">A physician participant in an American Medical Informatics Association listserv I subscribe to had some time ago commented that the CMS, in their requirement that physicians meet certain percentages on measures regarding adherence to the "Meaningful Use" incentive program for EHRs, were calculating those percentages incorrectly.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">He followed up with an actual response from CMS, and has given me permission to repost.  I am redacting his name:</div><div class="MsoNormal"><br /></div><blockquote class="tr_bq"><div class="MsoNormal">... I have posted previously that the CMS calculator found at <a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=mnsZV_x_TUmIjS3hVz8N2LbSo8knNNEIzqgX1E2MFvWksVZnCP86blNjPEz3cFW5L-p0fS64-Xw.&URL=http%3a%2f%2fwww.cms.gov%2fRegulations-and-Guidance%2fLegislation%2fEHRIncentivePrograms%2fStage_2.html" target="_blank">http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Stage_2.html</a> appears to calculate improperly.  Last night I received a response from CMS regarding my concern:</div><div class="MsoNormal"><br /></div><div class="MsoNormal" style="margin-left: .5in;">“Dear Mr. (sic) [name redacted],</div><div class="MsoNormal" style="margin-left: .5in;"><br /></div><div class="MsoNormal" style="margin-left: .5in;">Thank you for your recent inquiry. Below is the information you requested about the attestation calculator.</div><div class="MsoNormal" style="margin-left: .5in;"><br /></div><div class="MsoNormal" style="margin-left: .5in;">As adopted by CMS, measures generally require that providers achieve "more than" a specific percentage. <b>The language in these measures is clear; "more than 50 percent" would equate to 51 percent or more.</b> This has consistently been the policy from the beginning of the program.</div><div class="MsoNormal" style="margin-left: .5in;"><br /></div><div class="MsoNormal" style="margin-left: .5in;">The attestation calculator now rounds fractions of a percent to the closest whole number. This correctly identifies when the required performance level is reached.</div><div class="MsoNormal" style="margin-left: .5in;"><br /></div><div class="MsoNormal" style="margin-left: .5in;">The tracking number for this inquiry is 2014-XXXXX. . . . “</div><div class="MsoNormal"><br /></div><div class="MsoNormal"><br /></div><div class="MsoNormal">My examples included a numerator of 549 with a denominator of 10,000 for a metric that required “greater than 5%”.  These are screen shots of the submission:</div></blockquote><br /><br /><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhz4oQ46S84r4Sngb24v9Pa9ZGQwMsdKclLNIrq5OxygKMLJGGKhi8FHYQyCVhakiWWGKCj_wYEPDAVkgBA_La0WQxm0UiKpVx9XWgp61BWs_Ot8HivmbQJu11s0bx0yLQlxc0ty6HrHVbX/s1600/calc.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="335" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhz4oQ46S84r4Sngb24v9Pa9ZGQwMsdKclLNIrq5OxygKMLJGGKhi8FHYQyCVhakiWWGKCj_wYEPDAVkgBA_La0WQxm0UiKpVx9XWgp61BWs_Ot8HivmbQJu11s0bx0yLQlxc0ty6HrHVbX/s1600/calc.jpg" width="400" /></a></div><br /><blockquote class="tr_bq"><div class="MsoNormal"></div><div class="MsoNormal" style="margin-left: .5in;"></div><div class="MsoNormal"><br /></div><div class="MsoNormal">Note that the calculator appears to use 3 significant figures, but in fact rejects the calculation by rounding to only 1 significant figure.  </div><div class="MsoNormal"><br /></div><div class="MsoNormal">Years ago at a CMS conference I remember the speaker remarking that physicians and hospitals only had to enter the numbers “and we could agree on the arithmetic.”  I learned in fourth grade how to round numbers, and how to count significant digits.  I do not agree with their arithmetic, nor do I accept their determination that “more than 50 percent" would equate to 51 percent or more”.  Granted, one hopes that those attempting to attest will not have numbers that skim so closely to the metric limit, but it could happen.</div></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal">I note in the reply from CMS this statement:</div><blockquote class="tr_bq"><div class="MsoNormal"><br /></div><b>"The language in these measures is clear; 'more than 50 percent' would equate to 51 percent or more."</b></blockquote><br />I emphasize:  <span style="color: red;"><span style="font-size: large;"><b> </b></span></span><br /><br /><span style="color: red;"><span style="font-size: large;"><b>THE - LANGUAGE - IN - THESE - MEASURES - IS - CLEAR.</b></span></span><br /><br />Here are  actual instructions for, say, CPOE measurement on medication ordering (<a href="http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/downloads/Stage2_EPCore_1_CPOE_MedicationOrders.pdf">http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/downloads/Stage2_EPCore_1_CPOE_MedicationOrders.pdf</a>):<br /><br /><blockquote class="tr_bq"><u><b>Attestation Requirements</b></u><br /><u><b>DENOMINATOR/NUMERATOR/THRESHOLD/EXCLUSION</b></u><br /><br />Measure 1: Medication<br /><br />DENOMINATOR: Number of medication orders created by the EP during the EHR reporting period.<br /><br />NUMERATOR: The number of orders in the denominator recorded using CPOE.<br /><br />THRESHOLD: The resulting percentage must be more than 60 percent in order for an EP to meet this measure.<br /><br />EXCLUSION: Any EP who writes fewer than 100 medication orders during the HER (sic) reporting period. </blockquote><br />Now, I had a perfect "800" in math on my SAT test in 1974, so (while probably excluding me from some employment in today's culture of stupid due to having "too much experience"), I do believe I am perfectly well qualified to determine that "more than 60 percent" would mean, anything more than 60.0, such as, say, 60.1%.<br /><br />Let's consider possible explanations.<br /><br /><u><b>Possibility (1)</b></u><br />Perhaps CMS is performing their calculations with an old Pentium-1 computer whose CPU has the FDIV bug causing math errors (<a href="http://en.wikipedia.org/wiki/Pentium_FDIV_bug">http://en.wikipedia.org/wiki/Pentium_FDIV_bug</a>)?<br /><br />On second thought:<br /><br />I don't think that is a good explanation. <br /><br /><u><b>Possibility (2)</b></u><br />Perhaps I have become demented from too much exposure to the numeracy-challenged since 1974?<br /><br />An experiment is in order:<br /><br />In 1969, we landed men on the Moon.  It took a lot of math to perform that feat, and miscalculation would have led to disaster, for example on the 25,000-MPH re-entry into Earth's atmosphere at precisely the correct angle required to avoid burn up, or skipping off the atmosphere like a stone off a pond, back out into space to be lost forever.<br /><br />I learned computing about that time on a Digital Equipment Corporation PDP-8/S, a computer from that era (<a href="http://cci.drexel.edu/faculty/ssilverstein/medinformatic1/gw-pdp8s.htm">http://cci.drexel.edu/faculty/ssilverstein/medinformatic1/gw-pdp8s.htm</a>).<br /><br />I wrote and ran a small program on a PDP-8 emulator WinEight (available free at <a href="http://www.sparetimegizmos.com/Software/WinEight.htm">http://www.sparetimegizmos.com/Software/WinEight.htm</a>) that perfectly emulates the old PDP-8.  Here is the program in the programming language FOCAL, 1969 version:<br /><br /><blockquote class="tr_bq">CONGRATULATIONS!!<br />YOU HAVE SUCCESSFULLY LOADED 'FOCAL,1969' ON A PDP-8 COMPUTER.<br /><br />SHALL I RETAIN LOG, EXP, ATN ?:YES<br /><br />PROCEED.<br /><br />*1.1 SET P=(601/1000)*100<br />*1.2 IF (P-60) 1.3, 1.4, 1.5<br />*1.3 TYPE "P IS LESS THAN 60%";G 1.6<br />*1.4 TYPE "P EQUALS 60%";G 1.6<br />*1.5 TYPE "P IS MORE THAN 60%"<br />*1.6 TYPE !;QUIT</blockquote><br />The program sets variable "P" to 601/1000, then multiplies by 100 to derive a percent.  It then compares the result stored in "P" to 60, and branches to the correct statement regarding the relation of P to 60%.  Let's run the program:<br /><br /><blockquote class="tr_bq">*<br />*GO<br /><b>P IS MORE THAN 60%</b><br />*</blockquote><br />Good news. <br /><br />I guess I am not demented after all.<br /><br /><u><b>Possibility (3)</b></u><br />Someone (or a group of people) at CMS doesn't or don't realize that in large datasets, <b>percentages are often not integer whole numbers.</b><br /><br />Possibility #3 can be illustrated best by a cartoon:<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiCRwf49Ok93IT5g9puPUujkyj3ul4BmKe8A8RqrIo0xa-IaaqSuPQaQrL1HN0B62MUgOK7Lcam4QlpMYcJK7erGTMTlgEUngVZ2fkD5omr5yNOIa8vwH_dDUQNEFcdUckR1lsJtHNkEyXH/s1600/dunce.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiCRwf49Ok93IT5g9puPUujkyj3ul4BmKe8A8RqrIo0xa-IaaqSuPQaQrL1HN0B62MUgOK7Lcam4QlpMYcJK7erGTMTlgEUngVZ2fkD5omr5yNOIa8vwH_dDUQNEFcdUckR1lsJtHNkEyXH/s1600/dunce.jpg" width="133" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Click to enlarge.  1+3 = 13, right?</td></tr></tbody></table><br /><br />Or perhaps this:<br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiUDXpKjjMtOtSTY_6Jibyh2Cf2AQJvS5BhjbKbKf43JslhQ3Ly9hKSQNypPSiY2v7EsycBsKEoCNGL3uf8ankUN8BXdRawaP6xZDCyqbNCramZgQkeYYs72OwJQ806XeQiW_JZkQBofhv8/s1600/Butterfinger-math.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="152" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiUDXpKjjMtOtSTY_6Jibyh2Cf2AQJvS5BhjbKbKf43JslhQ3Ly9hKSQNypPSiY2v7EsycBsKEoCNGL3uf8ankUN8BXdRawaP6xZDCyqbNCramZgQkeYYs72OwJQ806XeQiW_JZkQBofhv8/s1600/Butterfinger-math.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Math for Underachievers.  Click to enlarge.</td></tr></tbody></table><br />I leave it to the reader to determine which of the three possibilities is the explanation for the assertion by CMS that <b>"The language in these measures is clear; 'more than 50 percent' would equate to 51 percent or more."</b><br /><br />Note: this post was meant as satire and humor and irony, but innumeracy in our healthcare regulators is anything but funny.<b> </b><br /><br />-- SS

Innumeracy at the Centers for Medicare & Medicaid Services (CMS)

A physician participant in an American Medical Informatics Association listserv I subscribe to had some time ago commented that the CMS, in ...

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American Board of Internal Medicine Quietly Discloses Some Conflicts of Interest

We recently <a href="http://hcrenewal.blogspot.com/2014/03/american-board-of-internal-medicine.html">discussed</a> the American Board of Internal Medicine's exceedingly weak conflict of interest policy.  This came to light after the board's previous president was revealed to have simultaneously served for years on the board of directors of a privately held for-profit hospital purchasing organization.<br /><br />The susceptibility of ABIM leadership to conflicts of interest is particularly important because the board, in its role as the de facto sole source of credentialing for all US internists and internal medicine sub-specialists, sets what these physicians need to know to pass the certifying examinations. Conflicts of interest raise doubts about whether the examinations may be used to further commercial agendas and similar vested interests.<br /><br />Furthermore, the ABIM has been willfully expanding its scope into "maintenance of certification," that is, into requiring physicians to engage in ABIM educational and evaluation activities to maintain their previously obtained certification.  They have been criticized in particular (e.g., <a href="http://www.medscape.com/viewarticle/822914">here</a> and <a href="http://drwes.blogspot.com/2014/03/is-maintenance-of-certification-our.html">here</a>) for pursuing maintenance of certification in the absence of clear evidence that it improves physician performance or patients' outcomes.  Conflicts of interest affecting MOC raise further doubts that this "innovation" may also be about furthering commercial interests.<br /><br /><b>ABIM Begins Conflict of Interest Disclosure</b><br /><br />Now it appears that the ABIM is beginning to disclose more about its leadership's conflicts of interest.  One of our scouts notified me that the ABIM web-site now provides disclosures for the members of its <a href="http://www.abim.org/about/governance/board-of-directors.aspx">board of directors and officer,</a> <a href="http://www.abim.org/about/governance/abim-council.aspx">council,</a> and <a href="http://www.abim.org/about/executives.aspx">executives</a>.<br /><br />There seem to be limits to these disclosures.  As far as I can tell,They do not reflect a change in the preexisting ABIM <a href="http://www.abim.org/conflict-of-interest-policies.aspx">conflict of interest policy</a>, which still calls for conflicts to be disclosed, but only to ABIM leadership, while they are otherwise kept confidential.  Nor were these disclosures accompanied by any further explanation that I can find.  The disclosures include multiple categories, consulting relationships, peer educational activities, promotional activities, grants, intellectual property, stock/option, gift/ donations, expert witness, leadership in professional organizations, and other, which are not otherwise defined.  It was not clear, however, whether the disclosures covered services on corporate advisory boards or boards of directors, or service as executives or founders of companies.  The time course of the disclosed relationships were not clear.  Finally, ttere are no disclosures about members of <a href="http://www.abim.org/about/examInfo/committee.aspx">exam writing committees of sub-specialty board members</a><br /><br />Nonetheless, the disclosures do give an idea of the scope of conflicts of interest affecting ABIM leadership.  Because the disclosures have not otherwise been publicized, I thought it would be worthwhile to summarize them here.<br /><br /><b>Prevalence of Conflicts</b><br /><br />Of the 12 officers and directors, 8 disclosed relationships with for-profit health care corporations <br /><br />Of the 15 council members (one of whom is also a director), 9 revealed conflicts.<br /><br />Of the 12 executives, 5 revealed conflicts.<br /><br />Thus, a majority of ABIM physician leadership, and nearly a majority of  ABIM executives disclosed conflicts of interest.<br /><br /><b>Nature of Conflicts</b><br /><br />The conflicts were predominantly consulting relationships, grants, holdings of patents, or of stocks or options.  The conflicts of the officers, directors and council members primarily involved pharmaceutical, biotechnology and device companies.  Several officers, directors and council members had two kinds of relationships with the same company, for example, consulting relationships and grant funding.<br /><br /><br /><br /><br />It was striking that 15 companies had multiple relationships with officers, directors and council members.  All were large pharmaceutical, biotechnology, and device companies.  They were<br /><br />AbbVie (1 consulting relationship 2 grants)<br />Amgen (1 consulting, 1 grant, 2 stock holdings)<br />AstraZeneca (3 consulting, 1 grant)<br />Bristol-Myers-Squibb (2 consutling, 2 grants, 1 stocks)<br />Celgene (2 consulting, 1 grant)<br />Gilead (1 consulting, 2 grants, 1 stocks)<br />Johnson and Johnson (1 consulting, 2 grants [one through Janssen], 2 stocks) <br />Eli Lilly (1 consulting, 1 grant)<br />Medtronic (2 consulting, 1 grant)<br />Merck (2 consulting, 2 stocks)<br />Novartis (2 grants, 1 stocks)<br />Pfizer (1 consulting, 1 grant, 2 stocks)<br />Roche (1 consulting, 2 stocks)<br />Teva (1 consulting, 1 stocks)<br />Millennium (1 consulting, 1 grant)<br /><br />The officers, directors, and council members additionally had relationships with a vast number of companies, including in attempted alphabetical order: Abbott Laboratories, Agios, Allos, AllScripts, Arrowhead, Biocontrol Medical, Cephalon, Cephied, CorAssist, Cornovus, CVRx, Covidien, Dr Redy's Labs, Emergent Biosolutions, Express Scripts, Genentech, Gen-Probe, Hologic, Human Genome Sciences, Incyte,  ION(?), miRNA Therapeutics, Peluton Therapeutics, Pharmacyclics, Regeneron, Repros Therapeutics, Research to Practice (owned by AmerisourceBergen) Prime Healthcare, Rigel, Seattle Genetics, Sunesis, TG Therapeutics, UnitedHealthcare, Value Capture, Viamet, Ventrigen, Vertex, XCenda,  and ZS Pharma.<br /><br />Thus, the conflicts of interest were extensive, and involved major health care corporations.<br /><br /><b>Summary</b><br /><br />The American Board of Internal Medicine is to be congratulated for taking steps towards more transparency and honesty about conflicts of interest affecting its leadership.  However, the steps were baby steps.  Lacking still are definitions and time courses of the relationships disclosed, assurances of the completeness of disclosure of all relevant relationships, assurances that disclosure is now the policy going forward, and disclosures for members of committees and sub-specialty boards who are also very influential in constructing examinations and maintenance of certification activities.  These ought to be addressed.<br /><br />The disclosures reveal that the conflicts of ABIM leadership were extensive.  While disclosure is good, disclosure does not assure physicians and the public that certification and now maintenance of certification are not influenced by marketing needs and other commercial interests.  In my humble opinion, the ABIM now ought to phase out, as quickly as possible conflicts of interest affecting those who make its policy, write its exams, and conduct its other activities that can influence physician behavior, decisions made for patients, and health policy.  Also, in my humble opinion, the ABIM ought to suspend its efforts to promote maintenance of certification until it has greatly reduced the conflicts of interest that may affect this effort.

American Board of Internal Medicine Quietly Discloses Some Conflicts of Interest

We recently discussed the American Board of Internal Medicine's exceedingly weak conflict of interest policy.  This came to light after...

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