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The Story of CPRIT, Part 1: A Promising Start

HC Renewal readers who don’t live in Texas may not have followed the saga of the Cancer Prevention & Research Institute of Texas (CPRIT). It’s a fascinating story which will take me more than one post to tell even a partial version of, especially since a wealth of information is available because of FOIA requests and the superb reporting of the Houston Chronicle and The Cancer Letter. A <a href="http://www.statutes.legis.state.tx.us/Docs/CN/htm/CN.3.htm#3.67" target="_blank">constitutional amendment authorizing CPRIT</a> was proposed to the voters in November 2007. (In Texas, lots of things that could be passed legislatively elsewhere require amending the constitution, so that it’s now a very long document indeed.) With a pot of money second only to the NIH’s (up to $300 million in bonds per year was authorized for 10 years for a total of $3 billion), its ambitious goal was to make progress against cancer while making Texas a real leader in cancer research. Enabling legislation was passed and the institute got off to a good start in 2009 by putting together a leadership team that included Nobel prize winner Alfred Gilman as Chief Scientific Officer and Phillip Sharp (another Nobel prize winner) as head of its Scientific Review Council. The <a href="http://www.cprit.state.tx.us/news/nobel-laureate-phillip-a-sharp-phd-to-head-cprit-scientific-review-council/" target="_blank">press release announcing Sharp’s appointment</a> stated: <blockquote class="tr_bq">Research and prevention grant applications will be assessed using an external- to-Texas peer review process. . . . [P]olicies and processes [are being formalized] that will ensure CPRIT funds only the best scientific research and prevention projects, measures its success and shares results on progress so that Texas will lead the nation as a model for cancer research and prevention programs.</blockquote> The process was formalized; and the 2009 Policies and Procedures Guide has a diagram showing that grants were supposed to be submitted electronically, be triaged for merit, and (if they survived initial triage) first go through scientific peer review, then go through commercialization review for business worthiness (only if they were translational projects), be recommended for funding, and then be submitted for review and final funding approval by the CPRIT Oversight Committee (cf. <a href="http://s3.amazonaws.com/static.texastribune.org/media/documents/13-018.pdf" target="_blank">State Audit report</a>, Appendix 5). Peer review teams of eminent out-of-state scientists were put together, the process got going, and projects deemed worthy by the Scientific Review Council were routinely approved by <a href="http://www.cprit.state.tx.us/about-cprit/governingboard/" target="_blank">CPRIT’s Oversight Committee</a>, a group of political appointees plus the Attorney General and the State Comptroller. CPRIT money <a href="http://www.dallasnews.com/business/columnists/mitchell-schnurman/20121020-mitchell-schnurman-why-texas-growth-still-draws-high-achievers.ece" target="_blank">helped attract some eminent researchers to the state</a>.  But then, it all fell apart. Dr. Gilman, the Nobel laureate who had set up the scientific review process, submitted a letter of resignation in May 2012, effective the following October. In his resignation letter, he stated that he would like “to prevent further award of vast funds for research programs ostensibly within incubators that were not described and therefore could not have been reviewed.” The grant that he refers to and that had upset him so mightily was a large one-year combined award approved in March for an incubator at Rice University and for MD Anderson’s Institute for Applied Cancer Science.   Why was he so upset about this particular award? More on that in the next installment.

The Story of CPRIT, Part 1: A Promising Start

HC Renewal readers who don’t live in Texas may not have followed the saga of the Cancer Prevention & Research Institute of Texas (CPRIT)...

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A Condemnation of Suppression of Medical Research... by Ben Goldacre in the New York Times

Amazingly, this topic now seems to be in the mainstream. The Goldacre Version in the New York Times in 2013 In his <a href="http://www.nytimes.com/2013/02/02/opinion/health-cares-trick-coin.html">op-ed</a>, Ben Goldacre introduced it thus: <blockquote class="tr_bq">the entire evidence base for medicine has been undermined by a casual lack of transparency. Sometimes this is through a failure to report concerns raised by doctors and internal analyses, as was the case with Johnson & Johnson. More commonly, it involves the suppression of clinical trial results, especially when they show a drug is no good.</blockquote> He noted that this problems was supposed to be fixed by the registration of clinical trials, and by changes in editorial policies at medical journals: <blockquote class="tr_bq">many in the industry now claim it has been fixed. But every intervention has been full of loopholes, none has been competently implemented and, lastly, with no routine public audit, flaws have taken years to emerge. <div itemprop="articleBody"> </div><div itemprop="articleBody"> The Food and Drug Administration Amendments Act of 2007 is the most widely cited fix. It required that new clinical trials conducted in the United States post summaries of their results at clinicaltrials.gov within a year of completion, or face a fine of $10,000 a day.  But in 2012, the <a href="http://www.bmj.com/content/344/bmj.d7373">British Medical Journal</a> published the <a href="http://www.bmj.com/content/344/bmj.d7373">first open audit of the process</a>, which found that four out of five trials covered by the legislation had ignored the reporting requirements. Amazingly, no fine has yet been levied. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">An earlier fake fix dates from 2005, when the International Committee of Medical Journal Editors <a href="http://www.icmje.org/clin_trial.pdf">made an announcement</a>: their members would never again publish any clinical trial unless its existence had been declared on a publicly accessible registry before the trial began. The reasoning was simple: if everyone registered their trials at the beginning, we could easily spot which results were withheld; and since everyone wants to publish in prominent academic journals, these editors had the perfect carrot. Once again, everyone assumed the problem had been fixed. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">But four years later we discovered, in <a href="http://jama.jamanetwork.com/article.aspx?articleid=184503">a paper from The Journal of the American Medical Association</a>, that the editors had broken their promise: more than half of all trials published in leading journals still weren’t properly registered, and a quarter weren’t registered at all. </div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">Goldacre's conclusions were:</div><div itemprop="articleBody"> </div><blockquote class="tr_bq"><div itemprop="articleBody">Withholding data not only misleads doctors and patients; it’s an insult to the patients who have participated in clinical trials, believing that they were helping to improve medical knowledge. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Medicine routinely overcomes enormous technical challenges, and there is nothing complicated about the changes needed to prevent Johnson & Johnson, or Roche — or anybody — from withholding information.</div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">Hear, hear! </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Our Version, Starting in 2003 </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Note that 10 years ago, in 2003, in my article on American health care dysfunction that could have been only published in Europe, (Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Intern Med 2003 Mar;14(2):123-130.  Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/12719032">here</a>)  I noted that an important cause of this dysfunction is that:</div><div itemprop="articleBody"> </div><blockquote class="tr_bq"><div itemprop="articleBody">the scientific basis of medicine is increasingly under attack.</div><div itemprop="articleBody"> </div><div itemprop="articleBody">The integrity of medical research has been violated by the deliberate suppression of its results.</div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">At that time, I suggested one solution would be:</div><div itemprop="articleBody"> </div><blockquote class="tr_bq"><div itemprop="articleBody">Medical schools and universities must re-affirm their support of scholarly work in the spirit of free enquiry,...</div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">Furthermore, in <a href="http://hcrenewal.blogspot.com/2004/12/another-facet-of-ssri-suppression-of.html">one of our first posts</a> on Health Care Renewal in December, 2004, in the context of the discovery of internal company documents (in this case, from Eli Lilly) that showed that information about the adverse effects of a drug (in this case, increased aggression associated with fluoxetine, that is, Prozac), we wrote,</div><div itemprop="articleBody"> </div><blockquote class="tr_bq">The increasingly complex story of suppression of SSRI research seems to be part of a growing epidemic of suppression of medical research. </blockquote><blockquote class="tr_bq">Let's say it again. Withholding data from clinical research is unethical because: 1. it breaks the promise to research subjects that their voluntary participation has scientific or social value, but undisseminated research has no value; (See <a href="http://jama.ama-assn.org/cgi/reprint/283/20/2701.pdf">Emanuel EJ et al. What makes clinical research ethical? JAMA 2000; 283: 2701-2711.</a>) 2. it impedes scientific progress; 3. it prevents patients from receiving the best possible medical care. </blockquote><blockquote class="tr_bq"><div itemprop="articleBody">But until this unethical behavior starts having negative consequences for its perpetrators, the epidemic of research suppression is likely to continue. </div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">Note the similarity to what Goldacre published in the Times yesterday.  <a href="http://hcrenewal.blogspot.com/search/label/You%20heard%20it%20here%20first">You heard it here first</a>. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Summary </div><div itemprop="articleBody"></div><div itemprop="articleBody">To date we have published 102 posts with the label "<a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of medical research</a>."  Obviously, Ben Goldacre's NY Times op-ed shows that suppression of research still rarely leads to negative consequences for its perpetrators.  Obviously, by making drugs, devices, and other health care interventions appear safer and more effective than they really are, suppression of medical research has lead to huge revenues for health care corporations, and has made many health care executives exceedingly rich, and many of the health care professionals and academic leaders who have enabled or implemented research suppression somewhat rich.  In the face of such <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse incentives</a>, until we end the <a href="http://hcrenewal.blogspot.com/search/label/impunity">impunity</a> of those who suppress medical research (and by the way, those who authorize, direct, or implement all sorts of other unethical, criminal and corrupt behavior we discuss on Health Care Renewal) things will not get better.  I can only hope that having this subject appear in a New York Times op-ed may lead to some real progress. ADDENDUM (2 February, 2013) - see also <a href="http://1boringoldman.com/index.php/2013/02/02/watchful-waiting-no-more/">comments</a> on 1BoringOldMan blog.  </div><div itemprop="articleBody"> </div>

A Condemnation of Suppression of Medical Research... by Ben Goldacre in the New York Times

Amazingly, this topic now seems to be in the mainstream. The Goldacre Version in the New York Times in 2013 In his op-ed , Ben Goldacre intr...

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Modern Healthcare: "Health IT Iconoclasts"

The healthcare executive-targeted journal "<a href="http://www.modernhealthcare.com/" target="_blank">Modern Healthcare</a>" has named Dr. Ross Koppel, Dr. Deborah Peel, Dr. Larry Weed, and yours truly as "healthcare IT iconoclasts."  Dr. William Bria corroborated the importance of iconoclasty in this domain. (I would rather see the term "defender of patient's rights" rather then "iconoclast", but I'll settle for the latter if it gets the message out.) Author Joe Conn writes: <blockquote class="tr_bq">... health IT has long had its critics, even among its pioneers and proponents, as these four prominent health IT iconoclasts will attest. All four consider themselves to be proponents of health IT, but they rail against a tide of health IT boosterism. Their targets: misplaced priorities, failing to promote EHR usability and interoperability, inadequate concern for patient safety and privacy, overemphasizing EHR adoption, understating IT costs and overestimating the return on public IT investments. </blockquote> He then profiles the four. On Univ. of Pennsylvania professor and industry punching-bag Dr. Ross Koppel: <blockquote class="tr_bq"> Researcher Ross Koppel started an uproar in 2005 when he and a colleague coauthored an article in the Journal of the American Medical Association that found a first-generation computerized physician order entry system (CPOE) at the Hospital of the University of Pennsylvania was simultaneously creating new errors even as it reduced others. Koppel’s bombshell—he’s now an adjunct professor of sociology at the University of Pennsylvania— brought down the wrath of information technology boosters. The Healthcare Information and Management Systems Society, a health IT trade group, challenged the study’s “methodology and its subsequent outcomes,” and criticized its authors for their “limited view” and not “looking at the big picture.” ... In 2009, he revealed in another JAMA article that health IT vendors’ contracts included “hold harmless” clauses that shielded software developers from legal liability for medical errors their systems caused, even if the developers had been warned about the defects. “That got me major upheaval,” the worst of his career, Koppel recalls.</blockquote> On privacy advocate, psychiatrist Dr. Deborah Peel (no relation to <a href="http://en.wikipedia.org/wiki/Emma_Peel" target="_blank">Emma Peel</a>, although there are similarities in the "has guts" department): <blockquote class="tr_bq">“Let’s face it,” Peel says, “HHS is the agency that eliminated patient control over electronic medical records and has remained hostile to patients’ rights ever since.” Days before the 2002 revision [HHS redraft of the privacy rule of the HIPAA Health Insurance Portability and Accountability Act] went into effect, a group of patients calling themselves Citizens for Health, and more than dozen other plaintiffs, including Peel, sued HHS Secretary Tommy Thompson in federal court, alleging the revisions violated patients’ constitutional rights to privacy. They lost at both the trial and appeals-court levels and were denied a hearing on appeal to the U.S. Supreme Court in 2006. Peel launched the not-for-profit Patient Privacy Rights Foundation in 2003. ... “Where I’m coming from is, I’ve spent all this time in a profession with people being hurt,” Peel says. “Starting in the 1970s, when I first let out my shingle, people came to me and said, if I paid you in cash, would you keep my records private. Now, we’ve got a situation where you don’t even know where all your records are. We don’t have a chain of custody for our data, or have a data map” to track its location. </blockquote>  On SOAP-note and Medical Informatics pioneer Dr. Larry Weed: <blockquote class="tr_bq">It’s a rotten system,” declares Dr. Lawrence Weed, who at age 89 is the dean of healthcare information technology iconoclasts. Weed isn’t disparaging any particular brand of electronic health record system. A dismissive “they’re inadequate” would fairly well cover a Weed-guided tour of today’s EHR systems. “People don’t get the general picture,” he says. “It’s broken. It’s basically an unsound system.” By that he means the entire healthcare system, but not because its providers are using faulty information technology, but because they’re using IT the wrong way, at least in part. ... In 1984, to help physicians cope [with the knowledge explosion], Weed developed a computer-based, diagnostic support system he called the problem-knowledge coupler. The software company he founded, but is no longer with, PKC, now part of Sharecare, still sells the system. Weed still proselytizes with fervor, calling for the use of computers to store, retrieve and apply medical knowledge.</blockquote> On me: <blockquote class="tr_bq">The title of Dr. Scot Silverstein’s teaching website at Drexel University, “Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties,” [<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">link</a>] summarizes the veteran physician informaticist’s general outlook on the current state of affairs in health information technology. It tells you nothing, however, of the passion with which Silverstein speaks or writes about the subject. Also a frequent contributor to the popular reformist “Healthcare Renewal” blog, Silverstein writes with the fire you might expect coming from a self-described computer geek who says he has witnessed a faulty electronic health-record system mysteriously drop a single medication from a patient’s medication list. That missing drug led to a medical error that resulted in a year of suffering and, eventually, that patient’s death, he says. Silverstein’s passion is even more understandable when he tells you that patient was the doctor’s own mother. ... The health IT world, Silverstein says, parts neatly between “good IT” and “bad IT.” There are those who push hard for the good and complain about the bad, physicians and other clinicians he calls “pragmatic,” and for whom he has sympathy and respect. And then there are those who stay silent, ignoring or acquiescing to the bad, the “hyper-enthusiasts” for whom he holds only unmitigated scorn. “The doctors who don’t speak up about health IT, who work around it, which can cause its own bad results, those are traitors to the oath they took to first do no harm,” he says. “Physicians are still being accused of being Luddites for not adopting this stuff,” Silverstein says. “Physicians are not Luddites. When it’s good IT, it’s used. I see the tension now between hyper-enthusiasts, who turn a blind eye to the negatives, and pragmatic physicians and nurses who have work to do.”</blockquote> Finally, Dr. William Bria, longtime president of the Association of Medical Directors of Information Systems (<a href="http://www.amdis.org/" target="_blank">AMDIS</a>) sums up the article this way: <blockquote class="tr_bq">... When it comes to the criticism, “the one thing we can’t do with this information is to ignore it." “Many, many technologies have come and gone in the history of medicine over the centuries, and it often has been a maverick physician that has called a timeout on ineffective medications or treatments. “There is little question that, going forward, medicine will be using information tools,” Bria says. “However, I believe it’s becoming also very apparent that we need a modulation and a proper regulation of information technologies used in day-to-day care.” </blockquote> Amen to that. The article is available <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/IT_Iconoclasts.pdf" target="_blank">here</a>. -- SS

Modern Healthcare: "Health IT Iconoclasts"

The healthcare executive-targeted journal " Modern Healthcare " has named Dr. Ross Koppel, Dr. Deborah Peel, Dr. Larry Weed, and y...

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The lengths a hospital will go to in order to protect their EHR - Motion for Reconsideration of Denial of Motion for Reconsideration of Denial of Objections

My mother was injured and then died as a result of an EHR foul-up.  She sued the hospital where the mid-2010 accident occurred while she was still lucid, and I am now substitute plaintiff.  Yet the case has been held up through the defense (mis)using court process to stall. It seems the lengths a hospital will go to in order to protect their EHRs (i.e., from Discovery by an expert such as myself, which could show many problems) are amazing. To wit, their latest filing, in an attempt to <a href="http://idioms.thefreedictionary.com/throw+a+monkey+wrench+into" target="_blank">throw a monkey wrench</a> into the gears of the legal discovery process: <table border="1" cellspacing="0" class="ChamaeleonGrid" rules="all"><tbody><tr class="GridItem"><td>2/1/2013</td><td>Motion</td><td>BY [redacted] HOSPITAL MOTION FOR RECONSIDERATION OF JANUARY 17, 2013 ORDER DENYING MOTION FOR RECONSIDERATION OF COURT ORDER DATED JUNE 22, 2012 WITH MEMORANDUM OF LAW WITH SERVICE ON 02/01/2012</td></tr></tbody></table> They've filed a motion asking the Court to reconsider its decision that denied their mid-2012 motion asking the Court to reconsider its denial of their objections to the legal paperwork. Yes, that probably needs to be read several times in order to be understood; I cannot simplify it any further ... The new motion is a mere 521 pages in length (the original Motion for Reconsideration was a slim 485; of course they charge the hospital by the hour for document preparation and electronic filing with the Court). The major objection about the paperwork is, in essence, that a "Certificate of Merit" (a certification of case merit by a qualified medical professional) needed to be filed not just for Defendant (the hospital) but for each and every employee/agent for whom the Defendant is vicariously liable under the doctrine of Respondeat Superior: <blockquote class="tr_bq">Respondeat superior (<a href="http://en.wikipedia.org/wiki/Latin" title="Latin">Latin</a>: "let the master answer"; plural: respondeant superiores) is a <a href="http://en.wikipedia.org/wiki/Legal_doctrine" title="Legal doctrine">legal doctrine</a> which states that, in many circumstances, an <a class="mw-redirect" href="http://en.wikipedia.org/wiki/Employer" title="Employer">employer</a> is responsible for the actions of employees performed within the course of their employment.<a href="http://en.wikipedia.org/wiki/Respondeat_superior#cite_note-DFS-1"></a> This rule is also called the "Master-Servant Rule", recognized in both <a href="http://en.wikipedia.org/wiki/Common_law" title="Common law">common law</a> and <a href="http://en.wikipedia.org/wiki/Civil_law_%28legal_system%29" title="Civil law (legal system)">civil law</a> jurisdictions.<a href="http://en.wikipedia.org/wiki/Respondeat_superior#cite_note-Owen-2"></a></blockquote> A major problem with this claim is that the law simply says otherwise.  Also, Certificates of Merit have, under the identification field where the sued party's name is penned in, the label "defendant" ... not "defendant, employees, agents, their uncles and aunts, and their little dogs too for whom defendant is vicariously liable."  Not to mention, among other issues, that such misconceptions are specifically put to rest by the actual Civil Procedural Rules Committee rules as published by the state's court administrative body: <blockquote class="tr_bq">"The [certificate of merit] rule requires the filing of only a single certificate of merit as to a claim against a defendant that is based on the activities of licensed professionals who are not named in the action."</blockquote> Such a certificate was timely filed.  In fact, one Certificate was timely filed against the defendant hospital for corporate negligence, and another timely Certificate was filed for defendant's vicarious liability.<a href="http://www.blogger.com/blogger.g?blogID=9551150" name="1042.3."></a> That's why the court threw out the objections, and the Motion for Reconsideration of its denial of the objections.. In defense of their position that Certificates for each person for whom the defendant is vicariously liable should have been filed (which is an especially frivolous argument since there is a statement in the law that they do not need to be named), the hospital defense ignored all plaintiff's arguments regarding the filing of the Certificates of Merit such as above.  It then cites two cases where the Certificates of Merit were filed over a year late (there is a 60 day limit) or not filed at all.   But they didn't stop there.  The defendants also wanted the (local) court to 'certify' (give permission for) them to appeal the denial of their objections to Superior Court (the certification may be done if the issues at law are felt possibly controversial).  The local court threw that request out, too. The defense appealed to Superior Court anyway, apparently claiming manifest injustice was done by the local court.  Several hundred more pages, more fees.  The Superior Court dismissed the appeal - or, perhaps stated more accurately, refused to even consider it. All this eats up time. Now, I'm not an attorney, nor do I have access to the major legal databases.  However, Google is getting to be very good at pulling up legal cases due to its indexing of many other resources, such as legal books and publications and public case docket repositories. When I Google <a href="https://www.google.com/search?q=%22Motion%20for%20Reconsideration%20of%20Denial%20of%20Motion%20for%20Reconsideration%22" target="_blank">"</a><a href="https://www.google.com/search?q=%22Motion%20for%20Reconsideration%20of%20Denial%20of%20Motion%20for%20Reconsideration%22" target="_blank">Motion for Reconsideration of Denial of Motion for Reconsideration"</a> or "Motion for Reconsideration of Motion for Reconsideration", very little comes up.  One case is from the early 1990's in the High Court of American Samoa. (If you know where that is without looking it up, you're more geographically literate than I.) <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/AVvXsEgLgUdjSUQJNnvKCAA1UztFR5UVaE4SyPxNJFsBnksQoPEbba202g5VuSovFV1-EQs3lvXR9Lvw15cZQjxzXb2h_yi_7aBhNDcdzKaDQXecy6IRVH31nRs4puEgTOiI6JHd-SqpBtbZBVab/s1600/monkeywrench.jpg" style="margin-left: auto; margin-right: auto;"><img border="0" height="142" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgLgUdjSUQJNnvKCAA1UztFR5UVaE4SyPxNJFsBnksQoPEbba202g5VuSovFV1-EQs3lvXR9Lvw15cZQjxzXb2h_yi_7aBhNDcdzKaDQXecy6IRVH31nRs4puEgTOiI6JHd-SqpBtbZBVab/s200/monkeywrench.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">When all else fails ... throw a monkeywrench into the Wheels of Justice  ... and be paid handsomely for it!</td></tr></tbody></table> The Defense stalling maneuvers have served to help me advise other Plaintiff's attorneys in EHR-related medical malpractice and evidence spoliation matters (the motion above will be presented at my upcoming talk at the American Association for Justice Winter Conference in Florida as an example of how far a hospital will go to protect their EHR).   The stalling has also been serving as a useful learning experience for me regarding the working of the Court system, enhancing my abilities to assist the Plaintiff's side.  Perhaps I should be paying tuition to the Defense in my mother's case ... (The Plaintiff's Bar - and injured patients - need help.  I have, for instance, learned in sworn testimony of hospital IT experts that some major commercial EHR's permit a clinician to alter their notes prior to their final "signoff" and resultant "record lock" -- which can be days later -- without leaving an electronic trail or any evidence whatsoever of the changes.  I have learned that some EHR's permit late-entered notes to appear in apparent chronological sequence in an EHR printout with whatever apparent time is desired.  I have learned that the audit trails and other metadata themselves of major commercial EHRs can be altered by someone with sufficient database privileges with no trace, save for perhaps database engine transaction logs on backup tapes, highly difficult to retrieve.) In effect, one motive for hospitals to acquire EHR's might be the EHR's abilities to facilitate "retroactive risk management" through, in essence, alteration of history. Finally, I hope I won't have to see a "Motion for Reconsideration of Denial of Motion for Reconsideration of Denial of Motion for Reconsideration of Denial of objections to the paperwork." -- SS

The lengths a hospital will go to in order to protect their EHR - Motion for Reconsideration of Denial of Motion for Reconsideration of Denial of Objections

My mother was injured and then died as a result of an EHR foul-up. She sued the hospital where the mid-2010 accident occurred while she was...

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US Senate Subcommittee Asks What the RUC is About

It has been a long time coming, but the issue of how the US Medicare and Medicaid system sets the fees it pays doctors, and hence sets the incentives on doctors that drive their health care decisions, finally got some public attention again.  The background is complex, and may glaze the eyes of readers hoping for simple solutions to simple problems.  One wonders if the complexity was deliberately created to discourage solutions.  Yet we have created a complex, obscure, opaque health care system.  If we want to meaningfully improve it, we must address its "inside baseball" qualities.  Those already familiar with and interested in the topic, skip the following section. Background - the Resource Based Relative Value System Update Committee (RUC) We have <a href="http://hcrenewal.blogspot.com/search/label/RUC">frequently posted</a>, first <a href="http://hcrenewal.blogspot.com/2007/03/on-disparities-between-reimbursement-of.html">here in 2007</a>, and more recently <a href="http://hcrenewal.blogspot.com/2010/07/primary-care-and-hc-renewal-ruc-kus.html">here,</a>  <a href="http://hcrenewal.blogspot.com/2010/06/ruc-off-new-england-journal-once-again.html">here</a>, <a href="http://hcrenewal.blogspot.com/2011/02/replace-ruc.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2011/03/getting-out-of-our-ruc-open-letter-to.html">here</a>, about the little-known group that controls how the US Medicare system pays physicians, the RBRVS Update Committee, or <a href="http://hcrenewal.blogspot.com/search/label/RUC">RUC</a>. Since 1991, Medicare has set physicians' payments using the Resource Based Relative Value System (RBRVS), ostensibly based on a rational formula to tie physicians' pay to the time and effort they expend, and the resources they consume on particular patient care activities. Although the RBRVS was meant to level the payment playing field for cognitive services, including primary care vs procedures, over time it has had the opposite effect, as explained by Bodenheimer et al in a 1997 article in the Annals of Internal Medicine.(1) A system that pays a lot for procedures, but much less for diagnosing illnesses, forecasting prognoses, deciding on treatment, and understanding patients' values and preferences when procedures and devices are not involved, is likely to be very expensive, but not necessarily very good for patients. As we <a href="http://hcrenewal.blogspot.com/2009/02/what-ruc-again-one-of-worlds-most.html">wrote before</a>, to update the system, the Center for Medicare and Medicaid Services (CMS) relies almost exclusively on the advice of the <a href="http://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your-practice/coding-billing-insurance/medicare/the-resource-based-relative-value-scale/the-rvs-update-committee.shtml">RBRVS Update Committee</a>. The RUC is a private committee of the AMA, <a href="http://www.ama-assn.org/ama1/pub/upload/mm/380/toptenthings.pdf">touted</a> as an "expert panel" that takes advantage of the organization's First Amendment rights to petition the government. Membership on the RUC is allotted to represent specialty societies, so that the vast majority of the members represent specialties that do procedures and focus on expensive, high-technology tests and treatments. However, the identities of RUC members were opaque for a long time, and the proceedings of the group are secret.  As Goodson(2) noted, RUC "meetings are closed to outside observers except by invitation of the chair." Furthermore, he stated, "proceedings are proprietary and therefore not publicly available for review." In fact, the fog surrounding the operations of the RUC seems to have affected many who write about it. We have posted (<a href="http://hcrenewal.blogspot.com/2007/12/is-sustainable-growth-rate-main-problem.html">here</a>, <a href="http://hcrenewal.blogspot.com/2008/07/can-we-fix-medicare-while-pretending.html">here</a>, <a href="http://hcrenewal.blogspot.com/2008/12/no-such-ruc-new-england-journal-takes.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2010/06/ruc-off-new-england-journal-once-again.html">here</a>) about how previous publications about problems with incentives provided to physicians seemed to have avoided even mentioning the RUC. Up until 2010, after the US recent attempt at health care reform, the RUC seemed to remain the great unmentionable. Even the leading US medical journal seemed reluctant to even print its name. That <a href="http://hcrenewal.blogspot.com/2010/10/ruc-it-up-how-us-government-fixes.html">changed</a> in October, 2010.  A combined effort by the Wall Street Journal, the Center for Public Integrity, and Kaiser Health News yielded two major articles about the RUC, <a href="http://online.wsj.com/article/SB10001424052748704657304575540440173772102.html">here</a> in the WSJ (also with two more spin-off articles), and <a href="http://www.publicintegrity.org/articles/entry/2571/">here </a>from the Center for Public Integrity (also <a href="http://www.kaiserhealthnews.org/Stories/2010/October/27/AMA-center-public-integrity.aspx">reprinted</a> by Kaiser Health News.) The articles covered the main points about the RUC: its de facto control over how physicians are paid, its "secretive" nature (quoting the WSJ article), how it appears to favor procedures over cognitive physician services, etc. In 2011, after the "<a href="http://www.replacetheruc.org/">Replace the RUC</a>" movement generated some more interest about this secretive group, and its complicated but obscure role in the health care system, the current RUC membership was finally revealed.  It was relatively <a href="http://hcrenewal.blogspot.com/2011/04/rucing-about-conflicts-of-interest.html">easy for me to determine </a>that many of the members had conflicts of interest (beyond their specialty or sub-specialty identity and their role in medical societies that might have institutional conflicts of interest, and leaders with conflicts of interest).   Then that year a lawsuit was filed by a number of primary care physicians that contended that the RUC was functioning illegally as a de facto US government advisory panel.  It appeared that things might change.  However, it was not to be.  A judge <a href="http://careandcost.com/2012/05/19/medicare-physician-payment-the-rucs-hollow-victory/">dismissed the lawsuit</a> in 2012, based on his contention that the law that set up the RBRVS system prevented any challenges through the legal system to the mechanism used to set payment rates.  The ruling did not address the legality of the relationship between the RUC and the federal government.  And then everything was quiet again, until.... A Senate Committee Takes Up the RUC Meanwhile, after the attempt at health care reform made by the Affordable Care Act (aka "Obamacare"), which aimed to increase insurance coverage, there has been growing concern that there will not be enough primary care physicians available to manage the larger insured patient population.  So, as <a href="http://www.washingtontimes.com/news/2013/jan/29/us-shortage-16000-doctors-health-care-act-kicks-in/">reported</a> by the Washington Times, a US Senate committee published a report on this issue: <blockquote class="tr_bq">The United States needs 16,000 more primary care physicians to meet its current health care needs, a problem that will only get worse if nothing is done to accommodate millions of newly-insured residents under President Obama’s health care law in the coming decade, according to a Senate<a href="http://www.washingtontimes.com/topics/senate/"></a> report released Tuesday.</blockquote> Mirable dictu, the report cited the influence of the RUC as part of the problem: <blockquote class="tr_bq">Mr Sanders said some of the blame appears to rest with a board of 31 physicians who make reimbursement recommendations to the Centers for Medicare and Medicaid Services (CMS), which private insurers frequently adopt as well. The American Medical Association's Relative Value Scale Update Committee, or RUC, is populated by many more specialists that primary care physicians, multiple witnesses said Tuesday. 'Therefore, it should come as no surprise that it has accelerated higher payments — larger paychecks — to specialists over primary care doctors,' Mr Sanders' report said.</blockquote> Senator Sanders' subcommittee then held a hearing during which the RUC came up for more criticism, as <a href="http://www.medpagetoday.com/PublicHealthPolicy/WorkForce/37085">reported</a> by MedPage Today: <blockquote class="tr_bq">Sen. Bernie Sanders (I-Vt.), chair of the Senate Health, Education, Labor and Pensions Subcommittee on Primary Health and Aging, criticized the American Medical Association's Relative Value Scale Update Committee (RUC), which develops annual recommendations on physician pay updates for Medicare. Sanders noted that the RUC is dominated by specialists, whose opinions are accepted by Medicare more than 90% of the time. 'Specialists sitting on the committee determine reimbursement rates,' he said during the hearing on the physician shortage<a href="http://www.help.senate.gov//hearings/hearing/?id=dc487385-5056-a032-522c-082a29c4a406" target="_blank"></a> that is anticipated as more people become insured under the Affordable Care Act (ACA). 'We have to look at that.'</blockquote> Several witnesses identified problems with the RUC:   <blockquote class="tr_bq">Andrew Wilper, MD, acting chief of Medicine at the Department of Veterans Affairs Medical Center in Boise, Idaho, told the senators that Congress could mandate further oversight of the RUC and create greater separation between physicians and the boards that dictate their payment rates. 'At a minimum, the public deserves transparency in decision making from the RUC,' Wilper said. 'We should set a process for rate-setting that is not encumbered by conflicts of interest and is not favoring specialties. A rational observer might conclude that the federal government and AMA are plotting to bring an end to the primary care workforce in the U.S.'</blockquote> Also Modern Healthcare <a href="http://www.modernhealthcare.com/article/20130129/NEWS/301299968/senator-plans-bill-to-tackle-doc-shortage">reporte</a>d (subscription required) that Dr Wilper <blockquote class="tr_bq">described the RUC as 'a secretive group of physicians that wield tremendous influence.'</blockquote> Furthermore, <blockquote class="tr_bq">Uwe Reinhardt, economics professor at Princeton University, said in addition to adding primary care physicians to the RUC, the panel needs a third party to perform outside audits of the AMA panel's recommendations</blockquote> However, the AMA was there to provide their usual defense of the RUC, as per Medpage Today, <blockquote class="tr_bq">'The RUC is an independent group of physicians from many specialties, including primary care, who use their expertise on caring for Medicare patients to provide input to CMS [the Centers for Medicare and Medicaid Services],' RUC chair Barbara Levy, MD, said in a statement. 'More than 300 people participate in a typical RUC meeting and information on the panel is <a href="http://www.ama-assn.org/go/rbrvs" target="_blank">publicly available</a>.' Levy noted that 'CMS recently adopted RUC recommendations for the creation of codes to recognize the value of the work, often done by primary care providers, in transitioning patients from one care setting to the next.' The AMA also added two primary care-related seats to the RUC last February: a representative from the American Geriatrics Society and a rotating seat for a practicing primary care physician.</blockquote> Note that this brief response did not add anything to the more voluminous response the AMA made in 2009 to some of my posts on the RUC, all of which were easily countered (look <a href="http://hcrenewal.blogspot.com/2009/06/letter-from-ruc-and-my-reply.html">here</a>).    After the hearing, per MedPage Today, <blockquote class="tr_bq">The problems with the RUC are 'one of the more important issues that arose out of this hearing,' Sanders told MedPage Today after it was over. 'I don't think we have the transparency we need.' Legislation to address the RUC -- as well as other factors exacerbating the PCP shortage -- is expected to come 'quickly' said Sanders.</blockquote> Comments I salute Senator Sanders and his subcommittee for addressing the obscure and often quite <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic topic</a>, getting it some public attention, and at least raising the possibility of a legislative solution. However, this is just a baby step.  The hearing and report generated minimal media coverage (I included links to the most visible above).  Given that Senator Sanders is widely regarded as well to the left of most of his legislative colleagues, the likelihood that any measure he would craft on this would be passed is minimal. Meanwhile, questions we have raised again and again, most recently <a href="http://hcrenewal.blogspot.com/2011/04/rucing-about-conflicts-of-interest.html">here</a> in 2011, remain unanswered.  - How did the government come to fix the payments physicians receive? Government price-fixing has not been popular in the US, yet this has caused no outcry. - Why is the process by which they are fixed allowed to be so opaque and unaccountable? Why are there no public hearings on the updates, and why is there no input from practicing physicians or organizations other than those related to the RUC? - How did the RUC become de facto in charge of this process? - Why does the AMA [keep the membership of the RUC so opaque, and] give no input into the RUC process to its general membership? - Why is the RUC membership so dominated by procedural specialists? Why were primary care physicians, who made up at least a sizable minority of physicians when the update process was started, not represented according to their numbers? - Why has there been so little discussion of the RUC and its responsibility for an extremely expensive health care system dominated by high-technology, expensive, risky and invasive procedures? Economists have beaten us over the head with idea that incentives matter.  The RUC seems to embody a corporatist approach to fixing prices for medical services to create <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse incentives</a> for physicians to do more procedures, and do less conversing with and examining patients, examining the best clinical research evidence about their problems, and rigorously thinking about how best to help them.  More procedures at higher prices helps physicians who do procedures.  It may help even more the corporations that provide the devices and drugs whose use is necessitated by such procedures, and the hospitals who can charge a lot of money as sites for performance of procedures.  It may even help insurance companies by driving ever more money through the health care system, and thus allow rationalization for higher administrative expenses as a function of overall money flow. Yet incentives favoring procedures over all else may lead to worse outcomes for patients, and more costs to patients and society.  If we do not figure out how to make incentives given to physicians more rational and fair, expect health care costs to continue to rise, while access and quality continue to suffer.   ADDENDUM (1 February, 2013) - see also <a href="http://careandcost.com/2013/02/01/the-ruc-health-care-finances-star-chamber-remains-untouchable/">comments</a> by Brian Klepper on the Care and Cost blog. ADDENDUM (3 February, 2013) - see also <a href="http://theincidentaleconomist.com/wordpress/its-past-time-to-dismantle-the-ruc/">comments</a> by Austin Frakt in the Incidental Economist blog.   References 1. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. (Link <a href="http://www.annals.org/content/146/4/301.full">here</a>.) 2. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. (Link <a href="http://jama.ama-assn.org/cgi/content/short/298/19/2308">here</a>.)

US Senate Subcommittee Asks What the RUC is About

It has been a long time coming, but the issue of how the US Medicare and Medicaid system sets the fees it pays doctors, and hence sets the i...

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AMIA: Enhancing patient safety and quality of care by improving the usability of EHR systems, but ... no sympathy for victims of bad health IT?

A panel of experts from the American Medical Informatics Association have written a paper "Enhancing patient safety and quality of care by improving the usability of electronic health record systems: recommendations from AMIA." The paper is publicly available <a href="http://jamia.bmj.com/content/early/2013/01/24/amiajnl-2012-001458.full.pdf+html" target="_blank">at this link</a> in PDF. The authors are  Blackford Middleton (Harvard Medical School),  Meryl Bloomrosen (AMIA),  Mark A Dente (GE Healthare IT),  Bill Hashmat (CureMD Corp.), Ross Koppel (Dept. of Socology, Univ, of Pennsylvania), J Marc Overhage (Siemens Health Services), Thomas H Payne (U. Washington IT Services),  S Trent Rosenbloom (Vanderbilt Informatics), Charlotte Weaver (Gentiva Health Services) and Jiajie Zhang (University of Texas Health Science Center at Houston). The paper states what has been obvious to this author - and many others - for many years: <blockquote class="tr_bq">ABSTRACT:  In response to mounting evidence that use of electronic medical record systems may cause unintended consequences, and even patient harm, the AMIA Board of Directors convened a Task Force on Usability to examine evidence from the literature and make recommendations. This task force was composed of representatives from both academic settings and vendors of electronic health record (EHR) systems. After a careful review of the literature and of vendor experiences with EHR design and implementation, the task force developed 10 recommendations in four areas: (1) human factors health information technology (IT) research, (2) health IT policy, (3) industry recommendations, and (4) recommendations for the clinician end-user of EHR software. These AMIA recommendations are intended to stimulate informed debate, provide a plan to increase understanding of the impact of usability on the effective use of health IT, and lead to safer and higher quality care with the adoption of useful and usable EHR systems.</blockquote> The paper is a respectable start at acknowledgement of the issues ... albeit years late. That said: I noted some typical language in the article characteristic of the reluctance of the health IT industry and its friends to directly confront these issues.  I wrote a letter to the authors that, as I indicate below, not unexpectedly went unanswered except for one individual -- not even a physician -- who's gone out on a limb professionally in the interest of patient's rights, and as a health IT "iconoclast" (i.e., patient advocate) suffered for doing so (<a href="http://www.modernhealthcare.com/article/20130126/MAGAZINE/301269955" target="_blank">link</a>).  The lack of a response to the letter is itself representative, in my opinion, of a pathology that renders more rights to the healthcare computer and its makers than patients.   More on this below. First, I note I am rarely if ever cited by the academics.  They are not prohibited from doing so.  I've probably been writing on these issues -- poorly done health IT, improper leadership, the turmoil created, etc., publicly for longer than anyone else in the domain. I also note that the paper is somewhat in the form of an analytical debate.  Analytical debates are relatively ineffective in this domain.  They are like popcorn thrust against a battleship.  The paper, also, appearing as it does in a relatively obscure specialty journal (Journal of the American Medical Informatics Association), will probably get more exposure from this blog post than the entire readership of that journal.  The authors need to be relating these issues in forums that are widely read by citizens and government, not in dusty academic journals - that is, assuming they want the messages to widely diffuse. In my review of the article, I note the following: <blockquote class="tr_bq"><div>... In an Agency for Healthcare Research and Quality (AHRQ) workshop on usability in health IT in July 2010, all eight participating vendors agreed that usability was important and many suggested it was a competitive differentiator, although some considered that usability was in the eye of the beholder and that the discipline of usability evaluation was an imperfect science, with results that were not useful.</div></blockquote><div></div><div> A paper like this should have clearly repudiated antiquated viewpoints like that, not merely made note of them.   Not taking a stand is a sign of weakness...or sympathy.</div><div> As a matter of fact, if leaders such as this had paid attention to the 'iconoclasts' and their 'anecdotes', my own mother might not have gone through horrible suffering and death, with me as sad witness as I related to them in my letter below. <blockquote class="tr_bq">... End-users of EHR systems are ultimately accountable for their safe and effective use, like any tool in clinical care. </blockquote> I see a linguistic <a href="http://en.wikipedia.org/wiki/Sleight_of_hand" target="_blank">sleight of hand</a> via use the word "tool" to describe HIT and trying to blend or homogenize this apparatus with other "tools" in clinical care.  The HIT "tool" is unlike any other since no transaction of care can occur without it going through this device, and as such, all care is totally dependent on it.  Further, unlike pharma and medical devices, this "tool" is unvetted and unregulated but its use forced upon many users. <blockquote class="tr_bq">... [AMIA] subcommittees reviewed the literature on usability in health IT, current related activities underway at various US Federal agencies, lessons learned regarding usability and human factors in other industries, and current federally funded research activities.</blockquote></div><div> <div></div> <div>Did they speak with the source of the most candid information?  The plaintiff's and defendant's Bars? Need I even ask that question?</div><div></div><div> <blockquote class="tr_bq"><div>... Recent reports describe the safe and effective use of EHR as a property resulting from the careful integration of multiple factors in a broad sociotechnical framework</div></blockquote> This is not merely 'recent' news.  The field of Social Informatics (<a href="http://www.dlib.org/dlib/january99/kling/01kling.html" target="_blank">link</a>), that has studied IT in its social contexts for decades now, has offered observations on the importance of considering multiple factors in a broad sociotechnical framework.   The authors all know this - or should know this, or should have made it their business to know this.  The statement sounds somewhat protective of the HIT and hospital industries for their longstanding negligence towards those issues. <div dir="ltr"></div> <blockquote class="tr_bq"><div dir="ltr">... User error may result in untoward outcomes and unintended negative consequences. These may also occur as a result of poor usability, and may also be an emergent property only demonstrated after system implementation or widespread use.</div></blockquote></div><div> I note the use of the term "user error" and lack of the term "use error" with significant disdain.  As I wrote <a href="http://hcrenewal.blogspot.com/2011/11/two-opposing-views-of-ehr-1.html" target="_blank">here</a> regarding the views of a HIT industry exexcutive holding the mystical "American Medical Informatics Certification for Health Information Technology",  NIST itself now defines "use error" (as opposed to "user error") as follows: <blockquote class="tr_bq">“Use error” is a term used very specifically by NIST to refer to user interface designs that will engender users to make errors of commission or omission. It is true that users do make errors, but many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging, misuse of color-coding conventions, omission of information, etc. From "NISTIR 7804: Technical Evaluation, Testing and Validation of the Usability of Electronic Health Records." It is available at <a href="http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf" rel="nofollow">http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf</a> (PDF).</blockquote><div dir="ltr"></div><div dir="ltr"> In the article, indefinites were exchanged with what should have been stronger, declarative statements, and vice versa: <blockquote class="tr_bq">User error ... may also represent a potential health IT-related error yet to happen.</blockquote></div><div dir="ltr"></div><div dir="ltr"> I most decidedly wish they'd stop this "may" verbiage in policy papers like this.</div><div dir="ltr"></div> <blockquote class="tr_bq"><div dir="ltr">... Anecdotal reports suggest that these application differences [where clinicians use more than one commercial EHR system] result in an increased training burden for EHR users.</div></blockquote><div dir="ltr"></div><div dir="ltr"> "Anecdotal"?  How about "obvious to a third grader?"  "Anecdotal" in academic papers often is a term of derision for inconvenient truths such as reports of health IT problems.  Its use often reflects a need for authors using the term (per a senior clinician from Victoria, Australia on the 'anecdotes' issue, <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html" target="_blank">link</a>) "to attend revision courses in research methodology and risk management."</div><div dir="ltr"></div> <blockquote class="tr_bq"><div dir="ltr">... Some suggest that the expected gains sought with the adoption of EHR are not yet realized.</div></blockquote><div dir="ltr"></div><div dir="ltr"> "Some"?  How about "credible experts?"  "Suggest?"  They merely hint at it?  How about "opine?"   </div><div dir="ltr"></div><blockquote class="tr_bq"><div dir="ltr">... The design of software applications requires both technical expertise and the ability to completely understand the user’s goal, the user’s workflow, and the socio-technical context of the intent</div></blockquote><div dir="ltr"></div><div dir="ltr"> In the meantime, AMIA has been promoting national rollout of a technology where, most often, the latter does not apply.</div><div dir="ltr"></div> <blockquote class="tr_bq"><div dir="ltr">To ... transform our healthcare delivery system ... clinicians need to use usable, efficient health IT that enhances patient safety and the quality of care.</div></blockquote><div dir="ltr"></div><div dir="ltr"> This is the typical hyperenthusiast mantra.  Where's the proof?  And, transform into what, exactly?  Vague rhetoric like this in allegedly scientific papers is most unwelcome.</div><div dir="ltr"></div> <blockquote class="tr_bq"><div dir="ltr">Some experts suggest that improving the usability of EHR may be critical to the continued successful diffusion of the technology.</div></blockquote><div dir="ltr"></div><div dir="ltr"> More weak talk.  Why not come right out and say "Credible experts opine that ...."?</div><div dir="ltr"></div> <blockquote class="tr_bq"><div dir="ltr">... While some EHR vendors have adopted user-centered design when developing health information technologies, the practice is not universal and may be difficult to apply to legacy systems.</div></blockquote><div dir="ltr"></div><div dir="ltr"> From the patient advocacy perspective, that's their problem...it's a risk of being in this business.  Patients should not be expected to be used as experimental subjects while IT sellers figure out what other industry sectors have long mastered.   Further, they should be held accountable for failures that result in harm.  Another risk of doing business in this sector that clinicians have long learned to live with...</div><div dir="ltr"></div> <blockquote class="tr_bq"><div dir="ltr">... Some believe it is difficult or impossible to reliably compare one product with another on the basis of usability given the challenges in assessment of products as implemented.</div></blockquote><div dir="ltr"></div><div dir="ltr"> Nothing is "impossible" and again, if it's "difficult", that's the industry's problem.  There is risk of being in the business of medicine or medical facilitation; nobody promised a rose garden, and a rose garden should not be expected. </div> <blockquote class="tr_bq"><div dir="ltr">... Many effects of health IT can be considered to be ‘emergent’ or only discovered after monitoring a system in use</div></blockquote><div dir="ltr"> One might ask,  where's the industry and AMIA been regading postmarket surveillance (common in other health sectors) for the past several decades?</div><div dir="ltr"></div> <blockquote class="tr_bq"><div dir="ltr">... AMIA believes it is now critical to coordinate and accelerate the numerous efforts underway focusing on the issue of EHR usability.</div></blockquote><div dir="ltr"></div><div dir="ltr"> Only "now?"</div><div dir="ltr"></div> <blockquote class="tr_bq"><div dir="ltr">... Establish an adverse event reporting system for health IT and voluntary health IT event reporting</div></blockquote><div dir="ltr"></div><div dir="ltr"> No, no, no ...voluntary reporting doesn't work.  Even mandatory reporting is flawed, but it's better than voluntary. I am invariably disappointed by recommendations like this.  I've observed repeatedly, for example, that "volunatary reporting" of EHR problems already exists - in the form of the FDA MAUDE database - and most HIT sellers' reports are absent.  See my posts on MAUDE <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=MAUDE">here</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=maude_death">here</a> and <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">here</a>.  (Also, the only one that seems to report may have <a href="http://hcrenewal.blogspot.com/2010/04/healthcare-it-corporate-ethics-101.html" target="_blank">ulterior motives</a>, i.e., restraint of trade.)</div><div dir="ltr"></div> <blockquote class="tr_bq"><div dir="ltr">... A voluntary reporting process could leverage the AHRQ patient safety organizations (PSO) ... This work should be sponsored by the AHRQ.</div></blockquote><div dir="ltr"></div><div dir="ltr"> These folks clearly don't want any teeth in this.  AHRQ is a research-oriented government branch, not a regulator, nor does it have regulatory expertise.</div><div dir="ltr"> <div>AMIA recommends: </div><blockquote class="tr_bq"><div dir="ltr"><h4>Research and promote best practices for safe implementation of EHR</h4></div></blockquote>In 2013 this is valuable information in the same sense that advice to use sterile technique during neurosurgery is valuable. <div dir="ltr"></div> <div dir="ltr">"Promoting best practices" has been done for decades.  Not mentioned is avoiding worst practices.   I've long written these are not the same thing, as toleration of the inappropriate leadership by health IT amateurs (a term I use in the same sense that I am a Radio Amateur, not a telecommunications professional), politics, empire-building and other dysfunction that goes on in health IT endeavors negates laundry lists of "best practices." </div> What is required is to research and abolish worst practices, including the culture and dynamics of the 'health IT-industrial complex.'  I made this point in my very first website in 1998.  It appears the authors don't get it and/or won't admit to the dysfunction that goes on in health IT projects.   </div><div dir="ltr"></div><blockquote class="tr_bq"><div id="divRpF57737" style="direction: ltr;">... The adoption of useful and usable EHR will lead to safer and higher quality care, and a better return on investment for institutions that adopt them.</div></blockquote><div style="direction: ltr;"></div><div style="direction: ltr;"> "Will?"  With respect to my observation above about the paper's prominent misuse of indefinites vs. stronger declarative terms, the word "may" would have been the appropriate term here.  As I wrote about similar statements from ONC in the NEJM in my 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>", I'm quite disappointed seeing speculation and PR presented as fact from alleged scientists and scientific organizations. Finally, I wrote the following email letter to the authors, to which (except for Ross Koppel) I received no reply.  While Dr. Koppel (a PhD) graciously expressed sympathy for my me and mother, the others (many MD's) were silent.</div><div style="direction: ltr;"> Perhaps the silence is the best indicator of their concern for the rights of computers and HIT merchants relative to the rights of people: </div><blockquote><div style="direction: ltr;">Mon, Jan 28, 2013 at 1:12 PM </div></blockquote><blockquote><div style="direction: ltr;">Dear authors, I've reviewed the new paper "Enhancing patient safety and quality of care by improving the usability of electronic health record systems: recommendations from AMIA" and wanted to express thanks for it. It's a good start.  Late, but a good start at returning the health IT domain to credibility and evidence-based practice. It's too bad it didn't come out years earlier.  Perhaps my mother would not have gone through a year of horrible suffering and death, with me as sad witness, due to the toxic effects of bad health IT.  Perhaps you should hear how horrible it was to hear my mother in an extended agitated delirium; to hear her cry hysterically later on when the rehab people told her that her weight was 95 pounds; to have to make her a "no code" and put her on hospice-care protocols, and then to have watched her aspirate a sleeping pill when she was agitated, and die several days later of aspiration pneumonia and sepsis ... in the living room of my home ... and then watch the Hearse take her away from my driveway...as a result of bad health IT. I will be writing more thoughts on your article at the Healthcare Renewal blog, of course, but wanted to raise three issues: 1.  The use of "may" and "will" is reversed, and conflating the term "anecdote" with risk management-relevant case reports.  <ul><li>They may also represent a potential health IT-related error yet to happen.  --->  They likely represent a potential health IT-related error yet to happen</li></ul><ul><li>Anecdotal reports suggest that these application differences result in an increased training burden for EHR users.  ---> Credible reports indicate...</li></ul><ul><li>Some suggest that the expected gains sought with the adoption of EHR are not yet realized. ---> Credible experts opine ....</li></ul><div dir="ltr"><ul><li>Some experts suggest that improving the usability of EHR may be critical to the continued successful diffusion of the technology. --->  "Credible experts opine that ..."</li></ul></div><div dir="ltr"><ul><li>The adoption of useful and usable EHR will lead to safer and higher quality care, and a better return on investment for institutions that adopt them. ---> The adoption of useful and usable EHR may lead to safer and higher quality care</li></ul></div> You really need to show more clarity ... and guts ... in papers like this, and drop the faux academic weasel words. 2.  You neglected to speak to the best source for information on EHR-related harms, evidence spoliation, etc... med mal attorneys. 3.  You also neglected to speak to, or cite, the writings of a Medical Informaticist on bad health IT now going back 15 years - and whose mother was injured and died as a result of the issues you write about - me.  In fact I am rarely cited or mentioned by anyone with industry interests. An apparent contempt for 'whistleblowers' such as myself makes me wonder ... what kind of people are the leaders of health IT, exactly?  Do they value computer's rights over patients'? It is not at all clear to me which has been the primary motivator of many of the health IT leaders. I think the rights which I value are quite clear. Sincerely, Scot Silverstein</div></blockquote></div></div> I neglected to mention the horror of seeing my mother put in a Body Bag before being taken to the Hearse in my driveway. -- SS

AMIA: Enhancing patient safety and quality of care by improving the usability of EHR systems, but ... no sympathy for victims of bad health IT?

A panel of experts from the American Medical Informatics Association have written a paper " Enhancing patient safety and quality of car...

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Broken Promises: Latest HCA Settlement Suggests Skepticism about the Next Big Thing in Health Care

A long time ago in the US, most people got care from physicians who were self-employed, or part of physician partnerships.  If they had to be hospitalized, it was at hospitals that were community or academic non-profit organizations.   If they had health insurance, it was likely from a non-profit Blue Cross Blue Shield affiliate.  However, with the rise of market fundamentalism, we have heard the promises of increased efficiency and innovation from for-profit health care.  So hospitals, insurance companies, and now increasingly physicians' practices have been bought up by for profit corporations. Many politicians and policy-makers seemed to believe the promises, and often joined the cheering sections for the latest and greatest for-profit conversions.  Should they have done so?  Let us look at a case that recently hit the news again and think about it.. Background - HCA Acquired Health Midwest Way back in 2002, large for-profit hospital chain HCA, formerly Columbia/HCA, acquired a sizable non-profit hospital system, Health Midwest.  As the Los Angeles Times then <a href="http://articles.latimes.com/2002/oct/17/business/fi-tenet17">reported</a>, <blockquote class="tr_bq"><div class="area" id="area-article-first-block"><div class="mod-latarticlesarticletext mod-articletext" id="mod-a-body-first-para">In a setback for Tenet Healthcare Corp., rival hospital giant HCA Inc. said Wednesday that it has agreed to buy Health Midwest, a 14-hospital chain based in Kansas City, Mo., for $1.13 billion. Santa Barbara-based Tenet and HCA were the two finalists in a rare opportunity to acquire, in one swoop, a dominant hospital system in a growing urban market. The 20-member board of Health Midwest, a nonprofit company that has been struggling financially, said it voted unanimously to go with HCA.</div></div></blockquote> The biggest factor in the decision by the Health Midwest board to accept the HCA offer was apparently the almighty dollar. <blockquote class="tr_bq"> 'HCA's bid was much higher,' [Tenet spokesperson Harry] Anderson said, noting that he could not disclose Tenet's offer because of a confidentiality agreement. </blockquote> But in addition to cash, HCA made some promises that sounded attractive to the board. <blockquote class="tr_bq"> In addition to the cash price, HCA said it would spend $450 million for capital improvements over the next five years.</blockquote> That promise came from the top of HCA, as <a href="http://nashvillepost.com/news/2003/4/1/hca_closes_health_midwest_deal_finally">reported</a> by the Nashville post, <blockquote class="tr_bq"> HCA Chief Executive Jack Bovender said: 'This has been a comprehensive, thorough process with a lot of community participation. We are ready to get to work to improve these hospitals through significant capital infusion and by making long term operational improvements.'</blockquote>  Furthermore, as the Los Angeles Times also <a href="http://articles.latimes.com/2002/oct/17/business/fi-tenet17">reported</a> <blockquote class="tr_bq">Health Midwest spokesman Chris Whitley said price was not the only factor in the decision. 'As important to the board was to find a party that would offer a strong commitment to maintain and honor the various religious, cultural and charitable traditions,' he said.</blockquote>There were objections by people who did not have decision making authority, but they apparently did not carry much weight <blockquote class="tr_bq">Labor and community activists in Kansas City have opposed a takeover of a nonprofit health system by an investor-owned corporation, raising concerns that such a conversion would lead to cuts, hurting employees and consumers.</blockquote> In retrospect, why Health Midwest was so trusting of HCA at the time was unclear.  HCA, after all, did not have a track record then that should have inspired trust.  The HCA acquisition of Health Midwest was approved only a few years after what was then Columbia/ HCA settled allegations of extensive Medicare fraud.  the $1.7 billion the company paid made it the largest Medicare fraud case settled up to that time (and was larger than the amount it later spent on this acquisition.    See <a href="http://hcrenewal.blogspot.com/2010/05/how-did-ceo-who-presided-over-company.html">this post</a> for some details and sources.)  This certainly could have raised a "red flag" before the deal was concluded.  But it did not.  This deal was typical of many deals in which for-profit corporations, some backed by <a href="http://hcrenewal.blogspot.com/search/label/private%20equity">private equity firms</a>, took over sometimes struggling non-profit hospitals, while promising great things for their communities.  For example, see our posts about the take-over of a health care system called <a href="http://hcrenewal.blogspot.com/search/label/Caritas%20Christi">Caritas Christi</a>, by <a href="http://hcrenewal.blogspot.com/search/label/Cerberus">Cerberus Capital Management</a>.  Caritas Christi was given the reassuring name of <a href="http://hcrenewal.blogspot.com/search/label/Steward%20Health%20Care">Steward Health Care</a>, and then proceeded to take over, or try to take over additional hospitals. (Click the links for this long story.)   Broken Promises - the New HCA Settlement A new legal settlement by HCA suggests that such takeovers of non-profit hospitals by for-profit corporations ought to be regarded with much greater skepticism.  This time, <a href="http://www.nytimes.com/2013/01/25/business/hca-must-pay-kansas-city-foundation-162-million.html">per the New York Times</a>, <blockquote class="tr_bq">HCA, the nation’s largest profit-making hospital chain, was ordered on Thursday to pay $162 million after a judge in Missouri ruled that it had failed to abide by an agreement to make improvements to dilapidated hospitals that it bought in the Kansas City area several years ago. </blockquote> Thus the new HCA settlement suggested that those fine promises made by HCA executives and their cheer leaders when HCA was seeking to take over Health Midwest were broken. <blockquote class="tr_bq"><div itemprop="articleBody">The trouble in the Kansas City area began a year after HCA acquired a dozen hospitals from Health Midwest in 2003 for $1.125 billion. As part of the deal, HCA agreed to make $300 million in capital improvements in the first two years and an additional $150 million in the following three. The hospital chain also agreed to maintain the levels of care that had been provided to low-income individuals and families in the area for 10 years. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">But when the members of the Health Care Foundation of Greater Kansas City, a nonprofit created from the proceeds of the sale of the hospital, received their first report from HCA in 2004 they discovered the hospital was already way behind. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Of the $300 million it was supposed to spend in the first two years, its own documents showed it had spent only about $50 million, according to Mark G. Flaherty, one of the founding members of the foundation and its general counsel. </div><div itemprop="articleBody"> </div>HCA’s reports to the foundation also indicated that the level of charitable care it provided at the system’s large inner-city hospital had fallen while charitable care provided at the more affluent suburban hospital had risen sharply, Mr. Flaherty said. </blockquote><blockquote class="tr_bq"><div itemprop="articleBody">'That was a big red flag to us,' he said.</div><div itemprop="articleBody"> </div><div itemprop="articleBody">After repeatedly asking HCA executives for explanations but receiving none, the foundation sued HCA in 2009. The case went to trial for several weeks in 2011. </div></blockquote>  Note that there were alleged violations of two key provisions of the original deal, improvements to existing hospitals and guarantees of charitable care.  So here is at least one case, involving the largest US for-profit hospital corporation, showing violation of the sorts of promises that those promoting for-profit take-overs tout as showing at least the goodwill of the new corporate owners. Should the HCA Track Record Have Led to Questions About Trustworthiness? It is unclear how often anyone has bothered to check whether similar promises made in other deals were fulfilled.  It appears that such inquiries might actually involve a lot of bother.  Note that in this case it took almost six years for the community foundation to obtain enough information to conclude that HCA had not met its obligations and file a lawsuit, and another almost four years to get the case resolved. The New York Times hinted that there was at least one other inquiry about a contemporaneous HCA deal.  While "a judge ruled in HCA's favor, deciding that Portsmouth Regional Hospital [in New Hampshire] would remain part of HCA after community leaders tried to regain control," the court proceedings did produce <blockquote class="tr_bq"> testimony in a 2011 trial, [in which] a former hospital official claimed he had difficulties getting HCA to pay for what he and others described as critical equipment and facility upgrades. </blockquote> Meanwhile, there have been other recent events that should raise further questions about the trustworthiness of HCA going forward.  Last year extensive reporting suggested that HCA hospitals put short-term revenue ahead of patients' welfare through overuse of lucrative cardiac procedures and and undertreatment of poor patients in emergency departments and debilitated patients with bed sores (see <a href="http://hcrenewal.blogspot.com/2012/08/paging-doctor-ebdita-how-private-equity.html">this post</a>).   Also last year HCA settled allegations it provided kickbacks to physicians at some of its hospitals to refer patients to its hospitals (see <a href="http://hcrenewal.blogspot.com/2012/09/just-latest-legal-settlement-for-hca.html">this post</a>).      Moreover, the record over the long term raises a big question as to why the good people of Missouri, the "show me" state, trusted HCA sufficiently for hospital acquisition deal to go forward in 2003.  As we wrote above, HCA was only a few years out of making the biggest settlement for federal health care fraud known at that time.  Summary  In 2010, we <a href="http://hcrenewal.blogspot.com/2010/04/more-doubts-about-private-equity-taking.html">suggested</a> that the take-over of non-profit hospitals by for-profit firms owned by private equity ought to be viewed with extreme skepticism.  In 2010, in<a href="http://wendellpotter.com/deadlyspin/"> Deadly Spin</a>, former CIGNA public relations chief Wendell Potter showed how the conversions of non-profit Blue Cross Blue Shield health insurance plans to for-profit corporations were justified by the need to gather more capital to provide services comparable to new for-profit competitors, but were really motivated by the greed of executives who "would earn bigger pay packages for managing larger businesses, and if they could convert them to for-profit companies, they stood to earn even more."  I submit that if anyone were able to look carefully at the results of the various deals that allowed for-profit corporations to take over hospitals, other organizations that directly take care of patients, health insurance companies, and now even physicians' practices, they would likely find that a lot of fine sounding promises made were broken and assurances made were false.   From now on, I can only hope that health care professionals, policy-makers, politicians, but mainly the public at large will be appropriately skeptical of the fluffy promises made by those who stand to personally gain from the latest big thing in health care.  In particular, we all should be acutely skeptical the next time someone promises lower costs, better care, innovation, etc, etc by converting a community non-profit hospital to a subsidiary of a big for profit corporation.

Broken Promises: Latest HCA Settlement Suggests Skepticism about the Next Big Thing in Health Care

A long time ago in the US, most people got care from physicians who were self-employed, or part of physician partnerships. If they had to b...

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