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The RUCkus Continues: Former Medicare Administrator Calls the "RUC Process" "Incredibly Flawed," and the AMA Chair Says He's "Inaccurate"

We have posted frequently about the role of the RBRVS Update Committee (RUC) in fixing the rates at which Medicare pays physicians. These payment rates have been much more generous for procedures than for "cognitive" services, (that is, services including interviewing and examining patients, making diagnoses, forecasting prognoses, recommending tests or treatments, and counseling patients.) Several authors have suggested that how the RUC fixes payment rates is a major cause of the decline of primary care. (See our previous posts on this <a href="http://hcrenewal.blogspot.com/2007/03/on-disparities-between-reimbursement-of.html">here</a>, <a href="http://hcrenewal.blogspot.com/2007/12/is-sustainable-growth-rate-main-problem.html">here</a>, <a href="http://hcrenewal.blogspot.com/2008/05/payments-for-patient-centered-medical.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>, <a href="http://hcrenewal.blogspot.com/2009/02/what-ruc-again-one-of-worlds-most.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2009/06/letter-from-ruc-and-my-reply.html">here</a> and important articles by Bodenheimer et al,[1] and Goodson.[2]) An Interview with a former Medicare administrator Health Affairs just published an interview(3) with Kerry Weems, a recent administrator of the US Center for Medicare and Medicaid Services (CMS) under the Bush administration, who had some remarkable criticism for the RUC. <blockquote> Iglehart: The last question I wanted to ask you relates to the Specialty Society Relative Value Scale Update Committee [RUC] of the American Medical Association. The AMA formed the RUC to act as an expert panel in developing relative value recommendations to CMS. The twenty-nine-member committee essentially determines, through the relative values it establishes for the codes that form the basis of Medicare payments, how much doctors will earn from providing services to beneficiaries. In recent years the RUC has come under criticism based on the view that its specialty- dominated composition undervalues primary care services and, in some instances, overvalues specialty services. I have two questions, Kerry, regarding the RUC. You have been in government for twenty-six years; have you ever heard of an administration that has seriously questioned the RUC process, and whether CMS ought to somehow internalize it or delegate it to another body? Weems: I think there is a general consensus that the RUC has contributed to the poor state of primary care in the United States. In many ways the supposition behind the RUC process, behind the whole relative value scale, is incredibly flawed. It's an input measurement system, so it asks, What's the cost of my inputs, and that's how I'm going to price my outputs. It has no relationship to perhaps the market value of what you might buy. So because it's highly procedure based, it's prejudiced against just standard primary care evaluation and management [E&M] visits, because in an E&M visit it's hard to document what happens in the same way that it is when you remove a mole, or perform some other procedure. So the process itself is flawed. I don't think that we can make a change without a statutory change giving us the ability to do that. But it's something that is drastically needed. You know, it's funny that we talk about better coordination of care and creating the medical home. Well, the place where this can occur is in an E&M visit, which has been highly undervalued by the RUC. Iglehart: You say that the RUC process is seriously flawed and needs to be overhauled. Was there ever any discussion during the eight years of the George W. Bush administration about doing that? Weems: There were a number of discussions, but it's a hard nut to crack. Those discussions never ripened to the point where we could say we've got something better. Iglehart: But you'd anticipate under the Obama administration that those discussions will continue? Weems: Sure. And, you know, you can even see the early attempts at trying to crack that. Representative [Pete] Stark [D-CA] introduced last year the so-called CHAMP [Children's Health and Medicare Protection Act] bill, in which he proposed to develop a new payment approach that would have provided more money to primary care physicians. He split it up into several different categories. This probably wasn't the right approach, but again, he was trying to work through the problem, trying to provide more money for primary care. His heart was in the right place. </blockquote> There are a number of important points here. First, a former CMS administrator charged that the RUC has a substantial role in the decline of primary care in the US. Such charges have been made by well-reputed academics who have analyzed the role of the RUC from the outside. But as we have said before, aspects of what the RUC does are obscure, especially because the proceedings of RUC meetings are not made public. But now someone more directly involved has made the same charges. Second, a former CMS administrator has called the "RUC process ... incredibly flawed." Even the second Bush administration felt these flaws were sufficient to have "a number of discussions," but found "it's a hard nut to crack." Hence he said that although there is something fundamentally wrong with the "RUC process," the government could not easily fix it. Yet RUC leadership has repeatedly said that the RUC is merely a private advisory committee which gives recommendations to CMS using its rights to free speech and to petition the government. (Note also that above, Inglehart first said that the RUC was formed as "an expert panel" to make "recommendations." But then he said the committee "determines ... how much doctors will earn.") If the RUC is simply an advisory committee, and CMS did not like the advice the RUC was giving, why couldn't CMS leaders simply ignore the RUC? Weems' remarks do not make sense if the RUC is merely an outside private group providing advice. But they do make sense if the RUC is acting like a government agency. So this interview once again raises the question: why does CMS rely exclusively on the RUC to update the RBRVS system, apparently making the RUC de facto a government agency, yet without any accountability to CMS, or the government at large? A response by the Chair of the Board of the AMA Within days of this interview, Dr Rebecca Patchin, the Chair of the Board of Trustees of the American Medical Association (AMA), wrote a response to the Weems interview. (Amazingly, the response appeared as a <a href="http://healthaffairs.org/blog/2009/06/24/the-rucs-record-defending-primary-care/#more-1469">blog post </a>on the Health Affairs Blog.) First, she implied that a former CMS administrator did not know what he was talking about when it came to the RUC. <blockquote>In the interview, inaccurate statements were made about the role of the AMA/Specialty Society RVS Update Committee (RUC), which advises CMS regarding the relative levels of reimbursement for different medical procedures performed by physicians. </blockquote> Now I feel like I am in good company. The leaders of the RUC have charged that I made inaccurate statements about the RUC as well (see post <a href="http://hcrenewal.blogspot.com/2009/06/letter-from-ruc-and-my-reply.html">here</a>). However, Dr Patchin failed to identify any particular statements by Kerry Weems or his interviewer as inaccurate, much less provide any evidence to that effect. Note that while the RUC leaders also charged me with making inaccurate statements, they did not specify any particular statements as inaccurate, much less produce evidence in support of their contentions. Next, Dr Patchin wrote: <blockquote>Every time the RUC has been asked to review payments for E&M (evaluation and management) codes, the RUC has sent CMS recommendations that would lead to higher payments. </blockquote> This may be so, but it ignores an important issue. While the RUC may have made some recommendations to increase payments for cognitive services, it has made many more recommendations to increase payments for procedural services. Furthermore, while payments for individual procedures went up, and the volume of procedures also went up, the global budget for physicians' services, called the Sustainable Growth Rate (SGR), resulted in across the board cuts. Since raises for procedures were larger and more frequent than raises for cognitive services, the net effect was that payments for procedures increased relative to cognitive services. Even more important, it begs that question: what has the RUC done at times when no one asked it "to review payments for E&M ... codes?" After all, the RUC leadership has argued again and again that it is only a private advisory committee (and see below for another such argument). As such, it should be able to choose how often it deals with payments for cognitive services. It should not have to wait to be asked to review them. So why wasn't the RUC reviewing these payments more frequently? Then, Dr Patchin reiterated: <blockquote>To clarify: The RUC makes recommendations to CMS, and then CMS makes its payment decisions. </blockquote> and again, <blockquote> Bottom line: the RUC makes recommendations, CMS makes payment decisions. </blockquote> This, once more, begs the questions. Why didn't the RUC make more recommendations to improve payments for cognitive services? Why doesn't CMS get recommendations about payments to physicians from sources other than the RUC? Why doesn't CMS make the process for setting physicians' payments, and updating and revising the RBRVS system more broad-based and transparent? Why did the administrator of CMS feel unable to change or ignore the "RUC process?" I don't have the capacity to find out the answers to these questions. Answering them might take some investigative reporting, or even a Congressional investigation. Given that physicians' payments are key incentives driving the health care system, and that payments favoring procedures are likely to be a major cause for rising volume and costs of procedures, which, in turn, is likely to be a major reason our health care system is so expensive, why do we know so little about how these payment rates are set? 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/cgi/content/full/146/4/301">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>. 3. Iglehart JK. Doing more with less: a conversation with Kerry Weems. Health Aff 2009; <a href="http://content.healthaffairs.org/cgi/content/full/hlthaff.28.4.w688/DC1">http://content.healthaffairs.org/cgi/content/full/hlthaff.28.4.w688/DC1</a>

The RUCkus Continues: Former Medicare Administrator Calls the "RUC Process" "Incredibly Flawed," and the AMA Chair Says He's "Inaccurate"

We have posted frequently about the role of the RBRVS Update Committee (RUC) in fixing the rates at which Medicare pays physicians. These pa...

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Announcing the AdSense for Mobile Applications beta

You don't have to be a mobile expert to see how smartphones are revolutionizing our daily lives. Lower prices, faster network speeds and unlimited data plans mean that people often reach for their cell phone rather than their computer when they are seeking information. As a result, mobile applications have become more and more popular, helping people find music, make restaurant reservations or check bank balances — all on their phone. We want to contribute to the growth of these mobile applications, which is why we're happy to announce our beta launch of <a href="http://www.google.com/ads/mobileapps">AdSense for Mobile Applications</a>. After all, advertisers are looking for ways to reach potential customers when they are engaged with mobile content, and application developers are looking for ways to show the best ads to their users. We have already had a successful trial of this service with a small number of partners, and are excited that we can now offer this solution to a broader group. AdSense for Mobile Applications allows developers to earn revenue by displaying text and image ads in their iPhone and Android applications. For our beta launch, we've created a <a href="http://www.google.com/ads/mobileapps">site</a> <link: com="" ads="" mobileapps=""> where developers can learn more about the AdSense for Mobile Applications program, see answers to frequently asked questions and sign up to participate in our beta. Advertisers can also learn about the benefits of advertising in mobile applications. We're excited to open up this beta to more developers, and look forward to offering new features for our mobile advertisers and publishers in upcoming releases. We also want to say a big thank you to the partners who worked with us on the trial stages of this project including Backgrounds, Sega, Shazam, Urbanspoon and more. Check out this short video of Howard Steinberg, Director of Business Development at <a href="http://urbanspoon.com/">Urbanspoon</a>, discussing his experience with AdSense for Mobile Applications. <object height="340" width="560"><param name="movie" value="http://www.youtube.com/v/AaMDikYsO_g&hl=en&fs=1&rel=0"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/AaMDikYsO_g&hl=en&fs=1&rel=0" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" height="340" width="560"></embed></object> Posted by Susan Wojcicki, Vice President, Product Management</link:>

Announcing the AdSense for Mobile Applications beta

You don't have to be a mobile expert to see how smartphones are revolutionizing our daily lives. Lower prices, faster network speeds and...

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The Day in the Cloud Challenge has begun

Today, we invite you to take part in the <a href="http://www.dayinthecloud.com/?utm_source=google&utm_medium=blog&utm_campaign=ogb">Day in the Cloud Challenge</a>, an online scavenger hunt that's being played simultaneously on the ground and in the air aboard Virgin America flights across the U.S. The Day in the Cloud demonstrates how people can use <a href="http://www.google.com/apps/">Google Apps</a> to stay connected with friends, family and co-workers when they're away from their homes — even at 35,000 feet in the air. <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh1okR5FMDKhZzof8y_cD1_jawsFmevVmntFZSaXo6GZH7hXsYUhcEXQlYLVzbhDn5IfKTtNvDJyAzvaRSJsPafeRhY6-RLp8DwWeLjIOXcN_5l6hmCF5ZuR9y9GME-wS9fAINcPX1SLVVs/s1600-h/Game_Play_Screen.png" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5350913163529906818" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh1okR5FMDKhZzof8y_cD1_jawsFmevVmntFZSaXo6GZH7hXsYUhcEXQlYLVzbhDn5IfKTtNvDJyAzvaRSJsPafeRhY6-RLp8DwWeLjIOXcN_5l6hmCF5ZuR9y9GME-wS9fAINcPX1SLVVs/s400/Game_Play_Screen.png" style="display:block; margin:0px auto 10px; text-align:center;cursor:pointer; cursor:hand;width: 400px; height: 237px;" /></a> The <a href="http://www.dayinthecloud.com/?utm_source=google&utm_medium=blog&utm_campaign=ogb">online game</a> will be available until 11:59pm PDT today, so find a quiet spot, do some finger stretches, and take the challenge. Posted by Vivian Leung, Google Apps Team

The Day in the Cloud Challenge has begun

Today, we invite you to take part in the Day in the Cloud Challenge , an online scavenger hunt that's being played simultaneously on the...

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Let's make the web faster

From building data centers in different parts of the world to designing highly efficient user interfaces, we at Google always strive to make our services faster. We focus on speed as a key requirement in product and infrastructure development, because our <a href="http://googleresearch.blogspot.com/2009/06/speed-matters.html">research</a> indicates that people prefer faster, more responsive apps. Over the years, through continuous experimentation, we've identified some performance best practices that we'd like to share with the web community on <a href="http://code.google.com/speed">code.google.com/speed</a>, a new site for web developers, with tutorials, tips and performance tools. We are excited to <a href="http://groups.google.com/group/make-the-web-faster">discuss</a> what we've learned about web performance with the Internet community. However, to optimize the speed of web applications and make browsing the web as fast as turning the pages of a magazine, we need to work together as a community, to tackle some larger challenges that keep the web slow and prevent it from delivering its full potential: <ul><li>Many protocols that power the Internet and the web were developed when broadband and rich interactive web apps were in their infancy. Networks have become much faster in the past 20 years, and by collaborating to update protocols such as HTML and TCP/IP we can create a better web experience for everyone. A great example of the community working together is <a href="http://en.wikipedia.org/wiki/HTML_5">HTML5</a>. With HTML5 features such as AppCache, developers are now able to write JavaScript-heavy web apps that run instantly and work and feel like desktop applications.</li></ul><ul><li>In the last decade, we have seen close to a <a href="http://www.webmonkey.com/print/blog/Google_Throws_Its_Weight_Behind_HTML_5">100x improvement</a> in JavaScript speed. Browser developers and the communities around them need to maintain this recent focus on performance improvement in order for the browser to become the platform of choice for more feature-rich and computationally-complex applications.</li></ul><ul><li>Many websites can become faster with little effort, and collective attention to performance can speed up the entire web. Tools such as Yahoo!'s <a href="http://developer.yahoo.com/yslow/">YSlow</a> and our own recently launched <a href="http://code.google.com/speed/page-speed/">Page Speed</a> help web developers create faster, more responsive web apps. As a community, we need to invest further in developing a new generation of tools for performance measurement, diagnostics, and optimization that work at the click of a button.</li></ul><ul><li>While there are now more than 400 million broadband subscribers worldwide, broadband penetration is still relatively low in many areas of the world. Steps have been taken to bring the benefits of broadband to more people, such as the <a href="http://googlepublicpolicy.blogspot.com/2008/11/vote-for-broadband-in-white-spaces.html">FCC's decision</a> to open up the white spaces spectrum, for which the Internet community, including Google, was a strong champion. Bringing the benefits of cheap reliable broadband access around the world should be one of the primary goals of our industry. </li></ul>To find out what Googlers think about making the web faster, see the video below. If you have ideas on how to speed up the web, please <a href="http://moderator.appspot.com/#15/e=79951&t=79d39">share</a> them with the rest of the community. Let's all work together to make the web faster! <object height="340" width="560"><param name="movie" value="http://www.youtube.com/v/IWWBnJEsUtU&hl=en&fs=1&rel=0"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/IWWBnJEsUtU&hl=en&fs=1&rel=0" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" height="340" width="560"></embed></object> Posted by Urs Hoelzle, SVP, Operations and Bill Coughran, SVP, Engineering

Let's make the web faster

From building data centers in different parts of the world to designing highly efficient user interfaces, we at Google always strive to make...

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Practicing (Clinical Trials) Medicine Without a License

Another story of dubious clinical research, this time <a href="http://www.tampabay.com/news/business/article1012526.ece">reported</a> by the St Petersburg (Florida, US) Times: <blockquote> Vladimir Martin called himself 'doctor' and ran 17 clinical trials of new drugs for major pharmaceutical companies before one patient noticed he didn't have a medical license. The patient alerted the St. Petersburg Times, whose resulting story led to a state investigation. On Saturday, Martin, 43, was arrested on charges of practicing medicine without a license. He was later released from the Pinellas County Jail on $10,000 bail. The felony charge carries a maximum sentence of five years in prison and maximum fine of $5,000. The Clearwater man, who changed his last name from Kossatchev after moving to Florida in 2003, went to medical school in the former Soviet Union and practiced in a hospital in his native Ukraine. Ruth Weber, a 74-year-old Clearwater resident, told the Times in April 2008 that the man who called himself Dr. Martin enrolled her in a study for lower-back pain and adjusted the dosage of her medicine. Only licensed physicians are supposed to conduct such activities. Patients in the study were randomly selected to receive a new Johnson & Johnson painkiller called tapentadol, a placebo or the potent narcotic oxycodone. Though Dr. Robert Lee Jackson, a Clearwater osteopath, was listed by the FDA as the physician conducting the study, Weber said she never saw Jackson. In weekly visits to Alliance Medical Research Group on Belcher Road, Weber said it was Martin who drew blood, doled out medication and, at one point, doubled her dosage. Martin also conducted electrocardiograms on Weber, although his techniques were so rusty the electrodes kept slipping off, she said. Weber eventually dropped out of the study when she saw no improvement for her back pain. A second woman, Ann Reed, told investigators she also responded to an ad for a drug study trial at Alliance Medical Research. Martin took her blood, listened to her heart and gave her medications, Reed said. Martin sometimes had to stick her four times to draw blood, she said. Like Weber, Reed said she never saw Jackson during her trial, which involved 13 visits between May 2007 and March 2008. Greg Panico, a spokesman for Johnson & Johnson, said the company audited Alliance Medical after the Times' story and submitted its findings to the FDA. He declined to discuss the nature of the report, but said the drug company is no longer working with Alliance Medical. Panico also said data collected in the tapentadol study at that site was not submitted to the FDA. The drugmaker said it reported its findings to the <a href="http://www.sterlingirb.com/aboutus.php">Sterling Institutional Review Board</a> in Atlanta, which had been hired by Johnson & Johnson to oversee patient safety during the trial. Despite losing the Johnson & Johnson trial, Martin told investigators in July that he was conducting four other drug studies. </blockquote> A little Google searching turned up another example <a href="http://http://clinicaltrials.gov/ct2/show/study/NCT00387010">on ClinicalTrials.gov </a>of a commercially funded clinical study for which the Alliance Medical Research Group enrolled patients. This was a Phase III study sponsored by Cephalon, an "Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain." Note also that Sterling Institutional Review Board appears to be another example of a for-profit, commercial institutional review board. Here we have another example of remarkably bad implementation of commercially sponsored and commercially supervised clinical trials. We have posted a number of times about sloppy and mismanagement of commercially sponsored clinical research, often under the auspices of for-profit contract research organizations (CROs) and for-profit institutional review boards (IRBs). See <a href="http://hcrenewal.blogspot.com/2006/05/saga-of-study-3014-and-safety-of.html">this 2006 vintage post </a>on the infamous study 3014 on Ketek, sponsored by Sanofi Aventis. In my humble opinion, in the contemporary business world, many managers are driven mainly by quarterly profits. However, what works best to boost profits in the short run may not be what works to produce valid clinical research that maximizes the safety of and respect afforded human research subjects. When all the organizations involved in the research, the sponsor, the organization implementing the research, and the organization supervising research ethics are for-profit, the incentives to cut corners are multiplied. Cutting corners can jeopardize the validity of the studies, and the safety and respectful treatment of study subjects. I again submit that making human experimental research into a commercial enterprise, mainly serving the marketing of drugs and devices, may not produce good science, and may not be good for patients. It might be a better idea to leave human research to not-for-profit organizations and health care professionals. Hat tip to <a href="http://pharmagossip.blogspot.com/2009/06/alliance-medical-research-group.html">PharmaGossip</a>.

Practicing (Clinical Trials) Medicine Without a License

Another story of dubious clinical research, this time reported by the St Petersburg (Florida, US) Times: Vladimir Martin called himself ...

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Mark Leavitt, Head of CCHIT: Behind the Times and Uninformed on Health IT Realities?

Signs that a leader who alleges himself or herself to be objective and a scientist is, in fact, neither objective nor scientific include:<div> </div><div><ul><li>Resorting to <a href="http://www.nizkor.org/features/fallacies/ad-hominem.html">ad hominem</a> attacks when questioned or criticized.</li><li>Deficient familiarity with the current literature.</li><li>Opining that others' concerns expressed in that literature could be "laughed off." </li><li>Years-behind view of the situation on the ground.</li></ul></div><div> </div><div>The head of CCHIT, Mark Leavitt, has penned the following at iHealthBeat (emphases and comments in red italic mine):</div><div> </div><div> <blockquote><a href="http://www.ihealthbeat.org/perspectives/2009/health-it-under-arra-its-not-the-money-its-the-message.aspx">June 19, 2009 - Perspectives</a></blockquote><blockquote>Health IT Under ARRA: It's Not the Money, It's the Message by Mark Leavitt... Estimates by the Congressional Budget Office suggest the total incentive payout could reach $34 billion, although with expected savings the net cost is half that. Add to that another $2 billion that the Office of the National Coordinator for Health IT can use on various initiatives in support of the goal of having an EHR for every American by 2014. [Note the catchy marketing slogan, which carries the implicit message "what manner of people would oppose Mother and Apple Pie?" - ed.]But more important than the money itself is the message implicitly conveyed along with it. Will incentives be perceived as an intrusive, carrot-and-stick manipulation of health care providers' business decisions? Or will health care providers interpret ARRA as the correction of a reimbursement anomaly, welcoming the opportunity to modernize their information management and transform the care they deliver. [Cybernetic Miracle™ Alert - note the grandiose term "transform", as opposed to "facilitate" or "improve" - ed.]Some of the early signs have been worrisome. Before ARRA, most surveys concluded that cost was the No. 1 barrier to EHR adoption. But as soon as it appeared that the cost barrier might finally be overcome, individuals with a deeper-seated "anti-EHR" bent emerged. Their numbers are small, but their shocking claims -- that EHRs kill people, that massive privacy violations are taking place, [As an information scientist, I'm almost embarrassed to post <a href="http://news.google.com/archivesearch?q=hipaa+violation+complaint&btnG=Search&hl=en&ned=us&um=1&scoring=a" style="font-weight: bold;">this link</a> and <a href="http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=link&linkname=pubmed_pubmed&uid=18369111&ordinalpos=1&log$=relatedarticles&logdbfrom=pubmed" style="font-weight: bold;">this link</a>, the results of just a few minutes' work with public resources. Thorough, robust searches in <a href="http://www.dialog.com/sources/">Dialog</a>'s suite of databases, Current Contents, Lexis Nexis, SciFinder etc. would show far more - ed.]that shady conspiracies are operating -- [i.e., <a href="http://www.ehrstimulustour.com/" style="font-weight: bold;">HIT industry lobbies</a> - ed.]make stimulating copy for the media. Those experienced with EHRs might laugh these stories off, but risk-averse newcomers to health IT, both health care providers and policymakers [i.e., those who take due diligence and <a href="http://hcrenewal.blogspot.com/2009/03/health-it-hold-harmless-and-defects-gag.html" style="font-weight: bold;">fiduciary responsibilities</a> seriously - ed.]are easily affected by fear mongering. </blockquote>  </div> That is, Bah! to the apostates' narratives -- -- even though many of these narratives are in the peer-reviewed biomedical science and biomedical informatics literature ... <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEihjCTKnPgicc5ejVkr4Ex4OyrM2g1xnJVBBk6asH_ruJA_eC4iHj6sCB5fu-41HiMhGkDTur9LhwNe6gwuO0v52VKqj6SzqfXOaz1RsX3hfoxzTCdpc2P22sDi_3uwR5o_PeWW6rWTO05Q/s1600-h/dogbert.gif" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5350412883081586530" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEihjCTKnPgicc5ejVkr4Ex4OyrM2g1xnJVBBk6asH_ruJA_eC4iHj6sCB5fu-41HiMhGkDTur9LhwNe6gwuO0v52VKqj6SzqfXOaz1RsX3hfoxzTCdpc2P22sDi_3uwR5o_PeWW6rWTO05Q/s320/dogbert.gif" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 166px; height: 165px;" /></a>Bah! </div> I'm really tired of amateurish political rhetoric and marketing puffery masquerading as substantive debate on critical issues as above. However, being experienced with EHRs, their design, implementation and lifecycle, and concerned with widespread irrational exuberance over health IT (a facilitative tool that carries risk to patients and medical organizations if not done well) I am not at all "laughing these stories off", and will critique the above in a quite serious manner. Indeed, "laughing off" stories from credible sources and personnel (e.g., many AMIA members) about potential harm from an experimental technology affecting patients seems the height of hubris, or blindness of a kind mediated by incomplete knowledge or conflicts of interest. First, binary thinking. It seems those who critique health IT's drawbacks are "individuals with a deeper-seated anti-EHR bent." That is, they don't buy into the consensus of the industry "experts" and must therefore be biased and wrong. <div><div> <div><div>I, in fact, am a health IT proponent, but simply abhor poor HIT such as at my series <a href="http://tinyurl.com/b28s74">here</a>, or HIT sold to my organization in an unusable (but "Certified") state as in the Civil Complaint <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/DUCOM_EMR_Complaint.pdf">here</a> (PDF). I believe the rush to <a href="http://www.jamia.org/cgi/content/abstract/13/1/106">national EHR by 2014 is premature</a>, will waste massive amounts of money, and will cause disruption to an already strained healthcare system with resultant adverse effects. I believe far more research remains to be done before our social and technical understanding of "how to do clinical IT well" justifies mass government-mandated cybernetic re-engineering in healthcare. (See literature list below.)<div><div> </div><div>On the issue of ad hominem attacks against questions and critique, I documented those at Healthcare Renewal at "Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-Certified HIT" <a href="http://hcrenewal.blogspot.com/2009/06/open-letter-to-mark-leavitt-chairman.html" style="font-weight: bold;">at this link</a>. Both I and another physician, David Kibbe, MD, MBA, Health IT Consultant at American Academy of Family Physicians, were subjected to "nonlinear" commentary. It also seems Dr. Leavitt is unfamiliar with or deliberately downplaying a growing body of literature on health IT risks and failures. [Health IT failure never, ever puts patients at risk, as I wrote <a href="http://hcrenewal.blogspot.com/2009/05/health-it-failure-never-puts-patients.html" style="font-weight: bold;">here</a>, of course - ed.] Examples of this growing body of "unknown" or "ignored" or "downplayed" literature include: </div>  <div><div> </div><div>1. The article "<a href="http://www.jamia.org/cgi/content/full/16/3/291">Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop</a>", Bonnie Kaplan and Kimberly D. Harris-Salamone, Journal of the American Medical Informatics Association 2009;16:291-299. DOI 10.1197/jamia.M2997 - and the references cited.</div><div> </div><div>There are more than 70 references at the end of this article (See fulltext at link above), and my comments on the findings and recommendations of the multi-working group informatics workshop that created it are in the post "Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop" <a href="http://hcrenewal.blogspot.com/2009/03/health-it-project-success-and-failure.html">at this link</a>.</div><div> </div><div>2. This corpus of literature below. These are just examples and not a comprehensive listing:</div><div> </div><div><blockquote>Joint Commission: <a href="http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_42.htm">Sentinel Events Alert on HIT</a>, Dec. 2008. National Research Council report. <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">Current Approaches to U.S. Healthcare Information Technology are Insufficient</a>. Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions, Jan. 2009 <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15302.htm"> The National Programme for IT in the NHS: Progress since 2006,</a> Public Accounts Committee, January 2009. Summary points <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">here</a>. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm">Common Examples of Healthcare IT Difficulties</a> (my own 10-year-old website). S. Silverstein, MD, Drexel University College of Information Science and Technology. <a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians</a>, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009; 301(12):1276-1278 <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/regulation_and_oversight_hoffman.pdf">Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems</a>, Hoffman and Podgurski, Harvard Journal of Law & Technology 2008 vol. 22, No. 1 <a href="http://www.ncbi.nlm.nih.gov/pubmed/18213422">Failure to Provide Clinicians Useful IT Systems: Opportunities to Leapfrog Current Technologies</a>, Ball et al., Methods Inf Med 2008; 47: 4–7, <a href="http://jama.ama-assn.org/cgi/content/extract/301/9/919">IT Vulnerabilities Highlighted by Errors, Malfunctions at Veterans’ Medical Centers</a>, JAMA Mar. 4, 2009, p. 919-920. <a href="http://pediatrics.aappublications.org/cgi/content/abstract/116/6/1506">Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System</a>, Han et al., Pediatrics Vol. 116 No. 6 December 2005, pp. 1506-1512 <a href="http://jama.ama-assn.org/cgi/content/abstract/293/10/1197">Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors</a>. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203 <a href="http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf">Hiding in Plain SIght: What Koppel et al. tell us about healthcare IT</a>. Christopher Nemeth, Richard Cook. Journal of Biomedical Informatics. 38 (4): 262-3. <a href="http://www.jamia.org/cgi/content/short/15/4/408">Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes and Threats to Patient Safety</a>, Koppel, Wetterneck, Telles & Karsh, JAMIA 2008;15:408-423 <a href="http://www.nytimes.com/2009/03/06/opinion/06coben.html">The Computer Will See You Now</a>, New York Times, Armstrong-Coben, March 5, 2009, <a href="http://iig.umit.at/efmi/badinformatics.htm">Bad Health Informatics Can Kill</a>. Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI). <a href="http://archinte.ama-assn.org/cgi/content/short/167/13/1400">Electronic Health Record Use and the Quality of Ambulatory Care in the United States</a>. Arch Intern Med. 2007;167:1400-1405 <a href="http://www.jamia.org/cgi/content/abstract/13/1/106">Predicting the Adoption of Electronic Health Records by Physicians: When Will Health Care be Paperless?</a> Ford et al., J Am Med Inform Assoc. 2006;13:106-112 <a href="http://www.jamia.org/cgi/content/abstract/16/3/274">Resistance Is Futile: But It Is Slowing the Pace of EHR Adoption Nonetheless</a>, Ford et al., J Am Med Inform Assoc. 2009;16:274-281 <a href="http://archinte.ama-assn.org/cgi/reprint/165/10/1111.pdf">High Rates of Adverse Drug Events in a Highly Computerized Hospital</a>, Nebeker at al., Arch Intern Med. 2005;165:1111-1116. "<a href="http://articles.icmcc.org/2009/01/23/dutch-ehr-postponed-are-they-in-good-company/">Dutch nationwide EHR postponed: Are they in good company?</a>", ICMCC.org, Jan. 24, 2009 “<a href="http://www.ama-assn.org/amednews/2006/12/11/bisa1211.htm">Avoiding EMR meltdown</a>.” About a third of practices that buy electronic medical records systems stop using them within a year, AMA News, Dec. 2006. "The failure rates of EMR implementations are also consistently high at close to 50%", from <a href="http://www.infoclin.ca/assets/emr%20success%20methodologies%20framework%20development%20ishimr%202006%20v2.pdf">Proceedings of the 11th International Symposium on Health Information Management Research</a> – iSHIMR 2006 "Industry experts estimate that failure rates of Electronic Medical Record (EMR) implementations range from 50–80%.", from <a href="https://www.advancedmd.com/pressroom/white_papers/commonsense_to_emrs.pdf">A Commonsense Approach to EMRs</a>, July 2006 <a href="http://www.taxonomer.com/PublishTxgd001/index.htm">Adverse Effects of Information Technology in Healthcare</a>. This knowledge center presents a collection of information on the adverse effects of information technology in its application to healthcare. It also references sources of information on information security, and related media reports. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Goldfinch_pessimism_PAR.pdf">Pessimism, Computer Failure, and Information Systems Development in the Public Sector</a>. Shaun Goldfinch, University of Otago, New Zealand, Public Administration Review 67;5:917-929, Sept/Oct. 2007 The literature at my HIT website's "Other Resources" page (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=other">link</a>) The teachings of the field of Social Informatics about new Information and Communications Technologies (ICT's) and the unanticipated negative consequences they cause. An introductory essay entitled “Learning from Social Informatics” by R. Kling at the University of Indiana can be found <a href="http://rkcsi.indiana.edu/archive/SI/Arts/SI_report_Aug_14.doc">at this link</a> (MS-Word file). The book “Understanding And Communicating Social Informatics” by Kling, Rosenbaum & Sawyer, Information Today, 2005 (<a href="http://www.amazon.com/Understanding-Communicating-Social-Informatics-Communication/dp/1573872288/ref=sr_1_1/102-9749119-8288920?ie=UTF8&s=books&qid=1174318804&sr=8-1">Amazon.com link here</a>) was based on this essay. </blockquote></div><div> </div><div>3. The warnings of HIT dangers from the U.S. Joint Commission, the EFMI, as linked above, and others; doubts about cost savings from Wharton and Stanford professors (surely no amateurs). </div><div> </div><div>In the June 20, 2009 Wall Street Journal article "<a href="http://online.wsj.com/article/SB10001424052970204005504574235751720822322.html" style="color: rgb(102, 153, 204);">The Myth of Prevention</a>", Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford, echoed <a href="http://hcrenewal.blogspot.com/2009/06/wharton-on-healthcare-it-can-i-go-home.html" style="color: rgb(102, 153, 204);">several Wharton professor's doubts</a> about the cost savings and ultimate value of electronic medical records, touted as the cybernetic savior of healthcare:</div><div> </div><div>  <blockquote>... I have similar problems with the way President Obama hopes to pay for the huge and costly health reform package he has in mind that will cover all Americans; he is counting on the “savings” that will come as a result of investing in preventive care and investing in the electronic medical record among other things. It’s a dangerous and probably an incorrect projection.</blockquote></div><div> </div><div>There are also reports of problems from FDA-like agencies of other countries such as Sweden's, whose report entitled "The Medical Products Agency’s Working Group on Medical Information Systems: Project summary" (available in English translation at <a href="http://www.lakemedelsverket.se/upload/foretag/medicinteknik/en/Medical-Information-Systems-Report_2009-06-18.pdf" style="color: rgb(102, 153, 204);">this link</a> in PDF) stated:</div><div> </div><div style="font-family:georgia;">  <blockquote><div>It is becoming more common that electronic patient record systems and other systems are interconnected, for instance imaging systems or laboratory systems. It is obvious that such systems should not be regarded as “purely administrative”; instead they have the characteristic features that are typical for medical devices. They sort, compile and present information on patients’ treatments and should therefore be regarded as medical devices in accordance to the definition.Since the electronic patient record system often replaces/constitutes the user interface of “traditional” medical device systems, the call for 100% accuracy of the presented information is increased. Patient record systems have crucial impact on patient safety, and this has been proven to be the case after a series of incidents [including deaths - ed.] that has been reported to the Swedish National Board of Health and Welfare.  </div></blockquote></div><div> </div><div>On wonders if Dr. Leavitt would include the Swedish Medical Products Agency, who incidentally have a <a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108646.htm">cooperation agreement with our own FDA</a>, under the category of "fearmongers." Finally, stories of HIT mayhem of which Dr. Leavitt seems blissfully unaware are making their way to appropriate political circles. The whistleblowers are afraid to speak out publicly due to fear of job loss or retaliation. However, when the case examples do come out, it may be Dr. Leavitt who will be found to be "fear mongering" about those who care more about patients and their rights than about information technology.</div><div> </div><div>Health IT Under ARRA: It's Not the Money, It's the Message. Indeed.</div><div> </div><div>And Dr. Leavitt's message about those who think critically about health IT seems quite ill informed and mean spirited. </div><div> </div><div>Finally, to get past the <a href="http://www.nizkor.org/features/fallacies/ad-hominem.html">ad hominem</a> and other <a href="http://en.wikipedia.org/wiki/List_of_fallacies">logical fallacy</a> nonsense I believe will be coming my way, I'll just admit to any and all of it. I'm an SOB, I'm a disgruntled curmudgeon, I'm an HIT dilettante, my uncle was in the mafia, I kick little cygnet swans in the park to be mean to Chucky, the cob (father) , and Princess, the pen (mother). /sarc :-) </div><div> </div><div><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh7_n2tP9xo0-LteaFfG7X7klaFrboNttoMfHWIPtseqS2hofqwvADV7FRi62-G0wyTVtUqur42848Q2a8QeC3UBLRfQSfUnPxraclf5_RItFd2DCOuVQ25bwDjjB6jkSpGIgqMPMnsAyL8/s1600-h/swan_family_june22_2009.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5350396710705376466" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh7_n2tP9xo0-LteaFfG7X7klaFrboNttoMfHWIPtseqS2hofqwvADV7FRi62-G0wyTVtUqur42848Q2a8QeC3UBLRfQSfUnPxraclf5_RItFd2DCOuVQ25bwDjjB6jkSpGIgqMPMnsAyL8/s320/swan_family_june22_2009.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 316px; height: 215px;" /></a></div><div style="text-align: center;">The Mute Swan family of Towamencin Twp., PA. Click to enlarge. The cygnets have really grown this past month (major cuteness warning if you click <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cygnus.jpg">this picture</a> from June 1!) </div><div> Now that we're hopefully past the expected <a href="http://www.nizkor.org/features/fallacies/ad-hominem.html">ad hominem</a>, perhaps the real issues can be addressed. As a final piece of advice to Dr. Leavitt, I can add that dismissing concerns of others, Dogbert-style, is not a way to win friends and influence people. </div><div>Humor and a little humility work much better. -- SS</div></div></div></div></div></div></div>

Mark Leavitt, Head of CCHIT: Behind the Times and Uninformed on Health IT Realities?

Signs that a leader who alleges himself or herself to be objective and a scientist is, in fact, neither objective nor scientific include: Re...

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An Original Excuse

The Associated Press just published <a href="http://www.google.com/hostednews/ap/article/ALeqM5iqRyDDIAJ4RAA-ImdqfMw4q86TcQD98UHT7G0">a story </a>about another company which apparently failed to report adverse events associated with its product: <blockquote> Complaints about a contact lens solution linked to a 2007 outbreak of eye infections that blinded several people went unreported by the manufacturer for more than a year, government documents show. The documents show Advanced Medical Optics received complaints about the solution more than a year before it was recalled, and failed to promptly report nine complaints as required by law. The company pulled its Complete MoisturePlus off the market in May 2007 after the Centers for Disease Control and Prevention linked the fluid to dozens of cases of a serious infection called Acanthamoeba keratitis. Lawyers for customers suing AMO obtained the documents, which stem from a previously undisclosed inspection by the Food and Drug Administration, through a Freedom of Information Act request. The papers were obtained by The Associated Press. Of roughly 70 plaintiffs suing AMO and represented by the law firm Schmidt LLP, three had eyes removed, three others suffered blindness and about two dozen had at least one corneal transplant. The others suffered permanent vision damage. Beginning in February 2006 and continuing through November, AMO received a series of complaints about users who were diagnosed with the Acanthamoeba infections. But those reports were not disclosed until June 2007, when FDA inspectors came to investigate the company's headquarters following its product recall. </blockquote> What is most striking is the company's rationale for not reporting: <blockquote> When questioned by FDA inspectors, company officials said they were not obligated to report the complaints because the product's labeling does not say it protects against Acanthamoeba, according to the FDA documents. Kelly Morrison, a spokeswoman for Abbott Laboratories, which acquired AMO in February, said the company 'believed it was reporting customer complaints in compliance with FDA regulations.' She declined to elaborate. Abbott Laboratories is based in North Chicago. </blockquote> That is an original excuse. Did the "company officials" really mean to imply that in the absence of a promise to protect against a specific microbiologic organism, patients and physicians should assume that the product could be contaminated with that organism? This completely ignores the company's basic responsibility to supply a product that is uncontaminated with any harmful organisms, and unadulterated with any harmful substances, and hence to be vigilant for any events that suggest that the product could have been contaminated or adulterated. The "company officials'" bizarre excuse suggest a fundamental lack of comprehension of their responsibilities for the health and safety of the patients using their products. This is a particularly weird example of how little many leaders of health care organizations understand about health care.

An Original Excuse

The Associated Press just published a story about another company which apparently failed to report adverse events associated with its produ...

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