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Congresswoman Renee Ellmers on Health IT Concerns

A letter on Health IT from Congresswoman <a href="http://ellmers.house.gov/index.cfm?sectionid=94&sectiontree=2,94">Renee Ellmers</a>, (R) NC, Chairwoman of the U.S. House of Representative's Committee on Small Business, Subcommittee on Healthcare and Technology was just sent to Secretary of the Dept. of Health and Human Services Kathleen Sebelius. The themes in the letter will be familiar to readers of Healthcare Renewal. A PDF copy of the letter can be downloaded by clicking below, and the text follows. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh_2qirVMyivJO381vV0HLJ5llEXSAZTVTTq38vhgR-RkUBW0XIKs_CJQR43Sxm1tjdVyB8YkT_9FcRqSwIU02xHFgfYVe4TnyG4852AOTTRfq0U1PbZEmb8qgX06yZPn2b4IDfipISDnDD/s1600/ellmers.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5639969911782066050" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh_2qirVMyivJO381vV0HLJ5llEXSAZTVTTq38vhgR-RkUBW0XIKs_CJQR43Sxm1tjdVyB8YkT_9FcRqSwIU02xHFgfYVe4TnyG4852AOTTRfq0U1PbZEmb8qgX06yZPn2b4IDfipISDnDD/s320/ellmers.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 246px; height: 320px;" /></a>(<a href="http://smbiz.house.gov/UploadedFiles/Health_IT_Concerns_Sebelius_8.11.11.pdf" style="font-weight: bold;">click here</a> to download PDF) </div> Here is the text, along with several comments: <blockquote> August 11, 2011 The Honorable Kathleen Sebelius Secretary U.S. Department of Health and Human Services 200 lndependence Avenue, S.W. Washington, DC 20201 Via Facsimile: 202. 690.7380 Dear Secretary Sebelius: The House Small Business Committee, on which I serve, is required by the Rules of the House to study and investigate the problems of all types of small businesses. This jurisdiction extends to matters concerning small businesses and health care. I chair the Committee’s Subcommittee on Healthcare and Technology. On June 2, 2011, the Subcommittee held a hearing on the barriers to health information technology that are encountered by physicians and other providers in small practices. At the hearing, physicians testified that the cost to purchase and maintain a health IT system, is addition to staff training and downtime during the transition to health IT, are significant burdens for small practices. These barriers mere mentioned even by physicians who believe health IT would ultimately benefit their practices. Providers at the hearing also stated their concern about the Medicare reimbursement penalties that will be assessed against providers who do not demonstrate “meaningful use” of health IT by 2015. One of the frequently mentioned benefits of health IT has been a reduction in medical errors. However, recent news reports have noted incidents of health IT errors. An article in Sunday’s Pittsburgh Post-Gazette [a series, actually, <a href="http://hcrenewal.blogspot.com/2011/05/healthcare-renewal-cited-in-pittsburgh.html" style="font-weight: bold; font-style: italic;">here</a> and <a href="http://www.post-gazette.com/pg/11219/1165767-114-0.stm?cmpid=nationworld.xml" style="font-weight: bold; font-style: italic;">here</a>- ed.] cited a baby who was killed while computerized IV equipment prepared a lethal dose of an intravenous sodium chloride solution. The machine did not catch the pharmacy technician’s error. The article also noted that when a hepatitis C-positive kidney was accidentally transplanted from a live donor into a recipient, the physician team missed the electronic records alert, and the physicians complained that their electronic records system is cumbersome and difficult to adjust to any one physician’s needs. [You can be sure that my writings on health IT mission hostility, poor quality, lack of regulation, etc. as well as the cases of health IT-related injury and death I know of, including that of my own relative, will find their way to Rep. Ellmer's office - ed.] The Journal of the American Medical Association recently published a study of almost 4,000 computer-generated prescriptions that were received by a pharmacy chain. The report found that 12 percent of the prescriptions contained errors, which, the report said, is consistent with error rates with handwritten prescriptions. [I wrote about that <a href="http://hcrenewal.blogspot.com/2011/06/electronic-medication-prescribing-magic.html" style="font-weight: bold; font-style: italic;">here</a> - ed.] A modern, well-equipped office is critical to the practice of medicine, and health IT offers promise to all medical professionals. [But only when done well - and there is massive complexity behind those simple two words "done well" that is poorly recognized and/or ignored - ed.] Health IT has the potential to improve health care delivery, decrease medical errors, increase clinical and administration efficiency, and reduce paperwork. We most do all we can to ensure a commitment to our health care system and patient care. As technology rapidly evolves, I ask that you consider a study of health IT’s adoption, benefits and cost effectiveness. [Cart before the horse when being done AFTER a national multi-billion dollar rollout is put into law, <a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">as I wrote here</a>, but better late than never - ed.] As part of the study, I hope you will also consider medical error rates — both human and technological --so that all errors can he better assessed and prevented. [I have been calling for this for years now - ed.] Sincerely, Renee Ellmers Chairwoman Subcommittee on Healthcare and Technology House Committee on Small Business </blockquote> I find this letter from a leading member of the House of Representatives remarkable. Importantly, Chairwoman Ellmers has a medical background (HHS Secretary Sebelius, to my knowledge, does not). Here is part of Chairwoman Ellmer's <a href="http://en.wikipedia.org/wiki/Renee_Ellmers">background</a> from Wikipedia: <blockquote>In 1990, she graduated with a Bachelor of Science degree in Nursing. Ellmers worked as a nurse in Beaumont Hospital's surgical intensive care unit. In North Carolina, she was clinical director of the Trinity Wound Care Center in Dunn.</blockquote> The only other letters like it asking questions like this that I know of came from a Republican Senator to the HIT vendors, Sen. Grassley of Iowa (see <a href="http://hcrenewal.blogspot.com/2009/10/washington-post-emrs-no-cure-all-sen.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/01/grassley-asks-hospitals-about.html">here</a>). Sen. Grassley also wrote directly on HIT problems to HHS Secretry Sebelius on Feb. 24, 2010; see the letter <a href="http://www.scribd.com/doc/27483558/Grassley-Feb-24-Letters">here</a>. -- SS

Congresswoman Renee Ellmers on Health IT Concerns

A letter on Health IT from Congresswoman Renee Ellmers , (R) NC, Chairwoman of the U.S. House of Representative's Committee on Small Bus...

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Now a Mainstream Notion: "Profit-seeking Players in Finance and Health Care Have Captured Congress"

We have been writing - some might say wailing Cassandra-like - about health care dysfunction since I published about it in the European Journal of Internal Medicine in 2003.(1) However, while our dismal warnings were inspired by fears of  health care professionals who saw bad things happening in their local health care environments, the notion that things were really bad in health care really did not get a lot of traction. After all, we were in the second decade of a prolonged economic "great moderation," the good times were rolling, so who was really worried by a few whiners and complainers in health care? However, after the fall of Lehman Brothers ushered in the global financial collapse, or great recession, this complacency was disturbed, and it began to appear that our problems in health care were not unique, but were linked to much bigger problems in the general political economy. However, the stock market rebounded, the bankers went back to making money, and economists declared the great recession over, reassuring those on the right, although the middle class continued to whine and complain about unemployment, stagnant wages, and mortgage foreclosures. Furthermore, a Democratic administration legislated both financial and health care reform, reassuring those on the left. We on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> went on and on that things were not better, and health care reform no more than barely scratched the surface. Now with stock markets falling around the world, it appears that the great recession/ global financial collapse may not really be over.  In this increasingly dismal era, the notion that health care dysfunction has not really improved, and may in fact be an important component of the larger political economic problems may be getting more mainstream. To wit, last week, David Wessel <a href="http://online.wsj.com/article/SB10001424053111903885604576486001046286690.html">wrote</a> in the Wall Street Journal: <blockquote>Two big sectors of the U.S. economy have been on steroids: finance and health care. If anything is crowding out more productive activities, it's them, as ... [New York University economist Paul] Romer argued in a recent National Academy of Sciences lecture. The bloated financial sector—all those brains lured by big bucks who might otherwise have been employed in science, software, engineering or other fields—has harmed the U.S. economy more than any of our post-World War II communist adversaries did. The American health system costs more per person than any other, but isn't delivering the world's healthiest people. The U.S. isn't getting its money's worth from either sector. </blockquote> Furthermore, his diagnosis of the problem sounds like something we might have written on Health Care Renewal, if we wrote as well as he does: <blockquote>Profit-seeking players in finance and health care have captured Congress, resisted regulation that would curb their excesses and exploited antiquated rules and policy for private gain. [Paul Romer said,] 'The legislative process may just be too vulnerable to manipulation by very well-financed entities with an enormous amount of wealth and income at stake,' he said. 'Congress is for sale at bargain-basement prices.'</blockquote>My only quibble is that while those who have personally profited from health care and finance have exploited antiquated rules, they also cannily managed to dispose of many time-proven rules that stood in their way. In any case, we have written repeatedly about the linkages between finance and health care,(2) and how the current corrupt culture of finance has affected health care; that true health care reform will be very difficult because it will be resisted by those who have been made wealthy by the current system;(3) that they were made wealthy by the increasing commercialization of health care accompanied by the abandonment of previous regulations and safeguards;(4) and about their use of <a href="http://hcrenewal.blogspot.com/search/label/regulatory%20capture">regulatory capture</a> and <a href="http://hcrenewal.blogspot.com/search/label/embedded%20networks%20of%20influence">embedded networks of influence</a>(5) to further their aims. You heard it here first. Wessel's solution is: <blockquote>Congress should tie its own hands more often, retaining power to investigate and vote proposals up or down but avoiding the detailed crafting of legislative provisions that influence the flow of money. In other words, he wants more bodies such as the Base Closure and Realignment Commission (to decide which military bases to close), the Independent Payment Advisory Board (to identify ways Medicare can save money) and, perhaps, the new Joint Select Committee on Deficit Reduction (to find $1.5 trillion in deficit-reduction cuts). Maybe that's an answer. But it's clear that future prosperity depends on the U.S.—its government, business, people and universities—coalescing behind a strategy for growth and creating incentives so talent and capital flow to promising sectors where the U.S. still has an edge in an increasingly competitive global economy.</blockquote> My general suggestions maybe are complementary. True health care reform would help physicians and other health care professionals uphold their traditional values, including, as the AMA once stated, "the practice of medicine should not be commercialized, nor treated as a commodity in trade." True health care reform would put health care "delivery" back in the hands of mission-focused, not-for-profit organizations, which put patients' health, safety and welfare first. Health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses. Notes: 1. Poses RM. A cautionary tale: the dysfunction of American health care.  Eur J Int Med 2003; 14: 123-130.  Link <a href="http://www.ejinme.com/article/S0953-6205%2803%2900029-3/abstract">here</a>. 2.  Medical school leaders become stewards (as members of boards of directors) of for-profit health care corporations - An example is <a href="http://hcrenewal.blogspot.com/2010/12/duke-divinity-students-protest-pay-of.html">here</a>, and a summary of how we discovered this phenomenon in 2006 is <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">here</a>. The conflict of interest is severe because directors of for-profit corporations are supposed to have unyielding loyalty to the interests of the corporation and its stockholders, although they are frequently accused of acting mainly as cronies of the top hired executives (see <a href="http://hcrenewal.blogspot.com/2010/07/new-york-times-reports-university.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/01/one-small-step-towards-reducing.html">here</a>). Leaders of failed finance firms become stewards of academic medicine - We have found numerous examples, e.g., <a href="http://hcrenewal.blogspot.com/2010/04/failed-leaders-of-citigroup-as-leaders.html">here</a>, <a href="http://hcrenewal.blogspot.com/2010/04/wamu-worry-more-overlaps-between.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2010/03/members-of-board-of-now-bankrupt-lehman.html">here</a>, of top executives and/or board members of the finance firms who helped bring on the global financial collapse also being trustees of medical schools, academic medical centers, or their parent universities. Such "stewards" may bring to the academic environment the "greed is good" culture now pervasive in finance. 3.  For example, see <a href="http://hcrenewal.blogspot.com/2011/07/health-care-for-very-rich-is-different.html">this post</a> and its links   4. In the US, a Supreme Court decision was interpreted to mean that medical societies could no longer regulate the ethics of their members.  Until 1980, the US American Medical Association had  ruled that the practice of medicine should not be "commercialized, nor treated as a commodity in trade."  After then, it ceased trying to maintain this prohibition.  The result was increasing, now rampant commercialization.  See posts <a href="http://hcrenewal.blogspot.com/2007/12/relman-in-jama-on-threats-to-physicians.html">here</a> and <a href="http://hcrenewal.blogspot.com/2009/06/why-did-us-physicians-give-up-their.html">here</a>.   Furthermore, the notion that information asymmetry, uncertainty and ambiguity, and inability of patients to make coldly rational decisions about disease and its management made it impossible for health care to be an ideal free market, necessitating mechanisms to compensate for market failure became passe.  Such mechanisms were then abandoned, with disastrous results.  For further discussion, see <a href="http://hcrenewal.blogspot.com/2010/08/how-fallacy-of-perfect-health-care.html">this post</a>   5.  For example, see <a href="http://hcrenewal.blogspot.com/2011/06/embedded-networks-of-influence-in.html">this post</a>

Now a Mainstream Notion: "Profit-seeking Players in Finance and Health Care Have Captured Congress"

We have been writing - some might say wailing Cassandra-like - about health care dysfunction since I published about it in the European Jour...

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Retreat Back to Regulatory Capture: US FDA, NIH, Department of Health and Human Services All Back Off

After some brave words about transparency, integrity and all that, US government officials seem to be running back to the arms of the health care corporate CEOs. Weakening FDA Conflict of Interest Rules As <a href="http://www.reuters.com/article/2011/08/01/us-fda-bias-idUSTRE7703R320110801">reported</a> by Reuters, <blockquote>U.S. lawmakers likely will change the criteria for advisers reviewing new medicines next year because of complaints that the rules meant to prevent conflicts of interest make it harder to find real experts. Congressional lawmakers may require the Food and Drug Administration to relax the rules that bar advisers from reviewing a drug if they have even indirect financial ties to related manufacturers, as part of an FDA funding bill.</blockquote> This was not purely an initiative of legislators, but was egged on by a top FDA administrator <blockquote>The agency often must delay panel meetings while it searches for experts without conflicts, lawmakers and FDA officials say. Top doctors are usually the ones drugmakers hire as speakers or consultants. 'We have had difficulty in recruiting highly qualified people. And we've had delays in having panels because of this,' Dr. Janet Woodcock, head of the FDA's drugs center, told a House of Representatives hearing earlier this month. The result is that 23 percent of FDA advisory panels have vacancies, more than double the agency's stated goal, according to the FDA's quarterly report at the end of May.</blockquote> The rationale was that those paid by drug and device companies are the most expert: <blockquote>The FDA tightened guidelines in 2007 to minimize industry ties that could sway a panelist's view, partly inspired by the scandal with Merck's pain reliever Vioxx. Ten of the 32 panelists advising the FDA on the drug consulted for drugmakers. Nine of the 10 recommended putting the drug back on the market after it was pulled in 2004 over concerns about heart risk. The restrictions go too far, say lawmakers who want the FDA to approve more new medicines, in part because they promote American jobs. 'No longer can we deny experts simply because they have ties to industry,' said Georgia Representative Phil Gingrey during a House of Representative hearing on FDA funding last month. The committee's chairman, Fred Upton from Michigan, called the conflict of interest rules 'rigid and unrealistic.' Industry executives, who want the FDA to speed drug approvals, also support relaxing the rules. Biogen Idec CEO George Scangos said the guidelines 'exclude a lot of people who would be the best qualified.'</blockquote> Of course, the drug and device companies have been touting their paid "key opinion leaders" as the best and the brightest for a long time. There is plenty of evidence, however, that they are mainly those whom those companies find the most compliant, and in many cases, those who are willing to be stealth marketers on those companies' payrolls. (See this <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">post</a> about those who recruit KOLs regarding them as salesmen, and more <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">here</a>.)  "Key opinion leaders" supported by commercial grant funding may seem like experts to academic medical institutions' leadership who now value outside funding more than teaching and research excellence (see this <a href="http://hcrenewal.blogspot.com/2010/12/american-medical-schools-are-only-in-it.html">post</a>). Furthermore, as <a href="http://www.politico.com/news/stories/0811/60522.html">reported</a> by Politco, the Project on Government Oversight, a watchdog group, chastised FDA leadership for exaggerating the difficulty of finding unconflicted experts, concluding in their letter to the FDA Commissioner, "to gain the public trust, we must ensure that the FDA relies on the best available information for its policies, rather than personal opinions and biases." So far, government officials seem to be more worried about the opinions of corporate leaders than the public trust. Weakening NIH Conflict of Interest As <a href="http://http//www.nature.com/news/2011/110801/full/476017a.html">discussed</a> in Nature, <blockquote>Francis Collins hailed it as a 'new era of clarity and transparency in the management of financial conflicts of interest' (S. J. Rockey and F. S. Collins J. Am. Med. Assoc. 303, 2400–2402; 2010). But the director of the US National Institutes of Health (NIH) may have spoken too soon when he described a new rule, proposed last year, that would require universities and medical schools to publicly disclose online any financial arrangements that they believe could unduly influence the work of their NIH-funded researchers. Nature has learned that a cornerstone of that transparency drive — a series of publicly accessible websites detailing such financial conflicts — has now been dropped.</blockquote> In more detail, <blockquote>The NIH's parent agency, the Department of Health and Human Services (DHHS), proposed the new rule in May 2010, after congressional and media investigations revealed that prominent NIH grant recipients had failed to tell their universities or medical schools about lucrative payments from companies that may have influenced their government-funded research. The DHHS called the proposed websites 'an important and significant new requirement to … underscore our commitment to fostering transparency, accountability, and public trust'. Under the proposal, institutions with NIH-funded researchers would determine, grant by grant, if any financial conflicts existed for senior scientists on the grant. For example, these would include receiving consultancy fees, or holding shares in a company, 'that could directly and significantly affect the design, conduct, or reporting' of the research. The institutions would post the details online, where they would stay for at least five years. </blockquote> But of course the medical schools decided that it would just be too much trouble to do all this: <blockquote>'The websites don't appear out of nowhere,' says Heather Pierce, senior director of science policy at the Association of American Medical Colleges (AAMC) in Washington DC. They would 'require employees to not only create the website but to pull the information, review it, and make sure it is up to date and accurate'. That is not the only objection from the powerful academic lobbies. During the public comment period last summer, the Association of American Universities and the AAMC submitted a joint statement saying: 'There are serious and reasonable concerns among our members that the Web posting will be of little practical value to the public and, without context for the information, could lead to confusion rather than clarity regarding financial conflicts of interest and how they are managed.'</blockquote> Given how academic medical institutions have expanded their administrations and bureaucracy, the enormous amounts they spend on management, and the huge <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">compensation</a> they give their executives, and further given how much of their revenues come from government sources (Medicare, Medicaid money for patient care, Veterans Administration money supporting many faculty members, Medicare money funding graduate medical education, and NIH and other government research grants), the notion that getting a few staffers to process disclosures would be administratively or financially burdensome is just laughable. At least Iowa's Republican Senator Charles Grassley, seemingly one of the last politicians in Washington who cares about the integrity of government programs and spending, is upset. As <a href="http://blogs.nature.com/news/2011/08/senator_urges_white_house_not.html">reported</a> again by Nature, <blockquote>The US Senate's leading advocate for government transparency wrote today to the White House's budget office, demanding that it protect a proposed rule that would obligate universities to post their publicly-funded biomedical researchers' financial conflicts on a publicly accessible website. 'The public's business should be public... I urge OMB to follow through and approve a rule that includes a publicly available website,' Senator Charles Grassley, Republican of Iowa ..., wrote in in <a href="http://blogs.nature.com/news/Grassley.omb.pdf">this letter </a>to Jacob Lew, the director of the White House's Office of Management and Budget (OMB).</blockquote> Furthermore, he wrote: <blockquote>I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama's call for more transparency in the government.</blockquote> We will see if his protest does any good, but again it appears that government officials are more worried about the revenues of big health care organizations than the needs of the public. Retreating from Threats to Disbar Forest Laboratories CEO We previously <a href="http://hcrenewal.blogspot.com/2011/05/logical-fallacies-to-defend-ceos-from.html">posted</a> about how the US Department of Health and Human Services threatened to disbar the CEO of Forrest Laboratories from dealings with the government after his company pleaded guilty to obstruction of justice and misbranding, and paid a $313 million fine. Now, <a href="http://online.wsj.com/article/SB10001424053111903885604576490631294926432.html">per</a> Alicia Mundy writing for the Wall Street Journal, things have changed: <blockquote>The U.S. government dropped efforts to force the resignation of a prominent pharmaceutical-company chief executive, reversing course after protests from the company and major business groups. The about-face on Forest Laboratories's longtime leader, Howard Solomon, represents a significant retreat by the Department of Health and Human Services, which has said it wants to step up punishments against drug-company executives when wrongdoing happens on their watch. Forest agreed last year to plead guilty to misdemeanors involving marketing of its drugs including the antidepressant Celexa, and it paid $313 million to resolve the matter. Mr. Solomon wasn't personally accused of any wrongdoing. Nonetheless, the government notified him in April that it was considering excluding him from jobs at health-care companies that sell to the U.S. government. It invoked a little-used clause in the Social Security Act that allows such an action against corporate leaders of companies found guilty of criminal misconduct, even if the leaders had no knowledge of the misconduct. The exclusion move would have effectively forced Forest to remove Mr. Solomon from office, because Forest and other drug companies rely on business from U.S. government agencies such as Medicare and the Veterans Administration. In a letter to Mr. Solomon on Friday, the office of the inspector general of the Department of Health and Human Services said, 'Based on a review of information in our file, and consideration of the information your attorneys provided to us both in writing and in an in-person meeting, we have decided to close this case.'</blockquote> We have <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">discussed</a> - some might say endlessly - how despite numerous publicly reported cases of wrongdoing by health care organizations, hardly any individual who authorized, directed or implemented the bad behavior has ever faced any negative consequences. There have been recent fulminations by some government officials that this is going to change. The case of the Forest Laboratories CEO appeared to be an example of such change, but no more. The Wall Street Journal went on to discuss why the government may have changed course: <blockquote>The government's retreat came after a barrage of complaints from Forest and business groups including the U.S. Chamber of Commerce and the Pharmaceutical Research and Manufacturers of America, the drug industry's leading trade group. In July, Forest spent $80,000 to hire former Louisiana Sen. John Breaux to lobby the government regarding exclusion, according to Senate records. Mr. Breaux didn't return a call requesting comment. Forest said earlier that it was just trying to make its case that this was a highly unusual action by the U.S. government.</blockquote> Of course it was unusual. That is the whole problem. In any case, it looked like the government was much more concerned about the coddling of corporate CEOs and their lobbyists' and cronies' opinions than about deterring bad behavior by large health care organizations. Summary After a bit of blustering by the current US administration about transparency and integrity it appears to be back to business as usual in the US capital. Over the last 20 years, government has increasingly answered to corporate CEOs instead of "we, the people." Protecting patients' and the public's health has given way to protecting the financial health of large health care organizations, and the compensation of rich CEOs. Federalism is giving way to corporatism. As long as this continues, expect our health care system to continue its slow collapse. Eventually, expect the CEOs to get in their private jets and escape while the rest of us picks up the pieces. Until we dispel the fog of corporatism that has spread over the government that was once supposed to be of the people, by the people, and for the people, expect no real health care reform, and expect continuing rising costs, declining access, and worsening patient care. Obviously, true health care reform would start with the government and its officials putting patients' and the public's health first, way ahead of the financial comfort of corporate CEOs. See also <a href="http://alison-bass.blogspot.com/2011/07/tougher-nih-rules-about-financial.html">comments</a> by Alison Bass.

Retreat Back to Regulatory Capture: US FDA, NIH, Department of Health and Human Services All Back Off

After some brave words about transparency, integrity and all that, US government officials seem to be running back to the arms of the health...

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Why EHR's Are Mission Hostile

From "<a href="http://www.nejm.org/doi/pdf/10.1056/NEJMp1102099">Revisiting E&M Visit Guidelines — A Missing Piece of Payment Reform</a>" (free PDF as of this writing), Robert A. Berenson, M.D., Peter Basch, M.D, and Amanda Sussex, M.P.H., N Engl J Med 364;20 nejm.org May 19, 2011. Excerpt: <blockquote> ... Numerous problems have resulted. [From the CPT codes, Current Procedural Terminology codes used by physicians in billing, covering evaluation and management (E&M) services - ed.] The detailed guidelines often cause clinicians to overdocument, making the medical record an ineffective source of communication. ... A fundamental concern is that the office-visit descriptors and interpretive guidelines emphasize often-irrelevant elements of patients’ clinical histories and examinations, rather than decisionmaking and care-management activities. This is particularly problematic in the case of clinicians caring for patients with multiple chronic conditions. Now EHR experts argue that the priority placed on documentation has diverted software designers’ focus from more important activities that would improve the quality and efficiency of care. [3] The current focus produces EHR-generated data dumps, including repetitive documentation of elements of patients’ histories and physical examinations, that merely result in electronic versions of clinically cumbersome, uninformative patient records. [4]</blockquote> Then why are they popular? Here's why: <blockquote> Studies show that EHRs pay for themselves within a few years and then generate profit partly because of facilitated coding, not greater practice efficiency. [EHR's saving the government money? A pipe dream - ed.]</blockquote> Partial list of references cited in the excerpts above: [3] Park T, Basch P. A historic opportunity: wedding health information technology to care delivery innovation and provider payment reform. Washington, DC: Center for American Progress, 2009. (http://www.americanprogress.org/issues/2009/05/health_it.html.) [4] Hartzband P, Groopman JG. Off the record — avoiding the pitfalls of going electronic. N Engl J Med 2008;358:1656-8. In fact, I'd made similar observations about an ED EHR in a hospital where a relative was treated. I wrote: <blockquote>... I reviewed a printout from the ED system myself, and found a collection of what I call “legible gibberish” (a mass of information as if the EMR system is just a warehouse for clinical data) but no diagnosis of her problem. A nonspecific and non-useful diagnoses of “abdominal pain” was all I could find – and that was on page 8 of an 12 page printout. ... These observations and events cause me to believe your electronic medical records systems are not serving the patients and the physicians properly and could result in patient harm. </blockquote> The outputs of inpatient EMR's are far worse. See my Feb. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html">Two weeks, two reams</a>." The thousands of pages of data-dumped legible gibberish I've seen has been stunning, both in terms of the ignorance of basic information science and the wasted effort and dangers to patients represented when other physicians need to refer to these old records in caring for sick people. Berenson et al. add to our understanding of these phenomena. -- SS

Why EHR's Are Mission Hostile

From " Revisiting E&M Visit Guidelines — A Missing Piece of Payment Reform " (free PDF as of this writing), Robert A. Berenso...

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Medical Data Mix-up, Major System Error Down Under - But Nobody Harmed, Of Course

This from Down Under. Apparently an American IT system by Cerner was involved: <a href="http://www.theage.com.au/victoria/medical-data-mixup-major-system-error-20110804-1idht.html"></a><blockquote><a href="http://www.theage.com.au/victoria/medical-data-mixup-major-system-error-20110804-1idht.html">Medical data mix-up, major system error</a> Kate Hagan | August 5, 2011 MELBOURNE hospitals have sent incorrect patient records to GPs due to an error with Victoria's troubled health technology program over the past two months. The discharge summaries from Eastern Health and the Royal Victorian Eye and Ear Hospital mixed patients' names with other patient data, including test results and diagnoses.[A major patient misidentification error - ed.] The data was faxed to GPs under the HealthSMART program, which Health Minister David Davis has described as ''the myki of health''.[I think 'myki' refers to the contactless <a href="http://en.wikipedia.org/wiki/Myki">smartcard ticketing system</a> being introduced on public transport in Victoria, Australia. Did I mention I despise comparisons of healthcare to public transit, having started my career in the latter industry? - ed.] Mr Davis yesterday said: ''This latest error raises further concerns about [former health minister] Daniel Andrews's judgment when designing the HealthSMART system.'' The Health Department was alerted to the record mix-up last month after two GP clinics raised the alarm. Department spokesman Graeme Walker yesterday confirmed the bungle and said an investigation found that 13 incorrect discharge summaries were sent out over a seven-week period. ''There was an intermittent error in terms of the sending of discharge summaries in a small number of cases to GPs,'' he said. ''It was the link up between the software and the fax which caused some incorrect collating of material attached to the discharge summaries.'' Mr Walker said no patients suffered as a result of the bungle, which had since been fixed. AMA Victoria president Harry Hemley said the mix-ups were a major concern. ''When patients are admitted to hospital often their medication is changed and they are given a diagnosis,'' he said. ''Discharge summaries influence our ongoing treatment of the patient. If our [incorrect understanding] is that a patient is on a certain medication, that could have serious implications.''[Well, yes. How about - injury and death? - ed.] Mr Davis said yesterday he had been advised of a software fault that led to some patient discharge summaries being distributed to the wrong GP clinics. ''I have sought and received assurances that patient safety has not been compromised,'' he said.[Patients are NEVER harmed by IT foulups thanks to the <a href="http://en.wikipedia.org/wiki/Lords_of_Kobol" style="font-style: italic;">Lords of Kobol</a> overseeing the universe of Cybernetica - or something like that - ed.] Mr Davis told The Age in January that he was considering abandoning the HealthSMART program, which is five years late and has cost the state $405 million, including an $80 million cost overrun.[He should see what the UK just did with their NPfIT <a href="http://hcrenewal.blogspot.com/2011/08/you-saw-it-here-first-uk-nhs-pulls-plug.html">here</a> - they pulled the plug - ed.] The program, introduced by the former Labor government in 2003, is supposed to link computer systems in hospitals and give doctors immediate access to patient records. But clinical applications are only partially running in four hospitals and doctors say they are costly, outdated and difficult to use.[That is, they present a <a href="http://www.tinyurl.com/hostileuserexper">mission hostile</a> user experience - ed.] Victoria's Ombudsman and Auditor-General are currently examining a string of failed information technology projects in Victoria, including HealthSMART, which have run over budget and fall short of their goals despite repeated warnings by the watchdogs.[Repeated warnings by watchdogs ignored - that is quite familiar to me since my writings on these issues began - in 1999 - ed.] Dr Hemley said the government needed to take urgent action to implement a system that allowed doctors ready access to patient records, test results and medication details. ''We're sick of hearing how bad [HealthSMART] has been, we're waiting for the Ombudsman to come out with that report so we can get on with this IT business and start it happening so that we can communicate with each other,'' he said.[I wish them luck. Einstein on insanity: doing the same thing over and over again and expecting different results. - ed.] ''We've got to look at where mistakes have been made, eradicate them and move forward.''[Yes, it's that simple. Of course, achieving nuclear fission on your kitchen table is easy as long as you have the right components and a pamphlet by <a href="http://en.wikipedia.org/wiki/Alfred_E._Neuman">Dr. Alfred E. Neuman</a> on the topic - ed.] Asked whether affected patients had been notified of the error, the Health Department's Mr Walker said that would be done ''at the discretion of either the hospital or GP involved''. The Eye and Ear Hospital did not return calls from The Age yesterday and Eastern Health referred inquiries to the Health Department.</blockquote>-- SS

Medical Data Mix-up, Major System Error Down Under - But Nobody Harmed, Of Course

This from Down Under. Apparently an American IT system by Cerner was involved: Medical data mix-up, major system error Kate Hagan | Augu...

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Why Radiologists Should Review Reports Carefully , and Why Health IT Causes Screwups

Another way computers in medicine can lead to maimed and dead patients: <div class="lfr-portlet-column" id="layout-column_column-2"> <div id="p_p_id_EXT_4_" class="portlet-boundary portlet-boundary_EXT_4_ null"> <a name="p_EXT_4"></a> <div class="portlet-borderless-container" style=""> <div> <style>.firefox .portlet-boundary_EXT_4_ #article-comments p sup { }.ie #article-comments table { margin-bottom: 12px; margin-top: -8px; }#article-comments div { font-size: 12px; line-height: 1.7; text-align: left; }.ie .article-comments-date { margin-bottom: 5px; }</style> <div id="article-publish-date" class="article-date"> </div> <div id="article-tools-top"> </div> <div id="pagination-top"> </div> <div id="article-eyebrown" class="article-blurb"><a href="http://www.diagnosticimaging.com/radblog/display/article/113619/1917452" style="font-weight: bold;"></a></div><blockquote><div id="article-eyebrown" class="article-blurb"><a href="http://www.diagnosticimaging.com/radblog/display/article/113619/1917452" style="font-weight: bold;">Why Radiologists Should Review Reports Carefully</a> Diagnostic Imaging </div> <div id="article-authors" class="article-blurb"> </div> <div id="article-byline" class="article-blurb"> By Arun Krishnaraj, MD | August 2, 2011 </div> <div id="article-byline-location" class="article-blurb"> </div> <div id="article-bio" class="article-blurb"> </div> <div id="article-flag" class="article-blurb"> </div> <div id="article-teaser" class="article-blurb"> </div> <div id="article-deck" class="article-blurb"> </div> Mrs. Anderson called her doctor and spoke with pressured speech: “I think there is a mistake. That cannot be my ultrasound. I don’t have a gallbladder.” Mrs. Anderson was accessing our hospital’s open EHR, which allowed her to view her radiology reports, and noticed a discrepancy. An ultrasound had been performed which identified “multiple hypoechoic lesions, incompletely characterized.” Because the lesions discovered were indistinguishable from metastatic deposits by ultrasound an MRI was correctly recommended for more definitive characterization. However, the dictating radiologists overlooked a “canned” normal finding in his final report noting the presence of a normal appearing gallbladder. Mrs. Anderson’s gallbladder had been removed surgically 10 years prior. [In other words, he ticked a "normal" box or template and out came the report of a normal gallbladder - ed.] Mrs. Anderson’s case came to my attention when I dictated her liver MRI, comparing it to the ultrasound performed earlier in the week. The liver MRI fortunately demonstrated only multiple benign lesions. My report commented on expected post cholecystectomy changes in the right upper quadrant in the findings of the dictation but not in the impression. I did not read the portion of the prior ultrasound report describing the gallbladder because I was only concerned with the positive finding for which the MRI had been ordered, the liver lesions. [In other words, most doctors are too busy and distracted by their work to have to deal with computer-generated garbage - ed.] I received an e-mail the next day from the nurse practitioner (NP) caring for Mrs. Anderson. She said that Mrs. Anderson had called her office frantic that there was some kind of mix up and that her patient wanted to know which of her reports were correct. I reviewed both reports and realized there was a proofreading error on the ultrasound report, paged the dictating radiologist to amend the error, and explained to the NP how such errors occur with our speech recognition software and macros. [They're lucky this case was not like the infanticide by computer cases <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">here</a>. However, next time, luck may run out and a critical finding might be missed, or an incorrect one added that results in catastrophe - ed.] The NP understood and said she would explain to Mrs. Anderson that both her studies were accurate except for the oversight on the ultrasound dictation which would be amended. While the NP realized how such errors may make their way on to finalized reports, I now better understand the impact an incorrect report can have on a patient. [My mother could have told him this, but he'd need a megaphone to talk to her. Her incorrect report has caused her to change her address to a cemetery and she is now six feet under the ground - ed.] We are entering a new era of health care that is more patient centered. Part of this new paradigm is patient access to their medical records, easily accessible from the Internet. While physicians possess the ability to distinguish between an occasional proofing error, patients can not, nor should they be expected to. [And when physicians fail for any reason to distinguish such errors, patients are put in harm's way - ed.] In order to increase the efficiency of radiology reporting, most institutions have moved to speech recognition (SR) software with templated macros. The potential for typographical errors has been shown to be higher using SR software than traditional transcription services.1 [Wait - technology is supposed to, through cybernetic magic, reduce errors - ed.] However, there is a paucity of literature regarding how often errors occur because of the use of pre-populated macros. I learned first hand how my words can affect a patient’s mental well being by inducing unnecessary anxiety. More and more pressure is being placed on radiologists to increase <a href="http://www.diagnosticimaging.com/radblog/display/article/113619/1603443">their RVUs to maintain their salaries.</a> However, patients will not and should not excuse us from errors in what we report. In an era of more open access to all medical records, including radiology dictations, it will be critical for radiologists to take pause and examine their finalized reports carefully. [1] J Digit Imaging. 2008 Dec;21(4):384-9. Voice recognition dictation: radiologist as transcriptionist.</blockquote><div id="article-content-body"> </div> <div id="pagination-bottom"> </div> </div></div> <div id="article-evidence-based-med" class="article-blurb"> </div> <div id="article-guidelines" class="article-blurb"> </div> <div id="article-notes" class="article-blurb"> </div> <div id="article-references" class="article-blurb"> </div> </div> </div> <div id="p_p_id_56_INSTANCE_iLgx_" class="portlet-boundary portlet-boundary_56_ null"> <a name="p_56_INSTANCE_iLgx"></a> <div class="portlet-borderless-container" style=""> <div> </div> </div> </div> That might be sage advice for all doctors using computer-based equipment. -- SS

Why Radiologists Should Review Reports Carefully , and Why Health IT Causes Screwups

Another way computers in medicine can lead to maimed and dead patients: Why Radiologists Should Review Reports Carefully Diag...

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Debt Ceiling deal could endanger health care law - and it would be beneficial if health IT/HITECH were part of the trimmings

A story about the recent political deal to raise the Debt Ceiling entitled "Deal could endanger health care law" appeared in the Politico (hat tip Drudge Report): <blockquote style="font-family: arial;"><a href="http://www.politico.com/news/stories/0811/60634.html">Deal could endanger health care law</a>By <a href="http://www.politico.com/reporters/JenniferHaberkorn.html" rel="nofollow">JENNIFER HABERKORN</a> | 8/3/11 11:28 PM EDT Politico.com The <a href="http://www.politico.com/news/stories/0811/60549.html" target="_blank">debt ceiling agreement</a> could jeopardize millions of dollars, and perhaps billions, in initiatives from President Barack Obama’s health care reform law if the super committee can’t come up with required spending cuts.Many of the pots of money in the law — one of the Democrats’ most prized pieces of legislation — could get trimmed by the debt deal’s sequestration, or triggered cuts. The funds for prevention programs and community health centers, grants to help states set up insurance exchanges and co-ops, and money to help states review insurance rates could be slashed across the board if the panel can’t find enough cuts this fall. </blockquote><div style="overflow: hidden; color: rgb(0, 0, 0); background-color: transparent; text-align: left; text-decoration: none; border: medium none; font-family: arial;">My suggestion: </div> <div> <div style="font-size: 13px; color: rgb(0, 0, 0); direction: ltr; font-family: Arial;"> <div style="font-family: arial;" dir="ltr"> </div> <div dir="ltr" style="font-family:arial;">Put health IT and the HITECH Act (the health IT component that 'somehow' found its way into the fantastically-successful American Recovery and Reinvestment Act of 2009) on the table. Health IT devices are medical devices that are dangerous, unregulated and unproven (e.g., see 'Reading List' <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">here</a>) in their current state of development and lawless environment. Cutting HIT funding probably would be beneficial in avoiding waste as well. Note what just occurred in the UK: </div> <div style="font-family: arial;" face="arial" dir="ltr"> </div> <div dir="ltr"><a href="http://hcrenewal.blogspot.com/2011/08/you-saw-it-here-first-uk-nhs-pulls-plug.html">UK NHS pulls the plug on its £11bn IT system</a> -- SS </div></div></div>

Debt Ceiling deal could endanger health care law - and it would be beneficial if health IT/HITECH were part of the trimmings

A story about the recent political deal to raise the Debt Ceiling entitled " Deal could endanger health care law " appeared in the...

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