Health Care Policy of the Insiders, by the Insiders, for the Insiders - the Newt Gingrich Case Files

Newt Gingrich's rise to the top of the pack of Republican contenders for the US presidency has earned him increased scrutiny.  The resulting investigative reporting has provided a revealing set of case studies showing how insiders have come to dominate US health care policy.<br /><br />Below I have reorganized the information presented in a series of news articles from mid-November to mid-December, 2011.<br /><br /><b>Mr Gingrich's Consulting Empire</b><br /><br />A general description of Mr Gingrich's health care "think tank" appeared in the Washington Post.(1)<br /><blockquote><em>A think tank founded by GOP presidential candidate Newt Gingrich collected at least $37 million over the past eight years from major health-care companies and industry groups</em>, offering special access to the former House speaker and other perks, according to records and interviews.<br /><br />The Center for Health Transformation, which opened in 2003, <em>brought in dues of as much as $200,000 per year from insurers and other health-care firms</em>, offering some of them 'access to Newt Gingrich' and 'direct Newt interaction,' according to promotional materials.</blockquote><br />Despite its name, the CHT was for-profit. Much of its actual workings are confidential, per the Post,(1)<br /><blockquote>Susan Meyers, a center spokeswoman, declined to comment on the think tank’s income or staffing levels because it is a private-sector organization.</blockquote><br />Despite its pretentious name, the CHT was apparently a vehicle for its wealthy corporate clients to influence health policy to favor their business interests.  A NY Times article(2) reported that:<br /><blockquote>His consultancy practice was centered around <em>his ability to help big corporate interests speak the language of Republicans and navigate the corridors of Capitol Hill on issues vital to their businesses.</em></blockquote><br />According to a Bloomberg article(3), the work was quite lucrative:<br /><blockquote>Two companies founded by Newt Gingrich announced yesterday that they had <em>grossed $55 million between 2001 and 2010,</em> part of an effort to quiet questions about how the former U.S. House speaker earned millions since he resigned from Congress in 1999.<br /><br />That revenue supports the Center for Health Transformation and The Gingrich Group LLC, which have a staff of as many as 30 people, stage health-care policy events, and provide advice to clients, Nancy Desmond, the chairman and chief executive officer of the firms, said in a written statement. </blockquote><br />The CHT was linked to a small corporate empire, as described by the Washington Post,(4)<br /><blockquote>Former House speaker Newt Gingrich transfigured himself from a political flameout into a thriving business conglomerate. The power of the Gingrich brand fueled <em>a for-profit collection of enterprises that generated close to $100 million in revenue over the past decade</em>, said his longtime attorney Randy Evans.<br /><br />Among Gingrich’s moneymaking ventures: a health-care think tank financed by six-figure dues from corporations; a consulting business; a communications firm that handled his speeches of up to $60,000 a pop, media appearances and books; a historical documentary production company; a separate operation to administer the royalties for the historical fiction that Gingrich writes with two co-authors; even an in-house literary agency that has counted among its clients a presidential campaign rival, former senator Rick Santorum (R-Pa.).<br /><br />Separate from all of that was his nonprofit political operation, American Solutions for Winning the Future.</blockquote><br /><strong>Relationships with Big Health Care Corporations</strong><br /><br />The Center for Health Transformation was largely funded by big health care corporations. The Post first noted,(1)<br /><blockquote>The biggest funders, ... [included] firms such as <strong>AstraZeneca, Blue Cross Blue Shield and Novo Nordisk,</strong>...</blockquote><br />Also,(1)<br /><blockquote>The center has listed scores of firms and industry groups as members over the years, amounting to a Who’s Who of the medical field, from <strong>GE Healthcare</strong> to the <strong>American Hospital Association</strong> to <strong>Wellpoint</strong>, the nation’s largest health insurer. </blockquote><br />Other clients were listed in a Bloomberg article,(5)<br /><blockquote>Among the member companies were drugmaker <strong>Johnson & Johnson</strong> (JNJ) and health insurer <strong>Blue Cross and Blue Shield Association</strong>....</blockquote><br />Also,(5)<br /><blockquote><strong>Pfizer Inc</strong>. (PFE), the world’s largest drugmaker, had consulting contracts with Gingrich, according to two people familiar with the arrangements. Pfizer spokesman Ray Kerins didn’t respond to requests for comment.<br /><br />The <strong>Pharmaceutical Research and Manufacturers of America</strong>, the industry’s trade group, was also a client. His firm 'was retained by the PhRMA general counsel’s office at one time to provide advice on a positioning project,' the group said. </blockquote>In addition, as noted below, clients included important firms in the health care information technology (IT) sector, including <strong>GE</strong>, <strong>IBM</strong>, <strong>Microsoft</strong>, <strong>Allscripts</strong>, and <strong>Siemens</strong>.<br /><br />Below, we present several cases in which Mr Gingrich apparently intervened on behalf of his clients to promote their business interests in the guise of promoting his views on health policy solutions.  In some cases, the views he promoted did not fit with what is generally regarded as his political philosophy, suggesting that the interests of his paying clients overrode his political views.<br /><br /><strong>Case: End of Life Care</strong><br /><br />The New York Times reported,(2)<br /><blockquote>Writing on the Web site of the Washington Post, <em>Mr Gingrich praised Gundersen Lutheran Health System of LaCrosse, Wis., for its successful efforts to persuade most patients to have 'advance directives,'</em> saying if Medicare had followed Gundersen's lead on end-of-life care and other practices, it would 'save more than $33 billion a year.'</blockquote><br />Note that<br /><blockquote><em>Gundersen was one of the paying clients of Mr. Gingrich's Center for Health Transformation</em>....</blockquote><br />However, <br /><blockquote>within weeks, Mr. Gingrich would find himself <em>on the wrong end of what some Republicans labeled the 'death panel' issue.</em></blockquote><br />At that point, Mr Gingrich abruptly changed his tune, <br /><blockquote>As it happens, <em>shortly after Mr. Gingrich wrote his article praising Gundersen, he joined the conservative critics of the provision</em>. 'You are asking us to trust turning power over to the government,' Mr Gingrich told George Stephanopoulos of ABC News that August 'when there are clearly people in America who believe in establishing euthanasia, including selective standards.'</blockquote><br />This suggested that Mr Gingrich took up the cause of end-of-life decision making not be cause he deeply believed in it, but because it was expeditious given the wishes of his clients, despite the assertion made by his spokesperson,(2)<br /><blockquote>Mr. Hammond said that Mr. Gingrich did not take policy positions for pay; rather, he said, clients sought him out because of the views he already held and his expertise in communicating ideas.</blockquote><br /><strong>Case: Medicare Prescription Coverage Sans Negotiations about Drug Prices</strong><br /><br />As reported by Bloomberg,(5)<br /><blockquote>When U.S. House Republican leaders in 2003 were short of votes to pass a $395 billion Medicare prescription drug benefit, they recruited former House Speaker Newt Gingrich for help.<br /><br />In a hushed room on Capitol Hill, <em>Gingrich told his former Republican colleagues that if he could endorse the measure, they should be comfortable with it, too</em>, said two former senior House aides who attended the closed-door session.<br /><br />Two days later, after a vote was held open for three hours as leaders corralled the final ayes, the measure passed and was eventually signed into law by President George W. Bush.<br /><br /><em>What Gingrich didn’t mention during the Republican caucus meeting was that he was also building a for-profit, health-care research company and seeking financing from drugmakers, which were investing $128.6 million in lobbying for passage of the new benefit for seniors. </em><em><br /></em></blockquote><br />Note that the legislation that provided Medicare drug coverage forbade the government from negotiating prices with drugmakers.  This was unprecedented, because drug coverage from the US Veterans Administration and Medicaid did not come with the obligation to pay whatever the drug-makers charged.  The inability of Medicare to negotiate the prices it paid for drugs certainly helped the companies' revenues while driving up the costs of Medicare, the federal deficit and the costs of health care in general.<br /><br /><strong>Case: Promoting Expensive Diabetes Care</strong><br /><br />The Washington Post reported,(4)<br /><blockquote><em>Novo Nordisk, a Denmark-based drug firm that specializes in diabetes treatments.... paid a total of $1.2 million</em> to Gingrich’s foundation over six years as a 'founding charter member.'<br /><br />'It was strictly a business, nonpolitical relationship,' Novo Nordisk spokesman Ken Inchausti said. 'We admired his leadership on issues related to health-care delivery systems. We thought the CHT brought something to the table to us in terms of finding ways to help people prevent diabetes.'<br /><br /><em>Gingrich loaned his celebrity to causes that, whatever their other merits, could also be good for Novo Nordisk’s bottom line. For instance, he was the keynote speaker at Novo Nordisk’s 'diabetes summit' in 2005 and joined the company in issuing a 'call to action' to fight diabetes in Texas and Georgia</em>.</blockquote>One wonders how many of the widely promoted "summits" and other star-studded conferences on health care featuring corporate  and political leaders as speakers are just stealth health policy advocacy or stealth marketing.<br /><br /><strong>Case: Irrational Exuberance for Electronic Health Records</strong><br /><br />My fellow Health Care Renewal blogger has often discussed the <a href="http://hcrenewal.blogspot.com/search/label/irrational%20exuberance">"irrational exuberance"</a> for electronic health records (EHRs) despite scant information about their benefits, and increasing data suggesting their harms.  It now appears that Mr Gingrich, sponsored by copious funds from the health care IT sector, has been a major source of such exuberance.  <br /><br />Mr Gingrich had a complex relationship with the health care information technology (IT) industry. It began to come out first in a NY Times story,(6)<br /><blockquote>When the center [for Health Transformation] sponsored a 'health transformation summit' at the Florida State Capitol in March 2006, lawmakers who attended Mr. Gingrich's keynote speech inside the House chamber received a booklet promoting not just ideas but also the specific services of two dozen of his clients. Executives from some of those companies sat on panels for discussions that lawmakers were encouraged to attend after Mr. Gingrich's address.<br /><br />Gerard White, president of Clearwave, which paid about $50,000 to become a center member, <em>used the occasion to pitch his company's system for managing patient data</em>.</blockquote><br />This had all began earlier,<br /><blockquote>Two years before the Florida 'summit,' Mr. Gingrich made a presentation to Republican lawmakers in Georgia, promoting the work of his member companies by citing specific benefits if they were hired. For example, 'VitalSpring could save the State Employee Program over $20 million a year.'<br /><br />Minutes of the members-only conference call from March 2004 said <em>the center had 'arranged joint meetings' for members to present their work on electronic health records to top federal officials,</em> noting that Mr. Gingrich 'reported very positive feedback overall from these meetings.'<br /><br />He also<em> pressed for passage of a federal bill to increase the use of electronic health records</em>, collaborating with one of its co-sponsors, Representative Patrick J. Kennedy of Rhode Island, and Senator Hillary Rodham Clinton of New York, both Democrats.</blockquote><br />Furthermore,<br /><blockquote><em>Many of the ideas he has pushed involve the increased use of information technology, and companies specializing in that are well represented in the center's roster</em>. They also figured prominently in an early center initiative, teaming up in 2003 with the conservative Georgia Public Policy Foundation to promote changes in health care in Mr. Gingrich's home state.<br /><br />At his discussion with Georgia House Republicans in 2004, Mr. Gingrich gave examples of companies whose services could 'both improve health and start saving money,' according to the center's summary of his presentation.</blockquote><br />And there is more,<br /><blockquote>In Washington, Mr. Gingrich's push for electronic health records illustrated how his own policy advocacy and ties to former Congressional colleagues made him a sought-out consultant for companies like Astra Zeneca and Siemens. Mr. Gingrich hailed HealthTrio, one of the center's 'founding charter members,' during a hearing held in 2003 by Senator Larry Craig, Republican of Ohio. <em>Telling the senator that HealthTrio's chief executive had helped design the electronic records program in the United Kingdon, Mr. Gingrich said the company 'estimates we could have an electronic health record for American for about 10 cents per month, per person</em>.' <br /><br /><em>The center later arranged for HealthTrio and I.B.M to meet with senior federal health officials and congressional leaders 'to review the U.K. approach</em> and how it might be applied in the U.S.,' according to center records.<br /><br /><em>Some of the ideas promoted by the center found their way into the electronic health records legislation proposed by Mr. Kennedy, which was prepared with input from Mr. Gingrich</em>.</blockquote>This is especially ironic, given that the UK NHS electronic health record initiative has become a crashing failure (for example, see<a href="http://hcrenewal.blogspot.com/2011/08/you-saw-it-here-first-uk-nhs-pulls-plug.html"> this post</a>).<br /><br />Even more involvement with the push for electronic health records (EHRs) appeared in a Boston Globe article,(7)<br /><blockquote>Newt Gingrich seized the TV airwaves in 2009 to bash President Obama’s stimulus package, calling it 'entirely a pork-barrel bill' that would do little to solve the recession.<br /><br />Later, in a separate web video, the former House speaker stepped back from his blanket criticism. He explained that <em>he strongly supported spending $27 billion of stimulus funds to encourage doctors and hospitals to create electronic medical records for their patients. Left unsaid was that the Gingrich Group, his consulting business in Washington, received large payments from medical technology companies that stand to profit from the federal money</em>.</blockquote><br />In particular,<br /><blockquote><em>The stimulus infusion Gingrich supported is expected to benefit health care technology companies, including those who have been clients such as <strong>GE Healthcare</strong> and <strong>Allscripts</strong></em>.<br /><br />GE Healthcare said it pays Gingrich’s center to act as a 'collaborator and facilitator' among a diverse group of health care interests.<br /><br /><em>'We work with the Center for Health Transformation in an effort to improve the effectiveness of the health system through the use of information technology,' said GE Healthcare spokesman</em> Corey Miller.<br /><br />Allscripts spokeswoman Ariana Nikitas said the company ended its relationship with Gingrich’s center two years ago but considered the venture 'a think-tank to advance health care efforts.'</blockquote><br />It does not stop there. Per the NY Times,(8)<br /><blockquote>Mr. Gingrich was <em>cheering a $19 billion part of the [Obama stimulus] package that promoted the use of electronic health records, something that benefited clients of his consulting business</em>. 'I am delighted that President Obama has picked this as a key part of the stimulus package,' he told health care executives in a January 2009 conference call.<br /><br />After the bill was passed a month later, <em>Mr. Gingrich's consultancy, the Center for Health Transformation, joined two of his clients, Allscripts and Microsoft, in an 'Electronic Health Records Stimulus Tour'</em> that traveled the country, encouraging doctors and hospitals to buy their products with billions in federal subsidies. </blockquote>We, particularly InformaticsMD, have frequently commented on how health care information technology has been promoted not just by enthusiasts in the field, and by companies that manufacture such devices, but by the government.  The bandwagon has gone down the road despite little clinical evidence that such technology is beneficial, and increasing evidence of its harms.  Now it appears that an important reason for this ruch to promote expensive, but unproven devices comes from the sort of stealth health care policy advocacy on behalf of corporate vested interests described above. <br /><strong>Summary</strong><br /><br />So Newt Gingrich parlayed his political track record into a lucrative "consultancy" which enthusiastically promoted the health policy objectives of its clients, who included some of the biggest US health care corporations.  Some of the policy positions the consultancy promoted seemed to run counter to Mr Gingrich's political record.  Worse, some of the initiative he successfully promoted seem to have contributed to US health care dysfunction.<br /><br />These stories, some of which are many years old, only came out after Mr Gingrich became the front runner for the Republican nomination for US President.  Had he not chosen to re-enter politics, it is not clear when reporters would have had time to due the required investigations.  One wonders how many similar stories have not been made public because they do not involve prominent presidential candidates.<br /><br />The bottom line seems to be that there are myriad ways corporate and political insiders push health policy agendas because of self-interest, regardless of their effects on patients' and the public's health.  Health policy in the US has become an insiders' game.  Unless it is redirected to reflect patients' and the public's health, facilitated by the knowledge of unbiased clinical and policy experts rather than corporate public relations, expect our efforts at health care reform to just increase health care dysfunction.  <br /><br />Physicians, public health advocates, whatever unbiased health policy experts remain must educate the public about how health policy has been turned into a corporate sandbox.  We must try to somehow activate the public to call for health care policy of the people, by the people, and for the people.<br /><br /><strong><span style="font-size: x-small;">References</span></strong><br /><span style="font-size: x-small;"><br /></span><br /><span style="font-size: x-small;">1.  Eggen D. Gingrich think tank collected millions from health-care industry.  Washington Post.  November 17, 2011.  Link </span><a href="http://www.washingtonpost.com/politics/gingrich-think-tank-collected-millions-from-health-care-industry/2011/11/16/gIQAcd72VN_story.html"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">.</span><br /><span style="font-size: x-small;">2. Rutenberg J. Gingrich faces more scrutiny over corporate clients. NY Times, November, 17, 2011. Link </span><a href="http://www.nytimes.com/2011/11/18/us/politics/newt-gingrich-faces-more-scrutiny-on-corporate-clients.html"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">.</span><br /><span style="font-size: x-small;">3. Benson C, Lerer L. Gingrich health center and group paid $55M. Bloomberg, November 22, 2011. Link </span><a href="http://www.bloomberg.com/news/2011-11-22/corporations-pay-gingrich-health-center-and-consulting-group-55-million.html"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">.</span><br /><span style="font-size: x-small;">4. Tumulty K, Eggen D. Newt Gingrich Inc.: how the GOP hopeful went from political flameout to fortune. Washington Post, November 26, 2011. Link </span><a href="http://www.washingtonpost.com/politics/newt-gingrich-and-how-he-got-rich/2011/11/21/gIQAftOglN_story.html"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">.</span><br /><span style="font-size: x-small;">5. Davis JH, Jensen K. Gingrich campaigning as change agent profited as an insider. Bloomberg, November 18, 2011. Link </span><a href="http://www.bloomberg.com/news/2011-11-18/gingrich-running-as-change-agent-profits-from-washington-insider-status.html"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">.</span><br /><span style="font-size: x-small;">6. McIntire M, Rutenberg J. Gingrich gave push to clients, not just ideas. NY Times, November 29, 2011. Link </span><a href="http://www.nytimes.com/2011/11/30/us/politics/gingrich-gave-push-to-clients-not-just-ideas.html"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">.</span><br /><span style="font-size: x-small;">7. Rowland C. Newt Gingrich supported $27 billion of President Obama's stimulus for electronic medical records, helping his consulting clients. Boston Globe, December 16, 2011. Link </span><a href="http://www.boston.com/Boston/politicalintelligence/2011/12/gingrich-stimulus-support-benefited-his-consulting-clients/IoXiAqmY1h1A74SYCwckdJ/index.html"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">.</span><br /><span style="font-size: x-small;">8. Rutenberg J, McIntire M. Gingrich push on health care appears at odds with G.O.P. NY Times, December 16, 2011. Link </span><a href="http://www.nytimes.com/2011/12/16/us/politics/gingrichs-health-care-policy-history-at-odds-with-gop.html"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">.</span>

Health Care Policy of the Insiders, by the Insiders, for the Insiders - the Newt Gingrich Case Files

Newt Gingrich's rise to the top of the pack of Republican contenders for the US presidency has earned him increased scrutiny.  The resul...

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Hospital Executives - What Will They Think of Next?

Health care organizations are now most often run by people with management, not clinical backgrounds.  It seems like business schools have taught managers to sign on to whatever the latest management fashions are.  So what are the latest fashions in hospital management?  Here are a few hot items.<br /><br /><strong>Retreading Pharmaceutical Representatives </strong><br /><br />My jaundiced reading of the business news suggests that most executives think that marketing is the most important part of their organizations, and that clever marketing can sell any product or service. For example, the pharmaceutical industry spends about twice as much on marketing as it does on research and development (despite pharma executives' protestations that they run research driven businesses) (see <a href="http://hcrenewal.blogspot.com/2008/01/blogscan-575-billion-spent-yearly-on.html">this post</a>). So it should be no surprise that now hospitals are using "hospital representatives" to market referrals to their institutions to doctors.<br /><br />From <a href="http://www.usatoday.com/money/industries/health/story/2011-12-13/hospitals-sales-reps/51887938/1">last week's USA Today</a>:<br /><blockquote>n northwest Indiana, Carrie Sota visits five or six doctors' offices every workday as part of her new sales job.<br /><br />But Sota <em>isn't selling the physicians on a prescription drug or a medical device. She's promoting her hospital — the University of Chicago Medical Center</em>.<br /><br />Sota, 30, is one of four employees the academic medical center has hired in recent months to <em>make 'sales calls' on physicians in the hope that they will send more patients to the hospital</em>. 'We are trying to build meaningful relationships,' said Sota, who was previously a saleswoman for a small medical device company.<br /><br />The University of Chicago Medical Center is one of <em>a growing number of hospitals nationwide hiring former drug and device sales reps to visit doctors' offices to persuade them to use their services over competing facilities.</em><br /><br />Rather than handing out samples of prescription drugs, the sales reps call on doctors armed with the latest information on how their facility is reducing hospital-acquired infections and improving patient-satisfaction scores.<br /><br />In visits that can last five to 20 minutes, reps try to win doctors' loyalty by helping them get better times on operating room schedules or easier patient referrals to hospital-based specialists. The sales reps can also carry messages back to the hospital, such as a doctor's request for a new medical device to be available in surgery.</blockquote><br />The article suggested a few problems with this approach. First, the point of the marketing is not to improve the match between patients' needs and the services the hospital provides. Rather, it is to generate referrals that have the potential to provide the maximum revenue:<br /><blockquote>While hospitals have always tried to woo doctors to refer patients to them, the institutions are growing more direct in their efforts. The hospitals mine data <em>to see which doctors have the most profitable, well-insured patients, and then they assign those doctors to a sales rep</em>.</blockquote><br />So in particular,<br /><blockquote>Many of the physician liaisons<em> focus on specialists, who bring in patients for services with the highest profit margins, including orthopedics, cardiac care and cancer care</em>, [Duke University Health System physician liaison manager Christine] Perry said.</blockquote><br />Second, the hospital reps have incentives based on revenue, not on value to the patient:<br /><blockquote>About two-thirds of Tenet's liaisons are former drug and device sales reps, and<em> they can make tens of thousands of dollars in bonuses if doctors increase their referrals to the hospitals</em>. </blockquote><br />Third, across the system, the revenues generated may be much less than the costs incurred, since most of the marketing will only succeed in moving patients from one hospital to another:<br /><blockquote>Paul Ginsburg, president of the non-partisan Center for Studying Health System Change, said, 'When you look at the health system, this is a waste of resources. It's a zero-sum game.'<br /><br />He added: 'The net results of changing physician-referral patterns is that one hospital gains at a cost of others, and all the hospitals burn resources to pay (sales)people who take up the doctor's time.'</blockquote><br />Of course, the reps could succeed in persuading doctors to refer patients to specific hospitals for services the doctors originally did not think the patients needed. That would be good wer<span style="background-color: white;">e</span> the patients to need those services, but bad if they were not.<br />Fourth, we have discussed (for example, <a href="http://hcrenewal.blogspot.com/2007/05/fool-me-once-shame-on-you-fool-me-twice.html">here</a> and <a href="http://hcrenewal.blogspot.com/2008/04/more-about-cynical-world-of-drug-reps.html">here</a>) how pharmaceutical representatives use sophisticated psychological and emotional manipulation, despite claims that all they do is provide unbiased information and educational, to influence physicians to prescribe drugs. Again, this may result in patients getting drugs whose benefits do not outweigh their harms. It is possible that hospital representatives will do something similar:<br /><blockquote>'These people are really good and really assertive and very sophisticated,' said Stephen Newman, Tenet's chief operating officer.</blockquote><br /><strong>Unbundling Payments</strong><br /><br />The airlines decided a while ago that they could make more money by charging passengers for each checked bag, and even for those little meals on plastic trays. It looks like hospital executives have discovered a new way to unbundle. <br /><br />As reported last month by <a href="http://www.stltoday.com/business/local/outpatient-sticker-shock-for-a--minute-treatment/article_a2915e64-1499-11e1-bf45-001a4bcf6878.html">the St Louis Post-Dispatch</a>, hospitals have begun charging often hefty "facility fees" for patients seen as outpatients in hospital clinics or hospital owned practices, even for very minor procedures or just office visits, and even for Medicare patients. (Private physicians who see patients in their own offices cannot charge such fees to Medicare patients, and most private insurance companies will not cover such fees.):<br /><blockquote>A few weeks after Allison Zaromb took her 4-year-old son Meir to see a dermatologist in an outpatient office at the SSM Cardinal Glennon Children's Medical Center campus, she received separate bills from the doctor and the hospital.<br /><br />The cost for a 3-minute procedure to treat Meir's warts totaled $538, which included a $220 bill for physician services - and <em>a separate bill for a $318 hospital 'facility fee.'</em><br /><br />Zaromb, a periodontist who lives in University City, is now suing SSM Health Care Corp. and Cardinal Glennon Children's Medical Center in a proposed class action lawsuit on behalf of other patients</blockquote><br />More generally,<br /><blockquote>With the proliferation of hospital-owned outpatient centers and hospital-owned physician practices, hospital 'facility fees' have become increasingly common. <em>Such hospital facility fees often involve greater dollar amounts than the fees charged by physicians</em>.</blockquote><br />Technically, it all appears to be legal:<br /><blockquote>Under federal regulations, <em>health systems are permitted to charge a hospital facility fee for an outpatient service if it's done in a clinic that is 'hospital-based' - meaning that the clinic is owned and operated as part of a hospital or health system, regardless of whether the clinic is physically located on the hospital grounds.</em></blockquote><br />This technique does seem to be a way to increase revenue. But one person's revenue is another person's cost, so it also seems to be a great way to further increase the already high cost of US health care. It is not obvious, however, that these increased costs will lead to increased quality of care or value for the patient:<br /><blockquote>'From a consumer's perspective, when you go see your doctor, you go see your doctor - whether it's in an office inside a larger hospital complex or right across the street,' [Zaromb's lawyer John] Phillips said. 'The doctor's practice remains the same. ... <em>They're making the doctor's office a ‘hospital-based' clinic for one reason: to make money by charging a facility fee, not to improve consumer service</em>.'</blockquote><br /><strong>Negotiating the Costs of Medical Devices</strong><br /><br />One of the favorite topics on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>, at least before we found even more outrageous subjects, was the stratospheric cost of medical devices. For example, look at posts from 2005 <a href="http://hcrenewal.blogspot.com/2005/09/1600-screw-and-other-outrages.html">here</a>, <a href="http://hcrenewal.blogspot.com/2005/08/imaging-test-pre-certification-blues.html">here</a>, <a href="http://hcrenewal.blogspot.com/2005/08/wooden-headed-health-care.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2005/08/new-york-times-examines-why.html">here</a>. So last month we found out that hospital executives have come up with a revolutionary idea to combat the high cost of devices. They will actually try to see what prices the device companies charge other hospitals, and then negotiate the prices down, as <a href="http://www.reuters.com/article/2011/11/30/us-hospitals-idUSTRE7AS2ZI20111130">Reuters</a> reported as big news in late November:<br /><blockquote>Implantable devices make up a sizable chunk of typical hospital budgets, and <em>administrators are devising new ways to limit that cost</em> as they brace for cuts to government reimbursement and treat more patients who can't pay for care.<br /><br />That means methodically working through each category of device, from heart valve replacements and stents to spinal products, to <em>see where they can negotiate lower prices</em>. It also means creating databases of shared information on pricing between hospitals.</blockquote><br />Imagine that! Of course, the notion that buyers ought to bargain with sellers to get the best price goes back a few years. However, only in 2011 did it apparently occur to hospital executives that they ought to negotiate the prices of one their most expensive purchases. This suggests that there has been something profoundly wrong with the basic assumptions underlying the commonly accepted wisdom that making the health care system more of a market will lead to more financially efficient care.  <br /><br /><strong>Summary</strong><br /><br />In 1988, Alain Enthoven advocated in <a href="http://www.amazon.com/gp/product/0444703594/102-6581115-0444916?n=283155">Theory and Practice of Managed Competition in Health Care Finance</a>, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post <a href="http://hcrenewal.blogspot.com/2006/03/consequences-of-breaking-physicians.html">here</a>). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post <a href="http://hcrenewal.blogspot.com/2005/04/growing-proliferation-of-managers.html">here</a>). Health care went from being controlled by clinicians to controlled by a growing volume of managers.  Most of these managers were generic, in that they had little if any knowledge of, experience in, or sympathy to the values of health care. These generic managers have used the same techniques advocated for the management of supermarkets or automobile manufacturers to manage health care organizations, despite all the obvious differences in context, goals, values, and people involved. <br /><br />So these generic managers have brought us such "innovations" as the "hospital (marketing) representative," and the "facility fee" for outpatient visits, but only thought to negotiate device prices in 2011. But that is why we pay them <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">the big bucks</a>.<br /><br />How many more arguments do we need that health care organizations ought to be lead by people who understand the health care context, share its core values, and are accountable for how these organizations affect patients' and the public's health?

Hospital Executives - What Will They Think of Next?

Health care organizations are now most often run by people with management, not clinical backgrounds.  It seems like business schools have t...

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EHR: "The Dangerous Decade"

A new perspective piece has appeared in the Journal of the American Medical Informatics Association. Although it is not freely available, I thought posting the abstract and the opening would be of interest:<br /><br /><a href="http://jamia.bmj.com/content/19/1/2.abstract"></a><br /><blockquote><a href="http://jamia.bmj.com/content/19/1/2.abstract">The dangerous decade</a><br />JAMIA<br />Published Online First 24 November 2011<br />Enrico Coiera, Jos Aarts, Casimir Kulikowski<br /><br /><span style="font-weight: bold;">Abstract</span><br /><br />Over the next 10 years, more information and communication technology (ICT) will be deployed in the health system than in its entire previous history. Systems will be larger in scope, more complex, and move from regional to national and supranational scale. <span style="font-weight: bold;">Yet we are at roughly the same place the aviation industry was in the 1950s with respect to system safety.</span> Even if ICT harm rates do not increase, <span style="font-weight: bold;">increased ICT use will increase the absolute number of ICT related harms.</span><span style="color: red;"> </span><span style="font-style: italic; font-weight: bold;"><span style="color: red;"> </span></span> Factors that could diminish ICT harm include adoption of common standards, technology maturity, better system development, testing, implementation and end user training. Factors that will increase harm rates include complexity and heterogeneity of systems and their interfaces, rapid implementation and poor training of users. <span style="font-weight: bold;">Mitigating these harms will not be easy, as organizational inertia is likely to generate a hysteresis-like lag, where the paths to increase and decrease harm are not identical.</span></blockquote><br /><br />The perspective piece then opens with this:<br /><br /><div id="p-2"></div><blockquote><div id="p-2">There is a paradox in the relationship between information and communication technology (ICT) and patient safety. ICT can improve the quality, safety and effectiveness of clinical services and patient outcomes,1 although the evidence base for this is sometimes weak.2 As a consequence, the rapid deployment of ICT on a national scale is a priority for many nations faced with a diminishing clinical workforce, increasing workloads, and resource constraints. 3 4<a class="xref-bibr" href="http://jamia.bmj.com.ezproxy2.library.drexel.edu/content/19/1/2.full#ref-4" id="xref-ref-4-1"></a></div><div id="p-3">However, ICT use can also lead to patient harm.5 Many commentators have raised concerns that ICT has yet to deliver on its promises,6 or that the rapid adoption of ICT is a risk.7 7a Errors persist in clinical practice even after ICT is introduced,8 because manual processes co-exist with the automated, and the interfaces between the two are seldom perfect. Others counter that such overemphasis on ICT-related harm only delays the implementation of a crucial technology that will save lives.9</div><div id="p-4"><span style="font-weight: bold;">It appears that we are caught in a bind.</span> The demands for health system reform are now so compelling that there appears no choice but to implement complex ICT on a large, often national, scale. Yet these ICT systems appear less mature than we would like and our understanding about how to implement and use them safely remains in its infancy. <span style="font-weight: bold;">As such, we are faced with a pressing policy challenge on both the national and international stages.10</span></div></blockquote><div id="p-4"><a class="xref-bibr" href="http://jamia.bmj.com.ezproxy2.library.drexel.edu/content/19/1/2.full#ref-11" id="xref-ref-11-1"></a></div><br />They raise these rhetorical questions:<br /><br /><blockquote>... Where is the ‘kill switch’ in our health ICT systems when large-scale privacy breaches are occurring, or large volumes of critical patient data are being corrupted? Who is authorized to activate such a switch? <span style="color: red; font-style: italic; font-weight: bold;"></span></blockquote><br /><span style="color: #330033;">The answers to these questions are, quite frankly: nowhere, and nobody. What we have instead is an environment of 'irrational exuberance' -- as well as 'rational exuberance', i.e., opportunism, often of a pecuniary nature.</span><br /><br />To the authors' other observations I would add that:<br /><br />1) "Organizational inertia" is probably too narrow a concern. I would broaden it to "cultural inertia", especially since the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=ecosystem">health IT "ecosystem"</a> is <span style="font-weight: bold;">grossly lacking </span>of a culture of safety and accountability;<br /><br />2) The authors note that "<span style="font-style: italic;">Predicting the actual harm rate and total patient harms that we</span><span style="font-style: italic;"> will see through the use of ICT in healthcare over the next decade is currently not possible</span>."<br /><br />While I agree, and agree this inability needs to be remediated, extrapolations can be performed to achieve estimates. Regarding increased ICT use increasing the absolute number of related harms,<span style="font-style: italic; font-weight: bold;"><span style="color: red;"> </span></span><span style="color: red;"><span style="color: #330033;">that number could <span style="font-style: italic; font-weight: bold;">already</span> be quite substantial as I wrote</span></span><span style="color: #330033;"> in an April 16, 2010 thought experiment </span><span style="color: #330033;">at </span><span style="color: #330033;">"</span><span style="font-weight: bold;"><a href="http://hcrenewal.blogspot.com/2010/04/if-benefits-of-hit-can-be-guesstimated.html">If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers</a></span>."<br /><br />Ironically and tragically, that post was written <span style="font-weight: bold;">just five days</span> before I wrote a confidential warning letter to a hospital about EHR deficiencies I'd noted in my mother's care there, and just one month before she was severely injured at that hospital by an EHR-related error of a nature as identified in the letter. Thus, the numbers in the thought experiment should be incremented accordingly;<br /><br />3) I would say regarding safety that the health IT sector is roughly in the same place as aviation was in the 1920's (e.g., unregulated, experimental technology abounding), not the 1950's, and as the maritime passenger service was in ca. 1912 (April to be precise); and<br /><br />4) The authors observe that "<span style="font-style: italic;">There is however caution in the [2011 IOM] report [on health IT safety </span><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf" style="font-style: italic;">here</a><span style="font-style: italic;">, PDF] that safety regulations would impede industry innovation, an argument which would literally not fly in the aviation industry ... the caution toward recommending regulation may however be misplaced. Simply put, </span><span style="font-style: italic; font-weight: bold;">if healthcare wants the benefits of ICT then it must actively manage its risks</span>."<br /><br />I strongly agree that the IOM's cautions on regulation are misplaced, as I wrote <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">here</a>. Robust regulation could diminish ICT harm as in pharmaceuticals and medical devices (and aviation).<br /><br />Innovation will not be harmed, and the IT industry needs to -- and can afford to -- accept the responsibilities and obligations of being involved in healthcare. See for example "<a href="http://www.chtlj.org/sites/default/files/media/articles/v021/v021.i4.Zollers.pdf" style="font-weight: bold;">No More Soft Landings For Software: Liability for Defects in an Industry That Has Come of Age</a>" (PDF), Zollers, McMullin et al., Santa Clara Computer & High Technology Law Journal,<span class="title"><a href="" name="number4"> Vol. 21 No. 4, 2005.</a></span><br /><br />-- SS

EHR: "The Dangerous Decade"

A new perspective piece has appeared in the Journal of the American Medical Informatics Association. Although it is not freely available, I...

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As U.S. Presidential Campaign Ramps Up, Newt Gingrich Plays Down Support for Health IT

Presidential candidate Newt Gingrich, who I recall hearing in person as an an invited speaker at a health IT meeting some years ago (AMIA, I believe), has been pushing health IT rather uncritically in recent years.<br /><br />However, he seems to have backed off that position at the election cycle heats up:<br /><br /><blockquote><p class="date"><a href="http://www.ihealthbeat.org/articles/2011/12/16/as-campaign-ramps-up-gingrich-plays-down-support-for-health-it.aspx" style="font-weight: bold;">As Campaign Ramps Up, Gingrich Plays Down Support for Health IT</a><br /></p><p class="date">iHealthbeat.org<br /></p><p class="date">Friday, December 16, 2011<br /></p><p class="date">Now that he is a frontrunner in the race for the Republican presidential nomination, former House Speaker Newt Gingrich (R-Ga.) is downplaying his previous support for health IT adoption, <i>The Hill</i>'s "<a href="http://thehill.com/blogs/healthwatch/politics-elections/199643-gingrich-moves-away-from-electronic-health-records" target="_blank">Healthwatch</a>" reports (Pecquet, "Healthwatch," <i>The Hill</i>, 12/15).<span style="font-weight: bold;"><br /></span></p><p class="date"><span style="font-weight: bold;">History of Supporting Health IT</span></p><p class="date">During the George W. Bush administration,<i> </i>Gingrich worked with former CMS administrator Mark McClellan and former National Coordinator for Health IT David Brailer on federal efforts to promote health IT, according to the <a href="http://www.nytimes.com/2011/12/16/us/politics/gingrichs-health-care-policy-history-at-odds-with-gop.html?pagewanted=2" target="_blank"><i>New York Times</i></a> (Rutenberg/McIntire, <i>New York Times</i>, 12/16).<br /></p><p class="date">Gingrich also worked with former Senate Majority Leader Tom Daschle (D-S.D.) to co-author the forward of a book titled, "Paper Kills 2.0," which gives examples of how federal funds for health IT could be used in pilot projects to improve health care (Rowland, <a href="http://bostonglobe.com/news/politics/2011/12/16/clients-gingrich-firm-benefited-from-his-support-stimulus-funds/Egk68IClYJMtuVYWr1Iz9K/story.html" target="_blank"><i>Boston Globe</i></a>, 12/16).<br /></p><p class="date">Shortly before the passage of the 2009 federal economic stimulus package, Gingrich criticized the legislation as a "big politician, big bureaucracy, pork-laden bill." However, at the same time, Gingrich praised a provision of the stimulus package that allocated $19 billion to promote the use of health IT. He said, "I am delighted that President Obama has picked this as a key part of the stimulus package."</p></blockquote><div style="BORDER-BOTTOM: medium none; TEXT-ALIGN: left; BORDER-LEFT: medium none; BACKGROUND-COLOR: #ffffff; COLOR: #000000; OVERFLOW: hidden; BORDER-TOP: medium none; BORDER-RIGHT: medium none; TEXT-DECORATION: none"><div style="BORDER-BOTTOM: medium none; TEXT-ALIGN: left; BORDER-LEFT: medium none; BACKGROUND-COLOR: #ffffff; COLOR: #000000; OVERFLOW: hidden; BORDER-TOP: medium none; BORDER-RIGHT: medium none; TEXT-DECORATION: none"><div style="BORDER-BOTTOM: medium none; TEXT-ALIGN: left; BORDER-LEFT: medium none; BACKGROUND-COLOR: #ffffff; COLOR: #000000; OVERFLOW: hidden; BORDER-TOP: medium none; BORDER-RIGHT: medium none; TEXT-DECORATION: none"><p></p>His views have apparently changed somewhat:<br /><br /><blockquote><span style="font-weight: bold;">... Campaign Plays Down Health IT Support</span><br /><br />On Wednesday, Gingrich unveiled a new brain science initiative that does not include any mention of EHRs, even though the technology was a major component of the brain science proposals he discussed over the summer.</blockquote><br /><br />Politics aside (it is probably not too far from the truth to say that all politicians hold out their fingers to see what direction the wind is blowing, although Mr. Gingrich is probably becoming more aware of HIT downsides thanks to lobbying of both sides of the aisle by people such as myself and like-minded experts [1]), I cannot disagree with this:<br /><br /><blockquote>In August, Gingrich said he aimed to bolster brain science research in part by modernizing FDA through the use of EHRs. <span style="font-weight: bold;">Gingrich said EHRs would allow for "much faster [FDA] approval times because you can monitor in real time everyone who uses the drug. And if you start getting inappropriate responses, you can change within weeks"</span> ("Healthwatch," The Hill, 12/15).</blockquote><br /><br />In fact, I was championing exactly this idea ca. 2001 when I was employed at Merck Research Labs in the Research Information Systems division. Unfortunately, the answer from more senior personnel was that doing so would be "impossible" due to inability to blind, to control the data quality, etc., responses I considered unreasonable at the time but did not argue with to avoid getting on the Short List early in my employment there.<br /><br />I also tried to present the idea to Merck as a former employee in Nov. 2006, at an invited presentation to the Clinical Risk Management & Safety Surveillance department of MRL entitled “<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/silverstein_merck_informatics_nov2006.ppt" style="font-weight: bold;">Medical Informatics Perspectives on Leveraging the EMR in Pharma</a>" (PPT).<span style="font-size:11.0pt; mso-bidi-font-family:Arial;mso-bidi-Times New Roman"font-family:";font-size:10.0pt;" > </span>Also see my 2007 paper "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Silverstein_Drug_Surveillance.pdf" style="font-weight: bold;">A Medical Informatics Grand Challenge: the EMR and Post-Marketing Drug Surveillance</a>" where I address a number of issues related to using EHR's in this fashion (PDF).<br /><br />Using EHR's (e.g., with special screens and training) for well-defined Phase IV post-marketing surveillance studies would be one of the best uses for the technology [2].<br /><br />Finally, <span style="font-weight: bold;">I note that we need post-marketing surveillance of EHR's, CPOE's and other clinical IT systems themselves, not just drugs.</span> Information technology cannot improve healthcare until it itself is improved significantly regarding its current deficiencies (see "reading list" <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">here</a> for illustrations).<br /><br />-- SS<br /><span style="font-size:85%;"><br />Notes:<br /><br />[1] Health IT risks are a non-partisan issue.</span><br /><br /><span style="font-size:85%;">[2] I should note that while I believe EHR's could facilitate postmarketing surveillance of drugs and devices, I take a dim view of more grandiose proposed uses of EMR's such as for comparative effectiveness research (CER). See my essay in the Journal of the American Association of Physicians and Surgeons (AAPS) entitled "<span style="font-weight: bold;">The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry?</span>" <a href="http://www.jpands.org/vol14no2/silverstein.pdf">here</a> (PDF).</span><br /><br /><br /></div></div> </div>

As U.S. Presidential Campaign Ramps Up, Newt Gingrich Plays Down Support for Health IT

Presidential candidate Newt Gingrich, who I recall hearing in person as an an invited speaker at a health IT meeting some years ago (AMIA, I...

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A comment posted to the website "Doctors Helping Doctors Transform Healthcare", Peter Basch, William Bria et al.

A new website has appeared that purports to be:<br /><br /><blockquote>A collaborative effort led primarily by doctors for doctors to provide a "trusted resource" for physicians as they work to transform health care - initially through the use of health IT.</blockquote><br />The site is entitled "<span style="font-weight: bold;">Doctors Helping Doctors Transform Health Care</span>" and is at <a href="http://doctorshelpingdoctorstransformhealthcare.org/">this link</a>. (I note that when one encounters such platitudinous and potentially highly ideological titles, one should ask "<span style="font-style: italic;">transform how, and into what</span>, <span style="font-style: italic;">exactly?</span><span style="font-style: italic;">"</span> I presume "transform" means, in part, to <span style="font-style: italic;">reduce</span><span style="font-style: italic;"> </span><span>risk</span> and <span style="font-style: italic;">improve</span><span style="font-style: italic;"> safety</span><span style="font-style: italic;"> </span><span style="font-style: italic;">and outcomes</span> - while <span>protecting</span> patient<span style="font-weight: bold;"> and</span> physician rights.)<br /><br />The site has a significant number of people on their advisory board (<a href="http://doctorshelpingdoctorstransformhealthcare.org/leadership/">link</a>), but no information on compensation. I note there are industry people involved, representing a potential conflict of interest.<br /><br />According to one of the principals, <a href="http://doctorshelpingdoctorstransformhealthcare.org/author/pbasch/"><strong style="font-weight: normal;">Peter Basch, MD</strong></a>, Medical Director, Ambulatory EHR and Health Information Technology Policy, MedStar Health, Washington, DC, <a href="http://doctorshelpingdoctorstransformhealthcare.org/2011/why-doctors-helping-doctors/">on funding:</a><br /><br /><p><strong></strong></p><blockquote><p><strong>A Few Words About Our Supporters</strong></p> <p>It takes resources to create and maintain this site, to make the work of <em>Doctors Helping Doctors</em> possible. We have solicited unrestricted contributions from individuals and organizations who believe in our mission and are able to support its work. In particular, we wish to thank Patrick Soon-Shiong of the Chan Soon-Shiong Family Foundation, John Glaser of Siemens Health Services; and Andy Slavitt of Optum’s Institute for Sustainable Health.</p></blockquote><p></p><br />To my knowledge, I've never met Dr. Basch, but at meetings I have met one of the other principals of the new website, <a href="http://doctorshelpingdoctorstransformhealthcare.org/author/wbria/"><strong style="font-weight: normal;">William Bria, III, MD</strong></a>, Chief Medical Information Officer, Shriners Hospitals for Children; President and Co-Founder, Association of Medical Directors of Information Systems (AMDIS), St. Petersburg, FL.<br /><br />Dr. Basch's writing has appeared at Healthcare Renewal before, such as at<span style="font-weight: bold;"> </span>the Jan. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/01/throwing-national-research-council.html">Throwing The National Research Council Report On Health IT Under The Bus, Part 1: MedStar Health</a>."<br /><br />In the new site, Dr. Basch states that:<br /><br /><blockquote>As early adopters, EHR implementers, and practicing physicians, we have seen the “bad and the ugly” as well as the promise of health IT. We understand how health IT can and should be used to make care better, safer, and more value-laden. As such, we believe that unnecessarily harsh criticism of Meaningful Use—which we have heard from some quarters—<span style="text-decoration: underline;">and</span> uncritical cheerleading—which we have also heard—are equally unhelpful.<br /><br /><span style="font-weight: bold;">We see physician “extremism” essentially marginalizing</span> what is needed now more than ever—a clear and constructive physician voice, articulating not for compliance with Meaningful Use, but rather leveraging the opportunity that Meaningful Use presents, and consistently inserting the highest ideals that led us all to choose a career in medicine.</blockquote><br />While on the surface this is not an unreasonable position, I fear the word "extremism" is used as a metaphor for those who express genuinely critical appraisals of the state of health IT as it now exists, on issues regarding safety, efficacy, usability, need for regulation, vendor, buyer and user liability, and other "unpleasant" topics.<br /><br />I do note precious little on the site about educating physicians on the considerable downsides of health IT as it currently exists, nor on the scientific literature expressing doubts about its safety, efficacy, usability, ROI and other issues (such as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">here</a>).<br /><br />There is, it would seem obvious, no ethical excuse for introducing medical devices and other technology of unknown benefit and of unknown risk magnitude (as recently reported by the IOM, see <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">this post</a>), that is <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">unregulated</a>, into life-critical domains such as medicine without explicit acknowledgement of <span style="font-style: italic;">experimentation</span>. Human subjects experimentation requires, of course, explicit informed consent under the <a href="http://grants.nih.gov/grants/policy/hs/ethical_guidelines.htm">many guidelines</a> formulated as a result of past systemic abuses. Also, users need to be fully aware of the risks.<br /><br />Such informed consent cannot be accomplished, and awareness attained by physicians regarding the dangers of use of health IT in its present form, through simple "best practices" protagonism.<br /><br />For instance, health IT can be inherently defective and/or <a href="http://www.tinyurl.com/hostileuserexper">mission hostile</a> (worse, the industry is unregulated), and can injure or kill. Several illustrative examples just off the top of my head are at:<br /><br /><ul><li><span style="font-size:85%;">"<a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html">FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death</a>";</span></li></ul><ul><li><span style="font-size:85%;">"<a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">Lifespan (Rhode Island): Yet another health IT 'glitch' affecting thousands</a>";</span></li></ul><ul><li><span style="font-size:85%;">"<a href="http://hcrenewal.blogspot.com/2010/07/maude-database-patient-outcome-death.html">FDA MAUDE Database: Patient Outcome - Death</a>" and "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">FDA Manufacturer and User Facility Device Experience (MAUDE) database - case reports of EHR defects</a>";</span></li></ul><ul><li><span style="font-size:85%;">"<a href="http://hcrenewal.blogspot.com/2010/12/ecri-healthcare-it-in-top-ten-health.html">ECRI: Healthcare IT In Top Ten Health Technology Threats to Patient Safety</a>";</span></li></ul><ul><li><span style="font-size:85%;">"<a href="http://iig.umit.at/efmi/badinformatics.htm">Bad Health Informatics Can Kill</a>" [European Federation for Medical Informatics];<br /></span></li></ul><ul><li><span style="font-size:85%;"> "<a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">A Study of an Enterprise Health information System</a>" [Australia - severe deficiencies in software engineering noted in major U.S. vendor ED EHR system that cause user confusion as well as data corruption/loss];</span></li></ul><ul><li><span style="font-size:85%;">"<a href="http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009/0160182009specification.pdf">Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software</a>" [ISO/UK NHS - with an accounting of EHR-related medical errors in Annex A];<br /></span></li></ul><ul><li><span style="font-size:85%;"> and a personal account "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary">A Diary of EHR-Initiated Tragedy</a>."</span></li></ul><br />Not even including privacy and confidentiality issues (see <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">this query link</a> on those issues), should physicians, nurses, patients and other stakeholders not be explicitly educated on the issues of risk, that can be greatly replicated/amplified across hundreds or thousands of patients by EHRs as opposed to paper, and on actual injuries and deaths that have occured? If not, why not?<br /><br />Are not these issues and the issue of the <a href="http://hcrenewal.blogspot.com/2010/08/health-it-via-observation-and-research.html">lack of a culture of safety in the health IT field</a> at least as important, <span style="font-weight: bold;">if not more important</span> for clinicians, patients, healthcare executives and other stakeholders to be strongly aware of than "best practices" and "meaningful use?"<br /><br />(I note that the "<span style="font-style: italic;">negative reports are mere anecdotes</span>" argument commonly used by health IT pundits only shows, as in the Aug. 2011 essay by a senior clinician in Australia "<a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things</a>", that those making that argument need to attend revision courses in research methodology and risk management.)<br /><br />In consideration of the "Doctors Helping Doctors" site's seemingly uncritical pro-HIT advocacy, I have posted the following note at the end of Dr. Basch's introductory essay. The comment appears <a href="http://doctorshelpingdoctorstransformhealthcare.org/2011/why-doctors-helping-doctors/#comment-20">at this link</a> and is awaiting moderation.<br /><br />The comment's remaining online would be a sign that the site is not another attempt to "<a href="http://hcrenewal.blogspot.com/2011/03/how-lousy-health-it-gets-pushed-on.html">control the channel</a>", and is truly serious about being "trusted." It would be a sign of a site truly concerned with "physicians helping physicians transform health care" <span style="font-weight: bold;">while not sacrificing patients as unconsenting test subjects</span> of unregulated, experimental <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">software-based medical devices</a> in the process.<br /><br /><cite class="fn"><a class="url" href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" rel="external nofollow"></a></cite><blockquote><cite class="fn"><a class="url" href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" rel="external nofollow">S Silverstein MD</a></cite> <span class="says">says:</span> <div class="comment-meta commentmetadata"> <a href="http://doctorshelpingdoctorstransformhealthcare.org/2011/why-doctors-helping-doctors/#comment-20">December 17, 2011 at 10:29 pm</a> </div><br />Doctors,<br /><br />One way to help doctors transform healthcare would be to educate them on the downsides of information technology in healthcare, how to avoid them, and the conflicting literature on benefits (e.g., as at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglis">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist</a>).<br /><br />I do not see such information here yet.<br /><br />I do expect some such information will follow.<br /><br />Sincerely,<br /><br />Scot Silverstein<br /><br />---------------------------------------------------<br />Scot M. Silverstein, MD<br />Consultant/Independent Expert Witness in Healthcare Informatics (May 2010-present)<br />Adjunct faculty in Healthcare Informatics and IT (Sept. 2007-present)<br />Assistant Professor of Healthcare Informatics and IT, and Director, Institute for Healthcare Informatics (2005-7)<br /><br />Drexel University<br />College of Information Science and Technology<br />3141 Chestnut St., Philadelphia, PA 19104-2875<br /><br />Email: sms88 AT drexel DOT e-d-u<br />Bio: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm">http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm</a><br />Common Examples of Healthcare IT Difficulties: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/ </a><br /><br />Note: I am cross-posting this comment on Healthcare Renewal blog under the title "A comment posted to the website 'Doctors Helping Doctors Transform Healthcare, Peter Basch, William Bria et al.'"</blockquote><br />It is my hope the comment stays, and receives a reasoned reply.<br /><br />-- SS<br /><br /><span style="font-weight: bold;">Dec. 23, 2011 addendum:</span><br /><br />My comment appears to have disappeared. I leave it to the reader to determine what that means about the site "Doctors Helping Doctors Transform Healthcare."<br /><br />-- SS

A comment posted to the website "Doctors Helping Doctors Transform Healthcare", Peter Basch, William Bria et al.

A new website has appeared that purports to be: A collaborative effort led primarily by doctors for doctors to provide a "trusted resou...

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Medtronic Settles, Yet Again

And the march of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> continues... Circling around the block and coming in front of the viewing stand again is device manufacturer Medtronic.  <br /><br /><strong>The Latest Medtronic Settlement</strong><br /><br />As Bloomberg <a href="http://www.bloomberg.com/news/2011-12-13/medtronic-to-pay-23-5-million-to-settle-allegations-of-doctor-kickbacks.html">reported</a>:<br /><blockquote><em>Medtronic (MDT) Inc., the world’s biggest maker of heart rhythm devices, agreed to pay $23.5 million to settle claims it paid kickbacks to doctors who implanted its pacemakers and defibrillators in patients</em>, the U.S. Justice Department said in a statement.<br /><br />Medtronic agreed yesterday to settle two lawsuits filed in federal courts in California and Minnesota <em>accusing the company of violating the federal False Claims Act by paying physicians $1,000 to $2,000 for each patient who was implanted with one of the company’s devices</em>, according to the Justice Department.<br /><br />'Patients who rely on their health-care providers to implant vital medical devices <em>expect that those decisions will be made with the patients’ best interests in mind,</em>' Tony West, assistant attorney general for the Justice Department’s Civil Division, said in an e-mailed statement. <em>'Kickbacks, like those alleged here, distort sound medical judgments</em> with financial incentives paid for by the taxpayers.' </blockquote><br />As usual, Medtronic did not admit doing anything wrong:<br /><blockquote>Medtronic said in an e-mailed statement that it <em>makes no admissions that the studies were 'improper or unlawful.' </em>The company also said it established a reserve for the anticipated payment in the fourth quarter of fiscal year 2011.<br /><br />'We are happy that the investigation is behind us, so we can continue designing and executing clinical trials that generate evidence to improve patient care, outcomes and cost effectiveness,' Marshall Stanton, vice president of clinical research and reimbursement for the cardiac and vascular group....</blockquote><strong>Previous Legal Settlements by Medtronic</strong><br />Note that this is not the first time Medtronic has been accused of paying doctors (kickbacks, this time, which seem to be the ethical equivalent of bribes) to use its products. The Bloomberg report also noted:<br /><blockquote><em>In 2006, Medtronic agreed to pay $40 million to settle allegations that its Sofamor Danek unit violated state laws and the False Claims Act by paying sham consulting fees and providing lavish trips to doctors who used its products from 1998 to 2003</em>. </blockquote>Perusing the <a href="http://hcrenewal.blogspot.com/search/label/Medtronic">Medtronic file on Health Care Renewal</a> also showed that Medtronic has had to settle other lawsuits alleging misconduct:<br /><br />- In 2008, Medtronic subsidiary Kyphon settled a suit for $75 million and signed a corporate integrity agreement for allegations that it defrauded Medicare through a scheme that lead to excessive hospitalization for patients who received the company's spine surgery device (link <a href="http://hcrenewal.blogspot.com/2008/05/corporate-integrity-agreement-for.html">here</a>)<br />- In 2010, Medtronic settled multiple civil lawsuits for $268 million for allegations that it marketed an implantable cardiac defibrillator with faulty leads whose failures lead to 13 deaths (link <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">here</a>)<br /><br /><strong>Cases of Apparent Conflicts of Interest Generated by Medtronics' Payments</strong><br />In fact, paging through the <a href="http://hcrenewal.blogspot.com/search/label/Medtronic">Medtronic file on Health Care Renewal</a>, we also found these cases of apparent conflicts of interest that Medtronic caused by making payments to or otherwise creating financial relationships with:<br /><br />- FDA advisory board members (2007 link <a href="http://hcrenewal.blogspot.com/2007/07/blogscan-more-conflicted-members-on-fda.html">here</a>), <br />- health care professionals who appeared on public television programs about heart disease and treatments of it (2007 link <a href="http://hcrenewal.blogspot.com/2007/10/funding-of-mysterious-human-heart-and.html">here</a>),<br />- members of a non-profit organization which was supposed to guide the FDA regarding drug development  (2007 link <a href="http://hcrenewal.blogspot.com/2007/11/questions-about-board-of-new-reagan.html">here</a>), <br />- prominent academic orthopedic surgeons who were in positions to influence other physicians' choices of orthopedic devices (2008 link <a href="http://hcrenewal.blogspot.com/2008/09/more-lucrative-payments-to-orthopedic.html">here</a> and 2009 links <a href="http://hcrenewal.blogspot.com/2009/01/on-wisconsins-talking-heads.html">here</a>, <a href="http://hcrenewal.blogspot.com/2009/07/polly-want-million-plus.html">here</a> and <a href="http://hcrenewal.blogspot.com/2009/12/20-million-dollar-journal-editor.html">here</a>), <br />- a military surgeon who wrote questionable articles about the supposed virtues of a Medtronic bone growth product (2009 link <a href="http://hcrenewal.blogspot.com/2009/05/breach-of-trust.html">here</a>), <br />- a top leader of US Veterans Affairs Department who objected to the appointment of an industry critic as US Surgeon General (2010 link <a href="http://hcrenewal.blogspot.com/2010/10/toxic-and-dangerous-watchdog-vs.html">here</a>), <br />- spine surgeons apparently who could promote Medtronics' spine surgery products in (2010 link <a href="http://hcrenewal.blogspot.com/2010/12/blogscan-medtronics-multi-million.html">here</a>) and who did not disclose all such payments when writing ostensibly scholarly articles on the subject (2010 link <a href="http://hcrenewal.blogspot.com/2010/12/spine-surgeons-reticent-about.html">here</a>)<br /><br />So prior to the current settlement for "alleged" kickbacks, Medtronic had a long history of allegations that it had financial relationships with physicians who were in a position to promote the use of its products or its policy interests.<br /><br /><strong>Why the Bad Behavior Continues</strong><br /><br />The latest settlement by Medtronic illustrates why the anemic approach by US government agencies to health care corporate misbehavior does not deter bad behavior.<br /><br />- The punishment was a fine not large enough to have any effect on the finances of the corporation.. Such a relatively small financial penalty might just be seen as a cost of doing business by company executives.  (See <a href="http://brodyhooked.blogspot.com/2011/12/here-we-go-again-with-form.html">these comments</a> on the current case by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.)<br />-  The punishment was not a result of any specific bad behavior.  In this case, like many others, the corporation did not have to admit to anything.  This leads to the paradox of a punishment meted out for apparently nothing other than "alleged" actions, making it appear that the actual punishment was just a payment by the company to allow it to continue the sorts of actions that were alleged with impunity.  (Such punishments without clear crimes happen all the time in cases affecting the finance sector.  See a federal judge's condemnation of this practice <a href="http://hcrenewal.blogspot.com/2011/11/will-citigroup-ruling-challenge-health.html">here</a>.)  <br />-  The punishment seems unrelated to the corporation's historic behavior.  In this case, there was no reference to the company's previous settlements, or the other allegations of questionable payments to physicians and health care decision makers in other circumstances listed above.  (Keep in mind that <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> strives to present interesting cases, but does not have the resources to report on every single case of bad behavior by health care organizations.  Hence the list above of apparent bad behavior may not be complete.)<br />-  The punishment applied to the corporation as a whole, and hence may disadvantage many people, stockholders and corporate employees in particular, who had nothing to do with the alleged bad behavior.  On the other hand, those who authorized, directed, or implemented the bad behavior were not subject to any negative consequences.  <br /><br />So why on earth would corporate leaders cease bad behavior which could increase revenues short-term and hence increase their compensation (e.g., in 2011, the Medtronic CEO received $9,624,709 according to the <a href="https://www.proxydocs.com/0/000/427/737/proxy_statement.pdf">2011 proxy statement</a>), when the likelihood of any negative consequences for them appears to be near zero?  <br /><br />This would be bad enough if the bad behavior only causes financial disadvantage for stockholders or corporate employees.<br /><br />However, the bad behavior in question seems to repeatedly involve paying physicians and other health care decision makers in ways likely to influence their decisions in favor of Medtronics' products and corporate well-being.  Making decisions this way, however, is unlikely to be good for patients' and the public's health, as it is likely to lead to excess use of expensive tests and treatments that may have adverse effects, sometimes severe.  Thus patients may suffer unnecessary morbidity and mortality, and the public at large may pay far too much for medical care.<br /><br />So will we see in our lifetimes honest, tough policing of health care corporate behavior?  Will the punishments start to fit the crime, and will they be significant enough to deter future misbehavior?  Why do we continue to accept government actions that seem more solicitous of the executives of big corporations than the public for whose benefit government is supposed to be run?  Where is the outrage?    <br /><br />So, once more, with feeling.... in my humble opinion, until the people responsible for the bad behavior experience negative consequences from that behavior, they will continue to perform, direct, and condone bad behavior. We will not achieve real health care reform in the US until we effectively deter unethical, self-serving behavior by leaders of health care organizations.<br /><br />ADDENDUM (15 December, 2011) - <a href="http://gooznews.com/?p=3437">On the GoozNews blog</a>, Merrill Goozner called Medtronic's actions "a crime against science."

Medtronic Settles, Yet Again

And the march of legal settlements continues... Circling around the block and coming in front of the viewing stand again is device manufact...

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FDA Recalls Draeger Health IT Device Because "This Product May Cause Serious Adverse Health Consequences, Including Death"

More health IT madness, in the form of an actual FDA recall:<br /><br /><a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=6d6383ecf8a447d49bdd4de3b034a759&URL=http%3a%2f%2fwww.fda.gov%2fMedicalDevices%2fSafety%2fRecallsCorrectionsRemovals%2fListofRecalls%2fucm282461.htm"></a><br /><blockquote><a href="http://www.fda.gov/MedicalDevices/Safety/ucm282461.htm" target="_blank">FDA Recall notice</a><br /><br /><span style="font-weight: bold;">Draeger Medical Inc., Infinity Acute Care System Monitoring Solution </span>(M540)<br />Recall Class: Class I <span style="color: red; font-style: italic; font-weight: bold;">[the most serious type of recall, see below - ed.]</span><br />Date Recall Initiated: October 18, 2011<br />Product: Infinity Acute Care System Monitoring Solution (M540), Catalog number MS25510<br />All serial numbers are affected by this recall.<br /><br />This product was manufactured from March 1, 2011 through September 30, 2011 <span style="font-weight: bold;">and distributed only to the Rush University Medical Center</span> (Chicago, Illinois) from July 1, 2011 through September 30, 2011.<br /><br />Use: This product is a networked solution system used to monitor a patient’s vital signs and therapy, control alarms, review Web-based diagnostic images, and access patient records. The number of monitored vital signs can be increased or decreased based on the patient’s needs.<br /><br />Recalling Firm: Draeger Medical, Inc. 3135 Quarry Rd., Telford,<br />Pennsylvania 18969-1042<br /><br />Manufacturer: Draeger Medical GmbH, Moislinger Allee 53-55_23558, Lubeck, Germany<br /><br />Reason for Recall: The weight-based drug dosage calculation may indicate incorrect recommended values, <span style="font-weight: bold;">including a drug dosage up to ten times the indicated dosage. </span>Additionally, there may be a <span style="font-weight: bold;">5-10 second delay between the electrocardiogram and blood pressure curves (waveforms) at the Infinity Central Station.</span> <span style="font-weight: bold;"><br /><br />This product may cause serious adverse health consequences, including death.</span><br /><br />Public Contact: Draeger Medical, Inc. 3135 Quarry Road Telford, Pennsylvania 18969-1042_215-660-2349<br /><br />FDA District: Philadelphia<br /><br />FDA Comments: On October 17, 2011, the company sent the Rush University Medical Center a letter stating that users should enter the patient’s weight by way of the admin/demographics screen to ensure the drug dosage is calculated as intended.<br /><br />Additionally, the company’s letter states that users should follow the instructions for Use of the Infinity Acute Care System Monitoring Solution. The Instructions for Use includes, "For primary monitoring and diagnosis of bedside patients, use the bedside monitor. Use the Infinity Central Station only for remote assessment of a patient's status." <span style="color: red; font-style: italic; font-weight: bold;">[That is, clinicians should work around the device's defects, which would seem to hold the computer's rights over the patients' rights -- rather than taking the device out of service immediately and having the vendor fix it - ed.]</span><br /><br /><span style="font-weight: bold;">Class I recalls are the most serious type of recall </span> and involve situations in which there is a <span style="font-weight: bold;">reasonable probability that use of these products will cause serious adverse health consequences or death.</span><br /><br />Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.</blockquote><br />I find a software company advising clinicians to make sure to "work around" blatant IT defects in "acute care environments" the height of arrogance and contempt for patient safety. Yes, acute care environments are not unpredictable, chaotic environments often moving a mile a minute. They are <span style="font-style: italic;">precisely</span> the environment where everyone can sit around on their butts and leisurely hold, over pizzas and cokes, a committee meeting where each and every move can be discussed, just like in a software development shop ...<br /><br />I also find the statement that this medical device was "<span style="font-weight: bold;">distributed only to the Rush University Medical Center" </span>remarkable.<span style="font-weight: bold;"> </span>If true, it raises a number of issues that make me very uncomfortable:<br /><span style="font-weight: bold;"><br /></span><ul><li>How did the company's letter to Rush make its way to FDA? Whistle blower?</li></ul><ul><li>What testing was done by the manufacturer of this medical device <span style="font-weight: bold;">before</span> release to a live-patient environment?</li></ul><ul><li>Who approved this software "going live?" What due diligence was performed?</li></ul><ul><li>Was this a software beta test of experimental software on live subjects?</li></ul><ul><li>Did Rush University Medical Center have some sort of quid pro quo (e.g., financial arrangement) with the software company?</li></ul><ul><li>Did Rush seek IRB approval of this device?</li></ul><ul><li>Were patients presented with an informed consent process regarding its use in their care?</li></ul><ul><li>Were any patients actually injured or did any die as a result of this software?</li></ul><br />The answers to these questions need to be sought by FDA.<br /><br />-- SS<br /><span style="font-weight: bold;"><br /></span>

FDA Recalls Draeger Health IT Device Because "This Product May Cause Serious Adverse Health Consequences, Including Death"

More health IT madness, in the form of an actual FDA recall: FDA Recall notice Draeger Medical Inc., Infinity Acute Care System Monitoring S...

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