Justice Delayed - Two Device Companies Still Settling Cases from 10 Plus Years Ago

Here we go again.  After a hiatus during which the US media and perhaps parts of the government were preoccupied with such issues as the ongoing controversy over health care reform, and a government shutdown apparently arising out of this controversy, the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a> involving big health care organizations has resumed. <br /><br />In alphabetical order,...<br /><br /><br /><b>Boston Scientific</b><br /><br /><a href="http://www.startribune.com/business/228211891.html">From</a> the Minneapolis Star-Tribune on 17 October, 2013, an account of a settlement arising from alleged misbehavior that started in 2002,<br /><br /><br /><blockquote class="tr_bq">A $30 million settlement between the U.S. Department of Justice and Boston Scientific will likely end a <i>case involving the sale of defective heart devices from 2002 through 2005</i> by subsidiaries Guidant, Guidant Sales and Cardiac Pacemakers.</blockquote><br />Note that the allegations were particularly egregious since they involved a company selling products they knew to be defective in ways that could prove fatal as if they were quite safe, <br /><br /><blockquote class="tr_bq">The settlement closes a fraudulent-claims lawsuit that alleged <i>Guidant knowingly sold defective implantable defibrillators to health care facilities that implanted them into thousands of Medicare patients. </i></blockquote><br />In particular,<br /><br /><br /><blockquote class="tr_bq">The government’s complaint said that <i>Guidant knew as early as April 2002 that its Prizm 2 line of devices was defective </i>and <i>knew in November 2003 that its Renewal 1 and 2 devices were capable of short-circuiting</i> and delivering an electric shock that 'arcs' back onto the device instead of being directed to an irregularly beating heart.<br /><br />According to Boston Scientific’s website, <i>83 malfunctions and nine reported deaths have been connected with the Renewal devices and 40 confirmed malfunctions and five patient deaths have been associated with the Prizm devices. </i>About 500 Renewal devices remain implanted worldwide; about 1,400 Prizm devices remain in patients, according to the website.<br /><br />Although Guidant took action to fix the defects, the government alleged that <i>the company continued to sell its remaining stock of the old, defective versions of the devices. </i>In fact, federal officials say that as Guidant learned about the cause of the defect, <i>it took steps to hide the problem from patients, doctors and the Food and Drug Administration.</i><br /><br />According to the government, <i>Guidant did not fully disclose the problem until May 2005,</i> when two Minneapolis doctors publicly aired their concerns about one of the defibrillators after it failed to revive a 21-year-old Grand Rapids, Minn., patient. Guidant later admitted it had known for three years that the device could short-circuit, but chose not to alert doctors or the public.</blockquote><br />This is only the latest settlement made by Boston Scientific since 2005,<br /><br /><br /><blockquote class="tr_bq">Boston Scientific paid $27.5 billion to acquire Guidant in 2006. It has been paying quite a bit since in relation to Guidant’s defective defibrillators.<br /><br />In 2007, <i>Boston Scientific paid $240 million to settle claims with thousands of patients who had sued Guidant after the defective devices were recalled. Later, in February 2010, Guidant pleaded guilty to misleading the FDA about problems with the devices and paid a fine of $296 million.</i></blockquote><br />In fact, the then case of the allegedly concealed implantable cardiac defibrillators (ICD) was one of the first cases of apparently unethical health care corporate management behavior leading to bad patient outcomes we <a href="http://hcrenewal.blogspot.com/2005/05/guideants-short-circuit.html">discussed</a> on Health Care Renewal.  (Look <a href="http://hcrenewal.blogspot.com/2011/01/guidant-boston-scientific-gets.html">here</a> for a more recent summary of this case.) <br /><br />Yet despite the fact that this apparently deeply unethical conduct lead to patient deaths, no individual who authorized, directed or implemented the bad behavior has suffered any negative consequences for it over the eight years since the details first became public.<br /><br />One physician who helped bring this case to light was also apparently concerned about the impunity of those responsible,<br /><br /><br /><blockquote class="tr_bq"> Dr. Robert Hauser, one of the doctors who went public back in 2005, criticized the settlement on Thursday.<br /><br />'The $30 million should have little impact on their business,' Hauser said in an e-mail. 'I find it very disturbing that such a small settlement was accepted by the DOJ in view of the magnitude of wrongdoing by Guidant management.' <br /> </blockquote><br /><b>Stryker Corp</b><br /><br />This week, MLive.com <a href="http://www.mlive.com/business/west-michigan/index.ssf/2013/10/stryker_to_pay_132_million_to.html">reported</a> on another settlement involving allegations of unethical behavior by a device company dating back to 2003,<br /><br /><blockquote class="tr_bq"> An investigation by federal authorities found that Stryker Corp. subsidiaries in five foreign countries <i>made illicit payments and tried for several years to bribe doctors, health care professionals and government-employed officials in order to obtain or retain business.</i><br /><br />Stryker <a href="http://topics.mlive.com/tag/Stryker/index.html"> </a>has agreed to <i>pay more than $13.2 million</i> to settle the charges.<br /><br />The SEC charged the Kalamazoo-based medical technologies company with <i>violating the Foreign Corrupt Practices Act,  alleging that its subsidiaries in Argentina, Greece, Mexico, Poland and Romania made illicit payments totaling approximately $2.2 million</i> 'that were incorrectly described as legitimate expenses in the company’s books and records.'<br /><br />The SEC said descriptions of the payments varied from a charitable donation to consulting and service contracts, travel expenses, and commissions. <br /><br />The SEC states that Stryker made about $7.5 million in illicit profits as a result of the improper payments. It did not specify during what year all of the events occurred, but indicated <i>some as far back as 2003.</i></blockquote><br />Note that the payments seemed deliberately designed to corrupt health care professionals and managers, for example,<br /><br /><blockquote class="tr_bq">According to the SEC’s order, Stryker’s subsidiary in Greece made a purported 'donation' of nearly $200,000 in 2007 to a public university in Greece to fund a laboratory that was a pet project of a public hospital doctor. <i> In exchange for the payment, the doctor agreed to provide business to Stryker.</i></blockquote><br />Also,<br /><br /><br /><blockquote class="tr_bq">The SEC stated that its investigation also found that Stryker subsidiaries bribed foreign officials by paying their expenses for trips that lacked any legitimate business purpose.<br /><br />'For example,<i> in exchange for the promise of future business from the director of a public hospital in Poland, Stryker paid travel costs for the director and her husband in May 2004</i>,' according to the SEC. 'This included a six-night stay at a New York City hotel, attendance at two Broadway shows, and a five-day trip to Aruba.'</blockquote><br />As in the case above, it appears that no individual who authorized, directed or implemented the questionable payments will suffer any negative consequences.  In fact, as is usual in such cases,<br /><br /><blockquote class="tr_bq"> The settlement does not not require Stryker to admit or deny the allegations,...</blockquote><br />However, an SEC official did say,<br /><br /><blockquote class="tr_bq"> <i>Stryker’s misconduct involved hundreds of improper payments over a number of years </i>during which the company’s internal controls were fatally flawed. Companies that <i>allow corruption to occur</i> by failing to implement robust compliance programs will not be allowed to profit from their misconduct.</blockquote><br />While Health Care Renewal has not discussed this particular case before, it is hardly the first case of bad conduct by Stryker that we have discussed.  In the past we noted<br />-  In 2012, a Stryker subsidiary pleaded guilty to misbranding in response to allegations that its marketers conspired to defraud physicians in order to sell a product to promote bone growth that proved harmful to patients (look <a href="http://hcrenewal.blogspot.com/2012/01/unequal-justice-under-law-comparing.html">here</a>).<br />-  In 2010, Stryker settled a case alleging unfair and deceptive sales practices again used for bone growth accelerators (look <a href="http://hcrenewal.blogspot.com/2010/09/at-end-of-summer-everybody-well-nearly.html">here</a>).   <br />-  In 2009, some apparently low-level Stryker employees pleaded guilty to promoting off-label use of these same products (look <a href="http://hcrenewal.blogspot.com/2009/02/three-troubled-device-companies.html">here</a>).  <br />- In 2007, Stryker made an agreement allowing federal supervision after charges one of its units had violated anti-kickback laws when making supposed "royalty" payments, often huge, to orthopedic surgeons in connection with its production of prosthetic hips and knees.  Several other device companies signed deferred prosecution agreements, and as a result, for a time all had to make public their payments to doctors and various non-profit organizations.  (See summary <a href="http://hcrenewal.blogspot.com/2007/11/more-about-surgeons-who-received-large.html">here</a>.)  <br /><br /><b>Summary</b><br /><br /> This recent crop of settlements has some features in common.  The settlements involved multinational device companies.  The settlements occurred at least a decade after the alleged bad behavior started.  The settlements required only small payments - at least on a corporate scale -from the companies involved, but no negative consequences for anyone who authorized, directed, or implemented the bad behavior.  Finally, the settlements were made by companies who had striking past records of previous settlements of bad behavior.<br /><br />The <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a> demonstrates the pervasiveness of unethical behavior, often involving harm to patients or sullying of health care professionals, involving large, rich health care corporations.  It also demonstrates the impunity of the top leaders of such corporations who often make huge amounts of money despite, or perhaps because of their companies' misconduct.  Despite intermittent threats by US government officials to get tough with unethical behavior by health care corporations, this pattern has continued for years, as we have documented.  <br /><br />True health care reform would hold leaders of health care organizations accountable for their organizations' behavior, and its effects on patients and health care professionals.  <br /><br />

Justice Delayed - Two Device Companies Still Settling Cases from 10 Plus Years Ago

Here we go again.  After a hiatus during which the US media and perhaps parts of the government were preoccupied with such issues as the ongoing controversy over health care reform, and a government…

Đọc thêm »

Back to the Future - Another Medical Device Company Accused of Hiding ICD Defects

Suppression of data about defects in and failures of implantable cardiac defibrillators (ICDs) was one of the big issues we featured in the early days of <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> (2005-06).  <br /><br />At that time, Guidant, later acquired by Boston Scientific, was accused of hiding data that certain of its defibrillator models failed, possibly leading to preventable patient deaths (see <a href="http://hcrenewal.blogspot.com/2006/03/call-for-transparency-and-physician.html">this post</a> and follow links backward).  Boston Scientific, which acquired Guidant, settled a civil lawsuit and was put on probation in 2011 after it pleaded guilty to misdemeanor charges of failing to file required reports with the US Food and Drug Administration (see post <a href="http://hcrenewal.blogspot.com/2011/01/guidant-boston-scientific-gets.html">here</a>).   Similarly, in 2010, Medtronic settled multiple patients' lawsuits charging that it knowingly marketed a faulty ICD (see post <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">here</a>).<br /><br /><strong>St Jude and the Obscure Riata Data</strong><br /><br />Now in 2012, A Wall Street Journal <a href="http://online.wsj.com/article/SB10000872396390444223104578036752346768278.html">article </a>suggested that St Jude Medical Inc hid problems with its Riata implanted cardiac defibrillator (ICD) for years.    <br /><br /><blockquote class="tr_bq">In December, 2010, St Jude Medical Inc issued a warning letter to doctors: Wires inside Riata defibrillator leads—cables that connect the heart to implantable defibrillators—were sometimes breaking through their insulation from the inside out.<br /><br /><br />The problem, which ultimately led to a recall last year, could cause defibrillators to send unnecessary jolts to the heart or fail to deliver lifesaving shocks to return chaotic heart rhythms back to normal. The company said it had identified dozens of cases with visible signs of the problem, and pulled Riata from the market.<br /><br />For many doctors, this was the first notice of a problem with Riata.<br /><br />But before that 2010 warning, physicians including Alan Cheng, director of Johns Hopkins Medicine's arrhythmia service; Samir Saba, chief of electrophysiology at the University of Pittsburgh Medical Center; and Ernest Lau at the Royal Victoria Hospital in Belfast, Ireland, say they had encountered this so-called "inside-out abrasion" in their own practices between 2006 and 2009. When these doctors brought the incidents to the attention of St. Jude they say they were told by company officials and field representatives that the incidents were isolated. The malfunctions described by the doctors didn't result in deaths.<br /><br />St. Jude had been tracking the problem for several years, according to company documents collected by the Food and Drug Administration and reviewed by The Wall Street Journal. Cases involving the so-called inside-out abrasion date to at least October 2005, the documents show. Inside-out abrasion became a focus of an internal St. Jude audit, which examined multiple cases of the failure before April 2008.</blockquote>The Journal article noted that more transparency about device failures might allow physicians to spot problems earlier and prevent harm to patients.<br /><blockquote class="tr_bq">more than a dozen physicians and device-safety experts say that if St. Jude had acknowledged the inside-out failure earlier, physicians might have identified the scope of the problem sooner.<br /><br /><br />In some cases, doctors concede that they, too, believed the failures were isolated and therefore didn't act quickly to report problems to St. Jude or the FDA, which may have made it harder to spot the growing trend of failures. The leads were implanted in more than 13,000 patients since July 2008.<br /><br />'Every time you have a failed lead, you assume it's an isolated event, but, you start to string together isolated events, and then you have a recall,' said Dr. Saba. </blockquote><strong>Summary</strong><br /><br />So, for Health Care Renewal, this is a straightforward case, at least so far.  Yet another health care organization, this time, a medical device company, failed to reveal data that might have reflected unfavorably on one of its products, and hence lead to decreases in short-term revenue.  However, by suppressing the information, the company may have allowed doctors to keep implanting a potentially faulty device, and exposed patients to risk, possibly of fatality.  <br /><br />We have discussed many at least somewhat parallel cases of suppression of research (<a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">here</a>), and many cases of other kinds of deception by health care organizations (<a href="http://hcrenewal.blogspot.com/search/label/deception">here</a>).  Yet these cases continue to occur, physicians and other health care professionals continue to be fooled by secrecy and data suppression, and patients continue to be harmed by drugs, devices, or other interventions made by people who knew, or ought to have known that they were more dangerous than they appeared to be.  <br /><br />One problem may be that the people with the most influence on medical practice and health policy continue to cheer lead for the veracity of information about drugs, devices, and other health care interventions supplied by the people who most stand to gain from selling same.  A few weeks ago, the editor of the august New England Journal of Medicine, Dr Jeffrey M Drazen MD, scoffed at physicians' skepticism of pharmaceutical industry funded clinical research, claiming that there were only "a few examples of industry misuse of publications...." [Drazen JM. Believe the data. N Engl J Med 2012; <span class="citation"> 367:1152-1153.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMe1207121">here</a>.</span>]  In doing so, Dr Drazen seemed to ignore all the stories about suppression of medical research (some of which we have discussed <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">here</a>), manipulation of medical research (some discussed <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">here</a>), and deception (some discussed <a href="http://hcrenewal.blogspot.com/search/label/deception">here</a>) and secrecy (some discussed <a href="http://hcrenewal.blogspot.com/search/label/secrecy">here</a>) practiced by large health care organizations, including but not limited to drug, device, biotechnology, and health care information technology companies.<br /><br />Instead, the possibility that St Jude kept hidden data about the failings of one of its ICD models reminds us how skeptical we ought to be about the information provided, or not provided by those with vested interests in selling health care goods or services.  Physicians, health care professionals, those interested in health policy, and the public at large need to collectively exert pressure on the leaders of health care organizations to promote greater transparency, especially about data reflecting on benefits and harms of health care goods and services.  . 

Back to the Future - Another Medical Device Company Accused of Hiding ICD Defects

Suppression of data about defects in and failures of implantable cardiac defibrillators (ICDs) was one of the big issues we featured in the early days of Health Care Renewal (2005-06).  At that time, …

Đọc thêm »

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 manufacturer Medtronic.  The Latest Medtronic SettlementAs Bloomberg …

Đọc thêm »

My doctor will now need to code for when I get bitten by George or Martha Goose

The bureaucrats always seem to find new ways to waste precious medical resources and capital to justify their existence.<br /><br />Here's the latest twist:<br /><br />I regularly feed swans, ducks and geese at my local park. In fact, I don't seek them out; the geese in particular come to me when they see me on the trail. They know me for years.<br /><br />They have tremendous vision, so I can't escape them.<br /><br />Per the WSJ, medical coding is about to become so hypergranular (could the reason be that bureaucrats needed work to do?) as to be reasonably considered insane:<br /><a href="http://online.wsj.com/article/SB10001424053111904103404576560742746021106.html#printMode"><br /></a><blockquote><a style="font-weight: bold;" href="http://online.wsj.com/article/SB10001424053111904103404576560742746021106.html#printMode">Walked Into a Lamppost? Hurt While Crocheting? Help Is on the Way </a> <span style="font-weight: bold;"><br /><br />New Medical-Billing System Provides Precision; Nine Codes for Macaw Mishaps</span> <span style="font-weight: bold;"><br /><br />Wall Street Journal</span> <span style="font-weight: bold;">Sept. 13, 2011</span><br /><br />... Billing experts who translate doctors' work into codes are gearing up to start using the new system in two years. They say the new detail is welcome in many cases. But a few aspects are also causing some head scratching.<br /><br />Some codes could seem downright insulting: R46.1 is "bizarre personal appearance (<a href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=bizarre%20personal%20appearance">see code</a>)," while R46.0 is "very low level of personal hygiene (<a href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=very%20low%20level%20of%20personal%20hygiene">see code</a>)."<br /><br />It's not clear how many klutzes want to notify their insurers that a doctor visit was a W22.02XA, "walked into lamppost, initial encounter" (or, for that matter, a W22.02XD, "walked into lamppost, subsequent encounter").<br /><br />Why are there codes for injuries received while sewing, ironing, playing a brass instrument, crocheting, doing handcrafts, or knitting—but not while shopping, wonders Rhonda Buckholtz, who does ICD-10 training for the American Academy of Professional Coders, a credentialing organization.<br /><br />... Much of the new system is based on a World Health Organization code set in use in many countries for more than a decade. Still, the American version, developed by the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services, is considerably more fine-grained.<br /><br />The WHO, for instance, didn't see the need for <span style="font-weight: bold;">72 codes about injuries tied to birds. But American doctors whose patients run afoul of a duck (</span><a style="font-weight: bold;" href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=duck">see codes</a><span style="font-weight: bold;">), macaw (</span><a style="font-weight: bold;" href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=macaw">see codes</a><span style="font-weight: bold;">), parrot (</span><a style="font-weight: bold;" href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=parrot">see codes</a><span style="font-weight: bold;">), goose (</span><a style="font-weight: bold;" href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=goose">see codes</a><span style="font-weight: bold;">), turkey (</span><a style="font-weight: bold;" href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=turkey">see codes</a><span style="font-weight: bold;">) or chicken (</span><a style="font-weight: bold;" href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=chicken">see codes</a><span style="font-weight: bold;">) will be able to select from nine codes for each animal,</span> notes George Alex, an official at the Advisory Board Co., a health-care research firm.<span style="font-weight: bold;"><br /><br />There are 312 animal codes in all</span>, he says, compared to nine in the international version. There are separate codes for <span style="font-weight: bold;">"bitten by turtle"</span> and <span style="font-weight: bold;">"struck by turtle."</span> (<a href="http://graphicsweb.wsj.com/documents/MEDICALCODES0911/#term=Turtle">See codes</a>.)</blockquote><p></p>Examples:<br /><br /><blockquote>W6151XA Bitten by goose, initial encounter<br />W6151XD Bitten by goose, subsequent encounter <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[Killer Goose?]</span><br />W6151XS Bitten by goose, sequela<br />W6152XA Struck by goose, initial encounter<br />W6152XD Struck by goose, subsequent encounter<br />W6152XS Struck by goose, sequela<br />W6159XA Other contact with goose, initial encounter<br />W6159XD Other contact with goose, subsequent encounter<br />W6159XS Other contact with goose, sequela</blockquote><br />Sometimes my favorite Canada Goose couple, George and Martha, and their annual young'uns will overextend their beaks when being fed and nip my finger. They've never broken my skin (geese have no teeth, just ridges) but if they do ... my doctor is likely to have to code for "bitten by Canada Goose."<br /><br />I wonder if CDC will then send out the Goose Patrol. George and Martha, be careful, or your goose may be cooked!<br /><br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj6XkUrBC9v9JI3_z1vZzaD7SRS3KZiDFUT-QxmGIJVfx14pvYTdMWaWBuiRvBLLM_aU6CWXdgVj7NOne0qYYqD6YPhmK9OJB_WY6eZc2j5PfNTPXUDySG-yaA_7Zckgu2ahU-YstxIQoCT/s1600/george.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5655569935392590242" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj6XkUrBC9v9JI3_z1vZzaD7SRS3KZiDFUT-QxmGIJVfx14pvYTdMWaWBuiRvBLLM_aU6CWXdgVj7NOne0qYYqD6YPhmK9OJB_WY6eZc2j5PfNTPXUDySG-yaA_7Zckgu2ahU-YstxIQoCT/s320/george.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 296px;" /></a><span style="font-size:85%;">George, I'm going to feed you, but don't W6151XD</span><span style="font-size:85%;"> me (bite me) or the Feds will be after you ...</span><span style="font-size:85%;"> (click to enlarge photos) </span></div><br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjAe5L0wj033ueltsLPJXXnedf8mLjn-omiaw3gaLKiIY7YktgdknAW7yyAC9ujlx2KRCCRwOtKbwFxYWjvcVtTH8DOBRqtpCJYUpc4tHAOtGRIb6HzKaxaFfvx5oPN5GP1xEtX8Q4LpIGq/s1600/younguns.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5655571722736097122" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjAe5L0wj033ueltsLPJXXnedf8mLjn-omiaw3gaLKiIY7YktgdknAW7yyAC9ujlx2KRCCRwOtKbwFxYWjvcVtTH8DOBRqtpCJYUpc4tHAOtGRIb6HzKaxaFfvx5oPN5GP1xEtX8Q4LpIGq/s320/younguns.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 240px;" /></a><span style="font-size:85%;">Young'uns, you better watch out, too!</span><br /><br /></div><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjXo-FQb8mopRZE3moes-vRbr89rKLIhAWuRbW5gtrl9g76tMCsgDOOC7Tvpnys1OuKbk0LV0OpPg_vy6Y2OvXwi-58bqNM7LGveqzUfOxO67TBlY5wiLXBu_O9DEwWvw9Dap1zJmbJWpH_/s1600/molly.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5655632407985125138" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjXo-FQb8mopRZE3moes-vRbr89rKLIhAWuRbW5gtrl9g76tMCsgDOOC7Tvpnys1OuKbk0LV0OpPg_vy6Y2OvXwi-58bqNM7LGveqzUfOxO67TBlY5wiLXBu_O9DEwWvw9Dap1zJmbJWpH_/s320/molly.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 240px;" /></a><span style="font-size:85%;">This guy has already done a W6152XA and W6152XD to me with his wings, leaving me with a W6152XS (bruise on my leg</span><span style="font-size:85%;">) when I didn't feed him before the Canadas! You can just tell he's looking to create coding mayhem from that expression on his face.</span><br /></div><br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEip1c7cDSM2ESwSl6Ktg6ILHijLkMH7uUEingai21n_-yBr43pxwUQDqLpdEkOnYZywmE5xzdiDllY9M-Hiiof6RNCnKe0xqyNHAVEKs8h943Y_4ggHNiRktvDK5GHMS8H9sPnx40mInWr5/s1600/duck.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5655571946029411026" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEip1c7cDSM2ESwSl6Ktg6ILHijLkMH7uUEingai21n_-yBr43pxwUQDqLpdEkOnYZywmE5xzdiDllY9M-Hiiof6RNCnKe0xqyNHAVEKs8h943Y_4ggHNiRktvDK5GHMS8H9sPnx40mInWr5/s320/duck.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 240px;" /></a><span style="font-size:85%;">Is there an ICD-10 code for "foot bitten by cute little Mallard duckie?"<br /></span></div><span style="font-size:100%;"><br /></span><span style="font-size:100%;"><span style="font-size:100%;"><br />What a perverse waste of resources this coding mania represents...</span></span><br /><span style="font-size: 100%;"><span style="font-size: 85%;"><br /><span style="font-style: italic;">Hat tip: </span><a href="http://www.galen.org/" style="font-style: italic;">The Galen Institute</a><span style="font-style: italic;">/Grace-Marie Turner</span></span></span><br /><br />-- SS

• 
• 
• 
• 

1. 1
2. 2
3. 3
4. 4

• Previous
• Next

My doctor will now need to code for when I get bitten by George or Martha Goose

The bureaucrats always seem to find new ways to waste precious medical resources and capital to justify their existence.Here's the latest twist:I regularly feed swans, ducks and geese at my local park…

Đọc thêm »

Lo Bat for Implantable Cardiac Defibrillators

<a href="http://today.reuters.co.uk/News/newsArticle.aspx?type=healthNews&storyID=2005-02-11T195110Z_01_N11525845_RTRIDST_0_HEALTH-HEALTH-MEDTRONIC-DC.XML">Medtronic warned physicians </a>today about the possibility of battery failures in one of its models of implantable cardiac defibrillators (ICDs), 87,000 of which were manufactured before 2003. The market for these devices has recently expanded, since Medicare approved their prophylactic use for patients with congestive heart failure. Medicare <a href="http://www.indystar.com/articles/5/218124-6655-010.html">planned to pay </a>from $28 to $36K for the device, and the procedure to implant it.<br />I believe (but cannot find evidence at the moment to prove) that the price of the actual ICD is around $25K. If so, given that its circuitry cannot be that complex in this day and age, one would think that this would have been enough to buy an extremely reliable battery.<br />This reinforces <a href="http://hcrenewal.blogspot.com/2005/02/interesting-report-from-boston.html">the questions I recently raised </a>about the pricing of medical devices versus their value to the patient.

Lo Bat for Implantable Cardiac Defibrillators

Medtronic warned physicians today about the possibility of battery failures in one of its models of implantable cardiac defibrillators (ICDs), 87,000 of which were manufactured before 2003. The market…

Đọc thêm »