How the HIT zealots and profiteers have harmed physicians and nurses, not to mention patients, taxpayers, and the government

Any new technology introduced into a complex system, especially when introduced recklessly, has the potential to produce unexpected consequences, and the problems introduced can be worse than the problems the technology was attempting to solve.  This is a fundamental precept and empirical observation in the field of <a href="http://rkcsi.indiana.edu/" target="_blank">social informatics</a>, a domain that studies <span class="st">information and communication tools in their cultural or institutional contexts.</span><br /><br /><span class="st">Idealism combined with <a href="http://www.merriam-webster.com/dictionary/zealotry" target="_blank">zealotry</a> (</span><span class="st"><span class="ssens">excess of zeal;<b> </b>fanatical devotion</span>) and/or hyper-enthusiasm that ignores the downsides of an intervention, and silences credible critique,  has also proven to be a dangerous combination.</span><br /><br />Characteristic of the health IT hyper-enthusiasts been zealotry, silencing of credible critics, and spreading of illusory memes and technologies not yet fit for purpose; the characteristics of HIT profiteers is similar but for a different motive.  The end result in either case is harm to the interests and well-being of patients, physicians and nurses and other clinicians, taxpayers, and the government.<br /><br />(Doctors and nurses ... after reading the findings below, be prepared to countersue the health system officers who mandated your use of EHR's for breach of fiduciary responsibilities, including due diligence, if you are sued for EHR-caused medical malpractice.)<br /><br />---<br /><br /><blockquote class="tr_bq"><b>Medscape </b><br /><b>Business of Medicine</b><br /><a href="http://www.medscape.com/viewarticle/765567" target="_blank">Malpractice 'Discovery' Dangers in Your EHR</a><br />Leslie Kane, MA<br />Jul 16, 2012<br /><br />Introduction<br /><br />Picture this: You've been sued, and now the plaintiff attorney has the right to send in an expert to sit at your computer and examine information in your electronic health record (EHR). Besides any mistakes you might have made, <b>system-wide bugs or design flaws that lead to data inconsistencies could be found and held against you</b> in the discovery phase of a malpractice lawsuit.<br /><br />Doctors are becoming increasingly aware that EHRs can create certain malpractice risks. However, an expert in EHR and liability says there is a new category of malpractice risks in EHRs that most doctors have never considered. These include EHR system issues <b>that you were never aware of and didn't cause.</b></blockquote><br />You may have been coerced into using the EHR system via threat of Medicare cuts -- embedded without a public comment period in the HITECH section of ARRA thanks to the zealots and profiteers -- or via draconian hospital policies set by senior executives that threaten adverse personnel actions or other retaliation for those who refuse to use or are unable to learn to "effectively" use the corporate-chosen EHR (I have seen such policies in print).<br /><br />These executives have simply taken the word of the sellers that the technologies are harmless, and have likely negligently signed hold-harmless agreements with the sellers as a symbol of their confidence in the assessment.<br /><br /><blockquote class="tr_bq">"Every aspect of EHR selection, implementation, and use may be examined in the course of medical malpractice discovery to uncover the source of the incident, or undermine the records that are being presented in defense of the malpractice claim," says Ronald B. Sterling, CPA, MBA, national EHR expert, Silver Spring, Maryland, and author of Keys to EMR Success (Greenbranch Publishing; Phoenix, Maryland; second edition, 2010). "Anything could be a malpractice issue, from the product itself, the way it was set up, or how you've been using it."</blockquote><br />The same applies, I add, to any technology a clinician or healthcare facility might introduce into practice.<br /><br /><blockquote class="tr_bq">For example, authorized software upgrades can unknowingly cause liability problems. Upgrades to the software can change the historical data presentation you've already worked with. "An EHR upgrade can go back and affect data being stored for a patient," says Sterling. "The upgrade can affect the presentation and the reporting and usage of that information. I'm aware of upgrades in which a large amount of data was lost."</blockquote><br />I'm aware of numerous "upgrades" that nearly caused catastrophes - in fact they may have caused catastrophes that were not publicized- such as <a href="http://hcrenewal.blogspot.com/2010/08/huffington-post-investigative-fund-fda.html" target="_blank">here</a>.<br /><blockquote class="tr_bq"><br />"Even if the practice does everything perfectly, there could be <b>design flaws in the electronic health record</b> or the way the practices uses it or sets it up. This gets exposed in the light of discovery during a malpractice suit. <b>If the plaintiff attorney spots errors in the record -- even if the system, not the physician, creates them -- it calls into question every record you produce and every statement you make."</b></blockquote><br />Considering the evidence spoliation that can and does occur thanks to electronic systems, of which I am becoming aware of an increasing number of incidents, discrepancies ("errors" in the record) should arouse suspicions.   Those "hold harmless" agreements should look less and less appealing....<br /><br /><blockquote class="tr_bq">... "There are all kinds of issues I can now delve into, more than I'd find in the paper world. In the paper world, there is not a lot of supporting information," he says. "However, with an EHR, <b>you can see what time each event or note happened, whether it was before or after another event.</b> These could become critical points in a trial."</blockquote><br />Thank the zealots for this, docs.<br /><br />Sterling described several types of problems that could create difficulties for a doctor in a malpractice liability case.<br /><br /><blockquote class="tr_bq">... System or product bugs (defects). One doctor was using an EHR that had inherent errors in it. It wasn't documenting information correctly. The information being entered was not being stored in the right location, and the patient's medical note was ultimately incorrect. "This now calls into question anything in the note, even if you did the right thing," says Sterling.</blockquote><br />Caveat emptor.<br /><br /><blockquote class="tr_bq">Transferring paper records to EHR. What happens to the patient's history that was stored in the paper medical chart? The new EHR form may not specifically account for or match up with every notation you have in the old medical chart. If some information doesn't get transferred in, the plaintiff attorney may ask, "Did the doctor have the full picture of the patient's condition?" The discovery process may include comparing the patient's old paper record (if you still have it) with the history now in the EHR.<br /><br />Signing notes. Some doctors don't sign their notes. This creates a problem with billing, but it also could prompt the question of whether the doctor actually provided those services to the patient.</blockquote><br />The zealots never considered these issues, or didn't care.   "You're going to use EHR's whether you like it or not, because they <b>WILL</b> transform medicine.  So say we all."<br /><br /><blockquote class="tr_bq">... One physician was inadvertently distributing clinical notes that included inappropriate findings (such as results of tests that would not have been given to that patient). When the note was challenged during a malpractice trial, it called the patient's entire record into question.<br /><br />"Unfortunately, the physician had been using software that contained the test setups from the vendor," explained Sterling. "He was recording information on the screen and printing it, and the printed copy was appropriate when he gave it to the patient, but the electronic record contained inappropriate findings and events. Because the doctor was using the forms that contained the original test data (even though the data were not quite visible), the EHR incorporated these old findings."</blockquote><br />Just a "glitch", of course.   <br /><br /><blockquote class="tr_bq">One template affects other screens. When you use templates and you're charting by exception, you're viewing 1 screen. But when you check off items in the box, it sends those data to 5 or 6 other screens, and you may not be aware that the information is now contained on those screens. A doctor may decide to remove the information on 1 screen, but that deleted information has already populated 6 other areas and is still in the patient's medical record.</blockquote><br />Why would one expect that using tools of <a href="http://www.wapatientsafety.org/downloads/article-8.pdf" target="_blank">grossly inappropriate provenance</a> would <b>not </b>create problems?<br /><br /><blockquote class="tr_bq">Usage issues. The vendor stored it one way, but the doctor stored information another way, which changed the location in which information was stored. The historical record actually changed.<br /><br />"What happened when the doctor could not produce the record he gave to the patient because it no longer existed?" asked Sterling. "The attorney would look at it and say, 'This is not the piece of paper you provided.' "Any of these could be the killer issue that ends your chance of successfully defending yourself in a malpractice trial," he says.</blockquote><br />Sure, EHRs will 'revolutionize' medicine, once the EHRs actually don't introduce booby-traps to the practice of medicine exposing clinicians to the revolutionary guillotine.<br /><br /><blockquote class="tr_bq">Vendor Says, "Not My Fault!"<br /><br />One might think that a product defect or design flaw should be the responsibility of the vendor, and the doctor should be held harmless for those types of errors. But it doesn't work that way.<br /><br />"The doctor can be held liable because most vendors' contracts (signed by the physician) essentially say, 'We do not practice medicine; it is up to the physician to make sure this EHR is being used correctly.' The practices have to understand what they're using and verify that the system is appropriately set up to document the care they provide."</blockquote><br />I note that doctors forced to use hospital EHR's never see nor sign those contracts.<br /><br /><blockquote class="tr_bq">In a trial, the doctor would be held responsible for product problems.<br /><br />But just as scary, doctors could be held responsible for following vendor instructions. "I've seen situations in which the vendor tells doctors to do something, and doctors are relying on vendor and not doing their own proper analysis and design of the EHR that's tailored for their own practice," says Sterling. <b>"The vendor is not the one responsible for maintaining the patient's medical record."</b></blockquote><br />More than $20 billion of taxpayer "incentive" money has already gone to the accountability-free sellers of this technology, I might add.  <br /><br /><blockquote class="tr_bq">Bad News: You Need to Delve Into Technicalities<br /><br />Most doctors are unprepared to explore the technical elements of working with an EHR. "Doctors have to understand what happens when you push the buttons," says Sterling. That means they have to take the time to work with the EHR and explore various screens and scenarios before they ever use it with a patient.</blockquote><br />It would help to have people who actually know what they're doing around, a lesson hospitals have not yet fully learned when they depend on grossly inappropriate personnel of a business-computing background to lead HIT projects and make critical decisions on vendor contracts.<br /><br />In summary, the HIT hyper-enthusiasts and profiteers have successfully conned the government and healthcare sector into using, or coercing clinicians to use, technologies unproven to provide the fantastical levels of clinical and financial benefit claimed (as in many other posts), that introduce booby-traps to users' legal safety, that can be injurious to patient safety, and that suck money from healthcare that could be better used in, say, care of the underserved.<br /><br />What an enviable arrangement for the enthusiasts.<br /><br />-- SS

How the HIT zealots and profiteers have harmed physicians and nurses, not to mention patients, taxpayers, and the government

Any new technology introduced into a complex system, especially when introduced recklessly, has the potential to produce unexpected conseque...

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Senator Stephen H. Martin of Virginia: proposed limitations on use, storage, sharing, & processing of electronic medical record data

Here's a politician who certainly seems concerned with the <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy" target="_blank">privacy and confidentiality</a> and <a href="http://hcrenewal.blogspot.com/2009/04/have-we-suffered-complete-breakdown-in.html" target="_blank">flawed-analysis</a> downsides of electronic health records -  <a href="http://lis.virginia.gov/cgi-bin/legp604.exe?131+mbr+S41" target="_blank">Senator Stephen H. Martin</a> <span style="font-size: small;">of Virginia<span style="font-size: small;">:</span></span><br /><br /><hr size="1" /><div class="topLine"></div><div class="topLine"><b><a href="http://lis.virginia.gov/cgi-bin/legp604.exe?131+sum+SB1275" target="_blank">SB 1275</a> Medical data in an electronic or digital format; limitations on use, storage, sharing, & processing. </b></div><h4>SUMMARY AS INTRODUCED:</h4><blockquote class="tr_bq"><b>Medical data</b>. Prohibits any person that regularly stores medical data in an electronic or digital format from (i) participating in the establishment or implementation of the Nationwide Health Information Network; (ii) performing any analytic or statistical processing with regard to any medical records from multiple patients for purposes of medical diagnosis or treatment, including population health management; or (iii) processing medical data at a facility within the Commonwealth in any instance where a majority of the patients whose medical data is being processed do not reside in the Commonwealth. A database at which medical data is regularly stored in an electronic or digital format shall not store or maintain in a manner that is accessible by the operator or any other person, in an electronic or digital format, at any one time, medical data regarding more than 10,000 patients. </blockquote><br />Of note, the bill also counters the coercive aspects of the HITECH bill, stealthily sneaked into the Economic Recovery Act (ARRA) without so much as a peep of public comment, thanks to the Health IT lobby (as described by Robert O'Harrow Jr. in the WaPo in May 2009, see <a href="http://hcrenewal.blogspot.com/2009/05/machinery-behind-healthcare-reform-how.html" target="_blank">here</a>):<br /><br /><blockquote class="tr_bq"><b>The measure provides that any health care provider shall not be subject to any penalty, sanction, or other adverse action resulting from its failure or refusal to implement an online computerized medical record system. </b>A patient's consent to the sharing of his health care information shall be presumed not to grant consent to the electronic or digital storing or transmission of the information to any person other than for health care coverage purposes. Finally, the measure prohibits the Commonwealth from authorizing the establishment or operation of a health information exchange. </blockquote><br />The proposal seems authoritarian in terms of use of aggregated, de-identified medical data for public health purposes.  In the current environment, however, of health IT hyper-exuberance, misuse of medical data (e.g., putting it up for sale as at <a href="http://hcrenewal.blogspot.com/2009/10/private-medical-records-offered-for.html" target="_blank">link</a>, <a href="http://hcrenewal.blogspot.com/2009/10/health-it-vendors-trafficking-in.html" target="_blank">link</a>) and repeated major security breaches, perhaps a return to sanity requires putting the brakes on - hard - and performing a 'system reset.'<br /><br />It's clear the hyperenthusiasts will not like this proposed legislation. <br /><br />-- SS

Senator Stephen H. Martin of Virginia: proposed limitations on use, storage, sharing, & processing of electronic medical record data

Here's a politician who certainly seems concerned with the privacy and confidentiality and flawed-analysis downsides of electronic hea...

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How the "Revolving Door" and Other Aspects of Corporatism Benefited Amgen Just After its Settlement and Guilty Plea

At least here in these United States, our health care corporatism is bipartisan.  Here we present a sorry story of how a company that should have been shamed by dishonest behavior that likely harmed patients instead apparently was awarded special treatment through its cozy relationships with top government leaders <br />  <br /><b>Accusations of Kickbacks and Deceptive Marketing of Aranesp  </b><br /><br />Last month, biotechnology giant pleaded guilty to a charge of misbranding and settled civil charges with the US government for $762 million (look <a href="http://hcrenewal.blogspot.com/2012/12/amgen-settles-pleads-guilty-to.html">here</a>).  Soon after, New York Times <a href="http://www.nytimes.com/2012/12/20/business/amgen-workers-helped-us-in-aranesp-marketing-inquiry.html">article</a> described the unethical practices the company was alleged to have performed.  It opened with a vivid anecdote:<br /><br /><blockquote class="tr_bq">'I hope no one is taping this,' the Amgen<a class="meta-org" href="http://topics.nytimes.com/top/news/business/companies/amgen_inc/index.html?inline=nyt-org" title="More information about Amgen Inc"></a> manager remarked at a company sales meeting in 2005.<br /><br />The manager then <i>boasted of how she had given a $10,000 unrestricted grant</i> to a pet project of a doctor who was an adviser to the local  Medicare contractor. <i>In turn, she said, the doctor would help persuade the contractor to provide reimbursement for an unapproved use of Amgen’s anemia drug, Aranesp.</i>  </blockquote><br />Since that account appeared to be of a quid pro quo, it did sound like some a kickback or bribery.  In addition, <br /><br /><blockquote class="tr_bq">Amgen is also <i>accused of offering kickbacks to doctors and clinics to induce them to use its drugs</i>. These reportedly came as cash, rebates, free samples, educational and research grants, dinners and travel, and other inducements.   </blockquote><br />Of course, since this was the usual sort of settlement we see of health care corporate wrongdoing, in which the reason the company is paying what appears to be a large fine remains ambiguous,<br /><br /><br /><blockquote class="tr_bq"><div itemprop="articleBody">Except for those in the criminal count, <i>Amgen denied the other accusations, though it did issue a statement on Wednesday acknowledging the settlement</i>. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">'The government raised important concerns in the criminal prosecution,' Cynthia M. Patton, chief compliance officer at Amgen, said in the statement. 'Amgen acknowledges that <i>mistakes were made</i>, and we did not live up to our standards.'</div></blockquote><div itemprop="articleBody"><br />"Mistakes were made," what a handy phrase to avoid acknowledging that a real person or person made those mistakes.  Why government prosecutors did not leverage instances in which the mistakes were made by an identifiable person, for example, the manager in the anecdote above, to find out who ultimately authorized and directed the kickbacks and deceptive marketing, and then seek to indict them is a mystery.  The US Department of Justice now seems to be disinclined to ever pursue top  health care corporate executives who may have done wrong, while they exuberantly pursue fines from the companies they direct, fines which have almost no personal impact on those who authorized, directed or implemented the bad behavior.<br />   <br />The Times article also included a telling allegation that behind this apparent misbehavior was a changed corporate culture that put short-term revenue ahead of all other considerations.  </div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody">the corporate culture changed starting around 2000. That was when new management came in and Aranesp was approved, setting up a fierce marketing battle with Johnson & Johnson and its rival anemia drug, Procrit. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><b><i>'It was more important to make your numbers than to follow the rules,' </i></b>said [former Amgen sales representative and now whistle-blower Jill] ...Osiecki, who was based in Milwaukee and sold Aranesp. </div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">We have discussed how the "make your numbers" culture seems to have resulted from an over-generalization of the prevalent belief in business schools that "maximizing shareholder value," which usually seems to mean maximizing short-term revenue and/or doing whatever it takes to boost stock prices in the short-term (look <a href="http://hcrenewal.blogspot.com/2012/04/health-care-dysfunction-explained-by.html">here</a>).  In companies which make potentially beneficial but also potentially hazardous drugs, the risks of "make your numbers" are obvious.</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><b>Shameful Consequences for Patients  </b></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">These were disconcerting revelations.  They showed that some unidentified employees, probably including top leaders of a major health care corporation seemed to use kickbacks and lies to deceptively market a drug just to "make their numbers," and thus most likely score healthy bonuses.  Yet this drug is clearly dangerous.  The <a href="http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173_103951Orig1s5258lbl.pdf">official Aranesp label</a> states (in a black box warning, in capital letters):<br /><br /><blockquote class="tr_bq"> ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE</blockquote><br />Thus deceptive and unethical marketing practices likely lead to overuse of the drug, and overuse of the drug likely lead to sick (via myocardial infarction [heart attack], stroke, venous thromboembolism or thrombosis of vascular access [drug clots], or tumor progression) or dead patients. <br /><br />One would think that the consequences of the particular bad behavior alleged in this case would have lead to more zealous prosecution and to the pursuit of actual people who authorized, directed or implemented the bad behavior.  However, it did not.<br /><br /><br />One would also think that the nature and consequences of this bad behavior would harm the reputation of the company and its leadership.  Instead, it appears that soon after the settlement was announced, top US elected leaders were fawning over this company and its leadership, and rushing to legislate special treatment for it.<br /><br /><b>Special Treatment from Legislators </b><br /><br />Yet soon after these disconcerting revelations that should have shamed Amgen and its leadership, it appears that the company benefited from legislation narrowly crafted mainly just for to suit its interests, and with the aid of allies from both parties within the US government.  That story was again just <a href="http://www.nytimes.com/2013/01/20/us/medicare-pricing-delay-is-political-win-for-amgen-drug-maker.html">reported </a>by the New York Times.  The basics are:</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody">Just two weeks after pleading guilty in a major federal fraud case, <i>Amgen, the world’s largest biotechnology firm, scored a largely unnoticed coup on Capitol Hill: Lawmakers inserted a paragraph into the "fiscal cliff"  bill that did not mention the company by name but strongly favored one of its drugs. </i></div><div itemprop="articleBody">  </div><div itemprop="articleBody">The language buried in Section 632 of the law<a href="http://www.gpo.gov/fdsys/pkg/BILLS-112hr8eas/pdf/BILLS-112hr8eas.pdf" title="American Taxpayer Relief Act"> </a><i>delays a set of Medicare price restraints on a class of drugs that includes Sensipar, a lucrative Amgen pill used by kidney dialysis patients.</i> </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">The provision gives Amgen <i>an additional two years to sell Sensipar without government controls.</i> The news was so welcome that the company’s chief executive quickly relayed it to investment analysts.  But<i> it is projected to cost Medicare up to $500 million over that period.[That would almost make up for the fine the company had to pay for illegal marketing and to settle kickback charges - Ed]</i></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Amgen, which has a small army of 74 lobbyists<a href="http://www.opensecrets.org/lobby/clientlbs.php?id=D000000391&year=2012" title="Amgen’s lobbyists as of 2012"> </a>in the capital, was the only company to argue aggressively for the delay, according to several Congressional aides of both parties. </div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">But the Times article noted that it was not just the size of its army of lobbyists that did it.  </div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody"> <i>Amgen has deep financial and political ties to lawmakers like Senate Minority Leader Mitch McConnell, Republican of Kentucky, and Senators Max Baucus, Democrat of Montana, and Orrin G Hatch, Republican of Utah, who hold heavy sway over Medicare payment policy as the leaders of the Finance Committee. </i></div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">In particular, Amgen</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody">has a deep bench of <i>Washington lobbyists that includes Jeff Forbes, the former chief of staff to Mr. Baucus; Hunter Bates, the former chief of staff for Mr. McConnell; and Tony Podesta, whose fast-growing lobbying firm has unusually close ties to the White House</i>. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><i>Amgen’s employees and political action committee have distributed nearly $5 million in contributions to political candidates and committees</i> since 2007, including $67,750<a href="http://www.opensecrets.org/politicians/contrib.php?cycle=2012&cid=N00004643&type=C"> </a>to Mr. Baucus, the Finance Committee chairman, and $59,000 to Mr. Hatch, the committee’s ranking Republican. They gave an additional $73,000 to Mr. McConnell, some of it at a fund-raising event for him that it helped sponsor in December while the debate over the fiscal legislation was under way. More than $141,000 has also gone from Amgen employees to President Obama’s campaigns. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">What distinguishes the company’s efforts in Washington is the diversity and intensity of its public policy campaigns. <i>Amgen and its foundation have directed hundreds of thousands of dollars in charitable contributions to influential groups like the Congressional Black Caucus and to lesser-known groups like the Utah Families Foundation, which was founded by Mr. Hatch</i> and brings the senator positive coverage in his state’s news media. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><i>Amgen has sent large donations to Glacier PAC, sponsored by Mr. Baucus in Montana, and OrrinPAc, a political action committee controlled by Mr. Hatch in Utah. </i></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">And when Mr. Hatch faced a rare primary challenge last year, a nonprofit group calling itself Freedom Path<a href="http://images.nictusa.com/cgi-bin/fecimg/?C00492504" title="Freedom Path FEC filings"></a> sponsored advertisements in Utah that attacked his opponent, an effort that tax records released in November show was financed in large part by the Pharmaceutical Research and Manufacturers of America<a href="http://www.phrma.org/" title="PhRMA’s Web site"></a>, a trade group that includes Amgen. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">In some cases, <i>the company’s former employees have found important posts inside the Capitol. They include Dan Todd, one of Mr. Hatch’s top Finance Committee staff members on health and Medicare policy, who worked as a health policy analyst for Amgen’s government affairs office from 2005 to 2009</i>. <i>Mr. Todd, who joined Mr. Hatch’s staff in 2011, was directly involved in negotiating the dialysis components of the fiscal bill, and he met with 'all the stakeholders,</i>' Mr. Hatch’s spokeswoman said, not disputing when asked that this included Amgen lobbyists.</div></blockquote><div itemprop="articleBody"><br />In addition, a NY Times <a href="http://www.nytimes.com/2013/01/23/opinion/amgen-gets-a-gift-from-congress.html">editorial</a> today pointed out that Mitch McConnell, the Senate Minority Leader, (Republican - Kentucky) who "exerted great influence over the fiscal negotiations and praised the Medicare provisions" presumably including the specific provision that helped Amgen, also has "political and financial ties to Amgen."  Furthermore, Senator McConnell's willingness to use taxpayer's money to pay Amgen more seemed to contradict his "public statements [which] usually emphasize the need to cut federal spending on entitlement programs, <a href="http://www.lanereport.com/17882/2013/01/entitlement-spending-fix-will-require-medicare-eligibility-age-hike-means-testing-and-cpi-formula-change-mcconnell-says/?utm_source=Faster%20Lane%20Newsletter&utm_medium=Email&utm_campaign=jan-21-2013" target="_blank">as they did in Lexington Friday</a>," as <a href="http://www.weku.fm/post/mcconnell-helped-amgen-delay-price-limits-dialysis-drug">reported</a> by WEKU (the National Public Radio Station at Eastern Kentucky University ).   <br /><br /><br /></div><div itemprop="articleBody"><b>Can We Reform Health Care in the Corporatist States of America?  </b><br /><br /> In summary, Amgen seems to have leveraged its use of former legislative aides affiliated with both political parties as lobbyists, and its presumed influence over former employees who are currently legislative aides, that is, to people who have transited <a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">revolving doors</a> in both directions, to influence policy in its corporate favor.  It has also leveraged its contributions directly to politicians, to political action committees (PACs), and to non-profit advocacy groups to influence policy in its direction for this purpose.  All this leverage apparently resulted in continuing government favoritism to a company the government had just convicted of a crime, and to a company whose actions likely led to sick and dead patients.  Furthermore, legislators who publicly deplore excess government spending and enlarging government deficits supported spending more taxpayer money to favor a particular company that they ought to have shunned.  <br /><br /><br />The New York Times <a href="http://www.nytimes.com/2013/01/23/opinion/amgen-gets-a-gift-from-congress.html">editorial</a> deplored this case first as<br /><br /><blockquote class="tr_bq">a disheartening example of how intense lobbying and financial contributions can distort the legislative process in Washington</blockquote></div><div itemprop="articleBody"><br />and second as<br /><br /><blockquote class="tr_bq">a classic example of the power of special interests to shape legislation and shows how hard it may be to carry out the reforms needed to cut health care costs. </blockquote><br />But it was really much worse than that.   This case certainly shows the ongoing coziness between big health care organizations and government (this time, mainly legislative) leaders, facilitated by the apparently very common "<a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">revolving door</a>" interchange of influential people between corporate management and government.  Note that this coziness has now become bipartisan.  However, this was not merely expensive favoritism.  It was hypocritical expensive favoritism that benefited a corporation that ought to have been shamed and shunned for behavior that did not merely cost the government money, but likely harmed patients, sometimes even fatally.  </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"></div><div itemprop="articleBody">President Theodore Roosevelt <a href="http://www.theodoreroosevelt.org/TR%20Web%20Book/TR_CD_to_HTML364.html">condemned</a> malefactors of great wealth.  Our current political leaders in both parties seem to put their ties to corporate insiders who work for executives of great wealth ahead of any consideration of what might be good for patients, public health, or the citizenry at large.  </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">So the US now seems to be run by a soft, informal version of <a href="http://hcrenewal.blogspot.com/search/label/corporatism">corporatism</a>, the system in which government and big corporations overlap and jointly rule the people.  Since these days big corporations are run largely without accountability by increasingly rich executives, this ends up meaning government by the oligarchs, for the oligarchs, and of the oligarchs.  President Lincoln and President Theodore Roosevelt might be rolling in their graves.  </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">To meaningfully reform health care, it seems like we need to meaningfully reform our entire political system, and both make leaders of health care organizations accountable, and make government again of the people, by the people, and for the people.  </div>

How the "Revolving Door" and Other Aspects of Corporatism Benefited Amgen Just After its Settlement and Guilty Plea

At least here in these United States, our health care corporatism is bipartisan.  Here we present a sorry story of how a company that should...

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The HIT Scam

Worth a read -<br /><h1 class="post-title"><span style="font-size: small;"><a href="http://healthblog.ncpa.org/the-hit-scam/" rel="bookmark" title="Permanent Link to The HIT Scam">The HIT Scam</a><span style="font-weight: normal;"><span style="font-size: small;"> </span>By Greg Scandlen</span></span></h1><h1 class="post-title"><span style="font-size: small;"><span style="font-weight: normal;">Notable in the pi<span style="font-size: small;">ece are these observations:</span> </span></span></h1><blockquote class="tr_bq"><h1 class="post-title"><span style="font-size: small;"><span style="font-weight: normal;"> <span style="font-size: small;">... </span>even the editors of the <a href="http://www.washingtonpost.com/opinions/the-rush-to-digitize-patient-records-has-not-cut-costs/2013/01/14/09d90096-5c2d-11e2-beee-6e38f5215402_story.html?hpid=z3"><i>Washington Post</i></a> have come to agree the whole [national health I<span style="font-size: small;">T] </span>project was a fiasco — but only after we wasted $27 billion of taxpayer money. </span></span></h1>Yet, those who are enriching themselves on the $27 billion are just happy as clams over the program. John Hoyt, the Executive Vice President of the Healthcare Information and Management Systems Society (HIMSS) was quoted in a recent Health Change Bulletin as saying −<br /><br /><div style="padding-left: 30px;">This data suggests that the HITECH portion of the 2009 stimulus law is achieving its intended result of encouraging increased implementation and meaningful use of electronic health records among hospitals. Facilities…are laying the groundwork for interoperability to occur. Stage 6 and Stage 7 hospitals are fully prepared for provider-to-provider or facility-to-facility interoperability, as well as increasing the provider or facility’s ability to provide electronic health data reporting to public health and immunization registries to support population health review and syndromic surveillance.</div><div style="padding-left: 30px;"><br /></div>There, aren’t you greatly reassured? By the way, the <i>New York Times</i> piece cited above reported that –<br /><br /><div style="padding-left: 30px;">RAND’s <a href="http://www.rand.org/pubs/monographs/MG408.html" title="Abstract of the report.">2005 report</a> was paid for by a group of companies, including General Electric and Cerner Corporation, that have profited by developing and selling electronic records systems to hospitals and physician practices. Cerner’s revenue has nearly tripled since the report was released, to a projected $3 billion in 2013, from $1 billion in 2005.</div><div style="padding-left: 30px;"><br /></div>No doubt the companies that paid for the RAND study are also members of HIMSS. And General Electric certainly has what might be called a “special” relationship with President Obama.</blockquote><h1 class="post-title"><span style="font-size: small;"><span style="font-weight: normal;">I've <span style="font-size: small;">been writing on <span style="font-size: small;">similar issues for more than a decade.</span></span></span></span></h1><h1 class="post-title"><span style="font-size: small;"><span style="font-weight: normal;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;">It's well past the time when <span style="font-size: small;">the same rigor that applies to pharma and medical devices be <span style="font-size: small;">applied to the health IT sector<span style="font-size: small;">.  And the marketing hype, along with bad health IT, abolished.</span></span></span></span></span></span></span></span></h1><h1 class="post-title"><span style="font-size: small;"><span style="font-weight: normal;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;">-- SS</span> </span></span></span></span></span></span></span></span> </h1><span style="font-size: small;"> <a href="http://healthblog.ncpa.org/author/gscandlen/" rel="author" title="Posts by Greg Scandlen"></a></span>

The HIT Scam

Worth a read - The HIT Scam By Greg Scandlen Notable in the pi ece are these observations:   ... even the editors of the Washington Post ...

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GUEST BLOG - What Can Doctors Do to Combat Business Malfeasance in Health Care?

<span style="color: blue;"><i>Dr Gene Dorio is a an internist and geriatrician in California, <a href="http://articles.latimes.com/2011/nov/27/local/la-me-1127-lopez-dorio-20111127">described</a> in the Los Angeles Times as an "old school physician."  He would welcome discussion with anyone interested in his proposal.  Please email him directly at <span class="gI"><span class="go">grd51 at aol dot com, or email me for forwarding.  </span></span>   </i></span><br /><br />As a <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> reader, learning of medical business malfeasance irritates my moral conscience, yet lack of legal intervention frustrates my inner core.<br /><br />I am chairman of the Department of Medicine at a small community hospital in Southern California, and as I battle the Administration during Medical Executive Committee meetings, I am a lone voice. Some of my colleagues nod their heads, while others later tell me of their support, but few vocally nor in writing openly give their opinion. Why? <br /><br />Most fear hospital financial retaliation, but I also know they don’t have time to formulate an opinion. You would think well-educated doctors who daily advocate on behalf of patients would be better attuned to being involved in our great medical debate. Because they have remained silent, “big business” jumped in and took over financial medical decision-making. <br /><br />Using our medical license is the business scheme they use to make their money. With sophisticated business techniques, they have shut out doctors and dangled dollars as we all jump for their “carrots.” That successful business model and attitude is outside the realm of doctor’s poor business and public relations sense, with the noose continually tightening. <br /><br />Realizing business would be nowhere without our medical license is our trump card...which we haven’t played yet! <br /><br />What can we do? Logically, bring their business malfeasance forward on blogs (like <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>) with the hope physicians and the public will be upset. It does stir the pot for some of our colleagues, but for the most part, doctor attention is now focused on just trying to survive. The public is rendered helpless by the continually confusing medical legalese by the well-financed business propaganda machine. This is where our frustration arises, as the backlash-opinion tsunami of their business outrage never materializes, especially from doctors. <br /><br />Therefore, my first thought for a possible solution is focus on the public, clarifying the legalese, and use abhorrent stories of business abuse and patient care sacrifice for business profit. We must make them the villain. <br /><br />Secondly, organize physician writers into a small group launching a “counter offensive” against their propaganda. The public still highly respect physicians and gravitates to their opinions and stories. With the right motivated people, they would think-tank refined opinions for the national spotlight. <br /><br />Thirdly, network with national blogs and magazines, and city-printed newspapers for article publication as op-eds, letters to the editors, journal articles, and personal stories. <br /><br />Fourthly, and probably the hardest, not get discouraged. <br /><br /><a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> defines the problem, but not always the solution. Even when there might be solutions, they must be broadcast and directed at a higher level to ignite public opinion. <br /><br />If you think this might be worthy for 2013 (as if we aren’t all busy enough!), I will be happy to spearhead this project with those advocate colleagues and idealists who might be interested. <br /><br />Our profession is under assault from big business, and finding clarity is the shield we need to defend society and our patients.<br /><br />Dr Gene Dorio

GUEST BLOG - What Can Doctors Do to Combat Business Malfeasance in Health Care?

Dr Gene Dorio is a an internist and geriatrician in California, described in the Los Angeles Times as an "old school physician." ...

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"Slap on the Wrist" for a "Too Big to Fail" Hospital - Judge Rejects WakeMed Settlement

Maybe we are reaching an inflection point in how misbehavior by big health care organizations is handled in the US legal system. <br /><br />We have frequently discussed the march of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> made by big health care organizations.  Many of these settlements indicated severely bad behavior, often behavior that seemed overtly dishonest, sometimes criminal, and had the potential to harm patients.  Yet most of these settlements involved only fines, and sometimes written agreements that pledge the organization will do better in the future, often in the form of <a href="http://hcrenewal.blogspot.com/search/label/deferred%20prosecution%20agreement">deferred prosecution</a> or <a href="http://hcrenewal.blogspot.com/search/label/corporate%20integrity%20agreement">corporate integrity agreements.</a>  Yet the fines were often small compared to the amount the organization stood to make from the bad behavior.  It is not clear that any written agreements were enforced, or caused major penalties if the organization did not fulfill them.  And almost never did any individual within the accused organization suffer any negative consequences for authorizing, directing or implementing the bad behavior, even if such individuals may have personally profited from high compensation partially fueled by the bad behavior.<br /><br />Now and then, though, there are cases that are different.  Perhaps one has just come along that may signal things are going to change.<br /><br /><b>The Basics of the Case</b><br /><br />The case was first <a href="http://www.newsobserver.com/2012/12/19/2555092/wakemed-admits-to-false-medicare.html">reported</a> by the Raleigh (NC)  News & Observer in December, 2012.  Here are the basics:<br /><br /><blockquote class="tr_bq"><i>WakeMed has agreed to pay $8 million to settle an investigation into its practice of billing Medicare for expensive overnight care when the patients had been treated and discharged the same day.</i><br /><br />The settlement came after a lengthy <i>criminal investigation</i> into Medicare billing procedures used by nurses at the private, not-for-profit hospital’s Heart Center Observation Area.<br /><br /><i>Nurses there, according to federal court documents, routinely ignored physicians’ orders</i> for how a patient should be classified. Their actions resulted in the hospital receiving millions of unwarranted Medicare dollars for outpatients who were classified wrongly as inpatients.<br /><br />Though some WakeMed managers were aware of the billing practices, according to court documents, investigators found no evidence of anyone personally benefiting from the system.<br /><br /><i>No one, according to WakeMed officials, lost their job or was disciplined because of the investigation. </i></blockquote>The US Attorney made the usual sort of announcement:<br /><br /><blockquote class="tr_bq">'<i>This case will serve as a reminder that hospitals, just like individual health care providers, will be held accountable for their actions</i>,' [Thomas] Walker, the U.S. Attorney for the Eastern District of North Carolina, said in a statement. </blockquote><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.newsobserver.com/2012/12/19/2555092/wakemed-admits-to-false-medicare.html#storylink=cpy</div><br />So far, this is pretty usual.  There were accusations of inflated billing, a monetary fine that might look big to the average citizen, but that pales next to the revenue of the offending organization (over $943 million in the 2010-2011 fiscal year according to the <a href="http://www.guidestar.org/FinDocuments/2011/566/017/2011-566017737-087a1d7c-9A.pdf">WakeMed 2011 US form 990</a>),a stern statement by the US Attorney, but again no penalties for any individual, and here, a rather implausible statement that no one benefited from the deceptive practices.<br /><br />However, there were also some immediately appreciable atypical elements to this case.<br /><br /><b>Atypical Elements</b><br /><br />In addition to the fine to be paid, the case was to be settled using a deferred prosecution agreement:<br /><br /><br /><blockquote class="tr_bq">The hospital <i>faces two criminal charges – making material false statements relating to health care matters and aiding and abetting,</i> but under the settlement reached Wednesday, <i>prosecution will be deferred.</i> If the hospital complies with provisions in the settlement agreement, such as paying $8 million and allowing further monitoring, the charges will be dismissed in two years, according to court documents.<br /><br />As part of the agreement, which has yet to be approved in court,<i> [Wakemed CEO Bill] Atkinson acknowledged the wrongdoing described by prosecutors. He further acknowledged that WakeMed was responsible for the acts of the health-care organization’s employees and officers.</i></blockquote><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.newsobserver.com/2012/12/19/2555092/wakemed-admits-to-false-medicare.html#storylink=cpy</div><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.newsobserver.com/2012/12/19/2555092/wakemed-admits-to-false-medicare.html#storylink=cpy</div><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.newsobserver.com/2012/12/19/2555092/wakemed-admits-to-false-medicare.html#storylink=cpy</div>While we have sometimes seen deferred prosecution agreements used in cases in which for-profit health care corporations were accused of violating the law, they are rarely used in cases involving non-profit hospitals.  (The biggest one I recall was that of the University of Medicine and Dentistry of New Jersey, a complex case we started discussing in 2005.  See relevant posts <a href="http://hcrenewal.blogspot.com/search/label/UMDNJ">here</a>.)  Criminal charges against a non-profit hospital are also unusual.  Note also that as stated above the hospital system CEO seemed to admit that the hospital did wrong, raising further doubt about the conclusion above that no individual personally profited.<br /><br />The plot further thickened when the CEO seemed to contradict his own statement within the deferred prosecution agreement that acknowledged wrong-doing.<br /><br /><blockquote class="tr_bq">In an interview Wednesday, <i>Bill Atkinson, WakeMed’s president and CEO, wavered between accepting the charges – saying repeatedly  'I don’t want to minimize it, and I don’t want you to hear me doing that' – and being adamant that the hospital’s actions were simply a misinterpretation of complicated federal Medicare guidelines.</i><br /><br />Even though he endorsed a settlement agreement in which prosecutors contend two crimes occurred, <i>Atkinson said he doesn’t believe the hospital’s actions were criminal.</i><br /><i><br /></i><i>'I don’t think so, but the federal government thinks they could certainly turn it that way,</i>' he said. That description differs vastly from what prosecutors contend. 'They’re not going to minimize the media effect,' Atkinson said.</blockquote><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.newsobserver.com/2012/12/19/2555092/wakemed-admits-to-false-medicare.html#storylink=cpy</div><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"></div><br />The plot thickened further when in the same interview Atkinson seemed to deny that any individual did anything wrong:<br /><br /><blockquote class="tr_bq">Heidi McAfee, who retired earlier this year, was director of Patient Access during much of the period when the problematic billing occurred. Efforts to reach McAfee on Wednesday were unsuccessful, but Atkinson praised her years of work with WakeMed.<br /><br />'Do I think anybody intentionally did anything wrong?' Atkinson said. '<i>No, I don’t</i>.'<br /><br />He said WakeMed had not reported McAfee or any of the nurses to the N.C. Board of Nursing for ignoring doctor’s orders. </blockquote><br />So did the hospital acknowledge wrongdoing, or did it not?  If wrongdoing did occur, did any individual do it, or was it done by ghosts or spirits?  From this account, it was unclear. <br /><br /><b>This Time the Inconsistencies and Ambiguities are not Ignored</b><br /><br />Many of the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">settlements we have discussed</a> seem to have been based on similar illogic.  For example, they often involved accusations of bad behavior, often bad enough to put patients at danger, yet the settlements may included ritualistic statements by defendant organizations that they neither admitted nor denied wrongdoing.  Thus, the settlements left ambiguous and unknown what really happened, and their own appropriateness.  (Note that similar settlements are made all the time by big financial firms, and one intrepid judge did point out how little sense they make, see this <a href="http://hcrenewal.blogspot.com/2011/11/will-citigroup-ruling-challenge-health.html">post.</a>)<br /><br />Yet in most cases, the illogic is rapidly swept under the rug, noticed, if at all, by lowly outsiders like your humble bloggers on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal.</a><br /><br />This time, though, it was different.<br /><br /><u>Why Would the Nurses Ignore Doctors' Orders?</u><br /><br />An important part of the argument by the US Department of Justice in this case was that nurses "routinely ignored doctors' orders."  If it were true, this would be very unusual and would threaten the integrity of health care at the particular institution, since every hospital operates on the assumption that the doctors make management decisions and order tests, treatments, etc, and then the nurses, as well as technicians and therapists carry out these orders.<br /><br />However, In this case, a local nurse immediately and publicly disputed the notion that the nurses were independently flouting the doctors' orders.  As<a href="http://www.newsobserver.com/2012/12/22/2561738/nurse-rejects-wakemeds-claim-that.html"> reported</a> again by the News & Observer in December, 2012,<br /><br /><br /><div class="entry-content" id="story_text_top"><blockquote class="tr_bq">When Vicki Hewitt-McNeil read about WakeMed’s $8 million settlement for wrong Medicare billing, the Raleigh nurse didn’t buy the story.<br /><br />According to the settlement, a nursing director instructed her staff to admit patients as inpatients and ignore doctors’ orders to treat them on the less expensive outpatient basis.<br /><br />With two decades of nursing experience, Hewitt-McNeil didn’t like that the blame was shifted down the totem pole to nurses, who don’t wield the power of administrators and doctors.<br /><br /><i>'I honestly cannot believe this was the nursing department that did this,' Hewitt-McNeil said. 'That’s just not possible.'</i></blockquote> Furthermore,<br /><br /><blockquote class="tr_bq">[Ms Hewitt-McNeil]  also worked shifts at WakeMed as a pool nurse, similar to working as a substitute teacher. '<i>Nurses at WakeMed don’t have the autonomy to do anything,' Hewitt-McNeil said. 'You have to call a doctor for everything.'</i></blockquote><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.newsobserver.com/2012/12/22/2561738/nurse-rejects-wakemeds-claim-that.html#storylink=cpy</div><br /><br />Again, the contention that the nurses systematically disobeyed doctors or pretended to be following non-existent orders implied a fundamental break-down of the system and widespread unprofessional, unethical behavior by the nurses.  In addition, the charges did not suggest why the nurses would do something so bad, especially since they were in no position to personally benefit from their actions.<br /><br /> <u>What Did the Hospital Leadership Actually Admit? </u><br /><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.newsobserver.com/2012/12/22/2561738/nurse-rejects-wakemeds-claim-that.html#storylink=cpy</div></div><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.newsobserver.com/2012/12/22/2561738/nurse-rejects-wakemeds-claim-that.html#storylink=cpy</div><br />It took a few weeks, but someone - it is not clear who it was - noticed that while the Department of Justice asserted that the hospital CEO had admitted wrongdoing, the CEO's public statement seemed to equivocate.  So in mid January, 2013, as <a href="http://www.newsobserver.com/2013/01/15/2607671/wakemed-clarifies-statements-on.html">reported</a> again by the News & Observer,<br /><br /><blockquote class="tr_bq">Deb Laughery, a spokeswoman for the hospital, issued a clarification on Monday.<br /><br />'In an abundance of caution, <i>WakeMed confirms that it has agreed to a settlement with the United States as set forth in the Deferred Prosecution Agreement</i>,' the statement said, adding further that <i>statements of fact laid out in the agreement were 'true and accurate.'</i><br /><br />In the clarification, WakeMed officials acknowledged that the hospital formally faced federal criminal charges. The hospital also retracted any suggestions that the settlement only involved a small number of cases.</blockquote><br />The hospital public relations person apparently could not bring herself to say that the hospital admitted wrongdoing, but by acknowledging that statements of fact in the deferred prosecution agreement were "true and accurate," she seemed to be indirectly admitting again that wrongdoing occurred, and that the hospital was responsible for the actions of its employees.<br /><br /><u>The Judge Notices the Emperor Has No Clothes</u><br /><br />Despite their internal inconsistencies and illogic, most legal settlements of accusations of wrongdoing by big health care organizations are accepted by judges.  In this case, again things were different.  As <a href="http://www.newsobserver.com/2013/01/17/2614178/judge-refuses-to-accept-wakemed.html">reported</a> yesterday, on 17 January, 2013 again by the News & Observer,<br /><br /><blockquote class="tr_bq"> WakeMed officials and federal prosecutors spent two years hammering out an $8 million proposal to settle a Medicare fraud investigation.<br /><br /><i>A federal judge shredded the 116-page agreement</i> in less than 30 minutes on Thursday.<br /><br />U.S. District Judge Terrence Boyle ticked off a list of his grievances about the proposal, forcing federal prosecutors into the unusual position of defending the defendants. </blockquote><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.newsobserver.com/2013/01/17/2614178/judge-refuses-to-accept-wakemed.html#storylink=cpy</div><br />Quelle surprise!  The judge took particular offense that the settlement seemed disproportionately lenient,<br /><br /><blockquote class="tr_bq"> The agreement, Boyle said, appeared to be a <i>'slap on the hand' for a 'too big to fail' corporate giant. </i>Only the day before, Boyle told the lawyers, he sentenced a woman to a year in prison in a $235,000 insurance fraud case.</blockquote><br />Furthermore,  <br /><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.newsobserver.com/2013/01/17/2614178/judge-refuses-to-accept-wakemed.html#storylink=cpy</div><br /><blockquote class="tr_bq">Boyle was irked that no criminal charges had been filed in the case. He ended the hearing by telling the prosecutor either to fold his briefcase or take it to a federal grand jury for official indictments.<br /><br />'<i>There are lots of corporations that steal from the government,' Boyle said. 'Most of them are convicted, fined and banished.'</i></blockquote><br />Also,<br /><br /><br /><blockquote class="tr_bq">'Why are you coming to court if you tell me you don’t need me?' Boyle asked Gilmore, the prosecutor who rose before him Thursday. 'I’m just window dressing in this case.'<br /><br />'Why not take a guilty plea, defer imposition of the judgment and sentence, and come back in two years later and take a post hoc dismissal?' Boyle asked later.<br /><br />Boyle lamented the increased number of health care fraud cases across the country.<br /><br />'Who are the victims in this case?' Boyle asked before answering his own question. 'Every American wage earner and every American citizen.'<br /><br />Boyle continued: 'It’s very difficult for society and the court to <i>differentiate between the everyday working Joe or Jane who goes to prison and the nonprofit corporate giant who doesn’t go to jail, who gets a slap on the hand and doesn’t miss a beat.'</i></blockquote><br />Exactly.   And finally, just to demonstrate the sense of impunity of the leadership of this particular nonprofit corporate giant<br /><br /><blockquote class="tr_bq">Boyle, who’s been a federal judge for 28 years, also criticized WakeMed for failing to send a top administrator or a board member to answer his questions. It’s rare for a criminal case to be resolved without a defendant at the defense table.<br /><br />Deb Laughery, a WakeMed spokeswoman, said after the hearing that none attended because the board approved a resolution earlier in the week supporting the proposed settlement.</blockquote><br /><b>Summary</b><br /><br />For years now the leadership of large health care organizations have grown rich while denying accountability for their actions that made this so.  This denial has been largely abetted by governmental regulators and law enforcers, who while often recognizing that corporate misbehavior has occurred, have seemed unable or unwilling to pursue anything but the most lenient resolutions of such cases.  These resolutions are often fines that might appear big to gullible members of the public, but are actually small in comparison to the money to be made; sometimes deferred prosecution and corporate integrity agreements that rarely are enforced; and almost never any negative consequences for the people who authorized, directed, or implemented the bad behavior.  Thus the leaders of health care organizations have enjoyed impunity, have become the new untouchables, and thus health care organizations become ever better at raking in money and ever worse at providing good health care.<br /><br />As I have said again and again,  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 /><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.newsobserver.com/2013/01/17/2614178/judge-refuses-to-accept-wakemed.html#storylink=cpy</div><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.newsobserver.com/2013/01/17/2614178/judge-refuses-to-accept-wakemed.html#storylink=cpy</div><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.newsobserver.com/2013/01/17/2614178/judge-refuses-to-accept-wakemed.html#storylink=cpy</div><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.newsobserver.com/2013/01/15/2607671/wakemed-clarifies-statements-on.html#storylink=cpy</div>

"Slap on the Wrist" for a "Too Big to Fail" Hospital - Judge Rejects WakeMed Settlement

Maybe we are reaching an inflection point in how misbehavior by big health care organizations is handled in the US legal system.  We have fr...

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The Tragic Case of Aaron Swartz: Unequal Justice for Web Activists vs Health Care Corporate Executives

The recent tragic case of the suicide of Aaron Swartz raises many issues, and has inspired an outpouring of news coverage and internet discussion.  Yet one issue it should raise that has not received much notice so far is that of how individuals and top executives are treated differently before the law.<br /><br /><b>Summary of the Case</b><br /><br />Aaron Swartz was a prodigy who <strike>developed</strike>  helped develop the RSS system for disseminating updates on web-site contents, and who helped develop the Reddit web-site.  He was an advocate for information freedom, and more broadly, <a href="http://www.nakedcapitalism.com/2013/01/aaron-swartzs-politics.html">according to</a> Matt Stoller, "a political activist interested in health care, financial corruption, and the drug war."  Furthermore, he "recognized that politics is a corrupt money driven system, but also that it could be cracked if you spent the time to understand the moving parts." <br /><br />Although apparently very well known among internet activists and computer scientists, Mr Swartz did not attract a lot of mainstream media attention, at least until 2011 when he was arrested "on a series of felony counts including wire fraud, computer fraud, unlawfully obtaining information from a protected computer and recklessly damaging a protected computer," <a href="http://www.nytimes.com/2011/07/25/business/media/aaron-swartzs-web-activism-may-cost-him-dearly.html">according to the New York Times</a>.  His alleged crime was that he downloaded thousands of scientific scholarly articles from the site JSTOR, and was accused of intending to make them publicly available for free.  Note that the articles were already publicly available, but only online through expensive subscriptions.  At the time, the US Department of Justice took this to be a very serious crime:<br /><br /><blockquote class="tr_bq">'<i>Stealing is stealing, whether you use a computer command or a crowbar, and whether you take documents, data or dollars</i>,' <i>the United States attorney for Massachusetts, Carmen M. Ortiz, said</i> last week in a statement about the case. 'It is equally harmful to the victim whether you sell what you have stolen or give it away.' </blockquote><br />The charges Ms Ortiz filed lead to Mr Swartz's arrest<br /><br /><blockquote class="tr_bq">on a series of felony counts including wire fraud, computer fraud, unlawfully obtaining information from a protected computer and recklessly damaging a protected computer. If convicted on all counts, the Justice Department said he could face up to 35 years in prison and $1 million in fines. </blockquote><br />Yet Mr Swartz certainly was not accused of either violence or of planning to personally profit from his alleged crimes.  At the time of his arrest, the severity of the allegations baffled many:<br /><br /><blockquote class="tr_bq"> 'This makes no sense,' said David Segal, executive director of Demand Progress, an organization Mr. Swartz founded to rally support online for an open Internet. 'It’s like trying to put someone in jail for allegedly checking too many books out of the library.'</blockquote><br />JSTOR got the hard drives that contained the articles in question back from Mr Swartz, and planned no further action:<br /><br /><blockquote class="tr_bq">Asked if it was pleased that someone misusing the service could be brought to justice, a spokeswoman for Jstor wrote in an e-mail response: 'We wanted the content back, and we were able to secure it and ensure it wasn’t distributed. We were not interested in further legal action around this incident. We have no comment on the prosecution or how they have chosen to characterize it.'</blockquote><br />Since 2011 the case got little notice until Mr Swartz ended his own life this month.  After his death, his family and partner issued a statement, as <a href="http://www.guardian.co.uk/technology/2013/jan/13/aaron-swartz-family-mit-government">reported by the Guardian</a>:<br /><br /><br /><blockquote class="tr_bq">In a statement released late Saturday, Swartz's parents, Robert and Susan, siblings Noah and Ben and partner Taren Stinebrickner-Kauffman said the Reddit<a href="http://www.guardian.co.uk/technology/reddit" title="More from guardian.co.uk on Reddit">t</a> builder's demise was not just a 'personal tragedy' but '<i>the product of a criminal justice system rife with intimidation and prosecutorial overreach</i>'.<br /><br />They also attacked the Massachusetts Institute of Technology (MIT) for not supporting the internet activist in his legal battles and refusing to stand up for 'its own community's most cherished principles'.</blockquote><br />And according to the New York Times <a href="http://www.cnbc.com/id/100376112">(via CNBC</a>), Harvard Professor Larry Lessig, Director of the Safra Center for Ethics, where Swartz had been a fellow protested<br /><br /><blockquote class="tr_bq">the idea that he could have seen serious prison time was infuriating. Lawrence Lessig, the Harvard Law professor who founded Creative Commons to advocate greater sharing of creative material online, called the prosecution's case absurd and said that boxing in Mr. Swartz with an aggressive case and little ability to mount a defense ''made it make sense to this brilliant but troubled boy to end it.'</blockquote><br /><b> Hounding Swartz but Failing to Pursue Health Care Corporate Executives</b><br /><br />The Daily Beast just ran <a href="http://www.thedailybeast.com/articles/2013/01/15/aaron-swartz-s-unbending-prosecutors-insisted-on-prison-time.html">a story</a> that suggests that Swartz should have known better to have done something that would have attracted the wrath of one of the toughest federal prosecutors, but one who is also a "liberal's dream."  It opened its piece on US Attorney Carmen Ortiz thus:<br /><br /><blockquote class="tr_bq"> Until she was accused of driving the 26-year-old cyber wunderkind and public-access activist Aaron Swartz<a href="http://www.thedailybeast.com/articles/2013/01/13/mourning-aaron-swartz-internet-activist-and-free-information-advocate.html"></a> to suicide<a href="http://www.thedailybeast.com/articles/2013/01/14/aaron-swartz-s-thought-crime-was-tragically-treated-like-real-crime.html"></a>, the top federal prosecutor in Massachusetts was <i>a liberal’s dream</i>.<br /><br /> Not for nothing was United States Attorney Carmen Ortiz championed by the late Sen. Edward Kennedy and appointed by President Obama nearly four years ago.</blockquote><br />Then, it suggested how tough Ms Ortiz really is:<br /><br /><blockquote class="tr_bq">She is Hispanic and was raised in a New York housing project, and after her husband died of cancer she raised two daughters on her own. <i>She has taken on political corruption, and she has been so aggressive against white-collar crime that her office collected more in forfeitures and fines than any other jurisdiction in the country</i>.<br /><br /><div class="text parbase section"></div><a href="http://www.blogger.com/blogger.g?blogID=9551150" name="body_text3" style="visibility: hidden;"></a>Her avowed motive in becoming a prosecutor was because 'there’s a greater chance for justice.'</blockquote><br />that is a pretty amazing summary.  However, it seems decidedly at odds with Ms Ortiz's record dealing with misdeeds by health care corporations, as discussed on<a href="http://hcrenewal.blogspot.com/"> Health Care Renewal</a>.  Ms Ortiz, whose harsh views of Swartz appear above, has been quoted at least three times about three different cases on this blog.  In all instances, her quotes were in the context of legal settlements she made with large health care corporations.<br /><br /><u>Forest Pharmaceuticals </u><br /><br />In September, 2010, how Ms Ortiz led the pursuit of a settlement with Forest Pharmaceuticals became apparent (look <a href="http://hcrenewal.blogspot.com/2010/09/forest-pharmaceuticals-pleads-guilty-to.html">here</a>).   The company was accused of promoting its anti-depressant Celexa for use in adolescents and children.  Such drugs have since been shown to increase the risk of suicide by such young patients, and this drug was only approved for adults.  At the time, Ms Ortiz said, "Forest Pharmaceuticals deliberately chose to pursue corporate profits over its obligations to the F.D.A. and the American public."  Although the offense may have lead to use of the drug by many adolescents and children, and hence may have lead to some of them attempting or committing suicide, the case was settled only with fines.  As is usual in such legal settlements, no individual corporate executive who authorized or lead the off-label and potentially dangerous marketing of the drug was arrested, or accused, and none suffered any negative consequences.<br /><br /><u>GlaxoSmithKline </u><br /><br />In October, 2010, how Ms Ortiz led the pursuit of a settlement with GlaxoSmithKline became apparent (look <a href="http://hcrenewal.blogspot.com/2010/10/glaxosmithkline-subsidiary-pleads.html">here</a>.)  The company was accused of selling drugs that were not what they appeared to be, apparently because the wrong drugs were put in labelled containers.  Obviously, taking one drug, like Paxil, GSK's anti-depressant which has a number of known adverse effects, including suicide risk for adolescents and children as noted above, when a patient is supposed to be taking a wholly different drug could lead to patient harm.  At that time, Ms Ortiz said, "We will not tolerate corporate attempts to profit at the expense of the ill and needy in our society -- or those who cut corners that result in potentially dangerous consequences to consumers."   Again, while the settlement involved a guilty plea by a GSK subsidiary, again no individual corporate executive who had authority over the drug manufacturing was arrested or accused, much less suffered any negative consequences.<br /><br /><u>St Jude Medical </u><br /><br />In January, 2011, Ms Ortiz led the pursuit of a settlement with St Jude Medical (look <a href="http://hcrenewal.blogspot.com/2011/01/st-jude-medical-settles-again.html">here</a>).  The company was accused of paying kickbacks to doctors to implant its cardiac defibrillators (ICDs) and pacemakers.  Obviously, providing kickbacks to doctors may have lead them to plant devices in patients who did not really need them, yet the devices and the implantation procedures can have adverse effects.  At that time, Ms Ortiz said, "The United States alleges that St Jude solicited physicians for the studies in order to retain their business and/or convert their business from a competitor's product."  Again, as is usual, the settlement did not require any executive who authorized or directed the activities leading to the kickbacks suffered any negative consequences.<br /><br />So in summary, in three major cases involving unethical practices by big health care corporations that could have put patients at risk, US Attorney Carmen Ortiz provided strong words, but did not apparently seek any punishment of any form of any of the corporate leaders who authorized or directed the bad, and potentially dangerous behavior.  Yet in the sorry case of Aaron Swartz, Ms Ortiz charged a gifted computer activist whose alleged crimes certainly did not put any individuals at risk of adverse medical effects or any bad physical outcomes with crimes that if proven would have lead to years in jail and millions in fines for him as an individual.<br /><br /><b>Equal Justice Under the Law?</b><br /><br />So it seems ironic, or worse, that the main narrative of the Swartz case has become: well meaning but reckless hacker versus implacably tough law enforcer.  As noted above, Ms Ortiz's office appeared anything but tough when dealing with misdeeds by big pharmaceutical and device companies.  So the real question is why she went after Mr Swartz so relentlessly, when his alleged crime was non-violent and physically hurt nobody, when she failed to pursue corporate executives who enriched themselves while leading companies whose unethical practices likely harmed a lot of patients.<br /><br />In that light, the dark imaginings of Matt Stoller do not seem so far-fetched.  On Naked Capitalism he <a href="http://www.nakedcapitalism.com/2013/01/aaron-swartzs-politics.html">wrote</a>,<br /><br /><blockquote class="tr_bq"> As we think about what happened to Aaron, we need to recognize that it was not just prosecutorial overreach that killed him. That’s too easy, because that implies it’s one bad apple. We know that’s not true. What killed him was corruption. Corruption isn’t just people profiting from betraying the public interest. It’s also people being punished for upholding the public interest. In our institutions of power, when you do the right thing and challenge abusive power, you end up destroying a job prospect, an economic opportunity, a political or social connection, or an opportunity for media. Or if you are truly dangerous and brilliantly subversive, as Aaron was, you are bankrupted and destroyed.</blockquote><br /><br />I did not know Aaron Swartz, but am very sorry that we have lost someone so intelligent and imaginative.  I hope one question that his untimely death raises is what has become of the idea of equal justice under the law, and how its apparent demise has enabled the dysfunction of our health care system, and our whole society. 

The Tragic Case of Aaron Swartz: Unequal Justice for Web Activists vs Health Care Corporate Executives

The recent tragic case of the suicide of Aaron Swartz raises many issues, and has inspired an outpouring of news coverage and internet discu...

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