healthy4u

Novel Idea on Healthcare IT: Worth a Billion Dollars!

From an <a href="http://www.amia.org/">AMIA</a> announcement: <blockquote>CMS Innovation Center Announces $1 Billion Funding Opportunity: CMS announced a new initiative, the Health Care Innovation Challenge, which will provide grants for new ideas to improve care and lower costs for those in Medicare, Medicaid and CHIP. CMS will award up to $1 billion in grants for a 3 year period and is encouraging providers, payers, local government, public-private partnerships and multi-payer collaboratives to develop new and innovative ways to improve care. To learn more about the grants and application process, check out the CMS Innovation Center website and be sure to register for the CMS webinar on Thursday.</blockquote> CMS, I have an idea! It's a really, really novel idea! "Let's regulate HIT to improve its safety, usability, usefulness, fitness for purpose, effectiveness, etc." ™ That will lower healthcare costs! Save lives, too! ---------------------------------- Can I have my Billion Dollars now? <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhhinLWA0LEqtIx0hVUJ7BPLp62RwF2t6YjMjk5lObwSrXxX4ixGktTylUJpX3p3Fs1ty_pliiW-F7mrn6m4CFH1GqwZ4cfVYxz-97Vv0EJUIKBKGhfWEZr2hwI8k42p1RGUSDY2Q-L4TEW/s1600/Billion_Front.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5675578351849844338" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhhinLWA0LEqtIx0hVUJ7BPLp62RwF2t6YjMjk5lObwSrXxX4ixGktTylUJpX3p3Fs1ty_pliiW-F7mrn6m4CFH1GqwZ4cfVYxz-97Vv0EJUIKBKGhfWEZr2hwI8k42p1RGUSDY2Q-L4TEW/s320/Billion_Front.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 310px; height: 134px;" /></a>You can do a lot in health IT with a billion dollars - if you're not the HIT industry, that is, that has squandered a large wad of these over the past several decades. </div> -- SS

Novel Idea on Healthcare IT: Worth a Billion Dollars!

From an AMIA announcement: CMS Innovation Center Announces $1 Billion Funding Opportunity: CMS announced a new initiative, the Health Care ...

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Abbott Laboratories to Settle for $1.3 Billion Allegations Including Giving Doctors Kick-Backs and Training Them to Make False Diagnoses

It looks like the march of billion dollar <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> by health care organizations is on its way again.  The Proposed Abbott Laboratories Settlement Last month Bloomberg <a href="http://www.bloomberg.com/news/2011-10-21/abbott-said-to-agree-to-pay-1-3-billion-to-end-depakote-suits.html">reported</a>: <blockquote>Abbott Laboratories (ABT) agreed to pay at least $1.3 billion to settle claims by the U.S. government and 24 states alleging the company illegally marketed its Depakote epilepsy drug, people familiar with the accords said. Abbott executives, federal prosecutors and state officials reached a tentative agreement calling for the drugmaker to pay about $800 million to resolve civil claims over Depakote and about $500 million in criminal penalties for marketing the epilepsy medicine for unapproved uses, said three people familiar with the settlement who declined to be identified because the agreement hasn’t been made public. Abbott said earlier this week it was reserving $1.5 billion to cover costs of the potential settlement. </blockquote> A billion here, and billion there, it begins to add up: <blockquote>The settlement would be the third-largest illegal pharmaceutical marketing accord in U.S. history, behind the $2.3 billion Pfizer paid in 2009 over the marketing of its Bextra painkiller and other drugs and the $1.4 billion Eli Lilly & Co. paid the same year over sales of its Zyprexa anti-psychotic medicine. </blockquote> Encouraging Dishonesty, Giving Kick-Backs The Bloomberg report only briefly discussed the behavior by Abbott that lead to the settlement: <blockquote>In February, the government joined cases brought by former Abbott employees alleging the company engaged in so-called off-label marketing starting in the late 1990s. The suits contend the illegal sales practices resulted in false claims being submitted to government health programs. The whistle-blowers claim the drugmaker marketed Depakote for unapproved uses including agitation and aggression in patients with dementia, autism, sexual compulsion and other disorders. </blockquote> However, an <a href="http://articles.chicagotribune.com/2011-11-13/business/ct-biz-1113-abbott-20111113_1_whistle-blower-epilepsy-drug-illegal-marketing">article</a> published last week in the Chicago Tribune further described the allegations made by the whistle-blowers. In summary, <blockquote>The lawsuits against Abbott allege that the company encouraged and trained sales reps to market Depakote off-label to nursing home directors, geriatric doctors and other long-term care facilities. The company also gave doctors illegal kickbacks to talk about off-label uses of the drug in an effort to boost sales, according to the lawsuits, which were filed in federal courts in Virginia, Illinois and the District of Columbia. The FDA approved Depakote in 1983 to treat certain seizures in adults and children over 10. Since then, the drug has received approval for the treatment of other types of seizures, manic episodes of bipolar disorder and the prevention of migraine headaches. However, Depakote was never approved to treat Alzheimer's disease or other types of dementia or for general treatment of bipolar disorder. According to the whistle-blower lawsuits, though, Abbott sales reps specifically marketed Depakote to treat agitation and aggression associated with dementia.</blockquote> One whistle-blower alleged that Abbott encouraged doctors to make false diagnoses that would enable the government to pay for the use of Depakote: <blockquote>During a nationwide conference call in 2007, an Abbott trainer allegedly coached sales reps on how to explain to doctors that they could miscode a patient's illness in order to bypass federal regulations. For example, a physician could code a patient as having 'late onset of bipolar' or 'underlying seizure disorder' instead of 'agitation associated with dementia,' according to her complaint. Abbott held training sessions focused on off-label promotion but brought in outside consultants and held the training away from its North Chicago headquarters. At one training event, McCoyd and another sales representative allegedly were asked to share their techniques for off-label marketing but were forbidden from preparing or distributing any written materials about the topic. Upper-level management who attended the sales training purposely left the room when the off-label training sessions began, according to the complaint.</blockquote> The whistle-blowers also alleged that Abbott gave kick-backs (presumably the same idea as bribes) to doctors for prescribing Depakote: <blockquote>The complaints also allege that doctors were given kickbacks to talk about off-label uses of Depakote. According to McCoyd's filing, Abbott salespeople were given about $20,000 to $30,000 each year to 'educate' physicians and other heath care providers about off-label use of Depakote. Abbott paid doctors who promoted the drug between $500 and $2000 per speech, the complaint states. The money allegedly was funneled through intermediaries and associations, including the Alzheimer's Association, although the association told the Tribune it has 'no knowledge' of such activities. Using the organizations to pay doctors was done to 'disguise the direct payments to doctors and Abbott's substantial and direct involvement' in the events, the complaint alleges.</blockquote> Summary So it appears that Abbott is about to settle a case involving some very serious allegations, including training physicians to make false diagnoses, and giving physicians kick-backs. These sort of actions seriously subvert physicians' core values (and any physicians who made such false diagnoses or accepted such kick-backs would have seriously violated core ethical principles.) These actions also may have directly harmed patients. There appears to be no good evidence that Depakote has benefits that exceed its harms for patients with dementia, autism, etc. So encouraging doctors to prescribe the medicine for these patients was likely to have subjected some patients to side-effects without providing them any benefit. That would contradict the physicians' obligations to put the interests of individual patients first, and to avoid harming them. As the Tribune article noted, <blockquote>[Dr Adriane} Fugh-Berman, with PharmedOut, said companies put patients at risk when they promote drugs that haven't gone through the FDA's regulatory process. 'These drugs are being promoted for conditions they have not been shown to be effective, and they might be dangerous,' she said.</blockquote> So a $1.3 billion penalty would actually be a cheap price to pay for such ethical offenses. Note that the Bloomberg report did mention "criminal penalties," so this may be one of the infrequent cases in which a big health care organization actually would plead guilty to some crime. Note however that neither article mentioned anything about any individual who authorized, directed, or implemented the conduct in question suffering any negative consequence or paying any penalty. These reports are preliminary, so it may be that such penalties are part of the final settlement. But it is also possible that this settlement becomes another, and particularly flagrant example of health care corporate executive impunity. If no one turns out to have to pay a penalty for training physicians to lie to the government, and giving them kick-backs to prescribe a possibly useless and likely harmful medicine, what will deter other executives from authorizing and directing such actions again to make more money? Note in the Bloomberg article: <blockquote>Sales of Depakote 'rocketed to over $1.4 billion per year' as a result of improper marketing, according to a complaint filed in February by ex-Abbott sales representative Meredith McCoyd. 'Compensation for senior executives soared as well.' </blockquote> Furthermore, if no one turns out to have to pay a penalty for these actions, this case will just contribute to the ongoing demoralization of health care professionals. It will be another example of how insiders take advantage of the system for their personal gain, to the disadvantage of patients, and at further cost to an already overly expensive health care system that fails to provide adequate access and quality care. So I repeat, repeat, repeat... to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

Abbott Laboratories to Settle for $1.3 Billion Allegations Including Giving Doctors Kick-Backs and Training Them to Make False Diagnoses

It looks like the march of billion dollar legal settlements by health care organizations is on its way again. The Proposed Abbott Laborato...

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The Parallels Between Health Care and Financial Dysfunction: Leadership's Impunity as Demonstrated by the Citigroup Case

For years, we have noted the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">parade of legal settlements</a> made by large health care organizations.  The parade is notable on one hand because it illustrates how often some of our best known health care corporations and institutions behave badly.  Impunity for Health Care Leaders It is notable on the other hand because it illustrates how the leaders of these organizations have virtual impunity.  In very few cases has any person who authorized, directed, or implemented bad behavior faced any negative consequences.  The executives of these organizations often have gotten to continue making millions of dollars while the financial costs of settlements are borne by the company as a whole, and hence by all the employees, no matter how poorly paid or uninvolved, and all stockholders, no matter how powerless they were to prevent the bad behavior. The legal settlements that now seem to be the only effort made by the government to ensure fairness, honesty, and a level playing field in the health care "industry" seem to have no deterrent effect.  Some of the most famous health care companies have been subject to successive settlements, each of which failed to deter the next bout of bad behavior.  For example, we just <a href="http://hcrenewal.blogspot.com/2011/10/what-pfizer-v-few-consequences-for-long.html">posted</a> about NINE separate settlements made by global pharmaceutical giant Pfizer Inc from 2002 to 2011, the largest for $2.3 billion.  Yet a succession of Pfizer CEOs made tens of millions a year, and left with golden parachutes (see post <a href="http://hcrenewal.blogspot.com/2011/08/what-pfizer-iii-enormous-pay-for-poor.html">here</a>).  Johnson and Johnson subsidiaries have settled with corporate guilty pleas to several misdemeanors, while the company CEO made tens of millions a year and served as an adviser to the President.  (See summary of offenses<a href="http://hcrenewal.blogspot.com/2011/10/exporting-us-health-ecosystem-and-its.html"> here</a>, CEO's compensation <a href="http://hcrenewal.blogspot.com/2011/03/despite-recalls-legal-settlements.html">here</a>, and his White House role <a href="http://hcrenewal.blogspot.com/2011/08/why-cultivate-weldons-confidence-ceo.html">here</a>.)  With the rise of the "Occupy Wall Street" movement and its spin-offs, and the resurgence of the global financial crisis now threatening the Euro-zone in particular, the discussion of how the world's finance system has become fiercely dysfunctional that should have occurred after the crisis began in 2008 is now starting.  That discussion has now focused on the relative impunity of the leadership of finance firms, a striking parallel to what has gone on in health care. The Citigroup Settlement The case that has created headlines is that of Citigroup, and a new settlement of allegations brought against it by the US Securities and Exchange Commission (SEC).  A <a href="http://www.bloomberg.com/news/2011-11-02/citigroup-finds-obeying-the-law-is-too-darn-hard-jonathan-weil.html">commentary</a> by Jonathan Weil in Bloomberg explained it thus: <blockquote>Five times since 2003 the Securities and Exchange Commission has accused Citigroup Inc’s main broker-dealer subsidiary of securities fraud. On each occasion the company’s SEC settlements have followed a familiar pattern. Citigroup neither admitted nor denied the SEC’s claims. And the company consented to the entry of either a court injunction or an SEC order barring it from committing the same types of violations again. Those 'obey-the-law' directives haven’t meant much. The SEC keeps accusing Citigroup of breaking the same laws over and over, without ever attempting to enforce the prior orders. The SEC’s most recent complaint against Citigroup, filed last month, is no different. </blockquote> As in most of the health care cases, Citigroup has been subject to multiple legal settlements, each of which apparently failed to deter the next bit of bad behavior. Also, while the SEC made the company promise in particular settlements not to misbehave again, the SEC never held the company accountable for these promises. Other features of the Citigroup settlement paralleled many of those in health care. The company was never made to admit bad behavior. No top executive ever paid any penalty. However,unlike many health care cases, the Citigroup case produced an uproar, partially because the presiding judge refused to accept the settlement without questions. A Judge Questions the Settlement Instead, the judge had caustic questions for both the SEC and Citigroup. For example, as <a href="http://www.washingtonpost.com/business/economy/judge-chafes-over-citigroup-settlement/2011/11/09/gIQAQ13m6M_story.html">reported</a> by the Washington Post, <blockquote>A federal judge Wednesday challenged the SEC’s plan to settle a fraud case against Citigroup for $285 million, saying that the deal would recoup only a fraction of investors’ losses and would leave the firm free to proclaim its innocence in private lawsuits over the remaining damages. The judge used the Citigroup case to mock the SEC’s traditional way of doing business — allowing defendants to settle without admitting or denying wrongdoing. The unproven allegations, U.S. District Court Judge Jed S. Rakoff said, 'are no better than rumor or gossip.' 'Does not the SEC of all agencies have an interest in establishing what the truth is?' Rakoff asked.</blockquote> Also, he mocked the SEC practice of requiring promises of good behavior, that go unenforced, <blockquote>SEC settlements routinely include court orders prohibiting defendants from committing similar violations in the future and exposing them to potentially severe consequences if they do. However, the agency has refrained from enforcing those injunctions against repeat offenders. Citigroup was subject to two injunctions that predated the current case, SEC chief litigation counsel Matthew T. Martens said. Rakoff suggested that the injunctions are 'just for show.' The SEC lawyer said the agency takes past offenses into account when determining an appropriate penalty. Other SEC officials said after the hearing that past injunctions can be enforced only when the SEC catches a defendant in an ongoing violation. The proposed settlement also calls for Citigroup to take remedial steps to reduce the risk of future violations; Rakoff asked if those were merely 'window dressing.'</blockquote> This unusual hearing was covered by the Wall Street Journal, the New York Times, Bloomberg, and other major media outlets. Finance's Own Parade of Settlements Meanwhile, the NY Times did some in-depth reporting to show that the Citigroup case was hardly a fluke. There has been a parade of legal settlements of bad behavior by finance firms paralleling <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">the parade we have discussed by health care organizations</a>, although the former occurred without there being a "Finance Renewal" blog to comment on them. As <a href="http://www.nytimes.com/2011/11/08/business/in-sec-fraud-cases-banks-make-and-break-promises.html">written</a> by Edward Wyatt, <blockquote>Citigroup is far from the only such repeat offender — in the eyes of the S.E.C. — on Wall Street. Nearly all of the biggest financial companies, Goldman Sachs, Morgan Stanley, JPMorgan Chase and Bank of America among them, have settled fraud cases by promising the S.E.C. that they would never again violate an antifraud law, only to do it again in another case a few years later. A New York Times analysis of enforcement actions during the last 15 years found at least 51 cases in which 19 Wall Street firms had broken antifraud laws they had agreed never to breach. </blockquote> In particular, <blockquote>Of the 19 companies that the Times found to be repeat offenders over the last 15 years, 16 declined to comment. They read like a Wall Street who’s who: American International Group, Ameriprise, Bank of America, Bear Stearns, Columbia Management, Deutsche Asset Management, Credit Suisse, Goldman Sachs, JPMorgan Chase, Merrill Lynch, Morgan Stanley, Putnam Investments, Raymond James, RBC Dain Rauscher, UBS and Wells Fargo/Wachovia.</blockquote> The NY Times article also found some experts willing to criticize the current effeteness of government regulation and law enforcement: <blockquote>Senator Carl Levin, a Michigan Democrat who is chairman of the Senate permanent subcommittee on investigations and has led several inquiries into Wall Street, said the S.E.C.’s method of settling fraud cases, is 'a symbol of weak enforcement. It doesn’t do much in the way of deterrence, and it doesn’t do much in the way of punishment, I don’t think.' Barbara Roper, director of investor protection for the Consumer Federation of America, said, 'You can look at the record and see that it clearly suggests this is not deterring repeat offenses. You have to at least raise the question if other alternatives might be more effective.' </blockquote> Also, <blockquote>some experts view many settlements as essentially meaningless, particularly since they usually do not require a company to admit to the accusations leveled by the S.E.C. Nearly every settlement allows a company to 'neither admit nor deny' the accusations — even when the company has admitted to the same charges in a related case brought by the Justice Department....</blockquote> Summary As we learn more about what has gone wrong with our political economy, the parallels with what has gone wrong with health care become more obvious. Of course, health care must operate within a larger environment, and there has been increasing overlap between the leadership of finance and of health care. As the economy continues to sag, with rising unemployment and under-employment, increasing foreclosure, homelessness and poverty, and the decreasing likelihood of an even minimally comfortable retirement for many, it appears peoples' minds are increasingly focused on what has gone wrong, and particularly how ill-informed, incompetent, self-interested, conflicted and corrupt leadership of financial firms has lead to this severe economic dysfunction. I also hope that as the health care crisis continues to worsen, with rising costs, decreasing access, and degrading quality, peoples' minds will also increasingly focused on what has gone wrong, and particularly, as we have been saying for nearly seven years, how ill-informed, incompetent, self-interested, conflicted and even corrupt leadership of health care organizations has lead to this severe health care dysfunction. Maybe someone will now take seriously our calls for... true health care reform that requires competent, ethical leadership that upholds health care's core values within a governance structure of accountability, integrity, transparency, and honesty. Tackling the deep problems in health care will require tackling the deeper problems in the global political economy which helped to generate them.

The Parallels Between Health Care and Financial Dysfunction: Leadership's Impunity as Demonstrated by the Citigroup Case

For years, we have noted the parade of legal settlements made by large health care organizations. The parade is notable on one hand becaus...

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EHRevent.org Leadership: "Heck, getting out of bed in the morning is dangerous- it just beats the alternative"

I have posted about the organization EHRevent.org on numerous occasions. I expressed concerns that this organization's representation as an alternative aggregator of health IT difficulty cases, compared to established organizations and resources such as FDA's Medwatch and MAUDE database, was probably not a good idea: <blockquote>November 15, 2010: <a name="5203906860886106791"></a><a style="FONT-WEIGHT: bold" href="http://hcrenewal.blogspot.com/2010/11/ehreventorg-web-site-to-collect-ehr_15.html">EHRevent.org: Web Site to Collect EHR Safety Reports </a> November 16, 2010: <a style="FONT-WEIGHT: bold" href="http://hcrenewal.blogspot.com/2010/11/emrevent-survey-amateurism-bias-or.html">EHRevent: survey amateurism, bias, or something else?</a> November 17, 2010: <a style="FONT-WEIGHT: bold" href="http://hcrenewal.blogspot.com/2010/11/some-answers-about-ehreventorg-for.html">Some answers about new site "EHRevent.org" for health IT and drug adverse event reporting</a> November 22, 2010: <a href="http://hcrenewal.blogspot.com/2010/11/ehreventorg-ceo-edward-fotsch-md-real.html">EHRevent.org CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error? </a> July 24, 2011: <a href="http://hcrenewal.blogspot.com/2011/07/ehrevent-and-national-database-of-ehr.html">EHRevent.org and "The National Database of EHR Errors Being Called For" - Where's the Beef?</a></blockquote> The Nov. 22, 2010 post "<a href="http://hcrenewal.blogspot.com/2010/11/ehreventorg-ceo-edward-fotsch-md-real.html">EHRevent.org CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error? </a>" is particularly relevant to this one. I saw the following remarkable comment by EHRevent.org CEO Edward Fotsch MD on the <a href="http://www.histalk.com/">HISTalk</a> blog. It was in a comment section regarding the new Institute of Medicine report "Health IT and Patient Safety: Building Safer Systems for Better Care" on health IT risks (my initial post on that topic is <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">here</a>): <blockquote><a href="http://histalk2.com/2011/11/08/news-11911-2/#comment-18043">ed fotsch Says</a>: Re: the IOM/ONC report it seems to me that the IOM started with the wrong question. Question #1 posed should have been- ‘Are Health IT/EHR systems, when implemented appropriately, safer and better than the current paper system in most hospitals and MD offices; as opposed to the question that apparently was posed: ‘are EHRs safe.’ Heck, getting out of bed in the morning is dangerous- it just beats the alternative. Once question #1 HAD been answered, question #2 could have been tee’d up- ‘How can we make EHRs better?” But that ship has sailed and now they and we in Tidy-Bowl mode. The wrong question was asked so we’re dealing with what may be the right answer to the wrong question. And it will be hard to get the toothpaste back in the tube, worms back in the can, etc. on this one from an ONC/IOM standpoint- and yes the press will have a field day, those running for office will have more fodder and Republicans (no issue per se with Republicans BTW) who are pushing for less (not more) government regulation will have a field day with this set of recommendations. November 8th, 2011 at 10:53 pm</blockquote> While I do not know Dr. Fotsch, my questions about this comment are as follows: <ul> <li>Are its viewpoints entirely objective with regard to health IT? </li> <li>Is it consistent with a physician-executive who thinks critically about risk, and knows the literature (such as <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">here</a>), or with someone who leans toward technologically deterministic views about healthcare IT?</li> <li>Is it a reasonable view from the CEO of an organization seeking a position of enormous public responsibility as the "central place for reporting adverse EHR events or near misses or potential problems or issues with electronic health records", as described of EHRevent.org in the aforementioned Nov, 22, 2010 post?</li> <li>It is an appropriate comment for someone holding such a position?</li></ul> These questions repeat some of the concerns as expressed in my previous posts. I <a href="http://histalk2.com/2011/11/08/news-11911-2/#comment-18171">responded as follows</a> at HIStalk in the same comment thread. Emphases in the original: <blockquote>To Dr. Fotcsh: My opinion differs. I believe the IOM asked the correct questions. The answer to your proposed question “‘Are Health IT/EHR systems, when implemented appropriately, safer and better than the current paper system in most hospitals and MD offices” is – nobody really knows. The IOM explicitly acknowledges this: ---------------------------------- … “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect. More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.” ---------------------------------- The technology is experimental. In my opinion, that invokes the medical adage “First, do no harm.” There exist protocols for human subjects experimentation. The health IT industry has exempted itself from those protocols. My overall thoughts on the IOM report are at <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html</a> </blockquote> -- SS

EHRevent.org Leadership: "Heck, getting out of bed in the morning is dangerous- it just beats the alternative"

I have posted about the organization EHRevent.org on numerous occasions. I expressed concerns that this organization's representation as...

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CEOs First to Benefit from For-Profit Takeovers of Non-Profit Hospitals

Last year, we <a href="http://hcrenewal.blogspot.com/2010/03/now-private-equity-jumps-into-health.html">noted</a> concerns about the againy fashionable practice of for-profit corporations taking over previously not-for-profit hospitals and hospital systems. Two examples we cited were the planned acquisitions of Detroit Medical Center (DMC) by Vanguard Health, which was owned by the Blackstone Group, and of Caritas Christi Health Care by Cerberus Capital Management. At the time, we noted, "for-profit leaders tend to expect even larger compensation than not for-profit CEOs. Their decisions tend to be driven by their short-term compensation, rather than the good of the organization." So we asked, "will making a not-for-profit health care organization into a for-profit corporation really lead to more efficiency and lower costs?" In a <a href="http://hcrenewal.blogspot.com/2010/04/more-doubts-about-private-equity-taking.html">later post</a>, we worried about "ever-increasing executive compensation while making money becomes the overwhelming priority for the organization, completely eclipsing such quaint concepts as quality of care, reasonable costs, or adequate access." About one and one-half years later, we have some follow-up from the media about the results of these deals, especially as they pertain to executive compensation. Detroit Medical Center, Vanguard Health Systems, Blackstone Group Our <a href="http://hcrenewal.blogspot.com/2010/03/now-private-equity-jumps-into-health.html">post</a> last year quoted then Mike Duggan, then CEO of DMC, that "We were being choked to death by the nonprofit business model." This month, the Detroit Free Press <a href="http://www.freep.com/article/20111103/BUSINESS06/111030446/DMC-CEO-Mike-Duggan-make-2-41-million-pay-bonuses-stock-options">reported</a>, <blockquote>Detroit Medical Center CEO Mike Duggan's total compensation this year from Vanguard Health Systems, the private health care company that bought the DMC, is $2.41 million in pay, bonuses and several years of stock options, up from the $1.98 million in 2009 when DMC was a nonprofit, according to public documents. About $1.3 million of Duggan's total compensation is in stock options that he would start receiving next year through 2019, the documents show. </blockquote> Note also that, <blockquote>The package also calls for Duggan to get $1 million if he's fired or $5 million if Vanguard sells the DMC to another company -- fairly common conditions in contracts, experts said. Duggan's new compensation package puts him in the top tier of local health care executives. </blockquote> It seems like Mr Duggan is no longer being "choked to death." Cursory review of the media reveals that since the acquisition, DMC has some major construction projects planned. However, I saw nothing yet about whether the acquisition has decreased costs, increased access, or improved the quality of care. I should note that Mr Duggan appears just a bit uncomfortable with his generous compensation in this era of anger about the power of the one percent: <blockquote>Duggan said he agreed with Occupy Wall Street protesters who point to the growing gap between the poor and rich: "I do believe people should be able to work hard and earn a lot of money. (But) the gap between the top and the bottom is not fair in this country," he said. "I don't have the ability to fix the world, but my wife and I are making a gesture that's appropriate for us. If people say we get paid a lot of money, I think they are right. I'm trying to do something to share some of the benefit."</blockquote> The gesture mentioned above would be <blockquote>he and his wife plan to create a foundation next year to hold the stock earnings, after taxes, for scholarships for children of DMC employees.</blockquote> Whether it is carried out, of course, remains to be seen. Caritas Christi Health Care, Steward Health Care, Cerberus Capital Management The initial <a href="http://www.boston.com/business/healthcare/articles/2010/03/25/equity_firm_set_to_buy_caritas/">story</a> about the proposed take-over in the Boston Globe noted that one rationale was how: <blockquote>Caritas has long struggled financially, but since coming to the chain two years ago, [CEO Dr Ralph] de la Torre has worked to strengthen its financial position by aggressively cutting costs and boosting revenue from medical care. It posted operating income of $30.5 million for the fiscal year ending last Sept. 30 compared with a $20.5 million loss the prior year.</blockquote> The aim would be: <blockquote>to provide quality community-based care at a reasonable cost.</blockquote> Some specific goals of the proposed take-over would be <blockquote>Under the agreement, Cerberus will invest $430 million to $450 million immediately to pay off Caritas debt, finance renovation projects, and provide working capital, while also assuming its pension liability.</blockquote> To pursue all this, <blockquote>While de la Torre and other senior executives will retain their current salaries and benefits, they would be eligible for additional compensation from Cerberus based on the financial performance of the hospitals, Caritas officials said. They said the details of those financial incentives have yet to be worked out.</blockquote> Last month, a Boston Globe <a href="http://articles.boston.com/2011-09-15/yourtown/30160931_1_compensation-hospital-executive-teaching-hospital">article</a> provided a little more clarity about these compensation arrangements: <blockquote>Ralph de la Torre, former chief executive of Boston-based Caritas Christi Health Care, drew a total pay package of $2.2 million from the Catholic hospital system in 2009, making him the best-compensated hospital executive in Boston that year, according to documents filed with the state attorney general’s office. The package, which included base salary, a performance bonus, and incentive compensation linked to improving finances at the hospital chain, marked an increase from the $1.2 million de la Torre earned from Caritas in 2008.</blockquote> Note that after the take-over, the Caritas Christi system was renamed as Steward Health Care. So prior to the actual take-over by Cerberus, but presumably while initial negotiations about it were going on, Dr de la Torre had already become the best paid hospital CEO in Boston. Becker's Hospital Review <a href="http://www.beckershospitalreview.com/compensation-issues/caritas-christis-2010-form-990-shows-executive-pay-before-for-profit-conversion.html">noted</a> that De la Torre's 2010 total compensation was exactly $2,270,076. The Caritas Christi 2010 <a href="http://www.beckersasc.com/media/CC_2010Filing.pdf">IRS form 990 </a>also listed 19 executives who received more than $400,000. Of these, 11 received more than $600,000. Meanwhile, according to this form, the system's losses were accelerating, going from -$6,583,625 in 2008 to -$23,858,733 in 2009. So, it seems that Dr De la Torre became significantly richer in anticipation of the proposed (and now accomplished) take-over of Caritas Christi by Cerberus Capital Management, even though his hospital system's hemorrhaging of money was increasing at that time. Again, I was not able to find any clear evidence whether the take-over had decreased costs, increased access, or improved quality of care. I did find one report suggesting that some Steward Health nurses did not think that it had stabilized their pensions as promised. <a href="http://www.bizjournals.com/boston/news/2011/10/28/steward-employees-to-protest-today.html">According to </a>the Boston Business Journal, <blockquote>Nurses and other health care workers from several of the hospitals owned by the for-profit Steward Health Care, plan to protest outside the company's Boston headquarters today at 1:30. They include nurses from St. Elizabeth’s Medical Center, Brighton, Norwood Hospital, Good Samaritan Hospital in Brockton, Morton Hospital in Taunton, Quincy Medical Center Carney Hospital in Dorchester, Holy Family Hospital in Methuen and Merrimack Valley Hospital in Haverhill. Nurses argue that Steward, owned by New York private equity firm Cerberus Capital Management, has not honored agreements to the workers, including a commitment to create a defined-benefit pension plan. They also say that Steward has threatened to eliminate essential services in retaliation for the nurses demand for the pension plan.</blockquote> Summary Two acquisitions by private equity firms of non-profit hospital systems have resulted in increased compensation for the systems' CEOs, and perhaps other top executives.  These increases predated any recognizable improvements in quality or access, or decreases in health care costs. Acquisitions of non-profit hospitals and hospital systems by for-profit entities, including private equity firms, is one of the newly fashionable ways our health care leaders have promised to improve care, increase access and control costs. The evidence about whether this tactic accomplishes these aims is not yet in. However, it appears that this tactic may be another, and a rapid way for top health care executives to increase their personal incomes. Health care professionals, patients, and the public at large ought to be increasingly skeptical of the latest fashions in health care management, especially those that have potential to further enrich managers. As we recently <a href="http://hcrenewal.blogspot.com/2011/11/health-care-also-needs-to-challenge.html">noted</a>, more people in the US and other countries are frustrated that their attempts to work hard and follow the rules of the economic system yield less rewards. Meanwhile, it appears that well-connected insiders are increasingly gaming the system for their personal profit. We have noted how health care executives' compensation seems independent of their talent, skill, or innovation, much less their ability to uphold the values and fulfill the mission of their organizations. Their compensation often seems to rise inexorably, regardless even of the financial status of their organizations. Now it appears that inflating compensation in anticipation of or due to a merger or acquisition is another mechanism by which insider executives gain, while others in health care lose. Once more with feeling .... true health care reform requires competent, ethical leadership that upholds health care's core values within a governance structure of accountability, integrity, transparency, and honesty. Tackling the deep problems in health care will require tackling the deeper problems in the global political economy which helped to generate them.

CEOs First to Benefit from For-Profit Takeovers of Non-Profit Hospitals

Last year, we noted concerns about the againy fashionable practice of for-profit corporations taking over previously not-for-profit hospita...

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IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care" - Nix the FDA; Create a New Toothless Agency

<div style="text-align: center;">[Authors' note: This major part of this post was written before I had the actual IOM report itself. Having now read that report, available <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">here</a> in PDF, my opinions are unchanged.]</div> The <a href="http://www.iwatchnews.org/">Center for Public Integrity</a> has published a story ahead of the Thursday release of the Institute of Medicine's report on health IT safety. This was a panel, by the way, that rejected my testifying, live, about my own relative's IT-<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary"></a> related harm, despite my Medical Informatics credentials and explicit requests [see note below]. The IOM report apparently recommends that an extraordinary special accommodation be afforded to the healthcare IT industry regarding regulation of health IT software devices. Excerpts from the Center for Public Integrity's article: <a href="http://www.iwatchnews.org/2011/11/07/7325/panel-recommends-new-agency-regulate-safety-health-information-technology" itemprop="url"></a> <blockquote><div class="field field-name-body field-type-text-with-summary field-label-hidden clearfix" itemprop="description"><div class="field-items"><div class="field-item"><div style="font-weight: bold;"> <a href="http://www.iwatchnews.org/2011/11/07/7325/panel-recommends-new-agency-regulate-safety-health-information-technology" itemprop="url">Panel recommends new agency to investigate safety of health information technology</a></div>Health information technology has been touted as crucial to better health care, but a new report says an entirely new regulatory agency is needed to oversee this largely unregulated sector, which can also injure or kill patients if it’s not operating properly. </div></div></div></blockquote><div class="field field-name-body field-type-text-with-summary field-label-hidden clearfix" itemprop="description"><div class="field-items"><div class="field-item"><div style="color: black;"> </div><div style="color: black;">We would never have known that if not for the efforts of a small group of specialists with a conscience writing on this issue over the past decade; the industry long emphasized only the beneficence of the technology.</div> <blockquote>In pushing for a new oversight body, the respected Institute of Medicine, an independent research and advisory organization, is explicitly advising that the Food and Drug Administration (FDA) not be tasked with the job — a recommendation that is bound to be controversial. [Indeed - ed.]  The eagerly anticipated report, titled “Health IT and Patient Safety: Building Safer Systems for Better Care,” will be publicly released Thursday. A copy was obtained by iWatch News. The study details nine other recommendations for how to ensure patient safety when doctors and other health care providers use health information technology, or health IT. The findings from the report were presented October 28 to the Department of Health and Human Services (HHS) and its agencies.</blockquote> I do not consider the IOM's rationale for excluding the FDA to be reasonable...more below. <blockquote>... the push [by the Administration] is occurring so far without any agency really ‘watch dogging’ the safety of health IT — the software, hardware and systems that record and manage patients’ health information. These expensive devices by and large have not gone through any regulatory checks for safety in the way that food, drugs and other medical technology must; most of that oversight is handled by the FDA. But at the moment, no one is required to report instances of harm caused by health information devices and no government agency currently monitors their safety.</blockquote> This is a scandal of major proportions, considering the government has taken the approach "ready, shoot, aim" in putting in place penalties for non-adopters on a fantastically rushed timeline, via the HITECH Act within ARRA, while ignoring the risks. <blockquote>“With all of that money, marketing and public outreach, most simply affirm the value of health IT as an article of faith, rather than investigate it via careful evaluation,” said Ross Koppel, adjunct professor of sociology at the University of Pennsylvania and its School of Medicine, and investigator for RAND Corporation. He is listed as one of the reviewers of the report. </blockquote>"Faith" (e.g., irrational exuberance) in a technology has no place in science or medicine. Addendum:  from the report itself: <blockquote class="tr_bq">... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk. Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety. </blockquote><blockquote class="tr_bq">[IOM (Institute of Medicine). 2012. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">Health IT and Patient Safety: Building Safer Systems for Better Care</a> (PDF). Washington, DC: The National Academies Press, pg. S-2.] </blockquote> Also in the IOM report: <blockquote class="tr_bq">… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect. More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”</blockquote> In other words, nobody has any real idea of the magnitude of harms, which also implies nobody knows if the magnitude of harms exceeds the magnitude of benefits.  National rollout under these conditions is a horribly unethical situation on first principles. <blockquote>Though a variety of studies have concluded that the use of health IT may improve patient safety, mistakes made in the systems or difficulty using the technology can lead to serious injury or death, according to the report. </blockquote> Other studies actually show little or no benefit or cost savings. See <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">this reading list</a> for examples. So, it has been article of faith that the technology in its present form is of benefit, and is not a risk. <blockquote>An allergy might be omitted from a computer record, for example, or an incorrect medication dosage might be recorded. In Rhode Island, a Lifespan <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">computer glitch</a> [5] caused about 2,000 patients to receive the wrong types of medications. In <a href="http://www.huffingtonpost.com/2010/04/20/electronic-medical-record_n_545441.html">another instance</a> [6] in March 2009, an unattended patient suffered multiple seizures for hours after a computer failed to alert doctors the patient was moved from the intensive care into their ward.</blockquote> And people die needlessly (a few examples are at <a href="http://hcrenewal.blogspot.com/2010/07/maude-database-patient-outcome-death.html">link</a>, <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">link</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary">link</a>). <blockquote> As reports of patient harm began to emerge, the federal Office of the National Coordinator (ONC) for health IT asked the Institute of Medicine (IOM) a year ago to establish a Committee on Patient Safety and Health Information Technology to make recommendations to the government about how to maximize health IT safety.</blockquote> I would rephrase that to: as reports on patient harm were no longer able to be<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda"> suppressed by the industry</a>... <blockquote> In its report, the IOM committee says the FDA would likely restrict market innovation in health IT, which could also jeopardize patient safety.</blockquote> There has been little to no real "innovation" in health IT in well over a decade; if anything, the usability and quality has deteriorated. Further, there is no data supporting the contention that FDA regulation of IT harms innovation. Pharma IT (regulated) is far more innovative than the IT in healthcare delivery (unregulated). <blockquote>Stringent regulations “can negatively impact the development of new technology by limiting implementation choices and restricting manufacturers’ flexibility to address complex issues,” the report says. </blockquote> Bull. It will keep the companies honest and "encourage" them to adhere to good software engineering and usability principles (unlike <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">here</a>), which will save lives. It's unfortunate such "encouragement" is needed, I note. <blockquote>The FDA currently <a href="http://www.iwatchnews.org/2010/02/23/7047/fda-considers-regulating-safety-electronic-health-systems">receives voluntary reports</a> [7] of health IT-related incidents, but has no resources or protocols through which to take action; the agency <a href="http://www.vuvox.com/collage/detail/02b26ea6c3">has long fought a losing battle</a> [8] with health IT vendors over trying to monitor the technology. The report also notes the agency does not have the investigative capabilities, funding or manpower to regulate devices such as electronic health records, personal health records or health information exchanges. </blockquote>Then give them the resources, not develop an entire new agency. The FDA has the talent and experience. [Note: I have no connections to FDA whatsoever - ed.] <blockquote>... To adequately oversee health IT safety, the committee recommends that the secretary of health and human services create and fund a new independent watchdog agency, along the lines of the National Transportation Safety Board. Like NTSB, the new agency would conduct investigations and make recommendations for all stakeholders, including the secretary of the health and human services, vendors and health care organizations. Vendors of the technology would be required to report adverse events, while reporting would be voluntary for clinicians. Like NTSB, though, the new agency would also have no enforcement power. </blockquote> That is to say, it will be toothless and ignored, leaving a cavalier industry that should have gotten its act together twenty years ago to continue on with its nihilistic ways. <blockquote>The panel also recommends that the HHS secretary publicly report on the progress of health IT safety each year, beginning in 2012. If the secretary determines at any time that adequate safety progress has not been made, only then should the FDA take the regulatory lead and be given the resources to do so, the report recommends, adding that the agency should be developing a framework now to be prepared.</blockquote> This makes little sense. In fact, it's an extraordinary special accommodation to the health IT industry (or should I say lobby) relative to other healthcare medicine/device sectors, and is bizarre. It continues health IT as a <a href="http://hcrenewal.blogspot.com/2010/01/meaningfully-experimental-protocols-and.html">human subjects research experiment</a> without informed consent and opt-out. With catastrophe-inviting events like <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">this one</a> becoming more commonplace, just how many patients will have been maimed or died in the meantime while the HHS Secretary's 'determination of adequate safety progress' is being made? (What, exactly, will be deemed 'adequate', I also ask?) <blockquote>Creating a new independent agency would, of course, require resources; the current budget for NTSB is set at $559 million over the 2010 to 2014 period. In the current climate of fiscal restraint, convincing Congress to appropriate that sort of cash for a new government body might be a tall order.</blockquote> I note that it's a waste of taxpayer money to create a new agency to maintain/increase health IT industry profits at the expense of patients - not a wise choice IMO. <a href="http://www.grassley.senate.gov/"></a> <blockquote><a href="http://www.grassley.senate.gov/">... Republican Sen. Chuck Grassley</a> [11] of Iowa, senior member of the Senate Finance Committee, said the new report “adds more to the list of unresolved questions, including which government agency, if any, should regulate health care information technology.” Grassley, who <a href="http://media.washingtonpost.com/wp-srv/politics/documents/erecords102409.pdf">wrote</a> [12] HHS and health IT vendors two years ago asking what was being done to ensure the safety of the devices, said “the approach seemed to be, write checks first, solve the problems later, instead of the other way around.” </blockquote> Having spoken extensively with Sen. Grassley's staff on these issues, I agree - except for the "seemed to be" disclaimer. Replace "seemed to be" with "was." <blockquote>The Institute of Medicine committee does have one dissenter. Dr. <a href="http://news.uchicago.edu/profile/richard-cook">Richard Cook</a> [13] from the University of Chicago feels the FDA is indeed the proper agency to oversee health IT safety. Cook writes that health IT is considered a “Class III medical device,” that is to say, a device that performs integral medical functions, which the FDA already has the jurisdiction to regulate.</blockquote> Dr. Cook is a co-author of the short 2005 paper "<a href="http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf" style="font-weight: bold;">Hiding in plain sight: What Koppel et al. tell us about healthcare IT</a>" which I consider seminal in understanding why health IT as it exists today is so poorly done. <blockquote>In its report, the IOM panel also recommended that another study be done to quantify health IT-related deaths, serious injuries or unsafe conditions so that the safety concerns can be properly addressed. “You can only improve what you measure,” says the report.</blockquote> As I wrote in Oct. 2010, that is <a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">putting the cart before the horse again</a>. We study these issues while a national rollout under threat of penalty is underway? That's simply crazy. <blockquote>Other recommendations in the report: establishing and enforcing criteria for the safety of electronic health records, funding a new Health IT Safety Council to set standards for safety, and requiring all health IT vendors to publicly register and list their products with the Office of the National Coordinator.</blockquote></div></div></div> No issues there, except these efforts should have occurred over a decade ago, at the latest. Finally, while I disagree with the action agenda, I do thank the IOM for bringing the issues of health IT risks out into the sunlight. Perhaps now these issues will start to be addressed, and ultimately patient safety and human rights safeguarded. From the report's introduction: <blockquote>... Caught in the middle are the patients—the ultimate recipients of care. Stories of patient injuries and deaths associated with health information technologies (health IT) frequently appear in the news, juxtaposed with stories of how health professionals are being provided monetary incentives to adopt the very products that may be causing harm. These stories are frightening, but they shed light on a very important problem and a realization that, as a nation, we must do better to keep patients safe ... the entire committee believes the current state of safety of health IT must not be permitted to continue.</blockquote> I've been writing words like that for over a decade. -- SS Addendum Nov. 8, 2011: The IOM has issued this press release: <blockquote><div class="MsoNormal"> From: National Academies News <InternetMailforONPI@nas.edu> Date: November 8, 2011 8:25:43 AM PST To: National Academies News <InternetMailforONPI@nas.edu> Subject: Health Information Technology and Patient Safety - For Immediate Release Health Information Technology and Patient Safety – For Immediate Release</div><div class="MsoNormal"> </div>Health IT and Patient Safety: Building Safer Systems for Better Care, a new report from the Institute of Medicine, is available for IMMEDIATE RELEASE. The report examines a broad range of health information technologies and recommends actions that the government, health care providers, and technology vendors should take to improve patient safety. Contrary to some early news accounts, the report does not recommend that a new agency be established to regulate these technologies. Reporters can obtain a copy of the report by contacting the National Academies' Office of News and Public Information; tel. <a href="http://www.blogger.com/blogger.g?blogID=9551150" value="+12023342138">202-334-2138</a> or e-mail <a href="mailto:news@nas.edu" title="mailto:news@nas.edu">news@nas.edu</a>. In addition, members from the committee that wrote the report will discuss their recommendations and take questions at a one-hour public briefing starting at 10:30 a.m. EST Thursday, Nov. 10, in Room 100 of the National Academies’ Keck Center, 500 Fifth St. N.W., Washington, D.C. Those who cannot attend may participate through a live audio webcast accessible at <a href="http://www.nationalacademies.org/" target="_blank" title="http://www.nationalacademies.org/">http://www.nationalacademies.org</a>. </blockquote> I am not sure why they state "Contrary to some early news accounts, the report does not recommend that a new agency be established to regulate these technologies." From the report prepub, page 6-28 to 6-29: <blockquote> ... To truly improve patient safety, a new approach is needed. The committee believed that the experiences of other industries such as transportation and nuclear energy in creating the NTSB and the NRC were instructive, and concluded that the development of an independent, federal entity was best suited to performing the needed above-described analytic and investigative functions for health IT–related adverse events in a transparent, nonpunitive manner. The committee envisions an entity that would be similar in structure to the NTSB or the NRC, which are both independent federal agencies created by and reporting directly to Congress. Among other responsibilities, these entities conduct investigations, for the purpose of ensuring safety. NTSB is a nonregulatory agency that does not establish fault or liability in the legal sense but investigates incidents. The NRC is a regulatory body that has the ability to issue fines and fees. The committee considered both agencies and concluded the NTSB to be most similar to the needs of health IT–assisted care. An independent, federal entity analogous in form and function to the NTSB is needed. This entity would not have enforcement power and would be nonpunitive. Instead, it would have the authority to conduct investigations and, upon their completion, make recommendations. </blockquote>This recommendation followed: <blockquote style="font-weight: bold;"> ... Recommendation 8: The Secretary of HHS should recommend that Congress establish an independent federal entity for investigating patient safety deaths, serious injuries, or potentially unsafe conditions associated with health IT. This entity should also monitor and analyze data and publicly report results of these activities.</blockquote> Hopefully this issue will we clarified when the final report is generally available and the public briefing occurs. I hope it's not an issue over the word "entity" vs. "agency", a difference that in practice would probably make no difference, economically speaking. Addendum #2, Nov. 8, 2011: After re-reading all of this, it seems the issue at question in the National Academies press release above is "regulation" vs. "investigating and monitoring." That apparently being the case, let me state again that I have problems with the fact that the recommendations seem to preclude true regulation that should start ASAP, not at the whim of the Secretary of HHS when he/she decides that "adequate safety progress has not been made." That represents, in my opinion, a special accommodation to the healthcare IT industry as previously mentioned. In fact, Dr. Cook had a dissenting recommendation in Appendix E of the report that I agree with: <blockquote> Recommendation 9: The Secretary of Health and Human Services should direct the FDA to exercise its authority to regulate health IT, including all EHRs and associated components, and health information exchanges, as Class III medical devices. [Under the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act - ed.]</blockquote> -- SS [Note] Regarding the IOM, my presenting in person the events that led to my relative's travails was rejected on the basis of 'protocol.' Despite the remarkable aspect of a physician/Medical Informatics specialist's relative (in fact, a specialist writing on health IT risks for over a decade) being gravely injured as a result of health IT-related disruption of care continuity, despite support for my personal attestation by internal members of the study group, my live testimony was rejected. Considering the issues were not just relevant to the IOM study, but at its heart, the rejection on procedural grounds brings to mind the <a href="http://en.wikipedia.org/wiki/Three_wise_monkeys">simian adage</a> "see no evil, hear no evil, speak no evil." The Institute of Medicine, on matters of life and death, acted more as an "Institute of Protocol" (or perhaps "Institute of Politics") in my opinion than an institute of science. I believe this lessens the credibility of their action agenda.

IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care" - Nix the FDA; Create a New Toothless Agency

[Authors' note: This major part of this post was written before I had the actual IOM report itself. Having now read that report, avail...

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Lifespan (Rhode Island): Yet another health IT "glitch" affecting thousands - that, of course, caused no patient harm that they know of - yet

There's been yet another health IT "glitch" that, of course, caused no patients to be harmed. See other "glitches" <a href="http://hcrenewal.blogspot.com/2011/05/twelve-hour-health-it-glitch-at.html" style="font-weight: bold;">here</a>, <a href="http://hcrenewal.blogspot.com/2011/01/orderless-in-seattle-software-glitch.html" style="font-weight: bold;">here</a>, <a href="http://hcrenewal.blogspot.com/2010/03/will-it-take-luminosity-of-dozen.html" style="font-weight: bold;">here</a> and at other posts which can be found by searching this blog on the banal term 'glitch'. I note that when a clinician makes a mistake, it's called "malpractice." When health IT causes errors that can injure or kill, it's commonly referred with the banal, now-standard euphemism for computing malpractice: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjivTnAMIjZskLX87kQCR-LOWelEzDEUzupVGbOaKKCNKfoQe3kVzfxxERhVQOn9TIenOfKan-gR82Ogh9aqBulFgBlwHxLj2qCFmPiVm2j7sRFcyZRcO8vEFZfhsbqSGkn4802s3h9mfDF/s1600/glitch-mmo.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5671179020595590226" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjivTnAMIjZskLX87kQCR-LOWelEzDEUzupVGbOaKKCNKfoQe3kVzfxxERhVQOn9TIenOfKan-gR82Ogh9aqBulFgBlwHxLj2qCFmPiVm2j7sRFcyZRcO8vEFZfhsbqSGkn4802s3h9mfDF/s320/glitch-mmo.jpg" style="cursor: pointer; display: block; height: 90px; margin: 0px auto 10px; text-align: center; width: 180px;" /></a></div> Presenting the latest healthcare IT "glitch", affecting thousands: <blockquote><a href="http://www.wpri.com/dpp/news/local_news/providence/providence-rhode-island-state-senator-jamie-daniels-calls-for-review-of-lifespan-after-medical-errors">Computer glitch led patients to receive wrong meds</a> Senator calls for review of Lifespan WPRI.com (Providence, RI) Updated: Thursday, 03 Nov 2011, 5:47 AM EDT Published : Wednesday, 02 Nov 2011, 11:56 PM EDT Reported by Steve Nielsen PROVIDENCE, R.I. (WPRI) - Rhode Island State Senator Jamie Doyle says he is shocked to hear a <a href="http://www.lifespan.org/">Lifespan</a> computer glitch caused thousands of patients to receive the wrong types of medication. [Appx. 2,000 across five Lifespan hospitals according to the Providence Journal, see below, and the <a href="http://www.washingtonpost.com/business/ri-senator-wants-investigation-after-up-to-2000-hospital-patients-got-wrong-form-of-medicine/2011/11/03/gIQAufcviM_story.html">WaPo</a> - ed.] Doyle is now calling for an independent review of all the hospitals Lifespan runs, and a review of the Rhode Island Department of Health. The DOH is investigating after learning patients who were supposed to receive medications taken once a day instead received medications meant to be taken more than once per day.</blockquote> Health IT, of course, is unregulated by FDA or anyone, and vetted for safety only so far as the seller wishes to spend money on such tasks - which cuts their margins.  Ultimately, debugging is on live patients. <blockquote>[11/5/2011 note: As an anonymous commenter pointed out, the 2,000 or so errors at Lifespan should probably be multiplied by the number of organizations using the same software ---> "The entire country may have suffered 25,000-50,000 errors from this one glitch alone", the commenter astutely notes - ed.]</blockquote> Of course, the customary "we did feel lucky today, and the gun was empty" disclaimer follows: <blockquote>"Lifespan has not reported any adverse events or situations where patients required additional medications, but the information gathering and investigation is still ongoing," said DOH spokeswoman Annemarie Beardsworth.</blockquote> In other words, there could have been adverse events, we just at the Dept. of Health don't know yet with certainty, because none have been reported yet. <blockquote>In addition, some patients who were meant to get a medication with a coating did not receive a coating. The coating can help with stomach pains of other problems. "I just don't feel comfortable right now with some of the things that are coming out of there," Doyle said, "I really don't want to point fingers in any direction. but what we need to do is we need answers." Senator Doyle wants to have the review started in the next two to three weeks. </blockquote> Mr. Doyle, see my academic site on HIT failures <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">here</a> and an account of repercussions <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary">here</a> from an EHR-related medication error. <blockquote> Lifespan released the following statement Wednesday: "Lifespan is actively contacting 2,000 patients affected by this issue to ensure they receive the correct form of their medications. So far, we have reached out to more than 90 percent of the patients, many of whom were already taking the correct medication." Lifespan expects to finish contacting patients by Thursday.</blockquote> It will be interesting to understand the nature of this particular "glitch" and who the software vendor is. All it takes is a single "glitch" to seriously reduce a patient's lifespan. Siemens software may be involved. See this mutually self promoting, marketing-style Siemens document "<a href="http://www.medical.siemens.com/siemens/en_US/gg_hs_FBAs/files/IT_Solutions_And_Consulting/New_2009/09-06-25_NewportHospita_CaseStudy_A9133-9564-C1-4A00.pdf">Newport Hospital - a Lifespan Partner - At the Forefront of EMR Adoption</a>" (PDF), also cached <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/NewportHospital_CaseStudy.pdf">here</a>. (As an aside, one wonders if the hospital and/or its leadership received special financial or other "incentives" in allowing their name to be used in corporate promotions.) Also, Siemens was a company that apparently did not listen to an internal informatics specialist physician's concerns that their health IT for critical care was endangering patients (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit">link</a>). They terminated the whistleblower. Also see my Aug. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/08/why-siemens-healthcare-fails.html">Why Siemens Healthcare Fails"</a> which I had emailed at the time to the Siemens Healthcare CEO Hermann Requardt. -- SS Nov. 4, 2011 addendum: Felice Fryer of the Providence Journal sent me a link to the story of Nov. 3, 2011 she wrote with a few more details, <a href="http://digital.olivesoftware.com/Olive/ODE/ProJo/LandingPage/LandingPage.aspx?href=VFBKLzIwMTEvMTEvMDM.&pageno=MQ..&entity=QXIwMDEwNA..&view=ZW50aXR5">here</a>. Excerpts: <div class="InfoComponentTextHedLine_hl1"></div><blockquote><div class="InfoComponentTextHedLine_hl1">Flaw found in hospitals’ prescriptions </div><div class="InfoComponentTextHedLine_hl2">Some patients discharged from Lifespan hospitals got right drugs in wrong form due to software error </div> <div class="InfoComponentTextByline">By FELICE J. FREYER JOURNAL MEDICAL WRITER </div> Some 2,000 patients of the Lifespan hospital group were discharged with incorrect prescriptions over the past 9 to 15 months because of a software glitch. [It took a year or more to discover these mounting errors? This is beyond the "red flag" warning signs I used to write about. This is crossing the chasm into the territory of "asking for catastrophe" - ed.] The prescriptions listed the right medications, but in the wrong form: people who were supposed to get time-release pills received prescriptions for short-acting ones. The error affected dozens of generic medications for a variety of conditions. Lifespan discovered the problem on Oct. 25 and had fixed the software by Friday, according to Dr. Mary Reich Cooper, Lifespan’s senior vice president and chief quality officer. The hospitals have placed calls to nearly all the affected patients, although not all have called back, Cooper said. Most patients reached had already obtained the correct medication because the error was noticed by someone at the hospital, or a pharmacist or doctor outside, she said. So far, Cooper said, there is no evidence that anyone was harmed. But Dr. Michael D. Fine, state Health Department director, said that the incident is an example of how electronic medical records, which normally help reduce errors, can sometimes amplify them by quickly affecting large numbers of people. “It’s the flip side of what has otherwise been a process that has improved accuracy and reliability,” he said. [I don't notice mention of a "flip side" to health IT in the aforementioned glossy hospital/IT company marketing brochure - ed.] The Health Department is investigating the incident. Fine also plans to examine whether the department should regulate the safety of electronic systems in health care. [Readers of this blog know my opinion on that matter - ed.] Asked whether he was worried there may be other as-yet-unrecognized software glitches, Fine said, “I’m reasonably concerned about the accuracy and integrity of electronic medical records.”... The software in question is not in use at other hospitals in Rhode Island, and the software vendor, Siemens, is notifying hospitals elsewhere in the country, according to Cooper. [In the interests of public health, I believe it incumbent on Siemens to make this "glitch" widely known not just to the hospitals but to the public in areas served by those hospitals, especially with the admission that "the (RI) hospitals have placed calls to nearly all the affected patients, although not all have called back." To not do so reflects negligence in my opinion - ed.] ... The errors arose from the process known as “medication reconciliation,” in which the physician compares the medications a patient was taking before hospitalization with those prescribed during hospitalization, and ensures that the patient goes home with a correct set of prescriptions. The Lifespan hospitals recently adopted an electronic system for this process. Doctors were correctly prescribing medication, and the prescriptions looked right on the computer screen, Cooper explained. But when printing out the prescription list, the software was cutting off a two-letter abbreviation that indicated certain medications should be in long-acting form or coated to protect the stomach. [As at Case 9 from FDA's MAUDE database at the post "<a href="http://hcrenewal.blogspot.com/2009/10/out-policy-is-to-always-have-unabashed.html">Our Policy Is To Always Have Unabashed Faith In The Computer</a>". Do these vendors robustly validate their products? The current errors, in fact, were only peripherally related to medication reconciliation. They were primarily related to computer errors impairing (sabotaging?) the clinicians. It would seem med recon now needs to include comparing what the doctor enters to what is output to the nurses and other healthcare personnel who provide written instructions to patients. Is such a task performable by healthcare personnel when the computer cannot be trusted? Further, do the doctrine of the "learned intermediary" and "hold vendor harmless" clauses seem appropriate here? - ed.] ... Cooper said the risk of harm from taking a short-acting medication instead of a long-acting one was “very, very minimal.” [Cooper misses the point, and IMHO such nihilistic attitudes have no place in healthcare - ed.] But Fine, the health director, said such mistakes “can be scary.” People taking medication for angina or high blood pressure would find their medication wearing off over the course of the day, putting them at risk of heart attack or stroke, he said. </blockquote> Medical errors that might seem innocuous or minor to health IT amateurs can prove catastrophic.  I've seen it happen, leading to injury and death. -- SS

Lifespan (Rhode Island): Yet another health IT "glitch" affecting thousands - that, of course, caused no patient harm that they know of - yet

There's been yet another health IT "glitch" that, of course, caused no patients to be harmed. See other "glitches"...

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