WHO YOU GONNA BELIEVE?
Ghostwriting Charges and Stonewalling at the American Psychiatric Association
The American Psychiatric Association came under a searchlight this past December over allegations of ghostwriting. The story originated with a public letter from Project on Government Oversight (POGO) to the Director of NIH, and it was picked up by Duff Wilson writing in the New York Times. The book was Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care. The named authors were Charles Nemeroff, now chairman of psychiatry at the University of Miami, and Alan Schatzberg, formerly chairman of psychiatry at Stanford University. Both are well known for ethical controversy – see here and here. Soon, these allegations were being dissected in the blogosphere, with stellar contributions from Daniel Carlat, 1boringoldman, Ed Silverman, and Alison Bass.
The APA and its publishing arm, known as American Psychiatric Press, Inc. or APPI, came to the defense of the two prominent academic authors over the ghostwriting charge. In particular, an APA employee named Mark Moran authored a denial of the charge in the January 2011 issue of the APA news magazine, Psychiatric News. As the controversy played out, letters from attorneys demanded retractions, and partial qualifications of the original story appeared in the New York Times and on the POGO weblog. There was never any doubt that the heavy lifting was done by a pair of professional writers employed by a medical communications company under a financial grant from a drug company. Nemeroff defended his role by averring that he ‘scrutinized’ the work product of the professional writers. Threatening letters from lawyers for Nemeroff and Schatzberg were publicized, and the APA weighed in.
The coup de grâce was administered by blogger Daniel Carlat’s withering review of the book’s artful construction to highlight the use of the sponsoring company’s antidepressant and anti-anxiety drug in primary care, while muting important information about the drug’s liabilities. Nevertheless, the APA held to its legalistic stance in defense of the ‘authors.’ This behavior is counterproductive for professional medical organizations, as I have discussed before, because it misses the ethical forest for the legal trees.
Now comes the good part. In response to the piece by Mark Moran in Psychiatric News, Leemon McHenry prevailed on Robert Rubin and myself to write with him to the magazine’s editors. Leemon is a faculty member in the Department of Philosophy at California State University, Northridge. He also has experience evaluating legal documents arising in litigation over antidepressant drugs. Robert Rubin has partnered with me in outing several notable ethics compromises involving Nemeroff and Schatzberg, going back as far as 2002, though we always call ourselves equal opportunity critics.
Our letter sent in late January to Dr. Carolyn Robinowitz, the Interim Editor of Psychiatric News, has been posted today on the POGO site. In our letter, we challenged much of Mr. Moran’s defense, and we called attention to what WASN’T in the public domain, despite all the claims and counterclaims. Essentially, the partial qualifications of the original reports that appeared in The New York Times and in the letter to NIH from POGO resulted from the inconclusiveness of some of the documents. We called on the APA to come clean with the release of all relevant materials, in the interest of transparency.
For instance, what WASN’T known were the specifics of the contract involving the corporation, the (ahem) authors, the publisher (APPI), and the medical communications company. Or the money flow to the ‘authors’ from the contract in addition to their royalties. Or the legal release form transferring ownership of the work product to the ‘authors’ and APPI. Or the corporation’s planned marketing activities, given that the corporation ordered 10,000 copies of the book. Or the correspondence among all parties that might reveal who actually did what.
Leemon McHenry’s perspective is that this hidden layer of documents may well be available if they could be unsealed in pending litigation. Naturally, corporations and their attorneys strive to keep the information hidden. But our general point is that the APA has a different duty – which is to transparency rather than to stonewalling. Did the APA do that? Sadly, no, they did not. Here is the curt reply from the Executive Editor Catherine Brown denying publication of our letter after a delay of almost 8 weeks. Now that’s what I call stonewalling.
Senin, 04 April 2011
Minggu, 03 April 2011
Medicare/Medicaid Cuts? Spend Money on Patients - Not Computer Experiments
There has recently been much debate about how to save this country from European-style financial ruin. From "GOP 2012 budget proposal cuts taxes on rich, cuts Medicare in the future", Examiner.com, April 3, 2011:
I propose the cuts to Medicare and Medicaid, which will directly affect medical care delivery to the elderly and poor, be traded for cutting extravagant expenditures for experimental medical computer technology. This could be accomplished through repeal of HITECH and diversion of those funds to patient care, where it's more urgently needed.
Let scarce taxpayer dollars be spent on the health of human beings, not on machines of uncertain value and risk at their current state of evolution in 2011.
At my Jan. 2011 post "US House of Representatives Proposes to Defund Largest Non-Consented Medical Experiment in U.S. History: HITECH" I had written about H.R.408, the Spending Reduction Act of 2011 Introduced in the House of Representatives:
I commented that it looked like HITECH was one of a number of spending extravaganzas on the proposed chopping block.
Health IT under the country's current financial condition is indeed an extravagance, especially considering the experimental nature of the technology and the doubts expressed by experts as to its true value in its current state of development (see "An Updated Reading List on Health IT" at my Drexel Univ. Healthcare IT failures site).
This recent revelation should also be considered:
The quality of the technology is likely far, far worse than anyone, including the pessimists, imagined. The HIT problem reports in FDA's MAUDE database (link) are child's play compared to the following.
The unprecedented, recent, detailed analysis of a major American electronic health record system for use in Emergency Departments (of all places) by an Australian health IT expert at the following links is simply astonishing, if not downright frightening. See:
If even a fraction of this analysis is correct, we should simply take those billions of dollars and turn them into cigar wrappers.
Or perhaps coffins.
I will also repeat some of my rationale in my Jan. 2011 post for repeal of HITECH:
To these I will add a few more reasons to convert HITECH extravagance in time of financial distress and high unemployment to direct care provision:
Despite the fact that the Director of FDA's Center for Device and Radiological Health Jeffrey Shuren (a physician and lawyer) testified these reports were likely just the "tip of the iceberg", ONC director Blumenthal glibly stated, per the Aug. 2010 Huffington Post Investigative Fund article FDA, Obama Digital Medical Records Team at Odds over Safety Oversight, that FDA's reports of health IT related injuries and deaths were “anecdotal":
More reasons for diverting HITECH funds to patient care include government waste driven by irrational exuberance and idealism:
Finally, here's another reason to withdraw HITECH for now:
I reiterate from my January 2011 post:
I would not weep for the HITECH act's passing. It would allow the restoration of health IT back to an unrushed and careful experiment.
It would also give time to work out the significant issues causing health IT difficulty (such as raised in 2009 by our National Research Council) before we embark on national health IT diffusion.
In other words, its passing would reduce risk and help restore an essential level of sanity and due diligence to the healthcare IT sector, now afflicted by irrational exuberance bordering on delirium.
We would avoid the largest unconsented medical experiment in US history, which as I have repeatedly written I feel would be disastrous with current levels of understanding of this technology and how to design, deploy and manage it. (My mother's May 2010 HIT-related injuries only strengthened my convictions in this regard.)
Disclosure: I have no financial conflicts of interest regarding HITECH or health IT to weep about. Others do, and it's not hard to predict their financial interests will push them to oppose HITECH repeal "by any means necessary."
A replacement HITECH act that's "HIGH" on research and caution, but not so high on stealth, coercion and idealistic euphoria would be welcomed.
-- SS
On Tuesday House Budget Committee Chairman Paul Ryan (R-WI) is expected to release the Republicans’ 2012 budget proposal. Currently Democratic and Republican leaders are trying to negotiate a compromise on the 2011 budget would make some cuts to discretionary spending. Republicans have said they would not be able to propose really significant cuts to lower the deficit until 2012. According to reports, the GOP proposal would dramatically cut taxes on corporations and the rich, while also making significant cuts to Medicare and Medicaid.
I propose the cuts to Medicare and Medicaid, which will directly affect medical care delivery to the elderly and poor, be traded for cutting extravagant expenditures for experimental medical computer technology. This could be accomplished through repeal of HITECH and diversion of those funds to patient care, where it's more urgently needed.
Let scarce taxpayer dollars be spent on the health of human beings, not on machines of uncertain value and risk at their current state of evolution in 2011.
At my Jan. 2011 post "US House of Representatives Proposes to Defund Largest Non-Consented Medical Experiment in U.S. History: HITECH" I had written about H.R.408, the Spending Reduction Act of 2011 Introduced in the House of Representatives:
In a new bill in the House of Representatives, the ‘‘Spending Reduction Act of 2011’’ (link - PDF), it is proposed to cut unobligated funds of, among others, division A of the "American Recovery and Reinvestment Act of 2009":
... Spending Reduction Act of 2011
DIVISION A—APPROPRIATIONS PROVISIONS
... TITLE XIII—HEALTH INFORMATION TECHNOLOGY
Title XIII of the ARRA along with title IV of division B is better known as HITECH:SEC. 13001. SHORT TITLE; TABLE OF CONTENTS OF TITLE.
(a) SHORT TITLE.—This title (and title IV of division B) may be cited as the ‘‘Health Information Technology for Economic and Clinical Health Act’’ or the ‘‘HITECH Act’’.
I commented that it looked like HITECH was one of a number of spending extravaganzas on the proposed chopping block.
Health IT under the country's current financial condition is indeed an extravagance, especially considering the experimental nature of the technology and the doubts expressed by experts as to its true value in its current state of development (see "An Updated Reading List on Health IT" at my Drexel Univ. Healthcare IT failures site).
This recent revelation should also be considered:
The quality of the technology is likely far, far worse than anyone, including the pessimists, imagined. The HIT problem reports in FDA's MAUDE database (link) are child's play compared to the following.
The unprecedented, recent, detailed analysis of a major American electronic health record system for use in Emergency Departments (of all places) by an Australian health IT expert at the following links is simply astonishing, if not downright frightening. See:
- Analysis of Cerner Problems Defined by ED Directors, http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=120&Itemid=116
- A study of an Enterprise Health information System, http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146
If even a fraction of this analysis is correct, we should simply take those billions of dollars and turn them into cigar wrappers.
Or perhaps coffins.
I will also repeat some of my rationale in my Jan. 2011 post for repeal of HITECH:
- This country cannot afford HITECH at this time. Put simply, we are broke, and the national deficit is ballooning far out of control. The money would be far better spent at this time on care of those who cannot afford that care.
- HITECH appeared as if out of nowhere, with little to no input time from stakeholders. This suggests lobbying by those with conflicts of interest to push this bill onto the public, affecting their medical care without informed consent (see my March 2009 post "Draft Patient Rights Statement and Informed Consent on Use of HIT"). The bill includes persuasion along with economic coercion for non-adopting organizations and physicians. ("Adoption" = adherence to government-set standards of "meaningful use" of poorly usable technology.) I disapprove of the stealth process by which HITECH appeared. This is the U.S., not the old USSR.
- Mass social experiments involving major systemic changes to our healthcare delivery system, with exceptional claims being made about IT, need to be backed by exceptional evidence. That evidence is lacking. In fact, the evidence might actually point in the negative direction. See my aforementioned post "An Updated Reading List on Health IT."
- The technology is not ready. It is dangerous in unqualified hands, which most every medical center and physician office is in 2011 (i.e., an IT backwater). The field of health IT was somehow transformed from an experimental field into the 'savior of medicine' without the proof of value and safety that would ordinarily be required to move an experimental technology from lab to national rollout. Per the Washington Post, this process appears to have been a highly politicized one, favoring the corporate elites. The Washington Post’s 2009 article on the influential HIT vendor lobby “The Machinery Behind Healthcare Reform” is at this link.
To these I will add a few more reasons to convert HITECH extravagance in time of financial distress and high unemployment to direct care provision:
- A similar experiment in the much smaller and strongly government-managed healthcare system of the UK didn't exactly have stellar results (link, link). We also have been warned not to make the same multi-billion dollar errors (link).
- The cavalier attitudes by the administration-appointed ONC director Blumenthal towards evidence of health IT-caused adverse effects, including deaths, reported to him by the FDA (see this Feb. 23, 2010 Internal FDA Memorandum on Health IT Safety Issues, PDF).
Despite the fact that the Director of FDA's Center for Device and Radiological Health Jeffrey Shuren (a physician and lawyer) testified these reports were likely just the "tip of the iceberg", ONC director Blumenthal glibly stated, per the Aug. 2010 Huffington Post Investigative Fund article FDA, Obama Digital Medical Records Team at Odds over Safety Oversight, that FDA's reports of health IT related injuries and deaths were “anecdotal":
ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” He told the Investigative Fund that he believed nothing in the report indicated a need for regulation.These exact cavalier attitudes about "anecdotes" just failed in the Supreme Court. (See my Mar. 27, 2011 post about the Zicam decision in "Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style").
More reasons for diverting HITECH funds to patient care include government waste driven by irrational exuberance and idealism:
- The irrational exuberance and idealism about this technology purportedly saving money, a dreamer's dream explicitly refuted, for example, by notable figures at Wharton (link) and Stanford (link). (Also see "Pessimism, Computer Failure, and Information Systems Development in the Public Sector", Shaun Goldfinch, Public Administration Review 67;5:917-929, Sept/Oct. 2007).
- More on purported cost savings - Peter Orszag, former head of the Congressional Budget Office, said the use of electronic health records, without a major change in health care delivery, "would not significantly reduce overall health care costs" in the agency's 2007 report on long-term health care spending. He also said that according to data from the report, the return on investment for EHR's "is not going to be as substantial as people think." The CBO concluded that predictions of cost savings from EHR's relied on "overly optimistic" assumptions and said much is unknown about the potential impact of health information technology. [That is, it is an experimental technology - ed.] Mass savings from health IT is an assertion that is both unproven and highly unlikely in my view.
- Yet another irrationally exuberant dream about the use of the massive amounts of uncontrolled clinical data, entered by myriad observers in an infinite variety of situations into these systems, to be used for research. This is the antithesis of sound methods for data collection and management in medical research. It is a dreamer's concept of the "Randomized Controlled Clinical Trial Made Easy." (See my essay "The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry." Also see "Have we suffered a complete breakdown in the scientific method with regard to EHR and clinical IT?".)
Finally, here's another reason to withdraw HITECH for now:
- As I'd written in a series of essays at this blog query link, we simply don't know how to make computerized medical information reasonably private and secure. (One might wonder whether the current administration, sponsors of the out-of-the-blue HITECH act, actually wants healthcare information to be private and secure.)
I reiterate from my January 2011 post:
I would not weep for the HITECH act's passing. It would allow the restoration of health IT back to an unrushed and careful experiment.
It would also give time to work out the significant issues causing health IT difficulty (such as raised in 2009 by our National Research Council) before we embark on national health IT diffusion.
In other words, its passing would reduce risk and help restore an essential level of sanity and due diligence to the healthcare IT sector, now afflicted by irrational exuberance bordering on delirium.
We would avoid the largest unconsented medical experiment in US history, which as I have repeatedly written I feel would be disastrous with current levels of understanding of this technology and how to design, deploy and manage it. (My mother's May 2010 HIT-related injuries only strengthened my convictions in this regard.)
Disclosure: I have no financial conflicts of interest regarding HITECH or health IT to weep about. Others do, and it's not hard to predict their financial interests will push them to oppose HITECH repeal "by any means necessary."
A replacement HITECH act that's "HIGH" on research and caution, but not so high on stealth, coercion and idealistic euphoria would be welcomed.
-- SS
With this device in your chest, an Elvis suit for the doc?
The April 3, 2011 NY Times has a nice piece about pacemakers and AICDs from a little-known and low market share German device manufacturer, Biotronik. Apparently this company's pacemakers have pretty much cornered the market among cardiologists at University Medical Center in Las Vegas.
(By the way, the Times has gone to a pay-wall, so the above link to it can't be counted on to work for too long after this posting comes out. Try a search engine. There's no permalink as one used to use to make sure the link stayed put.)
In any case, how fitting it all seems in anything-goes Nevada. According to the article the Feds may or may not be going after this egregious example of conflict of interest. Let's hope they are. But at least we can make sure that what plays in Vegas doesn't stay in Vegas.
Apparently some of the cardiologists at UMC are (or were) pulling down up to 5k a month in consulting fees. That may or may not have anything to do with the fact that the small German device-maker went from having, oh, zero 2-3 years ago to 95% of all devices implanted there last year, by total number of patients.
Good work, gentlemen. Let the word go out. Come to America and roll the dice in Las Vegas. It's almost enough to make me want to become a brimstone-spouting right wing pastor. "To gamble, it's of the devil."
But this is a place where the state's new governor is a former chair of the gaming commission.
Of course, the real culprit here is, collectively, those cardiologists and the middle-man distributors who court them. According to the article, the cardiologists who didn't enroll their patients (and presumably take dough) were on what the sales guys called the "loser" list.
Yes, "winning" in health care is about market share and effective sales. No surprise here. We knew that already, of course, from Wendell Potter's Deadly Spin, with which most readers of this blog are no doubt already familiar.
It sure as hell isn't about the patient winning. But last time I checked, professionalism and the Hippocratic Oath have something to say about the patient being the one who's supposed to win.
One understands that these gotta-make-a-buck middle-men, and the device vendor-manufacturers, are interested in the almighty share. Birds gotta fly, fish gotta swim. But the doctors--a sad commentary indeed if, as this articles says, "[they] then did the rest."
In this same vein, loss of meaning, clearly the word "university" in hospitals' names has ceased to have much real meaning. The article says the hospital CEO never bothered to ask the docs whether they had a conflict of interest.
Alas, too often that's equally true across the rest of the country. "University" centers behave just like proprietary players, as anyone reading this blog can't have failed to notice.
Maybe just a wee bit more glaring in Vegas, though, where guys in Elvis suits fall out of the sky and pay-to-play pacemakers fall into patients' chests.
Sabtu, 02 April 2011
Making a Stat Less Significant: Common Sense on "Side Effects" Lacking in Healthcare IT Sector
At my Mar. 27, 2011 post "Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style" I wrote that the SCOTUS decided in MATRIXX INITIATIVES, INC., ET AL. v. SIRACUSANO ET AL. (link to PDF) that:
Wall Street Journal author and "Numbers Guy" Carl Bialik adds to that point in an article today "Making a Stat Less Significant" where he writes:
In other words, when one is not sure that every incident of a side effect is being reported, one should not cavalierly dismiss "anecdotal" reports of side effects, especially from reliable reporters.
The practictioners of Medical Informatics, along with the HIT Industry and its customers, appear to have failed in that regard with respect to clinical IT (electronic medical records, CPOE etc.) For years they have argued that these medical devices should not be regulated because that would "stifle innovation" and that reports of device adverse events were "anecdotal." Many in the field still make these arguments.
This view extends all the way up to the Director of the Office of the National Coordinator for Health IT, who glibly stated per the Aug. 2010 Huffington Post Investigative Fund article FDA, Obama Digital Medical Records Team at Odds over Safety Oversight that FDA's own reports of health IT related injuries and deaths were “anecdotal":
Those "injury findings" appear in an FDA Internal Memo made available by the aforementioned Huffington Post Investigative Fund and archived at the following link:
That memorandum itself emphasizes how FDA's own knowledge of these events is partial due to reporting impediments and lack of knowledge of resources such as FDA's MAUDE database.
The known reports were likely "the tip of the iceberg" according to the Director of FDA’s Center for Devices and Radiological Health (CDRH) Jeffrey Shuren, MD, who also happens to be a lawyer.
As at the aforementioned "tip of the iceberg" link, at an HHS meeting of the HIT Policy Committee's Adoption/Certification Workgroup on February 25, 2010, Shuren testified:
The problem with ignoring testimony and reports of health IT-related difficulties and dismissing them as "anecdotal" goes back to the issue of "knowing that every incidence of that side effect is being reported."
While FDA itself admits significant doubt about completeness of reporting in its memo, what's worse is that Koppel and Kreda at University of Pennsylvania wrote a paper from which one might conclude that the healthcare and health IT industries are themselves aligned to conceal health IT adverse events reports.
In their remarkable article Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Journal of the American Medical Association, 2009;301(12):1276-1278, we learn that there is little motivation for device safety in the health IT industry:
We additionally learn that:
I think any reasonable person would conclude there is great doubt as to whether "every incidence of [HIT side effects] is being reported."
I also pointed out in JAMA (link) and on my Drexel website (link) how agreeing to these terms caused hospital executives to violate both their fiduciary duties to their organization's workers as well as Joint Commission safety standards obligations.
(I've personally reported health IT defects I'd observed in hospitals where my relatives were patients to FDA's MAUDE database, discovering that the institution itself, whose officials I alerted to the problems, did not. An example is here.)
The above is all common sense.
Thus, the dismissal of reports of health IT-related patient injury, deaths, and "near misses" represents a failure of common sense, as well as a massive abrogation of fiduciary responsibilities and legal and ethical obligations among the Medical Informatics, health IT vendor, healthcare delivery, and healthcare regulatory sectors.
One end result is that it permits software like this to be mandated by state governments on hundreds of hospitals. One can only imagine the public, press and legal reactions if mission-critical software issues of this magnitude were brought forth after an aviation or nuclear power plant disaster.
The cavalier dismissals of HIT mishap reports clearly fall into the "knew, or should have known" category of negligence.
Plaintiff attorneys for patients injured or killed via HIT-related mishaps should take note.
-- SS
Note: my WSJ comment on this issue appears here.
... We conclude that the materiality of adverse event reports cannot be reduced to a bright-line rule ... Because adverse reports can take many forms, assessing their materiality is a fact-specific inquiry, requiring consideration of their source, content, and context.
Wall Street Journal author and "Numbers Guy" Carl Bialik adds to that point in an article today "Making a Stat Less Significant" where he writes:
To determine whether a medical side effect is significant in an experiment requires knowing that every incidence of that side effect is being reported. Researchers can feel confident that is happening in a controlled clinical trial of a drug, but they can't be sure when a drug is being sold to the general public, as was the case with Zicam.
In other words, when one is not sure that every incident of a side effect is being reported, one should not cavalierly dismiss "anecdotal" reports of side effects, especially from reliable reporters.
The practictioners of Medical Informatics, along with the HIT Industry and its customers, appear to have failed in that regard with respect to clinical IT (electronic medical records, CPOE etc.) For years they have argued that these medical devices should not be regulated because that would "stifle innovation" and that reports of device adverse events were "anecdotal." Many in the field still make these arguments.
This view extends all the way up to the Director of the Office of the National Coordinator for Health IT, who glibly stated per the Aug. 2010 Huffington Post Investigative Fund article FDA, Obama Digital Medical Records Team at Odds over Safety Oversight that FDA's own reports of health IT related injuries and deaths were “anecdotal":
ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” He told the Investigative Fund that he believed nothing in the report indicated a need for regulation.
Those "injury findings" appear in an FDA Internal Memo made available by the aforementioned Huffington Post Investigative Fund and archived at the following link:
Internal FDA memorandum on HIT risks (PDF) to Jeffrey Shuren MD JD (Director, Center for Devices and Radiological Health). Health Information Technology (H-IT) Safety Issues. "This is an Internal Document Not Intended for Public Use." Feb. 23, 2010.
(My description/summary of the memorandum is at my Aug. 2010 post "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun?")
That memorandum itself emphasizes how FDA's own knowledge of these events is partial due to reporting impediments and lack of knowledge of resources such as FDA's MAUDE database.
The known reports were likely "the tip of the iceberg" according to the Director of FDA’s Center for Devices and Radiological Health (CDRH) Jeffrey Shuren, MD, who also happens to be a lawyer.
As at the aforementioned "tip of the iceberg" link, at an HHS meeting of the HIT Policy Committee's Adoption/Certification Workgroup on February 25, 2010, Shuren testified:
... In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.
Even within this limited sample, several serious safety concerns have come to light. The reported adverse events have largely fallen into four major categories: (1) errors of commission, such as accessing the wrong patient’s record or overwriting one patient’s information with another’s; (2) errors of omission or transmission, such as the loss or corruption of vital patient data; (3) errors in data analysis, including medication dosing errors of several orders of magnitude; and (4) incompatibility between multi-vendor software applications and systems, which can lead to any of the above.
The problem with ignoring testimony and reports of health IT-related difficulties and dismissing them as "anecdotal" goes back to the issue of "knowing that every incidence of that side effect is being reported."
While FDA itself admits significant doubt about completeness of reporting in its memo, what's worse is that Koppel and Kreda at University of Pennsylvania wrote a paper from which one might conclude that the healthcare and health IT industries are themselves aligned to conceal health IT adverse events reports.
In their remarkable article Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Journal of the American Medical Association, 2009;301(12):1276-1278, we learn that there is little motivation for device safety in the health IT industry:
Healthcare information technology (HIT) vendors enjoy a contractual and legal structure that renders them virtually liability-free—“held harmless” is the term-of-art—even when their proprietary products may be implicated in adverse events involving patients. This contractual and legal device shifts liability and remedial burdens to physicians, nurses, hospitals, and clinics, even when these HIT users are strictly following vendor instructions...HIT vendors are not responsible for errors their systems introduce in patient treatment because physicians, nurses, pharmacists, and healthcare technicians should be able to identify—and correct—any errors generated by software faults.
We additionally learn that:
The significant disparity between buyers and sellers in knowledge and resources [about healthcare IT problems] is profound and consequential. Vendors retain company confidential knowledge about designs, faults, software-operations, and glitches. Their counsel have crafted contractual terms that absolve them of liability and other punitive strictures while compelling users’ non-disclosure of their systems’ problematic, or even disastrous, software faults.In other words, health IT customers and users have a gag order imposed on them regarding software faults and defects.
I think any reasonable person would conclude there is great doubt as to whether "every incidence of [HIT side effects] is being reported."
I also pointed out in JAMA (link) and on my Drexel website (link) how agreeing to these terms caused hospital executives to violate both their fiduciary duties to their organization's workers as well as Joint Commission safety standards obligations.
(I've personally reported health IT defects I'd observed in hospitals where my relatives were patients to FDA's MAUDE database, discovering that the institution itself, whose officials I alerted to the problems, did not. An example is here.)
The above is all common sense.
Thus, the dismissal of reports of health IT-related patient injury, deaths, and "near misses" represents a failure of common sense, as well as a massive abrogation of fiduciary responsibilities and legal and ethical obligations among the Medical Informatics, health IT vendor, healthcare delivery, and healthcare regulatory sectors.
One end result is that it permits software like this to be mandated by state governments on hundreds of hospitals. One can only imagine the public, press and legal reactions if mission-critical software issues of this magnitude were brought forth after an aviation or nuclear power plant disaster.
The cavalier dismissals of HIT mishap reports clearly fall into the "knew, or should have known" category of negligence.
Plaintiff attorneys for patients injured or killed via HIT-related mishaps should take note.
-- SS
Note: my WSJ comment on this issue appears here.
Jumat, 01 April 2011
Logical Fallacies in Support of Payments for Board Members of Non-Profit Health Insurers
The kerfuffle over the huge golden parachute given the departing CEO of an ostensibly non-profit Massachusetts health insurer/ managed care organization continues to evolve (see posts here and here), providing some new insight into governance problems afflicting health care organizations.
One of the issues that aroused initially aroused concern was that Massachusetts Blue Cross Blue Shield paid the members of its board of trustees substantial amount, an unusual practice for a non-profit organization. Board members who feel they owe their pay to the CEO they are supposed to be overseeing might be particularly inclined to over pay that same CEO.
Nonetheless, the Boston Globe just reported that other non-profit Massachusetts health insurers were defending their payments to board members:
Special pleading: Our board members are experienced and independent
I doubt any non-profit organization would admit to not wanting experienced, independent board members, but very few other non-profits pay their board members. Asserting that board members of the Massachusetts insurance companies especially deserve pay because of characteristics they share with other members of other boards who are not paid amounts to a special pleading.
The second statement seems just to be a simple exaggeration, since 2000 hours a year implies that the board members work there full-time (40 hours/week * 50 weeks = 2000 hours).
Special Pleading: Our board members are skilled and experienced
Again, board members of all sorts of non-profit organizations could be described in similar terms. So using this as an argument for paying board members when members with the same attributes of other boards are not paid is another special pleading.
Special Pleading: Our boards have great responsibility
Of course, boards of hospitals have their own "distinct regulatory considerations," as do boards of academic institutions Boards of hospitals are also responsible for the health of their patients and boards of academic institutions are responsible for the education of their students. So this is a third example of a special pleading.
Special Pleading: Our responsibility, our time, our effort
Appeal to Tradition: Our tradition is to pay directors
It is true that the four non-profit Massachusetts health insurers all apparently did pay their board members, although in many other states, members of the boards of non-profit health insurers were not paid. But in the absence of any further argument that Massachusetts organizations were right when the others were wrong, this amounts to an appeal to tradition. The rest of this personal statement was again a special pleading.
Summary
Board members of non-profit organizations generally are said to have three duties, as per BoardSource:
- The Duty of Care: "a board member owes the duty to exercise reasonable care when he or she makes a decision as a steward of the organization."
- The Duty of Loyalty: "a board member must give undivided allegiance when making decisions affecting the organization. This means that a board member can never use information obtained as a member for personal gain, but must act in the best interests of the organization."
- The Duty of Obedience: "The duty of obedience requires board members to be faithful to the organization's mission. They are not permitted to act in a way that is inconsistent with the central goals of the organization."
The notion that boards stewarding non-profit organizations, including health care organizations, have these core responsibilities seems to have become increasingly ignored and forgotten in an increasingly commercialized health care environment. Simply fulfilling these duties should not be regarded as exceptional board service, and certainly not so exceptional as to require pay. The fallacious arguments made on behalf of lucrative payments given to members of the boards of two of the more highly regarded non-profit health insurance corporations in the country indicate how low governance and stewardship of health care organizations has sunk.
Again, we need governance of health care organization by people who understand their fundamental duties, who are willing to be accountable, and who put their organizations' mission ahead of personal gain.
Those who profess concern about the stewardship of health care need not go far to find examples of fundamental misconceptions about what such stewardship involves. We need to restore core values of governance to our health care organizations.
One of the issues that aroused initially aroused concern was that Massachusetts Blue Cross Blue Shield paid the members of its board of trustees substantial amount, an unusual practice for a non-profit organization. Board members who feel they owe their pay to the CEO they are supposed to be overseeing might be particularly inclined to over pay that same CEO.
Nonetheless, the Boston Globe just reported that other non-profit Massachusetts health insurers were defending their payments to board members:
The state’s second- and third-largest health insurers said yesterday their board members have decided to keep paying themselves five-figure annual fees despite objections from the state attorney general and an inquiry into directors’ compensation at nonprofit health plans.The rationales for these decisions were fascinating, amounting to four variations of special pleading, plus an appeal to tradition.
Special pleading: Our board members are experienced and independent
'Good governance is advanced by the recruitment and retention of experienced, independent, reasonably compensated directors,' Harvard Pilgrim said in its statement. 'In 2010, our board worked more than 2,000 hours.'
I doubt any non-profit organization would admit to not wanting experienced, independent board members, but very few other non-profits pay their board members. Asserting that board members of the Massachusetts insurance companies especially deserve pay because of characteristics they share with other members of other boards who are not paid amounts to a special pleading.
The second statement seems just to be a simple exaggeration, since 2000 hours a year implies that the board members work there full-time (40 hours/week * 50 weeks = 2000 hours).
Special Pleading: Our board members are skilled and experienced
Wellesley-based Harvard Pilgrim, however, said in its statement that board members 'apply their specialized experience and skills in the areas of medicine, accounting, finance and law, to support our company and its mission. Our board serves as responsible, independent fiscal stewards for our members’ premium dollars.'
Again, board members of all sorts of non-profit organizations could be described in similar terms. So using this as an argument for paying board members when members with the same attributes of other boards are not paid is another special pleading.
Special Pleading: Our boards have great responsibility
Tufts, based in Watertown, said its board believes there is 'an additional overlay of responsibility' for directors of a health insurance company.
'Unlike the directors of other nonprofits, they are subject to distinct regulatory considerations,' the Tufts statement said. 'Therefore, compensation for time, commitment and skill of top talent is a responsible approach for the oversight of an organization that provides health care coverage to hundreds of thousands' of members.
Of course, boards of hospitals have their own "distinct regulatory considerations," as do boards of academic institutions Boards of hospitals are also responsible for the health of their patients and boards of academic institutions are responsible for the education of their students. So this is a third example of a special pleading.
Special Pleading: Our responsibility, our time, our effort
Appeal to Tradition: Our tradition is to pay directors
The history and tradition of nonprofit health plans is to pay [directors] in this state. These are people from various walks of life who bring a skill set. These are not political hacks. . . . It’s because of the responsibility, the time, the effort, and the work you have to put into it. It’s a lot of homework.
It is true that the four non-profit Massachusetts health insurers all apparently did pay their board members, although in many other states, members of the boards of non-profit health insurers were not paid. But in the absence of any further argument that Massachusetts organizations were right when the others were wrong, this amounts to an appeal to tradition. The rest of this personal statement was again a special pleading.
Summary
Board members of non-profit organizations generally are said to have three duties, as per BoardSource:
- The Duty of Care: "a board member owes the duty to exercise reasonable care when he or she makes a decision as a steward of the organization."
- The Duty of Loyalty: "a board member must give undivided allegiance when making decisions affecting the organization. This means that a board member can never use information obtained as a member for personal gain, but must act in the best interests of the organization."
- The Duty of Obedience: "The duty of obedience requires board members to be faithful to the organization's mission. They are not permitted to act in a way that is inconsistent with the central goals of the organization."
The notion that boards stewarding non-profit organizations, including health care organizations, have these core responsibilities seems to have become increasingly ignored and forgotten in an increasingly commercialized health care environment. Simply fulfilling these duties should not be regarded as exceptional board service, and certainly not so exceptional as to require pay. The fallacious arguments made on behalf of lucrative payments given to members of the boards of two of the more highly regarded non-profit health insurance corporations in the country indicate how low governance and stewardship of health care organizations has sunk.
Again, we need governance of health care organization by people who understand their fundamental duties, who are willing to be accountable, and who put their organizations' mission ahead of personal gain.
Those who profess concern about the stewardship of health care need not go far to find examples of fundamental misconceptions about what such stewardship involves. We need to restore core values of governance to our health care organizations.
Wendell Potter on "Insurers’ Cynical Calculations on the Cost of Doing Business"
On his blog, Wendell Potter, former head of public relations for CIGNA, discussed big health insurance/ managed care organizations' attitudes toward paying financial penalties for wrong-doing:
We have frequently discussed the parade of legal settlements involving major health care organizations, including drug, device, biotechnology companies, and hospitals and health care systems as well as insurers and managed care organizations. We have repeatedly noted that fines or payments imposed on these organizations seem to have little deterrent effect. Now we have some documentation that this is true from someone who used to be in the belly of the beast.
So I get to repeat: we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.
Having served as head of PR for two of the country’s largest health insurers — CIGNA and Humana — I know from personal experience that such fines are not widely considered newsworthy.
Insurers know this, and so, annoying as being charged with breaking the law might be, they largely shrug off the fines and the threat of a day’s worth of bad publicity that occasionally accompany them. They are perfectly willing to risk being caught because they long ago realized that the fines are never severe enough to make them radically change the way they do business. Such a change would involve dealing more honestly with both their customers and the doctors who provide care to the people they insure.
We have frequently discussed the parade of legal settlements involving major health care organizations, including drug, device, biotechnology companies, and hospitals and health care systems as well as insurers and managed care organizations. We have repeatedly noted that fines or payments imposed on these organizations seem to have little deterrent effect. Now we have some documentation that this is true from someone who used to be in the belly of the beast.
So I get to repeat: we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.
Kamis, 31 Maret 2011
Rabu, 30 Maret 2011
wallyibong: Jackie Chan is dead - RIP Jackie Chan Rumors True ...
wallyibong: Jackie Chan is dead - RIP Jackie Chan Rumors True ...: "The death of Jackie Chan is currently trending now on Twitter. Though it's not yet April, some of the Twitter fan has been fooled by this ru..."
Quakebook Blog: Welcome to 2:46 QuakeBook
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Scam Sniper: A Sightseeing firms breach, net's cyber criminals ...
Scam Sniper: A Sightseeing firms breach, net's cyber criminals ...: "A sightseeing company by the name of CitySites owner of Twin America, reported that the credit card details of 110,000 customers has been s..."
The BULLDOG Estate: FarmVille Scam: Beware of the “White Kitty” Notice...
The BULLDOG Estate: FarmVille Scam: Beware of the “White Kitty” Notice...: "Tweet Source: farmvillefreak FarmVille White Kitten We’re here again to alert you to another scam. Like they say, “if it’s too good to..."
Scam Sniper: Phishing campaign targets First Data merchant acco...
Scam Sniper: Phishing campaign targets First Data merchant acco...: "Share App River, an e-mail security vendor, is warning of a phishing attack which targets First Data merchant accounts. Intended victims ..."
How Large Health Care Organizations Set the "Rules of the Game" to Dominate Health Care
The notion that health care is increasingly "dominated by large, bureaucratic organizations which do not honor ... [its] core values"(1) just made it into a main-stream, large circulation US medical journal. A brand new commentary in the American Journal of Medicine(2) by Supri and Malone declared:
The article then described the main types of large, powerful health care organizations:
Note that there are even more kinds of large and powerful health care organizations, including non-profit hospitals and hospital systems, employers acting as payers for health care, government agencies, device and biotechnology companies, health care information technology companies, public relations firms, medical education and communication companies, contract research organizations, professional societies, patient advocacy groups, accrediting bodies, health care charities, etc, etc, etc. But the point is that the large organizations, not the patients, the physicians, nor the public dominate.
Supri and Malone suggested that each kind of organization sets the "rules of the game," that is, the priorities important to the organization, which are very different from the core values that many of us believe ought to guide health care:
For example,
Similarly, it cited the rules for managed care, "manage care," that is, "restrict utilization of health care" regardless of patients' needs; the pharmaceutical industry, "charges as much as we want, because insurance will pay;" and "corporate hospital chains ... test as much as we want, because insurance will pay." Thus it made the point that US health care now is driven by the priorities of large organizations whose interests at best may disregard and at worst may conflict with providing the best possible care for individual patients.
Further, the resulting complexity is to the benefit of the large organizations:
This is very important, and suggests that the system will just become more bureaucratic, complex and opaque until it finally collapses.
Finally, it raised the point that the organizations collude to promote their priorities at the expense of patients' and the public's health:
Although Supri and Malone did not differentiate the leadership of large organizations from the organizations themselves, we have pointed out that the top leaders of various kinds of organizations seem to think alike, becoming a sort of de facto executives' guild, with a "superclass" of oligarchs at its pinnacle. The guild may be enabled by these leaders' often huge compensation and other benefits and corporate arrangements that keep them shielded from the vicissitudes of daily life that patients, health care professionals, and lower level organizational employees must face. Furthermore, the leadership of these organizations is often interlinked, for example, by leaders of one organization serving on boards of directors or trustees of others.
It is so nice for us at Health Care Renewal to have some company. It is a very important blow to the anechoic effect for these sorts of views to appear in a mainstream medical journal.
When I interviewed a motley group of physicians and health care professionals in the early part of the 21st century, many expressed concerns about how medicine had been taken over by large organizations which did not honor its values. The article published in 2003(1) in Europe which tried to summarize their concerns probably could not have been published at that time in the US, but its publication remote from its main topic only made it more anechoic. It may be that an article published in a respected American journal will generate some more echoes. Here is hoping that Health Care Renewal can help create some such echoes.
Obviously, those who lead large organizations in health care will not be happy about that, so it is possible this article's appearance in a main-stream journal may incite some pushback, perhaps generated by the public relations machines of the large health care organizations (see this post about how Wendell Potter's excellent Deadly Spin documented how large organizations use propaganda and disinformation to undermine viewpoints that threaten their domination.)
In conclusion, I strongly support Supri and Malone's final sentiments:
But now almost 8 years since the publication of "A Cautionary Tale," we still have a long way to go.
References
1. Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Inte Med 2003; 14: 123-130. Link here.
2. Supri S, Malone K. On the critical list: the US institution of medicine. Am J Med 2011; 124: 192-193. Link here.
To explain why we have the most expensive health care system in the world and yet one of the lowest performing, we need to take a perspective that focuses on the US institution of medicine as a whole. We expose the hidden rules by which this institution operates and discuss how its powerful organizations shape, control and perpetuate this ailing system.
The article then described the main types of large, powerful health care organizations:
The US institution of medicine is not a single, comprehensive and cohesive system of health care. Instead, it is comprised of a myriad of large and powerful organizations, including insurance companies, Health Maintenance Organizations (HMOs), corporate for-profit hospital chains, and pharmaceutical companies. This institutional structure is large and vast, and has over the years become ever more labyrinthine.
Note that there are even more kinds of large and powerful health care organizations, including non-profit hospitals and hospital systems, employers acting as payers for health care, government agencies, device and biotechnology companies, health care information technology companies, public relations firms, medical education and communication companies, contract research organizations, professional societies, patient advocacy groups, accrediting bodies, health care charities, etc, etc, etc. But the point is that the large organizations, not the patients, the physicians, nor the public dominate.
Supri and Malone suggested that each kind of organization sets the "rules of the game," that is, the priorities important to the organization, which are very different from the core values that many of us believe ought to guide health care:
Not only is the institutional structure large, it is dynamic, and actively creates, shapes, and maintains the institution of medicine. It does this through what we call setting the “rules of the game”; that is, by imposing the terms by which the system operates.
For example,
Insurance companies have set the rule 'restrict choice and coverage.' They enact this through their elaborate system of copayments and deductibles, exclusion clauses and loopholes, each designed to deter patients from claiming the health care they need, and to override physicians' medical judgment.
Similarly, it cited the rules for managed care, "manage care," that is, "restrict utilization of health care" regardless of patients' needs; the pharmaceutical industry, "charges as much as we want, because insurance will pay;" and "corporate hospital chains ... test as much as we want, because insurance will pay." Thus it made the point that US health care now is driven by the priorities of large organizations whose interests at best may disregard and at worst may conflict with providing the best possible care for individual patients.
Further, the resulting complexity is to the benefit of the large organizations:
As each organization has created its own 'rules of the game,' the institution of medicine has grown into a complex entity that few really understand. This very complexity actually works to the advantage of the organizations that comprise the system, creating an operating environment that allows them to siphon off billions of dollars. It is one of the main reasons why the cost of health care has spiraled out of control.
This is very important, and suggests that the system will just become more bureaucratic, complex and opaque until it finally collapses.
Finally, it raised the point that the organizations collude to promote their priorities at the expense of patients' and the public's health:
Although each organization sets their 'own rules of the game,' they are also strongly and deeply interlinked, and cooperate and collaborate to protect the system of health care that they have devised, so that it remains intact and continues to serve their own interests.
Although Supri and Malone did not differentiate the leadership of large organizations from the organizations themselves, we have pointed out that the top leaders of various kinds of organizations seem to think alike, becoming a sort of de facto executives' guild, with a "superclass" of oligarchs at its pinnacle. The guild may be enabled by these leaders' often huge compensation and other benefits and corporate arrangements that keep them shielded from the vicissitudes of daily life that patients, health care professionals, and lower level organizational employees must face. Furthermore, the leadership of these organizations is often interlinked, for example, by leaders of one organization serving on boards of directors or trustees of others.
It is so nice for us at Health Care Renewal to have some company. It is a very important blow to the anechoic effect for these sorts of views to appear in a mainstream medical journal.
When I interviewed a motley group of physicians and health care professionals in the early part of the 21st century, many expressed concerns about how medicine had been taken over by large organizations which did not honor its values. The article published in 2003(1) in Europe which tried to summarize their concerns probably could not have been published at that time in the US, but its publication remote from its main topic only made it more anechoic. It may be that an article published in a respected American journal will generate some more echoes. Here is hoping that Health Care Renewal can help create some such echoes.
Obviously, those who lead large organizations in health care will not be happy about that, so it is possible this article's appearance in a main-stream journal may incite some pushback, perhaps generated by the public relations machines of the large health care organizations (see this post about how Wendell Potter's excellent Deadly Spin documented how large organizations use propaganda and disinformation to undermine viewpoints that threaten their domination.)
In conclusion, I strongly support Supri and Malone's final sentiments:
The sum of the 'rules of the game' devised by these organizations has resulted in a fragmented, haphazard and broken system of health care. Reform is long overdue, and demands root and branch transformation of the 'rules of the game' governing the US institution of medicine. This requires us to understand these rules, who is setting them, and how these rules are being used to exploit the system of medicine. Only then can we begin to heal our ailing health care system.Well said!
But now almost 8 years since the publication of "A Cautionary Tale," we still have a long way to go.
References
1. Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Inte Med 2003; 14: 123-130. Link here.
2. Supri S, Malone K. On the critical list: the US institution of medicine. Am J Med 2011; 124: 192-193. Link here.
Data Theft is Alive and Well in Secure Networks.
Data theft is alive and well in secure networks
http://blog.imperva.com/2010/12/data-theft-is-alive-and-well-in-secure-networks.html
http://blog.imperva.com/2010/12/data-theft-is-alive-and-well-in-secure-networks.html
Selasa, 29 Maret 2011
BLOGSCAN: The Place Where the Compass Spins
The 1 Boring Old Man blog is on a roll. Read this summary post, see its amazing introduction below, then peruse the main page and the archives:
At the North Pole, the magnetic compass apparently spins at random, not knowing where to point. Is it because there’s no North? or is North everywhere? That’s the way I feel about this Atypical Antipsychotic story I’ve been preoccupied with for a couple of months. It’s like everyone’s walking around with a compass that doesn’t work any more. The Pharmaceutical Companies involved have forgotten what their products are used for. Many doctors seem to have forgotten why they became doctors. Whole industries have sprung up [Clinical Research Organizations, Clinical Research Centers, Medical Writing companies, etc] without being clear about what they’re even involved in. One has to move away from it all to avoid getting caught up in the confusion and becoming as blind as the other players. Once you get far enough away, it’s tempting to forget that it’s even there, that place where the compasses don’t work anymore.
"Government-Run Health Insurance" Run by Corporations? - Two Medicaid Examples
In the US, there seems to have been a constant argument between right- and left-wingers over "government-run" health insurance. The right tends to disparage all aspects of "government-run" health care, and in the case of insurance, uses the alleged faults of the two big US government health insurance programs as examples. (Medicare is a federal government health insurance program for the elderly and disabled. Medicaid is federal-state program for the poor.)
For example, per the Associated Press via BusinessWeek, from a currently prominent Republican hopeful for President, former Minnesota Governor Tim Pawlenty,
Republican Congressman Darrell Issa (California) wrote in 2010:
The left may advocate for government-run, "single-payer" insurance programs, perhaps using the alleged benefits of Medicare and Medicaid as examples.
Scholarly articles about health care policy may refer to Medicaid as a government "single-payer" system. (For example, see: Robinson JC. The commercial health insurance industry in an era of eroding employer coverage. Health Aff 2006; 25:1475-1486. Link here.)
In any case, I suspect most of us think of Medicaid as an example of "government-run" health care insurance, regardless of whether we believe that is a good or a bad thing.
Yet the reality may be more complex. Two recent stories, one a follow-up on an old Health Care Renewal post, provide some dots to connect.
Connecticut HUSKY Medicaid Program
In 2007, we posted about how the state of Connecticut was going to end participation in the HUSKY state Medicaid program for poor children by four insurance companies/ managed care organizations. They apparently refused to provide information about payments to physicians and denial of payments for prescription drugs to the state. The two largest organizations involved were Anthem Health Plans (a subsidiary of WellPoint), and Health Net. At the time, we noted that this case provided an example of the lack of transparency exhibited by major health organizations.
Late last year, the Connecticut Mirror documented more criticism of the HUSKY program based on a report that showed that participating companies were making big profits from it (but perhaps not from other state Medicaid programs):
In more detail, the relevant numbers were:
The insurers involved defended themselves by noting to participate in HUSKY they also had to participate in another program, Charter Oak Health Plan, "on which they lose money."
Last month, it looked to be the end of managed care in these Medicaid programs, again as reported by the Connecticut Mirror:
This article also noted:
So let us deal directly with the cognitive dissonance generated by these articles. In the ongoing US health reform debate, Medicaid is usually discussed as a "government-run" health care (insurance) program. Yet these news articles from Connecticut suggest at least in that state, part of Medicaid was out-sourced to mostly large, national, for-profit health insurance companies/ managed care organizations. Furthermore, as noted just above, these corporations seemed to be mainly calling the shots in how their part of Medicaid was run. So is this "government-run" health care (insurance)?
But wait, there is more....
Minnesota Medicaid Controversy
Last month, the Politics in Minnesota web-site ran a report on an unlikely reformer:
So here we go again. This article suggested that Minnesota had out-sourced a very large part of its Medicaid program.
Furthermore, it also appears that the state government knows little about what happens to the money it hands over:
In addition, there is reason to believe that Minnesota may be paying a significant amount for administration:
Then, there is reason to suspect that the private (and nominally not-for-profit) HMOs that Minnesota pays to run Medicaid have resisted accounting for how the money they got was spent:
Apparently in these parlous financial times, Mr Feinwachs got some attention. Last week, the state Governor announced his willingness to dig into the results of the state's out-sourcing of Medicaid, per the Minneapolis Star-Tribune:
So again in Minnesota, it appeared that the state had out-sourced a large proportion of its Medicaid program, covering apparently two-thirds of the state's Medicaid patients. It appears that knowledge of the out-sourcing of most of Medicaid was relatively anechoic, and that even the state's former Governor Pawlenty was unaware of it (see his comments in introduction to this post). Despite the amounts of money and the numbers of people involved, up to now the state government had apparently very little information about how billions of dollars were being spent by private, albeit nominally non-profit health insurance companies/ managed care organizations.
Summary
Two cases from two states suggest that some proportion of Medicaid, perhaps a very large proportion, has been out-sourced to private corporations, both nominally non-profit and for-profit.
In fact, a Washington Post article last year suggested that 70% of Medicaid patients are in managed care plans, most of which are likely out-sourced, not run by state Medicaid agencies.
Our two cases above further suggest that government officials may know little about how the money given to these corporations was spent, and how the corporations managed the supposedly "government-run" health insurance.
So much for the notion that the US Medicaid program is "government-run" health insurance. Whether one believes that government bureaucrats are good or bad at running health care, it seems that most Medicaid patients' care is managed by corporate, not government bureaucrats.
The likelihood that a substantial proportion of Medicaid patients actually get their health care coverage from corporations, be that non-profit or for-profit, raises some important questions.
- What proportion of the government funds provided these corporations goes to health care versus administration, overhead, etc?
- What then is the proportion of all Medicaid money spent on health care versus administration, overhead, etc at the federal, state, and corporate levels?
- What proportion of the revenue of major health insurers/ managed care organizations actually comes from tax-payers via Medicaid?
- To what extent do health insurers/ managed care organizations influence clinical care through their role implementing Medicaid?
- How transparent are their finances and their implementation of Medicaid?
- How well are they supervised and regulated by national and state government?
Meanwhile, it appears that there is far more overlap between government and corporate health insurance and managed care than most of us realized. That suggests the usual debate between the foes and proponents of "government-run" health care (insurance) was vastly too simplistic. Maybe some of those involved in the debate should have known that.
Meanwhile, the concerns I discussed in 2002 that "health care has become dominated by large, bureaucratic organizations" appear increasingly well-founded. This domination seems to be increasingly facilitated by collaboration - or should that be collusion? - among government and private bureaucracies. The danger, as we have repeatedly discussed, is that the leaders of these bureaucracies may feel increasing loyalty to the managers' and executives' guild, and decreasing pressure not to fulfill their own and their cronies' self-interest. We need at least to have some frank discussions about the increasing corporatism of health care and all of society, and what to do about it.
For example, per the Associated Press via BusinessWeek, from a currently prominent Republican hopeful for President, former Minnesota Governor Tim Pawlenty,
The former Minnesota governor was the latest politician to participate in the Health Policy Grand Rounds program that Dartmouth-Hitchcock Medical Center has organized for its staff during the past two presidential campaign cycles. Using Medicare and Medicaid as examples, he criticized the notion that government-run health care will produce efficiency and said the answer lies in empowering consumers.
Republican Congressman Darrell Issa (California) wrote in 2010:
an expansion of the federal bureaucracy at that rate will greatly increase the incidence of waste, fraud and abuse in health care. Already Medicare, which accounts for 14% of all federal spending, is rife with waste, fraud and abuse. Even Attorney General Eric Holder has said, 'By all accounts, every year we lose tens of billions of dollars in Medicare and Medicaid funds to fraud.'
A recent analysis by the Government Accountability Office (GAO) estimated that federal subsidy programs cost taxpayers about $100 billion every year in improper payments, with Medicare and Medicaid accounting for more than half of that.
The left may advocate for government-run, "single-payer" insurance programs, perhaps using the alleged benefits of Medicare and Medicaid as examples.
Scholarly articles about health care policy may refer to Medicaid as a government "single-payer" system. (For example, see: Robinson JC. The commercial health insurance industry in an era of eroding employer coverage. Health Aff 2006; 25:1475-1486. Link here.)
In any case, I suspect most of us think of Medicaid as an example of "government-run" health care insurance, regardless of whether we believe that is a good or a bad thing.
Yet the reality may be more complex. Two recent stories, one a follow-up on an old Health Care Renewal post, provide some dots to connect.
Connecticut HUSKY Medicaid Program
In 2007, we posted about how the state of Connecticut was going to end participation in the HUSKY state Medicaid program for poor children by four insurance companies/ managed care organizations. They apparently refused to provide information about payments to physicians and denial of payments for prescription drugs to the state. The two largest organizations involved were Anthem Health Plans (a subsidiary of WellPoint), and Health Net. At the time, we noted that this case provided an example of the lack of transparency exhibited by major health organizations.
Late last year, the Connecticut Mirror documented more criticism of the HUSKY program based on a report that showed that participating companies were making big profits from it (but perhaps not from other state Medicaid programs):
The three managed care companies in the state's HUSKY insurance program for low-income children and families recorded profits of $18.8 million last year, according to figures released by the state Department of Social Services.
In one part of HUSKY, the insurers made margins of at least 20 percent and spent less than 72 percent of their revenues on medical care.
The figures released this month drew criticism from members of the Medicaid Care Management Oversight Council, who are in the midst of considering moving HUSKY out of managed care.
In more detail, the relevant numbers were:
AmeriChoice, part of UnitedHealthcare, spent 62 percent of its revenue on medical care and posted a 22.9 percent profit margin in the HUSKY B program.
By contrast, the federal health reform law sets minimum medical care ratios for insurers of 80 percent or 85 percent, depending on the type of plan. The provision does not apply to Medicaid plans, but was cited as a benchmark in the council's discussion.
None of the insurers met those benchmarks in HUSKY B, which covers children whose family income does not qualify for Medicaid. Last year, it covered between 13,000 and 16,000 children, many whose families earned below 300 percent of the federal poverty level.
Aetna spent 70.5 percent on medical care and made a 20 percent margin, while Community Health Network of Connecticut, a non-profit with far more enrollees than the other insurers, spent 71.8 percent of its revenues on medical care and made a 20.6 percent margin.
Margins were lower, and medical care ratios higher, in HUSKY A, a Medicaid program that enrolled as many as 358,088 children and adults in 2009.
Community Health Network reported a 95.1 percent medical care ratio and a -0.3 percent margin. AmeriChoice spent 86.3 percent of its revenue on medical care and achieved a 3.5 percent margin, while Aetna had an 83.9 percent medical care ratio and 6.5 percent margin.
Overall, the medical care ratio was 90.7 percent for both HUSKY programs and all three insurers. The overall margin was 2.3 percent.
The insurers involved defended themselves by noting to participate in HUSKY they also had to participate in another program, Charter Oak Health Plan, "on which they lose money."
Last month, it looked to be the end of managed care in these Medicaid programs, again as reported by the Connecticut Mirror:
The Malloy administration announced plans Tuesday to move the HUSKY and Charter Oak health programs out of managed care and increase care coordination in the state's other Medicaid programs, an effort officials said would save money while giving the state more control over health programs that serve more than 500,000 people.
This article also noted:
In the current system, the state pays three managed care companies set fees for each HUSKY and Charter Oak member every month, and the companies use the money to pay medical claims. Critics say it gives the managed care companies an incentive to deny care since they get to keep the money not spent on medical costs.
So let us deal directly with the cognitive dissonance generated by these articles. In the ongoing US health reform debate, Medicaid is usually discussed as a "government-run" health care (insurance) program. Yet these news articles from Connecticut suggest at least in that state, part of Medicaid was out-sourced to mostly large, national, for-profit health insurance companies/ managed care organizations. Furthermore, as noted just above, these corporations seemed to be mainly calling the shots in how their part of Medicaid was run. So is this "government-run" health care (insurance)?
But wait, there is more....
Minnesota Medicaid Controversy
Last month, the Politics in Minnesota web-site ran a report on an unlikely reformer:
Dave Feinwachs is no stranger to the Capitol.
For three decades he was the general counsel to the Minnesota Hospital Association. In that capacity, he negotiated with state agencies and testified regularly before legislative committees on health care issues.
But early last year, Feinwachs said, he was ordered by his superiors at the hospital association not to provide any further testimony at the Capitol. The reason for the muzzle: his vocal insistence that health maintenance organizations (HMOs) should contribute money to help salvage the state’s General Assistance Medical Care program for indigent adults.
Feinwachs says he abided by the prohibition on testimony before legislative committees, but apparently it was not enough to keep him in the good graces of his employer. In November he was fired as the group’s principal attorney. Feinwachs will not discuss the reason for his termination, citing potential litigation. But it almost certainly had something to do with his ongoing zealous campaign to force greater transparency and accountability on the state’s HMOs - primarily Blue Cross & Blue Shield, HealthPartners, Medica and UCare - which receive roughly $3 billion annually to run health plans for many of the state’s poorest residents.
So here we go again. This article suggested that Minnesota had out-sourced a very large part of its Medicaid program.
Furthermore, it also appears that the state government knows little about what happens to the money it hands over:
In the next two years, Minnesota is slated to funnel about $6 billion to the state’s HMOs to provide health care for 550,000 of the state’s poorest residents. To put that figure in perspective, it is nearly 20 percent of the state’s expected 2012-13 general fund revenues - and nearly identical to the state’s projected $6.2 billion deficit. In coming up with a solution to Minnesota’s financial crisis, Feinwachs and others believe, legislators must at least have a clear accounting of this massive pot of health care dollars.
HMOs, meanwhile, are not exactly yearning for scrutiny, especially as they launch a pitch to administer even more of the state’s health care spending.
In addition, there is reason to believe that Minnesota may be paying a significant amount for administration:
Feinwachs believes that the administrative overhead collected by HMOs could be in the neighborhood of 16 percent. He concedes, however, that this is no more than a 'guesstimate' pieced together from the limited information that is publicly available.
Then, there is reason to suspect that the private (and nominally not-for-profit) HMOs that Minnesota pays to run Medicaid have resisted accounting for how the money they got was spent:
Past attempts to bolster accountability and transparency for HMOs have largely run into a brick wall. For instance, when legislators considered requiring the health plans to chip in on a plan to restore the General Assistance Medical Care program last year, they were told by officials from the Department of Human Services that such a move would be illegal. Efforts to provide more financial disclosure have been rebuffed by the argument that such information is proprietary and not subject to the state’s data practices rules. The complexity of Minnesota’s patchwork of publicly funded health care plans, which very few individuals clearly understand, has also helped forestall changes.
'We can’t let the complexity of data and information beat us down, and I think that’s what happened in the years past,' Hosch said. 'The systems almost seem like they’re deliberately complex in order to confuse us.'
Apparently in these parlous financial times, Mr Feinwachs got some attention. Last week, the state Governor announced his willingness to dig into the results of the state's out-sourcing of Medicaid, per the Minneapolis Star-Tribune:
It's high time that Minnesota started treating its nonprofit health plans for what they are -- some of state government's largest vendors.
Reforms announced this week by Gov. Mark Dayton's office are a promising first step toward scrutinizing health plan contracts for savings and finding new ways to rein in Minnesota's soaring medical costs.
Managing care for more than 500,000 low-income, disabled and elderly Minnesotans enrolled in state public health programs is a $3.1 billion-a-year business for health plans in Minnesota, with the state and federal government jointly footing the bill.
Over the past decade, the state's portion of this outsourced care has increased from 5 percent to 11 percent of the state budget, according to Dayton's office.
The state also has more than 249,000 people -- typically the sickest of the sick -- in a fee-for-service public program. That spending is also ripe for a cost-savings review.
On Wednesday, Dayton announced plans to do what good business leaders do in difficult financial circumstances. His administration is going to start driving harder bargains with health plans.
Key parts of the plan include making the contracting system more competitive, making financial information more transparent, and doing deeper auditing of plans' books to analyze administrative and medical expenses.
So again in Minnesota, it appeared that the state had out-sourced a large proportion of its Medicaid program, covering apparently two-thirds of the state's Medicaid patients. It appears that knowledge of the out-sourcing of most of Medicaid was relatively anechoic, and that even the state's former Governor Pawlenty was unaware of it (see his comments in introduction to this post). Despite the amounts of money and the numbers of people involved, up to now the state government had apparently very little information about how billions of dollars were being spent by private, albeit nominally non-profit health insurance companies/ managed care organizations.
Summary
Two cases from two states suggest that some proportion of Medicaid, perhaps a very large proportion, has been out-sourced to private corporations, both nominally non-profit and for-profit.
In fact, a Washington Post article last year suggested that 70% of Medicaid patients are in managed care plans, most of which are likely out-sourced, not run by state Medicaid agencies.
Our two cases above further suggest that government officials may know little about how the money given to these corporations was spent, and how the corporations managed the supposedly "government-run" health insurance.
So much for the notion that the US Medicaid program is "government-run" health insurance. Whether one believes that government bureaucrats are good or bad at running health care, it seems that most Medicaid patients' care is managed by corporate, not government bureaucrats.
The likelihood that a substantial proportion of Medicaid patients actually get their health care coverage from corporations, be that non-profit or for-profit, raises some important questions.
- What proportion of the government funds provided these corporations goes to health care versus administration, overhead, etc?
- What then is the proportion of all Medicaid money spent on health care versus administration, overhead, etc at the federal, state, and corporate levels?
- What proportion of the revenue of major health insurers/ managed care organizations actually comes from tax-payers via Medicaid?
- To what extent do health insurers/ managed care organizations influence clinical care through their role implementing Medicaid?
- How transparent are their finances and their implementation of Medicaid?
- How well are they supervised and regulated by national and state government?
Meanwhile, it appears that there is far more overlap between government and corporate health insurance and managed care than most of us realized. That suggests the usual debate between the foes and proponents of "government-run" health care (insurance) was vastly too simplistic. Maybe some of those involved in the debate should have known that.
Meanwhile, the concerns I discussed in 2002 that "health care has become dominated by large, bureaucratic organizations" appear increasingly well-founded. This domination seems to be increasingly facilitated by collaboration - or should that be collusion? - among government and private bureaucracies. The danger, as we have repeatedly discussed, is that the leaders of these bureaucracies may feel increasing loyalty to the managers' and executives' guild, and decreasing pressure not to fulfill their own and their cronies' self-interest. We need at least to have some frank discussions about the increasing corporatism of health care and all of society, and what to do about it.
Senin, 28 Maret 2011
AlBlue’s Blog: [Mac] Data loss on Leopard USB drives
AlBlue’s Blog: [Mac] Data loss on Leopard USB drives: "One of the cardinal rules in upgrading operating systems is always wait for at least the .2 release before using it for production use. Leop..."
Minggu, 27 Maret 2011
Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style
At my Sept. 2010 post "The Dangers of Critical Thinking in A Politicized, Irrational Culture" I wrote:
For "anecdotes" of patient harm due to medical devices even from the most reliable of sources to be counted as "evidence" of device risk, apparently, the stories need to be blessed with Statistical Holy Water. The Holy Water must also be of a brand approved by the academic pundits.
For me, this is no longer merely a professional debate. My elderly mother became one of those "anecdotes" in May last year.
I address the casual, Dogbert-style, waving-of-the-hand "Bah!" dismissal of health IT harm "anecdotes" at numerous other posts as well, such as "EHR Problems? No, They're Merely Anecdotal" and "Health IT: On Anecdotalism and Totalitarianism".
Bah! Your Health IT adverse events reports are anecdotes, and anecdotes don't make data!
In those posts I also mention how Australian informatics professor Dr. Jon Patrick had essentially hit the flaws of this argument out of the Southern hemisphere with a short editorial in the journal "Applied Clinical Informatics" entitled "The Validity of Personal Experiences in Evaluating HIT." That essay is free at the link and is worth reading.
Interestingly and thankfully, the "anecdotes are meaningless" crowd have now lost, and lost big - Supreme Court style. In fact, the U.S. Supreme Court has shown far more common sense than many esteemed academics and industry pundits.
As noted in this post at Derek Lowe's pharmaceutical industry "In the Pipeline" blog, the company that made "Zicam", a zinc-based over-the-counter cold remedy, tried to defend shareholder suits that the company withheld case reports of Zicam causing permanent loss of smell via arguing that such reports "did not reach a level of statistical significance", i.e., were "anecdotal." The case went to the U.S. Supreme Court.
The Supreme Court would have none of that argument:
The full court decision is at this link: http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf (PDF file), but a passage I consider key to this issue is as follows:
This is common sense incarnate. It applies not just to drugs, but to medical devices, to health IT, and to other domains as well.
In essence, it is saying that adverse events reports, especially repeated ones, from trustworthy sources are not to be lightly dismissed, but should serve at the very least as red flags that there may be a systemic problem requiring further investigation.
One wonders how and if public healthcare IT vendors will begin disclosing "anecdotal" reports of their products causing patient harm to their own stockholders.
One also wonders if the academic anecdotalists (up to the level of the chair of the Office of the National Coordinator for Health Information Technology at HHS) will cease their unfettered dismissal of health IT AE reports as mere "anecdotes" and therefore let's roll out this 100% beneficent technology nationwide ASAP, e.g., as at my Feb. 2011 post "A Somewhat Harsh Farewell to David Blumenthal of ONC, From a Patient Injured by Health IT - My Mother":
That sounds a bit like the refrain of the makers of Zicam.
One might also wonder if the anecdotalists merely lack common sense, or are using this form of epistemological dementia to obscure conflict of interest.
On a final note, my favorite comment at the aforementioned "In the Pipeline" blog story is this by anonymous commenter "Still Scared of Dinosaurs":
Perhaps this Dilbert cartoon is apropos to the Supreme Court decision:
-SS
Addendum:
I thought it appropriate to share these thoughts with the leadership of the Joint Commission, the organization that accredits healthcare organizations in the United States:
... It's the EMR "anecdotalists" (as opposed to the "Markopolists") who say that "anecdotes" of HIT-related injury are meaningless. They deem reports of safety issues and HIT-related misadventures and risk as simply "anecdotal", and that "anecdotes don't make evidence" (or "anecdotes don't make data").
For "anecdotes" of patient harm due to medical devices even from the most reliable of sources to be counted as "evidence" of device risk, apparently, the stories need to be blessed with Statistical Holy Water. The Holy Water must also be of a brand approved by the academic pundits.
For me, this is no longer merely a professional debate. My elderly mother became one of those "anecdotes" in May last year.
I address the casual, Dogbert-style, waving-of-the-hand "Bah!" dismissal of health IT harm "anecdotes" at numerous other posts as well, such as "EHR Problems? No, They're Merely Anecdotal" and "Health IT: On Anecdotalism and Totalitarianism".
Bah! Your Health IT adverse events reports are anecdotes, and anecdotes don't make data!In those posts I also mention how Australian informatics professor Dr. Jon Patrick had essentially hit the flaws of this argument out of the Southern hemisphere with a short editorial in the journal "Applied Clinical Informatics" entitled "The Validity of Personal Experiences in Evaluating HIT." That essay is free at the link and is worth reading.
Interestingly and thankfully, the "anecdotes are meaningless" crowd have now lost, and lost big - Supreme Court style. In fact, the U.S. Supreme Court has shown far more common sense than many esteemed academics and industry pundits.
As noted in this post at Derek Lowe's pharmaceutical industry "In the Pipeline" blog, the company that made "Zicam", a zinc-based over-the-counter cold remedy, tried to defend shareholder suits that the company withheld case reports of Zicam causing permanent loss of smell via arguing that such reports "did not reach a level of statistical significance", i.e., were "anecdotal." The case went to the U.S. Supreme Court.
The Supreme Court would have none of that argument:
"Matrixx’s [Zicam's manufacturer - ed.] premise that statistical significance is the only reliable indication of causation is flawed. Both medical experts and the Food and Drug Administration rely on evidence other than statistically significant data to establish an inference of causation. It thus stands to reason that reasonable investors would act on such evidence.
The full court decision is at this link: http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf (PDF file), but a passage I consider key to this issue is as follows:
... We conclude that the materiality of adverse event reports cannot be reduced to a bright-line rule ... Because adverse reports can take many forms, assessing their materiality is a fact-specific inquiry, requiring consideration of their source, content, and context.
This is common sense incarnate. It applies not just to drugs, but to medical devices, to health IT, and to other domains as well.
In essence, it is saying that adverse events reports, especially repeated ones, from trustworthy sources are not to be lightly dismissed, but should serve at the very least as red flags that there may be a systemic problem requiring further investigation.
One wonders how and if public healthcare IT vendors will begin disclosing "anecdotal" reports of their products causing patient harm to their own stockholders.
One also wonders if the academic anecdotalists (up to the level of the chair of the Office of the National Coordinator for Health Information Technology at HHS) will cease their unfettered dismissal of health IT AE reports as mere "anecdotes" and therefore let's roll out this 100% beneficent technology nationwide ASAP, e.g., as at my Feb. 2011 post "A Somewhat Harsh Farewell to David Blumenthal of ONC, From a Patient Injured by Health IT - My Mother":
"Nothing [ONC has] found would give them any pause that a policy of introducing EMR's could impede patient safety." - David Blumenthal
That sounds a bit like the refrain of the makers of Zicam.
One might also wonder if the anecdotalists merely lack common sense, or are using this form of epistemological dementia to obscure conflict of interest.
On a final note, my favorite comment at the aforementioned "In the Pipeline" blog story is this by anonymous commenter "Still Scared of Dinosaurs":
One of the most important ideas real statisticians must get into their heads is "Thou shalt not worship the 0.05 threshold". The whole concept of "statistical significance" for AEs is idiotic and the fact that Matrixx based any part of their defense on it indicates that their stupidity did not end when they named the company.
Perhaps this Dilbert cartoon is apropos to the Supreme Court decision:
-SS
Addendum:
I thought it appropriate to share these thoughts with the leadership of the Joint Commission, the organization that accredits healthcare organizations in the United States:
-- SSFrom: Scot Silverstein
Sent: Sunday, March 27, 2011 10:41 AM
To: MGiuntoli, Anita; Chassin, Mark; Schyve, Paul; Legaspi, Shirley
Cc: Ross Koppel; 'David Kreda'
Subject: Re: MATRIXX INITIATIVES, INC., ET AL. v. SIRACUSANO ET AL.Not a complaint this time [about health IT failure - ed.], but an observation.
The JC has noted health IT risks in the Sentinel Events Alert "Safely implementing health information and converging technologies" of 2008.
The company that made "Zicam", a zinc-based over-the-counter cold remedy, tried to defend shareholder suits that the company withheld case reports of Zicam causing permanent loss of smell via arguing that such reports "did not reach a level of statistical significance", i.e., were "anecdotal." The case went to the U.S. Supreme Court.
The Supreme Court would have none of that argument:
"Matrixx’s [Zicam's manufacturer] premise that statistical significance is the only reliable indication of causation is flawed. Both medical experts and the Food and Drug Administration rely on evidence other than statistically significant data to establish an inference of causation. It thus stands to reason that reasonable investors would act on such evidence.
The full court decision is at this link: http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf (PDF file), but a passage I consider key to this issue is as follows:
... Because adverse reports can take many forms, assessing their materiality is a fact-specific inquiry, requiring consideration of their source, content, and context.
This is common sense incarnate. It applies not just to drugs, but to medical devices, to health IT, and to other domains as well.I believe JC should start to pay serious attention to "anecdotal reports" of health IT-caused patient injury, and consider reliable reporting of these events as an Accreditation standard.As I noted in my July 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" in response to Koppel and Kreda's JAMA article on HIT industry practices, "hold harmless" and "gag" clauses must go, and be replaced with proactive reporting of healthcare IT-related "events."Scot Silverstein
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