On Health Care Renewal, we have noted how the direct care of patients in the US is increasingly in the hands of large corporations, often for-profit. We have noted the plight of the corporate physicians who swore oaths to put patients first, and now report to managers who put revenue first.
Health Care Renewal was hardly the first to raise these issues. For years, the renowned editor emeritus of the New England Journal, Dr Arnold Relman, has been warning about the effects of the commercial practice of medicine, which once was illegal in most US states, and until 1980 was condemned by the American Medical Association (look here).
Yet in a world in which market fundamentalism (or economism, or neoliberalism) is increasingly dominant, there is little room for the view that turning health care into a business, and having the new health care businesses lead by people who are only interested in increasing short term revenue (financialization) and increasing their own compensation might be bad for patients' and the public's health.
However, close reading of a recent article suggests that many physicians "get" this problem, although may be reticent about protesting it.
Summary of the JAMA Article
Tilburt et al authored an article published in July, 2013 that focused on physicians views about "controlling health care costs."(1) They sent a survey to 3900 randomly chosen physicians less than 65 years old and in active practice. 2556 (65%) responded.
The survey included questions about who should be responsible for reducing health care costs, and about the physicians' enthusiasm for various means of cutting costs. The results that got the most publicity were that physicians thought others (trial lawyers, health insurance companies, pharmaceutical and device manufacturers, hospitals and health care systems, patients, and government) were more responsible for controlling costs than physicians.
Nonetheless, the physicians were relatively enthusiastic about potential cost control measures that would improve "quality and efficiency of care," for example, promoting 75% were very enthusiastic about continuity of care, 69% about promoting chronic disease care coordination, and 70% about "rooting out fraud and abuse." They were also relatively enthused about "improving conditions for evidence-based decisions," for example, 51% were very enthusiastic about "expanding access to quality and safety data," and and 50% about "promoting head-to-head trials of competing treatments" (also known as a type of comparative effectiveness research).
Strikingly, however, 63% of physicians were "very enthusiastic" about "limiting corporate influence on physician behavior." The article did not further explain that item.
An Almost Unnoticed Result
The article's results section noted "some or strong enthusiasm for improving conditions for evidence-based decisions," including "limiting corporate influence on physician behavior." It included no further comments on this issue.
The public discussion it generated largely ignored physicians' views on corporate influence..
An accompanying editorial by Dr Ezekiel Emanuel and Mr Andrew Steinmetz (2) called the survey's findings "discouraging" and chided physicians for not having an "all hands on deck" approach to controlling health care costs, stating they "must lead" on this issue, because they "captains of the ship." It ignored the notion that the physicians may have thought that their first responsibility was to "individual patients best interests," and thus controlling costs (especially costs that do not accrue directly to patients) should be a secondary concern. It also belittled their enthusiasm about curbing "fraud and abuse," implying that it was "sufficiently vague" that it "may offer only modest improvements but certainly will not transform the health care system." Instead, Emanuel and Steinmetz wanted physicians to support six strategies for transforming health care delivery, without citing evidence in support of these strategies. The Emanuel and Steinmetz editorial ignored the physicians' views on corporate influence.
A post on the In My Humble Opinion blog by Dr Jordan Grumet in turn wondered why physicians should support "Ezekiel's fantasies about healthcare [which] are unsubstantiated." Dr Grumet decried how particularly primary care physicians have been marginalized, and suggested that if Emanuel and Steinmetz want physicians to act like the captains of the ship they perhaps should not dictate their navigation. But Dr Grumet apparently did not notice that physicians may realize that their captaincy has been challenged by corporate influence. .
Media coverage in, for example, the Los Angeles Times, Fox News, and the Pioneer Press focused on the question of whether physicians were denying a responsibility to control costs, and whether that responsibility was really theirs. It did not comment on the issue of corporate influence.
However, so far the striking result that a large, well conducted survey showed that the majority of physicians support limiting corporate influence on their behavior remains almost completely unnoticed.
Summary
We now have some reasonably good data suggesting that the majority of physicians are very troubled by "corporate influences" on them.
It could be that they are troubled by the most direct corporate influences, the practice of medicine by physicians who are employees of corporations, often large, and for-profit.
Dr Arnold Relman reminded us that physicians used to shun the commercial practice of medicine (look here). Yet now increasing numbers of physicians are employees of for-profit corporations. Physicians and other health professionals who sign on as full-time employees of large corporate entities have to realize that they are now beholden to managers and executives who may be hostile to their professional values, and who are subject to perverse incentives that support such hostility, including the potential for huge executive compensation. It is not clear why physicians seem to be willing to sign contracts that underline their new subservience to their corporate overlords, and likely trap them within confidentiality clauses that make blowing the whistle likely to lead to extreme unpleasantness.
It could also be that physicians are troubled by slightly less direct corporate influences. We have blogged about
- suppression and manipulation of clinical research by corporations sponsoring such research to assess their own products and services
- deceptive corporate practices like stealth marketing of stealth lobbying
- financial arrangements among physicians (and other health professionals) and health care corporations (e.g., drug, biotechnology and device corporations) which often seem to deliberately produce conflicts of interest meant to help market products and services, particularly the use of paid "key opinion leaders" as marketers
- institutional conflicts of interest that involve academic institutions, disease advocacy organizations, and other non-profit groups in corporate marketing and public relations
Furthermore, stories about and criticisms of these issues remain markedly muted in the media, and even more muted in medical and health care scholarship and scholarly journals. We have attributed this anechoic effect to individual and institutional conflicts of interest, fear of offending conflicted friends, relatives, colleagues and supervisors, and fear of offending the rich and powerful.
Despite the anechoic effect, the article by Tilburt et al suggests that physicians want to reduce corporate influence in medicine. Yet this evidence of physicians' discomfort with corporate influences itself has been greatly muted by the anechoic effect.
While the survey results are reminiscent of opinions I have heard from many physicians, it is striking that there is no perceptible organized movement by physicians against excess corporate influence. At best, public expression of concerns about excess corporate influence has been muted and fragmented, often relegated to blogs and sometimes derided as coming from malcontents, dissidents, disgruntled employees, and other assorted trouble-makers. But again it looks like the majority of physicians may (often silently) agree with these "whiners and complainers."
Physicians need to realize that they mostly agree that to fulfill their oaths to put patients first, they have to reduce the influence of rich and powerful organizations, like health care corporations, with other agendas. Maybe once they realize this, they will be able to start doing something to reduce such influences. Maybe once they start, they will be able to rethink the notion that direct health care should ever be provided, or that medicine ought to be practiced by for-profit corporations. I submit that we will not be able to have good quality, accessible health care at an affordable price until we restore physicians as independent, ethical health care professionals, and until we restore small, independent, community responsible, non-profit hospitals as the locus for inpatient care.
Roy M. Poses MD on Health Care Renewal
References
1. Tilburt JC, Wynia MK, Sheeler RD et al. Views of physicians about controlling health care costs. JAMA 2013: 310: 380-388. Link here.
2. Emanuel EJ, Steinmetz A. Will physicians lead on controlling health care costs? JAMA 2013; 310: 374-375. Link here.
Doctors now spend more time with computers than they do with patients
This bodes poorly for future physician quality:
I can assert this is not what the EMR pioneers intended. They intended health IT to reduce workloads and inefficiencies so clinicians could spend more time performing care. The tools they prototyped decades ago, unfortunately, are no longer in control of, or serving, the clinicians they intended the tools to serve. Instead they are largely serving a permanent and growing bureaucracy.
They are, in fact, mis-serving clinicians e.g., through production of reams of legible gibberish (http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html), clinically mission-hostile designs (http://www.tinyurl.com/hostileuserexper), outright defects (http://hcrenewal.blogspot.com/search/label/glitch) and marauding hyperenthusiast-extremists pushing the technology on ill-informed management (http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html).
I think the illustration was appropriate; see article link for the artwork.
Let me say this bluntly: most people lacking full medical training cannot grasp this concept. They do not know what they do not know. Worse, many non-clinicians I've encountered, especially in the health IT domain, seem to be unable or unwilling will to accept that simple truth (perhaps in part due to the Dunning-Kruger effect).
Perhaps decreasing patient satisfaction scores might change the current state of affairs?
Or, if unable to "exist in service to patient care" due to industry problems, it needs to cease to exist (i.e., be put on hold or put on ice) until it can perform to expectations.
-- SS
The doctor won't see you now
DANIELLE OFRI
Pittsburgh Post-Gazette
August 11, 2013 12:03 am
Like the mail carrier or the milkman of yore, the doctor makes rounds every day in the hospital. If it's an academic institution, a bevy of medical students, interns and residents accompany an attending physician from room to room, checking up on the patient, doing a daily physical exam, reviewing the latest test results and highlighting the relevant teaching points. That's been the mainstay of medical education, and that's how my colleagues and I were taught to train the next generation of doctors.
Alas, this image would be true today only if a computer terminal were plunked in the bed instead of a patient. A new study in the Journal of General Internal Medicine confirms what any physician or patient could tell you: Doctors spend more time with computers than they do with patients. In fact, computers handily beat out patients: Medical interns spent 40 percent of their day with a computer compared with 12 percent of their day with actual living, breathing patients. (Discussing cases with other health care professionals and educational activities were the other main activities of the day.)
... Nurses are practically chained to their computers these days. A typical outpatient office visit today consists of a doctor focused directly at a screen, and a patient waiting, ahem, patiently, while the doctor thrashes it out with the computer, furiously typing notes, orders and prescriptions, occasionally whacking the side of the computer in frustration.
I can assert this is not what the EMR pioneers intended. They intended health IT to reduce workloads and inefficiencies so clinicians could spend more time performing care. The tools they prototyped decades ago, unfortunately, are no longer in control of, or serving, the clinicians they intended the tools to serve. Instead they are largely serving a permanent and growing bureaucracy.
They are, in fact, mis-serving clinicians e.g., through production of reams of legible gibberish (http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html), clinically mission-hostile designs (http://www.tinyurl.com/hostileuserexper), outright defects (http://hcrenewal.blogspot.com/search/label/glitch) and marauding hyperenthusiast-extremists pushing the technology on ill-informed management (http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html).
I think the illustration was appropriate; see article link for the artwork.
... For many doctors, nurses and patients, the experience of technology today--particularly the electronic medical record -- makes it feel as though technology is front and center while actual medical care is secondary. The expansion of the EMR has taken us to the point that caregivers hardly need to see a patient at all; the practice of medicine can be entirely virtual.
It can be "virtual" if one wants low quality, that is. Here's why:
... It was a brazen revolution in the 1890s when Sir William Osler pulled medical students out of the lecture hall and into the ward, with the startling idea that students needed to learn medicine with actual patients. But our technological march has steadily sapped this Oslerian ideal, and our trainees today are missing out on many of the finer points of medicine. Despite the impressive leaps forward in simulation technology, you simply cannot learn the subtleties of assessing a wound, palpating a spleen, asking the right questions, navigating a patient's fears, engendering trust, without actually being with patients.
Let me say this bluntly: most people lacking full medical training cannot grasp this concept. They do not know what they do not know. Worse, many non-clinicians I've encountered, especially in the health IT domain, seem to be unable or unwilling will to accept that simple truth (perhaps in part due to the Dunning-Kruger effect).
... And for patients, medical care has become an increasingly isolating experience, as their caregivers seem more beholden to technologies than to their illnesses, which are most certainly not virtual.
Perhaps decreasing patient satisfaction scores might change the current state of affairs?
... We need to rethink the role of technology in medicine, especially the electronic medical record. The new mantra of "patient-centered care" needs to apply equally to our computerized systems. With each new iteration of the EMR, we need to ask ourselves how patients are benefiting, as opposed to whether we are merely satisfying administrative documentation mandates. The EMR needs to exist in service to patient care, not simply as an end in itself.
Or, if unable to "exist in service to patient care" due to industry problems, it needs to cease to exist (i.e., be put on hold or put on ice) until it can perform to expectations.
Who Would Have Thought, Comrades, That The Most Severe Form of Attempted Internet Censorship Could Originate in a Community Hospital, Abington Memorial, That Alleges Itself A Non-Profit Public Servant?
I would not have thought such an attempt at abridgement of fundamental American rights could originate in a local hospital, until this Motion by the defense in the EHR-related lawsuit initiated by my deceased mother in which I am now substitute plaintiff proved otherwise:
The hospital was attempting to have the Court issue a Motion for Prior Restraint (http://en.wikipedia.org/wiki/Prior_restraint), including against my writings here in the Healthcare Renewal blog, in a civil matter.
In my view this attempt sets a very deleterious precedent for others opposed to hospital practices. A topic frequently discussed at this blog is imperial management. Hospital management seems to have now become so arrogant that it apparently believes itself to have supra-Constitutional reach. This bodes poorly for both patients' and clinicians' rights. How many other hospitals might try this, and not just against parties to litigation, hoping to get a favorable ruling?
Excerpts of plaintiff attorney's legal response are below (full PDF of this civil document is available at http://www.ischool.drexel.edu/faculty/ssilverstein/Abington_Memorial_Hospital_PL%20response%20to%20DF%20motion%20for%20prior%20restraint.PDF). The response was, in fact, largely right out of the U.S. Constitution. It is stunning that a community hospital, allegedly a servant of the public, would pull the legal stunts described which seem more akin to the methods of the former Soviet Union:
I would expect the defendant's counsel was following the instructions of, or at least was in collaboration with, hospital counsel, hospital senior management and the healthcare system Board of Directors.
The court, a civil Court of Common Pleas in this county in Pennsylvania, in fact did promptly make a decision: hospital motion for censorship denied.
The First Amendment lives, at least in Montgomery County, Pennsylvania.
However, as the stories aggregated on this blog and others increasingly show, hospitals' mission of public service increasingly seems to be dying.
Attempted use of courts to abridge First Amendment rights by a hospital seems like the pinnacle of abandonment of pretenses of public service and accountability. Corporate interests come first, not patients.
This is a reason I increasingly am of the belief that hospital management cannot be trusted. Accordingly, in my opinion, patients - especially acute inpatients - should have 24x7, independent advocates following every aspect of their care, receiving a daily full printout of any electronic records generated, and (if legal) even using one of the many new, small video/audio recording devices in encounters with hospital personnel.
"He said/she said" is no longer an option when dealing with a Сою́з Сове́тских Социалисти́ческих Респу́блик mentality.
Perhaps Abington Memorial Hospital should consider adopting the rousing music above for their HR morale-building exercises.
I was a Medical Resident there in 1985-87. Like Lev Davidovich Bronshtein, I guess I've been excommunicated for failure of obedience to the Party line.
Da Svedanya for now, Comrades!
-- SS
| 75 | E | 4/19/2013 | Motion | BY ABINGTON MEMORIAL HOSPITAL MOTION TO PROHIBIT COMMENTARY ABOUT THIS LITIGATION TO ANY PUBLIC CONTEXT WITH MEMORANDUM OF LAW WITH SERVICE ON 04/19/2013 | No | 9267260 |
The hospital was attempting to have the Court issue a Motion for Prior Restraint (http://en.wikipedia.org/wiki/Prior_restraint), including against my writings here in the Healthcare Renewal blog, in a civil matter.
In my view this attempt sets a very deleterious precedent for others opposed to hospital practices. A topic frequently discussed at this blog is imperial management. Hospital management seems to have now become so arrogant that it apparently believes itself to have supra-Constitutional reach. This bodes poorly for both patients' and clinicians' rights. How many other hospitals might try this, and not just against parties to litigation, hoping to get a favorable ruling?
Prior restraint (also referred to as prior censorship or pre-publication censorship) is censorship imposed, usually by a government, on expression before the expression actually takes place.
Prior restraint is often considered a particularly oppressive form of censorship in Anglo-American jurisprudence because it prevents the restricted material from being heard or distributed at all. Prior restraint ... takes an idea or material completely out of the marketplace. Thus it is often considered to be the most extreme form of censorship.
... most of the early struggles for freedom of the press were against forms of prior restraint. Thus prior restraint came to be looked upon with a particular horror, and Anglo-American courts became particularly unwilling to approve it, when they might approve other forms of press restriction.
Excerpts of plaintiff attorney's legal response are below (full PDF of this civil document is available at http://www.ischool.drexel.edu/faculty/ssilverstein/Abington_Memorial_Hospital_PL%20response%20to%20DF%20motion%20for%20prior%20restraint.PDF). The response was, in fact, largely right out of the U.S. Constitution. It is stunning that a community hospital, allegedly a servant of the public, would pull the legal stunts described which seem more akin to the methods of the former Soviet Union:
... as the entirety of the blog describes, Dr. Silverstein was troubled with, and expressed his opinion that, the defendant’s counsel’s repeatedly advancing an argument [that the same attorney had made three years prior regarding a medical malpractice case in the very same hospital - ed.] that was soundly rejected by another court [related to Certificates of Merit that delayed proceedings in my mother's case for almost two years - ed.], and the defendant’s failure to reference that case in any substantive way as opposing authority, was, in his protected opinion, malicious and unethical. As above, Dr. Silverstein’s comments on the matter are, as defendant agrees, his beliefs, opinions and viewpoints, all of which are protected speech under the Pennsylvania and United States Constitutions; that defendant’s counsel is dissatisfied with protected speech is not a matter for this court to address.
I would expect the defendant's counsel was following the instructions of, or at least was in collaboration with, hospital counsel, hospital senior management and the healthcare system Board of Directors.
... Unhappy that their improper tactics are now being exposed through Dr. Silverstein’s opinions in his blog, defense counsel initially threatened litigation. Now they ask this court to enjoin Dr. Silverstein, via prior restraint, from expressing his views. This extraordinary request comes in spite of the defendant offering nothing but pure speculation as the foundation upon which they ask this Court to strip the plaintiff of his First Amendment rights.
... Their request to strip plaintiff of his First Amendment rights is at odds with the Constitution, the caselaw, and the realities of the jury selection process, which has multiple safeguards in place to remove anyone who may have read and been influenced by Dr. Silverstein’s writings. Importantly, because of the defendant’s procedural tactics, this case, while over two years old, has only just begun discovery and the jury section process is nowhere in the near future.
... The simple fact is that Dr. Silverstein’s blog contains what defendant recognizes are his “beliefs, opinions and viewpoints” and, as such, they are protected. Neither defendant nor its counsel can meet the strict requirements of their unprecedented request to strip Dr. Silverstein of his constitutional rights. Their Motion must be swiftly denied.
Dated: 28 May 2013
The court, a civil Court of Common Pleas in this county in Pennsylvania, in fact did promptly make a decision: hospital motion for censorship denied.
| 182 | 6/24/2013 | Order | OF 6/20/13 DANIELE,J MOTION IS DENIED; CC | No | 9343590 |
The First Amendment lives, at least in Montgomery County, Pennsylvania.
However, as the stories aggregated on this blog and others increasingly show, hospitals' mission of public service increasingly seems to be dying.
Attempted use of courts to abridge First Amendment rights by a hospital seems like the pinnacle of abandonment of pretenses of public service and accountability. Corporate interests come first, not patients.
This is a reason I increasingly am of the belief that hospital management cannot be trusted. Accordingly, in my opinion, patients - especially acute inpatients - should have 24x7, independent advocates following every aspect of their care, receiving a daily full printout of any electronic records generated, and (if legal) even using one of the many new, small video/audio recording devices in encounters with hospital personnel.
"He said/she said" is no longer an option when dealing with a Сою́з Сове́тских Социалисти́ческих Респу́блик mentality.
 |
| Click for Patriotic music! |
Perhaps Abington Memorial Hospital should consider adopting the rousing music above for their HR morale-building exercises.
I was a Medical Resident there in 1985-87. Like Lev Davidovich Bronshtein, I guess I've been excommunicated for failure of obedience to the Party line.
 |
| My old residency ID. I've now been excommuncated. |
Da Svedanya for now, Comrades!
-- SS
A War on Patients: Panel Says EHRs Should Not Be Vetted Before Marketing and Deployment
"First, do harm - it's a learning experience, and injured or dead patients are just a bump in the road, anyway" - the apparent creed of the healthcare computing hyperenthusiasts
Joe Conn and Modern Healthcare published the following article:
Work group says OK to some HIT safety regs (link), Joe Conn, Modern Healthcare, Aug. 7, 2013
Health Care Revolving Door Roundup
Increasingly, the regulatory and law enforcement functions of the US government in the health care sphere seem to be blending with the management of large health care organizations. One mechanism for this is the "revolving door," the constant interchange of personnel between government agencies and corporate management.
Here is a list of some of this year's interesting cases of people transiting the revolving door between US government agencies that are supposed to regulate health care organizations or enforce the relevant laws and the organizations subject to these regulations and laws. Note that this list may not be complete. It is difficult to keep track of these transitions.
Leader of Health Care Fraud Section of Philadelphia US Attorney's Office to Teva Pharmaceuticals
Via MainJustice.org in March, 2013,
Leader of US Department of Justice Fraud Section in Charge of Health Care Issues to Law Firm as Defender of Companies and Senior Executives
The initial notice again was via MainJustice.org in March, 2013
Mr Sheldon's new job was made clear on the firm's website,
FDA Deputy Commissioner for Global Regulatory Operations and Policy to Mylan
This story, in April, actually made it (briefly) to Reuters,
Leader of Health Care Fraud Enforcement of Philadelphia US Attorney's Office to Law Firm as Industry Defender
From Bloomberg, in August, 2013,
The law firm's website states,
Summary
In each of these cases, a person with responsibility for regulation of and/or law enforcement for health care organizations went through the revolving door to either work for health care corporations subject to such regulation and/or law enforcement, or work for legal firms that specialize in defending such corporations and their leaders in regulatory and law enforcement actions.
As far as I know, none of these instances was the least bit illegal. However, like previous examples of the revolving door, they raise the concern that people in government regulation or law enforcement who think that they may have future lucrative job prospects helping health care organizations attenuate regulation and law enforcement may not be the most enthusiastic, aggressive, or persistent regulators or law enforcers. Why would one want to upset one's future employer?
While these cases of the revolving door are legal, they are clearly conflicts of interest in the sense that the prospect of such future employment likely may increase the risk of compromising a government official's devotion to serving the public and enforcing the law, if not in the legal sense. In some particular case, the revolving door may actually lead to corruption according to the Transparency International definition, abuse of entrusted power for private gain, if not according to the legal definition. Thus the continuing occurrence of government officials blithely transiting the revolving door no doubt was a reason that more than 40% of the public consider the US health care sector to be corrupt (see this post.)
True health care reform would require curtailing the severe sorts of conflicts of interest created by the revolving door. This might require both improving pay and working conditions for government regulators and law enforcers, and specific laws to prevent immediate transitions from being a regulator/ law enforcer to handling corporate responses to or defenses of such regulation and enforcement.
Of course, I can already hear the protests of those people who decry paying more for government or increasing government regulation. I can at least hope that the protests are not from those who personally profit from the current seemingly corrupt system.
Here is a list of some of this year's interesting cases of people transiting the revolving door between US government agencies that are supposed to regulate health care organizations or enforce the relevant laws and the organizations subject to these regulations and laws. Note that this list may not be complete. It is difficult to keep track of these transitions.
Leader of Health Care Fraud Section of Philadelphia US Attorney's Office to Teva Pharmaceuticals
Via MainJustice.org in March, 2013,
John Pease, who led the government and health care fraud section in the U.S. Attorney's Office in Philadelphia, has left the Justice Department for a job with a pharmaceutical company.
Pease, 45, is a new senior counsel at Teva Pharmaceuticals, where he oversees government investigations of the company for the Americas. 'I was just ready to try something different,' Pease said in an interview.
Leader of US Department of Justice Fraud Section in Charge of Health Care Issues to Law Firm as Defender of Companies and Senior Executives
The initial notice again was via MainJustice.org in March, 2013
Sam Sheldon, the deputy chief in the Criminal Division's Fraud Section who oversaw health care fraud prosecutions, is leaving the Justice Department to join Quinn Emanuel Urquhart & Sullivan LLP.
Mr Sheldon's new job was made clear on the firm's website,
Sam Sheldon is head of the firm’s Health Care Practice Group. He is a trial lawyer who represents companies and senior executives in litigation before the United States federal government including Department of Justice and Department of Health and Human Services, and other law enforcement and regulatory agencies.
FDA Deputy Commissioner for Global Regulatory Operations and Policy to Mylan
This story, in April, actually made it (briefly) to Reuters,
Generic drugmaker Mylan Inc said on Tuesday it hired Deborah Autor, deputy commissioner for global regulatory operations and policy at the U.S. Food and Drug Administration, to help oversee its global regulatory strategy.
Leader of Health Care Fraud Enforcement of Philadelphia US Attorney's Office to Law Firm as Industry Defender
From Bloomberg, in August, 2013,
Marilyn May, a False Claims Act litigator at the U.S. Justice Department, joined Arnold & Porter LLP’s Washington office as litigation counsel with a focus on healthcare, pharmaceutical and medical device industry defense work.
May was the head of healthcare fraud enforcement in the U.S. Attorney’s Office in the Eastern District of Pennsylvania. She coordinated healthcare fraud cases and investigations as well as handled False Claims Act cases involving pharmaceutical and medical device companies, hospitals, nursing homes and other healthcare providers, the firm said.
The law firm's website states,
Her litigation practice focuses on pharmaceutical, medical device and healthcare defense matters.
Summary
In each of these cases, a person with responsibility for regulation of and/or law enforcement for health care organizations went through the revolving door to either work for health care corporations subject to such regulation and/or law enforcement, or work for legal firms that specialize in defending such corporations and their leaders in regulatory and law enforcement actions.
As far as I know, none of these instances was the least bit illegal. However, like previous examples of the revolving door, they raise the concern that people in government regulation or law enforcement who think that they may have future lucrative job prospects helping health care organizations attenuate regulation and law enforcement may not be the most enthusiastic, aggressive, or persistent regulators or law enforcers. Why would one want to upset one's future employer?
While these cases of the revolving door are legal, they are clearly conflicts of interest in the sense that the prospect of such future employment likely may increase the risk of compromising a government official's devotion to serving the public and enforcing the law, if not in the legal sense. In some particular case, the revolving door may actually lead to corruption according to the Transparency International definition, abuse of entrusted power for private gain, if not according to the legal definition. Thus the continuing occurrence of government officials blithely transiting the revolving door no doubt was a reason that more than 40% of the public consider the US health care sector to be corrupt (see this post.)
True health care reform would require curtailing the severe sorts of conflicts of interest created by the revolving door. This might require both improving pay and working conditions for government regulators and law enforcers, and specific laws to prevent immediate transitions from being a regulator/ law enforcer to handling corporate responses to or defenses of such regulation and enforcement.
Of course, I can already hear the protests of those people who decry paying more for government or increasing government regulation. I can at least hope that the protests are not from those who personally profit from the current seemingly corrupt system.
Today's Bad Health IT Systems: More Dangerous Than Paper?
I believe in 2013 that they are.
(Definition of bad health IT is here: http://www.ischool.drexel.edu/faculty/ssilverstein/cases/)
I recently posted about two "glitches" in a major EHR seller's clinical systems, Siemens Healthcare, affecting safety-critical functions of medication reconciliation and medication ordering.
Considering these, plus the many "glitches" reported by the only EHR seller who does so via FDA's MAUDE database (see here: http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html), and the others posted at this blog at query link: http://hcrenewal.blogspot.com/search/label/glitch, the following issue needs serious consideration by policymakers.
Namely, the issue that enterprise electronic medical command-and-control systems, which today's "EHRs" in reality are, are on their face more risk-prone than the paper systems they are replacing.
The "glitches" reported above are clearly the tip of the iceberg due to industry norms of secrecy, the absence of most of the industry in reporting to FDA MAUDE or anywhere, and my limited sources of information. It is likely the true level of "glitches" in live EHR/clinical IT installations is far, far higher - conservatively, I believe, at least two orders of magnitude.
Workarounds to IT "glitches" such as recommended in the Siemens bulletins at the aforementioned posts cause hospital officials to have to reliably get the notices to all users of the systems, including medical students, nurses, physicians and allied health professionals.
The workarounds also cause users to:
1) have to deviate from habits of use acquired in training and active use of the systems in question;
2) remember, without fail, to deviate from habits of use acquired in training and active use of the systems in question, in effect giving them the responsibility of caring for sick patients and for "sick" information technology;
3) keep in mind any other extant workarounds that exist waiting for "fixes"; and
4) be constantly on guard for information storage failures.
In fact, the recent Siemens "glitches" and workarounds represent a clear danger to patient safety. If these were more conventional medical devices, they'd be recalled.
See my Dec. 14, 2011 post "FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death" (http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html) and July 23, 2012 post "Health IT FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems"(http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html) for examples where health IT defects similar to the Siemens issues were, in fact, recalled.
Further, with paper records or tangible images, a page or image can be lost, or it can be illegible. In the case of lost, in any quality paper record keeping system the information stewards or others using the paper (e.g., office staff or ward clerks) will generally note the absence and act accordingly. Further, illegible notes or orders will most often be recognized as illegible and result in attempted clarification or other corrective actions.
On the other hand, when electronic systems:
1) lose modified information en masse as in the Siemens examples but keep the old, or
2) when outright errors such as en masse truncation occur (as in the thousands of prescriptions whose long-acting suffixes were cut off at Lifespan in Rhode Island, see "Yet another health IT "glitch" affecting thousands" here: http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html), or
3) images are lost (see "Potential Image Loss in GE Centricity PACS" here: http://hcrenewal.blogspot.com/2012/11/potential-image-loss-in-ge-centricity.html) without warning-
- There are no "flags" that the obsolete, truncated or missing information is erroneous.
What remains is perfectly legible, perfectly convincing and perfectly deceiving.
Electronic healthcare information systems on their face create more risk than paper record systems. Further, the problem with "bugs" and "glitches" will not go away with today's industry models of "hiring down" and lack of regulation. Every new upgrade or patch is suspect for introducing new bugs.
Paper does not suffer these issues, unless disappearing ink is used to cross out the old and add new information ...
Not that I am advocating for a return to 100% paper, but certain critical functions probably are best left to paper. Further, hundreds of billions of dollars can certainly buy:
1) a lot of Health Information Management professionals to perform continuous QA of paper,
2) a lot of document imaging systems to make the paper records available anywhere, anytime they are needed, and
3) a lot of data entry personnel to relieve clinicians of clerical burdens so they may use their valuable experience more productively, as guest poster Howard Brody points out at http://hcrenewal.blogspot.com/2013/07/guest-post-incompetent-management.html.
4) a lot of sensible regulation of this industry's product quality.
-- SS
(Definition of bad health IT is here: http://www.ischool.drexel.edu/faculty/ssilverstein/cases/)
I recently posted about two "glitches" in a major EHR seller's clinical systems, Siemens Healthcare, affecting safety-critical functions of medication reconciliation and medication ordering.
Considering these, plus the many "glitches" reported by the only EHR seller who does so via FDA's MAUDE database (see here: http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html), and the others posted at this blog at query link: http://hcrenewal.blogspot.com/search/label/glitch, the following issue needs serious consideration by policymakers.
Namely, the issue that enterprise electronic medical command-and-control systems, which today's "EHRs" in reality are, are on their face more risk-prone than the paper systems they are replacing.
The "glitches" reported above are clearly the tip of the iceberg due to industry norms of secrecy, the absence of most of the industry in reporting to FDA MAUDE or anywhere, and my limited sources of information. It is likely the true level of "glitches" in live EHR/clinical IT installations is far, far higher - conservatively, I believe, at least two orders of magnitude.
Workarounds to IT "glitches" such as recommended in the Siemens bulletins at the aforementioned posts cause hospital officials to have to reliably get the notices to all users of the systems, including medical students, nurses, physicians and allied health professionals.
The workarounds also cause users to:
1) have to deviate from habits of use acquired in training and active use of the systems in question;
2) remember, without fail, to deviate from habits of use acquired in training and active use of the systems in question, in effect giving them the responsibility of caring for sick patients and for "sick" information technology;
3) keep in mind any other extant workarounds that exist waiting for "fixes"; and
4) be constantly on guard for information storage failures.
In fact, the recent Siemens "glitches" and workarounds represent a clear danger to patient safety. If these were more conventional medical devices, they'd be recalled.
See my Dec. 14, 2011 post "FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death" (http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html) and July 23, 2012 post "Health IT FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems"(http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html) for examples where health IT defects similar to the Siemens issues were, in fact, recalled.
Further, with paper records or tangible images, a page or image can be lost, or it can be illegible. In the case of lost, in any quality paper record keeping system the information stewards or others using the paper (e.g., office staff or ward clerks) will generally note the absence and act accordingly. Further, illegible notes or orders will most often be recognized as illegible and result in attempted clarification or other corrective actions.
On the other hand, when electronic systems:
1) lose modified information en masse as in the Siemens examples but keep the old, or
2) when outright errors such as en masse truncation occur (as in the thousands of prescriptions whose long-acting suffixes were cut off at Lifespan in Rhode Island, see "Yet another health IT "glitch" affecting thousands" here: http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html), or
3) images are lost (see "Potential Image Loss in GE Centricity PACS" here: http://hcrenewal.blogspot.com/2012/11/potential-image-loss-in-ge-centricity.html) without warning-
- There are no "flags" that the obsolete, truncated or missing information is erroneous.
What remains is perfectly legible, perfectly convincing and perfectly deceiving.
Electronic healthcare information systems on their face create more risk than paper record systems. Further, the problem with "bugs" and "glitches" will not go away with today's industry models of "hiring down" and lack of regulation. Every new upgrade or patch is suspect for introducing new bugs.
Paper does not suffer these issues, unless disappearing ink is used to cross out the old and add new information ...
Not that I am advocating for a return to 100% paper, but certain critical functions probably are best left to paper. Further, hundreds of billions of dollars can certainly buy:
1) a lot of Health Information Management professionals to perform continuous QA of paper,
2) a lot of document imaging systems to make the paper records available anywhere, anytime they are needed, and
3) a lot of data entry personnel to relieve clinicians of clerical burdens so they may use their valuable experience more productively, as guest poster Howard Brody points out at http://hcrenewal.blogspot.com/2013/07/guest-post-incompetent-management.html.
4) a lot of sensible regulation of this industry's product quality.
-- SS
Can Digital Disappearing Ink (An EHR "Glitch") Kill Patients? Part 2
At "Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients?" just yesterday, on August 5, 2013, I wrote about a Siemens EHR "glitch" worse than any paper records system problem. Typed order changes in the medication reconciliation process on patient discharge are disappearing into thin air, unknown to the clinicians typing the orders. This is likely due to an issue such as some programmer forgetting to put in a statement to write the text to disk, complicated by software testing problems that missed the defect.
I noted:
Paper records may have illegible writing that would generally cause the reader to make a phone call or otherwise contact the writer, but those events are one-offs. EHR defects potentially affect hundreds of installations and thousands of patients, en masse. (If patients are not dying en masse from such errors, then the whole argument against paper and for IT on the issue of vastly improved safety goes out the windows, but that's an argument for another time.)
Siemens has just released another "glitch" announcement, this time with CPOE (computerized order entry):
Text is as follows:
I note that "glitches" are not uncommon after software patches and upgrades. See examples at the query link http://hcrenewal.blogspot.com/search/label/glitch. This reflects inadequate vetting of the patches.
I also note that "medication orders not operating properly" is a very, very serious matter.
"May only affect some customers?" (I suspect from this double-indefinite that who is affected is not rigorously known). "Taking a conservative approach?" I ask: what would a non-conservative approach entail?
Again, they mean "yet."
When does this issue occur and what are the potential risks?
This problem - manually changed data apparently not written to disk - seems similar to the "digital disappearing ink" med reconciliation bug in the aforementioned Aug. 5, 2013 post.
Immediate steps you should take to avoid the potential risk of this issue:
Again, a workaround. How many times will this workaround be forgotten, compared to issues of illegibility in a paper record resulting in a phone call to the writer?
Perhaps they should have been working more diligently to detect the "glitch" before it went live.
Also, perhaps the touted power of EHRs to reduce medical errors needs to be re-examined. Considering bugs like these - creating en-masse problems far worse than possible with paper (another en-masse example at http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html) - then, if the EHRs are so essential to safety, one would expect significant morbidity and mortality from these defects.
If one is to believe patients are not being injured by "glitches", then the expenditure of hundreds of billions of dollars for these systems on the basis of "error reduction" compared to paper is likely a waste of money and resources.
-- SS
I noted:
... "Glitch" is a banal term used by health IT extremists (those who have abandoned a rigorous scientific approach to these medical devices as well as basic patient protections, in favor of unwarranted and inappropriate overconfidence and hyper-enthusiasm). The term is used to represent potentially injurious and lethal problems with health IT, usually related to inadequate software vetting and perhaps even "sweatshop floor in foreign country directly to production for U.S. hospital floors" development processes (this industry is entirely unregulated).
Paper records may have illegible writing that would generally cause the reader to make a phone call or otherwise contact the writer, but those events are one-offs. EHR defects potentially affect hundreds of installations and thousands of patients, en masse. (If patients are not dying en masse from such errors, then the whole argument against paper and for IT on the issue of vastly improved safety goes out the windows, but that's an argument for another time.)
Siemens has just released another "glitch" announcement, this time with CPOE (computerized order entry):
 |
| (Medication orders "glictch" safety complaint. Click to enlarge, text below) |
Text is as follows:
August 2, 2013
Safety Advisory Notification
Soarian® Clinicals Medication Orders, Safety Complaint ID# EV06643783
Dear Customer:
This notification is to inform you that the Soarian Clinicals Medication Orders may not be operating properly in some cases in Soarian Clinicals 3.3 Service Pack 6 and above.
I note that "glitches" are not uncommon after software patches and upgrades. See examples at the query link http://hcrenewal.blogspot.com/search/label/glitch. This reflects inadequate vetting of the patches.
I also note that "medication orders not operating properly" is a very, very serious matter.
Although this may affect only some customers, we are taking a conservative approach and are alerting you to this potential problem. As such, please forward this notification to appropriate personnel as soon as possible.
"May only affect some customers?" (I suspect from this double-indefinite that who is affected is not rigorously known). "Taking a conservative approach?" I ask: what would a non-conservative approach entail?
This letter is being sent as a precautionary measure as there have been no adverse events reported from customers.
Again, they mean "yet."
When does this issue occur and what are the potential risks?
The issue occurs while placing medication orders. In certain cases, when users select orders from predefines or personal favorites and make changes on the order detail forms, the changes are correctly saved and displayed on the forms but the Order As Written (OAW) is not refreshed to reflect the changes. The incorrect OAW is displayed in Siemens Pharmacy in the Order As Written window but the discrete order details are correct. As a result dispensing or administering relying solely on the OAW prior to pharmacy validation may result in error. [Putting patients directly in harm's way, patients who never consented to the use of these experimental and unvetted medical devices - ed.] Once the order is validated the OAW in Soarian is updated correctly.
This problem - manually changed data apparently not written to disk - seems similar to the "digital disappearing ink" med reconciliation bug in the aforementioned Aug. 5, 2013 post.
Immediate steps you should take to avoid the potential risk of this issue:
To prevent this issue from occurring at your facility, dispensing or administering of unvalidated order should rely on the order details displayed. Secondly, any deviations from the predefined or personal favorites should be phoned in to pharmacy as a verbal order. During validation, if the pharmacist sees a discrepancy between the order detail and the OAW, verbal follow up with the ordering physician is required.
Again, a workaround. How many times will this workaround be forgotten, compared to issues of illegibility in a paper record resulting in a phone call to the writer?
Steps that Siemens is taking to correct this complaint:
We are diligently working to develop a correction and will test and deliver it as soon as possible.
Perhaps they should have been working more diligently to detect the "glitch" before it went live.
Also, perhaps the touted power of EHRs to reduce medical errors needs to be re-examined. Considering bugs like these - creating en-masse problems far worse than possible with paper (another en-masse example at http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html) - then, if the EHRs are so essential to safety, one would expect significant morbidity and mortality from these defects.
If one is to believe patients are not being injured by "glitches", then the expenditure of hundreds of billions of dollars for these systems on the basis of "error reduction" compared to paper is likely a waste of money and resources.
-- SS
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