HIMSS 2016 Presentation: Plaintiff’s Lawyers Are The Cause of EHR Problems. They’re Using Pristine, White-as-the-Blowing-Snow EHRs as “An Opportunity for Litigation”

In perhaps the most ill-informed, perverse rationalization/defense of bad health IT I’ve seen to date, the following appeared in an article about an upcoming HIMSS presentation (Healthcare Information and Management Systems Society‘s health IT mega-industry trade show, http://www.himssconference.org).

I remind readers of the definition of bad health IT coined by myself and Australian polymath/informatics scientist Dr. Jon Patrick in 2012, as at my Drexel University College of Computing and Informatics website “Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties” at http://cci.drexel.edu/faculty/ssilverstein/cases/:

Bad Health IT (“BHIT”) is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.


To this definition I should add “that does not support evidentiary trustworthiness.”

The article tries to make the case that Plaintiff’s lawyers are “targeting” the innocent EHR:


Amid surge in malpractice lawsuits, EHRs often targeted in litigation, attorney says
Healthcare IT News, Feb. 4, 2016
Greg Goth
http://www.healthcareitnews.com/news/amid-surge-malpractice-lawsuits-ehrs-often-targeted-litigation-attorney-says

Byline:  Providers often wind up defending their electronic health records, rather than what got them sued in the first place, Mary Re Knack will explain at HIMSS16


The article continues:


As if healthcare executives don’t have enough worries about implementing electronic health records, yet another issue is starting to ramp up.

“What’s been happening more frequently in the last few years is that certain plaintiffs’ lawyers – a kind of group of them who communicate with each other – have started to see the medical record as an opportunity for litigation,” said Mary Re Knack, a Seattle-based attorney for the firm Ogden Murphy Wallace.

Knack will be presenting an exploration of these emerging litigation troubles in the session “Just Press Print: Challenges in Producing EHRs in Litigation” with colleague Elana R. Zana at HIMSS16, beginning in late February.


A group of colluding plaintiff’s lawyers “see the medical record as an opportunity for litigation?”   This statement appears to say, in the words of a colleague, “it’s those $%$%# plaintiff’s attorneys again, preying on our worthy docs and hospitals and their good intentions with HIT for the nation’s good.”

Ms. Knack seems to veer in the direction of the Defense side as at http://www.omwlaw.com/seattle-attorneys/m-re-knack/:


Ms. Knack is a member of the Healthcare and Litigation Departments.  Her practice focuses on healthcare, insurance, product liability, mass tort, and civil matters.  Ms. Knack provides a wide range of legal services to members of the healthcare industry including negotiating and structuring arrangements, business, regulatory, confidentiality and privacy-related compliance services including HIPAA and state laws, licensing and risk management related services, and related investigations.


The reality in my direct experience is different.  Starting after the EHR-related injury and demise of my mother in 2010, I began lending my medical informatics expertise to lawyers as an Independent Expert Witness towards deciphering and authenticating the legible gibberish that often passes for “medical records.”  In working with and speaking at national meetings to Plaintiff’s lawyers at their invitation, I find that the only thing plaintiff’s lawyers see EHRs as is a badly-designed tool that causes or contributes to medical malpractice itself by disrupting doctors and nurses, and befuddles any reader, attorney or clinician, regarding the true course of clinical events.

They see, in my experience, bad health IT not as an “opportunity for litigation”, but as an impediment to knowing the facts of the case, and a cause of unnecessary patient harm.

(In fact, in late 2014 I spoke to U.S. House members at the Capitol on just those issues, accompanied by several Plaintiff’s attorneys who’d seen horrible patient harms as a result of bad health IT, begging the congresspeople to investigate and take action.)

An early quote in the article is, I’m sure, an inadvertent but an outright condemnation of the health IT industry:


Electronic health record design is paramount among those issues, Knack said, because EHR vendors quite naturally did not build the software with litigation in mind.


It’s bad enough that EHR vendors did not build the software with clinicians and clinical care in mind, resulting in a Complaint Letter from almost 40 medical societies to HHS one year ago (see my Jan. 28, 2015 post “‘Meaningful Use’ not so meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing” at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html, which contains a link to the aforementioned medical societies letter).

Ms. Knack now avers that EHR vendors did not build the software with adequate due diligence towards evidentiary/litigation matters.

In other words, the software is not designed to produce court-ready records that can be easily shown to be complete, free from alteration, and trustworthy in order to meet the business record exception to hearsay (Also known as the Business Entry Rule, this exception to the evidentiary rule, which excludes hearsay from a trial, allows business records to be admitted if the proper foundation is laid to show the document is reliable, https://www.law.cornell.edu/wex/business_records_exception).

I take great issue with the declaration that such evidentiary faults were incorporated “quite naturally” by the vendors.  It’s not like medical malpractice is a State Secret, and the need for records trustworthiness kept under cover by the National Security Agency.

I thus feel compelled to correct Ms. Knack’s statement to read as follows:


Electronic health record design is paramount among those issues, Knack said, because EHR vendors quite negligently did not build the software with litigation in mind.

Next:


“The data is all stored behind these templates, and depending on what you are trying to look at, whether it’s a summary or lab reports or such, the data then populates the template on a screen. But when you print it, it doesn’t print out as cleanly or as nicely,” Knack said.


In fact, the arrangement of data on the screens is often very, very bad in terms of understanding the patient (e.g., see my Dec. 6, 2013 post “EHR Pastel Madness: Cognitive Overload in Critical Care” at http://hcrenewal.blogspot.com/2013/12/ehr-pastel-madness-cognitive-overload.html).  Usability of most commercial EHRs leaves much to be desired, and that does not involve paper printouts.

That said, I do agree with Ms. Knack that paper printouts – the reams and reams that come out of these systems even after short hospitalizations – are often informationally cryptic, sloppy, filled with distracting irrelevancy, and tiring to use.  See my Feb. 27, 2011 post “Electronic Medical Records: Two Weeks, Two Reams” at http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html for instance.  (Indeed, my own mother’s thousands of pages are a nightmare, even for me who trained in the paper days at the very hospital in which those records were generated, was there almost every day observing events of my mother’s care in 2010-11, and who is a Medical Informatics specialist).

This raises the following questions:

  • Why doesn’t that paper “print out as cleanly or nicely” as the (already problematic) screens?
  • Who designed the systems this way?  Again in my own experience as a developer and CMIO, it is not hard to produce quality output, see for instance my report at http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story
  • Who approved the purchase of these systems whose paper output is not “clear and nice”?  It’s not as if hospitals don’t have HIM medical record experts, legal counsel, and others to have demanded better;
  • Who implemented the systems as such?
  • Who complacently leaves them in the condition of producing bad paper printouts?


(Note, an anecdote regarding the health IT Industry in the U.S.: the cardiology information system I developed, linked to above in the 2nd bullet point, was seen in 2000 by German engineers at Siemens Healthcare Erlangen as exemplary, and they offered me a position to further develop it, that I declined due to a simultaneous superior offer from Merck Research Labs.  However, in 2007 when I again spoke to Siemens, this time to Americans at the former Shared Medical Systems in Malvern, PA that had been acquired by Siemens, they found a system that actually produced clear, detailed outputs in a critical care area and was in use at the time in a major healthcare system in the region “impractical” – and never followed up with me.  Pearls before….)

Making matters far worse for the EHR sellers and those who actually bought and implemented these cybernetic behemoths, the issues of record evidentiary fitness do not just concern litigation.   That’s just the tip of the iceberg:

A colleague, EHR/HIT Systems and Policy Analyst Dr. Reed Gelzer (https://www.linkedin.com/in/reed-gelzer-4410899) also points out that:

Records management fitness is required also for:

1. Accurate clinical quality measures  
2. Regulatory reporting
3. Alternate payment model services reporting
4. Release of Information for business associates of all kinds, including transitions of care
5. Valuation of clinical organizations in mergers and acquisitions
6. Data quality assurance for each and every potential end-use of clinical information that is dependent on narrative notes (all forms of workload coding/RVUs, episode-of-care costing, etc.)
7. Risk Management of all types, not just medmal.  (Including D&O – Directors & Officers as well as the secondary and re-insurers)

A cavalier approach to evidentiary fitness thus is a gargantuan, bull-in-a-china-shop intrusion of information technology medical amateurs into the clinical setting.  The harm that is/will be caused goes far beyond the trial court.

Then this:


… One of these obvious challenges in trying to review somebody’s care is how do you see it? How do you even read what the care was? Who did what? And when?

“You may have a case that’s very straightforward medical malpractice, but because of the way the medical records get printed out, the same piece of data may appear in five places. Somebody who looks at it, whose goal is to show how it’s confusing, can then start to challenge the care that was given based on the fact the medical record is confusing,” Knack explained. “They can take another step, and that is questioning whether the data in the medical record is accurate or if it has been changed.”


In other words, Plaintiffs lawyers get a pile of evidentiary crap that is, in fact, often confusing (even to a Medical Informatics specialist/physician such as myself), and, evil upon evil, they question whether there’s been any alteration or withholding of an alterable electronic record under sole control of the defendant, to prejudice plaintiffs and advantage defendant.

Medical record alteration is, unfortunately, not that uncommon.   See the search https://www.google.com/search?q=medical+record+alteration&ie=utf-8&oe=utf-8, for instance.

EHRs have a huge vulnerability in that regard.  Plaintiff attorneys are rightly being diligent in questioning the trustworthiness of records.  As it is legally incumbent upon the producer of records to prove they are what they purport to be, and since hospitals and medical professionals have an inherent conflict of interest in producing records that could damage their defense regarding malpractice, in my view the Courts should be as diligent as well before allowing records to be admitted as trustworthy business records.

Last quote from the article:


… As a result, Knack said, a healthcare provider can find itself in litigation that is ostensibly about the care provided, when in actuality that organization has to “defend how the medical record works.”


No, in reality they (rightly) have to defend their decisions to acquire, implement, and fail to remediate bad health IT that produces crap outputs.

More on evidentiary issues below. First, an aside.  It seems to me – if one wants to speak about liability, aside from medical malpractice – that there’s significant grounds for product liability lawsuits regarding these IT systems being unfit for purpose, as well as corporate liability for failure of officers with a fiduciary responsibility to perform due diligence on these critical medical records apparatuses.
  
Further, if the printouts are bad compared to the screens, then it seems incumbent on hospitals to produce for legal and clinical purposes the actual screens.  Ultra-clear screenshots can be accomplished with ordinary off-the-shelf cellphones and no special conditions, as in the example I just took, unaltered, of the screen I am composing this essay on:


Cellphone screenshot: Click to enlarge





Let’s get down to the real problems with EHRs and evidentiary issues. 

It’s not “certain plaintiffs’ lawyers – a kind of group of them who communicate with each other –  seeing the medical record as an opportunity for litigation.”

It’s negligent and opportunistic EHR vendors, complacent hospital officers, and a legislative and justice system that needs education as to clinical and evidentiary problems caused by the prior two groups.

Here’s more on the true problems:

Electronic medical records (EMRs or EHR, for electronic health record) came about as a result of a belief by pioneers in the field of Medical Informatics at organizations such as Harvard, the University of Utah, and others, as early as the 1950’s, that computers could streamline storage and retrieval of needed medical information, help standardize the language used in medical record-keeping (thus helping the accuracy and portability of records), provide automated computer-generated alerts and reminders, and solve the issue of illegible handwriting.
  
The term “EMR” itself is an anachronism.  EMR systems today are no longer just electronic filing systems replacing the paper chart, as they were early in their development. They are now integrated systems for order entry, results reporting, alerts and reminders, etc. They are now, in effect, enterprise clinical resource “nervous systems” for control of the clinical activities of a hospital or clinic.  All transactions related to care must increasingly pass through EMR systems as an intermediary between clinicians and patients.  The records of such transactions are increasingly only in electronic form.

Importantly, EMR technology is not regulated in any meaningful way, as is IT in other sectors, such as the pharmaceutical industry (where the FDA provides regulation of quality and security of systems used to store and manipulate clinical trial data and drug manufacturing), the aviation industry (where the FAA regulates safety and testing to assure freedom from potentially catastrophic malfunctions), and other mission critical sectors of industry.   


There is no regulatory pre-market or postmarket surveillance of EMR systems in place regarding reliability, safety, information security and other areas as there is in other healthcare sectors, and efforts to have such regulation initiated by the FDA and others have been resisted by the health IT industry. 

Some examples of EMR hazards can be found in the article “E-Health Hazards: Provider Liability and Electronic Health Record Systems” by attorney Sharona Hoffman & engineer Andrew Podgurski, Case Western University (freely available at http://scholarship.law.berkeley.edu/cgi/viewcontent.cgi?article=1813&context=btlj).
  
Without regulation of EMRs, critical issues have been neglected, such as the optimal presentation and understandability by doctors and nurses of EMR outputs (often created using templates, checklists, menus etc. of various kinds) and of the need for assurance that information in EMR systems is complete unaltered, and trustworthy.  

Critically, the electronic record is a malleable and ephemeral record of events, backed up by an equally malleable and ephemeral electronic audit trail, both under the sole control of a defendant hospital or clinic. 

——————————————————–

The largest problem I’ve seen in Discovery is hospital and defense resistance towards production of the one item in electronic records that can allay legitimate concerns about withholding or alteration (and I say “can” because the industry has also been negligent in audit trail implementation and security): the audit trail.

An audit trail (sometimes called an audit log) is an automatically generated accounting of who accessed an electronic record, when, and the actions they took, such as document creation, alteration or deletion. 

An audit trail is the only way to authenticate electronic medical records as complete, free from alteration, and trustworthy.  An audit trail is akin to a banking statement, but instead of tracking monetary deposits, withdrawals and other financial changes, it tracks deposits, withdrawals and changes to clinical medical information. Without an audit log, the record is not authenticatable as complete and free from alteration.  Absence of an audit log would leave the electronic medical record subject to undetectable tampering or selective information withholding.  Its production is essential for evidentiary purposes, without exception.


Audit logs track changes within a record chronologically by capturing data elements, such as date, time, and user stamps, for each update to an EHR. An audit log can be used to analyze historical patterns that can identify data inconsistencies.


EMRs are vulnerable to manipulation. Electronic data are not tangible. Electronic data are invisible bits of data on some electronic storage media such as magnetic disk. As such, data can be manipulated on that media.  Detection of omissions, erasures, and alterations that would characterize tampering with paper records is not available with printouts of electronic medical records. The audit trail replaces those visual cues. 


The only way to tell if electronic records have been altered or partially withheld is via an electronic audit trail that can track creation of, and changes to, the record content.


Literature supports the necessity of reviewing an audit trail to ensure a complete medical record. 


From “ELECTRONIC HEALTH RECORDS SYSTEMS: TESTING THE LIMITS OF DIGITAL RECORDS’ RELIABILITY AND TRUST”, Drury, Gelzer, and Patricia Trites, Ave Maria Law Review, Summer 2014, pg. 263, free at http://lr.avemarialaw.edu/Content/articles/v12i2.Gelzer.pdf:


… EHRs can be designed, configured, implemented, and used to render false representations in the course of “regular business.” This, then, is a principal distinguishing aspect of EHRs that tests the boundaries of current evidentiary procedures that presume their reliability and trustworthiness is no worse than other records management systems. In their current unregulated, non-standardized states where the current primary market drivers of their use exclude prior inspection against long-standing records management requirements, they illustrate the necessity of scrutiny of all outputs produced for rendering into legal proceedings. This necessity arises not simply from substantial possibility of legally dubious record management processes, but also the possibility that reliability supports, such as audit trails and near and long-term records management functions, may themselves be missing, difficult to use, or of uncertain veracity as verified by the OIG [Dept. of Health and Human Services, Office of Inspector General] survey. 


(See my Dec. 10, 2013 post “44% of hospitals reported to HHS that they can delete the contents of their EHR audit logs whenever they’d like” at http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html for more on the latter point and the referenced OIG report.)

In summary, it sounds like HIMSS attendees are going to hear a misdirecting presentation from, what appears to me, apologists for gross EHR defects due to industry and hospital negligence, with the blame being shifted to a patient’s only hope for fair addressing of malpractice – the Plaintiff’s Bar.

I consider this disappointing.

Finally, not all counsel on the defense side take anti patient-rights stances on these matters.  While I don’t agree with everything in it, and have some points of significant disagreement, I’ve found the 2014 book “Electronic Medical Records and Litigation” by attorney Matthew Keris of defense firm Marshall Dennehey Warner Coleman Goggin useful.  I think there’s realistic acknowledgement in the book of the ill effects of bad health IT, without internecine barrister-barrister attacks.

Finally, I am an independent expert witness in healthcare informatics, meaning I will work with defense when the facts and evidence merit.  In my presentations to lawyers, I include slides geared to defense.  In part these slides advise defense counsel that through their efforts in advising their clients, they hold the key, through advice rendered, to the prevention of bad health IT from ever seeing the light of day in hospitals, and thus from causing or contributing to medical malpractice, patient harm and death, and evidentiary mayhem.

I wish more of that advice-giving would occur.

— SS


At least former ONC chair Blumenthal now says “health IT can [even] cause safety issues.” Other than that, it’s unicorns and fairies in the Harvard Business Review.

The truth about healthcare IT, that it is perilously insecure, and is causing clinician despair and patient harm, is increasingly becoming mainstream. 

For example, seen at the eclectic, widely read, multi-author website of Beauchamp Brogan Distinguished Professor of Law at the University if Tennessee Glenn Reynolds, Instapundit (http://pjmedia.com/instapundit/):

REMEMBER THE HEALTHCARE.GOV LAUNCH? Apparently so did some hackers:

“To improve the quality of our health care while lowering its cost, we will make the immediate investments necessary to ensure that, within five years, all of America’s medical records are computerized,” President Obama said. “This will cut waste, eliminate red tape and reduce the need to repeat expensive medical tests.”  While the shift Obama and many others pushed may have improved care, electronic medical records led to quite the unique hostage situation in Los Angeles this week. There, a hospital fell prey to a cyberattack — and the hospital has escaped its plight by paying hackers a $17,000 ransom.

Government mandates and electronic security don’t seem to be a very good mix.

Posted at by Stephen Green on Feb 18, 2016 at 7:31 am Link

and this:

MY USA TODAY COLUMN: Futuristic Data Security With A Pen And A Pad. “If I were running an intelligence agency, I’d have all my important stuff done in handwriting or on mechanical typewriters (the old kind that type over the same fabric ribbon multiple times) and distributed in sealed envelopes. If I were setting up a voting system, I’d use paper ballots instead of electronic voting machines. And if I were running a hospital, I’d seriously consider doing everything on paper.”

Posted at by Glenn Reynolds on Feb 22, 2016 at 1:21 pm Link

and this:

YES. NEXT QUESTION: Are Mandatory Electronic Medical Records Causing Doctor Burnout?

Posted at by Sarah Hoyt on Dec 17, 2015 at 4:39 am Link

However, former ONC chair David Blumenthal (now president of the Commonwealth Fund) apparently hasn’t received the message.  He and a colleague wrote the following in the Harvard Business Review.

Speeding Up the Digitization of American Health Care
https://hbr.org/2016/02/speeding-up-the-digitization-of-american-health-care 
David Blumenthal
Aneesh Chopra
February 22, 2016

No more of those infuriating forms to fill out at doctors’ offices: the information is all in the computer. Doctors and hospitals don’t repeat tests you’ve had someplace else: they’re all in the computer. All your caretakers know exactly what medicines you’re on and what you’re allergic to: that’s in the computer. When your elderly mother moves from a hospital to a rehabilitation center, the nurses and doctors there know all about her before she arrives: all in the computer.

The usual utopian trope, and as usual it ignores the self-corrective effects of being asked to repeat information that would otherwise be taken as fact from a computer, which can and does propagate errors (which can and does have deadly effects).

These and many other feats of information management will soon be routine in the United States. Indeed, in some places they are already happening. Our health system is undergoing a digital revolution that will profoundly affect the health care of Americans.

“Soon” has been the mantra of the zealots since about 1950.  Further, the assumption in such articles is that the effects are all beneficent (“profoundly affect” means “in good ways only”), and the results are quite mixed on that score.

Many providers and policy-makers tend to see these issues as technical failings of the electronic records that have been recently been adopted with federal support. This has caused some critics to say that the federal investment – estimated at $31 billion over 10 years – is not paying off.

But this diagnosis is only partly correct. Underlying the challenges facing the digital health revolution are economic and social issues that must be addressed if the potential value of electronic records is to be realized.

Aside from the conflict of interest of such passages being written by a person who contributed to those tens of billions spent, in fact, the federal investment has largely been a huge waste for healthcare and a huge boon for the IT industry, disenfranchising the medical community (including physicians and nurses) and creating mayhem for patient care, e.g., http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html and http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html).

I can also add that the “economic and social issues that must be addressed” were reasonably understood and needed to be addressed before the likes of Blumenthal and ONC put the cart before the horse, “ready, fire, aim”-style on nationsl rollout of health IT.  See my July 2010 post “Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?” , my Oct . 2010 post “Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?” and my June 5, 2012 post “Cart Before the Horse, Part 3: AHRQ’s ‘Health IT Hazard Manager’“.

Further –

Some history on the issue of risk (this blog has a long memory):

Mr. Blumenthal, Feb. 22, 2016, in the new HBR article:

“… some electronic health records are complex and difficult to use. This is frustrating for doctors and nurses, slows them down, and can even cause safety issues.”

Mr. Blumenthal, April 30, 2010:

http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented

http://hcrenewal.blogspot.com/2010/05/david-blumenthal-on-health-it-safety.html

… Blumenthal said that although an advisory committee concluded that more information was necessary, he called the evidence of the reports “anecdotal and fragmented” at best … [Blumenthal’s] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. “The [ONC] committee [investigating FDA reports of HIT endangerment] said that nothing it had found would give them any pause that a policy of introducing EMR’s could impede patient safety,” he said.

(Ironically and tragically, just weeks later, on May 19, 2010 my mother was severely injured and later died as a result of a dangerously faulty EHR.)

Mr. Blumenthal’s views on risk of 2010 as ONC chair represent either deliberate mistruths or ignorance.  Both of those traits tend to be long term, so why should any physician believe the views he expresses in the Harvard Business Review in 2016?

I grant that the views of 2016 in the new article are somewhat more in line with reality, but with significant faults including but not limited to:

1) Since the magnitude of the “safety issues” that health IT can “even” cause are unknown (best estimates are from the ECRI Deep Dive study, which are alarming as at http://healthleadersmedia.com/print/index.cfm?content_id=290834&topic=TEC), it is reckless at best to promote the continued rapid expansion of this technology.

2) On causality, Mr. Blumenthal’s views are either erroneous or deliberately misdirect to blame the “health care markets”:

“If health care markets functioned well in the U.S, HITECH would have been unnecessary. The industry would have wired itself like our financial, travel, and retail sectors.”

Mr. Blumenthal fails to realize, still, the primary reason why healthcare practitioners have resisted computerization: bad health IT.

http://cci.drexel.edu/faculty/ssilverstein/cases/

Bad Health IT (“BHIT”) is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy, promotes evidentiary non-trustworthiness, or otherwise demonstrates suboptimal design and/or implementation. 

The Jan. 2015 letter to HHS from about 40 medical societies was clear on these issues:    http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf

The health IT industry needs to provide worthwhile products before they are shoved down physicians’ and patient’s throats.

Not to mention the outright peril such systems place patients under:

Feb. 18, 2016
Hollywood Presbyterian Medical Center: Negligent hospital IT leaders allow hacker invasion that cripples EHRs, disrupts clinicians … but patient safety and confidentiality not compromised

http://hcrenewal.blogspot.com/2016/02/hollywood-presbyterian-medical-center.html

Forbes Feb. 23, 2016:
White Hat Hackers Hit 12 American Hospitals To Prove Patient Life ‘Extremely Vulnerable’

http://www.forbes.com/sites/thomasbrewster/2016/02/23/hackers-tear-hospitals-apart/#1b049f9c40d7

Then this statement is made:

Patients tend to be loyal to doctors and hospitals at least in part because that’s where they’re known – that’s where their records reside. If that information can travel to another hospital or doctor at the push of a button, patients can more easily leave current providers behind. That’s not good for business.

That’s risible.  Patients don’t hang around care they don’t like because they can’t “push a button” to transfer their records.  In fact, if anything, it’s an impediment to cost-cutters that it’s not easy for bureaucrats to force patients to go to the cheapest “provider” due to records “stuck” at one office or organization. 

Clinicians have very clearly stated their reasons for hating health IT.  See the Medical Societies letter linked above, for example.  There’s no need to make up nonsensical reasons, such as doctors and hospitals holding patients “captive” through their records.

And as for vendors, if you can move information from one vendor system to another, providers can switch out or build upon records more easily in search of a better product. That’s lost revenue for the company.

On that point I am in agreement.

But technical fixes and better records won’t be enough. We need incentives that reward quality and safety improvement and cost reduction.

Not mentioned is reasonable regulation regarding compromised safety, for which “incentives” alone are insufficient.

And we need penalties for providers and vendors that slow-walk the digital revolution to protect their economic interests.

These words are totalitarian.  Responses to glaringly obvious adverse consequences, such as protecting patients from cybernetic harm and the ability to practice good medicine without distraction and burnout don’t seem to count.  All that matters is the “revolution.”

If we make the market for good health care work, a lot of our current [wicked (https://en.wikipedia.org/wiki/Wicked_problem), intractable – ed.]technical problems will melt away as providers and vendors compete to make service and care better for their customers: the nation’s patients.

My comment about this statement, that massive healthcare IT sociotechnical problems will simply “melt away” is best summarized in a picture of a land where that can plausibly occur:

Mr, Blumenthal seems unaware of the domain of Social Informatics, “the interdisciplinary study of the design, uses and consequences of information technologies that takes into account their interaction with institutional and cultural contexts” (see http://www.dlib.org/dlib/january99/kling/01kling.html).  Problems in fields as wickedly complex as at the intersection of healthcare and IT do not and will not “melt away.”  However, they need to be managed.  What we have now is mismanagement of those problems, with imposition of painfully inappropriate mandates and lack of meaningful regulation and safety surveillance, among other defects.

“Speeding up” healthcare digitization as a national plan in 2016?  No. 

National implementation needs to be seriously rethought in 2016, and massively scaled back and slowed down until we have more of a handle on how to manage change correctly. 

Anything else is reckless.

End note: the grandiose term “revolution” with respect to health IT is a hyper-enthusiast’s or zealot’s term, is hyperbolic, hackneyed and no longer believed except by the most seriously deluded, and needs to be promptly abandoned.  Leave “revolutions” to the Lenins and Trotskys of the world.

— SS

It Has Come to This? – Donald Trump’s “Truly Absurd,” “Word Salad,” “Gibberish” Health Care Policy

Health Care Renewal is officially non-partisan.  We do not endorse candidates for office, or political parties.  That does not prevent us from commenting on policy issues, and on pronouncements and actions by politicians and government officials when they relate to the issues that interest us.

So, we have criticized excessive coziness among politicians and government officials on one hand, and big health care organizations and their leaders on the other.  We have noted conflicts of interest affecting politicians, particularly the revolving door, and other shadings towards corporatism.  We have noted how health care policy discussions may focus on health care financing, while ignoring some of the bigger issues we discuss  (For example, see our discussions of health care reform, and particularly this one of the then new US Affordable Care Act). These include: leadership of health care organizations by generic managers (managerialists) who are unsympathetic or even hostile to the health care mission; deceptive practices involving marketing, the manipulation and suppression of research, stealth health policy advocacy, stealth lobbying, etc; and timidity in regulation and law enforcement, leading to outright impunity of health care leaders.

We have criticized politicians and government leaders of all parties and from all sides of the political spectrum.  For example, in retrospect we criticized the (Democratic) Clinton administration’s laissez faire attitude to conflicts of interest at the National Institutes of Health (see summary here and links to older posts).  We criticized flagrant examples of the revolving door involving top Bush adminstration officials (e.g., most recently here), and yet more involving Obama administration officials (e.g., most recently here).

Yet we also acknowledge that most policy discussions by political and government figures are at least well-intended and based in some degree on the facts and knowledge of the health care context (even if we think the results might be misguided, wrong-headed, or tangential.)  So, while health care is not so far the most important issue in the tumultuous 2016 US presidential race, there has been considerable discussion of it.  Most major candidates have staked out health care positions that again appear well-intended and based to some degree on the facts and context (although my point is not to comment on their merits.)

But there has been one major exception. 

The Leading Candidate with No Health Care Plan

Donald Trump currently seems to be the leading Republican presidential candidate.  As reported by the Minnesota Post,

Trump doesn’t have a health care plan. Go to the issues section of his campaign. Really, go there, you won’t believe what you see. A typical campaign website has position papers. Trump has none. The link to ‘Issues’ takes you to a pretty frightening page of short embedded videos of Trump himself summarizing his positions at a level of detail that you should find insulting.

But he doesn’t even have one of those on health care.

In addition to ‘Issues,’ the site’s homepage has a pulldown menu called ‘Positions.’ I don’t get the difference, but who cares? “Positions” are actual written-out position statements, not videos, but only on five issues, none of which are remotely related to health care (nor many other major issues).

So for Trump’s health-care thinking, we have to rely on what he says in debates and speeches and, I suppose, tweets, some of which have been controversial.

The Candidate with No Health Care Policy Advisers

On February 20, 2016, Politico reported that Mr Trump’s campaign also apparently has no health policy advisers.  The article noted that Mr Trump had written in one of his books that he would

Lock the best health care policy minds in a room – and don’t let them out until they’ve crafted a plan for providing terrific coverage for everyone.

But he has not said who those advisers might be.  Furthermore, the reporter was unable to determine who, if anyone, is currently advising Mr Trump about health care,

Sam Clovis, Trump’s national policy adviser, insists the campaign is talking with lots of health care experts – but declined to name any of those advisers.

‘We have experts around the world who help us on these various topics,’ Clovis said in an interview with POLITICO. ‘We get very frank and honest input if we do not expose these people to the scrutiny of the press. … As we get further along they might want to come out of the shadows.’

However,

POLITICO scoured the landscape of notable policy wonks – from academics to lobbyists to congressional staffers to think tank fellows – but was unable to find anyone, on either side of the political divide, who acknowledged whispering health care policy tips in the billionaire’s ear. Or for that matter, of hearing of anyone who had talked to his campaign.

‘He seems to be a one-man policy shop,’ said Michael Cannon, director of health policy studies at the libertarian Cato Institute, and a leading critic of Obamacare.

So Mr Trump has no clear health care plan, and apparently no health care advisers.  Furthermore, reports of what this candidate has said about health care reveals some anomalies, to say the least.

Reducing Pharmaceutical Costs to Zero?

The Washington Post in a “Fact Checker” feature on February 18, 2016, entitled, “Trump’s truly absurd claim he would save $300 billion a year on prescription drugs,” quoted Mr Trump three times on the costs of pharmaceuticals,

‘We are not allowed to negotiate drug prices. Can you believe it? We pay about $300 billion more than we are supposed to, than if we negotiated the price. So there’s $300 billion on day one we solve.’ –Donald Trump, remarks at Plymouth State University, Holderness, N.H., Feb. 7, 2016

‘So I said to myself wow, let me do some numbers. If we competitively bid drugs in the United States, we can save as much as $300 billion a year.’ –Trump, remarks in Manchester, N.H., Feb. 8

‘We’re the largest drug buyer in the world. We don’t negotiate. We don’t negotiate. You pay practically the same for the country as if you go into a drug store and buy the drugs. If we negotiated the price of drugs, Joe, we’d save $300 billion a year.’ –Trump, interview on MSNBC, Feb. 17

The problem here is that the $300 billion figure turns out to be ridiculous.  The Post article noted,

To put Trump’s $300-billion-a-year claim in perspective, let’s first note that Sanders cites a 2013 estimate from the Center for Economic and Policy Research that negotiated drug prices would result in savings to Medicare of between $230 billion to $541 billion over 10 years.

So for virtually the same policy, Sanders is claiming savings averaging $38 billion a year — and Trump is promising a figure eight times larger. (Clinton offers no estimated savings.)

What’s going on here? It’s unclear, because as usual the Trump campaign refuses to respond to any queries about Trump’s numbers.

Furthermore,

total spending in Medicare Part D (prescription drugs) in 2014 was $78 billion. So Trump, in effect, is claiming to save $300 billion a year on a $78 billion program. That’s like turning water into wine.

Finally,

It’s possible that Trump is being sloppy and when he discusses Medicare, he really means to say he would force government-led pricing on all prescription drugs. But the numbers don’t add up that way either.

In fact, depending on the source you consult, total annual spending on prescription drugs in the United States is between $298 billion a year to $423 billion. So that would mean Trump is claiming that he can eliminate virtually any cost to prescription drugs. It would suddenly be free!

So Mr Trump’s claims made on at least three occasions about the magnitude of savings that would result from his (unoriginal) proposal to have the government negotiate drug prices were mathematically implausible, if not impossible. 

“Word Salad” about the Mandate

Rather right-wing columnist Jennifer Rubin, writing in the Washington Post on February 22, 2016, provided two sets of quotes from interviews with Mr Trump about his position on the “mandate” within the Affordable Care Act (ACA).  Note that the mandate imposes a (relatively modest) extra tax on people who do not have health insurance, providing an incentive to have such insurance.  For example, on “Meet the Press,”

DONALD TRUMP: Well, on the mandate, if you look at the mandate, we had a situation where we were, Anderson Cooper, who’s terrific, by the way, and did a terrific job, but we were talking over each other. Look, I want, we’re going to repeal and replace Obamacare. Obamacare is a total and complete disaster. It’s going to be gone. We’re going to come up with a great healthcare plan, whether it’s healthcare savings accounts, we have a lot of different things. We’re going to get rid of the lines between states, we’re going to have great competitive bidding. But I say all the time, you can call it anything you want. People are not going to die in the middle of the street. People are not going to die on the sidewalk if I’m president, okay?

CHUCK TODD: Well, let me get something definitive from you on this.

DONALD TRUMP: But Chuck, I say that, excuse me, I say that to packed houses with thousands and thousands of people, Republicans mostly, and I get standing ovations. I’m not going to let that happen. If I’m president, we’re not going to have people dying on the streets. So you can call it whatever you want. I don’t call it a mandate, I just say it’s common sense.

CHUCK TODD: No, I understand that. Well, let me ask you this. Do you think that it should be a law that anybody who can afford health insurance has to have it?

DONALD TRUMP: I think, no, I think it’s going to be up to them, okay? I want it to be up to them. But I’m really talking about people that can’t afford it. We’re not going to let people die in squalor because we are Republicans, okay? That’s part of the problem with the Republicans, where somehow they got fed into this horrible position. We’re going to take care of people. But no, people don’t have to have it. We’re going to have great plans, they’re going to be a lot less expensive than Obamacare. They’re going to be private. There are going to be lots of different options. We’re going to have a lot of different options. Right now you have no options. You know why? Because the insurance company controlled Obama because they gave him a lot of money. That’s why you have lines around the states. And you can’t get competitive bidding.

Her summary was:

He insists whatever inanity he said earlier was a mistake, denies he took or takes a liberal position and declares there will not be people ‘dying in the streets.’ (Does he understand there is a duty now to treat people, but what we are debating is insurance?) Then he ends with assurances he is loved by crowds. Superlatives by the bushel may be funny, but they also substitute for concrete answers. It may seem like a word salad or stream of consciousness at first glance, but it is a salad he tosses up over and over again, each time avoiding close scrutiny.

An article on February 22, 2016, in the left leaning MotherJones stated that Mr Trump had already contradicted his previous approval of the “mandate,”

Trump has now made clear that he doesn’t like the individual mandate after all—he just misspoke when he said that to Anderson Cooper a few days ago.

So while Mr Trump has drawn attention to his position on the mandate, that position seems hopelessly incoherent, or as Ms Rubin called it, “word salad.”

More “Gibberish”

The Minnesota Post article also noted,

When asked Thursday night under Rubio’s prodding to describe his plan for health care, he said, as he always does, that he wants to repeal the Affordable Care Act and replace it with something ‘much better.’ Then he says (and this is a direct quote from the debate transcript): ‘I want to keep pre-existing conditions. I think we need it. I think it’s a modern age. And I think we have to have it.’ This is gibberish, especially the explanation that ‘I think it’s a modern age,’ which may have some meaning but I can’t imagine what.

In addition, in the most recent debate, Mr Trump did emphasize that he wanted insurance companies to be able to sell policies across state lines, although his wording was not so clear,

That weird and confusing phrasing — about ‘getting rid of the lines around the states,’ which Rubio mocked — as best as anyone can tell means that Trump wants national health insurers to be able to offer standardized plans all over the country, instead of having to meet the particular standards and requirements imposed by individual states. Different states require different things of health insurers, which prevents national firms from offering plans in all states.

As the article noted, this is not a new idea, and how much difference this change would make is not clear. Nonetheless, even after being badgered repeatedly, Mr Trump could not add more substance to his health care plan, nor explain how he might get more substance.

With Rubio pressing in and badgering Trump from the sidelines — the same way Rubio was badgered a few weeks ago by Chris Christie and the way Trump often badgers other candidates — and with CNN’s Dana Bash following up, Trump said his three things: Repeal Obamacare and replace it with something much better, get rid of the lines around the states, and don’t let people die in streets. I always assumed that there was more to his plan, but I never came across the details. And, during the exchange Thursday night, it came out that there is no more. Here’s that chunk of the transcript so you can decide for yourself if I’m missing something. (I’ve done a tiny bit of editing for flow.)[italics added for emphasis- Ed]

BASH: Mr. Trump, Senator Rubio just said that you support the individual mandate. Would you respond?

TRUMP: I just want to say, I agree with that 100 percent, except pre-existing conditions, I would absolutely get rid of Obamacare. We’re going to have something much better, but pre-existing conditions, when I’m referring to that, and I was referring to that very strongly on the show with Anderson Cooper, I want to keep pre-existing conditions. I think we need it. I think it’s a modern age. And I think we have to have it. (APPLAUSE)

BASH: OK, so let’s talk about pre-existing conditions. What the insurance companies say is that the only way that they can cover people [who have pre-existing conditions and would be more expensive to cover] is to have a mandate requiring everybody purchase health insurance. Are they wrong?

TRUMP: I think they’re wrong 100 percent. What we need — look, the insurance companies take care of the politicians. The insurance companies get what they want. We should have gotten rid of the lines around each state so we can have real competition. We thought that was gone, we thought those lines were going to be gone, so something happened at the last moment where Obamacare got approved, and all of that was thrown out the window.

The reason is some of the people in the audience are insurance people and insurance lobbyists and special interests. They got — I’m not going to point to these gentlemen, of course, they’re part of the problem, other than Ben [Carson], in all fairness. And, actually, the governor [John Kasich], too. Let’s just talk about these two, OK? Because I don’t think the governor had too much to do with this.

But, we should have gotten rid of the borders, we should have gotten rid of the lines around the states so there’s great competition. The insurance companies are making a fortune on every single thing they do. I’m self-funding my campaign. I’m the only one in either party self-funding my campaign. I’m going to do what’s right. We have to get rid of the lines around the states so that there’s serious, serious competition. And you’re going to see — excuse me. You’re going to see pre-existing conditions and everything else be part of it, but the price will be down, and the insurance companies can pay. Right now they’re making a fortune. (APPLAUSE)

BASH: But just to be specific here, what you’re saying is getting rid of the barriers between states, that is going to solve the problem…

TRUMP: That’s going to solve the problem. And the insurance companies are going to say that they want to keep it. They want to say — they say whatever they have to say to keep it the way it is. I know the insurance companies, they’re friends of mine. The top guys, they’re friends of mine. I shouldn’t tell you guys, you’ll say it’s terrible, I have a conflict of interest. They’re friends of mine, there’s some right in the audience. One of them was just waving to me, he was laughing and smiling. He’s not laughing so much anymore. Hi.
Look, the insurance companies are making an absolute fortune. Yes, they will keep pre-existing conditions, and that would be a great thing. Get rid of Obamacare, we’ll come up with new plans. But we should keep pre-existing conditions.

RUBIO: Dana, I was mentioned in his response, so if I may about the insurance companies…

BASH: Go ahead.

RUBIO: You may not be aware of this, Donald, because you don’t follow this stuff very closely, but here’s what happened. When they passed Obamacare they put a bailout fund in Obamacare. All these lobbyists you keep talking about, they put a bailout fund in the law that would allow public money to be used, taxpayer money, to bail out companies when they lost money. And we led the effort and wiped out that bailout fund. The insurance companies are not in favor of me, they hate that. They’re suing right now to get that bailout money put back in.

Here’s what you didn’t hear in that answer, and this is important, guys, this is an important thing. What is your plan? I understand the lines around the state, whatever that means. This is not a game where you draw maps…

TRUMP:…And you don’t know what it means?

RUBIO: What is your plan, Mr. Trump? What is your plan on health care?

TRUMP: You don’t know. The biggest problem…

RUBIO: …What’s your plan?

TRUMP: … You know, I watched him melt down two weeks ago with Chris Christie. I got to tell you, the biggest problem he’s got is he really doesn’t know about the lines. The biggest thing we’ve got, and the reason we’ve got no competition, is because we have lines around the state, and you have essentially….

RUBIO: …You already mentioned that [inaudible] plan. I know what that is, but what else is part of your plan?…

TRUMP: …You don’t know much…

RUBIO: …So, you’re only thing is to get rid of the lines around the states. What else is part of your health-care plan?…

TRUMP: …The lines around the states...

RUBIO: …That’s your only plan…

TRUMP … Excuse me. Excuse me.

RUBIO: … His plan. That was the plan?…

TRUMP:…You get rid of the lines, it brings in competition. So, instead of having one insurance company taking care of New York or Texas, you’ll have many. They’ll compete, and it’ll be a beautiful thing.

RUBIO: Alright…So that’s the only part of the plan? Just the lines?

TRUMP: The nice part of the plan — you’ll have many different plans. You’ll have competition, you’ll have so many different plans.

RUBIO: Now he’s repeating himself.

TRUMP: No, no, no. I watched him repeat himself five times four weeks ago…

RUBIO:… I just watched you repeat yourself five times five seconds ago…

TRUMP: I watched him meltdown on the stage like that, I’ve never seen it in anybody…

BASH:…Let’s stay focused on the subject…

TRUMP:…I thought he came out of the swimming pool…

RUBIO:…I see him repeat himself every night, he says five things: Everyone’s dumb, he’s gonna make America great again…We’re going to win, win win. He’s winning in the polls…And the lines around the state. (APPLAUSE)

BASH: Senator Rubio, you will have time to respond if you would just let Mr. Trump respond to what you’ve just posed to him…

RUBIO: … Yeah, he’s going to give us his plan now, right? OK…

BASH [to Trump]:…If you could talk a little bit more about your plan. I know you talked about…Can you be a little specific?…

TRUMP: … We’re going to have many different plans because… competition…

RUBIO: … He’s done it again.

TRUMP: There is going to be competition among all of the states, and the insurance companies. They’re going to have many, many different plans.

BASH: Is there anything else you would like to add to that…

TRUMP: No, there’s nothing to add. What is to add?

After being repeatedly asked about the substance of his health care policy agenda, Mr Trump only seems to have repeated the notion of selling health insurance across state lines to increase competition, interrupted by non sequiturs insulting Senator Rubio and insurance executives.  The Minnesota Post writer and I could find absolutely no other content in Mr Trump’s , despite repeated inquiries about the substance of his health care plan.

It does seem reasonable to describe Mr Trump’s health care policy ideas as gibberish.

Summary 

Health care and public health affect all Americans, and all people around the world.  Health care in the US is more expensive and less accessible than it is in many other developed countries.  For all the money the country spends, there is no clear evidence that the quality of patient care, or patients’ outcomes are better than, or sometimes even comparable to those of other countries  The reforms embodied in the Affordable Care Act (ACA, PPACA, “Obamacare’) have increased the proportion of insured patients, but insurance remains expensive for many, and insurance coverage now often has major gaps that mean a major illness can bankrupt a middle-class patient.

Furthermore, the law has done nothing to reduce concentration of power in health care.  It has done nothing to make health care leaders more accountable, especially for their organization’s unethical or even criminal behavior, decrease their ability to line their pockets regardless of such behavior, and thus reduce their impunity.  It will not obviously decrease conflicts of interest affecting those who make decisions about patient care or health policy, lock the revolving door between government and the health care industry, end manipulation of clinical research to serve vested interests, or suppression of research whose results offend such interests, etc, etc.

So health care policy is increasingly important, and increasingly demands serious discussion.  A US presidential campaign ought to provide some impetus for such discussion, although health care policy is certainly not the only thing that needs to be discussed.

Most presidential candidates have at least attempted a serious discussion of health policy, if not in person, then in position papers or on their web-sites.

However, the currently leading candidate for the Republican nomination does not seem to have serious ideas about health care. Yet he has said “We’re going to come up with a great healthcare plan.”  To substantiate such claims, he has repeated a few vague talking points, and when challenged, seems unable to manage any substantive conversation beyond them.  Some of his verbal pronouncements have been nothing short of ridiculous.  

“in the big lie there is always a certain force of credibility….” said a 20th century world leader who inspired adulation, and led to disaster.  

We live in perilous times when a candidate with such reckless approaches to critical problems continues to attract adulation.

ADDENDUM (29 February, 2016) – This post was republished on the Naked Capitalism blog on February 28, 2016.  

ADDENDUM (1 March, 2016) – This post was republished on OpEdNews on February 29, 2016.

“How Employed Physicians’ Contracts May Threaten Their Patients and Professionalism” Authored by Health Care Renewal Bloggers Published in Annals of Internal Medicine

We have noted that increasing numbers of physicians provide patient care as employees of large organizations, often hospital systems, sometimes for-profit.  Since in these settings physicians must answer to generic management which may be more concerned with short-term revenues than patient care, these new arrangements are frought with hazards for physicians and patients.

One set of hazards may be found in the contracts employed physicians must sign.  

My fellow blogger, Dr Wally Smith, and I authored an article just published online “How Employed Physicians’ Contracts May Threaten Their Patients and Professionalism.” Here is the link.

In it we listed multiple contractual provisions that may be found in employed physicians contracts  that may threaten professionalism and good patient care:

 Confidentiality clauses – which may hide quality and safety problems, medical errors, unethical conduct, other problematic contract clauses, and malfeasance
Productivity clauses – which may provide incentives for actions that primarily increase employers’ revenues, and thus may encourage overtreatment
“Leakage control” clauses – which may discourage referrals outside of the employers’ systems and thus discourage appropriate referrals for particular patients, potentially threatening quality
Clauses that allow termination without cause – which may reduce access for the terminated physicians’ patients, and may discourage complaints by physicians about quality, safety, unethical behavior, or malfeasance
Noncompete clauses – which may reduce access and physicians’ ability to leave unsatisfactory positions
Clauses that restrict outside activites – which may restrict teaching or research, or academic freedom or free speech

We also noted clauses in contracts that employers may sign with third parties that may also threaten professionalism and good patient care:

“Gag” clauses affecting employees – which may hide quality and safety problems, medical errors, unethical conduct and malfeasance
“Anti-poaching” clauses – which may reduce patients’ access to care, and physicians’ ability to leave unsatisfactory positions.

We were able to find cases illustrating all the clauses published in the news media, or publications such as Medscape or Medical Economics.  However, they have largely anechoic in the scholarly medical and health services literature, and largely unaddressed by the medical societies that ostensbibly protect physicians’ professionalism and patients’ and the public’s health.   

We suggested that such contractual problems may be becoming more frequent in a health care system in which physicians more often are corporate. We suggested that all physicians confronted with new employment contracts should seek competent legal connsel and try to negotiate egregious provisions.  However, such actions may now be futile given the increasing market dominance of the hospital systems that are employing increasing numbers of physicians.

We urged medical societies to inform physicians about such employment issues, and better support physicians who struggle with them.  However, these contract problems may merely be a reflection of an increasingly commercialized, deregulated health care system run by generic managers who may put revenue generation ahead of supporting physicians’ professionalism.  So, better enforcement of existing laws, and new laws including bans on the commercial practice of medicine may be the only solutions to this newly recognized plight of corporate physicians and their patients.   

Will There Ever Be Enough Straws to Break Corporate Health Care Managers’ Impunity’s Back? – Novartis Settles Yet Again, This Time for Bribing Doctors

Umpteenth verse, same as the first…

As just reported by Bloomberg,

Novartis AG said it agreed to pay $25 million to settle a U.S. Securities and Exchange Commission case that claimed the Swiss drugmaker paid bribes to health professionals in China to increase sales from 2009 to 2013.

In particular,

The SEC detailed a number of Foreign Corrupt Practices Act violations where Novartis employees provided items of value to health-care professionals in China, under the supervision of complicit managers. It also cited examples of how the company improperly recorded as legitimate expenses payments employees made for travel and entertainment, conferences, lecture fees, marketing events, educational seminars and medical studies.

For some vivid examples,

In one example cited in the SEC order on Novartis, a sales representative at the drugmaker’s Sandoz China subsidiary submitted a $1,154 receipt to buy holiday gifts for 25 health-care professionals, which was instead used to pay for their spa and sauna sessions. A regional sales manager approved the purchase, the SEC said.

The SEC order also cited how Sandoz China sponsored 20 health-care professionals to attend a 2009 medical conference in Chicago. During the trip, the company paid for the group’s recreational activities such as a Niagara Falls excursions, $150 in ‘walking around’ money for their spouses, and cover charges to a strip club. The group was accompanied by a Sandoz China senior manager and other staff, according to the SEC.

So, thus far, the allegations were that Novaris bribed Chinese physicians to use their products, and the bribes includes gifts, travel money, and admission to a strip club.  It is likely that these bribes induced the physicians to unnecessarily or excssively prescribe Sandoz drugs to patients, leading to excess expenses, overtreatment, and quite likely adverse effects that should have been prevented.

As per the Wall Street Journal, and as usually happens in such cases, Novartis was allowed to settle without “admitting or denying the findigs.” In the Bloomberg article, a Novartis spokesperson gave the usual vague response,

‘The issues raised by the SEC, which relate to our subsidiaries in China and go back as far as 2009, largely pre-date many of the compliance-related measures introduced by Novartis across its global organization in recent years,’ Novartis spokesman Eric Althoff said in an e-mailed statement Thursday.

The implication was that the company no longer does these bad things, but did not include a promise not to do them. And, of course, just like in many, many other health care cases, and in many, many other cases involving big, powerful, or influential organizations, no one at a top management level went to jail, or even suffered any negative consequences, even for such sleazy allegations as those in this case.  Finally, partially because the amount of this settlement was so small related to the financial bulk of the company involved, this case was relatively anechoic, only reported in the small items in the business press.

Summary

As we are distracted by bloviating billionaires and other spectacles on the US 2016 campaign trail, we continue to accumulate evidence of the corruption of large health care organizations and the impunity of their leaders.  Yet this evidence remains anechoic, even given the apparent recidivism involved.  For example, it was only in last November that we discussed what were then the latest misadventures by Novartis and its leadership.  At that time, our post included these section headings covering 2014-15:

–  Japanese Health, Labor and Welfare Ministry Found that Novartis Concealed Serious Adverse Effects
– Novartis Executive Pleads Guilty to Bribing Polish Official
– Novartis Subsidiary Sandoz Settles Allegations that it Misrepresented Pricing Data to US Medicaid
– Express Scripts Settles Allegations that it Accepted Kickbacks from Novartis
– Novartis Settles US Allegations of Kickbacks to Enhance Sales of Multiple Drugs

Furthermore, in that post we also documented Novartis’ previous record.   In March, 2014, we had noted:
– Italian authorities had fined Novartis and Roche for colluding to promote the use of an expensive opthamologic treatment
– the NY Times published interviews with physicians ostensibly showing how Novartis turned them into marketers for the drug Starlix
– Japanese investigators charged Novartis with manipulating clinical research
– Indian regulators canceled a Novartis import license, charging the company with fraud.

Also,  in 2013, Novartis was fined for anti-competitive practices in its marketing of Fentanyl by the European Commission (look here), and in 2011 its Sandoz subsidiary settled allegations of misreporting prices in the US for $150 million (look here)   Other Novartis misadventures from 2010 and earlier appear here.  So Novartis has quite an impressive, if not infamous record of ethical failures.

Yet no Novartis top manager suffered any negative consequences then (although one apparent mid-level company manager at the Polish subsidiary did plead guilty), and all these previous episodes apparently did not suggest a pattern of recidivism to US authorities this time sufficient to attempt to impose any negative consequences on higher level managers.  Meanwhile, Novartis executives continue to be paid handsomely.  The 2015 Novartis executive compensation report listed over 51 million Swiss francs paid

Also, this goes on while large health care companies continue to pay out dizzying amounts to physicians, health care professionals, hospitals and academic institutions, which partially may secure their loyalty.  Novartis, for example, which ProPublica lists as only the 28th biggest payer to physicians, paid out $31.7  million in 2013-14 just to US physicians.    The 2015 Novartis board of directors included Dr Nancy C Andrews, the Dean of the Duke Medical School and Vice-Chancellor for Academic Affairs at Duke University,  Dr Dimitri Azar, Dean of the College of Medicine at the University of Chicago, Illinois, and Dr Charles L Sawyers, a professor and department chair at Weill-Cornell Medical School.   I am unaware that anyone of them have publicly raised any concerns about Novartis’ recent misadventures, although I am also unaware whether anyone has publicly asked them such questions. 

No wonder that ordinary US (and other countries’ citizens) feel that they are trapped in a hopeless economic situation by rigged systems designed to benefit from the corrupt insiders.  No wonder that someone of them are seeking the protection of some of those powerful insiders.  But I digress…

In terms of health care, as we have said like a broken record (if anyone remembers what that means), or, if you prefer, where every verse is same as the first…

There seems to be increasing recognition that the continuing rise in US health care costs is unsustainable, and that these costs are not buying us good health care.  There are calls to avoid unnecessary, and sometimes harmful care.  Yet there is a persistent disconnect between how continuing dishonest behavior by health care organizations, impunity of their leaders, and lack of accountability by their board members fuel rising costs, shrinking access, and bad outcomes for patients.

To truly reform health care, we will have to at least recognize the causes of the current dysfunction.  Recognizing how health care dysfunction is created by unaccountable, dishonest leadership should lead to true reform that would promote well-informed, honest, accountable leadership that puts patients’ and the public’s health ahead of personal gain.

Our musical interlude (“second verse, same as the first,”) Herman’s Hermits, Henry VIII

Lown Institute/ Right Care Alliance 2016 Conference

I am back from the annual Lown Institute/ Right Care Alliance meeting in Chicago.  A considerable part of the meeting was devoted to issues that may be familiar to readers of Health Care Renewal.

Shannon Brownlee, in her keynote talk, “Introducing the Right Care Alliance,” called our current US health care system “corrupt.”  She noted how clinical research has been “hijacked,” (see our posts on the suppression and manipulation of clinical research).  She noted how the multi-million dollar compensation of CEOs whose hospitals serve – not always well – primarily poor people (see our posts on executive compensation and mission-hostile management).  She called for a national conversation to “expose the dark matter” of medicine, and right the wrongs of a new “gilded age.”

The Right Care Alliance has a Vision Statement which calls for health care in which

Healthcare is a right, not a commodified privilege, and access to healthcare is universal, equitable, and affordable. Everybody in, nobody out.

There is meaningful public transparency around costs and outcomes that matter to patients and communities.

The science and practice of medicine is free of commercial bias and the profit motive.

among other imperatives.

Not to toot our own horns too much, but Dr Adriane Fugh-Berman of PharmedOut.org and I led a workshop on deceptive pharmaceutical and device promotion in the context of health care corruption.

Hopefully, much of the conference content will eventually show up on the web, but so far one nice video summary has been produced:

John Stossel Discovers Health Care Dysfunction, Blames it on “Socialists” – Like Maurice Greenberg (AIG), John Thain (Merrill Lynch), Sanford Weill (Citigroup), and David H Koch?

We have been ranting for a while about the dysfunctionality of the US health care system.  Unfortunately, many people only realize how bad things are when they become patients, when they have bigger things to worry about than complaining.   Furthermore, even if they complain, many patients may not feel they understand enough about what has gone wrong to suggest solutions.

Bad Customer Service at New York Presbyterian

This may not apply when media pundits, especially those with strong ideological views, become patients.  So this week Fox News commentator and well known libertarian John Stossel disclosed his new illness, and vented his opinions about his hospital stay.   Mr Stossel unfortunately developed lung cancer, although he was optimistic about his prognosis: “My doctors tell me my growth was caught early and I’ll be fine. Soon I will barely notice that a fifth of my lung is gone.”

However, he was not happy about his hospital’s customer service:

But as a consumer reporter, I have to say, the hospital’s customer service stinks. Doctors keep me waiting for hours, and no one bothers to call or email to say, ‘I’m running late.’ Few doctors give out their email address. Patients can’t communicate using modern technology.

I get X-rays, EKG tests, echocardiograms, blood tests. Are all needed? I doubt it. But no one discusses that with me or mentions the cost.

Also,

I fill out long medical history forms by hand and, in the next office, do it again. Same wording: name, address, insurance, etc.

And,

In the intensive care unit, night after night, machines beep, but often no one responds. Nurses say things like ‘old machines,’ ‘bad batteries,’ ‘we know it’s not an emergency.’

Finally,

Some of my nurses were great — concerned about my comfort and stress — but other hospital workers were indifferent.

Unfortunately, long wait times, poor communications, excess paperwork, and misapplied technology are all too familiar problems to those in the health care system.

Moreover, this all was happening at one of the most highly rated US hospitals, 

After all, I’m at New York-Presbyterian Hospital. U.S. News & World Report ranked it No. 1 in New York.

Were “Socialist Bureaucracies” Responsible?

Mr Stossel had his own ideas about the causes of these problems. 

Customer service is sclerotic because hospitals are largely socialist bureaucracies. Instead of answering to consumers, which forces businesses to be nimble, hospitals report to government, lawyers and insurance companies.

Whenever there’s a mistake, politicians impose new rules: the Health Insurance Portability and Accountability Act paperwork, patient rights regulations, new layers of bureaucracy…

Also,

Leftists say the solution to such problems is government health care. But did they not notice what happened at Veterans Affairs? Bureaucrats let veterans die, waiting for care. When the scandal was exposed, they didn’t stop. USA Today reports that the abuse continues. Sometimes the VA’s suicide hotline goes to voicemail.

Patients will have a better experience only when more of us spend our own money for care. That’s what makes markets work.

A “Socialist Bureaucracy” with a VIP Penthouse?

I am sorry to hear Mr Stossel has lung cancer, and hope that his prognosis is indeed good.  I am a bit surprised that a media celebrity who became a patient found big issues with “customer service” at such a prestigious hospital.  After all, many big hospitals have programs to give special treatment to VIPs (for example, see these posts from 2007 and 2011).

In particular, back in 2012 we posted about the contrast between the VIP services specifically at New York – Presbyterian Hospital and how poor patients are treated there.  Then we quoted from a 21 January, 2012 article from the New York Times focused on the ritzy comforts now provided for wealthy (but perhaps not very sick) patients at the renowned New York Presbyterian/ Weill Cornell Hospital.  It opened,

The feverish patient had spent hours in a crowded emergency room. When she opened her eyes in her Manhattan hospital room last winter, she recalled later, she wondered if she could be hallucinating: ‘This is like the Four Seasons — where am I?’

The bed linens were by Frette, Italian purveyors of high-thread-count sheets to popes and princes. The bathroom gleamed with polished marble. Huge windows displayed panoramic East River views. And in the hush of her $2,400 suite, a man in a black vest and tie proffered an elaborate menu and told her, ‘I’ll be your butler.’

It was Greenberg 14 South, the elite wing on the new penthouse floor of NewYork-Presbyterian/Weill Cornell hospital. Pampering and décor to rival a grand hotel, if not a Downton Abbey, have long been the hallmark of such ‘amenities units,’ often hidden behind closed doors at New York’s premier hospitals. But the phenomenon is escalating here and around the country, health care design specialists say, part of an international competition for wealthy patients willing to pay extra, even as the federal government cuts back hospital reimbursement in pursuit of a more universal and affordable American medical system.

Additional amenities include:

A waterfall, a grand piano and the image of a giant orchid grace the soaring ninth floor atrium….

Also,

the visitors’ lounge seems to hang over the East River in a glass prow and Ciao Bella gelato is available on demand….

An architect who specializes in designing such luxury facilities for hospitals noted:

‘These kinds of patients, they’re paying cash — they’re the best kind of patient to have,’ she added. ‘Theoretically, it trickles down.’

It appears that someone failed to book Mr Stossel into the penthouse.  Instead, he found out what service was like for the masses.

Perhaps this was why Mr Stossel railed at the “socialist bureaucracies” he perceived as running New York – Presbyterian Hospital.  However, calling the hospital management “socialist” seems – not to put too fine a point on it – wrong.

A “Socialist Bureaucracy” Paying Millions to its CEOs?

First of all, New York Presbyterian is hardly a government agency.  It is a private, non-profit corporation.  Every year as such it files a form 990 with the dread US Internal Revenue Service. (The latest publicly available version is from 2013, here.)  Obviously, US government agencies do not file with the IRS.

In fact, the New York Presbyterian system seems about as far from a federal government agency as one can imagine.

First, its top managers are paid like for-profit corporate executives.  In 2014, we posted about the humongous compensation given to its previous, long-serving CEO, Dr Herbert Pardes, who received multi-million dollar compensation every year through his 2011 retirement, and then continued to receive several million a year from the system in his retirement.  His successor, current CEO Dr Steven Corwin, received $3.6 million in 2012.  (More recent compensation figures are not yet available.)

A “Socialist Bureaucracy” Dominated by Managers, with Stewardship by Top Financial Executives, and one of the Koch Brothers?

The current leadership of New York Presbyterian is dominated by businesspeople, not physicians, nurses, or other health care professionals.  Only 10 of 33 listed senior leaders are health care professionals.  The rest have administrative/ management or legal backgrounds and training.  Many appear to be generic managers, that is, people with background and experience primarily in administration or management, but not in medicine, health care, public health, etc.

The hospital system’s board of trustees was and is filled with some of the top business executives in the US, including some finance executives who have been cited as responsible for the global financial collapse/ great recession.

For example, we wrote about Mr Dick Fuld, a trustee until recently.  Mr Fuld was the CEO who presided over the bankruptcy of Lehman Brothers, which heralded the beginning of the great financial crisis/ great recession of 2008 onward.  Mr Fuld seemed to lack the sort of compassionate approach one might expect from someone charged with the stewardship of a big hospital system.  He had once publicly said about those who sold Lehman Brother stock short: “what I really want to do is I want to reach in, rip out their heart, and eat it before they die.”

Another recently retired board member was Sanford I Weill, architect of the mergers that created the now federally bailed out Citigroup.  In 2014, we posted about how Mr Weill, contemplating retirement from the board of trustees of Weill Cornell Medical School, one of the two medical schools with primary affiliations with New York Presbyterian, managed to bequeath his board seat to his daughter, Ms Jessica Bibliowicz, also the CEO of a finance firm, National Financial Partners.  Ms Bibliowicz now also seems to have Mr Weill’s seat on the New York Presbyterian board. 

Also, still on the board are two top finance CEOs who have been blamed for the global financial collapse.  These are  Maurice R Greenberg of the federally bailed out AIG, and John A Thain, CEO of the nearly collapsed Merrill Lynch (merged into Bank of America).  See this post for more information about their roles in the global financial collapse.

Finally, one other board member is David H Koch, described by Wikipedia

Koch is an influential libertarian. He was the 1980 candidate for Vice President of the United States from the United States Libertarian Party and helped finance the campaign. He founded Citizens for a Sound Economy. He and his brother Charles have donated to political advocacy groups and to political campaigns, almost entirely Republican

With socialists like these …?   

Summary

I do not doubt that John Stossel found the customer service at New York Presbyterian not up to his expectations.  And I actually have no doubt that New York Presbyterian has to operate within a complex health care system in which government bureaucracy plays a large role, and sometimes a counter-productive one.  Furthermore, I have no doubt that the management of New York Presbyterian is very bureaucratic, and this may in part may be a reason for poor customer service, and other failings.

However, to say that the management and governance of the hospital system is “socialist” is dead wrong.  In fact, like many other large health care organizations, the New York Presbyterian system appears to be run largely by “managerialists,” that is generic managers who have little experience or background in health care, may have little understanding or sympathy for its values, and approach health care with the same management techniques that might be applied to selling soap powder.  Furthermore, the stewardship of this particular hospital system seems to be largely up to some of the biggest, and loudest “capitalists,” and one of the most prominent “libertarians” in the US.

But to someone with a hammer, most problems look like nails.

Maybe Mr Stossel needs to complain to Mr Koch.

In conclusion, I am glad that some of the problems in the dysfunctional US health care system are getting more public attention.  However, now we need to calmly and rationally consider what is causing them and what to do about them without the blinders of ideology or vested interests. 

IMHO, true US health care reform would put the operation of US health care organizations more in the hands of people who have knowledge and experience in health care, and are willing to be accountable to support health care professionals’ values.  Furthermore, oversight and stewardship of these organizations should represent the patients and public which the organizations are supposed to serve. 

Back to Paper After U.S. Coast Guard EHR Debacle: Proof of Hegel’s Adage “We Learn From History That We Do Not Learn From History”?

I have become blue in the face writing about healthcare information technology mismanagement over the years.  In fact, the original focus of my 1998 website on health IT (its descendant now at http://cci.drexel.edu/faculty/ssilverstein/cases) was on HIT project mismanagement.

If this industry actually had learned anything from history, I would not be reading nor writing about brutally mismanaged HIT endeavors in 2016.  Sadly, that is not the case.

The Coast Guard, founded by Alexander Hamilton, has this as its motto and mission:

http://www.gocoastguard.com/about-the-coast-guard
Semper Paratus – Always Ready.

The Coast Guard is one of our nation’s five military services. We exist to defend and preserve the United States. We protect the personal safety and security of our people; the marine transportation system and infrastructure; our natural and economic resources; and the territorial integrity of our nation–from both internal and external threats, natural and man-made. We protect these interests in U.S. ports and inland waterways, along the coasts, on international waters.

We are a military, multi-mission, maritime force offering a unique blend of military, law enforcement, humanitarian, regulatory, and diplomatic capabilities. These capabilities underpin our three broad roles: maritime safety, maritime security, and maritime stewardship. There are 11 missions that are interwoven within these roles.

It seems the Coast Guard personnel need personal protection from the HIT industry, for the motto of that industry, sadly appears to be something like “Stupra Acetabulus” (Screw the Suckers).

From Politico, one of only a few publications that in recent years has taken a critical approach to this industry and pulls no punches:

http://www.politico.com/story/2016/04/ehr-debacle-leads-to-paper-based-care-for-coast-guard-servicemembers-222412

EHR debacle leads to paper-based care for Coast Guard servicemembers
By Darius Tahir
04/25/16

The botched implementation of an electronic health records system sent Coast Guard doctors scurrying to copy digital records onto paper last fall and has disrupted health care for 50,000 active troops and civilian members and their families.

Five years after signing a $14 million contract with industry leader Epic Systems, the Coast Guard ended its relationship with the Wisconsin vendor, while recovering just more than $2.2 million from the company. But it couldn’t revert back to its old system, leaving its doctors reliant on paper.

This state of affairs is simple inexcusable.  It represents gross negligence and severe multi-axial incompetence at best – but likely primarily not by the Coast Guard, whose core competency does not include HIT.

There’s no clear evidence the EHR disaster has harmed patients, and a Coast Guard spokesman said the use of paper records hasn’t affected “the quality of health care provided to our people.”

Proof by lack of evidence is not reassuring in a debacle of this kind.  However, the Coast Guard admits that paper records aren’t the clear and present danger the IT pundits make them out to be.

Politico is skeptical of the claim:

That seems unlikely. Without digital records, if a patient goes outside a Coast Guard clinic, it can take weeks for the paper record to follow him or her back to the Coast Guard, says Michael Little of the Association of the United States Navy. And since the Coast Guard primarily provides outpatient, rather than hospital, services, many of its patients seek outside care.

“It’s one thing if you’re doing paper-based [care] in Ohio, but what about if you’re on paper records in [an] icebreaker or cutter in Alaska, and you need your gall bladder removed?” said Little, the organization’s director of legislative affairs.

In this case, I disagree that the lack of records is so dangerous.  There’s the telephone, FAX machines, the patient himself or herself, and the hand-carried note.  Used with care, those serve care reasonably well. 

With the Department of Veterans Affairs weighing whether to buy a top-of-the-line commercial electronic health record and the Pentagon beginning a multibillion-dollar EHR implementation, the Coast Guard case displays how poorly the process can go for the government, even when the biggest names in health IT are involved.

Not just the government.  I’d also argue that this shows that the “biggest names” are, at best, overextended, and at worst, badly needing external investigation as to their software development, customization, implementation and support practices, as well as hiring practices (e.g., see my August 15, 2010 post “EPIC’s outrageous recommendations on healthcare IT project staffing
at http://hcrenewal.blogspot.com/2010/08/epics-outrageous-recommendations-on.html) and contracting.

Reversion to a purely paper-based system is a rare event in the recent annals of electronic records, said Thomas Payne, a health IT expert at the University of Washington. “I can think of examples where that has happened, but in the last decade that is much less common.”

I believe that is because of the general invisibility of, and immunity from, the risks and harms that occur from “making do” with bad health IT due to financial pressures.  Hence one sees hair-raising examples like I wrote of at my Nov. 17, 2013 post “Another ‘Survey’ on EHRs – Affinity Medical Center (Ohio) Nurses Warn That Serious Patient Complications ‘Only a Matter of Time’ in Open Letter“at http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html where going back to paper to allow a complete rethinking of the EHR implementation would likely have been the safe response.

See also, for example, my July 2013 post “RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals” at http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html (there are links there to still more examples).

The Coast Guard is tight-lipped about the causes, timeline and responsibility for the debacle. “Various irregularities were uncovered, which are currently being reviewed,” a spokesman said.

The causes are all covered at http://cci.drexel.edu/faculty/ssilverstein/cases/, and have been since the late 1990s.  In the alternative, the book “Managing Technological Change: Organizational Aspects of Health Informatics” (http://www.amazon.com/Managing-Technological-Change-Organizational-Informatics/dp/0387985484) by Lorenzi & Riley does likewise for an even longer period, since the mid 1990s – for those willing or able to learn from history and from the pioneers

There’s no shortage of candidates: the service relied on five separate vendors to build the new system, and its own planning seems to have been at fault.

Lawmakers are looking into the matter, said a spokesman for the Senate Appropriations Committee, which is “monitoring the situation.”

This is symptomatic, in my view, of the fact that there are a lot of “Beltway Bandit” IT consultant companies doing business, few of them very good.

Bungled implementation, followed by chaos

In September 2010, the Coast Guard bid out the contract to Epic Systems, then added an array of other contracts to software vendors and consultants to help implement it. Since 2010, the agency spent, on net, just more than $34 million on health IT.

In a January 2011 speech, Coast Guard Chief Medical Officer Mark Tedesco cited the success of Epic installations at Kaiser Permanente and Cleveland Clinic. He predicted that the Epic implementation would improve the health of its population and save money.

Overall it’s a cheaper system for us to run than to upgrade to [the next generation military EHR], because of what that would’ve meant to us infrastructure-wise and support-personnel wise,” he said.

It’s stunning to think what this says about the next-generation military EHR.  The previous one was not very good, either (see my June 4, 2009 post “If The Military Can’t Get Electronic Health Records Right, Why Would We Think Conflicted EHR Companies And IT-Backwater Hospitals Can?” at http://hcrenewal.blogspot.com/2009/06/if-military-cant-get-electronic-health.html). 

Trouble, apparently, struck quickly. The solicitation for the EHR contract envisioned rolling out the software within six months at two to three pilot sites, before deploying it to a total of 43 clinics and the sickbays aboard the Coast Guard’s fleet.

That didn’t occur; the system never deployed to any clinic or cutter, said Eric Helsher, an executive with Epic. The next missed deadline was March 2012, which Trent Janda — the Coast Guard doctor serving as project leader — announced in a summer 2011 newsletter of the Uniformed Services Academy of Family Physicians.

One can only wonder what penalties the contract called for if the goals and timelines were not met.  That software was not deployed even to any pilot sites is nearly unimaginable to me.

As Janda set the new goal, he acknowledged there had been “multiple hurdles and delays,” and explained that the service had expanded its ambitions.

“Immediately upon award of the contract, we began a comprehensive analysis of the clinical workflows and existing information systems,” Janda wrote. “Many of the weaknesses became apparent as we compared ourselves to industry standards and best practices. Frequently, a weakness would lead to others, ultimately leading to the need for an additional system. The work-flow analysis quickly grew into a system wide re-engineering project like a snowball rolling down the mountainside.”

This sounds like a groundbreaking level of project mayhem and chaos, even for HIT.

The comment reveals that the agency failed to do necessary advance planning, says Theresa Cullen, an informatics executive with the Regenstrief Institute who formerly worked with Veterans Health Affairs and the Indian Health Service.

“They should have done a full needs assessment,” she said. “One would have normally done the workflow evaluation prior to the release of the RFP.”

If true, I believe it was an obligation of EPIC and the multiple contractors to have pointed that out to their future customer, and adjusted their bids accordingly, taking into account the time and resources needed for this type of work – or not placed a bid at all.  Such deficiencies and what they mean towards project progress and failure are obvious – to anyone who’s learned from history.

… Cullen also found it odd that the Coast Guard didn’t hire consultants to implement the new system until September 2012. The service ended up hiring Leidos, which also maintained its old EHR.

The Coast Guard further complicated the process by deciding to team up with the State Department. Its original request was complicated enough, with installations spanning six time zones. The partnership with State meant implementing across 170 countries. (A spokeswoman for State said the agency was investigating its options, but refused additional comment).

The sheer number of sites led Cullen to question whether Coast Guard and State had devoted enough resources to the project. Between Epic and Leidos, the project was budgeted for roughly $31 million. That was “an inadequate amount of funding for what you’re asking to do,” she said. Consultants receive roughly $100 an hour, and Epic’s work with clinicians is time-consuming.

Again, those hired knew, should have known, or should have made it their business to know that under such conditions, if true, project failure was the predictable outcome.  They are supposed to be the HIT experts, after all, not the Coast Guard.

While a very efficient health care system could implement the EHR, she said, the Coast Guard lacks that reputation. She speculated that Epic intentionally underbid the contract. (Epic’s Helsher said that “the contract was viable and we were fully motivated to lead a successful install.”)

Someone is right, and someone is wrong.  I leave it to the reader to decide who was correct and who wasn’t.

Anecdotes of further delays pepper various newsletters and reports from 2012 through 2015. Server failures scuttled a pilot rollout in 2014, then developed into deeper problems, and last July the systems started failing on a more regular basis.

Perhaps the “anecdotes” need to be turned into “teachable moments” through legal discovery by federal law enforcement.

The Coast Guard advised retirees and dependents that month that, due to incompatibility between its EHR and the Department of Defense’s new medication reconciliation system, they couldn’t get their prescriptions filled at Coast Guard clinics.

Around Labor Day, Coast Guard health care personnel were directed to copy information from electronic files onto paper, for fear of losing their data.

That is just about the most pathetic sentence I’ve ever had to read in my 24 years in Medical Informatics.

… doctors are frustrated. One complained in the Uniformed Services Academy of Family Physicians newsletter of “unique challenges which seemed to revolve around many electronic record keeping changes.” “The question we pose is, how is this affecting shipboard life?” Little said. “This is the most important thing that’s happening right now in the Coast Guard.”

My advice to the Coast Guard is to treat the IT invaders and consultants as it would a invading maritime fleet from a hostile nation.

The vendors who worked with the Coast Guard either don’t know what went wrong, or aren’t telling. Leidos — also the lead company implementing the Pentagon’s EHR project — declined comment, as did Lockheed Martin, which was contracted to implement access to the EHR through mobile devices, and Apprio, which was to provide credentialing services.

I believe they have a very good idea of “what went wrong”, and aren’t telling (per the Fifth Amendment)?  If they have “no idea” what went wrong, what, I ask, are they doing in the IT consulting business?

… The EHR giant [EPIC] says it’s not entirely clear why the Coast Guard pulled the plug. But the situation wasn’t Epic’s fault, company executive Eric Helsher said.

They pulled the plug out of fear for their members’ well-being, hopefully.

It seems everyone seeks to escape culpability, with the blame placed on the customer.

The Coast Guard spokesman said the decision was “driven by concerns about the project’s ability to deliver a viable product in a reasonable period of time and at a reasonable cost.”

It seems there’s still some who don’t continue down the sunk-cost fallacy road (https://www.logicallyfallacious.com/tools/lp/Bo/LogicalFallacies/173/Sunk_Cost_Fallacy) and are willing to walk away from bad HIT.

… In general, software contracts deserve more scrutiny, said Kingston, who served on the House Appropriations Committee. “These things don’t get the scrutiny a weapons system does.”

Considering the reputation of military costs, that’s saying quite a lot.  The lesson that should have been learned from history is that HIT is both exploratory, and a relative free-for-all.

Caveat emptor.

One last piece of (free!) advice for the Coast Guard leadership.

Read this paper:

Pessimism, Computer Failure, and Information Systems Development in the Public Sector.  (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand).  Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT.  linkto pdf

That may be the most valuable learning experience of all for their next attempt to implement EHRs.

— SS

JAMA LAYS AN EGG

JAMA LAYS AN EGG 
Three months ago I took JAMA to task over a Viewpoint opinion piece about conflict of interest. The authors proposed dancing around the reality of financial conflict of interest in medicine by talking instead about confluence of interest. I countered with a proposal for the term competing interests, which would not paper over the problem. In that postI also included a letter I had sent to JAMA in response to the opinion piece, but which JAMA had declined to publish. I questioned whether JAMA had deep sixed all the critical replies it received.
Now I can report that, in the April 26, 2016 print edition, JAMA has finally published one critical letter and a replyfrom the original authors. So JAMA didn’t deep six everything. This new correspondence appears 174 days after print publication and 214 days after on-line publication of the original Viewpoint article. That glacial delay is problematic – it disables meaningful dialogue.
The new critical letter is from a group in Europe, and it thoughtfully discusses weaknesses in the Viewpoint authored by Cappola and FitzGerald. These Viewpoint authors did not do justice to the critical letter in their reply. Moreover, they disclosed multiple potential competing interests, but they did not follow their own advice by clarifying why we should disregard those obvious competing interests. As we all know, the mere disclosure of competing interests does not by itself remove the problem. It can be a device for hiding in plain sight. Substantively, the reply from Cappola and FitzGerald is mostly hand waving and restatement of biased opinion, without real analysis or incisive thought.
The closing sentences of their reply letter illustrate these issues: “Everyone has biases. Rather than present these pejoratively, as a clash of values that undermines validity, it seems more constructive to mine the complexity of these biases, present them in an accessible fashion, and seek to determine whether they are confluent with the interests of patients, scientists, and regulators who might base their decisions on the results of a given piece of work.” The reference to complexity of biases concerns the matter of nonfinancial bias like fame and careerism in science. The reference to presenting biases in an accessible fashion concerns the ill-considered proposal to include a bias heat map on patients’ consent forms. This idea rightly was panned by the European critics. Meanwhile, where did the compromised and disgraced key opinion leaders disappear to in all this wishful thinking? Where did the corrupt corporations disappear to? They paid billions of dollars in penalties for felony crimes and plea-bargained settlements. They have been airbrushed out of the Cappola-FitzGerald narrative. These authors come across like Bambi confronting Godzilla.

If this is the best that an associate editor of JAMA and a fellow of the Royal Society can do then JAMA needs a fix. This effort is too little and much too late.

Medicare’s Comprehensive Primary Care Initiative – A Two Year Report

After all the buzz (for example) around the coming launch of CMS’ Comprehensive Primary Care “Plus” program,  the New England Journal of Medicine (or NEJM) just published a “special article” on the original Comprehensive Primary Care (CPC) initiative.
This is important if you think CMS’ approach to supporting primary care is the fix for what ails the U.S. health care system.
Population Health Blog readers may recall that two years ago, CMS launched CPC. This is a still ongoing four-year multi-payer study to determine whether primary care that is “turbocharged” with medical home-style capabilities (see here, here and here – see page 8) would increase quality and lower health care costs. 
The term “multi-payer” is important, because CMS recognized that clinics struggled with providing medical home care to some, but not all, patients on the basis of their insurance.  Better to have one standard of care to all patients.
The NEJM article is an analysis of CPC’s results after two years. 
To summarize how CPC was set up, 502 clinics (from 978 applicants) across 8 states participated along with a total of 39 other insurers.  In addition to the usual fee schedules, the Medicare and the other insurers paid a per patient severity-based “care management fee” that, on average, ranged from $8 to $40 per beneficiary per month (PBPM). Practices were also promised an additional bonus if, after two years, they reduced health care costs (i.e., shared savings) and improved various quality measures and performed well in surveys about the patients’ experience of care.
These CPC practices’ outcomes were compared to a propensity matched group of non-participating practices with a similar electronic health record (EHR) infrastructure that cared for a set of patients with similar levels of disease and baseline costs. 30% of these practices had applied but were not accepted in the initiative. The total number of comparison practices was 908.
Results?  Not good.
Aft the end of two years, there was no statistically (p > .05) significant difference in the growth of health care costs between the CPC and control sites.  This was true whether just claims costs were examined (a negligible difference of $11 per patient per month favoring the CPC sites), or whether claims costs plus the additional fees were examined (a difference of $7 favoring the comparison sites).
When patient costs were examined by the burden of disease, there was no indication that more costly patients achieved any savings. 
CPC sites had a statistically significant reduction in outpatient office visits, but not in hospitalizations.
While the difference in claims expense failed to be statistically significant, the total additional fees collected by the participating sites amounted to a financially significant $389,000. This represented a 15% increase in their income
Was quality of care improved?
Patients with diabetes and a high burden of illness were more 3% more (p<.05) likely to receive the recommended follow-up measures to manage their disease. Otherwise, “the initiative did not have significant effects on the processes used as measures of the quality of care for the full sample.”
Patient experience of care?
While surveys showed small increases in patient support, “there were no significant effects on other composite measures: ability of patients to obtain timely appointments, care, and information; how well providers communicate with patients; provider’s knowledge of care patient received from other providers; and overall rating of providers by patients.”
Yikes. Ouch. Egads.
The authors correctly point out that CPC is a four year program and that it still may be too early to see the impact of the medical home turbocharging.  That was pointed out in the negative one year evaluation.  Maybe something will turn up at three or four years.
In addition, CMS has a lot of other value-based initiatives underway, which may have biased the results.  There may be a “ceiling effect” among the participating sites as well as the control sites, which were already working to reduce (for example) rehospitalizations or pursue the fee schedule modifiers.
It’s also important to note that the impact on the other insurers’ costs and patient quality was not reported.  It’s possible that they saw a benefit.
The PHB’s take?
1.  Many care management programs achieve claims reduction with savings (for example) within one to two years.  If CPC hasn’t succeeded by now, it probably won’t.  And if the just-announced CPC Plus is modelled after this, it’s hard to see how that program will turn out any differently.
2. It is possible that, within all the statistical noise, there were some primary care sites with particularly robust approaches to care that did bend the cost curve.  CMS should seek these sites out and find out more about their secret sauce.  More on that in a future post.
2.  If CPC’s approach to care is ultimately shown to not bend the curve, what’s the problem? 
The PHB continues to believe that one size doesn’t fit all and not all patients benefit from care management. Many patients, even those with chronic conditions are quite stable and need minimum attention; some patients are so sick that no intervention will keep them out of emergency rooms and hospitals. As pointed out here, as more and more patients are enrolled in care management, the return on investment can paradoxically go down. Better to focus on patients who are not only at risk, but have “impactable” condition profiles.
In addition, CPC is based on a 5 year-old model of care. Things have changed since then: modern population health brings many more resources to the table.  That not only includes in-depth analytics support (for example, to define those patients who are at greatest risk) but mHealth. For example, there is one innovative company (the PHB’s Shameless Commerce Dept. over on the right side of your screen) that provides recently discharged patients with an app-enabled handheld configured to provide close follow-up.  And so on.
3. It may be that care management works best in a managed care setting.  CPC is a study of classic fee-fore-service Medicare beneficiaries with access to any participating Medicare provider. In Medicare managed care, the insurers and their providers have an even larger incentive to maximize quality and lower cost.  If that’s the case, CMS – despite their commitment to innovation – may want to get out of the care management business, because they just don’t know how to do it.