Wednesday, May 28, 2014

Sovaldi - a "Revolution" in Clinical Care, or in Marketing and Public Relations?

The continuing public discussion of the sky high price Gilead has set for Sovaldi (sofosbuvir,) its new antiviral drug for hepatitis C, continues to avoid considering the lack of good evidence that the drug is as safe and effective as its proponents claim.

We first posted about the Sovaldi debate on March 27, 2014, and its focus on price rather than the quality of the evidence underlying loud claims about the miraculous qualities of the drug.  We suggested that there is no good evidence supporting claims that most hepatitis C patients have very bad outcomes if untreated, treatment prevents most bad outcomes, Sovaldi cures nearly all patients, and Sovaldi has very few side effects.

In a subsequent post we wrote that initially, "no one but your humble blogger seemed to be publicly skeptical about published assertions that the drug was some sort of modern miracle, and a triumph of medical science."

On May 7, we noted an assessment by the German Institute for Quality and Efficiency in Health Care (IQWiG) of information submitted by "industry" (presumably Gilead) to the German government.  This assessment found multiple problems with the evidence, including limited generalizability, problems with randomization, lack of information about important outcomes, and lack of ability to quantify benefit.   Also  the US based Institute for Clinical and Economic Review noted that there was little evidence that compared to previous treatments, Sovaldi is better, and no evidence that Sovaldi produces cures in the long term.

Nonetheless, the notions that the evidence supporting Sovaldi (and perhaps other similar drugs) is weak, and that the drugs therefore should not yet be considered miracle cures have not seemingly affected the public discussion. 

Examples of the Latest Discussion

Washington Post/ Kaiser Health News


On May 12, 2014, in an article on the dilemma the drug's US price of $1000/ pill presents to Medicare, Richard Knox wrote this about a patient with the infection:

Previous drug treatments didn't clear the virus from Bianco's system. But it's almost certain that potent new drugs for hep-C could cure him.

In other words, the article asserted that Sovaldi and similar drugs cure nearly everyone with hepatitis C, even those not cured by previous treatment.

 Reuters

On May 20, 2014, in an article about how US health insurers are balking at the price of Sovaldi, was this statement by the main trade organization for US for-profit health care insurers, America's Health Insurance Plans (AHIP),

Sovaldi has shown tremendous results, and it's the kind of medical innovation we need to sustain. 

In the article's text was the assertion,


The new drug has demonstrated an ability to cure well over 90 percent of patients in just 12 weeks or less with few side effects.

Prior to the Sovaldi approval, hepatitis C treatments took 24 or 48 weeks, cured about 75 percent of patients and involved many more pills as well as injectable interferon that causes flu-like symptoms and other side effects that led many people to avoid or discontinue treatment.

In other words, the article asserted that Sovaldi can cure over 90% of patients compared to the cure rate of 75% provided by previously available treatments, and implied Sovaldi has fewer side effects.

CNBC

On May 22, 2014, in an article on the high costs of new drugs, a quote from Dr Douglas Dieterich, "a liver disease specialist at Mount Sinai Hospital," who "has consulted for pharmaceutical companies, including Gilead," appeared,

I don’t think there’s any question that treating patients with hepatitis C will lower overall health-care costs in the coming 20 years,...

If we could get rid of the liver disease in these patients with hepatitis C, prevent them from dying of liver cancer, cirrhosis and liver failure, then there’s no question the cost will be less.

The implication was that the new drugs can get rid of the disease, that is, cure it, and in doing so prevent early mortality, cirrhosis, and liver failure.

CTV

The discussion of Sovaldi in Canada seems similar. On May 25, 2014, an article on the high cost of hepatitis C drugs in Canada from CTV, "Canada's largest private broadcaster," (look here) quoted a Canadian physician,

 Dr. Curtis Cooper, director of the viral hepatitis program at the Ottawa Hospital, said the drugs Sovaldi and Galexos offer a revolution for patients with the hepatitis C virus (HCV).

'It only requires 12 weeks of treatment and (they) are producing cure rates of 90 to even 100 per cent,' he told CTV News.


And later, addressing the treatment of a particular patient,

We're talking about curative therapies, which could potentially save her from liver failure, save her from liver cancer

Again, the assertions were that the drug cures 90%, maybe 100% if patients, and that cure will prevent liver failure and cancer.

Is There Any Good Evidence?

Again, while there is much discussion, and some outrage over the $1000 per pill price of Sovaldi in the US (in Canada, a bargain at Canadian $650 per pill), all the discussion seems to assume that the pill is really a "revolution" (as per CTV), that provides
- cure rates of 90 - 100%, much better than previously available treatments
- lower adverse effect rates than than those caused by previously available treatments
-  prevention of complications of hepatitis C, including cirrhosis, liver failure, liver cancer, and early death.
I have found just one recent media article that throws a bit of evidence-based cold water on these claims, and refers to a new systematic review that should be generating a lot of interest, and provoking much more skepticism about the drug, but so far is not.

The Single Skeptical Article

On May 22, 2014, a MedPage Today article noted a new systematic review of sofosbuvir (Sovaldi) that had a very different message from the articles above.  In summary,

The evidence base for one of the star hepatitis C drugs is poor and the guidelines for its use are flawed, according to a report obtained by the National Association of Medicaid Directors.

According to the report, studies of sofosbuvir (Sovaldi) are generally of poor quality, mostly directed by the drug's maker, and don't answer key questions, including whether the drug is better and safer than the current standard of care.

The only available guidelines for its use -- guidelines created by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America -- are 'methodologically flawed,' according to the report, which was prepared by the Center for Evidence-Based Policy at Oregon Health and Science University in Portland (OHSU).

In addition, their authors and sponsors had 'multiple and significant conflicts of interest,' the report argued.

The Report from the Center for Evidence-Based Policy

The report is public, available without cost direct form the Center (email < centerebp@ohsu.edu> ), although not yet directly available on the web.  It directly addresses all four of the major claims made about Sovaldi that we discussed in our first post n the topic.

- Most hepatitis C patients have very bad outcomes if untreated


The report cited the best data about outcome prevalence,

approximately 15% to 25% of people infected with HCV will clear the virus during the acute stage without treatment.  Seventy-five to 85% of infected individuals will develop a chronic HCV infection, and 60% to 70% of patients with chronic infection will develop chronic liver disease.  Over 20 to 30 years, 5% to 20% of infected patients will develop cirrhosis and 1% to 5% will die of cirrhosis or liver cancer.

Although a majority of chronically infected patients will develop some liver disease, only a minority will develop cirrhosis or liver cancer.

- Treatment prevents most bad outcomes


The report stated,

Because of the slow progression of the disease, clinical trials have not evaluated these patient-important conditions [cirrhosis, hepatocellular carcinoma, decompensated liver disease, liver transplant, or death] as trial outcomes.  Instead a surrogate endpoint of sustained virologic response (SVR) has been used to measure success of treatment.  The SVR is defined as undetectable HCV-ribonucleic acid (RNA) levels.  The standard measure of treatment success has been SVR at 24 weeks post treatment (SVR24).

Several long-term studies of patients with chronic HCV infection have shown an association between achieving SVR24 and patient-important clinical outcomes.

So there is no direct evidence that treatment prevents any of the bad outcomes.  There is only indirect evidence that treatment may reduce the rate of some bad outcomes.  For example,

A 2014 observational study of a VA population found that ... the 5180 (4%) of patients who were able to achieve an undetectable viral load with interferon-based treatment had a 45% reduction in the risk of death ... and 27% reduction in the composite clinical endpoint ... of newly diagnosed cirrhosis, HCC [hepatocellular carcinoma], or liver related hospitalization.

However, at best, based on an observational analysis that could have been biased, treatment only may have prevented a minority of bad outcomes.

- Sovaldi cures nearly all patients


As we noted earlier, there have been only two randomized controlled trials published that compared sofosbuvir with anything else.  One compared it to placebo, and one was the trial we discussed earlier that compared it sofosbuvir with ribavirin to pegylated interferon with ribavirin.  (Look here.)  

All other studies were designed to refine drug dose, drug combination or duration of treatment.

Also,

All studies were rated as having a high risk of bias.  No study was judged to have good applicability....  The overall summary judgement for each of the published studies yielded a rating of poor.

Furthermore, the review found even more problems with the only study that compared sofosbuvir to active treatment (peg-interferon) than we did.  In particular, that study did not compare sofosbuvir with ribavirin to the current standard regimen of PEG plus weight-based ribavirin.  Instead, it compared it to a regimen that included low dose ribavirin.  By comparing sofosbuvir plus a higher dose or ribavirin, an active drug, to a peg-interferon plus a lower dose of ribavirin, the study design seemed designed to artificially enhance the efficacy of the sofosbuvir containing regimen.   Furthermore, the study did not assess the measure of sustained viral response at 24 weeks currently accepted as the best surrogate variable.  Instead it used SVR at 12 weeks, which may be correlated with SVR24 but is often higher. Thus this choice of endpoint seemed designed to increase the apparent efficacy of the regimens it evaluated. 

So sofosbuvir has so far been compared to another active anti-viral regimen against hepatitis C in only one study.  That study was poorly designed and implemented, and its problems seemed likely to enhance the apparent efficacy of sofosbuvir.  Nonetheless, that one study did not show that sofosbuvir was more efficiacious, or safer than peg-interferon.

- Sovaldi has very few side effects.

The review had this summary,

The FDA compiled reports of adverse events from four trials....  There were no treatment-related deaths reported [note that we found there were deaths in the one trial that compared sofosbuvir to PEG, look here].

Approximately 78% of patients receiving placebo, 88% of patients on SOF + RBV treatment and 95% of patients receiving PEG + SOF +RBV reported a side effect from treatment.  The most common side effects were fatigue, anemia, nausea, rash, headache, insomnia and pain....

Thus it seems likely that Sovaldi has a lot of side effects, and whether it has fewer than standard treatment is unclear.  Furthermore,

studies on sofosbuvir were small, included populations that were healthier than the general hepatitis C population, were of short duration and had limited follow-up.  In many of the studies, the manufacturer was responsible for recording and reporting adverse events.  In general, reporting of adverse events is often incomplete and discrepancies between clinical trial reports and publications are common....  All of these factors would lead to a bias in under-reporting the true nature of adverse events.

Thus there is no good evidence that sofosbuvir has few side effects, or is dramatically safer than older treatments.

Summary

While there continues to be concern, if not outrage, that the latest treatment for hepatitis C is priced at $1000 per pill, most of those expressing concern seem to assume that the pill is a wonder drug, promising nearly everyone a cure without major side effects.  However, as we first noted in March, 2014, there is no strong evidence to that effect.  In fact, now three skeptical looks at the evidence by people with more resources and perhaps more expertise than we possess have shown similar conclusions.

It is a tribute to the power of the anechoic effect that there has been almost no recognition by physicians and other health professionals, journalists, and most amazingly, insurance companies who stand to lose billions paying for Sovaldi, that there is little good evidence that Sovaldi works, much less is superior to previous treatments.  Instead, even America's Health Insurance Plans thought the drug had "tremendous results," not very different from the assertion by the drug's manufacturer that the drug provides "a finite cure," (as reported by Reuters).  One might think that the insurance companies have enough money to invest in some real evidence-based medicine experts who could provide a skeptical assessment of the pricy new drugs and devices for which these companies may pay.  Is it that the commercial insurers are so now so dominated by generic managers who know nothing about health care, medicine, or biomedical science, much less evidence-based medicine that they are unable to resist the marketing and public relations hype?

The Sovaldi case is a signal example of how our health care system is awash in marketing hype and public relations buzz that has swamped rational skeptical thinking about logic and evidence.  That marketing and PR is ever enriching managers while it will send the rest of us, health care professionals included, to the poor house.  And all the money we spend will not buy us the promised miracles and triumphs.

As we have said until blue in the face, true health care reform would bring some skeptical thinking and regard for evidence and logic into the health policy discussion.  

"Texas VA Run Like a ‘Crime Syndicate,’ Whistleblower Says" - Can Reports About the Benefits of EHRs at the VA Healthcare System Be Trusted?

More and more is leaking out about alleged executive malfeasance at the Veteran's Administration healthcare system in the U.S.

This article just appeared:

Texas VA Run Like a ‘Crime Syndicate,’ Whistleblower Says
May 27, 2014

http://www.thedailybeast.com/articles/2014/05/27/exclusive-texas-va-run-like-a-crime-syndicate-whistleblower-says.html

For years, employees at a Texas VA complained that their bosses were cooking the books. For years, the VA insisted there was no widespread wrongdoing.

New whistleblower testimony and internal documents implicate an award-winning VA hospital in Texas in widespread wrongdoing—and what appears to be systemic fraud.

Emails and VA memos obtained exclusively by The Daily Beast provide what is among the most comprehensive accounts yet of how high-level VA hospital employees conspired to game the system. It shows not only how they manipulated hospital wait lists but why—to cover up the weeks and months veterans spent waiting for needed medical care. If those lag times had been revealed, it would have threatened the executives’ bonus pay.

What’s worse, the documents show the wrongdoing going unpunished for years, even after it was repeatedly reported to local and national VA authorities. That indicates a new troubling angle to the VA scandal: that the much touted investigations may be incapable of finding violations that are hiding in plain sight. 

“For lack of a better term, you’ve got an organized crime syndicate,” a whistleblower who works in the Texas VA told The Daily Beast. “People up on top are suddenly afraid they may actually be prosecuted and they’re pressuring the little guys down below to cover it all up.”

Read the linked article in its entirety.  It contains document images of altered electronic orders, the EHR system apparently being used for "creative storytelling" to allow for "good metrics", and an employee "performance plan" evaluation submitted by a whistleblower containing perverse incentives:

... The VA’s 2012 performance plan, provided to The Daily Beast by the whistleblower, contains five critical elements to evaluate success, each one containing multiple sub-criteria. But critical element No. 5, the “Results Driven” component that contains the “wait time” criteria, is worth 50% of the overall score. That’s as much as all the other elements combined.

I won't delve into the gory details of the article further...read it yourself...but I do raise the following issues:

1.  The VA EHR system VistA CPRS has been touted as among the best EHR's in the world, based on reports that come out of the VA.

  • Can these reports on the benefits and safety of VistA CPRS be trusted, considering what may be going on systemically regarding altered data related to "making the numbers" and getting bonuses?
  • It is well known that EHRs slow clinicians down, through annoying alerts and reminders and other decision support, cryptic and complex order-entry processes, and the general need to navigate multiples screens and templates to perform what used to take seconds on pen and paper.   Is it also possible that the inability of the VA system to meet its care obligations in a timely manner is related to adverse effects on productivity of the EHR system itself?

2.  EHR audit trails are an automatically-generated log of user activities, such as viewing, printing, altering or deleting an electronic document or other data.  They are the only way to authenticate an electronic record as complete and unaltered, since all paper/handwriting cues are gone in the computer world.

  • It may be of interest to investigate the electronic audit trails generated by the VA electronic health records (EHRs)... or the lack thereof, for as I understand it those audit trails are often only active for VIPs ("very important persons") in the VA VistA CPRS EHR system.
  • Even worse, in the commercial sector hospitals admit they can alter or delete the EHR system audit trails - see my post at http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html.  It's likely the same applies in the VA, and it would be of concern that any audit trails of test and visit scheduling or other activities could be undergoing a "disappearing act" in the wake of this scandal, in addition to the actual test/scheduling data itself.

It is unfortunate that this scandal sheds doubt on claims made about activities, including EHR use, at the VA hospitals.  I myself have taught my students that the VA model has been a model for others to emulate, at least as far as EHRs are concerned.

-------------

As an important aside:

I am personally familiar with very odd events at the VA, namely in 1995.  At http://hcrenewal.blogspot.com/2009/06/computer-and-other-mysteries-at.html regarding the computer-related radiation brachytherapy debacle at the Philadelphia VA Hospital I wrote [and I am adding some additional comments now in brackets]:

... I have some familiarity with odd events at the Philadelphia VA Hospital. (Not including the fact that I spent a few months there as a medical intern in the early 1980's). In the mid 1990's I took my father there for evaluation for increased service-related disability. He had been treated for skin lesions in the Army in WW2 and after by the VA with Fowler's solution (an arsenical) and as a consequence of this (even then-outdated and dangerous) treatment, had developed widespread basal cell carcinomatosis over a major portion of his body, with chronic bleeding and discomfort.

I accompanied my father to the exam but did not identify myself as an MD, only as his son. [I was on vacation and was rather casually dressed.  I looked like any other schlep bringing his elderly veteran father in for care.]

My father was seen in an evaluation by several physicians and students (arsenic-caused basal cell carcinomatosis is quite rare now) in my presence, and he was then handed his (paper) chart to take with him back to the main desk.  [As we were walking] I told my dad I wanted to look at the note. The note by a physician who'd seen him stated (paraphrasing):

"Mr. Silverstein said he'd taken more than the prescribed dose of arsenic for years, and even shared it with his wife."

My father and I were shocked and dumbfounded. He'd said no such thing, and being a retired pharmacist of 40+ years, thought anyone making such a statement would have had to have been insane. (My mother had even harsher words when she heard about this.) [Along the lines of, "ARE THEY CRAZY???"]

Needless to say, I was upset. I [identified myself and] confronted the physician who wrote the note, but that physician [a relatively young woman] would not change it, bizarrely claiming that they "remembered my father telling that story in a visit several years prior." Needless to say, such a claim violated all the precepts of medical information integrity of which I was familiar.  [I wondered to myself, "what type of utter imbecile would even say such a thing to a Yale physician/medical informatics faculty member?"]

In an initial attempt to counteract this disability exam sabotage, I actually crossed out the statement in the chart, writing "this is untrue" or words to that effect and signed my own name.

The head of the Philadelphia VA Hospital would not return my calls on this matter.

That is, until Jesse Brown, then Secretary of the Department of Veterans' Affairs, inquired directly a few days later.

Unknown to the VA examiners, my father had been sent for the disability exam after reporting problems to Sen. Jay Rockefeller's office about prolonged delays in having his case heard.  Sen. Rockefeller's staff [specifically, Ms. Charlotte Moreland, http://votesmart.org/public-statement/25153/retirement-of-charlotte-moreland, who my mother had befriended through many telephone conversations] had set up the exam!

Sen. Rockefeller's staff was rather upset at the story I reported upon my return to New Haven about the bizarre chart fabrication at my father's VA disability exam, and apparently relayed the story up the chain of command, as it were.

After that, the head of the Philadelphia VA Hospital really, really wanted to speak to me and called me at Yale several times. He wanted to set up a phone conference between me, himself, and the doctors who'd seen my father. I told his administrative assistant that there was "nothing to talk about", and that the false statement in my father's chart would be removed. Period.

I think it was. My father's increased disability was granted in the end, but what was going on here with disability exams was never fully investigated to my knowledge (having done disability exams myself years prior for the regional transit authority, police, fire etc. in Philadelphia, I suspected an "incentive" program to deny vets a disability determination). If I had not examined my father's chart, we might have never known a reason for his being turned down.

A culture of honesty and accountability seemed lacking then, and seems lacking now.

In retrospect, it seems there may indeed have been an "incentive program" for, in essence, limiting positive disability determinations by sabotage, thus causing negative determinations on benefits.

Ironically, among other experiences, it was the impoverished experiences at the Phila. VA as an intern in 1981, with a decade of computer experience under my belt at that time, that led me to pursue a career in Medical Informatics.

With inadequate staff and resources, especially at night when a medical student and I and a minimum of nurses covered something like 50 patients - and at that early stage of my career I am honestly admitting that I did not know what I was doing, really - and large amounts of time wasted on paperwork, I thought there had to be a better way via computing.

I never expected that computers in medicine could become a tool for "creative data alteration" for executive enrichment, an impediment to good care, and a risk in and of itself, as was outed by a whistleblower recently in Athens, Georgia as at http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html.

-- SS

May 28, 2014 Addendum:  

Also see "How VA Clinics Falsified Appointment Records" at http://www.huffingtonpost.com/2014/05/28/va-clinics-falsified-records_n_5402547.html

-- SS

Monday, May 26, 2014

Athens Regional Medical Center: Hospital management is "addressing computer problems" AFTER patients are put at bodily risk, not before, only in response to irate clinicians; then claiming everything will be fixed soon while doctors resign.


Maybe hospital management gurus could address these computer problems BEFORE turning them loose on patients?

Physicians in Georgia seem to have more guts than their colleagues elsewhere.  Rather than letting patients be guinea pigs for the naive fantasies of hospital executives about health IT, these physicians said "get these [expletive] computer systems out of our hospital"...

Then they started resigning their appointments:

Athens Regional addressing new computer system problems encountered by doctors

By Donnie Z. Fetter
Friday, May 23, 2014

http://onlineathens.com/health/2014-05-22/athens-regional-addressing-new-computer-system-problems-encountered-doctors

Doctors affiliated with Athens Regional Medical Center (http://www.athenshealth.org/) have expressed concerns that a computer system installed this month at the hospital endangers patients.

Not "may endanger patients."  "Endangers patients."  That's quite direct.

However, the hospital's chief executive said Athens Regional is taking "swift action" to address those concerns.

I'm not impressed.  The executives should perhaps have done due diligence and taken action BEFORE this bad health IT was set loose on live, unsuspecting patients.

It's not as if the issues are unknown (as Google or anyone who actually knows what they're doing regarding health IT will easily demonstrate).  Further, those executives have the legal obligation to maintain a safe healthcare environment.

In a letter dated May 15 and provided to the Athens Banner-Herald this week, multiple doctors noted such concerns as “medication errors ... orders being lost or overlooked ... (emergency department) patients leaving after long waits; and of an inpatient who wasn’t seen by a physician for (five) days.”

Any of these issues and the multitude more I can predict exist can lead to severe injury or death, especially in fragile patients and the elderly.  Trust me, I know both professionally and personally...
 
The letter was addressed to ARMC President and CEO James G. Thaw and Senior Vice President and CIO Gretchen Tegethoff. It was signed by more than a dozen physicians, including Carolann Eisenhart, president of the medical staff; Joseph T. Johnson, vice president of the medical staff; David M. Sailers, surgery department chair; and, Robert D. Sinyard, medicine department chair.

The doctor who provided the letter to the Banner-Herald refused a request to openly discuss the issues with the computer system and asked to remain anonymous at the urging of his colleagues.

Refused a request to openly discuss the issues with the computer system and asked to remain anonymous at the urging of his colleagues ... due to fear the executives would then return the doctor's concerns with genuine love and appreciation, and give him or her a generous promotion and pat on the back, no doubt.  (Actually, quite likely was a fear of retaliation, e.g. sham peer review as at http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians.)

Note the educational background of CIO Gretchen Tegerhoff, the executive with fiduciary obligations to implement health IT of the highest quality and to have robustly researched all of the issues involved (and whom the Board should have thoroughly vetted as to required background for health IT leadership):

University of Georgia
Terry College of Business, Executive Program, Finance
2014 – 2014 (expected)

The George Washington University - School of Business
Master of Science, Information Systems Technology
2001 – 2003

West Virginia University
BS, Medical Technology
1993 – 1997

Note the career progression that is the envy of, say, someone who's completed the rigors of medical training (premed, medical school, internship/residency, clinical postdocs) and beyond that, completed an additional PhD, MS or post-doctoral fellowship in Medical Informatics at unknown universities such as Harvard, Yale, Stanford, Johns Hopkins, Columbia, etc. (reverse chrono):

Technical Analyst
STG (9 months)
[Provided U.S. Department of State with systems support and application maintenance.]

Clinical Systems Analyst
George Washington University Hospital (3 years 8 months)

Technical Support Specialist/Installer
Intellidata, Inc. (9 months)

Clinical Research Associate
QUINTILES, INC. (9 months)

Information Specialist
THE EMMES CORPORATION (1 year 8 months)

Writer/Editor
ASPEN SYSTEMS CORPORATION (7 months)

Medical Technologist
PROVIDENCE LABORATORY ASSOCIATES (8 months)

This background led directly to:

Chief Information Officer
George Washington University Hospital (6 years 8 months)

and then the current role:

Athens Regional Health System
Vice President and Chief Information Officer
Athens Regional Health System

If you believed that the qualifications required for medical practice - let alone medical leadership roles - is at least an order of magnitude more robust, you'd not be mistaken.

Perhaps even worse, business-IT amateur meddlers in clinical affairs sell the "best practices" that lead to debacles like this, and perhaps to IT-related patient injury and death, via their alphabet-soup "leadership" organizations.  This CIO also holds this credential:


Faculty
CHIME Healthcare CIO Boot Camp (8 months)

It should be noted, and scandalously so considering the negligence that leads to patient endangerment and this kind of physician revolt from the outset, that IT-related patient harms are not uncommon.  For example, per the Harvard community's med mal insurer CRICO, see "Malpractice Claims Analysis Confirms Risks in EHRs" at
http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html, the ECRI Institute, see "ECRI Deep Dive Study of Health IT harms" at
http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html as well as "ECRI Institute's 2014 Top 10 Patient Safety Concerns for Healthcare Organizations" at
http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html, "FDA Internal Memo on H-IT risks - for internal use only" (uncovered by investigative reporter Fred Schulte) at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html, and others as posted at this blog.

“From the moment our physician leadership expressed concern about the Cerner I.T. conversion process on May 15, we took swift action and significant progress has been made toward resolving the issues raised,” Thaw wrote Thursday in an email. “Providing outstanding patient care is first and foremost in our minds at Athens Regional, and we have dedicated staff throughout the hospital to make sure the system is functioning as smoothly as possible through this transition."

This raises several questions:

  • How about the moments from the time of decision to acquire the technology?  What safety consideration were in effect during that time? 

  • What if the "significant progress" is insufficient to prevent a patient from being maimed or killed due to toxic effects of bad health IT?  Who's responsible? 

  • Perhaps most importantly from the human rights perspective - are patients being provided informed consent about these "issues raised" and are they afforded the opportunity to seek care elsewhere until the "swift progress" is completed?  

One wonders if the executives were aware of analytic work on Cerner ED systems such as performed by U. Sydney professor Jon Patrick at "A study of an Enterprise Health information System",  http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146; or this site on health IT difficulties:  http://cci.drexel.edu/faculty/ssilverstein/cases/, or this blog and others.

It's not as if a simple Google search won't find them, such as https://www.google.com/search?q=healthcare+IT+failure.  Perhaps they need to read more...or hire experts BEFORE go-live.

Back to the article:

The intended goal of the system designed by health care information technology company Cerner is to improve efficiency and connectivity by providing doctors, nurses and other medical professionals with a shared data set and to eventually allow patients online access to their medical records, Athens Regional executives previously said.

Good intentions or not, badly designed and/or implemented technology harms or kills, and those harmed, or the dead, really don't care what the system is 'intended to do.'  Patients are not guinea pigs towards an IT company's or hospital's experiments with computers - regarding which the executives are usually in to at a level way over their collective heads.

But doctors noted the new system often proved too cumbersome to be effective at the time the letter was written.

“The Cerner implementation has driven some physicians to drop their active staff privileges at ARMC,” noted the letter. “This has placed an additional burden on the hospitalists, who are already overwhelmed.

That's just horrendous for safety.

Joint Commission, where are you?
 
Other physicians are directing their patients to St. Mary’s (hospital) for outpatient studies, (emergency room) care, admissions and surgical procedures. ... Efforts to rebuild the relationships with patients and physicians (needs) to begin immediately.”

Doctors voted with their feet.  Bravo.

I suggest they consider the following remedies as well if appropriate, from my post at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html:

... When a physician or other clinician observes health IT problems, defects, malfunctions, mission hostility (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting):

(DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.)


  • Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "disruptive physician" and/or or being subjected to sham peer review (link).
  • Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks at this link. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger Dr. Scott Monteith in a comment to me about this post.)
  • Inform the State Medical Society and local Medical Society of your locale.
  • Inform the appropriate Board of Health for your locale.
  • If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "Quality Insights of PA."
  • Inform a personal attorney.
  • Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.
  • As clinicians are often forced to use health IT, at their own risk even when "certified" (link), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:
"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.]

We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients. We assume responsibility for any such malpractice.

With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at http://www.jointcommission.org/assets/1/18/SEA_42.PDF, the IOM report on HIT safety at http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF, and the FDA Internal Memorandum on H-IT Safety Issues at http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology.

CMO __________ (date, time)
CIO ___________ (date, time)
CMIO _________ (date, time)
General Counsel ___________ (date, time)
etc."
  • If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.
  • As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.

These measures can help "light a fire" under the decision makers, and "get the lead out" of efforts to improve this technology to the point where it is usable, efficacious and safe.

More from the article:

Doctors called the time line to install the EHR system too “aggressive” and said there was a “lack of readiness” among the intended users.

For financial incentive reasons in part, I'm sure.  Computers, after all, seem to have more rights than patients...or than physicians and nurses.

Since receiving the letter, Thaw said Athens Regional has added "specialized staff" to meet daily with physicians to discuss computer system and safety issues.

Again, the key word is "AFTER."   A good move, considering the hospital will be up to its head in defections, accreditation inspections and hearings, and possible medical malpractice and corporate liability lawsuits otherwise.

"Regardless of what system we are using, our focus on patient safety is unwavering, and we will never put a system ahead of doing what is right for our patients," Thaw said. "Our team is working around the clock to resolve any remaining issues, and we remain dedicated to delivering outstanding patient care every step of the way."

Feel-good executive boilerplate and an outright lie on its face.  If the focus on safety was unwavering, this problems would not now need emergency remediation.  As I had written many years ago here: http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story, this type of shallow executive puffery and rhetoric only makes clinicians angrier.

And while events like this go on, the industry pundits suggest all that's needed is a Health IT 'Safety Center' instead of regulation like the rest of the healthcare industry ("Feds Call For Health IT Safety Center", May 20, 2014, http://www.govhealthit.com/news/feds-call-hit-safety-center?topic=,26#.U4FVDnYsC).  This is sort of like putting the safety of our country's hospitals in the hands of Consumer Reports.

That's not exactly the ticket to a rapid cure to these problems, which are more common than most physicians have the bravery (or career options in the face of retaliation) to admit.

At least nurses' unions are taking action, as at http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html and http://hcrenewal.blogspot.com/2014/05/a-nurses-union-national-nurses-united.html.

Additional thought:  at least the writer of the article did not use the customary euphemism for problems with patient-endangering bad health IT, specifically: "glitches" (http://hcrenewal.blogspot.com/search/label/glitch).

-- SS

May 27, 2014 Addendum:

The CEO has apparently resigned, see http://onlineathens.com/local-news/2014-05-23/thaw-resigns-athens-regional-ceo

I also solicit physicians from the area of this hospital to contact me regarding any patient harms that did occur as a result of this debacle, via my email address located here: https://www.blogger.com/profile/03994321680366572701.  I will forward any reports through appropriate legal channels to attorneys who can take action, which in 2014 is probably the only language this industry will actually listen to.

-- SS

May 27, 2014 Addendum 2:

The reader comments at http://onlineathens.com/health/2014-05-22/athens-regional-addressing-new-computer-system-problems-encountered-doctors are interesting, and distressing.

-- SS

May 29, 2014 Addendum:

More here:  http://flagpole.com/news/in-the-loop/james-thaw-out-as-armc-ceo

If I were that's hospital's new leadership, I'd immediately go back to whatever system (whether paper or not) was in place before this implementation, and take the time to implement new health IT properly, safely and carefully.

For at this point, if patient injury or death occurs as a result of a system flaw (whether in design or implementation), I believe charges of criminal negligence against the organization and its leaders would be justified.

The following is an example of one state's statute defining criminal negligence:

''A person acts with 'criminal negligence' with respect to a result or to a circumstance described by a statute defining an offense when he fails to perceive a substantial and unjustifiable risk that such result will occur or that such circumstance exists. The risk must be of such nature and degree that the failure to perceive it constitutes a gross deviation from the standard of care that a reasonable person would observe in the situation.''

I believe other states' statutes are similar.

-- SS

June 13, 2013 Addendum:

My post on Athens Regional Medical Center's physician revolt was accessed today by someone at Cerner; note the referring link:  http://cerner.vertabase.com/project/document/index.cfm?&0.12455576848

Vertabase (http://www.vertabase.com/) makes project management software.

Cerner.vertabase.com/project/document is some sort of password-protected document resource.

I find that interesting - perhaps it's for internal communications and they are learning something from me.



Domain Name (Unknown) 
IP Address159.140.254.# (Cerner Corporation)
ISPCerner Corporation
Location
Continent : North America
Country : United States  (Facts)
State : Kansas
City : Kansas City
Lat/Long : 39.1111, -94.6904 (Map)
LanguageEnglish (U.S.)
en-us
Operating SystemMacintosh MacOSX
Browser Safari 1.3
Mozilla/5.0 (Macintosh; Intel Mac OS X 10_8_5) AppleWebKit/536.30.1 (KHTML, like Gecko) Version/6.0.5 Safari/536.30.1
Javascriptversion 1.5
Monitor
Resolution : 1440 x 900
Color Depth  : 24 bits
Time of Visit Jun 13 2014 11:47:42 am
Last Page ViewJun 13 2014 11:47:42 am
Visit Length0 seconds
Page Views 1
Referring URL
http://cerner.vertabase.com/project/document/index.cfm?&0.12455576848
Visit Entry Pagehttp://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html
Visit Exit Pagehttp://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html
Out Click
Time Zone UTC-6:00
Visitor's TimeJun 13 2014 10:47:42 am
Visit Number 1,342,222

 -- SS

Note: also see my June 16, 2014 followup post at http://hcrenewal.blogspot.com/2014/06/masters-of-obvious-aat-athens-regional.html

Thursday, May 22, 2014

Big Door Keep Revolving - Our Latest Roundup About the Blurred Lines Between the Health Care Industry and the Government Bodies that are Supposed to Regulate and Make Policy Affecting It

The revolving door continues to turn connecting US government bodies that make health policy or regulate health care and the health care industry.  Sometimes these transitions are obvious, sometimes they are obscure.  The press sometimes makes the revolving door the subject, but more often it is just an aside.

The latest roundup of transitions through the door includes, in chronological order of media attention...

Former White House Press Secretary to Consultancy Serving Health Care Corporations

As reported by the Washington Post in April, 2014, Robert Gibbs was White House Press Secretary until he departed for the private sector,

Since departing the White House in 2011, Gibbs has taken a path familiar to other former White House officials who use their ties to a president to enrich themselves and establish a new career. 

In particular, he

co-founded The Incite Agency, a consulting and media relations firm that advises Fortune 500 companies, including health-care firms.

The story was apparently generated after the Democratic House Minority Leader openly criticized someone who served in the Democratic President's White House, so the thrust of the story was about how Mr Gibbs has apparently changed his ideas on Obamacare since his White House days,


House Minority Leader Nancy Pelosi (D-Calif.) suggested Sunday that former top Obama aide Robert Gibbs's comment that the employer mandate portion of the Affordable Care Act won't survive might be related to Gibbs's business interests.

'I don't know who his clients are or what his perspective is,' Pelosi told CNN's 'State of the Union.' 'But we are celebrating the fact that we have over seven million who have signed up.'

The Post also noted,

The speech Gibbs gave this past week in Colorado is consistent with how the Harry Walker Agency bills Gibbs as a potential paid speaker. On its Web site, pitches Gibbs by noting that he 'played a major role in the daily White House policy debates over the shape of healthcare reform.' It suggests that during such speeches, Gibbs 'articulates the future for the Patient Protection and Affordable Care Act.'

The pitch concludes by stating that 'The future of Obamacare -- and how it will affect your business -- is yet to be seen, and few are better prepared than Gibbs to guide you through that conversation.'
Again, note that this article seemed to be inspired by Rep Pelosi's direct criticism of a fellow Democrat, not by the revolving door transition per se.  

President of Global Government and Scientific Affairs at Natural Products Association to Director of the Division of Dietary Supplements at the FDA then Back to Natural Products Association as CEO

This round trip through the door was noted rather obliquely in a New York Times article in late April, 2014, focused on how slowly the FDA has reacted to apparently dangerous "dietary supplements,"

Before joining the F.D.A. in 2011, Dr. [Daniel] Fabricant was a top executive at an industry trade group, the Natural Products Association.

The article had previously identified Dr Fabricant as

the director of the division of dietary supplement programs in the agency’s Center for Food Safety and Applied Nutrition.

But,

The F.D.A. recently announced that Dr. Fabricant is leaving the agency this month to return to the trade group as its chief executive.
While the NY Times article thus mentioned as an aside that a government official with major responsibility for regulating dietary supplements had these relationships with the dietary supplement industry, it did not question whether that relationship had anything to do with slow responses by the FDA to reports of toxic dietary supplements. 

Spokesman for the Speaker of the House of Representatives to Spokesman for America's Health Insurance Plans

USA Today briefly but directly noted this in mid-May, 2014,

House Speaker John Boehner’s spokesman, Brendan Buck, has spent a lot of time over the years helping his boss and congressional Republicans criticize President Obama’s health care law.

Now Buck is leaving Capitol Hill to be spokesman for America’s Health Insurance Plans, the trade association that represents thousands of health insurance companies.

'Brendan’s experience and skill set will allow him to hit the ground running on Day One,' said Karen Ignagni, president and CEO of AHIP. 'He’s an effective communicator who knows how to tackle complex policy issues and skillfully navigate an ever-changing health care and media environment.'

What made this interesting seems to be how it represented a change of tune on Mr Buck's part.  Note that many people believe that commercial health insurers will benefit from all the new policy holders that Obamacare sends them, so

As the health insurance  industry’s trade group, AHIP supports the law’s mandate that individuals obtain health insurance. The trade group has praised the Affordable Care Act’s ability to expand insurance coverage.

But never mind that the man in the government for whom Mr Buck previously worked,

Boehner likes to call Obamacare a 'train wreck.'

FDA Director of the Office of Medical Policy for the Center for Drug Evaluation and Research to Greenleaf Health Consultancy

This so far has appeared only in a mid-May, 2014,  press release.   It describe Dr Sherman's career at the FDA,

During her FDA tenure, Sherman was a driving force for innovation, new programs and policy. Sherman was responsible for spearheading and implementing the Sentinel Initiative, the Critical Path Initiative, biosimilars policy and the new Breakthrough Therapy Designation.

As Director of CDER’s Office of Medical Policy and Associate Center Director for Medical Policy Sherman was responsible for developing, coordinating, and implementing medical policy programs and strategic initiatives as well as establishing and chairing CDER's Medical Policy Counsel [sic]. This included overseeing the regulation of prescription drug promotion and advertising.

Sherman began her career with FDA in the Division of Antiviral Drug Products at CDER in 1989—first as a medical reviewer and then as a clinical team leader. In 1998, she was appointed Deputy Office Director for the Office of Drug Evaluation I. In 1999, she assumed the duties of Deputy Office Director for the newly established Office of Medical Policy in CDER. 

But now she will be "Principal, Drug and Biological Drug Products" for Greenleaf, described as,

Greenleaf Health is a full service regulatory consulting firm that provides strategic guidance to companies regulated by the FDA and those developing innovative solutions to pressing public health challenges around the globe

Note that Greenleaf was already well populated with FDA officials who had previously transited the big revolving door,

Patrick Ronan, former FDA Chief of Staff and currently president of Greenleaf; Dr. Daniel Schultz, former Director of the Center for Devices ('CDRH') and Radiological Health and currently Greenleaf's Principal for Medical Devices and Combination Products; Michael Chappell, former Associate Commissioner for Regulatory Affairs, and currently Greenleaf's Principal for Regulatory Compliance; Heather Rosecrans, former Director of CDRH's 510(k) staff and currently Senior Vice President for Medical Devices and Combination Products; Linda Carter, formerly Associate Director of CDER's Office of Evaluation I and currently Vice President of Drug and Biological Drugs; and Taryn Fritz Walpole, former FDA Deputy Chief of Staff, and currently Chief Operating Officer and Senior Vice President for Regulatory Affairs

So maybe it has become so routine for middle and upper level FDA managers to go to work for consultancies that help industry to deal with the FDA that no journalist found this revolving door transition interesting.

Summary

Again, there appears to be constant traffic among health care corporations and the government bodies that regulate them and make policy that affects them.  The traffic may be so heavy and routine that it no longer appears to be news, unless accompanied by an ironic detail or two.

However, as we have said many times before, the constant interchange of health care insiders among government, large health care corporations, and the consultancies, marketing, public relations, lobbying and legal firms which represent them certainly suggests that health care, like many other sectors, seems to be run by an amorphous group of insiders who owe allegiance neither to government nor industry.

However, those who work in government are supposed to be working for the people, and those who work on health care within government are supposed to be working for patients' and the public health.  If they are constantly looking over their shoulders at potential private employers who might offer big checks, who indeed are they working for?


Attempts to turn government toward private gain and away from being of the people, by the people, and for the people have no doubt been going on since the beginning of government (and since the Constitution was signed, in the case of the US).  However, true health care reform  would require curtailing the severe sorts of conflicts of interest created by the revolving door.

Real heath care reform would require multi-year cooling off periods before someone who worked in the commercial world can get a job in a government whose work has direct effect on his or her previous employer or industry sector, and before someone who worked in government whose work had direct effect on a particular economic sector can accept a job for a company in that sector.   

A very short observation on EHRs and the Veterans Administration healthcare scandal

As has been in the news lately, it has been revealed that U.S. veterans' medical care was being delayed at a number of Veteran's Administration-run hospitals, perhaps many others as well not yet known.

A timeline for the Veterans Administration medical scandal is here:  http://www.usatoday.com/story/news/politics/2014/05/21/veterans-healthcare-scandal-shinseki-timeline/9373227/

The Obama administration is facing a serious scandal in which government officials are alleged to have falsified data to hide how long veterans were waiting to see doctors at VA hospitals. The controversy has led to calls for the resignation of Veterans Affairs Secretary Eric Shinseki, who has served for five years. Here is a timeline of events leading up to the current situation, which President Obama on Wednesday called "intolerable" and "disgraceful."

I will not comment on the issues per se.

I will only make this pithy observation:

The VA system possesses the best electronic medical records systems in the world, VistA CPRS, and is unhampered by EHR sellers' issues and agendas as the VA created it themselves over decades.  You can even download VistA CPRS and explore it with fictitious patients and medical data from test servers set up for that purpose, at http://www.ehealth.va.gov/EHEALTH/CPRS_demo.asp.

EHR's and other clinical IT, according to not-very-impartial organizations such as the industry trade group HIMSS, the sellers themselves, and a whole cadre of pundits highly invested in the technology and its implementation, are purportedly going to "revolutionize" medicine (rather than the somewhat less grandiose purpose of merely facilitating clinicians in providing better care).

The "revolution" includes reducing the need for human resources, increasing efficiency, saving gobs of money, and according to one billionaire, allowing a small group of doctors to remotely manage the care for an entire city's patients.  (See my Jan. 20, 2014 post "Computers + a few docs can manage 'an entire city', and other cybernetic miracles" at http://hcrenewal.blogspot.com/2014/01/computers-few-docs-can-manage-entire.html; I am not making that up.)

Yet here we have the VA, highly computerized - but instead of being the medical utopia promised by the information technology hyperenthusiasts, the VA is unable to even guarantee patients a two-week waiting period for care, with delays leading to possible patient injuries and deaths.

Thus, to those who promote the meme that spending hundreds of billions of dollars on this technology will 'revolutionize' medicine, increase "efficiency", reduce errors, reduce costs etc. and realize all the other fantastical claims made for the technology, I say, "sure, and I have a bridge for sale in Brooklyn."



This bridge at 40.7057° N, 73.9964° W is for sale to the highest-bidding hospital.  Its purchase, plus a few hundreds of millions of dollars of IT thrown into the bargain, will revolutionize healthcare at the lucky hospital with the winning bid.
 
-- SS

Tuesday, May 20, 2014

More Stories of Million Dollar Plus Hospital Executives, but Now the NY Times Challenges the Talking Points

It is spring, time for birds to sing, flowers to bloom, and hospital executives to get more money.  As we do periodically, we have amassed a series of media accounts of the big to enormous compensation paid to top non-profit hospital leaders.  These reports follow a certain pattern, but this year's spring crop included something different.

The Pattern

In the groundbreaking science fiction series "Fringe," "The Pattern" was a series of apparently inexplicable events which eventually pointed to the existence of a parallel universe.




In non-profit hospitals, The Pattern of the discussion of executive compensation is this.  Nearly all non-profit hospitals must release minimal data on the total compensation of a few of the highest paid executives.  When these reports come out, sometimes the local media take a look, either at an individual hospital or hospital system, or at a number of local hospitals.  They almost inevitably find that some, usually most executives make what appears to be lots of money.  This could be hundreds of thousands of dollars at small community hospitals, or millions of dollars at larger hospitals and hospital systems.  Sometimes the reports end there.  Sometimes the reporters ask hospital representatives or local experts to explain the apparently exalted compensation figures.  The explanations are usually very similar, and so we have called this part of The Pattern The Talking Points.

The Talking Points

It seems nearly every attempt made to defend the outsize compensation given hospital and health system executives involves the same arguments, thus suggesting they are talking points, possibly crafted as a public relations ploy.   We first listed the talking points here, and then provided additional examples of their use here, here here, here, here, and here, and here

They are:
- We have to pay competitive rates
- We have to pay enough to retain at least competent executives, given how hard it is to be an executive
- Our executives are not merely competitive, but brilliant (and have to be to do such a difficult job).

The talking points are usually supplied by hospital public relations personnel, sometimes by hospital trustees or executives, sometime by various health care consultants.  The talking points are rarely questioned.

So let us look at some recent media articles for The Pattern, grouped in chronological order, to illustrate.

Jersey Boys

On April 6, 2014, Crain's New York Business reported some of the biggest yearly compensation figures seen for non-profit hospital CEOs.  

Ronald Del Mauro, the former president and chief executive of Barnabas Health, pulled in almost $22 million in 2012, the year after he retired from New Jersey's largest health system. Joseph Trunfio, president and chief executive at Atlantic Health, made $10 million.

Never before have such outsized compensation packages appeared on Crain's annual list of top-paid hospital executives

The explanations fit the pattern.  First from a Barnabas spokesperson,

'When Mr. Del Mauro began his career, Saint Barnabas Medical Center was a stand-alone community hospital,' she said, adding that Barnabas is 'well positioned both financially and operationally, despite significant industry challenges. His retirement package is a function of over four decades of service ... and reflects his exceptional legacy.'

He was just another brilliant executive, in other words.

Then about Mr Trunfio,

In a statement, Karen Kessler, board chair of Atlantic Health System, said that while Mr. Trunfio's 'current agreement does not have these bonus provisions, his compensation is performance-based, aligned with industry standards and intended to assure we retain top executive talent to provide the best quality of care to the communities we serve.'

There in italics were the competitive market rates and retention arguments, and a repeat ("top talent") of the brilliance argument.

Meanwhile, on April 28, 2014, NJBiz had its own report on non-profit executive compensation in the state.   Their summary included,


Heading up the list is Robert C. Garrett, CEO of the Hackensack University Health Network at $2.12 million, followed by Richard P. Miller, Virtua Health ($1.99 million); John K. Lloyd, Meridian Health System ($1.68 million); Barry H. Ostrowsky, Barnabas Health ($1.67 million); and Stephen K. Jones, Robert Wood Johnson Health System ($1.55 million).

Several New Jersey multi-hospital systems paid several top executives more than $1 million in 2012. Hackensack, for instance, has two executives over the million-dollar mark.

[It is not clear why the two different reports listed two different people from Barnabas - Ed]


Then came The Talking Points, for example, from Hackensack Hospital,

'The pay for HackensackUMC's executives reflects its complexity and is consistent with those levels paid to executives in other similarly situated not-for-profit academic and integrated health systems,' Hackensack said in a statement. "The compensation philosophy is to provide market-competitive base salaries....

 The bit about complexity implies the brilliance argument, since only a brilliant CEO could cope with such complexity.  Then we had two versions of the competitive market based payment argument.  

Here is another version of the same thing, this time from one "Joel Cantor, director of the Center for State Health Policy at Rutgers University,"

On the other hand, hospital systems are large, complex organizations. Ultimately, CEO compensation is driven by the market for senior talent.  

My favorite version of the brilliance argument came from one Ms Betsy Ryan, president of the New Jersey Hospital Association,


They literally are on call 24/7, 365 days a year and they are running an institution where lives are at stake
 
More on that later.....

Smatterings of Data from Connecticut and Pennsylvania

There were a series of reports that simply noted large amounts, but did not look for explanations.  

HartfordBusiness.com recounted a state report of the top 10 most highly paid executives of individual hospitals (but did not account for the pay given to executives of hospital system).  The figures started at $3.26 million for the CEO of Yale-New Haven Hospital, and finished with $1.48 million for the senior vice-president and chief of staff at the same institution.

The Pittsburgh Post-Gazette reported pay at the West Penn Allegheny Health System, including that given to a former CEO, $1.89 million, and to a former chief administrative officer, $1.29 million.    

Then the Pittsburgh Tribune noted even bigger compensation given out at competitor UPMC.

UPMC CEO Jeffrey Romoff got an 8 percent raise two years ago, placing his generous compensation package near the top of the nonprofit hospital industry. 

The 68-year-old Romoff, who leads the largest integrated health system in Western Pennsylvania and one of the biggest in the nation, brought in $6.6 million in 2012, up from $6.1 million in 2011, according to tax documents UPMC made public on Friday.

Also,

UPMC paid 30 other executives and doctors more than $1 million each in 2012, up from 21 employees who were in the $1 million club the year before.


Wake Forest Baptist

The Winston-Salem Journal reported details of executive compensation at Wake Forest Baptist on May 16, 2014.  Its CEO, Dr John McConnell, had "total compensation [which] rose 0.8 percent to $2.06 million in 2012."  Then, however, "Donny Lambeth, the former president of N.C. Baptist, had a 52 percent drop in total compensation to $1.18 million."  Also, "Dr. Thomas E. Sibert, president of Wake Forest Baptist Health and chief operating officer, received a 10 percent drop in total compensation to $1.02 million."  Then, "Edward Chadwick, chief financial officer, had a 2.3 percent drop in total compensation to $956,465."  It is interesting that some executives actually saw small decreases.  Then again, the system lost $4.5 million for fiscal 2012-2013.

The article also offered up the usual explanations, first provided by the hospital system itself,

there are few executives with the required skill set to manage and provide leadership for an integrated (center) such as ours

There goes another version of the brilliance argument.  Then,

Its executive compensation packages, it said, 'are fiscally responsible, appropriate for the marketplace and an essential part of the effort to recruit and retain skilled executives and visionary leaders for the medical center.'

Those included the competitive market rates and the retention arguments, plus the ante for brilliance was upped to the visionary level.

The article ladled on one another version, this time supplied by "John Challenger, chief executive of outplacement consultancy Challenger, Gray & Christmas,"

 'Communities who want the best health-care system they can get should support paying the compensation levels required to attract top talent,' Challenger said.

'Cutting salaries will result in an exodus of top talent to systems that will pay it,...'

So "top talent" = brilliance argument, threatening an "exodus" = retention argument.

So there they go again, again.


Something Different: the New York Times Challenges the Pattern 

We have previously challenged the talking points.  For example, in August, 2013 we wrote,

As we have noted before, there is little evidence in support of these talking points.  What evidence there is on the topic suggests there is no real free market in interchangeable CEOs, and that CEOs are not very mobile, especially not across different kinds of organizations (look here).  There is little evidence that hospital (or other health care) executives are particularly brilliant, or any more brilliant than multitudes of physicians, nurses, and other health care professionals who work hard to make their institutions run.
Yet most discussions of executive compensation in hospitals, and indeed in health care, follow The Pattern.

So it was refreshing in this season of outsized compensation reports is that the New York Times ran an article that challenged The Pattern, albeit with limitations.  The most obvious problem with the pattern is that the arguments are out of context, and not challenged in context.  However, in the NY Times,

Physicians, the most highly trained members in the industry’s work force, are on average right in the middle of the compensation pack.

That is because the biggest bucks are currently earned not through the delivery of care, but from overseeing the business of medicine.

The base pay of insurance executives, hospital executives and even hospital administrators often far outstrips doctors’ salaries, according to an analysis performed for The New York Times by Compdata Surveys: $584,000 on average for an insurance chief executive officer, $386,000 for a hospital C.E.O. and $237,000 for a hospital administrator, compared with $306,000 for a surgeon and $185,000 for a general doctor.

Note that this comparison only refers to salaries, not total compensation, so

And those numbers almost certainly understate the payment gap, since top executives frequently earn the bulk of their income in nonsalary compensation.

We just saw examples of non-profit hospital CEOs making over $1 million to over $6 million in total compensation.  That would imply that non-profit CEOs may make from three times to over thirty times the total compensation of a surgeon, and from over five times to over thirty-five times the compensation of a general internist.  (And the ratio for such outliers as Mr Del Mauro above would be even higher.)  

So is a hospital CEO thirty times more brilliant than a general internist?  

That suggests also that we go back to another version of the brilliance argument found in one article above.  In the NJBiz article, the NJ Hospital Association President said, about CEOs, not physicians,

They are literally on call 24/7, 365 days a year and they are running an institution where lives are at stake.

They may be on call in a sense, but they are never on first call.  Their decisions may ultimately affect lives, and perhaps put lives at risk.  But they never have to make a decision about a patient that could literally cost that patient his or her life.  And they almost never have to be accountable for what happens to individual patients.  

It is easy to argue that physicians' responsibilities for life and death decisions are much more direct.  Explain, then, those pay ratios again.  

Actually, in an opinion piece about executive compensation in FierceHealthFinance, Ron Shinkman described the life of a typical seven-figure a year hospital executive,

While the days of seven-figure club members are long, they are also predictable--check the census and cash flow reports, confer with the medical staff, get updates on supplies, negotiate with payers, have some meetings on long-term planning. If it is a large hospital in a large market, those meetings are likely focused on site expansion and acquisition. If it is a medium-sized facility, tI expect they spend their time focused on finding a larger partner. Breakfast and dinner meetings and events switch focus to development and fundraising.

There may also be some meetings on quality initiatives, but they are of nominal consequence. Members of the seven-figure club enjoy little to no accountability from their customers.

So is executive compensation in hospitals, or other parts of the health care system, based on executives' brilliance.  Or is it based on their ability to be rentiers, rent-seekers, who can control the choke points of money flow, and make sure they get more than their share before what is left can go to real health care? 


Of course, hospital executives and their ubiquitous spokespeople do not discuss what they do day to day.  Maybe they need to, and also need to address the implications of these statements in the NY Times article, given that the US has the highest health care costs of any developed country, but nowhere near the best results,

And studies suggest that administrative costs make up 20 to 30 percent of the United States health care bill, far higher than in any other country. American insurers, meanwhile, spent $606 per person on administrative costs, more than twice as much as in any other developed country and more than three times as much as many, according to a study by the Commonwealth Fund.

As a result of the system’s complexity, there are many jobs descriptions for positions that often don’t exist elsewhere: medical coders, claims adjusters, medical device brokers, drug purchasers — not to mention the 'navigators' created by the Affordable Care Act.

Among doctors, there is growing frustration over the army of businesspeople around them and the impact of administrative costs, which are reflected in inflated charges for medical services.

We had previously argued (see above) against the talking points, and specifically that there is nothing to suggest that hospital executives are any more, much less an order of magnitude more brilliant than physicians or other health care professionals. But I confess as a physician I did not have the courage to extend that argument to a direct comparison of executive versus health care professional pay. The Times article, written by someone who is not a physician, did not have to worry about appearing self-serving.  I am glad, for it is high time to discuss the degree that the incentives produced by executive pay in health care have become perverse, and how to change these incentives to make health care leaders more accountable for health, and less focused on their own riches.