Thursday, April 25, 2013

The Myth of the Tough Prosecutor as a Distraction from Health Care Corporate Executives' Impunity

The tragic case of the Boston Marathon bombing illustrates how myth making about tough law enforcement obscures the impunity enjoyed by top health care executives.

A "Tough to a Fault" Prosecutor

A recent Reuters article touted the toughness of the prosecutor who will take on the case of the surviving accused Boston terrorist:

As the top federal law enforcer in Massachusetts, U.S. Attorney Carmen Ortiz has taken heat for being tough to a fault and coming down too hard on some defendants.

But as she builds a possible death penalty case against suspected Boston Marathon bomber Dzhokhar Tsarnaev, 19, the unflinching approach that earned her opponents in the past could become a legal asset for the biggest case of her career, said attorneys who have faced off against her.

'The criticism lately has been that they've over-charged some people and been overly harsh,' said Peter Elikann, a Boston defense attorney.'I don't think that's relevant for Tsarnaev because no one is going to accuse any prosecutor of making too big a deal out of this case.'


Similarly, an article in Bloomberg included this:


Ortiz’s former bosses insist that she’s ready for her moment on the big stage.

'She’s tough-minded and exceptionally professional,' [former Massachusetts Attorney General Scott] Harshbarger said. 

One of the cases cited as an example of Ms Ortiz's toughness was her prosecution of electronic information freedom activist Aaron Swart.  As Rueters noted,

One of Ortiz's best-known cases to date was her prosecution of Aaron Swartz on wire fraud and hacking allegations for downloading millions of articles from an academic database.

Swartz, a 26-year-old computer prodigy, hanged himself in his Brooklyn, New York, apartment in January, prompting friends and family to partly blame Ortiz's prosecution for his death.


At the time, Ms Ortiz was criticized for being unreasonably harsh, but then as now toughness was touted as her style.

Not So Tough on Corporate Crime

However, as we pointed out then, while Ms Ortiz was noted for being tough on individuals accused of various offenses, she was notably not so tough on individuals involved in alleged corporate health care wrong doing.

In particular, as we wrote before, Ms Ortiz was involved in three settlements of notably bad behavior by large health care corporations, none of which involved prosecution of, or any penalties for the individuals at the corporations who authorized, directed or implemented the bad behavior.

Forest Pharmaceuticals
In September, 2010, how Ms Ortiz led the pursuit of a settlement with Forest Pharmaceuticals became apparent (look here).   The company was accused of promoting its anti-depressant Celexa for use in adolescents and children.  Such drugs have since been shown to increase the risk of suicide by such young patients, and this drug was only approved for adults.  At the time, Ms Ortiz said, "Forest Pharmaceuticals deliberately chose to pursue corporate profits over its obligations to the F.D.A. and the American public."  Although the offense may have lead to use of the drug by many adolescents and children, and hence may have lead to some of them attempting or committing suicide, the case was settled only with fines.  As is usual in such legal settlements, no individual corporate executive who authorized or lead the off-label and potentially dangerous marketing of the drug was arrested, or accused, and none suffered any negative consequences.

GlaxoSmithKline
In October, 2010, how Ms Ortiz led the pursuit of a settlement with GlaxoSmithKline became apparent (look here.)  The company was accused of selling drugs that were not what they appeared to be, apparently because the wrong drugs were put in labelled containers.  Obviously, taking one drug, like Paxil, GSK's anti-depressant which has a number of known adverse effects, including suicide risk for adolescents and children as noted above, when a patient is supposed to be taking a wholly different drug could lead to patient harm.  At that time, Ms Ortiz said, "We will not tolerate corporate attempts to profit at the expense of the ill and needy in our society -- or those who cut corners that result in potentially dangerous consequences to consumers."   Again, while the settlement involved a guilty plea by a GSK subsidiary, again no individual corporate executive who had authority over the drug manufacturing was arrested or accused, much less suffered any negative consequences.

St Jude Medical
In January, 2011, Ms Ortiz led the pursuit of a settlement with St Jude Medical (look here).  The company was accused of paying kickbacks to doctors to implant its cardiac defibrillators (ICDs) and pacemakers.  Obviously, providing kickbacks to doctors may have lead them to plant devices in patients who did not really need them, yet the devices and the implantation procedures can have adverse effects.  At that time, Ms Ortiz said, "The United States alleges that St Jude solicited physicians for the studies in order to retain their business and/or convert their business from a competitor's product."  Again, as is usual, the settlement did not require any executive who authorized or directed the activities leading to the kickbacks suffered any negative consequences.



Despite this, note that Bloomberg in its recent coverage of the Tsarnaev prosecution even tried to make Ms Ortiz failure to hold any individuals accountable for this health care corporate misbehavior seem like tough prosecution.


The office has been a leader in health-care fraud prosecutions, securing $4 billion in civil and health-care recoveries in 2012. Those included a $3 billion payment from GlaxoSmithKline Plc (GSK), which pleaded guilty to charges that it illegally promoted prescription drugs. 

Again, note that apparently being a "leader" in health care fraud prosecution involved pushing for big fines to be paid by the corporations involved in actions that may have harmed many patients, but no punishment for  the individuals who may have authorized, directed or implemented the bad behavior, but being "tough" on Aaron Swartz involved pushing for a long imprisonment of someone whose alleged crime was not violent, and did not result in anyone being hurt.


Summary

As we have noted again and again and again, leaders of large health care organizations, particularly the largest health care corporations, seem to enjoy virtual impunity.  No matter how bad the behavior of the corporations which they are supposed to be leading, and no matter whether such behavior might have harmed patients, they almost never have to face any negative consequences, especially not fines they must pay themselves, much less prison time.  We have documented many legal settlements of often egregiously bad alleged behavior that did not involve any penalties for top corporate leaders.

One way corporate leaders thus escape accountability seems to be the cultivation of myths that distract the public from what is going on.  One such urban legend seems to be the toughness of government prosecutors.  If prosecutors are believed to be uniformly tough and uncompromising, then the public may be lead to believe either that they are tough and uncompromising on corporate crime   

As we have said repeatedly, true health care reform would require making the leaders of health care organizations accountable, especially for the effects of their actions on patients' and the public's health.

Wednesday, April 24, 2013

Johns Hopkins: Thanks to EHRs, time with patients seems “squeezed out” of medical training, investigator says

Question:  Who would have thought it?  That there is yet another potentially deadly unintended consequence of bad health IT and health IT hyper-enthusiasm?

Suggested answer:  anyone who truly understands the issues at the intersection of medicine, information science, information technology, and Social Informatics - which probably excludes 95% of the health IT "experts", pundits and opportunists.

Which only goes to show how dense such people can be - as the medical trainees of today will be treating them, their families, and their children in the future:

Johns Hopkins Medicine
Release Date: 04/23/2013

Medical interns spend just 12 percent of their time examining and talking with patients, and more than 40 percent of their time behind a computer, according to a new Johns Hopkins study that closely followed first-year residents at Baltimore’s two large academic medical centers. Indeed, the study found, interns spent nearly as much time walking (7 percent) as they did caring for patients at the bedside.

I can honestly say much if not most of my time in training, several decades ago, was spent at the bedside.

Compared with similar time-tracking studies done before 2003, when hospitals were first required to limit the number of consecutive working hours for trainees, the researchers found that interns since then spend significantly less time in direct contact with patients. Changes to the 2003 rules limited interns to no more than 30 consecutive hours on duty, and further restrictions in 2011 allow them to work only 16 hours in a row.

“One of the most important learning opportunities in residency is direct interaction with patients,” says Lauren Block, M.D., M.P.H., a clinical fellow in the Division of General Internal Medicine at the Johns Hopkins University School of Medicine and leader of the study published online in the Journal of General Internal Medicine. “Spending an average of eight minutes a day with each patient just doesn’t seem like enough time to me.”

An understatement, as most critical information comes from the H&P and ongoing patient interaction - not from cybernetics.  Further, that's probably all the time a butcher spends processing a slab of meat...

“Most of us went into medicine because we love spending time with the patients. Our systems have squeezed this out of medical training,” says Leonard Feldman, M.D., the study’s senior author and a hospitalist at The Johns Hopkins Hospital (JHH).

For the study, trained observers followed 29 internal medicine interns — doctors in their first year out of medical school — at JHH and the University of Maryland Medical Center for three weeks during January 2012, for a total of 873 hours. The observers used an iPod Touch app to mark down what the interns were doing at every minute of their shifts. If they were multi-tasking, the observers were told to count the activity most closely related to direct patient care.

The researchers found that interns spent 12 percent of their time talking with and examining patients; 64 percent on indirect patient care, such as placing orders, researching patient history and filling out electronic paperwork; 15 percent on educational activities, such as medical rounds; and 9 percent on miscellaneous activities. 

Researching the history is made more complex by today's low-usability EHR systems, so much so that I personally know of cases (through my legal work) where trainees and even attendings did not know the patient's history.  In the past, this would have been considered a severe medical faux pas.

The researchers acknowledge that it’s unclear what proportion of time spent at the bedside is ideal, or whether the interns they studied in the first year of a three-year internal medicine training program make up the time lost with patients later in residency. But 12 percent, Feldman says, “seems shockingly low at face value. Interns spend almost four more times as long reviewing charts than directly engaging patients.”

Not to be critical of the Hopkins piece, it is excellent - but academics often use disclaimers and softeners in their conclusions as a custom and tradition.  At a blog I can be more direct:  12% is shockingly low.  No "seems" is actually necessary.

Feldman says questions raised by his study aren’t just about whether the patients are getting enough time with their doctors, but whether the time spent with patients is enough to give interns the experience they need to practice excellent medicine. 

Personally, I would really be nervous under the care of graduates who'd only spent a tenth of their clinical hours actually seeing, speaking to and examining patients, and a majority of their time frittering around with computers.

With fewer hours spent in the hospital, protocols need to be put in place to ensure that vital parts of training aren’t lost, the researchers say.

“As residency changes, we need to find ways to preserve the patient-doctor relationship,” Block says. “Getting to know patients better can improve diagnoses and care and reduce medical errors.” 

As opposed to getting to know the (needlessly complex and confusing) EHR better, which adds little.

The researchers say better electronic medical records may help reduce time spent combing through patient histories on the computer.

After several decades of the health IT industry being in business,  it's sad that an organization of the (deserved) stature of Johns Hopkins has to provide remedial education 101 to that industry in 2013.

Perhaps that's the most important finding of all in this study.


There's some wisdom in this comic strip.  Click to enlarge.


-- SS
 

Tuesday, April 23, 2013

WellPoint's Former Manager-Queen Got $20.6 Million and Its Nobility Got Millions

Score another for our new would be royalty, that is, for the hired managers who run big corporations.  Early this month a few scattered reports came out showing just how much even apparently failed executives of big health care organizations can make on their way out the door. 

A New Fortune for the Abdicating Queen of WellPoint

Last year we discussed the abdication of Angela Braly, the former queen of giant insurance company WellPoint.  We then speculated about how much she might abscond with.  Now the Associated Press has reported:

 The compensation paid to outgoing Wellpoint Inc. CEO Angela Braly last year rose 56 percent, even as the company's shares slid on lower enrollment in its Blue Cross Blue Shield health plans.

Braly, who resigned in August, received 2012 compensation valued at $20.6 million, according to an Associated Press analysis of the company's annual proxy statement. Most of the increase came from stock options.

Braly, 51, became CEO in 2007. She received a $1.2 million salary last year, up slightly from $1.1 million in 2011. Her compensation included a performance-related bonus of nearly $1.4 million. More than 85 percent of Braly's compensation came from stock options and awards, which totaled $17.8 million. That total was up from about $10 million the year before.

She also received $179,618 in other compensation, including $3,700 spent on security measures for her and her family due to concerns about her safety 'as a result of the national health care debate,' according to the proxy, which was filed Tuesday with the Securities and Exchange Commission.

Despite Bad Financial Performance and Investors' Losses

Remember, though, that Braly was asked to leave:

 investors had grown frustrated with the company's performance, leading Braly to resign last August. 

In particular, in terms of financial performance

shares fell 8 percent last year to close 2012 at $60.92, while the Standard & Poor's 500 index rose more than 13 percent.

WellPoint's 2012 earnings were nearly flat compared to 2011. The insurer earned $2.65 billion, or $8.18 per share, last year, as total revenue climbed 1.6 percent to $61.71 billion.

A slightly different analysis by the Indianapolis Business Journal came up with similar results,

 WellPoint’s membership growth came mainly from its acquisition of Virginia-based Amerigroup Corp., which operates Medicaid managed care plans for states. The rest of WellPoint’s existing business lost customers during 2012.

And while WellPoint has boosted earnings per share by continuing to buy back shares, overall profit was unchanged last year compared with about $2.6 billion in 2011.

WellPoint raised its dividend in 2012 and acquired 1-800-Contacts Inc. But its stock price fell 8 percent to close the year at $60.92 per share. Even taking into account dividends, WellPoint shares lost 6.3 percent of their value during the year.

So while the nominal owners of the company, the investors, lost money on their investments, the CEO who presided over this loss left with a huge pile of cash.

The Royal Court of WellPoint Also Prospered

Incidentally, the Indianapolis Business Journal also showed that WellPoint executives who did not leave generally got big increases in their compensation, again while the company owners to whom they ostensibly report lost money,


WellPoint Inc.’s top brass all enjoyed double-digit bumps in 2012 compensation, according to a proxy released April 2, even though the stock price fell and the company admittedly did not meet its financial goals.

The Indianapolis-based health insurer’s board of directors approved higher salaries and larger potential stock awards heading into 2012 after most of its top executives saw their pay hold steady or decline in 2011.

The company’s performance merited its executives receiving only 83 percent of their target stock awards. But because the board had already established larger pools of stock to award to executives, the value of those awards still rose over previous years. Bonus amounts fell in 2012 compared with the previous year.

The extra cash and stock drove up Chief Financial Officer Wayne DeVeydt's overall pay 11.9 percent to nearly $4.4 million.

Ken Goulet, executive vice president of WellPoint's commercial insurance business, saw his total compensation rise 18.2 percent to nearly $4.4 million.

And Lori Beer, executive vice president of information technology, enjoyed a 17.9-percent boost. She earned $3.2 million, although that was still below the nearly $4.5 million she received in 2010.

John Cannon, the general counsel, saw his compensation more than double to nearly $6.5 million. But that was partly because WellPoint hiked his salary by $350,000 and gave him a $500,000 bonus for agreeing to serve as interim CEO after the August resignation of former CEO Angela Braly.

Despite Angry Policy-Holders and Ethical Missteps

So the compensation given the outgoing CEO and some of the remaining top hired managers seemed wildly out of proportion to the company's financial results.  Could the generosity they received be based on how well the company performed in other dimensions?  That, of course, seems equally improbable.

The Los Angeles Times noted,

 Braly had also caught the ire of consumers and even President Obama in 2010 for trying to raise rates by up to 39% in California. The national outrage that ensued helped Obama win approval for his healthcare overhaul in Congress.

Furthermore, as we have discussed again and again, most recently here, WellPoint has a very sorry record of ethical misadventures.   (The updated list is at the end of this post.)  So one could certainly not justify the huge payments given WellPoint hired managers by their upstanding ethical leadership.

Summary

In a new book just published by Robert A G Monks, entitled Citizens Disunited, the author describes one of the biggest problems affecting the US economy and society as the rise of "manager-kings."  Clearly, Angela Braly could be called the former "manager-queen" of WellPoint.  The company seemed to be run primarily for the benefit of the queen and her court, while its investors lost money, its customers became outraged, and it stumbled from one ethical quandary to another.

In the eighteenth century, British colonial subjects in North America succeeded in a revolution that lead them out from under the rule of a British King.  How many examples do we have to have before there is action to repudiate the rule of our new manager-kings and queens?  And to turn health care back into a calling meant to put patients' and the public's health first, rather than a feudal society meant to benefit its nobility?

As we have said again, again, again,...

True health care reform would decrease the size and scope of health care organizations, and make their leaders accountable to ownership, when appropriate, and to the community at large for patients' and the public health. 



Appendix: WellPoint's Ethical Misadventures

  • settled a RICO (racketeer influenced corrupt organization) law-suit in California over its alleged systematic attempts to withhold payments from physicians (see 2005 post here).
  • subsidiary New York Empire Blue Cross and Blue Shield misplaced a computer disc containing confidential information on 75,000 policy-holders (see 2007 story here).
  • California Anthem Blue Cross subsidiary cancelled individual insurance policies after their owners made large claims (a practices sometimes called rescission).  The company was ordered to pay a million dollar fine in early 2007 for this (see post here).  A state agency charged that some of these cancellations by another WellPoint subsidiary were improper (see post here).  WellPoint was alleged to have pushed physicians to look for patients' medical problems that would allow rescission (see post here).  It turned out that California never collected the 2007 fine noted above, allegedly because the state agency feared that WellPoint had become too powerful to take on (see post here). But in 2008, WellPoint agreed to pay more fines for its rescission practices (see post here).  In 2009, WellPoint executives were defiant about their continued intention to make rescission in hearings before the US congress (see post here).
  • California Blue Cross subsidiary allegedly attempted to get physicians to sign contracts whose confidentiality provisions would have prevented them from consulting lawyers about the contracts (see 2007 post here).
  • formerly acclaimed CFO was fired for unclear reasons, and then allegations from numerous women of what now might be called Tiger Woods-like activities surfaced (see post here).
  • announced that its investment portfolio was hardly immune from the losses prevalent in late 2008 (see post here).
  • was sanctioned by the US government in early 2009 for erroneously denying coverage to senior patients who subscribed to its Medicare drug plans (see 2009 post here).
  • settled charges that it had used a questionable data-base (built by Ingenix, a subsidiary of ostensible WellPoint competitor UnitedHealth) to determine fees paid to physicians for out-of-network care (see 2009 post here). 
  • violated state law more than 700 times over a three-year period by failing to pay medical claims on time and misrepresenting policy provisions to customers, according to the California health insurance commissioner (see 2010 post here).
  • exposed confidential data from about 470,000 patients (see 2010 post here) and settled the resulting lawsuit in 2011 (see post here).
  • fired a top executive who publicly apologized for the company's excessively high charges (see 2010 post here).
  • California Anthem subsidiary was fined for systematically failing to make fair and timely payments to doctors and hospitals (see 2010 post here).
  • management was accused of hiding the company's political contributions from the company's own stock-holders (see 2012 posts here and here).
  • settled charges that its Anthem subsidiary cheated former policy-holders out of money owed when that company was converted from a mutual insurance company (see 2012 post here)


Friday, April 19, 2013

SILVERSTEIN v. ABINGTON MEMORIAL HOSPITAL: MOTION TO PROHIBIT COMMENTARY ABOUT THIS LITIGATION TO ANY PUBLIC CONTEXT: Do computers have more rights than patients?

Herein is an issue of potential Internet censorship and/or attempted prior restraint of the rights of a citizen to express him/herself freely:

At my post "Hospital defense maliciousness, aided and abetted by attorneys who ignore the ABA and Pennsylvania's Ethical Rules of Conduct Regarding "Candor Towards the Tribunal" I wrote about how a defense attorney in a case I unfortunately am substitute plaintiff in, that involving EHRs and the injury and the death of my mother, violated the requirement under the Code of Conduct of lawyers to exhibit candor before the tribunal, and perhaps 18 Pa.C.S. §4904 relating to unsworn falsification to authorities as well.

As also mentioned, the lawfirm was displeased, but did not respond to my offer to consider amending any factually erroneous assertions at that post.

Now here is their response:

4/19/2013MotionBY ABINGTON MEMORIAL HOSPITAL MOTION TO PROHIBIT COMMENTARY ABOUT THIS LITIGATION TO ANY PUBLIC CONTEXT WITH MEMORANDUM OF LAW WITH SERVICE ON 04/19/2013

The Motion text is here in PDF (it is a public document available to anyone on the Montgomery County, PA Prothonotary website).

The court has yet to rule on this new motion and Substitute Plaintiff's (me) replies.

I will, of course, abide by the Court's decision.

First: I note that I have been writing about issues of court process, not the substance of the case's actual issues.   I think citizens have a right to know about process in their courtrooms.  I am also Joe Public, exercising my rights to freedom of expression; I am not an attorney breaking some rule of case publicity.  I am not even the suit's initiator.  What rule(s) am I breaking, exactly, I'd like to know from the Defense.

Further, in my opinion, considering that multiple authorities including the Institute of Medicine of the National Academies (link), FDA (link), Joint Commission (link), ECRI Institute (link), National Institute of Standards and Technology (link), AHRQ-Agency for Healthcare Research and Quality at HHS itself (link) and others have written about risks of health IT to patients and the need for far more study and data on the issue, in my view there is a compelling public interest in being informed about the progress of this lawsuit.

We have not reached the day yet, I hope, when computers have more rights than patients.

I note that if the involved lawfirm, Marshall Dennehey Warner Coleman Goggin, would stick to the Rules of Conduct for attorneys, it would seem they have nothing to fear.

I note the remarkable statement about "unjustified and malicious personal attacks against Moving Defendant and defense counsel", i.e., pointing out exactly what they did.  Namely, fail to provide the required Candor towards the Tribunal regarding the undisclosed 2008 Stroud v. AMH decision on COM's, known to them (same hospital, same counsel) at the time multiple, frivolous contrary claims about COM's to harm my mother's case were made to the courts from 2010 to just recently in 2013. 

In fact, that statement itself may be an example of legal misconduct - rendering false charges and certifying them in writing to a court as true.  I note that I didn't write the Rules of Professional Conduct for attorneys; attorneys did, including Rule 3.3: "Candor before the Tribunal" whose obvious violation and my pointing it out is certainly not an "unjustified and malicious personal attack."

As far as "fair trials" go - their stated concern in this latest filing - the defense should have thought about that before breaking the aforementioned Rule of Professional Conduct, causing numerous delays.  (I wonder how many med mal cases with proper paperwork are stalled more than 2 years before Discovery even begins - the case was filed 7/16/2010.)

It seems to me that my mother deserved to be alive at the time of her fair trial ("Justice delayed is justice denied.")  I would certainly like to know if the Defense thinks otherwise.


-- SS

Apr. 19, 2013 Addendum:

As noted at Wikipedia regarding what appears to be a Motion for Prior Restraint:

Prior restraint is often considered a particularly oppressive form of censorship in Anglo-American jurisprudence because it prevents the restricted material from being heard or distributed at all. Other forms of restrictions on expression (such as actions for libel or criminal libel, slander, defamation, and contempt of court) implement criminal or civil sanctions only after the offending material has been published. While such sanctions might lead to a chilling effect, legal commentators argue that at least such actions do not directly impoverish the marketplace of ideas. Prior restraint, on the other hand, takes an idea or material completely out of the marketplace. Thus it is often considered to be the most extreme form of censorship. The United States Supreme Court expressed this view in Nebraska Press Assn. v. Stuart by noting:

The thread running through all these cases is that prior restraints on speech and publication are the most serious and the least tolerable infringement on First Amendment rights. A criminal penalty or a judgment in a defamation case is subject to the whole panoply of protections afforded by deferring the impact of the judgment until all avenues of appellate review have been exhausted. Only after judgment has become final, correct or otherwise, does the law's sanction become fully operative.
A prior restraint, by contrast and by definition, has an immediate and irreversible sanction. If it can be said that a threat of criminal or civil sanctions after publication 'chills' speech, prior restraint 'freezes' it at least for the time.

Also, most of the early struggles for freedom of the press were against forms of prior restraint. Thus prior restraint came to be looked upon with a particular horror, and Anglo-American courts became particularly unwilling to approve it, when they might approve other forms of press restriction.

-- SS

Healthcare computing 'glitch' time again: 15 patients possibly given wrong antibiotic after lab error at Regina General Hospital

Just another computer "glitch", that innocuous euphemism for a catastrophe-promoting IT defect, this time causing patients to receive the wrong antibiotics:

Regina Leader-Post
April 17, 2013

15 patients possibly given wrong antibiotic after lab error at Regina General Hospital 

Fifteen patients in southern Saskatchewan were potentially treated with the wrong antibiotic stemming from a lab error at Regina General Hospital, the Regina Qu'Appelle Health Region announced Tuesday.

According to the RQHR, lab reports between late January and late March erroneously deemed Clindamycin would effectively treat the patients' infections when those bugs were actually resistant to the drug.  [The biological bugs, not the cybernetic bugs, that is - ed.]

Only one of the 15 patients suffered adverse effects. The 15th patient, an adult male, experienced short-term negative effects but has since been switched to another antibiotic. Citing patient confidentiality, the health region would not elaborate on the man's condition.

Dr. Jessica Minion, a medical microbiologist in the General Hospital's laboratory, said a computer glitch caused the faulty reports between Jan. 23 and March 28. 

Need I add that this "glitch" could very easily have killed people?

Minion added she and other medical staff will now cross-check lab reports against lab tests after a change has been made within the computer system.

Wait - if the "glitch" is fixed, why is cross-checking still needed?  Doesn't sound like there's much confidence in this computing system...

The lab became aware of the problem on March 28 when the doctor treating the man who experienced problems notified the hospital, Minion said. Lab staff then sifted through records and determined a total of 15 people had been prescribed Clindamycin since the erroneous reports began Jan. 23. 

Clindamycin itself is not an innocuous drug, with many potential serious side effects.

"It was a very identifiable mistake that was being made in the computer system, and there is a very clear trail of who exactly it affected," she said. "So we are quite confident that we have identified everybody that would have been affected."

Only by the grace of God, none of those affected are six feet (2 meters) under, either due to their primary infections or drug adverse events from a drug they should never have been given.

At least this time the oft-heard refrain "but patient safety was not compromised" was not proffered.

-- SS

Thursday, April 18, 2013

Guest Post: the Slow Grind of Justice



 Health Care Renewal presents a guest blog by Steve Lucas, a retired businessman who formerly worked in real estate and construction who has a long standing interest in business ethics, and has long observed the health care scene.

The March 14, 2013 Akron Beacon Journal print edition highlights what I am sure Mercy Medical Center hopes is the end of a long legal battle with Aultman Health Foundation. 

Cheryl Powell writes in "High court throws out appeal by Aultman" highlights the Ohio Supreme Courts dismissal of Aultman’s suit brought in regards to a 2010 court ruling that Aultman pay Mercy $6.1 million for unfair business practices. 
A review of that legal action can be found on this Health Care Renewal post.


The legal battle centers on 'secret ´bonuses paid to select brokers for switching employers from other insurance plans to Aultman’s insurance company, AultCare.

Aultman Hospital is AultCare’s only in-network hospital in Canton.'


It is important to remember that AultCare is an aggressive for-profit insurance company.


At the end of the two-month trial in Stark County Common Please Court, jurors decided Aultman should pay Mercy more than $6.1 million in damages for engaging n a pattern of corrupt activity by influencing brokers with money.

'Evidence during the trial showed that for a period of time, brokers weren’t allowed to disclose the payments to anyone, even the clients they represented.

Aultman officials have said the confidentiality requirement was dropped in 2004, well before Mercy filed its lawsuit.


We see an all too familiar behavior pattern: someone sensing that he or she is about to be caught drops an activity and then feigns innocence for our past transgressions. How often have we seen a drug company sign a consent agreement only then to return to court to sigh another consent agreement? How often are we told that an activity was committed by a low level sales person and that person is no longer with the company?


Aultman has continued to criticize the case Mercy filed, calling it a waste of resource for the non-profit health-care organizations.

'We have always felt that this case was not positive for our community, that resources were shifted in a way that was not beneficial to the community' [the attorney representing Aultman, Allen] Schulman said. 'I don’t think that it serves the community well.'

[ Mercy President and Chief Executive Thomas] Cecconi said Mercy felt an obligation to fight Aultman’s business practices for the community’s sake.


Conclusion

Once again we find the use of the legal system perverted by one party in an effort to gain a business advantage over another entity.

Aultman has used its non-profit status to shield the activities of a for-profit insurance subsidiary.  Perhaps someone thought that no one would sue a large non-profit hospital for the actions of the subsidiary.

Aultman used the tired old refrain that “we don’t do that anymore” as a defense for past business practices that garnered questionable profits. This after the fact admission does not absolve them of responsibility for those actions.

When all else fails Aultman uses the appeal that it reflects badly on the community. It really does not matter that they were the ones who engaged in this activity. Additionally they make the claim this will result in a decline in resources available when they profited from the original activity.

These are old concepts to HCR readers. The use of the legal system, from law suits being filed against those who would blow the whistle, to grinding out appeals to bleed a person or organization dry, all in an effort to protect a questionable or even illegal activity. In this case there is still the issue of Mercy’s legal fees involved in Aultman’s appeal.

Smaller markets are seeing a consolidation of hospitals and medical practices. The opportunity for one party to take advantage of this is growing as patients and doctors are presented with limited opportunities to seek appropriate medical care. When the hospital owns the insurance company, and your care will be dictated by the policy available through only one company, the opportunity for abuse has to be acknowledged.

Mercy has begun to grow again by offering the community a less corporate medical experience. Interestingly, Mercy and Aultman have collaborated on securing scarce oncology drugs. It appears some doctors still feel it is about caring for the patient, and less about loyalty to a corporate logo.

Steve Lucas

Tuesday, April 16, 2013

Fred Schulte: "GOP senators call for overhaul of electronic health records program"

Fred Schulte, investigative reporter at the Center for Public Integrity (link to bio), has authored a new article worth reading in its entirety:

GOP senators call for overhaul of electronic health records program
Lawmakers say Obama's $35 billion initiative pushing health information technology isn't working.

Six U.S. Senators are calling for an overhaul of the federal government’s $35 billion plan for doctors and hospitals to switch from paper to electronic medical records, citing concerns from patient privacy to possible Medicare billing fraud.

The report issued Tuesday by the half-dozen Republicans concedes that many lawmakers and medical experts believe the digital systems can reduce health care costs and improve the quality of care by reducing duplicative testing and cutting down on medical errors.  [Eventually, and with great effort the details of which many in the field lacking appropriate education and expertise are painfully unaware - ed.]

But the report asserts that the Obama administration’s push to use billions of dollars in stimulus money helping doctors and hospitals buy digital systems needs to be “recalibrated.”

“Now, nearly four years after the enactment…and after hundreds of pages of regulations implementing the program,” the document says, “we see evidence that the program is at risk of not achieving its goals and that $35 billion in taxpayer money is being spent ineffectively in the process.”

I've been calling for a "recalibration" (i.e., a cessation of putting the cart before the horse) and slowing down, for years.  See for instance my July 2010 post "Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?" and its hyperlinks at http://hcrenewal.blogspot.com/2010/07/meaningful-use-final-rule-have.html.

Among the report’s conclusions:
  • Despite expectations of cost savings, the digital systems may be increasing unnecessary medical tests and billings to Medicare.
  • The government has not demanded that the various digital systems be able to share medical information, a critical element to their success.
  • Few controls exist to prevent fraud and abuse. Many doctors and hospitals are receiving money by simply attesting that they are meeting required standards.
  • Procedures to protect the privacy of patient records are lax and may jeopardize sensitive patient data.”
  • It remains unclear whether doctors and hospitals that have accepted stimulus funding will be able to maintain the systems without government money.

I have as an even larger concern the quality and fitness (and hence safety) of today's health IT systems.  In what may be the first robust study, the findings as I have pointed out on this blog are of great concern:

Health Leaders Media
April 5, 2013
HIT Errors 'Tip of the Iceberg,' Says ECRI 

Healthcare systems' transitions from paper records to electronic ones are causing harm and in so many serious ways, providers are only now beginning to understand the scope.  [I understood the scope years ago as reflected in my writings - ed.]

Computer programs truncated dosage fields, leading to morphine-caused respiratory arrest; lab test and transplant surgery records didn't talk to each other, leading to organ rejection and patient death; and an electronic systems' misinterpretation of the time "midnight" meant an infant received antibiotics one dangerous day too late.

These are among the 171 health information technology malfunctions and disconnects that caused or could have caused patient harm in a report to the ECRI Institute's Patient Safety Organization. Thirty-six participating hospitals reported the data under a special voluntary program conducted last year.

Karen Zimmer, MD, medical director of the institute, says the reports of so many types of errors and harm got the staff's attention in part because the program captured so many serious errors within just a nine-week project last spring.  [Including 8 injures and 3 possible deaths in just 9 weeks as I wrote at "Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI Deep Dive Study of Health IT Events" here - ed.]

The volume of errors in the voluntary reports was she says, "an awareness raiser."

"If we're seeing this much under a voluntary reporting program, we know this is just the tip of the iceberg; we know these events are very much underreported."

... ECRI is currently evaluating a similar, and much larger list of reports from many of the 800 hospitals that contract with ECRI's PSO services.

The fact that only GOP Senators so far have made this call is perhaps somewhat surprising, considering the abuse that side of the aisle often takes for being pro-business and anti-citizen rights.

On the other hand, hospital accidents are a truly non-partisan issue.  A Democrat or Republican (or member of any other poitical party), and their loved ones, are all in the same boat.

As this point in time, I recommend any patient have a strong advocate following everything done, not done, supposed to be done, not supposed to be done, med and allergy lists and fulfillment, action on lab and imaging reports, etc. -- importantly, not depending on IT-dependent clinicians to do so.

-- SS

Thursday, April 11, 2013

Hospital defense maliciousness, aided and abetted by attorneys who ignore the ABA and Pennsylvania's Ethical Rules of Conduct Regarding "Candor Towards the Tribunal"

At Healthcare Renewal we've written of hospitals' deviations from the core mission of compassionate, ethical and safe patient care, towards profiteering at patient's and the community's expense.

What we haven't written about is maliciousness.

At my Feb. 2013 posts about my late mother's (now my) lawsuit regarding injury and death that involved EHR problems, namely "The lengths a hospital will go to in order to protect their EHR - Motion for Reconsideration of Denial of Motion for Reconsideration of Denial of Objections"   and   "More on the lengths a hospital will go through to protect their EHR from discovery", I'd opined that the defense's repeated position that individual Certificates of Merit [COMs] were required naming or otherwise "identifying by specialty" every single licensed professional for whom the parent hospital was being held vicariously liable was contradicted by state law and procedure.

I'd posted this as an example:

From the official publication of the Civil Procedure Rules Committee in the state [of PA], effective a decade ago:


Such a single COM for vicarious liability had been timely filed at the outset of the case in 2010, as well as a COM for direct hospital liability.

Yet the defense persisted in their multiple-COM position, filing a Motion for Reconsideration of a denial of their COM position, an "emergency" petition for review with Superior Court of PA not certified for appeal by the local judge that was also denied (not even heard), a Motion for Reconsideration of the denial of the initial Motion for Reconsideration, "protective orders" for witnesses to prevent their being deposed, and even a complaint that the judge of record had no authority to let the first Motion for Reconsideration expire on its own, which they do if not responded to in 30 days.  This all ate up time.

Except they "forgot" to tell the judge that their COM argument had been thrown out several years prior by the U.S. District Court in these parts - same defendant, same defense attorney.  (More on this lack of mandatory Candor Before the Tribunal below.)

Instead of candor, defense attorney Carolyn B. DiGiovanni of the lawfirm Marshall Dennehey Warner Coleman Goggin filed motions - like this one of 12/6/2010 below - seeking to have the court strike the vicarious liability COM as "inadequate under the rules" and get the organization off the hook for vicarious liability for its agents/employees, that I cite directly.  Emphases mine:

... 16. In the instant [current, i.e., Silverstein v. AMH - ed.] case, Plaintiff chose to file only one Certificate of Merit on her vicarious liability claim against Abington Memorial Hospital, which is insufficient under the Rules. [Well, no, actually; it was precisely what the rules called for.  See below - ed.]

17. Despite the fact that Rule 1042.3(a)(2) specifically addresses those situations involving vicarious liability, Plaintiff has failed to comply with the mandates of Rule 1042.3(a)(2) that a separate Certificate of Merit must be filed pursuant to (a)(1) as to the other licensed professionals for whom the vicarious Defendant is responsible.

18. In the present case, although Plaintiff filed a Certificate of Merit, Plaintiff did not file a timely Certificate of Merit which supports her direct claims of liability against the agents, employees and/or subcontractors for whom she claims Defendant, Abington Memorial Hospital, is vicariously liable, in accordance with the Pennsylvania Rules of Civil Procedure.

19. As Plaintiff has failed to timely produce [multiple - ed.] Certificates of Merit which satisfy the mandates of Pa.R.C.P. 1042.3 within sixty (60) days of the filing of the Complaint, entry of partial judgment of non pros [non-prosecution - ed.] on Plaintiffs claim for vicarious liability is warranted as a matter of law.

20. Accordingly, Defendant, Abington Memorial Hospital, files the instant Motion seeking to strike the Certificate of Merit and for the entry of partial judgment of non pros on Plaintiffs claim for vicarious liability pursuant to Pa. R Civ. P. 1042.7.

The truth of the above claims was certified in writing to the local court:


"I, Carolyn B. DiGiovanni, Esquire, Attorney for Defendant, Abington Memorial Hospital, verifies that the facts set forth in the Motion or Defendant, Abington Memorial Hospital to Strike Certificate of Merit and for Entry of Partial Judgment of Non Pros Pursuant to Rule 1042.6 are true to the best of her knowledge, information and belief. If the above statements are not true, the deponent is subject to the penalties of 18 Pa.C.S. §4904 relating to unswom falsification to authorities."  (Click to enlarge)

This legal misconduct kept the case mired in procedure for several years, with no Discovery conducted (except the defense helping themselves to my mother's medical records):

Legal misconduct: Behavior by an attorney that conflicts with established rules of professional conduct and is punishable by disciplinary measures..

This nonsense is finally over.

The judge has explicitly denied any further Motions for Reconsideration of the Certificate of Merit issue, and  has granted a Motion to Compel both Discovery (including all EHR metadata) in 30 days, and depositions within 45 days.

(If we discover that EHR problems were causing other injuries or deaths, it may be time for a visit to the DA's Office of this jurisdiction.)

Here's what I believe ended this matter, a revelation showing what I believe is hospital defense maliciousness regarding the rights of the injured and deceased (e.g., my mother, who died in June 2011, might have been able to participate in her own trial if these delays had not occurred):

My mother's (now my) attorney recently discovered  a 2006 case in U.S. District Court of Eastern Pennsylvania, Stroud vs. Abington Memorial Hospital, where the same defense for the same hospital tried exactly the same COM attack tactic, and were denied.   The Stroud case was presented to the Silverstein court just a few weeks ago.

The Stroud decision of August 2008 is at this link:  http://www.gpo.gov/fdsys/pkg/USCOURTS-paed-2_06-cv-04840/pdf/USCOURTS-paed-2_06-cv-04840-3.pdf .

One of the defense attorneys in that case was the selfsame Carolyn B. DiGiovanni  (then at law firm White & Williams LLP according to the Lexis-Nexis transcript), now acting as principal counsel in the 2010 case Silverstein vs. Abington Memorial Hospital:


Stroud v. AMH, Aug. 2008.  A familiar lawyer name.  Click to enlarge.


In Stroud in Aug. 2008 the U.S. District Court of Eastern PA concluded:

... II. Motion as to Vicarious Liability Claims Based on Other Actors’ Conduct

Hospital also seeks judgment in its favor as to any vicarious liability claims of negligence against the Hospital that Plaintiff might bring based on the actions of any Hospital personnel other than Defendant McAllister.

Hospital takes the position that Plaintiff did not timely file any certificates of merit (“COM”) to support such claims except as to Dr. McAllister and, therefore, that any vicarious liability claims for the acts of any nurse, physician (other than Dr. McAllister), or other personnel should be dismissed. 

After careful review of the Pennsylvania certificate of merit rule, however, we conclude that Plaintiff is in compliance. ... We do not believe more [than one COM -ed.] is required of Plaintiff.

The parties put forth differing interpretations of the Rule and its official “Note.” We read the first sentence of the “Note” following Rule 1042.3(a)(2) to reiterate that a COM (the contents of which is described in subsection (a)(1)) is required as to a particular defendant even when the plaintiff is bringing a claim of vicarious liability as described in subsection (a)(2) against that defendant.

We do not read it to require that a COM be filed as to a non-party [i.e., parties to whom the hospital is charged with vicarious liability for their actions such as employees and contractors - ed.].

We observe that the Note clearly states that the expert statement underlying the COM “is not required to identify the specific licensed professionals who deviated from an acceptable standard of care.” [ Pa. R. Civ. P. 1042(a)(2) Note.]  It would be incongruous for a plaintiff to be relieved of having his expert detail specific negligent individuals in his or her supporting written statement yet be required to simultaneously file separate COMs as to those individuals. 

While the Hospital directs our attention to the Note that accompanied a prior version of this rule as authority for its interpretation of the intention of the rule, we find it more persuasive that the Pennsylvania Supreme Court, by order entered on February 11, 2005, specifically re-wrote the Note to subsection (a)(2) — the only apparent change to this rule at that time. We believe that the Court’s decision to delete a provision that explicitly stated that COMs “must be filed as to the other licensed professionals whether or not they are named defendants in the action” (emphasis added) must be given effect.

We conclude that where the conduct of other licensed professionals who are not named as defendants in the action is the basis for a claim of vicarious liability against a named defendant [i.e., hospital - ed.] (for whom a COM is filed), no further COM [beyond one - ed.] is required. This interpretation is bolstered by the fact that the Form COM provided in Pa. R. Civ. P. 1042.8 [now 1042.9 - ed.] contemplates the certificate naming a “Defendant” (in the blank line following the title “Certificate of Merit as to”). We also note that, in the case discussed by Plaintiff in his opposition, Yee v. Roberts, 878 A.2d 906 (Pa. Super. Ct. 2005), the Superior Court reiterated that a timely-filed COM was necessary as to a claim of vicarious liability against a dental partnership but did not suggest that an additional COM would have been necessary as to the non-party employee (identified by her first name in the complaint) whose conduct was alleged to be negligent.


In other words, the Certificate of Merit argument proffered by the hospital and its defense in 2010-2013, including the same Carolyn B. DiGiovanni who'd heard with her own ears and seen with her own eyes the same contention denied in 2008 (a contention that helped keep Silverstein vs. AMH in the incipient pleading stages with no Discovery for years) was entirely frivolous.

Remarkably, the existence of the 2008 Stroud decision as above was never divulged to the current local PA court, in what appears to me to be a violation of the intent if not the letter of the ABA and PA Rules of Professional Conduct for attorneys:

PA Rule 3.3. Candor Toward the Tribunal.

 (a)  A lawyer shall not knowingly:

   (1)  make a false statement of material fact or law to a tribunal or fail to correct a false statement of material fact or law previously made to the tribunal by the lawyer;

   (2)  fail to disclose to the tribunal legal authority in the controlling jurisdiction known to the lawyer to be directly adverse to the position of the client and not disclosed by opposing counsel; or 

   (3)  offer evidence that the lawyer knows to be false.


Not only was the Aug. 2008 Stroud case decision on COMs "known to the lawyer", it was a case in which they had been directly and professionally involved.

Obviously, mentioning the 2008 Stroud decision at the outset would likely have been entirely destructive - right from day 1 - of any claim that multiple COM's on vicarious liability were needed in 2010.

In the face of the aforementioned 2008 Stroud v. AMH decision, this type of filing and the deliberate lack of Candor Toward the Tribunal was malicious, in my opinion, to delay proceedings - quite disrespectful of my injured and now deceased mother and to my own rights as substitute plaintiff.

The judge's latest decision ordering an end to this court procedural misuse is at this link.  The judge seemed somewhat angry:

... When the Superior Court of Pennsylvania denied Defendant's petition for review, Silverstein v. Abington Mem. Hosp.,No. 99 EDM 2012, as we explained in the January 13 order, we considered the [Certificate of Merit] matter concluded.

Specifically, our order found that the alternative request for reconsideration had been "deemed denied" or "expired" as well, citing Stephens v. Messíck,7gg A.2d793, 801 (Pa. Super. Ct.2002) ("A motion for reconsideration appeals to the court's discretion . . . . Normally, motions for reconsideration expire on their own . . . ."). 

Undeterred, Defendant, on February 1,2013, filed a motion for reconsideration of our denial of the motion for reconsideration of our denial of the "Motion of Defendant, Abington Memorial Hospital, to Strike Certificate of Merit and for Entry of Partial Judgment of Non Pros [got that? - ed.]  pursuant to pa.R.C.P . 1042.7,and sent us a copy of the second motion for reconsideration....

We now, however, in the hope of putting the matter to rest, order as follows: 1) Defendant's motion for reconsideration of our denial of Defendant's earlier motion for reconsideration is deníed.

We pause to comment that the theory espoused in Defendant's "reply" to plaintiff's answer in opposition to the second motion for reconsideration-that we declined to entertain Defendant's first motion for reconsideration based on the erroneous belief we had no jurisdiction to do so - is incorrect[This lawyer was trying to tell a judge what he could and could not do - ed.]

... This Court, at least this jurist, will entertain no further requests for reconsideration of the subject matter of these motions and orders, barring contrary direction from a higher authority,  and we encourage the parties not to file any such further requests. [The reconsideration 'requests' came solely from the defense, I add - ed.]

By the Court, Joseph A. Smyth, Jr.

Thank God, because I was fully expecting, barbershop-mirror style, a "Motion for Reconsideration of Denial of Motion for Reconsideration of Denial of Motion for Reconsideration."

Sadly, this is the hospital where I'd completed my residency in 1987 with solid recommendations - including for a medical informatics postdoc that helped give me my current expertise - from its current Chief Medical Officer, then a residency program director.

This form of hospital defense abuse - frivolously and with malice trying to stall or evade court process guaranteed to citizens in the Constitution, especially when they are frail and may soon die - must not be permitted.

Finally, I observe that perhaps Marshall Dennehey Warner Coleman Goggin needs to provide better CLE instruction on the PA and ABA Rules of Professional Conduct.

-- SS

April 11, 2013 addendum:

Health Leaders Media
April 5, 2013
HIT Errors 'Tip of the Iceberg,' Says ECRI 

Healthcare systems' transitions from paper records to electronic ones are causing harm and in so many serious ways, providers are only now beginning to understand the scope.  [I understood the scope years ago as reflected in my writings - ed.]

Computer programs truncated dosage fields, leading to morphine-caused respiratory arrest; lab test and transplant surgery records didn't talk to each other, leading to organ rejection and patient death; and an electronic systems' misinterpretation of the time "midnight" meant an infant received antibiotics one dangerous day too late.

These are among the 171 health information technology malfunctions and disconnects that caused or could have caused patient harm in a report to the ECRI Institute's Patient Safety Organization. Thirty-six participating hospitals [a small number indeed - ed.] reported the data under a special voluntary program conducted last year.

Karen Zimmer, MD, medical director of the institute, says the reports of so many types of errors and harm got the staff's attention in part because the program captured so many serious errors within just a nine-week project last spring.  [Including 8 injures and 3 possible deaths in just 9 weeks as I wrote at "Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI Deep Dive Study of Health IT Events" here - ed.]

The volume of errors in the voluntary reports was she says, "an awareness raiser."

"If we're seeing this much under a voluntary reporting program, we know this is just the tip of the iceberg; we know these events are very much underreported."

... ECRI is currently evaluating a similar, and much larger list of reports from many of the 800 hospitals that contract with ECRI's PSO services.

It's about damn time someone looked at EHR-related mishaps seriously.

-- SS

April 13, 2013  Addendum:

This hospital is apparently insured via a consortium of 8 regional nonprofit hospitals:


(Click to enlarge)

The frivolous filings (including several that were hundreds of pages long) and legal misconduct likely cost insurer Cassatt RRG a small fortune, a disgrace for charitable organizations to have their funds wasted in this manner for defense lawyer enrichment.  I feel Cassatt needs to know about this, so I will inform them.

-- SS

April 18, 2013 Addendum:

From my counsel on 4/16 I am informed the defense lawfirm is upset at this posting.  I have, being a reasonable author, offered through my counsel to consider revisions if defense would identify statements they believe non-factual, along with a basis of claims of non-factuality.  Nothing has been received in response.

-- SS

Saturday, April 06, 2013

WALK THE WALK



WALK THE WALK

For some time a jeremiad theme has been dominant in the psychiatric sector of the academic-industrial complex. Blockbuster psychiatric medications are going off patent, the pipeline is viewed as alarmingly empty, and several corporations are scaling back or even abandoning their research programs in this area. Analyses of the reasons range from the enlightened to the pragmatic to the pedantic to the foolish. Everyone predicts that things will turn bleak in academic clinical research if the corporate spigot is turned off.

Lost in the wailing is a clear understanding that the defecting corporations are acting out of their own enlightened self interest. For 50 years, no fundamentally incisive innovations have occurred, so the defectors are telling the academics to get their act together in respect of better understanding disease mechanisms. Trouble is, too many academic clinical investigators have devolved into key opinion leaders promoting corporate marketing messages at the expense of generating original clinical science. Now they are squawking about being caught with their pants down.

The latest academic psychiatrist to opine about this issue is Steven Hyman at Harvard Medical School. In a new commentary that has just appeared, Dr. Hyman talks up his favorite theme of translational medicine, which sounds lovely until you perceive that he has no contemporary examples of same in psychopharmacology. It’s all airy rhetoric. Dr. Hyman is not just a Harvard professor – he is a former Director of the National Institute of Mental Health (NIMH). Then he was Provost at Harvard under President Larry Summers. Now he is Director of a psychiatric research center at Harvard.

Someone else who noticed Dr. Hyman’s new commentary is our fellow blogger Dr. John M. (Mickey) Nardo across at 1Boringoldman.com. His take on the Hyman piece is right on target. Basically, the Hyman commentary is a hortatory fantasy that we can all do better by buying in to his vision of interdisciplinary research, pooling the efforts of academia, industry, and government. Problem is, his vision hasn't worked so far. Here is an example.
   
Towards the end of his term as NIMH Director, Dr. Hyman set the ball rolling for new centers cast in his mold of translational research. Dr. Nardo mentioned “… a bunch of centers that haven’t produced very much.” The model of such failed centers is the one that existed at Emory University under the direction of Charles Nemeroff. It was called the Emory-GlaxoSmithKline-NIMH Collaborative Mood Disorders Initiative 5U19MH069056 (Principal Investigator Charles Nemeroff). It was conceived with all the right buzzwords about innovative models of drug discovery and translational benefit for patients through partnerships of academic centers with commercial drug makers (the Request for Applications (RFA) actually used this language). From the start, the Initiative was poorly managed and it never lived up to its billing. 

Annual Progress Reports from the Initiative to NIMH, obtained through a FOIA request, reveal unacceptably low scientific productivity, and lack of leadership to promote the intended scientific synergies among laboratories. When I assessed the overall productivity of this project four years after the end of the first 5-year funding period, it was apparent that the U.S. taxpayer received little value for the $5.3 million investment by NIMH. Only 7 original scientific publications could be attributed to the federal support (that count excludes a host of potboiler review articles and other academic padding). Five of these 7 originated from a single participating laboratory at Emory. The NIMH component, under Dennis Charney, also was a serious underperformer.

The collaborating drug company GlaxoSmithKline obtained valuable preclinical information from the Emory laboratories, much of which has never been published even though federal funding supported the work. If the data are being treated as confidential proprietary information by GSK, then that posture would be contrary to the spirit of the original RFA. Maybe GSK just decided it was worthless data. In addition, GSK benefited from the conduct of a Phase II clinical trial of one of their candidate drugs in posttraumatic stress disorder (PTSD), even though this study returned a negative result. Even worse, the trial did not meet the stated criteria of the RFA. It was not based on any well founded theory of PTSD. Instead, it was a routine, exploratory study of a new compound. Because the study design did not permit strong inference, nothing substantive was learned from the negative result. This Phase II trial could have been performed better and less expensively by GSK itself as a normal business activity. GSK certainly did not need scarce NIMH dollars for this routine, early Phase II trial. The Emory-GSK-NIMH Initiative added no scientific value.

Notwithstanding the clear evidence of under-productivity, NIMH under Director Thomas Insel, MD, continued the Initiative for all 5 years of the original funding period, and then renewed the Initiative for a second 5 year period at an increased funding level under a new P.I., Helen Mayberg, M.D. Dr. Mayberg is a respected clinical scientist, but she is not a psychiatrist, she is not a psychopharmacologist, and she has no track record of research in the priorities announced by the RFA. What actually is going on? Did NIMH just hand a favor to Dr. Insel’s former employer, Emory University, to the tune of another $6 million?

One lesson of this episode is that the chatter by federal scientific administrators (Hyman, Insel) about translational research strategies and innovative models of drug discovery is mostly vacuous rhetoric. The RFA was an imprudent conceit to begin with, having no base in solid clinical science, and this expensive Initiative failed catastrophically to meet its grandiose objectives. It is ironic that Dr. Hyman presumes to scold and sermonize to the field yet again about translational research, as it was he who set the ball rolling in the first place for the disastrous Emory-GlaxoSmithKline-NIMH Collaborative Mood Disorders Initiative. Last time I looked, nobody has been held accountable for the failure of the Initiative. Where is NIMH Director Thomas Insel when we need him to set standards of accountability and ethics?

So, the next time you hear academic psychiatrists lamenting how bad it is, remind them about this scandalous example of waste and mismanagement of federal research funding. Cleaning up cesspools like this would be a step to unblocking the drug development pipeline. And we need leaders who walk the walk, not just talk the talk.

Thursday, April 04, 2013

Another Sign of Resistance? - Doctors Sue Hospital Systems Alleged to Put Money Ahead of Mission

In two recent instances, physician groups have filed lawsuits against hospital systems alleging that managers were directly putting revenue ahead of patient welfare.  Although so far this is all about allegations, and nothing has been decided in courts of law, the details provided in the current news coverage are disturbing.

We will present the cases in the order that news reports were published.

Prime Healthcare Services

California Watch reported on a lawsuit filed against Prime Healthcare Services, a California based for-profit hospital system that has got its share of unfavorable media coverage.  In summary,

A dozen Southern California doctors are accusing the leadership of a Prime Healthcare Services hospital of refusing to notify them about their patients because they won’t engage in profit-driven practices, according to a request for a restraining order filed this week.

The San Bernardino County physician group suing Chino Valley Medical Center and its director say it has been asked to needlessly admit patients from the emergency room into hospital beds, according to the lawsuit filed Wednesday in San Bernardino County Superior Court. The group’s doctors also have been urged to document patient conditions as more complex or severe than they are, the filing says.

The doctors suing the hospital maintain that both practices are meant to drive up hospital bills. The result of their refusal to go along, they say, is that they’re not receiving what they characterize as legally mandated notifications when their patients land in the hospital.

 The physicians have asked the judge to lift the alleged freeze in communication, saying it puts fragile patients in danger. 

The article described one particularly concerning incident

[The lawsuit] ... claims one patient with a serious breathing condition was admitted without her doctor’s knowledge. During her stay, Chino Valley staff operated to remove her gallbladder.

'Because (Inland) was not contacted, no doctor gave the required pulmonary clearance nor did the patient receive proper respiratory treatment prior to surgery,' the lawsuit says.

The suit alleges that such practices put patients 'at serious risk of injury and even death.'

The article also described allegations that at the root of the problem was the hospital system's management's insistence on revenue ahead of all other concerns:

The physician group suing Chino Valley holds contracts with about a dozen managed care firms that expect group doctors to handle local members’ care in the case of a hospitalization.

The Inland doctors say that instead, they’ve been stonewalled. In their lawsuit, they say the silence is a result of their refusal to follow the direction of the hospital’s president and chief medical officer, Dr. James Lally, a defendant in the case.

Lally suggested that the physicians document serious medical conditions, such as a certain type of pneumonia that Medicare pays hospitals a premium to treat, the suit says.

Lally also discouraged doctors from putting patients on 'observation' status, according to the suit. That means a doctor will monitor a patient’s condition, rather than sending him or her home or admitting the patient to a hospital bed.

The lawsuit alleges that Lally prefers doctors to admit patients into the hospital so the hospital can receive 'significantly higher Medicare reimbursements.'

This is not the first time that Prime has been accused of mischief:


A yearlong California Watch series documented high rates of lucrative and severe medical conditions at Prime hospitals, as well as an aggressive approach to admitting ER patients into hospitals, rather than treating them in the ER and sending them home.

State hospital data analyzed by California Watch showed that Prime hospitals admitted about 63 percent of Medicare-funded ER patients into hospitals in 2009, compared with 39 percent at the state’s other leading for-profit chain, Tenet Healthcare Corp. In response, Prime said the analysis 'utterly fails to consider the medical basis for admissions.'

The U.S. Justice Department is investigating Prime’s billing practices, according to a document the chain filed as part of a hospital purchase plan. Dr. Prem Reddy, founder of the Ontario, Calif.-based chain, has overseen rapid growth since Prime’s 2001 start as the company expanded into a coast-to-coast 21-hospital chain.

Also,


Prime Healthcare has been criticized for aggressively admitting paying patients since its founding. Reddy once referred to an ER as a 'gold mine,' according to court testimony from the medical director of the first hospital taken over by the Prime founder. The reference, which the medical director said during a 2005 trial, was to numerous Kaiser and Medicare patients who could be admitted for further care.

Another doctor told the Orange County Board of Supervisors in 2006 that when Prime took over Huntington Beach Hospital, doctors were urged to admit insured patients with maladies as minor as a headache.

Yet, Prime Healthcare claims to honor the value of compassion:

 We provide an environment that is caring and conducive to healing the whole person physically, emotionally and spiritually. We respect the individual needs, desires and rights of our patients.

Dignity Health

Our second story comes from Nevada courtesy the Las Vegas Sun.   It involves Dignity Health, a multi-state non-profit health system.  The story basics are:

Two former St. Rose Dominican Hospital emergency room doctors say they were forced to transfer patients from one St. Rose hospital to another so its owners and their boss could profit — at the expense of patient safety.

The doctors allege in similar lawsuits that the frequent patient transfers among the three St. Rose hospital campuses — Rose de Lima and Siena in Henderson and San Martin in the southwest valley — put profit ahead of patient care. When they resisted, they say they were retaliated against and eventually fired.

The 3-year-old ambulance company that was used to shuttle patients was partly owned by both the hospital company and the director of the emergency department at the Siena campus at the time, Dr. Richard Henderson. According to their lawsuits, Henderson pushed hard in emails to ER doctors to promote patient shuttling and authorized bonuses to doctors who transferred the most patients to other St. Rose facilities.

Again, there was one telling incident:


Both lawsuits invoke the case of a gravely sick 16-day-old baby who arrived at St. Rose de Lima hospital, where a doctor determined the child needed pediatric critical care services at the Siena campus and requested a Henderson Fire Department unit for transport.

But according to the lawsuits, Henderson ordered that Community Ambulance transport the child instead. He made the request despite longer wait times for Community Ambulance compared to Henderson Fire Department’s quicker response times of 10 minutes or less, according to the lawsuits.

This article also described how money allegedly came before patient care:


The court papers include email exchanges between Henderson and the other doctors in the ER group. In a November 2010 email, he discusses ways to punish doctors who do fewer patient transfers and reward those who tally more transfers:

'(T)op quarter $1,000, next quarter $500. Bottom quarter up or out talk at annual evaluation.' In other words, according to doctors who received the email, Henderson proposed that doctors would be divided into strata based on who recommended the most transfers, with the top group winning bonus money while those who performed the least would eventually be terminated.

Transferring patients was such a priority that doctors were ordered to fill out non-transfer forms, explaining a decision not to transfer patients.

In another email, Henderson expressed concern that doctors were too quick to rule out transfers: 'How do you weed out the people that call a runny nose ‘unstable for transfer’? The performance we (admin) are looking for are transfers. Suggestions?'

A former member of the medical staff put it this way: There was constant pressure to transfer transfer transfer.'

Note that Dignity Health was until recently called Catholic Healthcare West (look here).  It still claims the mission:

 We are committed to furthering the healing ministry of Jesus. We dedicate our resources to:
  • Delivering compassionate, high-quality, affordable health services;
  • Serving and advocating for our sisters and brothers who are poor and disenfranchised; and
  • Partnering with others in the community to improve the quality of life.
Note also that under its former name, Catholic Healthcare West has received our previous attention, for accusations that it overcharged uninsured patients (look here),  which it later settled (look here), and for settling a lawsuit claiming the system filed false Medicare claims (look here). 

Summary

 Just another day at the office....  Here are two more examples of how large health care organizations, in this case, large hospital systems, seem to put short-term revenue ahead of all other concerns, and in particular, ahead of patient welfare.  In both cases, the alleged practices seemed to make a mockery of the hospital systems high-flown mission or values statements.  In both cases, the hospital systems had records of past questionable behavior.  Yet many hospital systems have grown rich and powerful, and made their leaders personally rich, by trading on their reputation for community care and service, and marketing their warm and fuzzy missions and values. 

Over the years, we have documented over and over how leadership of health care organizations have subverted their organizations' missions and the values of health care professionals.  Yet for a long time, many health care professionals just kept their noses to their grindstones, ignoring what was going on or suffered in silence.  Now at least a few have broken the silence.  Health care professionals and society at large needs to hold large health care organizations' leadership accountable for their missions, and push out leaders who put their own pocketbooks and their organizations' revenue ahead of patients' and the public's health.