The HIT Scam

Worth a read -

The HIT Scam By Greg Scandlen

Notable in the piece are these observations:

 ... even the editors of the Washington Post have come to agree the whole [national health IT] project was a fiasco — but only after we wasted $27 billion of taxpayer money.

Yet, those who are enriching themselves on the $27 billion are just happy as clams over the program. John Hoyt, the Executive Vice President of the Healthcare Information and Management Systems Society (HIMSS) was quoted in a recent Health Change Bulletin as saying −

This data suggests that the HITECH portion of the 2009 stimulus law is achieving its intended result of encouraging increased implementation and meaningful use of electronic health records among hospitals. Facilities…are laying the groundwork for interoperability to occur. Stage 6 and Stage 7 hospitals are fully prepared for provider-to-provider or facility-to-facility interoperability, as well as increasing the provider or facility’s ability to provide electronic health data reporting to public health and immunization registries to support population health review and syndromic surveillance.

There, aren’t you greatly reassured? By the way, the New York Times piece cited above reported that –

RAND’s 2005 report was paid for by a group of companies, including General Electric and Cerner Corporation, that have profited by developing and selling electronic records systems to hospitals and physician practices. Cerner’s revenue has nearly tripled since the report was released, to a projected $3 billion in 2013, from $1 billion in 2005.

No doubt the companies that paid for the RAND study are also members of HIMSS. And General Electric certainly has what might be called a “special” relationship with President Obama.

I've been writing on similar issues for more than a decade.

It's well past the time when the same rigor that applies to pharma and medical devices be applied to the health IT sector.  And the marketing hype, along with bad health IT, abolished.

-- SS 

GUEST BLOG - What Can Doctors Do to Combat Business Malfeasance in Health Care?

Dr Gene Dorio is a an internist and geriatrician in California, described in the Los Angeles Times as an "old school physician."  He would welcome discussion with anyone interested in his proposal.  Please email him directly at grd51 at aol dot com, or email me for forwarding.    

As a Health Care Renewal reader, learning of medical business malfeasance irritates my moral conscience, yet lack of legal intervention frustrates my inner core.

I am chairman of the Department of Medicine at a small community hospital in Southern California, and as I battle the Administration during Medical Executive Committee meetings, I am a lone voice. Some of my colleagues nod their heads, while others later tell me of their support, but few vocally nor in writing openly give their opinion. Why?

Most fear hospital financial retaliation, but I also know they don’t have time to formulate an opinion. You would think well-educated doctors who daily advocate on behalf of patients would be better attuned to being involved in our great medical debate. Because they have remained silent, “big business” jumped in and took over financial medical decision-making.

Using our medical license is the business scheme they use to make their money. With sophisticated business techniques, they have shut out doctors and dangled dollars as we all jump for their “carrots.” That successful business model and attitude is outside the realm of doctor’s poor business and public relations sense, with the noose continually tightening.

Realizing business would be nowhere without our medical license is our trump card...which we haven’t played yet!

What can we do? Logically, bring their business malfeasance forward on blogs (like Health Care Renewal) with the hope physicians and the public will be upset. It does stir the pot for some of our colleagues, but for the most part, doctor attention is now focused on just trying to survive. The public is rendered helpless by the continually confusing medical legalese by the well-financed business propaganda machine. This is where our frustration arises, as the backlash-opinion tsunami of their business outrage never materializes, especially from doctors.

Therefore, my first thought for a possible solution is focus on the public, clarifying the legalese, and use abhorrent stories of business abuse and patient care sacrifice for business profit. We must make them the villain.

Secondly, organize physician writers into a small group launching a “counter offensive” against their propaganda. The public still highly respect physicians and gravitates to their opinions and stories. With the right motivated people, they would think-tank refined opinions for the national spotlight.

Thirdly, network with national blogs and magazines, and city-printed newspapers for article publication as op-eds, letters to the editors, journal articles, and personal stories.

Fourthly, and probably the hardest, not get discouraged.

Health Care Renewal defines the problem, but not always the solution. Even when there might be solutions, they must be broadcast and directed at a higher level to ignite public opinion.

If you think this might be worthy for 2013 (as if we aren’t all busy enough!), I will be happy to spearhead this project with those advocate colleagues and idealists who might be interested.

Our profession is under assault from big business, and finding clarity is the shield we need to defend society and our patients.

Dr Gene Dorio

"Slap on the Wrist" for a "Too Big to Fail" Hospital - Judge Rejects WakeMed Settlement

Maybe we are reaching an inflection point in how misbehavior by big health care organizations is handled in the US legal system. 

We have frequently discussed the march of legal settlements made by big health care organizations.  Many of these settlements indicated severely bad behavior, often behavior that seemed overtly dishonest, sometimes criminal, and had the potential to harm patients.  Yet most of these settlements involved only fines, and sometimes written agreements that pledge the organization will do better in the future, often in the form of deferred prosecution or corporate integrity agreements.  Yet the fines were often small compared to the amount the organization stood to make from the bad behavior.  It is not clear that any written agreements were enforced, or caused major penalties if the organization did not fulfill them.  And almost never did any individual within the accused organization suffer any negative consequences for authorizing, directing or implementing the bad behavior, even if such individuals may have personally profited from high compensation partially fueled by the bad behavior.

Now and then, though, there are cases that are different.  Perhaps one has just come along that may signal things are going to change.

The Basics of the Case

The case was first reported by the Raleigh (NC)  News & Observer in December, 2012.  Here are the basics:

WakeMed has agreed to pay $8 million to settle an investigation into its practice of billing Medicare for expensive overnight care when the patients had been treated and discharged the same day.

The settlement came after a lengthy criminal investigation into Medicare billing procedures used by nurses at the private, not-for-profit hospital’s Heart Center Observation Area.

Nurses there, according to federal court documents, routinely ignored physicians’ orders for how a patient should be classified. Their actions resulted in the hospital receiving millions of unwarranted Medicare dollars for outpatients who were classified wrongly as inpatients.

Though some WakeMed managers were aware of the billing practices, according to court documents, investigators found no evidence of anyone personally benefiting from the system.

No one, according to WakeMed officials, lost their job or was disciplined because of the investigation. 

The US Attorney made the usual sort of announcement:

'This case will serve as a reminder that hospitals, just like individual health care providers, will be held accountable for their actions,' [Thomas] Walker, the U.S. Attorney for the Eastern District of North Carolina, said in a statement.

Read more here: http://www.newsobserver.com/2012/12/19/2555092/wakemed-admits-to-false-medicare.html#storylink=cpy

So far, this is pretty usual.  There were accusations of inflated billing, a monetary fine that might look big to the average citizen, but that pales next to the revenue of the offending organization (over $943 million in the 2010-2011 fiscal year according to the WakeMed 2011 US form 990),a stern statement by the US Attorney, but again no penalties for any individual, and here, a rather implausible statement that no one benefited from the deceptive practices.

However, there were also some immediately appreciable atypical elements to this case.

Atypical Elements

In addition to the fine to be paid, the case was to be settled using a deferred prosecution agreement:

The hospital faces two criminal charges – making material false statements relating to health care matters and aiding and abetting, but under the settlement reached Wednesday, prosecution will be deferred. If the hospital complies with provisions in the settlement agreement, such as paying $8 million and allowing further monitoring, the charges will be dismissed in two years, according to court documents.

As part of the agreement, which has yet to be approved in court, [Wakemed CEO Bill] Atkinson acknowledged the wrongdoing described by prosecutors. He further acknowledged that WakeMed was responsible for the acts of the health-care organization’s employees and officers.

Read more here: http://www.newsobserver.com/2012/12/19/2555092/wakemed-admits-to-false-medicare.html#storylink=cpy

Read more here: http://www.newsobserver.com/2012/12/19/2555092/wakemed-admits-to-false-medicare.html#storylink=cpy

Read more here: http://www.newsobserver.com/2012/12/19/2555092/wakemed-admits-to-false-medicare.html#storylink=cpy

While we have sometimes seen deferred prosecution agreements used in cases in which for-profit health care corporations were accused of violating the law, they are rarely used in cases involving non-profit hospitals.  (The biggest one I recall was that of the University of Medicine and Dentistry of New Jersey, a complex case we started discussing in 2005.  See relevant posts here.)  Criminal charges against a non-profit hospital are also unusual.  Note also that as stated above the hospital system CEO seemed to admit that the hospital did wrong, raising further doubt about the conclusion above that no individual personally profited.

The plot further thickened when the CEO seemed to contradict his own statement within the deferred prosecution agreement that acknowledged wrong-doing.

In an interview Wednesday, Bill Atkinson, WakeMed’s president and CEO, wavered between accepting the charges – saying repeatedly  'I don’t want to minimize it, and I don’t want you to hear me doing that' – and being adamant that the hospital’s actions were simply a misinterpretation of complicated federal Medicare guidelines.

Even though he endorsed a settlement agreement in which prosecutors contend two crimes occurred, Atkinson said he doesn’t believe the hospital’s actions were criminal.

'I don’t think so, but the federal government thinks they could certainly turn it that way,' he said. That description differs vastly from what prosecutors contend. 'They’re not going to minimize the media effect,' Atkinson said.

Read more here: http://www.newsobserver.com/2012/12/19/2555092/wakemed-admits-to-false-medicare.html#storylink=cpy

The plot thickened further when in the same interview Atkinson seemed to deny that any individual did anything wrong:

Heidi McAfee, who retired earlier this year, was director of Patient Access during much of the period when the problematic billing occurred. Efforts to reach McAfee on Wednesday were unsuccessful, but Atkinson praised her years of work with WakeMed.

'Do I think anybody intentionally did anything wrong?' Atkinson said. 'No, I don’t.'

He said WakeMed had not reported McAfee or any of the nurses to the N.C. Board of Nursing for ignoring doctor’s orders. 

So did the hospital acknowledge wrongdoing, or did it not?  If wrongdoing did occur, did any individual do it, or was it done by ghosts or spirits?  From this account, it was unclear.

This Time the Inconsistencies and Ambiguities are not Ignored

Many of the settlements we have discussed seem to have been based on similar illogic.  For example, they often involved accusations of bad behavior, often bad enough to put patients at danger, yet the settlements may included ritualistic statements by defendant organizations that they neither admitted nor denied wrongdoing.  Thus, the settlements left ambiguous and unknown what really happened, and their own appropriateness.  (Note that similar settlements are made all the time by big financial firms, and one intrepid judge did point out how little sense they make, see this post.)

Yet in most cases, the illogic is rapidly swept under the rug, noticed, if at all, by lowly outsiders like your humble bloggers on Health Care Renewal.

This time, though, it was different.

Why Would the Nurses Ignore Doctors' Orders?

An important part of the argument by the US Department of Justice in this case was that nurses "routinely ignored doctors' orders."  If it were true, this would be very unusual and would threaten the integrity of health care at the particular institution, since every hospital operates on the assumption that the doctors make management decisions and order tests, treatments, etc, and then the nurses, as well as technicians and therapists carry out these orders.

However, In this case, a local nurse immediately and publicly disputed the notion that the nurses were independently flouting the doctors' orders.  As reported again by the News & Observer in December, 2012,

When Vicki Hewitt-McNeil read about WakeMed’s $8 million settlement for wrong Medicare billing, the Raleigh nurse didn’t buy the story.

According to the settlement, a nursing director instructed her staff to admit patients as inpatients and ignore doctors’ orders to treat them on the less expensive outpatient basis.

With two decades of nursing experience, Hewitt-McNeil didn’t like that the blame was shifted down the totem pole to nurses, who don’t wield the power of administrators and doctors.

'I honestly cannot believe this was the nursing department that did this,' Hewitt-McNeil said. 'That’s just not possible.'

 Furthermore,

[Ms Hewitt-McNeil]  also worked shifts at WakeMed as a pool nurse, similar to working as a substitute teacher. 'Nurses at WakeMed don’t have the autonomy to do anything,' Hewitt-McNeil said. 'You have to call a doctor for everything.'

Read more here: http://www.newsobserver.com/2012/12/22/2561738/nurse-rejects-wakemeds-claim-that.html#storylink=cpy

Again, the contention that the nurses systematically disobeyed doctors or pretended to be following non-existent orders implied a fundamental break-down of the system and widespread unprofessional, unethical behavior by the nurses.  In addition, the charges did not suggest why the nurses would do something so bad, especially since they were in no position to personally benefit from their actions.

 What Did the Hospital Leadership Actually Admit?

Read more here: http://www.newsobserver.com/2012/12/22/2561738/nurse-rejects-wakemeds-claim-that.html#storylink=cpy

Read more here: http://www.newsobserver.com/2012/12/22/2561738/nurse-rejects-wakemeds-claim-that.html#storylink=cpy

It took a few weeks, but someone - it is not clear who it was - noticed that while the Department of Justice asserted that the hospital CEO had admitted wrongdoing, the CEO's public statement seemed to equivocate.  So in mid January, 2013, as reported again by the News & Observer,

Deb Laughery, a spokeswoman for the hospital, issued a clarification on Monday.

'In an abundance of caution, WakeMed confirms that it has agreed to a settlement with the United States as set forth in the Deferred Prosecution Agreement,' the statement said, adding further that statements of fact laid out in the agreement were 'true and accurate.'

In the clarification, WakeMed officials acknowledged that the hospital formally faced federal criminal charges. The hospital also retracted any suggestions that the settlement only involved a small number of cases.

The hospital public relations person apparently could not bring herself to say that the hospital admitted wrongdoing, but by acknowledging that statements of fact in the deferred prosecution agreement were "true and accurate," she seemed to be indirectly admitting again that wrongdoing occurred, and that the hospital was responsible for the actions of its employees.

The Judge Notices the Emperor Has No Clothes

Despite their internal inconsistencies and illogic, most legal settlements of accusations of wrongdoing by big health care organizations are accepted by judges.  In this case, again things were different.  As reported yesterday, on 17 January, 2013 again by the News & Observer,

 WakeMed officials and federal prosecutors spent two years hammering out an $8 million proposal to settle a Medicare fraud investigation.

A federal judge shredded the 116-page agreement in less than 30 minutes on Thursday.

U.S. District Judge Terrence Boyle ticked off a list of his grievances about the proposal, forcing federal prosecutors into the unusual position of defending the defendants.

Read more here: http://www.newsobserver.com/2013/01/17/2614178/judge-refuses-to-accept-wakemed.html#storylink=cpy

Quelle surprise!  The judge took particular offense that the settlement seemed disproportionately lenient,

 The agreement, Boyle said, appeared to be a 'slap on the hand' for a 'too big to fail' corporate giant. Only the day before, Boyle told the lawyers, he sentenced a woman to a year in prison in a $235,000 insurance fraud case.

Furthermore, 

Read more here: http://www.newsobserver.com/2013/01/17/2614178/judge-refuses-to-accept-wakemed.html#storylink=cpy

Boyle was irked that no criminal charges had been filed in the case. He ended the hearing by telling the prosecutor either to fold his briefcase or take it to a federal grand jury for official indictments.

'There are lots of corporations that steal from the government,' Boyle said. 'Most of them are convicted, fined and banished.'

Also,

'Why are you coming to court if you tell me you don’t need me?' Boyle asked Gilmore, the prosecutor who rose before him Thursday. 'I’m just window dressing in this case.'

'Why not take a guilty plea, defer imposition of the judgment and sentence, and come back in two years later and take a post hoc dismissal?' Boyle asked later.

Boyle lamented the increased number of health care fraud cases across the country.

'Who are the victims in this case?' Boyle asked before answering his own question. 'Every American wage earner and every American citizen.'

Boyle continued: 'It’s very difficult for society and the court to differentiate between the everyday working Joe or Jane who goes to prison and the nonprofit corporate giant who doesn’t go to jail, who gets a slap on the hand and doesn’t miss a beat.'

Exactly.   And finally, just to demonstrate the sense of impunity of the leadership of this particular nonprofit corporate giant

Boyle, who’s been a federal judge for 28 years, also criticized WakeMed for failing to send a top administrator or a board member to answer his questions. It’s rare for a criminal case to be resolved without a defendant at the defense table.

Deb Laughery, a WakeMed spokeswoman, said after the hearing that none attended because the board approved a resolution earlier in the week supporting the proposed settlement.

Summary

For years now the leadership of large health care organizations have grown rich while denying accountability for their actions that made this so.  This denial has been largely abetted by governmental regulators and law enforcers, who while often recognizing that corporate misbehavior has occurred, have seemed unable or unwilling to pursue anything but the most lenient resolutions of such cases.  These resolutions are often fines that might appear big to gullible members of the public, but are actually small in comparison to the money to be made; sometimes deferred prosecution and corporate integrity agreements that rarely are enforced; and almost never any negative consequences for the people who authorized, directed, or implemented the bad behavior.  Thus the leaders of health care organizations have enjoyed impunity, have become the new untouchables, and thus health care organizations become ever better at raking in money and ever worse at providing good health care.

As I have said again and again,  until the people responsible for the bad behavior experience negative consequences from that behavior, they will continue to perform, direct, and condone bad behavior. We will not achieve real health care reform in the US until we effectively deter unethical, self-serving behavior by leaders of health care organizations.

Read more here: http://www.newsobserver.com/2013/01/17/2614178/judge-refuses-to-accept-wakemed.html#storylink=cpy

Read more here: http://www.newsobserver.com/2013/01/17/2614178/judge-refuses-to-accept-wakemed.html#storylink=cpy

Read more here: http://www.newsobserver.com/2013/01/17/2614178/judge-refuses-to-accept-wakemed.html#storylink=cpy

Read more here: http://www.newsobserver.com/2013/01/15/2607671/wakemed-clarifies-statements-on.html#storylink=cpy

The Tragic Case of Aaron Swartz: Unequal Justice for Web Activists vs Health Care Corporate Executives

The recent tragic case of the suicide of Aaron Swartz raises many issues, and has inspired an outpouring of news coverage and internet discussion.  Yet one issue it should raise that has not received much notice so far is that of how individuals and top executives are treated differently before the law.

Summary of the Case

Aaron Swartz was a prodigy who developed  helped develop the RSS system for disseminating updates on web-site contents, and who helped develop the Reddit web-site.  He was an advocate for information freedom, and more broadly, according to Matt Stoller, "a political activist interested in health care, financial corruption, and the drug war."  Furthermore, he "recognized that politics is a corrupt money driven system, but also that it could be cracked if you spent the time to understand the moving parts."

Although apparently very well known among internet activists and computer scientists, Mr Swartz did not attract a lot of mainstream media attention, at least until 2011 when he was arrested "on a series of felony counts including wire fraud, computer fraud, unlawfully obtaining information from a protected computer and recklessly damaging a protected computer," according to the New York Times.  His alleged crime was that he downloaded thousands of scientific scholarly articles from the site JSTOR, and was accused of intending to make them publicly available for free.  Note that the articles were already publicly available, but only online through expensive subscriptions.  At the time, the US Department of Justice took this to be a very serious crime:

'Stealing is stealing, whether you use a computer command or a crowbar, and whether you take documents, data or dollars,' the United States attorney for Massachusetts, Carmen M. Ortiz, said last week in a statement about the case. 'It is equally harmful to the victim whether you sell what you have stolen or give it away.' 

The charges Ms Ortiz filed lead to Mr Swartz's arrest

on a series of felony counts including wire fraud, computer fraud, unlawfully obtaining information from a protected computer and recklessly damaging a protected computer. If convicted on all counts, the Justice Department said he could face up to 35 years in prison and $1 million in fines. 

Yet Mr Swartz certainly was not accused of either violence or of planning to personally profit from his alleged crimes.  At the time of his arrest, the severity of the allegations baffled many:

 'This makes no sense,' said David Segal, executive director of Demand Progress, an organization Mr. Swartz founded to rally support online for an open Internet. 'It’s like trying to put someone in jail for allegedly checking too many books out of the library.'

JSTOR got the hard drives that contained the articles in question back from Mr Swartz, and planned no further action:

Asked if it was pleased that someone misusing the service could be brought to justice, a spokeswoman for Jstor wrote in an e-mail response: 'We wanted the content back, and we were able to secure it and ensure it wasn’t distributed. We were not interested in further legal action around this incident. We have no comment on the prosecution or how they have chosen to characterize it.'

Since 2011 the case got little notice until Mr Swartz ended his own life this month.  After his death, his family and partner issued a statement, as reported by the Guardian:

In a statement released late Saturday, Swartz's parents, Robert and Susan, siblings Noah and Ben and partner Taren Stinebrickner-Kauffman said the Redditt builder's demise was not just a 'personal tragedy' but 'the product of a criminal justice system rife with intimidation and prosecutorial overreach'.

They also attacked the Massachusetts Institute of Technology (MIT) for not supporting the internet activist in his legal battles and refusing to stand up for 'its own community's most cherished principles'.

And according to the New York Times (via CNBC), Harvard Professor Larry Lessig, Director of the Safra Center for Ethics, where Swartz had been a fellow protested

the idea that he could have seen serious prison time was infuriating. Lawrence Lessig, the Harvard Law professor who founded Creative Commons to advocate greater sharing of creative material online, called the prosecution's case absurd and said that boxing in Mr. Swartz with an aggressive case and little ability to mount a defense ''made it make sense to this brilliant but troubled boy to end it.'

 Hounding Swartz but Failing to Pursue Health Care Corporate Executives

The Daily Beast just ran a story that suggests that Swartz should have known better to have done something that would have attracted the wrath of one of the toughest federal prosecutors, but one who is also a "liberal's dream."  It opened its piece on US Attorney Carmen Ortiz thus:

 Until she was accused of driving the 26-year-old cyber wunderkind and public-access activist Aaron Swartz to suicide, the top federal prosecutor in Massachusetts was a liberal’s dream.

 Not for nothing was United States Attorney Carmen Ortiz championed by the late Sen. Edward Kennedy and appointed by President Obama nearly four years ago.

Then, it suggested how tough Ms Ortiz really is:

She is Hispanic and was raised in a New York housing project, and after her husband died of cancer she raised two daughters on her own. She has taken on political corruption, and she has been so aggressive against white-collar crime that her office collected more in forfeitures and fines than any other jurisdiction in the country.

Her avowed motive in becoming a prosecutor was because 'there’s a greater chance for justice.'

that is a pretty amazing summary.  However, it seems decidedly at odds with Ms Ortiz's record dealing with misdeeds by health care corporations, as discussed on Health Care Renewal.  Ms Ortiz, whose harsh views of Swartz appear above, has been quoted at least three times about three different cases on this blog.  In all instances, her quotes were in the context of legal settlements she made with large health care corporations.

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.

So in summary, in three major cases involving unethical practices by big health care corporations that could have put patients at risk, US Attorney Carmen Ortiz provided strong words, but did not apparently seek any punishment of any form of any of the corporate leaders who authorized or directed the bad, and potentially dangerous behavior.  Yet in the sorry case of Aaron Swartz, Ms Ortiz charged a gifted computer activist whose alleged crimes certainly did not put any individuals at risk of adverse medical effects or any bad physical outcomes with crimes that if proven would have lead to years in jail and millions in fines for him as an individual.

Equal Justice Under the Law?

So it seems ironic, or worse, that the main narrative of the Swartz case has become: well meaning but reckless hacker versus implacably tough law enforcer.  As noted above, Ms Ortiz's office appeared anything but tough when dealing with misdeeds by big pharmaceutical and device companies.  So the real question is why she went after Mr Swartz so relentlessly, when his alleged crime was non-violent and physically hurt nobody, when she failed to pursue corporate executives who enriched themselves while leading companies whose unethical practices likely harmed a lot of patients.

In that light, the dark imaginings of Matt Stoller do not seem so far-fetched.  On Naked Capitalism he wrote,

 As we think about what happened to Aaron, we need to recognize that it was not just prosecutorial overreach that killed him. That’s too easy, because that implies it’s one bad apple. We know that’s not true. What killed him was corruption. Corruption isn’t just people profiting from betraying the public interest. It’s also people being punished for upholding the public interest. In our institutions of power, when you do the right thing and challenge abusive power, you end up destroying a job prospect, an economic opportunity, a political or social connection, or an opportunity for media. Or if you are truly dangerous and brilliantly subversive, as Aaron was, you are bankrupted and destroyed.

I did not know Aaron Swartz, but am very sorry that we have lost someone so intelligent and imaginative.  I hope one question that his untimely death raises is what has become of the idea of equal justice under the law, and how its apparent demise has enabled the dysfunction of our health care system, and our whole society. 

New York Times: "In Second Look, Few Savings From Digital Health Records", and AMA Med News on EHR Harms

This post should perhaps be entitled "I told you so."

A letter I wrote in response to the Wall Street Journal's "A Health-Tech Monopoly", Feb. 11, 2009 was published Feb. 18, 2009 under the header Digitizing Medical Records May Help, but It's Complex.

I wrote:

Dear Wall Street Journal,

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.

The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.

Scot Silverstein, M.D.
Faculty, Biomedical Informatics
Drexel University Institute for Healthcare Informatics
Philadelphia

I also had penned essays on the need for a moratorium on HITECH (Nov. 2008, "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" and Jan. 2009, "I Ask Again: Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?").  My theme was that the issues with implementation of good health IT and elimination of bad health IT, and the issue of how to implement most efficiently, needed to be better understood before a national rollout.  Hold off multi-billion dollar national initiatives "until we know how to get HIT right", I wrote.

Now the New York Times has this, citing a new RAND paper:

In Second Look, Few Savings From Digital Health Records
By REED ABELSON and JULIE CRESWELL

January 10, 2013

The conversion to electronic health records has failed so far to produce the hoped-for savings in health care costs and has had mixed results, at best, in improving efficiency and patient care, according to a new analysis by the influential RAND Corporation.

Optimistic predictions by RAND in 2005 helped drive explosive growth in the electronic records industry and encouraged the federal government to give billions of dollars in financial incentives to hospitals and doctors that put the systems in place.

“We’ve not achieved the productivity and quality benefits that are unquestionably ["unquestionably?" why?- ed.]  there for the taking,” said Dr. Arthur L. Kellermann, one of the authors of a reassessment by RAND that was published in this month’s edition of Health Affairs, an academic journal.

Noted is the provenance of the 2005 report that created the windfall for the electronic records industry:

RAND’s 2005 report was paid for by a group of companies, including General Electric and Cerner Corporation, that have profited by developing and selling electronic records systems to hospitals and physician practices. Cerner’s revenue has nearly tripled since the report was released, to a projected $3 billion in 2013, from $1 billion in 2005.

A retraction:

The report predicted that widespread use of electronic records could save the United States health care system at least $81 billion a year, a figure RAND now says was overstated. The study was widely praised within the technology industry and helped persuade Congress and the Obama administration to authorize billions of dollars in federal stimulus money in 2009 to help hospitals and doctors pay for the installation of electronic records systems ... But evidence of significant savings is scant, and there is increasing concern that electronic records have actually added to costs by making it easier to bill more for some services.

In my Feb. 2009 WSJ letter, I'd written that "it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants."  It appears I was correct.

Officials at RAND said their new analysis did not try to put a dollar figure on how much electronic record-keeping had helped or hurt efforts to reduce costs. But the firm’s acknowledgment that its earlier analysis was overly optimistic adds to a chorus of concern about the cost of the new systems and the haste with which they have been adopted.

Not mentioned are harms that bad health IT is creating.

The recent analysis was sharply critical of the commercial systems now in place, many of which are hard to use and do not allow doctors and patients to share medical information across systems. “We could be getting much more if we could take the time to do a little more planning and to set more standards,” said Marc Probst, chief information officer for Intermountain Healthcare, a large health system in Salt Lake City that developed its own electronic records system

A "little more" planning?  How about several years' worth, to ensure the technologies are safe, effective and properly vetted, along with a system for post-market surveillance as exists in other healthcare sectors?

Technology “is only a tool,” said Dr. David Blumenthal, who helped oversee the federal push for the adoption of electronic records under President Obama and is now president of the Commonwealth Fund, a nonprofit health group. “Like any tool, it can be used well or poorly.” While there is strong evidence that electronic records can contribute to better care and more efficiency, Dr. Blumenthal said, the systems in place do not always work in ways that help achieve those benefits.

Dr. Blumenthal seems to be triangulating from his earlier 2010 NEJM statement that:

... The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

Meantime, in the real world signs of my expressed concerns about a quagmire are appearing:

... Late last year, a physician practice in Panama City, Fla., filed a lawsuit against the health care technology firm Allscripts after the company stopped supporting an electronic records system called MyWay that it had sold to 5,000 small-group physicians at a cost of $40,000 per physician. The lawsuit said that the system had problems and that the physician group was unable to meet the criteria for federal incentive money. A spokeswoman for Allscripts said it would defend itself vigorously.

A clue as to the candidness of the new report:

... The new analysis was not sponsored by any corporations, said Dr. Kellermann, who added that some members of RAND’s health advisory board wanted to revisit the earlier analysis.

Finally, this from the horse's mouth:

Dr. David J. Brailer, who was the nation’s first health information czar under President George W. Bush, said he still believed tens of billions of dollars could eventually be squeezed out of the health care system through the use of electronic records. In his view, the “colossal strategic error” that occurred was a result of the Obama administration’s incentive program.

I repeat my admonition from 2009 that I can only hope patients get something worthwhile for the $20 billion, which by now is probably many times that amount.

Finally, I note the American Medical News cites me in a Jan. 14, 2013 article as follows:

... Other experts on health IT said the Pennsylvania [PA Patient Safety Authority] study probably underestimates the extent of health IT safety problems. They say that is because the research is based on voluntary reports and that health professionals are unaware that a patient safety incident was caused by an EHR failure.

“These systems are incredibly complex,” said Scot M. Silverstein, MD, a consultant in medical informatics at Drexel University in Philadelphia. “They’re not just huge filing cabinets, they are enterprise resource management systems. There are many ways that things can go wrong that may not be seen as the computer having caused the mess-up in the first place.”

For example, he said, it would be difficult for a practicing physician to detect when data are missing from a record or that an alert failed to pop up.

Yet the title of the article is "EHR-related errors soar, but few harm patients" with a table at the bottom labeled "How rarely EHR problems harm patients." More evidence that EHRs always receive special accommodation. 

I was an invited reviewer of the PA Patient Safety Authority report, and wrote about the major deficiencies of its dataset at my posts Dec. 13, 2012 post "Pennsylvania Patient Safety Authority: The Role of the Electronic Health Record in Patient Safety Events" and a follow-up Dec. 19 post "A Significant Additional Observation on the PA Patient Safety Authority Report -- Risk."

My major point was that one simply cannot know what one cannot know, when using a very incomplete dataset gathered in a setting of systematic impediments to accuracy and completeness.  For instance, as I wrote in those earlier posts, through my work I personally know of cases of harms up to and including death that should have been in the PA database, but apparently are not - and I'm just one person.

We simply don't know in 2013 how many EHR errors harm patients, and the effects of increasing adoption by organizations and physicians less technology-able than current adopters.  I hope the magnitude of harms is truly small, but hope is not enough; this study and report was just a 'dipping of the toes into the water' towards understanding the realities.

Incidentally, we also don't know how severely the known toxic effects of bad health IT might affect care in times of duress, e.g., an epidemic.  However, I am certainly not sanguine about EHRs in their present state as robustly facilitating national emergency preparedness.

My dreaded prediction for the future?  A 2016 AMA News story entitled "Known EHR-related harms soar."

-- SS

Pfizer's Pfourteenth Settlement - a Small Reminder of Continuing Impunity

Well, that did not take long.  Less than a month after its last legal settlements were announced, Pfizer had to settle again.

The Details of the Settlement

This case, involving charges filed by the Texas Attorney General, was only reported locally, e.g., here in the Houston Business Journal:

The state of Texas will receive more than $36 million from two civil Medicaid fraud settlements with Pfizer Inc and Endo Pharmaceuticals,  Attorney General Greg Abbott said Friday.

Both companies will pay $18.17 million to the state, plus attorney fees and relator shares. The federal government is also entitled to a share of the total settlement, Abbott’s statement said.

As usual, the settlement was about deceptions:

 State and federal law requires drug companies disclose to the Medicaid program the prices they charge pharmacies, wholesalers and distributors for their products. Texas’ lawsuits claimed the companies misreported the price of various generic drugs and overcharged Medicaid for certain products.

As usual, Pfizer had excuses:
 

In the Pfizer settlement, the state’s investigation originally targeted entities that are now wholly owned subsidiaries of Pfizer.

In making the settlements, neither company is admitting to any wrongdoing.

New York-based Pfizer released a statement saying the safety of its subsidiaries’ products was not an issue of the investigation and Pfizer was not a target or subject of the case.

'Pfizer’s subsidiaries are resolving this investigation to avoid the further time and cost of litigation,' the company said in its statement. 'The majority of the Texas investigation focused on reporting that took place prior to the subsidiaries being acquired by Pfizer. The company remains committed to providing accurate pricing information to the Texas Medicaid program and providing quality pharmaceutical products to the citizens of Texas.'

 Of course, Pfizer acquired the companies (which were listed in the settlement document as ESI Lederle, Lederle Labs, and Pharmacia) in order to make money from them.  Furthermore, in acquiring the subsidiaries, Pfizer assumed responsibility for them and their actions.

As usual, there was no hint in the minimalist coverage of this settlement of any sort of negative consequences for anyone who authorized, directed, or implemented the relevant behavior, which did involve deception upon the government of Texas.

Nobody Held Responsible, Even After 14 Settlements

As is also usual, there was no mention in the media coverage, or the settlement document that Pfizer has made numerous other settlements in the recent past.   By my best count, the total was up to thirteen from the beginning of the 21st century to the present, as most recently tabulated here, and listed in the Appendix below.  (There may easily have been more that I missed.)

At the time of the twelfth and thirteenth settlements, we wondered whether the sheer volume of documentation of Pfizer's actions, and the sheer number of legal actions against it would finally lead to the end of the impunity of Pfizer's leaders.  After all, one would think that if the town drunk showed up in court for his fourteenth drunk driving charge, the book would be figuratively thrown at him.  Instead, at best, Pfizer had a wet noodle thrown at it.  The costs of this settlement, and even the cumulative costs of all the previous ones over time just added up to costs of doing business.  And these costs were not paid by the people who profited the most from the bad behavior, but were diffused among all stock-holders, employees, patients, and payers. 

Of course, leadership and governance of Pfizer is by some very fancy people indeed, and our society has not been good lately at holding such fancy people to any standards whatsoever.

 The sorts of practices discussed in Pfizer's multiple settlements have added to the revenue that have helped a lot of people live in the style to which they have become accustomed.  Pfizer has had some very, very well paid executives.  In 2011, according to the company's 2012 proxy statement, its CEO, Ian Read, got more than $25 million, that is to repeat more than twenty-five million dollars, count them, in total compensation.  All the rest of its named executive officers got more than $5 million in total compensation.  That 2012 report justified this other worldly munificence in part because

 We continued to improve our reputation in society through engagement with our customers, our shareholders, and the investor community.

Really, after now 14 settlements? 

The issue of the impunity of leaders of large organizations has finally made it to the big time.  For example, a New York Times editorial called the latest US government settlement with the large banks whose exploitative mortgage practices helped to usher in the global financial collapse or great recession "another slap on the wrist."  Writ large, continuing impunity is the sort of problem that indicates a degree of societal corruption that can destroy particular civilizations.

I am just a simple country doctor and can only do my small part to keep the barbarians outside the gate, but at least those who care about what has gone wrong with health care ought to be calling for vigorous, impartial law enforcement that holds leaders of health care organizations accountable for wrong-doing, and in general, changes that make leaders of health care organizations broadly accountable for their actions.

There are some luminaries from health care and academia on the current Pfizer board, like  Dennis A. Ausiello, M.D.,
Jackson Professor of Clinical Medicine at Harvard Medical School and Chief of Medicine at Massachusetts General Hospital;  Frances D. Fergusson, Ph.D., President Emeritus of Vassar College; Helen H. Hobbs, M.D., Investigator of the Howard Hughes Medical Institute since 2002, is a Professor of Internal Medicine and Molecular Genetics and Director of the McDermott Center for Human Growth and Development at the University of Texas (UT) Southwestern Medical Center; and Marc Tessier-Lavigne, Ph.D., President of The Rockefeller University since March 2011. Maybe some people at their base institutions ought to be asking them about Pfizer's multiple ethical lapses and what they are doing to make its leadership more accountable. 

APPENDIX - Pfizer's Settlements

In the beginning of the 21st century, according to the Philadelphia Inquirer, Pfizer made three major settlements,

October 2002: Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor.

May 2004: Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000.

April 2007: Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.

Thereafter, Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post here).  Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post here).  The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post here).  Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post here).   In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see this story in Bloomberg).  In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this post). Finally, in August, 2012, Pfizer settled allegations that its subsidiaries bribed foreign (that is, with respect to the US) government officials, including government-employed doctors (see this post).

In December, 2012, Pfizer settled federal charges that its Wyeth subsidiary deceptively marketed the proton pump inhibitor drug Protonix, using systematic efforts to deceive approved by top management, and settled charges by multiple states' Attorneys' General that it deceptively marketed Zyvox and Lyrica (see this post).  

At University of Miami, Faculty Without Confidence in their Hired Managers Afraid to Identify Themselves

The University of Miami has provided some vivid examples of the contrast between the power and privileges of the leaders of large health care organizations and the subservient role of faculty and staff. 

Background

Back in 2006, we noted that while the University of Miami was paying its janitorial support staff less than seven dollars an hour, and supplying them with no health insurance, its President, Donna Shalala, was living in a 9000 square foot official mansion, with staff hired to make her bed.  While Ms Shalala did not seem very perturbed about the living conditions of the lowliest University staffers, as a member of the board of directors of UnitedHealth, she approved the munificent compensation given to its then CEO, Dr William McGuire (look here), who was a billionaire until he was forced to give up  some of the backdated stock options she had approved (look here).  More recently, we discussed how Ms Shalala's "visionary" leadership included presiding over the hiring of Dr Charles Nemeroff, who had previously been forced to resign as chairman of psychiatry at Emory University for various unethical activities (look here).  Last year, while awaiting the construction of a new presidential mansion, Ms Shalala presided over layoffs of hundreds of faculty and staff, which may have been necessitated by bad spending decisions made by her or those who reported to her (look here). 

The Faculty Protest

All these shenanigans apparently finally succeeded in upsetting the faculty, as described in a new article in the Miami Herald.  The article's headline was about the resignation of the University of Miami Miller Medical School's second highest ranking executive in response to faculty anger:

Amid roiling faculty anger over drastic budget cuts, the University of Miami announced that the No. 2 executive at the Miller School of Medicine, Jack Lord, is 'stepping down.' 

Dr Lord was apparently taking the fall for the previous mass layoffs, some affecting faculty in 2012:

[Medical School Dean Pascal]  Goldschmidt defended his administration’s performance: 'Last year we had many challenging issues to fix, as do many medical schools in the U.S. Thanks to Jack Lord’s leadership and hard work by everyone at the Miller School, we have met those challenges and turned things around financially.'  The announcement comes after a tumultuous year in which the medical school suffered a severe financial crisis and its leaders responded with a major overhaul that included the layoffs last spring of over 900 full-time and part-time employees — moves that angered many professors.

In a letter to faculty sent on Wednesday, Goldschmidt insisted the problems have been fixed. Goldschmidt credited Lord for helping improve the medical school’s finances, which showed a surplus of about $9 million for the first six months of this fiscal year — compared to a $24 million loss for the first six months of the previous fiscal year.

Lord, a physician who had been an executive at Humana, became chief operating officer last March, as the restructuring plans started.

However, the faculty's anger was not just directed at Dr Lord, who as noted above seemed to have been hired to take responsibility for the layoffs:

The change, announced by Dean Pascal Goldschmidt, comes as a petition circulates among tenured medical school faculty expressing no confidence in both Goldschmidt and Lord.

In particular,

Meanwhile, several sources sent The Herald a copy of a petition being circulated among school faculty members who 'wish to express, in the strongest possible terms, the concern we feel for the future for our school of medicine.' The petition blamed 'the failed leadership of Pascal Goldschmidt and Jack Lord. ... We want to make clear that the faculty has lost confidence in the ability of these men to lead the school.'

Furthermore,

 Many faculty members, who had spent decades at the medical school without seeing mass layoffs, were angry that the cuts were made without consulting them. A report by a faculty senate committee said medical school professors described the layoffs as 'unprofessional,' 'graceless' and 'heartless.' 

Yet there is no hint that Dr Goldschmidt, or President Shalala to whom he reports are yet affected by this protest.  

Tenured Faculty Scared into Anonymity

In fact, while the faculty are upset, they are also afraid.

The report contended that the internal turmoil had prompted some faculty members to consider leaving and that 'fear is widespread.' It also cited instances of employees suffering retribution for criticizing the administration.

There is so much fear that the faculty constructed an elaborate mechanism to register protest while remaining individually anonymous.

A half-dozen people closely connected to the medical school who requested anonymity told The Herald that they’ve heard that between 400 and 600 of the school’s 1,200 faculty have added their names to individual copies of the petition.

The petitions are addressed to the chair of the faculty senate, Richard L. Williamson, a law professor. Williamson said last week he would not comment on how many had signed the petition because it was 'an internal matter' and may never become public. He said the number of those who know how many have signed is 'extremely small and none of them will talk.'

Three sources told the Herald that faculty are sending individually signed copies of the petition to the senate chair with the understanding that Williamson would not reveal their names to UM administrators. 

Summary

Read more here: http://www.miamiherald.com/2013/01/03/3166198_p2/um-medical-school-names-new-coo.html#storylink=cpy

Read more here: http://www.miamiherald.com/2013/01/03/3166198/um-medical-school-names-new-coo.html#storylink=cpy

Read more here: http://www.miamiherald.com/2013/01/03/3166198/um-medical-school-names-new-coo.html#storylink=cpy

Read more here: http://www.miamiherald.com/2013/01/03/3166198/um-medical-school-names-new-coo.html#storylink=cpy

 So, up to half of the University of Miami's medical faculty may be so upset with the current administration, apparently in part due to faculty and staff layoffs after questionable decisions by administrators some of whom may have lived large at university expense, that they essentially voted no confidence.  Yet the faculty are afraid to put their own names on their protest.

So this is not just a story about allegedly incompetent university executives, and about the contrast between the rewards such executives get and the results of their dubious management.  It is also a story about how the executives' power now threatens a bed-rock value of academia, the ability of faculty (and by extension, staff and students), to speak freely, even if that speech offends the university's management.  In this case, while apparently hundreds of faculty condemned the administration for autocratic, incompetent, self-serving actions, they all feared what that same administration could do to them if their identities were known.

In the last few years there has been a lot of prattle about the "flat organization," and there have probably been at least a few small high technology start ups that really were run on a collegial basis.  However, as we have shown again and again, throughout the corporate world, extending to health care corporations, and then to non-profit health care organizations, top management insiders have assumed more power and paid themselves better and better at the expense of all others (look here).  Even now in universities, which used to be examples of collegiality, and were run in somewhat democratically  by their faculties, faculty are obviously afraid to challenge the hired managers. 

Clearly, universities in which faculty cannot disagree with management are not going to be able to exercise the free enquiry that is core to their academic role.  In a health care context, why should anyone trust medical schools or academic medical centers run as tin-pot dictatorships by some hired executives?  Clearly, real health care reform would restore free speech and free enquiry to academic medicine.

Hat tip to Prof Margaret Soltan on University Diaries.

Read more here: http://www.miamiherald.com/2013/01/03/3166198/um-medical-school-names-new-coo.html#storylink=cpy

Read more here: http://www.miamiherald.com/2013/01/03/3166198/um-medical-school-names-new-coo.html#storylink=cpy