Congress anticipates physicians to implement EHR’s and review patient histories in detail, when they have the ability to’t even review their own bills before acting, and post a PDF on the internet?

This has to be the lamest, most inept, and/or most patronizing Congress in history:

Washington Examiner
Baucus claims it’s too difficult to put health care bill on the web
By: BARBARA HOLLINGSWORTH
09/24/09

A proposal by Sen. Jim Bunning, R-Ky., that would have required the Senate Finance Committee to post the final language of the $900 billion health care reform bill, as well as a Congressional Budget Office cost analysis, on the committee’s website for 72 hours prior to a vote was rejected 12-11.

… Chairman Max Baucus, D-Mont., himself admitted that “This probably sounds a little crazy to some people that we’re voting on something before we’ve seen legislative language.” Indeed.

Baucus’ excuse - that it would take his committee staff two weeks to post the bill on the internet – sounds a tiny crazy too.

This very same Congress is pushing physicians to implement EHR’s under penalty of Medicare payment reductions, while they claim an inability to post a PDF or Word document on the web. Implementing EHR’s is only several orders of magnitude more complex…

Or, perhaps the “inability” to post the text has to do with text that appears at pages 80-81 of the bill:

“Beginning in 2015, payment [under Medicare] would be reduced by five percent if an aggregation of the physician’s resource use is at or above the 90th percentile of national utilization.” Thus, in any year in which a particular physician’s average per-patient Medicare costs are in the top 10 percent in the nation, the feds will cut the doctor’s payments by 5 percent.”

As in the Washington Times:

This provision makes no account for the results of care, its quality or even its efficiency. It just states that if a physician authorizes costly care, no matter how successfully, the government will punish him by scrimping on what already is a low reimbursement rate for treating Medicare patients. The incentive, therefore, is for the doctor always to provide less care for his patients for fear of having his payments docked.

And because no physician will know who falls in the top 10 percent until year’s end, or what total average costs will break the 10 percent threshold, the pressure will be intense to withhold care, and withhold care again, and then withhold it some more. Or at least to prescribe cheaper care, no matter how much less effective, in order to avoid the penalties.

No metrics on quality of care, outcomes, patient satisfaction, or other aspects of the complex process of medical care are apparently involved. Just an “aggregation of the physician’s resource use.”

Now, we should ask:

• Is this what our government means by “data driven healthcare?”
• Do they realize the likely adverse consequences of such half-baked measures?
• Are those who would propose such a bill friends of patients, and friends of doctors?

Where have I seen this before? (How about: biomedical dilettantes helping impair R&D at a pharmaceutical company, now in sale mode due to a poor pipeline of new drugs, through cutting drug discovery resources on the simplistic metric of “cost per user per database?”)

Ultimately, this Medicare strategy is the end result of allowing medical dilettantes (no matter how well they’ve “self educated” themselves about medicine) to control the playing field. It is a poster example of a perverse incentive in direct conflict with the obligation of physicians to provide the ideal care.

In the end, patients and physicians get screwed.

– SS

[Source : Health Care Renewal]

The fall season is upon us and the markets are filled with advertising for Halloween, so our thoughts naturally turn to the current stories of ghostwriting in medical journals. Here’s a lighthearted take on that topic. This parody began on Margaret Soltan’s blog a few days ago, and it has just kept growing.

GHOSTING MATILDA

Once a jolly bagman signed on to some articles.
Corporate ghosts even promised him a fee.
And he sang as he watched and waited till they were in print,
These will be grand right up there on my CV.

Ghosting Matilda, ghosting Matilda,
Who’ll come a-ghosting Matilda with me?
And he sang as he watched and waited till they were in print,
These will be grand right up there on my CV.

This month it’s Janssen, next it’s Bristol-Myers Squibb.
Wyeth and Lilly soon might want to talk to me.
Novartis might sign me up, also AstraZeneca ?
Soon I’ll be famous like that guy at Emory.

Ghosting Matilda, ghosting Matilda,
Who’ll come a-ghosting Matilda with me?
Novartis might sign me up, also AstraZeneca ?
Soon I’ll be famous like that guy at Emory.

Up came an editor, looking for the telltale signs.
Ghost writing’s hard to cover up, you see.
And he found them in the documents: metadata do not lie ?
Bagman just sold his name and passed these off on me.

Ghosting Matilda, ghosting Matilda,
Who’ll come a-ghosting Matilda with me?
And he found them in the documents: metadata do not lie ?
Bagman just sold his name and passed these off on me.

Up jumped the bagman, pointing fingers right and left,
You’ll never prove that I lied, said he.
I will state that underlings failed to send disclosure forms;
Let them be blamed instead, while I get off scot-free.

Ghosting Matilda, ghosting Matilda,
Who’ll come a-ghosting Matilda with me?
I will state that underlings failed to send disclosure forms;
Let them be blamed instead, while I get off scot-free.

Out! said the editor, you’re now persona non grata.
So, too, the Dean and the Provost concurred.
Bagman’s ghost may be heard now, sighing in the library ?
Could have been grand right up there on my CV.

Ghosting Matilda, ghosting Matilda,
Who’ll come a-ghosting Matilda with me?
Bagman’s ghost might be heard now, sighing in the library ?
Could have been grand right up there on my CV.

[Source : Health Care Renewal]

About a year after we started Health Care Renewal, in late 2005, we wrote multiple posts about the complex and unfortunate case of Dr Aubrey Blumsohn’s attempts to keep a research project honest. The early posts were here, here, here, and here. In this post, we summarized the case thus:

• Dr Aubrey Blumsohn, a senior lecturer at Sheffield University, and Professor Richard Eastell performed a research project on the effects of the drug risedronate (Actonel, made by Procter & Gamble Pharmaceuticals [P&G]) under a contract between P&G and the University.
• Even though the research contract designated Blumsohn and Eastell as “Investigators” under whose direction the project would be carried out, Blumsohn wasn’t given access to the original data collected by the project.
• Despite numerous requests, (like this one), P&G refused access to this data repeatedly.
  Blumsohn was concerned that he and Eastell could be accused of scientific fraud if they continued to make presentations and write articles and abstracts without access to the data which they were supposedly writing about.
• Blumsohn became suspicious that some of the analyses done by P&G could be misleading, especially related to a graph shown to him that omitted 40% of patient data.
• Blumsohn objected to P&G arranging for papers and abstracts to be written by a professional writer, but with Blumsohn listed as first author. Blumsohn was concerned that such ghost-written documents were mainly meant to convey “key messages” in support of P&G’s commercial interests.
• Eastell warned Blumsohn not to aggravate P&G, because the company was providing a allow to the University which “is a good source of income.”
• After repeated failed attempt to get the data, Blumsohn complained to numerous officials at Sheffield University, including Eastell, medical school Dean Tony Weetman, University Vice-Chancellor Robert Boucher, and the Head of the University’s Department of Human Resources, Ms R Valerio.
• Still unable to get the data, he spoke with news reporters about his case. At this point, Sheffield suspended him, but then offered him a severance agreement if he signed a contract binding him not to make any detrimental or derogatory statements about the University and its leaders.

So the case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research. Although Health Care Renewal, being US based, most often writes about such issues in the US, this case is a reminder that they are global. (Note that we posted more about this case in 2006, here, here and here, but since then it has not gotten much public attention.)

Last weekend the (UK) Guardian returned to it:

The Guardian has learned that one of Britain’s leading bone specialists is facing disciplinary action over accusations that he was involved in ‘ghost writing’.

The General Medical Council will call Professor Richard Eastell in front of a fitness to practice committee. Eastell, a bone expert at Sheffield University, has admitted he granted his name to go forward as first author of a study on an osteoporosis drug even though he did not have access to all the data on which the study’s conclusions were based. An employee of Proctor and Gamble, the US company making Actonel, was the only author who had all the figures.

Experts believe the practice is widespread in Britain.

In a letter published in the Journal of Bone and Mineral Research, which carried the original study, he said: ‘In the original paper one of the authors, a statistician working for P&G, Ian Barton, had full access to all the data.’ The authors had full access to all the analyses of the data that they requested, he stated – but those analyses were carried out by the company.

The letter, published in 2007, also acknowledged flaws in the study. A later independent analysis of the data ‘identified some errors and poor practice’, he wrote. The study was designed to show the strengths of Actonel which was in fierce competition with a rival bone-strengthening drug called Fosamax, made by Merck.

Eastell’s paper concerned a study carried out on behalf of Proctor and Gamble, comparing the bone density of women prescribed Actonel with others who were not. Only the company knew which women were on the drug and which were taking something else.

Eastell’s colleague, Dr Aubrey Blumsohn, wanted the codes which would state which of the patients who suffered fractures had been on the drug. The company refused. Blumsohn took his concerns to Eastell, but in a conversation which Blumsohn says he taped , Eastell stated he was concerned that persistent requests might damage the relationship they had with the company. Eastell is said to have told him: ‘The only thing that we have to watch all the time is our relationship with P&G. Because … we’ve the huge Sheffield Centre Allow [from P&G] which is a good source of income, we’ve got to really watch it.’ .

So, after four years, this case has generated an official hearing of sorts. The hearing is obviously late, and seemingly will only be devoted to only one aspect of this case (ghost writing). However, at least our friends in the UK are doing something. I can’t recall a single case that resulted in any serious consideration of imposing negative consequences on anyone who was accused of suppressing research, manipulating research, endorsing ghost-writing, or intimidating a whistle-blower. In fact, many of the more troubling cases have never resulted in any sort of public discussion either at the institutions at which they occurred, or at any organization with relevant regulatory, or even just moral authority. So the GMC hearing is at least a step forward. Two cheers for the British GMC, and none for US universities, academic medical centers, professional societies, and government regulators.

(If anyone can remind me of a case in which there was a public discussion at the relevant institution, or some public consideration of the case by a regulatory agency, professional society, or some group with moral authority, please remind me of it, and I would be happy to post about it.)

[Source : Health Care Renewal]

We have posted frequently about the governance and leadership of academic medical organizations. While one would think that health care organizations, and especially academic health care organizations ought to be held to a particularly high standard of governance, we’ve noted how their governance is often unrepresentative of key constituencies, opaque, unaccountable, unsupportive of the academic and health care mission, and not subject to codes of ethics. How the governance of organizations with such exemplary missions and sterling reputations got this way has been unclear.

Now there are new insights from the ongoing discussion of one of the most interesting and controversial cases of disputed organizational governance. We have often come back to the example of Dartmouth College, of which Dartmouth Medical School is a significant component. We most recently discussed here an ongoing dispute about the extent that the institution’s board of trustees ought to represent the alumni at huge, or instead, ought to be a self-elected body not clearly accountable to anyone else. (For our take on this complex case, begin here and follow the links backward.) The latest development in the case is a lawsuit filed by Dartmouth alumni challenging an increase in the number of self-elected, or “charter” trustees, which they charged broke an 1891 agreement that established numerical parity between alumni-elected and charter trustees.

Soon after this lawsuit was filed, an important article by Harvey Silverglate (one of the founders of FIRE, the Foundation for Individual Rights in Education) and Joseph Malchow appeared. For those interested in the case, the article includes extensive detail, with multiple citations, on all the twists and turns of the case, and is very much worth reading. (See this post on FIRE’s Torch blog for more background and discussion.)

However, the article also features extensive scholarship on governance of US not-for-profit institutions, focused on academic institutions (including medical academia), and with relevance to other not-for-profit or non-governmental health care organizations. In particular, the article sheds light on how the governance of such organizations has become so degraded.

First, Silverglate and Malchow summarized the duties of governing boards:

Traditionally, fiduciary duty [of the board of trustees] has been understood as having two components: the duty of loyalty and the duty of care. The duty of loyalty requires a fiduciary to act in a manner he or she reasonably believes to be in the ideal interests of the organization. The duty of care obliges directors to inform themselves of reasonably available information prior to making a business decision. More recently, courts have considered the duty to act in good faith [the duty of obedience] as a fiduciary requirement. This component, similar to the duty of care, is satisfied when a director makes informed decisions without conflicts of interest.

The question central to the dispute regarding Dartmouth governance is to what or to whom do fiduciaries owe their duty. Corporate directors have a relatively straightforward task of serving the corporation and its shareholders. In the case of a charitable trust, however, which generally does not have ‘ascertainable beneficiaries who can enforce their rights,’ the duty of fiduciaries is instead directed toward fulfilling or furthering the organization’s mission

So just to summarize, considerable discussion, scholarship, and I believe some some laws support the notion that the board of a not-for-profit organization is obliged to take reasonable care to make informed decisions free of conflicts of interest to uphold the organization’s mission.

However, currently, many boards value deference to the organization’s (usually hired) top managers and avoidance of internal conflict within the board more highly than these obligations:

Dartmouth, to be sure, is far from the only place where fealty to organizational leaders—and the notion of ‘going along in order to get along’ —has been placed before true fiduciary duty.

Silverglate and Malchow have some important ideas about how we came to this.

Not-for-profits became more like for-profit corporations:

During the 1980s, traditional nonprofit organizations supported by donations and governed by donors and volunteers became increasingly displaced by professionally staffed commercial nonprofits, supported by allows, contracts, and earned income, and governed by insider boards. The shift in governance was armored by progressively professionalized and entrepreneurial management, which was perceived to be more adept at control of the ebb and flow of funds in the American market.

Top hired not-for-profit executives assumed more power at the expense of other constituencies, including the professionals who did the work:

By the 1990s, with faculty power firmly institutionalized at colleges and universities, a notion that university presidents were bereft of power took hold. The AGB [Association of Governing Boards], in 1996, argued that university presidents needed to regain power with a pivotal document of its own: Renewing the Academic Presidency: Stronger Leadership for Tougher Times. Though this outlook was applied to varying degrees at colleges and universities, an imperative toward greater executive power in universities was thus established.

Presidential and professorial decision-making power, combined with the rise of the administrative bureaucracy in academia, have generally relegated trustees to a secondary role in campus affairs.

Attempts at reforming governance were inappropriately based on a for-profit corporate model, and particularly the need to project unity and avoid confrontation among the leadership trumped transparency:

Aligning academic boards with the cultural trends of increased critical oversight has obvious benefits, but some boards have moved to adopt the norms of for-profit corporate governance that are simply not applicable to the university context. Admittedly, this is a thin distinction when considered on a theoretical level. But in practical terms, misguided nonprofit reforms—some of which, upon close examination, actually violate an institution’s mission—are readily evident.

For example, some nonprofit boards have emphasized the adoption of formal nondisclosure pledges or confidentiality agreements that step well beyond nondisclosure of proprietary information. This is hardly unusual in the business sector, where bottom-line strictures demand a certain degree of internal accord and non-transparency. And though there is evidence that nonprofit board directors have, from time to time, attempted to hush public dissent, only recently have dominant majorities of some nonprofit boards proposed and ratified binding pledges not to publicly air differences. According to a 2006 BoardSource publication, ‘If a board member does not support a decision for whatever reason, [he or] she has a responsibility to remain silent or step down from the board.’ (Recall the resignation offer made to Zywicki before his second term was denied.)

These directives, written in highly influential publications in the realm of university governance, disregard the important role that public discussion has on decision-making at universities and nonprofits in general. ‘In the nonprofit context, nondisclosure agreements or the use of ‘executive session’ rules to curtail debates about policy and procedure depart from established norms. They shut down opportunities for public dialogue and for communication with other concerned and influential parties, including reporters,’ nonprofit specialist Norman I. Silber wrote in the Oregon Law Review.

Emphasis on raising money rather than upholding the mission has lead to board deference to hired executives.

Fidelity to institutional leaders, rather than institutional mission, is now paramount in higher education, as deviation from accepted decisions is perceived as potentially shrinking the donor base. Administrators cringe at public disagreement; rather than focusing on the long-term likelihood that competing ideas will result in implementation of the fittest, they tend to focus on the short-term possibility that a particular alumni subset may be offended. This shortsighted outlook isn’t only an insult to the intelligence of alumni and other constituencies, but it is ultimately detrimental to the institution, as established ideas are enthroned and unchallenged. It is also based on false premises: as in the case of Dartmouth, there’s no established correlation between public criticism and donor decline.

Boards are increasingly composed of executives of for-profit corporations, particularly in the finance field, who might grant the same deference to the organizations’ leaders that they would like from their own board. That’s, hired executives identify more with other executives than with the organizations they’re supposed to be leading:

Judge Cabranes noted that trustees, especially business executives, tend to act toward university presidents as they wish their boards would act toward them—deferentially. And the phenomenon of board members believing they serve at the pleasure of the executive is what one nonprofit attorney and blogger, has termed ‘upside down board.’ The ascendance of the hedge-fund community, a peculiar province of graduates of elite institutions, has contributed to the prevalence of the upside down board….

The article suggests some issues that need to be addressed to make governance more accountable, transparent, ethical and honest. Boards need to be reminded of their duties, and that their loyalty should be to the mission, not the organization’s executives, or the views of the board’s majority. Transparency and open discussion are more important than projecting the (sometimes false) impression of unity. New board members should be chosen for their loyalty to the mission rather than their similarity to and congeniality with current board members.

I strongly recommend that anyone who adores how health care organizations are run ought to read Silverglate and Malchow’s full article. It should be required reading for current and would-be board members of academic and health care not-for-profit organizations (but I will not hold my breath waiting for them to read it.)

[Source : Health Care Renewal]

From theBostonChannel.com comes this story on executive compensation in a not-for-profit health care organization,

Boston Medical Center – a financially troubled hospital – gave its outgoing CEO a one-time, almost $3.5 million payment, in addition to her $1.3 million annual salary, Team 5 Investigates reported Friday.

Elaine Ullian, 61, has led the city’s major ’safety net’ hospital for the last 15 years. She recently announced she will retire when her contract expires in January.

The hospital’s financial situation is such that hospital leaders say it could face closure in the years ahead. It is currently suing the Executive Office of Health and Human Services over how it gets paid for treating poor and uninsured patients.

Team 5 Investigates discovered, in a review of the hospital’s financial filings with the say, that Ullian was paid $3,466,458 ‘in recognition of exceptional performance over a period of 15 years.’

The almost $3.5 million bonus was on top of Ullian’s 2008 compensation of $1,348,504 including salary and benefits.

In a written statement to Team 5 Investigates, Ted English, the chairman of BMC’s board stated that Ullian’s ‘compensation is set by a committee of the Boston Medical Center Board of Trustees who consult with independent compensation advisors. It is based on her performance evaluation and measurable goals that are reviewed annually.’

‘The Board thinks about Elaine Ullian to be one of the most competent and successful hospital CEOs in the country and believes she’s primarily responsible for the success of Boston Medical Center over the past 15 years,’ English’s statement said.

Boston Medical Center was formed by the merger of University Hospital (the Boston University teaching hospital), and Boston City Hospital, the legendary municipal hospital. (Note: I served as an internal medicine intern and resident in the University Hospital program, and rotated through Boston City frequently.) Thus, as noted above, BMC is the city’s primary “safety net” hospital for the care of the poor. BMC has for its mission:

We will provide consistently excellent and accessible health services to all in need of care regardless of status or capability to pay – exceptional care, without exception.

Such generous pay seems inconsistent with this mission and the organization’s not-for-profit status. Such a golden parachute seems inconsistent with the current threats to its finances.

Any worry about the CEO’s retirement finances should further be reduced by her ongoing part-time work on the boards of directors of three public for-profit health care corporations, Hologic, a medical device company specializing in “womens’ health,” ThermoFisher Scientific, a manufacturer of laboratory equipment and supplies for health care and research, and Vertex Pharmaceuticals, a biotechnology company focusing on small-molecule drugs. For her work as a director of Hologic, she received $304,698 in total compensation in 2008, and owned 40,000 shares or equivalent of common stock (per the company’s 2009 proxy statement). For her work for ThermoFisher Scientific, she received $275,319 total compensation, and owned 61,068 shares or equivalent (per the 2009 proxy statement). For her work for Vertex Pharmaceuticals, she received $337,480 total compensation, and owned 79,500 shares or equivalent (per the 2009 proxy statement). As Robert AG Monks put it, corporate directors are supposed to “demonstrate unyielding loyalty to the company’s shareholders” [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.] Therefore, Ms Ullian’s directorships seem to pose conflicts with her primary employment as CEO of an academic medical center which must buy products used in womens’ health, buy laboratory supplies, and implement basic and clinical research.

The BMC board chair’s assertion that the CEO is “primarily responsible for the success” of the institution merits special comment. It seems obvious that the main determinant of the success of a medical center is the work done by its health care professionals and support personnel. A medical center cannot provide care, much less good care, without doctors, nurses, therapists and technicians, supported by supply, logistics, cleaning, maintenance, dietary, clerical, medical record, financial and yes, even health care information technology workers and systems (and if I left out an important group of support personnel, I apologize now.) The chair’s assertion advocates the hubris central to the ethos of contemporary business managers, but is at odds with the clinical context. (Of course, if the CEO was primarily responsible for the organization’s success, she should now shoulder primary blame for its current awkward financial situation, but such consistency might be the hobgoblin of minds too tiny to comprehend the gravitas of the C-level manager.)

A long time ago, in a galaxy far, far away, health care was a calling. Doctors once pledged to avoid all commercialization (see post here), and hospital directors or superintendents (not CEOs) did not earn riches, much less become “imperial.” (See Ludmerer’s Time to Heal.) But in the culture of wretched excess that spread from the financial world, hospital CEOs now seem to feel entitled to become wealthy, as they claim responsibility for all successes, while all failures are blamed on someone else. The current system has made hired managers into an ersatz aristocracy, entitled to fill their pockets while denying any responsibility for ever rising costs, declining access, poor quality and demoralized professionals. In my humble thought, to accomplish true health care reform, health care again must become a calling, lead by people who will put the mission ahead of the accumulation of wealth and power.

[Source : Health Care Renewal]