Saturday, February 7, 2009

Healthcare IT Backwater: The $20 Billion Abyss? Case Two

(Note: case one of this series is here, case three is here.)

In my post "Will the U.S. spend the Economic Recovery Act's $20 billion for Healthcare IT more wisely than the UK?", I expressed concern that the answer to the titular question might in fact be "no."

In this second post of a series I present more cases that stand as exhibits to my thesis above, the first case of the series at this link being mine personally, the others being that of other individuals who shall remain nameless.

The overarching theme is that hospitals and healthcare remain an IT backwater that will likely phagocytize quite a bit of money with little to show in return. This is largely due to starry and/or dollar$ign-eyed HIT utopians and opportunists who do not understand the field's dependencies, complexities and politics - or do not care about them because it's bad for business.

Congress, are you listening?

Case Two:

This case was communicated to me by a former student of mine in healthcare informatics after an exhange where I wrote in my inimitable style:


I hate to point this out (and let the Joint Commission Sentinel Event Alert and the National Research Council reports on HIT be my witness), but ... $20 billion has just been queued up to be handed out to some good people, but also a lot of electronic snake oil salespeople. I'm almost certain I won't see any of it, because I actually know what I'm doing and don't tolerate fraud and incompetence in health IT.

The student, now a very talented applied consultant, wrote me as follows (names of people and companies redacted):


From the perspective of someone that sits on the funnel of information between HIT vendors, practices and hospitals, I can almost guarantee that ALL HIT vendors are snake oil salespeople.

For example, we’ve discovered a major performance issue with [our commercial EHR] which causes Microsoft SQL errors. Our clients called [EHR vendor], [EHR vendor] says that they don’t support Microsoft SQL. Can you say WTF?

The clients have NO support contracts with Microsoft so it is more than likely a $150/hr bill on top of already existing [EHR vendor] agreements.

The formula is fairly simple and very Business 101: Your best employee is your customer. Our research has shown the only way to make it fair for everyone, lower EMR costs, and to get our most bang for our buck is to make the patient manage their own records like the way we manage our bank accounts and credit cards. Once we get the patients to contribute effort, it will lower costs for the providers to be able to purchase the software.

I’m super surprised that the banking industry has not jumped on the bang wagon to develop a personal health record. If you think about it, the financial industry has already done the leg work on security, access and data warehousing. Hell, those smart chips in credit cards these days can be used as a key to access a patient’s record that’s sitting in a secure data center somewhere.

To which I replied:


Is this SQL issue publicly known? Also, Is MS-SQL the only SQL server that can be used, i.e., is [vendor EHR] dependent upon it and written to use it as its db engine? Does [EHR vendor] market MS SQL for use with [EHR] or say it can be used? Seems grounds for legal action if the above apply.

To which the former student replied:


I just got done speaking to [executive] who is the president of [EHR vendor]. He said he was going to pay the clients for any Microsoft bills. But my problem is, it took me to make them realize how wrong they were. Unbelievable.

Anyway, today I am in [another city] at a multi-specialty practice where I am performing an EMR readiness assessment. They are currently on [vendor Practice Management system] but do not have EMR.

They installed the Practice Management product a few years ago but unfortunately could not get enough consensus on how they want to use EMR so the EMR project was scrapped. Now just a few years later everyone wants the medicare incentives for ePrescribe.

Unfortunately for this group they have three major problems:

1) they do not have centralized billing which is causing some AR (Accounts Receivable) issues. So for example, John Doe the patient uses Ortho and cardio. If John Doe has a balance at ortho, cardio doesn’t even know about it and continues to see John Doe.

Also because they do not have centralized billing, there is an overabundance of billers at each speciality with an almost 1 to 1 ratio of providers to billers. Uh...someone doesn’t understand MGMA standards.

2) no centralized purchasing which causes them not to leverage group purchasing and “oh btw” has also afforded them to violate major Microsoft licensing laws.

3) all their providers, even those in the same practice, want their own custom templates. This actually cracks me up since they all use the same template when they are dictating which “oh btw” is sent via a gmail account and zero encryption to the transcribing company. Boy, are they going to be surprised when my buddy from OCR gives them a call tomorrow.

With everything stacked against them, I will more than likely tell them they are not ready. With their lack of standardization, it would be a complete waste of everyone’s time and money to even attempt this EHR.

This practice just absolutely thinks IT is a nuisance and treats it like an abused dog. Just to give you an idea, their IT director makes under $60K/yr and can barely tell me the difference between a serial port vs. cereal port.

Keep in mind, they expect this guy to be their infrastructure manager, [PM and EHR] administrator, project manager and HIPAA security/Compliance officer. On the whiteboard today he spelled HIPAA: HIPPA. I kinda feel bad for him because someone set him up to fail.

I will more than likely take over this IT department. Their proctologist is hilarious though. His boat has a domain-appropriate name, and because of his office location in he shows all of his patients his boat from the exam room window. You can just see his paternal pride.


And then this:


I'm getting to the point where I'm starting to become the Michael Clayton of HIT. The good guys and the bad guys all look to me for answers.

You will roll your eyes at this one: I found today where one of the billing companies where my team is managing their IT has lost $550K in claims and billable productivity because some providers use EMR, some don't and some are half in half out. There is not only the paper chase for the billing staff but it is also the electronic paper chase. And the reason we discovered this was because I saw the liability with these multiple silos of information so we created a pseudo-malpractice lawsuit and used the clinical system as the majority of the data store.



The sociotechnical issues in these case accounts are almost too numerous to lay out in a blog post. A full academic paper would probably be needed to do it justice. A skilled medical informaticist at the outset, however, might have prevented these problems.


It should be understood I am not "against" health IT nor a luddite. I completed a postdoctoral fellowship in Biomedical Informatics in 1994 out of love for the idea of improving healthcare through IT. It is clear, however, as these examples and others at my academic website "Common Examples of Healthcare IT Difficulty" illustrate, that significant further research is needed in order to determine how to best make this technology meet the needs of real world clinicians, and how to best implement it under real world conditions.

I do not advocate abandonment of health IT, only a return to the understanding that this technology remains largely experimental. This understanding was usurped in the past decade by an overaggressive and indeed opportunistic HIT industry, enamored of profit potential, and the irrational exuberance has now spread in a manner reminiscent of other speculative bubbles of late.

HIT should be treated as experimental, not as a drop-in panacea for healthcare's ills. In its present state is is perhaps as likely to exacerbate those ills. This is probably not technology that should be deployed en masse at present. We cannot afford as a society to learn how to do this by trial and error.

EHR today as a plug-and-play panacea that will save $80 billion per year? Or, $20 billion abyss?

I report, you decide.

Case three is here. Case one of this series is here.

-- SS

Healthcare IT Backwater: The $20 Billion Abyss? Case One

(Note: case two of this series is here, case three is here.)

In my post "Will the U.S. spend the Economic Recovery Act's $20 billion for Healthcare IT more wisely than the UK?", I expressed concern that the answer to the titular question might in fact be "no."

In the next few posts I present a few recent cases that stand as exhibits to my thesis above, the first being mine personally, the others being that of other individuals who shall remain nameless.The overarching theme is that hospitals are significantly behind other industries in IT strategy and leadership, an "IT backwater" if you will.

Congress, are you listening?

Case One:

Several months ago (just before the appearance of the Joint Commission Sentintal Event Alert on HIT and the National Research Council report on HIT that stated approaches to HIT are "inadequate"), I received an inquiry from an executive recruiter.

The recruiter had been retained by a large East Coast hospital system to hire a Director of Informatics.

The recruiter told me three things: first, that I was the first candidate he was speaking with. Second, that he knew little of Biomedical Informatics, and could I please inform him about the field. Third, that the hospital had already selected an EHR vendor and was now looking for an expert to make it all work.

I refrained from asking the questions I ask here:

  • Why does a hospital system retain a recruiter for a highly specialized executive position who knows nothing about the nature of the field?
  • Why doesn't the NFL retain me, a physician informaticist, as a talent scout for football champions? ( the second question is sarcastic with reference to the first, of course.)

I did spend some time explaining to the recruiter than under the right circumstances and with the appropriate hospital leadership, I might be interested in the position, although the "system selection first, expert selection second" was a fundamental strategic error.

I then explained the challenges and issues in the field that led many hospitals astray and resulted in project difficulties and failures. Being new to the field, I'm not sure the recruiter believed me. In my own due diligence, I noted the CIO of the organization was a typical hospital MIS professional and had no biomedical or biomedical informatics experience.

At the conclusion of our conversation, the recruiter said that there were many more candidates he would talk to and after that, if the organization expressed interest in me, he would contact me again. I did not expect to hear from him again as I had deviated from the traditional "health-IT-it-must-be-good" religion.

Lo and behold, just a few days ago I got a call from the recruiter asking if I was still interested in the role. I asked for specifics on reporting and on resources the position would control.

The answer: The position reports to the CIO (a non medical professional). To the position reports 1.5 FTE's. That's one-and-a-half FTE's.

I responded to the recruiter along these lines (see my ten year old essay "Ten critical rules for applied informatics positions: What every Chief Medical Informatics Officer should know" for more on these issues):

  • I ran a biomedical research library in pharma for drug discovery and had more than 50 staff reporting to me. How could I run an entire HIT implementation for a multi hospital system - with patient lives at stake - with 1.5 FTE at my disposal?
  • How would going from 50 FTE to 1.5 FTE help my career?
  • Why would the CIO and hospital believe an informatics domain expert who'd once been a CMIO at a large hospital should only have 1.5 FTE reporting to him/her?

I didn't ask these, but perhaps should have:

  • What reasonable rationale does a non medical CIO have in requiring that a physician informaticist building clinical tools that happen to involve computers report to them, rather than to medical leadership?
  • What kind of weak medical leadership would allow such a reporting relationship?

Indeed, such an organizational structure was a strategic error, out of the same playbook as the "select vendor then select expert" strategy as above. The position is actually a non-management non-executive "Director of Nothing" role, engineered for frustration and failure.

(Some would argue that dotted-line relationships are sufficient for such a Director of Informatics role, which in reality creates an "internal consultant" role at best. I would argue, then, that all formal hierarchical relationships in hospital MIS departments should be ended and replaced with dotted lines. I don't think that would sell well to a CIO.)

I can also make a few additional points to those who might opine that "doctors can't manage people":

  • Medical residents have more direct reports, in far more complex and mission critical settings, than one and a half. I had ten or more med students, interns, jr. residents, pharmacy trainees, etc. during my own medical residency, in diverse settings including ICU's, intermediate units, and regular hospital floors.
  • Private physicians have been managing staff since modern medicine began (and probably long before as well!)
  • An enterprise clinical IT project is at least as complex an endeavor as, say, a clinical trials information system in pharma. You can be sure pharma does not put generalist MIS personnel in charge of clinical trials information systems and then appoint a single domain expert with only 1.5 FTE at his or her disposal.

The above points would be completely lost on most hospital IT backwater CIO's, who even if they did understand would probably be loathe to give up the territory to a "non IT professional" such as an informatics trained physician, anyway.

Rare as hen's teeth in hospitals is the appropriate position, i.e., true VP of Medical Informatics. In effect, hospitals put at risk millions of dollars of IT investment and patient well being due to the backwardness, reactionary bias and ego issues of their CIO's and other executives who believe that an empowered physician informaticist, even when available, "is not a sine qua non of health IT projects."

I told the recruiter I was not interested in this role as it was ill conceived.

In a stunning example of "Physicians' Expected Helplessness", though, the recruiter tried not once, but twice, to pick my brains on how he might advise his client hospital to structure the Director of Informatics role. I declined to provide free information, but did offer my services as a consultant on position structure to the hospital. The recruiter made as a condition to presenting me to the hospital as a possible consultant that I tell him some of my specific ideas. I declined.

Such scenarios are not uncommon. I know several physician informaticists holding such roles currently. Most are quite unhappy due to the imbalance between responsibility and authority in a most political type of job; those that claim not to be are either in denial or do not desire true leadership roles.

In summary, $20 billion is about to be given by the Federal Government to healthcare organizations who make major strategic blunders on HIT (and with their own precious capital, let alone government handouts!), hire retained recruiters who need education on HIT issues and biomedical informatics, and then compound their errors by structuring critical roles in a manner guaranteed to make maximal contributions from the experts either unpleasant or impossible.

It should be understood I am not "against" health IT nor a luddite. I completed a postdoctoral fellowship in Biomedical Informatics in 1994 out of love for the idea of improving healthcare through IT. It is clear, however, as these examples and others at my academic website "Common Examples of Healthcare IT Difficulty" illustrate, that significant further research is needed in order to determine how to best make this technology meet the needs of real world clinicians, and how to best implement it under real world conditions.

I do not advocate abandonment of health IT, only a return to the understanding that this technology remains largely experimental. This understanding was usurped in the past decade by an overaggressive and indeed opportunistic HIT industry, enamored of profit potential, and the irrational exuberance has now spread in a manner reminiscent of other speculative bubbles of late.

HIT should be treated as experimental, not as a drop-in panacea for healthcare's ills. In its present state is is perhaps as likely to exacerbate those ills. This is probably not technology that should be deployed en masse at present. We cannot afford as a society to learn how to do this by trial and error.

Do we today have a hospital IT backwater $20 billion abyss? I report, you decide.

Case two of this series is here, case three is here.

-- SS

"Physicians' Expected Helplessness"

At "Physicians' Learned Helplessness", HC Renewal Blog described a term coined by a lawyer and presented in an article in Medscape General Medicine.

The lawyer suggested that physicians have developed a "learned helplessness" [Bond C. The training of the "helpless" physician. Medscape General Medicine 2007; 9(3):47].

This learned helplessness obstructs physicians from standing up for their profession, its faithful execution (faithful to science and to the Hippocratic oath, the ability to be faithful being interfered with by an increasing number of opportunistic non medical interlopers), and to their own livelihoods.

Two major points the lawyer described accounting for physicians' learned helplessness are:
Beyond the basics of medical economics, young physicians are generally not introduced to the regulatory and political environment in which they will have to practice.
and
Young physicians become so well trained in deferring gratification that many give up on ever getting any meaningful rewards for their sacrifices. With their resilience worn away, many just give up the fight.

These are keen observations by a lawyer. I am going to coin a new term to describe what I have observed as a corollary to physicians' learned helplessness:

"Physicians' expected helplessness"

In a comment to my post "Will the U.S. spend the Economic Recovery Act's $20 billion for Healthcare IT more wisely than the UK?", where I presented a government report on a true quagmire, the UK's national program for health IT, I received a comment that:

"... I believe that you have been a little too divisive in setting the business IT crowd up as an antagonist ... the rhetoric that you use has been at times abrasive and exclusionary... implying, whatever your intention, that there shouldn't be any role in health care implementations whatsoever for IT generalists."

Ignoring the hysterical conclusion that my "intention is that there should be no role whatsoever in HIT for IT generalists" [** see note below], this comment was not at all unique.

The comment reminded me of many other comments and pieces of feedback that I and like minded medical colleagues describing healthcare and health IT incompetence and malfeasance have received over the years: "be nice."

Here's the problem.

Why do people expect outspoken physicians and other clinicians to defend their professions and ultimately the patients to whom they are responsible in an "inclusionary" and genteel manner?

People want doctors to be their staunch defenders when they are sick. They want doctors to spare no language, make no compromise in getting them the very best treatment. They don't advice doctors to be "genteel" when helping them with an overbearing and unfair denial of life saving treatment by an insurer, for example - unless the patient is Darwinian extinction-level daft, that is.

But in defending their own occupation from invasion, for example by non medical IT leaders who believe their wisdom supercedes that of clinicians in development and deployment of medical tools (electronic health records, CPOE, decision support etc.) that happen to involve computers, people expect physicians to be - passive and polite?

The union leaders defending bus drivers I observed in my time as Medical Programs Manager in the Philadelphia regional transit authority would have laughed a person issuing such a comment right out of the room. In fact, I dare say nobody would be so bold as to even issue such a weak-kneed, emasculate comment in the presence of such personnel.

Why, then, to physicians?

Due to an expectation of physician helplessness, that is, "physicians' expected helplessness."

I call on my clinical colleagues to fight both physician's learned helplessness, and end others' expectations of physicians' helplessness, especially by those who count on it towards their own ends.

As one Transport Worker's Union leader said in discussing medical issues about busdrivers and other line personnel, while banging his fist on the table, "What the f*** are you idiots doing to my membership?" (I knew the union leader to be generally polite from my off hours encounters with him on the local commuter train.)

Such attitudes at crucial moments did help preserve his members' rights against edicts of senior management (who we reported to). Such directness would probably help protect physicians' rights as well, allowing them to better care for patients, and avoiding phenomena as recently described in the NY Times here: "When Doctors and Nurses Can’t Do the Right Thing."

Appeasement of non medical interlopers in medicine, who overstep their bounds and core competiencies, helps neither physicians nor patients.

It does help the career aspirations and incomes of those appeased, however.

-- SS

Note:

[**] I, in fact, teach such IT personnel at the graduate level to prepare them for facilitative roles in HIT. I am concerned, however, when such personnel are put in medical leadership roles, through either custom and tradition or managerial imperialism, that takes them outside their core competencies.

Thursday, February 5, 2009

Will the U.S. spend the Economic Recovery Act's $20 billion for Healthcare IT more wisely than the UK?

The Congress is about to pledge more than $20 billion towards healthcare information technology as part of the Economic Recovery Plan.

As a Medical Informaticist, I could be a cheerleader, or simply remain silent, and benefit directly from this money.

... If I were an opportunist, that is, not an honest, critical thinking physician-computer scientist.

I have written multiple posts on Healthcare Renewal about the difficulties and even perils of healthcare IT. I suggested a possible moratorium on massive investment (here and here) until the issues are better understood, via robust research.

Healthcare IT is an experimental technology whose benefits are unclear, and about which varied organizations such as the National Research Council and the Joint Commission have recently issued less than stellar reports. See the Joint Commission Sentinel Event Alert on HIT and the National Research Council report "Current Approaches to U.S. Health Care Information Technology are Insufficient." This technology in 2009 is no magic bullet nor panacea.

In an editorial accompanying the very recent article "Clinical Information Technologies and Inpatient Outcomes", Archives of Internal Medicine 169(2), Jan. 26, 2009 (full text is available as of this writing at this link), it is observed that although the study is suggestive of clinical IT benefit, more research is needed. I also note that medical informatics expert David Bates, MD at Brigham & Women's Hospital, the editorial's author, pointed out:


"... organizations have been nervous about making large investments in technology that is difficult to implement , creates major issues with change management , carries a substantial risk of failure , and has uncertain benefits ." ... It is not sufficient just to have bought the technology—it has to be [implemented and] used effectively in a much broader quality structure. When it is not used effectively, it may even worsen performance ."


(This sounds remarkably like what I have been writing for the past ten years at great professional peril. I began such writing after observing firsthand as a CMIO that poorly conceived and implemented HIT, and poorly suited conceivers and implementors, wasted money, resources and time hospitals really don't have - and in one case put sick patients at great risk.)

So, as we are about to spend $20 billion for the technology that in the President's words will "improve healthcare quality and reduce costs...and save $80 billion per year", I present the UK National Health Service's progress since 2006 on their national HIT initiative. They are several years "ahead" of us, especially in terms of spending.

I won't comment on this summary futher, only saying that it speaks for itself. Will we repeat the same errors? A full report is also available (HTML version; and PDF version):

The National Programme for IT in the NHS: Progress since 2006 - Public Accounts Committee

14 Jan 2009

Conclusions and recommendations



1 Recent progress in deploying the new care records systems has been very disappointing, with just six deployments in total during the first five months of 2008-09. The completion date of 2014-15, four years later than originally planned, was forecast before the termination of Fujitsu's contract and must now be in doubt. The arrangements for the South have still not been resolved. The Department and the NHS are working with suppliers and should update the deployment timetables. Given the level of interest in the Programme, the Department should publish an annual report of progress against the timetables and revised forecasts. The report should include updates on actions to resolve the major technical problems with care records systems that are causing serious operational difficulties for Trusts.

2 By the end of 2008 the Lorenzo care records software had still not gone live throughout a single Acute Trust. Given the continuing delays and history of missed deadlines, there must be grounds for serious concern as to whether Lorenzo can be deployed in a reasonable timescale and in a form that brings demonstrable benefits to users and patients. Even so, pushing ahead with the implementation of Lorenzo before Trusts or the system are ready would only serve to damage the Programme. Future plans for deployment across the North, Midlands and East should therefore only follow successful deployment and testing in the three early adopter Trusts. This will mean that lessons can be learned before any decision is taken to begin a general roll-out.

3 The planned approach to deploy elements of the clinical functionality of Lorenzo (release 1) ahead of the patient administration system (release 2) is untested, and therefore poses a higher risk than previous deployments under the Programme. The Department and the NHS should undertake a thorough assessment of whether this approach to deployment will work in practice. No Trust other than the three early adopters should be invited to take the first release of Lorenzo until it is certain that release 1 and release 2 will work effectively together.

4 Of the four original Local Service Providers, two have left the Programme, and just two remain, both carrying large commitments. CSC is responsible for deploying care records systems to the whole of the North, Midlands and East after taking over Accenture's contracts. As well as deploying systems in London, BT is responsible for the N3 broadband network and the Spine. In the light of the experience of Accenture's and Fujitsu's departures from the Programme, it is vitally important that the Department assesses BT's and CSC's capacity and capability to continue to meet their substantial commitments. The assessment should consider the impact on the strength of the Department's position of having only two suppliers responsible for the Programme's major components.

5 The termination of Fujitsu's contract has caused uncertainty among Trusts in the South and new deployments have stopped. One option being considered for new deployments is for Trusts to have a choice of either Lorenzo provided through CSC or the [Cerner] Millennium system provided through BT. There are, however, considerable problems with existing deployments of [Cerner] Millennium and serious concerns about the prospects for future deployments of Lorenzo. Before the new arrangements for the South are finalised, the Department should assess whether it would be wise for Trusts in the South to adopt these systems. Should either of the Local Service Providers take on additional commitments relating to the South, the Department should take particular care to assess the implications of the extra workload for the quality of services to Trusts in the Local Service Providers' existing areas of responsibility.

6 The Programme is not providing value for money at present because there have been few successful deployments of the [Cerner] Millennium system and none of Lorenzo in any Acute Trust. Trusts cannot be expected to take on the burden of deploying care records systems that do not work effectively. Unless the position on care records system deployments improves appreciably in the very near future (i.e. within the next six months), the Department should assess the financial case for allowing Trusts to put forward applications for central funding for alternative systems compatible with the objectives of the Programme.

7 Despite our previous recommendation, the estimate of £3.6 billion for the Programme's local costs remains unreliable. The Department intends to collect some better data as part of the process of producing the next benefits statement for the Programme. In the light of that exercise, the Department should publish a revised, more accurate estimate for local costs and, thereby, for the cost of the Programme as a whole.

8 The Department hopes that the Programme will deliver benefits in the form of both financial savings and improvements in patient care and safety. In March 2008, the Department published the first benefits statement for the Programme, for 2006-07, predicting total benefits over 10 years of over £1 billion. There is, however, a lot of work to do within the NHS to realise and measure the benefits. Convincing NHS staff of the benefits will be key to securing their support for the Programme, and the credibility of the figures in the benefits statement would be considerably enhanced if they were audited. We consider future benefits statements should be subject to audit by the Comptroller and Auditor General. The Department should also review achievements under the Programme so that lessons can be identified and shared where products and services are working well.

9 Little clinical functionality has been deployed to date, with the result that the expectations of clinical staff have not been met. Deploying systems that offer good clinical functionality and clear benefits is essential if the support of NHS staff is to be secured. For all care records systems offered under the Programme, the Department and the NHS should set out clearly to NHS staff which elements of clinical functionality are included in existing releases of the software, which ones will be incorporated in the next planned releases and by what date, and which will be delivered over a longer timescale.

10 The Department has taken action to engage clinicians and other NHS staff but there remains some way to go in securing their support for the Programme. To assess and demonstrate the impact of its efforts to secure support for the Programme, the Department should repeat its surveys of NHS staff at regular intervals (at least every year) and publish the results.

11 Patients and doctors have understandable concerns about data security. However extensive the Care Record Guarantee and other security provisions being put in place are, ultimately data security and confidentiality rely on the actions of individual members of NHS staff in handling care records and other patient data. To help provide assurance, the Department and the NHS should set out clearly the disciplinary sanctions that will apply in the event that staff breach security procedures, and they should report on their enforcement of them.

12 The Department does not have a full picture of data security across the NHS as Trusts and Strategic Health Authorities are required to report only the most serious incidents to the Department. The Department's view is that it is not practical for it to collect details of all security breaches but at present it can offer little reassurance about the nature and extent of lower-level breaches that may be taking place. Given the importance of data security to the success and reputation of the Programme, the Department should consider how greater assurance might be provided through regular reporting. The Department should also report annually on the level of 'serious untoward incidents', on any penalties that have been imposed on suppliers for security breaches, and on the steps being taken to keep patient data secure.

13 Confidentiality agreements that the Department made with CSC in respect of two reviews of the delivery arrangements for Lorenzo are unacceptable because they obstruct parliamentary scrutiny of the Department's expenditure. The Department made open-ended confidentiality agreements in respect of these reviews, with the result that information will not be disclosed even after commercial confidentiality has lapsed with the passage of time. We believe this is improper. The Department should desist from entering into agreements of this kind.

Does the word "quagmire" apply, I ask?

Via what magic will we in the U.S. do better if pushed to achieve widespread EHR by 2014, just five years from now, I ask?

Why will we spend the $20 billion more wisely than the UK (especially when several of the major HIT contractors there were American HIT companies such as Cerner and IDX and management consultants CSC and Accenture?)

Helloo-oooooo, U.S. Congress. Anyone paying attention?

Probably not, I am afraid.

I note this rather inappropriate analogy from Sen. Sheldon Whitehouse of Rhode Island:

Just look at what private technology and innovation have already done with the internet. Google, eBay, Amazon, YouTube, Facebook. Whose life has not been changed? Now imagine what can happen in health care. Wonderful opportunities beckon, both in the near term, because funding this infrastructure will create jobs in the information technology sector, and in the long term, to help us bring down the spiraling health care costs that threatens to engulf our economy.


Reminds me of former Intel chief Craig Barrett lamenting that his 45 horses had EHR's, so why not 300+ million humans?

Anything you don't understand must be easy to accomplish, in effect.

How hard could it be, if you have all the right tools, after all, to accomplish nuclear fission on your kitchen table?

Unfortunately, quite hard, as I’m afraid those with naïve views about healthcare IT are about to discover, at taxpayer expense.


-- SS

Wednesday, February 4, 2009

Aetna Settles

As reported by the Hartford Courant:



Aetna will reimburse more than $5.1 million on 73,000 health claims for college students it underpaid between 1998 and April 1, 2008, under a nationwide agreement announced Monday by New York Attorney General Andrew M. Cuomo.

The claims involved out-of-network care in which Aetna Student Health — formerly called Chickering Student Health — paid physicians what it considered reasonable and customary. Doctors whose charges were higher could bill students for the balance.

Aetna will reimburse students if they paid such a balance. If a student wasn't balance-billed, Aetna will reimburse the doctor. The company says its under-payments averaged $25 each nationwide.

The inadequate claim payments stem from outdated information that Aetna and other insurers used from the databases of Ingenix, a UnitedHealth Group unit.

The $5.1 million agreement is in addition to the $20 million Aetna agreed to pay in a settlement last month of Cuomo's investigation of the out-of-network payment system.


We had posted earlier here about a settlement UnitedHealth made related to its use of the database run by its Ingenix subsidiary.

Note first that Aetna and UnitedHealth are supposed to be fierce competitors. Yet they used the same database, a database constructed by a UnitedHealth subsidiary. This is a reminder that although many have promised that a competitive, market-based health care system would decrease costs, improve access and improve quality, the system that was supposed to be competitive mostly was not. In this example, multiple, supposedly competing managed care organizations/ health insurance companies all appeared to use one company's database. (We have also noted how nearly all managed care organizations/ health insurance companies all basically use a payment schedule for physicians provided by the US government.) Various such anti-competitive practices by managed care organizations / health care insurance companies have to date mostly elicited yawns from health care and policy researchers, the press, government regulators, and the legislature.

Second, note that Aetna's use of the UnitedHealth Ingenix database allowed it to underpay physicians, sometimes resulting in excess out of pocket expenses for students. That does not seem to square with Aetna's high-minded mission statement:

Aetna is dedicated to helping people achieve health and financial security by providing easy access to safe, cost-effective, high-quality health care and protecting their finances against health-related risks.

Aetna surely was not protecting these students' "finances from health-related risks."

This is, of course, just one of many examples we have discussed of cynical marketing techniques by health care corporations. Every big health care organization seems to boast about how it enhances high-quality, accessible, reasonably priced care. But few really seem to do so.

Paul Trossel defined organizational integrity as "how top management of an organisation lives by its own standards." Here again is an example of a failure of organizational integrity in health care, and its (in this case) financial adverse effects on patients.

For a company the size of Aetna, a $25 million settlement is practically petty cash. And like many previous settlements we have discussed, it enacts no penalties on the leaders who actually made the decisions in question. Thus it is unlikely that further settlements like this will promote better organizational integrity, more competition in the health care "market," lower costs, better access, or better quality.

Monday, February 2, 2009

Pfizer Settles (For a Mere $2,300,000,000)

Last week, in thee Wall Street Journal, Ron Winslow reported on this little item that slipped out at the time the giant Pfizer/ Wyeth merger was announced (see our previous post here):

In a disclosure nearly drowned out by news of its $68 billion acquisition of Wyeth, Pfizer Inc. said it agreed to pay $2.3 billion to settle a federal investigation into its alleged off-label marketing of the now-withdrawn painkiller Bextra.

The settlement, which requires the approval of a federal judge, would be the largest ever paid by a drug company to resolve alleged marketing missteps. It easily eclipses the $1.4 billion Eli Lilly & Co. agreed to pay earlier this month to settle similar charges related to its antipsychotic medicine Zyprexa.

Pfizer mentioned the settlement in two sentences in a news release about its earnings. The $2.3 billion charge it took for the deal -- the New York company described the figure as 'pretax and after tax' -- is the main reason its fourth-quarter net income fell 90% to $266 million from $2.72 billion a year earlier.

Pfizer released its earnings at the same time it announced an agreement to acquire Wyeth to form a pharmaceutical behemoth that would have annual revenues of more than $70 billion.

On Monday, Pfizer declined to elaborate on the settlement. A spokeswoman for Michael Sullivan, the U.S. attorney in Massachusetts who led the probe, declined to comment.

The FDA approved Bextra to treat arthritis, rheumatoid arthritis and menstrual pain. It isn't clear what off-label uses Pfizer's marketing of Bextra allegedly involved.


So far, I have found no other details about this in the media. Of course, it's merely a $2.3 billion settlement. It is just amazing that something this big can produce so few echoes. Ah, but that is the anechoic effect, again (see this post).

We have posted about numerous settlements of charges of misbehavior by drug, device, insurance and other health care organizations. Stacking them all up suggests the magnitude of bad behavior by the leaders of health care organizations. Yet it's not clear that all these monetary penalties are discouraging bad behavior.

In some cases, like this one, it is not immediately clear what bad behavior the settlement addressed. Without knowing what actions might cause monetary loss, it is hard to avoid such actions in the future.

In almost all cases, the monetary penalties accrue to the organization as a whole, not to the individuals whose behavior incited the settlement. And I have not so far ever heard of a case in which the organization which has to pay a settlement turns around and enforces a penalty upon the responsible leaders. Thus, the deterrent effect, even of large penalties, is thus diffuse. An executive, knowing that bad behavior may increase short term profits, and hence may markedly increase his or her compensation in the short run, may be undeterred by the threat of a future settlement that he or she does not have to pay. Instead, the settlement may come out of the pockets of stock-holders, employees as a whole, customers, clients, or patients, or the public.

If we want to prevent health care leaders from continuing "childish" behaviors, allowing health care to "spin out of control," (as per President Obama' inaugural address, see post here), we must do a better job of enforcing negative consequences, as the mother of any five-year old will tell us.

Clinical Information Technologies and Inpatient Outcomes: When We Detect a Possible "VIOXX moment", How Promptly Should We Act?

I recently read the article "Clinical Information Technologies and Inpatient Outcomes" , Archives of Internal Medicine 169(2), Jan. 26, 2009 and found it fascinating. Full text is available as of this writing at this link .

The authors conducted a cross-sectional study of urban hospitals in Texas using a "Clinical Information Technology Assessment Tool" (CITAT), a
questionnaire designed to measure a hospital’s level of automation based on physicians' reported interactions with actual information systems.

They then examined whether greater automation of hospital information was associated with reduced rates of inpatient mortality, complications, costs, and length of stay for 167,000 patients older than 50 years admitted to responding hospitals between Dec. 1, 2005, and May 30, 2006.

Here is one of the study's findings as summarized in its abstract:


Results We received a sufficient number of responses from 41 of 72 hospitals (58%). For all medical conditions studied, a 10-point increase in the automation of notes and records was associated with a 15% decrease in the adjusted odds of fatal hospitalizations (0.85; 95% confidence interval, 0.74-0.97).
Higher scores in order entry were associated with 9% and 55% decreases in the adjusted odds of death for myocardial infarction and coronary artery bypass graft procedures, respectively.

Having designed highly customized, detailed information systems for outcomes improvement and mortality and morbidity reduction in invasive cardiology, I am fascinated by suggestions of significant mortality risk reductions in Myocardial Infarction (MI) and Coronary Artery Bypass Grafts (CABG) related to usage of (non specialized) Computerized Physician Order Entry (CPOE) technology.

The authors acknowledge that there are many possible confounding variables in this study, which is based on surveys of physician health IT usage and hospital reporting data, not on far more robust randomized controlled trials. While I agree with the authors that followup validation of this cross sectional study's findings are needed, I do have a concern.

I am troubled by the implication of such a cardiology mortality reduction based on CPOE use, if real.

If this finding is real, one implication is that increased MI and CABG mortality in organizations *not* using CPOE are due to preventable errors of omission and commission in ordering. Importantly, these errors do not necessarily require expensive computers to correct. They can be corrected through human means.

While this reduced cardiology mortality association sounds possibly spurious on the basis of this implication, in my mind this is an alarming finding, potentially meriting prompt and comprehensive investigation.


After a possible "VIOXX moment" is discovered, just how long do we as a society wait before conducting a more thorough investigation?

Finally, the following question also arises. Do observational studies of HIT, subject to confounders and false conclusions of causality regarding associations, possibly create more problems than they solve? For example, the "red flag" described above? Are such studies - as opposed to robust controlled clinical trials - akin to unnecessary medical testing that finds anomalies and "unidentified bright objects", resulting in more fritter that wastes time and money?

I do not know the answer to this question, but I do tend much more towards robust HIT evaluation studies. One reason is that significant money is about to be poured into HIT.

I feel it's best we actually know what we're doing when $20 billion has just been queued up to be handed out for HIT. Some of it will go to good people, but also a significant amount will go to pre-Flexner style electronic snake oil salespeople in vendor organizations and hospitals, who will squander the funds on preventable IT misadventure. Let the Joint Commission Sentinel Event Alert on HIT and the National Research Council report "Current Approaches to U.S. Health Care Information Technology are Insufficient" be my witness.

(I'm not confident critical thinking people such as myself who have not succumbed to irrational exuberance over HIT will see any of that $20 billion, because we actually know what we're doing and don't suffer health IT malpractice and mal-practitioners easily.)

-- SS