Spectranetics Settles

I could not let this story, which came out just before the new year, completely slip by.  As reported by the Colorado Springs Gazette:

Spectranetics, the Colorado Springs-based medical-laser manufacturer, will pay $5 million to resolve federal government allegations that the company illegally imported and marketed unapproved medical devices, the U.S. Department of Justice said Tuesday.

Spectranetics will not face criminal prosecution, although it 'has accepted responsibility for its conduct' and agreed that 'officers and employees who acted on behalf of the company engaged in multiple areas of wrongdoing,' according to a Justice Department news release.

The investigation had been under way since at least Sept. 4, 2008, when agents from the U.S. Food and Drug Administration and Immigration and Customs Enforcement raided the company’s Springs headquarters, seeking information and correspondence.

Spectranetics manufactures sophisticated medical lasers used to clear blockages in coronary and leg arteries.

At issue in the federal probe were allegations that Spectranetics imported medical devices and provided them to physicians for use in patients without federal regulatory approval, the Justice Department said.

Also, Spectranetics allegedly conducted a clinical study that didn’t comply with federal regulations, while it also promoted products for which it hadn’t received FDA approval or clearance, according to the Justice Department.

Spectranetics’ actions caused false claims to be submitted to Medicare from 2003 to 2008, the agency also alleged.

Spectranetics will pay $4.9 million in civil damages to resolve the claims, the Justice Department said. In addition, the company said it has agreed to a future forfeiture of $100,000 in cash or property.

Spectranetics has also instituted measures to prevent similar conduct and will cooperate in 'an ongoing criminal investigation,' the agency said.

Also ongoing are a class-action lawsuit initiated by shareholders, and possibly a US Securities and Exchange Commission investigation. The Gazette also noted,

The company also went through a management shake-up; then-President and CEO John Schulte resigned a few weeks after the September 2008 raid.

Another day, another settlement of charges of wrong-doing by a health care organization.  So my stock response is xataloging legal settlements seems to be a useful way to assess the sorts of bad behavior manifested by large health care organizations (see some posts here). However, as we have said frequently, such settlements, including the "corporate integrity agreements" now frequently attached to them, seem to have done little to deter bad behavior. Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts will suffer any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior.

As seems standard operating procedure for such settlements, the fine in this case was barely more than a financial speed bump, given that the company had revenues of about $104 million in 2008 (per its 2008 annual report).  At least the CEO who was in charge at the time of the admitted wrongdoing actually lost his job.  However, presumably he was able to leave with at least the 792,354 shares of stock, currently worth $5,340,466, based on today's price of $6.74, 2.5% of outstanding shares which he beneficially owned prior to his departure, according to the company's 2008 proxy statement.

I once again submit that would-be health care reformers who want to improve care, reduce costs and improve access should advocate for real negative consequences for people who implement, direct or approve the various versions of fraud, kickbacks, and miscellaneous wrongdoing, corruption and malfeasance we have discussed on Health Care Renewal.

IT Religion and Windows 7 "God Mode"

I've written in the past that IT has become something of a religion, with computers as an altar or shrine, programmers and technicians as clergy, programming a sacrament, and an irrational exuberance and "faith" prevailing about the computer's miraculous capabilities despite growing literature to the contrary. Of course, my focus has been on computers in medicine.

I am generally very happy with Windows 7. Microsoft has done well, but this caught my attention:

Understanding Windows 7's 'GodMode'
CNET News
January 4, 2010 12:41 PM PST

Although its name suggests perhaps even grander capabilities, Windows enthusiasts are excited over the discovery of a hidden "GodMode" feature that lets users access all of the operating system's control panels from within a single folder.

By creating a new folder in Windows 7 and renaming it with a certain text string at the end, users are able to have a single place to do everything from changing the look of the mouse pointer to making a new hard-drive partition.

... To enter "GodMode," one need only create a new folder and then rename the folder to the following:

GodMode.{ED7BA470-8E54-465E-825C-99712043E01C}

Once that is done, the folder's icon will change to resemble a control panel and will contain dozens of control options.

I've tried it, and it works. Upon renaming a new desktop folder as above, the folder actually transforms into the following icon and label:



Then, on opening the "God Mode" icon a comprehensive list of control options appears. Very convenient and useful.

While the name was clearly intended to be humorous, I think that the originators of this name could and should have come up with a less theistic name. Not on religious grounds, but on psychological ones - i.e., the impact such nomenclature might have on IT personnel.

I'm already seeing comments such as "Did you know that you can become a God? Well, at least on Windows 7!" on IT enthusiast sites...

The culture of IT is already patronizing enough towards end users, thank you very much.

I felt the same way ca. 1976 when visiting professors from MIT implemented the programming language "Logo" on Boston University's IBM 370-based RAX timesharing system. The RAX/370 monitor command for restarting after a Logo interpreter fault was "RESAT GOD" (resume at symbolic address 'God', a symbol defined by the professors to represent an address in the 370's user program address space). Since the Logo interpreter was in beta, I had to type that Charlton Heston-esque command often...

Note: having spent some time in Saudi Arabia, I'm not sure how well this Windows 7 holiness will go over in that part of the world...

-- SS

Addendum: I've discovered that renaming a folder to, say, "Bob.{ED7BA470-8E54-465E-825C-99712043E01C}" creates an icon with identical capabilities, but with a ... somewhat less presumptuous name. :)

More on Perversity in the Healthcare IT World: Is Meditech Employing Sockpuppets?

(Note to readers: also see my Jan. 7, 2010 followup post "Socky the Meditech Sockpuppet on Vacation?")

At "Are Dissmissive Industry and Government Reactions to Physician Concerns about EHR's and other Clinical IT Simply Perverse?" I observed that cavalier dismissals of physician reports on HIT unusability and difficulties fit quite well the definition of "perverse:"

Merriam-Webster dictionary:

Perverse (adj).
Etymology: Middle English, from Anglo-French purvers, pervers, from Latin perversus, from past participle of pervertere
Date: 14th century

1 a : turned away from what is right or good : corrupt b : improper, incorrect c : contrary to the evidence or the direction of the judge on a point of law
2 a : obstinate in opposing what is right, reasonable, or accepted : wrongheaded b : arising from or indicative of stubbornness or obstinacy
3 : marked by peevishness or petulance : cranky
4 : marked by perversion : perverted

In a later post, "An Honest Physician Survey on EHR's" I reported on the comments submitted by hundreds of physician members of the American Association of Physicians and Surgeons (an organization mainly of physicians in private practice who strongly support physician independence and other conservative views, founded in 1943) in a 2008 survey about HIT:

AAPS - PHYSICIAN ATTITUDES & ADOPTION OF HEALTH INFORMATION TECHNOLOGY (PDF)

The common theme in their feedback was how HIT in its present form disrupted private practice physicians, distracted them from the physician-patient relationship and impaired their ability to properly care for patients. See the above-linked post and AAPS survey report.

An anonymous, usually lively and even combative reader "IT Guy," who claims to be an IT professional at an HIT vendor, on occasion leaves comments to my HIT posts.

These are typically in the form of unsubstantiated refutations of the material in the posts, and ad hominem attacks in the unmitigated defense of HIT, e.g., referring to this writer as "a teaching professor at a major university who has virtually no understanding of statistical analysis" or as a "grandstanding self-promoter" (See, for example, here at January 5, 2010 8:53:00 AM EST. Read the entire thread.)

In the latest case, "IT Guy" commented on my report of the AAPS HIT survey responses as follows:

IT Guy said...

It's the March of the Ludites.

Thanks for a very funny post.

January 4, 2010 12:28:00 PM EST

I failed to see the humor in dozens of adverse comments about HIT from private practice physicians, and replied with a link to my initial post about HIT industry perversity mentioned above, which elicited the even more perverse response:

IT Guy said...

No one is dissmissive of legitimate concerns. Luddites are a different story. Most of the "concerns" in that diatribe are of the Luddite variety.

January 4, 2010 1:33:00 PM EST

In other words, a survey of physician concerns is a "diatribe" and it is up to the "IT guys" to determine which physician concerns are "legitimate" and which are of the "Luddite" variety.

"IT Guy" remains anonymous and has been so since he first started posting comments here, despite prodding to reveal his identity to better facilitate an understanding of where his/her viewpoints arose. He/she has neglected to do so.

Even the blogger profile is blank, click to enlarge:




Now, I welcome anonymous comments and have a thick skin - to a point. When the comments go ad hominem or perverse, I do consider deleting them.

However, when such comments are potentially revelatory of major issues, I promote and amplify them - as now. Read on.

This person also apparently uses the anonymous moniker "Programmer" at the HIStalk blog where he similarly attacks my comments made under my actual name S Silverstein or under MedInformaticsMD. The HIStalk site owner actually edited out defamatory comments made about me in Oct. 2009 at HIStalk comment #28 at this HIStalk comment thread and apologized for this entry on his blog:

#28 Programmer [at HIStalk blog - ed.]

October 20th, 2009 at 11:57 am

Yes, it’s that simple. If you select for pre-IT and post-IT data and use a large enough sample size the other factors with equal out. If the sample size is large enough you should have a relatively small margin of error.

[i.e., "Programmer" -- who I soon show is also "IT Guy" -- opines that in comparing clinical adverse event rates pre- and post healthcare IT installation, all you need is a large enough sample size, which then nullifies or cancels out, for example, changes occurring over time that are not related to the intervention, and other potential confounders in a pre-post comparison. If only evaluation studies in healthcare informatics were that simple ... it is concerning that IT vendor personnel might have such beliefs - ed.]

And the fact that a teaching professor at a major university has virtually no understanding of statistical analysis makes me say “at least I don’t have to worry about losing my job to one of his students."

[Latter sentence was removed by HIStalk owner - ed.]

Now, back at HC Renewal see this combative comment thread where "IT Guy" a.k.a. "Programmer" refers to that removal, and repeats the above statistical faux pas and ad hominem ("just to make sure I read the whole thing"), and adds another ad hominem for good measure. I let them remain. (Comment dated October 20, 2009 1:35:00 PM EDT.) HIStalk's "Programmer" and HC Renewal's "IT guy" are apparently one and the same.

Getting to the core of this posting, I repeat, when such comments are potentially revelatory of major issues in HIT, I promote them - as here.

The raison d'être for this posting is an interesting pattern:

Before "IT Guy" posts comments at HC Renewal, "hits" appear from a major health IT vendor's IP in our publicly-accessible Sitemeter log, with outclicks to the comment sections of posts where "IT Guy's" comments then appear.

For example:

Domain Name (Unknown)
IP Address 12.11.157.# (Medical Information Technology) [Meditech - ed.]
ISP AT&T WorldNet Services
Location
Continent : North America
Country : United States (Facts)
State : Massachusetts
City : Milford
Lat/Long : 42.1544, -71.521 (Map)
Language English (U.S.)
en-us
Operating System Microsoft WinXP
Browser Internet Explorer 6.0
Mozilla/4.0 (compatible; MSIE 6.0; Windows NT 5.1; SV1; .NET CLR 1.1.4322; .NET CLR 2.0.50727; .NET CLR 3.0.04506.30; .NET CLR 3.0.04506.648)
Javascript version 1.3
Monitor
Resolution : 1024 x 768
Color Depth : 32 bits
Time of Visit Jan 4 2010 11:49:49 am
Last Page View Jan 4 2010 12:55:12 pm
Visit Length 1 hour 5 minutes 23 seconds
Page Views 12
Referring URL
Visit Entry Page http://hcrenewal.blogspot.com/
Visit Exit Page http://hcrenewal.blogspot.com/
Out Click 0 comments
https://www.blogger.com/comment.g?blogID=9551150&postID=4799128165855153590&isPopup=true
Time Zone UTC-5:00
Visitor's Time Jan 4 2010 11:49:49 am
Visit Number 643,748

At the time of the outclick, there were "0 comments" to that post, as shown in the log above. Shortly after, IT Guy's aforementioned "Funny March of the Luddites" comment appeared ... as comment #1.

Likewise today, several "hits" appeared from IP 12.11.157.# with outlinks to the comment thread, for instance as seen below when only 23 comments were present, mostly from "IT Guy", Dr. Poses and myself:

Domain Name (Unknown)
IP Address 12.11.157.# (Medical Information Technology)
ISP AT&T WorldNet Services
Location
Continent : North America
Country : United States (Facts)
State : Massachusetts
City : Milford
Lat/Long : 42.1544, -71.521 (Map)
Language English (U.S.)
en-us
Operating System Microsoft WinXP
Browser Internet Explorer 6.0
Mozilla/4.0 (compatible; MSIE 6.0; Windows NT 5.1; SV1; .NET CLR 1.1.4322; .NET CLR 2.0.50727; .NET CLR 3.0.04506.30; .NET CLR 3.0.04506.648)
Javascript version 1.3
Monitor
Resolution : 1024 x 768
Color Depth : 32 bits
Time of Visit Jan 5 2010 9:38:07 am
Last Page View Jan 5 2010 9:57:40 am
Visit Length 19 minutes 33 seconds
Page Views 3
Referring URL
Visit Entry Page http://hcrenewal.blogspot.com/
Visit Exit Page http://hcrenewal.blogspot.com/
Out Click 23 comments
https://www.blogger.com/comment.g?blogID=9551150&postID=4799128165855153590&isPopup=true
Time Zone UTC-5:00
Visitor's Time Jan 5 2010 9:38:07 am
Visit Number 644,308

After that, more comments from "IT Guy" appeared starting with ... #24.

The pattern has remained consistent.

Now, the evidence is circumstantial but it does not take a Sherlock Holmes to realize it is quite likely this commenter is an employee of a healthcare IT vendor named in the above links, Medical Information Technology, Inc., a.k.a. Meditech.

I am concerned that a possible employee of an HIT company - any HIT company -- might find physician concerns about HIT as serious as those expressed in the AAPS survey "funny" and "of the Luddite variety." I also am concerned that an employee might think that in situ pre-post evaluations of the technology need not take into account possible confounders.

If this person is an HIT vendor employee and IT professional at this HIT company or any other -- I think it likely he/she holds such a position at some HIT company and such attitudes -- then a number of questions are raised:

• How common is this attitude among HIT vendor employees? Is this a systemic problem?
  

• How do such attitudes translate into satisfying customer requests for remediation of HIT defects and problems?

• Should HIT vendors be doing better due diligence in their hiring practices to assure they hire IT personnel with a service mentality and who understand that clinicians are the enablers of medicine, they the facilitators? (A point my graduate healthcare informatics students are taught and grasp readily.)
  

At the very least, perhaps employees of HIT companies (such as the one in the logs above at Meditech, whoever they may be) should pay more attention to improving HIT, rather than spending 1 hour 5 minutes 23 seconds reading 12 posts here during business hours.

"IT Guy" is welcome to continue submitting anonymous comments, but if they contain ad hominem they will be deleted.

-- SS

Addendum 1/5/10:

A HC Renewal reader with an MBA non-anonymously relates the following (emphases mine):

In reading this thread of comments I have to believe IT Guy is a salesperson. My only question is: Were you assigned this blog or did you choose it? We had this problem a number of years ago where a salesperson was assigned a number of blogs with the intent of using up valuable time in trying to discredit the postings.

In my very first sales class we learned to focus on irrelevant points, constantly shift the discussion, and generally try to distract criticism. I would say that HCR is creating heat for IT Guy’s employer and the industry in general.

I find it sad that a company would allow an employee to attack anyone in an open forum. IT Guy needs to check with his superiors to find out if they approve of this use of his time, and I hope he is not using a company computer, unless once again this attack is company sanctioned.

Steve Lucas

I think that is an interesting possibility - someone paid to disrupt. It fits, and again invoking Sherlock Holmes, there is the means, the motive and the opportunity. Time for another definition:

Sock puppeting: "the act of creating a fake online identity to praise, defend or create the illusion of support for one’s self, allies or company." (NY Times)

If true (unfortunately for the salesperson), I make this observation:

To most of the readers of Healthcare Renewal, who find a focus on irrelevancy and irrationality to be signs of foolishness and hysteria (we clinicians have seen it all, by the way), this salesperson has nothing to sell.

Another perversity also comes to mind. If what Mr. Lucas suggests is indeed occurring, a company behind such actions would be exhibiting self destructive behavior in trying to disrupt and discredit those who could actually help them to make better products and be more competitive. I remind that patients are the true "customer."

It also follows that, if this analysis is true, the defamatory attacks left at HIStalk and here at HC Renewal would have been made with foreknowledge of their falsity and with malice.

Not a particularly wise HIT vendor strategy with the HIT industry under investigation by US Senator Grassley (see Oct. 2009 PDF letter to a number of vendors and management consultant firms here).

Having worked in pharma, however, another self-destructive industry due to its internal pathologies, I've seen worse done to critics. Incidentally, another probable blog troll/sockpuppet comment from that industry is in the comments section at this Jan. 2008 post.

-- SS

One Small Step Towards Reducing Conflicts of Interest Affecting Academic Medical Leaders

Two articles, one in the New York Times by Duff Wilson, the other in the Boston Globe by Liz Kowalczyk, brought the issue of the conflicts of interest generated by leaders in academic medicine sitting on the boards of health care corporations to wide attention.  The news was that Partners Healthcare, the large hospital network that includes two of Harvard University's main teaching hospitals, for the first time is limiting the role its leaders can take on such boards of directors.  As written by Duff Wilson,

The owner of two research hospitals affiliated with the Harvard Medical School has imposed restrictions on outside pay for two dozen senior officials who also sit on the boards of pharmaceutical or biotechnology companies. The limits come in the wake of growing criticism of the ties between industry and academia.

Medical experts say they believe the conflict-of-interest rules at the institution, Partners HealthCare, go further than those of any other academic medical center in restricting outside pay from drug companies. The rules, which became effective on Friday, impose limits specifically on outside directors who guide some of the nation’s biggest companies.

Senior officials at the two hospitals, Massachusetts General and Brigham and Women’s Hospitals in Boston, must limit their pay for serving as outside directors to what the policy calls 'a level befitting an academic role' — no more than $5,000 a day for actual work for the board. Some had been receiving more than $200,000 a year. Also, they may no longer accept stock.

The proper pay for time spent on board meetings under the new policy was calculated at $500 an hour for a 10-hour day, said Christopher Clark, a senior lawyer at Partners and director of a new office for interactions with industry. Stock and options were banned because they tie the director’s fortunes to company profits.

As far as I know, this policy is the first instance of a US not-for-profit academic medical institution limiting the role its leaders and/or faculty may take as directors of for-profit health care corporations. So it is an important step. Furthermore, also as far as I know, the coverage this news item received on Sunday is the first time this issue has been discussed openly in the mainstream media.

A New Species of Conflicts of Interest

On the other hand, we first discussed the conflicts posed by leaders of academic medicine sitting on the boards of for-profit health care corporations in 2006 on Health Care Renewal, calling it a "new species of conflict of interest" at that time.  Since then, we have found many other examples of such conflicts.  We noted that sitting on a corporate board is a particular problem for an academic medical leader because a corporate director has a legal obligation to advance the profits and financial fortunes of the corporation he or she serves. 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.]  This legal requirement ties a corporate board member far more tightly to the interests of the corporation than do the obligations of, for example, a consultant to the corporation. 

Moreover, some have charged that many for-profit corporate board members are just cronies of the top corporate leaders.For example,

Tthe cronyism of major corporate boards, especially those in the finance area, has become legendary. Rubber-stamp directors who rarely buck the chairman or challenge the CEO are unfortunately all too common. These boards did not serve either their companies or shareholders well.

[per Ritholtz B. Bailout Nation.  Hoboken, NJ: John Wiley & Sons, 2009. pp. 198-199.]

In that case, this would only makes things worse, tying board members to the personal interests of top managers of health care corporations, rather than to the interests of the entire stockholder population.

A (Baby) Step in the Right Direction

Given the potential severity of board of directors level conflicts of interest for academic medical leaders, any step that reduces them deserves applause.  That being said, Partners Healthcare's restrictions on these conflicts are at best baby steps in the right direction.

Note that the new policy only affects a small number of people.  Liz Kowalczyk wrote, "the policy affects roughly 25 vice presidents, clinical department heads, and other top executives...."  So it neither affects lower ranking clinical leaders, or Partners' own board.

The policy's limit on directors' compensation ($500/ hour, or $5000/ day, assuming a 10-hour day, which would annualize to $1,040,000 per year assuming an 8-hour day, and $1,300,000 assuming a 10-hour day), might be comparable to the current exaggerated earnings of top Partners' executives, but substantially exceeds the compensation of most practicing physicians or medical academics, and hence does not seem to be a very significant limitation.  Requiring payments be made in cash rather than stock options might be regarded as an improvement rather than a restriction. 

The policy does not restrict the number of boards a Partners leader may sit on.

Finally, the policy does not do anything substantial to manage to conflicts generated by board members' legal obligations to their companies and stockholders, nor their tendency to become cronies of top corporate management. 

Are Conflicts of Interest Even a Problem?

While acknowledging the new, slightly restrictive policy, top Partners leaders did not seem to want to acknowledge that there is any downside to academic medical leaders sitting on health care corporations' boards.  For example,

'We thought it was a very good idea to have institutional officials serve on boards, but we did not want to have personal enrichment,' [former Partners Chief Academic Officer and current Professor] Dr. [Eugene] Braunwald said.
[NY Times]

Note that for most people, $500/hour appear to be personally enriching.  

Also,

'These relationships also have significant benefits,' ... [Christopher Clark, director of Partners Office for Interactions with Industry] said. 'They give us some insight into how the companies work and how they are doing, and making sure the companies are aware of the academic perspective.'
[Boston Globe]

Mr Clark did not note the many other ways to see how companies work and to communicate the academic perspective to them which do not involve academic leaders being paid by these companies.

Dr Dennis Ausiello, chief of medicine at Massachusetts General Hospital, said

Pfizer and other companies were crucial to translate academic research into drugs that benefit patients. At Partners, he has oversight of a research, ventures and licensing office that seeks to commercialize the hospitals’ intellectual property.

'I’m very proud of my board work,' he said. 'I’m not there to make money. I certainly think I should be compensated fairly and symmetrically with my fellow board members, but if my institutions rule otherwise, as they have, I will continue to serve on the board.'

While drug companies do make products that are good for society, could they not continue to do so without academic leaders on their boards? If Dr Ausiello did not care about his compensation, why did he continue to accept it?

So it is hardly clear that Partners Healthcare's leadership even now would credit Harvard Professor Emeritus and Editor Emeritus of the New England Journal of Medicine Dr Arnold Relman's point of view,

I think that’s a gross conflict for an official of an academic medical center to be on the board of a pharmaceutical company.

It’s happening more and more around the country. If it isn’t stopped, I think the academic institutions are going to lose the confidence of the country and the government and they will no longer deserve the tax exemption or anything else. They will be part of industry itself.

Indeed. But at least now, the issue may be apparent to more people than just the dedicated readers of Health Care Renewal.  The more it is discussed, the more academic medical leaders may realize how much credibility they would gain if they were seen as impartial experts and dedicated physicians, rather than the protectors of corporate stockholders, or worse, the cronies of corporate bosses.

ADDENDUM (4 January, 2010) - see also comments by Professor Margaret Soltan on University Diaries, Merrill Goozner on the GoozNews blog, and Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

ADDENDUM (6 January, 2010) - see also comments by Dr Daniel Carlat on the Carlat Psychiatry Blog.

Several Vignettes from a Healthcare IT Consultant/Informaticist

Reproduced with permission. These vignettes and the candid 2008 physician survey results recently posted here make one wonder whether health IT in its present form is not "meaningfully useful," but rather "meaninglessly useless":

• A Michigan hospital system uses Cerner for their EHR. This hospital system 'supports' 2 ambulatory systems, eClinical Works and NextGen. Despite huge investments of time and money on all sides (physicians, hospitals, others), there's very little interoperability between these systems. People are 'pulling their hair out,' discouragement is growing, costs are skyrocketing, and some people are backing away from HIT vendors in general. Even doctors are realizing that it makes no sense to spend $100k (or more) to recoup $44k in 'incentives' for systems that don't work.

• In a major NextGen deployment in a primary care setting we're finding that physicians who thought that they wanted structured data are now backing away from and actively avoiding the structured data. Instead they are opting for the 'free text' sections of the system (this is true for both the people entering the data, and the people who are reading and making sense of the data). The structured data have proven to often not be clinically meaningful.

• On the medical-legal front, professional liability issues associated with structured data are increasing. [In a] recent newsletter from a Michigan-based medical malpractice company ... note in the newsletter under "Additional Features Creating Risk" the patient safety and risk issues associated with structured data in a SureScripts approved eRx system. Surprisingly very little is said about the medical-legal dimension of HIT.

• Most important are patient safety issues. Recently I surveyed 2 pharmacists and 12 physician leaders and asked them to interpret an Rx generated by a structured data eRx system (which is used by a number of Michigan-based CMHs). Both pharmacists and 9 of the 12 physicians INCORRECTLY interpreted the Rx. Currently colleagues [and I] are working on a much larger study of the flawed structured data associated with a SureScripts approved eRx system.

How long, do I ask, will it take for the U.S. to reach the heights of glory and accomplishment in clinical IT as the UK has achieved for its £12.7 bn , under present assumptions and attitudes of irrational (or purchased) exuberance?

-- SS

An Honest Physician Survey on EHR's

I often believe surveys of physicians about EHR's do not present the results candidly, but rather are selective in what is reported - and what is omitted - and generally sugar-coated. Examples of very candid reports are rare, probably due to pushback, such as this recent report on ED EHR's in New South Wales from Australia.

Often the pushback takes the form of the report "lacking peer review", which in a non-free market, vendor-dominated situation (as in pharma, with money flowing everywhere but up) is as likely to produce censorship or, at best, groupthink, as objective science.

Here is one that is candid, by the American Association of Physicians and Surgeons.

The Association of American Physicians and Surgeons , founded in 1943, regularly testifies before the U.S. Department of Health and Human Services regarding development and implementation of health information technology. It consists largely of physicians in private practice. I've been a member of the organization, but was not at the time this survey was performed and written up:

PHYSICIAN ATTITUDES & ADOPTION OF HEALTH INFORMATION TECHNOLOGY (PDF)

Results Compiled on 6/9/2008

Specialties Responding:

Family Practice 73
Psychology 38
Internal Medicine 33
OBG 27
Orthopedic Surgery 27
Ophthalmology 26
General Surgery 22
Dermatology 21
ENT/OTO 15
AN 14
Neurology 13
Pain Management 13
Urology 12
Pulmonary
Diseases 11
Neurosurgery 8
Vascular Surgery 6
Cardiology 5
Radiology 5
Gastro 5
Emergency Med 4

I am simply reproducing some of the comments received below without additional comment:

A patient's medical history is nobody's business but the doctor's and the patient's.

All EHRs examined are cumbersome and ineffiecient

As a 'computer programmer,' can see pushing buttons to make statements about a patient's health, really makes patient care more distant, takes the personal, hand-touched art out of practicing medicine, AND lends itself to inaccuracies and errors

As a primary care physician, I rarely see patients for one problem, yet most EHRs Ive tested are based on the 'problem/visit' models.Expanding the visit to include the 'oh, by the way, doc's' is cumbersome and even more time consuming.

Better--paper record (for patient, also, to keep)

Big Brother is watching you--1984

Can't view my study printouts and look for change--pages 'turn' too slow

Comment: I do write notes on my computer but it is not part of any 'system.' I do not send bills via computer.

Comment: as anesthesiologists, we use the hospital's EMR, but we haven't implemented our own. Possibility that it won't lead to improvements in quality of care

Comment: However, I work with a physician's group to promote EHRs and run into many obstacles

Comment: we have spent upwards of $200,000 on Nextgen software plus hardware for our clinic and have never been able to make it function over the past 5 years

Compatibility

Concern about presumed access to record by multiple non-insurance third parties.

continued cost of support, maintenance, and updates of hardware and software

cost benefit ratio too high

Cost of upgrades

degradation of personal dr/pt relationship. Instead of a conversation between two people there is the intrusion of a mechanical 'other.'

Distraction from personal patient care

diverts attention from patient to data processing

Doesn't work. Studies show no better. Push for EHR due to 'Big Brother's' appetite for info and control.

Don't need it or want it. Concern about accuracy. Many of the automated consult letters I receive contain glaring errors and omissions.

EHR generates false pre-programmed info that does not truly reflect the time actually spent with the patient allowing the MD to 'upcode' for the visit and bill higher. It is more honest for me t spend 20' with my patient and write wo words of actually pertinent info.

Ehr in use for nurses only at my second site and it slows down the care they give.

EHR is most impersonal. It does not give a fell for what is going on with patient.

EHR notes are poor, very poor. Full of useless verbiage and usually no place for physicians to add specific notes (or they are lost in the mass of irrelevant detail automatically supplied by the program. Also encourages physicians, who are often pressed for time, to make any specific notes.)

EMR are very time consuming, result in production of lengthy repetitive notes of questionable clinical value and reliability.

Comment: companies go out of business and new systems need to be installed.

Comment: Federal and state govt. will continually add requirements

EMR printouts contain extensive boiler plate data. The real data is hard to glean from the chaff.

Fills the chart with negative (non-used) information

Getting the computer 'right' will become more important than taking care of the patient.

Have started process

Have used EHR and find written records more reliable and practical

I am a fulltime ER doctor. I have no say but if they go electronic, I go.

I am blind

I am concerned with control that's being exercised here. There's no room for creativity, judgement and financial shortfalls. If the government or insurance companies would take the overhead including this financial then it might be palatable

I am not a good 'typer'--on a keyboard--I do not type at all. Don't want to type, never will. I am not trained as a secretary or clerk.

I do not want to have to turn on a computer everytime I speak to a patient or need a chart with consulting with another physician or a pharmacist.

I feel like I would be a secretary to enter data on my patients so that government can easily slide into socialized medicine.

I hate typing and anything that distracts me from writing and examining

I have not found a system that will speed up my patient encounter. All make it slower--with keyboard--not patient--time.

I see no benefits; would certainly disrupt my thinking process.

If mandated--no standard for format. Took 15 years to finally get standard for electronic billing.

If purchased would be faced with frequent expensive changes to format. They still can't get the new NPI number to work! Everyone I know who spent $50,000 to buy a system either junked it or are planning to!

In 2000, I lost my billing staff. Led to a computer-based billing system due to that. The transition was horrible! I could not use the system myself and training for staff was expensive; the IT guy was expensive; billing personnel who had experience with my system were few. In the end, 4 years later, I had an AR $136,000 and as aconsequence, I closed that practice

Inappropriate EMR causes defocus from reason for visit, etc. Problem with sketches.

Still would need 2 charts--one paper, photos, etc. and 1 EMR

Inefficient. They do not provide the clinical data that I need.

It is impossible to skim through an electronic record to find data. It is impossible to sketch the affected anatomy in electronic records. If the computer breaks down or the technology becomes obsolete, the patient record disappears. It takes too long to enter data into a computer.

You still need a paper chart to share reports and other patient paper records.

It will be of no value in my single practitioner spine surgery practice lack of any standard format/compatibility of various systems

Lack of personal patient interplay

Less time with patient, more time with computer. There are better ways to give ER docs access to patient's med records. Survey ER docs to learn what info they would need when pt. is unconscious. Put that into pt. ID card using 2D Barcodes or magnetic strips. Card readers in ERs can then access that info. If AAPS helped develop and sponsor this for its members, it could be a source of $$ for AAPS

loss of dr-patient relationship

Loss of patient control over privacy of records

Loss of quality of patient's personal records. Physical deterioration of data over many years

Inadequate accuracy of voice recognition technology Lack of evidence that EHRs
are any better or equal to paper records except in narrow applications

I purchased an EHR system and was unimpressed. Main reason: prefer personal notes. I believe dictated notes are more specific and detailed and are customized for each patient visit

May not be able to get to computer records in case of computer crash or power failure (eg. Katrina).

most software have major problems in functionality and changes how physicians practice in a potentially negative way

Must have voice recognition for input at 100% accuracy and reliability.

my patients are given copies of all reports (lab, x-ray, consults) as they are collected and told to keep in their medical file

No adequate voice recognition systems

No clinical evidence that this improves outcome. No clinical evidence that there is a return of investment.

No evidence that EHR will improve care or reduce costs to the patient/doctor/healthcare system.

No improvement in quality of care provided.

Once they force us into the more expensive, time-consuming system that does not work, they
own us! It is too easy for the courts, government, hackers and insurance companies to take 'all,' once it is in the system!

One of worst business decision we made.

open source software is available (but VA Vista split into Open Vista and World Vista groups and is written in a language that is not known to many programmers) but I haven't taken the time to find something that could work--I don't know if any of them can keep up with the government requirement

oppose all government interference

Paper charts are much more accurate and efficient for me.

Patient safety

perpetuation of errors

Preoccupation with the computer takes time from patient. Increased errors from EMR especially CPOE. We already have well established safety checks and reviews in our system for tracking tests and medicines. No system especially CPOE have been tested for safety and efficacy nor approved by any regulatory agency and thus the alteration of care from these (?) is nothing but an experiment and patients have not signed consent. Preoccupation with the computer takes time from patient. Increased errors from EMR. We already have well-established safety checks in our system for tracking tests and medicines. No systems have been tested for safety and efficicacy nor approved by any regulatory agency

Reduced time with patients. My patients complain about other doctors playing with EHR computer instead of looking at them during visit.

reliance on psychological pen and paper tests

Slower system than handwritten notes

slows review of chart at each office visit

some parties are paying $10,000 per month for technical support

Sorry, I cannot fill this out--I have visual problems

Still building the software

Studies are not showing conclusive evidence that EMRs improve patient care or safety, but do increase practice costs.

systems are difficult to implement; I've been trying for 2 years

The EHR in the hospital slows me down. A paper record is more efficient for me.

The systems seem to impede quality clinical care and passing along of relevant clinical information

There is not one advantage to me, at all!

There is one product I would use, PRAXIS. [www.informed.com] I would need $30,000 infrastructure and $30,000 adoption overhead grant in order to do so

They don't improve patient care--just adds to overload

time taken up up for data; focus on computer rather than on patient in the exam room

Too rigid. I like to draw pictures of what I see on ophthalmological exam.

Typed, dictated note can be read much more quickly. I use a print about 1/2 the size of your print on this page and there are perhaps 4 or 5 pages of regular print per page which I read without glasses. Computer and power problems do not hide my records.

Unfunded mandate with huge cost in a severely declining reimbursement arena.

without a personalized note, it is worthless.

Read the entire report as linked above. No additional comments are needed.

-- SS

Held Hostage To Health IT? Here Is What Physicians Have To Put Up With Instead Of The Paper Chart...

I might have titled this post "Transforming simplicity in medicine into complexity." It's a wonder clinicians can get clinical work done at all any more.

The following material makes the reports of poor alignment of EHR's to clinical needs, clinician distraction, and the slowing of clinician productivity more understandable by laypeople.

The following are PDF's from a real healthcare organization, publicly accessible (at present), some with actual screen shots of the applications.

How about a 90-page guide simply for entering orders, incidentally grossly mislabeled as "Medical Informatics Physician Education Program" instead of "CPOE application training program" suggesting the authors do not know what Medical Informatics actually is - and also labeled as "Session 1":

• Managing Patient Care Using CPOE (1.2MB PDF)

Here's what it takes to simply discharge a patient:

• House Wide Discharge (Depart Process) training manual (1 MB PDF) - 30 page training manual
  

"Depart Process" is apparently a new buzzword. (Borrowed from the airline industry?) In the B.C. era (before computers), discharge required no 30 page training manual.

I find the introduction to the 30 page "Depart Process Training Manual" interesting:

Good News! The discharge process has been revised and will be a smoother, less complex process for all. The new process will be to use the House Wide Discharge (HWD) Process, (Depart) when discharging your inpatients.

"Less" complex? One can imagine what the "Depart Process" was like before this 30 page training manual.

Here's what it takes to enter or review a note:

• Electronic Documentation –Clinical Notes (12 MB PDF)

Holy complexity, Batman! Entering a clinical note used to involve opening a chart and applying pen to the right paper.

Here is what medical professionals have to contend with when even a minor change is made:

• Tab Changes in the Power Chart (150kb PDF)

Here's what happens if physicians don't complete their H&P's in 24 hours with the EHR system:

• Suspension (31kb PDF)

I especially find the introduction to this "H&P suspension" letter of interest:

You may remember earlier this year when we started immediate suspensions for H&Ps missing at 24 hours as outlined in our Rules and Regulations. Many of you were caught off guard by this and resented being called after you had already missed the deadline and were suspended [I'll bet - ed.].

We certainly heard your complaints [doctors are simply "complainers" - ed.] and stopped the immediate suspensions until we could create a better process. Since then we have been working on ways to achieve the goal of 100% H&Ps present within 24 hours. We have met repeatedly and received recommendations from HIM [Health Information Management a.k.a. Medical Records - ed.] directors, administration, and senior medical staff leaders. Final proposals have been approved by the Medical Executive Committee and are presented to you here.

Beginning January 4, 2010, we will again begin suspending at 24 hours if an H&P is not available on the chart. The stopwatch will start at the time of the admit order. We will make every ["every?" - ed.] effort to contact the physician as the 24 hour deadline grows near. For the few physicians who have had multiple late H&Ps this past year, you will be contacted separately and required to formulate an action plan to present to administration and senior leadership.

Repeatedly late H&Ps will trigger recommendation for a shortened reappointment. Additional measures have been proposed by senior leadership for adoption, if necessary. These include limiting service sizes, stopping all admissions for suspended physicians (not just elective admits) or required use of a nurse practitioner (for a charge) to complete the H&P. [In fact, perhaps physicians should be charging hospitals for their time in being forced to use IT such as this - ed.]

Mussolini could not have done better in getting the trains out on time. At least trains were not experimental technology. (I'd thought it was deplorable as an internal medicine intern in the early 1980's at the now-defunct Hospital of the Medical College of Pennsylvania when our penurious paychecks of about $300 per week were merely withheld if we had not completed our discharge summaries.)

I've commented in the past that physicians and other clinicians are now held hostage to needlessly complex and difficult to use health IT (see my eight part series on the HIT mission hostile user experience here). I don't see anything here to make me change my mind.

Needless to say, being a Medical Informaticist I am not against health IT: I am pro-health IT.

What I do oppose is bad health IT - ill conceived, poorly implemented, mission hostile HIT designed with little thought to, or willful ignorance of, real world side effects in the clinic, office and subspecialty area.

Health IT can be designed to be far better than most commercial HIT from major vendors is now, of which the above links show but one example. This requires, however, that HIT be viewed not as computer projects that involve clinicians, but as medical projects that involve computers.

From that view flows the need for a major shift in HIT power structures and an educational and certification process for IT personnel (such as recommended by the ONC director Dr. Blumenthal that I highlighted in the post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership").

For sake of comparison, from the same hospital system as above, here's what physicians must go through to be found competent:

• Privilege Criteria Grid (120kb PDF)

Here's what IT personnel must currently go through to earn the privilege of designing the tools clinicians must use, and of working in healthcare settings:

The same symbol applies to oversight of such tools themselves by accepted biomedical regulators such as FDA who regulate drugs and tangible medical devices. As I have written before, HIT is a virtual medical device, but a medical device nonetheless. It is a device that by the admissions of its own producers is entirely capable of effecting major impacts on and alterations to clinical care, although the makers rarely admit to adverse impacts.

These discrepancies are astonishing.

-- SS