Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"

In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available at this link, the opening statement is (emphases mine):

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

I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals.

Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced.

I note the lack of footnotes showing the source(s) of these statements.

I also note the lack of mention of literature refuting or potentially refuting these statements of certainty. I can think of more than a few examples of the latter just off the top of my head [ref. 1-15 below, certainly not a comprehensive list but merely skimming the surface].

In politics, however, no such sourcing is necessary. It's easy for a politician to say "Free markets will not give us the healthcare system we want" or, conversely, "I never heard about the DOJ's selective dismissal of charges against people intimidating voters at a voting site in Philadelphia."

So, did the NEJM publish fact, or political platitude?

Can someone provide a list of peer reviewed, rigorous studies that back the assertions of certainty in 10.1056/NEJMp1006114, and override the body of literature that could cast doubt on these assertions of certainty?

Since it's people's lives at stake, not an inventory of widgets, I've promoted the idea of holding off on national roll outs until we:

• learn sufficiently from failures such as the UK's NPfIT (National Programme for IT) in the NHS and our own military's AHLTA debacle on how to avoid same, which can injure and kill patients and wastes massive money and resources healthcare can ill afford, and more importantly that can be better used elsewhere - such as care of the poor;

• improve the technology's usability, safety and efficacy through the years of Medical Informatics and other disciplinary research needed, that was short circuited through the invention of the ONC office by Bush (although national HIT then remained a goal, not a mandate), and the 'militarization' of ONC under Obama whereby HIT was unilaterally declared a proven technology and mandated for national rollout;

• end the contractual "hold vendor harmless clauses" (see Koppel and Kreda's 2009 JAMA article here), and fear-based censorship of information on health IT problems, patient injuries and deaths related to the devices; and

• meaningfully regulate these devices that have increasingly become governors of care delivery.
  

I have written extensively on these topics at this blog, at my academic website on health IT failure, and other sources (see list at end of my bio).

When there are significant doubts about a medication or medical device, we ought not push for national rollout.

Health IT devices have gotten special accommodation, and it's not on the basis of any rigorous science I am familiar with.

-- SS

References: (hyperlinks to these and others can be found at my medical informatics teaching sites here and here):

1. Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop by Bonnie Kaplan and Kimberly D. Harris-Salamone. From the May/June 2009 issue of JAMIA.

2. "E-Health Hazards: Provider Liability and Electronic Health Record Systems.” Hoffman and Podgurski’s followup paper on EHR medical and legal risks

3. Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203

4. Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Arch Intern Med. 2007;167:1400-1405. The authors examined electronic health records (EHR) use throughout the U.S. and the association of EHR use with 17 basic quality indicators. They concluded that “as implemented, EHRs were not associated with better quality ambulatory care.”

5. Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand)

6. Bad Health Informatics Can Kill. his site contains summaries of a number of reported incidents in healthcare where IT was the cause or a significant factor. It comes from the Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI).

7. The U.S. National Research Council’s "Current Approaches to U.S. Health Care Information Technology are Insufficient."

8. The UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program.

9. Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) (released under the UK’s Freedom of Information Act).

10. A report on the serious problems with the Department of Defense’s AHLTA system, Electronic Records System Unreliable, Difficult to Use, Service Officials Tell Congress. (This system, as I wrote here, is slated for abandonment. I cannot imagine it was greatly improving outcomes).

11. A New York Times report “Little Benefit Seen, So Far, in Electronic Patient Records” on Jha’s research at the Harvard School of Public Health, that compared 3,000 hospitals at various stages in the adoption of computerized health records and found little difference in the cost and quality of care.

12. An American Journal of Medicine paper “Hospital Computing and the Costs and Quality of Care: A National Study” by Himmelstein and Woolhandler at Harvard Medical School, that also concluded “as currently implemented, hospital computing might [very] modestly improve process measures of quality but not administrative or overall costs."

13. A Milbank Quarterly article “Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London.

14. Health Affairs, 29, no. 4 (2010): 639-646 Electronic Health Records’ Limited Successes Suggest More Targeted Uses, Catherine M. DesRoches et al.

15. NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks" (PDF here)

Addendum 7/14:

I think this statement at "The Road to Hellth" blog in a post entitled "Meaningful Ruse" that cites my posts is apropos:

... Meaningful use entered our vocabulary in early 2009 as part of a $20+ billion gift from doctors, hospitals and the taxpayers to the needy folks at Cerner, GE, Siemens, Allscripts, Epic and other purveyors of complex, expensive and difficult-to-use and potentially even dangerous medical software products.

-- SS

Professional Integrity for Sale? “Sure,” Says Medscape!

Some chiropractors also practice homeopathy. According to Frank King, D.C., many more should be doing just that:

Homeopathy is an energetic form of natural medicine that corrects nerve interferences, absent nerve reflexes, and pathological nerve response patterns that the chiropractic adjustment alone does not correct. The appropriate homeopathic remedies will eliminate aberrant nerve reflexes and pathological nerve responses which cause recurrent subluxation complexes.

Not only does homeopathy correct nerve interferences, it empowers the doctor of chiropractic to reach the entire nervous system. What this means is that we can now better affect the whole person, and all of the maladies that affect us. Homeopathy’s energetic approach reaches deep within the nervous system, correcting nerve interferences where the hands of chiropractic alone cannot reach. Homeopathy is the missing link that enables the chiropractor to truly affect the whole nervous system!

But that’s not all:

Financial Rewards

Homeopathy means a multiple increase in business. Personally, I have been able to see and effectively help more patients in less time. The additional cash flow from broadening your scope of practice, increasing your patient volume and selling the homeopathic remedies is a wonderful adjunct. Better yet are the secondary financial benefits:

• Homeopathy is like an extension of you that the patient can take with them to apply throughout each day in between visits. The actual therapeutic benefits of homeopathy along with the inner comforts of the patient as they connect you with each dose they take.
• The dynamic broadening of your effective scope of practice multiplies the number of patients you can help and the multiple problems that each patient usually has. As you correct one set of problems, there are commonly other problems most patients don’t even tell their chiropractors. This doesn’t have to be the case anymore. Homeopathy empowers the chiropractor to correct conditions ranging from allergies to warts with incredible effectiveness!
• Obviously, the rule of multiples will exponentially increase when a homeopathic procedure is properly implemented into your practice. Many of the conditions people are suffering with have no viable solution without the dynamic duo of chiropractic and homeopathy.
  

You can be the doctor people will seek out, travel long distances to see, and pay cash for your valuable services. Take it from someone who has experienced it first hand, it’s a great position to be in.

This is no surprise. Most chiropractors relinquished whatever ethical integrity they might have had when they bought into the “subluxation” myth, and the field as a whole has a fine tradition of “practice building.”

Naturopaths, likewise, don’t mind winking at practice ethics in order to make an extra buck. Nor do MD quacks, of course. Hey, it’s getting harder and harder to make a living just by slogging through the morass of needy patients, onerous third-party billing requirements, diminishing payments, increasingly cumbersome practice guidelines, next-to-impossible-to-keep-up-with (nothing to say of tedious and technical!) medical literature, and all the rest. Why not sprinkle your practice with a little ‘diagnostic’ sugar that will appease those clingy patients—for a while, anyway—and that you won’t have to find billing codes for (because there aren’t any)? Heck, why not check out this offering from “bio-pro, inc. Amazing Anti-Aging Solutions (Healthier Patients, More Patients)”:

HOWW TOOOO ….

The “must do” seminars for those who own or are managing a Complimentary [sic]Medicine Practice.

Three day course teaches you:

How to relate to the patient, evaluate, test and diagnose

How to use solutions, mixtures, methods, supplies and equipment

How to protocol administration for Chelation, Oxidation, Chelox, TriOx, Ascorbates, UVBI

How to design and organize your office

How to hire and fire staff and to computerize

How to use public relations and marketing

How to manage compliance with Medicare, State Medical Boards and governmental regulatory agencies

Manuals included…

Each attendee receives one set of training materials, including:

Protocol Manual

Physicians Manual

Office Procedure Manual

Forms Book

Marketing Manual

Patient Results Manual

Employee Manual

Audio tapes

and other related material.

Bio-pro was founded in 1978 by the late Charles H. Farr, MD, PhD, the self-styled “father of oxidative medicine,” who was also a founder of the American College for Advancement in Medicine, the Mother of All Pseudomedical Pseudoprofessional Organizations (PPO). But none of this is surprising, right? After all, quacks quack.

What may have come as a surprise to beleaguered physicians who still play by the rules was this offering, just a few days ago, from Medscape Business of Medicine:

Six Ways to Earn Extra Income From Medical
Activities

You’re chasing after claims but watching reimbursement sink.

It’s a common story, and primary care doctors and even specialists are keeping their ears to the ground for other ways to boost their bottom line. Luckily, doctors have some fairly lucrative options that can help them maintain their income — and perhaps even increase it.

We looked at 6 avenues that physicians have taken to earn extra revenue. None of these activities require a tremendous amount of time. Participating in just 1 or 2 activities can put enough money in your pocket to allow you to breathe a little easier when the bills come in.

So what are those ‘6 avenues’? Let’s see:

• Work with Attorneys
• See Nursing Home Patients
• Serve as a Medical Director
  

So far, so not necessarily bad…

• Team Up with Pharmaceutical Companies
  

What??! Team up with pharmaceutical companies? Couldn’t that mean, like, just doing legitimate research and trying like hell to do it right? Uh, nope:

Drug and device companies spend billions of dollars each year to discover and promote new medicines and treatments, and they rely heavily on doctors to participate in these endeavors whether through clinical trials or serving as a speaker or consultant. It’s not uncommon for physicians to earn a minimum of 5 figures a year either speaking or doing clinical studies within their medical practice. Some doctors make in excess of $100,000 annually — on top of their income from seeing patients.

O’course, you gotta watch out for those pesky ethics killjoys, warns Medscape:

Although some extra money is nice, too much can turn heads — and not in a good way. In late January, The Boston Globe reported on an allergy and asthma specialist who was issued an ultimatum by his hospital, the prestigious Brigham and Women’s Hospital (Boston, Massachusetts): Stop moonlighting on behalf of pharmaceutical companies or resign from your staff position.

What it all comes down to is this:

Pros: With typical payments running about $1500-$2500 for a single talk, there’s substantial opportunity to supplement your regular income…

Cons: These arrangements are coming under increasing scrutiny from hospitals, legislators, regulators, and the media. In fact, some of the doctors whom we contacted for this article declined to talk about their involvement with drug companies.

Uh, no kiddin’. Funny that the “increasing scrutiny” doesn’t seem to come from organized medicine, medical schools, mainstream medical journals, state medical boards, or doctors in general. A couple of years ago I lamented the publication of a couple of book reviews, in the lofty New England Journal of Medicine, that celebrated trendy pseudomedicine. Shortly thereafter I received this from an emeritus editor:

I think the incursion into the bastions of medicine has to do with the fact that everything nowadays—absolutely everything—has become a market. If quackery appeals to the readers of the NEJM, it will be there. ”Is it true?” is no longer the question anyone asks, but “Will it sell?” And I think that applies to the editors of most major journals, as well.

True, dat. As for Medscape, this isn’t its first ethical gaff, and I agree with Bernard Carroll that it seems to have “a right hand – left hand problem.”

Oh yeah: what were the other 2 “avenues”? Those would be:

• Become a Media Personality
• Consult for Wall Street

On the Pitfalls of Going Electronic: Should Physicians Reject Hospital EMRs?

Yes, I believe they should, and with a spine, especially when they're lousy and their design and implementation have been led by people with superficial "certification" and/or no clinical credentials whatsoever. And sometimes no discernible IT credentials, either, unless you consider the "school of hard knocks" a credential.

(More on the credentials issue below. Also see my website "Common Examples of Healthcare IT Difficulties" for more on these issues.)

A viewpoint article was just published in the NEJM by Harvard physicians Pamela Hartzband, M.D. and Jerome Groopman, M.D. entitled "Off the Record — Avoiding the Pitfalls of Going Electronic" (NEJM 358:1656-1658, April 17, 2008).

The authors note:

... The ultimate goal of the electronic medical record — a technological solution being championed by the Bush administration, the presidential candidates, and New York Mayor Michael Bloomberg, as well as Google, Microsoft, and many insurance companies — is to make all patient information immediately accessible and easily transferable and to allow its essential elements to be held by both physician and patient. The history, physical exam findings, medications, laboratory
results, and all physicians' opinions will be collected in one place and available at a single keystroke. And there is no doubt that these records offer many benefits. We worry, however, that they are being touted as a panacea for nearly all the ills of modern medicine. Before blindly embracing electronic records, we should consider their current limitations and potential downsides.

As we have increasingly used electronic medical records in our hospital and received them from other institutions, we've noticed several serious problems with the way in which notes and letters are crafted. Many times, physicians have clearly cut and pasted large blocks of text, or even complete notes, from other physicians; we have seen portions of our own notes inserted verbatim into another doctor's note. This is, in essence, a form of clinical plagiarism with potentially deleterious consequences for the patient.

Residents, rushing to complete numerous tasks for large numbers of patients, have sometimes pasted in the medical history and the history of the present illness from someone else's note even before the patient arrives at the clinic. Efficient? Yes. Useful? No. This capacity to manipulate the electronic record makes it far too easy for trainees to avoid taking their own histories and coming to their own conclusions about what might be wrong. Senior physicians also cut and paste from their own notes, filling each note with the identical medical history, family history, social history, and review of systems. Though it may be appropriate to repeat certain information, often the primary motivation for such blanket copying is to pass scrutiny for billing. Unfortunately, these kinds of repetitive notes dull the reader, hiding the important new data.

Writing in a personal and independent way forces us to think and formulate our ideas. Notes that are meant to be focused and selective have become voluminous and templated, distracting from the key cognitive work of providing care. Such charts may satisfy the demands of third-party payers, but they are the product of a word processor, not of physicians' thoughtful review and analysis. They may be "efficient" for the purpose of documentation but not for creative clinical thinking.

In effect, the doctors have keenly observed that not only do EMR's impair documentation and thinking by seasoned professionals, especially those pressed for time, but the use of these technologies impairs the training of the next generation of physicians. I benefited much through learning how to properly document medical observations, findings, differential diagnoses, treatment plans, and other high level cognitive processes. IT designed by non clinicians with the maintenance of payor profit as a principal motivator may be, in effect, causing a further dilution in the quality of medical training. Social informatics predicts such unexpected adverse outcomes of any new information and communications technology (ICT).

However, the current environment of irrational exuberance over Health IT, as well as the potential for capital transfer from the healthcare to the IT and payer sectors and the motivators and conflicts this generates among hospital management, consultants, regulators and others, has had a marked blinding effect.

The NEJM authors also note:

Similarly, electronic medical records can reproduce all of a patient's laboratory results, often dropping them in automatically. There is no selectivity, because it takes human effort to wade through all the data and isolate the information that is pertinent to the patient's current problems. Although the intent may be to ensure thoroughness, in the new electronic sea of results, it becomes difficult to find those that are truly relevant.

A colleague at a major cancer center that recently switched to electronic medical records said that chart review during rounds has become nearly worthless. He bemoaned the vain search through meaningless repetition in multiple notes for the single line that represented a new development. "It's like `Where's Waldo?'" he said bitterly. Ironically, he has started to handwrite a list of new developments on index cards so that he can refer to them at the bedside.

...The worst kind of electronic medical record requires filling in boxes with little room for free text. Although completing such templates may help physicians survive a report-card review, it directs them to ask restrictive questions rather than engaging in a narrative-based, open-ended dialogue. Such dialogue can be key to making the correct diagnosis and to understanding which treatment best fits a patient's beliefs and needs.

... These problems, we believe, will only worsen, for even as we are pressed to see more patients per hour and to work with greater "efficiency," we must respond to demands for detailed documentation to justify our billing and protect ourselves from lawsuits. Though the electronic medical record serves these exigencies, it simultaneously risks compromising care by fostering a generic approach to diagnosis and treatment.

I agree with these assessments, especially for hospital based enterprise EMR's forced on doctors by management.

Physician leadership of HIT projects would be of great benefit. However, here's what typical healthcare organizational leaders have to say about physician leadership of HIT initiatives, in this case Denis Baker, the CIO of Sarasota Memorial Hospital, a major medical center on the Gulf Coast of Florida in an interview here:

I think that physicians bring a certain aspect to the job, but I don’t think they necessarily know how a hospital works. I think they know how their practice works and how they interact with the hospital, but I don’t think they absolutely know what nursing does, or any of the ancillary departments, and what they do.

Worse, as far as I can tell, the CIO making that statement appears to lack formal education in medicine, information systems, information technology and biomedical information science i.e., informatics. (I was unable to find any such credentials but will correct this if mistaken.)

Stereotypes of physicians do not come any more patronizing than that.

Oh, wait ... yes they do.

His statement is little different than a decade ago when I wrote this essay about stereotypes and observed others in influential positions holding marginalizing views of physicians - and indeed of professional education of any kind:

Several healthcare MIS Recruitment firms have published interesting views on healthcare MIS leadership, views that most clinicians will not identify with. " I don't think a degree gets you anything ," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers.

Healthcare MIS recruiter Betsy Hersher of Hersher Associates , Northbrook, Illinois, agreed, stating " There's nothing like the school of Hard Knocks ." (Who's Growing CIO's, Healthcare Informatics, Nov. 1998, p. 88).

In seeking out CIO talent, recruiter Lion Goodman " doesn't think clinical experience yields [hospital] IT people who have broad enough perspective . Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues ," according to Goodman.

It appears there's been little change in ten years.

Oh, wait ... yes there has been "change."

"Specialists" and "managers" in HIT projects now undergo certification by vendor-centric groups such as the Health Information Management Systems Society HIMSS.

Here's a description of the value of certication as a HIMSS Certified Professional in Healthcare Information and Management Systems (CPHIMS):

CPHIMS status provides both internal and external rewards. As a Certified Professional in Healthcare Information and Management Systems, you:

• Distinguish yourself from your peers as certified in healthcare information and management systems;
• Expand your career opportunities;
• Signal that you have mastered proven, broad-based concepts through successful completion of the Certified Professional in Healthcare Information and Management Systems Examination;
• Provide yourself with skills and tools to help you make a difference in your career, your organization, and your community;
• Enjoy the pride of recognition of knowing that you are among the elite in a critical field of healthcare; and
• Have a premier credential based on a sound assessment to distinguish yourself in an increasingly competitive marketplace.

Wow! "You are among the elite" after taking this exam!

Here are the eligibility standards:

Baccalaureate degree plus five (5) years of associated information and management systems experience*, three (3) of those years in healthcare.

Graduate degree plus three (3) years of associated information and management systems experience*, two (2) of those years in healthcare.

*Associated information and management systems experience includes experience in the following functional areas: administration/management, clinical information systems, e-health, information systems, or management engineering.

And now, the certification instrument:

The CPHIMS credential is awarded to individuals who demonstrate eligibility for the Certification Program and who successfully complete a qualifying examination. The examination consists of 115 multiple-choice test items, presented during a 2-hour session. Scoring is based on 100 items pre-selected for desirable psychometric characteristics. The additional 15 test items are included as pretest items. Performance on pretest items does not affect a candidate’s score.

That is the certification that will be used to hire more "experts" in HIT.

This is pathetic. My exams to become a licensed ham radio operator were more challenging. I consider such a credential unmeritorious at best, fraudulent at worst. (I haven't even inquired as to costs.)

However, medical credentialing exams are just a bit more thorough.

By several orders of magnitude, that is.

In conclusion, medicine is in very sad shape when in an era of out of control technology costs ($100 million for an EMR?), unclear benefit and irrational exuberance over HIT it's demanded of physicians that they use tools designed by business IT personnel, processes and methodologies best known for failure, produced by an industry rife with conflicts, whose leaders often lack substantive credentials, patronize those who do, produce ill-conceived and/or shoddy products whose use is mandated by non-clinician hospital managers and that as the NEJM writers note, impair medical practice and education.

-- SS