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Dr. Scott Monteith: On a New Wonder "Drug" on the Market

I've posted several guest posts by Dr. Scott Monteith, a psychiatrist/informaticist, at Healthcare Renewal.

These include the Mar. 2011 post "On 'The Best Compromise' on Physicians and Use of Troublesome Health IT", the Jan. 2011 post "Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith" and the Dec. 2010 post "Meaningful Use and the Devil in the Details: A Reader's View".

Here's a new guest post from Dr. Monteith regarding a new "Wonder Drug" on the market:

New Drug on the market!

This new drug claims to be incredibly effective. It’s very expensive, but the sellers assure us that it’s worth it!

Using the drug is complicated, and the health care team will likely experience side effects including frustration, reduced efficiency, fatigue, lack of attention, confusion, and cognitive dissonance (as the drug often “appears” not to work -- but it really does work and we know because the manufacturers consistently tell us it does).

By the way, the sellers of this new drug say that side effects are the fault of the people who use the drug, not the drug itself.

The drug isn’t proven to work, but its investors view it as promising and tell us that this small detail can be ignored. Besides, it would be costly to prove that it’s effective (remember, it’s already a very expensive drug).

And there are case studies showing that it appears to work. Some people reportedly really like it (these people, in fact, often become drug salesmen). Never mind that there are also large numbers of case studies indicating that it’s ineffective and dangerous, and can even kill people.

[Of course, cases of success are scientifically robust and universally valid; cases of adverse events are merely anecdotal (link) - ed.]

Nor do we have clear best practices related to correct dosages and when to take it, but the drug’s producers tell us that more of the drug is generally better than less. Everyone will have to figure out these minor details on their own. It’s recommended that you hire experts to help you with this detail. No problem – there are experts around every corner (they’re called “consultants”).

Please join the manufacturers in their campaign to use and promote this new drug – the government has! Uncle Sam will pay you an incentive to use this new experimental drug over the next few years. If you refuse to use it, however, beware! Uncle Sam will penalize caregivers who refuse to use the drug by reducing their payments by 1% in the first year, and then accelerating these reductions in years 2-5.

We also need to work hard to keep groups of citizens from regulating it, or asking inconvenient questions like “can you please prove that it works before we take it and risk side effects and spend large amounts of money on it?” (You know, the same kind of nasty questions that we ask of other health care interventions.)

Almost forgot…once you start the drug, it’s very hard to quit to using it. No, it’s not heroin. Don’t be silly!

Finally, we’re working hard to keep the manufacturers safe from any liability associated with the drug. Yes, yes, I know – they claim it’s safe and works and all problems are related to the people who take it. But these “safe harbors” (whether through government intervention or strong user agreements) are necessary ... just in case ...

By now I’m sure that you want to run out to your pharmacy to buy this wonderful new drug. You may also want to invest in its maker as well. So here are the details…

The generic name is “HIT.” The trade name is “EHR.” It’s stock symbol is ONC.

I think the point is very well made.

-- SS

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Dr. Scott Monteith on "The Best Compromise" on Physicians and Use of Troublesome Health IT

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Dr. Extormity's Testimony at Healthcare IT Hearing

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Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith

Psychiatrist-medical informaticist Dr. Scott Monteith was a guest blogger on the complications of "Meaningful Use of EHR's" in the Dec. 21, 2010 post "Meaningful Use and the Devil in the Details: A Reader's View."

He also testified at the Office of the National Coordinator's Health IT Standards Committee Implementation Workgroup which recently had a meeting, Jan. 10-11, 2010, as I wrote about here.

With his permission I am reproducing his testimony to the Committee (which is supposed to also be posted to the meeting website) without further comment. None is needed.

Emphases in the original:

HIT Testimony in DC January 11, 2011

My name is Scott Monteith, a board-certified psychiatrist and Fellow of the APA from Michigan. I work in private practice and with Community Mental Health (CMH). I also teach in MSU’s medical school.

My 21 year interest in HIT includes:

being a CCHIT Juror;

appointed by our Governor to three terms on the Controlled Substances Advisory Commission, which has a role overseeing Michigan’s Automated Prescription System;

a member of the Business Operations Workgroup for Michigan’s Health Information Network;

working with malpractice insurance companies to manage growing risks from EHRs;

and more.

I’m “pro-HIT.” For all intents and purposes, I haven’t handwritten a prescription since 1999.

That said and with all due respect to the capable people who have worked hard to try to improve health care through HIT, here’s my frank message:

ONC’s strategy has put the cart before the horse. HIT is not ready for widespread implementation. The problem isn’t Luddite doctors not adopting; the problem is that HIT isn’t ready, especially if we want safe and efficacious bells and whistles like CDS, interoperability, etc.

To describe ONC’s handling of HIT promotion, let me use an analogy:

It’s as if policy makers said, “Let’s promote a cure for cancer. By curing cancer, we can save money and improve the quality of people’s lives.”

Like our collective fantasy for the benefits of widespread HIT use, which I share, who can argue with the dream of curing cancer, or the good intentions behind it?

The problem is that finding a cure for cancer isn’t as simple as declaring a cure, and then merely getting resistant doctors to start using it.

Continuing the analogy, ARRA dollars are incenting doctors to use Laetrile, the supposed cancer cure that was not evidence-based and didn’t work.

ONC has promoted HIT as if there are clear evidence-based products and processes supporting widespread HIT implementation.

But what’s clear is that we are experimenting…with lives, privacy and careers.

As a clinician, I’m here to report that certified EHRs are not necessarily producing better documentation or improved care.

Yes, EHR-generated documentation is usually more legible, but it’s often “legible gibberish.” And there’s a lot of it, including meaningless data, burying relevant information.

Example:

A colleague requested records for his mother’s nearly two-week hospital stay; this particular hospital is an early adopter of EHRs. He received almost 2,900 pages.

Finding relevant data in the midst of 2,900 pages can be like finding a needle in a haystack.

Here’s another example of EHRs degrading documentation:

In our CMH, administration inserted language into the doctors' treatment plans. The problem is that the language is patently false and untrue.

Unfortunately, administration controls the EHR, and physicians cannot change the untrue language.

“Ghost writing” clinical notes – often incorrectly – is increasingly common, whether through fixed fields, no or limited free text, inserted language that cannot be changed, multi-authored documents, or other means.

I have documented scores of error types with our certified EHR, and literally hundreds of EHR-generated errors, including consistently incorrect diagnoses, ambiguous eRxs, etc.

As a CCHIT Juror, I’ve seen an inadequate process. Don’t get me wrong, the problem is not CCHIT. The problem stems from MU.

EHRs are being certified even though they take 20 minutes to do a simple task that should take about 20 seconds to do in the field. Certification is an “open book” test. How can so many do so poorly?

For example, our EHR is certified, even though it cannot generate eRxs from within the EHR, as required by MU.

To CCHIT’s credit, our EHR vendor did not pass certification. Sadly, our vendor went to another certification body, and now they’re certified.

MU does not address many important issues. Usability has received little more than lip-service. What about safety problems and reporting safety problems? What about computer generated alerts, almost all of which are known to be ignored or overridden (usually for good reason)?

The concept of “unintended consequences” comes to mind.

All that said, the problem really isn’t MU and its gross shortcomings, it is ONC trying to do the impossible:

ONC is trying to artificially force a cure for cancer, basically trying to promote one into being, when in fact we need to let one evolve through an evidence-based, disciplined process of scientific discovery and the marketplace.

Thank you for the opportunity to be a part of this process.

Actually, I will make one comment:

In the current climate of "cybernetics over all" in healthcare, this is not the type of testimony that will get the good Dr. any dinner invitations.

-- SS

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Meaningful Use and the Devil in the Details: A Reader's View

A reader, Dr. Scott Monteith, a psychiatrist, shared his thoughts on government-mandated 'Meaningful Use' of Electronic Medical Records ('MU') with me after reading a number of my EHR posts, and asked if he could share his thoughts via Healthcare Renewal.

Dr Monteith is a graduate of the University of Michigan and Michigan State University where he was chief resident. He is a board certified psychiatrist, clinical assistant professor in the departments of psychiatry and family medicine at Michigan State University, and has worked in the same community health center for 20 years serving people suffering from severe and persistent mental illness. His interest in Health Information Technology goes back over 20 years. He has served as a CCHIT Juror, was appointed by Michigan’s Governor Granholm to the Controlled Substances Advisory Commission which has an oversight role for the Michigan Automated Prescription System, and was a member of the Business Operations group of the Michigan Health Information Network.

Dr. Monteith writes:

From Medical Economics:
“While 85% of physicians were aware of the financial incentives for implementing an electronic health record (EHR) system, more than 35% did not know that they face government-assessed financial penalties for not complying, according to a survey of more than 500 physicians by Physicians' Reciprocal Insurers, a New York-based medical liability insurance company. The penalties are equal to a 1% reduction of the physician's annual Medicare payments per year up to 5%. However, those penalties do not seem to be having the intended effect, as more than 65% of physicians who were unaware of the financial penalties said this would not cause them to implement system."
The above Medical Economics article reflects a reality that is consistent with what we are seeing in the clinical ‘trenches.’
Eligible Providers (EPs) are realizing that Meaningful Use (MU) incentives are not as simple as…using a certified EHR + being part of Medicare and/or Medicaid + applying for MU + attesting to MU.
Receiving $44k (or $64k) in incentives seems not only increasingly elusive, but of questionable benefit even if some or all of the incentives are realized.

The ‘carrot & stick’ of Meaningful Use (MU) seems to increasingly be viewed as ‘meaningless and useless’ by at least some clinicians. Some are asking if ‘MU’ will stand for ‘meaningless and useless’ in the future.

There seems to be a long list of reasons why MU is so challenging. From what I have gleaned, there appear to be two main issues:

1. the cost to meet MU may be too high (and, said another way, the ROI might be too low); and

2. there are too many uncertainties associated with MU (largely stemming from the risk of burdensome bureaucratic entanglement – an unknown and potentially huge “cost”).

As we know, MU reimbursement flows through two streams: Medicare and Medicaid.

And one’s incentive dollars and/or penalties are based on Medicare/Medicaid volume.

So small Medicare/Medicaid volume means small incentives/penalties. With the perception of inevitable Medicare and Medicaid cuts, these two funding streams become increasingly irrelevant for more and more providers.

Another issue stems from the fact that MU and the associated EHR “certification” are losing credibility because they do not address “usability.” My users simply want EHRs that “work,” and “work” well (like their iPhones).

Users ultimately want and expect usability. They hoped that certification would help guide them in this important respect, but they are finding that is not the case.

To the extent that certification is not meaningfully addressing ‘usability,’ therefore, MU is viewed as ‘useless’ in guiding purchasing decisions.

Further, many are simply not confident that they will meet MU.

Other challenges I’ve encountered include:

One big problem with MU is that many people believe that wedding one’s self to MU (ARRA) will open a can of bureaucratic worms (and they might be correct)

MU is 864 pages of details. How many users will read all 864 pages of the government’s final rule for MU? (And of those few who do, how many will understand it?). If one doesn’t know the MU rules, how will one prepare for MU? Hire consultants and IT experts? How much will this cost?

How will one establish that one is MU-certified? In year one there will be self-attestation. But who/what will certify users as to whether or not users are meeting MU in the other years? How much will it cost (direct costs to pay above certification organization/entity)?

How much will it cost users to become certified (indirect costs to prepare for your certification)?
Currently it appears that one must recertify every year for incentives. But how often will one have to recertify to avoid penalties? What will be the ongoing cost in terms money, time, energy, business flow? Will the ROI be positive or negative (and how positive or negative)?

To what future governmental audits might one be subjected if one gets incentive dollars and/or wants to avoid penalties (especially after the inevitable celebrated cases of abuse)? It is not hard to imagine receiving a letter from the government that says, in essence: “You self attested that you met MU in year one. You are now being audited to substantiate your attestation.”

How many people will be audited after receiving ARRA dollars? How much time will the audit take? For how long will you need to keep records? What records?
What will Congress (and the FBI) do when someone gets ARRA dollars through the “incentives” (or avoids “penalties” in the penalty phase), but they haven’t properly completed the MU certification process, or properly/fully documented it (perhaps no fault of their own)?

What liability does one incur by claiming to meet MU, but then later discovering that someone in the government says that you have not met MU?
Given that one needs to do things for MU that establish X percent of a given function (e.g., Rxs) are accomplished through an EHR, one needs both a numerator and denominator to establish the percentage. But how does one capture the data to establish MU percentages for Rxs (and other tasks) that are done on paper?

Are incentive dollars taxable? The answer appears to be “yes.” But many doctors are already “signing over” their dollars to institutions. Unfortunately, neither the doctors nor the institutions are making accommodations for the tax implications. That is, what happens when institutions get the dollars, but because the dollars flow through the clinician, the clinician gets the tax bill?

What happens if you change EHRs, for example, due to moving to new practice? Will you have to start all over again? Will you have to reimburse the government?
Today there are over 400 EHR vendors. In five years, it is expected that at least 350 will ‘go under’ (no longer exist). What then? Recertify? Give back ARRA dollars?
Will the goal line (either in terms of criteria or time) for MU be moved? (It might move; some say it definitely will move.) How often will this occur? What are the implications for your MU and any ARRA dollars that you have received?
The Republican “Pledge” is calling for no incentives be spent (including related to HIT).

Of course, my own opinion is that setting standards for "meaningful use" implies that use of EHR's can be meaningful to the doctor & patient (rather than to the government and to payors); the literature is conflicting on this point.

Further, doing do at a time when HIT is widely acknowledged to be of poor usability (even by HIMSS itself) is putting the cart before the horse, as I wrote at my post "Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?"

We report; you decide.

-- SS

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