Increased Lab Ordering with EHR's?

ONC has once more proffered typical politically-motivated spin with regard to the Harvard study "Giving Office-Based Physicians Electronic Access To Patients’ Prior Imaging And Lab Results Did Not Deter Ordering Of Tests" that I wrote about at "Another Health IT Mythbuster: Doctors order more X-rays, not fewer, with computer access."

That study had the rather tame, reasonable conclusion:

... These findings raise the possibility that, as currently implemented, electronic access does not decrease test ordering in the office setting and may even increase it, possibly because of system features that are enticements to ordering. We conclude that use of these health information technologies, whatever their other benefits, remains unproven as an effective cost-control strategy with respect to reducing the ordering of unnecessary tests.

The ONC response (posted here at present) to such a mild conclusion about an experimental technology seemed very splenetic.

As I mentioned at the aforementioned post, ONC has thrown good science under the bus before, for political purposes in my view:

... On the other hand, coming from a political office that clearly does not understand how to conduct qualitative research and creates political promotion pieces masquerading as "research", such a statement is not surprising. See "ONC: "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results" at this link, where essential research methodologies were thrown under the bus for publication in Health Affairs.

At least the deviations from rigorous research methodologies were admitted:

“... Our findings must be qualified by two important limitations: the question of publication bias [e.g., bias in evidence selection - ed.], and the fact that we implicitly gave equal weight to all studies regardless of study design or sample size.”

Unfortunately, the media, politicians, financial decisionmakers and others are likely not to really comprehend, in-depth, the full significance of that sentence.

I am in the unfortunate situation of again having to stuff ONC's - um, stuff - back into the bull.

First, hat tip to Histalk where I found the link below:

National Coordinator for HIT Farzad Mostashari, MD takes issue with the recently published report that found doctors with online access to patients’ charts ordered more tests. Mostashari disputes the study, which raised questions as to whether or not EHRs cut costs. Mostashari’s contends that the study was based on 2008 data and before the start of the Meaningful Use program and thus does not address certified EHRs’ capabilities for data exchange and clinical data support.

The fatal passage in the linked ONC piece at http://www.healthit.gov/buzz-blog/meaningful-use/study-facts/ is this:

"Also, the study data were from 2008, before the passage of the HITECH Act and the linking of payment incentives to the meaningful use of EHRs."

This seems a variation of the typical excuse-making in IT - "they were using v. 1.0; it's all fixed in the later version."

The outcomes of (Orwellian-named) "Meaningful Use" (MU) have not been studied, to my knowledge. Futher, the criteria chosen for "Meaningful Use" were primarily best guesses as to what could be beneficial. ("Meaningful Use" should have been more accurately termed "good faith use.")

Claiming that 2008 data on EHR-related test ordering is invalid because "Meaningful Use" was not in effect at the time is, in fact, jumping to an unsupported conclusion that "Meaningful Use" will counter whatever multiple medical/social factors caused the increased ordering in the first place -- because, of course, MU is "Meaningful" and deterministically guaranteed to work out, nationally, as planned, among all outpatient and inpatient settings.

This seems a form of "begging the question":

Begging the Question is a fallacy in which the premises include the claim that the conclusion is true or (directly or indirectly) assume that the conclusion is true. This sort of "reasoning" typically has the following form.

- Premises in which the truth of the conclusion is claimed or the truth of the conclusion is assumed (either directly or indirectly).
- Claim C (the conclusion) is true.

This sort of "reasoning" is fallacious because simply assuming that the conclusion is true (directly or indirectly) in the premises does not constitute evidence for that conclusion. Obviously, simply assuming a claim is true does not serve as evidence for that claim. This is especially clear in particularly blatant cases: "X is true. The evidence for this claim is that X is true."

I note that the MU criteria are themselves evolving and not finalized. Making predictions about the future is the domain of fortune tellers with crystal balls, not scientists:

Health IT WILL reduce costs and improve caregivers’ decisions and patients’ outcomes. It is written in the stars!

ONC seems to think it is capable of such certainty, as I wrote in mid-2010 at "Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records":

... 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.

In its current piece, ONC goes on to state:

Reducing Test Orders Is Not the Way that Health IT Is Meant to Reduce Costs

The ultimate impact of EHRs on reducing cost will be through improvements in the coordination and quality of care, and the prevention of unnecessary and costly complications and hospitalizations. [Note the mysterious disappearance of the word "tests" - ed.] Providers who are embracing new delivery and payment models such as Accountable Care Organizations and Patient-Centered Medical Homes know that meaningful use of EHRs is a critical foundation for being able to improve quality while reducing cost.

That is, simply, a lie. Reducing test utilization has long been claimed as a benefit of EHR's.

For example, from http://www.healthit.gov/patients-families/benefits-health-it:

EHRs reduce unnecessary tests and procedures. Have you ever had to repeat medical tests ordered by one doctor because the results weren’t readily available to another doctor? Those tests may have been uncomfortable and inconvenient or have posed some risk, and they also cost money. Repeating tests—whether a $20 blood test or a $2,000 MRI--results in higher costs to you in the form of bigger bills and increased insurance premiums. With EHRs, all of your care providers can have access to all your test results and records at once, reducing the potential for unnecessary repeat tests.

It is also another example of "moving the goalposts", a defense often used by those without a sound argument; by politicians; and sometimes by - scoundrels.

(I observed another "moving of the goalposts" at my aforementioned post "Another Health IT Mythbuster: Doctors order more X-rays, not fewer, with computer access." In that post I observed Michael Furukawa, a health economist in the ONC office, stating that the researchers’ focus was not "deep enough" to support the study’s conclusions. He wrote: “The data are sound, the methods are appropriate, but the focus is limited,” he said. “They only looked at one piece of health IT.”)

Well, yes, and the piece they looked at should set off red flags that the assumptions about health IT and savings might be erroneous - not generate excuses that the goalposts were too close, and need to be moved further away.

This is not to mention that it appears most healthcare errors have little to do with documentation, as I outlined in my Dec. 2010 post "Is Healthcare IT a Solution to the Wrong Problem?"

I particularly take issue with the ONC statement that:

... this was not a randomized trial, but an observational study (the National Ambulatory Medical Survey) that was not designed to answer the question of cost, or associations between EHRs and quality. As a result, many other variables that could affect physician behavior could not be examined in this study

Yet in the aforementioned ONC "predominantly positive results" literature survey described at this link, ONC "implicitly gave equal weight to all studies regardless of study design or sample size." Their review thus included qualitative studies that were probably not meant to be evaluative, and observational studies subject to severe methodological bias, yet all were weighted equally. Further, studies contradicting the 'narrative' of health IT efficacy and beneficence such as in this list appear to have been excluded.

This appears a prime example of, at best, "the pot calling the teakettle black", and raises doubts as to ONC's objectivity and perhaps even intellectual honesty. Of course, they are a political office with a mission, so perhaps this can be understood. (Not excused, but understood.)

ONC also views risk management-critical reports of health IT-caused harm as "anecdotal", a scientific and ethical faux pas (or is it willful blindness?) of major proportions.

As I wrote at my April 2001 post "Making a Stat Less Significant: Common Sense on "Side Effects" Lacking in Healthcare IT Sector":

... This view [of negative HIT reports being 'anecdotes'] extends all the way up to the Director of the Office of the National Coordinator for Health IT, who glibly stated per the Aug. 2010 Huffington Post Investigative Fund article FDA, Obama Digital Medical Records Team at Odds over Safety Oversight that FDA's own reports of health IT related injuries and deaths were “anecdotal":

ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” He told the Investigative Fund that he believed nothing in the report indicated a need for regulation.

Those "injury findings" appear in an FDA Internal Memo made available by the aforementioned Huffington Post Investigative Fund and archived at the following link:

Internal FDA memorandum on HIT risks (PDF) to Jeffrey Shuren MD JD (Director, Center for Devices and Radiological Health). Health Information Technology (H-IT) Safety Issues. "This is an Internal Document Not Intended for Public Use." Feb. 23, 2010.

(My description/summary of the memorandum is at my Aug. 2010 post "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun?")

The definitive take-down of the "anecdote" canard is at this link.

One could wonder if a criteria for work at ONC is a Ddulite disposition ('Luddite' with first four characters reversed):

Ddulites: Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures.

Instead of logical fallacy and "spin", perhaps the ONC would be better served by sponsoring some (independent, objective) researchers to actually conduct research supporting their claims about the effects of the "Meaningful Use" program.

Finally, perhaps ONC should ask my mother what she thinks about EHRs. She has specially-acquired firsthand expertise. They can find her here.

-- SS

Addendum 3/9/12:

At my Feb. 2011 post "Does EHR-Incited Upcoding (Also Known as "Fraud") Need Investigation by CMS, And Could it Explain HIT Irrational Exuberance " is another side effect on costs of EHR's in inpatient settings, specifically, the ED.

-- SS

Addendum 3/11/12:

Another article in 2010 by Himmelstein, Woolhandler & Wright had reached related conclusions:

Hospital Computing and the Costs and Quality of Care: A National Study

David U. Himmelstein, MD, Adam Wright, PhD,Steffie Woolhandler, MD, MPH

The American Journal of Medicine Volume 123, Issue 1 , Pages 40-46, January 2010

Background

Many believe that computerization will improve health care quality, reduce costs, and increase administrative efficiency. However, no previous studies have examined computerization's cost and quality impacts at a diverse national sample of hospitals.

Methods

We linked data from an annual survey of computerization at approximately 4000 hospitals for the period from 2003 to 2007 with administrative cost data from Medicare Cost Reports and cost and quality data from the 2008 Dartmouth Health Atlas. We calculated an overall computerization score and 3 subscores based on 24 individual computer applications, including the use of computerized practitioner order entry and electronic medical records. We analyzed whether more computerized hospitals had lower costs of care or administration, or better quality. We also compared hospitals included on a list of the “100 Most Wired” with others.

Results

More computerized hospitals had higher total costs in bivariate analyses (r=0.06, P=.001) but not multivariate analyses (P=.69). Neither overall computerization scores nor subscores were consistently related to administrative costs, but hospitals that increased computerization faster had more rapid administrative cost increases (P=.0001). Higher overall computerization scores correlated weakly with better quality scores for acute myocardial infarction (r=0.07, P=.003), but not for heart failure, pneumonia, or the 3 conditions combined. In multivariate analyses, more computerized hospitals had slightly better quality. Hospitals on the “Most Wired” list performed no better than others on quality, costs, or administrative costs.

Conclusion

As currently implemented, hospital computing might modestly improve process measures of quality but does not reduce administrative or overall costs.

-- SS

Health IT Culture: Severe Overconfidence (Arrogance?) Shows In The Industry's Very Terminology For Their Deliverables

Health IT commentator Neil Versel notes in his piece "HIMSS12 notes" at his site Meaningful Health IT News that:

I am in 100 percent agreement with something Dr. Wendy Sue Swanson, a.k.a. Seattle Mama Doc, said during an engaging presentation Monday at the HIMSS/CHIME CIO Forum. She made the astute observation that there needs to be better distinction between expertise and merely experience when it comes to celebrities being held up as “experts” in healthcare and medicine. Let’s just say that Swanson, as a pediatrician, is no fan of some of the things Jenny McCarthy and Dr. Mehmet Oz have told wide audiences.

He posted a link to his piece in a social networking site we both visit. I commented:

To that, I add "healthcare IT" where it seems anyone who's done anything with a computer in some medical setting can get away with calling themselves a "medical informatics expert" or "health IT expert." As in ham radio levels of just a few years ago, we need distinctions between novice class, technician class, general class, advanced class, and extra class.

In his piece Neil also linked to what he correctly termed "scathing critique" of the venue for HIMSS 2012 at my HC Renewal post "HIMSS Annual Meeting in Las Vegas - Fitting for People Who Gamble With People's Lives to Make a Buck?"

I replied to him via the social networking site that:

"I like to point out ironies that seem to escape others, although I have heard from other colleagues that I was not alone in finding Las Vegas a somewhat peculiar place for a medical meeting about improving health! However, others' mileage may vary."

Neil noted that he likes pointing out ironies, too, and gave as an example as the meetings held at the Loews Hotel near Vanderbilt University Medical Center, being that Loews Hotels is a corporate cousin of Lorrilard Tobacco.

Finally, Neil comments:

Popular topics this year were the expected meaningful use and ICD-10, plus the buzzwords of the moment, business analytics and big data. I’d be happy I never hear the word “solution” as a synonym for “product” or “service” again. To me, that represents lazy marketing. Get yourself a thesaurus.

I agreed, and replied that:

"Solution", the common term in IT for anything an IT department or company provides, is a one-word example of a language usage akin to 'begging the question.'

This term, in one mere word, reflects a stunning arrogance within the IT culture.

I also noted that:

... there needs to be terminological consistency. If the IT vendors can call their wares "solutions", then doctors should call their treatments and drugs "cures." Come to my office for your cure; I am a curer; I write cures, not prescriptions.

I also noted that the term "meaningful use" phrase selected by the U.S. government/HHS for EHR adoption according to printed guidelines is another example of terminology that, ante hoc, assumes its semantics are correct.

How do we know the use is "meaningful" until such use is studied rigorously and outcomes, costs. etc. assessed?

Answer: we don't.

And this administration criticized the previous one for politicizing science ... George Orwell could not have selected better terms than "meaningful use", "certified EHR", and "solution" as examples of "Newspeak" in 1984.

-- SS

Henry Ford Health System Decides Meaningful Use Not That Meaningful

The CMIO for inpatient services for Henry Ford Health System discusses the Michigan system's decision to hold off on applying for meaningful use funding in 2011, and what that means for its long-term vision of connecting clinical goals with IT support. April 15, 2011. Podcast running time: 3:58 (link to podcast).

Excerpts:

“The clinician experience of delivering care has never been more complicated. Implementation and adoption of these Electronic Health Records seems to be to many people an end in itself—and that’s unfortunate.

The implementation and adoption of EHR is a means to an end and one of those ends is better patient care and another one is clinician efficiency or better and more effective care. And that part feels to me that it gets lower priority and gets overlooked for the sake of adoption and implementation especially now with the federal requirements coming on.

Now we must adopt, adopt, adopt. And the clinician experience is left behind. The complexity of being a physician is almost overwhelming both in the hospital and clinic setting and that’s one of my great concerns.”

- John Frownfelter, MD CMIO, Henry Ford Health System

Health IT in its present poorly usable form only makes being a clinician more overwhelming. As I wrote at "Meaningful Use Final Rule", meaningful use initiatives before "meaningful usability" has been achieved have put the cart before the horse.

Henry Ford, inventor of the assembly line, would probably have approved. An assembly line is appropriate for building identical widgets, but inappropriate for the implementation of health IT in the extremely complex, poorly bounded, conflicted, highly variable, uncertain, high-tempo work domain of hospitals, especially if the implementation is just for implementation's sake.

-- SS

Healthcare IT Delirium

The delirium surrounding healthcare IT seems to be worsening.

In an Aug. 2010 post "EPIC's outrageous recommendations on healthcare IT project staffing" I wrote that health IT company Epic, one of the largest, seemed to not care about healthcare or IT education or experience in its recommendations to hospitals on staffing of safety critical projects (i.e., the implementation of safety critical clinical cybernetic devices):

Epic emphasizes that many hospitals can staff their projects internally, choosing people who know the organization. However, they emphasize choosing the best and brightest, not those with time to spare. Epic advocates the same approach it takes in its own hiring: don’t worry about relevant experience, choose people with the right traits, qualities, and skills, they say.

The guide suggests hiring recent college graduates for analyst roles. Ability is more important than experience, it says. That includes reviewing a candidate’s college GPA and standardized test scores.

Based on a presentation by the company at my university, they apparently they mean it:

Career Presentation: Epic Systems Corporation - TONIGHT

The Drexel Women in Computing Society (WiCS) will organize a career presentation by Epic Systems Corporation tonight, January 19, 2011, from 6 to 7 p.m. at University Crossings, room 149 (32nd and Market Streets).

Epic Systems Corporation, located in Madison, Wisc., creates software for the healthcare industry and is hiring for many positions. They are recognized nationally as a leader in moving healthcare organizations from paper medical records to completely electronic ones. Epic hires from all majors, all degrees and all experience levels, and requires no software experience. [Or, as is obvious from this solicitation, healthcare experience - ed.] The presentation will include an overview of Epic's industry work, corporate philosophy and role-specific expectations.

This presentation is open to all graduate and undergraduate students at Drexel University. Pizza will be provided and resumes will be accepted after the presentation.

Other health IT merchants will probably soon follow suit.

As I also wrote at the aforementioned post:

Medical environments and clinical affairs are not playgrounds for novices, no matter how "smart" their grades and test scores show them to be, and these practices as described, in my view, represent faulty and dangerous advice.

The advice also is at odds with the taxonomy of skills published by the Office of the National Coordinator I outlined at the post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership."

This talent management ideology is also alien to medicine (at least since the Flexner Report of 1910), and at odds with critical thinking and common sense.

Then there's this, an attempt by Medical Informatics researchers of the American Medical Informatics Association (AMIA) to ex post facto put a scientific veneer on the troublesome and extremely costly "Meaningful Use of health IT" criteria mandated by the US Government. Those criteria were largely arrived at through "off-the-top-of-their heads" committee meetings (see "Meaningful Use and the Devil in the Details: A Reader's View" on this blog and "The MU Hearings: DrLyle Goes to Washington 1/18/11" at the HIStalk site):

On behalf of the CISWG Leadership Team [AMIA Clinical Information Systems work group - ed.]

In light of the HITECH Act and subsequent Meaningful Use objectives, it is imperative for the informatics community to consider the current science behind clinical information systems and to identify areas requiring further research. In keeping with this, the CISWG leadership is interested in developing a white paper, “The Science Behind the Meaningful Use Criteria”.

The purpose of this paper will be to synthesize the existing literature regarding each of the meaningful use criteria and develop recommendations for future research. We are requesting your assistance in this work.

We ask you, as experts in the field, to help identify current literature and subject matter experts for EACH of the meaningful use criteria. In addition, please state if you (1) believe there is evidence for the objective, and (2) if the evidence is supporting of the objective. Please do not delete other’s input but rather add your comments directly to the document (even if in conflict with others).

The document should result in a great asynchronous discussion. Please provide your input by the 7th of February. We appreciate any input you are able to provide. Thank you for your assistance and we look forward to sharing the results of this work in the future

My contribution will probably be that it's probably better to examine the science in a domain before putting it into national policy, not after ...

I'd also observed at "Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?" and at the followup post "Cart before the horse, again: IOM to study HIT patient safety for ONC" that a focus on "meaningful use" before a focus on health IT "meaningful usability" and health IT safety was putting the cart before the horse.

Recklessly so, in fact.

How not to do health IT: by putting the cart before the horse on usability and safety

Finally, in light of the recent experiences of a medical informatics-skilled hospitalist as I posted at "An MD hospitalist on EHR's: I might have inadvertently skipped something during the mayhem" ...

[The NY Times article on information overload in the military causing deaths] was eerily similar to / descriptive of my experience last night in the hospital: processing multiple information sources related to multiple different problems for a new admission (patient, family, ED staff, disjointed EMR - some documents in the Documents tab of the [major EHR vendor name redacted - ed.] system but most others in the hospital system Portal requiring a separate lookup, some radiology studies available through the EMR on any workstation but others requiring accessing the PACS system directly on scarcer dedicated workstations - plus paper record components, including EKGs, progress notes) ... all while various drone-equivalents are channeling information regarding multiple other admissions in the wings and/or patients decompensating on the floors or in the ICU.

Oh yeah, and then there's the "12 hour shift" thing. Oops, gotta run... Just slept all day after my night shift and have to head back to hospital for the next one. Still haven't submitted any charge tickets, btw, even for last week's shifts (I'm carrying around paper face sheets with scribbled notes on the back; I'm supposed to fax them to the billing office once I figure out what CPT / visit intensity code I want to use.)

Gosh, I hope I remembered to touch on 10 bullet points related to ten organ systems for my ROS for each of my admissions; might have inadvertently skipped something during the mayhem...

PS. I'd love to be wearing one of those brain wave contraptions mentioned in the article to see what my theta wave activity was.

... and the injury of my relative in 2010 due to interference of healthcare IT in clinician-clinician communications (including, but not limited to, me communicating with those caring for my relative, and them communicating among themselves and with the technology itself), all I can say is:

The field of health IT has become delirious.

On top of an irrational exuberance (see this blog query) largely unsupported by the literature (e.g. here), the technology is experimental, its rollout is a grand national experiment in social re-engineering of medicine, there is no patient informed consent, nobody is in control, and nobody is taking responsibility for regulating the domain despite known risks. The results will very likely reflect the Wild West free-for-all that is now extant.

This is crazy stuff.

Running off the rails. We seem to be going out of our way looking for this with HIT, sending it out full speed ahead on far too short a track ...

There's very little else I can do about it at this point, having tried writing, speaking, and political venues.

This will affect your healthcare, not just mine (at least I know what to look out for).

I suggest litigators stay closely attuned to hospital morbidity and mortality incidence (and incidents).

-- SS

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