"The stage 1 criteria were theory-based. Stage 3 needs to be evidence-based." - Jason Mitchell MD, AAFP

OK, and Stage 2 fits precisely where? Given that it now looms large before the provider community?

MY REC is now fielding calls regarding stage 2. I had one today from a doc, concerning Stage 2 CQMs as they apply to several specialities (Ortho, Pods, and Chiro). I could hear from my boss's office as he threw me and a colleague under the bus and gave the doc my name and my colleague Catelyn's name.

It was either me or Catelyn. I took it, and dutifully followed up. I will do my best for this physician, notwithstanding that I am not funded for it.

I did a Stage 1 Year 2 attestation a couple of weeks ago, I am not funded for those either. I felt kinda stupid. I went over and walked her through it (she was a hand-off), only to then realize "well, crap, this is year 2, we don't get any M3 credit for this."

Though, she'll no doubt speak kindly of me in our REC eval.
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"Stage 3 needs to be evidence-based."

Well, yes, but what will acceptably count as "evidence," given the persistent, loud chorus of inveterate irascible anti-HIT naysayers who claim that either [1] EHRs are a dispositive step backwards from the bucolic Better Days of the All-Knowing Doc with his black bag and clipboards and paper charts, or, -- only marginally more charitably, -- that EHR deployment comprises an unethical uncontrolled mass experiment willfully endangering the lives of patients in the service of lining the pockets of HIT vendors.

I dunno. These people are apparently a lot wiser than am I In The Ways of Science.

So, HIT deployment? "Uncontrolled"? Yes. Go-Lives are neither controlled double blind clinical trials, nor more generally randomly decided upon.

Which sort of leaves us with the lesser CER -- "Comparative Effectiveness Research," blighted with its host of methodological limitations. Nonetheless, to me, anyway, no excuse for not trying.

None of which is to confer my own uncritical endorsement of the MU criteria of any of the Stages, current or proposed. Separate issues. I have to believe that HIT deployment is both necessary and a net good.

If that makes me "an industry tool," so be it. I am now approaching the age (I turn 67 on Saturday) where this will be increasingly more than some contentious abstraction. Should I turn up in acute care, I will place my bet -- all other factors held constant -- with facilities and docs that are digitally savvy.

Maybe I'll be wrong. But, I rather doubt it.

THURSDAY MORNING UPDATE

The Office of the National Coordinator’s Health IT Standards Committee is urging ONC leaders to lean towards menu options and certification for use cases on Stage 3 meaningful use rather than core requirements, and to especially keep in mind that standards for a variety of clinical procedures are still evolving.

Standards committee vice chair and Beth Israel Deaconess Medical Center CIO John Halamka said their main concern was ensuring Stage 3’s aspirations could be met practically, given current standard maturity and implementation trends.

Presenting the standards committee’s comments on several dozen meaningful use objectives to the Health IT Policy Committee, Halamka said that although the ONC is making progress in the Health eDecisions Initiative, there aren’t currently standards or technologies that “represent knowledge/rules and enable their automated incorporation into EHR workflows.” In other words, standards and interoperability for some functionalities and clinical procedures are still catching up to aspirations...

Oh, but the ONC is in the pocket of the HIT vendor lobby, right?

Click the link. Read the full article.

MORE CONTENTION

...Patients and doctors alike understand the need for improved efficiencies and value in our era of exploding health care costs. We must strive to find a solution to our health care cost crisis that is transparent, cost-effective and ethical. Without such an effort, our health care system will collapse. Only recently has the Office of the National Coordinator of Health Information Technology recognized the problem and opened their Health IT Patient Safety Action and Surveillance Plan for public comment. This plan asks the EMR companies and interested stakeholders to develop their own methods to assure patient safety and reporting systems – a move that approaches the same ethical standards as equivalent of asking the foxes to watch the henhouse. Nonetheless, we should acknowledge their efforts.

But we should be cautious of EMR systems as we move forward. After all, these clinical systems have not been subjected to the same cost-benefit and ethical scrutiny as other clinical tools we use in health care. The scrutiny of EMRs should be no different than that found with pharmaceutical or medical device research where Institutional Research Board approval and proof of no conflict of interest is demanded. Why should clinical EMR systems be any different?

Given the profit motives and market consolidation occurring amongst the purveyors of these EMR systems and the potential for lethal EMR errors both from software and human interface issues, doctors and patients must especially question the ethics of the movement to deploy untested, novel technology on our patient population under restrictive covenants. As part of informed consent, patients should have full understanding of how and where their clinical data are used, including when it will be used for direct-marketing campaigns, prioritizing care delivery, or for research. Patients should be able to opt out of the use of their clinical data for these or any other purpose if desired, without restricting payment for care. Finally, physician and patient concerns about EMR systems should be allowed to be vetted publicly and without threat of professional or personal reprisal or the withholding of payments for care rendered, especially and particularly if these disclosures are performed in the best interest of patient care.

To do otherwise is unethical for our patients and the public at large.

Wes Fisher is a cardiologist who blogs at Dr. Wes.

You have to take all of this stuff seriously, even at the risk of "analysis paralysis." Still, I fret about the casual bandying of phrases such as "unproven technology."Maybe we should all still be riding around in oxcarts.

Need I elaborate for the snark-challenged? History, is, after all, sadly and amply littered with the corpses of those for whom the exuberant promises of myriad technologies unhappily didn't exactly work out as proffered for N=1.

Thursday, February 07, 2013
ONC Releases First Draft Test Scenario To Gauge EHR Systems' Usability

The Office of the National Coordinator for Health IT has released the first draft test scenario for assessing the real-world usability of electronic health record systems under Stage 2 of the meaningful use program, Modern Healthcare reports.

Under the 2009 federal economic stimulus package, health care providers who demonstrate meaningful use of certified EHR systems can qualify for Medicaid and Medicare incentive payments.

About the Test Scenarios

The use of test scenarios is optional. EHR vendors are not required to pass the test scenarios for their systems to receive certification under the meaningful use program...

"[V]endors are not required to pass the test scenarios for their systems to receive certification."

Yeah, of course, just fork over the $33.4k.

Just when you start having pangs of sympathy for ONC. "Real World Usability"? Are you kidding me?

You don't suppose a bit a plain -- non-abstract -- English might serve usefully here?

OK, this is about as good as it gets (below):

TEST SCENARIO NARRATIVE (pdf)
 
This test scenario represents the following clinically plausible scenario:
 
AmbulatoryPatient is seen by Provider. During this ambulatory visit, a medication, medication allergy, and problem list are recorded, changed, and accessed in the Provider’s EHR. This portion of the scenario tests:

• §170.314(a)(5) Medication list
• §170.314(a)(6) Medication allergy list
• §170.314(a)(4) Problem list

Patient is referred to Provider upon discharge from Hospital. During transition of care, a referral summary (C-CDA) is received, displayed, and incorporate in the Provider’s EHR.  This portion of the scenario tests:

• §170.314(b)(1) Transitions of care – receive, display, and incorporate transition of care/referral summaries

During incorporation of the referral summary (C-CDA), clinical information reconciliation is performed between the medication, medication allergy, and problem list stored in the EHR and those contained in the C-CDA. Upon completion of the clinical information reconciliation, the reconciled medication, medication allergy, and problem list are stored in the Provider’s EHR.

This portion of the scenario tests:

•  §170.314(b)(4) Clinical information reconciliation

Well, while the foregoing might indeed go to "data integrity" (i.e., what shows in the destination EHR is exactly what got entered into the source application, and is already set forth here: §170.314(d)(8) Integrity), I'm having difficulty seeing what this has to do with "real-world usability," which they seem to be conflating with "clinically plausible scenarios." The 68 dense pages of this particular "optional" draft test scenario never once mention anything regarding running this cert test procedure in "real time," modeling an actual sequential set of provider-HIT interface activities (i.e., quasi in situ).

How about 

"START THE STOPWATCH: you see a 67 year old established male patient with multiple chronic dx's for a semi-annual f/up visit during which time you have to quickly review the CC and vitals taken by your M.A. (after the front office staff have entered in any requisite demo and insurance change info), do an H&P that takes you past enough of the HPI and ROS to justify a measly $81 99213 while promulgating your SOAP (which maybe requires trying a change of meds, a blood & urine panel labs order, and perhaps ordering a referral out to a neurologist). All in less than 20 minutes. Tester shall make note of any EHR data errors during the test."

Far too onerous.

Door-to-door, with the CEHRT Examiner clock ticking, you've just had to accurately (one hopes) enter and/or otherwise traverse perhaps several hundred "structured data" and clinical impression narrative variables and come to an accurate dx and Plan.

Nah...

And we wonder why there are critics.

QUESTION FOR THE HIT CRITICS

How would you proposed to construct and administer controlled randomized "clinical trials" of EHRs? First of all, they couldn't be "double-blind" because either the paper charts or the EHRs would be visible to patients and practitioners alike, but, beyond that, consider some clinical trials summary participation and cost data for merely one cardiac drug:

We now have approximately 1,800 "certified" complete EHR systems; a base study design stratification requirement of 1,800, no? Then you'd have to define your "significant outcomes" of interest (no, you don't get to do that post hoc -- that's only allowed in anonymous blog comment world), and run your statistical power analyses for sample sizes.

Five years and many billions of dollars later you might have some useful findings to report.

But, I rather doubt it.

UNDERSTATEMENT OF THE WEEK

“Given that the country is in the midst of ICD-10, accountable care/healthcare reform implementation, value-based purchasing, meaningful use Stage 2 and HIPAA revisions, many clinicians, vendors and IT professionals are feeling overwhelmed.”

- John Halamka, MD, MS, Co-Chair, HIT Standards Committee

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More to come...