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Monday, April 18, 2011

Meaningful Use Attestation Day One, April 18th

Nice to see some good news about the opening of the Meaningful Use attestation portal (we'd had some concerns in the wake of a CMS provider call and webinar last week):
MONDAY, APRIL 18, 2011

The Attestation Experience

This morning at 8 am the CMS attestation website went live. At 8:30 am, I completed the attestation for Beth Israel Deaconess Medical Center...
One of Dr. Halamka's commenters, Paulo Andre, MD, posted this:
I completed my EHR attestation at 9.10 am. It took me 60 minutes to do it. Our EHR is Care360 EHR and you basically just need to run a series of meaningful use reports on Care360 and then upload the denominator/numerator numbers to the CMS website. It was an easy process. I have some screenshots of the process at

This is encouraging. Of course, it assumes that your EHR easily reports your compliance data (something we are not uniformly seeing), so that your ducks are all lined up for attestation and you can get this over with in an hour or so.

UPDATE: CMS reports that they had 150 attestations on Day One. Be interesting to see if they provide a Week One tally, one that includes, say, outpatient EPs vs inpatient facilities, EHR platforms involved, and dollar amount of the reimbursements.

Much more to come, including HIE patient data privacy issues and pending "opt-in" vs "opt-out" legislation and litigation...


I guess it's OK to talk about this now that the press release is out:
HealthInsight Selects Axolotl to Launch Community-based Health Information Exchange for State of Nevada
April 19, 2011

San Jose, Calif. Apr. 19, 2011 - HealthInsight, a private, non-profit organization dedicated to improving Nevada's health care system, announced today that it has selected Axolotl Corp. to build the community-based Health Information Exchange (HIE) infrastructure to help Nevada providers improve the timeliness, quality, and coordination of care for their patients.

The Nevada HIE will enable physicians to automatically update and securely receive and share patient information in real-time to support care and treatment decisions for their patients at the point of care, whether in their offices or at hospitals. Further, the Axolotl technology will enable providers to access key clinical information, including laboratory results, radiology reports and referrals, and to electronically submit and renew prescriptions from their electronic health record (EHR) system - without having to install specialized hardware and software in their practice...

A feverish time in my shop these days. In addition to the ongoing REC work and the new HIE, CMS 10th Scope of Work QIO contract is starting up soon; we've had to spin off our "Statutory QA" operation into a separate, firewalled corporation, we have a Beacon Community grant operation in Utah; and we're acquiring the New Mexico QIO (officially calling it "an affiliation").


Health Information Exchange is pitched via two ostensible value-adding propositions:
  • First and foremost, the "24/7 Anytime/Anywhere Point-of-Care" authorized access to your medical data in order to [1] expedite care in exigent circumstances and [2] attenuate the burden of redundant data acquisition and/or transcription;
  • Second, the aggregation of appropriately de-identified clinical data from routine care (as opposed to clinical trials) captured via EHRs for "Comparative Effectiveness Research" (CER) through which to help improved the quality of care (principally with respect to the top chronic conditions).
But, with respect to the latter goal, citizens and privacy advocates fret openly about possible adverse consequences of the misuse of sensitive "PHI" (Personal Health Information) by employers, health insurors, drug marketers, and others.

Hence things like the following in the health care news:
Poll: Huge majorities want control over health info

AUSTIN, TX – Patient Privacy Rights, the health privacy watchdog, has enlisted the help of Zogby International to conduct an online survey of more than 2,000 adults to identify their views on privacy, access to health information, and healthcare IT. The results were overwhelmingly in favor of individual choice and control over personal health information.

Ninety-seven percent of Americans believe that doctors, hospitals, labs and health technology systems should not be allowed to share or sell their sensitive health information without consent.

The poll also found strong opposition to insurance companies gaining access to electronic health records without permission. Ninety-eight percent of respondents opposed payers sharing or selling health information without consent...

Maine Civil Liberties Union, state senator seek HIE opt-in law

In an effort to "maximize people's control" over how their health information is disseminated, the Maine Civil Liberties Union, alongside privacy advocates and care providers, gathered last week to call on the state legislature to pass a medical patient privacy and consent bill.

The bill, “An Act To Ensure Patient Privacy and Control with Regard to Health Information Exchanges” (LD 1337), is sponsored by State Senator Roger Katz (R-Augusta).

[See also: ACLU brings suit against Rhode Island HIE.]

“Maine patients and healthcare providers can realize the benefits of a statewide health information exchange without sacrificing privacy or security,” said Katz. “In order to maximize trust, participation and value in a statewide exchange, we must protect a patient’s right to control what happens to their highly personal medical information.”...
Central to these debates is the differential concept of "opt-out" versus "opt-in" personal information privacy laws and policies, i.e., typically under the "opt-out" standard, the default condition is that of implicitly giving binding permission for the use of your information unless you explicitly, documentably "opt-out," whereas "opt-in" forbids trafficking in your data unless you have explicitly "opted-in." CER advocates worry that "opt-in" will materially -- perhaps fatally -- compromise the promise of non-trials clinical research (by significantly decreasing the volume of available data for the typically requisite analytical stratification). Their misgivings are heightened in light of the fact that the more aggressive privacy advocates are arguing for patient control going right down to the individual datum level: every dx and px, every med, every lab test result, etc.

The data privacy board members who will be appointed to our Nevada HIE (like those of all other HIEs) will certainly have their hands full. Apropos of this, consider the now-pending Nevada SB 43 (PDF), our state's nascent HIE legislation:
Sec 15(2) A covered entity that makes individually identifiable health information available electronically pursuant to subsection 1 shall allow any person to opt out of having his or her individually identifiable health information disclosed electronically to other covered entities, except:

(a) As required by the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191.

(b) As otherwise required by a state law.

(c) That a person who is a recipient of Medicaid or insurance pursuant to the Children’s Health Insurance Program may not opt out of having his or her individually identifiable health information disclosed electronically.
[emphasis mine]

Can you say "second class citizens"? Expect litigative pushback on this should it be enacted.

“Comparative effectiveness research” is now legislated as a priority for translational research. The goal is to inform decision making by assessing relative effectiveness in practice. An impressive effort has been mobilized to target efforts and establish a methodological framework. We argue that any such exercise requires a comparator with known and meaningful efficacy; there must be at least one anchoring group or subset for which a particular intervention has reproducible and meaningful benefit in randomized controlled trials. Without such, there is a likelihood that the effort will degenerate into comparative ineffectiveness research...

The Illusory Side of “Comparative Effectiveness Research”,
April 8th, 2011, the Health Beat Blog. Their argument is somewhat akin to asserting that, were you to win a marathon race and spank the field by a wide margin yet still failed to set a new world record time, your win merely demonstrated "comparative ineffectiveness" relative to the record.

Also, gotta love the clinical ivory tower terms-of-art hairspliiting regarding "effectiveness" versus "efficacy." Their response to my question:
It was presumptuous of us to assume that all knew the difference between efficacy and effectiveness. This is epidemiology-speak. Efficacy relates to demonstrable benefit in a randomized controlled trial. Effectiveness relates to demonstrable benefit in more general use, beyond the constraints of the RCT, particularly the selection criteria for subjects. RCTs usually have many such specifications including gender, age, coincident disease, etc. General practice may have no such constraints.

Epidemiologists do randomized clinical trials? That somehow escaped me. Whatever. The salient issue for purposes of improving health care is whether intervention X can be empirically shown to cause effect Y more "effectively" or "efficaciously" than the alternatives (which may include interventions A, B, C... or a placebo).
Epidemiology Studies

Epidemiology studies are conducted using human populations to evaluate whether there is a causal relationship between exposure to a substance and adverse health effects.

These studies differ from clinical investigations in that individuals have already been administered the drug during medical treatment or have been exposed to it in the workplace or environment.

Epidemiological studies measure the risk of illness or death in an exposed population compared to that risk in an identical (e.g., same age, sex, race, social status, etc.), unexposed population.

There are four primary types of epidemiology studies. They are:


More to come...

Friday, April 1, 2011

Springtime for Meaningful Use

CMS will begin taking MU attestations for year one incentive fund remittances on April 18th. I would expect that they will make a big PR play on it to help entice the laggard into participation.


I posted this on our HITRC earlier in the week. Have yet to get an answer:
Menu set item for "structured labs" (verbatim from the Final Rule, pg 224)

"More than 40% of all clinical lab tests results ordered by the EP or by an authorized provider of the eligible hospital or CAH for patients admitted to its inpatient or emergency department (POS 21 or 23) during the EHR reporting period whose results are either in a positive/negative or numerical format are incorporated in certified EHR technology as structured data."

Then, denominator & numerator specs on Final Ruie pg 133:
  • "Denominator: Number of lab tests ordered during the EHR reporting period by the EP or authorized providers of the eligible hospital or CAH for patients admitted to an eligible hospital’s or CAH’s inpatient or emergency department (POS 21 & 23) whose results are expressed in a positive or negative affirmation or as a number.
  • Numerator: The number of lab test results whose results are expressed in a positive or negative affirmation or as a number which are incorporated as structured data."

Am I correct to interpret this as every individual analyte parameter returned from a lab order going into the numerator? e.g., my primary doc routine f/u visit labs typically include CBC, UA, lipid panel, metabolic panel, PSA – dozens of individual analyte results each time. Every individual analyte assay is a "test" providing POS/NEG or quantitative data for a clinical decision regarding a patient, not just the parent panel in the order.

It seems to me to be in the provider's advantage to get numerator credit for every structured data "result" within a lab order (beyond the outright clinical decision utility of every analyte metric). But, I'm not sure how this will be construed.

I'm betting that this numerator specification will have to be re-written to say something like this:
  • "Numerator: The number of lab orders whose returned results are expressed in positive or negative affirmations or as numbers which are incorporated as structured data for at least one analyte finding."
The reason I say that owes to having looked at the way the e-MDs certified version reports it: "# of provider lab orders (+/- or numeric results) incorporated as structured data."

"orders," not "tests"

What constitutes the "order"? Everything the doc checks off on the lab sheet or CPOE entry, or every subsidiary parameter assessed by the lab pursuant to the aggregate lab request?

This is but one example of remaining MU interpretation issues.



An interesting read. Click the title above to go to an ONC page containing summary information, a link to the PDF document, and now-accruing public comments at the bottom (there are 36 as I post this, including a number of very good ones). Have your say should you wish. Public review and comment runs through April 22nd.

I will be interested in particular in the "usability" proffer, given what I have posted on this blog thus far on the topic (see pp. 13-14):
Strategy I.A.9: Encourage and facilitate improved usability of EHR technology. The government is collaborating with industry and researchers to improve the usability of EHRs. The usability of EHRs is considered a key barrier to meaningful use and adoption. NIST is developing a set of objective and standardized criteria (standards and test methods) that can be used to evaluate and improve the usability of health IT systems. NIST has released a Common Industry Format (CIF), a standard for developers to report usability test findings and demonstrate evidence of usability in their products in a format that allows for independent evaluation of a single product and comparison across multiple products. NIST is developing guidance and tools for RECs and professional societies on available tools and resources to incorporate concepts of usability in selecting and implementing EHR systems. AHRQ is developing toolkits that medical practices can use to assess the usability of EHR systems and assess the redesign workflow. In addition, AHRQ conducted research and convened industry workgroups that provide perspectives on what constitutes usability and how to systematically improve the usability of EHRs.

ONC has directed one of its four Strategic Health IT Advanced Research Projects (SHARP) (see Strategy V.B.2) to further EHR usability through better cognitive and user-centered design. In addition, ONC is working with private sector groups to encourage the collection of usability information and its dissemination to vendors and consumers through mechanisms they can trust.

A lot to accomplish in a short time.


LOL. Click the image to enlarge. When I go into the mostly small primary care ambulatory clinics I serve and bring up "workflow," I usually get the MEGO blank stares. This is from a booklet I'm assembling for my REC to try to cut to the chase and sell the concept to those lacking any clue or interest (i.e., most of them). Irrespective of the nominal swimlanes and/or nested complexity of any process, this is really the core logic.


More on workflow. Just got permission from the California Health Care Foundation to use in my nascent document a couple of workflow graphics contained in a recent paper they published entitled "Workflow Analysis: EHR Deployment Techniques." (PDF, author, S.A. Kushinka, MBA, Full Circle Projects, Inc.)

Rx refill request, pre- and post EHR deployment
(click either image below to enlarge):

  • Pre EHR, 15 steps between begin and end, shortest path, 13 steps;
  • Post-EHR, 5 steps between begin and end, shortest path, 3 steps.
Beyond the reduction in the number process steps per se (which should yield faster task completion times), it should be noted that, all other things being held equal, every additional task step in a process increases the probability of error (unless everything goes perfectly every time). Additionally, nearly all of the pre-EHR tasks are substantively physical in nature (related to chart and form chasing and pushing), while those following EHR deployment involve much less physical, more efficient EHR interaction.

Thanks, Dawn Weathersby, MSN, RN*, CHCF, and Mr. Kushinka.
*UPDATE: Small world. I probably could simply have used those two Rx workflow graphics above under "Fair Use," but I figured it only polite to ask permission. The author of the CHCF paper, S.A. Kushinka said "yeah, no problem, but I'll copy my contact at CHCF." That person emailed me back to also say "yeah, no problem, just give us a cite." I also sought out Dawn Weathersby, whose name appears in the graphics. Her name had sounded familiar. Turns out she once worked for Lumetra, the then-California QIO, within the federal DOQ-IT program that I had also worked within back during 2005-2007, and these workflows were part of DOQ-IT ("Son of REC") stuff on her part, and are consequently public domain. Dawn is now Director of Healthcare Product Strategy for Oracle. I heard from her today, so I have to give her a shout here.


I was on a HITRC "Privacy & Security CoP" call/webinar today. I snipped these (below) out of their slides.

A Meaningful Use HIPAA-compliant "Privacy and Security Audit" (replete with remediation of any deficiencies uncovered) is one of the Core Set requirements for Stage One Year One attestation (one of the 15 core criteria). I'll be really charitable here and just round up to an expected 6 REC hours per audit assistance.

Our REC is to engage about 1,500 providers. OK, that's 4.5 FTE (9,000 hrs) just to get them through this one measure. Along with all the other Meaningful Use adoption support hand-holding.


More to come...