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

http://mdinteractive.blogspot.com/2011/04/medicare-ehr-incentive-attestation-with.html

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

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").
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SOME HIE ISSUES

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...
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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.”...
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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.
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ON "CER." SOME NIT-PICKY RED HERRING NAYSAYING
REGARDING "COMPARATIVE EFFECTIVENESS RESEARCH"?

“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...

From 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:

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More to come...