Certification versus Meaningful Use


Recently, clinicians have asked me “why should I implement my organization’s preferred EHR when I’ve found a less expensive vendor that promises meaningful use?”

This illustrates a basic misunderstanding of the difference between Certification and Meaningful Use.

The certification process will be codified in a December 2009 Notice of Proposed Rulekmaking (NPRM) and will define the process for certifying electronic health records including modular and open source approaches. (The Standards for data exchange will be codified in a December 2009 Interim Final Rule and become law immediately.) We know that ONC will specify certification criteria and that NIST will oversee certification conformance testing which will be performed by multiple organizations. However, we will not have the final certification criteria or the defined process until Spring after a period of comment on the NPRM.

Meaningful Use is about electronic documentation to enhance quality/efficiency and actual data exchange among payers, providers and patients. The definition of meaningful use will be codified in a December 2009 Notice of Proposed Rulemaking. We will not have the final meaningful use criteria until Spring after a period of comment on the NPRM.

Thus, it is too early for any software company to declare their product will meet all Certification criteria. In the
interim, a vendor can claim product conformance with the latest CCHIT criteria, which is the best indicator of functionality we have at the moment.

Meaningful Use is not about products but about processes – how the software is used and how data flows in an ecosystem of stakeholders. Vendors should not be making claims about meaningful use.

Take a look at the data exchanges in the August 2009 recommendations for meaningful use:

  • ePrescribing
  • Sending reminders to patients
  • Checking insurance eligibility
  • Submitting claims
  • Providing patients with an electronic copy of their record
  • Providing patients electronic access to their records
  • Capability to exchange key clinical information (e.g., problem list, medication list, allergies, test results) among care providers and patient authorized entities
  • Capability to submit data to immunization registries
  • Capability to provide syndromic surveillance data to public health agencies

To achieve these 9 data exchanges, multiple sending and receiving parties need to participate.

In the case of Beth Israel Deaconess, achieving this level of interoperability by 2011 will require that we focus on a
small number of software vendors. Over time, as standards and implementation guides become more specific and widely implemented, it will be easier to add additional vendors. However for now, we are focusing on getting the work done with our home built EHR and one purchased EHR (eClinicalWorks). Given scope, time, and resources, there is no way we can implement all 9 data exchanges among payers, providers and patients with another purchased EHR in time for Stimulus funding.

Thus, as you make decisions about what EHR to use, remember that certification describes the features of a product.
Meaningful use describes actual data capture and exchange among multiple stakeholders in an entire healthcare ecosystem.

Products may be certified in a single clinician office, but meaningful use “takes a village”. It cannot be promised by a vendor.

John D. Halamka, MD, MS, is CIO of the CareGroup Health System, CIO and Dean for Technology at Harvard Medical School, Chairman of the New England Health Electronic Data Interchange Network (NEHEN), CEO of MA-SHARE, Chair of the US Healthcare Information Technology Standards Panel (HITSP), and a practicing emergency physician. He blogs regularly at Life as a Healthcare CEO, where this post first appeared.

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4 replies »

  1. John – you rightfully make the distinction between certification and Meaningful Use. It is not yet clear exactly how clinicians using a “certified” EHR will report their data to CMS in order to qualify for Meaningful Use incentive payments. Likely, it will follow the claims-based method used by PQRI, with CPT II codes included in claims. There is also the potential for EHR vendors to be able to directly report Meaningful Use data to CMS, though this is still under review. Web-based EHR vendors such as the one I am working with (Practice Fusion) are interested in developing ways that help clinicians automatically upload Meaningful Use data to CMS without having to implement looking up and adding CPT II codes to Medicare and Medicaid billings (a burden to smaller practices).
    I would beg to differ on your view that “certification describes the features of a product”. Rather, I would say that “certification” should describe the capabilities of a product, rather than its features. The difference is more than semantics. The CCHIT approach has been historically “feature” focused, but that is a fault of CCHIT. It is the capabilities of a product that counts, more than the specifics of features. For examples, feature-centered CCHIT certification criteria around ensuring security of data focuses on how data is handled within a LAN – not surprising, since legacy client/server EHR systems have been the main systems in the market in the past. But the features (the architecture) used by web-based EHRs will be different that what is appropriate for a LAN-confined system – the “features” don’t necessarily translate; however the “capabilities” need to be the same. A web-based EHR needs to assure data safety and security to the same level as a local client/server system, regardless of how the “feature” is structured.
    Fortunately, CCHIT is no longer the only player in the certification realm. Though the ONC has yet to define how certifying bodies will be recognized (that should be forthcoming in December), Drummond (an organization with a long history of certifying software in many different sectors) has recently announced its intent to pursue appointment as a certifying body. Others (e.g. MGMA, JACHO) have also hinted at interest in this as well. My hope is that these alternative certification pathways will be more “capability” focused, and less “structural” or “feature” focused, and will help emerging technologies be able to offer very-useful, “certified” EHRs (based on whatever “feature” set is needed to achieve the desired “capability”).

  2. As RBAR concludes, defining meaningful use of devices that are not meaningfully useful is indeed the Myth of Sisyphus equivalent. John, your ONC committee buddies, and your friends at HIMSS, are your hearts filled with rapture?

  3. From what I know about “meaningful use”, it is a bogus parameter that confuses process (EMR use) with outcome (better healthcare). Are any parameters likely useful by common sense assessment or research literature?
    •ePrescribing >>> poss. mild benefit (reduction of legibility errors, only potential allergy- and interaction check depending on software and user patterns)
    •Sending reminders to patients >>> poss. mild benefit, although the question is: Reminders for what, and is the reminder generated and/or initiated by the EMR?
    •Checking insurance eligibility>>>no benefit (except administrative)
    •Submitting claims>>>no benefit (except administrative)
    •Providing patients with an electronic copy of their record >>> doubtful benefit – how many patients will make productive use of their records, and how many of those would have done so with paper copies?
    •Providing patients electronic access to their records >>> doubtful benefit, dito
    •Capability to exchange key clinical information (e.g., problem list, medication list, allergies, test results) among care providers and patient authorized entities >>> potential substantial benefit for coordination of care, but how can data be exchanged? Per request? Per password access by some local providers? Will a doctor in another state be able to access when he/she sees the same patient, or the ER physician in the next town?
    •Capability to submit data to immunization registries >>> poss. mild benefit for PH, barely any individual benefit
    •Capability to provide syndromic surveillance data to public health agencies >>> poss. mild benefit for PH, barely any individual benefit
    The whole meaningful use thing is as good an indicator as counting the number of cars in a city as an indicator of effective transport – cars may bring people fast from A to B, but they have drawbacks as well as poss. unproductive use patterns, and there are alternate solutions.

  4. Sure, meaningful USE of an EHR system assumes that it is actually USED to meet the requirements. But, unless the software does provide necessary capabilities, like eRX, for instance, any talk about process changes is pointless.