Wednesday, October 13, 2010

Clarifying Certification Part II

I was recently asked a few more questions about certification and I'll share my answers with the HIT community.

1.  Per your first blog about certification, I understand that all hospitals and eligible providers need to have certified EHR technology, which means that they must acquire software (complete or modular) that supports all Meaningful Use functions (25 for Eligible Professionals and 24 for hospitals � 15 core/10 menu, 14 core/10 menu respectively).   Since Meaningful Use only requires attestation for 5 of the 10 menu set items, does the unused technology need to be installed?

The answer, based on every conversation I've had with vendors and government staffers,  seems to be Yes.   In the Meaningful Use Final Rule, the term is  �utilize� � so all the technology has to be purchased and installed.   However, providers will just report on the use of those functions they select from the menu set.

Here is the relevant sentence from the Meaningful Use Final Rule -  "Under all three EHR incentive programs, EPs, eligible hospitals, and CAHs must utilize certified EHR technology if they are to be considered eligible for the incentive payments."

HITECH defines �certified EHR technology� as a �qualified EHR� that is certified pursuant to the certification program(s) established by the National Coordinator as meeting the standards adopted by the Secretary.  Here�s the statutory definition verbatim and note how Congress made a distinction between ambulatory and inpatient - �CERTIFIED EHR TECHNOLOGY.�The term �certified EHR technology� means a qualified electronic health record that is certified pursuant to section 3001(c)(5) as meeting standards adopted under section 3004 that are applicable to the type of record involved (as determined by the Secretary, such as an ambulatory electronic health record for office-based physicians or an inpatient hospital electronic health record for hospitals).�

The flexibility in the menu set is reporting on Meaningful Use measures in Stage 1, not the flexibility to use an incomplete EHR.  Certification is not associated with the core/menu flexibility.  Also in the first year of meaningful use under the Medicaid program there is no core/menu analysis, as the statute permits Medicaid providers to receive the EHR incentives for �adopting, implementing or upgrading to certified EHR technology� in their first participation year (a provider�s first participation year may be any year between 2011 through 2016).

Here are some examples of how hospitals and providers might attest to Meaningful Use:
a.  An eligible hospital may choose to defer meeting the advance directive measure for a variety of reasons that would prevent them from achieving the 50% requirement, but their Certified EHR Technology would need to include that capability.
b.  An eligible professional may choose to defer meeting the send patient reminders for preventative and follow-up care measure for variety of reasons that would prevent them from achieving the 20% requirement, but their Certified EHR Technology would need to include that capability.
c.  In either case if the eligible professional/hospital defers it for 2011, nothing precludes them from using that capability or electing to make that one of their reported menu measures for 2012 in addition to or in lieu of one of their five 2011 menu measures.

2.  NIST testing procedure for �170.302 (a) Drug-drug, drug-allergy interaction checks includes the language "Provide certain users with the ability to adjust notifications provided for drug-drug and drug-allergy interaction checks."   What do you think about that?

I agree that drug-drug interaction notification requires tuning to avoid alert fatigue.  Sometimes even minor interactions with trivial clinical consequences pop up, interrupting workflow.   There should be tuning allowed to adjust such alerts to the level of severity optimized for a given practice.   However, I cannot think of a use case in which an allergy alert should be altered/suppressed.

The test procedure developed by NIST is faithful to the certification criterion adopted in the Standards and Certification final rule.  ONC has received comments on this issue from several stakeholders and is reviewing them.

3.  In many ambulatory settings, clinicians use a hospital information system to route medication prescriptions to in hospital pharmacies.   Hospital-based systems are more likely to use HL7 for in hospital message routing instead of NCPDP, the standard used for e-prescribing.  Is this acceptable?

The Standards and Certification final rule does not specify the standards to be used for in hospital medication workflows, so HL7 routing from ambulatory care clinics to an internal outpatient pharmacy is fine.  However,  to be designated as  "Certified EHR technology", the hospital information system must also have the capability (used or unused) of routing prescriptions to external retail or mail order pharmacies using NCPDP Script.

I hope this is helpful.
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