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.


Mary Dee Harris said...

John, I'm not sure I agree with your interpretation of the first issue you brought up regarding the first question here. I have seen this interpretation elsewhere, that an EMR is required to implement all 25 functions and only the provider gets to select which 5 menu items they want to use.

If you look at View Criteria for any of the EMRs identified as "Complete EHR" on the HHS "Chapel" list (, you will see most of them do not have all criteria checked. In fact, I have yet to see any that have all of them checked.

Am I missing something here?

John Halamka said...

I do not represent any government organization, so my comments are only my opinion. However, after speaking with numerous vendors and government staffers, my opinion is that functionality needed to support all 2011 Meaningful Use measures must be installed in the offices of Eligible Professionals and in Hospitals. This means that a Complete EHR or modules from multiple vendors must be installed such that all boxes are checked.

Anonymous said...

I agree with your interpretations, but I am interested in your personal views on the real-world rationale behind requiring EPs who meet the exclusion criteria for certain measures (for example CPOE and eRx) to access modules certified against the corresponding criteria before they have a combination considered to be "Certified EHR Technology."

I work as a regulatory compliance specialist for a medical association that serves physicians in a non-primary care medical specialty, and our members will meet the exclusion criteria for almost all of the MU measures that offer exclusion criteria. It is impossible to explain to my members why ONC has this comprehensiveness requirement for modular combinations -- certainly, my members will always have a need for, and meet, the exclusion criteria for several of these PCP-oriented measures. Any thoughts?

Anonymous said...

I am with Mary Dee. I disagree with this interpretation. One has to use a certified EHR in a meaningful way. One does not have to utilize every certified aspect of that EHR.

John Halamka said...

I've spoken to numerous policymakers about it and I've tried to convey a consensus of their words which is "acquire ALL Core and Menu Set Stage 1 functionality, install it, and report on your use of 20 functions. You cannot just acquire software for the 20 functions." I've edited the blog post a bit to make this clearer.

Anonymous said...

John and Mary Dee:

If I may interject, I think the confusion is stemming from the fact that Complete EHRs for EPs are certified for all criteria in 45 CFR 170.302 (general) and 304 (ambulatory), whereas Complete EHRs for eligible hospitals are certified for all criteria in 45 CFR 170.302 (general) and 306 (inpatient).

So, if you look at the ONC's CHPL website for a Complete EHR product certified for the EP version of the program, it can still be a Complete EHR but not certified for any of the Part 170.306 criteria. Likewise, a Complete EHR for the eligible hospital version of the program does not need to be certified against the Part 170.304 criteria.

This is why the CHPL lists several Complete EHRs which may seem to the naked eye to not be certified for all criteria. Consumers need to pay attention to the regulatory citations in the checklist.

As an additional note, 170.302(w) is an optional criterion, so you could also have a Complete EHR not certified for that one.

Anonymous said...

In response to Mary Dee: It looks like the boxes that are not checked are either 170.304xxx or 170.306xxx depending on if the system is ambulatory or inpatient. 304 contains criteria for ambulatory systems. So, if you are an inpatient system, you would not be required to have any of those boxes checked.

Bristow said...

Thank you for clarifying the first issue as the ONC and CMS had a very confused response to this question in their developer's conference call in July. We had emailed you earlier and really appreciate your effort to verify this with the government officials.

Ferdinand Velasco said...

I just read an AHA bulletin referring to an ONC Q&A that appears to settle this question. However, I couldn't find the Q&A on the ONC and CMS FAQ pages. Here's the text from the AHA note:

Question [9-10-017-1]:
Under the Medicare and Medicaid EHR Incentive Programs Final Rule, eligible health care providers are permitted to defer certain meaningful use objectives and measures and still receive an EHR incentive payment. However, it is our understanding that in order for us to have our EHR technology certified, we must implement all of the applicable capabilities specified in the adopted certification criteria regardless of whether we intend to use all of those capabilities to qualify for our EHR incentive payment. Is our understanding correct?
ONC Answer:
Yes, this understanding is correct. The flexibility offered as part of the Medicare and Medicaid EHR Incentive Programs Final Rule is not mirrored in the Initial Set of Standards, Implementation Specifications, and Certification Criteria Final Rule because we believe that it is important to accommodate eligible health care providers’ ability to achieve meaningful use. We recognize that in some circumstances an eligible health care provider may not know which meaningful use measures they will seek to defer until they begin implementation and in others an individual provider (even within a specialty) will want to choose different measures to defer based on their local situation and implementation experience. Thus, in order to possess EHR technology that meets the definition of Certified EHR Technology, it must be tested and certified by an [ONC-Approved Testing and Certification Body] to all applicable certification criteria adopted by the Secretary.

David said...

Ferdinand, the link to the ONC FAQ page is Click the link on question #17.