Questions and Answers on HL7 MeaningfulUse Stage2 Webinar

I presented a Free HL7 webinar today on HL7 Standards for Meaningful Use Stage 2.  It was the largest webinar audience I've ever addressed (over 360 people), and also one of the largest webinars HL7 has ever done.

We had time at the end to answer a several audience questions, but given the volume of participants, there was no way we could get to every question.  However, just like the last time I did a HL7 webinar, I promised to make an attempt to answer every question submitted, and am doing so now in this blog post.

Where Can I get...

1. the slides?
   HL7 will be making the slides available to attendees in a couple of days.  You should be getting an e-mail with the information on how to retrieve the slides once they have been posted.
2. the standards?
   HL7 Consolidated CDA Draft Standard is available from HL7
   HL7 Version 2.5.1 Standard  is available from HL7
   HL7 Version 2.5.1 Implementation Guides are available from HL7
   The CDC 2.5.1 Immunization Guide is available from the CDC
   The PHIN Syndromic Surveillance guide is available from the CDC (for Hospitals and Emergency Rooms only, an ambulatory guide is in the works but is not part of Stage 2).
   The Cancer Reporting guide is available from the CDC (for Ambulatory only, as Hospitals already have a method and requirement for reporting).
   The Laboratory Reporting Guide will be available from HL7 when they have finished Reconciliation.
3. the audio.  I'm sorry for the audio problems.  If you think there is a section you missed, this presentation was also given in March a conference in Valley Forge.  The folks there streamed the video out over Internet2, and so you can see a video recording of the material here.

I'll take the letter C for $44,000... 

1. Is CCR included in Meaningful Use?
   Yes and No.  The ASTM CCR Standard is a data set.  One XML representation of this data set  is what most people call "the CCR", but that is not the only standard representation.  The other standardized representation is the CCD.  The named standards for 2014 include CCD Version 1.1, which is a standardized representation of the ASTM CCR, and the sections that appear in CCD Version 1.1 also appear in other document types in that guide.  But that's probably not the question that was being asked.  If you want to know if the ASTM XML representation is included, the answer is simply NO.
2. Are CCD and CCR competing standards?
   NO.  The CCD is an implementation of CCR, and thus CCR is a core component of CCD.  However, the ASTM XML representations of the CCR and the HL7 CDA representations do compete.
3. What is the official use case of the CCD?
   The primary use case for the CCD is to provide a snapshot in time containing the pertinent clinical, demographic, and administrative data for a specific patient.
4. Why is the CCD not enough?
   CCD does not include other data specific to a providers scope of practice that identify other inputs (e.g., Review of Systems, Physical Examination, history of present illness), nor does it address details about what happened during the course of treatment (e.g., operative course, hospital course).  This information a) helps the receiving provider understand more about the patient and the sending provider's decision making and b) allows the sending provider to reuse clinical documentation already being generated.
5. How do you define the scope (which ones, and how far in the past) of labs to be included when sending a Consolidated CDA Document?
   MU appears to be concerned with laboratory results that were performed during the encounter, but is not specific.  The Test Results section says: The section often includes notable results such as abnormal values or relevant trends, and could contain all results for the period of time being documented.  See this post on relevant for more details.
6. What level of CDA is used?
   The CDA Consolidation guide itself allows for documents to be at level 1, 2 or 3.  The focus of Meaningful Use is on structured data, so the answer is level 3.
7. Can you explain the incompatibilities between Consolidated CDA and HITSP C32?
   Yes I can, but I haven't yet, that post is coming.  The main issue is with the Problem Concern Act in the two documents, which bubbles up through everything.  There are other minor details.  It's not hard, just slogging that needs to be done.  
8. What do you suggest that providers and vendors do now to address these incompatibilities?
   Keep listening here, look into the issues, and share your findings with others, as I will do here when I complete my own analysis.  If we could just get CMS and ONC to stop publishing stuff that needs feedback for a month or so, I might be able to do that.  And believe me, I share your pain.  
9. How far along is HL7 in their work with NIST to update the HL7 evaluators used by vendors for Certification preparations?
   I'm told that the new test plans and specifications will be published for public comment when they are available, just as last time.  I haven't heard the schedule yet, but I'll try to find out where they are at.  
10. Specifically on offering places to upload and test against proposed Stage 2 specifications for Public Health and CCDA?
    A CCDA Schematron was built, but not included in the December Publication.  I will ask that the corrections currently being made include Schematrons in the next release.  Also, MDHT will be releasing Version 1.1 Real Soon Now, and that will include CCDA test tools.
11. With CCDA and the added Clinical Documents will there be a section for Provider electronic Signature?
    There already is a place to record the presence of an electronic signature of the document in the CDA standard, and so it is available today in any CDA implementation guide.  However, you might also be  talking about a digital signature, which is cryptographic proof that an electronic signature was obtained. The esMD S&I Framework project is talking about both electronic and digital signatures.
12. Are the Standards that “could be” within the consolidated CDA - if they are not specifically named by ONC or CMS - are they “optional” to be in the CDA - (i.e. LOINC for age and vital signs)?
    If MU says SHALL, you won't be certified if you don't. If Consolidated CDA says SHALL, then to conform, you must do it, and to be certified you must conform.  If the Consolidated CDA says SHOULD, and MU is silent then to conform, you do not need to do it, but you should probably have a good reason. 
13. Can you talk about the MDHT project and how it could help EHR vendors in implementing Patient summaries and other types of documents?
    WOW.  Awesome! Dave deserves an award for putting that stuff together (and so does John but I'll have to address that some other day).  But Doug really does a great job talking about it, so I'll let his words fill in for mine.

Education

1. Is there any certification programme where an individual Healthcare Integration consultant can get certified and can benefit Healthcare providers in “Meaningful Use”  implementation Projects?
   There are at least three ways to answer this question. 1) ONC funded several workforce development programs at the undergraduate and graduate level and freely available undergraduate curriculum development, and certification testing  2) HL7 offers education and certification opportunities and also has an online e-learning program.  I teach at HL7 Working Group Meetings especially like the CDA class they offer during their educational summits.  Other organizations also offer CDA and HL7 training.   

Import and Reconciliation

1. Your thoughts on the clinical reconciliation mention in the NPRM for problems, medications and allergies from medical summaries.  ie: it seems clear that a CCD received in as part of a CCDA into an EMR, will have to digest these 3 sections of data (if present, and hopefully requiring standard nomenclature) and discretely display them in some section of a reconcilation area within a patient chart.
   IHE has a great answer for how to do this.  See Tuesday's post.
2. Is there a requirement to “import” discrete data  like Allergies, Problems from the Summary documents and update the EMR database?
   I feel like the Magic Eight Ball ... "Answer Hazy ... ask again later".  The notion of  incorporation  in the 2014 criteria has drawn a lot of criticism, because " incorporation of labs" is not the same as "incorporation of problems, medications and allergies".  The HL7 Policy Advisory Committee's expressed view (and my own) is that incorporation of the later requires some sort of reconciliation process.

Will it Stick?

1. What about the push to incorporate CCD summary data into the EHR as structured data in the patient record. Do you think that will be required in Stage 2?
   I would personally hope so.  As I mentioned above, the "incorporation" definition has certainly drawn quite a bit of attention, and it seems likely that there will be some clarification, but I would expect that it would be clarified rather than dropped.
2. Consider ICD-10 deadlines have moved, will there be a change in ICD-10 requirement for the summary document?
   ONC has signaled in the proposed rule that they anticipate following the CMS lead on ICD-10.  If CMS delays, any requirement in MU on ICD-9 or 10 will be challenging because the regulations will change in the middle of the Certification period.  I would hope ICD-10 would be dropped altogether, and others, including members of the  HIT Standards Committee have made similar suggestions.  Note: CMS hasn't made a decision yet, but they've certainly moved in the direction of a delay, so don't count any chickens (or skis on fire) yet. 
3. When will ICD9 be replaced by ICD10 in the context of coding meaningful use problem lists?
   Never if I'm reading current leanings.  The propose rule suggests SNOMED CT, and only retains ICD for Diagnoses (which is not the same as problems).  SNOMED CT has resulted in some backlash, and it's possible we could go back to the ICD or SNOMED model we had under the 2011 criteria, but I don't see ONC leaning in that direction.

Vocabulary Questions

1. What vocabulary is used to code diagnostic imaging procedures?
   No vocabulary is specified expressly for the purpose of recording diagnostic imaging procedures explicitly in the rule. However, the rule does say that Procedures must use ICD-10-PCS or HCPCS/CPT-4. Given that ICD-10-PCS includes imaging procedures, I would assume that is what must be used.  Consolidated CDA identifies SNOMED CT, ICD-9-CM Procedures, or ICD-10-PCS, or CPT-4 or LOINC as possible options (SHOULD or MAY), but has no specific requirements.  
2. How all labs will handle LOINC...
   Labs aren't incented under meaningful use, and I don't know what would incent them to use LOINC until the payers (including CMS) step in.  Some payers already have, and I know that most labs can already map their own codes to LOINC because of that.
3. There was direct mention of SNOMED-CT as vocabulary for Problems and LOINC for laboratory result messages. Is it correct to also indicate that SNOMED-CT is required for qualitative laboratory results in concert with LOINC for the specific tests?
   It would certainly be a good idea (CHI and HITSP both had it years ago), but it's not stated that way in the rule.  However, the implementation guide specified by the rule does require SNOMED CT for qualitative results in Microbiology, and so it is required for certain kinds of tests, but possibly not all tests.
4. Are there any efforts to harmonize SNOMED and MedDRA  vocabularies? In the EU, we are using MedDRA for pharmacovgiliance reporting as part of EVMPD.
   This is not my area of expertise, but I would expect that such an activity would be easy to find out about.  But Dr. Google says no.
5. Could you speak to the difference between “problems” and “diagnoses” and why SNOMED-CT is proposed for the former and ICD-10 for the latter?
   SNOMED-CT has long been agreed as being the best way to describe problems for the purposes of clinical decision support.  When you get to the term Diagnosis you have to distinguish between clinical and administrative uses of the term.  The term Diagnosis is so often used in billing that it appears someone forgot that the use of the term encounter diagnosis was still meant (according to several members of the HIT Standards committee) to be in the clinical context.  This is another reason why ICD-10-CM could disappear from the final rule.   

Infobutton

1. Can you expand on how Infobutton is to be used for Patient Education?
   Here is one possible scenario: On completion of a patient encounter, a clinician activates the patient education Infobutton associated with patient's diagnosis (or medication, or lab result).  The EHR locates appropriate content from a web accessible resource.  The clinician displays it, discusses it with the patient, and then prints it out.
2. Can you please provide functional scenarios for the Infobutton and Provider Reference Content?
   Here is one possible scenario drawn from the standard:
   A clinician is reviewing a problem list module of an EHR and is unfamiliar with a rare disease (Camurati-Engelmann Disease) that the patient, a 15-year-old female, has. The problem list module provides an infobutton link next to the "Camurati-Engelmann Disease" problem. The user clicks on the infobutton link, initiating an infobutton event.

Laboratory Reporting

1. Does the Electronic Laboratory Reporting include Blood Bank and Pathology or just LAB and MIC?
   The HL7 ELR guide describes the transmission of laboratory-reportable findings to appropriate local, state, territorial and federal health agencies using the message.  That includes pathology.  I don't see any reference to blood banking in the guide, but the experts can be found here. 
2. For Laboratory results, is it your impression that for stage 2 MU, Pathology discrete results will be required?
   This is not clearly stated in the HL7 LRI guide, nor is it clearly stated in other reference content.  It is an excellent question to post to ONC, and I will be doing so.  I would have to assume yes until ONC says otherwise.
3. We use ORU for the lab resuts with embedded PDF document, Do it qualify meaningful use?
   Since that does not follow the required, the answer is NO.
4. Why does IHE XD_LAB CDA based spec not show up in the S&I Laboratory Result Interface Initiative?
   Because the initiative was scoped to harmonize the HITSP and eLINCs Laboratory Reporting guides for HL7 Version 2.5.1, not replace them with something even better  ;-)

Odds and Ends

1. Is the HL7 also the normal output data format for most patient-care devices?
   I would assume that HL7 Version 2 and/or IEEE are the most common, but that's not my area of expertise.  It is for these guys though.
2. Wondering why HL7 version 3 isn't in the picture
   Hmm, given that CDA was the first Version 3 standard published by HL7, I thought about putting the answer to this question in the CDA section, but I expect the person asking it wouldn't expect to find it there, and for many CDA != Version 3.  I agree and disagree alternately depending on who I'm talking to.  The NwHIN Exchange specifications do include use of Version 3 (in their use of XCPD for example).  The real answer is that MU is step-wise refinement, and you might see Version 3 cropping up in later stages (even as early as Stage 3).
3. Are there any MU standard directly related to clinical research activities?
   No.  But you could use Infobutton to locate a clinical trial (a use case of the IHE Request for Clinical Knowledge profile I just finalized for public comment).
4. QRDA updated DSTU is for Stage 2, not beyond...
   QRDA has not been proposed in the Meaningful Use certification rule, although CMS has interest in it for quality reporting, which is related to that rule.  The QRDA updated DSTU may be for that "data file defined by CMS", but that also depends on which update to the DSTU you are talking about.  The update for "Category 1" is being supported by CMS, and is targeted (as I understand it) at some pilot programs for quality reporting.  The update supporting Category 3 is needed for aggregated reporting and for Query Health, and that is almost certainly NOT going to be ready for Stage 2, but could be for stage 3.  I believe both updates are included in the same HL7 project scope statement.