Transitions of Care Initiative Consolidated CDA’s alignment with Meaningful Use Stage 2 NPRMs and ToC Recommendations 1

Summary of Analysis Conclusions C-CDA supports MU2 requirements. Good choice! –One exception due to a constraint (to be discussed) –In some cases, supporting MU2 in C-CDA requires some non- obvious interpretation MU2 supports most of the ToC requirements! Analysis findings are separated into two categories: –Companion Guidance - For inclusion in the ToC C-CDA Companion Guide (outside the scope of HL7 balloted standards) –C-CDA Revisions - For recommendation to the HL7 SDWG to ensure that implementation is very clear to developers We seek consensus on six recommendations to HL7 –Clarifications to ensure consistent use for implementations –Concerns addressable through revision to the C-CDA standard. 2

Sources for Analysis ONC and CMS NPRMs for Meaningful Use 2 (MU2) Consolidated CDA (C-CDA), December edition ToC CEDD, Use Cases, information packets, etc. Previous spreadsheet mappings between HITSP C83, CCD, and other CDA documents, updated for C-CDA and MU2 Analysis by Keith boone and others including EHRA Vetting through ONC S&I Framework ToC Implementation Guidance subworkgroup Discussions with CDA experts via HL7 listserv, Assumptions: –Take the NPRMs as is – don’t debate the merits of requirements in this forum –Map all MU2 data against potential C-CDA header, sections, and entries –Compare MU2 data against existing C-CDA document types for “goodness of fit”

Analysis Findings – Resolved through Companion Guide 4 MU2 RequirementFinding RaceOptional within the C-CDA Header Template EthnicityOptional within the C-CDA Header Template Preferred LanguageOptional within the C-CDA Header Template Optionality differences between MU2 NPRMs and Consolidated CDA standard.

Analysis Findings – Resolved through Companion Guide (continued) 5 ToC RequirementRecommendation Emergency ContactsToC recommends exchange of support contact information in every care transition scenario Existence of Advance Directives (yes/no) Capturing existence of advance directive is already a required functionality in MU2, so it is reasonable to include this information in transition of care exchange consistent with ToC recommendations Best practices for information exchange identified by ToC Community

Analysis Findings – Resolved through HL7 Ballot Issue 1 of 6 6 MU2 Requirement Laboratory tests and value(s)/result(s), including any tests and values/results pending Draft Issue Description: Clinicians would prefer to see pending results within the Results section. Concept included in C-CDA Result Organizer and Result Observation but moodCode & actStatus constraints seem to prohibit pending results. Additionally, it would be desirable to distinguish between a test pending (ordered but not yet performed) and a result pending (test performed but results not yet received) Possible solution: Modify constraints on Result Organizer and Result Observation entries to allow moodCode=RQO (not just EVN as currently) with actStatus=completed. Examples: Culture and sensitivity ordered and test started but not resulted yet; sample sent but haven't heard that the lab has received it; the lab has received a sample but not tested it; the testing is taking time to perform; the sample is being sent out to another lab; we are testing now but have not acquired reportable data yet; the troponin levels are so high the lab is doing dilutions before reporting the result; the results have not been reviewed/released, etc. There are several distinct cases, all which we interpret as 'pending'.

Analysis Findings – Resolved through HL7 Ballot Issue 2 of 6 7 MU2 Requirement Smoking status Draft Issue Description: ONC NPRM (l) specifies a value set that is not in C-CDA: Current every day smoker; current some day smoker; former smoker; never smoker; smoker, current status unknown; and unknown if ever smoked Possible solution: Social History Observation needs vocabulary and value set for MU: Alternatively, if these values do not exist in a code system, add text to C-CDA to indicate that these allowed values must be expressed in the narrative block Examples: Not applicable

Analysis Findings – Resolved through HL7 Ballot Issue 3 of 6 8 MU2 Requirement Referring or transitioning provider’s name and contact information; names and contact information of any additional care team members beyond the referring or transitioning provider and the receiving provider; names of providers of care during hospitalizations Draft Issue Description: Some providers of care may be related to only a specific encounter and some may be part of the patient’s longitudinal care team (e.g., the PCP). We request guidance as to how to properly capture a longitudinal care team member vs. an encounter- specific “care team” member. Possible solution: Explicitly address how “care team” (longitudinal) concept should be represented. Consider clarifying use across doc types of encompassingEncounter ( Consult Note, Discharge Summary), serviceEvent ( CCD). Examples: Clinically relevant examples of “care team” and “providers of care during hospitalizations” – may be in ToC Companion Guide

Analysis Findings – Resolved through HL7 Ballot Issue 4 of 6 9 MU2 Requirement Recommended patient decision aids (if applicable to the visit) Draft Issue Description: The relationship between the NPRM wordings and the right C-CDA section may not be obvious. We assume that these “aids” can expressed as part of the patient instructions Possible solution: Include minor wording changes in the 4.28 Instructions Section description to encompass MU language. Add the phrase “patient decision aids." Examples: “Patient decision aids help patients understand their health condition, the available treatment/screening options and the possible outcomes of these options.” (source: informedmedicaldecisions.org) E.g., “Managing Acute Low Back Pain” shared decision making program

Analysis Findings – Resolved through HL7 Ballot Issue 5 of 6 10 MU2 Requirement Future scheduled tests (ONC) / “List of diagnostic tests pending” (CMS) Draft Issue Description: The relationship between the NPRM wordings and the right C-CDA section may not be obvious. We assume that both these phrases refer to tests that have been suggested for the patient but not actually performed yet. Possible solution: Include minor wording changes in the 4.39 Plan of Care Section description to encompass MU language. Add the phrase "future scheduled tests." While "tests" are equivalent to "observation" in RQO mood, including the phrase "future scheduled tests (= requested observations)" will make it crystal clear Examples: Clinical examples of a tests commonly suggested post-discharge

Analysis Findings – Resolved through HL7 Ballot Issue 6 of 6 11 ToC Recommendation Indication of whether Medication List has been Reconciled Draft Issue Description: ToC recommends that there be a consistent method of indicating whether or not a Medication List has been reconciled, as well as a date/time and name who attested to the reconciliation. This is clinically very important, and Med Rec is a MU2 functional requirement, but not currently an information exchange requirement Possible solution: TBD Examples: Need to distinguish between “copy forward” (didn’t discuss meds) encounters vs cases where new med was prescribed by specialist but med rec was not done, vs where med rec was truly done

Are we agreed? That these last six issues, as modified per today’s discussion, are worth submitting to HL7 Structured Documents for consideration on the next ballot? That the other issues are acceptable to clarify through S&I Framework implementation guidance (Companion Guide)?

Document Type “Goodness of Fit” Discussion started recently: today’s goal is just to frame the problem Challenges –Transitions are not all equal in their data needs, per ToC work –Regulations specify a “floor not a ceiling” –No C-CDA doc type perfectly matches MU2, though some can support MU2 by adding sections (see spreadsheet) and/or allowing “unknowns” for other sections –Variety allows flexibility for senders, but may pose challenges for receiving EHRs and human readers –MU2 has requirements upon receiving a “summary of care record” (e.g., counting # sent, execute CDS and/or reconciliation upon incorporation) – so how do you know you’ve received a MU2 SOCR? Solutions? TBD… –Provide guidance on how to achieve MU using Doc Types A, B, C… as a base? –Provide standardized way to assert conformance to MU2? –Determine to what extent document types even matter, or is it just section and entry-level conformance that matter?