CDAE2_AIG_CCDA_EXCHANGE_R1_D1_2016MAY
HL7 CDA® R2 Attachment Implementation Guide:
Exchange of C-CDA Based Documents, Release 1 -
US Realm
May 2016
HL7 DSTU Ballot
Sponsored by:
Attachments Work Group
Durwin Day, Co-Editor/CoChair
Craig Gabron, Co-Editor/CoChair
Robert Dieterle, Co-Editor
Deborah Meisner, Co-Editor
Laurie Burckhardt, Co-Editor
Dan Vreeman, Co-Editor
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Table of Contents
Sponsored by: 1
Attachments Work Group 1
Important Notes 2
Table of Contents 3
1 Preface 7
1.1 Revision History 7
1.2 Acknowledgements 7
2 Introduction 8
2.1 Audience 8
2.2 Purpose 8
2.3 Scope 9
2.4 History 9
2.5 Approach 9
3 Background 11
3.1 Reference Material 11
3.2 Relationship of Standards and Implementation Guides (IG) 12
3.3 Understanding C-CDA 13
3.4 ISO Object Identifiers (OID’s) 14
3.5 Structured/Unstructured Documents 15
3.6 Base64 Encoding Content 17
3.7 Document Succession 19
4 LOINC (Logical observation identifiers name and codes) 20
4.1 Overview of LOINC 20
4.2 Use of LOINC in Attachments 21
4.3 Using the LOINC Database to Identify Valid Attachment Types 22
5 Business overview for attachments 24
5.1 Attachment Exchange 24
5.2 Solicited and Unsolicited Attachments 25
5.3 Attachment Activity 26
5.4 Attachment Scenarios 30
6 Attachment Business Flows 31
6.1 Solicited Attachment Exchange 31
6.2 Unsolicited Attachment Exchange 36
7 Attachments conformance requirements 39
7.1 US Realm Header Requirements 39
7.2 Structured Document Requirements 39
7.3 Unstructured Document Requirements 40
7.4 Validation Requirements 41
7.5 Document Succession Requirements 41
7.6 C-CDA R1.1 and R2.1 Structured Document Requirements (Request and Response) 41
7.7 CDP1 R1.1 Documents Requirements (Request and Response) 42
7.8 Other Structured CDA Documents for Attachments Requirements (Request and Response) 42
7.9 Unstructured Document (Request and Response) 42
7.10 LOINC Modifier Code Requirements 43
7.11 Attachment Unique ID Requirements 43
7.12 Transport and Metadata Requirement 43
APPENDIX A Abbreviations, acronyms, and definitions 45
APPENDIX B ASC X12 Transaction Standards and error flows 48
APPENDIX C consolidated clinical documentation architecture r2.1 50
C.1 Overview of Implementation Guide 50
C.2 Document Templates 50
C.3 LOINC Codes 51
APPENDIX D Clinical Documents for Payers – Set 1 r1.1 53
D.1 Overview of Implementation Guide 53
D.2 Document Templates 53
D.3 LOINC Codes 53
APPENDIX E Digital Signatures on Attachments 55
E.1 User Story– Digital Signature by Authorized Signer 56
E.2 Creating a Digital Signature 56
E.3 Verifying an XAdES-based Signature 57
APPENDIX F CDA Document for Attachments Transport and payload 59
F.1 Transport Options 59
F.2 Metadata Requirements 60
F.3 Overview of X12 (Synchronous or Real Time) 61
F.4 Overview of a payload over eHealth Exchange with ASC X12N Message 62
F.5 Overview of a Payload Over CONNECT with XDR 65
F.6 Overview of Payload Over Direct (ASC X12 Message) 72
F.7 Overview of Payload Over Direct 73
F.6 Overview of Payload Over Direct (ASC X12 Message) 74
F.7 Overview of Payload Over Direct 75
APPENDIX G Fast Healthcare Interoperability Resources (FHIR) 76
G.1 What is FHIR 76
G.2 Introduction to FHIR Resources, Extensions 76
Table of Figures
Figure 1 - Relationship of Standards and Implementation Guides 12
Figure 2: Example - Claims Attachment (Solicited) 33
Figure 3: Example - Prior Authorization (Solicited) 34
Figure 4: Example - Referral Attachment (Solicited) 35
Figure 5: Example - Post Adjudicated Claim Attachment (Solicited) 36
Figure 6: Example - Claims Attachment (Unsolicited) 37
Figure 7: Example – Prior Authorization (Unsolicited) 37
Figure 8: Example - Referral Attachment (Unsolicited) 38
Figure 9: Example - Notification Attachment (Unsolicited) 38
Figure 10: ASC X12 Transaction Flows 47
Figure 11: X12 Real-time 61
Figure 12: CONNECT with ASC X12N Specification 63
Figure 13: CONNECT w/ ASC X12 275 65
Figure 14: Direct Message 72
Figure 15: Direct Message 73
Figure 16: Direct Message 74
Figure 17: Direct Message 75
Table of Tables
Table 1: Supported File Formats 17
Table 2: Base64 Index 18
Table 3: Request Attachment Activity 27
Table 4: ASC X12N Attachment Activity 29
Table 5: Request and Response LOINC Code Usage for Solicited Structured Attachments 32
Table 6: C-CDA R2.1 Clinical Document Types with Recommended LOINC Code for Requests 50
Table 7: C-CDA R2.1 Clinical Document Types with Recommended LOINC Code for Requests 53
Table 8: - Transport Options 59
Table 9: - XD* Submission Set Metadata 66
Table 10 - XD* Document Entry Metadata 68
1 Preface
1.1 Revision History
The following provides a historical view of the iterations for this document and why each major revision was made.
Date / Purpose /March 27, 2016 / Version 1.0
1.2 Acknowledgements
The writers and editors of the HL7 Attachment Supplement Specification: Exchange Implementation Guide Release 1 want to acknowledge those who have provided years of hard work and dedicated efforts to bring forward the research and development needed to achieve the goal of information exchange amongst the healthcare industry stakeholders. This includes the current and past members of the Attachments Work Groups (formerly the Attachments Special Interest Group (ASIG)) and the Structured Documents Workgroup at HL7.
The information needs of the industry that were identified and developed over the years became key input into the foundational content found in the HL7 Implementation Guides for CDA® Release 2: Consolidated CDA Templates.
2 Introduction
This Supplement applies to electronic clinical documents that conform to the requirements of the HL7 US Realm Header which is specified in HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm). Conformance to the HL7 US Realm Header is indicated by assertion of the templateID 2.16.840.1.113883.10.20.22.1.1 with valid extensions.
Documents that meet this requirement at the time of publication of this Supplement include those conforming to the following balloted HL7 implementation guides:
· Consolidated CDA (C-CDA)
· Clinical Documents for Payers
· Medication Therapy Management
· Clinical Oncology Treatment Plan and Summary
These implementation guides will be collectively referred to as CDA Implementation Guides for Attachments. The combined set of document level templates defined in the CDA Implementation Guides for Attachments will be referred to as CDA Documents for Attachments in this guide.
The Appendices in this document are provided as guidance for implementers and are not necessarily required.
2.1 Audience
The audience for this Supplement is implementers (such as system architects and implementation developers) responsible for the exchange of Attachments between healthcare providers (hereafter known as ‘providers’), and health plans/utilization management organizations and/or their business associates (hereafter known as ‘payers’).
2.2 Purpose
This Supplement is intended to be used along with the CDA Implementation Guides for Attachments and provides guidance to implementers as they develop the means for exchanging supporting information as defined in Section 2.3.
This Supplement will serve to direct implementers to the appropriate HL7 implementation standard used to format the content based on the clinical document being exchanged as an Attachment. Refer to the Sections 3.0 & 4.0 in any of the CDA Implementation Guides for Attachments for additional information regarding levels of constraint, conformance statements, conformance verbs, cardinality, vocabulary conformance, and null flavor.
This Supplement is independent of the method for exchange (e.g., transport, networking, connectivity, security/privacy).
This Supplement will refer to healthcare supporting/additional information as Attachments. Additionally, a healthcare claim or encounter may be referred to as a Claim without mention of encounter and Healthcare Administrative Activities will include any or all of the activities as defined in Section 2.3.
2.3 Scope
This Supplement is limited in focus to use of the CDA Documents for Attachments to exchange clinical information between entities in an electronic clinical document. Examples of that exchange using existing standards are included, however, use of those standards as examples does not limit implementations to only those exchange standards.
This Supplement offers guidance for re-associating that clinical document with the healthcare administrative activity for which additional information was originally needed.
This Supplement is limited in scope to those functions which support the exchange of healthcare information between providers and payers as part of the administrative business functions of both.
Examples of Healthcare Administrative Activities requiring this supporting information include, but are not limited to:
· healthcare claim or encounter
· healthcare services review (e.g., prior authorizations/precertifications, referrals, notifications)
· post adjudicated claim audits
2.4 History
The Administrative Simplification provision of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 mandated the use of named healthcare electronic data interchange standards for the electronic conveyance of healthcare data that meets the business purposes specifically addressed under HIPAA. A Notice of Proposed Rule Making (NPRM) was issued in 2005 for Claims Attachments, but was withdrawn before a final rule was generated. In 2010, the Patient Protection and Affordable Care Act (ACA) re-instituted the original requirement under HIPAA for Attachments.
2.5 Approach
The HL7 Attachment Work Group (AWG) worked with payers and other industry stakeholders to identify the types of attachments needed to support claims and prior authorization of healthcare services.
The AWG collaborated with the Accredited Standards Committee (ASC) X12N Standard Development Organization (ASC X12) to define an electronic transaction that could be used to support the request for Attachments. The ASC X12 277 Health Care Information Status Notification Transaction Set was the most viable ASC X12 option.
The AWG determined that a proposed claims attachment standard combining the standards development efforts of ASC X12 and HL7 would be one of the possible options to support sending an Attachment. The proposed solution was the ASC X12 275 Patient Information Transaction Set with the HL7 Clinical Document embedded within the BDS/Binary segment.
The AWG determined it was in the best interest of providers and/or their vendors to support only one way for the exchange of the clinical information. Rather than one standard for the provider-to-provider information exchange and another for provider-to-payer information exchange, the AWG agreed to adapt their approach to leverage and be consistent with the C-CDA formatting of clinical documentation.