co… · Web viewAS_CDATEMPGD_R2_INFORM_2015DEC. HL7 Attachment Supplement Specification: Exchange Implementation Guide Release 1. For use with: Consolidated CDA Templates for Clinical

AS_CDATEMPGD_R2_INFORM_2015DECMAY

HL7 Attachment Supplement Specification:Exchange Request and Response Implementation

Guide Release 1For use with:

Consolidated CDA Templates for Clinical Notes, Release 2 or

Additional CDA R2 Templates – Clinical Documents for Payers – Set 1

DECMAY 2015

HL7 Informative Document: Ballot

Sponsored by:Attachments Work Group

Durwin Day, Co-Editor/CoChairCraig Gabron, Co-Editor/CoChair

Penny ProbstRobert Dieterle, Co-Editor

Copyright © 2015 Health Level Seven International ® ALL RIGHTS RESERVED. The reproduction of this material in any form is strictly forbidden without the written permission of the publisher. HL7 International and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. Pat & TM Off.

Page 2 HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1© 2015 Health Level Seven International. All rights reserved. DecemberMay 2015

1 IMPORTANT NOTES:

HL7 licenses its standards and select IP free of charge. If you did not acquire a free license from HL7 for this document, you are not authorized to access or make any use of it. To obtain a free license, please visit http://www.HL7.org/implement/standards/index.cfm.

If you are the individual that obtained the license for this HL7 Standard, specification or other freely licensed work (in each and every instance "Specified Material"), the following describes the permitted uses of the Material.A. HL7 INDIVIDUAL, STUDENT AND HEALTH PROFESSIONAL MEMBERS, who register and agree to the terms of HL7’s license, are authorized, without additional charge, to read, and to use Specified Material to develop and sell products and services that implement, but do not directly incorporate, the Specified Material in whole or in part without paying license fees to HL7. INDIVIDUAL, STUDENT AND HEALTH PROFESSIONAL MEMBERS wishing to incorporate additional items of Special Material in whole or part, into products and services, or to enjoy additional authorizations granted to HL7 ORGANIZATIONAL MEMBERS as noted below, must become ORGANIZATIONAL MEMBERS of HL7.B. HL7 ORGANIZATION MEMBERS, who register and agree to the terms of HL7's License, are authorized, without additional charge, on a perpetual (except as provided for in the full license terms governing the Material), non-exclusive and worldwide basis, the right to (a) download, copy (for internal purposes only) and share this Material with your employees and consultants for study purposes, and (b) utilize the Material for the purpose of developing, making, having made, using, marketing, importing, offering to sell or license, and selling or licensing, and to otherwise distribute, Compliant Products, in all cases subject to the conditions set forth in this Agreement and any relevant patent and other intellectual property rights of third parties (which may include members of HL7). No other license, sublicense, or other rights of any kind are granted under this Agreement. C. NON-MEMBERS, who register and agree to the terms of HL7’s IP policy for Specified Material, are authorized, without additional charge, to read and use the Specified Material for evaluating whether to implement, or in implementing, the Specified Material, and to use Specified Material to develop and sell products and services that implement, but do not directly incorporate, the Specified Material in whole or in part. NON-MEMBERS wishing to incorporate additional items of Specified Material in whole or part, into products and services, or to enjoy the additional authorizations granted to HL7 ORGANIZATIONAL MEMBERS, as noted above, must become ORGANIZATIONAL MEMBERS of HL7.

Ownership. Licensee agrees and acknowledges that HL7 owns all right, title, and interest, in and to the Materials. Licensee shall take no action contrary to, or inconsistent with, the foregoing.

Licensee agrees and acknowledges that HL7 may not own all right, title, and interest, in and to the Materials and that the Materials may contain and/or reference intellectual property owned by third parties (“Third Party IP”). Acceptance of these License Terms does not grant Licensee any rights with respect to Third Party IP. Licensee alone is responsible for identifying and obtaining any necessary licenses or authorizations to utilize Third Party IP in connection with the Materials or otherwise. Any actions, claims or suits brought by a third party resulting from a breach of any Third Party IP right by the Licensee remains the Licensee’s liability.

Following is a non-exhaustive list of third-party terminologies that may require a separate license:

HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1 Page 3May December 2015 © 2015 Health Level Seven International. All rights reserved.

May 2012


Terminology Owner/ContactCurrent Procedures Terminology (CPT) code set

American Medical Association http://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your-practice/coding-billing-insurance/cpt/cpt-products-services/licensing.page?

SNOMED CT International Healthcare Terminology Standards Developing Organization (IHTSDO) http://www.ihtsdo.org/snomed-ct/get-snomed-ct or [email protected]

Logical Observation Identifiers Names & Codes (LOINC)

Regenstrief Institute

International Classification of Diseases (ICD) codes

World Health Organization (WHO)

Table of Contents1 IMPORTANT NOTES:..........................................................................................................2

PREFACE..................................................................................................................................81.1 Revision History.......................................................................................................81.2 Acknowledgements..................................................................................................8

2 INTRODUCTION................................................................................................................92.1 Audience..................................................................................................................92.2 Purpose....................................................................................................................92.3 Scope.....................................................................................................................102.4 Overview................................................................................................................10

2.4.1 Background.......................................................................................................102.4.2 Approach...........................................................................................................11

2.5 Organization of This Guide.....................................................................................122.6 Additional Attachment Information - Request and Response.................................13

2.6.1 Solicited and Unsolicited Attachments...............................................................132.6.2 Request Attachment Activity.............................................................................142.6.3 Response Attachment Activity...........................................................................152.6.4 Understanding Attachment Activities................................................................162.6.5 Attachment Request/Response Re-Association using Attachment ID................20

2.7 Definitions and Acronyms......................................................................................232.7.1 Definitions.........................................................................................................232.7.2 Acronyms..........................................................................................................24

2.8 Health Level Seven Organization...........................................................................24

3 UNDERSTANDING C-CDA IMPLEMENTATION GUIDES......................................................253.1 What is Clinical Document Architecture (CDA)?.....................................................253.2 Taking Advantage of Structured/Unstructured Content.........................................26

3.2.1 Structured Content............................................................................................273.2.2 Unstructured Content........................................................................................27

3.3 What are C-CDA R2 and CDP1 ?.............................................................................29

4 ADDITIONAL INFORMATION (ATTACHMENTS) GENERAL..................................................304.1 Standards to Accomplish Information Exchange of The Request and Response....304.2 LOINC (Logical Observation Identifiers Names and Codes)....................................30

4.2.1 Obtaining LOINC and Other Resources From the Regenstrief Institute..............31


May 2012

4.2.2 Use of LOINC for Attachments...........................................................................314.3 Using the LOINC Code As An Identifier In Messages...............................................324.4 Requesting/Responding/Submitting Attachment Information................................32

4.4.1 Using LOINC Code to Request/Respond Attachment Information (Solicited)......334.4.2 Using LOINC Code to Submit Attachment Information (Unsolicited)..................364.4.3 Using “Modifier LOINC Codes” to Constrain The Request..................................37

4.5 Using the LOINC Database to Identify Valid Attachment Types..............................404.5.1 Identifying Valid Attachment Types In The LOINC Table....................................404.5.2 Identifying Valid Attachment Types Using RELMA and The Online LOINC Search Application (http://search.loinc.org)................................................................................41

4.6 ISO Object Identifiers (OID’s).................................................................................42

5 EXAMPLES - ADDITIONAL INFORMATION (ATTACHMENTS) USE CASES...........................445.1 Example – Claim Attachment.................................................................................45

5.1.1 Claim Attachment – Solicited Attachment Example...........................................455.1.2 Claim Attachment – Unsolicited Attachment Example.......................................46

5.2 Example – Prior Authorization Attachment.............................................................465.2.1 Prior Authorization Attachment – Solicited Attachment Example.......................465.2.2 Prior Authorization Attachment – Unsolicited Attachment Example...................47

5.3 Example – Referral Attachment.............................................................................485.3.1 Referral Attachment – Solicited Attachment Example.......................................485.3.2 Referral Attachment – Unsolicited Attachment Example...................................49

5.4 Example – Notification Attachment........................................................................505.4.1 Notification Attachment – Unsolicited Notice of Facility Discharge with Discharge Summary Example..........................................................................................................50

5.5 Example – Post Adjudicated Claim Attachment......................................................515.5.1 Post Adjudicated Claim Attachment – Solicited Attachment Example................51

6 IMPORTANT INFORMATION NOT PREVIOUSLY ADDRESSED IN THIS SUPPLEMENT...........53

7 OBTAINING NEW ATTACHMENT TYPES............................................................................557.1 Process for Requesting New Attachment Types.....................................................557.2 Updates to the LOINC database.............................................................................55


8 APPENDICES...................................................................................................................56

APPENDIX A — BUSINESS REQUIREMENTS FOR REQUESTING AND SUBMITTING ATTACHMENT (METADATA).............................................................................................57

APPENDIX B — ASC X12 ASC X12N STANDARDS THAT SATISFY THE BUSINESS REQUIREMENTS LISTED IN APPENDIX A..........................................................................58

APPENDIX C — USE OF STYLESHEETS AS A PART OF THE C-CDA PACKAGE CONTENT.......59

APPENDIX D — C-CDA DOCUMENT TRANSPORT AND PAYLOAD.........................................608.1 Transport Options..................................................................................................608.2 Overview of X12 (real-time)...................................................................................60

8.2.1 Security Metadata.............................................................................................618.2.2 Error Handling...................................................................................................61

8.3 Overview of a payload over CONNECT with ASC X12 ASC X12N Message.............628.3.1 ASC X12N 275 over CONNECT (CORE)...............................................................628.3.2 CONNECT SAML Assertions................................................................................638.3.3 IHE XD* Metadata..............................................................................................64

8.4 Overview of a payload over CONNECT with XDR....................................................648.4.1 esMD Security Metadata....................................................................................718.4.2 Error Handling...................................................................................................71

8.5 Overview of payload over Direct (X12 Message)....................................................718.6 Overview of payload over Direct............................................................................72

APPENDIX E — ASC X12 ASC X12N STANDARDS TRANSACTION AND ERROR FLOW..........74

APPENDIX F — C-CDA DOCUMENT TYPES..........................................................................76What are C-CDA Document Types?....................................................................................76


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Table of FiguresFigure 1: Example - Claims Attachment (Solicited)..............................................................45Figure 2: Example – Claims Attachment (Unsolicited)..........................................................46Figure 3: Example – Prior Authorization (Solicited)...............................................................47Figure 4: Example – Prior Authorization (Unsolicited)...........................................................48Figure 5: Example – Referral Attachment (Solicited)............................................................49Figure 6: Example – Referral Attachment (Unsolicited)........................................................49Figure 7: Example – Notification Attachment (Unsolicited)...................................................51Figure 8: Example – Post Adjudicated Claim Attachment (Solicited)....................................51Figure 11-1: X12 (real-time)..................................................................................................60Figure 11-2: CONNECT with ASC X12 ASC X12N Specification..............................................63Figure 11-2: CONNECT w/ X12 275........................................................................................64Figure 11-3: Direct Message..................................................................................................72Figure 11-3: Direct Message..................................................................................................72

Table of TablesTable 1: Request Attachment Activity Table........................................................................14Table 2: ASC X12 ASC X12N Attachments Activity Table......................................................18Table 3: Attachments ID Re-association Table.....................................................................21Table 4: Clinical Document Types with Recommended LOINC Code for Requests................34Table 5: Request and Response LOINC Code Usage for Solicited Structured Attachments...36Table 6: Time Window Modifier LOINC Codes.......................................................................38Table 11-2: XD* Submission Set Metadata............................................................................66Table 11-3: XD* Document Entry Metadata...........................................................................67Table 7b: LOINC Codes for Specific C-CDA Documents........................................................78


PREFACE

1.1 Revision HistoryThe following provides a historical view of the iterations for this document and why each major revision was made.

Date PurposeJanuary 2015 Version 1.0

March 10, 2015 Version 1.1 Updated references to C-CDA and CDP1 RCDNov 23, 2015 Version 2.0 Change Attachment use

1.2 AcknowledgementsThe writers and editors of this document want to acknowledge the years of hard work and dedicated efforts of the current and past members of the Attachments Special Interest Group (ASIG), the Structured Documents and Attachments Work Groups at HL7 in building bringing forward the research and development needed to achieve the goal of information exchange amongst the provider community and health plans/healthcare insurance companies.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 for Clinical Notes Volume 1 Introductory Material and Volume 2 Templates and Supporting Material and Additional CDA R2 Templates – Clinical Documents for Payers – Set 1. These standards are expected to be widely used in the exchange of clinical information between providers as well as between providers and patients in satisfying many exchange criteria established under the Medicare/Medicaid EHR Incentive Program (aka, “Meaningful Use”).This material contains content from LOINC® (http://loinc.org ). The LOINC table, LOINC codes, and LOINC panels and forms file are copyright © 1995-2015, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and are available at no cost under the license at http://loinc.org/terms-of-use .


May 2012

Meisner, Debbi, 11/26/15,

I think the word should be bring vs. building

2 INTRODUCTION This guide is intended to be used in conjunction with the HL7 Implementation Guides for CDA Release 2: Consolidated CDA Templates for Clinical Notes Volume 1 Introductory Material and Volume 2 Templates and Supporting Material (referred to as C-CDA R2 in this guide) and Additional CDA R2 Templates – Clinical Documents for Payers – Set 1 (referred to as CDP1 in this guide) to describe to HealthCare industry stakeholders how to implement components of the C-CDA R2 and CDP1 for the purposes described in this guide in section 2 3 .2 below. C-CDA Implemenatation Guides will jointly refer to C-CDA R2, CDP1 and other CDA implementation guides based on C-CDA R2. The combined set of document level templates defined in the C-CDA Implementation Guides will be referred to as C-CDA Documents in this guide.This supplement guide 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 Aattachment. Refer to the Sections 3.0 & 4.0 in the C-CDA Implementation Guides for additional information regarding levels of constraint, conformance statements, conformance verbs, cardinality, vocabulary conformance, and null flavor.

2.1 AudienceThe audiences for this supplement are implementaters, such as architects and developers, responsible for the exchange of supporting/attachment informationAttachments among between healthcare providers (herearafter known as ‘providers’), health plans/utilization management organizations and/or their business associates (hereafter known as ‘payers’).

2.2 PurposeThis guide is intended to be used as a supplement to the C-CDA Implementation Guides. It provides guidance to implementers as they exchange additional supporting information needed amongst payers/UMO’s (Utilization Management Organization) and providers. Examples of Healthcare Administrative Activities requiring this supporting information include, but are not limited to, additional informationAttachments in suport of:

In support of a healthcare claim or encounter In support of healthcare services review (e.g., prior

authorizations/precertifications, referrals) In support of post adjudicated claim audits



Spelling?

For the purposes of this supplement, healthcare supporting/additional information will be referred to as Attachments. Additionally, a healthcare claim or encounter may be


May 2012

referred to as a Claim without mention of encounter. Throughout this supplement, Healthcare Administrative Activities will include any or all of the activities listed above.Attachments are a means of electronically exchanging supporting information to augment each of the examples above. The ultimate goal of Attachments standardization in providing structured, standardized electronic data is to enable the fully automated exchange and processing of supplemental information in the various healthcare activities shown above. While some processes will always require human intervention, use of fully structured Aattachments may significantly reduce human intervention and turnaround time for adjudication or resolution.

2.3 ScopeThis supplement is limited in scope to those functions which support the exchange of healthcare information among between providers and payers in support of the administrative business functions of both as identified in section 2 3 .2 of this supplement.This supplement is limited in focus to use of the C-CDA Documents to exchange clinical information amongst between entities in a single electronic clinical document. This may already exist as is, or need to be created for this exchange.It will also offer guidance as to how to re-associate that single clinical document with the healthcare administrative activity for which additional information was originally needed. It may describe scenarios for those business events which could be broader than the intended scope of this supplement to assist the audience in understanding the context of how the single clinical document exchange fits into the overall picture. While the single clinical document can exist entirely on its own, this supplement will focus on the electronic exchange of that document from one point to another. This supplement will present examples of that exchange using existing standards, however, use of those standards as examples does not limit implementations to only those exchange standards.This supplement is independent of the the method for exchange (e.gi.e., transport, networking, connectivity, security/privacy).

2.4 Overview The sections below provide the historical background of claim Aattachments as well as a description of the approach used by the Attachments Work Group (AWG) to develop this supplement.

2.4.1 Background


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. An NPRM was issued in 2005, but was withdrawn before a final rule was generated. In 2010, the Patient Protection and Affordable Care Act (PPACA) re-instituted the original requirement under HIPAA for Aattachments.The Centers for Medicare & and Medicaid Services (CMS) worked with Health PlansPayers and key industry stakeholders to identify the types of attachments needed by the healthcare industry. This group also worked with the Accredited Standards Committee (ASC) X12N Standard Development Organization (ASC X12N) Insurance Subcommittee (ASC X12N) to define an electronic transaction that could be used to support the request for Attachments informations. The ASC X12N 277 Health Care Information Status Notification Ttransaction Set and the ASC X12N 275 Patient Information tTransaction Set87 Response were the most viable ASC X12 ASC X12N options. It was also determined that a proposed claims attachment standard combining the standards development efforts of ASC X12 ASC X12N and Health Level Seven International (HL7) would be one of the possible options to support sending the Aattachment information. The proposed ASC X12 ASC X12N solution was the ASC X12N 275 Patient Information Ttransaction Set with the HL7 Clinical Document embedded within the BDS/Binary segment. It was evident, that while the healthcare industry continues to evolve technically, in many cases it still relies heavily on paper based or imaged (scanned) health records for Aattachments data. Many healthcare delivery systems were not capable of providing discrete codified data. In addition, the healthcare industry like many other industries was moving towards using newer technologies such as Extensible Markup Language (XML) to transfer data. As all of this was occurring in the industry, parallel efforts within the HL7 organization brought forth the Clinical Document Architecture (CDA) - the first ANSI-accredited XML-based standard in the healthcare industry.

2.4.2 Approach

With the advent of “Meaningful Use” and its clinical document exchange requirements between providers and other legally permitted entities, along with it’s similarity to the business model for clinical document exchange previously described in the attachments model, a re-assessment of the attachments model was undertaken. It revealed that the content found in the C-CDA (the standard named for Meaningful Use) is largely consistent with that needed for attachments purposes.After much discussion, the AWG determined that it was not in the best interest of providers and/or their vendors to support multiple formats for this exchange HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1 Page 13May December 2015 © 2015 Health Level Seven International. All rights reserved.

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Need to be consistend in whether to capitalize transaction. When looking at the X12 TR3 – they do not use the word transaction at all. So 275 Patient Information Transaction Set is how they address it. Need Laurie B to weigh in.


When referring to the standards and the organization it is ASC X12 when referring to the TR3’s it is ASC X12N

based on the recipient. Rather than one standard format for the provider-to-provider information exchange and another (i.ee.g., the original Additional Information Specification (AIS)) for provider-to-payer information exchange, the AWG agreed to adapt their approach to leverage and be consistent with that of the C-CDA with respect to formatting clinical documentation.The AWG then performed a gap analysis between the C-CDA content and the AIS content for each transaction type. The AIS’s were the original attachments specifications. Information needed for purposes described in section 3.2 that was present in the AIS but not in the C-CDA was identified and passed to the Structured Document Work Group for inclusion into the C-CDA. In some cases, the result was information from the original AIS’s being added to the C-CDA, and are now identified by their corresponding clinical document (Aattachment) types (see section 4.3). In other cases, the information was deemed not necessary or present in the claim transaction (e.g., Ambulance).Information present in the C-CDA but not in the AIS was evaluated and found to be acceptable for the purposes of Aclaims attachments. In the Fall of 2013, additional work was done by the Electronic Submission of Medial Documentation (esMD) Initiative to map existing CMS Medicare Fee For Service (FFS) and other use cases where an enhanced set of information is required to be supported toin the proposed C-CDA R2 templates. The resulting analysis revealed the need for additional, highly constrained document templates to augment those defined by the C-CDA R2. This work resulted in the creation of documents defined in the Clinical Documents for Payers – Set 1 (CDP1). The C-CDA Documents are intended to have a broad industry footprint and not to be implementation specific. Information specific to implementations as described in section 3.2 is not included in the C-CDA. This supplement was created to capture the Attachments specifications not available in the C-CDA. The C-CDA Doocuments by themselves do not fully satisfy the needs of the industry for Aattachment information exchange. Additional metadata/enveloping is needed to assist in the correct pairing with a healthcare administrative activity and the Aattachment itself. For this purpose, ASC X12 ASC X12N had developed a suite of Technical Report Type 3 (TR3) documents standards for use with the original AIS’s. Throughout this supplement, references and examples of Aattachment activity may cite specific ASC X12 ASC X12N standards TR3s previously developed for this purpose, however there is no intent by the authors of this supplement to limit those metadata/enveloping standards to those provided by ASC X12N, and is provided for example purposes only.Note: The second release of the C-CDA named C-CDA R2 was split into two volumes. This two-volume implementation guide (IG) contains an overview of Clinical Document Architecture (CDA) markup standards, design, and use (Volume 1) and a consolidated library of CDA templates for clinical notes Page 14 HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1© 2015 Health Level Seven International. All rights reserved. DecemberMay 2015

applicable to the US Rrealm (Volume 2). These two volumes comprise a Draft Standard for Trial Use (DSTU). The C-CDA R2 replaces the HL7 Implementation Guides for CDA Release 2: IHE Health Story Consolidation, DSTU Release 1.1.

2.5 Organization of This GuideThis supplement specifies general information and additional conformance criteria for the implementation of Aattachments information exchange. The primary guidance to create Aattachment document types is contained within the C-CDA Implementation Guides. , with Aadditional conformance criteria specific to Aattachments is provided within this supplement and is organized into chapters with references to tables and figures throughout. 2 – Preface. This chapter provides revision history and acknowledgements.3 – Introduction. This chapter provides foundational information about the evolution of Attachments, including terminology, definitions and acronyms specific to understanding Aattachments.4 – Understanding C-CDA Documents. This chapter offers introductory information about the C-CDA Documents and for utilizing them to convey attachment information.5 – Additional Information ( Attachments ) General . This chapter provides information about standards, use of LOINC codes in request/response, Modifier LOINC Codes, using the Regenstrief LOINC Mapping Assistant (RELMA) Assistnat (RELMA) to navigate the LOINC database and OID’s.6 – Examples (Additional Information (Aattachments) Use Cases). This chapter provides representative examples for the request/response of attachment information.7 – Important Information Not Previously Addressed in This Supplement. This chapter provides insight into assumptions of the Aattachment model not specifically addressed elsewhere. 8 – Obtaining New Attachment Types. This chapter provides basic guidance to the industry onfor the process of requesting new Attachment types.9 – Appendices. This chapter provides additional information regarding required metadata, candidate enveloping standards, content neutral transports and the use of stylesheets. The Appendices also contain non-normative examples for the most common transport, metatdata, and enveloping standards.


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[2.6] Additional Attachment Information - Request and Response

Typically, in the course of doing business payers will need additional information from a provider to determine if the level of service being performed or requested is consistent with the patient’s insurance benefits. Payers also have general medical policies established that must be checked for consistency with the patients insurance benefits. It is important to note that in all cases the request for additional aAttachments information comes in one of two forms, electronic or non-electronic. This supplement takes no position regarding the requirement to use electronic requests or responses, rather it simply addresses what information in a standardized format is to be exchanged when electronic requests or responses are used. However, while this supplement by necessity must define the complete attachment activity scenario, it only addresses attachment scenarios where an electronic exchange of an Attachment standard electronic response is involved.

2.5.1[2.6.1] Solicited and Unsolicited Attachments

For the purposes of this supplement, we will use the terms “solicited” and “unsolicited” to help clarify the scenarios for which one or more standards are to be used. The response, whether solicited or unsolicited, refers to the act of providing additional aAttachments information needed. Solicited and unsolicited scenarios are tied closely to the response side of the attachment activity without regard to the mode of the request. They are also aligned closely with the entity establishing the Aattachment re-association ID that is used to match the attachment itself with either the claim, referral, or prior authorization attachment activity (more about Aattachment re-association ID in section 3.6.5).A solicited Aattachment refers to the act of requesting and/or responding with information which was requested after a healthcare entity determines a need for additional information to complete the healthcare administrative activity. An unsolicited Aattachment refers to the act of providing additional information that conforms to a set of rules-based criteria invoked at the time of the submittal of a healthcare administrative activity. This information is based on advance knowledge of rules defined by the information receiver. An unsolicited attachment would never be sent in response to a standard electronic attachment request. A key component of both scenarios is the entity establishing the linkage to re-associate the healthcare administrative activity with the corresponding attachment information.

In the solicited scenario, the entity creating the request for an Aattachment would assign an attachment ID used to re-associate the


Aattachment response to the original aAattachment request. This Aattachment identifier must be returned with the attachment Attachment response. In the unsolicited scenario, the entity that is the source for the Aattachment information would assign an Aattachment ID. This Aattachment identifier must be provided with the Attachment additional information to be re-associate with the healthcare administrative activity.

This supplement guide takes no position with respect to the business reasons that initiate unsolicited attachments. However, industry best practices suggest that in the absence of business rules established in advance, attachment information should not be sent.

2.5.2[2.6.2] Request Attachment ActivityA request for additional informationan Attachment can originate in numerous ways and may be initiated by unique triggering business events depending on the originating actor. The table below reflects some of the more common scenarios for illustrative purposes:

Table 1: Request Attachment Activity Table

Healthcare Administrative

Activity

Request Attachment IDAttachment

Activity BasisMode Timing

Assigning Actor Linkage

Claim

Standard Electronic

After claim receipt and review Payer

Payer request and provider

responseSolicited

Phone call, US Postal Service, Patient request,

etc

After claim receipt and review Payer


responseSolicited

Rules Based At time of claims submital1 Provider

Provider claim and

Attachmentadditional information submittal

Unsolicited

Prior Authorization Standard

ElectronicAfter prior

authorization receipt and review

PayerPayer request and provider

responseSolicited


etc

After prior authorization

receipt and review

Payer Payer request and provider

response

Solicited

1 Payers request criteria (rules based) for a certain type of claim for a specific health care provider, procedure, or service is known in advance to the provider .HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1 Page 17May December 2015 © 2015 Health Level Seven International. All rights reserved.

May 2012

Rules BasedAt time of prior authorization

request2Provider

Provider Prior Authorization request and Attachmentadditional information submittal

Unsolicited

Referral

Standard Electronic

After referral receipt and review Payer


responseSolicited


etc)

After referral receipt and review Payer


responseSolicited

Rules BasedAt time of referral

request2Provider

Provider referral request and additional informatio

nAttachment submittal

Unsolicited

Notification Rules Based

At the time of scheduled

admission or service, actual admission or discharge,

approval for Health Services

Review

Provider or Payer Unknown Unsolicited

Post Adjudicated

Claim

Standard Electronic

After claim adjudicated Payer


responseSolicited

2.5.3[2.6.3] Response Attachment ActivityThe act of exchanging Attachments from an information source to an information receiver is considered a response3. The information source is considered the entity that posesses the attachment informationcreates the Attachment needed by the receiving entity to support the healthcare administrative activity.

2.5.4[2.6.4] Understanding Attachment Activities Because this supplement addresses all facets of the process in the requesting of and responding with Aattachments information, and because the actor’s role will vary depending on the activity type, a table (Table 2) has been developed to better illustrate these activities. Each row in the table represents a unique aattachment activity that would require a unique business flow to describe that activity. Additionally, each row will call for a unique set of electronic exchange standards to be used.

2 Payers request criteria (rules based) for certain types of prior authorizations or referral is known in advance to the provider.3 A response may also be thought of an attachment submittal in the unsolicited scenarioPage 18 HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1© 2015 Health Level Seven International. All rights reserved. DecemberMay 2015

As described later in Section 5.1 of this supplement, there are multiple standards available in the industry to accomplish the exchange of information for attachment purposes (e.gi.e.,, request, response, acknowledgement, etc). For the purposes of this supplement, example scenarios and use cases will reference those standards, such as ASC X12N’s, previously developed to accomplish Aattachments information exchange for example purposes ONLY. Out of scope are specific standards and methods for connectivity in moving the Aattachment information from point to point.Table 2 (Attachments Activity Table) below describes all scenarios addressed by this supplement for attachment exchange purposes. Column headings and table values are described below:

Healthcare Administrative Activity – The type of healthcare administrative activity of the originating actor for the ‘request’ activity type.

Activity ID – A symbolic ID used to express, in abbrieviated form, the attachment activity. (NOTE: This ID will be used to uniquely determine the standard(s) necessary to accomplish the attachment exchange activity described in the row of the table)

Activity Type – Describes the type of activity of the originating actor.o Request – explicitly requested Aattachment information, either

electronically or some other method.o Response – Aattachment information provided electronically

in response to an explicit request.o Attachment Submission – aAttachment information provided

electronically in response to an “advance rule based” request for attachment informationAttachments (e.gi.e.,, mutually known rules, policy or guidelines).

Attachment Activity Basiso Solicited – aAttachment information which is:

an explicit request or the response to an explicit request.

o Unsolicited – Aattachment information from the Originator Actor to the Receiver Actor based ONLY on a “rules based” request and in the absence of an explicit request.

Actoro Originator – the actor originating or initiating the attachment

activity.o Receiver – the actor receiving the attachment activity.


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Example Figure ID – Identifies specific Figures/Illustrations within this Supplement that depict the specific Healthcare Administrative Activity.

Envelope/Transaction Standard Example – Identifies examples of electronic standards available to accomplish the specific attachment activity for that table row.


Table 2: ASC X12 ASC X12N Attachments Activity Table

Healthcare Administrative

Activity

Activity ID Originator Activity Type

Attachment Activity Basis Actor Example Figure

ID

Envelope/Transaction

StandardExample

Solicited Unsolicited Originator Receiver

Claims Attachment

#1 Request X Payer Provider1

ASC X12N 2774

#2 Response X Provider Payer ASC X12N 2755

#3 Attachment Submission X Provider Payer 2 ASC X12N 2755

Prior AuthAttachment


ASC X12 ASC X12N N 2786


#6 Attachment Submission X Provider Payer 4 ASC X12N 2757

ReferralAttachment

#7 Request X Payer/Referring Provider

Referred To Provider

5ASC X12N 2786

#8 Response X Referred To Provider

Payer/Referring Provider

ASC X12 ASC X12NN 2757

#9 Attachment Submission X Referred To Provider

Payer/Referring Provider 6 ASC X12N 2757

Notification Attachment #10 Attachment Submission X Facility provider Primary care

provider 7 ASC X12N 2757

Post Adjudicated

Claim Attachment


ASC X12N 2774


*References to the Envelope Transaction Standards are generic in this table. Implementers should use the version of the Technical Report published for the purposes of exchanging Attachments based on their business requirements or regulatory mandate.

4 ASC X12Nn 277 – Health Care Information Status Notification - Technical Report Type 3 for Health Care Claim Request for Additional Information5 ASC X12Nn 275 – Patient Information – Technical Report 3 for Additional Information to Support a Health Care Claim or Encounter6 ASC X12Nn 278 – Health Care Services Review Information Technical Report 3 for Health Care Services Request for Review and Response7 ASC X12Nn 275 – Patient Information – Technical Report 3 for Additional Information to Support a Health Care Service ReviewHL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1 Page 21May December 2015 © 2015 Health Level Seven International. All rights reserved.

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To better understand the relationship of the row values for each attachment activity, a “table interpretation template” was developed:Table interpretation template:Activity “Activity ID” represents the information exchange for the “Healthcare Administrative Activity” “Solicited / Unsolicited” “Originator Activity Type” for additional informationAttachments from the “Originator” to the “receiver”.By substituting the row values found for each of the heading columns identified in “BOLD” type, a high level use case description can be created. The following examples are derived from the table using the template above:

2.5.4.1[2.6.4.1] Claim Attachment Scenarios (Examples) Activity #1 represents the information exchange for the Claims

Attachment solicited request for additional information from the payer to the provider.

Activity #2 represents the information exchange for the Claims Attachment solicited response for additional information from the provider to the payer.

Activity #3 represents the information exchange for the Claims Attachment unsolicited A a ttachment submission from for additional information from the provider to the payer.

2.5.4.2[2.6.4.2] Prior Authorization Attachment Scenarios (Examples) Activity #4 represents the information exchange for the prior

authorization A a ttachment solicited request for additional information from the payer to the provider.

Activity #5 represents the information exchange for the prior authorization A a ttachment solicited response for additional information from the provider to the payer.

Activity #6 represents the information exchange for the prior authorization attachment unsolicited A a ttachment submission for additional information from the provider to the payer.

2.5.4.3[2.6.4.3] Referral Attachment Scenarios (Examples) Activity #7 represents the information exchange for the Referral

Attachment solicited request for additional information from the payer/referred to provider to the referring provider.


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Activity #8 represents the information exchange for the Referral Attachment solicited response for additional information from the referring provider to the payer/referred to provider.

Activity #9 represents the information exchange for the referral attachment unsolicited A a ttachment submission for additional information from the referring provider to the payer/referred to provider.

2.5.4.4[2.6.4.4] Notification Attachment Scenarios (Examples) Activity #10, represents the information exchange for the notification

attachment unsolicited A a ttachment submissions for additional information from the facility provider to the primary care provider.

2.5.4.5[2.6.4.5] Post Adjudicated Claims Scenarios (Examples) Activity #11 represents the information exchange for the Post

Adjudicated Claim solicited request for additional informationAttachments from the payer to the provider.

Activity #12 represents the information exchange for the Post Adjudicated Claim solicited response for Attachmentsadditional information from the provider to the payer.

2.5.4.6[2.6.4.6] Attachment Activity Table association to standards Use of this table permits standards correlation to each of the activity ID’s with a current ASC X12 ASC X12N TR3standard(s), or any other future standard(s) that perform a comparable function. Future regulation could expand to other standards comparable to the ASC X12 ASC X12N TR3sstandards, to which the activity ID could correalate.

2.5.4.7[2.6.4.7] Attachment Scenario and Scope The activities above are not meant to reflect and/or include business events activitiesy other thaen those directly related to the requesting and responding with Aattachments information. Triggering events which create the need for Aattachment request or response/submittal may be indicated in examples in Chapter 6 but are NOT in scope for this Supplement. They are present to help the implementer understand where an attachment activity may fit within the overall business process. For example, when a provider requests authorization from a payer prior to rendering a service, the act of submitting the prior authorization request is not included in scope. Only the payer’s requesting Attachments additional information and the provider’s subsequent submittal of that Attachment additional information are included.


2.5.5[2.6.5] Attachment Request/Response Re-Association using Attachment ID

An essential component of an attachment activity is the ability to re-associate the Aattachment with the request through the use of an Aattachment ID. Depending on the attachment activity, the entity responsible for assigning an Aattachment ID will vary.

When the Aattachment is unsolicited, the Aattachment ID SHALL be used in both the attachment and the enveloping metadata. When the Aattachment is solicited, the Aattachment ID SHALL be used only in the enveloping metadata (for more information on enveloping metadata, see Appendix A - Business Requirements for requesting and submitting attachment (Metadata)).

The table on the next page highlights how the Aattachment ID will be integrated into the attachment activity processes.


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Table 3: Attachments ID Re-association TableHealthcare

Administrative Activity

Activity ID Relationship Attachment Activity

Attachment ID creator

Intended Re-association linkage

Claim Attachment

Paired together as a solicited request/

response for claims Aattachments infomation

Activity #1 represents the information exchange for the Claims Attachment solicited request for additional information from the payer to the provider

Payer

Provider returns the ID from the request (#1) in their claims

attachment informationattachment response

(#2)Activity #2 represents the information exchange for the Claims Attachment solicited response for additional information from the provider to the payer

Stand alone Activity #3 represents the information exchange for the Claims Attachment unsolicited attachment submission for additional information from the provider to the payer Provider Provider inserts ID into both claim

and aattachment submission

Prior Authorization Attachment

Paired together as a solicited request/ response for prior

authorization Aattachment infomations

Activity #4 represents the information exchange for the prior authorization A a ttachment solicited request for additional information from the payer to the provider.

PayerProvider returns the ID from the

request (#4) in their prior authorization attachment information response (#5)Activity #5 represents the information exchange for the prior authorization A a ttachment

solicited response for additional information from the provider to the payer.

Stand aloneActivity #6 represents the information exchange for the prior authorization A a ttachment unsolicited attachment submission for additional information from the provider to the payer.

ProviderProvider inserts ID into both prior

authorization request and attachment information

Referral Attachment

Paired together as a solicited request/

response for Referral attachment

infomationAttachments

Activity #7 represents the information exchange for the Referral Attachment solicited request for additional information from the payer/referred to provider to the referring provider.

Activity #8 represents the information exchange for the Referral Attachment solicited response for additional information from the referring provider to the payer/referred to provider.

Payer

Referring provider returns the ID from the request (#7) in their prior authorization attachment information response (#8)

Stand aloneActivity #9 represents the information exchange for the referral A a ttachment unsolicited attachment submission for additional information from the referring provider to the payer/referred to provider.

ProviderReferring provider inserts ID into

both the Referral request and attachment information

Notification Attachment Stand Alone

Activity #10, represents the information exchange for the notification A a ttachment unsolicited attachment submissions for additional information from the facility provider to the primary care provider.

Facility Provider (Unknown)

Post Adjudicated Claim

Attachment

Paired together as a solicited request/ response for post adjudicated claim

attachment informationAttachments

Activity #11 represents the information exchange for the Post a A djudicated Claim Attachment solicited request for additional information from the payer to the provider

Activity #12 represents the information exchange for the Post a A djudicated Claim Attachment solicited response for additional information from the provider to the payer

Payer

Provider returns the ID from the request (#11) in their post adjudicated claim attachment information response (#12)


2.6[2.7] Definitions and Acronyms

2.6.1[2.7.1] DefinitionsAttachment ( s ) Information . The additional information needed in support of a healthcare administrative activity.Attachment Submission. Refers to additional information submitted to a payer but done so based on advance knowledge of this information need (e.gi.e., rules based on medical policy) rather than in response to a near-term request from the payer. Attachment Type – Refers to the type of document (i.e., CCD, History and Physical, Discharge Summary) describing the additional information to be exchanged.Attachment Type Identifier – Refers to the LOINC code used to identify the Attachment Type.C-CDA. Consolidated – Clinical Document Architeture C-CDA Documents – Document level templates defined in the C-CDA R2 and CDP1C-CDA Implementation Guides – C-CDA R2 and CDP1Claim May represent a healthcare claim or a healthcare encounter.GIF -– Graphics Interchange Format is a Ddigital bitmap image format Healthcare Administrative Activity. Healthcare activities where the need for additional informationAttachments may be required (e.g., Claims, Referrals, Prior Authorizations, etc). This includes but is not limited to establishing coverage, conforming with treatment protocols, providing historical documentation for future treatment or other administrative functions.JPEG – Joint Photographic Exerts Group is a compressed Ddigital Pphotography Image compressed using the Joint Photographic Experts Group method.Mod-10 – Algorithm applied to a series of numbers to arrive at a single (0-9) digit (check digit). When used in LOINC codes, the algorithm is applied to the digits to left of the hyphen to compute the check digit to the right of the hyphen.Modifier – Refers to the “Item Selection” or “Time Window” value used to further constrain an Aattachment Ttype request.Modifier LOINC Code – Refers to the LOINC Code used as the modifier in a request for an Aattachment Ttype.Object Identifier (OID) - An ISO Object Identifier (OID) is a globally unique string consisting of numbers and dots (e.g., 2.16.840.1.113883.3.1). This string


In the Acronym Section – remove from definitions





expresses a tree data structure, with the left-most number representing the root and the right-most number representing a leaf.Payer - Refers to a healthcare entity, such as a health insurance company or UMO, that receives and process claims, prior authorizations and referrals.PDF – PDF is a file format developed by Adobe as a means of distributing compact, platform-independent documents.PNG – A bitmapped image format that employs lossless data compression. Structured Document – a CDA header paired with a structuredBody elementStylesheet Unstructured Document – a CDA header paired with a nonXMLbody element

2.6.2[2.7.2] AcronymsTo aid the implementer, this section will restate any acronyms used in this supplement in one common place.

AIS – Additional Information Specification. ASC X12N 277 – Health Care Information Status Notification - Technical Report

Type 3 for Health Care Claim Request for Additional Information

ASC X12N 275 – Patient Information – Technical Report 3 for Additional Information to Support a Health Care Claim or Encounter

ASC X12N 278 – Health Care Services Review Information Technical Report 3 for Health Care Services Request for Review and Response

ASC X12N 275 – Patient Information – Technical Report 3 for Additional Information to Support a Health Care Service Review

AWG – HL7 Attachment Work Group. CDA – Clinical Document Architecture. C-CDA – HL7 Implementation Guides for CDA Release 2: IHE Health

Story Consolidation, DSTU Release 1.1. C-CDA R2 - HL7 Implementation Guides for CDA Release 2:

Consolidated CDA Templates for Clinical Notes Volume 1 Introductory Material and Volume 2 Templates and Supporting Material

CDP1 - HL7 Implementation Guides for CDA Release 2: Additional CDA R2 Documentation Templates -- Clinical Documents for Payers – Set 1

GIF - Graphics Interchange Format (See Definitions). JPEG –Joint Photographic Experts Group(See Definitions).



Need to add a definition as this is mentioned in the document





LOINC – Logical Observation Identifiers, Names and Codes (http://loinc.org).

OID – Object Identifier (See Definitions). PDF –Portable Document Format (See Definitions). PNG – Portable Network Graphics (See Definitions). TIFF – Tagged Image Format used for scanned images. UMO – Utilization Management Organization.

[2.8] Health Level Seven OrganizationFounded in 1987, Health Level Seven, Inc. (http://www.HL7.org) is a not-for-profit, ANSI-accredited standards developing organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services. For information on membership and obtaining HL7 standards, contact:

Health Level Seven 3300 Washtenaw Ave., Suite 227 Ann Arbor, MI 48104-4261 (734) 677-7777 mailto:[email protected] http://www.hl7.org


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http://www.hl7.org/

mailto:[email protected]

http://www.HL7.org/

http://loinc.org/

3 UNDERSTANDING C -CDA IMPLEMENTATION GUIDES

This Section will explain the C-CDA Implementaiton Guides at a high level. Implementers should rely on the detail found in the individual guides to understand how to utilize each Standard.

3.1 What is Clinical Document Architecture (CDA)?CDA is a document markup standard that specifies the structure and semantics of a clinical document (such as a discharge summary or progress note) for the purpose of exchange. A CDA document is a defined and complete information object that can include text, images, sounds, and other multimedia content. It can be transferred within a message and can exist independently, outside the transferring message. CDA documents are encoded in Extensible Markup Language (XML), and they derive their machine processable meaning from the RIM (HL7’s Reference Information Model), coupled with terminology. The CDA R2 model is richly expressive, enabling the formal representation of clinical statements (such as observations, medication administrations, and adverse events) such that they can be interpreted and acted upon by a computer. On the other hand, CDA R2 offers a low bar for adoption, providing a mechanism for simply wrapping a non-XML document with the CDA header or for creating a document with a structured header and sections containing only narrative content. The intent is to facilitate widespread adoption, while providing a mechanism for incremental semantic interoperability. Information about the components for CDA is being presented at a high level and is intended to convey only what is necessary for the implementer to understand the application with respect to Aattachments. Refer to the C-CDA Implemenatation Guides for technical guidance on implementation of CDA for Aattachments. A CDA document has two primary groupings of information, a header and a body:

The headero Identifies and classifies the document and provides information

on authentication, the encounter, the patient, and the involved providers.

The body o Contains the clinical report, organized into sections whose

narrative content can be encoded using standard vocabularies.


o Can be represented using a nonXMLBody or a structuredBody element.

nonXMLBody is used when the content is an external file such as a TIFF image, MS RTF document, PDF, etc. The NonXMLBody class is provided for those applications that can do no more than simply wrap an existing non-XML document with the CDA Header.

structuredBody is used when the body will be XML structured content. XML structured content is always inserted into the structuredBody element, never as an external file. The StructuredBody contains one or more Section components.

For the purposes of this supplement: A header paired with a structuredBody element will be referred to as

a “Structured Document”. A header paired with a nonXMLBody element will be referred to as an

“Unstructured Document”8.More information about CDA can be found on the HL7 website (www.hl7.org).

[3.2] Taking Advantage of Structured/Unstructured Content

Use of the CDA standard allows for a wide-range of implementation flexibility with respect to the implementer’s (CDA originator and consumer) technical abilities. For the most of implementers, a CDA document may simply be rendered to a common internet XML aware browser using a stylesheet9, much like one might view a PDF on a personal computer application. Even in an unstructured document <nonXMLBody>, the Header may be partially rendered using a stylesheet. However, when exchanging information using the unstructured document, this mechanism may not work without additional engineering. The body of this document must either be made referenceable by the browser in a URL schema it recognizes, or separately decoded into its binary format. In theis instance where the body type is in an Unstructured Document and the body content contains a media type (e.gi.e., JPEG, GIF, PDF, etc), that content would require additional software to interpret and render the is encapsulated 8 It is important to note that the header in either structured or unstructured scenarios is always considered structured and as such, available for computer processing(parsing) to occur with its content.9 The stylesheet in the C-CDA R2 (See Appendix C) and CDP1 (See Appendix X) are provided by HL7 to the implementer as options and are not required to be used by the implementer. The implementer may choose to create their own customized stylesheet to render the information to a browser.HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1 Page 31May December 2015 © 2015 Health Level Seven International. All rights reserved.

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http://www.hl7.org/

data using an appropriate viewer for the type of document (e.gi.e., image viewer, adobe reader, etc).

This requires several steps, including configuring the browser to display the non-HTML content if needed (e.g., for application/pdf, application/msword or text/rtf content), linking to externally referenced content, or linking to and decoding the embedded base-64 encoded content. In addition, considerations should be given to security concerns that might be introduced by displaying content such as application/pdf, application/msword, text/rtf or text/html which could include scripts.The use of a stylesheet to render a CDA document to a browser sets a low technical bar for the receiver of a CDA document. No matter what the technical level of the originator, the receiver will have the choice of leveraging the originator’s highest level of technical sophistication or simply choose to render using a stylesheet and a browser. This will enable receivers of Aattachments to interpret the content of a clinical document without having to be an expert on CDA. Initially the limited capability of participants to support fully structured attachments and the need for further development of attachment content requires the use of the unstructured content capability of the C-CDA R2. For Aattachments purposes, even though a structured document template may be defined in C-CDA R2 (attachment types where a document level template exists, excluding Unstructured Document), the use of


the unstructured version of that document (e.gi.e., nonXMLbody) is permitted. However,, provided that the required content defined for the equivalent structured document conformance must be is present in the unstructured (nonXMLbody) document representation.

3.1.1[3.2.1] Structured ContentEach C-CDA Implemenatation Guide describes the respective document types and conformance requirements for each of the structured documents listed in Appendix F of this supplement. Conformance criteria for each of those document types, their sections and any applicable entries are found in the appropriate section of the C-CDA Implementation Guides.

3.1.2[3.2.2] Unstructured Content In addition to the structured document types described in 4.2.1 Structured Content, there is a document which is available to be used for exchange of ANY document type. This is the Unstructured Document (described specifically in Section 1.1.24 of the C-CDA R2 Volume 2 Templates and Supporting Material).

In many environments much of the patient record is still captured in an unstructured format that is encapsulated within an image file or as unstructured text in an electronic file such as MSWORD or PDF. a word processing or Portable Document Format (PDF) documents. There is a need to raise the level of interoperability for these documents to provide full access to the longitudinal patient record across a continuum of care. Until this gap is addressed, image and multi-media files will continue to be a portion of the patient record that remains difficult to access and share with all participants in a patient’s care. The Unstructured Document is here to bridge that gap.

The Unstructured Document: Must be at the document level and should be limited to document

types defined in Regenstrief’s LOINC database “external value set” (See section 5.5.1.1 “Using the LOINC Database to Identify Valid Attachment Types” for more information.

If a LOINC code is not available for your document type, please refer to Section 78.1 Process for Requesting New Attachment Types.

May include content for document types already defined in the C-CDA Documents as structured, but unstructured content should adhere to conformance statements for the Header.


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Supported File Formats Value Set

Value Set: SupportedFileFormats [SUPPORTED-FILE-FORMATS-OID]Word Processing/Narrative Formats CodeMSWORD application/mswordPDF application/pdfPlain Text text/plainRTF Text text/rtfGraphic Formats CodeGIF Image image/gifTIF Image image/tiffJPEG Image image/jpegPNG Image image/png

Value Set: SupportedFileFormats 2.16.840.1.113883.11.20.7.1A value set of the file formats supported by the Unstructured Document IG.Value Set Source: http://www.hl7.orgCode Code System Code System OID Print Nameapplication/msword Media Type 2.16.840.1.113883.5.79 MSWORDapplication/pdf Media Type 2.16.840.1.113883.5.79 PDFtext/plain Media Type 2.16.840.1.113883.5.79 Plain Texttext/rtf Media Type 2.16.840.1.113883.5.79 RTF Texttext/html Media Type 2.16.840.1.113883.5.79 HTML Textimage/gif Media Type 2.16.840.1.113883.5.79 GIF Imageimage/tiff Media Type 2.16.840.1.113883.5.79 TIF Imageimage/jpeg Media Type 2.16.840.1.113883.5.79 JPEG Imageimage/png Media Type 2.16.840.1.113883.5.79 PNG Image


3.2[3.3] What are C-CDA R2 and CDP1 ? C-CDA Implementaiton Gudes define clinical information in a format based on CDA, constrained by conformance statements consistent with industry best practices for specific types of clinical documents. Some broadly used clinical document types have been more fully developed in CDA than others. Examples of those clinical document types are: In the C-CDA R2

Continuity of Care Document (CCD) Consultation Note Diagnostic Imaging Report (DIR) Discharge Summary History and Physical Operative Note Procedure Note Progress Note Care Plan Referral Note Transfer Summary Patient Generated Document

In the CDP1 Enhanced Encounter Document Enhanced Discharge Document Enhanced Operative Note Document Enhanced Procedure Document Interval Document

Other clinical information not listed above may also be exchanged using C-CDA R2 by taking advantage of the “Unstructured Document”, as described in Section 1.1.24 of the C-CDA R2: Volume 1 Introductory Material. Throughout the C-CDA R2 implementers will see references to sending and receiving EHR systems. This is because the C-CDA R2 was written from the perspective of exchange between EHR systems. For the purposes of this supplement there is no assumption that exchange will occur between two EHR systems. Instead, as you will see in the use case portion of this supplement (Chapter 6), the additional informationAttachment a payer is seeking may exist in a provider’s electronic repository, such as an EHR system, and may/may not be passed through a practice management system or be sourced directly from the EHR. Section 1 of the C-CDA R2: Volume 1 Introductory Material describes at a high level how templates are used to represent the organization of CDA structure in a document. Metadata found in the Header as well as specific clinical information found in the Body components as Documents, Sections within those documents, and entries within those sections are explained are described HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1 Page 35May December 2015 © 2015 Health Level Seven International. All rights reserved.

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in Sections 1-4 of the C-CDA R2: Volume 2 Templates and Supporting Material and Sections 5-7 of the CDP1.


[4] ADDITIONAL INFORMATION ( ATTACHMENTS) - - GENERAL

This Supplement and the C-CDA Implementation Guides do not require a specific standard for enveloping, however the industry best practices for required metadata to be contained in that envelope are specified in Appendix A of this Supplement.

3.3[4.1] Standards to Accomplish Information Exchange of The Request and Response

The authors of this Supplement acknowledge that there may be more than one standard that could accomplish the information exchange.They further acknowledge the development of a full suite of standard transactions was developed by ASC X12 ASC X12N. These transactions are specifically for requesting additional informationAttachments, responding to that request, as well as and the acknowledgment of the response and conformanceing to the business requirements found in Appendix A. Additional information regarding those standard transactions can be found in Appendix “B” of this document. For the purposes of this document, references to requests and responses to requests in examples and/or use cases will include a reference to the specific ASC X12 ASC X12N transaction that could be used10. Non-Normative examples for the use of standard enveloping, messaging and transports to request and exchange CDA Aattachments are included in Appendix C. As the technologies mature, we expect additional standards to be developed and are open to adapting this supplement to include them as well.

3.4[4.2] LOINC (Logical Observation Identifiers Names and Codes)

The HL7 encoding of Aattachments makes extensive use of the code set Logical Observation Identifier Names and Codes (LOINC®). LOINC provides a universal set of codes and names for identifying laboratory and clinical tests, measures, documents, and other clinical observations. LOINC is an openly developed vocabulary standard used worldwide to facilitate the exchange and pooling of clinical results for care delivery, outcomes management, public health reporting, and research purposes. LOINC achieves these aims by creating a unique identifier code and a structured name for each observation. When used in conjunction with widely adopted messaging standards, LOINC can be an essential ingredient for efficient electronic processing and storage of clinical data that comes from many independent sources.

10 It is anticipated that regulations for HIPAA Attachments will initially mandate the use of the ASC X12 ASC X12N Standards found in Appendix B of this Supplement.HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1 Page 37May December 2015 © 2015 Health Level Seven International. All rights reserved.

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LOINC is a controlled terminology that contains unique identifiers and “fully specified” names constructed in a formal structure that distinguishes among tests and observations that are clinically different. LOINC creates codes and a formal name for each concept that corresponds to a single kind of document, observation, measurement, or test result. For example, LOINC code 18842-5 (Discharge Summary) identifies a document with a formal name:

Discharge summarization note:Find:Pt{Setting}:Doc:{Provider}

The display name (called the LOINC Long Common Name) for this term is the familiar “Discharge Summary”.The formal LOINC name is “fully-specified” in the sense that it contains the features necessary to disambiguate among similar clinically distinct observations. The fully-specified name is constructed according to a six-part semantic model that produces an aggregate or pre-coordinated expression that intentionally does not capture all possible information about the testing procedure or result – only enough to unambiguously identify it.More information about the LOINC naming conventions can be found in the LOINC Users’ Guide and other resources available from the LOINC website (http://loinc.org).

3.4.1[4.2.1] Obtaining LOINC and Other Resources From the Regenstrief Institute

LOINC is produced, distributed, and copyrighted by the Regenstrief Institute, and is made available for both commercial and non-commercial use without charge under the license at http://loinc.org/terms-of-use. LOINC is published in regular releases, typically twice per year (in June and December).The LOINC database and many other resources are available from the LOINC website:

http://loinc.org Regenstrief also develops and distributes the RELMA desktop mapping program. RELMA is available from the LOINC website at no cost and provides tools for browsing the LOINC database and mapping local terms to LOINC. In addition, Regenstrief also provides the online LOINC search application (http://search.loinc.org) that enables searching of the LOINC database from a web browser.The LOINC website has a variety of useful documentation resources including Users’ Guides for LOINC and RELMA, an FAQ, and some online tutorials that are available to download for offline review. From the LOINC website, you can also subscribe to the LOINC mailing list and find out about upcoming meetings and training events.


3.4.2[4.2.2] Use of LOINC for AttachmentsIn the context of Aattachments, LOINC codes are used for several purposes. At a high level, LOINC codes are used to identify the specific kind of information being communicated in both a request and response (e.g., a discharge summary or diagnostic imaging report (DIR)). LOINC codes may also be used to request a specific C-CDA Document by specifying the LOINC code that corresponds to the specific document ID (see Appendix F for a complete list). This enables allows the requester to ask for a specific Attachment, for example, , for example, the C-CDA R2 Op Note, specifically and not just an Op Note. This can then which may be responded to by the provider by supplying the Op Note from either of the C-CDA Implementation Guides.. LOINC codes may also be used to specify certain modifier variables in fulfilling the request for information (e.g. variables that indicate a modification to the default time period). In Aattachment responses that use HL7 C-CDA Document. , LOINC codes are used to identify the Aattachment (document) Ttype (Document), sections, and sometimes the individual entries (tests or observations). While a LOINC code can identify information at the section and sometimes the entry level, a request for additional information (attachmentAttachments) should always be requested at the Ddocument level. In a structured document, the section/entry LOINC code may be helpful to the recipient in extracting/parsing information within the document.

In this way, LOINC codes are used to identify: An electronic Aattachment in its entirety (e.g.,Discharge Summary Report), as an Attachment Type Identifier.A specific document level template (e.g. C-CDA R2 Op Note versus the CDP1 Enhanced Op Note) Attachment Document Identifier.A category of clinical report (e.g., send any reports of CAT scans of the head that are related to the claim or a specific service), as an Attachment Type Identifier appearing in the C-CDA Header.The implicit scope of a request activity (e.g; e.g., to modify a request for information for a period 30 days prior to treatment), as a Modifier LOINC Code.

3.5[4.3] Using the LOINC Code As An Identifier In Messages

Each term in the LOINC database is assigned a unique, permanent code called the LOINC code. This is the code that systems should use to identify test results in electronic reports. The LOINC code has no intrinsic structure except HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1 Page 39May December 2015 © 2015 Health Level Seven International. All rights reserved.

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that the last character in the code is a Mod-10 check digit. Consistent with the use of LOINC allowed by the LOINC License, this supplement guide requires that LOINC codes be used as published in the LOINC database, without leading zeroes and with the hyphen that precedes the check digit (e.g., "8709-8" and "10154-3").Along with the code, this supplemental guide strongly recommends that one of the published LOINC names also be transmitted in the message. For most purposes, the LOINC Long Common Name is the best name to include in electronic messages.

[4.4] Requesting/Responding/Submitting Attachments Information

The LOINC codeset plays a critical role in the requesting/responding/submitting of Aattachment informations, especially when the recipients EHR system is capable of interpreting a codified request and generating/creating the attachment informationAttachments being requested automatically and without human intervention. In C-CDA Documents, the LOINC populated in the Document Type Code is used to identify the requested Attachment. A LOINC/Document TypeCode may be used to:

[a)] Identify the specific document type constituting the attachment informationAttachment being requested.

a)[b)] Identify which document (s) to respond with when multiple document types exist that could satisfy the request. These LOINC codes, Known as “Modifier LOINC Codes”, may be used to “modify” the request in “a” above. More about these may be found in Section 4.4.4, “Using Modifier LOINC Codes to Constrain the Request.

A LOINC Document ID Code may be used to:[a)] Identify the specific document template that should be used to

generate the Aattachment.

[4.4.1] Using LOINC Code to Request/Respond Attachment Information (Solicited)

When requesting attachment informationan Attachment, a single LOINC is used to codify the specific document type being requested. In C-CDA Documents, there could be multiple LOINC codes which represent a single document type (e.gi.e., Operative Note) in general or that are further specialized (depending on “setting” and “Specialty/Training/Professional Level”). The LOINC Codes that are valid for each C-CDA Document type are defined in the respective C-CDA Implementation Guide Those tables identify Page 40 HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1© 2015 Health Level Seven International. All rights reserved. DecemberMay 2015

the general LOINC code as "”recommended", and LOINC codes specialized by speciality/training/professional level as “”ValueSets”11.Examples of those clinical document types, their recommended LOINC Code and the table in C-CDA R2 they are referenced in are found in the table below:

11 The exception is Consultation Notes that may represent the "preferred" code as ‘Root Level Document Type Code’ and "additional codes" as either Specialized by Setting, Specialized by Setting and Specialty or Specialized by Specialty…this is being corrected in an upcoming version.HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1 Page 41May December 2015 © 2015 Health Level Seven International. All rights reserved.

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Table 4: Clinical Document Types with Recommended LOINC Code for Requests

Clinical document Type

"Recommended" LOINC

LOINC Long Description

C-CDA R2

Table Referen

ce

ValueSet

Care Plan 52521-2Overall Plan of Care/Advance Care Directive

Consultation Note 11488-4 Consult Note Table

#28 ConsultDocumentType

CCD 34133-9Summarization of Episode Note

Diagnostic Imaging Report 18748-4

Diagnostic imaging Report LOINC Imaging Document Codes

Discharge Summary 18842-5

Discharge Summary

Table #37 DischargeSummaryTypeCode

Enhanced Encounter 77601-3

Enhanced Encounter

LOINC code for Enhanced Encounter

History and Physical 34117-2

History and Physical note

Table #41 HPDocumentType

Interval 77600-5 Interval LOINC code for Interval Document

Operative Note 11504-8Provider-unspecified Operation Note

Table #44

SurgicalOperationNoteDocumentTypeCode

Procedure Note 28570-0 Provider-unspecified

Table #48

ProcedureNoteDocumentTypeCodes

Clinical document Type

"Recommended" LOINC

LOINC Long Description

C-CDA R2

Table Referen

ce

ValueSet

Procedure Note

Progress Note 11506-3Provider-unspecified Progress Note

Table# 51 ProgressNoteDocumentTypeCode

Referral Note 57133-1 Referral Note Table# 54 ReferralDocumentType

Transfer Summary 18761-7

Provider-unspecified Transfer Summary

Table# 57 TransferDocumentType


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As mentioned in C-CDA R2, use of the "recommended" LOINC is preferred but not required. For the purposes of Aattachments, the use of the "recommended" LOINC is preferred as the single LOINC used in the request for attachment informationan Attachment. However, use of the "Value Set" LOINC code in the request may also be permitted if the requestor deems it appropriate for their business purposes. To accommodate both Payer/UMO needs for Aattachments information and the flexibility afforded the EHR Systems by C-CDA R2, special rules for requesting and responding have been developed for Aattachments. Special request/response rules for solicited Structured Aattachments are described in Table 5 below.

Table 5: Request and Response LOINC Code Usage for Solicited Structured Attachments

Request LOINC Responding EHR System Payer/UMO System

“Recommended” LOINC

Respond with "recommended" LOINC if able. If EHR system only capable of creating specialized LOINC, respond with “value set” LOINC code closest to matching request for that document type12.

If response contains "recommended" LOINC code, consider response a match to request. If response not a match, cross-walk “value set” LOINC code to ‘recommended’ code for document type and consider a match if identical to the Request LOINC.

“Value Set” LOINC

Respond with same "value set" LOINC as in the request if able. If unable, respond with other "value set" LOINC or "recommended" LOINC closest to the matching request for that document type12.

If response contains "value set" LOINC Code identical to request, consider response a match to request. If response not a match, cross-walk "value set" LOINC Code to "recommended" and/or other "value set" LOINC code for document type and consider a match if either the "recommended" or "value set" LOINC for document type found.

For solicited unstructured Aattachment type request and response, the LOINC Code used in the request SHALL be returned in the response. Information on locating valid unstructured LOINC codes from the Regenstrief LOINC database is available in section 5.5.1.1.

12 Document Type for “setting” and “Specialty/Training/Professional Level”

[4.4.2] Using LOINC Code to Submit Attachments Information (Unsolicited)

When submitting Aattachment information in an unsolicited model, the specific LOINC code to be used as the Aattachment Ttype ID follows these rules:

In the C-CDA Implementation Guides there are LOINC codes specified as “Recommended” and “Value Sets”. For structured documents and their unstructured counterparts, the “Aattachment Ttype ID” SHOULD be the “Recommended” LOINC Code, but the “Value Set” LOINC Codes are permitted.

For unstructured documents that do not have a structured counterpart, refer to section 5.5.1.1 for determining valid LOINC codes for unstructured Aattachment types.

3.5.1[4.4.3] Using “Modifier LOINC Codes” to Constrain The Request

Modifier LOINC Codes are used to further inform the recipient of the request for an Attachment attachment information if a specific “Time Window” or “Item Selection” criteria should be applied to constrain which document types within that time window or item selection criteria should be responded with.Below you will find a table of “Time Window” Modifier LOINC Codes and “Item Selection” Modifier LOINC Codes. These should be considered as illustrative purposes, with the full set of LOINC modifier codes available for use indicated as such on the LOINC database.


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Table 6: Time Window Modifier LOINC Codes

LOINCcode Long Description Example (if appropriate)

18789-8 Include all data of the selected type within the date window associated with the service

NOTE: This is the default value; it will be assumed if no time window modifier code is included

Tests performed during a hospital stay or a note written to describe a clinic visit

18790-6 Include all data of the selected type on or before the date of service

A pathology report to verify the diagnosis for the claim, or per-operative test results

18791-4 Include all data of the selected type within or aligned to a service

Radiology report for test performed during a visit or ordered during the visit and performed within five days

18792-2 Include all data of the selected type on or after the date of service

Status on follow-up

18803-7 Include all data of the selected type that represents observations made 30 days or fewer before the starting date of service

18804-5 Include all data of the selected type that represents observations made three months or fewer before the starting date of service

18805-2 Include all data of the selected type that represents observations made six months or fewer before the starting date of service

18806-0 Include all data of the selected type that represents observations made nine months or fewer before the starting date of service

18807-8 Include all data of the selected type that represents observations made one year or less before the starting date of service

LOINCcode Long Description Example (if appropriate)

53033-7 Include all data of the selected type that represents observations made two years or less before the starting date of service

18793-0 Use no fixed time limit on data—any of the selected type are relevant no matter when obtained


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3.6[4.5] Using the LOINC Database to Identify Valid Attachment Types

The AWG has reached out to the industry stakeholders to identify attachment information the types of Attachments that are known to be currently needed. However, we expect that as the Aattachment information eexchange matures, the need for new Aattachment types will grow. Rather than including Aattachment Ttypes in this supplement as a “static” value set and requiring publication of a new version of this supplement before new types can be used, the Aattachments types will be implemented as a “dynamic” value set, external to this supplement.The LOINC database, maintained and managed by the Regenstrief Institute, will maintain the content of the external value set of LOINC codes available for usage in the exchange of Aattachments information, and is further described below.Regenstrief provides specialized Aattachment features in LOINC, RELMA, and the online LOINC Search application.

Additional information about the use of the RELMA program and the LOINC database for Aattachment purposes and can be found at:

http://loinc.org/attachments

3.6.1[4.5.1] Identifying Valid Attachment Types In The LOINC Table

The LOINC Table (available in several file formats) contains a field called [HL7_ATTACHMENT_STRUCTURE]. This field can be populated by one of these values UNSTRUCTURED or STRUCTURED.

3.6.1.1[4.5.1.1] UNSTRUCTURED LOINC TermsLOINC terms with this value are approved by the HL7 AWG for use as an unstructured Aattachment ONLY.

When sent as an Aattachment, implementers SHALL use the Unstructured Document template of the C-CDA R2 (see section 1.1.24 in C-CDA R2 : Volume 2 Templates and Supporting Material). Conformant Unstructured Documents must carry the document-level templateId asserting conformance with the C-CDA R2 guide.

SHALL contain exactly one [1..1] templateId (CONF:7710) such that itPage 48 HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1© 2015 Health Level Seven International. All rights reserved. DecemberMay 2015


a. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.1.10" (CONF:10054).

Implementers SHALL NOT use LOINC codes where the [HL7_ATTACHMENT_STRUCTURE] is Null or STRUCTURED as an Unstructured Document Aattachment (see section 1.1.24 in C-CDA R2 : Volume 2 Templates and Supporting Material). Over time, HL7 may develop additional guides for communicating Aattachments in a structured way. As new implementation guides are developed by HL7 for these Aattachment Ttypes, Regenstrief will update the value of the [HL7_ATTACHMENT_STRUCTURE] field to reflect the presence of a guide for structured reporting.

3.6.1.2[4.5.1.2] STRUCTURED LOINC TermsLOINC terms with this value are approved by the HL7 AWG for sending as structured content using the C-CDA Documents. This does not mean that they must always be sent as fully structured content, but rather that such a structured specification exists and is approved for use. As indicated in the C-CDA Implementation Guides, any particular Aattachment Ttype can be sent in a manner that conforms to CDA Level 1 (nonXMLBody), CDA Level 2 (structuredBody with sections that contain a narrative block), or CDA Level 3 (structuredBody containing sections that contain a narrative block and coded entries).If the Aattachment is sent as CDA Level 1 (nonXMLBody) or CDA Level 2 (structuredBody with sections that contain a narrative block), it must include the required content defined for the fully structured document (CDA Level 3). That is, the expected information content in the documents is the same in both cases.

3.6.2[4.5.2] Identifying Valid Attachment Types Using RELMA and The Online LOINC Search Application (http://search.loinc.org)

Both the RELMA desktop mapping program and the online LOINC search application http://search.loinc.org provide many functions for searching and browsing the LOINC database. Both applications are maintained and enhanced by the Regenstrief Institute on a regular basis, with new releases made available on the LOINC website. The following sub-sections provide a basic overview of how to use these tools to identify valid Aattachment ttypes, but the most current information is available at:



May 2012


http://search.loinc.org/

3.6.2.1[4.5.2.1] Searching RELMAFrom the Search tab or the Mapping tab, a query on the HL7_ATTACHMENT_STRUCTURE field will return all of the LOINC codes of that kind (e.gi.e. UNSTRUCTURED or STRUCTURED). RELMA uses a Google-like search syntax, so a search for keywords can be combined with a search on a particular field in the LOINC database. For example, to search for all the LOINC terms with value in HL7_ATTACHMENT_STRUCTURE of “UNSTRUCTURED” containing the word “consent”, you could enter this query in the search box:

consent HL7ATTACHMENTSTRUCTURE:unstructuredAs with all search results in RELMA, the rows in the search results grid can be highlighted and then exported (to a CSV file, the clipboard, or other options).

3.6.2.2[4.5.2.2] Browsing RELMA

The RELMA program also provides a convenient viewer for browsing the LOINC terms used in Aattachments. The Aattachments viewer is available from the “HIPAA” menu.From the main Aattachments viewer, three sub-sections are available: Structured, Unstructured, and Request Modifier Codes.The Structured tab presents the high level Aattachment Ttype classifications from the C-CDA R2 and this supplement, the set of LOINC document codes in that classification, and a linkage to the set of allowed section and entry-level codes where appropriate.The Unstructured tab lists all of the LOINC codes that are approved by the HL7 Attachments WG for use as an unstructured Aattachment ONLY (e.gi.e., they have a value of UNSTRUCTURED in the HL7_ATTACHMENT_STRUCTURE field).The Request Modifier Codes tab lists all the LOINC codes that can be used as request modifiers, as described in Section 5.4.3 of this supplement.

3.6.2.3[4.5.2.3] Identifying Valid Attachment Types Using The Online LOINC Search Application ( http://search.loinc.org )

The search syntax of the online LOINC search application is the same as that of RELMA. This powerful search syntax can search on keywords anywhere in the LOINC records or with a particular field. For example, to search for all the LOINC terms with value in HL7_ATTACHMENT_STRUCTURE of “UNSTRUCTURED” you could enter this query in the search box:

HL7ATTACHMENTSTRUCTURE:unstructuredPage 50 HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1© 2015 Health Level Seven International. All rights reserved. DecemberMay 2015

http://search.loinc.org/

Similar to RELMA, the rows in the search results grid of the online search application can be highlighted and then exported to a CSV file.

3.7[4.6] ISO Object Identifiers (OID’s)OID is an acronym, used throughout HL7 specifications to mean ISO object identifier. ISO is the International Organization for Standardization (http://www.iso.ch), and we will see below that the International Telecommunications Union (ITU, http://www.itu.int) is also relevant. The HL7 OID registry, mentioned below, can be used to find, or create, OIDs for use in attachment implementations; and the mention of ISO and ITU is for background information only. The CDA uses OIDs to uniquely specify where to find more information regarding a coded data value or an identifier for a person, organization, or other entity.An OID is a globally unique string consisting of numbers and dots (e.g., 2.16.840.1.113883.6.103). This string expresses a tree data structure, with the left-most number representing the root and the right-most number representing a leaf.Each branch under the root corresponds to an assigning authority. Each of these assigning authorities may, in turn, designate its own set of assigning authorities that work under its auspices, and so on down the line. Eventually, one of these authorities assigns a unique (to it as an assigning authority) number that corresponds to a leaf node on the tree. OID’s present a systematic way to identify the organization responsible for issuing a code or entity identifier. HL7 is an assigning authority, and has the OID prefix "2.16.840.1.113883." broken down as follows:

(2) represents the OID was assigned by a joint ISO-ITU (16)represents assigning authority which is specific to the country (840)reflects the USA (1) is specific to the organization (113883) represents Health Level Seven (as the assigning authority).

Any OID that begins with this is further described by a registry maintained by the HL7 organization. For example, the OID 2.16.840.1.113883.6.103 (above) was established by HL7 as a globally unique identifier for the ICD-9-CM code set for diagnoses. Beyond that, the HL7 organization assigns any numbers - and these are maintained in a registry available on the HL7.org website. HL7 uses its registry to assign OIDs within its branch for HL7 users and vendors upon their request.


May 2012

http://www.itu.int/

http://www.iso.ch/

HL7 is also assigning OIDs to public identifier-assigning authorities both U.S. nationally (e.g., the U.S. State driver license bureaus, U.S. Social Security Administration, US National Provider Identifier (NPI) registry, etc.) and internationally (e.g., other countries' social security administrations, citizen ID registries, etc.) Additional reference information about OIDs, including the current directory of OIDs assigned by HL7, is available at http://www.hl7.org/oid/index.cfm. Organizations that wish to request an OID for their own use (e.g., to be able to create identifiers within a CDA document), may also obtain one from HL7 at this site.


http://www.hl7.org/oid/index.cfm

[5] EXAMPLES - - ADDITIONAL INFORMATION ( ATTACHMENTS) - - USE CASES

The following sections indicate examples of attachment activities covered by this Supplement. These examples will provide typical business flows for each of these attachment activities. Where these examples depict information exchange consistent with an attachment activity (see Table 2: Attachment Activity Types), those specific activities will be identified and correlated back to an entry in that table using their “Attachment Activity ID #”. Some of the examples may include information exchanges that are considered out of scope for this supplement but necessary to reflect the complete business flow. Those considered out of scope will be clearly marked.As previously noted, where attachment activities are indicated the corresponding ASC X12 ASC X12N standard will also be indicated for example purposes, but should not be construed to be limited ONLY to that ASC X12 ASC X12N standard. Is it assumed for these standard references, the attachment activity will be an electronic standard. However, it may be possible for the request activity to be non-electronic (e.gi.e., manual, paper, phone call, etc), provided that the necessary metadata (see Appendix A) is communicated for inclusion in the electronic response.In the sub-chapter sections below, you will find general examples for the solicited and unsolicited scenarios where additional information aAttachments are used in support of a healthcare claim or encounter, prior authorizations, referrals, notifications and post-adjudicated claims review/audits. These examples are intended for illustrative purposes only and should not be construed as exhaustive.


May 2012

3.8[5.1] Example – Claim Attachment When a provider submits a claim to a payer, the claim may meet a condition(s) which requires an Attachment additional supporting information be provided to the payer to complete the adjudication of the claim. When the conditions are of a consistent and recurring nature, the payer may make these conditions known in advance to the provider so that the provider may submit the additional informationAttachment with the claim (unsolicited). When the condition is of a more “ad hoc” basis, upon receipt/review of the claim the payer may request an Attachmentadditional information from the provider directly related to that claim (solicited).

3.8.1[5.1.1] Claim Attachment – Solicited Attachment ExampleExample Scenario: A provider submits a healthcare claim/encounter to a payer who, upon review, determines that it needs additional information from the provider to complete the adjudication of the claim. The payer initiates a request for that additional information. The provider receives that request, and responds to the payer with the additional informationAttachment needed.The diagram below depicts the business flow of the example above for a solicited claim attachment.

Arrow #1 represents a claim which is submitted from a provider to a payer.

Arrow #2 (Attachment Activity #1) represents the request for additional information from the provider. (if electronic, ASC X12N 2774)

Arrow #3 (Attachment Activity #2) represents the provider’s response with additional informationan Attachment (ASC X12N 2755).

Figure 1: Example - Claims Attachment (Solicited)



I changed additional information in the diagram but markup is not showing.

(OUT OF SCOPE: Information exchange depicted by Arrows#1 is considered out of scope for this supplement as it only acts as a triggering event for additional information needed.)


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3.8.2[5.1.2] Claim Attachment – Unsolicited Attachment Example

Example Scenario: A payer has provided instructions to providers when specific additional information is needed for pre-defined conditions found on a claim. The provider submits a claim to the payer and the supplemental information in addition to the claim.The diagram below depicts the business flow of the example above for an unsolicited claim Aattachment.


Arrow #2 (Attachment Activity #3) represents the provider’s submittal of additional informationan Attachment previously agreed to between payer and provider (ASC X12N 2755).

Figure 2: Example – Claims Attachment (Unsolicited)

3.9[5.2] Example – Prior Authorization Attachment Often healthcare services require specific authorization of coverage in order to secure reimbursement. Depending on the service to be provided and the specifics of patient’s condition/diagnosis, additional patient-specific criteria (e.g. age, sex, etc.) and plan coverage, clinical or other information might be needed to support approval of the service. The need for authorization may be known to the healthcare provider based on:

contracts with the payer, eligibility, formulary or benefit inquiries, prior experience with providing the service for patients covered by

the plan.Alternatively the provider may learn of the need for authorization by virtue of a service denial orcommunication from the payer.



Same as Figure 1

3.9.1[5.2.1] Prior Authorization Attachment – Solicited Attachment Example

Example Scenario: When the provider is not aware that additional information is needed, only the request for authorization will be sent. The payer/utilization management organization (UMO) receives the request for authorization and upon review, determines that it needs additional information from the provider. The payer/UMO initiates a request for the required documentation. The provider responds to the payer with the additional informationAttachment needed.The diagram below depicts the business flow of the example above for an solicited prior authorization attachment.

Arrow #1 represents a Service Authorization Request which is submitted from a provider to a payer (ASC X12N 2786).

Arrow #2 (Attachment Activity #4) represents a request for additional information in support of a service authorization request from the payer to the provider (ASC X12N 2786).


Figure 3: Example – Prior Authorization (Solicited)

(OUT OF SCOPE: Information exchange depicted by Arrow #1 is considered out of scope for this supplement as it only acts as a triggering event for additional information needed.)

3.9.2[5.2.2] Prior Authorization Attachment – Unsolicited Attachment Example

Example Scenario: When the requirement is known, the provider may submit the request at the time the service is planned. This request for prior authorization would be accompanied by the required additional information aAttachment in support of the request. The diagram below depicts the business flow of the example above for an unsolicited Prior Authorization Attachment. HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1 Page 57May December 2015 © 2015 Health Level Seven International. All rights reserved.

May 2012


Same a Figure 1-2

Arrow #1 represents a Service Authorization Request which is submitted from a provider to a payer (ASC X12N 2786).


Figure 4: Example – Prior Authorization (Unsolicited)

3.10[5.3] Example – Referral Attachment

Patients may be referred to other providers for consultations, services, evaluations, etc. The referral is usually initiated from a care provider, but may be initiated by a payer or other entity. The initiator of the referral may provide clinical information for use by the “referred to” provider (unsolicited). When information is not sent and additional information is needed, the “referred to” provider may request that pertinent information be sent (solicited). The following diagrams depict the referral processes.

3.10.1[5.3.1] Referral Attachment – Solicited Attachment ExampleExample Scenario: Provider “A” is caring for a patient and refers that patient to a specialist (Provider “B”) for further assessment. Provider “A” sends a referral to Provider “B”. Provider “B” receives the request and, upon review, determines they need additional information from Provider “A” and sends them a request. Provider “A” responds with the additional information aAttachment.The diagram below depicts the business flow of the example above for an Solicited Referral Attachment.

Arrow #1 represents a Referral Request which is submitted from provider “A”(referring) to a provider “B”(referred too) (ASC X12N 2786).

Arrow #2 (Attachment Activity #7) represents a request for additional information in support of a referral request from the provider “B” to provider “A” (ASC X12N 2786).



Same as above

Arrow #3 (Attachment Activity #8) represents provider “A” response with additional informationan Attachment to provider “B” (ASC X12N 2757).

Figure 5: Example – Referral Attachment (Solicited)

(OUT OF SCOPE: Information exchange depicted by Arrows #1 is considered out of scope for this supplement as it only acts as a triggering event for additional information needed.)

3.10.2[5.3.2] Referral Attachment – Unsolicited Attachment ExampleExample Scenario: Provider “A” is caring for a patient and needs to refer that patient to a specialist (Provider “B”) for further assessment. Provider “A” forwards a referral along with any necessary medical records as an additional information aAttachments to provider “B”.The diagram below depicts the business flow of the example above for an unsolicited Prior Authorization Attachment.

Arrow #1 represents a Referral which is submitted from a provider “A” to provider “B” (ASC X12N 2786).

Arrow #2 (Attachment Activity #9) represents the submittal of medical records from provider “A” to provider “B” as an additional information aAttachment (ASC X12N 2757).

Figure 6: Example – Referral Attachment (Unsolicited)


May 2012


See above


See above

3.11[5.4] Example – Notification Attachment

Notification can be used to send unsolicited information among providers, payers, delegated UMO entities and/or other providers. This information can take the form of copies of health service reviews or notification of scheduled treatment, or the beginning and end of treatment. A participant who is the recipient of the information may acknowledge they received the data, or reject the data due to specific application layer processing, but may not respond with any review decision outcome. Notification falls into four categories:Advance Notification used to communicate scheduled admissions or services. Completion Notification used to communicate patient facility admission or discharge and services completion for any specific episode of care. Information Copy used for any Health Services Review information sent to primary care provider(s), service provider(s), or other healthcare entities requiring the information for specific purposes.Change Notification used to report changes to the detail of a previously sent notification or information copy.

The information source is the entity that knows the outcome of the service review request, and can be either a UMO or a provider. For example, in a situation where the primary care provider can authorize specialty referrals that do not require review for medical necessity, appropriateness, or level of care, the primary care provider is the information source and may have responsibility for notifying both the UMO and the service provider of the specialty referral. In cases where the UMO is the decision maker, the UMO would send a notice of certification to the requesting provider and the service provider.

3.11.1[5.4.1] Notification Attachment – Unsolicited Notice of Facility Discharge with Discharge Summary Example

Example Scenario – A facility provider discharges a patient of a primary care provider, and forwards a notification to that effect.The diagram below depicts the business flow of the example above for a notification Aattachment.

Arrow #1 (Attachment Activity #10) represents the request for additional information from the provider. (if electronic, ASC X12N 2757)


Figure 7: Example – Notification Attachment (Unsolicited)

3.12[5.5] Example – Post Adjudicated Claim Attachment After the adjudication of a claim or encounter, a payer may elect or be requested to review that claim or encounter to be sure the adjudication was consistent with applicable medical policy. This may include a scenario where additional information from the provider of service may be needed.

3.12.1[5.5.1] Post Adjudicated Claim Attachment – Solicited Attachment Example

Example Scenario: A payer, after adjudicating a claim/encounter, reviews that claim and decides to perform some type of post-adjudication re-consideration of the original disposition. The payer initiates a request for that additional information. The provider receives that request, and responds to the payer with the additional informationan Attachment needed.The diagram below depicts the business flow of the example above for a solicited claim Aattachment.


Arrow #2 represents a payers remittance advice to the provider. Arrow #3 (Attachment Activity #11) represents the request for

additional information from the provider. (if electronic, ASC X12N 2774)



May 2012


Same as above

Figure 8: Example – Post Adjudicated Claim Attachment (Solicited)

(OUT OF SCOPE: Information exchange depicted by Arrows #1 and #2 are considered out of scope for this supplement as they only act as a triggering event for an additional information neededAttachment.)


4[6] IMPORTANT INFORMATION NOT PREVIOUSLY ADDRESSED IN THIS SUPPLEMENT

In Chapter 6, use cases are presented describing anticipated scenarios depicting attachment activities. While business rules are not included in those scenarios, the authors of this supplement believe there are some industry “best practices” that enhance the attachment activity, and may be addressed in mutual trading partner agreements, companion guides, operating rules or regulations. Examples of these business rules include, but are not limited to the following:

[1.] The C-CDA Implementation Guides offer specific document types in structured format along with an unstructured format suitable for other document types not defined in the structured formats. The unstructured format should never be construed to include the patient’s entire medical record, unless specifically asked for in the request.

[2.] Timeliness considerations for responses to requests for attachment information may be unique to the stakeholders needs, scenario’s, etc. Establishing standard timeliness guidance should be avoided. However, establishing reasonable expectations of minimum and maximum time between request and response may be appropriate.

a. For solicited requests, consideration should be given to the request envelope including a “respond-by” date for the response to be completed on or before that date to successfully complete the attachment activity.

b. For unsolicited responses, policy should be developed to guide payers in claims and prior authorization attachment activities and providers in referral attachment activities what to do if the attachment is received but the claim, prior authorization or referral never arrives and/or cannot be re-associated with the claim, prior authorization or referral itself.

c. Guidance should be developed to communicate the ‘in advance’ payer rules for unsolicited attachment activity. This may include payers publishing on their provider web-sites information or other routine provider communications defining the requirements for unsolicited attachment submission(s).

d. Proactively defined criteria and situations should be identified where non-conformance with ‘in advance’ rules for unsolicited attachment activity could result in a HIPAA disclosure violation. Examples could include a response attachment activity that


May 2012

exceeded the request (patient complete medical record) or response attachment activity not consistent with ‘in advance’ rules.

2.[3.] Attachment information, by default, is considered to be at the clinical document level. In some cases, the requestor of attachment information may need information at the sub-document level (section or entry). In this case, development of guidance based on scenarios may be helpful to identify the most appropriate document type to request the needed information. Absent that guidance, it would be up to the requestor of attachment information to determine the most appropriate document type to use for the request.

[4.] Use of the unstructured document is intended to accommodate attachment types for which a structured format hasn’t been developed. Structured document types MAY also be sent in an unstructured format (e.g., H&P Scanned Image, discharge summary PDF, etc). It should be thought of as attachment types that would exist at the document level, and where appropriate, capable of being developed into a structured template.


5[7] OBTAINING NEW ATTACHMENT TYPESSince its inception, Regenstrief has developed LOINC as an open standard. Regenstrief welcomes requests for new LOINC terms. It is because of submissions from the LOINC community that the vocabulary has been able to grow and adapt so quickly. Regenstrief is also always happy to receive specific suggestions about revisions or enhancements to existing content like synonyms and term descriptions as well. The general process for how to request these enhancements to LOINC are described on the LOINC website:

http://loinc.org/submissions/

5.1[7.1] Process for Requesting New Attachment Types

To request a new Aattachment Ttype, initial contact should be made to the HL7 Attachments WG via any of the work group Co-Chairs found at the following link: (http://www.hl7.org/special/Committees/claims/leadership.cfm)Regenstrief Institute assigns LOINC codes upon request from various agencies. In the context of attachments, the LOINC codes for new Aattachment Ttypes (initially Unstructured) are received by the AWG which forwards appropriate requests to the Regenstrief for consideration. Requests go through a review process to ensure the concept has not been previously added and the meaning is clear. Some complex requests are discussed and decided by the LOINC Committee before they are completed by Regenstrief. The AWG, having initially received a request considered as unstructured, would coordinate with the submitter of the new Aattachment Ttype request to assist in the development of content (Sections/Entries) necessary to advance the Aattachment information from Unstructured to Structured formatting.

5.2[7.2] Updates to the LOINC databaseWith each release (semi-annually), the LOINC database contains additional new terms and some edits to existing terms. LOINC development follows best practices for terminology system development by never reusing or deleting codes. If a LOINC term is identified as erroneous or a duplicate of a previous term it is flagged as “deprecated” in the database, but the record is not removed. Changes in concept status are made very judiciously.

There are various mechanisms for staying abreast of LOINC updates that are available from the LOINC website. You can join the LOINC announcement email list (http://loinc.org/mailing-lists), subscribe to the LOINC news RSS feed (http://feeds.feedburner.com/LOINCNews), follow on Twitter (@LOINC), or check the website for other new features.


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http://feeds.feedburner.com/LOINCNews

http://loinc.org/mailing-lists

http://www.hl7.org/special/Committees/claims/leadership.cfm


6[8] APPENDICES


May 2012

APPENDIX A — BUSINESS REQUIREMENTS FOR REQUESTING AND SUBMITTING ATTACHMENT (METADATA).When an EHR or other patient record system creates any clinical document (Attachmentattachment information) consistent with the C-CDA Implementation Guide Standards, it does so without regard to the recipient or that recipient’s purpose for obtaining that Attachmentattachment information. Because of this, the recipient may need additional information (metadata) to better understand which healthcare attachment activity for which the Attachment attachment information being provided is intended to provide additional information for.The following metadata SHALL accompany the attachment information being exchanged:

Requestor (Payer/UMO) Name and Identifier (plan ID, HPID, etc) Request receiver Name and ID (ETIN, etc) Provider of Service Name and ID (NPI) Attachment Control ID (payer or provider assigned, depending on

solicited/unsolictied) Attachment Information ID needed (LOINC Code), both in request

and response Date Requested and Response Due Date Payer Contact Information Date of Service/Encounter

In addition to the metadata above, the following MAY be included if the situation indicates:

Patient Control Number (assigned by provider on claim) Patient Medical Record Number (assigned by provider on claim) Property and Casualty Claim Number Case Reference ID Attachment Request Tracking ID


[APPENDIX B —] ASC X12 ASC X12N STANDARDS TECHNICAL REPORTS THAT SATISFY THE BUSINESS REQUIREMENTS L ISTED IN APPENDIX A .ASC X12 ASC X12N has created several standards for envelopingTechnicalReports Type 3 for enveloping the Aattachments content and have been mentioned earlier in this guide. However, we are repeating them in this appendix to provide a more user friendly list. Each of these standards may also mention acknowledgement standards when using each.

ASC X12N 277 – Health Care Claim Request for Additional Information4

ASC X12N 275 – Additional Information to Support a Health Care Claim or Encounter5

ASC X12N 278 – Health Care Services Request for Review and Response6

ASC X12N 275 – Additional Information to Support a Health Care Service Review7


May 2012


There are no footnotes on this page


The enveloping needs to stay in or the sentence won’t make sense.

APPENDIX B —[APPENDIX C —] USE OF STYLESHEETS AS A PART OF THE C-CDA PACKAGE CONTENTHL7 has provided one or more stylesheets as part of this implementation package for the C-CDA Documents ; however, these are neither balloted standards, nor are they required for use. Use of HL7 provided stylesheets is entirely up to the implementer.The following files comprise the package:


APPENDIX C —[APPENDIX D —] C-CDA DOCUMENT TRANSPORT AND PAYLOAD

This appendix covers standards based approaches to sending a C-CDA Document using electronic transactions. This Appendix will use CDA any C-CDA Document.

6.1[8.1] Transport OptionsX12 275, CONNECT w/ X12 275 (X12 message), CONNECT (XDR), Direct (X12 message), and Direct are five transport and payload mechanisms covered in this appendix.

Transport Message/Metadata Clinical PayloadX12 (real-time) (SOAP) ASC X12N 275 with CAQH CORE CDACONNECT (SOAP) ASC X12N 275 with CAQH CORE CDACONNECT (SOAP) XDR CDADirect (SMTP) ASC X12N 275 (X12 MIME) CDADirect (SMTP) XML MIME CDA

6.2[8.2] Overview of X12 (real-time)This section defines how a transaction may be submitted with the X12 275. Submission under this mechanism is constrained to real-time transmissions (batch transmissions are out of scope):

Figure 11-9: X12 (real-time)


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ASC X12 ASC X12N EnvelopeInterchange/functional Groups

X12

<SOAP Body>

</SOAP Body>

</SOAP Header>

<SOAP Header>

SOAP Envelope over HTTP

ASC X12N 275 with CDA

Security Metadata (optional)

6.2.1[8.2.1] Security MetadataWhen using the Phase II CAQH CORE Rule 270: Connectivity Rule 2.2.0, the Security Metadata must be placed in the Body element of the SOAP envelope, as illustrated below (example is for using standards defined by the HL7 Digital Signature and Delegation of Rights DSTU and applied to transaction as specified in the S&I PPA Implementation Guide):

<securityMetadata><digitalSignature>...</digitalSignature><delegationofRights>...</delegationofRights >

</securityMetadata>

6.2.2[8.2.2] Error HandlingEnvelope level errors shall be handled in accordance with Phase II CAQH CORE Rule 270: Connectivity Rule Version 2.2.0. To handle CORE-compliant envelope processing status and error codes, two fields called errorCode and errorMessage are included in the CORE-compliant Envelope. errorMessage is a free form text field that describes the error for the purpose of troubleshooting/logging. When an error occurs, PayloadType is set to CoreEnvelopeError.

Errors in processing security metadata shall be treated as CORE envelope level errors. The CORE envelope error codes will use the security specific error codes identified in Error: Reference source not found. Error: Reference source not found shows the error, the error code, and a description of information which may populate the attributes of the CORE errorMessage field

X12 Interchange Envelope Conformance errors in the transaction shall be communicated in an X12 TA1 response. The possible TA1 error codes are located in the ASC X12 ASC X12N TA1 005010X231A1 Implementation Specification.

X12 Standard Conformance & Implementation Guide Conformance errors in the transaction shall be communicated in an X12 999 response. The possible 999 error codes are located in the ASC X12 ASC X12N 999 005010X231A1 Implementation Specification.

Application processing errors in the transaction shall be communicated in an X12 824 response. The possible 824 error codes are located in the ASC X12 ASC X12N 824 005010X186A1 Implementation Specification. When the error has been caused by a specific segment or segments, the response should identify the segment or segments that caused the error. It is the responsibility of the responder to select an appropriate error code from the Insurance Business Process Application Error Codes.

The relevant ASC X12 ASC X12N Implementation Guides for error and acknowledgment handling are available at http://store.x12.org/store/healthcare-5010-original-guides.

The Insurance Business Process Application Error Codes are maintained by the Washington Publishing Company and are available at http://www.wpc-edi.com/reference/codelists/healthcare/insurance-business-process-application-error-codes/.Page 72 HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1© 2015 Health Level Seven International. All rights reserved. DecemberMay 2015

http://www.wpc-edi.com/reference/codelists/healthcare/insurance-business-process-application-error-codes/

http://www.wpc-edi.com/reference/codelists/healthcare/insurance-business-process-application-error-codes/

[8.3] Overview of a payload over CONNECT with ASC X12 ASC X12N Message

This section defines how a CDA document may be sent over CONNECT with the CAQH CORE ASC X12 ASC X12N Document Submission Service Interface Specification

6.2.3[8.3.1] ASC X12N 275 over CONNECT (CORE)Healtheway (previously the Nationwide Health Information Network (NHIN)) adopted the Phase II CAQH CORE Rule 270: Connectivity Rule Version 2.2.0 to exchange ASC X12 ASC X12N Administrative Transactions between one or more Health Information Exchanges via the Internet. CONNECT is the open-source solution used by CMS supporting Exchange participants. The “CAQH CORE X12 Document Submission Service Interface Specification”13 defines specific constraints on the use of the CAQH CORE Connectivity Rule. Error: Reference source not found below presents the components of a request or response message using 275 and CONNECT with the NHIN CAQH CORE X12 Document Submission Service Interface Specification.Specific CONNECT implementations may provide support for X12 transactions with a CAQH CORE wrapper without an XDR wrapper. Implementations of CONNECT should be capable of sending and receiving CAQH CORE-wrapped X12 transactions with an XDR wrapper, and optionally without an XDR wrapper based on trading partner agreements.

CDA transactions using XDR specifications shall conform with NHIN Document Submission v2.0 transmissions. The XDR XML body element will contain a reference to the 275, where the metadata information block is encapsulated with the XDR submission set and its document attributes. XDR submission specifications (i.e., submission set & document metadata attributes) for esMD are available in Section 3.2 (Submission Specifications) within the NHIN esMD XDR Specification.14

13 http://healthewayinc.org/images/Content/Documents/specs/2011/caqh-core-x12-document-submission-service-specification-v1-0-508.pdf14 http://exchange-specifications.wikispaces.com/file/view/ESMD_XDR_Production_Specification_v1.0.pdfHL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1 Page 73May December 2015 © 2015 Health Level Seven International. All rights reserved.

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http://exchange-specifications.wikispaces.com/file/view/ESMD_XDR_Production_Specification_v1.0.pdf

http://exchange-specifications.wikispaces.com/file/view/ESMD_XDR_Production_Specification_v1.0.pdf

http://healthewayinc.org/images/Content/Documents/specs/2011/caqh-core-x12-document-submission-service-specification-v1-0-508.pdf

http://healthewayinc.org/images/Content/Documents/specs/2011/caqh-core-x12-document-submission-service-specification-v1-0-508.pdf

Figure 11-10: CONNECT with ASC X12 ASC X12N Specification

Note: Per specifications, encoding for XDR may be indicated in the metadata, and encoding must be Base64.15

6.2.4[8.3.2] CONNECT SAML AssertionsSAML assertions for transactions with CMS must conform to the “Implementation Guide for Health Information Handlers for Electronic Submission of Medical Documentation Project,” section 5.3.5.5: esMD SAML Assertions Details, which states:

The CONNECT SAML Assertions define the exchange of metadata used to characterize the initiator of a request so that it may be evaluated by the Payer Gateway in local authorization decisions. The purpose of this SAML Assertion exchange is to provide the Payer Gateway with the information needed to make an authorization decision using the policy enforcement point for the requested esMD function. Each initiating SOAP message must convey information regarding the Registration Requestor’s attributes and authentication using SAML 2.0 Assertions.

SAML assertions for transactions with Commercial Payers must conform to the eHealth Exchange Authorization Framework Specification v3.0.

15 Nationwide Health Information Network Electronic Submission of Medical Docmentation: esMD XDR Production Specification, Version 1.0Page 74 HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1© 2015 Health Level Seven International. All rights reserved. DecemberMay 2015

6.2.5[8.3.3] IHE XD* MetadataSystems using an HPD Plus DSMLv2 document payload over CONNECT or Direct should adopt the IHE Cross Enterprise Document Reliable Interchange (XDR) profile with XDS Repository Submission Request Provide and Register Document set – b (ITI-41) transaction metadata.

Cross-Enterprise Document Reliable Interchange (XDR) provides document interchange using a reliable messaging system. This permits direct document interchange between EHRs, PHRs, and other healthcare IT systems in the absence of a document sharing infrastructure such as XDS Registry and Repositories.

Cross-Enterprise Document Media Interchange (XDM) provides document interchange using a common file and directory structure over several standard media, including email. This permits the use of person-to-person email to convey documents. XDM defines no new metadata but leverages the existing XDS metadata.

6.3[8.4] Overview of a payload over CONNECT with XDRThis section defines how a transaction may be sent over CONNECT with the eHealth Exchange CAQH CORE X12 Document Submission Service Interface Specification.

The Nationwide Health Information Network has adopted the Phase II CAQH CORE Rule 270: Connectivity Rule Version 2.2.0 to exchange ASC X12 ASC X12N Administrative Transactions between one or more Health Information Exchanges via the Internet. The “CAQH CORE X12 Document Submission Service Interface Specification” defines CONNECT specific constraints on the use of the CAQH CORE Connectivity Rule. The figure below presents the components of a transaction using CONNECT with the NwHIN Exchange CAQH CORE X12 Document Submission Service Interface Specification:


May 2012

Figure 11-11: CONNECT w/ X12 275

Note: Per specifications, encoding for XDR may be indicated in the metadata, and encoding must be Base64.16

16 Nationwide Health Information Network Electronic Submission of Medical Docmentation: esMD XDR Production Specification, Version 1.0Page 76 HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1© 2015 Health Level Seven International. All rights reserved. DecemberMay 2015

Table 11-7: XD* Submission Set Metadata

S.No

Existing or

Extension

XD* Metadata Attribute

Definition17 Data Type Required18

1 Existing Author Represents the humans and/or machines that authored the document. This attribute contains the following sub-attributes: authorInstitution, authorPerson, authorRole, authorSpecialty, authorTelecommunication

R2

1.1 Existing authorInstitution (sub-attribute of author)

XON.1 - Name of the Provider or Agent sending the request XON.10 - ID of the Provider or Agent sending the request

XON R2

1.2 Existing authorPerson (sub-attribute of author)

Contact person for administrative questionsXCN.2 - Last NameXCN.3 - First NameXCN.4 - Middle NameXCN.5 - SuffixXCN.6 - Prefix

XCN O

1.3 Existing authorTelecommunication

Telephone/fax/email for esMD administrative questionsXTN.1 - [NNN] [(999)]999-9999 [X99999] [B99999] [C any text]XTN.4 - Email AddressXTN.6 - area codeXTN.7 - phone numberXTN.8 - extension

XTN O

2 Existing Comments Description of reason for the replacement, follow up, or termination for a prior request

O

3 Existing contentTypeCode

The code specifying the type of clinical activity that resulted in placing these XDS Documents in this XDS-Submission Set. These values are to be drawn for a vocabulary defined by the XDS Affinity Domain.

R2

4 Existing contentTypeCodeDisplayName

R2

17 Where appropriate, constraints or detail specific to esMD is indicated separately within this column18 R=Required; R2=Required if known; O=OptionalHL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1 Page 77May December 2015 © 2015 Health Level Seven International. All rights reserved.

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5 Existing entryUUID A unique ID or a globally unique identifier within the document submission request for the SubmissionSet. Intervening portal generates this as part of generating the XDR/XDM message

UUID R

6 Existing intendedRecipient

Intended Recipient represents the organization(s) or person(s) for whom the Document Submission set is intended.

The Intended Recipient for the Registration Request will be a Payer or Payer Contractor to whom the Provider or Agent sends the message. This Intended Recipient will be identified by the Unique Payer ID.

For Payer, use XON datatype:XON.1 - Organization NameXON.10 - Organization NPI or Alternate ID

XON/XCN R2

7 Existing patientID The patientId represents the subject of care of the document.

R2

8 Existing sourceID Globally unique identifier, in OID format R9 Existing submissionTim

ePoint in Time at the Document Source when the Submission Set was created and issued for registration to the Document Registry. Shall have a single value.

This shall be provided by the Document Source (in case of e-mail with significant delay).

Timestamp should be to at least the second

DTM R

10 Existing title Represents the title of the Submission Set. O11 Existing uniqueID A globally unique identifier, in OID format, assigned by the

Sender to the submission set in the transmission. The length of this Unique Identifier shall not exceed 128 bytes.

R


Table 11-8: XD* Document Entry Metadata

S.No

Existing or

Extension

XD* Metadata Attribute

Definition Data Type Required19

1 Existing author Represents the humans and/or machines that authored the document. This attribute contains the following sub-attributes: authorInstitution, authorPerson, authorRole, authorSpecialty. Note that the sender information is carried in the Submission Set author attribute, not necessarily this one.

R2

1.1 Existing authorInstitution (sub-attribute of author)

XON.1 - Name of the Provider or Agent XON.10 - ID of the Provider or Agent f

XON R2

1.2 Existing authorPerson (sub-attribute of author)

Contact person for esMD administrative questionsXCN.2 - Last NameXCN.3 - First NameXCN.4 - Middle NameXCN.5 - SuffixXCN.6 - Prefix

XCN O

2 Existing classCode The code specifying the particular kind of document. Supports environments where content is provided without context, for example a PDF document or a patient's document as patients do not understanding coding systems. Could consider a well-known class code which identifies the entry as a "directed" entry.

XDR/XDM - R2

3 Existing classCodeDisplayName

The name to be displayed for communicating to a human the meaning of the classCode. Shall have a single value for each value of classCode.

XDR/XDM - R2

4 Existing comments Description of reason for the replacement, follow up, or termination for a prior request

O

5 Existing confidentialityCode

The code specifying the level of confidentiality of the Document.

XDR/XDM - R2

6 Existing creationTime Represents the time the author created the document in the Document Source. Shall have a single value. If the

DTM XDR/XDM - R2

19 R=Required; R2=Required if known; O=OptionalHL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1 Page 79May December 2015 © 2015 Health Level Seven International. All rights reserved.

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creation time of the document is unknown it is better to specify nothing than use a value that is misleading.

7 Existing entryUUID A unique ID or a globally unique identifier within the document submission request for the SubmissionSet. Intervening portal generates this as part of generating the XDR/XDM message

UUID R

8 Existing formatCode Globally unique code for specifying the format of the document.

XDR/XDM - R2

9 Existing formatCodeDisplayName

The name to be displayed for communicating to human readers the meaning of the formatCode.

XDR/XDM - R2

10 Existing hash Hash key of the request/response XML document. SHA1 XDR - OXDM - R

11 Existing healthcareFacilityTypeCode

This code represents the type of organizational setting of the clinical encounter during which the documented act occurred.

XDR/XDM - R2

12 Existing healthcareFacilityTypeCodeDisplayName

The name to be displayed for communicating to a human the meaning of the healthcareFacilityTypeCode. Shall have a single value corresponding to the healthcareFacilityTypeCode.

XDR/XDM - R2

13 Existing languageCode Specifies the human language of character data in the document. The values of the attribute are language identifiers as described by the IETF (Internet Engineering Task Force) RFC 3066.

XDR/XDM - R2

14 Existing mimeType MIME type of the document in the Repository. Shall have a single value.

R

15 Existing patientID The patientId represents the subject of care of the document.

XDR/XDM - R2

16 Existing practiceSettingCode

The code specifying the clinical specialty where the act that resulted in the document was performed.

XDR/XDM - R2

17 Existing practiceSettingCodeDisplayName

The name to be displayed for communicating to a human the meaning of the practiceSettingCode. Shall have a single value corresponding to the practiceSettingCode.

XDR/XDM - R2

18 Existing sourcePatientId

The sourcePatientId represents the subject of care medical record Identifier (e.g., Patient Id) in the local patient Identifier Domain of the Document Source. It shall contain two parts:Authority Domain IdAn Id in the above domain (e.g., Patient Id).

XDR/XDM - R2

19 Existing title Represents the title of the document. Max length shall be O


128 bytes in UTF-8 format.20 Existing typeCode The code specifying the precise kind of document R221 Existing typeCodeDispl

ayNameThe name to be displayed for communicating to a human the meaning of the typeCode. Shall have a single value corresponding to the typeCode.

R2

22 Existing uniqueID Globally unique identifier for the document in submission-set assigned by the Document Source in OID format. Shall have a single value.

A globally unique identifier assigned to each document in the SubmissionSet. The length of the Unique Identifier shall not exceed 128 bytes. The structure and format of this ID shall be consistent with the specification corresponding to the format attribute. This ID will be generated based on the UUID.Generated based on the UUID. The same ID will be returned with the response message.

R

23 Existing URI Required in XDM to address the location in the zip package of the document

XDR - OXDM - R


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6.3.1[8.4.1] esMD Security MetadataWhen using CONNECT, the Security Metadata must be placed in the Body element of the SOAP envelope. Refer to illustration in section 8.2.1: Security Metadata.

6.3.2[8.4.2] Error HandlingXD* error codes are defined in Section 4 of Integrating the Healthcare Enterprise’s (IHE’s) Information Technology Industry (ITI) Technical Framework, Volume 3. For errors related to processing the XD* metadata, the esMD Response to a Registration Request will use the XD* error codes.

For errors related to processing the esMD Security metadata in the context of Provider Registration, the esMD Response to a Registration Request will use the esMD security specific error codes identified in Error: Reference source not found. Error: Reference source not found shows the esMD error, the esMD error code, and a description of information which will populate the fields of the ebRS RegistryResponse.

Application processing errors shall be communicated in an ebRS RegistryResponse using the Insurance Business Process Application Error Codes. It is the responsibility of the responder to select an appropriate error code from the Insurance Business Process Application Error Codes; codes that are highly relevant to the esMD Registration Request are identified in Section Error: Reference source not found, Error: Reference source not found.

The ebRS RegistryResponse errorCode field must contain the selected esMD error or Insurance Business Process Application Error Codes. When the error has been caused by a specific HPD Plus attribute, the ebRS RegistryResponse location field should identify the Object Class and Attribute that caused the error.

6.4[8.5] Overview of payload over Direct (X12 Message)This section defines how a transaction may be sent using Direct. The figure below presents the components of a transaction over Direct:

Figure 11-12: Direct Message

Note: XDM and XDR metadata allow for indication of encoding method. This method must be Base64.20 XDM is optional in cases where more than one clinical document is included in Attachment 1.

6.5[8.6] Overview of payload over DirectThis section defines how a transaction may be sent Direct. The figure below presents the components of a transaction over Direct:

Figure 11-13: Direct Message

20 XDR and XDM for Direct Messaging Specification, Version 1, finalized 9 March 2011. See section 6.0: MetadataHL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1 Page 83May December 2015 © 2015 Health Level Seven International. All rights reserved.

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Note: XDM and XDR metadata allow for indication of encoding method. This method must be Base64.21 XDM is optional in cases where more than one clinical document is included in Attachment 1.

21


[APPENDIX E —] ASC X12 ASC X12N STANDARDS TRANSACTION AND ERROR FLOW

ASC X12 ASC X12N has created several standards for enveloping the Aattachment content and have Review7

\


May 2012



May 2012

APPENDIX D —[APPENDIX F —] C-CDA DOCUMENT TYPES

What are C-CDA Document Types?C-CDA Implementaiton Gudes define clinical information in a format based on CDA, constrained by conformance statements consistent with industry best practices for specific types of clinical documents. Some broadly used clinical document types have been more fully developed in CDA than others. Examples of those clinical document types are: In the C-CDA R2

Continuity of Care Document (CCD) Consultation Note Diagnostic Imaging Report (DIR) Discharge Summary History and Physical Operative Note Procedure Note Progress Note Care Plan Referral Note Transfer Summary Patient Generated Document

In the CDP1 Enhanced Encounter Document Enhanced Discharge Document Enhanced Operative Note Document Enhanced Procedure Document Interval Document

Other clinical information not listed above may also be exchanged using C-CDA R2 by taking advantage of the “Unstructured Document”, as described in Section 1.1.24 of the C-CDA R2: Volume 1 Introductory Material. Throughout the C-CDA R2 implementers will see references to sending and receiving EHR systems. This is because the C-CDA R2 was written from the Page 88 HL7 Attachment Supplement Specification: Request and ResponseExchange Implementation Guide, Release 1© 2015 Health Level Seven International. All rights reserved. DecemberMay 2015

perspective of exchange between EHR systems. For the purposes of this supplement there is no assumption that exchange will occur between two EHR systems. Instead, as you will see in the use case portion of this supplement (Chapter 6), the additional information a payer is seeking may exist in a provider’s electronic repository, such as an EHR system, and may/may not be passed through a practice management system or be sourced directly from the EHR. Section 1 of the C-CDA R2: Volume 1 Introductory Material describes at a high level how templates are used to represent the organization of CDA structure in a document. Metadata found in the Header as well as specific clinical information found in the Body components as Documents, Sections within those documents, and entries within those sections are explained are described in Sections 1-4 of the C-CDA R2: Volume 2 Templates and Supporting Material and Sections 5-7 of the CDP1.


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Table 9b: LOINC Codes for Specific C-CDA Documents

Guide

Document Template LOINC(exampl

e)LOINC Long Description

None specified (default) 61000-n No specific document format requested

C-CDA R2

Continuity of Care Document (CCD) urn:hl7ii:2.16.840.1.113883.10.20.22.1.2:2014-06-09

61001-n CCDAR2: Continuity of Care Document

C-CDA R2

Consultation Note urn:hl7ii:2.16.840.1.113883.10.20.22.1.4:2014-06-09

61003-n CCDAR2: Consultation Note

C-CDA R2

Diagnostic Imaging Report (DIR) urn:hl7ii:2.16.840.1.113883.10.20.22.1.5:2014-06-09

61004-n CCDAR2: Diagnostic Imaging Report

C-CDA R2

Discharge Summary urn:hl7ii:2.16.840.1.113883.10.20.22.1.8:2014-06-09

61005-n CCDAR2: Discharge Summary

C-CDA R2

History and Physical urn:hl7ii:2.16.840.1.113883.10.20.22.1.3:2014-06-09

61006-n CCDAR2: History and Physicial

C-CDA R2

Operative Note urn:hl7ii:2.16.840.1.113883.10.20.22.1.7:2014-06-09

61007-n CCDAR2: Operative Note

C-CDA R2

Procedure Note urn:hl7ii:2.16.840.1.113883.10.20.22.1.6:2014-06-09

61008-n CCDAR2: Procedure Note

C-CDA R2

Progress Noteurn:hl7ii:2.16.840.1.113883.10.20.22.1.9:2014-06-09

61009-n CCDAR2: Progress Note

C-CDA R2

Care Planurn:oid:2.16.840.1.113883.10.20.22.1.15

61010-n CCDAR2: Care Plan

C-CDA Referral Note urn:oid:2.16.840.1.113883.10.20.22.1.14

61011-n CCDAR2: Referral Note

Guide

Document Template LOINC(exampl

e)LOINC Long Description

R2C-CDA R2

Transfer Summary urn:oid:2.16.840.1.113883.10.20.22.1.13 61012-n

CCDAR2: Transfer Summary

CDP1 Enhanced Encouner Document urn:oid:2.16.840.1.113883.10.20.35.1.1 62001-n

CDP1: Enhanced Encouner Document

CDP1 Enhanced Discharge Document urn:oid:2.16.840.1.113883.10.20.35.1.2

62002-n CDP1: Enhanced Discharge Document

CDP1 Enhanced Operative Note Document urn:oid:2.16.840.1.113883.10.20.35.1.3

62003-n CDP1: Enhanced Operative Note

CDP1 Enhanced Procedure Document urn:oid:2.16.840.1.113883.10.20.35.1.4

62004-n CDP1: Enhanced Procedure Note

CDP1 Interval Document urn:oid:2.16.840.1.113883.10.20.35.1.5

62005-n CDP1: Interval Note

The requester should only specify a format if a specific document is preferred. Provider may return any appropriate document type consistant with curent regulation or, in the absence of applicable regulations, with trading partner agreement.


May 2012