EMDI Program Guide v3.7

Overview

The EMDI Program Guide is intended for healthcare providers and stakeholders who are interested in participating in the EMDI program. These organizations should have the capability to build the architecture and the supporting infrastructure necessary for interoperability. The primary intended audiences are healthcare providers, such as hospitals, physicians, Home Health Agency (HHA) services, Durable Medical Equipment, Prosthetic, Orthotic, & Supplies (DMEPOS), labs, comprehensive primary care networks such as Comprehensive Primary Care Plus (CPC+), and virtual physician networks. Other audiences include:

Document transfer vendors, such as Health Information Handlers (HIH), Heath Information Service providers (HISP), and clearinghouses.
Interface Vendors, such as Electronic Health Records (EHR) and document management system vendors.
Other payers, such as Medicaid State Agencies and commercial payers.
IT vendors involved in facilitating the physician’s digital signature on medical record documents.
Suppliers and ambulance providers

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The goals for the EMDI program are to:

The goal of EMDI is to ‘Reduce Provider Burden’. EMDI program obtains this goal by harmonizing Health IT standards to achieve interoperability and establishing a secure communication between providers to share structured electronic medical documentation.

To achieve this goal, following objectives have been identified:

Process Perspective:
- Improve medical document sharing
- Automate manual processes
- Improve provider workflow
- Reduce claims re-submission
Financial Perspective:
- Reduce time
- Reduce cost
- Reduce resources
Provider Perspective:
- Improved provider-to-provider communication
- Provider’s satisfaction
Growth Perspective:
- Expansion of EMDI beyond pilot
- Additional use cases for EMDI workflow

To achieve these goals, CMS will:

Develop and maintain the EMDI Program Guide containing the content specifications and transport specifications needed for EMDI pilots and implementations.
Identify and fill in the gaps in the current standards to achieve an increased level of interoperability among providers.
Encourage EMDI participants with others to conduct pilots.
Demonstrate the utility of standards by establishing pilot programs with existing health information handlers, health information service providers, document transfer vendors, interface vendors, healthcare organizations, and healthcare providers.
Facilitate the implementation of secure transport of interoperable electronic medical documentation and help overcome barriers faced by organizations during the pilot implementation.
Define and collect data for measures to determine the success of the pilot program.

Revision Log

Date	Version	Description	Modified By
04/30/2019	3.5	Section 1.4: CMS and Other Industry Efforts in Interoperability Section 1.4.1: HL7 Da Vinci Section 1.4.2: DME eRx Pilots with EMDI Section 1.4.3: ONC FHIR at Scale Taskforce (FAST) Section 1.8.4: FHIR based technologies Section 4: EMDI Related Programs and Initiatives Section 4.3: CMS and HL7 Initiatives Section 4.4: Alternative DME Electronic Order System Appendix H: EMDI FHIR Implementation Guidance	Nandini Ganguly
06/30/20193.6	3.6	Global: Renamed EMDI Implementation Guide to EMDI Program Guide. Global: Removed unnecessary capitalization and acronyms to be consistent. Global: Verified links and section links. Global: Removed EMR reference from all sections. Global: Rearranged sections for improved flow.	Nandini Ganguly
08/30/2019	3.7	Global: Added cross-reference for all sections Global: Verified acronym naming convention Global: Restructure the Use Case section for improved flow Global: Verified all links are valid and accurate	Nandini Ganguly

Revision Log

Date	Version	Description	Modified By
10/24/2016	0.1	Initial Draft	Pallavi Talekar
10/26/2016	0.2	Updated based on direct edits and comments from Melanie Combs-Dyer	Pallavi Talekar
10/26/2016	0.3	QA review	Kylie Carpenter
11/03/2016	0.4	Continued updates based on information provided by CMS and software vendors	Pallavi Talekar
11/10/2016	0.5	Updates based on comments from Hyland and CIOX Health. Updates in general for various TBD items	Pallavi Talekar
11/22/2016	0.6	Added LOINC codes for documentation requests	Pallavi Talekar
03/03/2017	0.7	Updated the Implementation Guide to an XLC template and address the comments from stakeholders, Included updated data elements and XLM sample code.	Archana Narayan
04/07/2017	1.0	Updated IG with FHIR related content as well refined the content. Made some corrections and formatting changes. Updated Single schema with few elements updated.	Pallavi Talekar
05/05/2017	1.1	Updated the guide with comments from CMS and data standards SME.	Pallavi Talekar
05/19/2017	2.0	Combined HHA and DME versions to make a common Implementation Guide for both. Changed the version to be 2.0 as it’s a major change.	Pallavi Talekar
06/16/2017	2.1	Added Appendix J for FHIR Implementation Guide. Added identified list of resources.	Pallavi Talekar
07/21/2017	2.2	Added sections regarding Appropriate Use Criteria (AUC), Section 2.1.4., Section 3.1.5, Section 4.2. Appendix L and Appendix N have been updated.	Pallavi Talekar
08/18/2017	2.3	Update language in assumptions around EMDI requirements that may vary per organization existing system and infrastructure. Changes made in section 3.1.1 and 2.2.2	Pallavi Talekar
09/18/2017	2.4	Update language in the section 3.1.1 Assumptions to include Compliant and Striving pilots definitions.	Pallavi Talekar
10/23/2017	2.5	Section for Signatures has been added under Assumptions in Section 3.1.6 and under Pilot Implementation Overview in Section 4.3. Section 5.4 Contributors has been added to recognize external contributors of IG Section 5.5 Points of Contact has been moved at the end of Section 5 and has been updated with contacts for eClinical template workgroup. Also, Table 13 has been updated with current EMDI Project Manager and a new resource.	Pallavi Talekar
11/30/2017	2.6	Section 1.3 Additional Considerations has been added to Section 1 Introductions to include a reference to the ONC Interoperability Standards Advisory.	Ray Wilkerson
01/17/2018	2.7	Section 2.3.3 Structured Formats with details for CCDA and CDP1. Appendix N: Referenced Documents for CCDA has been added Appendix L: Acronyms for CCDA and CDP1 has been updated Section 5.4: Contributors has been updated	Pallavi Talekar
02/26/2018	2.8	Section 2.1.5: DME eOrder System section has been added to specify criterias for DME eOrder system Section 2.3: Standards and Protocols has been updated Appenxix G: CMS Suggested Clinical Data Elements Section 5.5 Points of Contact has been updated to add Vidya Sridhar’s information	Pallavi Talekar
06/08/2018	3.0	Global: Rearrangement of Implementation Guide sections Global: Improvement for accuracy of information Global: Removed Pilot Guidance from Implementation Guide. Will be delivered as a separate guide Global: Removed the Prior Authorization and Pre- Claim section Section 2: EMDI use cases moved to overview section Section 2.2: Revised Use case workflow sequence diagrams to capture acknowledgements accurately Section 2.2.1: Updated the workflow of service delivery in use case 1 Section 2.4: Revised standards and protocols section Section 4: Updated Assumptions/Constraints/Risk section Section 5: Grouped Clinical templates, AUC, and DME eOrder System under ‘Other suggested programs and functionality’ Section 5.2: Combined Appropriate use program information in one section Appendix B: Added Signature data block and removed beneficiary and subscriber data block from metadata elements.	Pallavi Talekar Ray Wilkerson Briana Barnes Nandini Ganguly
08/31/2018	3.1	Global: Rearrangement of Implementation Guide sections Global: Updated language from ‘recommended standards/formats’ to ‘identified standards/formats’ Global: Include Hospice Care as a provider Global: Remove Laboratory Testing as a provider Section 1: Updated the Introduction to include the goal of reducing provider burden Section 1.3: Added language for the Overarching Goals of Promoting Interoperability and the 21^st Century Cures Act Section 2.3: Updated content for Interface vendors and Document Transfer Vendors (HIH/HISP/Clearinghouse) Section 3.2: Removed organization names for EHR, Document Management, and HIH System options Section 3.3: Removed language for Standards	Briana Barnes
10/31/2018	3.2	Added content to the Introduction section that reference the HITECH Act Updated 'Additional Considerations’ to enhance the flow of the section/language Updated language on the EMDI Overview Included assumptions for EMDI use cases Reorganized the structured of the IG to include Pilot Participants before Use Case EMDI Identified Standards and Implementation Specification: Included language to differentiate the standards Direct: Updated language and included link to Direct Trust site Connect: Included link to Connect site Content Standard: Included language to describe its relevance to EMDI. Included additional language relevant to APIs Messaging Data Standards: Included language that speaks to relevance of this standard for EMDI X12: Updated language for relevancy of how it used by EMDI stakeholders Signatures: Included additional language about the importance of signatures Updated Implementation Standard and Security to Pre-Pilot Conditions Removed acronym ‘CDE’ to minimize confusion LOINC Code: Updated language for relevance to EMDI	Nandini Ganguly Briana Barnes
12/27/2018	3.3	Section 2.4.2: Content Standards: Definition of structured medical document added Section 2.6.2: Digital Signatures Section 3.4: Risks, Issues and Constraints Section 4.0: Metadata elements	Nandini Ganguly Briana Barnes
02/29/2019	3.4	Section 2.1: EMDI Purpose Section 2.1.3: How does EMDI fulfill this gap Section 3.1: EMDI Program Assumptions Section 3.2: Use Case Assumptions Section 5.4: HL7 Da Vinci DME Order Use Case using FHIR	Nandini Ganguly