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Template Usage Information:

  1. Project Name and ID



Enter the name of the project here: FHIR DME Orders

Project ID: 1496

Complete this section for all “Direct to Normative” ballot projects and when a project proceeds from “Informative to Normative” or “STU to Normative”.

Forward PSS to the TSC (via tscpm@HL7.org); this triggers American National Standards Institute (ANSI) Project Initiation Notification (PINS) submission.

 X

TSC Notification:  Informative/STU to Normative 

Date:  12/18/2018

 

- or -                     Direct to Normative (no STU) (includes reaffirmations)       

 

Identify ISO, IEC or ISO/IEC standard to be adopted in text box below

Enter info here if an ISO, IEC, or ISO/IEC Standard is to be adopted as an American National Standard; Enter the designation of the standard(s) to be adopted:

Includes text from ISO, IEC or ISO/IEC standard: Check here if this standard includes excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption.

Yes

 

No

Select the unit of measure used in the standard; if no measurements are in the standard, select N/A

 

N/A

 

U.S.

Metric

 

Both

 

Investigative Project (aka PSS-Lite)

Date : 

Check this box when the project is investigative or exploratory in nature, which allows limited project scope definition. Sections 1-Project Name, 2-Sponsoring Group(s)/Project Team, 3a-Project Scope, 3b-Project Need, 3e-Project Objectives/Deliverables/Target Dates, 3i-Project Document Repository, 6b-[Realm, if known], and 6d-[applicable Approval Dates] are required for Investigative Project. Investigative Project specific instructions are highlighted in yellow. An investigative project must advance in two WGM cycles, requiring a full scope statement. Otherwise the project will be closed.

2. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

Primary Sponsor/Work Group
(1 (And Only 1) Allowed)

Orders and Observations

2.b. Co-sponsor Work Group(s)

Co-sponsor Work Group(s):

(Enter co-sponsor approval dates in Section 6.d Project Approval Dates)


Indicate the level of involvement that the co-sponsor will have for this project:

 Request formal content review prior to ballotWGMs

 Request periodic project updates. Specify periodWGMs

 Other Involvement. Specify details here: 

2.c. Project Team

All names should have confirmed their role in the project prior to submission to the TSC.

Project facilitator (1Mandatory)

Robert Dieterle

Other interested parties and their roles


Multi-disciplinary project team (recommended)


     Modeling facilitator

TBD

     Publishing facilitator

Vocabulary facilitator

Rob Hausem

     Domain expert rep

Robert Dieterle, Daniel Rutz

     Business requirement analyst

Robert Dieterle, Melanie Combs-Dyer

     Conformance facilitator (for IG projects)


     Other facilitators (SOA, etc)




Implementers (2Mandatory for STU projects)

FHIR Project Note: The implementer requirement will be handled by the “balloting” project.  Therefore work groups do not fill out the above section.  However, feel free to list implementers specific to your work group’s resources if you know of any.

1) CMS

2) DMEHub

3. Project Definition

3.a. Project Scope


This project will define exchange methods, use of other interoperability "standards" (e.g. CDS Hooks and SMART on FHIR) and specific use of FHIR resources to effectively exchange orders for DME and associated supplies and medications, supporting clinical information (to qualify the order or establish medical necessity), provenance of the order and supporting clinical information, between the ordering provider and the intended supplier. Support will be provided for the communication of substantiating review (e.g. prior authorization, appropriate use, medical review services) information (e.g. tracking and authorization numbers).



The following diagrams depict work flow for the DME eRx orders facilitated via a SMART on FHIR application (note: focus is on the exchange standard and not on the creation of the SMART on FHIR application.



This project will utilize, where possible, existing profiles for each of the relevant FHIR releases (e.g. Argonaut for DSTU2, US Core for STU3, and US Core for R4). Creation of resources, extensions and profiles will be limited to situations here the current artifacts do not meet the requirements for DME ordering. The following diagram depicts the anticipated scope of the DME eRx Implementation Guide.


The ultimate goal is to support the electronic exchange of DME orders, supporting documentation and provenance between the ordering provider and the supplier using FHIR DSTU2, STU3, and R4 releases of the FHIR standard.

The project team plans to work with existing FHIR artifacts where possible. If changes are necessary, the project team will work with the responsible Work Group to review and implement (via tracker items or new PSS) any necessary enhancements to base FHIR resources, extensions, and/or profiles.



3.b. Project Need


Payers, Providers, Suppliers and Patients need the ability to order Durable Medical Equipment (DME) electronically to eliminate paper / FAX / verbal orders, ensure accurate ordering, minimize denials, reduce time required to supply patients with needed DME and related supplies. There is currently no well adopted standard for ordering DME equipment and supplies. An informal survey of the DME industry leaders conducted by a CMS contractor noted that over 90% of all orders are conducted by FAX or verbal exchanges and the fewer than 5% utilize any published standards (excluding NCPDP for items that can be ordered via the pharmacy networks). This implementation guide will provide a standard for adoption by providers and suppliers for the exchange of DME orders using FHIR based standards.


3.c. Security Risks


Will this project produce executable(s), for example, schemas, transforms, style sheets, executable program, etc.  If so the project must review and document security risks. Refer to the Cookbook for Security Considerations for additional guidance, including sample spreadsheets that may be used to conduct the security risk assessment. 

Yes

X

No

Unknown


3.d. External Drivers


None


3.e. Project Objectives / Deliverables / Target Dates

Within each row, enter the explicit work product(s) / objective(s).  Indicate their target date at the right in WGM/Ballot Cycle format.  Include the project end date as the last objective (for standards projects, the end date will be the projected ANSI approval date). 

Target Date(in WGM or ballot cycle format, e.g.

‘2017 Sept WGM’ or

‘2017 Jan Ballot’)

Ballot for Comment (First Ballot Cycle)

2019 May Ballot

Submit for STU Ballot (Second Ballot Cycle)

2019 Sep Ballot

Complete STU Reconciliation

2020 Jan WGM

Request STU Publication

2020 Jan WGM

Submit for STU 2 Ballot (Third Ballot Cycle)

2020 Sep Ballot

Complete STU 2 Reconciliation

2021 Jan WGM

Request STU 2 Publication

2021 Jan WGM

STU Period

2021 Jan -2022 Jan

Submit for Normative Ballot

2022 May Ballot

Complete Normative Reconciliation

2022 Sep WGM

Submit Publication Request

2022 Oct

Project End Date (all objectives have been met)

2022 Dec


3.f.   Common Names / Keywords / Aliases


FHIR DME Orders, DME eRx


3.g. Lineage


n/a

3.h. Project Dependencies




3.i.   HL7-Managed Project Document Repository Location


Projects must adhere to the TSC's guidelines (which were approved on 2016-04-04 and summarized in Appendix A).

A template to create a Project Page on the HL7 Wiki is available at: http://wiki.hl7.org/index.php?title=Template:Project_Page.

Enter the SPECIFIC URL of the HL7-MANAGED SITE where supporting project documents, deliverables, ballot reconciliation work and other project information will be kept
HTTP: //confluence.hl7.org/pages/viewpage.action?pageId=39158184 or above this link.


3.j.   Backwards Compatibility


Are the items being produced by this project backward compatible?


Yes

No

Unknown

X

N/A

If you check 'Yes' please indicate the earliest prior release and/or version to which the compatibility applies:


For V3, are you using the current data types? 

(Refer to TSC position statement on new projects using R2B for more information on the current V3 data types)

Yes

No

Unknown

X

N/A



If you check no, please explain the reason:

If desired, enter additional information regarding Backwards Compatibility.


3.k. External Vocabularies


Will this project include/reference external vocabularies?

X

Yes

No


Unknown

N/A

If Yes, please enter the vocabularies: HCPCS, SNOMED, CPT, ICD, RxNorm, LOINC


4. Products (check all that apply)



Arden Syntax


V2 Messages – Administrative


Clinical Information Modeling Initiative (CIMI)


V2 Messages - Clinical


Clinical Context Object Workgroup (CCOW)


V2 Messages - Departmental


Domain Analysis Model (DAM)


V2 Messages – Infrastructure


Electronic Health Record (EHR) Functional Profile


V3 Domain Information Model (DIM / DMIM)

X

FHIR Extensions


V3 Documents – Administrative (e.g. SPL)

X

FHIR Implementation Guide (enter FHIR product version below)


V3 Documents – Clinical (e.g. CDA)

X

FHIR Profiles (enter FHIR product version below)


V3 Documents - Knowledge

?

FHIR Resources


V3 Foundation – RIM


Guidance (e.g. Companion Guide, Cookbook, etc)


V3 Foundation – Vocab Domains & Value Sets


Logical Model


V3 Messages - Administrative


New/Modified/HL7 Policy/Procedure/Process


V3 Messages - Clinical


New Product Definition (please define below)


V3 Messages - Departmental


New Product Family (please define below)


V3 Messages - Infrastructure


Non Product Project - (Educ. Marketing, Elec. Services, etc.)


V3 Rules - GELLO


White Paper


V3 Services – Java Services (ITS Work Group)


Creating/Using a tool not listed in the HL7 Tool Inventory


V3 Services – Web Services (SOA)

If you checked New Product Definition or New Product Family, please define below:


For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

DSTU2, STU3, R4


5. Project Intent (check all that apply)



Create new standard


Supplement to a current standard

Revise current standard (see text box below)


X

Implementation Guide (IG) will be created/modified

Reaffirmation of a standard


Project is adopting/endorsing an externally developed IG:

New/Modified HL7 Policy/Procedure/Process


Specify external organization in Sec. 6 below;





Externally developed IG is to be (select one):


White Paper (select one):


Adopted  - OR -

?

Endorsed


Balloted Informative OR

Non-balloted WG White Paper


N/A  (Project not directly related to an HL7 Standard)











If revising a current standard, indicate the following:


-    Name of the standard being revised:
-    Date it was published (or request for publication, or ANSI designation date)
-    Rationale for revision
-    The relationship between the new standard and the current standard (is it designed to replace the current standard, a supplement to the current standard, etc.)


5.a. Ballot Type (check all that apply)


X

Comment (aka Comment-Only)


Joint Ballot (with other SDOs)

Informative


N/A  (project won’t go through ballot)

X

STU to Normative     - OR -

Normative (no STU)











If necessary, add any additional ballot information here.  If artifacts will be jointly balloted with other SDOs, list the other groups.



5.b. Joint Copyright

Check this box if you will be pursuing a joint copyright.  Note that when this box is checked, a Joint Copyright Letter of Agreement must be submitted to the TSC in order for the PSS to receive TSC approval.

Joint Copyrighted Material will be produced?


Yes

X

No


6. Project Logistics

6.a. External Project Collaboration


Include SDOs or other external entities you are collaborating with, including government agencies as well as any industry outreach.  Indicate the nature and status of the Memorandum of Understanding (MOU) if applicable.

For projects that have some of their content already developed:

How much content for this project is already developed?

10%

Was the content externally developed ? :

Y

CMS

Is this a hosted (externally funded) project?  (not asking for amount just if funded)

X

Yes

No


6.b. Realm


Universal 

- OR -

 X

Realm Specific



 

Check here if this standard balloted or was previously approved as realm specific standard

U.S.

Includes vocabulary and profiles that are specific to the US healthcare system

Support US Healthcare workflows


6.c. Stakeholders / Vendors / Providers

This section must be completed for projects containing items expected to be ANSI approved, as it is an ANSI requirement for all ballots

 

Stakeholders

 

Vendors

 

Providers


 

Clinical and Public Health Laboratories

  

Pharmaceutical

  

Clinical and Public Health Laboratories


  

Immunization Registries

X
  

EHR, PHR

  

Emergency Services


  

Quality Reporting Agencies

X
  

Equipment

  

Local and State Departments of Health


  

Regulatory Agency

 

Health Care IT


Medical Imaging Service

  

Standards Development Organizations (SDOs)

X 

Clinical Decision Support Systems

 

Healthcare Institutions (hospitals, long term care, home care, mental health)

X
  

Payors


  

Lab

  

Other (specify in text box below)

X 

Other (specify in text box below)

  

HIS

  

N/A

  

N/A

  

Other (specify below)


 

 


  

N/A

 

 


Other:  Federal Healthcare Agencies (e.g. CMS), Providers (e.g. Physicians)










6.d. Project Approval Dates

Click here to go to HL7 Project Scope Statement Instructions#Appendix A for more information regarding this section.
Approvals are by simple majority vote of the approving body

Sponsoring Work Group Approval Date:

WG Approval Date

2019-01-03

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date






Family Management Group Approval Date(s)

CIMI Projects: CIMI Management Group

CIMI MG Approval Date

N/A

CDA Projects: CDA Management Group

CDA MG Approval Date

N/A

FHIR Projects: FHIR Management Group

FMG Approval Date

V2/Publishing Projects: V2 Management Group

V2 MG Approval Date

N/A

US Realm Projects: US Realm Steering Committee Approval
(Email WG approved PSS to: tscpm@HL7.org)

USRSC Approval Date

Affiliate Specific Projects: Affiliate Approval Date

Affiliate Approval Date

N/A

Submit PSS to Steering Division after all of the above approvals are received

Steering Division (of Primary Sponsor WG) Approval Date:

SD Approval Date CCYY-MM-DD

Last PBS Metrics Score:

X

 Green

 Yellow

 Red

PBS Metrics Reviewed? (required for SD Approval if not green)

 Yes

 No

ARB and Steering Division approval may be in parallel

Architectural Review Board Approval Date:

(required for externally developed content)

ARB Approval Date

N/A

TSC Approval

If applicable, TSC has received a Joint Copyright/Distribution Agreement (containing the verbiage outlined within the SOU),
signed by both parties.

Yes

No

 N/A


Technical Steering Committee Approval Date:
(Email SD WG approved PSS to: tscpm@HL7.org)

TSC Approval Date