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Template Usage Information:

  1. Project Name and ID



Enter the name of the project here: Payer Coverage Decision Exchange

Project ID: 1515

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.

 

TSC Notification:  Informative/STU to Normative 


 

- 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)

Financial Management

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

Co-sponsor Work Group(s):

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

Attachments

Indicate the level of involvement that the co-sponsor will have for this project:
X Request formal content review prior to ballotWGMs
X 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, Viet Nguyen

Other interested parties and their roles

Viet Nguyen and Lloyd McKenzie (technical FHIR support)

Multi-disciplinary project team (recommended)


     Modeling facilitator

Lloyd McKenzie

     Publishing facilitator

Paul Knapp

     Vocabulary facilitator

Viet Nguyen

     Domain expert rep

Lenel James, Robert Dieterle,

     Business requirement analyst

Christol Green, Mary Kay McDaniel, Linda Michaelsen, Nick Radov, Amit Shah, Mary Lynn Bushman, Durwin Day

     Conformance facilitator (for IG projects)

Lloyd McKenzie

     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) United Healthcare

2)BCBS Alabama

3. Project Definition

3.a. Project Scope


This PSS will use FHIR to exchange specific coverage/treatment decisions to another payer to allow for continued coverage of specific treatments without needing to repeat the review and authorization process that creates a burden for the provider, patient, and the payer.  The decisions may be based on commercial guidelines that can be uniquely referenced or based on specific payer rules (may be difficult to define in a structured, rules based, resource or be limited by the proprietary nature of the payer's evaluation process). In addition, the need exists to exchange the supporting documentation that was used to validate the necessity for coverage of specific treatments.

This PSS builds on existing or in process implementation guides for the automation of requests to a payer for coverage information (Coverage Requirements Discovery – CRD), access to payer information (Payer Data Exchange – PDex) and the Health Record Exchange Library/Framework (HRex).

This project will define patient driven/authorized exchange methods to meet the anticipated requirements for coverage portability.

This project will reference, where possible, the "standards" defined by the Health Record exchange (HRex) Library/Framework Implementation Guide which in turn will utilize prior work from Argonaut, US Core and QI Core effort for FHIR DSTU2, STU3, and R4 where appropriate. The following diagram depicts the anticipated scope of the HRex Exchange Library/Framework IG.


The ultimate goal is to support the portability of coverage by exchanging information between payers to define decision making and supporting documentation with regard to treatment for chronic illnesses without the need to burden the provider and/or patient or risk a discontinuity of care.

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 need a method of communicating the basis for specific coverage/treatment decisions (especially for chronic conditions) to another payer to allow for continued coverage of specific treatments without needing to repeat the review and authorization process that creates a burden for the provider, patient, and the payer. While this may not cover all situations, the ability to understand the basis for the decision (e.g. specific commercial clinical guidelines) and the relevant clinical information supporting the decision may allow the new payer to continue coverage for the existing services without additional burden to the provider or patient.

This PSS builds on existing or in process implementation guides for the automation of requests to a payer for coverage information (Coverage Requirements Discovery – CRD), access to payer information (Payer Data Exchange – PDex) and the Health Record Exchange Library/Framework (HRex).

Currently, no FHIR implementation guide exists to standardize the exchange of coverage decisions and supporting documentation. This implementation guide will provide a standard for adoption by payers for the definition, exchange, and evaluation of documentation supporting portability of coverage.


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


CMS NPRM


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’)

Standard For Trial Use (First Ballot Cycle)

2019 September Ballot

Complete STU Reconciliation

2020 January

Request STU Publication

2020 January WGM

Submit for STU 2 Ballot (Second Ballot Cycle)

2021 May Ballot

Complete STU 2 Reconciliation

2021 Aug

Request STU 2 Publication

2021 Sept WGM

STU 2 Period

2021 Sept -2023 May

Submit for Normative Ballot

2023 May Ballot

Complete Normative Reconciliation

2023 Sept WGM

Submit Publication Request

2023 Oct

Project End Date (all objectives have been met)

2023 Dec


3.f.   Common Names / Keywords / Aliases


Da Vinci, Coverage Decision Exchange, Coverage Decisions


3.g. Lineage


n/a

3.h. Project Dependencies


Health Record Exchange Framework

Payer Data Exchange


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
https://github.com/HL7/davinci-pcovex


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?

R4, STU3, DSTU2


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)



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?

0%

Was the content externally developed ? :

Y

Da Vinci

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

X
 

Clinical and Public Health Laboratories

 
 

Pharmaceutical

X
  

Clinical and Public Health Laboratories


  

Immunization Registries

X
  

EHR, PHR


  

Emergency Services

X
  

Quality Reporting Agencies


  

Equipment


 

Local and State Departments of Health

X
  

Regulatory Agency

 X 

Health Care IT

X 

Medical Imaging Service


  

Standards Development Organizations (SDOs)

X 

Clinical Decision Support Systems

 X 

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

X
  

Payors

X
  

Lab

 X
 

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

2019-03-12

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date


Attachments


2019-03-12


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

2019-03-20

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

2019-03-26

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

2019-03-26

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