Warning:
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Template Usage Information:
- Submit template change requests to PMO@HL7.org
- For Reaffirmations, please refer to the FAQ in Hl7 Project Scope Statement Instructions for a list of which sections and fields should be completed
Project Name and ID
Enter the name of the project here: Payer Data Exchange (PDex) | ||||||||||
| Project ID: | 1489 | |||||||||
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 | Date: | ||||||||
| - 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 | 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 ballot | WGMs |
| X | Request periodic project updates. Specify period | WGMs |
| Other Involvement. Specify details here: | ||
Co-sponsor Work Group(s): (Enter co-sponsor approval dates in Section 6.d Project Approval Dates) | Pharmacy | |
| Indicate the level of involvement that the co-sponsor will have for this project: | ||
| X | Request formal content review prior to ballot | WGMs |
| X | Request periodic project updates. Specify period | Pharmacy Conference Calls |
| 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) | Mark Scrimshire, Tony Benson |
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 | |
Vocabulary facilitator | Viet Nguyen |
Domain expert rep | Mark Scrimshire, Tony Benson |
Business requirement analyst | Robert Dieterle, Mary Kay McDaniel, Linda Michaelsen |
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) Humana | |
2) Cerner | |
3. Project Definition
3.a. Project Scope
This project will define exchange methods (e.g. push, pull, triggers, subscription, bulk), use of other interoperability "standards" (e.g. CDS Hooks and SMART on FHIR) and specific use of FHIR resources to effectively exchange payer information regarding current, previous, or potential future care, including the provenance of the data, of one or more specific patients/members with authorized individuals and organizations including providers responsible for evaluating/specifying/ordering/delivering care for the patient. The scope includes exchange of member specific or general program related data such as network information (e.g. provider directory) and drug benefits (formulary). The following diagram depicts one scope and flow of relevant information (it is illustrative and not fully prescriptive).
Initial use cases are focused on a patient seeing a provider (e.g. PCP) for the first time (relevant payer history) , a repeat visit for the same patient with the same provider (what happened since the last visit that occurred outside of my institution / HIE / ...), and a visit of a patient with specialist (+care team information). Additional use cases include enabling individuals to search for options regarding current or potential future care including searching for providers or covered drugs that are part of a payer’s plan. Each of these use cases focuses on a subset of the total payer record for the patient or interested party that may be appropriate for the specific setting. Specific guidance will be given for query capability and subsequent filtering of results. The project is focused on identifying patterns of exchange (interaction and content) that are appropriate for establishing implementation guidance to ensure standardization in the request and response across providers, payers, and individuals. The goal of the resulting implementation guides is to make payer information available to their members, providers, and other authorized payers and non-members. This project references, where possible the "standards" defined by the Health Record exchange (HRex) Framework Implementation Guide which in turn uses work from US Core and FHIR R4. The following diagram depicts the anticipated scope of the HRex Framework IG. The implementation guides under this project will use the US Core profiles (either through HRex or directly). If any FHIR implementation guides are unable to use a US Core profile, we will follow the Cross Group Projects WG's variance request process, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide(s) where applicable.
The project utilizes 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. Update to the Scope (in response to requirements in the May 1, 2020 CMS Final Rule for data interoperability and findings through continued development of the Implementation Guides) 1) Expand the scope of exchanges to include exchanging the same payer data a) payer to member and, at the direction of the member, b) payer to payer and/or c) payer to third party. Note: these are patient directed exchanges where consent is implicit. 2) Include the ability to make basic payer directory information (e.g. provider network) available to the member 3) Include the ability to make Formulary information available to members and non-members. |
3.b. Project Need
Updated to include exchanges with members, other payers and third parties Providers, members, interested individuals, and other payers need access to payer information including current and prior healthcare services received by the patient/member and plan information to more effectively manage the patients care and make informed healthcare decisions. Currently, no other FHIR implementation guides exists to standardize the method of exchange (push, pull, triggers, subscription, etc.) or the formal representation (e.g. Bundles, Profiles and Vocabulary) for specific elements of payer information of interest to providers, members, interested individuals, and other payers. This implementation guide will provide a standard for adoption by payers, providers, and third party applications for the exchange of payer information. This project will address many of the payer exchange requirements covered in May 1, 2020 CMS Final Rule on Interoperability. |
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
On March 4 2019, CMS issued a Notice of Proposed Rule Making (NPRM) requiring that that covered payers (Medicare Advantage, Medicaid, CHIP and FFE Qualified Health Plans) make specific data available to their members. In addition, payers must make clinical data available to another health plan and/or third party application at the members request. In addition to the clinical data, the payer must also make the provider network directory information available to the member via the API. On May 1, 2020, CMS and ONC issued their final rules and selected FHIR R4 as the release for certification. This PSS has been updated to reflect the final rule requirements for FHIR R4 |
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
Payer Data exchange, PDex, Da Vinci |
3.g. Lineage
n/a |
3.h. Project Dependencies
HealthRecord Exchange Framework |
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. Below is the list of the original PSS and subequent updates to the PSS: PSS for Payer Data Exchange (PDex) (Update 3)
PSS for Payer Data Exchange (PDex) |
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 | |
X | 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? FHIR R4 and future releases of FHIR |
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: | FHIR |
| - Date it was published (or request for publication, or ANSI designation date) | |
| - Rationale for revision | Creating a new resource filling a gap in data requirements |
| - 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.) | Expected for FHIR R5 (New version of FHIR) |
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 | 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 |
| Clinical and Public Health Laboratories | |
X | Immunization Registries |
| 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 |
| Other (specify in text box below) | |
X | Other (specify in text box below) |
| HIS |
| N/A | |
| N/A |
| Other (specify below) |
| ||
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| N/A |
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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 | 2022-02-15 (Update 3) | ||||||||||||||
Administrative review – in parallel with Work Group Approval | ||||||||||||||||
Co-Sponsor Group Approval Date | Attachments Pharmacy | 2022-03-01 (Update 3) 2022-03-07 (Update 3) | ||||||||||||||
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 | 2018-12-19 2019-04-16 (updated) 2022-03-23 (Update 3) | ||||||||||||||
V2/Publishing Projects: V2 Management Group | V2 MG Approval Date | N/A | ||||||||||||||
US Realm Projects: US Realm Steering Committee Approval | USRSC Approval Date | 2019-01-29 2019-05-06 Update 2022-04-05 (Update 3) | ||||||||||||||
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 | 2019-01-12 2019-05-08 (updated) | ||||||||||||||
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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), |
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Technical Steering Committee Approval Date: | TSC Approval Date | 2019-05-08 | ||||||||||||||