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Template Usage Information:

  1. Project Name and ID



Enter the name of the project here: FHIR Risk Adjustment

Project ID: 1705

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)

Clinical Quality Information

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

Co-sponsor Work Group(s):

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

None

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

 Request formal content review prior to ballot

 Request periodic project updates. Specify period

 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)Yan Heras, Linda Michaelsen, Viet Nguyen

Other interested parties and their roles

Financial Management WG (approval date: 03-09-2021) 

Payer/Provider Information Exchange (approval date: 3-30-2021)

Patient Care (approval date: 4-12-2021)

Multi-disciplinary project team (recommended)


     Modeling facilitator

Yan Heras, Linda Michaelsen

     Publishing facilitator

Yan Heras

     Vocabulary facilitator

Yan Heras, Rob McClure

     Domain expert rep

John Graham, Amy Neftzger, Brian Murtha, Brent Zenobia, Robert Dieterle

     Business requirement analyst

John Graham, Amy Neftzger, Brian Murtha, Ben Hamlin, Linda Michaelsen, Brent Zenobia

     Conformance facilitator (for IG projects)

Yan Heras

     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) Providence

2) BCBS Alabama

3) United Healthcare
4) Epic
5) Cigna

3. Project Definition

3.a. Project Scope


The risk adjustment use case acknowledges the importance of risk-adjusted premium calculations to government managed care and seeks to

  • better inform clinicians of opportunities to address risk adjusted conditions,
  • better enable payers to communicate risk adjustment information, and
  • enhance government sponsors’ ability to allocate funding accurately.

To accomplish this:

  • Payers need a standard protocol to share and receive clinical data related to risk adjustment with responsible providers.
  • Providers need a standard protocol to share and receive clinical data related to risk adjustment with responsible payers.
  • Payers and providers need a standard methodology to communicate risk based coding, documentation and submission status of chronic illnesses.

The resulting bi-directional, real-time, FHIR-based communication will connect payer intelligence with EHR data at the point of care, facilitating providers documentation of relevant chronic illnesses. This model ensures accurate and complete patient assessment to support Value-Based Care programs.

This project may utilize specific triggers and exchange methods (CDS Hooks, Pull, etc.), use of other interoperability "standards" (e.g. SMART on FHIR, CQL) and specific use of FHIR resources to effectively verify and facilitate documentation supporting chronic illness needed for risk adjustment, medical necessity and care coordination.

This project will define a standard methodology for payers to communicate risk based coding gaps to providers. This project will also define a approach to trigger the evaluation and/or collection of documentation for specific chronic conditions that are sufficient in scope to satisfy both clinical and administrative needs. The project team will select an initial set of chronic conditions (e.g. CHF, COPD, Diabetes) to use as demonstrations/examples of the underlying framework.

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 R4 where appropriate.  If this FHIR implementation guide is 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 where applicable.

The ultimate goal is to support the accurate documentation of chronic illnesses to support communication of risk based coding gaps and to facilitate risk adjustment and care management.

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


Providers need to accurately document chronic illness in their patient for clinical care, care coordination, risk adjustment, and to show medical necessity. Payers need this information for accurate risk adjustment, to document medical necessity for covered procedures and devices, and to facilitate care coordination and potential portability of coverage decisions.

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), definition of documentation and payer rules (Documentation Templates and Payer Rules) access to provider information (Clinical Data Exchange – CDex), the Health Record Exchange Library/Framework (HRex), and reporting gaps in care in the Data Exchange for Quality Measures (DEQM).

Currently, no FHIR implementation guide exists to standardize the format of communicating risk based coding gap between payers and the method of chronic illness documentation evaluation and management. This implementation guide will provide a standard for adoption by both providers and payers to communicate risk based coding gaps and for the evaluation and documentation of chronic illness.


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, Risk adjustment requirements for payers


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)

2022 Jan Ballot

Complete STU Reconciliation

2022 May

Request STU Publication

2022 May WGM

Submit for STU 2 Ballot (Second Ballot Cycle)

2022 Sep Ballot

Complete STU 2 Reconciliation

2023 Jan

Request STU 2 Publication

2023 Jan WGM

STU 2 Period

2023 Jan -2024 Jan

Additional STU cycles as neededas needed

Submit for Normative Ballot

2024 Jan Ballot

Complete Normative Reconciliation

2024 May WGM

Submit Publication Request

2024 Sep WGM

Receive ANSI Approval2025 Jan 

Project End Date (all objectives have been met)

2025 Jan 


3.f.   Common Names / Keywords / Aliases


Da Vinci, Risk Adjustment, Risk Based Coding Gaps


3.g. Lineage


n/a

3.h. Project Dependencies


FHIR R4, US-Core


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-ra


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, R5


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?


Was the content externally developed ? :

N


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

 X
 

Pharmaceutical

X
  

Clinical and Public Health Laboratories

X
  

Immunization Registries

X
  

EHR, PHR

X
  

Emergency Services

X
  

Quality Reporting Agencies

X
  

Equipment

 X
 

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

CQI approved to be the primary sponsoring WG and approved the PSS on 2021-03-12 

(PSS was initially sponsored by the FM WG and was approved 2019-03-12. 

The FM WG approved to relinquish primary sponsorship on 2021-03-09)

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date





N/A

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

2021-04-21

(original PSS 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

2021-04-27

(original PSS 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

2021-05-14

(original PSS approval date: 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

2021-06-07