The below depicts the anticipated prior authorization workflow to improve access to care for cancer patients with a focus to leverage the implementation guides developed by the HL7 Da Vinci Accelerator as well as CodeX mCODE. CodeX Use Case members continue to endeavor to partner in operationalize this effort via the current Proof-of-Concept.

Public Use Case Calls have been pended while use case Members continue to work diligently towards Piloting.

We do anticipate having a 2023 Year in Review Public Call in December 2023 - date TBD. Stay tuned.

Please reach out to Use Case Coordinator, Kim Boyd (kim.boyd@pocp.com) to obtain updates.

Project Overview

Problem:

Payers vary widely on how prior authorization for cancer therapy is accomplished. Some use a web portal for oncologists to enter data into an electronic form. Others use oncology clinical pathways to develop a proposed treatment option. Despite the method, many prior authorization processes among payers rely on manual inspection, with no automation or standard interface to health systems.
Prior authorization imposes a burden on patients, providers and payers
Current manual processes require duplicate data entry, are costly and may delay treatment

Description:

There is national interest, both in industry and the federal government, for standardization of the prior authorization process. The goal is reduction of costs by automation and standardization of health system-to-payer prior authorization interaction. This has the potential to greatly reduce oncologist burden, which is a known factor in physician burnout.

Target Outcome:

Provide a standard method to supplement the Da Vinci Coverage Requirements Discovery (CRD), Document Template Rules (DTR) and Prior Authorization Support (PAS) FHIR-based information exchange framework with cancer specific data as defined by mCODE, to enable prior authorization auto-approvals.
Base the solution on approaches referenced in CMS Proposed rules
- December 2022 Proposed rule CMS Advancing Interoperability and PA Rule
- December 2020 Proposed rule CMS interoperability rules.
Reduce clinician, health system, patient and payer burden

Value:

Patients receive timely care without delay because prior authorization turnaround time is reduced
Provider burden reduced with automated approvals, and real-time access to payer approval requirements and documentation rules
Payer burden is reduced by automating manual processes using a standardized information exchange

Equity:

The CodeX Prior Authorization in Oncology are committed to supporting an equitable health care system and have committed to the Federal Moonshot initiative.

We believe that improving and automating the prior authorization process for patients, providers and payers can result in timely delivery of appropriate and high-quality care. With timely delivery of care, we can assist in curing and/or prolonging the life of a patient and optimizing the patient’s quality of life.

Commitment #1: Define, model and scaling an automated prior authorization process for cancer patients via the use of FHIR-based healthcare data standards to extract and exchange the necessary information to expedite the prior authorization process for cancer patients and reduce burden for providers and payers. These data standards include the clinical specialty data standards (mCODE representing oncology data, and RTTD representing radiation therapy data) as well the Da Vinci FHIR standards addressing value-based care transactions including those needed for prior authorization. Clinical specialty data standards such as mCODE are essential to ensuring accurate clinical representation for the decision support needed to ensure correlation of the right treatments to the right cancer patients.

Commitment #2: In alignment with industry technical and data standards, modify or create as necessary, open-source technical specification(s) documenting the workflow and criteria necessary to expedite the prior authorization in oncology process.

Commitment #3: Implement the Prior Authorization in Oncology FHIR driven real-time process with point-of-care decision support for stakeholders to assist in expediting care for cancer patients.

Commitment #4: Capture metrics through this use case in hopes of providing additional insights and learnings that can potentially be applied to informing new best practice in prior authorization in oncology as well as reduction of burden for patients, providers, and payers.

Project Plan

Phase	Milestone	Timeline
Discovery	Use case identification - Breast and Prostate cancer	COMPLETE
Proof of Concept	Breast Cancer treatment regimen proof of concept complete - demoed at DaVinci Burden Reduction examples call, and at the April 2021 DaVinci Education and FHIR Implementation Event. Proof of concept for breast cancer and colorectal cancer prior authorization Demonstration of the Da Vinci CRD/DTR/PAS IGs working in a medical oncology flow Test and demonstrate use of adaptive forms in questionnaires to show variations and flexibility of trigger (encounter, order) Document scenarios and open-source code for the questionnaires and CQL	COMPLETE
Planning	Plan out high level project plan for synthetic environment Proof-of-Concept, deliverables, success measures, high level timeline, key stakeholders, etc. The focus by use case members is on Prostate cancer PA. See Project Plan found here - PA in Oncology - Documents	COMPLETE
Execution	Use Case Moved to Execution Phase in November 2022	IN PROGRESS
Phase 1	Radiation Oncology Prior Auth Proof-of-Concept for Prostate Cancer (MVP) with Synthetic Data Phase 1 include multiple POC Phases to test end-to-end connectivity, use of SMART on FHIR app, POC is in a test environment with synthetic patient and clinical data with defined test scenarios. This will be replicated in multiple phases. Then will go to Live Pilot with live patient and clinical data. Design – Validate workflows, define process and requirements, includes demographic and patient clinical data elements Build & test the exchange of prior authorization between provider and payer systems using EHR test patients Evaluate lessons learned and rescope iteratively Implementation into production environment Use of mCODE data elements in PA transactions Demonstrate PA transactions in the FHIR-based Da Vinci CRD/DTR/PAS information exchange	Progressing towards Oct 2023 POC 3.0 DELAYED to December 2023 - see 10.11.23 Member call discussions and key takeaways June 2023 POC 2.0 Successful COMPLETE
Phase 2	Prior Authorization Pilot Scale Advance and apply lessons learned from Phase 1 (MVP) Add additional cancer types Expansion consideration into medical oncology and progress into modality sequencing Potentially health equity Add additional participating organizations (Payer, Provider, Oncology EHR)	As of January 2023 - Target 1st Live Pilot in Q3/Q4 2024

Quick Links:

Prior Authorization One-Pager

FHIR-Based Prior Authorization for Oncology Fact Sheet.pdf

PA Proof of Concept Timeline

Execution Phase Quick Links

Member Meetings - Key Takeaways and Decisions

Planning Phase Quick Links

HL7 FHIR IG mCODE

Radiation Oncology Prior Authorization Demographic and Clinical Data Elements Breast and Prostate as of Nov 2022

PA In Oncology Workflow Diagram as of 8.2.22 CRD DTR PAS Denoted

Discovery Phase Quick Links

Prior Authorization in Oncology–high level project plan

Summary and Next Steps from June 3, 2021, Discovery Session on Oncology Provider-Payer Data Exchange

Increasing Burden of Prior Authorization in Oncology (ASCO)

Da Vinci Burden Reduction

CMS Proposed Rule - DRLS and PAS

AMA 2019 Prior Authorization Physician Survey

Data Element / Profile / Value Set Analysis

Member Call Discussions and Key Takeaways

Date	Key Findings and Takeaways	Members Present
Execution Phase
11.29.23	PA team met with RTTD use case members to discuss partnership and workflow process to capture DVH standardized information (will be a 2024 project) Coordination on upcoming public call presenters and content	Evernorth/eviCore Brian Poteet, Edifecs Oncora Medical Univ of Michigan Elekta Varian MITRE Mettle Solutions Dogwood Health - PMO
11.22.23	Discussed using 270/271 to solve for payer ID challenges Encourage CodeX UC members to attend Da Vinci work next quarter where they will focus on ID challenges using the 270/271 Created 5 test patients in the EHR test system Provider NPI and Practitioner NPI now available to the Smart App. Awaiting testing with tech and payer partner	eviCore/Evernorth McKesson, US Oncology Mettle Solutions
11.07.23	PA to present at December Community of Practice meeting POC 3.0 (Dec 2023) - Update on new data elements in Varian system. Patient member identifier works and queries easily Once testing is done, create a new list of patients and where we want to enter the information in EHR Inconsistencies in how health systems, practices enter member is a challenge Demo for ONC - January 24^th	eviCore/Evernorth McKesson, US Oncology Mettle Solutions Varian
11.01.23	November 15th meeting (member cancelled) Worked on outline for upcoming Dec 13th public call - Year in Review Co-Founder David Lindsay with Oncora Medical provided demonstration of	eviCore/ Evernorth Edifecs Oncora Medical Mckesson/USONC Varian MCG Mettle Solutions Dogwood Health, PMO POCP, Coordinators
10.25.23	Moving towards next steps to POC 3.0; testing new data available in EHR server	eviCore/Evernorth Mettle Solutions Varian USONC
10.18.23	Discussed draft of EOY Public Call - tentatively scheduled for Dec 15th. Invitation to be sent out shortly.	eviCore/Evernorth Edifecs Pfizer Oncora Medical Varian
10.11.23	POC 3.0 to be delayed to December 2023 (tentatively). Inclusion and testing of more information in the FHIR server is cause for delay	eviCore/Evernorth Mettle Solutions Varian McKesson
10.4.23	Tentative date set for Year in Review Public call - 12.13.23 at 2pm ET	evicore/Evernorth MITRE McKesson
9.27.23	POC 3.0 progressing, but timeline moved due to need for testing of systems and additional data elements. Expect POC 3.0 in mid November vs. October	evicore/Evernorth McKesson/USONC Varian
9.20.23	POC 3.0 will progress, great that new data will be available. needs to be tested once in the system Sites confirmed for testing Preparing for demonstration with CMS/ONC Anticipating holding a Public Call in December 2023 - Year in Review	eviCore/Evernorth Edifecs McKesson USONC
9.13.23	EHR will be able to pull in more information but may result in moving POC 3.0 Clinical sites are ready to test	eviCore/Evernorth Varian
9.6.23	Discussed upcoming USCDI v5 submission, determined the data points needed for this use case are already represented in USCDI Updates to all three Da Vinci IGs that support this use case Payer ID challenges	eviCore/Evernorth McKesson USONC Oncora Medical POCP
8.23.23	Discussed informing next version (v5) of USCDI	Evernorth McKesson USONC AMA ASTRO Mettle Solutions Varian
8.9.23	Will produce a whitepaper on findings after the 1.0 Pilot Prepare in late November to do a technical demonstration for ONC/CMS	eviCore/Evernorth, McKesson AMA USC Oncora Medical Varian Telligen Mettle Solutions
7.26.23	Detailed for ONC current learnings from implementing the IG process (CRD, DTR, PAS) in synthetic environment	Guests from ONC, Evernorth/evicore, Pfizer, Edifecs, McKesson USONC, AMA, USC, Mitre, ASTRO, Telligen, Varian
7.12.23	Worked on content for 7.26 listening session with ONC Clarified expected outcome of PA automation in oncology using Da Vinci IGs (CRD, DTR, PAS)	eviCore, McKesson USONC, AMA, Varian, Mettle Solutions
6.28.23	POC 2.0 successfully completed! Successful integration between EHR, FHIR server and the smart app are functional. able to query the FHIR server get some basic data.	Evernorth, Varian, ASTRO, Oncora Medical, USONC
6.14.23	Presenting on UC at June CoP SMART on FHIR app integration is progressing Anticipate successful 6.30.23 POC and goal of end-to-end connectivity	Evernorth, McKesson, Edifecs, Pfizer, USC, AMA
5.31.23	Finalized Early Findings and Observations Summary Discussed content for upcoming listening session with CMS/ONC Discussed next CoP scheduled for June 30th	ASTRO, Edifecs, Evernorth, MCG, McKesson, Oncora Medical, USONC, Varian
5.3.23	Continued drafting and review of POC Early Findings Summary	eviCore, Pfizer, McKesson, Oncora Medical, Varian
4.19.23	Members are preparing for June CodeX Community of Practice Drafting POC Early Findings Summary to be shared internal and externally Preparing to Schedule listening sessions with CMS/ONC	ASTRO, Evernorth, Pfizer, Varian, McKesson
4.5.23	Good progress on app development and connections Will be attending connectathon New rule will neither expedite or delay progression. All teams are working toward the pilot Post POC and Post Pilot Summaries are being discussed	Evernorth, eviCore, McKesson, Ontada, Telligen, Edifecs
3.22.23	CMS Interop/PA NPRM discussions. Set up listening session with CMS to discuss oncology nuances RTTD Use case leads joined the call, discussing their progression and potential needs to support PA How to integrate treatment plan to the CRD workflow because now its CPT code based	Pfizer, ASTRO, McKesson, EnableCare, Ontada, Evernorth, USONC, Oncora Medical, POCP, Varian, MITRE and Telligen
3.8.23	Technical updates - EHR moving to close gaps on data within their FHIR server to support POC and pilot Initial discussions on medication oncology Getting other payer involved	Evernorth, Ontada, McKesson, Varian, ASTRO, USC, Oncora Medical
2.22.23	Initiated discussions on content of learnings from POC and pilot - Whitepaper? Need to get others involved - EHRs, payers, etc. to scale and move to other areas of cancer care Update on technical next steps and potential hurdles	MCG, Telligen, Evernorth, McKesson, ASTRO, POCP, Edifecs
2.15.23	Smart on FHIR App tested and working well for CRD process Questionnaires being build for DTR process Continued discussions to understand the potential volume for Pilot 1.0 and the how long to test	eviCore/Evernorth, McKesson, Mettle Solutions
2.8.23	Post pilot whitepaper to inform others	McKesson, Varian, Evernorth/eviCore
2.1.23	Discussions on volume of patients EHR Validation process Legal requirements for App access to user server	McKesson, Varian, Evernorth/eviCore
1.25.23	Members continued review and modifications of the UC Phases to accomplish POC and Pilot	McKesson, Telligen, evicore/Evernorth, Varian, USONC, and Pfizer
1.18.23	Technical team members modified wording on phases based on technical processes Discussions continued around what documentation would be needed to support internal approval to Execute on a Live Pilot	Telligen, McKesson, Varian and Evernorth/eviCore
1.11.23	Members confirmed the phases and timing of phases for the POC MVP to Pilot Confirmed the goals of each phase Agreed to have FAH join the next member meeting to discuss PA quality measures	Telligen, Pfizer, ASTRO, McKesson, USONC, eviCore, Edifecs, and Varian
1.5.23	Reconfirmed that POC MVP will be multi-phased approach Will begin in Q2 2023	Varian, eviCore, McKesson USONC, Telligen
12.21.22	First draft Connectivity Sequencing Documentation (i.e., SMART on FHIR app Launch) reviewed and approved	Varian, eviCore
12.7.2022	CMS Interoperability and PA rule being released. Members preparing to respond by March 2023 deadline Draft of technical sequencing documentation progressing	MCG, MITRE, eviCore, McKesson, Telligen
11.30.2022	Payer, EHR systems successfully connected Development of SMART on FHIR app in progress Reaffirmed breast cancer is the next synthetic pilot followed by an operational pilot. Will stay focused on radiation An important consideration before progressing to different treatment methodologies is to expand the pilot pool to include multi-EHR environments Members would like to invite the Office of Burden Reduction and Health Informatics to a December call to update them on POC progression	eviCore, Edifecs, MCG, McKesson and MITRE

Conference Call Schedule & Dial-Ins

CodeX: Oncology Prior Auth Use Case Public Calls

The Last Tuesday, every other month - 3:00 - 4:00 EST

July 25, 2023
September 26, 2023

Meeting Details:

Register in advance for this meeting:

https://hl7-org.zoom.us/meeting/register/tJwpf--hpz0rH9U8X8uOO4O8WosEnCX--RoS

After registering, you will receive a confirmation email containing information about joining the meeting.

Reach out to Kim Boyd (kim.boyd@pocp.com) to be added to the invitation and received updates and modifications to call schedules.

Use Case Team

Role	Name	Organization	Email
Use Case Coordinator	Kim Boyd	Point-of-Care Partners	kim.boyd@pocp.com
Clinical Coordinator	Dr. Liz Canzone	The MITRE Corporation	ecanzone@mitre.org
Deputy Program Manager	Michele Galioto, RN	Point-of-Care Partners	michele.galioto@pocp.com
Terminology Coordinator	TBD
Technical Lead	Rob Dingwell	The MITRE Corporation	bobd@mitre.org

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