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Welcome to the CodeX September newsletter! CodeX (Common Oncology Data Elements eXtensions) is a HL7 FHIR Accelerator, launched at the end of 2019, that is building a community to enable interoperable cancer data modeling and applications. Check out some of our exciting updates below.

Join Us in Welcoming our Newest CodeX Members

We are excited to announce the Centers for Disease Control and Prevention (CDC) has joined CodeX as a Founder/Premier member.

The American Cancer Society Cancer Action Network (ACS CAN) has also joined CodeX as a Founder/Premier member.

And niAnalytics, a software development company with expertise in radiation therapy, has joined as a Developer/Implementer member. 

Please email me, Steve Bratt (sbratt@mitre.org), if you’d to like to become a CodeX member and drive the future of smarter data for the fight against cancer. Founder membership opportunities extend through the end of 2020.

Integrated Trial Matching - Open Public Call

The Integrated Trial Matching use case team had an open call on September 16th where they discussed recent achievements in their effort to make clinical trial participation equitable and easy for all patients and providers. 

The open call provided background information on this project, a demonstration of the work done in Phase 0 (implementation of a proof-of-concept), and discussed details for future phases. Please follow this link if you would like to view the presentation slides and a video of the Phase 0 demonstration. 

Registry Reporting Use Case - Starting Soon

The Registry Reporting CodeX use case team is excited to announce that project work will begin in October 2020! Stay informed by visiting the Registry Reporting Confluence page for information related to the project kickoff and any other exciting news and updates. The project team is in communication with health systems interested in piloting the solution, and also exploring how synthetic data could enhance the use case.

Oncology Clinical Pathways: Prior Authorization

CodeX presented at the Da Vinci Burden Reduction weekly call on August 28th and discussed how to leverage oncology clinical pathways and mCODE data elements supporting prior authorization. The use case goal is to improve the current state of oncology prior authorization to reduce clinical burden when requesting oncology treatment regimens.

Also some exciting news in the health information exchange world: The Council for Affordable Quality Healthcare Committee on Operating Rules for Information Exchange (CAQH CORE) updated the Prior Authorization and Referrals (278) Infrastructure Rules. Notably, the rule requires that there be a 2-business-day response turnaround by payers for a provider's prior authorization request, once all documentation is provided.

mCODE Education Materials and Knowledge Base

Coming soon: the mCODE (minimum Common Oncology Data Elements) Confluence page will contain educational resources such as knowledge base articles and FAQs. Interested mCODE community members will be able to search for detailed information of the mCODE profiles, model best practices, and troubleshoot tips for common problems.

mCODE Community of Practice

The next Community of Practice meeting will be held on September 25th, 2020 from 12-1pm ET. To join this call, register here. This month we will have two presentations: Keri Reardon, Senior Director at Alliance for Clinical Trials in Oncology, will be giving updates to the ICAREdata project, and Rob Lieberthal, Principal Health Economist at MITRE, will be discussing the health economics of mCODE and CodeX. 

Upcoming Briefings - HL7 Birds of a Feather

CodeX will be presenting at the HL7 34th Annual Plenary and Working Group Meeting on Tuesday, September 22nd at 6pm ET. This five day virtual event provides valuable news, updates, and educational resources to the health IT community, as well as the opportunity for HL7 work groups to come together and work on standards. To register and pay for this working group meeting, visit the HL7 events page.  (presentation can be found here

mCODE/CodeX in the News

Stay in Touch!

If you would like to stay up-to-date with the latest mCODE and CodeX related news and updates, please go to the CodeX home page, click on “Join a CodeX Listserv” and add their names to the CoP and/or other email lists. 

Thank you,
The CodeX Community Support Team



The CodeX Oncology Clinical Pathways: Prior Authorization project team will be presenting at the Da Vinci Prior Authorization Support weekly conference call on Friday, August 28th at 3pm EDT. If you would like to join the call, please follow this link.

Led by Dr. Jim O’Connor and Carmela Couderc, the CodeX Prior Authorization team will discuss how to leverage oncology clinical pathways and mCODE data elements supporting prior authorization. The use case goal is to improve the current state of oncology prior authorization to reduce clinical burden when requesting oncology treatment regimens.

Dear CodeX Community


Since our last update on mCODE and CodeX, the world has changed dramatically.  I hope you and yours are safe. 


If you are on reading this, you also understand the impact that cancer has on those close to and far from you and yours. You understand the potential for a common language for cancer data to improve cancer care, research and policy, and to reduce burden and cost.


Here is an abbreviated summary of the substantial progress over the past 4 months:

mCODE Standard

  • The mCODE 1.0 FHIR Implementation Guide (IG) officially became an HL7 Standard for Trial Use on March 18th.  This is a big deal.  It signals to vendors and other implementers that mCODE is stable and ready for developers to kick the tires. We are already seeing vendors implementing this version of mCODE.


Building the CodeX Community

  • Many thanks to our Founding CodeX members, so far! A number of other organizations are in the process of joining. CodeX members drive development and execution of Use-Case-Based Projects and support sustainable program management for the vibrant community that CodeX aims to be.  Due to challenges that many are facing, and in response to requests, we’ve extended the deadline for organizations to be Founders until the end of 2020.  Our first member meeting/call is being planned for August or September.  Please email me, Steve Bratt (sbratt@mitre.org),  if you’d to like to become a CodeX member and drive the future of smarter data for the fight against cancer.


  • The CodeX / mCODE Community of Practice (CoP) has been an amazing forum. The CoP open the public as a place for sharing updates on CodeX use case projects, as well as sharing independent initiatives that organizations are conducting with mCODE as their lingua franca. To receive notices about future CoP calls, go to the CodeX home page, click on "Join a CodeX Listserv" (upper right side of home page), and add your name and organization to the CoP and other email lists.

Use Case Projects

  • The most advanced of our CodeX projects is “Integrated Trial Matching for Cancer Patients and Providers”.  Phase 0 – a Proof of Concept using only mCODE data elements – is nearly complete. The American Cancer Society’s Cancer Action Network, Cancer Insights, TrialScope, BreastCancerTrials.org, MITRE and others are collaborating to enable mCODE-based, interoperable, scalable, and accessible clinical trial matching services that give patients and their providers maximum visibility into reasonable trial matches. The next public meeting and demonstration is scheduled for September 16, 2020 at 1PM ET. Register here.


  • Use Cases in the Planning Phase include Registry Reporting, Radiation Therapy Treatment Data, and Clinical Pathways / Prior Authorization Support.   We are working with current and prospective members and partners to develop plans that include identified stakeholders, short phases, clear objectives and deliverables, and measures of success.  Expect announcements on some of these over the next 2 months.

  

Synthetic mCODE Data for Testing and Demos

  • Finally, we all know the importance of data to developing and demonstrating functional software and workflows to support use cases. Real patient data is best, but has limitations due to PHI/PII.  Perhaps the most advance synthetic patient health record generator is Synthea™ an open-source patient population simulation made available by The MITRE Corporation.  We’ve used Synthea to generate 2200 synthetic mCODE records for patients with a focus on breast cancer. Please have a look, and let us know what you think. We are working to generate additional records for synthetic patients with Diffuse Large B Cell Lymphoma (DLBCL), so that we will have a test data appropriate for hematologic cancers and CAR-T therapies. 


Looking forward to your questions and participation in our shared mission.


Best regards,


Steve

--

Steven R. Bratt, Ph.D.

Leader, CodeX HL7 FHIR Accelerator https://bit.ly/3b6DHlD

Thanks to presenters Dr. Lawrence Shulman, Dr. Peter Gabriel of UPenn, Melanie Combs-Dyer - Director of Innovation at Mettle Solutions and Tyler Haydell - Senior Product Manager at Flatiron Health. The slides and a recording of the meeting can be found here. Please join the July 31, 2020 CodeX mCODE Community of Practice meeting on July 31, 2020, noon, where we will discuss the CodeX Oncology Clinical Pathways: Prior Authorization use case. We hope to see you there!


MITRE and the  HL7® FHIR® Accelerator CodeX Community invite you to a unique MITRE Listening Session on oncology clinical pathways and prior authorization of cancer therapies on June 26, 2020 from 10:00-11:30 EDT. 

Oncology is a dynamic specialty with a rapid expansion of new therapies and tumor genomics.  Over the past five years the use of oncology clinical pathways became a standard approach to assist oncologists in treatment recommendations.  Oncology clinical pathways can facilitate prior authorization for cancer treatments through interaction with payers using evidence-based treatment recommendations.  

The session will include three 15-minute presentations, each from a different stakeholder: health system, payer, and pathway vendor.  The focus of the presentations will be on the experiences, challenges, and opportunities of each stakeholder.  There will be opportunity for discussion at the end of the session. 

Register in advance for this meeting: 

https://mitre.zoomgov.com/meeting/register/vJItdOCtqDMjHf9HtHV-I6ZnIjEyp_KpsVs    

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

AGENDA  

Oncology Clinical Pathways and Prior Authorization Listening Session  

June 26, 2020 

Time 10 – 11 am ET  

Note: additional discussion time reserved from 11:00 – 11:30 ET 

  • Introduction 
    • CodeX – Steve Bratt, PhD, FHIR CodeX Accelerator Lead, MITRE 
    • 5 minutes to set the stage for the listening session
  • Health system perspective
    • Larry Shulman, MD/Peter Gabriel, MD, MSE  
    • University of Pennsylvania Cancer Center 
    • 15-minute presentation
  • Payer perspective
    • Melanie Combs-Dyer  
    • Director of Innovation, Mettle Solutions LLC 
    • 15-minute presentation
  • Pathways vendor perspective 
    • Tyler Haydell  
    • Senior Product Manager  
    • Flatiron Health 
    • 15-minute presentation

Discussion / Q&A

  • 40 minutes

Since last October’s Cancer Data Summit, we’ve made substantial progress in our goal to enable interoperability across cancer patient data and systems. Using mCODE™ to collect, share, and extract data from EHRs means that every interaction between a clinician and cancer patient provides data that could be used to improve care for all future patients.

More and more people are learning how mCODE could help their organizations meet the needs of cancer patients. Stakeholders—including patients, vendors, providers, payers, research organizations, and government agencies—are starting to work together within the new CodeX™ HL7 FHIR Accelerator and elsewhere.

New CodeX Members and Use Cases

One way to bring oncology stakeholders together is through CodeX (Common Oncology Data Elements eXtensions), the new HL7 FHIR Accelerator focused on implementing and testing solutions. 

CodeX is building a community to accelerate interoperable data modeling and application development, leveraging mCODE. By convening project work groups, CodeX is developing and testing solutions around new use cases, including radiology, clinical pathways, registry reporting, and patient - clinical trial matching.

CodeX members get the benefits of HL7’s Accelerator Program, pioneered through efforts such as the Argonaut and Da Vinci projects. CodeX members can work and learn together, and leverage advanced tooling and processes that speed implementation, adoption and, ultimately, value to cancer patients and all stakeholders.

Founding CodeX Members (so far) include: The Alliance for Clinical trials in Oncology Foundation, EMD Digital, HL7, MITRE, and Pfizer. Many other organizations are in the process of joining.

Please visit here for more information on membership and use cases. 

New CodeX / mCODE Community of Practice

We created the CodeX / mCODE Community of Practice to expand the network of health systems, which have been and will be at the forefront of piloting mCODE in real-world settings. This group of cancer centers meets online monthly to share experiences and develop best practices for implementing mCODE into production EHRs and other systems.

Joining the Community of Practice is free and open to all interested parties. Participants in the first meeting in January included:  Brigham and Women’s Hospital, Dana Farber Cancer Institute, Duke University Health System, Intermountain Medical Center, Kaiser Permanente, Memorial Sloan Kettering Cancer Center, MITRE, Partners HealthCare, Trinity Health/Saint Joseph Health System, University of California San Francisco Medical Center, and the University of Texas Southwestern Medical Center.

If you're interested in joining the Community of Practice, please contact Blake Bergstrom, bbergstrom@mitre.org

New ICAREdata Study Pilots

The ICAREdata Study is piloting the application of mCODE to support the prospective collection of high-quality real-world data to enable clinical oncology research.  The ICAREdata Study collaborates with clinical trials to collect key outcome data not yet well represented in EHRs and partners with clinical sites to share this critical outcome data, as well as the rest of mCODE.  ICAREdata’s hypothesis is that dramatic improvements in clinical trial operational efficiency and reductions in clinical trial cost will be achieved by using the patient’s EHR as the source of study data.

In Phase 2 of our ICAREdata work, MITRE and the Alliance for Clinical Trials in Oncology are partnering with clinical trials to demonstrate the real-world data from the EHR based on mCODE can support equivalent clinical trial endpoints. The first trials include: 

  • A071701 – Genomically Guided Treatment Trial in Brain Metastases
  • A021703 – SOLARIS: Randomized Double-blind Phase III Trial of Vitamin D Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer

We are looking for other partners/clinical trials. Those that have already begun planning for the implementation of prioritized mCODE data elements within their EHRs to support the ICAREdata Study include:

  • Massachusetts General Hospital
  • Brigham and Women’s Hospital
  • Dana Farber Cancer Institute
  • The Mayo Clinic
  • The University of Pennsylvania Health System

mCODE Version 1.0 Approved

The mCODE underwent an HL7 ballot as a trial standard in September 2019. The ballot process involves collecting comments from the broad HL7 voter community and formally resolving each comment. All comments have now been addressed, and the mCODE team expects HL7 to officially publish mCODE Standard for Trial Use version 1.0 in March 2020. 

mCODE 1.0 contains 90 data elements across six domains: patient, disease, labs/vitals, treatment, genomics, and outcomes.  The 1.0 version—stable for adoption and approved for trial use—will be available in March from here and on GitHub for developers to test.


On behalf of the mCODE / CodeX Team ... Very best regards,


Steven R. Bratt, Ph.D.

Leader, CodeX HL7 FHIR Accelerator

Leader, MITRE Health Standards and Interoperability Group