Welcome to the CodeX May 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.
Reminder: Hear from Epic and the CodeX Prior Authorization in Oncology team during the June Community of Practice call this Friday. Register for the June 25, 12-1 ET call.
Recent CodeX Use Case Achievements
Use cases involving the mCODE standard continue to make strides in real-world initiatives, deployments of mCODE are happening more widely, moving beyond synthetic data to real patient data. CodeX teams are demonstrating how the mCODE standard could be employed to collect oncology data once and enabling it to be shared for multiple purposes, such as in gaining prior authorization, adjudicating claims, disseminating information to multiple registries and helping patients and providers find clinical trials.
Recent updates across the eight CodeX active use cases are below:
ICAREdata or EHR Endpoints for Clinical Trials has nine health systems implementing tools to capture and/or extract mCODE data in their electronic health record systems, with collection underway at three institutions. Five clinical trials partnered with this use case to have ICAREdata methods embedded in their protocols and more trials are under joining through a companion protocol.
- The University of Chicago (UChicago) and MITRE teams completed validation of queries to generate comma-separated values (CSV) files to support mCODE extraction. In collaboration with Epic, these queries will be made available to other Epic sites in the community to accelerate implementation.
- The form to capture mCODE Cancer Disease Status is available as Epic-released development to all Epic customers as of the November 2020 release.
- Data modeling work continues for a new ICAREdata pilot for mCODE-enabled adverse event reporting.
The Trial Matching use case is collecting real patient data from patients who have consented and been onboarded to understand whether initial data elements being shared via the standard are sufficient to narrow down the trials for which the patients may qualify. Trial match results are being returned in a FHIR bundle. The team is also collecting app end user feedback from patient and providers to inform Phase 2 work and scaling conversations.
The use case for cancer Registry Reporting continues to work with the Centers for Disease Control and Prevention (CDC) and Center for International Blood and Marrow Transplant Research (CIBMTR) and additional organizations to identify data elements required for reporting information to cancer registries including mCODE. Team members are planning a pilot for a proof of concept with the University of California San Francisco and the California Cancer Registry - additional California based systems are welcome to join this pilot. The team is also coordinating with the Michigan Cancer Surveillance Program (MCSP) for support of a pilot activity involving Michigan based health systems, again interested systems are welcome to join. All pilots plan to leverage the CDC’s eCR/MedMorph Reference Architecture, with a cancer reporting module specifically developed for this use case. Reach out to Greg Shemancik (firstname.lastname@example.org) for more information.
The Radiation Therapy use case team moved to the Execution stage after the CodeX Steering Committee meeting vote on June 2nd. With much of the planning completed, the use case team is expected to participate in the Integrating the Healthcare Enterprise – Radiation Oncology (IHE-RO) Connectathon in early November. During this Connectathon, radiation oncology systems will generate end of treatment summary reports that will be retrieved by other information systems. This radiation therapy end of treatment summary data has been defined by the CodeX Radiation Therapy terminology team and will be used and tested by the CodeX vendor systems participating at the IHE-RO Connectathon. Currently, substantial testing and technical documentation work is underway to prepare for these Connectathon goals and deliverables. Additionally, the terminology team is meeting to define and model radiation therapy prescription data elements, which will be leveraged to achieve transmission of an in-progress treatment summary – the project team’s anticipated next phase of work. Reach out to Anthony DiDonato (email@example.com) if you’re interested in joining this project.
The Prior Authorization in Oncology team hosted a multi-stakeholder discovery session with 70 participants on June 3. Review the session summary and next steps from this lively 90-minute session. The team is planning a second public discovery session to identify a strong starting place to advance provider-payer data exchange within the oncology ecosystem. Look for registration information to join CodeX Members United Healthcare/Optum, MITRE, Mettle Solutions, and Pfizer for a follow-on session. All interested community members are welcome. Reach out to firstname.lastname@example.org with any questions or for more information about joining this effort.
mCODE/CodeX Community of Practice Recap - mCODE Role in Exchanging Genomic Data Has Potential
A large audience on the May 28th mCODE/CodeX Community of Practice call (presentation slides and recording) heard Dr. Jim Chen, Associate Professor, Medical Director, Clinical/Research Informatics James CCC from The Ohio State University present “Small Data – for Big Data: mCODE and Genomics.”
The use of mCODE in exchanging genomic data for a variety of purposes could support better patient care and research, contends Jim Chen, MD, medical director of clinical and research informatics at the James Comprehensive Cancer Center of The Ohio State University.
During the presentation, Chen called on attendees to work toward a use case that could enable an mCODE approach to improving the capture and sharing of genomic information.
There’s a growing understanding that no two patients, diseases or responses to treatment are alike, and the growing use of genomic research can help optimize treatment by taking patient variations into account, Chen said. This is particularly true in oncology care, where biomarkers are helping to identify cancer variations and the best approaches to treatment.
Clinical pathways are becoming increasingly complex as oncologists and researchers look to improve cancer treatment. “Therapies and biomarkers are multiplying, and there are also emerging biomarkers being discovered,” he added. Multiplied across all cancer types, that can result in increased opportunities to personalize care – but more challenges for clinicians, who need better ways to exchange information.
However, no standards exist for exchanging data on the increasing number of biomarkers, and the importance of that grows as genomic testing gains complexity. Where in the past genomic testing would look at a single gene marker, today it’s more likely to involve comprehensive genomic panels. Various companies are promoting these panels, and they generally used proprietary formats. “There are no standards for transmitting molecular data,” Chen asserted.
That’s where work by CodeX could make a difference, he said. Finding a standardized way to share biomarker information could result in huge benefits in care for cancer patients. “If we don’t get the biomarker right, your patient is not going to get treated (correctly),” he said. “If you don’t have the key fact right,” it can change medical care. For example, there are no ways to represent fusion genes.
“There are even more biomarkers on the horizon. People are talking about this idea of immune-phenotyping, for example what is the expected amount of white blood cells and is that prognostic,” he said. “That’s the challenge you have a limited amount of space to think about a continually growing list of biomarkers.”
The key is to capture all this growing amount of information for patient care, “so we really need to think long and hard about this,” Chen said. “There are many sorts of other types of genomic alterations that are actionable. All companies are coming up with their new genomic signatures. But how do you embed that in mCODE. These are the types of things we’re really challenged by.”
The question becomes how this information is effectively transmitted in mCODE, which cannot handle many actionable biomarkers in its current form. So what can we do to change things?” One idea is to create a biomarker template for mCODE, which can contain what the biomarker is, what the biomarker value is and what the biomarker interpretation is. A use case could help with the ability to use FHIR to share patient information across organizations to see if there are applicable treatments. “If I wanted to send a list through mCODE, how would I do that? How would I send a whole host (of patients) at one time?”
“I believe mCODE will shine in the future. Obviously, collaboration will be key. Everybody has a stake in making sure the data is transmitted accurately and consistently,” Chen concluded. “What do we need to know, what is the minimal amount needed to do the work, and that should determine the structure of the data. And how do we transmit this among institutions.”
The mCODE standard is currently available for use as a first version of a standard for trial use, referred to as STU1. A second version of the standard (STU2) has been balloted by the standards community, and about 65 comments on the revised version have come in, based on CodeX experience and other stakeholder input, for mCODE STU2 closed May 17th. Follow progress on mCODE by reviewing the continuous integration (CI) build. Also, review differences between STU1 and STU2 via this change log.
Look for the 2.0 release in September.
Join the June CodeX/mCODE Community of Practice call this Friday with Ryan Bernard, who will provide an update on Epic's implementation of mCODE and plans to iteratively develop an Implementation Guide describing how to collect and access mCODE data elements. Additionally, Melanie Combs-Dyer and Sreekanth Puram from Mettle Solutions will be sharing a summary of the CodeX multi-stakeholder discovery session on oncology provider-payer data exchange. The Prior Authorization team will also be demonstrating a breast cancer chemotherapy regimen prior authorization workflow. Register for the June 25, 12-1 ET call. Participation is open to all.
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 our CodeX Confluence home page and click "Join a CodeX Listserv." Please contact Steve Bratt or Kim Ball with any questions, comments, or content ideas!
- New Approach Could Make Clinical Trials More Equitable and Accessible. The MITRE Corporation. June 2021.
- The Future of Oncology Data is Happening Now. ASTRO Blog. June 2021.
- American Cancer Society Cancer Action Network. (2021. May 18). ACS CAN and CodeX Lead Project to Expand Cancer Clinical Trial Enrollment Through Improved Technology [Press release]
- Informonster Podcast Steve Bratt, CodeX Program Manager, and Carmela Couderc, Clinical Informaticist at MITRE, to discus mCODE and CodeX and accelerating healthcare innovation. Part One. Part Two.
- Structured Data Capture for Oncology; Alexander K. Goel, Walter Scott Campbell, and Richard Moldwin; JCO Clinical Cancer Informatics 2021 :5, 194-201
- HL7 News February 2021 Edition - CodeX Community Accelerates Smarter Data for the Fight Against Cancer (p.16)
- HL7 News October 2020 Edition - CodeX Community Stress-Tests the Value of a Common Language for Cancer Data
- "The Dish on Health IT" Podcast - Episode 11: HL7 CodeX: Transforming Cancer Care and Research