mCODE Lite (mCODE-LITE)
0.1.0 - draft

mCODE Lite (mCODE-LITE), published by MITRE. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/CodeX-HL7-FHIR-Accelerator/mcode-lite/ and changes regularly. See the Directory of published versions

mCODE Lite

Official URL: http://mitre.org/mcodelite/ImplementationGuide/fhir.mcodelite Version: 0.1.0
Draft as of 2024-09-12 Computable Name: McodeLite

Purpose

The purpose of this knowledge artifact is to inform the reader on how to leverage mCODE in the creation of derived implementation guides for federal health initiatives. This IG is in development not formally published by Health Level 7. Rather, it is an informative, mostly narrative-driven document. Examples may be provided for illustrative purposes but should not be considered complete. The goal is to provide scoped views into mCODE that may be tailored to use cases in federal health.

Background

Since its initial publication in March 2020, the minimal Common Oncology Data Elements (mCODE) Fast Healthcare Interoperability Resources (FHIR) Implementation Guide (IG) has significantly made an impact on standardizing the exchange of cancer data. Now in its third standard for trial use edition (mCODE STU3), parts of mCODE have been adopted by a wide community of providers, payers, standards development organizations (SDOs).

The mCODE specification however asserts that it is a "domain of knowledge" implementation in that there may be more specific use cases which merit further clarification on which mCODE elements are relevant for use.

mCODE's development history began with a provider's view of a minimal and actionable set of elements that empowered shared-decision making between a provider and patient for the diagnosis, treatment, and monitoring of cancer. The mCODE scope has since evolved to expand a broader set of elements that were informed by several drivers:

  • addressing more specific clinical use cases in the HL7 CodeX FHIR Accelerator. such as integrated trials matching and cancer registry reporting.
  • use in clinical research such as pragmatic clinical trials, and interventional or observational studies.
  • federally driven health-interoperability initiatives like CC-DIRECT and USCDI+ Cancer.

mCODE still aims to "capture data once, use many times" in the approach to cancer data interoperability. However, pragmatically, each of these efforts may vary in scope. Some initiatives like the CMS Enhancing Oncology Model (EOM) narrows down mCODE to less than 20 elements while USCDI+ cancer adds additional elements which were included as part of the USCDI core data requirements. Subsequently, there is a need to better identify how mCODE could apply or be further refined to address these efforts.

Approach

The approach in creating a lightweight version of mCODE involved the following steps:

  • gathering relevant data models relevant to ONC and CMS-related federal health initiatives. These include but are not limited to the following efforts currently in development:

A summary of the actionable and minimal mCODE-lite elements are shown below:



It is important to realize that neither mCODE, nor this guidance is exclusionary of any other FHIR resources that may be included in a data exchange. Implementers may include external FHIR base resources (e.g. as included in USCDI+ Cancer), profiles, and additional open components and extensions to existing mCODE profiles. This allows for extensibility of mCODE as further health interoperability requirements expand.

In comparing data element requirements in these data models, we recognize that structural and semantic mapping will change over time with evolving requirements and versioning. Moreover, constraining the IG too tight towards one of the model (e.g.: EOM) will make an overarching IG unusable for conformance to other related IGs (e.g.: USCDI+ Cancer).

Recognizing that these specifications may change, our focus is instead to identify requirement and modeling patterns and recommended approaches for further profiling if needed.

All profiles that appear in this document are specified must-support (MS) at the profile. Specifications at the element level are avoided as much as possible.

How to read this guide

The IG provides mostly narrative with hyperlinks to the related mCODE STU3 resource. Profiles derived from their relevant mCODE profile if further constraints or extensions are needed.

Examples on how to apply this guide for specific federal initiatives are added in the Case Study menu. Note that they are meant to be illustrative and will not comprehensively cover all aspects of conformance to their respective FHIR data submission requirements.

Profiles that are included in this guidance do not change mCODE. The only change is that they were marked as "must-support" at the highest level as a starting template for modification.

Credits

Our thanks to the contributing organizations which drive the guidance in this IG:

  • Global Alliant
  • Centers of Medicare and Medicaid Services (CMS)
  • MITRE Corporation