Data Element
Secondary Cancer Condition
Description

Also known as secondary malignant neoplasm, secondary cancer condition is used to describe either a new primary cancer or cancer that has spread from the place in which it started to other parts of the body (Source: NCI).
Submitted By: May Terry / MITRE Corporation
Data Element Information
Rationale for Separate Consideration Secondary cancer condition could be covered under the USCDI V4 Problems class however such a problem cannot stand on its own. Rather it is provided in context with a primary cancer condition. For example, an EHR which captures the diagnosis of a patient with metastatic breast cancer will record the problem as 1) a diagnosis of breast cancer, and 2) a supporting diagnosis that the cancer has metastasized to the liver. That secondary diagnosis must be tied to its primary as a secondary code because it a patient may have multiple primary cancers, one of which is metastatic, and it would be uncertain which cancer was the one that was metastasized.
Use Case Description(s)
Use Case Description Several use cases are actively implementing this data element.

The CodeX Clinical Trial Matching Use Case aims to automate the existing trial matching process and complete the eligibility screening in one step to increase enrollment and diversity of patients in clinical trials. There are 11 key partners, including industry, advocacy organizations, and research, involved in the use case. Additionally, this use case is in process of rolling out into prospective phase at one health site, UTSW. 

The CodeX Registry Reporting Use Case aims to share cancer registry data in a standardized, low burden method to better track patient outcomes. There are 7 key partners, including government, industry, and research, involved in the use case. Note that CDC and other stakeholder involvement in the use case led to mCODE’s utilization for cancer data elements in the [IG].

The CodeX Prior Authroization Use Case aims 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. There are there are approximately 11-12 organizations involved in the PA use case. Those organizations are associations, EHR, providers, health plans, technology vendors who support payers and providers, and a utilization management organization. HHS – OBRHI and ONC have expressed interest in the use case.

The CodeX Quality Measures Use Case aims to highlight new quality measures that could be developed – and new insights that could be made – if mCODE and other FHIR IGs (such as QI Core) were implemented and leveraged by an ecosystem of willing health organizations. There are 4 key partners including industry, research, and professional organization involved in the use case.

The CodeX Endpoints for Clinical Trials Use Case (ICAREdata) aims to enable clinical oncology research by prospectively gathering high quality real-world data. This use case is a joint effort between the Alliance Foundation for Clinical Trails (AFT) and the MITRE corporation with parti
Estimate the breadth of applicability of the use case(s) for this data element The submission is Level 0 since it is specific to cancer care.
ONC Priority
  • Address public health interoperability needs of reporting, investigation, and emergency response
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) Three terminologies are commonly referenced for the exchange of secondary/metastatic cancer conditions:
• International Classification of Diseases, 10th version, Clinical Modification (ICD-10-CM) guidelines for coding and reporting and includes specific guidelines on inclusion of secondary codes needed to properly code a neoplasm.
• SNOMED CT, which includes dedicated codes for describing metastatic malignant neoplasms.
• International Classification of Diseases for Oncology version 3 (ICD-O-3), which includes codes that assert a neoplasm is metastatic.

https://www.cms.gov/medicare/coding-billing/icd-10-codes/2023-icd-10-cm
Additional Specifications Multiple specifications which request the submission of metastatic conditions. They include:
• The HL7 minimum Common Oncology Data Elements (mCODE) FHIR IG specifies “must support” data elements and a value set of terminology codes (SNOMED CT, ICD-10-CM, and ICD-O-3) that represent a secondary cancer condition.
• The North American Association of Central Cancer Registries (NAACCR) data dictionary is a specification which influences cancer registry reporting requirements includes elements which imply asserting metastatic conditions for a primary cancer.
• The CMS Enhancing Oncology Model (EOM) Clinical Data Elements Guide version 1.1.
Current Use (Level 1) Captured, stored, or accessed in at least one production EHR or HIT module
Extent of exchange (Level 0) Limited environments, such as connectathons or pilots
Supporting Artifacts In support of cancer registry reporting requirements, secondary cancer condition has been exchanged between EHRs and state cancer registries which has NAACCR elements which assert metastasis to specific organs. These include NAACCR data elements for Mets at Dx Bone (item 1112), Mets at Dx Brain (item 1113), and Mets at Dx Liver (item 1115).
https://apps.naaccr.org/data-dictionary/data-dictionary/version=24/chapter-view/record-layout-table/
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) There are no restrictions on the standardization of this data element. All models and codes are available for public use.
Restrictions on Use (e.g. licensing, user fees) There are no restrictions on the use of this data element.
Privacy and Security Concerns Privacy and/or security concerns on the exchange of this element are no different than those applied to the Problems data class and problems data element.
Estimate of Overall Burden This element has been relatively easy to capture in clinical applications as an electronic form field which specifies that a cancer was metastasized to a body site. These include:
• EHRs with specialized oncology modules for entering cancer diagnoses.
• College of American Pathology (CAP) cancer protocol templates for invasive cancers and include fields specifying metastatic sites.
There is some conversion from form data into ICD-10-CM as secondary codes supporting the primary billing code for a cancer.
There should be no additional significant time from the provider in the capture of this element because asserting that a cancer has metastasized to a certain site is already part of the cancer diagnosis workflow. Many specialized oncology EHRs already support fields which specify metastatic cancer.
Other Implementation Challenges None
ONC Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 1 - Data element is captured, stored, or accessed in at least one production EHR or HIT module.
Criterion #3
Maturity - Current Exchange		 Level 0 - Data element is electronically exchanged in limited environments, such as connectathons or pilots.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.
Evaluation Comment This data element is a specialized use of subset of the Problems data element in the Problems data class in USCDI v4.

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