MOPA — Medical Oncology Prior Authorization
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MOPA — Medical Oncology Prior Authorization - Local Development build (v0.1.1-snapshot-080926) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Use Case 1: Breast Cancer PA

Page standards status: Informative

Context

This page defines Use Case 1 — the first concrete instantiation of the MOPA data requirements pattern for a specific cancer type. It serves as the template for subsequent use cases (lung, colorectal, hematologic malignancies, and others). Each future use case follows the same structure: a cancer-specific set of data requirements with mCODE coverage assessment, gap analysis, and recommended profiles.

Scope

This use case covers systemic anti-cancer therapy authorization for breast cancer, including:

  • Early-stage (adjuvant and neoadjuvant) chemotherapy and targeted therapy
  • Metastatic breast cancer systemic therapy (all lines)
  • HER2-directed therapy, endocrine therapy, CDK4/6 inhibitors, PARP inhibitors, immunotherapy (PD-L1+), and antibody-drug conjugates

Important Note on Staging

mCODE supports AJCC/TNM-based staging through cancer stage and TNM-specific profiles. The gap for breast cancer PA is not basic staging representation. The gap is PA-specific profiling:

  • Whether clinical stage or pathologic stage is required
  • Whether the AJCC stage group is sufficient or T/N/M components are needed
  • Which AJCC edition / staging method is acceptable
  • How staging is linked to the primary breast cancer condition and evidence source
  • How to distinguish current disease state from historical diagnosis stage

Breast Cancer PA Data Requirements

The breast cancer PA use case targets SNOMED CT code 254837009 "Malignant tumor of breast".

Required data categories

Category Requirement group mCODE basis Coverage Gap / Action
Diagnosis Primary breast cancer condition mcode-primary-cancer-condition Strong Add breast cancer value set binding and laterality expectation
Staging AJCC TNM stage group mcode-tnm-stage-group Strong foundation Constrain to clinical or pathologic stage; specify accepted AJCC edition
Staging T / N / M categories mcode-tnm-primary-tumor-category, mcode-tnm-regional-nodes-category, mcode-tnm-distant-metastases-category Strong foundation Require when stage group alone is insufficient for authorization logic
Biomarkers ER status mcode-tumor-marker-test Strong foundation Bind to breast-specific ER value set; normalize positive/negative/percent
Biomarkers PR status mcode-tumor-marker-test Strong foundation Same as ER
Biomarkers HER2 status mcode-tumor-marker-test Strong foundation Distinguish IHC vs ISH/FISH; consider HER2-low profile
Disease status Current disease status / progression mcode-cancer-disease-status Strong foundation Require evidence date and prior treatment association
Regimen Ordered anti-cancer regimen AntiCancerRegimenRequestGroup New — defined in this IG MVP artifact; instantiatesCanonical → PlanDefinition
Performance ECOG performance status mcode-ecog-performance-status Strong Conditional — add lookback period guidance
Therapy history Prior systemic therapy mCODE cancer-related medication profiles Strong for events Add class-based value sets for HER2-directed, endocrine, CDK4/6, taxane, anthracycline
Therapy context Line of therapy Profiled Da Vinci CRD ext-request-category CRD context expansion proposed; mCODE order semantics need guidance Carry lineOfTherapy on RequestGroup with the required TreatmentLineVS binding
Therapy context Treatment setting / intent Da Vinci CRD ext-request-category CRD context expansion proposed Carry the patient-specific category on AntiCancerRegimenRequestGroup
Genomics BRCA1/2 status mcode-genomic-variant, mcode-genomics-report Partial Require germline vs somatic distinction; conditional for PARP inhibitor authorization
Exceptions Contraindication / intolerance AllergyIntolerance, Condition Partial Define exception profile with reference to avoided drug/regimen
Exceptions Exception documentation DTR QuestionnaireResponse Generic Drive from DTR when structured evidence is unavailable

Priority Gaps

Gap Why High Priority Proposed Artifact
Regimen as first-class object Oncology PA is regimen-centered, not drug-order-centered AntiCancerRegimenRequestGroup (MVP) + AntiCancerRegimenPlanDefinition
Line of therapy Required for metastatic sequencing and payer policy RequestGroup.extension:category/lineOfTherapy, profiled from the CRD Request Category and bound to TreatmentLineVS
Treatment setting Most breast cancer logic branches by setting Patient-specific CRD ext-request-category on RequestGroup
Staging constraints PA needs clinical vs pathologic stage, T/N/M, AJCC edition Breast cancer PA staging guidance
Biomarker normalization ER/PR/HER2 observations need PA-ready normalized values Breast-specific value sets and result normalization rules
Exception documentation Needed when guideline-concordant care requires exception DTR QuestionnaireResponse + structured exception/contraindication profile

See Also