Capability Statement for systems acting as an Oncology CRD Client (e.g., an EHR or oncology ordering system). A conformant client claims support for the Da Vinci CRD oncology profile defined in this IG by meeting the requirements below.

Capability Statement for systems acting as an Oncology CRD Service (e.g., a payer or prior-authorization platform). A conformant service claims support for the Da Vinci CRD oncology profile defined in this IG by meeting the requirements below.

A canonical, reusable anti-cancer therapy regimen definition represented as a FHIR PlanDefinition order set. This resource is NOT patient-specific; it is referenced by AntiCancerRegimenRequestGroup instances via RequestGroup.instantiatesCanonical.

A regimen definition describes the protocol — component drugs, timing, cycle structure, and sequential phase ordering. Treatment intent and line of therapy are patient-specific ordering categories and are carried on the RequestGroup via the category extension; this canonical definition does not carry those attributes.

mCODE Migration Candidate — This profile is proposed for inclusion in mCODE STU5. It addresses the gap documented in the mCODE gap analysis: mCODE does not currently represent anti-cancer regimens as first-class, computable entities.

A patient-specific ordered anti-cancer therapy regimen instance. This resource is included in the CDS Hooks draftOrders Bundle and referenced in context.selections at order-select and order-sign.

CDS Hooks Context. This profile is designed for use in the Da Vinci CRD workflow. The RequestGroup is the primary prior-authorization subject — the unit of evaluation for coverage policy — not the individual MedicationRequest components within it.

Two-Stage Hook Pattern. The MOPA workflow uses order-select and order-sign as distinct stages:

• order-select (informational): The RequestGroup is present in context.draftOrders but component MedicationRequest resources may not yet be finalised. The CRD service returns informational cards indicating approvability. This is advisory — the order is not yet committed.
• order-sign (final determination): The RequestGroup is accompanied by finalised component MedicationRequest resources. The CRD service returns the final coverage determination (Authorization Satisfied, PA required, or DTR required).

CRD Order Profile Proposal. This profile serves as the domain-specific layer for oncology regimens. A complementary CRD order profile for RequestGroup is proposed (MOPA-DV-CRD-003) to formalize RequestGroup as a standard order type in the Da Vinci CRD IG, analogous to existing CRD profiles for MedicationRequest and ServiceRequest.

RequestGroup.instantiatesCanonical SHALL be populated with the canonical URL of the AntiCancerRegimenPlanDefinition when the canonical regimen definition is known.

Two scheduling patterns are supported in regimen actions:

1. Cycle-day timing — Each action (or action.action for phased regimens) uses the local extension http://hl7.org/fhir/us/codex-mopa/StructureDefinition/regimen-days-of-cycle on action.timingTiming to declare which days of the cycle the drug is administered. The action.timingTiming.repeat carries the machine-computable cycle period.

2. Sequential phase ordering — For multi-phase regimens (e.g., AC→T), top-level action groups represent phases and action.relatedAction with relationship = after-end declares that the second phase begins after the first.

mCODE Migration Candidate — This profile is proposed for inclusion in mCODE STU5. It is the MVP artifact for oncology prior authorization: the selected clinical unit passed to the CRD service.

A human-readable label that identifies a DataRequirement entry within an OncologyDataRequirementsLibrary. Used by tools such as DTR questionnaire generators and CRD content viewers to display requirement names without parsing profile URLs.

The first DataRequirement entry in every condition-specific Library (the primary cancer condition) SHALL carry a label of the canonical form '[Cancer Type] Diagnosis' (e.g., 'Breast Cancer Diagnosis') to make the diagnostic prerequisite explicit and machine-discoverable.

mCODE Migration Candidate — Proposed for inclusion in mCODE STU5.

Constrains the Da Vinci CRD Request Category extension for a patient-specific anti-cancer regimen line-of-therapy category. The instance extension URL remains http://hl7.org/fhir/us/davinci-crd/StructureDefinition/ext-request-category; this profile adds oncology terminology semantics only. Its use on RequestGroup requires the proposed CRD RequestGroup extension-context expansion.

mCODE Migration Candidate — This constraint profile and its terminology semantics are proposed for inclusion in mCODE STU5; the underlying extension remains owned by Da Vinci CRD.

Specifies the days within a repeating treatment cycle on which a regimen action is to be performed. Semantically identical to the HL7 core extension timing-daysOfCycle, but with context broadened to Timing so it can be applied to nested RequestGroup.action.action elements used in phased multi-agent regimens.

The cycle length is expressed via Timing.repeat.period / Timing.repeat.periodUnit on the same element. Day numbering starts at 1 (day 1 = first day of cycle 1).

This extension is a migration candidate for inclusion in the HL7 FHIR Extensions pack with an expanded context. See regimen-model.html.

Constrains the Da Vinci CRD Request Category extension for a patient-specific anti-cancer regimen treatment-intent category. The instance extension URL remains http://hl7.org/fhir/us/davinci-crd/StructureDefinition/ext-request-category; this profile adds oncology terminology semantics only. Its use on RequestGroup requires the proposed CRD RequestGroup extension-context expansion.

mCODE Migration Candidate — This constraint profile and its terminology semantics are proposed for inclusion in mCODE STU5; the underlying extension remains owned by Da Vinci CRD.

The clinical intent of an anti-cancer regimen. All codes are drawn from the SNOMED CT "Intents (nature of procedure values)" hierarchy (363675004).

mCODE Migration Candidate — Proposed for mCODE STU5.

Codes representing the ordinal line of systemic anti-cancer therapy. Used by LineOfTherapyRequestCategory for the patient-specific RequestGroup category.

mCODE Migration Candidate — Proposed for mCODE STU5.

Local codes defined by the MOPA IG for concepts that do not yet have an established representation in LOINC, SNOMED CT, or mCODE. These codes are migration candidates and should be retired in favor of standard codes as they become available.

Ordinal codes representing the line of systemic anti-cancer therapy. These codes are used in TreatmentLineVS and in the LineOfTherapyRequestCategory constraint profile for the RequestGroup lineOfTherapy category slice.

mCODE Migration Candidate — These codes are proposed for adoption in mCODE STU5 or as a SNOMED CT extension request. Once standard codes are available, this code system should be deprecated.

Fictional medical oncologist used across MOPA IG examples.

Fictional 57-year-old female patient used consistently across all MOPA IG examples. DO NOT use real patient data.

Canonical definition of pertuzumab (840 mg loading, then 420 mg IV) plus trastuzumab (8 mg/kg loading, then 6 mg/kg IV) plus docetaxel (75 mg/m² IV), every 21 days, for metastatic HER2-positive breast cancer. Treatment intent and line of therapy are carried on the RequestGroup via the category extension.

Canonical definition of weekly Paclitaxel (80 mg/m² IV) plus Trastuzumab (4 mg/kg loading, then 2 mg/kg IV) for 12 weeks in HER2-positive early breast cancer. The canonical definition carries protocol structure only — treatment intent and line of therapy are patient-context and live on the RequestGroup.

Canonical definition of dose-dense doxorubicin (60 mg/m²) plus cyclophosphamide (600 mg/m²) q14d × 4 cycles (AC phase), followed by paclitaxel (175 mg/m²) q14d × 4 cycles (T phase) for breast cancer. Demonstrates sequential phase ordering using action.relatedAction with relationship = after-end.

Patient-specific draft PHD regimen order for Jane Smith, first-line metastatic HER2+ breast cancer. Pertuzumab + Trastuzumab + Docetaxel q21d. Demonstrates palliative intent and first-line metastatic treatment setting.

Patient-specific draft ordered TH regimen for Jane Smith at order-select. instantiatesCanonical references RegimenTH. All Must Support elements populated. Demonstrates regimen-days-of-cycle (days 1, 8, 15 of a 21-day cycle) and is the primary reference example for AntiCancerRegimenRequestGroup.

Patient-specific draft ddAC→T order for Jane Smith. AC phase (doxorubicin + cyclophosphamide q14d x4) followed by T phase (paclitaxel q14d x4). Demonstrates sequential phase ordering with action.relatedAction relationship = after-end.

Collection Bundle placed in context.draftOrders of an order-select CDS Hooks request. At order-select the RequestGroup is present but individual MedicationRequests are still draft and are not required.

Collection Bundle placed in context.draftOrders of an order-sign CDS Hooks request. At order-sign the RequestGroup plus all companion MedicationRequests are present.

Draft MedicationRequest for cyclophosphamide 600 mg/m² IV in ddAC phase.

Draft MedicationRequest for docetaxel 75 mg/m² IV q21d in PHD regimen.

Draft MedicationRequest for doxorubicin 60 mg/m² IV in ddAC phase.

Metastatic HER2-positive breast cancer with liver and bone involvement, newly diagnosed Stage IV (de novo). Used in PHD regimen examples.

Draft MedicationRequest for paclitaxel 175 mg/m² IV q14d in T phase.

Draft MedicationRequest for paclitaxel 80 mg/m² IV weekly in TH regimen.

Draft MedicationRequest for pegfilgrastim 6 mg subcutaneous on day 2 of each ddAC cycle.

Draft MedicationRequest for pertuzumab IV q21d in PHD regimen.

Invasive ductal carcinoma of right breast, HER2-positive, Stage IIB (T2 N1 M0), diagnosed November 2025. Referenced by all MOPA examples depicting Jane Smith's adjuvant treatment course.

Draft MedicationRequest for trastuzumab IV q21d in PHD regimen.

Draft MedicationRequest for trastuzumab IV weekly in TH regimen.