DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer

Defines medical necessity, prior authorization requirements, and coding for multigene expression and protein/algorithmic assays (e.g., Oncotype DX Breast DCIS Score, BluePrint, DCISionRT) used to assess prognosis and guide adjuvant therapy decisions in individuals with breast cancer for Medicare Advantage and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyAssays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionOrdering physicians must obtain prior authorization via the online tool for participating providers for the Oncotype DX Breast DCIS Score; Medicare Advantage requires prior authorization and Commercial is recommended to use the tool.

SourceLink

3Tests specifically discussed

1Test considered medically necessary when online tool criteria met (effective 2025-07-01)

2Tests stated as not covered / not medically necessary

Medical Necessity Criteria

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Medically Necessary (Medicare Advantage Plans and Commercial Products)

Effective 7/1/2025 — considered medically necessary when medical criteria in the online authorization tool for participating providers is met:

ANY of the following

Oncotype DX Breast DCIS Score (CPT 0045U) when medical criteria in the online authorization tool for participating providers is met

Not Covered / Not Medically Necessary

The following tests are stated as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products because evidence is insufficient:

ALL of the following

BluePrint (Agendia) — insufficient evidence of clinical utility
DCISionRT (Prelude Corporation) — evidence insufficient to determine improvement in net health outcome

Prior Authorization Requirement

Prior authorization rules applied to tests covered by this policy:

ALL of the following

Prior authorization is required for Medicare Advantage Plans for Oncotype DX Breast DCIS Score
Prior authorization is recommended for Commercial Products via the online tool for participating providers for Oncotype DX Breast DCIS Score
All unlisted genetic testing CPT codes require prior authorization to determine the service rendered and medical necessity
Laboratories are not allowed to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician; only the ordering physician may handle authorization, appeal, or related administrative processes
If a laboratory provides a laboratory service that has not been authorized, the service will be denied as the financial liability of the participating laboratory and may not be billed to the member

Relevant CPT / Procedure Codes

Medically necessary / may be considered medically necessary when criteria metCPTCovered

0045U	Oncology (breast ductal carcinoma in situ), mRNA, gene expression profiling by real-time RT-PCR of 12 genes (7 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as recurrence score
81518	Breast Cancer Index (Biotheranostics) — referenced; see Genetic Testing Services policy
81519	Oncotype DX Breast (Genomic Health) — referenced; see Genetic Testing Services policy
81520	Prosigna (NanoString Technologies) — referenced; see Genetic Testing Services policy
81521	MammaPrint (Agendia) — referenced; see Genetic Testing Services policy
81522	EndoPredict (Myriad) — referenced; see Genetic Testing Services policy
81523	MammaPrint NGS (Agendia) — referenced; see Genetic Testing Services policy

Not covered / not medically necessaryCPTNot Covered

0295U	Oncology (breast ductal carcinoma in situ), protein expression profiling by immunohistochemistry of 7 proteins (COX2, FOXA1, HER2, Ki-67, p16, PR, SIAH2), with 4 clinicopathologic factors (size, age, margin status, palpability), utilizing formalin-fixed paraffin-embedded (FFPE) tissue, algorithm reported as a recurrence risk score
81479	Unlisted molecular pathology procedure — listed here as the code commonly used for BluePrint or other tests without a specific CPT; BluePrint specifically noted as not covered

Unlisted molecular testing requiring prior authorizationCPT

81479

Unlisted molecular pathology procedure — requires prior authorization to determine what service is rendered and coverage

Authorization, Documentation, and Billing Rules

Prior Authorization

Use online authorization tool for Oncotype DX Breast DCIS Score

Ordering physicians must obtain prior authorization via the online authorization tool for participating providers for the Oncotype DX Breast DCIS Score. Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products; include CPT code 0045U when requesting authorization.

0045U

Prior Authorization

Prior authorization required for unlisted genetic testing CPTs

All unlisted molecular pathology/genetic testing CPT codes require prior authorization to determine what service is being rendered and whether the service is covered or not medically necessary (example code commonly used: 81479).

81479

Documentation Required

Authorization must be obtained by ordering physician only

Only the ordering physician may obtain prior authorization, handle appeals, or participate in authorization-related administrative processes; laboratories, their representatives, or third parties must not obtain or facilitate authorization on behalf of the ordering physician. Violations may result in severe actions up to termination from the BCBSRI provider network and denial of claims billed by the laboratory.

Clinical and Policy Context

Multigene expression and protein/algorithmic assays evaluate tumor tissue using either mRNA-based gene expression profiles or protein immunohistochemistry combined with clinicopathologic factors to estimate recurrence risk and inform adjuvant management decisions in breast cancer and ductal carcinoma in situ (DCIS). These assays are used to help providers and patients decide on the addition of adjuvant chemotherapy, the benefit of radiotherapy after breast-conserving surgery for DCIS, or the need for extended endocrine therapy in individuals who remain recurrence-free after five years. (See overview and clinical application descriptions.)

Evidence and clinical utility vary across available assays. The Oncotype DX Breast DCIS Score (CPT 0045U) — an mRNA-based assay reported as a recurrence score using formalin-fixed paraffin-embedded tissue — has an assigned CPT and, effective 07/01/2025, is considered medically necessary when the medical criteria in the online authorization tool for participating providers is met; prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products. The policy identifies the specific CPT description for Oncotype DX Breast DCIS Score.

By contrast, other tests addressed in this policy do not have sufficient evidence of clinical utility and are stated as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products. Specifically, BluePrint (commonly billed using an unlisted molecular pathology CPT such as 81479) is considered to have insufficient evidence to demonstrate required clinical utility, and DCISionRT (CPT 0295U), a protein expression profile combined with four clinicopathologic factors to predict radiation benefit in DCIS, has evidence that is insufficient to determine improvement in net health outcome.

Prior authorization rules and administrative safeguards apply: unlisted genetic testing CPTs require prior authorization to determine the service rendered and coverage status; laboratories and their representatives are not permitted to obtain prior authorization on behalf of ordering physicians; and if a laboratory furnishes a service that was not authorized, the service will be denied and may not be billed to the member.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyAssays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2025

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer

Medical Necessity Criteria

Relevant CPT / Procedure Codes

Authorization, Documentation, and Billing Rules

Clinical and Policy Context

Key Terms

Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer

Medical Necessity Criteria

Relevant CPT / Procedure Codes

Authorization, Documentation, and Billing Rules

Clinical and Policy Context

Key Terms

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