DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis and Predict Therapeutic Response in Individuals With Breast Cancer

Blue Cross Blue Shield of Rhode Island draft medical coverage policy addressing use, coverage stance, and coding for DCISionRT and BluePrint molecular subtyping tests in individuals with breast cancer.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyAssays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis and Predict Therapeutic Response in Individuals With Breast Cancer

Policy CodePolicy N/A

Change TypeDraft

Effective DateN/A

Next Review DateN/A

Key ActionCheck the member's Benefit Booklet, Evidence of Coverage, or employer agreement to determine whether the tested service is a covered benefit or excluded for the member's plan; coverage may vary by group and contract.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2tests specifically addressed in policy

2CPT/PLA codes listed as not covered / not medically necessary

0States explicitly governed by this policy

Coverage determinations for DCISionRT and BluePrint

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Medically Necessary / Not Covered determinations

Coverage determinations for the listed tests are summarized below:

ALL of the following

For Medicare Advantage Plans: DCISionRT is not covered.
For Medicare Advantage Plans: BluePrint Molecular Subtyping Test is not covered.
For Commercial Products: DCISionRT is considered not medically necessary (insufficient evidence).
For Commercial Products: BluePrint Molecular Subtyping Test is considered not medically necessary (insufficient evidence).

Commercial group contract exclusions

Additional contract-level restrictions may apply:

ANY of the following

Some self-funded commercial groups may have contract exclusions related to expanded biomarker testing per the state mandate (R.I.G.L. §27-19-81); coverage for genetic testing services for those groups is determined by the group's contract and Benefit Booklet.
For groups with exclusions, a determination of covered with prior authorization, not medically necessary, or not covered as contract exclusion is available in the Coding section of the Genetic Testing Services or Proprietary Laboratory Analyses policies.

Clinical evidence conclusions (policy-level determinations)

Policy conclusions based on evidence summaries in the document include:

ANY of the following

BluePrint: Evidence is insufficient to demonstrate improvement in net health outcome for early-stage node-negative invasive breast cancer when used to guide adjuvant chemotherapy decisions; clinical utility is unknown.
BluePrint: Evidence is insufficient to demonstrate improved net health outcome when used to guide neoadjuvant systemic therapy decisions; clinical utility is unknown.
DCISionRT: Evidence (retrospective validation) is insufficient to demonstrate improved net health outcome for predicting radiotherapy benefit in DCIS; clinical utility is unknown.

Relevant CPT Codes and Coverage Status

Not covered / Not medically necessary (Medicare Advantage & Commercial)CPTNot 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 (DCISionRT)
0630U	Oncology (breast), mRNA, gene expression profiling by micro-array of 80 genes (80 content and 465 housekeeping), utilizing formalin-fixed paraffin-embedded tissue (FFPE), algorithm reported as index that is diagnostic of a molecular subtype (luminal, basal, Her2) (BluePrint) (New Code Effective 4/1/2026)

What providers must do

Documentation Required

Check member benefits and contract exclusions

Providers must refer to the member's Benefit Booklet, Evidence of Coverage, or employer (subscriber) agreement to determine whether the tested service is a covered benefit or excluded for the member's plan; benefits may vary by group and contract.

0295U
0630U

Prior Authorization

Prior authorization route for self-funded groups with expanded coverage

For self-funded groups that have expanded biomarker testing coverage with prior authorization, follow the Coding section of the Genetic Testing Services or Proprietary Laboratory Analyses policies to determine which tests require prior authorization.

Clinical and policy background

Multigene expression assays such as DCISionRT and BluePrint analyze tumor tissue biomarkers to provide prognostic or predictive information that may inform treatment decisions. DCISionRT combines immunohistochemical measurement of seven proteins (COX‑2, FOXA1, HER2, Ki‑67, p16/INK4A, PR, SIAH2) with four clinicopathologic factors (age at diagnosis, tumor size, palpability, and surgical margin status) to generate a recurrence‑risk score intended to predict radiation benefit after breast‑conserving surgery for ductal carcinoma in situ (DCIS). (See DCISionRT description in the policy.)

BluePrint is an 80‑gene mRNA expression assay that classifies invasive breast cancers into molecular subtypes (Basal‑type, Luminal‑type, and ERBB2/Her2‑type) by measuring downstream gene expression to characterize pathway functionality; it is intended to inform prognosis and may be used with other profiles to influence decisions about adjuvant or neoadjuvant systemic therapy. (See BluePrint description in the policy.)

The policy review summarizes the available evidence for each assay and concludes that, for the clinical uses addressed, the evidence is insufficient to demonstrate clinical utility or an improvement in net health outcomes. For DCISionRT, retrospective validation studies have not shown clear radiotherapy benefit at the reported score threshold and clinical utility is unknown. For BluePrint, observational and trial analyses (including I‑SPY2 correlative data) do not provide direct evidence that use of the test to guide adjuvant or neoadjuvant chemotherapy improves patient outcomes, and clinical utility remains unknown. Consequently, the policy does not cover DCISionRT or BluePrint for Medicare Advantage Plans and considers them not medically necessary for Commercial Products due to insufficient evidence of benefit.

Defined terms

Definitions

DCISionRTA test combining immunohistochemistry for 7 proteins (COX-2, FOXA1, HER2, Ki-67, p16/INK4A, PR, SIAH2) with 4 clinicopathologic factors (age at diagnosis, tumor size, palpability, surgical margin status) to produce a recurrence-risk score intended to predict radiotherapy benefit in ductal carcinoma in situ.

BluePrintAn 80-gene mRNA expression assay that classifies breast cancers into molecular subtypes (Basal-type, Luminal-type, ERBB2-type) to inform prognosis and potential treatment response.