DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Expression Profiling for Cutaneous Melanoma (DecisionDx-Melanoma and myPath Melanoma)

Defines medical necessity, prior authorization, and coverage for two gene expression profiling tests (DecisionDx-Melanoma CPT 81529 and myPath Melanoma CPT O090U/description) for Medicare Advantage and Commercial products of BCBSRI. Includes criteria for when tests are considered medically necessary and billing/code guidance.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyExpression Profiling for Cutaneous Melanoma (DecisionDx-Melanoma and myPath Melanoma)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2025

Next Review Date

Key ActionObtain prior authorization for DecisionDx-Melanoma (81529) and myPath Melanoma (O090U) through the ordering physician; laboratories or third parties must not obtain authorization on behalf of the ordering physician.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

2Tests addressed

Stage I-IIDecisionDx covered stages

Diagnostic uncertaintymyPath covered indication

Coverage Summary

This policy addresses two gene expression profiling (GEP) tests for cutaneous melanoma: DecisionDx-Melanoma (CPT 81529) and myPath Melanoma (CPT O090U). It applies to Medicare Advantage and Commercial products. The policy coverage stance is covered_with_criteria. Effective date: 2025-11-01; Policy last reviewed: 2025-07-02.

Medical Necessity Criteria

DecisionDx-Melanoma (CPT 81529) Medically Necessary Criteria

DecisionDx Melanoma may be considered medically necessary when ALL of the following criteria are met:

ALL of the following

Stage: The member has either Stage I melanoma (staging based on AJCC American Joint Committee on Cancer) OR Stage II melanoma (staging based on AJCC American Joint Committee on Cancer).
Document lists Stage I or Stage II as qualifying stages.
Metastatic disease: The member does NOT have metastatic disease.
Clinical utility: The results of testing will inform subsequent biopsy decisions, use of adjuvant therapy(ies), or follow-up screening protocols.
Intended clinical utility: inform biopsy, adjuvant therapy decisions, or follow-up.

ref": "b1_0

title":

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myPath Melanoma (myPath) Medically Necessary Criteria

myPath Melanoma may be considered medically necessary when the following criterion is met:

Diagnostic uncertainty: The member has a melanocytic neoplasm that is diagnostically uncertain or equivocal after histopathology.

Not Covered / Experimental

The policy's coverage stance is covered_with_criteria. Uses or indications that do not meet the specified medical necessity criteria in this policy are not covered under this policy. The brief does not list separate explicit 'not covered' criteria beyond stating coverage is subject to the medical criteria and benefit/contract exclusions.

Coding

Covered CPT for DecisionDx-MelanomaCPTCovered

81529

Oncology (cutaneous melanoma), mRNA, gene expression profiling by real-time RT-PCR of 31 genes (28 content and 3 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as recurrence risk, including likelihood of sentinel lymph node metastasis

Covered CPT/PLA for myPath MelanomaCPTCovered

O090U

Oncology (cutaneous melanoma), mRNA gene expression profiling by RT-PCR of 23 genes (14 content and 9 housekeeping), utilizing formalin-fixed paraffin-embedded (FFPE) tissue, algorithm reported as categorical result (ie, benign, intermediate, malignant)

Provider Actions

Prior Authorization

Prior authorization required for DecisionDx and myPath

Prior authorization is required for DecisionDx-Melanoma and myPath Melanoma for Medicare Advantage Plans and Commercial Products. Only the ordering physician may obtain authorization or participate in authorization, appeal, or other administrative processes related to authorization/medical necessity.

81529
O090U

Documentation Required

Prohibition on laboratory obtaining authorization

Laboratories or third parties are not allowed to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician. If a laboratory or third party supports any portion of the authorization process, BCBSRI will deem it a policy violation and may take severe action up to and including termination from the BCBSRI provider network. Services provided by a laboratory that have not been authorized will be denied as the financial liability of the participating laboratory and may not be billed to the member.

Background, Evidence & Definitions

Gene expression profiling (GEP) tests measure mRNA expression to assist diagnosis and prognosis of cutaneous melanoma using technologies such as qRT-PCR or RNA-Seq. DecisionDx-Melanoma measures expression of 31 genes (28 prognostic targets and 3 housekeeping) by qRT-PCR on FFPE tissue and reports a risk class (class 1 or class 2) and an algorithmic value used to stratify recurrence risk and likelihood of sentinel lymph node metastasis. myPath Melanoma measures expression of 23 genes (14 content and 9 housekeeping) by qRT-PCR on FFPE tissue and reports an algorithmic score and categorical classification (benign/intermediate/malignant) to aid diagnosis in histopathologically ambiguous melanocytic neoplasms.

Evidence Type	Reference
Systematic review	Concert Evidence Review for Coverage Determination for Cutaneous Melanoma Prognostic Algorithmic Tests published 12/22/2023; re-issued 7/1/2024
Guideline	NCCN Clinical Practice Guidelines in Oncology: Cutaneous Melanoma Version 2.2024
Professional opinion	American Academy of Dermatopathology (AUC Committee Members, 2022) - majority usually appropriate recommendations for MyPath in specified diagnostic uncertainty scenarios

Definitions

Clinically node negativeNo signs of lymph node metastases, consisting of a negative physical examination and preoperative ultrasound.

Revision History

2025-07-02Last review

Policy last reviewed on this date per document metadata.

2025-11-01Effective dateLatest

Policy effective date per document metadata; status is draft.