CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Gene Expression Profiling for Cutaneous Melanoma

Defines medical necessity and prior authorization requirements for DecisionDx‑Melanoma and myPath Melanoma gene expression profiling tests for members with cutaneous melanocytic lesions or stage I–II melanoma; applies to Medicare Advantage and commercial products of BCBSRI.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyGene Expression Profiling for Cutaneous Melanoma

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 11, 2025

Next Review DateFeb 7, 2025

Key ActionObtain prior authorization for DecisionDx‑Melanoma (81529) and myPath Melanoma (0090U) for Medicare Advantage and commercial products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Tests addressed

31DecisionDx genes

23myPath genes

Prior authAuthorization

Coverage Criteria

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inv-01: DecisionDx-Melanoma (81529) — Medical Necessity

DecisionDx-Melanoma is considered medically necessary when ALL of the following are met:

DecisionDx-Melanoma medical necessity: 1) The member has either stage I OR stage II cutaneous melanoma (AJCC staging); 2) The member does NOT have metastatic disease; 3) Test results will inform subsequent biopsy decisions, use of adjuvant therapy(ies), or follow-up screening protocols.

inv-02: myPath Melanoma (0090U) — Medical Necessity

myPath Melanoma is considered medically necessary when ALL of the following are met:

myPath medical necessity: The member has a melanocytic neoplasm that remains diagnostically uncertain or equivocal after standard histopathology.

myPath is intended as an add-on to histopathology

The myPath Melanoma assay is intended as an adjunct to standard histopathology when the diagnosis remains uncertain. It reports an algorithmic score and categorical classification (benign, indeterminate, malignant) based on expression of 23 genes measured by qRT‑PCR on FFPE tissue, and is performed on sections from an existing biopsy specimen. Recommendations and published guidance explicitly exclude use of myPath in situations where histopathology is definitive for melanoma or for distinguishing incompletely sampled sclerosing (desmoplastic) nevus from desmoplastic melanoma. Providers should order myPath only when histopathology has been performed and remains equivocal and when the test result will materially influence diagnostic classification or downstream management.

Some self‑funded commercial groups have contractual exclusions for expanded coverage of biomarker or genetic testing. Coverage for myPath (and other genetic tests) may therefore vary by employer plan. Before ordering, verify the member’s benefits in the Benefit Booklet or plan documents to confirm whether myPath is covered, requires prior authorization, is not medically necessary, or is excluded by contract.

Covered Indications

inv-15: Stage I or II cutaneous melanoma where results will inform biopsy, sentinel node decisions, adjuvant therapy, or follow-up.

Covered indication: Stage I or II cutaneous melanoma where results will inform biopsy, sentinel node decisions, adjuvant therapy, or follow-up.

AJCC staging applies

inv-16: Melanocytic neoplasm that is diagnostically uncertain after histopathology (myPath).

Covered indication: Melanocytic neoplasm that is diagnostically uncertain or equivocal after histopathology.

myPath intended as a diagnostic adjunct when histopathology is inconclusive

Eligibility Requirements

Eligibility for myPath requires that the specimen originate from a melanocytic lesion for which standard histopathology has been performed and remains diagnostically equivocal. The ordering clinician must be the treating physician responsible for prior authorization and appeals. Laboratories may not obtain authorization on behalf of the ordering physician. Prior authorization is required for Medicare Advantage and commercial products where applicable.

Coding

Covered CPT/PLA Codes — 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 Codes — myPath MelanomaCPTCovered

0090U

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 a categorical result (ie, benign, intermediate, malignant)

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for DecisionDx‑Melanoma (81529) and myPath Melanoma (0090U) for Medicare Advantage and commercial products.

DecisionDx‑Melanoma (81529)
myPath Melanoma (0090U)

Note

Only the ordering physician may initiate and complete the prior authorization, appeal, and related administrative processes for these tests. Laboratories are not permitted to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician.

Documentation Required

Authorization Process and Documentation

The ordering physician is responsible for obtaining prior authorization and for preparing and submitting any documentation required to support medical necessity determinations and appeals.

Denial Risk

Unauthorized Laboratory Services Denied

If a laboratory provides a laboratory service that has not been authorized, the service will be denied and the financial liability will rest with the participating laboratory/provider. BCBSRI will take action, up to and including termination from the BCBSRI provider network, if a laboratory or third party is found to have participated in obtaining authorization on behalf of the ordering physician.

Note

PROVIDER ACTIONS

Reiterates that the ordering physician is responsible for obtaining prior authorization, handling appeals, and ensuring all administrative requirements are met; laboratories and third parties must not act on behalf of the ordering physician in the authorization or appeal processes.

Definitions

DecisionDx‑Melanoma (81529) — test definition

Analytes & methodMeasures expression of 31 genes (28 prognostic genes + 3 endogenous control genes) by quantitative RT-PCR on formalin‑fixed, paraffin‑embedded (FFPE) tissue.

Specimen requirementsPerformed on standard tissue sections from an existing FFPE biopsy or wide local excision specimen.

Report outputsProvides a classifier ‘class’ stratifying tumors as Class 1 or Class 2; algorithm yields a value between 0 and 1 with a 0.5 crossover point and possible A/B subclassification.

Clinical purposePrognostic test to estimate recurrence risk and likelihood of sentinel lymph node metastasis to inform biopsy, sentinel node, adjuvant therapy, or follow‑up decisions.

CPT/PLA code81529 — mRNA gene expression profiling by real‑time RT‑PCR of 31 genes (algorithm reported as recurrence risk, including likelihood of sentinel lymph node metastasis).

myPath Melanoma (0090U) — test definition

Analytes & methodMeasures expression of 23 genes (14 content genes related to differentiation, signaling, immune response + 9 housekeeping genes) by quantitative RT‑PCR on FFPE tissue.

Specimen requirementsPerformed on five standard tissue sections from an existing FFPE biopsy specimen.

Report outputsProvides an algorithmic myPath score (range −16.7 to 11.1) and categorical classification: benign, indeterminate, or malignant (score cutoffs defined on report).

Clinical purposeIntended as an add‑on diagnostic adjunct to standard histopathology for melanocytic neoplasms that remain diagnostically uncertain; informs differential diagnosis between nevus and melanoma in specific scenarios.

CPT/PLA code0090U — mRNA gene expression profiling by RT‑PCR of 23 genes, algorithm reported as categorical result (benign, intermediate, malignant).

Background

Gene expression profiling tests such as myPath analyze mRNA expression by quantitative reverse‑transcription PCR on formalin‑fixed, paraffin‑embedded (FFPE) tissue sections from an existing biopsy. The myPath Melanoma test measures expression of 23 genes (14 melanoma‑related content genes and 9 housekeeping genes) and reports an algorithmic score and categorical classification. The assay is performed on standard tissue sections from the FFPE specimen and is intended to assist diagnosis when histopathology alone is inconclusive, not as a primary diagnostic substitute.

Not Covered

Certain genetic testing services, including biomarker assays, may be contractually excluded for some self‑funded employer groups. These contractual exclusions are plan specific; always refer to the member’s Benefit Booklet and related policies (for example, Genetic Testing Services and Proprietary Laboratory Analyses) to determine coverage and any applicable exclusions prior to ordering.