Gene Expression Profiling for Cutaneous Melanoma
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This policy governs coverage and prior authorization requirements for two gene expression profiling tests (DecisionDx‑Melanoma and myPath Melanoma) used in evaluation and management of cutaneous melanoma for Medicare Advantage and commercial members.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
DecisionDx‑Melanoma (81529) Medical Necessity
DecisionDx‑Melanoma may be considered medically necessary when ALL of the following are met:
DecisionDx Main Criteria
- Stage options: The member has either: Stage I (AJCC) OR Stage II (AJCC) cutaneous melanoma (staging based on AJCC)
Either stage I or II satisfies the stage requirement
- Non‑metastatic requirement: The member does NOT have metastatic disease
Must be non‑metastatic
- Clinical management impact: The results of testing will inform subsequent biopsy decisions, use of adjuvant therapy(ies), or follow‑up screening protocols
Test must be expected to change management
myPath Melanoma (0090U) Medical Necessity
myPath Melanoma may be considered medically necessary when ALL of the following are met:
Intended as an adjunct when histopathology is indeterminate
Recommendations exclude scenarios where pathology is definitive for melanoma or for distinction between incompletely sampled sclerosing (desmoplastic) nevus versus desmoplastic melanoma. This exclusion follows the evidence-based considerations for the 23‑gene myPath assay and the conditions identified by specialty review panels where testing is appropriate as an adjunct to histopathology, not a replacement for definitive histopathologic diagnosis.
Coverage and payment are subject to the member's subscriber agreement or employer agreement; those documents supersede the provisions of this medical policy. For member‑specific benefits, providers should consult the Benefit Booklet or contact the provider call center. If services are determined to be not medically necessary or are non‑covered benefits, the member may not be charged for those services unless the member has been informed and has agreed in writing in advance to assume financial responsibility.
Some genetic testing services may be not covered or contract‑excluded for self‑funded groups that have excluded expanded biomarker testing per the state Biomarker Testing Mandate (R.I.G.L. §27‑19‑81). For these groups, refer to the Genetic Testing Services and Proprietary Laboratory Analyses policies and the member’s Benefit Booklet to determine whether the specific test is covered and whether prior authorization is required.
CPT / PLA Codes and Test Scoring
| 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 |
| 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) |
| 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 |
| 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) |
Authorization, Documentation, and Billing Guidance
Coverage conditional on meeting medical criteria
Coverage for DecisionDx‑Melanoma (81529) and myPath Melanoma (0090U) is contingent on meeting the medical necessity criteria specified in this policy; prior authorization/medical criteria must be satisfied for these codes to be covered.
- Codes are covered only when the policy’s medical criteria are met (see Coverage Criteria sections for DecisionDx‑Melanoma and myPath)
Ordering physician must own authorization and appeals
The ordering physician is responsible for initiating and managing the authorization, appeals, and related administrative processes; laboratories and third parties are not permitted to obtain authorization on behalf of the ordering physician.
- Laboratories are prohibited from participating in or obtaining clinical authorization on behalf of the ordering physician
- BCBSRI may take severe action, including termination from the provider network, if a laboratory or third party supports any portion of the authorization process
Document medical-necessity criteria in the record
Documentation in the medical record must demonstrate that the specific medical criteria in this policy are met when DecisionDx‑Melanoma (81529) or myPath Melanoma (0090U) is ordered.
- Records should support the applicable policy criteria (e.g., Stage I–II for DecisionDx; histopathologically equivocal melanocytic neoplasm for myPath)
Unauthorized laboratory billing will be denied — lab liable
If a laboratory provides a service that has not been authorized, that service will be denied and the financial liability will be the responsibility of the participating laboratory; such services may not be billed to the member.
- Unauthorized laboratory services will be denied as the financial liability of the participating laboratory and may not be billed to the member
Claims for 81529 / 0090U may be denied if criteria not met
Claims for CPT 81529 or PLA 0090U may be denied if the medical criteria in this policy are not met.
- Coverage of these codes is contingent on meeting the policy’s medical necessity requirements; failure to meet criteria can result in claim denial
Ordering physician must complete prior authorization before testing
Prior authorization is required for the listed tests and must be completed by the ordering physician before the laboratory performs the service.
- Note explicitly prohibits laboratories or their representatives from obtaining authorization on the provider’s behalf
Test Characteristics and Scoring Requirements
Test Definitions and Terminology
Clinical Background and Evidence Summary
Cutaneous melanoma comprises the majority of melanoma cases. Gene expression profiling (GEP) tests for cutaneous melanoma analyze mRNA expression from formalin‑fixed, paraffin‑embedded (FFPE) tissue to provide diagnostic or prognostic information that may assist clinical management. The myPath Melanoma assay measures expression of 23 genes (14 melanoma‑pathogenesis genes and 9 housekeeping genes) using quantitative RT‑PCR on standard tissue sections and reports an algorithmic myPath score (range -16.7 to 11.1) with categorical classifications (benign, indeterminate, malignant). The test is intended as an adjunct to histopathology for diagnostically uncertain melanocytic neoplasms and is not intended to replace definitive histopathologic diagnosis.
Policy Revision History
Policy last reviewed on 2025-09-01 as indicated in document metadata.
Policy effective date set to 2025-01-11 in document metadata.
Provider updates published in June and September 2024 as listed in the policy's publication/notification history.
Provider updates published in February, July, and November 2023 as listed in the policy's publication/notification history.
Provider update published October 2021 as listed in the policy's publication/notification history.
Provider update published November 2020 as listed in the policy's publication/notification history.
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