ModifiedCapital BluecrossPolicy MP 2.360

Gene Expression Profiling for Melanoma

Defines medical necessity for gene expression profiling (DecisionDx-UM) for primary, localized uveal melanoma and considers other uses investigational; includes coding list and background, rationale, and policy history for Capital Blue Cross products.

Policy Summary

PayerCapital Bluecross

PolicyGene Expression Profiling for Melanoma

Policy CodePolicy MP 2.360

Change TypeTitle revision and removal of cutaneous melanoma criteria; administrative coding updates

Effective DateAug 1, 2025

Next Review Date

Key ActionProvider must document that the patient has primary, localized uveal melanoma (supporting ICD-10 code) to support medical necessity for DecisionDx-UM testing.

SourceLink

POLICY UPDATE CHANGES

Policy title changed to Gene Expression Profiling for Uveal Melanoma and gene expression profiling for cutaneous melanoma criteria and information removed.

Removed several CPT/HCPCS codes and added or removed other administrative coding updates over time (e.g., 0081U, 0314U, 0357U, 0490U, 81529 removed previously).

Administrative update removing Benefit Variations and updating the Disclaimer.

1Covered Indication (primary, localized uveal melanoma)

multipleInvestigational uses (including cutaneous melanoma)

1Proprietary test specified (DecisionDx-UM)

Coverage Summary

Overview: This policy (Policy Number MP 2.360) defines medical necessity for gene expression profiling using DecisionDx-UM for patients with primary, localized uveal melanoma and considers other uses investigational. Coverage stance: covered with criteria for DecisionDx-UM when the medically necessary criteria are met; other indications and non-DecisionDx-UM tests are investigational. Effective date: 8/1/2025. Last review: 6/10/2025.

Key policy facts

Policy numberMP 2.360

Effective date2025-08-01

Last review2025-06-10

Coverage stanceCovered with criteria (DecisionDx-UM medically necessary for primary, localized uveal melanoma; other uses investigational)

Proprietary test specifiedDecisionDx-UM (commercial CLIA laboratory-developed test)

Medical Necessity Criteria

Medically Necessary

Gene expression profiling for uveal melanoma with DecisionDx-UM is medically necessary for patients with ALL of the following:

Medically necessary criteria

Test specification: Test is DecisionDx-UM (gene expression profiling) for uveal melanoma
DecisionDx-UM is a commercial CLIA laboratory-developed test
Indication: Patient has primary, localized uveal melanoma
Provider must document primary, localized uveal melanoma (supporting ICD-10 code)

Investigational / Not Medically Necessary

Gene expression profiling for uveal melanoma that do not meet the medically necessary criteria is considered investigational:

Coding

Covered when medically necessary for UVEAL melanomamixedCovered

81552	Molecular pathology procedure (gene expression profiling) (listed in policy coding section)
C69.30	Malignant neoplasm of unspecified choroid
C69.31	Malignant neoplasm of right choroid
C69.32	Malignant neoplasm of left choroid
C69.40	Malignant neoplasm of unspecified ciliary body
C69.41	Malignant neoplasm of right ciliary body
C69.42	Malignant neoplasm of left ciliary body
C69.80	Malignant neoplasm of overlapping sites of unspecified eye and adnexa
C69.81	Malignant neoplasm of overlapping sites of right eye and adnexa
C69.82	Malignant neoplasm of overlapping sites of left eye and adnexa

1–10 of 13

1/2

Provider actions / billing note: When medically necessary, report the molecular pathology code 81552 for gene expression profiling (DecisionDx-UM). Providers must document that the patient has primary, localized uveal melanoma using an appropriate supporting ICD-10 diagnosis code (examples include C69.30, C69.31, C69.32, C69.40, C69.41, C69.42, C69.80, C69.81, C69.82, C69.90, C69.91, C69.92).

Provider Actions & Billing

Documentation Required

Document diagnosis of primary, localized uveal melanoma

Provider must document that the patient has primary, localized uveal melanoma (supporting ICD-10 code) to support medical necessity for DecisionDx-UM testing.

C69.30
C69.31
C69.32
C69.40
C69.41
C69.42
C69.80
C69.81
C69.82
C69.90
C69.91
C69.92

Background & Evidence Summary

Background: Gene expression profiling (DecisionDx-UM) is a commercial, CLIA laboratory-developed test that stratifies uveal melanoma tumors into prognostic risk groups. Clinical validity studies have shown that GEP class correlates strongly with metastasis and melanoma-specific mortality, and although there are no direct trials demonstrating clinical utility, a chain of evidence and observational data indicate that low-risk classification can support reduced surveillance and altered management without apparent harm.

Evidence summary

Clinical validitySix studies reported strong correlation between GEP classification and metastatic disease/melanoma-specific mortality

Clinical utilityNo direct studies; chain of evidence and observational data (Aaberg et al) show altered management and reduced surveillance for low-risk patients

Definition: DecisionDx-UM is a commercial gene expression profiling test for uveal melanoma provided as a CLIA laboratory-developed test (Castle Biosciences).

Medicare & External Determinations

Name	Number	Effective
BCBSA Medical Policy Reference	2.04.120	2025-02

Revision History

05/30/2018policy_created

New policy adopting BCBSA: Gene expression profiling for uveal melanoma with DecisionDx-UM medically necessary for primary, localized uveal melanoma; gene expression profiling for cutaneous melanoma investigational; coding added.

01/01/2019administrative_update

Administrative update added new code for DecisionDx-UM 0081U; removed unspecified codes from medically necessary coding section.

03/21/2019consensus_review

Consensus review — no changes to policy statement; references updated.

Policy Summary

PayerCapital Bluecross

PolicyGene Expression Profiling for Melanoma

Policy CodePolicy MP 2.360

Change TypeTitle revision and removal of cutaneous melanoma criteria; administrative coding updates

Effective DateAug 1, 2025

Next Review Date

Key ActionProvider must document that the patient has primary, localized uveal melanoma (supporting ICD-10 code) to support medical necessity for DecisionDx-UM testing.

SourceLink

On This Page

Investigational / Not Medically Necessary criteria

Other indications: Use of gene expression profiling for indications other than primary, localized uveal melanoma (including cutaneous melanoma)
Use for other indications is investigational
Non-specified tests: Any gene expression profiling test for uveal melanoma that is not DecisionDx-UM, unless otherwise specified and validated, is considered investigational or lacks sufficient evidence

Billing Rule

Report appropriate molecular pathology CPT/HCPCS code

When medically necessary, report the molecular pathology code 81552 for gene expression profiling (DecisionDx-UM).

81552

Documentation Required

Genetic counseling recommendation

Providers should offer or refer patients at risk for inherited disorders and undergoing genetic testing to formal genetic counseling performed by qualified personnel.

07/01/2019administrative_update

Administrative update added new codes for Pigmented Lesion Assay (PLA)/DermTech 0089U and myPath 0090U as investigational for cutaneous melanoma.

01/01/2020administrative_update

Administrative update added new code 81552 and removed end-dated code 0081U.

03/04/2020consensus_review

Consensus review — policy updated with literature; policy statements unchanged.

01/01/2021administrative_update

Administrative update added new code 81529 effective 01/01/2021.

05/26/2021consensus_review

Consensus review — no change to policy statement; background, rationale and references updated.

04/01/2022administrative_update

Administrative update added new code 0314U (listed 03/11/2022 entry).

09/09/2022consensus_review

Consensus review — policy statement unchanged; NCCN language added; FEP language revised; background, rationale and references updated.

01/01/2023administrative_update

Administrative update added new code 0357U effective 01/01/2023.

07/03/2023consensus_review

Consensus review — policy statements unchanged; references updated; coding reviewed and 0357U removed as it is a deleted code.

02/05/2024consensus_review

Consensus review — policy statement unchanged; references updated; coding reviewed and codes 81599, 84999, and 81479 removed.

10/01/2024administrative_update

Administrative update added new code 0490U effective 10/01/2024 (listed 09/18/2024 entry).

11/20/2024administrative_update

Administrative update removed NCCN statement.

02/18/2025minor_review

Material change: Policy title changed to Gene Expression Profiling for Uveal Melanoma and gene expression profiling for cutaneous melanoma criteria and information removed; references updated; coding reviewed and removed codes 0089U, 0090U, 0314U, 0490U, 81529. This is a material change.

06/10/2025administrative_updateLatest

Administrative update removing the Benefit Variations and updating the Disclaimer.