Gene Expression Profiling for Uveal Melanoma
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This policy governs coverage of the DecisionDx-UM gene expression profile test to prognosticate metastatic risk in individuals with primary, localized uveal melanoma for Blue Cross and Blue Shield of Kansas members.
No material clinical or coverage changes in this revision.
Coverage Criteria — DecisionDx-UM
Medically necessary indication
Covered when ALL of the following are met
Policy A: DecisionDx-UM is considered medically necessary for individuals with primary, localized uveal melanoma.
DecisionDx-UM is PCR-based and accepts FNA or FFPE specimens.
Clinical context: DecisionDx-UM intended to assess 5-year metastatic risk and inform follow-up planning.
Experimental / investigational
Not covered when ANY of the following are met
Policy B: Other uses considered experimental/investigational.
Evidence considerations for coverage
Summary of coverage-relevant evidence
Section Summary: Clinically Valid — six published studies and comparisons with clinicopathologic features support prognostic performance.
Direct Evidence and Section Summary: Clinically Useful indicate absence of direct evidence; chain-of-evidence and registry/claims analyses described.
Covered Indication (referenced)
Covered when ALL of the following are met (policy-level statement referenced elsewhere in document):
Policy history added coverage statement for DecisionDx-UM for primary localized uveal melanoma; see Policy section for full criteria.
Test description specifies acceptable specimen types (FNA or FFPE).
Guidance (prognostic biopsy) recommends informed discussion prior to prognostic biopsy and documentation.
Gene expression profiling for uveal melanoma that does not meet the primary, localized uveal melanoma indication is considered experimental / investigational and is not covered.
There is no direct evidence from randomized trials that using DecisionDx-UM to select different surveillance strategies or adjuvant therapies improves patient health outcomes. Observational data show GEP classification influences management decisions, but the effect of those changes on survival or other patient-centered outcomes remains uncertain.
Tests that measure novel circulating blood-borne biomarkers for uveal melanoma surveillance should be used only within well-designed clinical trials or structured research programs and are considered investigational outside of such settings.
Using DecisionDx-UM solely to select patients for interventions (for example, more intensive surveillance or adjuvant therapy) in the absence of evidence that such management changes improve outcomes may be considered not medically necessary.
Gene expression profiling performed outside the policy's specified clinical criteria for primary, localized uveal melanoma is considered experimental / investigational and is not covered.
Covered Indications for DecisionDx-UM
Prognostic testing with DecisionDx-UM for individuals with primary, localized uveal melanoma to inform metastatic risk and surveillance planning.
Covered when ALL of the following are met
Intended to assess 5-year metastatic risk and guide surveillance frequency/intensity.
Class 1A: 2% ; Class 1B: 21% ; Class 2: 72% (5-year metastasis risks described).
Clinical context and NCCN guidance note use of DecisionDx-UM classes among factors to risk-stratify for systemic imaging and surveillance.
Prognostication of metastasis risk in posterior (choroidal and ciliary body) uveal melanoma using a 15-gene expression profile
Covered when ALL of the following are met
Onken et al and other observational studies evaluated posterior uveal melanoma cohorts.
Onken et al: GEP rendered classification in 97.2% of cases; metastasis in 1.1% of class 1 vs 25.9% of class 2 in that cohort.
Prognostication of metastatic risk in patients with primary, localized uveal melanoma (DecisionDx-UM) — NCCN context and molecular testing preference
Covered when ALL of the following are met
NCCN (v1.2024) states molecular testing preferred over cytology alone and includes DecisionDx-UM classes among factors to risk-stratify for systemic imaging.
Guidelines note risk stratification should be based on highest risk factor present; multi-parameter prognostic models may be used with molecular testing.
Coding and Billing
| 81552 | Oncology (uveal melanoma), mRNA, gene expression profiling by real-time RT- PCR of 15 genes (12 content and 3 housekeeping), utilizing fine needle aspirate or formalin-fixed paraffin-embedded tissue, algorithm reported as risk of metastasis |
| 0081U | Previously added HCPCS/PLA code that was later deleted per history (contextual) |
Provider Actions, Documentation, and Prior Authorization
Prior Authorization and Coverage Linkage
Prior authorization may be required and, when requested, the ordering provider should document the intended management plan demonstrating how the test results will influence surveillance intensity or treatment decisions (management intent). Prior authorization or coverage determination for services billed with the listed procedure codes (including CPT 81552) is contingent on meeting the Policy clinical criteria (primary, localized uveal melanoma) and submission of the required documentation.
- Prior authorization may require a statement that results will change surveillance or treatment.
- Coverage of CPT code 81552 is contingent on meeting the Policy section criteria and is medically necessary only when performed according to Policy.
Evidence Limitation Risk
There is no direct evidence that use of DecisionDx-UM to select surveillance intervals or adjuvant therapies improves health outcomes; this evidence limitation should be used as part of the justification for utilization management and prior authorization decisions.
Medical Necessity and Coverage Conditions
Services billed under the codes listed in the Coding section (for example, CPT 81552) are considered medically necessary ONLY if performed according to the Policy criteria. Tests that do not meet Policy criteria are considered experimental/investigational and are not covered.
- Tests not meeting Policy criteria will be denied as experimental/investigational.
- Document how the requested service meets the Policy definition of primary, localized uveal melanoma.
Required Documentation
Required documentation must include confirmation of diagnosis of primary, localized uveal melanoma, the type of specimen submitted (fine-needle aspirate or formalin-fixed paraffin-embedded tissue acceptable), and the DecisionDx-UM ordering details. For prior authorization, include the intended surveillance or treatment plan demonstrating how the GEP result will be used.
- Document primary, localized uveal melanoma (tumor site, staging).
- Specify specimen type and collection details (FNA acceptable).
- Attach DecisionDx-UM order form or lab requisition and intended management actions tied to possible results.
Link GEP Result to Surveillance and Management Plan
When DecisionDx-UM results are used to guide care, document explicitly how the GEP class will inform surveillance intensity or other management actions (for example, frequency of liver imaging or consideration of referral for adjuvant trials). Registry and claims analyses have demonstrated associations between GEP class and surveillance intensity; link this to the member's individualized plan.
- State how Class 1 vs Class 2 results will change surveillance (e.g., low- vs high-intensity imaging schedule).
- If results will prompt referral to oncology or enrollment in adjuvant therapy trials, document the referral plan.
Adjuvant Therapy Selection and Documentation
Selection of patients for adjuvant therapy in published trials has used combinations of GEP class and tumor size (for example, class 2 plus longest basal diameter >12 mm for the crizotinib trial). Document any intent to use GEP results as eligibility criteria for adjuvant therapy or trial enrollment, and note that available trial evidence (e.g., crizotinib) has not demonstrated a clear relapse-free survival benefit.
- If using GEP to select for adjuvant therapy, record the specific criteria (GEP class, tumor dimensions) and intended agent or trial.
- Counsel patients that adjuvant therapies selected on this basis have limited evidence of improving outcomes.
Use of Prognostic Models in Surveillance Planning
Providers should consider and document use of multi-parameter prognostic models (e.g., LUMPO) in conjunction with GEP results when planning metastatic surveillance. These models combine clinical, pathological, and genetic features and can inform decisions about surveillance intensity and duration.
- When available, include results or model-derived risk estimates (e.g., LUMPO score) in the medical record.
- For patients without genetic analyses, consider modeling with LUMPO to estimate risk and inform imaging decisions.
Eligibility Requirements
Eligibility for coverage requires documentation that the patient has primary, localized uveal melanoma, that an acceptable analytic specimen (fine-needle aspirate or formalin-fixed paraffin-embedded tissue) is available for testing, and that a fully informed discussion documenting consent for prognostic biopsy and molecular testing has occurred. Coverage is limited to testing performed as DecisionDx-UM and when the test result is expected to inform surveillance intensity or clinical management as described in the policy.
Not Covered / Experimental Uses
Use of gene expression profiling for indications other than primary, localized uveal melanoma is considered experimental / investigational and is not covered.
DecisionDx-UM is not covered when the test result will not alter patient management or when there is no evidence that changes in management prompted by the test improve health outcomes.
Novel circulating blood-borne biomarker tests intended for uveal melanoma surveillance are considered investigational and should be performed only within clinical trials or formal research programs; they are not covered for routine clinical use.
Definitions and Key Terms
Background
Uveal melanoma arises from melanocytes in the uveal tract (choroid, ciliary body, iris) and carries a substantial long-term risk of metastasis. Primary, localized tumors are treated with surgery or radiotherapy; prognosis depends on factors including tumor size, ciliary body involvement, and genetic features. Gene expression profiling with DecisionDx-UM is a 15-gene assay designed to stratify 5‑year metastatic risk and to inform surveillance intensity and shared decision-making between clinicians and patients.
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