CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Gene Expression Profiling for Cutaneous Melanoma

Defines medical necessity, prior authorization, and coding for gene expression profiling tests for cutaneous melanoma (DecisionDx-Melanoma CPT 81529, myPath Melanoma CPT O090U, Pigmented Lesion Assay CPT OO89U) for Medicare Advantage and commercial products; includes clinical criteria for when tests are considered medically necessary and coverage distinctions among tests.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Gene Expression Profiling for Cutaneous Melanoma

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2024

Next Review Date

Key ActionPrior authorization is required for DecisionDx-Melanoma (CPT 81529) and myPath Melanoma (CPT O090U); Pigmented Lesion Assay (CPT OO89U) is covered without authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes.

3Tests addressed

2Require prior auth

1Covered without auth

Coverage Summary

Scope: Defines medical necessity, prior authorization, and coding for gene expression profiling tests for cutaneous melanoma — DecisionDx-Melanoma (CPT 81529), myPath Melanoma (CPT O090U), and Pigmented Lesion Assay (CPT OO89U) — for Medicare Advantage and commercial products; includes clinical criteria for when tests are considered medically necessary and coverage distinctions among tests.

Medical-Necessity Criteria

DecisionDx-Melanoma (CPT 81529) - Medically Necessary

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

ALL of the following

Patient diagnosed with cutaneous melanoma tumor with clinically negative sentinel node basins (clinically node negative defined as negative physical examination and preoperative ultrasound) who are considered for sentinel lymph node biopsy (SLNB) to determine eligibility for adjuvant therapy
Cutaneous melanoma > 0.3 mm in Breslow thickness without distant metastases where additional information beyond anatomic and pathologic staging is needed> 0.3 mm
Test will aid in the determination of appropriate adjuvant therapy
Test will influence the decision to perform sentinel lymph node biopsy (T1-T2 only)
ONE of the following adverse features
- Very high mitotic index (>= 22/mm2)>= 22/mm2
- Lymphovascular invasion
- Combination of adverse features
OR
- Significant uncertainty about adequacy of microstaging (e.g., positive deep margin)

myPath Melanoma (CPT O090U) - Medically Necessary

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

ALL of the following

Test is ordered by a board-certified dermatopathologist
Lesion is a non-metastatic, melanocytic lesion that has not been previously treated
Testing is an adjunct to histopathology because a clear distinction between benign and malignant cannot be made using clinical characteristics and histopathological features alone
Results will be used in conjunction with clinical evaluation, histopathological features and other diagnostic procedures to determine and/or alter the treatment plan
Patient may be subjected to additional intervention (e.g., re-excision and/or sentinel lymph node biopsy) as a result of diagnostic uncertainty

Pigmented Lesion Assay (PLA) (CPT OO89U) - Coverage statement

Coverage designation provided by policy:

Coverage designation: Pigmented Lesion Assay is listed as covered (the policy states: 'The following test is covered: Pigmented Lesion Assay')

Covered without prior authorization per policy

Coding

Covered CPT - 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 - 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 a categorical result (ie, benign, intermediate, malignant)

Covered CPT without authorization - Pigmented Lesion AssayCPTCovered

OO89U

Oncology (melanoma), gene expression profiling by RT-qPCR, PRAME and LINC00518, superficial collection using adhesive patch(es)

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for DecisionDx‑Melanoma (CPT 81529) and myPath Melanoma (CPT O090U) for Medicare Advantage Plans and Commercial Products. The Pigmented Lesion Assay (CPT OO89U) is covered without prior authorization.

Affected codes requiring prior authorization: 81529, O090U
Pigmented Lesion Assay (OO89U) is covered without authorization

Documentation Required

Ordering and authorization restrictions

Only the ordering physician may be involved in the authorization, appeal, and other administrative processes related to authorization and medical necessity. Laboratories, providers using laboratory representatives, or third parties are not permitted to obtain authorization on behalf of the ordering physician; doing so is a violation and may result in termination from the BCBSRI provider network and denial of payment.

Enforcement note: Laboratories or third parties found to support or obtain authorization on behalf of the ordering physician will be deemed in violation and may face termination from the BCBSRI provider network and denial of payment.

Billing Rule

Financial liability for unauthorized services

If a laboratory provides a laboratory service that has not been authorized, the service will be denied and the financial liability will fall on the participating laboratory; the laboratory may not bill the member for that unauthorized service.

Background

Gene expression profiling (GEP) assays measure the expression of multiple genes to aid diagnosis, prognosis, and clinical management decisions in cutaneous melanocytic lesions. The policy addresses: DecisionDx-Melanoma, a 31-gene prognostic test performed on formalin-fixed, paraffin-embedded tissue (28 prognostic genes and 3 endogenous controls) that reports a risk class and is intended to inform metastatic risk and sentinel lymph node considerations; myPath Melanoma, a 23-gene diagnostic adjunct (14 content genes and 9 housekeeping genes) performed on FFPE tissue that provides an algorithmic score and categorical classification to assist histopathology; and the noninvasive Pigmented Lesion Assay, which measures PRAME and LINC00518 (plus normalization genes) from adhesive patch superficial collections and reports risk categories and an algorithmic score.

Definitions

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

Name	Number	Type
MolDX: Pigmented Lesion Assay	L38151	LCD
MolDX: myPath Melanoma	L37859	LCD
MolDX: Melanoma Risk Stratification Molecular Testing	L37750	LCD