Molecular Testing in the Management of Pulmonary Nodules (Medical Coverage Policy)
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Policy governing coverage and medical necessity criteria for plasma-based proteomic screening and gene expression profiling tests used to risk-stratify pulmonary nodules and guide whether patients proceed to invasive diagnostic procedures; applies to Medicare Advantage and Commercial products of the payer.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Nodify XL2 medical necessity
Nodify XL2 (BDX-XL2) is considered medically necessary when ALL of the following are met:
See patient age and pre-test risk criteria for additional requirements
Percepta medical necessity
Gene expression profiling on bronchial brushings (including Percepta) is medically necessary when ALL of the following are met:
Policy provides stratification examples: e.g., nodules <10 mm with <10 pack-year history considered low, nodules 10–30 mm with 10–60 pack-year history considered intermediate; see policy table for full stratification
Test is intended for use following a non-diagnostic/indeterminate bronchoscopy
Coverage stance and test-specific guidance
Coverage, utility, and test-specific stances summarized from the policy excerpt:
The policy states that REVEAL Lung Nodule Characterization (MagArray) and Nodify CDT® are not covered for Medicare Advantage Plans and are not medically necessary for Commercial Products due to insufficient evidence demonstrating improvement in net health outcome.
Specifically, the proprietary test codes 0092U (REVEAL Lung Nodule Characterization) and 0360U (Nodify CDT®) are explicitly listed in the policy as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products.
The policy notes that no recent clinical validation studies were identified for Nodify CDT® or the Nodify Lung testing strategy, and that evidence is insufficient to demonstrate that these proteomic tests improve net health outcomes. For this reason, the tests are considered not medically necessary / not covered as stated.
Codes, Billing, and Test Parameters
| 0080U | Nodify XL2 (BDX-XL2) |
| 81479 | Percepta Bronchial Genomic Classifier (gene expression profiling) |
| 0080U | Oncology (lung), mass spectrometric analysis of galectin-3-binding protein and scavenger receptor cysteine-rich type 1 protein M130, with five clinical risk factors, utilizing plasma, algorithm reported as a categorical probability of malignancy (Nodify XL2) |
| 81479 | Unlisted molecular pathology procedure (used for Percepta bronchial genomic classifier claims) |
| 0092U | Oncology (lung), three protein biomarkers, immunoassay using magnetic nanosensor technology, plasma, algorithm reported as risk score for likelihood of malignancy (REVEAL Lung Nodule Characterization) |
| 0360U | Oncology (lung), enzyme-linked immunosorbent assay (ELISA) of 7 autoantibodies (p53, NY-ESO1, CAGE, GBU4-5, SOX2, MAGE A4, and HuD), plasma, algorithm reported as a categorical result for risk of malignancy (Nodify CDT) |
Prior Authorization, Billing, and Clinical Use Actions
Prior Authorization Required
Prior Authorization is required for the Percepta® Bronchial Genomic Classifier (Veracyte) test (file claims with CPT 81479) and for Nodify XL2 (BDX-XL2, 0080U) for Medicare Advantage plans. For Commercial products, prior authorization is recommended. Absence of prior authorization for Medicare Advantage may result in claim denial.
- Prior authorization required for Percepta (claim with CPT 81479) — Medicare Advantage; recommended for Commercial.
- Prior authorization required for Nodify XL2 (BDX-XL2, 0080U) — Medicare Advantage; recommended for Commercial.
- Lack of prior authorization on Medicare Advantage members may result in denial.
Coding, Filing, and Denial Risks
Percepta claims must be filed using CPT 81479 (Unlisted molecular pathology procedure). Codes 0092U (REVEAL Lung Nodule Characterization) and 0360U (Nodify CDT®) are not covered for Medicare Advantage and are not medically necessary for Commercial products; use of non-covered codes may trigger denials. Nodify XL2 (0080U) is covered when medical criteria are met but prior authorization requirements apply.
Documentation and Clinical Sequencing Context
Document clinical rationale connecting test use to management decisions: both Percepta and Nodify XL2 are intended to guide the choice between active surveillance (serial CT) and invasive diagnostic procedures following an indeterminate bronchoscopy or evaluation of pulmonary nodules. Include the patient's pre-test risk assessment, bronchoscopy result, specimen collection details (for Percepta: bronchial epithelial cytology brushings stored in RNA preservative at 4°C), and how the classifier result changed intended management.
- For Percepta include: indication (indeterminate bronchoscopy), pre-test risk category, specimen type and handling (bronchial brushings in RNA preservative, stored at 4°C), and post-test management plan (surveillance vs invasive procedure).
- For Nodify XL2 include: clinical risk assessment for pulmonary nodule, intended use as rule-out (likely benign) to support surveillance, and documentation of how result affected plan.
Clinical Context and Policy Scope
Pulmonary nodules are commonly detected on chest imaging; the central clinical decision is estimating the probability of malignancy to determine whether invasive diagnostic procedures (CT-guided biopsy, bronchoscopy, or surgery) are needed versus noninvasive management such as serial CT surveillance. Molecular tests, including plasma-based proteomic assays and bronchial gene expression profiling, have been developed to improve risk stratification and may help identify nodules at lower or higher risk of cancer so clinicians can choose CT surveillance instead of immediate invasive procedures when appropriate. However, the policy highlights that for some proteomic tests (for example Nodify CDT® and REVEAL), the available evidence is insufficient to confirm clinical benefit.
Key Terms and Test Descriptions
Policy Revision History
Policy effective date (Medical Coverage Policy — Molecular Testing in the Management of Pulmonary Nodules).
Policy last reviewed on this date as documented in the policy header.
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