Plasma-based proteomic screening and bronchial gene expression profiling for pulmonary nodules
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Policy governing coverage and prior authorization requirements for specific proteomic and gene-expression molecular tests used to risk-stratify pulmonary nodules for Medicare Advantage and Commercial Products in Rhode Island.
Effective 11/1/2025, Nodify XL2 (BDX-XL2) (CPT 0080U) and Percepta® Bronchial Genomic Classifier (CPT 81479) are considered medically necessary when the medical criteria in the online authorization tool are met.
Nodify CDT® (0360U) is listed as covered, and REVEAL Lung Nodule Characterization (0092U) is not covered / not medically necessary.
Coverage Criteria
General coverage logic and test-specific stance
Covered or medically necessary when ALL of the following programmatic conditions are met via the payer's online authorization tool:
Applies to tests listed as 'may be considered medically necessary' and unlisted genetic testing CPT codes; laboratories are not permitted to obtain authorization on behalf of the ordering provider; services provided without required prior authorization will be denied and billed to the laboratory.
See Coding section for CPT code details and the effective date for medically necessary designation (11/1/2025).
Some self-funded commercial groups may have contract exclusions that limit coverage of certain genetic testing services, including expanded biomarker testing required under Rhode Island law. For plan-specific determinations, refer to the member's Benefit Booklet and the Coding sections of the Genetic Testing Services and Proprietary Laboratory Analyses policies. When a contract exclusion applies, the excluded services will not be covered for that group even if the tests are otherwise listed in this policy.
REVEAL Lung Nodule Characterization (MagArray; CPT 0092U) is not covered for Medicare Advantage Plans and is not medically necessary for Commercial Products due to insufficient evidence of improved net health outcome. CPT descriptor: "Oncology (lung), three protein biomarkers, immunoassay using magnetic nanosensor technology, plasma, algorithm reported as risk score for likelihood of malignancy (REVEAL Lung Nodule Characterization)."
Coding and Test Status
| 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® Biodesix, Inc.) |
| 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) |
Provider Actions and Authorization
Prior Authorization Required
Prior Authorization is required for Percepta® (CPT 81479) and Nodify XL2 (CPT 0080U) for Medicare Advantage Plans and is recommended for Commercial Products. All unlisted genetic testing CPT codes also require prior authorization to verify the service rendered and coverage applicability.
Laboratory Participation Prohibited
Laboratories are not permitted to obtain clinical authorization or otherwise participate in the authorization process on behalf of the ordering physician. Use of a laboratory representative or third party to obtain authorization or to assist in appeals is a violation and may result in severe action, including termination from the BCBSRI provider network.
- Only the ordering physician may be involved in authorization, appeal, or other administrative processes related to prior authorization/medical necessity
- If a laboratory provides a service that was not authorized, the service will be denied and billed to the laboratory — the member may not be billed
Authorization and Documentation Requirements
Providers must request prior authorization using BCBSRI’s online authorization tool and meet the medical criteria posted in that tool for tests to be considered medically necessary. All required documentation of clinical appropriateness must be completed by the ordering physician.
- Authorization must be obtained through the payer's online authorization tool for participating providers
- Medical criteria in the online tool must be met for coverage determination
- Ordering physician is responsible for preparing and submitting documentation
Denial Risk for Unauthorized Services
Services provided without the required prior authorization — including authorizations obtained by laboratories or third parties on behalf of the ordering physician — will be denied. Denied laboratory-obtained or unauthorized services will be the financial liability of the laboratory and may not be billed to the member.
- Unauthorized services will be denied and billed to the laboratory
- BCBSRI may take severe action if a laboratory or third party is found to have supported the authorization process
Background
Pulmonary nodules are commonly identified on imaging and require risk stratification to estimate the likelihood of malignancy and guide management decisions between surveillance and invasive diagnostic procedures. Proteomic tests measure protein biomarkers in plasma and gene expression profiling assesses mRNA patterns in airway or tissue samples; both approaches have been investigated as adjuncts to clinical and radiographic risk models to reduce unnecessary biopsies or surgeries. Evidence for these technologies varies by test and, for some assays, is currently insufficient to demonstrate an improvement in net health outcomes.
Definitions
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