CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Plasma-based proteomic screening and bronchial gene expression profiling for pulmonary nodules

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.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyPlasma-based proteomic screening and bronchial gene expression profiling for pulmonary nodules

Policy CodePolicy N/A

Change TypeCoverage & coding updates (tests added/revised)

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionOrdering providers must obtain prior authorization via the payer's online authorization tool and meet the medical criteria there for tests considered medically necessary.

SourceLink

POLICY UPDATE CHANGES

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.

2medically necessary (effective 11/1/2025)

1currently covered

1not covered

Required

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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:

Authorization and criteria: Ordering provider obtains prior authorization via the online tool and meets the medical criteria specified there for the test

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.

Test-specific coverage: Coverage stance varies by test: Nodify CDT (CPT 0360U) is covered; Nodify XL2 (CPT 0080U) and Percepta Bronchial Genomic Classifier (CPT 81479) may be considered medically necessary when the online authorization tool criteria are met (effective 11/1/2025); REVEAL Lung Nodule Characterization (CPT 0092U) is not covered / not medically necessary.

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

Covered CPT CodesCPTCovered

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.)

Medically necessary with prior authorization (effective 11/1/2025)CPT | HCPCS | mixedCovered

0080U	Nodify XL2 (BDX-XL2) - may be considered medically necessary when criteria met
81479	Percepta® Bronchial Genomic Classifier - may be considered medically necessary when criteria met

Not Covered / Not Medically NecessaryCPTNot Covered

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)

REVEAL score threshold

REVEAL score cut point50 (single cut point on a 0–100 scale)

Score range0 to 100

Components used in score3 clinical factors (age, sex, nodule diameter) plus 3 proteins (EGFR, pro-surfactant protein B, TIMP1)

REVEAL intended nodule size

Intended nodule size range4 to 30 mm

Target populationCurrent smokers 25 years of age and older

Provider Actions and Authorization

Prior 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.

Percepta® Bronchial Genomic Classifier — CPT 81479
Nodify XL2 (BDX-XL2) — CPT 0080U
All unlisted genetic testing CPT codes require prior authorization

Denial Risk

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.

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

Proteomics — definition and methods

DefinitionProteomics: study of the structure and function of proteins, including concentration, structure, and other characteristics in tissues and fluids.

ImmunoassaysUse antibodies to detect protein concentration and/or structure (e.g., multi‑analyte immunoassay technology).

Mass spectrometryAnalytic technique that ionizes proteins into fragments to determine mass and composition for identification and characterization.

Gene expression profiling (GEP)

DefinitionGene expression profiling (GEP): measurement of gene activity within cells using mRNA as the bridge between DNA and proteins to assess risk for malignancy.

Molecular techniquesExamples include Northern blots, ribonuclease protection assay, in situ hybridization, cDNA arrays, oligonucleotide arrays, RT‑PCR, and transcriptome sequencing.