CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Molecular Testing in the Management of Pulmonary Nodules — Coverage Criteria

This policy governs the medical necessity, prior authorization, and coverage stance for plasma-based proteomic screening and bronchial brushing gene expression profiling used in the diagnostic workup of pulmonary nodules for Blue Cross Blue Shield - Rhode Island Medicare Advantage and commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMolecular Testing in the Management of Pulmonary Nodules

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2021

Next Review DateN/A

Key ActionObtain prior authorization for Percepta and Xpresys Lung 2 when providing testing for Medicare Advantage members and document physician-assessed pretest risk and bronchial brushing specimen handling.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3molecular tests addressed

97%reported specificity

91%reported NPV

No CPTno specific CPT for Percepta

Covered

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Coverage Criteria

Percepta (Bronchial Genomic Classifier) — Medicare Advantage

Covered when ALL of the following are met:

Percepta Medicare Advantage criteria: Patient is a current or former smoker aged >= 21; physician-assessed low or intermediate pretest risk of malignancy using clinical risk stratification; bronchoscopy was non-diagnostic (no actionable benign or malignant diagnosis obtained); Percepta Bronchial Genomic Classifier (BGC) results will be used to determine whether CT surveillance is appropriate instead of further invasive biopsy or surgical procedures.age >=21; low or intermediate pretest risk as assessed by physician

Intended for use following an indeterminate bronchoscopy to guide management of pulmonary nodules

Plasma-based proteomic screening

Coverage statements vary by product and plan:

Proteomic screening - Medicare Advantage: Xpresys Lung 2 (BDX-XL2) and REVEAL Lung Nodule Characterization may be considered medically necessary for Medicare Advantage when the BlueCHiP for Medicare medical necessity criteria are used for review.Use BlueCHiP for Medicare criteria

See related Medical Necessity policy for specific review criteria; prior authorization may be required for listed assays

Proteomic screening - Commercial: Coverage for plasma-based proteomic screening (e.g., Xpresys Lung 2, REVEAL) varies by commercial contract; benefits and medical necessity determinations depend on the member's plan and contract.Varies by commercial contract

Refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement

Not medically necessary — Commercial

Not medically necessary - Commercial: Percepta Bronchial Genomic Classifier (Veracyte) and REVEAL Lung Nodule Characterization (MagArray) are considered not medically necessary for Commercial Products due to insufficient evidence to determine effects on health outcomes.Commercial product plans

Benefits may vary between groups and contracts; refer to the appropriate Benefit Booklet or Evidence of Coverage.

Coverage by product

Coverage stance varies by product:

Commercial Products - PERCEPTA: For individuals with undiagnosed pulmonary nodules following indeterminate bronchoscopy, gene expression profiling of bronchial brushings (Percepta) has insufficient evidence to determine effects on health outcomes and is therefore not supported as medically necessary for Commercial Products in this policy context.

Although studies report ROC 0.74–0.81 and NPV approximately 91% in selected populations, missed cancers and lack of external validation were noted.

Medicare Advantage - Selected assays: Certain assays (for example, Xpresys Lung 2 and REVEAL Lung Nodule Characterization) are covered for Medicare Advantage plans when the specified Medicare Advantage criteria are met.

Specific coverage is contingent on meeting Medicare Advantage criteria described elsewhere in the policy; prior authorization may be required for listed tests.

Percepta (Bronchial Genomic Classifier) and REVEAL Lung Nodule Characterization are listed as not medically necessary for Commercial Products in this policy because the available evidence is judged to be insufficient to determine their effects on health outcomes. Benefits may vary by group and contract, so refer to the member's benefit booklet or subscriber agreement for specific coverage details.

For Percepta used in individuals with undiagnosed pulmonary nodules after an indeterminate bronchoscopy, the policy notes that although prospective multicenter studies report test accuracy metrics (receiver operating characteristic values of 0.74–0.81 and a reported negative predictive value of 91% in selected cohorts), there were a relatively high number of missed cancers and no validation in other populations. The policy therefore considers the evidence insufficient and indicates uncertainty about where Percepta would be placed in the clinical pathway outside of the post‑bronchoscopy setting; as a result, Percepta is not supported as medically necessary for Commercial Products.

This policy explicitly lists the Percepta Bronchial Genomic Classifier (Veracyte) and REVEAL Lung Nodule Characterization (MagArray) as not medically necessary for Commercial Products due to insufficient evidence to establish clinical benefit. Providers and payers should treat these assays as noncovered under Commercial plans per the policy statement unless the member’s contract specifies otherwise.

Percepta gene expression profiling is evaluated in the specific context of patients with undiagnosed pulmonary nodules following an indeterminate bronchoscopy. The policy’s assessment and limitations apply to that scope: reported performance characteristics derive from selected study populations, missed cancers were observed, and external validation is lacking. Consequently, the policy limits support for Percepta to contexts that meet validated criteria and notes uncertainty about use of the test at other points in the diagnostic pathway.

Coding and Billing

Referenced CPT/PLA CodeCPT

0092U

Nodule Characterization (0092U) Lung

Percepta coding guidanceCPT

81479

Unlisted molecular pathology procedure

Xpresyse LungHCPCSCovered

008OU

Oncology (lung), mass spectrometric analysis of galectin-3-binding protein and scavenger receptor cysteine-rich type 1 protein M130, with five clinical risk factors, plasma, algorithm reported as categorical probability of malignancy

REVEAL Lung Nodule CharacterizationHCPCSCovered

0092UU

Oncology (lung), three protein biomarkers, immunoassay magnetic nanosensor technology, plasma, algorithm reported as risk score for likelihood of malignancy (REVEAL Lung Nodule Characterization)

Age for Percepta testing

Age eligibility>= 21 years

Smoking history categories referenced

Smoking statusCurrent or former smokers

Pack‑year risk notesPack‑year categories referenced for risk stratification (examples in policy: <10 pk/yr, 10–60 pk/yr, >60 pk/yr)

Clinical contextGEP applied to airways of current or former smokers after indeterminate bronchoscopy to assess malignancy risk

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Medicare Advantage plans for select tests. Prior authorization must be obtained before performing Percepta Bronchial Genomic Classifier (Percepta BGC) and Xpresys Lung 2 for members covered under Medicare Advantage.

Affected tests: Percepta Bronchial Genomic Classifier (Veracyte) and Xpresys Lung 2 (Integrated Diagnostics).
Claims filing guidance for Percepta: use unlisted molecular pathology code 81479.
Prior authorization applies to Medicare Advantage only; these tests are not covered for Commercial Products unless criteria met.

Note

Clinical Pathway Positioning for Percepta

For Medicare Advantage members, gene expression profiling on bronchial brushings (including Percepta) is positioned for current or former smokers age ≥21 following an indeterminate (non-diagnostic) bronchoscopy. The test is intended to inform management (CT surveillance versus further invasive biopsy/surgery) when the physician-assessed pretest probability of malignancy is low or intermediate.

Background

Pulmonary nodules require estimation of malignancy probability to guide management between surveillance and invasive diagnostic procedures. Invasive tests such as CT‑guided biopsy, bronchoscopy, or surgical resection carry procedure‑related risks, so molecular assays have been proposed to improve risk stratification and reduce unnecessary invasive testing. This policy evaluates plasma proteomic classifiers and bronchial‑brushing gene expression profiling (eg, Percepta) as adjuncts to the diagnostic workup, but notes limited and inconsistent evidence for impact on patient‑centered outcomes. For Percepta specifically, studies report modest discriminatory performance and a reported NPV of 91% in selected cohorts but also documented missed cancers and lack of broader validation; therefore the policy does not support routine use of these molecular tests for Commercial Products and emphasizes that coverage varies by product and contract.

Definitions

Proteomics

DefinitionStudy of the structure and function of proteins, including concentration, structure, and other characteristics in tissues and fluids

Common methodsImmunoassays (antibody‑based detection) and mass spectrometry (ionization and mass/composition analysis)

Clinical useUsed to identify and characterize proteins as potential disease biomarkers, including cancer

Gene expression profiling (GEP)

DefinitionMeasurement of gene activity (messenger RNA) within cells to assess gene expression profiles

TechniquesIncludes Northern blots, RPA, in situ hybridization, cDNA and oligonucleotide arrays, RT‑PCR, and transcriptome sequencing