CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Management of Pulmonary Nodules — Molecular

Policy governs use and coverage of molecular tests (plasma-based proteomic screening and bronchial brushing gene expression profiling) in the diagnostic workup of pulmonary nodules for Blue Cross Blue Shield - Rhode Island Medicare Advantage and commercial products as described in the document segments provided.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyManagement of Pulmonary Nodules — Molecular (coverage of Percepta, Xpresys Lung 2, REVEAL)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date04|01 2021

Next Review DateN/A

Key ActionObtain and document prior authorization and physician-assessed pretest risk and indeterminate bronchoscopy result before ordering Percepta or Xpresys Lung 2.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3named tests addressed

91%NPV reported

97%specificity (proteomic v2)

0.74–0.81Percepta AUC

81479Percepta billed

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Coverage Criteria

GEP (Percepta) Initial criteria

Gene expression profiling on bronchial brushings (not limited to Percepta) is medically necessary when ALL of the following are met:

Percepta/GEP medical necessity: Patient is a current or former smoker age 21 years or older.age >= 21

From Medicare Advantage criteria; patient smoking history must be documented.

Percepta/GEP medical necessity: Physician-assessed low or intermediate pretest risk of malignancy using clinical characteristic stratification (examples in policy: intermediate risk 10–30 mm nodule with 10–60 pack-year smoking history; high risk >30 mm and >60 pack-year).pretest risk = low or intermediate

Pretest risk must be assessed and documented by the physician.

Percepta/GEP medical necessity: Bronchoscopy performed and result is non-diagnostic (an actionable benign or malignant diagnosis cannot be reached).bronchoscopy = non-diagnostic

Documentation of indeterminate bronchoscopy required.

Percepta/GEP medical necessity: PERCEPTA BGC results will be used to determine whether CT surveillance is appropriate in lieu of further invasive biopsy or surgical procedures.

Intended clinical use is to inform decision for surveillance versus additional invasive procedures.

Proteomic screening criteria

Plasma-based proteomic screening (e.g., Xpresys/Lung 2, REVEAL) may be considered medically necessary when reviewed using the Medicare Advantage medical necessity criteria referenced by the policy.

Proteomic screening: Proteomic plasma assays are used to risk-stratify pulmonary nodules to increase the number of patients managed with serial CT surveillance (active surveillance) rather than invasive diagnostic procedures; a likely malignant test result would indicate invasive diagnostic procedures.

Policy references Medicare Advantage criteria and validation studies; evidence for version 2 reports high specificity (97%) but overall evidence judged insufficient to demonstrate improved net health outcome.

Coverage summary

Coverage statements present in the document excerpts:

Commercial Products - PERCEPTA: For commercial products, evidence is insufficient to determine that PERCEPTA after indeterminate bronchoscopy improves net health outcome; concerns include missed cancers and lack of validation in other populations (reported studies: ROC 0.74–0.81; NPV 91%).

Supportive multicenter prospective studies exist but generalizability and clinical pathway placement are uncertain.

Medicare Advantage - Proteomic tests (Xpresys/REVEAL): Specific molecular/proteomic tests (e.g., Xpresys Lung 2 BDX-XL2 and REVEAL Nodule Characterization) have HCPCS/CPT codes listed and are covered for Medicare Advantage when the criteria are met; Xpresys noted as not medically necessary for Commercial Products.

Codes referenced: OO8OU (Xpresys Lung 2); REVEAL coding noted elsewhere (0092U).

The policy identifies specific tests that are considered not medically necessary for Commercial Products when evidence is insufficient to demonstrate improvement in net health outcome. These tests include the Percepta Bronchial Genomic Classifier (Veracyte) and the REVEAL Lung Nodule Characterization (MagArray). Benefits and coverage may vary by group or contract; refer to the member’s Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for definitive coverage determinations.

For Medicare Advantage Plans, the policy lists specific proteomic tests such as Xpresys Lung 2 (BDX-XL2) as covered when the plan’s medical necessity criteria are met and the associated code (e.g., OO8OU) is billed. However, the same test is described as not medically necessary for Commercial Products under this policy.

The document states that the Percepta Bronchial Genomic Classifier (Veracyte) and the REVEAL Lung Nodule Characterization (MagArray) are not medically necessary for Commercial Products due to insufficient evidence to show an improvement in net health outcome.

The policy notes that evidence for bronchial brushing gene expression profiling (Percepta) includes multicenter prospective studies reporting test accuracy metrics (reported AUC 0.74–0.81 and NPV 91%). Despite these performance measures, the evidence base showed a relatively high number of missed cancers and lacked validation in other populations, leading to a conclusion of insufficient evidence for Commercial Products.

Coding and Billing

Named CPT code referencedCPT

81479

Percepta (CPT code listed)

Percepta billingCPTCovered

81479

Unlisted molecular pathology procedure

Xpresys Lung 2BDX-XL2 (Medicare Advantage coverage group)HCPCSCovered

OO8OU

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 a categorical probability of malignancy (Xpresys/Lung 2BDX-XL2)

REVEAL Nodule CharacterizationHCPCSCovered

0092U

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

inv-12: Age — Current or former smokers age 21 and greater.

AgeCurrent or former smokers age 21 and greater

Smoking status requirementMust be a current or former smoker

Applicable plan contextMedicare Advantage Plans (Percepta CPT 81479)

inv-13: Nodule size / smoking pack-year risk stratification — Pretest risk categories with size and pack-year thresholds.

Intermediate pretest riskNodules 10–30 mm with 10–60 pack-year smoking history

Low pretest risk example

Provider Actions, Documentation & Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for selected tests for Medicare Advantage Plans. Providers must obtain prior authorization before performing Percepta Bronchial Genomic Classifier (Percepta BGC) or Xpresys/Lung2 for Medicare Advantage members.

Prior authorization required for Percepta (Percepta Bronchial Genomic Classifier, Veracyte) and Xpresys Lung 2 for Medicare Advantage Plans.

Documentation Required

Specimen and Handling Documentation Required

Percepta is performed on bronchial epithelial cell brushings collected during bronchoscopy and stored in an RNA preservative at 4°C immediately after collection. Documentation of the specimen type and handling must be available in the medical record.

Specimen: cytology brushings of bronchial epithelial cells collected during bronchoscopy (mainstem bronchus).
Storage: placed in RNA preservative and refrigerated at 4°C immediately after collection.

Background

Pulmonary nodules are frequently detected incidentally on imaging. The central clinical question in management is the probability of malignancy for a given nodule because that determines whether to pursue serial imaging surveillance or proceed to invasive diagnostic procedures (for example, CT-guided biopsy, bronchoscopy, or video-assisted thoracoscopic surgery). These invasive procedures carry risks such as pneumothorax and other procedure-related morbidities; molecular tests (proteomic plasma assays and bronchial brush gene expression profiling) have been proposed to refine risk stratification to avoid unnecessary invasive testing.

Definitions

inv-23: Proteomics — definition and methods summary.

DefinitionProteomics is the study 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 (protein ionization and fragment mass/composition analysis).

Clinical useProposed to identify and manage diseases including cancer by measuring protein characteristics in bodily materials.

inv-24: Gene expression profiling (GEP) — definition: measurement of gene activity (mRNA).

DefinitionGene expression profiling (GEP) measures activity of genes within cells by assessing messenger RNA (mRNA).

Measurement techniques