Molecular Testing in the Management of Pulmonary Nodules
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Defines medical necessity and coverage for plasma-based proteomic screening and bronchial brushing gene expression profiling used in evaluation/management of pulmonary nodules for Blue Cross Blue Shield - Rhode Island, with distinctions between Medicare Advantage Plans and Commercial products.
Policy last updated 08/17/2022; no clinical policy statement change indicated in document.
Coverage Summary
This policy defines medical necessity for molecular testing used in the evaluation and management of pulmonary nodules, specifically the bronchial gene expression profiling test Percepta (bronchial GEP) and certain plasma-based proteomic tests (e.g., Xpresys Lung2/BDX-XL2 and REVEAL). It distinguishes coverage between Medicare Advantage Plans (where these tests may be medically necessary when criteria are met) and Commercial products (which are considered not medically necessary). The policy takes a mixed coverage stance and addresses 3 tests in total.
Percepta (Bronchial Gene Expression Classifier) — Medical Necessity
Percepta (Gene expression profiling on bronchial brushings) - Medical necessity (Medicare Advantage and where applicable)
Medically necessary when ALL of the following are met:
ALL of the following
- Patient is a current or former smoker age 21 and greater
- Physician-assessed low or intermediate pretest risk of malignancy based upon clinical characteristic stratification
- Bronchoscopy is non-diagnostic (actionable benign or malignant diagnosis cannot be reached)
- PERCEPTA BGC results will be utilized to determine whether CT surveillance is appropriate in lieu of further invasive biopsies or surgical procedures
Pretest risk and nodule characteristics definitions (operational stratification provided in policy)
- Low (<10%): Nodules < 10 mm AND <10 pack-year smoking history<10% pretest risk
- Intermediate (10-60% or 10-65% described elsewhere): Nodules 10-30 mm AND 10 to 60 pack-year smoking history10-60% (10-65% appears in performance table)
- High (>60% or >65% described elsewhere): Nodules >30 mm AND >60 pack-year smoking history>60% (or >65% in performance table)
Percepta intended for current/former smokers after indeterminate bronchoscopy; high pretest risk patients generally not intended use
PERCEPTA post-test risk examples (from Table 2)
- Low pretest (<10%): PERCEPTA Negative -> Very Low (<1%); PERCEPTA Positive -> Low (<10%)
From Table 2
- Intermediate pretest (10-65%): PERCEPTA Negative -> Low (<10%); PERCEPTA Positive -> Intermediate (10-65%)
From Table 2
- High pretest (>65%): PERCEPTA Negative -> High (>65%); PERCEPTA Positive -> Very High (>85%)
From Table 2
Coding and billing
- There is no specific CPT for Percepta; claims should be filed with unlisted molecular pathology code 81479
Xpresys Lung2 (BDX-XL2) and REVEAL — Medical Necessity (Medicare Advantage)
Xpresys Lung2 (BDX-XL2) and REVEAL Lung Nodule Characterization - Medical necessity (Medicare Advantage Plans)
May be considered medically necessary when Medicare Advantage Plan medical necessity criteria is used for review (see referenced Medical Necessity policy).
ALL of the following
- Medicare Advantage medical necessity criteria are met (see Medical Necessity policy)
Refer reviewer to Medical Necessity policy as in brief
Commercial Products — Not Medically Necessary
Commercial Products - Not medically necessary
For Commercial Products the following tests are considered not medically necessary when used for pulmonary nodules:
ANY of the following
- Xpresys Lung 2 (BDX-XL2)
- Percepta Bronchial Genomic Classifier (Veracyte)
- REVEAL Lung Nodule Characterization (MagArray)
Coding
| 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 (Xpresys Lung2/BDX-XL2) |
| 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) |
| 81479 | Unlisted molecular pathology procedure (used to bill Percepta) |
Provider Actions & Billing
Prior authorization required for Xpresys Lung2 (Medicare Advantage Plans)
Prior authorization is required for Xpresys Lung2 (BDX-XL2) when submitted for Medicare Advantage Plans.
Documentation of bronchoscopy result and pretest risk
When ordering Percepta (bronchial gene expression profiling) providers must document that bronchoscopy was non-diagnostic (indeterminate) and record the physician-assessed pretest risk of malignancy as low or intermediate; Percepta results are intended to be used to decide CT surveillance versus further invasive biopsies or procedures.
Background & Evidence
Molecular tests discussed include plasma-based proteomic screening assays (example tests: Xpresys Lung2/BDX-XL2 and REVEAL Lung Nodule Characterization) and bronchial gene expression profiling (example: Percepta, a 23-gene GEP performed on bronchial brushings). These tests are used to risk-stratify pulmonary nodules to inform decisions about surveillance versus invasive diagnostic procedures. The policy notes these assays are offered as CLIA laboratory-developed tests (LDTs); Percepta is billed using unlisted molecular pathology code 81479 because no specific CPT exists for it.
| Study / Metric | Summary |
|---|---|
| Xpresys Lung2 specificity (version 2) | Specificity 97% for patients with low-to-moderate pretest probability (<50%) in a validation study; study limitations include many excluded patients and lack of independent validation |
| Percepta performance metrics | Reported ROC 0.74-0.81; negative predictive value ~91%; some missed cancers reported |
Operational Thresholds
Revision History
Policy became effective 04/01/2021 (Molecular Testing in the Management of Pulmonary Nodules).
Policy last updated 08/17/2022; document notes published/updated dates and distinguishes Medicare Advantage coverage criteria from Commercial product determinations.
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