CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Molecular Testing in the Management of Pulmonary Nodules

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 Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMolecular Testing in the Management of Pulmonary Nodules

Policy CodePolicy N/A

Change TypeClarified (dates updatedno clinical policy change)

Effective DateApr 1, 2021

Next Review Date

Key ActionFor Medicare Advantage Plans obtain prior authorization for Xpresys Lung2 (BDX-XL2); document non-diagnostic bronchoscopy and physician-assessed low or intermediate pretest risk when ordering Percepta and file Percepta claims with unlisted molecular pathology code 81479.

SourceLink

POLICY UPDATE CHANGES

Policy last updated 08/17/2022; no clinical policy statement change indicated in document.

3Tests addressed

Medicare vs CommercialCoverage distinction

Percepta NPV ~91%Reported negative predictive value

Coverage Summary

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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.

Key quick facts

Tests addressed3

Coverage distinctionMedicare vs Commercial

Percepta NPV~91% (reported in literature)

Effective date2021-04-01

Last review date2022-08-17

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

Title: Percepta (Gene expression profiling on bronchial brushings) - Medical necessity (Medicare Advantage and where applicable)

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

Test is Xpresys Lung2 (BDX-XL2, CPT 0080U) or REVEAL Lung Nodule Characterization (CPT 0092U) or equivalent plasma-based proteomic screening
Medicare Advantage medical necessity criteria are met (see Medical Necessity policy)
Refer reviewer to Medical Necessity policy as in brief

Prior authorization: Prior Authorization is required for Xpresys Lung2 (BDX-XL2) for Medicare Advantage Plans

Coding: Covered CPT codes for Medicare Advantage when criteria met include 0080U (Xpresys Lung2) and 0092U (REVEAL); Percepta billed with 81479

Title: Xpresys Lung2 (BDX-XL2) and REVEAL Lung Nodule Characterization - Medical necessity (Medicare Advantage Plans)

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)

Title: Commercial Products - Not medically necessary

Coding

Covered codes for Medicare Advantage Plans when criteria metCPTCovered

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)

Not medically necessary for Commercial ProductsmixedNot Covered

0080U	Xpresys Lung2 / BDX-XL2
0092U	REVEAL Lung Nodule Characterization
81479	Percepta (no specific CPT)

Provider Actions & Billing

Prior Authorization

Prior authorization required for Xpresys Lung2 (Medicare Advantage Plans)

Prior authorization is required for Xpresys Lung2 (BDX-XL2) when submitted for Medicare Advantage Plans.

0080U

Documentation Required

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.

81479

Billing Rule

Billing Percepta

There is no specific CPT for Percepta; claims should be filed using the unlisted molecular pathology procedure code 81479.

81479

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

Definitions

Bronchoscopy non-diagnostic (indeterminate)Bronchoscopy that does not yield an actionable benign or malignant diagnosis; Percepta is indicated following such a result in current/former smokers.

Proteomic screeningPlasma-based assays measuring multiple protein biomarkers (e.g., mass spectrometry or immunoassay) to estimate probability/risk of malignancy for pulmonary nodules.

Operational Thresholds

Thresholds / Examples

Percepta pretest risk categoriesLow <10%; Intermediate 10-60% (10-65% appears in performance table); High >60% (or >65% in performance table)

Percepta post-test risk examples (from Table 2)If pretest Low (<10%): Percepta Negative -> Very Low (<1%); Percepta Positive -> Low (<10%). If pretest Intermediate (10-65%): Negative -> Low (<10%); Positive -> Intermediate (10-65%). If pretest High (>65%): Negative -> High (>65%); Positive -> Very High (>85%).