CurrentBlue Cross Blue Shield - MassachusettsPolicy 029

Molecular Testing in the Management of Pulmonary Nodules prn.pdf

Defines Blue Cross Blue Shield Massachusetts commercial coverage stance for plasma-based proteomic screening tests (e.g., Nodify XL2, Nodify CDT, REVEAL) and bronchial brush gene expression profiling (Percepta GSC) in the management of CT-detected pulmonary nodules, including prior authorization requirements and coding designations as investigational.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyMolecular Testing in the Management of Pulmonary Nodules prn.pdf

Policy CodePolicy 029

Change TypeRevised (includes REVEAL additionannual review)

Effective DateOct 1, 2024

Next Review Date

Key ActionPrecertification/preauthorization is required for all products if the procedure is performed inpatient.

SourceLink

POLICY UPDATE CHANGES

Policy updated to include the REVEAL Nodule Characterization test.

Annual policy review with literature update through March 27, 2025; references added; minor editorial refinements; intent unchanged.

2Test types designated investigational (proteomic; bronchial GEP)

0092U, 0088UExample investigational CPT codes listed

Coverage Summary

Policy 029 defines the commercial coverage stance for molecular testing in CT-detected pulmonary nodules: plasma-based proteomic screening tests (examples: Nodify XL2, Nodify CDT, REVEAL Lung Nodule Characterization) and bronchial brush gene expression profiling (example: Percepta GSC) are considered INVESTIGATIONAL for Commercial Members.

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Surface header facts

policy_number029

effective_date2024-10-01

last_review2025-07-01

statusCURRENT

scope_summaryDefines Blue Cross Blue Shield Massachusetts commercial coverage stance for plasma-based proteomic screening tests (e.g., Nodify XL2, Nodify CDT, REVEAL) and bronchial brush gene expression profiling (Percepta GSC) in the management of CT-detected pulmonary nodules, including prior authorization requirements and coding designations as investigational.

subjectMolecular testing for pulmonary nodules (proteomic screening and bronchial gene expression profiling)

Medical Necessity & Authorization Criteria

Proteomic plasma-based screening (Commercial Members)

Policy statements for plasma-based proteomic screening tests for undiagnosed pulmonary nodules detected by CT:

ALL of the following

Plasma-based proteomic screening (including but not limited to Nodify XL2, Nodify CDT, REVEAL Lung Nodule Characterization) in individuals with undiagnosed pulmonary nodules detected by computed tomography is considered INVESTIGATIONAL

Gene expression profiling of bronchial brushings (Percepta GSC)

Policy statements for bronchial gene expression profiling following bronchoscopy:

ALL of the following

Gene expression profiling on bronchial brushings (including but not limited to Percepta Genomic Sequencing Classifier) in individuals with indeterminate bronchoscopy results from undiagnosed pulmonary nodules is considered INVESTIGATIONAL

Prior Authorization / Precertification

Authorization requirements for services described in this policy:

ANY of the following

Precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient
Outpatient: For Commercial Managed Care (HMO and POS) the outpatient service is not a covered service
Outpatient: For Commercial PPO and Indemnity the outpatient service is not a covered service

Coding

Investigational CPT codes (Commercial Members: Managed Care)CPTExperimental

0092U	Oncology (lung), three protein biomarkers; immunoassay using magnetic nanosensor technology, plasma; algorithm reported as risk score for likelihood of malignancy
0088U	Oncology (lung), mass spectrometric analysis of galectin-3-binding protein and scavenger receptor cysteine-rich type 1 protein M130, with five clinical risk factors (age, smoking status, nodule diameter, nodule-spiculation status and nodule location), utilizing plasma; algorithm reported as a categorical probability of malignancy

Provider Actions & Operational Impact

Prior Authorization

Precertification required for inpatient procedures

Precertification/preauthorization is required for all products if the procedure is performed inpatient.

Applies when the procedure is performed inpatient

Documentation Required

Report services with industry-standard codes

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

Include procedure, revenue, and diagnosis codes and relevant modifiers

Denial Risk

Outpatient coverage exclusion for Commercial plans

Outpatient plasma-based proteomic or bronchial gene expression profiling testing is not a covered outpatient service for Commercial Managed Care (HMO and POS), Commercial PPO, and Indemnity members.

Commercial Managed Care (HMO and POS)
Commercial PPO
Indemnity

Background & Evidence Summary

Molecular tests such as plasma proteomics and bronchial gene expression profiling have been proposed to risk-stratify CT-detected pulmonary nodules to guide management decisions (active surveillance versus invasive diagnostic procedures). The evidence base includes prospective cohorts, retrospective studies, and validation studies for specific assays (eg, Nodify XL2 evolution and REVEAL retrospective validation; Percepta GSC multicenter validation).

Limitations of the evidence include substantial evolution of some assays (making older studies less applicable to current versions), exclusions or small sample sizes in validation studies, need for independent validation in intended-use populations, and uncertainty about clinical utility and downstream effects on outcomes.

Overall, the policy concludes that the evidence is insufficient to demonstrate that plasma-based proteomic screening or bronchial gene expression profiling improves net health outcomes, and these tests are therefore considered investigational.

Evidence element	Key finding
Nodify XL2 specificity (validation study)	Specificity 97% for patients with low-to-moderate pretest probability (<50%) in one validation study; study limitations include excluded patients and need for independent validation
Percepta GSC performance (multicenter validation)	For intermediate pretest risk with inconclusive bronchoscopy: down-classify to low risk with 91% NPV; up-classify to high risk with 65% PPV
REVEAL Lung Nodule Characterization (MagArray)	Test reports a 0–100 score with cut point at 50 using 3 clinical factors and 3 proteins; validation was retrospective and needs independent validation
Overall evidence conclusion	Evidence insufficient to determine that proteomic screening or bronchial GEP improves net health outcomes

Proteomics: The study of the structure and function of proteins, used to identify and manage diseases via measurement techniques such as immunoassays and mass spectrometry.

Gene expression profiling (GEP): Measurement of gene activity (mRNA) in cells to detect cancer-associated expression patterns using molecular techniques (eg, microarrays, RT-PCR, transcriptome sequencing).