CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Molecular Testing in the Management of Pulmonary Nodules

This policy governs coverage for plasma-based proteomic screening and bronchial brushing gene expression profiling used in the evaluation and management of undiagnosed pulmonary nodules for Blue Cross Blue Shield - Rhode Island members.

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 DateAug 1, 2017

Next Review DateN/A

Key ActionDo not submit claims expecting coverage; these tests are considered not medically necessary and claims may be denied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

90%+reported negative predictive value for proteomic classifiers

91%Percepta reported NPV

32%surgeries potentially avoidable

24%false-negative proportion in one study

2017-2019Provider updates listed

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

≥12Cited references

Coverage Determinations

Plasma-based proteomic screening - Not covered / Not medically necessary

Coverage stance and criteria:

Plasma-based proteomic screening (including but not limited to BDX-XLZ, Xpresys Lung) for patients with undiagnosed pulmonary nodules detected by computed tomography is considered not covered / not medically necessary because evidence is insufficient to determine the effects of the technology on health outcomes.

Commercial policy language describes this as not medically necessary; policy statement uses 'not covered.'

Bronchial genomic classifier - Not covered / Not medically necessary

Bronchial gene expression profiling: Gene expression profiling on bronchial brushings (including but not limited to the Percepta Bronchial Genomic Classifier) for patients with indeterminate bronchoscopy results during evaluation of undiagnosed pulmonary nodules is considered not covered / not medically necessary because evidence is insufficient to determine the effects of the technology on health outcomes.

Percepta is a 23-gene test indicated for current or former smokers after an indeterminate bronchoscopy, but the policy finds evidence insufficient.

Plasma-based proteomic screening and bronchial gene expression profiling are not covered for the evaluation of undiagnosed pulmonary nodules because the available evidence is insufficient to demonstrate a beneficial effect on health outcomes. For commercial plans these technologies are considered not medically necessary when used for risk stratification of pulmonary nodules (eg, Xpresys Lung, BDX-XLZ, Percepta Bronchial Genomic Classifier).

Coverage and eligibility for these services are determined by the member's subscriber agreement, certificate, and/or employer agreement. This medical policy is provided for informational purposes and does not guarantee payment; the member-specific documents govern benefit determinations and supersede the provisions of this policy.

For commercial members, plasma-based proteomic screening and bronchial gene expression profiling are classified as not medically necessary because the evidence is inadequate to determine their impact on health outcomes. Therefore, these tests are excluded from coverage under the commercial classification.

Coding and Billing Codes

Unlisted codes for molecular testsCPT

84999

Unlisted chemistry procedure

Provider Requirements and Billing Guidance

Prior Authorization

Prior Authorization Requirement

Prior authorization is not applicable for the services described in this policy.

Note

Check Member-Specific Coverage

Benefits may vary by contract. Refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber/Employer Agreement to determine coverage and medical necessity for the requested service.

Note

Benefit Variability

Benefits may vary between groups and contracts. Please refer to the appropriate section of the Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for specifics about covered and not medically necessary services.

Clinical Background

Pulmonary nodules are frequently detected incidentally on chest imaging, and estimating the probability of malignancy is essential to guide management. Molecular approaches such as plasma proteomic classifiers and bronchial gene expression profiling have been proposed to improve risk stratification and potentially avoid invasive diagnostic procedures; however, the policy finds the evidence insufficient to support routine use of these tests for undiagnosed pulmonary nodules.

Definitions and Test Descriptions

Proteomics — definition and methods

DefinitionProteomics: the study of the concentration, structure, function, and other characteristics of proteins in tissues and bodily fluids.

Common methodsImmunoassays that use antibodies to detect protein concentration or structure.

Analytic techniqueMass spectrometry: ionizes proteins into fragments and determines mass and composition to identify and characterize proteins.

Gene expression profiling — definition

DefinitionGene expression profiling: measurement of gene activity (eg, mRNA) in cells to assess expression patterns.

Role in diagnosticsDetects cancer-associated gene expression in clinical samples to assess risk of malignancy.

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 DateAug 1, 2017

Next Review DateN/A

Key ActionDo not submit claims expecting coverage; these tests are considered not medically necessary and claims may be denied.

SourceLink

On This Page

Documentation Required

Billing Documentation

Submit claims for these tests using CPT 84999 — Unlisted chemistry procedure, with supporting documentation attached to the claim to explain the procedure performed.

Use CPT 84999 when no specific code exists for the test.
Include clinical documentation to support the medical necessity and description of the test.

Note

Policy Informational Note

This medical policy is provided for informational purposes only and is not a guarantee of payment or a substitute for clinical judgment. Benefits and eligibility are determined by the member's subscriber certificate and/or the employer agreement, which supersede this policy. BCBSRI may review and revise this policy at any time.

TechniquesIncludes Northern blots, ribonuclease protection assay, in situ hybridization, cDNA arrays, oligonucleotide arrays, RT-PCR, and transcriptome sequencing.

Percepta Bronchial Genomic Classifier — 23-gene test description

Test namePercepta Bronchial Genomic Classifier (23-gene)

Specimen/sourceAirway (bronchial) epithelial samples obtained after bronchoscopy.

IndicationIntended for current or former smokers following an indeterminate bronchoscopy result to assess risk of cancer and guide management of pulmonary nodules (eg, surveillance vs invasive procedures).

Xpresys Lung — plasma-based proteomic test description

Test nameXpresys Lung (plasma-based proteomic screening)

MethodMeasures relative abundance of proteins using multiple reaction monitoring mass spectrometry.

Intended roleAids differentiation of likely benign versus likely malignant pulmonary nodules to inform choice between serial CT surveillance and invasive diagnostic procedures; does not diagnose lung cancer.

plasma proteomic classifier — general definition and trial reference

DefinitionPlasma proteomic classifier: a blood-based protein classifier evaluated to characterize pulmonary nodules by measuring multiple plasma proteins.

Clinical evaluationEvaluated in studies including PANOPTIC and validation cohorts to distinguish benign from malignant nodules.

Intended useTo risk-stratify nodules as likely benign (supporting active surveillance) or likely malignant (supporting invasive diagnosis).

bronchial genomic classifier — general definition

DefinitionBronchial genomic classifier: a genomic test derived from bronchial epithelial samples that assesses airway genomic changes associated with lung cancer.

ApplicationUsed during diagnostic bronchoscopy to help evaluate the likelihood of malignancy and guide subsequent management decisions.

Evidence baseDerived and evaluated in prospective studies and clinical utility assessments (eg, derivation and impact studies cited in the literature).