CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Molecular Testing in the Management of Pulmonary Nodules_0.pdf

Defines medical necessity, prior authorization, and coverage status for plasma-based proteomic tests and bronchial gene expression profiling used in evaluating pulmonary nodules for Medicare Advantage and commercial products offered by Blue Cross & Blue Shield of Rhode Island, effective 2025-11-01.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMolecular Testing in the Management of Pulmonary Nodules_0.pdf

Policy CodePolicy N/A

Change TypeAdded coverage for Nodify XL2 & Percepta; coding updates

Effective DateNov 1, 2025

Next Review Date

Key ActionObtain prior authorization via the online authorization tool for Nodify XL2, Percepta, and all unlisted genetic testing CPT codes as required or recommended per product.

SourceLink

POLICY UPDATE CHANGES

Effective 11/1/2025 Nodify XL2 (0080U) and Percepta (81479) are considered medically necessary when online authorization criteria are met.

Nodify CDT (0360U) retained as covered; REVEAL (0092U) remains not covered.

3Named tests addressed

2Medically necessary when criteria met

1Not covered / not medically necessary

2025-11-01

Coverage Summary

Scope: Defines medical necessity, prior authorization, and coverage status for plasma-based proteomic tests and bronchial gene expression profiling used in evaluating pulmonary nodules for Medicare Advantage and Commercial Products offered by Blue Cross & Blue Shield of Rhode Island, effective 2025-11-01.

Headline takeaways: Nodify XL2 (CPT 0080U) and Percepta (CPT 81479) are considered medically necessary when the online authorization criteria are met (effective 11/01/2025); Nodify CDT (CPT 0360U) is covered; REVEAL (CPT 0092U) is not covered / not medically necessary because evidence is insufficient.

Usage statistics summary: Named tests addressed: 3; Tests considered medically necessary (when criteria met): 2; Tests not covered / not medically necessary: 1; Effective date: 2025-11-01.

Key thresholds and quick facts

REVEAL cut point50 (score range 0-100; single cut point at 50)

REVEAL intended nodule size range4 to 30 mm

Named tests addressed3

Tests considered medically necessary (when authorization criteria met)2

Tests not covered / not medically necessary1

Effective date2025-11-01

Medical Necessity Criteria

Medicare Advantage Plans and Commercial Products - Medical Necessity (effective 11/01/2025)

Medicare Advantage Plans and Commercial Products - Medical Necessity (effective 11/01/2025). Effective 11/1/2025, the following test(s) are considered medically necessary when the medical criteria in the online authorization tool for participating providers is met. Prior Authorization is required for Medicare Advantage Plans and recommended for Commercial Products.

ALL of the following

Prior authorization is required for the tests listed below per the online authorization tool for participating providers.
Prior Authorization required for Medicare Advantage; recommended for Commercial Products.
ANY of the following
- Nodify XL2 (BDX-XL2) (Biodesix®, Inc) - CPT code 0080U.
  Effective 11/01/2025. Subject to medical criteria in the online authorization tool; prior authorization required for Medicare Advantage; recommended for Commercial.

Authorization, Documentation & Laboratory Participation

Authorization and Laboratory Participation Restrictions

ALL of the following

Only the ordering physician may obtain authorization, participate in authorization, appeals, or other administrative processes related to prior authorization/medical necessity
Laboratories, laboratory representatives, or third parties may not obtain authorization or support the authorization/appeal process on behalf of the ordering physician; violations may result in termination from BCBSRI provider network
If a laboratory provides a laboratory service that has not been authorized, the service will be denied as the financial liability of the participating laboratory and may not be billed to the member

Coding

Covered CPT codes (Medicare Advantage & Commercial)CPTCovered

0360U	Oncology (lung), enzyme-linked immunosorbent assay (ELISA) of 7 autoantibodies, plasma, algorithm reported as a categorical result for risk of malignancy (Nodify CDT® Biodesix, Inc.)
0080U	Nodify XL2 (BDX-XL2) (Biodesix®, Inc) - effective 11/01/2025 when medical criteria met
81479	Percepta® Bronchial Genomic Classifier (Veracyte) - effective 11/01/2025 when medical criteria met

Not covered / Not medically necessaryCPTNot Covered

0092U

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

Unlisted genetic testing CPT codesCPT

UNLISTED

Unlisted genetic or molecular testing CPT codes require prior authorization to determine service and coverage

When no specific CPT exists, use an Unlisted CPT code for the service; all Unlisted genetic testing CPT codes require prior authorization to determine the service rendered and coverage status. Prior authorization is required for the Percepta and Nodify XL2 tests for Medicare Advantage Plans and recommended for Commercial Products.

Background & Evidence

Background: Plasma proteomic screening and bronchial gene expression profiling are molecular tests proposed to aid risk stratification of pulmonary nodules to reduce unnecessary invasive procedures. Tests addressed in this policy include Nodify CDT (Biodesix; CPT 0360U), Nodify XL2 (BDX-XL2; CPT 0080U), Percepta bronchial genomic classifier (Veracyte; CPT 81479), and REVEAL Lung Nodule Characterization (MagArray; CPT 0092U).

Overall evidence conclusion: While proteomic and gene expression tests have been studied (including prospective and retrospective cohorts and validation studies), evidence is considered insufficient for some tests (for example, REVEAL) to demonstrate an improvement in net health outcome.

Evidence	Value
REVEAL validation study NPV and sensitivity
Both 94% (reported in retrospective validation but with limitations)
REVEAL intermediate-risk reclassification
Model correctly identified 65% of intermediate-risk samples as low or high risk in validation

Proteomics: Proteomics is the study of the structure and function of proteins; techniques include immunoassays and mass spectrometry to identify and characterize proteins.

Gene Expression Profiling (GEP): Gene Expression Profiling measures gene activity within cells using molecular techniques (for example, RT‑PCR, arrays) to assess risk for malignancy.

Medicare Determinations

Name (type and number)	Notes
MolDX: Molecular Diagnostic Tests (MDT) - LCD L35160

MolDX: Proteomics Testing - Billing and Coding - Article A59641

Revision History

2025-11-01addedLatest

Effective 11/1/2025 Nodify XL2 (0080U) and Percepta (81479) are considered medically necessary when online authorization criteria are met; Prior Authorization is required for these tests for Medicare Advantage Plans and recommended for Commercial Products.

revised

Nodify CDT (0360U) retained as covered; REVEAL (0092U) remains not covered / not medically necessary.

added

All Unlisted genetic testing CPT codes require prior authorization to determine service rendered and coverage status.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMolecular Testing in the Management of Pulmonary Nodules_0.pdf

Policy CodePolicy N/A

Change TypeAdded coverage for Nodify XL2 & Percepta; coding updates

Effective DateNov 1, 2025

Next Review Date

Key ActionObtain prior authorization via the online authorization tool for Nodify XL2, Percepta, and all unlisted genetic testing CPT codes as required or recommended per product.

SourceLink

On This Page

Percepta® Bronchial Genomic Classifier (Veracyte) - CPT code 81479.

Effective 11/01/2025. Prior authorization required for Medicare Advantage; recommended for Commercial.

Covered Tests (existing)

Covered Tests (existing). The following test is covered for Medicare Advantage Plans and Commercial Products.

ALL of the following

Nodify CDT® (Biodesix®, Inc) - CPT code 0360U is covered for Medicare Advantage Plans and Commercial Products.
Covered when medical criteria in the online authorization tool for participating providers is met where applicable.

Not Medically Necessary / Not Covered

Not Medically Necessary / Not Covered. The following test is not covered for Medicare Advantage Plans and is not medically necessary for Commercial Products as evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

ALL of the following

REVEAL Lung Nodule Characterization (MagArray) - CPT code 0092U is not covered for Medicare Advantage Plans and is not medically necessary for Commercial Products.
Evidence is insufficient to support coverage; considered investigational/unproven for the intended use.

ALL of the following

Unlisted/Other Genetic Testing CPT Codes: All Unlisted genetic testing CPT codes require prior authorization to determine the specific service being rendered and whether the service is covered or not medically necessary.
Laboratories are not permitted to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician. Only the ordering physician may request authorization. If an unlisted laboratory service is provided without authorization, the service will be denied and may not be billed to the member; financial liability will rest with the participating laboratory.

Prior Authorization

Prior authorization required for specified tests

Prior authorization is required for Percepta (CPT 81479) and Nodify XL2 (CPT 0080U) for Medicare Advantage Plans and is recommended for Commercial Products. All Unlisted genetic testing CPT codes require prior authorization to determine the service rendered and coverage. Effective date: 2025-11-01.

Percepta Bronchial Genomic Classifier — CPT 81479 (PA required for Medicare Advantage; recommended for Commercial)
Nodify XL2 — CPT 0080U (PA required for Medicare Advantage; recommended for Commercial)
All Unlisted genetic/molecular testing CPT codes require prior authorization to determine service and coverage

Documentation Required

Ordering physician must perform authorization/appeal

Only the ordering physician may obtain authorization, participate in authorization/appeals, or perform other administrative processes related to prior authorization/medical necessity. Laboratories, laboratory representatives, or third parties may not obtain authorization or assist with authorization/appeals on behalf of the ordering physician; violations may result in severe action including termination from the provider network.

Billing Rule

Unauthorized lab services denied to laboratory

If a participating laboratory provides a laboratory service that has not been authorized, the service will be denied and the financial liability rests with the participating laboratory; such denied services may not be billed to the member.

added

Ordering physician must perform authorization/appeal processes; laboratories or third parties may not obtain authorization on behalf of the ordering physician and unauthorized lab services will be denied and billed to the laboratory.