BCBS RI molecular testing coverage update

Coverage and Medical Necessity Criteria

Nodify XL2 medical necessity

Nodify XL2 (BDX-XL2) is considered medically necessary when ALL of the following are met:

Nodify XL2 coverage criteria: 1) The test is ordered for management of a solitary pulmonary nodule measuring between 8 and 30 mm in greatest diameter;8–30 mm

See patient age and pre-test risk criteria for additional requirements

Nodify XL2 coverage criteria: 2) Patient age is 40 years or older;>= 40 years

Nodify XL2 coverage criteria: 3) Pre-test probability of cancer as assessed by the Mayo Clinic Model for solitary pulmonary nodules is 50% or less;<= 50%

Nodify XL2 coverage criteria: 4) The intended use is to assist the physician by identifying nodules with a high probability of being benign (i.e., to support CT surveillance rather than immediate invasive diagnostic procedures);

Nodify XL2 coverage criteria: 5) The pulmonary nodule would be a candidate for non-invasive CT surveillance instead of invasive procedures if classified as lower risk by the assay;

Programmatic note: Continued coverage is contingent on annual review of prospective clinical utility data and peer-reviewed studies.

Percepta medical necessity

Gene expression profiling on bronchial brushings (including Percepta) is medically necessary when ALL of the following are met:

Percepta coverage criteria: 1) Patient is a current or former smoker aged 21 years or older;>= 21 years

Percepta coverage criteria: 2) Physician-assessed pretest risk of malignancy is low or intermediate based on clinical characteristics (smoking history and nodule size stratification as described in policy tables);

Policy provides stratification examples: e.g., nodules <10 mm with <10 pack-year history considered low, nodules 10–30 mm with 10–60 pack-year history considered intermediate; see policy table for full stratification

Percepta coverage criteria: 3) The Percepta bronchial genomic classifier result will be used to determine whether CT surveillance is appropriate in lieu of further invasive biopsies or surgical procedures (intended use after an indeterminate bronchoscopy);

Test is intended for use following a non-diagnostic/indeterminate bronchoscopy

Coverage stance and test-specific guidance

Coverage, utility, and test-specific stances summarized from the policy excerpt:

General coverage linkage: Tests specified as covered (for example, Nodify XL2 CPT 0080U) are covered only when the medical necessity criteria in this policy are met; coverage for each test depends on satisfying those criteria.

Percepta billing and filing: Percepta has no unique CPT; claims should be submitted with unlisted molecular pathology procedure code 81479 and must be supported by documentation that medical criteria in this policy are met.

Not covered / Not medically necessary tests: REVEAL Lung Nodule Characterization (CPT 0092U) and Nodify CDT (CPT 0360U) are not covered for Medicare Advantage Plans and are not medically necessary for Commercial Products according to this policy excerpt.

Clinical utility statement: Molecular classifiers (e.g., Percepta) are intended to inform management decisions by identifying patients with low or intermediate pretest risk after nondiagnostic bronchoscopy who may be candidates for CT surveillance rather than invasive procedures; ongoing registry and prospective studies are cited to evaluate clinical utility.

The policy states that REVEAL Lung Nodule Characterization (MagArray) and Nodify CDT® are not covered for Medicare Advantage Plans and are not medically necessary for Commercial Products due to insufficient evidence demonstrating improvement in net health outcome.

Specifically, the proprietary test codes 0092U (REVEAL Lung Nodule Characterization) and 0360U (Nodify CDT®) are explicitly listed in the policy as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products.

The policy notes that no recent clinical validation studies were identified for Nodify CDT® or the Nodify Lung testing strategy, and that evidence is insufficient to demonstrate that these proteomic tests improve net health outcomes. For this reason, the tests are considered not medically necessary / not covered as stated.

For Commercial Products the policy explicitly states that 0092U (REVEAL Lung Nodule Characterization) and 0360U (Nodify CDT®) are not medically necessary and therefore not covered under the payer's policy.

Codes, Billing, and Test Parameters

Covered CPT/HCPCS/Proprietary test codesmixedCovered

0080U

Nodify XL2 (BDX-XL2)

Covered CPT/HCPCS/Proprietary test codesmixedCovered

81479

Percepta Bronchial Genomic Classifier (gene expression profiling)

Tests identified in policy (coverage status varies)mixed

0092U	REVEAL Lung Nodule Characterization (MagArray)
0360U	Nodify CDT® (Biodesix®, Inc)

Covered Codes (when criteria met)CPTCovered

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 (Nodify XL2)

Percepta billing guidanceCPT

81479

Unlisted molecular pathology procedure (used for Percepta bronchial genomic classifier claims)

Not covered / Not medically necessaryCPTNot Covered

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)
0360U	Oncology (lung), enzyme-linked immunosorbent assay (ELISA) of 7 autoantibodies (p53, NY-ESO1, CAGE, GBU4-5, SOX2, MAGE A4, and HuD), plasma, algorithm reported as a categorical result for risk of malignancy (Nodify CDT)

Nodule size for Nodify XL2 — parameter value

Nodule size (diameter)8–30 mm

Clinical contextFor management of a lung nodule

Intended decision impactIdentifies nodules that may be candidates for CT surveillance instead of invasive procedures

Patient age for Nodify XL2 — minimum age

Minimum patient age≥ 40 years

Population

Prior Authorization, Billing, and Clinical Use Actions

Prior Authorization

Prior Authorization Required

Prior Authorization is required for the Percepta® Bronchial Genomic Classifier (Veracyte) test (file claims with CPT 81479) and for Nodify XL2 (BDX-XL2, 0080U) for Medicare Advantage plans. For Commercial products, prior authorization is recommended. Absence of prior authorization for Medicare Advantage may result in claim denial.

Prior authorization required for Percepta (claim with CPT 81479) — Medicare Advantage; recommended for Commercial.
Prior authorization required for Nodify XL2 (BDX-XL2, 0080U) — Medicare Advantage; recommended for Commercial.
Lack of prior authorization on Medicare Advantage members may result in denial.

Denial Risk

Coding, Filing, and Denial Risks

Percepta claims must be filed using CPT 81479 (Unlisted molecular pathology procedure). Codes 0092U (REVEAL Lung Nodule Characterization) and 0360U (Nodify CDT®) are not covered for Medicare Advantage and are not medically necessary for Commercial products; use of non-covered codes may trigger denials. Nodify XL2 (0080U) is covered when medical criteria are met but prior authorization requirements apply.

Clinical Context and Policy Scope

Pulmonary nodules are commonly detected on chest imaging; the central clinical decision is estimating the probability of malignancy to determine whether invasive diagnostic procedures (CT-guided biopsy, bronchoscopy, or surgery) are needed versus noninvasive management such as serial CT surveillance. Molecular tests, including plasma-based proteomic assays and bronchial gene expression profiling, have been developed to improve risk stratification and may help identify nodules at lower or higher risk of cancer so clinicians can choose CT surveillance instead of immediate invasive procedures when appropriate. However, the policy highlights that for some proteomic tests (for example Nodify CDT® and REVEAL), the available evidence is insufficient to confirm clinical benefit.

Key Terms and Test Descriptions

Proteomics — definition and relevance

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

TechniquesIncludes immunoassays (antibody-based detection) and mass spectrometry (ionizes proteins into fragments to identify and characterize them).

RelevanceProtein-based biomarkers measured by proteomic methods are proposed to help identify and manage diseases such as cancer, including risk stratification of pulmonary nodules.

Gene expression profiling (GEP) — definition

DefinitionGene expression profiling (GEP) is the measurement of gene activity (mRNA) within cells to assess patterns associated with disease, including cancer.

Methods

Policy Revision History

2024-06-01effective_dateLatest

Policy effective date (Medical Coverage Policy — Molecular Testing in the Management of Pulmonary Nodules).

2024-02-21last_review_date

Policy last reviewed on this date as documented in the policy header.

OpenPayer

Molecular Testing in the Management of Pulmonary Nodules (Medical Coverage Policy)