CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

VeriStrat proteomic test for non-small-cell lung cancer

Policy governing coverage and use of the VeriStrat (Biodesix) serum proteomic assay (CPT 81538) to provide prognostic and predictive information for patients with non-small-cell lung cancer (NSCLC) for Blue Cross Blue Shield - Rhode Island members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyVeriStrat proteomic test for non-small-cell lung cancer

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionOrdering physician must handle authorization and related administrative processes; laboratories and third parties may not obtain authorization on behalf of the ordering physician.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1proprietary proteomic test addressed (VeriStrat, CPT 81538)

4ICD-10 codes listed as allowable

Medicare & Commercialplans referenced for coverage stance

NCCNguideline source cited in background

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.

Coverage Criteria

Medicare Advantage and Commercial Coverage

Covered when the following plan conditions are met:

Coverage prerequisites: Test (VeriStrat CPT 81538) is covered for management of non-small-cell lung cancer when filed with one of the listed ICD-10 diagnosis codes; benefits may vary by group/contract and specific benefit booklets should be consulted.

Applies to Medicare Advantage and Commercial products as stated.

Coverage for certain genetic testing services and expanded biomarker testing may be limited by group contract. Some genetic testing services are not covered for self-funded groups that have specifically excluded the expanded coverage of biomarker testing related to the state mandate. Members and providers should consult the member's Benefit Booklet to determine whether the plan includes a contractual exclusion and review the Coding sections of the Genetic Testing Services or Proprietary Laboratory Analyses policies for lists of covered, prior-authorized, not medically necessary, or excluded tests.

This medical policy is provided for informational purposes and is not a guarantee of payment. Coverage and payment decisions are governed by the member's subscriber agreement, member certificate, and/or employer agreement, which take precedence over this policy. Providers should verify member-specific benefits and eligibility with the provider call center prior to ordering or billing services.

Medical criteria: Not applicable. No separate medical necessity criteria are provided in this portion of the document.

Covered Indications

Use in management of non-small-cell lung cancer to provide prognostic and predictive classification (good vs poor overall survival).

Covered when billed with the listed ICD-10 diagnosis codes; applies to Medicare Advantage and Commercial products per policy.

Diagnostic coding requirement: VeriStrat (CPT 81538) must be filed with an appropriate ICD-10 diagnosis code from the list below to be considered covered.

See Coding section for exact ICD-10 codes permitted.

Allowed diagnosis codes

C33: Malignant neoplasm of trachea (ICD-10 C33)
C34: Malignant neoplasm of bronchus and lung (ICD-10 C34-C34.92)

Coding

Covered CPT CodesCPTCovered

81538

Oncology (lung), mass spectrometric 8-protein signature, including amyloid A, utilizing serum, prognostic and predictive algorithm reported as good versus poor overall survival.

Covered ICD-10 Diagnosis CodesICD-10Covered

C33	Malignant neoplasm of trachea
C34	Malignant neoplasm of bronchus and lung (range C34-C34.92 listed)
C38.4	Malignant neoplasm of mediastinum
C45.0	Mesothelioma of pleura

Provider Actions and Billing Responsibilities

Prior Authorization

Prior authorization is not generally applicable for this test. Providers must confirm plan-specific requirements because prior authorization rules are determined by the member's plan.

Affected code: CPT 81538 (VeriStrat®)

Billing Rule

Authorization Process Ownership — Ordering Physician Responsibility

Only the ordering physician shall be involved in prior authorization, appeals, or other administrative processes. Laboratories, laboratory representatives, or any third parties are prohibited from obtaining authorization or participating in the authorization or appeal process on behalf of the ordering physician.

Do not use a laboratory representative or third party to obtain authorizations or prepare documentation for authorizations/appeals.

Ordering Requirements

Step Therapy

Ordering physician must manage authorization

Ordering physicians must handle prior authorization, appeals, and related administrative processes for VeriStrat testing; laboratories and third parties are not permitted to obtain authorization on behalf of the ordering clinician.

Do not use laboratory representatives or third parties to facilitate authorization or appeals.

Documentation Required

Verify member eligibility and plan restrictions

Before ordering the test, providers must verify member eligibility and benefits with the payer because plan-specific restrictions and coverage determinations apply.

Contact the provider call center for member-specific benefits and eligibility information.

Not Covered

Certain genetic and biomarker testing services may be contractually excluded for self-funded groups; refer to the Coding section of the Genetic Testing Services or Proprietary Laboratory Analyses policies for specific lists of covered and excluded tests. Additionally, any test or service that is determined to be not medically necessary or is not covered by the member's benefit plan may be excluded from payment and may not be billed to the member unless there is a prior written agreement allowing the member to accept financial responsibility.

Services that are determined to be not medically necessary or that are not benefits under the member's plan may be excluded from payment. Providers may not charge members for non-covered or not medically necessary services unless the member has been informed in advance and has provided written agreement to assume financial responsibility, as described in the member's participation and subscriber agreements.

Definitions

VeriStrat — definition

Test nameVeriStrat (Biodesix)

MethodMass spectrometric 8-protein serum signature (includes serum amyloid A)

Report formatClassification reported as 'good' versus 'poor' overall survival

CPT code81538

NSCLC — definition

TermNon-small-cell lung cancer (NSCLC)

Included histologiesNonsquamous carcinoma (adenocarcinoma, large cell carcinoma, other nonsquamous types) and squamous cell carcinoma

Frequency Limits

Frequency limits for VeriStrat (CPT 81538)

Frequency limitNo frequency limits specified in this document for VeriStrat (CPT 81538)

ApplicabilityApplies to VeriStrat testing addressed under CPT 81538 in this policy

Plan variationMember benefits and eligibility may modify coverage; verify plan-specific rules

Background

Non-small-cell lung cancer (NSCLC) accounts for the majority of lung cancer cases and prognosis is strongly dependent on tumor stage. Metastatic disease carries a poor long-term survival outlook; factors such as tumor stage, age, sex, and performance status influence prognosis and treatment selection. The VeriStrat serum proteomic assay has been evaluated as a prognostic and predictive classifier in NSCLC to help stratify patients as having a good versus poor overall survival profile and has been studied particularly in the context of systemic therapies such as EGFR tyrosine kinase inhibitors and chemotherapy.

Assessment of prognosis or predictive information in advanced non-small-cell lung cancer, often in context of EGFR-TKI (erlotinib) therapy or chemotherapy

Assessment of prognosis or predictive information in advanced non-small-cell lung cancer, often in context of EGFR-TKI (erlotinib) therapy or chemotherapy — evidence and clinical context summarized from cited studies.

Intended clinical use: VeriStrat (serum proteomic classifier) is used to provide prognostic and predictive classification (reported as 'VeriStrat Good' vs 'VeriStrat Poor') in patients with advanced NSCLC to inform management decisions, including consideration of EGFR-TKI (eg, erlotinib) therapy or chemotherapy.

Multiple randomized and observational studies have evaluated prognostic and predictive performance in first- and later-line settings and across NSCLC histologies (see References).

Representative evidence

Randomized/phase III trials: Randomized phase III and other trials have stratified or evaluated VeriStrat status in relation to outcomes with erlotinib, docetaxel, and other regimens (eg, PROSE, ETOP EMPHASIS-lung, BR.21 analyses).
References include PROSE, ETOP EMPHASIS-lung, BR.21 and other studies.
Observational and retrospective studies: Retrospective and observational analyses report associations between VeriStrat classification and survival or time to progression in patients treated with EGFR-TKIs or chemotherapy.
See listed references for study details and populations.
Clinical impact studies: Studies have examined the impact of the VeriStrat test on treatment recommendations and clinical decision-making in advanced NSCLC.
See References for impact analyses.