Proteomic Testing for Targeted Therapy in Non-Small-Cell Lung Cancer
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This policy governs coverage of the VeriStrat® serum proteomic test (CPT 81538) to inform prognosis and targeted therapy selection for patients with non-small-cell lung cancer for Medicare Advantage and commercial products.
No material clinical or coverage changes in this revision.
Coverage Criteria for VeriStrat (Proteomic Testing)
Medically Necessary Coverage
Covered when the following testing is ordered for patients with appropriate lung cancer diagnoses:
Covered for Medicare Advantage and Commercial Products when filed with the listed ICD-10 diagnosis codes (e.g., C33, C34.x).
Some employer-sponsored, self-funded plans may have contractual exclusions that omit expanded biomarker or genetic testing coverage. Providers should consult the member's Benefit Booklet or employer agreement to determine plan-specific exclusions, since coverage for certain genetic testing services may differ for those groups.
If services are determined to be not medically necessary or otherwise non-covered benefits, the provider may not charge the member unless the member has been informed and has provided written agreement in advance to proceed at their own expense. Providers should follow their participation agreement and verify member-specific benefits before billing a member directly.
Medical criteria: Not applicable. No additional medical‑necessity criteria are specified in this document for VeriStrat proteomic testing.
This segment does not enumerate discrete clinical scenarios that are declared not medically necessary. Determinations of medical necessity or non‑covered status are made per the member's subscriber or employer agreement and applicable policy provisions.
Coding (CPT, ICD-10)
| 81538 | Oncology (lung), mass spectrometric 8-protein signature, including amyloid A, utilizing serum, prognostic and predictive algorithm reported as good versus poor overall survival. |
| C33 | Malignant neoplasm of trachea |
| C34.31 | Malignant neoplasm of upper lobe, right bronchus or lung |
| C34.32 | Malignant neoplasm of middle lobe, right bronchus or lung |
| C34.80 | Malignant neoplasm of overlapping sites of unspecified bronchus and lung |
| C34.81 | Malignant neoplasm of lower lobe, right bronchus or lung |
| C34.82 | Malignant neoplasm of other parts of bronchus or lung |
| C34.90 | Malignant neoplasm of unspecified bronchus or lung |
| C34.91 | Malignant neoplasm of upper lobe, left bronchus or lung |
| C34.92 | Malignant neoplasm of middle lobe, left bronchus or lung |
Provider Actions, Authorization & Billing Guidance
Prior authorization not required — ordering physician handles authorizations
Prior authorization is not applicable for this policy. The ordering physician is responsible for any authorization, appeal, or medical necessity processes and laboratories are prohibited from obtaining authorization or participating on the ordering physician's behalf.
- Policy header: Prior Authorization — Not applicable
- Ordering physician must handle authorization/appeal/medical necessity; laboratories may not obtain authorization or participate
Benefits and eligibility determined by subscriber/employer agreements
This policy is informational; benefits and eligibility are determined by the member's subscriber agreement, member certificate, or employer agreement and those documents supersede this medical policy.
- For member-specific benefits, contact the provider call center or consult the member's benefit booklet
Ordering physician exclusively responsible for authorization and appeals
Only the ordering physician shall be involved in authorization, appeals, and medical necessity processes; laboratories and their representatives are not allowed to obtain authorization or participate in the authorization/appeal process on behalf of the ordering physician.
- Use of a laboratory representative to obtain authorization or assist in appeals is a violation and may result in severe action, including termination from the BCBSRI provider network.
No specific prior-auth codes listed in this segment — check benefits
For informational purposes, the policy does not specify particular CPT/HCPCS codes in this segment that require prior authorization; consult subscriber/employer agreements or benefit booklets for plan-specific requirements.
- This document is not a guarantee of payment and is superseded by member-specific benefit documents.
Authorization ownership — ordering physician only; labs prohibited from obtaining authorizations
Only the ordering physician may handle prior authorization, appeals, and medical necessity processes; laboratories and third parties must not obtain authorization or participate on the physician's behalf, and violations may result in termination from the BCBSRI network.
- Laboratories are prohibited from facilitating any portion of authorization or preparing documentation for appeals.
- If a laboratory provides a service that was not authorized, the service will be denied as the laboratory's financial liability and may not be billed to the member.
Verify eligibility and benefits with subscriber agreement or provider call center
Verify member-specific benefits and eligibility via the member's subscriber agreement/member certificate or by calling the provider call center; those documents supersede this medical policy.
- Refer to the appropriate Benefit Booklet for plan-specific exclusions or custom coverage (e.g., self-funded groups with contract exclusions).
- Contact the provider call center for member-specific benefit information.
Unauthorized laboratory services will be denied and billed to the laboratory
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.
- Labs must ensure required authorizations are obtained by the ordering physician prior to performing services to avoid denial and financial liability.
Do not bill member for NMN or non-covered services without written consent
Services determined to be not medically necessary or non-covered benefits may not be charged to the member unless the member is informed in advance and provides written agreement to proceed at their own expense.
- Obtain written member agreement before performing non-covered or not medically necessary services if the member will be held financially responsible.
Background on NSCLC and Proteomic Testing
Non‑small‑cell lung cancer (NSCLC) represents the majority of lung cancer diagnoses and prognosis is strongly influenced by stage: localized disease has substantially better survival than metastatic disease. Proteomic testing such as VeriStrat has been proposed as a prognostic tool and to help predict response to targeted therapies, with potential value in informing treatment selection for patients with NSCLC.
Definitions
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