Prior authorization and benefit verification — verify benefits and authorize where required

Proteomic testing (including VeriStrat) is categorized as experimental/investigational and not supported for coverage; providers should verify member benefits and obtain prior authorization where required by the member’s contract, recognizing the policy does not support coverage.

• Verify member benefits with BCBSKS Customer Service
• Obtain prior authorization when required by the member contract, but note policy stance

Prior authorization not applicable — experimental/investigational tests not covered

Proteomic testing (e.g., VeriStrat) is classified as experimental/investigational and is not a covered service; prior authorization cannot be used to render these tests covered for NSCLC management.

• Tests are considered experimental/investigational for all NSCLC uses
• Prior authorization will not make an excluded test covered

Prior authorization not specified — follow member contract processes

The provided excerpts do not specify explicit prior authorization requirements for proteomic testing; providers should follow member contract and plan-specific prior authorization processes.

• No explicit prior authorization rules stated in the policy excerpts

Prior authorization likely required — unsupported indications likely denied

Proteomic testing to predict response for first‑line therapies or to guide treatment in early‑stage (I/II) post‑surgical patients is unsupported by identified studies; requests for such uses are likely to require prior authorization and are likely to be denied absent evidence of investigational approval.

• No studies identified using VeriStrat to guide first‑line therapy or early‑stage post‑surgical treatment
• Such indications lack evidentiary support and are likely to be denied

Prior authorization considerations — PROSE evaluated second‑line contexts, not first‑line

Evidence does not show VeriStrat has been used to direct first‑line therapy in newly diagnosed advanced NSCLC; the PROSE RCT evaluated VeriStrat in a second‑line context (erlotinib vs chemotherapy), limiting applicability to first‑line decisions.

• PROSE trial evaluated VeriStrat in second‑line erlotinib vs chemotherapy
• No direct evidence supporting first‑line use to direct therapy selection

Established genomic testing preferred — use guideline-directed molecular testing

Guideline-directed molecular testing for established genomic alterations (eg, sensitizing EGFR variants) guides targeted TKI use; proteomic testing is not a substitute and is not recommended by this policy for directing targeted therapy.

• NCCN recommends EGFR‑variant testing to guide EGFR TKI selection
• Proteomic assays are not endorsed as an alternative to established genomic testing

Reference to standard management — follow guideline-based care

Standard guideline-based systemic therapy is the comparator practice; the policy indicates proteomic testing has not been established to change standard management pathways.

• Standard medical management remains the comparator
• Proteomic testing is not established to alter guideline-based therapy selection

No step therapy rules specified — policy does not define sequencing

No step therapy rules are provided in the policy excerpts; the document reviews clinical studies and coding but does not specify step therapy sequencing or authorization requirements.

• Policy does not define step therapy rules in provided excerpts

Adherence to current treatment sequencing — studies used outdated regimens

Many evaluated studies used treatment regimens (eg, EGFR TKIs in EGFR‑unknown or wild‑type populations, or EGFR+VEGF combinations) that are no longer consistent with current guideline-recommended sequencing; providers should adhere to current standards when considering treatment sequencing.

• Studies used outdated treatment contexts (EGFR TKI in EGFR‑unknown/wild‑type)
• Apply current guideline-recommended sequencing rather than proteomic classification

Relevance to current step therapy — trial populations differ from current practice

Trials often used erlotinib in populations not consistent with current guideline-recommended sequencing (eg, EGFR wild‑type patients), limiting the relevance of those trials to contemporary step therapy pathways.

• TOPICAL and PROSE included erlotinib use in unselected/EGFR‑unknown populations
• Applicability to current sequencing is limited

Provider actions not applicable — no step therapy sequencing defined

This policy focuses on evidence review and coding; it does not define step therapy sequencing requirements or impose specific step edits based on proteomic classification.

• Policy does not establish step therapy rules; follow plan-specific utilization management if present

Benefit verification — verify benefits and legal mandates

Verify member benefits and consider state/federal mandates and the member’s contract language before determining eligibility for coverage of proteomic testing.

• Contact BCBSKS Customer Service to verify benefits
• Consider plan and state/federal mandates first

Required test context documentation — record assay type, timing, and intended use

When submitting proteomic test results or requests, document that the assay is a serum proteomic test performed prior to treatment or at progression and clearly state the intended use (prediction of OS/PFS or to influence selection of systemic therapy).

• Document test type (serum proteomic assay), timing (pre‑treatment or at progression), and intended use (prognosis or treatment selection)

Specimen and clinical data reporting — record sample type, histology, performance status

Document specimen type and pertinent clinical data that were used for testing—studies typically used pretreatment frozen serum or baseline plasma samples and reported tumor histology and ECOG performance status where available.

• Record specimen (pretreatment frozen serum or baseline plasma)
• Include histology and performance status in documentation

Required clinical outcome documentation — record OS/PFS and adjustment variables

When proteomic test results are used in clinical decision‑making, include documentation of relevant clinical outcomes (OS, PFS) and adjustment variables considered (age, sex, histology, performance status) as reported in evidence summaries.

• Document OS and PFS outcomes and any adjustments for age, sex, histology, or ECOG PS

Supporting trial documentation — include trial cohort details when relevant

Clinical trial reports included sample sizes, histology, ECOG performance status distribution, and EGFR‑variant status where available; include these supporting trial data when relevant to test interpretation.

• Include trial/sample sizes, histology, ECOG PS, and EGFR‑variant status if available

Medical necessity and member contract — codes only medically necessary per Policy and contract

Procedures and codes listed in the coding section are medically necessary ONLY if performed according to the Policy section; refer to the member contract at the time of service to determine coverage eligibility.

• Codes medically necessary only if consistent with Policy criteria
• Confirm member contract benefits at time of service

Provider actions summary — proteomic testing considered experimental/investigational

Use of proteomic testing (including VeriStrat) for any use in the management of non‑small‑cell lung cancer is considered experimental/investigational and not supported for coverage; providers should not expect coverage unless policy and member contract criteria are met.

• Proteomic testing (including VeriStrat) is experimental/investigational for all NSCLC uses
• Tests are not supported for coverage under this policy

Denial for experimental/investigational tests — likely denial basis

Requests for proteomic testing for NSCLC are likely to be denied on the basis that these tests are experimental/investigational and not medically necessary according to this policy.

• Denial reason: experimental/investigational exclusion for all uses in NSCLC

No explicit prior authorization/denial triggers — follow standard processes

The policy does not identify specific prior authorization or documentation triggers that would automatically permit coverage; absence of explicit triggers in the excerpts means usual benefit verification and prior authorization processes apply.

• No explicit prior authorization or denial triggers stated in provided text

Lack of evidence for first‑line use — no supporting studies

No studies identified use of VeriStrat to guide first‑line targeted therapy or first‑line chemotherapy in newly diagnosed advanced NSCLC; lack of direct evidence for first‑line use may lead to denial for such intended use.

• No studies supporting use to guide first‑line therapy
• Requests for first‑line guidance likely unsupported

Limits of evidence for early-stage NSCLC — no supporting studies for stage I–II uses

No studies were identified that used VeriStrat to inform therapeutic options for stage I–II NSCLC after surgery or in medically inoperable stage I–II disease; such uses are unsupported by the evidence reviewed and may be denied.

• No evidence for stage I–II post‑surgical or medically inoperable stage I–II uses

Coding and coverage caveat — code listing not coverage (repeat)

Inclusion of CPT or other codes in the policy’s coding section does not constitute member coverage; listed codes are medically necessary only if the procedure is performed according to the Policy section and member contract.

• Code listing is informational; verify policy clinical criteria and member contract for coverage

Coding inclusion note — listing does not imply coverage (repeat)

Inclusion or exclusion of codes in the document does not imply coverage or reimbursement; the presence of a code does not change the policy’s experimental/investigational stance.

• Code inclusion does not alter coverage determination

Ordering clinician unspecified — no explicit ordering requirements

The excerpts do not specify who may order the test; while oncology specialists commonly order proteomic testing in studies, the policy provides no explicit ordering‑clinician requirements.

• No explicit ordering-provider restrictions in policy excerpts
• Oncology specialists commonly involved in study settings

Ordering clinician context — oncology specialists commonly involved

No specific ordering-provider requirements are provided in the policy excerpt; tests in the literature were commonly ordered by treating medical oncologists in trial and clinical contexts.

• Ordering by treating medical oncologists is typical in studies
• Policy contains no formal ordering restrictions

Ordering context — tests performed in oncology trial settings

Studies were typically performed in oncology trial settings and tests were ordered in that context; the policy does not prescribe which specialties may order the test.

• Tests ordered in oncology trial settings
• Policy does not restrict ordering specialties

Ordering-provider study notes — policy does not specify specialties

Physician decision‑making studies report tests were ordered for NSCLC, but the policy does not specify which specialties may order the test; no explicit ordering‑provider requirements are provided in this excerpt.

• Physician decision‑making studies included various ordering clinicians
• No ordering restrictions in policy excerpt

Ordering provider absence — follow plan procedures

No specific ordering‑provider requirements are provided in this policy excerpt; providers should follow their plan’s ordering and authorization procedures.

• Follow plan‑specific ordering and prior authorization rules