CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Molecular classifier testing for non-small cell lung cancer (RiskReveal)

Policy governs coverage and prior authorization requirements for the RiskReveal (formerly DetermaRx) molecular diagnostic test as a predictive classifier for recurrence/metastasis in surgically resectable non-small cell lung cancer for BCBSRI Medicare Advantage and Commercial members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMolecular classifier testing for non-small cell lung cancer (RiskReveal)

Policy CodePolicy N/A

Change TypeAdded medical necessity for CPT 0288Uclarified prior authorization process

Effective Date8/1/2025

Next Review DateN/A

Key ActionObtain online prior authorization (ordering physician only) for RiskReveal (CPT 0288U) before testing for Medicare Advantage and recommended for Commercial members.

SourceLink

POLICY UPDATE CHANGES

RiskReveal (Razor Genomics) CPT 0288U is listed as medically necessary effective 8/1/2025 when online authorization criteria are met.

Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products via the online tool for participating providers.

0288UCPT code for RiskReveal (Razor Genomics)

8/1/2025Effective date

Medicare & CommercialPlans impacted

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Coverage Criteria

Medically Necessary Coverage (RiskReveal)

Covered when ALL of the following are met:

Medical necessity and authorization: Test is RiskReveal (Razor Genomics) CPT 0288U and medical criteria in the online authorization tool for participating providers are met.

Effective 8/1/2025 for Medicare Advantage and Commercial Products

Plan type requirement: Prior authorization is required for Medicare Advantage Plans; recommended for Commercial Products via the online authorization tool for participating providers.

Only the ordering physician may be involved in authorization, and laboratories or third parties may not obtain authorization on behalf of the ordering physician; unauthorized services provided by a laboratory will be denied and may not be billed to the member.

Coverage for genetic testing services may differ for self-funded employer groups that have specific contract exclusions. Members and providers should consult the member's Benefit Booklet (Evidence of Coverage or Subscriber Agreement) to determine whether a particular test is covered under the group's contract, since some services may be excluded despite general policy language.

Benefits for genetic testing can vary between groups and contracts. If a test is not listed as covered in the group's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement, the test may be considered not covered or the financial responsibility of the member. For Commercial Products, self-funded groups with contract exclusions may have additional restrictions; check the Coding sections of the Genetic Testing Services or Proprietary Laboratory Analyses policies for lists of covered, not medically necessary, or excluded services.

Covered Indications

Predicting recurrence or metastatic risk in surgically resectable NSCLC to inform adjuvant chemotherapy decisions

Covered when ALL of the following are met:

Indication: Patient has surgically resectable non-small cell lung cancer (NSCLC) and is being considered for adjuvant chemotherapy to reduce risk of recurrence or metastasis.

Intended for patients considered low-risk by clinical and pathologic criteria where additional risk stratification may change adjuvant therapy decisions.

Clinical context: Molecular classifier testing (RiskReveal) is intended to predict likelihood of disease recurrence or metastatic disease among patients already considered low-risk by clinical and pathologic criteria to inform adjuvant platinum-based chemotherapy decisions.

Adjuvant platinum-containing chemotherapy improves survival mainly in higher-risk patients and may harm lower-risk patients; accurate risk stratification is therefore required.

Coding

Covered CPT CodesCPTCovered

0288U

RiskReveal (Razor Genomics) — Test and Laboratory (formerly DetermaRx)

Tumor size and staging risk (AJCC 8th edition)

Tumor size thresholdAJCC 8th edition distinguishes tumors <1 cm (lower risk) from 1–2 cm (higher risk within T1), with each centimeter of size associated with increased recurrence risk.

Clinical implicationTumors <1 cm (T1a per AJCC 8th) are associated with lower recurrence risk than 1–2 cm tumors; this influences consideration for adjuvant chemotherapy.

Staging noteAJCC 8th edition redefined T1a as <1 cm (previously <2 cm); this change affects risk stratification used in adjuvant decision-making.

Provider Actions / Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Medicare Advantage Plans and is recommended for Commercial Products via the online authorization tool for participating providers for RiskReveal™ (Razor Genomics) — CPT 0288U.

RiskReveal™ (Razor Genomics) — CPT 0288U
Effective 2025-08-01

Documentation Required

Ordering Physician Must Participate

Only the ordering physician may participate in the authorization, appeal, or other administrative processes related to prior authorization/medical necessity. Laboratories, laboratory representatives, or third parties with relationships to a laboratory are not permitted to obtain authorization on behalf of the ordering physician.

Laboratories and lab representatives may not obtain authorization or participate in authorization processes

Ordering Requirements

Note

ORDERING REQUIREMENT — Ordering physician only; labs prohibited from obtaining authorization

Only the ordering physician shall be involved in authorization, appeal, or other administrative processes; laboratories are not allowed to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician.

Labs may not obtain authorization, facilitate authorization, or prepare documentation on behalf of the ordering physician
Use of laboratory representatives or third parties to obtain authorization is a policy violation and may lead to termination from the BCBSRI provider network

Not Covered / Exclusions

NOT COVERED: Certain genetic testing services may be excluded for some self-funded groups per contract exclusions. For group-specific determinations, consult the member's Benefit Booklet and the Coding sections of the Genetic Testing Services or Proprietary Laboratory Analyses policies for details on which tests require prior authorization, are not medically necessary, or are contract exclusions.

Definitions

Definition: molecular classifier

DefinitionA molecular classifier is a laboratory test of DNA, RNA, and/or proteins intended to predict likelihood of disease recurrence or metastasis in NSCLC patients.

PurposeUsed to improve risk discrimination among patients already considered low-risk by clinical and pathologic criteria to inform adjuvant chemotherapy decisions.

Specimen/assay typesMay involve analysis of deoxyribonucleic acid (DNA), ribonucleic acid (RNA), and/or proteins.

AJCC staging (8th edition)

Staging systemAmerican Joint Committee on Cancer (AJCC) staging system, 8th edition, is used to stratify NSCLC risk and guide adjuvant therapy decisions.

Clinical useAJCC staging identifies patients (e.g., Stage IB and IIA) for whom adjuvant chemotherapy should be considered; Stage IA generally does not warrant chemotherapy.

Frequency Limits

RiskReveal — test identity and frequency

Test nameRiskReveal (Razor Genomics) — formerly DetermaRx.

CPT code0288U — RiskReveal (Test and Laboratory).

Frequency / repetitionNo specific repeated-test interval provided; frequency limit entry lists RiskReveal without a defined period.

Effective medical necessity dateConsidered medically necessary effective 8/1/2025 when online authorization criteria are met.

Authorization requirementPrior authorization required for Medicare Advantage and recommended for Commercial Products via the online tool for participating providers.

Background

Non-Small Cell Lung Cancer (NSCLC) carries a substantial risk of recurrence even after apparently complete surgical resection. Adjuvant platinum-based chemotherapy provides a survival benefit primarily for patients at higher risk of recurrence, while lower-risk patients may derive little benefit and can be harmed by treatment-related toxicity. A validated molecular classifier that predicts the likelihood of recurrence or metastasis among surgically resected NSCLC patients—particularly those considered low risk by conventional clinical and pathologic criteria—can inform the decision whether to recommend adjuvant chemotherapy.