CurrentEmblemHealthPolicy MG.MM.LA.19bC4

Analysis of KRAS Status

Criteria for when analysis of KRAS gene mutation status is considered medically necessary for members to predict response to targeted therapies; applies to providers submitting prior authorization to EmblemHealth.

Policy Summary

PayerEmblemHealth

PolicyAnalysis of KRAS Status

Policy CodePolicy MG.MM.LA.19bC4

Change TypeNo material change

Effective Date

Next Review DateAug 8, 2025

Key ActionSubmit clinical evidence with the prior authorization request showing the patient meets criteria for KRAS analysis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3drugs listed that require KRAS analysis prior to initiation

3-4covered cancer types explicitly named

3specific CPT codes listed for testing

multipleICD-10 diagnosis codes enumerated

Coverage Criteria

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.

KRAS analysis is considered investigational and not medically necessary for all other indications that do not meet the specified criteria. This includes any clinical use or diagnosis not explicitly listed under the policy's covered indications (non‑small cell lung cancer, stage IV colon cancer, rectal cancer, colorectal cancer, or anal adenocarcinoma when testing is intended to predict response to Lumakras, Erbitux, or Vectibix prior to therapy).

Testing for indications other than the named cancer types and therapy‑prediction purposes is investigational and not medically necessary. KRAS analysis is limited to the covered clinical scenarios defined in the policy and is not authorized for other diagnostic, prognostic, screening, or research purposes outside those indications.

Covered Indications

Prediction of response to Lumakras (sotorasib), Erbitux (cetuximab) or Vectibix (panitumumab)

Covered when ALL of the following are met:

Indication: Prediction of response to Lumakras (sotorasib), Erbitux (cetuximab) or Vectibix (panitumumab) in members with non-small cell lung cancer (NSCLC), stage IV colon cancer, rectal cancer, colorectal cancer, or anal adenocarcinoma prior to initiation of therapy.

KRAS analysis is intended to guide targeted therapy selection prior to starting the listed agents.

Coding

Applicable Procedure CodesCPTCovered

81275	KRAS gene analysis; variants in exon 2 (eg, codons 12 and 13).
81276	KRAS gene analysis, variants in codons 12 and 13, additional variant(s) (eg, codon 61, codon 146).
81403	Molecular pathology procedure, Level 4.
88363	Examination and selection of retrieved archival tissue(s) for molecular analysis.

Applicable ICD-10 Diagnosis Codes (selection shown)ICD-10

C17.0	Malignant neoplasm of duodenum.
C18.0	Malignant neoplasm of cecum.
C18.7	Malignant neoplasm of sigmoid colon.
C19	Malignant neoplasm of rectosigmoid junction.
C20	Malignant neoplasm of rectum.
C21.0	Malignant neoplasm of anus, unspecified.
C33	Malignant neoplasm of trachea.
C34.10	Malignant neoplasm of upper lobe, unspecified bronchus or lung.
C34.11	Malignant neoplasm of upper lobe, right bronchus or lung.
C34.12	Malignant neoplasm of upper lobe, left bronchus or lung.

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Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for KRAS testing when intended to predict response to targeted therapies (for example, Lumakras, Erbitux, Vectibix). Providers must submit the clinical evidence that the patient meets the coverage criteria for the requested KRAS test.

Affected tests: KRAS mutation analysis when used to predict response to sotorasib, cetuximab, or panitumumab
Action required: Prior authorization submission with supporting clinical documentation

Note

Provider Action

Not stated.

Documentation Required

Required Clinical Documentation

The treating physician or primary care provider must submit clinical evidence demonstrating the patient meets the clinical criteria for the requested KRAS test. This documentation should include relevant diagnosis, stage, intended therapy (e.g., sotorasib, cetuximab, panitumumab), and any prior testing or treatments that support medical necessity.

Essential documentation: diagnosis, cancer stage, intended targeted therapy, prior molecular testing results (if any)
Consequence: Failure to submit required clinical evidence may prevent EmblemHealth from properly reviewing the prior authorization request

Denial Risk

Documentation Requirement / Denial Risk

Failure to submit the required clinical evidence may result in inability of EmblemHealth to properly review and process the prior authorization request and could lead to denial or delay of coverage.

Definitions

KRAS mutation status — definition and clinical relevance

DefinitionPresence of a mutation at codon 12 or 13 of the KRAS gene.

Clinical relevancePresence of a KRAS mutation correlates with lack of response to anti‑EGFR therapies such as cetuximab or panitumumab.

Prognostic noteIn colorectal cancer, KRAS‑positive tumors are associated with a worse prognosis.

Implication for therapy selectionDetection of KRAS mutation supports using alternative treatments rather than anti‑EGFR agents when predicting therapy response.

KRAS wild-type status — definition and clinical relevance

DefinitionThe typical or non‑mutated form of the KRAS gene (wild‑type).

Clinical relevanceTumors with KRAS wild‑type status increase the likelihood of response to anti‑EGFR therapies such as cetuximab or panitumumab.

Use in treatment planningIdentification of wild‑type KRAS can support selection of anti‑EGFR agents for eligible patients with colorectal and other listed cancers.

KRAS sequence variant analysis — test definition and uses

DefinitionKRAS sequence variant analysis is a molecular test used to detect variants in the KRAS gene to predict an individual’s response to anti‑EGFR drug therapy.

Typical targetsCommonly interrogates variants at codons 12 and 13 (and may include additional codons such as 61 and 146 as applicable).

Typical use casesUsed to predict response to anti‑EGFR therapies in metastatic colorectal cancer, anal cancer, and to inform therapy selection in other KRAS‑relevant malignancies listed by the policy.

Role in clinical workflowOften performed on tumor (somatic) tissue to guide targeted therapy decisions prior to initiation of agents like cetuximab or panitumumab.

Background

The KRAS gene is an oncogene encoding a RAS family GTPase; activating somatic mutations—most commonly involving codons 12 and 13 in exon 2 (with additional variants reported at codons 61 and 146)—lead to constitutive signaling that can drive malignancy. Detection of these KRAS mutations in tumor tissue is used to predict lack of response to anti‑EGFR monoclonal antibodies (for example, cetuximab and panitumumab) and to identify patients with specific actionable variants (for example, the G12C mutation targeted by sotorasib) when selecting targeted therapy for the covered cancer types.