Prior authorization / Medical necessity verification — Prior authorization required when medical necessity criteria must be verified before coverage

Prior authorization may be required when medical necessity must be verified before coverage. The policy's medical necessity criteria require that the individual has not previously had a genomic sequencing procedure using the same assay to investigate the same kind of alteration in the same genomic location; has recurrent, relapsed, refractory, metastatic, or advanced stage III/IV cancer; has one of the listed cancer types; has decided to seek further treatment; and that the sequencing procedure is FDA-approved or a validated diagnostic test performed in a CLIA-certified laboratory.

• Prior authorizationrecommended when medical necessity verification is required
• Medically necessary criteria must be documented (see policy A1–A5)
• Tests must be FDA-approved or CLIA-validated diagnostic laboratory tests

Confirm clinical validity for indicated variant–tumor pairings

Prior authorization should confirm the test is intended to detect somatic tumor variants (SNVs, indels, CNVs, fusions, with optional MSI and TMB) and is clinically appropriate for the tumor/variant pairing being investigated. The evidence base indicates clinical validity is variant- and tumor-specific; ensure the requested assay reports the relevant variants for the indicated cancer type.

• Assay scope: SNVs, indels, CNVs, fusions; may include MSI and TMB
• Confirm assay reports the variant/tumor pairing relevant to treatment decisions

Prior authorization recommendation — When testing is performed to identify biomarker-linked therapies that are regulatory-agency approved or to inform use of tumor-agnostic therapies

When testing is performed to identify biomarker-linked therapies that are regulatory-agency approved or to inform use of tumor-agnostic treatments, prior authorization is recommended to verify that testing aligns with guideline recommendations (eg, ASCO, NCCN) and that results will inform an approved therapy or appropriate clinical decision.

• Use multigene testing when patients are eligible for regulatory-approved biomarker-linked therapies
• Consider multigene panels when multiple biomarkers could affect therapy choice

PA requirement for listed genomic assay codes — Prior authorization may be required for comprehensive genomic profiling/targeted genomic sequence assays identified by the CPT/PLA codes

Prior authorization may be required for comprehensive genomic profiling assays identified by CPT/PLA codes listed in the Coding section. Confirm payer-specific code-level requirements and effective dates when submitting authorizations.

• Verify coverage/PA requirements for specific CPT/PLA/HCPCS codes prior to billing
• Refer to most recent coding updates for effective dates and added codes

Prior authorization — No explicit prior authorization requirements are specified in these sections.

No explicit prior authorization process, step therapy requirements, or detailed documentation checklist is provided in the policy text. Providers should follow payer-specific administrative procedures and local prior authorization portals for submission requirements.

• No explicit step therapy program is described in this policy
• No explicit denial triggers are listed in the policy text beyond failure to meet medical necessity criteria
• No comprehensive documentation checklist is provided in the policy; document clinical indication, prior testing history (same assay/alteration/location), tumor stage/status, and that the test is FDA-approved or CLIA-validated

Denial triggers — Failure to meet the medical necessity criteria (see Policy A)

Providers should be aware that denials may result if the medical necessity criteria are not met (for example, prior identical genomic sequencing using the same assay for the same alteration/location) even though the policy does not list an explicit denial triggers section. To reduce denial risk, include documentation showing the assay has not been previously used for the same alteration/location and that the patient meets the policy clinical criteria.

• Potential denial rationale: clinical utility not demonstrated for expanded panels when criteria not met
• Denial risk if prior same-assay sequencing for same alteration/location is documented

Required documentation — Document that the individual has not previously had genomic sequencing with the same assay for the same genomic location, has recurrent/advanced disease, and that the assay is FDA-approved or CLIA-validated

Documentation supporting authorization requests should include sufficient clinical information even though the policy does not provide a formal checklist. At minimum, submit: cancer diagnosis and stage, prior treatment history, intent to pursue further treatment, prior genomic testing history (including assay and genomic locations tested), and laboratory validation (FDA approval or CLIA certification).

• Minimum recommended documentation: diagnosis/stage, treatment plan, prior testing history (same assay/alteration/location), assay regulatory/validation status
• Include genomic profiling results when available (identified actionable alterations and genes tested) to support medical necessity

Single-gene testing alternative — Consideration of single-gene testing versus comprehensive profiling is relevant

Consider whether single-gene testing is appropriate per tumor-specific guidelines before authorizing broad panels when guideline-directed single-gene tests exist (eg, EGFR/ALK/ROS1 in NSCLC). The policy recognizes single-gene testing as a current comparator practice.

• Order single-gene tests first when guideline recommendations specify them for the tumor type
• If multiple biomarkers are relevant or tumor-agnostic therapy is considered, multigene panels may be preferred

Genetic counseling requirements

No explicit pre- or post-test genetic counseling requirements are stated in the policy sections referenced.

• Counseling is not mandated by this policy; follow local practice guidelines as appropriate.

Follow intended-use statements for FDA-cleared tests

Some FDA-cleared tests indicate intended use by 'qualified health care professionals'; ordering clinicians should follow the test's intended-use statements.

• Check the assay's labeling for any restrictions on who may order the test.

Order testing within oncology care when results will guide treatment

Testing should be ordered in the context of advanced/metastatic solid tumors by oncology providers when results will inform selection of regulatory-approved biomarker-linked therapies or when recommended by tumor-specific guidelines.

• Ordering clinician should be managing care for a patient seeking further treatment for advanced/recurrent cancer.

Ordering clinician responsibility

The ordering clinician must be managing the patient’s care and the patient must be seeking further treatment for advanced or recurrent cancer; the policy does not list narrower provider-type requirements in the referenced excerpt.

• Document that the ordering clinician is responsible for the patient’s ongoing cancer care and treatment decisions.