Submit required documentation with prior authorization request

Provide the specific test name (or complete gene list for custom tests), the laboratory performing the test, clinical notes documenting the indication and relevant signs/symptoms, prior related test results, family history if applicable, how the test result will impact clinical decision making, and all relevant CPT/HCPCS codes billed. Failure to submit complete documentation may affect review outcome.

• Specific gene, trade or proprietary test name or full gene list
• Name of laboratory performing the test
• Clinical notes: indication and related signs/symptoms
• Prior related test/laboratory results
• Family history, if applicable
• How results will impact clinical decision making
• All relevant CPT/HCPCS codes billed

Document intended management impact for limited‑evidence assays

For comprehensive cfDNA or CTC panels with limited evidence of clinical utility, include documentation of how test results are intended to change patient management; prior authorization may be required to establish medical necessity when used instead of tissue testing.

• Document intended impact on treatment decisions or trial eligibility
• Provide rationale if cfDNA/CTC used in lieu of tissue testing

Obtain prior authorization for unlisted codes to avoid denial

If billing an unlisted code for a potentially covered service, obtain prior authorization to reduce the risk of a post-service denial; the policy recommends PA for unlisted codes submitted for potentially covered services.

• Prior authorization is recommended for unlisted codes to avoid post-service denial
• Provide supporting documentation of medical necessity when requesting PA

Recommend PA before submitting unlisted codes for potentially covered tests

When submitting an unlisted code for a service that may fall under this policy, request prior authorization to confirm coverage and appropriate coding prior to service delivery to prevent post‑service denials.

• Recommend PA when unlisted code submitted for potentially covered services
• Confirm coding and coverage before performing the test

Provide complete documentation when ordering tests

Ordering clinicians must supply required documentation elements at time of request; the policy does not mandate a specific form but incomplete documentation may affect review outcome.

• Provide full documentation as listed in policy (test name/gene list, lab, clinical notes, prior results, impact on management, codes)
• Policy does not specify a required form for submission

Pursue tumor tissue testing after negative liquid biopsy

If a liquid biopsy (ctDNA/cfDNA) is negative for an actionable alteration, obtain follow-up tumor tissue testing when feasible, as guidelines recommend tissue testing if liquid biopsy is negative.

• Negative ctDNA does not exclude tumor mutations — pursue tissue testing if possible
• Document rationale if tissue testing is infeasible

State clinical actionability of test results in request

Ordering clinicians must identify how test results will influence targeted therapy decisions or clinical trial eligibility when requesting testing; include this in documentation.

• State whether results will guide targeted therapy or trial enrollment
• Include prior test results and clinical rationale

Ensure appropriate ordering clinician documents intent

Order ctDNA/CTC testing through clinicians managing the cancer (e.g., oncologists) when results will affect targeted therapy or trial eligibility; document the responsible ordering clinician in the request.

• Ordering should be by clinicians managing the cancer when results will influence therapy or trial eligibility
• Document ordering clinician in submission

Required documentation elements to include with test requests

Include the test name or complete gene list, laboratory name, clinical indication and signs/symptoms, prior related test results, family history if applicable, how the results will affect clinical decision making, and all CPT/HCPCS codes billed when requesting review or prior authorization.

• Test name or full gene list
• Laboratory performing the test
• Clinical indication and signs/symptoms
• Prior related test results
• Family history if applicable
• Planned clinical action based on results
• All relevant CPT/HCPCS codes

Document tissue unavailability and intended clinical use

When using cfDNA/ctDNA because tumor tissue is unavailable or infeasible, document the reason tissue is unavailable and state that results will inform targeted therapy decisions or trial eligibility.

• Document that tissue biopsy is not feasible or insufficient for molecular analysis
• Explain how liquid biopsy results will inform therapy or trial eligibility

Supply documentation supporting unlisted code medical necessity

Provide supporting documentation for any unlisted code to demonstrate medical necessity, correct coding, and pricing at the claim level; all unlisted codes will be reviewed for these elements.

• Supply clinical rationale demonstrating medical necessity
• Ensure coding accuracy and supply documentation to support pricing at claim review

Unlisted codes undergo claim‑level medical necessity review

Be aware that all unlisted codes are subject to claim‑level review for medical necessity, correct coding, and pricing; provide thorough documentation at submission to support coverage.

• Unlisted codes reviewed at claim level for medical necessity and correct coding
• Provide documentation supporting that testing is for a covered indication

Risk of denial when coverage criteria are not met

Tests will be considered not medically necessary and may be denied when the policy criteria I.-II. are not met, including for routine surveillance, monitoring for recurrence without active treatment planning, or repeat testing without documented clinically significant change.

• Routine surveillance or monitoring without active treatment planning is not medically necessary
• Repeat testing without documented clinically significant change is not medically necessary
• Named tests listed in policy are not covered when criteria I-II are not met

Denial risk due to insufficient evidence of clinical utility

Lack of high‑quality evidence that CTC or ctDNA testing improves patient‑centered outcomes (quality of life, PFS, OS) may lead to denial when tests are ordered for prognostic purposes or without evidence they will change management.

• Clinical utility evidence is limited; use for prognosis or risk prediction alone is insufficient to establish medical necessity
• Provide documentation that testing will change management to mitigate denial risk

Unlisted code submissions for non‑covered services will be denied

If an unlisted code is submitted for a service that is not covered under this policy, it will be denied as not covered; unlisted codes for potentially covered services should have prior authorization to avoid denial.

• Unlisted codes for non-covered services will be denied as not covered
• Obtain prior authorization for unlisted codes when service may be covered

Unlisted code denial for non‑covered services

Submission of unlisted codes for services not covered by this policy will be denied as not covered; confirm coverage and seek prior authorization when appropriate before performing the test.

• Verify coverage before submitting unlisted codes
• Unlisted codes for non‑covered services are denied

Ordering clinician must provide required documentation elements

The ordering clinician must provide the required documentation elements (indication, prior tests, how results will impact management, lab and test name); the policy does not specify a required submission form.

• Provide indication, prior tests, intended impact on management, lab name and test name
• No specific form is mandated by the policy

Have treating clinicians order tests that will affect therapy or trial eligibility

Ordering should be performed by clinicians who manage the patient’s cancer (for example, oncologists) when results will influence targeted therapy choices or clinical trial eligibility; document the responsible clinician on the request.

• Prefer ordering by clinicians managing the cancer when test results will affect therapy or trial enrollment
• Document ordering provider on request