Verify prior authorization for listed panel and MRD codes

Certain broad molecular profiling panels, ctDNA panels, and MRD assays are listed with CPT and proprietary PLA/GSP codes in the policy; providers must verify prior authorization requirements with the member's plan before ordering these tests.

• Examples of panel and proprietary codes referenced: 81445, 81455, 0037U, 0239U, 0242U, 0340U, 0422U

Confirm indication and use correct panel codes

Order tumor-type agnostic and lung-focused molecular profiling panels only for the diagnoses and clinical contexts specified in the policy and use the appropriate panel coding (PLA/GSP or applicable CPT) when submitting for authorization or claims.

• Tumor‑type agnostic panels covered only when member meets listed diagnoses and is seeking further cancer treatment (see policy).
• If a panel is performed, appropriate panel codes (PLA/GSP or CPT) should be used.

Confirm ctDNA panel indication before prior authorization

When ordering broad or lung‑focused ctDNA panel tests, confirm the patient meets the tumor‑type indications listed in the policy and, if ordering ctDNA concurrently with tissue testing, ensure the diagnosis is one of the allowed lung cancer types.

• Broad ctDNA panels limited to specified tumor list (e.g., metastatic lung, colorectal, pancreatic, prostate, etc.).
• If ctDNA performed simultaneously with tissue testing, concurrent use limited to specified lung diagnoses.

Obtain authorization when bladder FISH exceeds frequency limits

Bladder tumor FISH testing is subject to utilization frequency limits after diagnosis; obtain prior authorization or verify plan limits when tests exceed the stated yearly maxima.

• Frequency limits: Years 1–2 up to 4 tests/year; Year 3 up to 3; Year 4 up to 2; Years 5–15 up to 1/year.
• Use of validated assays required (UroVysion noted as FDA‑approved).

Document advanced/metastatic intent for broad NGS panels

For broad NGS panel testing in advanced/metastatic disease (for example NSCLC or colorectal cancer), document that testing is intended to guide systemic therapy or is for advanced/metastatic disease; payer may require prior authorization for broad NGS panels.

• Document disease stage (advanced/metastatic) and that results will inform systemic therapy.
• Prior authorization may be required by the Health Plan for broad NGS panels.

Apply MRD frequency limits and confirm authorization when outside guideline regimens

When MRD testing is ordered outside well‑established guideline regimens, adhere to default frequency limits and secure prior authorization as required by the plan to ensure the test frequency and indication align with policy.

• Default MRD frequency: typically once per patient per cancer diagnosis; for patients without known cancer, once every 12 months absent guideline regimen.
• Prior authorization may be required to enforce frequency limits and intended‑use alignment.

Require validated assay and document timing for bladder FISH

Ensure bladder FISH testing uses validated assays and that frequency limits by years since diagnosis are documented when requesting authorization; the policy references UroVysion as the FDA‑approved assay for the indicated chromosomal targets.

• Validate assay: UroVysion cited as FDA‑approved for bladder FISH.
• Document timing relative to diagnosis to demonstrate compliance with yearly maxima.

Align prior authorization with expanded NTRK indications

Update prior authorization practices to reflect expanded NTRK coverage: NTRK testing criteria now include all metastatic/progressive/advanced/inoperable or unknown solid tumors and added tumor types (e.g., recurrent/metastatic vaginal cancer); verify authorization aligns with these expanded indications.

• Policy revision added all metastatic/progressive/advanced/inoperable or unknown solid tumors to NTRK testing criteria.
• NCCN and FDA references cited support expanded coverage; ensure authorization reflects updated criteria.

Follow plan documents for prior authorization procedures

Prior authorization processes and specific codes are determined by the member's coverage documents and Health Plan administrative policies; verify plan‑level prior authorization requirements and procedures before ordering.

• Clinical policy is a medical necessity guide but does not guarantee payment; follow plan terms and state/federal requirements.
• Contact the Health Plan for exact prior authorization codes/processes.

Limit repeat testing to policy‑specified progression scenarios

Repeat broad or panel testing is limited to specified progression scenarios; order repeat testing only when the policy's progression criteria are met (e.g., progression on targeted therapy for NSCLC) and document the clinical rationale.

• Policy allows repeat tumor‑type agnostic panel testing for progression of advanced/metastatic NSCLC, gastric adenocarcinoma, or metastatic prostate cancer.
• Repeat lung‑focused panels allowed when progression on targeted therapy for NSCLC.

Sequence KIT testing after required prior endocrine therapies

Order KIT variant testing for ER‑positive, HER2‑negative breast cancer only in patients with disease progression after one or two prior lines of endocrine therapy including a CDK4/6 inhibitor; document prior therapies in the medical record.

• KIT testing eligibility requires documented prior endocrine therapy including at least one CDK4/6 inhibitor.
• Document menopausal/sex status criteria where applicable.

Order PIK3CA ctDNA testing only when therapy decisions depend on results

PIK3CA ctDNA testing must be ordered only when the patient has recurrent unresectable or stage IV HR+/HER2‑ breast cancer, is considering alpelisib+fulvestrant or capivasertib+fulvestrant, and has progressed on at least one prior line of therapy; document these therapy considerations.

• PIK3CA ctDNA coverage linked to consideration of specified therapies after progression on prior therapy.
• Document that patient is a candidate for alpelisib or capivasertib plus fulvestrant and prior therapy history.

Consider stepwise (single‑gene then panel) testing when clinically appropriate

If single‑gene testing will adequately inform treatment decisions (for example BRAF testing in certain melanoma stages), perform stepwise testing before broader panels and document rationale for not ordering a broader panel.

• NCCN accepts single‑gene or small panels for some indications; document that single‑gene testing is sufficient for clinical decision.
• Broader profiling may be considered if single‑gene testing is negative and further information is needed.

Adhere to step limits for NGS‑based MRD and authorize exceptions

NGS‑based MRD services (eg, Signatera) are generally allowed once per patient per cancer diagnosis unless there is clinical evidence of an a priori change in tumor genetic content; obtain prior authorization if additional testing frequency is requested.

• Default allowance: once per cancer diagnosis; exceptions require documented clinical evidence of changed genetic content.
• Prior authorization may be required for repeat NGS‑based MRD testing.

Document LCD criteria before ordering AR‑V7 CTC testing

AR‑V7 CTC testing is covered only when CMS LCD criteria are met; document tissue infeasibility and that the test meets LCD conditions (single test per diagnosis or on newly metastatic disease or at progression) before ordering.

• Document that tissue‑based testing is not feasible and include one of the LCD justifications (newly metastatic untested lesion, progression, concern for resistance).
• Only one AR‑V7 test per encounter unless second reasonable adjunct documented; duplicate testing by different methodologies is not covered.

Document therapy intent for fusion testing that could enable targeted agents

Positive fusion (e.g., NTRK) results may enable biomarker‑directed therapies such as larotrectinib, entrectinib, or repotrectinib; document tumor type/stage and how results will inform therapy when requesting authorization.

• NCCN lists these agents for NTRK fusion‑positive tumors; FDA labeling (repotrectinib) notes similar indications.
• Document that detection would inform use of listed targeted therapies.

Do not require prior EGFR TKI therapy for EGFR ctDNA testing under revised policy

The policy removed a prior requirement that EGFR ctDNA testing be contingent on prior EGFR tyrosine kinase inhibitor therapy; do not require EGFR TKI exposure as a prerequisite when ordering EGFR ctDNA under the revised criteria.

• Previously required EGFR TKI consideration criterion has been removed from EGFR ctDNA criteria per policy revision.

Notify and document patient counseling for potential incidental germline findings

Inform and document that somatic molecular profiling may reveal incidental germline variants; document that counseling or disclosure occurred prior to testing.

• Providers should communicate potential for incidental germline findings before somatic testing and record that counseling/disclosure occurred in the medical record.

Use appropriate panel CPT/PLA/GSP codes and bill adjunct analyses separately

When billing for panel tests, use the appropriate panel CPT, PLA, or GSP codes as indicated by the performing laboratory; additional IHC or cytogenetics analyses may be billed alongside PLA/GSP codes when applicable.

• Policy note: additional IHC and/or cytogenetics analyses may be billed alongside PLA or GSP panel codes.
• Reference the policy coding table and Concert Platform for registered tests and current coding guidance prior to claims submission.

Document indication, assay, and management impact for MRD cfDNA testing

For MRD (cfDNA) testing, document the patient's cancer history, that the cancer type/stage is within the MRD assay's intended use, and that identification of recurrence/progression would change management; specify the MRD assay used and prior MRD testing timing.

• Document cancer diagnosis, stage, and that detection would lead to a definitive management change.
• Record which MRD assay is used (eg, Guardant360 Response/Reveal, Signatera) and timing of any prior MRD tests.

Support ctDNA orders with diagnosis‑specific clinical documentation

Clinical documentation for ctDNA testing must support the specific diagnosis and context required by the policy (for example metastatic colorectal cancer for BRAF/KRAS testing or HR+/HER2‑ recurrent/stage IV breast cancer with prior progression for PIK3CA); include prior testing results and treatment history.

• Document tumor type (e.g., metastatic colorectal cancer) and prior testing/treatment history that justify ctDNA testing.
• Include rationale that tissue testing is infeasible when ctDNA is used as an alternative.

Provide AR‑V7 specific documentation per CMS LCD

For AR‑V7 CTC analysis, document that tissue‑based testing is not feasible and whether the test is being performed as the single test during the current cancer diagnosis, for newly metastatic disease, or at progression as required by the CMS LCD.

• Include explicit documentation of tissue infeasibility or one of the LCD‑listed clinical justifications.
• Ensure only one AR‑V7 test per encounter unless an adjunct test meeting LCD criteria is documented.

Document tumor type and stage for fusion testing to support coverage

When ordering NTRK, RET, or ROS1 fusion testing, document tumor type and disease stage (eg, metastatic/unresectable) and that a positive result would inform targeted therapy selection consistent with NCCN/FDA guidance.

• Document tumor type/stage and that detection would enable use of targeted agents (e.g., larotrectinib, entrectinib, repotrectinib).
• Note preference for RNA‑based NGS for fusion detection per NCCN when relevant.

Verify coverage against plan and state rules before ordering

Follow the member's coverage documents and Health Plan administrative policies; this clinical policy guides medical necessity but does not guarantee payment—verify plan and state rules before ordering tests.

• Coverage decisions are subject to the member's evidence of coverage, state Medicaid rules, and plan‑level administrative policies.
• Contact the Health Plan for authorization and coverage clarifications.