Confirm authorization and medical necessity before ordering

Services must meet authorization and medical necessity guidelines and are subject to the member’s benefit coverage at the time of request; providers must ensure ordered tumor marker testing aligns with medical necessity before submission.

• Application of criteria depends on the individual's benefit coverage at time of request.
• Quarterly measurement of designated serum biomarkers is permitted for follow-up/monitoring unless otherwise specified.

Verify PA and provide justification for proprietary/LDT tests

Proprietary or laboratory‑developed tests (e.g., Ova1Plus®, OvaWatch SM, BeScreened‑CRC) may require additional clinical documentation and payer review; verify prior authorization rules with the payer when ordering these assays.

• Document clinical indication and how the result will affect management when ordering proprietary/LDT tests.
• Ova1Plus® process may include reflex testing (Ova1 → Overa) as described by the test developer.

Obtain PA for panels or non‑guideline indications

Prior authorization may be required for multi‑biomarker panels or when testing is requested for indications not supported by NCCN guidance; for FDA‑approved ovarian risk assays (ROMA, OVA1, OVERA) coverage aligns with preoperative risk estimation when surgery is planned and the patient has not yet been referred to an oncologist.

• PA may be required for panels or non‑guideline indications.
• ROMA, OVA1, OVERA intended use: estimate ovarian cancer risk for patients with adnexal mass planned for surgery and not yet referred to an oncologist.

Check PA rules for listed procedure codes

When submitting claims, verify payer prior authorization requirements for the CPT/HCPCS codes listed in the policy (examples include 82105, 82232, 86304, 86301, 0092U, 0599U) and follow payer rules for those codes.

• Procedure codes listed in the policy are provided as a reference—confirm PA applicability per payer.
• Examples include CPT codes 82105, 82232, 86304 and proprietary PLA codes 0092U, 0599U.

No additional PA rules in publication history

The policy text in the referenced publication history section contains no additional prior authorization requirements; rely on the specified prior_auth sections and payer rules instead.

• No PA requirements are specified in the publication/history section.

Follow reflex testing workflows for proprietary assays

Follow laboratory‑specified reflex testing algorithms when ordering proprietary assays that use reflex workflows (for example: Ova1 performed first with automatic reflex to Overa if Ova1 result is intermediate risk).

• Ova1 is performed first and Overa is automatically conducted if Ova1 result falls into an intermediate‑risk category.
• Follow the manufacturer's/laboratory's reflex algorithm when ordering.

Provide accurate documentation and correct coding

Submit accurate, complete documentation and use appropriate industry coding standards to support medical necessity and claims payment; providers are responsible for documentation and correct coding.

• Code and bill according to industry standards (CPT, HCPCS, ICD‑10 etc.).
• Accurate documentation is required to support medical necessity and payment; incorrect coding may lead to denial or recoupment.

Document indication and rationale for proprietary/LDT tests

When ordering proprietary or LDT tests, include the clinical indication, the test name, and a rationale describing how the result will impact patient management.

• Document indication, test name (e.g., BeScreened‑CRC, Ova1Plus®, OvaWatch SM), and expected management change.
• Provide clinical justification when clinical utility is described as emerging.

Document guideline‑aligned indication and care plan

Ensure documentation supports the clinical indication and alignment with guideline recommendations (for example, for adnexal mass testing document that surgery is planned and oncologic referral status).

• Document that adnexal mass testing is for a patient scheduled for surgery and not yet referred to a gynecologic oncologist when using ROMA/OVA1/OVERA.
• Cite guideline‑based rationale (e.g., NCCN Biomarkers Compendium) when ordering tests outside single‑marker indications.

Record clinical timing and surveillance intent for germ cell tumor markers

Document clinical details that support the specific testing indication—for example, suspected germ cell tumor, pre‑ or post‑orchiectomy status, chemotherapy timing, and surveillance intent when ordering AFP, hCG, or LDH.

• Record timing relative to orchiectomy and chemotherapy cycles when ordering AFP, hCG, LDH per ASCO guidance.
• Indicate surveillance intent and planned interval (ASCO supports surveillance up to 10 years with specified frequency).

Ensure testing aligns with guideline‑supported indications

Order tests so they align with guideline‑based indications (NCCN and other specialty guidance); tests used outside guideline‑supported contexts (e.g., routine screening where not recommended) may be denied or require justification.

• NCCN indicates ROMA/OVA1/OVERA have specific intended use and that the Panel does not recommend these tests for routine determination of adnexal/pelvic mass status.
• Use guideline citations to justify non‑routine orders.

Risk of denial for incorrect coding or insufficient documentation

Claims may be denied or recouped if coding/billing guidelines, reimbursement policies, or documentation are inaccurate or incomplete—ensure compliance with payer instructions and supporting records.

• Inaccurate coding or failure to follow billing guidelines can result in claim denial or recoupment.
• Maintain documentation to substantiate medical necessity and the chosen CPT/HCPCS codes.

Non‑covered markers may be denied

Requests for serum tumor markers not specifically addressed in this policy (alone or in a panel) are subject to non‑coverage and may be denied—order only markers/indications covered or provide strong guideline‑based justification.

• All other serum tumor markers not addressed in the policy (alone or in a panel) DO NOT MEET CRITERIA.
• Provide guideline citations when requesting tests outside listed indications.

Proteomic‑pattern screening is not covered

Testing based on analysis of proteomic patterns in serum for cancer screening or detection is not covered and will not meet criteria; do not submit claims for proteomic‑pattern screening without documented exception.

• Proteomic pattern analysis in serum for screening/detection DOES NOT MEET CRITERIA.
• Examples of proprietary proteomic screening tests are described as investigational and not covered.

Confirm benefit coverage and medical necessity before ordering

Application of the policy criteria depends on the individual's benefit coverage at time of request; services must meet authorization and medical necessity for the member's plan before being provided.

For proprietary/LDT tests, document indication and expected clinical impact

For proprietary/LDT tests, document the clinical indication and how the test result will change management; note that some proprietary tests employ reflex algorithms.

Order ovarian risk tests only for preoperative adnexal mass assessment

Order ovarian risk biomarker testing (ROMA/OVA1/OVERA) only when aligned with guideline recommendations—these tests are intended for patients with an adnexal mass when surgery is planned and prior to oncologist referral.

Document planned surgery when ordering ovarian risk assays

Certain proprietary ovarian‑risk tests are intended for preoperative risk estimation in patients planned for surgery; ensure the clinical scenario (adnexal mass with planned surgery) is documented when ordering.

No ordering‑provider restrictions specified

No specific ordering provider restrictions are stated in the referenced section of the document.