CurrentProvidence Health PlanPolicy 414

Tumor Antigen Assays

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Defines medical necessity and coverage criteria for serum tumor antigen immunoassay testing (CA‑125, CA 15‑3/CA 27.29, CA 19‑9) for Providence Health Plan commercial members and describes coding and billing guidance.

Policy Summary

PayerProvidence Health Plan

PolicyTumor Antigen Assays

Policy CodePolicy 414

Change TypeOperational — diagnosis code update

Effective DateJul 1, 2026

Last ReviewJul 1, 2026

Next Review DateMay 1, 2027

Key ActionObtain and document an appropriate ICD-10 diagnosis and, when required, secure prior authorization for unlisted codes to avoid claim denials.

SourceLink

POLICY UPDATE CHANGES

Eligible diagnosis codes added to configuration per NCD updates.

3Tumor antigens addressed

CommercialPlan product

86300/86301/86304Listed CPT codes

AnnualReview cycle

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CurrentProvidence Health PlanPolicy 414

Tumor Antigen Assays

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Sign up for Providence Health Plan Policy 414 alerts

Get alerted when Policy 414 changes without checking for updates manually.

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Policy Summary

PayerProvidence Health Plan

PolicyTumor Antigen Assays

Policy CodePolicy 414

Change TypeOperational — diagnosis code update

Effective DateJul 1, 2026

Last ReviewJul 1, 2026

Next Review DateMay 1, 2027

Key ActionObtain and document an appropriate ICD-10 diagnosis and, when required, secure prior authorization for unlisted codes to avoid claim denials.

SourceLink

POLICY UPDATE CHANGES

Eligible diagnosis codes added to configuration per NCD updates.

3Tumor antigens addressed

CommercialPlan product

86300/86301/86304Listed CPT codes

AnnualReview cycle

Coverage Criteria

inv-01: Medically necessary indications by antigen

Covered when ANY of the following specific antigen-based criteria are met:

CA‑125 medically necessary: Testing for CA 125 may be considered medically necessary when any of the following are met: A) as part of the initial pre-operative work-up for women presenting with a suspicious pelvic mass to be used as a baseline for purposes of post-operative monitoring; OR B) during the first month post-treatment after initial surgery and/or chemotherapy for ovarian carcinoma (obtain three serum levels during the first month to determine CA‑125 half-life); OR C) at the completion of chemotherapy.

Surveillance schedule: generally every 3 months for 2 years, every 6 months for the next 3 years, then yearly thereafter; in advanced/recurrent disease may obtain prior to each treatment cycle.

CA 15‑3 / CA 27.29 medically necessary: Testing for CA 15‑3 or CA 27.29 may be considered medically necessary to aid in the management of patients with breast cancer, including assessment of recurrent disease or the patient's response to treatment with subsequent treatment cycles.

Use consistently either CA 15‑3 or CA 27.29 (not both) for serial monitoring.

CA 19‑9 medically necessary: Testing for CA 19‑9 is considered medically necessary to aid in the management of patients with an established diagnosis of pancreatic and biliary ductal carcinoma, including assessment of recurrent disease or the patient's response to treatment with subsequent treatment cycles.

Not indicated for diagnosing pancreatic or biliary ductal carcinoma.

inv-02: Not medically necessary

Considered not medically necessary when the specific antigen criteria above are not met (examples provided in policy):

CA‑125 not medically necessary: CA 125 testing is considered not medically necessary when the CA‑125 criteria are not met, including but not limited to evaluation of patients with signs or symptoms suggestive of malignancy or use for aiding in the differential diagnosis of a pelvic mass outside the specified indications.

CA 15‑3/CA 27.29 not medically necessary: CA 15‑3 or CA 27.29 testing is considered not medically necessary when the breast cancer monitoring criterion is not met, including evaluation of patients with signs or symptoms suggestive of malignancy when the monitoring indication is not satisfied.

CA 19‑9 not medically necessary: CA 19‑9 testing is considered not medically necessary when the CA 19‑9 criterion is not met, including use to evaluate or diagnose patients with signs or symptoms suggestive of malignancy or to diagnose pancreatic or biliary ductal carcinoma.

This policy defines coverage for serum tumor antigen immunoassays by antigen-specific indications. CA‑125 testing is covered when used as a pre‑operative baseline for women with a suspicious pelvic mass, during the first month post‑treatment for ovarian carcinoma (three measurements to determine CA‑125 half‑life), or at the completion of chemotherapy. CA 15‑3 or CA 27.29 are covered when used to manage patients with known breast cancer for assessment of recurrence or response to therapy, using one assay consistently for serial monitoring. CA 19‑9 is covered only to aid management of patients with an established diagnosis of pancreatic or biliary ductal carcinoma (for assessing recurrence or treatment response) and is not indicated for diagnosis of these diseases.

Testing is not medically necessary when the antigen‑specific coverage criteria above are not met. Examples include using tumor markers to evaluate patients with signs or symptoms suggestive of malignancy when the relevant covered indication does not apply, or using CA‑125 to aid in the differential diagnosis of a pelvic mass outside the listed pre‑operative baseline and surveillance contexts. CA 15‑3/CA 27.29 are similarly not necessary when not used for breast cancer management as described.

Covered Indications by Antigen

inv-14: CA‑125 — initial pre-operative baseline for suspicious pelvic mass; post-treatment monitoring; surveillance schedule

CA‑125 initial and post-treatment criteria: Obtain CA‑125 as part of the initial pre-operative work-up for women with a suspicious pelvic mass to establish a baseline for post-operative monitoring; obtain three serum CA‑125 levels during the first month after initial surgery and/or chemotherapy to determine CA‑125 half-life; obtain CA‑125 at the completion of chemotherapy.three measurements in first month

CA‑125 surveillance schedule: For surveillance after initial treatment, CA‑125 measurements are generally obtained every 3 months for 2 years, every 6 months for the next 3 years, and yearly thereafter.Every 3 months for 2 years, then every 6 months for next 3 years, then yearly thereafter

May be obtained prior to each treatment cycle in advanced or recurrent disease.

inv-15: CA 15‑3 or CA 27.29 — monitoring management of breast cancer for recurrent disease or treatment response; use one assay consistently

Not Covered / Limitations

Use of CA 19‑9 for diagnosis of pancreatic or biliary ductal carcinoma is explicitly not covered; CA 19‑9 is intended only for follow‑up and management of patients with an established diagnosis. Likewise, use of tumor markers (including CA‑125) for diagnostic differentiation of ovarian or pelvic masses outside the specific covered indications is not covered. Claims for such diagnostic uses will be considered not medically necessary.

Frequency Limits

CA‑125 (surveillance after initial treatment)

Surveillance scheduleEvery 3 months for 2 years, then every 6 months for next 3 years, then yearly thereafter

Use during advanced/recurrent diseaseMay be obtained prior to each treatment cycle to monitor response

Post-treatment timingThree serum levels in the first month post-treatment to determine CA‑125 half-life; obtain at completion of chemotherapy as an index of residual disease

Provider Actions & Documentation

Prior Authorization

Prior authorization recommended for unlisted codes; listed CPTs noted

Prior authorization is recommended for unlisted codes and may be appropriate depending on member benefits; listed CPT codes (86300, 86301, 86304) may be considered medically necessary when billed with an appropriate ICD‑10 per the Medicare NCD coding manual.

Listed CPT codes: 86300, 86301, 86304
Unlisted codes are reviewed for medical necessity, correct coding, and pricing at the claim level
Prior authorization recommended for unlisted codes submitted for potentially covered services to avoid post-service denial

Note

Order and use tumor antigen tests only for policy-specified indications

Ensure testing is ordered and documented according to the policy's covered indications: use CA‑125, CA 15‑3/27.29, or CA 19‑9 only for the specific management purposes described and follow the coding/billing guidance in the policy.

Use CA‑125 for pre‑operative baseline, post‑treatment monitoring, completion of chemotherapy, and surveillance per schedule

Coding

Covered CPT Codes (per policy guidance)CPT

86300	Immunoassay for tumor antigen, quantitative; CA 15-3 (27.29)
86301	Immunoassay for tumor antigen, quantitative; CA 19-9
86304	Immunoassay for tumor antigen, quantitative; CA 125

Ordering Requirements

Step Therapy

Ordering requirement: link test to appropriate ICD‑10 per NCD; consider prior auth

Order tumor antigen tests with an appropriate ICD‑10 diagnosis code consistent with the Medicare NCD coding guidance; obtain prior authorization as recommended for unlisted codes or when payer rules require it.

Billed CPT codes may be considered medically necessary only when submitted with one of the ICD‑10 codes from the Medicare NCD Coding Policy Manual
Prior authorization is recommended for unlisted codes or where indicated by member benefits to avoid denial

Background

Serum tumor‑associated antigen immunoassays measure circulating proteins or carbohydrate antigens that can correlate with tumor burden. These assays include CA‑125 (commonly elevated in epithelial ovarian carcinoma and used for pre‑operative baseline, post‑treatment monitoring, and surveillance), CA 15‑3 / CA 27.29 (used for monitoring breast cancer treatment response and recurrence, with recommendation to use one assay consistently), and CA 19‑9 (used to follow patients with an established diagnosis of pancreatic or biliary ductal carcinoma but not for diagnosis). The clinical value of these tests is primarily in monitoring disease course, treatment response, and recurrence rather than initial diagnostic evaluation.

Definitions

CA‑125 — definition and clinical context

DefinitionCA‑125 is a high molecular weight serum tumor marker elevated in ~80% of patients presenting with epithelial ovarian carcinoma; also elevated in fallopian tube, endometrial, and endocervical carcinomas

Primary clinical usesInitial pre‑operative baseline for suspicious pelvic mass; post‑treatment monitoring including half‑life assessment; surveillance and response monitoring

Surveillance noteSurveillance measurements generally obtained every 3 months for 2 years, then every 6 months for next 3 years, then yearly thereafter

CA 15‑3 / CA 27.29 — definition and clinical context

DefinitionCA 15‑3 and CA 27.29 are tumor markers used to monitor breast cancer response to therapy and assess residual or recurrent disease

Assay selection

Revision History

2026-06revisionLatest

Eligible diagnosis codes added to configuration to align with National Coverage Determination (NCD) updates.

2025-06revision

Annual policy update (no clinical policy statement changes).

2024-06creation

Policy created (new policy).