CurrentBlue Cross Blue Shield - MassachusettsPolicy 503

CA-125_Measurements_Policy

Defines medical necessity criteria, prior authorization rules, and coding guidance for serum CA-125 testing for commercial members (Managed Care HMO/POS, PPO, Indemnity). Describes covered indications (diagnosis, monitoring, recurrence) and investigational uses (screening asymptomatic patients and certain non-gynecologic cancers).

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyCA-125_Measurements_Policy

Policy CodePolicy 503

Change TypeClarified coding; literature review

Effective Date

Next Review Date

Key ActionPrecertification/preauthorization IS REQUIRED for all products if the CA-125 procedure is performed inpatient.

SourceLink

POLICY UPDATE CHANGES

11/2022 Annual policy review: Policy updated with literature review through October 2022. References added. Policy statements unchanged.

4/2023 Clarified coding information.

1/2021 Medicare information removed; see MP #132 for local and national coverage determinations.

1CPT code listed

40+ICD-10 diagnosis codes listed

2Investigator-listed non-covered cancer types (GI, hepatic/pancreatic)

Coverage Summary

Medical-Necessity Criteria

Medically Necessary

Measurements of CA-125 may be considered MEDICALLY NECESSARY when ALL of the following apply depending on indication:

ALL of the following

Patients with symptoms suggestive of ovarian cancer
Patients with known ovarian cancer to aid in monitoring of disease, response to treatment, and detection of recurrence (including assessing value of second-look surgery)
Individual patients with other gynecologic malignancies (e.g., endometrial cancer) in whom baseline CA-125 levels have been shown to be elevated
Patients with a pelvic mass with unknown diagnosis
Peritoneal primary cancer to aid in monitoring of disease
Patients with adenocarcinoma of unknown primary (abdominal or pelvic carcinomatosis)
Measurements as an indicator of tumor size or grade for cancer

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Investigational / Not Medically Necessary

Measurements of CA-125 are considered INVESTIGATIONAL (not covered) when ANY of the following apply:

ANY of the following

Asymptomatic patients as a screening technique for ovarian cancer
Use in colorectal cancer for diagnosis, monitoring, or prognosis
Use in gastric cancer for diagnosis, monitoring, or prognosis
Use in liver cancer for diagnosis, monitoring, or prognosis
Use in pancreatic cancer for diagnosis, monitoring, or prognosis

Coding

Covered CPTCPTCovered

86304

Immunoassay for tumor antigen, quantitative; CA 125

Relevant ICD-10 Diagnosis Codes (informational; medical necessity criteria must be met)ICD-10

C26.9	Malignant neoplasm of ill-defined sites within the digestive system
C34.00	Malignant neoplasm of unspecified main bronchus
C34.01	Malignant neoplasm of right main bronchus
C34.02	Malignant neoplasm of left main bronchus
C34.10	Malignant neoplasm of upper lobe, unspecified bronchus or lung
C34.11	Malignant neoplasm of upper lobe, right bronchus or lung
C34.12	Malignant neoplasm of upper lobe, left bronchus or lung
C34.30	Malignant neoplasm of middle lobe, bronchus or lung
C34.31	Malignant neoplasm of lower lobe, right bronchus or lung
C34.32	Malignant neoplasm of lower lobe, left bronchus or lung

1–10 of 72

1/8

Provider Actions & Billing Rules

Prior Authorization

Inpatient precertification required

Precertification/preauthorization is required for all products when the CA-125 procedure is performed inpatient.

Applies to all products if the CA-125 procedure is performed inpatient

Documentation Required

Medical necessity documentation

Medical necessity criteria listed in the policy must be met and documented for coverage; providers should report services using appropriate current procedure, revenue, and diagnosis codes.

Affected CPT code: 86304
Report appropriate current procedure, revenue, and diagnosis codes and document that medical necessity criteria are met

Background

CA-125 is a high-molecular-weight protein antigen commonly elevated in patients with known ovarian cancer and some other gynecologic malignancies and is widely used to monitor patients with known disease; levels may also be elevated in benign conditions (pregnancy, endometriosis, pelvic inflammatory disease, benign ovarian masses) limiting specificity.

Screening asymptomatic women with CA-125 is not supported (investigational) as a screening technique for ovarian cancer.

Definition: CA-125 = Cancer antigen 125, a tumor-associated antigen used as a serum biomarker primarily for ovarian cancer monitoring.

Evidence items

Literature review datethrough October 2022

Notable referencesPLCO trial (JAMA 2011), Lancet 1999 pilot trial, and relevant NCCN/USPSTF guidance cited

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