CurrentBlue Cross Blue Shield - MassachusettsPolicy 503

CA-125 Serum Measurements

This policy governs when measurement of the serum tumor marker CA-125 is considered medically necessary or investigational for Blue Cross Blue Shield Massachusetts commercial members, including indications for diagnosis, monitoring, and recurrence of gynecologic and select non-gynecologic malignancies.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyCA-125 Serum Measurements

Policy CodePolicy 503

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain precertification/preauthorization when CA-125 testing is performed inpatient for all products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 CPTCPT code listed for CA-125 testing

Multiple ICD-10Diagnosis codes listed to support coverage

InvestigationalInvestigational for screening

RequiredInpatient prior auth

Coverage Criteria for CA-125 Testing

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inv-01: Medically Necessary Indications

Measurements of CA-125 are considered medically necessary in the following clinical scenarios

Ovarian cancer (symptomatic or known): Patients with symptoms suggestive of ovarian cancer or with known ovarian cancer to aid in monitoring disease, response to treatment, and detection of recurrence (including assessing value of second‑look surgery)

Supported by policy language

Other gynecologic malignancies with elevated baseline: Individual patients with other gynecologic malignancies (e.g., endometrial cancer) in whom baseline CA‑125 levels have been shown to be elevated

Policy specifies use on an individual patient basis

Pelvic mass of unknown diagnosis: Patients presenting with a pelvic mass of unknown diagnosis

Listed as medically necessary

Peritoneal primary cancer: Primary peritoneal cancer to aid in monitoring of disease

Listed as medically necessary

Adenocarcinoma of unknown primary: Patients with adenocarcinoma of unknown primary (abdominal or pelvic carcinomatosis)

Listed as medically necessary

Indicator of tumor size or grade: Use as an indicator of tumor size or grade for cancer

Policy includes this use

inv-02: Investigational / Not Supported Uses

Measurements of CA-125 are considered investigational or not recommended in the following scenarios

Screening in asymptomatic women: Asymptomatic patients: CA‑125 used as a screening technique for ovarian cancer (investigational)

Policy explicitly states investigational for screening

Non‑gynecologic cancers (investigational): Use of CA‑125 for colorectal, gastric, liver, or pancreatic cancer diagnosis, monitoring, or prognosis (investigational)

Policy explicitly lists these uses as investigational

The policy specifies that CA-125 testing is investigational for certain uses beyond established gynecologic indications. Specifically, CA-125 is considered investigational when used as a screening test in asymptomatic women for ovarian cancer and when applied for diagnosis, monitoring, or prognosis of select non-gynecologic malignancies, including colorectal, gastric, liver, or pancreatic cancers. This investigational designation reflects limited specificity (CA-125 can be elevated in benign conditions) and lack of evidence supporting routine use in these settings.

Coding

Covered CPT CodesCPTCovered

86304

Immunoassay for tumor antigen, quantitative; CA 125

Associated ICD-10 Diagnosis Codes (partial list)ICD-10

C26.9	Malignant neoplasm of ill-defined sites within the digestive system
C34.00	Malignant neoplasm of unspecified main bronchus
C45.1	Mesothelioma of peritoneum
C48.1	Malignant neoplasm of specified parts of peritoneum
C54.1	Malignant neoplasm of endometrium
C56.1	Malignant neoplasm of right ovary
C56.2	Malignant neoplasm of left ovary
C56.9	Malignant neoplasm of unspecified ovary
C48.2	Malignant neoplasm of peritoneum, unspecified
R19.00	Intra-abdominal and pelvic swelling, mass and lump, unspecified site

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Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required for Inpatient Services

Precertification / preauthorization IS REQUIRED for all products if CA-125 testing is performed inpatient. Lack of required inpatient authorization may result in denial or reduced reimbursement. Providers must obtain inpatient authorization prior to the procedure when applicable.

Applies to all products when the service is performed in an inpatient setting
Failure to obtain inpatient authorization may lead to claim denial or payment delay

Note

Outpatient Prior Authorization

Outpatient CA-125 testing does not require prior authorization for Commercial Managed Care (HMO and POS). Commercial PPO and Indemnity outpatient services also do not require prior authorization. Providers should verify member-specific benefits and any product-specific rules before ordering outpatient testing.

Commercial Managed Care (HMO and POS) — outpatient: no prior authorization required
Commercial PPO and Indemnity — outpatient: no prior authorization required
Always confirm member contract benefits and eligibility at the time of service

Documentation Required

Coding and Documentation Expectations

Providers must report services using up-to-date procedure (CPT), revenue, and diagnosis (ICD-10) codes, and include modifiers where applicable. Inclusion of codes in this policy is informational and does not guarantee coverage; confirm medical necessity criteria and member contract terms prior to billing.

Report services with current industry-standard CPT, revenue, and ICD-10 codes
Inclusion of a code in policy does not imply member coverage or reimbursement
Medical necessity criteria must be met for coverage; verify member's contract benefits

Prior Authorization

Inpatient Preauthorization Requirement

For services described in this policy, precertification/preauthorization is required for all products if the procedure is performed inpatient. Providers should follow standard authorization processes and timelines for inpatient admissions to avoid denials.

Preauthorization required for inpatient procedures across all products
Follow payer-specific precertification procedures and submit required documentation

Background

CA-125 is a high-molecular-weight protein antigen that is commonly elevated in patients with known ovarian cancer and is an accepted tool to monitor disease status. It may also be elevated in some other gynecologic malignancies (for example, endometrial cancer) in select patients where baseline levels are known to be elevated. CA-125 levels can rise with recurrent disease, and the test is therefore used to monitor response to treatment and detect recurrence. However, CA-125 lacks specificity because levels may be elevated in nonmalignant conditions such as pregnancy, endometriosis, pelvic inflammatory disease, benign ovarian masses, or for no identifiable reason.

Definitions

CA-125 — definition and clinical contexts

DefinitionCA-125 is a high-molecular-weight protein tumor antigen commonly elevated in patients with ovarian cancer and used as a serum marker.

Primary clinical useMonitoring patients with known ovarian cancer to assess disease status, response to treatment, and detection of recurrence (rising CA-125 often an initial sign of recurrence).

Other gynecologic contextsMay be elevated and used to monitor some other gynecologic malignancies (e.g., endometrial cancer) in individual patients when baseline levels are informative.

Nonmalignant elevationsLevels can be elevated in benign conditions such as pregnancy, endometriosis, pelvic inflammatory disease, and benign ovarian masses.

Screening limitationInvestigated as a screening test for asymptomatic women but not established due to limited specificity and variable associations; policy lists screening as investigational.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyCA-125 Serum Measurements

Policy CodePolicy 503

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain precertification/preauthorization when CA-125 testing is performed inpatient for all products.

SourceLink

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