CA-125

POLICY NUMBER

L.2.04.424

DESCRIPTION

CA-125 is a high molecular weight protein antigen that is commonly elevated in patients with known ovarian cancer. CA-125 may also be elevated in other gynecologic malignancies, such as endometrial cancer, although the association is not as consistent as that with ovarian cancer. CA-125 has been widely used as a technique to monitor patients with known ovarian cancer or other gynecologic malignancies that, in individual patients, are associated with elevated levels of CA-125. Frequently, a rising CA-125 will be the initial signal of recurrent disease.

CA-125 has also been investigated as a possible screening tool for ovarian cancer, both in the general population and in patients considered at high risk of ovarian cancer.

Levels of CA-125 may also be elevated in nonmalignant conditions, including pregnancy, endometriosis, pelvic inflammatory disease, benign ovarian masses, and without any identifiable cause.

See separate policy for Urinary Biomarkers for Cancer Screening, Diagnosis, and Surveillance.

POLICY

Measurements of CA-125 may be considered medically necessary in patients with symptoms suggestive of ovarian cancer or in those with known ovarian cancer.

Measurement of CA-125 may be considered medically necessary in individual patients with other gynecologic malignancies, such as endometrial cancer, in whom baseline level of CA-125 have been shown to be elevated.

Measurement of CA-125 is considered investigational in asymptomatic patients as a screening technique for ovarian cancer.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

6/28/2007: Policy added. CA-125 was previously addressed in the Serum Tumor Markers policy

8/10/2007: Code reference section updated. Added ICD-9 codes 180.0, 198.82, 236.0, 236.1, 236.3, 789.39, and V10.43.

04/14/2010: Code reference section updated. Added ICD-9 diagnosis codes: 158.0, 158.8, 158.9, 184.8, 197.6, 218.0 - 218.9, 233.30, 233.39, 338.3, 789.30, 795.89, V10.41, V10.42 and V10.44. Also added the following verbiage: "*Some covered procedure codes have multiple descriptions. Coverage will only be made for covered codes when used for services outlined within the policy statement section."

11/17/2010: Added ICD-9 codes 789.33 and 789.34 to the Covered Codes table.

12/08/2011: Added ICD-9 code 620.2 to the Covered Codes table.

12/21/2012: Policy reviewed; policy statement unchanged. Added the following new 2013 CPT codes to the Code Reference section: 81500 and 81503.

02/20/2013: Deleted CPT codes 81500 and 81503 from the Code Reference section as these are addressed in the Proteomics-based Testing for the Evaluation of Ovarian (Adnexal) Masses medical policy.

08/21/2015: Code Reference section updated for ICD-10.

06/07/2016: Policy number L.2.04.424 added. Policy Guidelines updated to add medically necessary and investigative definitions.

07/25/2016: Code Reference section updated to make the following correction: ICD-10 diagnosis code range C76.60 - C76.62 should be C79.60 - C79.62.

09/30/2016: Code Reference section updated to add new ICD-10 diagnosis codes N83.00 - N83.299.

10/05/2017: Code Reference section updated to remove deleted ICD-10 diagnosis codes N83.20, N83.29, and ICD-9 diagnosis code 620.2.

10/01/2021: Code Reference section updated to add new ICD-10 diagnosis code C79.63 effective 10/01/2021.

11/28/2022: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

08/21/2023: Policy reviewed; no changes.

08/20/2024: Policy reviewed; no changes.

11/10/2025: Policy reviewed. Policy statements unchanged. Code Reference section updated to remove ICD-9 diagnosis codes.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 2.04.27

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy. 

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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