Carcinoembryonic antigen (CEA) is a protein polysaccharide found in some carcinomas. It is effective as a biochemical marker for monitoring the response of certain malignancies to therapy.

Indications

CEA may be medically necessary for follow-up of patients with colorectal carcinoma. It would however only be medically necessary at treatment decision-making points. In some clinical situations (e.g. adenocarcinoma of the lung, small cell carcinoma of the lung, and some gastrointestinal carcinomas) when a more specific marker is not expressed by the tumor, CEA may be a medically necessary alternative marker for monitoring. Preoperative CEA may also be helpful in determining the post-operative adequacy of surgical resection and subsequent medical management. In general, a single tumor marker will suffice in following patients with colorectal carcinoma or other malignancies that express such tumor markers.

In following patients who have had treatment for colorectal carcinoma, ASCO guideline suggests that if resection of liver metastasis would be indicated, it is recommended that post-operative CEA testing be performed every two to three months in patients with initial stage II or stage III disease for at least two years after diagnosis.

For patients with metastatic solid tumors which express CEA, CEA may be measured at the start of the treatment and with subsequent treatment cycles to assess the tumor's response to therapy.

Limitations

Serum CEA determinations are generally not indicated more frequently than once per chemotherapy treatment cycle for patients with metastatic solid tumors which express CEA or every two months post-surgical treatment for patients who have had colorectal carcinoma. However, it may be proper to order the test more frequently in certain situations, for example, when there has been a significant change from prior CEA level or a significant change in patient status which could reflect disease progression or recurrence.

Testing with a diagnosis of an in situ carcinoma is not reasonably done more frequently than once, unless the result is abnormal, in which case the test may be repeated once.

With the exception of routine or screening, any diagnosis other than those listed under the “Covered Diagnosis Codes” section will be denied as not medically necessary.  A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Carcinoembryonic antigen testing for routine or screening purposes is excluded from coverage. Therefore, any diagnosis code listed under the “Screening Diagnosis Codes” section will deny as not covered. The provider can bill the member for the non-covered service.

NOTE:

A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without a diagnosis code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. Also, if a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency.

For additional information on clinical trial participation, see Medicare Advantage Medical Policy Bulletin N-27, Clinical Trials.

Failure to provide documentation of the medial necessity of tests may result in denial of claims. Such documentation may include notes documenting relevant signs, symptoms or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

National Coverage Determination - 190.26

On-Line NCD Coding Policy Manual and Change Report

Transmittal 651, Change Request 4005

Transmittal 758, CR 4161

Transmittal 864, CR 4328

Transmittal 1050, CR 5293

Transmittal 1606, CR 6213

Transmittal 1645, CR 6304

Transmittal 1766, CR 6548

Transmittal 1963, CR 6964

Covered Diagnosis Codes

Non-covered Diagnosis Codes

Screening Diagnosis Codes