Policy Number:

A98-53

Description

Radioimmunoassay and immunohistochemical determinations of the serum levels of certain proteins or carbohydrates serve as tumor makers. When elevated, serum concentration of these markers may reflect tumor size and grade.

Type of Bill

12X, 13X, 14X, 22X, 23X, 71X, 74X, 75X

Revenue Codes

300 - 319

Indications and Limitations of Coverage and/or Medical Necessity

The CA 125 RIA is indicated for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures and other interventions.

The AxSYM CA 15-3 test assay is a microparticle enzyme immunoassay (MEIA) for the quantitative measurement of CA 15-3 values in human serum and plasma (EDTA) to aid in the management of breast cancer patients. Serial testing for patient CA 15-3 assay values must be used in conjunction with other clinical methods for monitoring breast cancer.

The IMx CA 15-3 test is a microparticle enzyme immunoassay (MEIA) for the quantitative measurement of CA 15-3 assay values in human serum and plasma (EDTA) to aid in the management of Stage II and Stage III breast cancer patients. Serial testing for patient CA 15-3 assay values must be used in conjunction with other clinical methods for monitoring breast cancer.

HCPCS Code

86316

Immunoassay for tumor antigen (e.g., cancer antigen 125), each

ICD-9 Codes That Support Medical Necessity

Diagnosis Definition

Malignant Neoplasm of Bone Connective Tissue, Skin, and Breast
173.5
174.0-174.9
175.0-175.9
Malignant Neoplasm of Genitourinary Organs
183.0
188.0
Malignant Neoplasms of Other and Unspecified Sites
198.81
Carcinoma in Situ
233.0

HCFA National Coverage Policy

Title XVIII of the Social Security Act, Section 1862(a)(1)(A). This section allows coverage and payment for only those services that are considered to be reasonable and medically necessary, i.e., reasonable and necessary are those tests used in the diagnosis and management of illness or injury or to improve the function of a malformed body part.

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

Sources of Information

1998 Physician ICD-9-CM, Volumes I & II
1998 CPT Physicians' Current Procedural Terminology, American Medical Association
Other Intermediaries' Policies
Medicare Part B Local Medical Review Policy
PMIC AB98-39, July 1998

Coding Guides

Reconsiderations and Appeals - Claims resubmitted with a different diagnosis code must include medical record documentation to justify the diagnosis code change. Submission with diagnoses other than those listed as "Covered Codes" will be individually reviewed by this Intermediary for medical necessity.

Documentation Requirements

All coverage criteria must be documented in the patient's medical record and made available to Medicare upon request. This information should be generally submitted on reconsideration only (or with the claim if the services are unusual or if denial is anticipated). See "Coding Guidelines" section above.

ICD-9-CM diagnosis codes are required on claim.

Medical records must clearly document the medical necessity for the test and the frequency of the test.

If documentation is requested for review, submit the following:

·	History and Physical
·	Physician orders/progress notes
·	Diagnosis/reason for test
·	Test results
·	Itemization of charges

Comments

This policy has been republished because of recent approval for coverage of AxSYM CA 15-3 and IMx CA 15-3.

The service must be considered acceptable under state standards of practice to be a specific and effective treatment for the beneficiary's condition;

This policy should be interpreted to incorporate future changes in the ICD-9-CM or CPT/HCPCS coding systems such that its original intent and scope will not be substantively changed.

Start Date of Comment Period:	April 16, 1996
Start Date of Notice Period:	October 1996
Original Effective Date:	November 1, 1996
Revised Effective Date:	June 1, 1998 (A96-08)
Revision History:	October 1, 1998 (A98-53)

Approval

This policy does not reflect the sole opinion of the Intermediary/Medical Director.