Immunoassay for Tumor Antigen Policy
POLICY NUMBER: (YPF # 80) (YPath # 17)

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

POLICY TYPE: Local medical necessity policy

CPT/HCPCS SECTION BENEFIT CATEGORY:
Pathology
Laboratory

CPT/HCPCS CODES:
82105 Alpha-fetoprotein; serum
84702 Gonadotropin, chorionic (hCG); quantitative
84703 Gonadotropin, chorionic (hCG); qualitative
86316 Immunoassay for tumor antigen (e.g., cancer antigen 125)

CPT codes and descriptions only are copyright 1998 AMA. All Rights Reserved.

CMS'S NATIONAL POLICY:
Title XVIII of the Social Security Act, section 1862 (a)(7) This section excludes routine physical checkups.
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 medically reasonable and necessary.
Title XVIII of the Social Security Act, section 1833 (e) This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

INDICATIONS AND LIMITATIONS OF COVERAGE AND/OR MEDICAL NECESSITY:
Procedure code 86316: Immunoassay for tumor antigen (cancer antigen 125 and cancer antigen 27.29), each - CA 125 is used primarily in the assessment of response to treatment and prognosis of ovarian cancer. - CA 27.29 is covered for detection of recurrent breast cancer.
All tests must be ordered by the treating/referring physician.
The tests should be used judiciously to allow adequate intervals in monitoring the course of diseases. Random or indiscriminate repetition of the tests should be discouraged.
Places of service are office (11), independent lab (81), and hospital outpatient department (22).

The following tests are not payable because of the lack of demonstrable medical necessity for the diagnosis and treatment of diseases:

a2-PAG Pregnancy-associated alpha2 glycoprotein
BCM Breast cancer mucin
CA 15-3 Cancer antigen 15-3
CA 19-9 Cancer antigen 19-9
CA 50 Cancer antigen 50
CA 72-4 Cancer antigen 72-4
CA 195 Cancer antigen 195
CA 242 Cancer antigen 242
CA 549 Cancer antigen 549
CA-SCC Squamous cell carcinoma
CAM 17-1 Monoclonal antimucin antibody 17-1
CAM 26 Monoclonal antimucin antibody 26
CAM 29 Monoclonal antimucin antibody 29
CAR3 Antigenic determinant recognized by monoclonal ab AR3
DU-PAN-2 Sialylated carbohydrate antigen DU-PAN-2
MCA Mucin-like carcinoma associated antigen
NSE Neuron-specific enolase
P-LAP Placental alkaline phosphatase
PNA-ELLA Peanut lectin bonding assay
SLEX Sialylated Lewis-X antigen
SLX Sialylated SSEA-1 antigen
SPAN-1 Sialylated carbonated antigen SPAN-1
ST-439 Sialylated carbonated ST-439
TAG12 Tumor-associated glycoprotein 12
TAG72 Tumor-associated glycoprotein 72
TAG72.3 Tumor-associated glycoprotein 72.3
TATI Tumor-associated trypsin inhibitor
TNF-a Tumor necrosis factor alpha
TPA Tissue polypeptide antigen

REIMBURSEMENT:
82105, 23.18
84702, 20.80
84703, 10.38
86316, 28.76

ICD-9-CM CODES THAT SUPPORT MEDICAL NECESSITY:
It is not enough to link the procedure code to a correct, payable ICD-9-CM diagnosis code. The diagnosis or clinical suspicion must be present for the procedure to be paid.

The following are covered indications for procedure code 82105:

070.22-070.23 Chronic viral hepatitis B with hepatic coma, with or without mention of hepatitis delta

070.32-070.33 Chronic viral hepatitis B without mention of hepatic coma, with or without mention of hepatitis delta

070.44 Chronic hepatitis C with hepatic coma

070.54 Chronic hepatitis C without mention of hepatic coma

155.0-155.2 Malignant neoplasm of the liver and intrahepatic bile ducts

183.0 Malignant neoplasm, ovary

186.0 Malignant neoplasm of undescended testis

186.9 Malignant neoplasm, other and unspecified testis

197.7 Secondary malignant neoplasm of liver, specified as secondary

198.6 Secondary malignant neoplasm of ovary

198.82 Secondary malignant neoplasm, genital organs

571.40 Chronic hepatitis, unspecified

571.41 Chronic persistent hepatitis

571.49 Other chronic hepatitis

789.1 Hepatomegaly

V10.43 Personal history of malignant neoplasm, ovary

V10.47 Personal history of malignant neoplasm, testis

The following are covered indications for procedure codes 84702, 84703:
181 Malignant neoplasm of placenta

183.0 Malignant neoplasm of the ovary

186.0 Malignant neoplasm of undescended testis

186.9 Malignant neoplasm, other and unspecified testis

198.82 Secondary malignant neoplasm of other genital organs

V10.43 Personal history of malignant neoplasm, ovary

V10.47 Personal history of malignant neoplasm, testis

V71.1 Observation for suspected malignant neoplasm

The following are covered indications for procedure code 86316 (CA 125):
183.0-183.9 Malignant neoplasm of the ovary and other uterine adnexa

198.6 Secondary malignant neoplasm of ovary

V10.43 History of condition, ovary

V71.1 Observation for suspected malignant neoplasm

The following are covered indications for procedure code 86316 (CA 27.29):
174.0-174.9 Malignant neoplasm of the female breast

175.0 Malignant neoplasm of the male breast

175.9 Malignant neoplasm of other and unspecified sites of male breast

198.81 Secondary malignant neoplasm of breast

REASONS FOR DENIAL:

Screening tests, in the absence of associated signs, symptoms or complaints are denied under 1862 (a)(7).

Claims submitted for any diagnosis other than one of those listed in the "ICD-9-CM Codes That Support Medical Necessity" section of this policy will be denied as not medically necessary.

Claims submitted for any of the tests indicated as non-covered in the "Indications and Limitations" section of this policy will be denied.

NON-COVERED ICD-9-CM CODES:
Any claim with an ICD 9 CM code not listed in the "ICD-9-CM Codes That Support Medical Necessity" section of this policy will be denied as not medically necessary.

Use of diagnosis V82.9 will result in the denial of claims as non-covered screening services.

SOURCES OF INFORMATION:
Adopted from Medicare Part B Clinical Lab Model Local Review Policy submitted to BPD. Carrier Medical Directors Clinical Laboratory Workgroup

CODING GUIDELINES:
The ordering physician's name and UPIN number must be indicated on the submitted claim in box 17 and 17a of the HCFA 1500 form or in the EA0 record, fields 22.0 and 20.0 when submitting electronically.
The appropriate ICD 9 CM diagnosis code must be linked to the test that is performed by the physician or laboratory.
ICD-9-CM code V82.9 (special screening of other conditions, unspecified conditions) should be used to indicate screening tests performed in the absence of a specific sign, symptom or complaint.
Claims for CPT code 86316 must be submitted with a narrative description of the specific antigen (CA 125 or CA 27.29). This information should be reported in Box 19 of the HCFA 1500 form for paper submissions and in the HA0 record when submitting electronically.

DOCUMENTATION REQUIREMENTS:
Documentation supporting the medical necessity of these tests, such as ICD-9-CM diagnosis codes, must be submitted with each service billed. Claims submitted without such evidence will be denied as not medically necessary.
Claims reporting procedure code 86316 must contain the name of the specific antigen tested. This information must also be documented in the medical record.

COMMENTS:
This policy was revised on 01/22/98 to add information to the "Indications," "Coding Guidelines," and "Reasons for Denial" sections. This information was not included in the published policy, but was presented at the June 12, 1996, Carrier Advisory Committee meeting.
For information on coverage of CPT Code 82378, Carcinoembryonic antigen (CEA), see CEA policy YPath #21 and The Medicare News Brief, 96-9.

CAC NOTES:
This policy was presented at the June 12, 1996, Carrier Advisory Committee meeting by Group Health Incorporated.

EFFECTIVE DATE: December 28, 1996

REVISION DATE: January 22, 1998

NOTE:
This policy does not reflect the sole opinion of the carrier or the Carrier Medical Director. Although the final decision rests with the carrier, this policy was developed in cooperation with the Carrier Advisory Committee, which includes representatives from The State Society of Family Physicians, The New York State Society of Internal Medicine, and The Medical Society of the State of New York.