National Coverage Determination (NCD) for Tumor Antigen by Immunoassay - CA 125 (190.28)

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1 National Coverage Determination (NCD) for Tumor Antigen by Immunoassay - CA 125 (190.28) Tracking Information Publication Number Manual Section Number Manual Section Title Tumor Antigen by Immunoassay - CA 125 Version Number 2 Implementation Date Effective Date of this Version 1/3/2006 1/1/2006 Information Benefit Category Diagnostic Laboratory Tests Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service. Item/Service Immunoassay 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. This policy specifically addresses tumor antigen CA 125. Indications and Limitations of Coverage Indications CA 125 is a high molecular weight serum tumor marker elevated in 80% of patients who present with epithelial ovarian carcinoma. It is also elevated in carcinomas of the fallopian tube, endometrium, and endocervix. An elevated level may also be associated with the presence of a malignant mesothelioma or primary peritoneal carcinoma.

2 A CA125 level may be obtained as part of the initial pre-operative work-up for women presenting with a suspicious pelvic mass to be used as a baseline for purposes of post-operative monitoring. Initial declines in CA 125 after initial surgery and/or chemotherapy for ovarian carcinoma are also measured by obtaining three serum levels during the first month post treatment to determine the patient's CA 125 half-life, which has significant prognostic implications. The CA 125 levels are again obtained at the completion of chemotherapy as an index of residual disease. Surveillance CA125 measurements are generally obtained every 3 months for 2 years, every 6 months for the next 3 years, and yearly thereafter. CA 125 levels are also an important indicator of a patient's response to therapy in the presence of advanced or recurrent disease. In this setting, CA 125 levels may be obtained prior to each treatment cycle. Limitations These services are not covered for the evaluation of patients with signs or symptoms suggestive of malignancy. The service may be ordered at times necessary to assess either the presence of recurrent disease or the patient's response to treatment with subsequent treatment cycles. The CA 125 is specifically not covered for aiding in the differential diagnosis of patients with a pelvic mass as the sensitivity and specificity of the test is not sufficient. In general, a single "tumor marker" will suffice in following a patient with one of these malignancies. (This NCD last reviewed November 2005) Note: Scroll down for links to the quarterly Covered Code Lists (including narrative). Cross Reference Also see the Medicare Claims Processing Manual, Chapter 120, Clinical Laboratory Services Based on Negotiated Rulemaking. Transmittal Information Transmittal Number 47 Coverage Transmittal Link Revision History

3 07/ Implemented NCD. Effective date 11/25/02. Implementation date 1/01/03. (TN AB ) (CR 2130) 07/ Published NCD in the NCD Manual without change to narrative contained in PM AB Coding guidance now published in Medicare Lab NCD Manual. Effective and Implementation dates NA. (TN 17 ) (CR 2130) 02/ Changes to the Covered Indications for Tumor Antigen by Immunoassay CA 125 to Add Primary Peritoneal Carcinoma. Effective Date: 01/01/2006. Implementation Date: 01/03/2006. (TN 47 ) (CR 4257) Other Covered Code Lists (including narrative) October 2014 (ICD-10, ICD-9 ) January 2013 October 2012 July 2012 April 2012 January 2012 October 2011 July 2011 April 2011 January 2011 October 2010 July 2010 April 2010 January 2010 October 2009 July 2009 April 2009 January 2009 October 2008 July 2008 April 2007 January 2007 Changes to Lab NCD Edit Software October 2014 January 2012 October 2011 January 2011 October 2010

4 July 2010 October 2009 July 2009 January 2009 October 2008 July 2008 April 2007 January 2007 October 2006 July 2006 April 2006 January 2006 October 2005 July 2005 April 2005 January 2005 October 2004 July 2004 April 2004 January 2004 October 2003 July 2003 April 2003 National Coverage Analyses (NCAs) National Coverage Analyses (NCAs) This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database. First reconsideration for Tumor Antigen by Immunoassay CA 125 (Addition of Primary Peritoneal Adenocarcinoma as a Covered Indication) (CAG-00290R) Coding Analyses for Labs (CALs) Coding Analyses for Labs (CALs) This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database. Original consideration for Tumor Antigen by Immunoassay CA 125 (Modification of Code List to Include ICD-9-CM Codes for Suspicious Ovarian Mass) (CAG-00284N)

5 Original consideration for Tumor Antigen by Immunoassay CA 19-9 (Modification of Code List to Include ICD-9-CM Code 156.2, Malignant neoplasm of Ampulla of Vater) (CAG-00275N) Original consideration for Tumor Antigen Immunoassay CA 125 (Revision to Include Additional Personal History of Malignancy Codes) (CAG-00245N) Additional Information Other Versions Tumor Antigen by Immunoassay - CA Version 1, Effective between 11/25/2002-1/1/2006

6 This is CMS Logo. Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report Tumor Antigen by Immunoassay CA 125 Immunoassay 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. This policy specifically addresses tumor antigen CA 125. HCPCS Codes (Alphanumeric, CPT AMA) Code Immunoassay for tumor antigen, quantitative, CA 125 ICD-9-CM Codes Covered by Medicare Program The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS website under Downloads: Lab Code List. The link is: Code Malignant neoplasm, specified parts of peritoneum Malignant neoplasm, peritoneum, unspecified Malignant neoplasm, endocervix Malignant neoplasm of corpus uteri, except isthmus Malignant neoplasm,ovary Malignant neoplasm, fallopian tube Malignant neoplasm, other specified sites of uterine adnexa Malignant neoplasm, other specified sites of female genital organs Secondary malignant neoplasm, ovary Secondary malignancy of genital organs Neoplasm of uncertain behavior of female genital organs Neoplasm related pain (acute)(chronic) Abdominal or pelvic swelling, mass or lump of other specified site Elevated cancer antigen 125 [CA 125] Other abnormal tumor markers V10.41 Personal history of malignant neoplasm, cervix uteri V10.42 Personal history of malignant neoplasm, other parts of the uterus V10.43-V10.44 Personal history of malignant neoplasm of female genital organs Indications CA 125 is a high molecular weight serum tumor marker elevated in 80% of patients who present with epithelial ovarian carcinoma. It is also elevated in carcinomas of the fallopian tube, endometrium, and endocervix. An elevated level may also be associated with the presence of a malignant mesothelioma or primary peritoneal carcinoma. NCD *October 14 Changes Red Fu Associates, Ltd. 118 October 2013

7 This is CMS Logo. Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report A CA 125 level may be obtained as part of the initial pre-operative work-up for women presenting with a suspicious pelvic mass to be used as a baseline for purposes of postoperative monitoring. Initial declines in CA 125 after initial surgery and/or chemotherapy for ovarian carcinoma are also measured by obtaining three serum levels during the first month post treatment to determine the patient s CA 125 half-life, which has significant prognostic implications. The CA 125 levels are again obtained at the completion of chemotherapy as an index of residual disease. Surveillance CA 125 measurements are generally obtained every 3 months for 2 years, every 6 months for the next 3 years, and yearly thereafter. CA 125 levels are also an important indicator of a patient s response to therapy in the presence of advanced or recurrent disease. In this setting, CA 125 levels may be obtained prior to each treatment cycle. Limitations These services are not covered for the evaluation of patients with signs or symptoms suggestive of malignancy. The service may be ordered at times necessary to assess either the presence of recurrent disease or the patient s response to treatment with subsequent treatment cycles. The CA 125 is specifically not covered for aiding in the differential diagnosis of patients with a pelvic mass as the sensitivity and specificity of the test is not sufficient. In general, a single tumor marker will suffice in following a patient with one of these malignancies. ICD-9-CM Codes That Do Not Support Medical Necessity Any ICD-9-CM code not listed in either of the ICD-9-CM covered or non-covered sections. Documentation Requirements Indicated if service request for CA125 is requested more frequently than stipulated. Sources of Information Clinical Pancreatic Guideline for the Use of Tumor Markers in Breast and Colorectal Cancer, American Society of Clinical Oncology. J Clin Oncol 14: , Chan DW, Beveridge RA, Muss H, et al. Use of Triquant BR Radioimmunoassay for Early Detection of Breast Cancer Recurrence in Patients with Stage II and Stage III Disease. J Clin Oncol 1977, 15(6): NCD *October 14 Changes Red Fu Associates, Ltd. 119 October 2013

8 Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report DRAFT ICD-10-CM Version Tumor Antigen by Immunoassay CA 125 Immunoassay 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. This policy specifically addresses tumor antigen CA 125. HCPCS Codes (Alphanumeric, CPT AMA) Code Immunoassay for tumor antigen, quantitative, CA 125 ICD-10-CM Codes Covered by Medicare Program The ICD-10-CM codes in the table below can be viewed on CMS website as part of Downloads: Lab Code List, at Code C45.1 Mesothelioma of peritoneum C48.1 Malignant neoplasm of specified parts of peritoneum C48.2 Malignant neoplasm of peritoneum, unspecified C48.8 Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum C51.8 Malignant neoplasm of overlapping sites of vulva C53.0 Malignant neoplasm of endocervix C54.1 Malignant neoplasm of endometrium C54.2 Malignant neoplasm of myometrium C54.3 Malignant neoplasm of fundus uteri C54.9 Malignant neoplasm of corpus uteri, unspecified C56.1 Malignant neoplasm of right ovary C56.2 Malignant neoplasm of left ovary C56.9 Malignant neoplasm of unspecified ovary C57.00 Malignant neoplasm of unspecified fallopian tube C57.01 Malignant neoplasm of right fallopian tube C57.02 Malignant neoplasm of left fallopian tube C57.4 Malignant neoplasm of uterine adnexa, unspecified C57.7 Malignant neoplasm of other specified female genital organs C57.8 Malignant neoplasm of overlapping sites of female genital organs C79.60 Secondary malignant neoplasm of unspecified ovary NCD *October 2014 Changes ICD-10-CM Version Red Fu Associates, Ltd. October

9 Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report DRAFT ICD-10-CM Version Code C79.61 Secondary malignant neoplasm of right ovary C79.62 Secondary malignant neoplasm of left ovary C79.82 Secondary malignant neoplasm of genital organs D39.0 Neoplasm of uncertain behavior of uterus D39.10 Neoplasm of uncertain behavior of unspecified ovary D39.11 Neoplasm of uncertain behavior of right ovary D39.12 Neoplasm of uncertain behavior of left ovary D39.2 Neoplasm of uncertain behavior of placenta D39.8 Neoplasm of uncertain behavior of other specified female genital organs D39.9 Neoplasm of uncertain behavior of female genital organ, unspecified G89.3 Neoplasm related pain (acute)(chronic) R19.09 Other intra-abdominal and pelvic swelling, mass and lump R97.1 Elevated cancer antigen 125 [CA 125] R97.8 Other abnormal tumor markers Z85.41 Personal history of malignant neoplasm of cervix uteri Z85.42 Personal history of malignant neoplasm of other parts of uterus Z85.43 Personal history of malignant neoplasm of ovary Z85.44 Personal history of malignant neoplasm of other female genital organs Indications CA 125 is a high molecular weight serum tumor marker elevated in 80% of patients who present with epithelial ovarian carcinoma. It is also elevated in carcinomas of the fallopian tube, endometrium, and endocervix. An elevated level may also be associated with the presence of a malignant mesothelioma or primary peritoneal carcinoma. A CA 125 level may be obtained as part of the initial pre-operative work-up for women presenting with a suspicious pelvic mass to be used as a baseline for purposes of postoperative monitoring. Initial declines in CA 125 after initial surgery and/or chemotherapy for ovarian carcinoma are also measured by obtaining three serum levels during the first month post treatment to determine the patient s CA 125 half-life, which has significant prognostic implications. The CA 125 levels are again obtained at the completion of chemotherapy as an index of residual disease. Surveillance CA 125 measurements are generally obtained every 3 months for 2 years, every 6 months for the next 3 years, and yearly thereafter. CA 125 levels are also an important indicator of a patient s response to therapy in the presence of advanced or recurrent disease. In this setting, CA 125 levels may be obtained prior to each treatment cycle. NCD *October 2014 Changes ICD-10-CM Version Red Fu Associates, Ltd. October

10 Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report DRAFT ICD-10-CM Version Limitations These services are not covered for the evaluation of patients with signs or symptoms suggestive of malignancy. The service may be ordered at times necessary to assess either the presence of recurrent disease or the patient s response to treatment with subsequent treatment cycles. The CA 125 is specifically not covered for aiding in the differential diagnosis of patients with a pelvic mass as the sensitivity and specificity of the test is not sufficient. In general, a single tumor marker will suffice in following a patient with one of these malignancies. ICD-10-CM Codes That Do Not Support Medical Necessity Any ICD-10-CM code not listed in either of the ICD-10-CM covered or non-covered sections. Documentation Requirements Indicated if service request for CA125 is requested more frequently than stipulated. Sources of Information Clinical Pancreatic Guideline for the Use of Tumor Markers in Breast and Colorectal Cancer, American Society of Clinical Oncology. J Clin Oncol 14: , Chan DW, Beveridge RA, Muss H, et al. Use of Triquant BR Radioimmunoassay for Early Detection of Breast Cancer Recurrence in Patients with Stage II and Stage III Disease. J Clin Oncol 1977, 15(6): NCD *October 2014 Changes ICD-10-CM Version Red Fu Associates, Ltd. October

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