503 Form

Medical Policy CA 125 Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History
• Endnotes Policy Number: 503 BCBSA Reference Number: 2.04.27A (For Plan internal use only) Related Policies
Serum Biomarker Human Epididymis Protein 4 (HE4), #290 Tumor Markers for Diagnosis and Management of Cancer, #167 Policy1 Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity

Measurements of CA-125 may be considered MEDICALLY NECESSARY in patients with symptoms suggestive of ovarian cancer or in those with known ovarian cancer, to aid in the monitoring of disease, response to treatment, and recurrence of disease (including assessing value of second-look surgery).

Measurements of CA-125 may be considered MEDICALLY NECESSARY in individual patients with other gynecologic malignancies, such as endometrial cancer, in whom baseline levels of CA-125 have been shown to be elevated.

Measurements of CA-125 may be considered MEDICALLY NECESSARY in patients with pelvic mass with unknown diagnosis.

Measurements of CA-125 may be considered MEDICALLY NECESSARY in peritoneal primary cancer to aid in monitoring of disease.

Measurements of CA-125 may be considered MEDICALLY NECESSARY in patients with adenocarcinoma of unknown primary (abdominal or pelvic carcinomatosis).

Measurements of CA-125 may be considered MEDICALLY NECESSARY as an indicator of tumor size or grade for lung cancer.

Measurements of CA-125 are considered INVESTIGATIONAL in asymptomatic patients as a screening technique for ovarian cancer.

Measurements of CA-125 are considered INVESTIGATIONAL in colorectal, gastric, liver, or pancreatic cancer diagnosis, monitoring or prognosis.

Prior Authorization Information
Inpatient

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  • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
  Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

  Outpatient Commercial Managed Care (HMO and POS) Prior authorization is not required. Commercial PPO and Indemnity Prior authorization is not required.

  CPT Codes / HCPCS Codes / ICD Codes
  Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non- coverage as it applies to an individual member.

  Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

  The following codes are included below for informational purposes only; this is not an all-inclusive list.

  The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity: CPT Codes CPT codes: Code Description 86304 Immunoassay for tumor antigen, quantitative; CA 125 ICD-10 Diagnosis Codes ICD-10-CM diagnosis codes: Code Description C26.9 Malignant Neoplasm of Ill-Defined Sites Within the Digestive System C34.00 Malignant Neoplasm of Unspecified Main Bronchus C34.01 Malignant Neoplasm of Right Main Bronchus C34.02 Malignant Neoplasm of Left Main Bronchus C34.10 Malignant Neoplasm of Upper Lobe, Unspecified Bronchus or Lung C34.11 Malignant Neoplasm of Upper Lobe, Right Bronchus or Lung C34.12 Malignant Neoplasm of Upper Lobe, Left Bronchus or Lung C34.30 Malignant Neoplasm of Lower Lobe, Unspecified Bronchus or Lung C34.31 Malignant Neoplasm of Lower Lobe, Right Bronchus or Lung C34.32 Malignant Neoplasm of Lower Lobe, Left Bronchus or Lung C34.80 Malignant Neoplasm of Overlapping Sites of Unspecified Bronchus and Lung C34.81 Malignant Neoplasm of Overlapping Sites of Right Bronchus and Lung C34.82 Malignant Neoplasm of Overlapping Sites of Left Bronchus and Lung C34.90 Malignant Neoplasm of Unspecified Part of Unspecified Bronchus or Lung C34.91 Malignant Neoplasm of Unspecified Part of Right Bronchus or Lung C34.92 Malignant Neoplasm of Unspecified Part of Left Bronchus or Lung C45.1 Mesothelioma of Peritoneum C47.4 Malignant Neoplasm of Peripheral Nerves of Abdomen 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 C49.4 Malignant Neoplasm of Connective and Soft Tissue Of Abdomen C54.1 Malignant Neoplasm of Endometrium

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  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 C56.3 Malignant neoplasm of bilateral ovaries 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 C57.10 Malignant Neoplasm of Unspecified Broad Ligament C57.11 Malignant Neoplasm of Right Broad Ligament C57.12 Malignant Neoplasm of Left Broad Ligament C57.20 Malignant Neoplasm of Unspecified Round Ligament C57.21 Malignant Neoplasm of Right Round Ligament C57.22 Malignant Neoplasm of Left Round Ligament C57.3 Malignant Neoplasm of Parametrium C57.4 Malignant Neoplasm of Uterine Adnexa, Unspecified C76.2 Malignant Neoplasm of Abdomen C76.3 Malignant neoplasm of pelvis C77.2 Secondary and Unspecified Malignant Neoplasm of Intra-Abdominal Lymph Nodes C77.5 Secondary and Unspecified Malignant Neoplasm of Intrapelvic Lymph Nodes C78.6 Secondary malignant neoplasm of retroperitoneum and peritoneum C79.60 Secondary Malignant Neoplasm of Unspecified Ovary C79.61 Secondary Malignant Neoplasm of Right Ovary C79.62 Secondary Malignant Neoplasm of Left Ovary C79.63 Secondary malignant neoplasm of bilateral ovaries C79.82 Secondary Malignant Neoplasm of Genital Organs D07.0 Carcinoma in Situ of Endometrium D07.1 Carcinoma in Situ of Vulva D07.2 Carcinoma in Situ of Vagina D07.30 Carcinoma in Situ of Unspecified Female Genital Organs D07.39 Carcinoma in Situ of Other Female 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 D48.4 Neoplasm of Uncertain Behavior of Peritoneum D49.5 Neoplasm of Unspecified Behavior of Other Genitourinary Organs D49.59 Neoplasm unspecified behavior of other genitourinary organ R19.00 Intra-Abdominal and Pelvic Swelling, Mass and Lump, Unspecified Site R19.01 Right Upper Quadrant Abdominal Swelling, Mass and Lump R19.02 Left Upper Quadrant Abdominal Swelling, Mass and Lump R19.03 Right Lower Quadrant Abdominal Swelling, Mass and Lump R19.04 Left Lower Quadrant Abdominal Swelling, Mass and Lump R19.05 Periumbilic Swelling, Mass or Lump R19.06 Epigastric Swelling, Mass or Lump R19.07 Generalized Intra-Abdominal and Pelvic Swelling, Mass And Lump R19.09 Other Intra-Abdominal and Pelvic Swelling, Mass And Lump Description

  CA-125 is an accepted tool for monitoring patients with known ovarian cancer and other gynecologic malignancies. It has been proposed for use as a screening test in asymptomatic women.

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  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 sign 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. Policy History Date Action 4/2023 Clarified coding information 11/2022 Annual policy review. Policy updated with literature review through October 2022. References added. Policy statements unchanged. 1/2021 Medicare information removed. See MP #132 Medicare Advantage Management for local coverage determination and national coverage determination reference.
  11/2019 ICD-9 codes removed. 10/2016 Clarified coding information. 11/2015 Ongoing medically necessary and investigational statements transferred from medical policy #167 Tumor Markers for Diagnosis and Management of Cancer. Clarified coding information.
  1/2015 Clarified coding information. 6/2014 Updated coding section with ICD10 procedure and diagnosis codes, effective 10/2015.
  4/2014 Clarified coding information.
  6/2012 Annual policy review. New references added. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

  References

  1. Buys SS, Partridge E, Black A et al. for the PLCO team. Effect of screening on ovarian cancer mortality: The prostate, lung, colorectal and ovarian (PLCO) cancer screening randomized controlled trial. JAMA 2011; 305: 2295-2303.
  2. Jacobs IJ, Skates SJ, MacDonald N et al. Screening of ovarian cancer: a pilot randomized controlled trial. Lancet 1999; 353(9160): 1207-10.
  3. Burke W. Daly M. Garber J et al. Recommendations for follow-up care of individuals with an inherited predisposition to cancer. II. BRCA1 and BRCA2. JAMA 1997; 277(12): 997-1003.
  4. United Kingdom Collaborative Trial of Ovarian Cancer Screening. Available online at: http://www.instituteforwomenshealth.ucl.ac.uk/academic_research/gynaecologicalcancer/gcrc/ukctocs Last accessed September 2011
  5. National Comprehensive Cancer Network. Ovarian Cancer. Clinical practice guidelines in oncology, v2.2011. Available online at: http://www.nccn.org/professionals/physician_gls/PDF/ovarian.pdf. Last accessed September 2011.
  6. U.S. Preventive Services Task Force. Screening for Ovarian Cancer: Recommendation Statement. May
  7. Available online at: http://www.uspreventiveservicestaskforce.org/3rduspstf/ovariancan/ovcanrs.htm. Last accessed August 2011.

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  7. The American College of Obstetricians and Gynecologists. ACOG Committee Opinion: number 280, December 2002. The role of the generalist obstetrician-gynecologist in the early detection of ovarian cancer. Obstet Gynecol 2002 Dec; 100(6):1413-6.
  8. Society of Gynecologic Oncologists Statement Regarding OvaSure™ available at http://www.sgo.org/WorkArea/showcontent.aspx?id=1846. FDA letter to the manufacturer, August 7, 2008
  9. Qing X et al. A Clinical Diagnostic Value Analysis of Serum CA125, CA199, and HE4 in Women with Early Ovarian Cancer: Systematic Review and Meta-Analysis. Comput Math Methods Med. 2022 May 25;2022:9339325

  Endnotes

  1 Based on expert opinion