Cancer Antigen 125 (CA-125) Testing
Corporate Medical Policy
File name: Cancer Antigen 125 (CA-125A) Testing
File Code: UM.DIAG.05
Origination: 02/2011
Last Review: 02/2014 (ICD-10 remediation only)
Next Review: 02/2014
Effective Date: 07/01/2011
Document Precedence
Blue Cross and Blue Shield of Vermont (BCBSVT) Medical Policies are developed to
provide clinical guidance and are based on research of current medical literature and
review of common medical practices in the treatment and diagnosis of disease. The
applicable group/individual contract and member certificate language determines
benefits that are in effect at the time of service. Since medical practices and
knowledge are constantly evolving, BCBSVT reserves the right to review and revise its
medical policies periodically. To the extent that there may be any conflict between
medical policy and contract language, the member’s contract language takes
precedence.
Description
Ovarian cancer is a malignancy of the ovaries that tends to elude early diagnosis. Most
women with this malignancy seek medical attention late in the disease course, at
which point the five year survival is only 15% to 20%. However, if diagnosed early, the
five-year survival rate can be as high as 90%. Therefore, researchers have tried to
develop various means of screening the general population for ovarian cancer to
improve long-term survival.
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 are
associated with elevated levels of CA-125 in individual patients. Frequently, a rising
CA-125 will be the initial sign of recurrent disease.
Policy
Medically Necessary:
CA-125 testing may be medically necessary under the following circumstances:
1
•
•
•
•
Patients with symptoms suggestive of ovarian cancer
Patients with known ovarian cancer.
Individual patients with other malignancies, such as endometrial cancer, in
whom baseline levels of CA-125 have been shown to be elevated.
As a screening test for ovarian cancer when there is a history of hereditary
cancer syndrome (a pattern of clusters of ovarian cancer within two or more
generations)
Investigational and Not Medically Necessary:
Measurement of CA-125 is considered experimental/investigational in asymptomatic
patients as a screening technique for ovarian cancer.
When service or procedure is covered
Women known to be at high risk for ovarian cancer are often screened regularly using
a
combination of the CA-125 test, transvaginal ultrasound and a rectal/pelvic
examination. It
should never be used as an isolated test. These include:
•
•
•
•
•
As a preoperative diagnostic aid in women with ovarian masses that are suspected
to be malignant, such that arrangements can be made for intraoperative
availability of a gynecological oncologist if the CA 125 is increased; or
As a screening test for ovarian cancer when there is a history of hereditary cancer
syndrome (a pattern of clusters of ovarian cancer within two or more generations);
or
Diagnosis of ovarian cancer in women with new symptoms (bloating, pelvic or
abdominal pain, difficulty eating or feeling full quickly, or urinary frequency and
urgency) that have persisted for three or more weeks, where the clinician has
performed a pelvic and rectal examination and suspects ovarian cancer; or
In members with adenocarcinoma of unknown primary, to rule out ovarian cancer;
or
In members with known ovarian cancer, as an aid in the monitoring of disease,
response to treatment, detection of recurrent disease, or assessing value of
performing second-look surgery.
When service or procedure may not be covered
CA-125 as a Screening Tool for Ovarian Cancer
Currently, there is no definitive evidence that ovarian cancer screening of the general
public
using serum CA-125 measurements decreases mortality of the screened group. To
date,
the published reports utilizing CA-125 with or without other modalities do not
demonstrate a
high enough sensitivity to justify its use in low-risk, asymptomatic women.
2
Administrative and Contractual Guidance
Benefit Determination Guidance
Benefits are subject to all terms, limitations and conditions of the subscriber contract.
For New England Health Plan (NEHP) members an approved referral authorization is
required.
Benefits for FEP members may vary. Please consult the FEP Service Plan Brochure.
Coverage varies according to the member’s group or individual contract. Not all groups
are required to follow the Vermont legislative mandates. Member Contract language
takes precedence over medical policy when there is a conflict.
If the member receives benefits through a self-funded (ASO) group, benefits may vary
or not apply. To verify benefit information, please refer to the member’s plan
documents or contact the customer service department.
Audit Information
BCBSVT reserves the right to conduct audits on any provider and/or facility to ensure
compliance with the guidelines stated in the medical policy. If an audit identifies
instances of non-compliance with this medical policy, BCBSVT reserves the right to
recoup all non-compliant payments.
Billing and Coding/Physician Documentation Information
See Attachments below for coding tables & instructions as applicable.
Eligible Providers
Allopathic Physicians (M.D.)
Osteopathic Physicians (D.O.)
Policy Implementation/Update information
02/2011-New Policy
02/2014- ICD-10 Remediation. Updated standard policy language added. RLJ.
Scientific Background and Reference Resources
Buys, Saundra S., MD, et al., “Ovarian cancer screening in the Prostate, Lung,
Colorectal
and Ovarian (PLCO) cancer screening trial: Findings from the initial screen of a
randomized
trial.” American Journal of Obstetrics and Gynecology,” Volume 193, pp. 1630-9,
2005).
3
· Centers for Medicare & Medicaid Services (CMS), Medicare Coverage Database, “NCD
for
Tumor Antigen by Immunoassay-CA-125,” Manual Section Number 190.28, Original
effective date 11/25/02, current effective date 1/1/06, <
http://www.cms.hhs.gov/pf/printpage.asp?ref=http://www.cms.hhs.gov/mcd/viewnc
d.asp?nc
d_id=190.28&ncd_version=2&basket=ncd%3A190%2E28%3A2%3ATumor+Antigen+by+Im
munoassay+%2D+CA+125 >, (accessed 3/4/09).
· Goonewardene, Tyronne, MRCP, et al., “Management of asymptomatic patients on
follow up
for ovarian cancer with rising CA-125 concentrations,” The Lancet Oncology,” Volume
8,
Issue 9, September 2007, pp. 813-821.
· Graham, Lisa, “ACOG Releases Guidelines on Management of Adnexal Masses,”
American
Family Physician,” Volume 77, Number 9, May 1, 2008, pp. 1320-1323.
· HAYES Medical Technology Directory, “CA-125 for Ovarian Cancer Screening in
AverageRisk Women," Lansdale, PA: HAYES, Inc., February 22, 2005.
· Hayes Update Search, “Ca 125 for Ovarian Cancer Screening in Average-Risk Women,
Lansdale, PA: Hayes, Inc. February 21, 2008.
· Kurman, Robert J., MD, et al., “Early detection and treatment of ovarian cancer:
shifting from
early stage to minimal volume of disease based on a new model of carcinogenesis,”
American Journal of Obstetrics and Gynecology (Reviews), April 2008, pp. 351-356.
· Mironov, Svetlana, MD, et al., “Ovarian Cancer,” Radiologic Clinics of North
America,
Volume 45, Number 1, January 2007.
· Nossov, Vladimir, MD, et al., “The early detection of ovarian cancer: from traditional
methods to proteomics. Can we really do better than serum CA-125?” American
Journal of
Obstetrics and Gynecology, Volume 199, Issue 3, September 2008, pp, 215-223.
· Pavelka, James C., MD, et al., “Hereditary Ovarian Cancer-Assessing Risk and
Prevention
Strategies,” Obstet Gynecol Clin N Am, Volume 34, 2007, pp. 651–665.
· Sevinc, Alper, et al., “Benign causes of increased serum CA-125 concentration,” The
Lancet
Oncology, Volume 8, Issue 12, December 2007, pp. 1054-1055.
· U.S. Preventive Services Task Force, “Screening for Ovarian Cancer:
Recommendation
Statement,” American Family Physician, Volume 71, Number 4, February 15, 2005.
· van Nagell, Jr., J. R., MD, and P. D. DePriest, MD, “Management of adnexal masses in
postmenopausal women,” American Journal of Obstetrics and Gynecology, Volume
193,
2005, pp.30–5.
4
Approved by BCBSVT Medical Director
Date Approved
Spencer Borden MD
Chair, Medical Policy Committee
Robert Wheeler MD
Chief Medical Officer
Attachment I
CPT code list
Code
Type
Number Brief Description
Policy Instructions
The following codes will be considered as medically necessary when applicable
criteria have been met.
CPT
Immunoassay for Tumor Antigen,
86304 quantitative; CA 125
Attachment II
ICD-9 Code List
Code
Type
Number
Description
The following diagnoses apply to this medical policy.
ICD-9
158.0
Malignant neoplasm of
retroperitoneum
ICD-9
158.8
Malignant neoplasm of specified
parts of peritoneum
ICD-9
158.9
Malignant neoplasm of peritoneum,
unspecified
ICD-9
180.0
Malignant neoplasm of endocervix
ICD-9
182.0
Malignant neoplasm of corpus uteri,
except isthmus
ICD-9
182.1
Malignant neoplasm of isthmus
5
ICD-9
182.8
Malignant neoplasm of other
specified sites of body of uterus
ICD-9
183.0
Malignant neoplasm of ovary
ICD-9
183.2
ICD-9
183.3
Malignant neoplasm of fallopian
tube
Malignant neoplasm of broad
ligament of uterus
ICD-9
183.4
Malignant neoplasm of parametrium
ICD-9
183.5
Malignant neoplasm of round
ligament of uterus
ICD-9
183.8
Malignant neoplasm of other
specified sites of uterine adnexa
ICD-9
183.9
Malignant neoplasm of uterine
adnexa, unspecified
Malignant neoplasm of other
specified sites of female genital
organs
ICD-9
184.8
ICD-9
198.6
Secondary malignant neoplasm of
ovary
ICD-9
198.82
Secondary malignant neoplasm of
genital organs
ICD-9
199.0
Disseminated malignant neoplasm
ICD-9
236.0
Neoplasm of uncertain behavior of
uterus
ICD-9
236.1
Neoplasm of uncertain behavior of
placenta
ICD-9
236.2
Neoplasm of uncertain behavior of
ovary
Neoplasm of uncertain behavior of
other and unspecified female
genital organs
ICD-9
236.3
ICD-9
338.3
Neoplasm related pain (acute)
(chronic)
ICD-9
789.30
Abdominal or pelvic swelling, mass,
or lump, unspecified site
ICD-9
789.31
Abdominal or pelvic swelling, mass,
or lump, right upper quadrant
6
ICD-9
789.32
Abdominal or pelvic swelling, mass,
or lump, left upper quadrant
ICD-9
789.33
Abdominal or pelvic swelling, mass,
or lump, right lower quadrant
ICD-9
789.34
Abdominal or pelvic swelling, mass,
or lump, left lower quadrant
ICD-9
789.35
Abdominal or pelvic swelling, mass,
or lump, periumbilic
ICD-9
789.36
Abdominal or pelvic swelling, mass,
or lump, epigastric
ICD-9
789.37
Abdominal or pelvic swelling, mass,
or lump, generalized
Abdominal or pelvic swelling, mass,
or lump, other specified site;
multiple sites
ICD-9
789.39
ICD-9
795.82
Elevated cancer antigen 125 [CA
125]
ICD-9
795.89
Other abnormal tumor markers
ICD-9
V10.43
Personal history of malignant
neoplasm of ovary
Personal history of malignant
neoplasm of other female genital
organs
ICD-9
V10.44
ICD-9
V16.41
Family history of malignant
neoplasm of ovary
ICD-9
V71.1
Observation for suspected malignant
neoplasm
ICD-9
V76.46
Screening for malignant neoplasms
of the ovary
Attachment III
ICD-10 Code List (Effective 10/1/2014)
Code
Type
Number
Description
7
The following diagnoses apply to this medical policy.
ICD-10
C45.1
Mesothelioma of peritoneum
ICD-10
C48.0
Malignant neoplasm of
retroperitoneum
ICD-10
C48.1
Malignant neoplasm of specified
parts of peritoneum
ICD-10
C48.2
Malignant neoplasm of peritoneum,
unspecified
Malignant neoplasm of overlapping
sites of retroperitoneum and
peritoneum
ICD-10
C48.8
ICD-10
C51.8
Malignant neoplasm of overlapping
sites of vulva
ICD-10
C53.0
Malignant neoplasm of endocervix
ICD-10
C54.0
Malignant neoplasm of isthmus uteri
ICD-10
C54.1
Malignant neoplasm of endometrium
ICD-10
C54.2
Malignant neoplasm of myometrium
ICD-10
C54.3
Malignant neoplasm of fundus uteri
ICD-10
C54.8
Malignant neoplasm of overlapping
sites of corpus uteri
ICD-10
C54.9
Malignant neoplasm of corpus uteri,
unspecified
ICD-10
C56.1
Malignant neoplasm of right ovary
ICD-10
C56.2
Malignant neoplasm of left ovary
ICD-10
C56.9
Malignant neoplasm of unspecified
ovary
ICD-10
C57.00
Malignant neoplasm of unspecified
fallopian tube
ICD-10
C57.01
Malignant neoplasm of right
fallopian tube
ICD-10
C57.02
Malignant neoplasm of left fallopian
tube
ICD-10
C57.10
Malignant neoplasm of unspecified
broad ligament
8
ICD-10
C57.11
Malignant neoplasm of right broad
ligament
ICD-10
C57.12
Malignant neoplasm of left broad
ligament
ICD-10
C57.20
Malignant neoplasm of unspecified
round ligament
ICD-10
C57.21
Malignant neoplasm of right round
ligament
ICD-10
C57.22
Malignant neoplasm of left round
ligament
ICD-10
C57.3
Malignant neoplasm of parametrium
ICD-10
C57.4
Malignant neoplasm of uterine
adnexa, unspecified
ICD-10
C57.7
Malignant neoplasm of other
specified female genital organs
ICD-10
C57.8
Malignant neoplasm of overlapping
sites of female genital organs
ICD-10
C79.60
Secondary malignant neoplasm of
unspecified ovary
ICD-10
C79.61
Secondary malignant neoplasm of
right ovary
ICD-10
C79.62
Secondary malignant neoplasm of
left ovary
ICD-10
C79.82
Secondary malignant neoplasm of
genital organs
ICD-10
C80.0
Disseminated malignant neoplasm,
unspecified
ICD-10
D39.0
Neoplasm of uncertain behavior of
uterus
ICD-10
D39.10
Neoplasm of uncertain behavior of
unspecified ovary
ICD-10
D39.11
Neoplasm of uncertain behavior of
right ovary
ICD-10
D39.12
Neoplasm of uncertain behavior of
left ovary
ICD-10
D39.2
Neoplasm of uncertain behavior of
placenta
9
Neoplasm of uncertain behavior of
other specified female genital
organs
ICD-10
D39.8
ICD-10
D39.9
Neoplasm of uncertain behavior of
female genital organ, unspecified
ICD-10
G89.3
Neoplasm related pain (acute)
(chronic)
ICD-10
R19.00
Intra-abdominal and pelvic swelling,
mass and lump, unspecified site
ICD-10
R19.01
Right upper quadrant abdominal
swelling, mass and lump
ICD-10
R19.02
Left upper quadrant abdominal
swelling, mass and lump
ICD-10
R19.03
Right lower quadrant abdominal
swelling, mass and lump
ICD-10
R19.04
Left lower quadrant abdominal
swelling, mass and lump
ICD-10
R19.05
Periumbilic swelling, mass or lump
ICD-10
R19.06
Epigastric swelling, mass or lump
ICD-10
R19.07
Generalized intra-abdominal and
pelvic swelling, mass and lump
ICD-10
R19.09
Other intra-abdominal and pelvic
swelling, mass and lump
ICD-10
R97.1
Elevated cancer antigen 125 [CA
125]
ICD-10
R97.8
Other abnormal tumor markers
Encounter for observation for other
suspected diseases and conditions
ruled out
ICD-10
Z03.89
ICD-10
Z12.73
Encounter for screening for
malignant neoplasm of ovary
ICD-10
Z80.41
Family history of malignant
neoplasm of ovary
ICD-10
Z85.43
Personal history of malignant
neoplasm of ovary
10
ICD-10
Z85.44
Personal history of malignant
neoplasm of other female genital
organs
11