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MEDICAL POLICY
For use with the UnitedHealthcare Laboratory Benefit Management Program, administered by BeaconLBS
ALPHA FETOPROTEIN (AFP)
Policy Number: CMP - 014
Effective Date: January 21, 2017
Table of Contents
BACKGROUND
POLICY
REFERENCES
POLICY HISTORY/REVISION HISTORY
Page
1
3
4
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INSTRUCTIONS FOR USE
This Medical Policy provides assistance in interpreting UnitedHealthcare benefit plans. When deciding
coverage, the enrollee specific document must be referenced. The terms of an enrollee's document (e.g.,
Certificate of Coverage (COC) or Summary Plan Description (SPD)) may differ greatly. In the event of a
conflict, the enrollee's specific benefit document supersedes this Medical Policy. All reviewers must first
identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage prior
to use of this Medical Policy. Other Policies and Coverage Determination Guidelines may apply.
UnitedHealthcare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary.
This Medical Policy is provided for informational purposes. It does not constitute medical advice.
UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist
us in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the
independent professional medical judgment of a qualified health care provider and do not constitute the
practice of medicine or medical advice.
BACKGROUND
Alpha fetoprotein (AFP), a glycoprotein antigen, is a normally produced by a developing fetus. AFP levels begin
to decrease soon after birth and are usually undetectable in the blood of healthy adults, except during
pregnancy.
Maternal serum screening is a noninvasive way to identify pregnancies at high risk for fetal chromosomal and
structural abnormalities in the first or second trimester in pregnancy. Clinical use of maternal serum screening
to evaluate risk of fetal abnormalities began in the 1970s, when high maternal serum AFP levels were shown to
be correlated with increased risk of open spina bifida (OSB).
In addition to maternal serum screening, an elevated level of AFP serves as a non-specific tumor associated
antigen and strongly suggests the presence of either primary liver cancer, or germ cell cancer of the ovary or
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testicle. It is generally accepted that serial measurements of AFP are performed to diagnose germ cell tumors in
patients with adenocarcinoma, or carcinoma not otherwise specified, involving mediastinal nodes; or the
diagnosis and monitoring of hepatocellular carcinoma (e.g., before considering liver transplantation).
Additionally, serial measurements of AFP and HCG together are used to diagnose and monitor testicular cancer
and some germ cell tumors of the ovary.
Pregnancy Screening
The current guidelines for clinical use of maternal serum screening are from the American College of
Obstetricians and Gynecologists (ACOG). In 2007, ACOG recommended first trimester, integrated, or sequential
screening to identify pregnancies at increased risk of Down syndrome if the patient presents in the first
trimester. For women who present after first trimester for screening, ACOG recommends Quadruple Marker
screening.
The Quadruple Marker Screen or “Quad” screen is available for women who present between 15 and 20 weeks
gestation. It combines measurements of maternal serum AFP, human chorionic gonadotropin (HCG), dimeric
inhibin A (DIA), and unconjugated estriol (uE3) with maternal age risk. Low maternal serum AFP, in the second
trimester, is correlated with increased risk of Down syndrome and trisomy 18, and high maternal serum AFP is
correlated with increased risk of OSB.
Hepatocellular Cancer (Liver Cancer)
Serum AFP is the most widely used tumor marker for detecting patients with liver cancer. Liver cancers can
cause elevated levels of AFP. As AFP is an established test for the diagnosis and monitoring, it is used as a
screening tool to rule out the presence of a liver neoplasm before liver transplantation. This is especially
pertinent in cases (such as alcoholic cirrhosis, cirrhosis of viral etiology, hemochromatosis, and alpha 1antitrypsin deficiency) where there is an increased risk of developing a primary liver tumor.
AFP can also be used to help figure out the best treatment for liver cancer and to follow patients after curative
surgery or other treatment. Liver cancer is not very common in the US, so AFP testing is not used as a general
population screening test. Screening with AFP has been successful in parts of Asia where liver cancer is
common.
Germ Cell Tumors
AFP is also elevated in certain germ cell tumors, such as some testicular cancers (those containing embryonal
cell and endodermal sinus types), certain rare types of ovarian cancer (yolk sac tumor or mixed germ cell
cancer), and germ cell tumors that start in the chest (mediastinal germ cell tumors).
Most testicular cancers are germ cell tumors. For treatment planning, germ cell tumors are broadly divided into
seminomas and nonseminomas because they have different prognostic and treatment algorithms. Nonseminomas include embryonal carcinomas, teratomas, yolk sac tumors, and choriocarcinomas. Human
chorionic gonadotropin (HCG) is almost always elevated and AFP is never elevated in choriocarcinoma, however
AFP, but not HCG, is elevated in yolk sac tumor or endodermal sinus tumor. However, many tumors are made
up of a mixture of different types of non-seminoma and elevation of serum AFP is seen in 40% to 60% of men
with non-seminomas. About 10% of men with testicular cancer will have a seminoma, which will have elevated
HCG, but will not have elevated AFP as seminomas do not produce AFP.
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Accepted guidelines provide that AFP and HCG measurements are valuable for determining prognosis and
monitoring therapy in patients with non-seminomatous germ cell cancer and should be measured prior to
removing the involved testicle. For patients with non-seminomas, the degree of tumor-marker elevation after
the cancerous testicular has been removed is one of the most significant predictors of prognosis. Because of
the low incidence of elevated AFP and HCG levels in early stage cancer, these markers have little value in
screening for testicular cancer.
Extragonadal germ cell tumors form from developing sperm or egg cells that travel from the gonads to other
parts of the body. These tumors may begin to grow anywhere in the body but usually begin in organs such as
the pineal gland in the brain, in the mediastinum, or in the abdomen. Extragonadal germ cell tumors can be
benign (noncancer) or malignant (cancer). Malignant extragonadal germ cell tumors are divided into two types,
non-seminoma and seminoma. Non-seminomas tend to grow and spread more quickly than seminomas. They
usually are large and cause symptoms. If untreated, malignant extragonadal germ cell tumors may spread to the
lungs, lymph nodes, bones, liver, or other parts of the body. Possible signs of extragonadal germ cell tumors
include chest pain and breathing problems.
AFP has been used as a screening modality for germ cell tumors when an adnexal mass in discovered in a premenopausal gynecologic patient. It is also used to follow female patients after removal of a germ cell tumor of
the ovary such as immature teratomas and endodermal sinus tumors.
POLICY
For the following CPT code(s) in Table 1, the patient should have a diagnosis (ICD-10-CM) code(s) listed in the
attached files below.
Table 1. HCPCS Codes (Alphanumeric, CPT AMA)
HCPCS Code
82105
Description
Alpha-fetoprotein; serum
ICD-10 Diagnosis Codes (Proven)
CMP-014 Alpha
Fetoprotein ICD10 v2.2
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REFERENCES
1. Bigbee W, Herberman RB. Tumor markers and immunodiagnosis. In: Bast RC Jr., Kufe DW, Pollock RE, et al.,
editors. Cancer Medicine. 6th ed. Hamilton, Ontario, Canada: BC Decker Inc., 2003.
2. National Cancer Institute Fact Sheet. Tumor Markers. Available at:
http://www.cancer.gov/cancertopics/factsheet/detection/tumor-markers (Accessed: January 3, 2012)
3. American Cancer Society Fact Sheet. Tumor Markers. Available at:
http://www.cancer.org/acs/groups/cid/documents/webcontent/003189-pdf.pdf (Accessed: January 3,
2012)
4. Tatsuta M. Yamamura H. Iishi H. Kasugai H. Okuda S. Value of serum alpha-fetoprotein and ferritin in the
diagnosis of hepatocellular carcinoma. Oncology. 43(5):306-10, 1986.
5. Centers for Medicare and Medicaid Services (CMS) Medicare National Coverage Determinations (NCD)
Coding Policy Manual and Change Report dated October 2011. Available at:
https://www.cms.gov/CoverageGenInfo/04_LabNCDs.asp#TopOfPage. (Accessed: December 5, 2011).
6. ACOG educational bulletin. Maternal serum screening. Number 228, September 1996 (replaces no. 154, April
1991). Committee on Educational Bulletins of the American College of Obstetricians and Gynecologists. Int J
Gynaecol Obstet. 1996;55(3):299-308.
7. ACOG Practice Bulletin No. 77: Screening for fetal chromosomal abnormalities. Obstet Gynecol.
2007;109(1):217-227.
8. Zhou L, Liu J, Luo F. Serum tumor markers for detection of hepatocellular carcinoma. World J Gastroenterol.
2006;12 (8): 1175-81.
9. Gilligan TD, et al. ASCO Clinical Practice Guidelines on uses of serum tumor markers in adult males with
germ cell tumors. J Clin Oncol. 2010 Jul 10;28(20):3388-3404.
10. National Cancer Institute of National Institutes of Health information on Hepatocellular cancer. Available at:
http://www.cancer.gov/cancertopics/pdq/screening/hepatocellular/healthprofessional/page3 (Accessed:
January 17, 2012).
11. National Cancer Institute of National Institutes of Health information on Testicular cancer. Available at:
http://www.cancer.gov/cancertopics/types/testicular (Accessed: January 17, 2012).
12. Sturgeon CM, Duffy MJ, Stenman UH, et al. National Academy of Clinical Biochemistry laboratory medicine
practice guidelines for use of tumor markers in testicular, prostate, colorectal, breast, and ovarian cancers.
Clin Chem. 2008;54 (12): e11-79.
13. International Germ Cell Consensus Classification: a prognostic factor-based staging system for metastatic
germ cell cancers. International Germ Cell Cancer Collaborative Group. J Clin Oncol. 1997;15 (2): 594-603.
14. ACOG Practice Bulletin No 83: Management of Adnexal Masses. Obstet Gynecol. 2007;110(1):201-214.
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POLICY HISTORY/REVISION HISTORY
Date
01/21/2017
12/03/2015
Action/Description
Updated ICD10 codes as per CMS recommendations. Removed ICD9 code file.
Annual Policy Review Completed – changes made:
Added ICD9 diagnosis codes related to liver neoplasm: 790.5, 790.6
Added ICD10 diagnosis codes related to liver neoplasm: R74.8, R74.9, R79.89, R79.9
10/01/2015
Removed ICD9 table. Embedded ICD9/ ICD10 PDF files.
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