MEDICAL POLICY
For use with the UnitedHealthcare Laboratory Benefit Management Program, administered by BeaconLBS
GYNECOLOGIC PAPANICOLAOU (PAP) TESTING
Policy Number: CMP - 043
Effective Date: January 21, 2017
Table of Contents
BACKGROUND
POLICY
REFERENCES
POLICY HISTORY/REVISION HISTORY
Page
1
5
7
8
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
Cervical cancer is a slowly progressing cancer. The normal cervical cells first gradually develop precancerous
changes, defined as cervical intraepithelial neoplasia (CIN), squamous intraepithelial lesion (SIL), or dysplasia,
that may turn into cancer if left untreated.1 Therefore, treating all pre-cancers can prevent most cancers.
Squamous cell carcinoma (80-90%) and adenocarcinoma (10-20%) are the two main types of cervical cancer.1
These pre-cancerous changes can be detected by the Papanicolaou (Pap) test and treated to prevent the
development of cancer. In cervical cytology, a Pap sample is obtained by using a spatula, brush, or broom to
acquire cells from the different areas of the cervix (both exocervix and endocervix).
The American Cancer Society (ACS) estimates that in the US for 2011 there will be approximately 12,710 new
cases of invasive cervical cancer diagnosed and about 4,290 women will die from cervical cancer.1-3
Unfortunately, not all American women take advantage of the benefits of Pap test screening. Between 60 -80%
of US women who are diagnosed with invasive cervical cancer have not had a Pap test in the past 5 years.1 In
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fact many of these women have never had a Pap test. Largest gain in reducing cervical cancer incidence and
mortality could be attained by increasing screening rates (regardless of test used) among women currently
unscreened or screened infrequently.4 When cervical cancers are detected at an early stage, the 5 year survival
is approximately 92%.4, 5
As, there are often no symptoms of cervical dysplasia until the disease has progressed into advanced cancer, it is
crucial that sexually active women, or women over age 20, have yearly Pap smears. In addition, women who
experience bleeding between menstrual periods, bleeding after intercourse, abnormal vaginal discharge,
abdominal pain or swelling, urinary symptoms, or pelvic pain should be evaluated by a healthcare provider, even
if it is not the regular time for a Pap test.
In countries where women do not have access to routine Pap tests, cervical cancer is much more common. In
fact, cervical cancer is the major cause of cancer deaths in women in many developing countries and these cases
are usually diagnosed at a late (invasive) stage, rather than as pre-cancers or early cancers.4
Risk Factors
There are multiple risk factors that predispose women to developing cervical cancer. These risk factors include
infection with Human Papillomavirus (HPV), smoking, immunosuppression, Chlamydia infection, diet, oral
contraceptives, multiple full-term pregnancies, young age at the first full-term pregnancy, poverty,
diethylstilbestrol (DES), and a family history of cervical cancer.1 HPV, a sexually transmitted infection, has been
strongly linked to cervical cancer. It has been stated that the demonstration that cervical cancer is caused by the
persistent infection by certain genotypes of HPV is one of the most important discoveries in the investigation of
cancer etiology over the past 25 years.6
This monumental discovery led to the development of two HPV vaccines that are currently on the market,
Gardasil (quadrivalent) and Cervarix (bivalent). Both vaccines protect against the two HPV types (HPV-16 and
HPV-18) that cause 70% of cervical cancers, 80% of anal cancers, 60% of vaginal cancers, 40% of vulvar cancers
as well as most HPV induced oral cancers. Gardasil also protects against the two HPV types (HPV-6 and HPV-11)
that cause the vast majority of genital warts (90%). The Advisory Committee on Immunization Practices (ACIP)
and the American College of Obstetrics and Gynecology (ACOG) recommend that bivalent or quadrivalent HPV
vaccination be routinely offered to girls between the ages of 11 and 12 years (as young as 9 years) to prevent
cervical dysplasia and cervical cancer. In addition, catch-up vaccination is recommended for women aged 13 to
26 years who have not been previously vaccinated. Given that these vaccines only cover some high-risk types of
HPV, women should continue with regular Pap smear screening after vaccination.
A task force appointed by the Society of Gynecologic Oncology (SGO) and the American Society of Colposcopy
and Cervical Pathology (ASCCP) have prepared an interim clinical guidance document for HPV primary screening
in the United States.7
The Pap Test and Other Conditions
While a Pap test does not test for the majority of sexually transmitted diseases (STDs), it may occasionally show
signs of infection. Certain types of Pap smear may include HPV testing on the sample that is taken from your
cervix, and it is also possible that swelling or damage from other STDs could show up on your Pap smear.
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Additionally, sometimes a “wet mount” is performed in conjunction with or separate from a Pap test. A wet
mount is a slide made from a swab of your vagina that looks for vaginal infections and other conditions that can
easily be identified visually such as Bacterial vaginosis (BV) and trichomoniasis.
There are many gynecological Issues in women who are human immunodeficiency virus positive (HIV+). HIV+
women are more likely to be infected with HPV than HIV-negative women and HIV+ women are 10 times more
likely to have abnormal Pap smears than HIV negative women.8 In addition, HIV+ women, especially women with
advanced HIV disease, are also more likely to develop dysplasia (abnormal cervical cells) as a result of HPV.8
The Centers for Disease Control (CDC) recommends that8:


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HIV+ women have a complete gynecological examination, including a Pap smear, when they are first
diagnosed and when they first seek prenatal care
HIV+ women have another Pap six months later
If both tests are normal (negative), yearly screening is recommended
Women who have had dysplasia should receive a Pap smear more often and may return to getting
annual Pap smears if they have had two normal exams in a row
Leiomyomas, also known as fibroids, are common benign tumors of the uterine corpus but may also appear in
the cervix.9 Whenever an asymptomatic cervical fibroid is discovered; the possibility of cervical cancer should be
ruled out.
Society Guidelines
Cervical cancer statistics demonstrate the clinical utility of screening for cervical cancer using the Pap test. Since
the introduction of the Pap test, the death rate from cervical cancer has significantly decreased. Guidelines for
use of the Pap test vary by age and clinical conditions.
American Congress of Obstetricians and Gynecologists (ACOG)5
ACOG has issued guidelines for Pap testing as well as testing for HPV. According to ACOG, both liquid based
cytology (LBC) and conventional methods of cervical cytology screening are acceptable for screening.
The ACOG Guidelines are based on Level A evidence and are as follows5:

Screening should begin at age 21 years. Screening before age 21 should be avoided because it may lead
to unnecessary and harmful evaluation and treatment in women at very low risk of cancer

Screening recommended every 3 years for women 21-29 years

Women aged 30 and older who have had 3 consecutive negative cervical cytology screening test results
and who have no history of CIN 2+, are not HIV infected, are not immunocompromised, and were not
exposed to DES in utero may extend the interval between screenings to every 3 years

In women who have had a total hysterectomy for benign indications and have no prior history of highgrade CIN, routine cytology testing should be discontinued

Co-testing using the combination of cytology plus HPV DNA is an appropriate screening test for women
older than 30 years. Any low-risk woman aged 30 years or older who receives negative test results on
should be rescreened no sooner than 5 years subsequently.
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American Cancer Society (ACS)/American Society for Colposcopy and Cervical Pathology (ASCCP)/American
Society for Clinical Pathology (ASCP)4
The ACS has developed guidelines for the screening for various cancers and the cervical cancer guidelines are in
line with ACOG recommendations. The ACS Guidelines are as follows4:






Cervical cancer screening should begin at age 21 years. Women under the age of 21 should not be
screened regardless of the age of sexual initiation or other risk factors.
Women at any age should NOT be screened annually by any screening method; rather, recommended
screening intervals for women are based on age and clinical history.
For women 21 to 29 years of age, screening with cytology alone every 3 years is recommended. For
women 21 to 29 years of age with 2 or more consecutive negative cytology results, there is insufficient
evidence to support a longer screening interval.
Women ages 30 to 65 years should be screened with cytology and HPV testing (‘‘cotesting’’) every 5
years (preferred) or cytology alone every 3 years (acceptable). There is insufficient evidence to change
screening intervals in this age group following a history of negative screens.
Women over 65 years of age with evidence of adequate negative prior screening and no history of
CIN2+ within the last 20 years should not be screened for cervical cancer with any modality. Once
screening is discontinued it should not resume for any reason, even if a woman reports having a new
sexual partner.
Women who have had a total hysterectomy may also choose to stop having cervical cancer testing
unless the hysterectomy was done as a treatment for cervical cancer or pre-cancer. Women who have
had a hysterectomy without removal of the cervix (supra-cervical hysterectomy) need to continue to
have screening.
U.S. Preventive Services Task Force (USPSTF)10
Likewise, the USPSTF also has issued recent recommendations for the screening of cervical cancer that are also
in agreement with ACOG recommendations. The USPSTF guidelines are as follows10:





The USPSTF recommends against screening for cervical cancer in women younger than age 21 years (D
recommendation).
The USPSTF recommends screening for cervical cancer in women aged 21 to 65 years with cytology
(Papanicolaou smear) every 3 years or, for women aged 30 to 65 years who want to lengthen the
screening interval, screening with a combination of cytology and HPV testing every 5 years. See the
Clinical Considerations for discussion of cytology method, HPV testing, and screening interval (A
recommendation).
The USPSTF recommends against screening for cervical cancer in women older than age 65 years who
have had adequate prior screening and are not otherwise at high risk for cervical cancer. See the Clinical
Considerations for discussion of adequacy of prior screening and risk factors (D recommendation).
The USPSTF recommends against screening for cervical cancer in women who have had a hysterectomy
with removal of the cervix and who do not have a history of a high-grade precancerous lesion (cervical
intraepithelial neoplasia grade 2 or 3) or cervical cancer (D recommendation).
The USPSTF recommends against screening for cervical cancer with HPV testing, alone or in combination
with cytology, in women younger than age 30 years (D recommendation).
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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 table below.
Table 1. HCPCS Codes (Alphanumeric, CPT AMA)
HCPCS Code
88141
Description
Cytopathology, cervical or vaginal (any reporting system), requiring
interpretation by physician
88142
Cytopathology, cervical or vaginal (any reporting system), collected in
preservative fluid, automated thin layer preparation; manual
screening under physician supervision
88143
Cytopathology, cervical or vaginal (any reporting system), collected in
preservative fluid, automated thin layer preparation; manual
screening and rescreening under physician supervision
Cytopathology smears, cervical or vaginal; screening by automated
system under physician supervision
Cytopathology smears, cervical or vaginal; screening by automated
system with manual rescreening under physician supervision
Cytopathology, slides, cervical or vaginal; manual screening under
physician supervision
Cytopathology, slides, cervical or vaginal; with manual screening and
computer-assisted rescreening under physician supervision
Cytopathology, slides, cervical or vaginal; with manual screening and
rescreening under physician supervision
Cytopathology, slides, cervical or vaginal; with manual screening and
computer-assisted rescreening using cell selection and review under
physician supervision
Cytopathology, slides, cervical or vaginal (The Bethesda System);
manual screening under physician supervision
Cytopathology, slides, cervical or vaginal (The Bethesda System); with
manual screening and rescreening under physician supervision
Cytopathology, slides, cervical or vaginal (The Bethesda System); with
manual screening and computer-assisted rescreening under physician
supervision
Cytopathology, slides, cervical or vaginal (The Bethesda System); with
manual screening and computer-assisted rescreening using cell
selection and review under physician supervision
Cytopathology, cervical or vaginal (any reporting system), collected in
preservative fluid, automated thin layer preparation; screening by
automated system, under physician supervision
Cytopathology, cervical or vaginal (any reporting system), collected in
preservative fluid, automated thin layer preparation; screening by
automated system and manual rescreening or review, under
physician supervision
88147
88148
88150
88152
88153
88154
88164
88165
88166
88167
88174
88175
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ICD-10 Diagnosis Codes (Proven)
CMP-043 Gyn PAP
ICD10 v2.2
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REFERENCES
1.
American Cancer Society. Detailed Guide to Cervical Cancer. Atlanta: American Cancer Society; 2011.
Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003094-pdf.pdf
(Accessed: September 23, 2011).
2.
American Cancer Society. Cancer Facts & Figures 2011. Atlanta: American Cancer Society; 2011.
Available at:
http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc029771.pdf (Accessed: September 23, 2011).
3.
Surveillance, Epidemiology and End Results (SEER) Program. National Cancer Institute. Available at:
http://seer.cancer.gov/statfacts/html/cervix.html (Accessed: September 23, 2011).
4.
Saslow D,Solomon D,Lawson HW, et al. American Cancer Society, American Society for Colposcopy and
Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention
and early detection of cervical cancer. J. Low. Genit. Tract Dis. 2012;16(3):175-204.
5.
Practice Bulletin No. 157 Summary: Cervical Cancer Screening and Prevention. Obstet Gynecol.
2016;127(1):185-187.
6.
Castellsague X. Natural history and epidemiology of HPV infection and cervical cancer. Gyn Oncol.
2008;110 S4-S7.
7.
Huh WK,Ault KA,Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical
cancer screening: Interim clinical guidance. Gynecologic Oncology. 2015;136(2):178-182.
8.
The Well Project. Women and HIV. Available at:
<http://www.thewellproject.org/en_US/HIV_The_Basics/Women_and_HIV.jsp> (Accessed: March 30,
2012).
9.
Disorders of the Lower Genital Tract in Blueprints. Obstetrics and Gynecology. Callahan TL, Caughey AB.
2009. Lippincott Williams and Wilkins, Baltimore MD.
10.
Moyer VA. USPSTF;Screening for cervical cancer: U.S. Preventive Services Task Force recommendation
statement. Ann. Intern. Med. 2012;156(12):880-891.
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POLICY HISTORY/REVISION HISTORY
Date
01/21/2017
10/01/2016
Action/Description
Updated ICD10 codes as per CMS recommendations. Removed ICD9 code file.
Annual policy review completed – changes made:
Background Section and HPV subsection:
Modified the following statement to reflect that the clinical guidance have been published (based on the
Huh, 2015 reference):
"A task force appointed by the Society of Gynecologic Oncology (SGO) and the American Society of
Colposcopy and Cervical Pathology (ASCCP) have prepared an interim clinical guidance document for HPV
primary screening in the United States.
References Section:
Added reference: Huh, 2015.
Updated ACOG reference from practice bulletin No. 131 version 2012 to practice bulletin No. 157 version
2016.
12/03/2015
10/01/2015
Annual Policy Review Completed – changes made:
Added ICD9 diagnosis codes related to pregnancy and persons at high risk:
V72.42, 795.4
Added ICD10 diagnosis codes related to pregnancy and persons at high risk:
R87.618, Z32.01
Removed ICD9 table. Embedded ICD9/ ICD10 PDF files.
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