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Cervical Cancer Screening Technologies with Pap and HPV

 

DESCRIPTION

Data suggest that cytological screening for cervical cancer reduces the incidence of cervical cancer by up to 50%. Several technologies have been investigated for their role in detecting cancerous and precancerous cervical lesions.

It is estimated that there will be 12,200 new cases, and 4210 deaths from cervical cancer in the United States in 2010. The high prevalence and natural history of cervical cancer, as well as the ability to cure patients in pre-invasive stages, create ideal conditions for wide-spread screening. Cytological screening, through the sampling of cells of the cervix, has been the gold-standard since the introduction of the  Papanicolaou (Pap) smear in the 1940s. The Pap smear involves sampling cells of the transformation zone of the cervix, the area most prone to malignant transformation.

False-negative Pap smears are troubling, because a patient with undetected pre-invasive cancer may progress to invasive disease before she undergoes another Pap test, particularly if the patient does not undergo regular Pap smear screening. Pap smear cytology is associated with a false negative results ranging from 15% to 55%. False negative results may be explained by various factors, including sampling errors, errors in slide preparation, and errors in slide interpretation. Different approaches to reducing the false negative rate have targeted each step in the process. This policy addresses the technologies that attempt to improve the accurate detection of cervical abnormalities.

Appreciation of the causative effect of human papilloma virus (HPV) infection in most cervical cancers has led to the development of screening techniques for the presence of certain high-risk HPV strains in an attempt to improve the specificity of traditional Pap smears.

The Bethesda classification system assigns a degree of atypia to cells seen on Pap smear; however a biopsy is necessary to gain information on the tissue structure, or histology, of lesions. The correlation between cytological grade and histological grade, and the natural history of cervical cancer, has been an area of rapidly evolving understanding. While HPV infection has been associated with the development of cervical cancer, many infections are cleared spontaneously and low grade lesions may regress or disappear, particularly in younger women.

Examples of available technologies are -

  1. ThinPrep®, manufactured by Cytyc and SurePathTM,  manufactured by Tripath, are monolayer slide preparation systems approved for marketing by the FDA. The intent of monolayer slide systems is preparation of slides containing a more representative collection of cells for examination. The technology involves dispersing the collected cervical cell sample in a liquid medium, then collecting cells in a filter and depositing them in a thin layer on the slide.
  2. FocalPointTM (formerly AutoPap), manufactured by TriPath, is an automated slide reading system that has been approved by the FDA for primary screening and rescreening for Pap smears. The system is not intended to be used on slides from patients designated as high risk, such as symptomatic patients, those with prior abnormalities or malignancies, or those with prior abnormal Pap diagnoses. The system reads each slide once and identifies slides without abnormalities that do not require manual reading (up to 25% of slides), slides that should be manually read, and slides that should have a second manual reading (about 15% of slides). This process replaces the traditional manual reading one, in which all slides are manually read and a 10% random sample of initially negative slides are reread for quality control purposes. The FocalPointTM technology uses a statistical classifier algorithm to calculate the likeihood that a slide contains abnormalities. The FocalPointTM system provides the capability for on-site scanning and analysis of slides. After scanning, the computer produces a QC score, which reflects and aggregate measure of numerous cytologic abnormalities. As the score increases, the likelihood of abnormal cells increases. Users of the system can choose different threshold QC scores for selection of slides to be manually rescreened.
  3. The ThinPrep® Imaging System is another type of automated slide reading system that is designed to be used with ThinPrep® monolayer slide preparations. The system combines computer imaging technology to identify microscopic fields of diagnostic interest with automated stage movement of a microscope in order to locate these fields. In routine use, the system selects 22 fields of view for a cytotechnologist to review. Following review of these fields, the cytotechnologist will either complete the diagnosis if not abnormalities are identified, or review the entire slide using the Autoscan feature if any abnormalities are identified. The FDA labeling states the ThinPrep® Imaging System is indicated "for assisting in primary cervical cancer screening of ThinPrep® Pap Test slides for the presence of atypical cell, cervical neoplasia, including its precursor lesions.." In contrast to the FocalPointTM technology, which deselects slides at low risk from further screening, the ThinPrep® Imaging System highlights areas for focused screening by cytotechnologists.
  4. Hybrid Capture® 2, manufactured by Digene, is a test that detects human papillomavirus (HPV), which has been implicated as a cause of cervical cancer. Positive HPV tests have been shown to be predictive of cervical abnormalities. Many studies have explored the use of HPV testing to improve the sensitivity of Pap smears.
  5. INFORM®, manufactured by Ventana, is an analyte specific reagent (ASR) in situ hybridization (ISH) test desgined to detect high and low risk forms of HPV in liquid based cytology specimens and tissue biopsies. The ISH technology is an automated slide based test for HPV DNA and was designed for use with Ventana's BenchMarkTM Automated Slide Staining System to analyze samples obtained via Cytyc's ThinPrepTM and/or TriPath's SurePathTM liquid based prep tests.

 

POLICY

Preparation of Pap smears using a monolayer slide preparation system may be considered medically necessary.

Primary screening and rescreening of Pap smears using the FocalPointTM or ThinPrep® automated slide reading systems may be considered medically necessary.

HPV testing of Pap smears that have an interpretation of atypical cells of undetermined significance (ASC-US) may be considered medically necessary.

HPV testing may be considered medically necessary only if there is an abnormal Pap smear documented in the medical record.

See also the Identification of Microorganisms Using Nucleic Acid Policy. 

Primary screening and rescreening of  Pap smears using the FocalPointTM system automated slide reading system in high-risk patients (e.g., symptomatic patients, those with prior abnormalities or malignancies, or those with prior abnormal Pap diagnoses) is investigational. 

HPV testing of Pap Smears to detect high and low risk forms of HPV for the likelihood of cervical cancer development using in situ hybridization (ISH) is considered investigational.

 

POLICY EXCEPTIONS

For Federal Employee Program (FEP) subscribers only, HPV testing, in conjunction with Pap smears, for the purpose of screening women for cervical abnormalities in women over age 30 may be considered medically necessary.

 

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

 

POLICY HISTORY

8/1998: Approved by Medical Policy Advisory Committee (MPAC)

8/21/2002: Policy Guidelines revised, CPT codes 88147, 88148, 88153, 88164, 88165 deleted, HCPCS P3000-P3001 deleted, HCPCS G0123-G0124, G0143-G0145 added

10/17/2005:  Code reference section updated; CPT-4: 87620, 87621, 87622, 88147, 88148 added; 88144, 88145 deleted; ICD-9 Procedure: "Microscopic examination of specimen from female genital tract" deleted; ICD-9 Diagnosis: 233.1 added; HCPCS: G0141, G0147, G0148 added; "with manual screening and computer-assisted rescreening by cytotechnologist under physician supervision," "Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, with manual screening and computer-assisted rescreening using cell selection and review under physician supervision" deleted

9/29/2006: Policy updated. Code reference section udpated. CPT codes 88174 and 88175; HCPCS P3000 and P3001 added to policy

11/14/2006: Code Reference section updated: CPT code 87622 deleted.

8/28/2007: In situ hybridization (ISH) for HPV testing is considered investigational.

7/22/2008: Policy reviewed, no changes

09/10/2010:  Policy reviewed; policy statement unchanged. The following ICD-9 codes were added to the Covered Codes Table:  795.00-795.04, 795.06, 795.08, 795.10, 795.11, 795.71, 796.9, V73.81 and V72.3. CPT code 87622 was moved from non-covered to covered. Revised the description of HCPCS code G0141.

12/30/2010: Policy description updated. Policy title changed from "Monolayer Slide Preparation and AutoSlide Reading Systems for Cervical Cancer Screening" to "Cervical Cancer Screening Technologies with Pap and HPV."

05/01/2011:  The policy statement regarding HPV testing in conjunction with Pap smears was revised to state that HPV testing may be considered medically necessary only if there is an abnormal Pap smear documented in the medical record.  FEP coverage guidelines for HPV testing in conjunction with Pap smears was added to the Policy Exceptions section.

05/07/2013: Removed ICD-9 procedure code 91.46 from the Code Reference section.

 

SOURCE(S)

Hayes Medical Technology Directory

Blue Cross Blue Shield Association policy #2.04.09

 

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document. 

Covered Codes

Code Number

Description

CPT-4

87620

Infectious agent detection by nucleic acid (DNA or RNA); papillomavirus, human, direct probe technique

87621

Infectious agent detection by nucleic acid (DNA or RNA); papillomavirus, human, amplified probe technique

87622

Infectious agent detection by nucleic acid (DNA or RNA); papillomavirus (HPV), human, quantification (Moved to covered  09-10-2010)

88142

Cytopathology, cervical or vaginal, (any reporting system) collected in preservative fluid, automated thin layer preparation, manual screening under physician supervision (ThinPrep)

88143

Cytopathology, cervical or vaginal, (any reporting system) collected in preservative fluid, automated thin layer preparation, with manual screening and rescreening under physician supervision

88147

Cytopathology smears, cervical or vaginal; screening by automated system under physician supervision

88148

Cytopathology smears, cervical or vaginal; screening by automated system with manual rescreening under physician supervision

88152

Cytopathology, slides, cervical or vaginal, with manual screening and computer-assisted rescreening under physician supervision

88154

Cytopathology, slides, cervical or vaginal, with manual screening and computer-assisted rescreening using cell selection and review under physician supervision

88166

Cytopathology, slides, cervical or vaginal, (Bethesda System); with manual screening and computer-assisted rescreening under physician supervision

88167

Cytopathology, slides, cervical or vaginal, (Bethesda System); with manual screening and computer-assisted rescreening using cell selection and review under physician supervision

88174

Cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation; screening by automated system, under physician supervision

88175

Cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation; with screening by automated system and manual rescreening, under physician supervision

ICD-9 Procedure

 

 

ICD-9 Diagnosis

180.0, 180.1, 180.8, 180.9

Malignant neoplasm of cervix uteri, code range

198.82

Secondary malignant neoplasm of genital organs

233.1

Carcinoma in situ of cervix uteri

236.0

Neoplasm of uncertain behavior of uterus

239.5

Neoplasm of unspecified nature of other genitourinary organs

795.00, 795.01, 795.02, 795.03, 795.04, 795.06, 795.08, 795.10

Abnormal Papanicolaou smear of cervix (cervical HPV) and vagina (vaginal HPV) code range (Added 09-10-2010)

795.11

Papanicolaou smear of vagina with atypical squamous cells of undetermined significance (ASC-US) (Added 09-10-2010)

795.71

Other nonspecific immunological findings, nonspecific serologic evidence of human immunodeficiency virus [HIV] (Added 09-10-2010)

796.9

Other nonspecific abnormal findings (Added 09-10-2010)

V73.81

Special screening examination, Human papillomavirus [HPV] (Added 09-10-2010)

V72.31

Gynecological examination

Note:  This code should be used as secondary to V73.81 when screening for abnormalities in women 30 years or older.  See Policy Statement.  (Added 09-10-2010)

HCPCS

G0123 

Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, screening by cytotechnologist under physician supervision 

G0124 

Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, requiring interpretation by physician

G0141

Screening cytopathology, smears, cervical or vaginal, performed by automated system, with manual rescreening, requiring interpretation by physician (Description revised 09-10-2010)

G0143

Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, with manual screening and rescreening by cytotechnologist under physician supervision

G0144 

Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation,  with screening by automated system, under physician supervision 

G0145

Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin layer preparation, with screening by automated system and manual rescreening under physician supervision 

G0147

Screen cytopathology smears, cervical or vaginal, performed by automated system under physician supervision 

G0148

Screening cytopathology smears, cervical or vaginal, performed by automated system with manual rescreening

P3000

Screening Papanicolaou smear, cervical, or vaginal, up to three smears, by technician under physician supervision

P3001

Screening Papanicolaou smear, cervical, or vaginal, up to three smears, requiring interpretation by physician 

Investigational Codes

Code Number

Description

CPT-4

87622

Infectious agent detection by nucleic acid (DNA or RNA); papillomavirus, human, quantification (added 6-3-2009)  See also Identification of Microorganisms Using Nucleic Acid medical policy

88365

In situ hybridization (eg, FISH), each probe

ICD-9 Procedure

 

  

ICD-9 Diagnosis

  

  

HCPCS

 

 

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