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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 SurePath^TM,  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. FocalPoint^TM (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 FocalPoint^TM technology uses a statistical classifier algorithm to calculate the likeihood that a slide contains abnormalities. The FocalPoint^TM 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 FocalPoint^TM 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 BenchMark^TM Automated Slide Staining System to analyze samples obtained via Cytyc's ThinPrep^TM and/or TriPath's SurePath^TM liquid based prep tests.

Primary screening and rescreening of Pap smears using the FocalPoint^TM 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 FocalPoint^TM 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.

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

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.

Blue Cross Blue Shield Association policy #2.04.09

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

Covered Codes

This is not an all-inclusive list of non-covered procedure codes.

The code(s) listed below and ANY code not listed in the previous section are considered non-covered for this procedure. 

Non-Covered Codes  

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