DESCRIPTION
In the United States, cervical cancer is the 12th most common cancer that women develop, and the 14th most common cause of cancer death for women. Cancer screening of the cervix, performed in an outpatient setting, is used to identify women at risk for cervical cancer.
Diagnostic tools to identify women at risk for cervical cancer are as follows:
Papanicolaou (Pap) Smear
A cytopathology examination used primarily to study cells from the cervix.
A sample of cervical cells is used in the preparation of a slide for microscopic analysis.
Designed for early detection of cervical carcinoma, before the lesion has advanced to the stage where overt symptoms are present.
Speculoscopy (e.g. Pap PlusSpeculoscopy, PapSure)
An adjunctive cervical cancer screening test.
Involves the attachment of a chemiluminescent light called a Speculite® to the upper dilator blade of the vaginal speculum. Visualization is aided by using 4-6X magnification to view an acetic acid washed cervical-vaginal area.
Designed to identify the presence or absence of any abnormal cervical areas that would be seen as white lesions against a blue background.
Monolayer slide prep, liquid - based cytology (e.g., ThinPrep®, SurePath®, MonoPrep Pap®)
Designed as an alternative to the Pap smear.
Produces a monolayer slide preparation that results in slides with a more representative collection of cells presented for examination.
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.
HPV-DNA, gonorrhea, and chlamidia testing can be performed on this same slide preparation
Automated slide reading systems are as follows:
Automated Microscope and Imaging System (e.g., ThinPrep Imaging System®)
Designed for assisting in primary cervical cancer screening of monolayer prepared test slides.
Involves a computer-aided imaging with an automated microscope to screen for the presence of atypical cells.
Algorithmic classification (e.g., FocalPoint™)
Designed for initial screening of cervical cytology slides.
Uses conventionally prepared Pap smears and SurePath® liquid based slides.
Not intended for slides designated by the laboratory as high risk.
Relies on statistical classifier algorithm to rate the likelihood that a slide contains abnormalities.
CervicographySM
An adjunctive cervical screening procedure performed after a Pap smear.
Involves swabbing the cervix with an acetic acid solution and photographing the outside of the cervix with a Cerviscope® camera after the Pap smear is obtained. The film is sent to National Testing Laboratories where it is developed into a slide and evaluated by a physician.
Intended to increase the sensitivity of the Pap smear in screening for cervical abnormalities and as a triage tool to determine which patients need further evaluation with colposcopy and biopsy.
Human Papillomavirus (HPV) DNA detection (e.g., Digene Hybrid Capture 2®, Cervista® HPV HR)
There is an association between human papillomavirus (HPV) and cervical cancer.
An adjunct to traditional Papanicolaou cytology testing when results indicate atypical squamous cells of undetermined significance (ASCUS)
Designed to differentiate between HPV DNA groups and high intermediate risk HPV types in cervical specimens.
Positive HPV tests have shown to be predictive of cervical abnormalities.
POLICY
Cervical cytology screening for cancer using the conventional method (e.g., Papanicolaou smear) or the monolayer slide preparation system (e.g., ThinPrep®, SurePath®, MonoPrep Pap®) is considered medically necessary.
Human Papillomavirus (HPV) testing, in conjunction with Pap smear, for the purpose of screening women for cervical abnormalities in women over the age of 30 is considered medically necessary.
Human Papillomavirus (HPV) testing, for women who have abnormal Pap smear results [e.g., atypical cells of undetermined significance (ASCUS)] is considered medically necessary.
Human Papillomavirus (HPV) testing, for the purpose of follow-up of a prior positive HPV test is considered medically necessary.
Automated slide reading systems using an automated microscope and imaging system (e.g. ThinPrep Imaging System®) for assisting in primary cervical cancer screening and rescreening of average risk, asymptomatic women is considered medically necessary.
Automated cervical cytology screening system using algorithmic classification (e.g., FocalPoint™) for primary cervical cancer screening and rescreening of average risk, asymptomatic women is considered medically necessary.
Automated cervical cytology screening systems using the algorithmic classification for the primary screening or rescreening of high risk individuals (e.g., symptomatic individuals, those with prior abnormalities or malignancies, or those with prior abnormal Pap diagnoses) are considered investigational.
Speculoscopy, as an adjunct to cancer screening program (e.g., initial and repeat Pap, or HPV DNA testing) of the cervix, is considered investigational.
CervicographySM is considered investigational.
Any devices utilized for cancer screening of the cervix must have FDA approval specific to the indication otherwise its use will be considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Pre-market approval from the U.S. Food and Drug Administration:
Liquid based preparations (e.g., ThinPrep®, SurePath®, MonoPrep Pap®) for the collection and preparation of specimens for cervical cancer screening
Automated slide reading systems (e.g., ThinPrep Imaging System®, FocalPoint™)
Human Papillomavirus (HPV) DNA detection (e.g., Digene Hybrid Capture 2®, Cervista® HPV HR)
Appropriate utilization of the automated microscope and imaging system (e.g., ThinPrep Imaging System®) involves:
The manual screening of an abnormality; and
If atypical cells are found on the manual review, the slides are sent to a pathologist for a final determination.
Classification systems for cervical cancer:
The Bethesda System reports results of the Pap smear as follows:
Atypical squamous cells of undetermined significance (ASCUS)
Low-grade squamous intraepithelial lesion (LSIL)
High-grade squamous intraepithelial lesion (HSIL)
The cervical intraepithelial neoplasia classification system (CIN) classifies cervical dysplasia on biopsy as follows:
CIN I - mild dysplasia
CIN II - moderate dysplasia
CIN III - severe dysplasia & carcinoma in situ
No controlled studies were found in the published literature that validate the application of speculoscopy, or cervicography for use as an adjunct for cancer screening of the cervix, thin-layer cytology for diagnoses unrelated to cancer screening of the cervix; or for automated cervical cytology using algorithmic classification screening programs in high risk populations.
SOURCES
American Cancer Society. (2010). Guidelines for early detection of cancer. Retrieved April 26, 2011 from http://www.cancer.org/healthy/findcancerearly/cancerscreeningguidelines/american-cancer-society-guidelines-for-the-early-detection-of-cancer.
American College of Obstetricians and Gynecologists. (2009, December). ACOG practice bulletin. Cervical cytology screening. Clinical practice guidelines for Obstetrician-Gynecologists, No.109. (96 articles and/or guidelines reviewed) Retrieved May 11, 2011 from http://www.guidelines.gov/content.aspx?id=15274.
American Society for Colposcopy and Cervical Pathology. (2006). 2006 consensus guidelines for the management of women with abnormal cervical screening tests. Retrieved May 23, 2011 from http://www.asccp.org/Portals/9/docs/pdfs/Consensus%20Guidelines/algorithms_cyto_07.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2010). Cervicography (2.04.04). Retrieved August 31, 2009 from BlueWeb. (17 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2010). Cervical cancer screening technologies with pap and HPV (2.04.09). Retrieved April 18, 2011 from BlueWeb. (16 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2010). Speculoscopy (4.01.15). Retrieved April 18, 2011 from BlueWeb. (10 articles and/or guidelines reviewed)
BlueCross BlueShield of Tennessee network physicians. July-September 2004.
Complete Guide to Medicare Coverage [Computer software]. (2009, July). Diagnostic pap smears (NCD 190.2, p. 2-91). The Ingenix.
Complete Guide to Medicare Coverage [Computer software]. (2009, July). Screening pap smears and pelvic examinations for early detection of cervical or vaginal cancer (NCD 210.2, p. 2-165). The Ingenix.
Institute for Clinical Systems Improvement (2005, October). Technology assessment report abstract: HPV DNA testing for screening and monitoring of cervical cancer. Retrieved August 16, 2007 from http://www.icsi.org/guidelines_and_more/technology_assessment_reports/technology_assessment_reports_-_active/hpv_dna_testing_for_the_screening_and_monitoring_of_cervical_cancer.html. (59 articles and/or guidelines reviewed)
Institute for Clinical Systems Improvement (2010, September). Healthcare guideline: Initial management of abnormal cervical cytology (pap smear) and HPV testing. Retrieved April 26, 2011 from http://www.icsi.org/new_category_10659/cervical_cytology__pap_smear__and_hpv_testing__initial_management_of_abnormal__pdf_.html. (64 articles and/or guidelines reviewed)
National Cancer Institute. (2011, April). Cervical cancer: Screening. Health professional version. Retrieved April 26, 2011 from http://www.cancer.gov/cancertopics/pdq/screening/cervical/healthprofessional/allpages. (70 articles and/or guidelines reviewed)
National Comprehensive Cancer Network. (2011). NCCN clinical practice guidelines in oncology: Cervical cancer screening, v.1.2011. Retrieved April 26, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/cervical.pdf.
U. S. Food and Drug Administration. (1982, June) Center for Devices and Radiological Health. 510(k) Premarket Notification Database.K821616. Retrieved August 11, 2005 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=51289.
U. S. Food and Drug Administration. (1995, December) Center for Devices and Radiological Health. 510(k) Premarket Notification Database.K955790. Retrieved August 11, 2005 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=112814.
U. S. Food and Drug Administration. (2003, June) Center for Devices and Radiological Health. 510(k) Premarket Notification Database.P020002. Retrieved April 26, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020002b.pdf.
U. S. Food and Drug Administration. (2003, June). Center for Devices and Radiological Health. Summary of Safety and Effectiveness Data. Retrieved April 26, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040052b.pdf.
U. S. Food and Drug Administration. (2003, March). Center for Devices and Radiological Health. Approval letter: Digene hybrid capture® 2 (HC2) High-risk HPV DNA test. Retrieved April 26, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf/P890064S009b.pdf.
U. S. Food and Drug Administration. (2008, December) Center for Devices and Radiological Health. 510(k) Premarket Notification Database.K950009/S008. Retrieved April 26, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf/P950009S008b.pdf.
U.S Department of Health and Human Services. Agency for Healthcare Research and Quality. (2010). Guide to preventive services 2010-2011. Retrieved April 26, 2011 from http://www.ahrq.gov/clinic/pocketgd1011/pocketgd1011.pdf.
ORIGINAL EFFECTIVE DATE: 10/1979
MOST RECENT REVIEW DATE: 10/8/2011
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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