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Medical Policy: 02.04.06
Original Effective Date: October 2003
Reviewed: September 2008
Revised: September 2008
This policy applies to all products unless specific contract
limitations, exclusions or exceptions apply. Please refer to the member's coverage
manual for benefit availability. Managed care guidelines related to referral authorization,
and precertification of inpatient hospitalization, home health, home infusion and
hospice services apply.
Description:
Cervical cancer remains a leading cause of death among women. A majority of cervical cancer is associated with the sexually-transmitted human papillomavirus (HPV) infection. Because cervical cancer often presents no symptoms until it has spread beyond the cervix, screening is an important measure. There are several techniques available for cervical cancer screening; some are stand alone tests while others are used in combination.
Papanicolaou (Pap) Smear is a cytopathology examination of cervical cells and is intended for early detection of cervical cancer before it has advanced to the stage where overt symptoms are present.
Liquid-based cytology, or thin layer cytology, produces a monolayer slide by dispersing the cervical cell sample in a liquid medium, collecting the cells in a filter, and depositing them in a thin layer on the slide. This method of cell collection permits the entire cellular sample to be preserved for testing instead of the 20 percent of cells that are smeared onto a glass slide during the conventional Papanicolaou preparation. It is designed as an alternative to the Pap smear.
Human Papillomavirus Deoxyribonucleic Acid (HPV-DNA) Testing detects high-risk types of HPV in cell DNA prior to conclusive visible changes to the cervical cells. There are more than 100 distinct types of HPV, with approximately 30 known to infect the human genital tract; 5 types cause approximately 75 percent of squamous intraepithelial lesions and cervical malignancy.
Speculoscopy is an endoscopic visualization of the cervix using specialized blue-white chemiluminescence along with acetic acid and low power magnification. A disposable blue-white chemiluminescent light is attached to the inner aspect of the upper speculum blade. Epithelial cells with increased keratinization and nuclear cytoplasmic ratios have an increased light reflection and appear white. The presence of white lesions is considered a positive result.
Cervicography is a visual screening technique that uses a specially-designed 35-mm camera to photograph the cervix following the application of a 3-5 percent acetic acid wash. The photographs, known as “cervigrams”, are evaluated by a colposcopist and interpreted as negative, atypical, positive, or defective.
Spectroscopy emits light from a probe onto the cervix permitting the examiner to visually inspect and categorize tissues as normal or diseased. Abnormal tissue absorbs and emits light differently than normal tissue. An example of spectroscopy is the LUMA™ Cervical Imaging System by MediSpectra. This non-contact optical analysis system is intended for use as an adjunct to colposcopy for the identification of high-grade disease (CIN 2, 3+) in women referred to colposcopy with a Pap test result of atypical squamous cell (ASC), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion or cancer (HSIL+).
Policy:
- Papanicolaou (pap) smear, for cancer screening of the cervix, may be considered medically necessary
- Thin-layer cytology (e.g., ThinPrep®), as a primary screening technique, may be considered medically necessary.
- Human Papillomavirus (HPV) DNA testing may be considered medically necessary for women with Atypical Squamous Cells of Undetermined Significance (ASCUS).
- Human Papillomavirus (HPV) DNA testing as a primary screening technique for cervical cancer is considered not medically necessary.
- Speculoscopy (e.g., Speculite® and PapSure®) as a primary screening technique for cervical cancer is considered investigational.
- Cervicography, as a primary screening technique or an adjunct for cancer screening of the cervix, is considered investigational.
- Spectroscopy as a primary screening technique for cervical cancer is considered investigational.
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Procedure Codes and Billing
Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, revenue codes, and/or ICD-9 diagnostic codes.
- CPT code 87620 for Papillomavirus, human, direct probe technique
- CPT code 87621 for Papillomavirus, human, amplified probe technique
- CPT code 87622 for papillomavirus, human, quantification
- CPT 0031T and 0032T to report Speculoscopy
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Selected References:
- Parham GP. Comparison of cell collection and direct visualization cervical cancer screening adjuncts. Am J Obstet Gynecol. Vol 188 Number 3. Mar 2003.
- Wright PC. Chapter 10: Cervical Cancer Screening Using Visualization Techniques. Journal of the National Cancer Institute Monographs, No 31, 2003.
- Cronje HS, van Rensburg E, Cooreman BF, et al. Speculoscopy vs. the acetic acid test for cervical neoplasia. International Journal of Gynecology & Obstetrics 69(2000) 249-53.
- Smith JC, Greer NL, Technology Assessment Committee. HPV DNA Testing for Cervical Cancer. Institute for Clinical Systems Improvement (ICSI). Technology Assessment Report #56 June 2001.
- Soloman D, Schiffman M, Tarone R. Comparison of Three Management Strategies for Patients with Atypical Squamous Cells of Undetermined Significance: Baseline results from a Randomized Trial. Journal of the National Cancer Institute;93(4) (2001) 293-99.
- Smith RA, et al. American Cancer Society Guidelines for the Early Detection of Cancer, 2004. CA Cancer J Clin 2004 Jan/Feb; 54(1):41-52.
- Health Technology Assessment Information Service. Windows on Medical TechnologyTM (December 2004). Pap Smear plus Speculoscopy for Cervical Cancer Screening. Retrieved March 1, 2005 from ECRI HTAIS.
- Health Technology Assessment Information Service. Health Technology Trends. (May 2004). HPV DNA test and revised guidelines are gaining acceptance for cervical cancer screening. Retrieved March 1, 2005 from ECRI HTAIS.
- Health Technology Assessment Information Service. Hotline Response (April 2006). Multispectral Imaging Systems for Cervical Cancer Screening. Retrieved August 18, 2008 from ECRI Institute HTAIS.
- Chilakapati MK, Sockalingum GD, Vidyasagar MS et al. An overview on applications of optical spectroscopy in cervical cancers. J Can Res Ther 2008;4:26-36.
- Siddiqi AM, Li H, Faruque F et al. Use of hyperspectral imaging to distinguish normal, precancerous, and cancerous cells. Cancer. 2008 Feb 25; 114(1):13-21.
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New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave
Des Moines, Iowa 50309
*Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved.
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
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affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
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