mp-095 - mp-095 - Medical Policies
Policy Number: MP-095
Latest Review Date: August 2019
Category: Medicine/OB Gyn
Policy Grade: Active Policy but no longer scheduled for regular literature reviews and updates effective October 22, 2012.
Description of Procedure or Service:
Speculoscopy is intended to be an adjunctive procedure to routine pelvic examination and Pap smear in the diagnosis of cervical and vaginal abnormalities. The procedure consists of visualization of acetowhite areas using low power (4-6x) magnification. This procedure is indicated for use in those women who are currently recommended for cervical screening with pelvic examination and Pap smear. Speculoscopy is only to be used as an adjunct to the Pap smear, and only the combination of the two tests affords the clinician-improved sensitivity in identifying women with mucosal abnormalities visualized on colposcopy. The test is performed following a routine Pap smear. The procedure includes activation of the chemiluminescent device and attaching to the inside, upper portion of a speculum with an adhesive strip. The cervix is swabbed with a 3-5% acetic acid solution. After 60 seconds for the solution to take effect, the lights are dimmed. The cervix is examined with a 5x magnification optic that is hand held. The practitioner looks for the presence of distinct white areas with at least one sharply demarcated border, which may indicate potential abnormalities, while normal tissue appears dark blue, or purple. Speculoscopy should never be used without Pap smear.
Two clinical roles of speculoscopy have been proposed, both as an adjunct to conventional cervical cancer screening with Pap smears, and as a technique to select women with atypical Pap smears for further evaluation for colposcopy. Speculoscopy is thought to potentially increase the sensitivity of cervical of cervical cancer screening by enhancing the visual inspection of the cervix.
Speculoscopy is considered not medically necessary and investigational.
According to the American Cancer Society for 2019, an estimated 4,200 women in the United States will die from cervical cancer. The rate of cervical cancer deaths declined significantly from the mid-20th century, when the Papanicolaou (Pap) test was first introduced as a screening tool. Cervical cancer screening is important to detect significant abnormal cell changes that may arise before cancer develops. Early detection permits treatment at an earlier stage.
In 2007, Twu et al evaluated the efficacy of the Pap smear, speculoscopy, and the combined treatment of Pap smear and speculoscopy. A total of 1701 were analyzed using each of the techniques. Final diagnosis of each patient was based on histological evaluation of colposcopic target biopsy. The results were as follows per the authors: “Of the 1084 colposcopic biopsy specimens obtained, 24 showed low-grade squamous intraepithelial lesion (LSIL) and 19 high-grade SIL (HSIL). HSIL were considered test-positive. Rate of colposcopy was 21.5% (125/582) in the premenopausal group and 63.9% (321/502) in the postmenopausal group (p<0.001). For premenopausal women, speculoscopy (75.0%) or PapSure (91.7%) provided higher sensitivity than Pap smear (50%) (p<0.05). In postmenopausal women, no statistical significance in sensitivity existed between PapSure (85.7%) and Pap smear (57.1%). Speculoscopy (96.8%) or PapSure (96.5%) had lower specificity than Pap smear (99.6%) (p<0.001).”
In 2005, Boonlikit et al compared the sensitivity and specificity of Pap smear plus speculoscopy with Pap smear alone. According to the authors, of 257 women recruited to the study, Pap smear plus speculoscopy could increase sensitivity from 6.67% with Pap smear alone and to 33.33% when Pap smear plus speculoscopy is used. The false negative rate was reduced from 93.33% with Pap alone and to 66.67% with Pap smear plus speculoscopy. In using Pap smear alone compared with combination of two tests, the specificity decreased from 97.52% to 77.68% and false positive rate increased from 2.48% to 22.31%, respectively. Adding speculoscopy to the Pap smear is able to significantly increase the sensitivity of the cervical screening. It also reduces the 'false negative" result. However, as expected, the specificity slightly decreases, due to the false positive from speculoscopy itself. One solution is to defer colposcopy for 6 months and to perform colposcopy only if either Pap smear or speculoscopy is positive.”
Summary of Evidence
Due to the limited literature on the sensitivity/specificity of this procedure compared with current technologies (thin layer or liquid Pap), the evidence is insufficient to determine the effects of net health outcome.
Practice Guidelines and Position Statements
American Society for Colposcopy and Cervical Pathology
In 2014, the ASCCP updated their guidelines for Managing Abnormal Cervical Cancer Screening Tests and Cancer Precursors. Speculoscopy is not mentioned.
National Comprehensive Cancer Network
In 2019, NCCN issued guidelines for cervical cancer. Speculoscopy was not mentioned.
American Cancer Society
The ACS published guidelines for cervical cancer screening in 2016; speculoscopy was not discussed.
U.S. Preventive Services Task Force
Speculoscopy for cervical cancer screening is not specifically discussed.
Speculoscopy, Pap smear, Papsure, colposcopy, cervicography, cervical cancer, LUMA
Approved by Governing Bodies:
The U.S. Food and Drug Administration approved Papsure in 1997. In 2002, Watson Diagnostics, Inc. acquired the rights to PapSure and Speculite from Trylon Corporation, and they continue to market the combination device as PapSure.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply.
FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Unlisted cytopathology procedure
- American Cancer Society. Key Statistics for Cervical Cancer. Available at: https://www.cancer.org/cancer/cervical-cancer/about/key-statistics.html.
- American Cancer Society. New cervical cancer early detection guidelines released. //www.cancer.org.
- American Cancer Society. The american cancer society guidelines for the prevention and early detection of cervical cancer. Available at : https://www.cancer.org/cancer/cervical-cancer/prevention-and-early-detection/cervical-cancer-screening-guidelines.html.
- American College of Obstetricians and Gynecologists (ACOG). Cervical Cytology Screening. ACOG Practice Bulletin, Clinical Management Guidelines for Obstetrician—Gynecologists, December 2009, No. 109.
- American Society for Colposcopy and Cervical Pathology. Updated consensus guidelines for managing abnormal cervical cancer screening tests and cancer precursors. August 2014. Available at: www.asccp.org.
- Blue Cross Blue Shield Association. Speculoscopy. Medical Policy Reference Manual, September 2010.
- Lonky Stewart A. Letters to the Editors: Speculoscopy. American Journal of Obstetrics and Gynecology, March 1999, Vol. 180, No. 3.
- Medscape Women’s Health eJournal. Innovation: Speculoscopy, //www.medscape.com/viewarticle/408820_4.
- Montz Frederick J. Advances in cervical cancer screening: Focus on speculoscopy. OBG Management, October 2002, pp. 1-12.
- National Comprehensive Cancer Network. Cervical cancer. Version 4. 2019. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cervical.pdf.
- Spitzer Mark. Letters to the Editors: Reply (Stewart A. Lonky article). American Journal of Obstetrics and Gynecology, March 1999, Vol. 180, No. 3.
- Twu NF, Chen YJ, Wang PH, et al. Improved cervical cancer screening in premenopausal women by combination of Pap smear and speculoscopy. Eur J Obstet Gynecol Reprod Biol, July 2007; 133(1): 114-118.
- Wright Jr Thomas C, Denny Lynette, et al. Use of visual screening methods for cervical cancer screening. Obstetrics and Gynecology Clinics, December 2002, Vol. 29, No. 4.
- Wright Jr Thomas C, Cox J Thomas, et al. 2001 Consensus guidelines for the management of women with cervical cytological abnormalities. JAMA, April 2002, Vol. 287, No. 16.
- Wright Jr TC, Massad LS, et al. 2006 consensus guidelines for the management of women with abnormal cervical screening tests. J Low Genit Tract Disease, July 2008; 12(3): 255
Medical Policy Group, February 2003 (3)
Medical Policy Administration Committee, February 2003
Available for comment February 19-April 7, 2003
Medical Policy Group, March 2004
Medical Policy Group, March 2005 (1)
Medical Policy Group, March 2006 (1)
Medical Policy Group, March 2007 (1)
Medical Policy Group, March 2008 (1)
Medical Policy Group, March 2009 (1)
Medical Policy Group, March 2010 (1) Description and Key Points updated, reference added
Medical Policy Group, September 2011 (1) Update to Key Points, no references added
Medical Policy Group, October 2012 (1): Active Policy but no longer scheduled for regular literature reviews and updates effective October 22, 2012.
Medical Policy Group, July 2019 (4): Updates to Description, Key Points, Key Words, Coding, and References. Removed Previous Coding section and deleted CPT codes 0031T and 0032T that were deleted in 2009. Added key word LUMA.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.