Latest Review Date: November 2024

Category: OB/Gyn                                     

POLICY:

Speculoscopy is considered investigational in all situations.

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 and is performed following a routine Pap smear. 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.

KEY POINTS:

A literature search was conducted through November 4, 2024.

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

There are no society guidelines that discuss speculoscopy.

U.S. Preventive Services Task Force

Speculoscopy for cervical cancer screening is not specifically discussed.

KEY WORDS:

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.

BENEFIT APPLICATION:

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.  

CURRENT CODING: 

CPT codes:               

REFERENCES:

1. American Cancer Society. Key Statistics for Cervical Cancer.  Available at: https://www.cancer.org/cancer/cervical-cancer/about/key-statistics.html.
2. American Cancer Society.  New cervical cancer early detection guidelines released.  //www.cancer.org.
3. 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.
4. American College of Obstetricians and Gynecologists (ACOG).  Cervical Cytology Screening.  ACOG Practice Bulletin, Clinical Management Guidelines for Obstetrician—Gynecologists, December 2009, No. 109.
5. 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.
6. Blue Cross Blue Shield Association.  Speculoscopy.  Medical Policy Reference Manual, September 2010.
7. Fontham ET, Wolf AM, Church TR, et al. Cervical cancer screening for individuals at average risk: 2020 guideline update from the American Cancer Society. A cancer journal for clinicians, July 2020, Vol 70, no. 5.
8. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
9. Lonky Stewart A.  Letters to the Editors:  Speculoscopy.  American Journal of Obstetrics and Gynecology, March 1999, Vol. 180, No. 3.
10. Medscape Women’s Health eJournal.  Innovation:  Speculoscopy, //www.medscape.com/viewarticle/408820_4.
11. Montz Frederick J.  Advances in cervical cancer screening:  Focus on speculoscopy.  OBG Management, October 2002, pp. 1-12.
12. National Comprehensive Cancer Network. Cervical cancer. Version 1. 2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cervical.pdf.
13. Spitzer Mark.  Letters to the Editors:  Reply (Stewart A. Lonky article).  American Journal of Obstetrics and Gynecology, March 1999, Vol. 180, No. 3.
14. 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.
15. 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.
16. 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.
17. 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

POLICY HISTORY:

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.

Medical Policy Group, November 2020 (4): Updates to Key Points and References. No change to policy statement.

Medical Policy Group, January 2022 (4): Policy statement updated to remove “not medically necessary”, no change to policy intent. Reviewed by consensus. References added. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, December 2022 (4): Reviewed by consensus.  No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, November 2023 (4): Reviewed by consensus.  Updates to Description, Key Points, Approved by Governing Bodies, and Benefit Application.  No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, November 2024 (4): Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

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.