Pending Policies - Medicine


Cervicography and Speculoscopy

Number:MED207.092

Effective Date:04-15-2018

Coverage:

This medical policy has become inactive as of the end date above.  There is no current active version and is not to be used for current claims adjudication or business purposes.

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Cervicography is considered experimental, investigational and/or unproven for all indications.

Speculoscopy (with or without directed sampling) is considered experimental, investigational and/or unproven as an adjunct to a program of cervical cancer screening including initial or repeat Papanicolaou (Pap) smears or DNA testing for human papillomavirus (HPV).

Description:

Cervicography

Background

Cervicography involves the use of a specialized camera that is described as easy to use and not requiring experience in colposcopy. The photographs, referred to as Cervigrams™, are static photographic images of the cervix similar to those seen during low-level magnification colposcopy. The images are sent to a central laboratory (National Testing Laboratories, the worldwide exclusive licensee of the product) for interpretation by colposcopists who have received specialized training in interpretation of Cervigrams™, interpreted as negative, atypical, positive, or defective.

Cervicography has been investigated in three general settings:

As an alternative to Papanicolaou (Pap) smear screening, as a primary screening technique for cervical cancer. This application has been investigated primarily in "resource poor" areas that do not have cytology expertise to interpret Pap smears.

As an adjunct to routine Pap smear screening to improve the sensitivity of Pap smear screening for cervical cancer. For example, it is estimated that negative cytology reports are issued on 20% or more of all invasive cervical cancers.

As a triage technique for colposcopy in patients found to have low-grade lesions on Pap smear specimens.

The management of low-grade lesions (i.e., atypical squamous cells of uncertain significance [ASCUS]), has been a subject of investigation. For example, colposcopy is an option for further workup of ASCUS lesions, and yet at colposcopy only 20% of these patients actually as a high-grade lesion. Furthermore, many low-grade lesions that may prompt colposcopy will spontaneously regress. If cervicography can be used to identify which ASCUS cytology results are most likely to harbor higher grade lesions and thus need colposcopy and biopsy, unnecessary colposcopies in patients with innocuous cytologic abnormalities would decrease. Other triaging strategies include repeat Pap smears or evaluation for human papilloma virus (HPV) infection.

Regulatory Status

In June 1982, the Cerviscope Optical System (Fotomedics) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process (approval or marketing clearance of devices). The FDA determined that this device was substantially equivalent to existing devices for viewing tissues of the vagina and cervix. Current information on this product could not be verified via web site searches on the internet and the current company contact information was not found. FDA Product Code: HEX.

In March 2006, the LUMA™ Cervical Imaging System (MediSpectra) was cleared for marketing by the FDA through the 510(k) process. It is used following a thorough colposcopic examination of the cervix as an adjunct to colposcopy. It may be considered a digital cervicogram. FDA Product Code: MWM.

Speculoscopy

Background

The procedure for conducting a speculoscopy involves several steps. First, the cervix is washed with 3-5% acetic acid. The examining room lights are then dimmed, and the cervix is visually examined using 5X magnifying loupes (small magnifying device that may be mounted on glasses). The examination takes place using a disposable blue-white chemiluminescent light that 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, in clear distinction to the dark blue of the normal epithelium. The presence of white lesions is considered a positive result; these areas may then be sampled for cytologic evaluation.

Speculoscopy must be distinguished from other methods of enhanced visual inspection of the cervix, including cervicography (described above) and colposcopy. Colposcopy involves the visual inspection of the cervix using a lighted microscope; unlike cervicography and speculoscopy, colposcopy has not been proposed as a primary screening method.

Two clinical roles of speculoscopy have been proposed, both as an adjunct to conventional cervical cancer screening and as a technique to select women with atypical cytological findings for further evaluation for colposcopy. For example, although cervical cancer screening is considered among the most successful cancer screening programs, it is still considered to be relatively insensitive (i.e., Pap smear cytology is associated with false-negative results ranging from 15% to 55%). Speculoscopy is thought to potentially increase the sensitivity of cervical cancer screening by enhancing the visual inspection of the cervix.

Management of women with atypical Pap smears has evolved over the past several years, with a focus on various strategies to select those women with high-risk lesions who would benefit from further evaluation with colposcopy. Screening for human papillomavirus (HPV) is increasingly accepted as part of initial cervical cancer screening for women aged 30 years and older. In 2012 guidelines developed jointly by the American Cancer Society (ACS), American Society for Colposcopy and Cervical Pathology (ASCCP), and American Society for Clinical Pathology (ASCP), “co-testing” of HPV and cytology every 5 years is the preferred screening strategy recommended for women aged 30-65 years; cytology alone every 3 years is included as an acceptable screening alternative. (25) Similarly, the U.S. Preventive Services Task Force (USPSTF) 2012 cervical cancer screening guideline recommends screening with a combination of cytology and HPV testing every 5 years for women for women aged 30 to 65 years who want to lengthen their screening interval. (27) Both 2012 guidelines recommend cytology only for women aged 21 to 29 years.

Regulatory Status

In 1995, speculoscopy using the Speculite® (Trylon Corp.; Monarch Beach, CA), a chemiluminescent light source, was cleared for marketing by the FDA through the 510(k) process. Later in 1995, the Pap Plus Speculoscopy (Trylon Corp.) was also cleared for marketing by the FDA and was later renamed PapSure®. It combined the Speculite® device with a vaginal speculum, which is used for obtaining a Pap smear. 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®. Current information on this product could not be verified via web site searches on the internet and the current company contact information was not found. Speculite® is intended for use only in conjunction with the Pap smear and is indicated for use in women currently recommended to undergo cervical screening with Pap smears. FDA Product Code: MPU.

Rationale:

This policy was created in 1990 and updated periodically with literature review, with the most recent search of the MedLine database through February 2018. Following is a summary of the key literature to date.

Cervicography

Cervicography has been the subject of several randomized studies that have studied its use in various settings (i.e., as a primary screening technique, an adjunct to Pap smear screening as a primary screening technique, and a triaging strategy for patients found to have low-grade lesions on Pap smear).

Cervicography as an Alternative to Pap Smear as a Primary Screening Technique

Schneider et al. reported on a study comparing cervicography with conventional Pap smear, a conventional Pap smear interpreted with the aid of PAPNET (neural network semiautomatic screening device), and a Pap smear prepared from a ThinPrep® solution and interpreted conventionally. (1) The study included 8,460 women from Costa Rica, considered a high-risk population for cervical cancer. Patients were referred for colposcopy and potential biopsy if there was an abnormal cytologic result by any 1 of these 3 methods. The sensitivities and specificities of the cytologic testing and cervicography for the most clinically important high-grade lesions compared to a referent diagnosis, which were made based on histologic, cytologic, and cervicographic results, are summarized in Table 1 below.

Table 1. Sensitivity of Cervicography and Cytology to Detect High-Grade Lesions

 

Sensitivity of Cytology, %

Sensitivity of Cervicography, %

High-grade lesions; women older than 50 years

84.6

26.9

High-grade lesions; women younger than 50 years

75.5

54.6

As noted in Table 1, the sensitivity of cervicography sharply drops among older, predominantly postmenopausal women. This observation is explained by the cephalad movement of the transformation zone in postmenopausal women. The transformation zone is the site of origin of most cervical cancers, and as it moves cephalad into the cervical canal, it is no longer well visualized with cervicography. The authors concluded that cytologic testing performed better than cervicography for the detection of high-grade intraepithelial lesions, while cervicography was only marginally better in the detection of invasive cervical cancer.

Cervicography as an Adjunct to Primary Pap Smear Screening

The combined use of Pap smear screening, cervicography, and human papilloma virus (HPV) testing has been investigated as a technique to reduce the false negative rate of Pap smear screening alone.

Autier et al. performed a randomized study comparing cytology alone versus cytology and cervicography. (2) A total of 5,550 women considered at low risk of cervical neoplasia were randomized to one of the screening strategies and rescreened 1 year later with combined cytology and cervicography. Women positive for either of the 2 initial screening tests were referred for colposcopy-biopsy. The principal study endpoint was the rate of histopathologically confirmed cervical intraepithelial neoplasia (CIN) lesions. In the cytology only group, 13 of the 2,772 (0.47%) Pap smears were read as abnormal. In contrast, in the combined group, 12 Pap smears were read as abnormal in addition to 101 Cervigrams™ that were read as abnormal. No woman was positive for both Pap smear and Cervigram™. A total of 13 patients in the cytology alone group were referred to colposcopy, compared to 113 in the combined group. Cervical intraepithelial neoplasia grade 2-3 (CIN 2-3) was identified in 4 of the patients in the cytology alone group compared to 6 in the combined group. Therefore, the majority of the patients with abnormal Cervigrams™ were either found to have no lesion or CIN 1 on subsequent colposcopy. CIN 1 lesions are generally thought to be transient in nature and require no specific treatment, but may be followed up with repeat Pap smears. While the addition of cervicography to cytology improved the detection of CIN 1 lesions, it did so at a cost of a decreased specificity. In addition, detection of CIN 2 and 3 lesions represents the most clinically significant target of screening.

Costa et al. reported on the results of 992 patients undergoing routine Pap smears who underwent simultaneous cervicography and human papilloma virus (HPV) testing. (3) All patients also underwent colposcopy as the reference tool. The combination of Pap testing with cervicography resulted in an increase in sensitivity but a decrease in specificity. The positive predictive value of combined Pap and cervicography (43%) was similar to that of Pap smear alone (45%).

Cervicography as a Triaging Strategy in Women with Atypical Squamous Cells of Undetermined Significance (ASCUS) or Low-Grade Squamous Intraepithelial Lesion (LSIL) on Pap Smears

The ASCUS/LSIL Triage Study (ALTS) was a multicenter, randomized trial that compared three different management strategies for 3,488 women with either ASCUS or LSIL on an initial Pap smear. (4) The strategies included: 1) immediate colposcopy (considered the reference standard), 2) triage to colposcopy based on the results of HPV testing, or 3) triage based on cytology results alone. The main study endpoint was detection of CIN 3, since there is a general consensus that this lesion is at high risk of progressing to invasive cancer and requires definitive treatment. All patients also underwent cervicography, as a "fail safe" mechanism in the noncolposcopy groups to prevent a missed cancer diagnosis. In Ferris et al. (2001) the cervicography results were then interpreted separately as a triaging technique for mildly abnormal cervical cytology results by comparing the results of the cervicography with the histologic results of those patients who underwent colposcopy. (5) Cervigrams™ were categorized as defective, negative, atypical, or positive. Positive Cervigrams™ were further subdivided into additional categories: positive, LSIL, high-grade intraepithelial lesion (HSIL), or cancer. If one considered an atypical Cervigram™ as an indication for referral to colposcopy, the sensitivity of cervicography to detect CIN 3 lesion (i.e., high-grade lesion requiring treatment) was 79.3% and would have required the referral of 41.8% of women for colposcopic examination. When increasing the threshold for colposcopic referral to Cervigrams™ interpreted as positive for LSIL, the sensitivity of detected CIN 3 dipped to 65.8%, requiring referral of 26.5% of women for colposcopic exam. In the ALTS trial, cytology and HPV testing were explored as triaging options. Table 2 shows the comparative results:

Table 2. Comparison of Results for Triaging Strategies for Abnormal Pap Smears

 

Cervicography, %

Cytology,

%

HPV Testing, %

Sensitivity for detecting CIN 3 lesions

79.3

86.3

96.3

Percentage referred for colposcopy

37

58

56

Positive predictive value for detecting CIN 3 lesions

8

9

10

Negative predictive value for detecting CIN 3 lesions

99

98

99

The authors concluded that cost-utility analyses will determine whether and when cervicography, compared with other clinical options, is useful in the management of mildly abnormal cervical cytology results.

In a subsequent study, Ferris et al. (2003) compared cervicography to on-site colposcopy and telecolposcopy in 264 women. (6) The authors found no statistically significant difference in rates of agreement or sensitivity and specificity for each of the screening methods when CIN 1 cases were considered. However, when evaluating CIN 2 and 3 cases, on-site colposcopy out-performed cervicography in rate of agreement and sensitivity (Table 3). Therefore, the authors indicated telecolposcopy detected more cervical neoplasia than cervicography.

Table 3. On-Site Colposcopy, Rates of Agreement and Sensitivity Compared to Cervicography

 

On-site Colposcopy

Cervicography

P value

Rates of Agreement—CIN 2-3

50.0

19.1

.04

Sensitivity—CIN 2

47.7

18.2

.049

In Cronje, 1,286 women were each screened with cytologic examination, cervicography, direct acetic acid test, and speculoscopy. (7) Results were compared to histologic examination to identify a suitable method for screening in a developing country. The authors concluded that none of the methods were individually sufficient for screening in a developing country. Cervicography results were 48.9 for sensitivity and 87.5 for specificity and were noted to be inadequate for the study purpose due to the low specificity. Finally, Howard et al. compared the diagnostic yield of cervicography and HPV testing among 304 women with ASCUS lesions detected on Pap smears. (8) The adjunctive tests were compared to the gold standard of colposcopy. The authors concluded that while both adjunctive tests increased the sensitivity of cytology, there was insufficient power to determine whether observed sensitivities were statistically significantly higher than expected, given that the adjunctive tests could improve the sensitivity by chance alone.

Studies continue to evaluate the potential role of cervicography in settings where adequate cytology services are not available. In addition, studies are evaluating the potential impact of combining cervicography with other tests as a risk-stratification or triage technique. For example, Wang et al. reported that combining results of liquid-based cytology, HPV testing, and cervicography could help determine the risk of subsequent development of cervical precancers. (9) Before this could be used in practice, replication/validation of these findings would be needed.

Two studies of interrater reliability using Cervigrams™ were published; both used convenience samples of Cervigrams™ obtained for other studies. In the first, 72 experienced (4 expert) colposcopists from 5 countries reviewed a sample of 50 Cervigrams™, representing a spectrum from normal to cancerous, for the presence of lesions and the site of suggested biopsy. (10) Their results were compared to those of the consensus (not histology). Agreement was 70% (65%–75%), which the authors concluded was sufficient for all centers to participate in a trial assessing the best management strategy for biopsy proven CIN1. The second study involved 919 Cervigrams™ from the ASCUS-LSIL Triage Study (all subjects referred to the study had either ASCUS or LSIL). (11) Each Cervigram™ was evaluated by 2 expert colposcopists for lesion severity and the number of lesions. The evaluators had complete agreement in 56.8% of cases, disagreement between high- and low-grade lesions in 37.8%, and absolute disagreement in 5.3%. HPV status and age were predictive of agreement. The authors concluded that caution is needed when using static images, even of high quality, for teaching and testing of colposcopists. Although neither study was intended to assess the screening capacity of cervicography, they illustrate challenges for the technology.

A multispectral digital colposcope, a modified colposcope with a video camera adapter and automated digital image analysis, is in development, and a report of the performance of this technology in a pilot study of 29 patients was identified. (12) Sensitivity was reported at 79% and specificity was 88%. Much larger study populations will be necessary to evaluate the test characteristics of this emerging technology.

Chen et al. conducted a study in Taiwan evaluating cervicography as an adjuvant screening tool for women with precancerous lesions identified by Pap smear. (13) A total of 125 women were enrolled, and 119 underwent cervicography. The investigators created a digital cervicography instrument using a digital camera with a macro lens and a circular-shaped continuous light source. They evaluated images in-house using the Reid colposcopic index (RCI) scoring system. Scores were dichotomized to a total RCI score of 0–2 (predictive of mild dysplasia) and a total RCI score of 3–8 (predictive of moderate or severe dysplasia). There were 112 cases of ASCUS or LSIL (by the Pap smear); 92 of these received an RCI score of 0–2 and 20 received an RCI score of 3–8. Of the 7 cases of HSIL (by the Pap smear), 1 received an RCI score of 0–2 and 6 received an RCI score of 3-8. A McNemar test to evaluate changes in classification after performing digital cervicography was statistically significant (p<0.01). The investigators used findings from digital cervicography primarily to show patients visual images with the goal of reducing their anxiety over having an abnormal Pap smear. No conclusions were made regarding the impact of digital cervicography on patient management (e.g., referral to colposcopy). It is important to note that the Chen study did not use standard cervicographic equipment or analysis methods so it is not clear whether their technique would be considered cervicography.

Ongoing and Unpublished Clinical Trials

An online search of site ClinicalTrials.gov through February 19, 2018 identified no clinical trials that would likely influence this review.

Practice Guidelines and Position Statements

American Society for Colposcopy and Cervical Pathology (ASCCP)

In 2001, the ASCCP published guidelines for the management of women with cervical abnormalities, in part based on the results of the ALTS study. These guidelines do not recommend cervicography as a triaging strategy. (14, 15)

The 2006 update of the consensus guidelines for the management of cervical abnormalities by the ASCCP do not mention cervicography or Cervigrams™. (16)

U.S. Preventive Services Task Force (USPSTF)

The USPSTF specifically does not recommend cervicography as part of a cervical cancer screening program. (17) The Task Force states that the sensitivity of cervicography is similar to that of Pap smears, but that both the specificity and positive predictive value are considerably lower than Pap smears. The positive predictive value is only about 1%–26%, and up to 10%–15% of Cervigrams™ are unsatisfactory in quality. The Task Force concludes that “There is insufficient evidence to recommend for or against routine screening with cervicography.” This recommendation was issued in 1996.

The USPSTF has not updated their guidelines for cervical cancer screening since 2003.

Summary of Evidence - Cervicography

Cervicography alone has an inferior sensitivity compared to cytology, and therefore is not recommended in settings where adequate cytology services are available. As an adjunct to Pap smear screening, cervicography may increase the sensitivity for detecting cervical abnormalities, but will decrease the specificity, potentially resulting in increased referrals for colposcopy. As a triaging strategy for patients with mildly abnormal cytology results, cervicography is a promising technique that appears to be similar in terms of positive and negative predictive values compared to other options, including repeat cytology or human papilloma virus (HPV) testing. However, if the original Pap smear was collected in a liquid medium, subsequent HPV testing in patients whose cytology was mildly abnormal could be done on the same sample. Therefore, these patients do not need to return for a repeat office visit. Both repeat Pap smear and cervicography would require an additional office visit. At present, no clinical guidelines are available from ACOG, USPSTF, or related organizations that recommend the use of cervicography in any of the above clinical situations.

There remains insufficient evidence on the reliability and diagnostic accuracy of cervicography, and insufficient evidence that cervicography has a benefit on net health outcome. Moreover, cervicography may no longer be commercially available. The continued existence of Fotomedics, the manufacturer of the U.S. Food and Drug Administration (FDA)-cleared Cerviscope Optical System and the National Testing Laboratories, previously mentioned as the worldwide exclusive licensee for analyzing Cervigrams™, could not be verified (e.g., no web sites or current contact information were identified). Therefore, the use of cervicography is considered experimental, investigational and/or unproven.

Speculoscopy

Speculoscopy as an adjunct to routine cervical cancer screening

To determine the clinical performance of speculoscopy compared to conventional Pap smear screening alone, speculoscopy must be evaluated in prospective studies of patients undergoing routine screening. Moreover, ideally, all patients would be referred to colposcopy, which is currently considered the gold standard. However, this type of testing is not feasible on a large scale, and thus it is likely that only patients with positive results on Pap smears or speculoscopy would then be referred to colposcopy. A search of the literature identified 4 prospective trials published in screening populations.

Edwards et al. conducted a multicenter trial in a health maintenance organization (HMO) setting in which 689 patients undergoing routine Pap smear screening immediately underwent a speculoscopy at the same office visit. The exam was performed by nurse practitioners and midwives. (19) Those with positive findings on either Pap smear screening (presence of atypical squamous cells of ASCUS or intraepithelial lesions) or speculoscopy (presence of aceto-whitening) subsequently underwent colposcopy. A total of 9.9% of patients (n=68) had normal results on Pap smear screening but a positive finding on speculoscopy. This group of patients represents the potential incremental yield of adding speculoscopy to routine screening. The results of the colposcopy in this group showed high-grade lesions in 3 patients, low-grade lesions in 28 patients, and normal findings in 37 patients. The clinical significance of low-grade lesions is uncertain; it is thought that the majority may be related to benign HPV infections or are otherwise self-limited. Therefore, a clearly clinically significant finding of a high-grade lesion was identified by speculoscopy alone in 3 of 689 patients (0.4%). The clinical significance of this increase is unclear, particularly in the context of an increase in the false-positive rate for referral to colposcopy (from 2.6% to 5.4%).

Wertlake et al. reported on the results of a larger trial of 5,692 women who received speculoscopy in addition to routine pelvic exam and cervical cancer screening. (20) Pap smears showing intraepithelial lesions were considered positive, and speculoscopy was considered positive if aceto-whitening was present. Note that unlike the Edwards et al. study, (19) this study did not consider ASCUS cells to constitute a positive Pap smear. A total of 839 patients with positive results on either test were referred for colposcopy. Of these, 648 patients (77%) were referred solely on the basis of speculoscopy results. Of the 839 referred for colposcopy, only 410 (51.3%) underwent the recommended colposcopy; of these 410 patients, 333 were identified only by speculoscopy. Among these 333 patients, 11 high-grade lesions were identified, while 154 had low-grade lesions, and 168 had findings that were interpreted as normal or reparative. Interpretation of these results is limited by the large number of dropouts in the study, but the results are similar to the above study; a marginal increase in the identification of high-grade lesions coupled with an increase in the false-positive rate for referral to colposcopy. Another similarly designed, prospective community-based study conducted in Italy reported similar results. (21) In this study of 3,300 women, an additional 407 women were referred to colposcopy on the basis of a positive speculoscopy alone. Of these, 6 high-grade lesions were found, 269 had normal colposcopy results, and 132 low-grade lesions were found. Consistent among all these studies is the increased detection of low-grade lesions by speculoscopy alone. As noted by Wertlake et al., "…the use of any of these visual aids [speculoscopy, cervicography, colposcopy] will require sound clinical algorithms for managing those patients with visual abnormalities only (Papanicolaou smear negative). Such algorithms are likely to be multifactorial, balancing the increase in disease detection with the potential for false-positive results.…" (20)

A multicenter study from Asia, published in 2007, evaluated the combined use of speculoscopy and Pap smear (PapSure®) for cervical cancer screening. (22) The study enrolled 1,813 premenopausal and postmenopausal women who had not received a Pap smear in the previous 3 years; 112 did not meet the study criteria or were lost to follow-up, leaving results of 873 premenopausal and 828 postmenopausal (94%) women for analysis. Colposcopy was conducted in 870 randomly selected women with negative screenings and 214 women who had positive screening test results. Nineteen women were diagnosed with high-grade squamous intraepithelial lesions (HGSIL) on biopsy, resulting in a rate of 1.1% for the population of 1,701 women. Sensitivity of Pap smear alone was 53%, speculoscopy alone was 63%, and the combined sensitivity was 90%, identifying 17 of 19 cases of HGSIL. Combined testing decreased specificity from nearly 100% with Pap smear alone to 90%. The positive predictive value of combined testing was 8.8%, and the negative predictive value was 99.9%. Speculoscopy identified 7 additional positive cases of HGSIL of a total of 19 (equating to 0.4% out of the 1,701 women included in the study and 37% of the population with cervical cancer). When evaluated by menopausal status, results were significant for premenopausal women but not for postmenopausal women; however, this result is limited by the low number of positive cases (n=7) in the postmenopausal group. These results are consistent with earlier studies reviewed above, with a 0.4% increase in detection rate and a larger increase in the number of women being referred for colposcopy.

Speculoscopy as a technique to triage for colposcopy

Evaluation of this role of speculoscopy would require a prospective, controlled trial comparing the diagnostic performance of speculoscopy to current best practice which involves cytology and HPV testing. The results of 2 multicenter trials on speculoscopy have been published, both prior to the now-accepted strategy of using HPV testing, as a triage strategy for colposcopy. The 2 studies are reviewed below:

Massad et al. reported on a multicenter study of 137 with atypical Pap smears who underwent colposcopy. (23) The exact nature of the atypia was not provided. Patients underwent Pap smear, followed by speculoscopy, and then colposcopy. Any acetowhite areas noted on the speculoscopy exam were considered positive. Of the 94 women who had positive colposcopy results, 73% and 27% had positive and negative speculoscopies, respectively. Using colposcopy as the gold standard, the sensitivity, specificity, and positive and negative predictive values for speculoscopy were 73%, 93%, 96%, and 62%, respectively. It is unclear how, based on this diagnostic performance, speculoscopy would be integrated into a program of cervical cancer screening. It is likely that a negative predictive value of 62% would be considered adequate to consider foregoing a colposcopy, and it is unclear how the positive predictive value of 96% would affect the decision to undergo colposcopy. The results are not compared with the alternative options of repeat cytology or HPV testing.

In a second study from the same group of investigators, 395 patients referred for colposcopy underwent a repeat cervical smear immediately followed by a colposcopy, performed by the same physician. (24) Histologic diagnoses were compared with cytology, speculoscopy, and colposcopy results. An antecedent acetowhite abnormality detected during speculoscopy was highly predictive (97% positive predictive value) of a subsequent abnormal colposcopy. This study has the same limitations as the earlier study by this research team.

Ongoing and Unpublished Clinical Trials

An online search of site ClinicalTrials.gov through February 19, 2018 identified no clinical trials that would likely influence this review.

Practice Guidelines and Position Statements

American Cancer Society (ACS), American Society for Colposcopy and Cervical Pathology (ASCCP), and American Society for Clinical Pathology (ASCP)

Speculoscopy is not mentioned in the ACS, ASCCP, and ASCP 2012 joint screening guideline for the prevention and early detection of cervical cancer. (25)

American College of Obstetrics and Gynecology (ACOG)

In 2009, ACOG issued a practice bulletin on cervical cancer screening. Speculoscopy was not included in the bulletin. (26)

U.S. Preventive Services Task Force (USPSTF)

Speculoscopy is not specifically discussed in the USPSTF 2012 cervical cancer screening recommendations. (27)

Summary of Evidence - Speculoscopy

There is insufficient evidence on the diagnostic accuracy of speculoscopy added to Pap smears compared to Pap smears alone. In addition, there is insufficient evidence on the diagnostic accuracy of speculoscopy for triaging women with a positive Pap smear to additional follow-up such as repeat cytology or human papilloma virus (HPV) testing. Thus, speculoscopy is considered experimental, investigational and/or unproven.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

58999

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Schneider DL, Herrero R, Bratti C, et al. Cervicography screening for cervical cancer among 8460 women in a high-risk population. Am J Obstet Gynecol. Feb 1999; 180(2 pt 1):290-8. PMID 9988789

2. Autier P, Coibion M, De Sutter P, et al. Cytology alone versus cytology and cervicography for cervical cancer screening: a randomized study. Obstet Gynecol. Mar 1999; 93(3):353-8. PMID 10074978

3. Costa S, Sideri M, Syrjanen K, et al. Combined Pap smear, cervicography and HPV DNA testing in the detection of cervical intraepithelial neoplasia and cancer. Acta Cytol. May-Jun 2000; 44(3):310-8. PMID 10833984

4. Solomon 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. J Natl Cancer Inst. Feb 21 2001; 93(4):293-9. PMID 11181776

5. Ferris DG, Schiffman M, Litaker MS. Cervicography for triage of women with mildly abnormal cervical cytology results. Am J Obstet Gynecol. Oct 2001; 185(4):939-43. PMID 11641682

6. Ferris DG, Litaker MS, Macfee MS, et al. Remote diagnosis of cervical neoplasia: 2 types of telecolposcopy compared with cervicography. J Fam Pract. Apr 2003; 52(4):298-304. PMID 12681091

7. Cronje HS, Parham GP, Cooreman BF, et al. A comparison of four screening methods for cervical neoplasia in a developing country. Am J Obstet Gynecol. Feb 2003; 188(2):395-400. PMID 12592246

8. Howard M, Sellors JW, Lytwyn A, et al. Combining human papillomavirus testing or cervicography with cytology to detect cervical neoplasia. Arch Pathol Lab Med. Nov 2004; 28:1257-62. PMID 15504060

9. Wang SS, Walker JL, Schiffman M, et al. Evaluating the risk of cervical precancer with a combination of cytologic, virologic, and visual methods. Cancer Epidemiol Biomarkers Prev. Nov 2005; 14(11 pt 1):2665-8. PMID 16284394

10. Elit L, Julian JA, Sellors JW, et al. Colposcopists' agreement on cervical biopsy site. Clin Exp Obstet Gynecol. 2007; 34(2):88-90. PMID 17629159

11. Jeronimo J, Massad LS, Schiffman M. Visual appearance of the uterine cervix: correlation with human papillomavirus detection and type. Am J Obstet Gynecol. Jul 2007; 197(1):47.e1-8. PMID 17618753

12. Young Park S, Follen M, Milbourne A, et al. Automated image analysis of digital colposcopy for the detection of cervical neoplasia. J Biomed Opt. Jan-Feb 2008; 13(1):014029. PMID 18315387

13. Chen ZP, Chen HM, Lee TT. Use of compact digital cervicography: an adjuvant screening tool for precancerous cervical lesions. Taiwan J Obstet Gynecol. Jun 2008; 47(2):187-91. PMID 18603504

14. Wright TC, Cox JT, Massad LS, et al. 2001 Consensus Guidelines for the management of women with cervical cytologic abnormalities. JAMA. Apr 24 2002; 287(16):2120-9. PMID 11966387

15. Wright TC, Cox JT, Massad LS, et al. 2001 Consensus Guidelines for the management of women with cervical intraepithelial neoplasia. Am J Obstet Gynecol. Jul 2003; 189(1):295-304. PMID 12861176

16. Wright TC, Massad LS, Dunton CJ, et al. 2006 consensus guidelines for the management of women with abnormal cervical cancer screening tests. Am J Obstet Gynecol. Oct 2007; 197(4):346-55. PMID 17904957

17. U.S. Preventive Services Task Force. Guide to Clinical Preventive Services. Baltimore: Williams and Wilkins, 1996, pp. 105-117. Available at: <http://www.uspreventiveservicestaskforce.org> (accessed July 2012).

18. Cervicography-Archived. Chicago, Illinois: Blue Cross Blue Shield Association Medical policy Reference Manual (February 2010) Medicine 2.04.04.

19. Edwards G, Rutkowski C, Palmer C. Cervical cancer screening with Papanicolaou smear plus speculoscopy by nurse practitioners in a health maintenance organization. J Lower Genital Tract Dis. Jul 1997; 1:141-47. PMID 25951019

20. Wertlake PT, Francus K, Newkirk GR, et al. Effectiveness of the Papanicolaou smear and speculoscopy as compared with the Papanicolaou smear alone: a community-based clinical trial. Obstet Gynecol. 1997; 90(3):421-7. PMID 9277656

21. Loiudice L, Abbiati R, Boselli F, et al. Improvement of Pap smear sensitivity using a visual adjunctive procedure: a co-operative Italian study on speculoscopy (GISPE). Eur J Cancer Prev. Aug 1998; 7(4):295-304. PMID 9806118

22. 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. Jul 2007; 133(1):114-8. PMID 16797826

23. Massad LS, Lonky NM, Mutch DG, et al. Use of speculoscopy in the evaluation of women with atypical Papanicolaou smears. Improved cost effectiveness by selective colposcopy. J Reprod Med. Mar 1993; 38(3):163-9. PMID 8387595

24. Lonky NM, Mann WJ, Massad LS, et al. Ability of visual tests to predict underlying cervical neoplasia. Colposcopy and speculoscopy. J Reprod Med. 1995; 40(7):530-6. PMID 7473444

25. Saslow D, Solomon D, Lawson HW, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. May-Jun 2012; 62(3):147-72. PMID 22422631

26. American College of Obstetrics and Gynecology. Practice Bulletin No. 109. Cervical Cytology Screening. 2009. Available at:<http://www.acog.org> (accessed July 2012).

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28. Speculoscopy-Archived. Chicago, Illinois: Blue Cross Blue Shield Association Medical policy Reference Manual (September 2012) Medicine 4.01.15.

Policy History:

Date Reason
9/14/2019 Document became inactive.
4/15/2018 Document updated with literature review. The following “for all indications” was added to the experimental, investigational and/or unproven cervicography coverage statement. No new references added.
4/1/2017 Reviewed. No changes.
4/15/2016 Document updated with literature review. Coverage unchanged.
11/1/2015 Reviewed. No changes.
7/1/2014 Document updated with literature review. Coverage unchanged.
12/15/2013 Document updated with literature review. The following was removed from Coverage section: Cervical pap smears and colposcopy are no longer addressed in a medical policy. Coverage of cervicography and speculoscopy remain experimental, investigational and unproven. Title was changed from Cancer Screening of the Cervix. Rationale completely revised.
1/1/2009 CPT/HCPCS code(s) updated.
4/1/2008 Policy reviewed without literature review; new review date only.
6/15/2006 Revised/updated entire document.
3/30/2004 Coverage revised.
6/25/2003 Title revised.
4/1/1999 Revised/updated entire document.
8/1/1998 Revised/updated entire document.
3/1/1997 Deleted.
6/1/1996 Revised/updated entire document.
5/1/1990 New medical document.

Archived Document(s):

Title:Effective Date:End Date:
Cervicography and Speculoscopy04-01-201704-14-2018
Cervicography and Speculoscopy04-15-201603-31-2017
Cervicography and Speculoscopy11-01-201504-14-2016
Cervicography and Speculoscopy07-01-201410-31-2015
Cervicography and Speculoscopy12-15-201306-30-2014
Cancer Screening of the Cervix04-01-200812-14-2013
Cancer Screening of the Cervix06-15-200603-31-2008
Cancer Screening of the Cervix03-30-200406-14-2006
Cervical Pap Smear04-01-199903-29-2004
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