HCT Medical Policy High-Resolution Anoscopy for Evaluation of Anal Lesions Policy # HCT109 Current Effective Date: 10/30/2014 Medical Policies are developed by HealthyCT to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Medical Policy contains only a partial, general description of plan or program benefits and does not constitute a contract. HealthyCT does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of HealthyCT or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Medical Policy may be updated and therefore is subject to change. Policy Statement High-Resolution Anoscopy (HRA) for the evaluation of anal lesions with or without biopsy is considered experimental, investigational and unproven as a screening test for anal dysplasia and cancer of the anus. There is insufficient evidence in the peer reviewed medical literature to conclude that HRA is effective as a screening test for anal dysplasia and cancer of the anus. Overview High resolution anoscopy also known as colposcopy of the anal canal, involves careful examination of the anal canal using an anoscope and a high-resolution colposcope. This procedure is used to examine the anus to identify abnormal anal cytology in high-risk populations and as an adjunct tool in anal cytology screening. During the procedure, an anoscope is inserted approximately two inches into the anal canal. Next a standard gynecologic colposcope is utilized to magnify the area in order to detect any suspicious lesions. A topical 3% acetic solution is applied to identify any dysplastic changes in the mucosa or suspicious lesions. Lugol s solution may also be topically applied to identify normal mucosa. If suspicious lesions are found, biopsies are taken and sent for microscopic cytology examination. The procedure is performed on an outpatient basis and takes about 20-30 minutes. Scientific Rationale The peer reviewed medical evidence from a number of controlled, comparison, retrospective, cohort and case studies have demonstrated that there is insufficient evidence in the peer reviewed medical Page 1 of 5
literature to conclude that HRA is effective as a screening test for anal dysplasia and cancer of the anus. 1-15 At the current time there are no randomized controlled trials comparing HRA to alternative screening methods. The largest single center cross-sectional study analyzed the prevalence of anal intraepithelial neoplasia defined by anal cytology screening and high-resolution anoscopy in a primary care population of 779 HIV-infected men and women. The main outcome measures were anal cytology and high-resolution anoscopy results. The prevalence of abnormal cytology was 43%: 62% in men who reported receptive anal intercourse, 39% in women who reported receptive anal intercourse, and 25% in all others (P trend <.0001). High-grade anal intraepithelial neoplasia prevalence was 27%: 44% in men who reported receptive anal intercourse, 26% in women who reported receptive anal intercourse, and 10% in all others (P trend <.0001). Two patients had squamous-cell cancer. Independent predictors of dysplasia were CD4 at screening, receptive anal intercourse, sexual orientation, and history of human papillomavirus disease. Anal cytology and histology findings were not well correlated. This study was limited because only patients with abnormal cytology had high resolution anoscopy. 2 Two smaller comparison studies evaluated the pathological diagnoses obtained by anal Papanicolaou (Pap) smear with those obtained by anal biopsy or by surgical excision or compared anorectal cytology specimens using two methods of pap smear. The first study evaluated specimens taken from 153 men who have sex with men (MSM). Analysis of these paired specimens showed that anal Pap smears were an inaccurate predictor of high-grade anal dysplasia. 3 The second study blindly evaluated 78 anorectal cytology specimens from 51 patients. Thirty-two patients had anoscopic evaluation and 30 patients had histologic correlation. Twenty-seven patients with abnormal anoscopic findings had confirmed abnormal histologic findings. Twenty-five of the 32 (78%) patients had abnormal cytology that correlated with abnormal anoscopic findings. This study found that anoscopy is important in confirming the presence of a lesion, but only a biopsy can accurately determine the grade of a lesion. 4 A cohort study evaluated diagnostic validation and precision measures of high-resolution anoscopy in comparison to histopathological results of anal biopsies performed in 128 HIV-positive patients. The prevalences of anal HPV infection and of anal squamous intraepithelial lesions in the studied population were, respectively, 79% and 39.1%. High-resolution anoscopy showed specificity of 90%, specificity of 19.23%, positive predictive value of 41.67%, negative predictive value of 75%, and a kappa coefficient of 0.076. This study concluded that high-resolution anoscopy demonstrated to be a sensitive, but not specific test for the detection of anal squamous intraepithelial lesions. 1 Another cohort study sought to estimate the prevalence of anal intraepithelial neoplasia in heterosexual women with genital intraepithelial neoplasia, and to compare anal cytology with colposcopy for their effectiveness in anal intraepithelial neoplasia screening. 205 women with confirmed intraepithelial neoplasia on the cervix, vagina, or vulva underwent anal cytology and anoscopy. Anoscopy identified 32% (25 patients) with anal Page 2 of 5
intraepithelial neoplasia out of 78 abnormal anoscopic examinations. In diagnosing anal intraepithelial neoplasia, anoscopy has 100% sensitivity and 71% specificity; anal cytology has 8% sensitivity and 94% specificity. In anal intraepithelial neoplasia screening, anoscopy is more sensitive but less specific than anal cytology. 5 Professional Guidelines: The HIV Medicine Association of the Infectious Diseases Society of America practice guideline (2009) recommends that anal cytologic screening (i.e.: anal Pap smears) in HIV-infected women and MSM is not considered to be the standard of care at this time but is being performed in some health care centers. Additional studies of screening and treatment protocols for anal dysplasia are in progress to clarify this issue. Abnormal anal Pap smear findings should be further evaluated by high-resolution anoscopy with biopsy of abnormal areas and topical therapy of high-grade dysplastic lesions. 16 The Standards Committee of the American Society of Colon and Rectal Surgeons practice guideline (2012) for anal squamous neoplasm indicate that screening procedures for LGAIN/HGAIN may include anal cytology, colposcopy, biopsy, and high-resolution anoscopy (HRA). However, some economic modeling studies have suggested that frequent anal cytology may be a cost-effective method to prevent anal cancer but there have not been any randomized or cohort studies to demonstrate improved survival or outcomes. The sensitivity of anal Pap smear evaluation compared with HRA-directed biopsies ranges from 69% to 93% and specificity ranges from 32% to 59%. 17 Related Codes 46601: Anoscopy; diagnostic, with high-resolution magnification (HRA) (eg, colposcope, operating microscope) and chemical agent enhancement, including collection of specimen(s) by brushing or washing, when performed. 46607: Anoscopy; with high-resolution magnification (HRA) (eg, colposcope, operating microscope) and chemical agent enhancement, with biopsy, single or multiple References 1. Gimenez F, Costa-e-Silva IT, Daumas A et al. The value of high-resolution anoscopy in the diagnosis of anal cancer precursor lesions in HIV-positive patients. Arq Gastroenterol. 2011 Apr- Jun;48(2):136-45. 2. Weis S.E., Vecino I., Pogoda J.M., Susa J.S. et al. Prevalence of anal intraepithelial neoplasia defined by anal cytology screening and high-resolution anoscopy in a primary care population of HIV-infected men and women. Diseases of the Colon and Rectum. 54 (4) (pp 433-441), 2011. 3. Panther L.A., Wagner K., Proper J. et al. High resolution anoscopy findings for men who have sex with men: Inaccuracy of anal cytology as a predictor of histologic high-grade anal intraepithelial Page 3 of 5
neoplasia and the impact of HIV serostatus. Clinical Infectious Diseases. 38 (10) (pp 1490-1492), 2004. 4. Friedlander M.A., Stier E., Lin O. Anorectal Cytology as a Screening Tool for Anal Squamous Lesions: Cytologic, Anoscopic, and Histologic Correlation. Cancer. 102 (1) (pp 19-26), 2004. 5. Santoso J.T., Long M., Crigger M. et al. Anal intraepithelial neoplasia in women with genital intraepithelial neoplasia. Obstetrics and Gynecology. 116 (3) (pp 578-582), 2010. 6. Dalla Pria A., Alfa-Wali M., Fox P et al. High-resolution anoscopy screening of HIV-positive MSM: Longitudinal results from a pilot study. AIDS. 28 (6) (pp 861-867), 2014. 7. Nathan M., Singh N., Garrett N. et al. Performance of anal cytology in a clinical setting when measured against histology and high-resolution anoscopy findings. AIDS. 24 (3) (pp 373-379), 2010. 8. Mathews W.C., Sitapati A., Caperna J.C. et al. Measurement characteristics of anal cytology, histopathology, and high-resolution anoscopic visual impression in an anal dysplasia screening program. Journal of Acquired Immune Deficiency Syndromes. 37 (5) (pp 1610-1615), 2004. 9. Berry J.M., Palefsky J.M., Jay N. et al. Performance characteristics of anal cytology and human papillomavirus testing in patients with high-resolution anoscopy-guided biopsy of high-grade anal intraepithelial neoplasia. Diseases of the Colon and Rectum. 52 (2) (pp 239-247), 2009. 10. Fox P.A., Seet J.E., Stebbing J. et al. The value of anal cytology and human papillomavirus typing in the detection of anal intraepithelial neoplasia: A review of cases from an anoscopy clinic. Sexually Transmitted Infections. 81 (2) (pp 142-146), 2005. 11. Richel O., Hallensleben N.D.L., Kreuter A et al. High-resolution anoscopy: Clinical features of anal intraepithelial neoplasia in HIV-positive men. Diseases of the Colon and Rectum. 56 (11) (pp 1237-1242), 2013. 12. De Andrade Heraclio S., De Souza A.S.R., Pinto F.R.G. et al. Agreement between methods for diagnosing HPV-induced anal lesions in women with cervical neoplasia. Acta Cytologica. 55 (2) (pp 218-224), 2011. 13. Swedish K.A., Lee E.Q., Goldstone S.E. The changing picture of high-grade anal intraepithelial neoplasia in men who have sex with men: The effects of 10 years of experience performing highresolution anoscopy. Diseases of the Colon and Rectum. 54 (8) (pp 1003-1007), 2011. 14. Mavrogianni P., Alexandrakis G. et al. The role of cytology and HPV typing as a screening tool in patients with intraanal warts. Journal of Clinical Gastroenterology. 45 (4) (pp e39-e43), 2011. 15. Nathan M., Singh N., Garrett N. et al. Performance of anal cytology in a clinical setting when measured against histology and high-resolution anoscopy findings. AIDS. 24 (3) (pp 373-379), 2010. 16. Aberg JA, et al. Primary care guidelines for the management of persons infected with human immunodeficiency virus: 2009 update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis 2009 Sep 1;49(5):651-81. Accessed at: http://cid.oxfordjournals.org/content/49/5/651.long Page 4 of 5
17. Fleshner PR, et al. The Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for anal squamous neoplasms. 2012. Accessed at: http://www.fascrs.org/gedownload!/practice_parameters_for_anal_squamous_neoplasms.2[1].pdf?item_id=15635003 Document History Date Action 10/30/2014 Original Version 07/22/2015 Added codes 46601 & 46607 Page 5 of 5