Latest Review Date: May 2024

Category: Surgery                                         

POLICY:

High resolution anoscopy for the diagnosis of suspicious anal lesions may be considered medically necessary when there are abnormal anal findings on physical exam or an abnormal anal pap smear.

High resolution anoscopy when used as a screening test for anal dysplasia or anal cancer is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Anoscopy is a procedure which examines the last two inches of the colon, including the perianal area and the distal rectum. High resolution anoscopy (HRA) is more complex than the standard anoscopy because it involves using an anoscope plus a high resolution colposcope. HRA is also known as colposcopy of the anal canal. During the procedure, acetic acid is applied to the anal canal to identify any suspicious areas. If a suspicious area is found, a biopsy may be taken.

A potentially precancerous condition called anal intraepithelial neoplasia (AIN), also known as anal squamous intraepithelial lesion (SIL), can be categorized into two groups; low grade SIL (LSIL) or high grade SIL (HSIL). LSIL often resolves spontaneously; however, HSIL is unlikely to resolve on its own without treatment. Although HSIL left untreated could eventually become cancerous, most HSIL will probably not. Squamous cell carcinoma (SCC) is the most common type of anal cancer, and appears to be linked to infection by the human papilloma virus (HPV). HPV is associated with a number of benign and malignant lesions in the anogenital tract and is recognized as a cause of cervical dysplasia and cancer.  Most cases of anal cancer are linked to the HPV virus.

HRA has been investigated for use in high-risk populations (e.g. receptive anal sex, immunocompromised individuals, HPV infection) for identifying abnormal anal cytology as an adjunct in anal cytology screening. Individuals who have HIV are 19 times more likely to be diagnosed with anal cancer. Based on similarities between anal intraepithelial neoplasia (AIN) and cervical intraepithelial neoplasia (CIN), anal Papanicolaou (Pap) smear cytology has been proposed for both screening high-risk individuals and surveillance after treatment of AIN.  There have not been randomized or cohort studies to demonstrate improved survival or clinical outcome with anal cytology screening.

KEY POINTS:

A literature review was conducted through May 10, 2024.

Summary of Evidence

Although anal cancer is fairly rare, the incidence of new cases has been rising for several years. Certain risk factors, such as having anal HPV and HIV, seem to increase the risk of developing this disease. However, many people with these risk factors will never develop cancer.

High resolution anoscopy has been investigated for the screening, diagnosing, and/or managing anal dysplasia and anal cancer. HRA provides a more detailed view of the anal canal and allows the opportunity to treat anal dysplasia. Areas in the tissue that appear suspicious for HSIL or cancer can be biopsied or destroyed all in the same procedure. Screening for AIN is controversial. There is a lack of evidence regarding HRA and screening asymptomatic individuals for anal dysplasia. For patients whose anal cytology results in dysplasia, a referral for HRA is suggested for diagnosis and management.

Practice Guidelines and Position Statements

National Comprehensive Cancer Network (NCCN)

The NCCN guidelines for Anal Carcinoma (V1.2024), includes high resolution anoscopy as a diagnostic tool in the work-up of individuals who present with anal margin lesions and anal canal cancer. With regard to the benefits and limitations of high resolution anoscopy, the NCCN states the following:

“High-grade anal intraepithelial neoplasia (AIN) can be a precursor to anal cancer, and treatment of high-grade AIN may prevent the developmental of anal cancer. AIN can be identified by cytology, HPV testing, digital rectal examination (DRE), high-resolution anoscopy, and/or biopsy. The spontaneous regression rate of high-grade AIN is not known, and estimates suggest that the progression of AIN to cancer in men who have sex with men might be quite low. However, a prospective cohort study of 550 HIV-positive men who have sex with men found the rate of conversion of high-grade AIN to anal cancer to be 18% (7/38) at a median follow-up of 2.3 years, despite treatment. In this study, screening led to the identification of high-grade AIN and/or anal cancer in 8% of the cohort.

Routine screening for AIN in high-risk individuals such as HIV-positive patients or men who have sex with men, is controversial because randomized controlled trials showing that such screening programs are efficacious at reducing anal cancer incidence and mortality are lacking whereas the potential benefits are quite large. Most guidelines do not recommend anal cancer screening even in high risk individuals at this time or state that there may be some benefit with anal cytology. Few guidelines recommend screening for anal cancer with DRE in HIV positive individuals.”

American Society of Colon and Rectal Surgeons

In 2018, the American Society of Colon and Rectal Surgeons revised its recommendations for anal squamous cell cancers.  They recommend the following:

• Screening with anal cytology (or anal Pap tests) may be considered in high risk populations as part of a comprehensive screening program, but the sensitivity and specificity of the test do not support its use for universal screening. (weak recommendations, moderate quality evidence)
• HPV testing may be used as an adjunct to screening for anal cancer. (weak recommendation, moderate quality evidence).
• HRA may be considered as a screening option for patients at high risk for cancer when performed by clinicians with appropriate training in the procedure. (weak recommendation, moderate quality evidence).
• Ablative treatments with conventional anoscopy or HRA are appropriate therapies for HSILs. (weak recommendation , moderate quality evidence).
• Patients who have been treated for anal dysplasia may be observed without regular cytology, HPV testing , or HRA; however, treatment of visible or palpable disease should be offered (weak recommendation , moderate quality evidence).

U.S. Preventive Services Task Force Recommendation

The U.S. Preventative Services Task Force Recommendation has not addressed anal cancer, anal dysplasia, or the treatment of high resolution anoscopy.

KEY WORDS:

Anal cancer, high grade, anal intraepithelial neoplasia, AIN, anal squamous intraepithelial lesion, SIL, high grade SIL, HSIL, HRA, anoscopy, ASCC

APPROVED BY GOVERNING BODIES:

Not applicable.

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. What is anal cancer? www.cancer.org/cancer/analcancer/detailedguide/anal-cancer-what-is-anal-cancer.
2. American Society of Colon and Rectal Surgeons. Clinical Practice Guidelines for Anal Squamous Cell Cancers. 2018. www.fascrs.org/sites/default/files/downloads/publication/cpg_anal_squamous_cell_cancers_2018.pdf. 
3. Benson AB, Venook AP, Al-Hawary MM, et al. Anal Carcinoma, Version 1.2024, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2024 Jun;21(6):653-677.
4. Berry JM, Jay N, Cranston RD et al. Progression of anal high-grade squamous intraepithelial lesions to invasive anal cancer among HIV-infected men who have sex with men. Int. J. Cancer. 2014 Mar 1; 134 (5), 134, 1147-1155.
5. Cappello C, Cuming T, Bowring J, et al. High-Resolution Anoscopy Surveillance After Anal Squamous Cell Carcinoma: High-Grade Squamous Intraepithelial Lesion Detection and Treatment May Influence Local Recurrence. Dis Colon Rectum 2020;63:1363-1371.
6. Cho SD, Groves E, Lao VV. History of High-Resolution Anoscopy. Clin Colon Rectal Surg. 2018 Nov;31(6):336-346.
7. Crawshaw BP, Russ AJ, Stein SL et al. High-resolution or expectant management for anal intraepithelial neoplasia for the prevention of anal cancer: is there really a difference? Dis Colon rectum 2015 Jan; 58(1):53-59.
8. Gimenez F, Costa-e-Silva IT, Jd 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.
9. Goldstone SE, Lensing SY, Stier EA, et al. A Randomized Clinical Trial of Infrared Coagulation Ablation Versus Active Monitoring of Intra-anal High-grade Dysplasia in Adults With Human Immunodeficiency Virus Infection: An AIDS Malignancy Consortium Trial. Clin Infect Dis. 2019 Mar 19;68(7):1204-1212. 
10. Gudur A, Shanmuganandamurthy D, Szep Z, Poggio JL. An Update on the Current Role of High Resolution Anoscopy in Patients With Anal Dysplasia. Anticancer Res. 2019 Jan;39(1):17-23.
11. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
12. Joint Clinical Trials Office. ANCHOR: Anal cancer/HSIL outcomes research study. jcto.weill.cornell.edu/open_clinical_trials/anchor-anal-cancerhsil-outcomes-research-study.  
13. Kaplan JE, Benson C, Holmes KH, et al, Centers for Disease Control and Prevention (CDC), National Institutes of Health, HIV Medicine Association of the Infectious Diseases Society of America. Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: Recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. MMWR Recomm Rep 2009;58(RR-4):1- 207.
14. Larsen HK, Hædersdal M, Kjær SK. High-resolution anoscopy can diagnose precursors to anal cancer. Ugeskr Laeger. 2023 Feb 27;185(9):V10220616. Danish.
15. Leeds IL, Fang SH. Anal cancer and intraepithelial neoplasia screening: a review. World J Gastrointest Surg. 20116 Jan 27;8(1):41-51.
16. Nadal LR, Saad SS, et al. Comparison between anal cytology, high-resolution anoscopy and HPV DNA genotyping by polymerase chain reaction in the post-treatment follow-up of condylomata acuminata. Rev Col Bras Cir. 2020;47:e20202543.
17. National Cancer Institute. HIV infection and cancer risk. www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hiv-fact-sheet. 
18. National Cancer Institute. Multi-center anal pre-cancer treatment and cancer prevention study launched in HIV infected persons. www.cancer.gov/news-events/press-releases/2015/anchor-trial-launch.
19. Palefsky JM, Cranston RD. Anal squamous intraepithelial lesions: Diagnosis, screening, prevention, and treatment. Jan 26, 2017. www.uptodate.com/contents/anal-squamous-intraepithelial-lesions-diagnosis-screening-prevention-and-treatment?search=high%20resolution%20anoscopy&source=search_result&selectedTitle=1~4&usage_type=default&display_rank=1#. 
20. Palefsky JM, Lee JY, Jay N,et al; ANCHOR Investigators Group. Treatment of Anal High-Grade Squamous Intraepithelial Lesions to Prevent Anal Cancer. N Engl J Med. 2022 Jun 16;386(24):2273-2282.
21. Siegenbeek van Heukelom ML, Marra E, et al. Detection Rate of High-Grade Squamous Intraepithelial Lesions as a Quality Assurance Metric for High-Resolution Anoscopy in HIV-Positive Men. Dis Colon Rectum. 2018 Jul;61(7):780-786.
22. Stewart DB, Gaertner WB, Glasgow SC, et al; Prepared on Behalf of the Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for Anal Squamous Cell Cancers (Revised 2018). Dis Colon Rectum. 2018 Jul;61(7):755-774.

POLICY HISTORY:

Medical Policy Group, December 2015 (4): new policy developed; service already included on investigational listing.

Medical Policy Administration Committee, January 2016

Available for comment January 14 through February 28, 2016

Medical Policy Group, September 2018 (4): Updates to Description, Policy, Key Points, and References. Updated policy statement to allow coverage for HRA for the diagnosis and management of lesions.

Medical Policy Administration Committee, October 2018

Available for comment October 2 through November 15, 2018

Medical Policy Group, October 2019 (5): Reviewed by consensus. Updates to Key Points. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, June 2021 (5): Reviewed by consensus. Updates to Key Points and references. Policy statement updated to remove “not medically necessary,” no change to policy intent. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, May 2022 (5): Reviewed by consensus. Updates to Key Points and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, May 2023 (11): Reviewed by consensus. Updates to Key Points, Benefit Application and references. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, May 2024 (11): Reviewed by consensus. Updates to Key Points, Benefit Application and References. 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.