Number: 045

Revised

Subject: Oral Cancer Screening Adjuncts

Reviewed: November 27, 2017

Important note

This Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary, experimental and investigational, or cosmetic. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors).

 Aetna makes no representations and accepts no liability with respect to the content of any external information cited or relied upon in this Bulletin. The discussion, analysis, conclusions and positions reflected in this Bulletin, including any reference to a specific provider, product, process or service by name, trademark, manufacturer, constitute Aetna’s opinion and are made without any intent to defame.

Aetna expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information including correction of any factual error. CPBs include references to standard HIPAA compliant code sets to assist with search functions and to facilitate billing and payment for covered services. New and revised codes are added to the CPBs as they are updated. When billing, you must use the most appropriate code as of the effective date of the submission. Unlisted, unspecified and nonspecific codes should be avoided.

Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply.

The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (for example, will be paid for by Aetna) for a particular member. The member's benefit plan determines coverage. Some plans exclude coverage for services or supplies that Aetna considers medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members.

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Policy

Aetna does not cover the use of oral cancer screening adjuncts. 

Background

The current clinical standard for the most definitive, accurate and reliable method for diagnosing oral mucosal lesions is the surgical biopsy. ¹

Some devices and instruments are marketed as a way for patients to benefit from improved identification of oral precancerous and early cancerous lesions, and possibly prevent the disease through early intervention. One technique involves chemiluminescence of tissue with a light source. ViziLite^® technology (Zila, Inc.) is one such device. Other devices and/or techniques are Brush Biopsy, VELscope^® (LED Dental Inc.) and the OraRisk^®HPV salivary test (Oral DNA^® Labs).  

An expert panel convened by the American Dental Association (ADA) Council on Scientific Affairs studied the use of adjuncts as triage tool for the evaluation of lesions, including potentially malignant disorders (PMDs), in the oral cavity. Reaffirming an ADA report from 2010, a published report in 2017 stated: “The panel concluded that no available adjuncts demonstrated sufficient diagnostic test accuracy to support their routine use as triage tool during the evaluation of lesions in the oral cavity” ²

Use of screening adjunct techniques may also delay diagnosis if the results are negative. By definition, a screening is not diagnostic and therefore false negative and false positive results are conceivable and concerning.

Aetna considers the surgical biopsy the most definitive, accurate and reliable method for diagnosing oral mucosal lesions. Aetna does cover surgical biopsies.

Codes⁴

D0431 – Adjunctive prediagnostic test that aids in detection of mucosal abnormalities including premalignant and malignant lesions, not to include cytology or biopsy procedures

Effective Dates

Original policy: November 22, 2005
Updated: November 28, 2007; October 4, 2010; July 11, 2011; September 10, 2012; November 5, 2013; August 25, 2015
Revised: November 20, 2006; October 13, 2008; August 24, 2009; February 28, 2011; July 23, 2014; November 27, 2017

See Aetna Medical Policy Bulletin #0686, #0760 and #0443

The above policy is based on the following references:

¹Omar E. Current concepts and future of noninvasive procedures for diagnosing oral squamous cell carcinoma - a systematic review. Head & Face Medicine. 2015;11:6. doi:10.1186/s13005-015-0063-z.

²Lingen M et al. Evidence-based clinical practice guideline for the evaluation of potentially malignant disorders in the oral cavity. J Am Dent Assoc 2017;148;712-727.e10 Copyright 2017 American Dental Association. All rights reserved. https://www.ncbi.nlm.nih.gov/pubmed/28958308

³Mehrotra, R., Singh, M., Thomas, S., Nair, P., Pandya, S., N Shakti Nigam, N., P Shukla, P. A cross-sectional study evaluating chemiluminescence and autofluorescence in the detection of clinically innocuous precancerous and cancerous oral lesions. J Am Dent Assoc 2010; Vol 141; No 2; 151-156.  Accessed July 23, 2017 at http://www.ncbi.nlm.nih.gov/pubmed/20123872.

⁴American Dental Association. CDT 2017: Dental Procedure Codes*

⁵The Oral Cancer Foundation website. Accessed July 23, 2017. http://www.oralcancerfoundation.org.

⁶Zila Pharmaceuticals website. Accessed July 23, 2017. http://www.denmat.com.

⁷Oh ES, Laskin DM.Efficacy of the ViziLite system in the identification of oral lesions. Journal of Oral Maxillofacial Surgery;65:424-426, 2007. Accessed July 23, 2017.

⁸Brocklehurst P, Kujan O, Glenny A-M, Oliver R, Sloan P, Ogden G, Shepherd S. Screening programmes for the early detection and prevention of oral cancer. Cochrane Database of Systematic Reviews 2010, Issue 11. Art. No.: CD004150. DOI: 10.1002/14651858.CD004150.pub3

⁹Rethman M. et al. Evidence-based clinical recommendations regarding screening for oral squamous cell carcinomas. J Am Dent Assoc 2010;141;509-520.

¹⁰Oral DNA^®Labs website. Accessed July 23, 2017. http://www.oraldna.com/oral-hpv-testing.html.

* Copyright 2016 American Dental Association. All rights reserved. 

Property of Aetna. All rights reserved. Dental Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical/dental advice. This Dental Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating health care professionals are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating health care professionals are solely responsible for medical/dental advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.