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Oral cancer screening adjuncts (045)

Number: 045
Revised

 

Subject: Oral cancer screening adjuncts

 

Reviewed: March 13, 2026

 

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This Clinical Policy Bulletin determines whether certain services or supplies are medically necessary, experimental, investigational, unproven (unsubstantiated), 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 the 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 an opinion by Aetna 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 considers adjunctive oral cancer screening systems to be experimental, investigational or unproven. 

 

Background

 

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

 

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 PRO Oral Cancer Detection light (DenMat) 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). 

 

To develop the evidence-informed guideline on the early detection of oral squamous cell carcinoma and potentially malignant disorders that was published in the March 2026 issue of the Journal of the American Dental Association (JADA,) a multidisciplinary guideline panel including representation from patients, general dentists, dental hygienists, head and neck surgeons, oral and maxillofacial pathologists, and oral medicine specialists studied the use of adjuncts as triage tools for the evaluation of lesions, including potentially malignant disorders (PMDs), in the oral cavity. Reaffirming the ADA’s published report from 2017, the findings in the guideline recommend against the use of cytology adjuncts to determine the need for biopsy or referral in adults with abnormal tissue in the oral cavity or on the lip because tests such as brush biopsy could produce false positive results. They also recommend against using adjuncts to screen asymptomatic adults without clinically evident mucosal abnormalities, as evidence supporting this use is lacking.

 

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 or punch biopsy the most definitive, accurate and reliable method for diagnosing oral mucosal lesions. Aetna does cover these biopsies.

 

Code

 

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; March 25, 2020; April 19, 2021; May 4, 2022; July 12, 2023; July 19, 2024
Revised: November 20, 2006; October 13, 2008; August 24, 2009; February 28, 2011; July 23, 2014; November 27, 2017; July 1, 2025; March 13, 2026

 

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

 

The above policy is based on the following references:

 

Urquhart, Olivia et al. Living evidence-informed guideline on the early detection of oral squamous cell carcinoma and potentially malignant disorders. The Journal of the American Dental Association, Volume 157, Issue 3, 224 – 234 March, 2026.  https://jada.ada.org/article/S0002-8177(26)00037-1/fulltext

 

Lingen 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. Accessed March 28, 2025

 

Mehrotra, 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 March 28, 2025

 

Oh 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 19, 2024. 

 

Brocklehurst 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

 

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

 

J Dent Res. 2021 Nov; 100(12): 1313–1320.Published online 2021 May 26. doi: 10.1177/00220345211014795 Oral Cancer Screening, Past, Present and Future.

 

National Cancer Institute (NCI). Oral Cavity and Nasopharyngeal Cancers Screening (PDQ®)–Health Professional Version. April 2024. Accessed on March 28, 2025. Available at URL address: https://www.cancer.gov/types/head-and-neck/hp/oral-screening-pdq

 

American Dental Association. CDT 2026 Dental Procedure Codes

 

 Copyright 2026 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.

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  • 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 (i.e., 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 a Clinical Policy Bulletin (CPB) and a member's plan of benefits, the benefits plan will govern.
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