Subject: Adjunctive Prediagnostic Test
Date: August 25, 2015
This Clinical Policy Bulletin explains how we determine whether certain services or supplies are medically necessary. We made these decisions based on a review of currently available clinical information including:
- Clinical outcome studies in the peer-reviewed published medical and dental 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 and dentists practicing in relevant clinical areas
- Other relevant factors
We expressly reserve the right to revise these conclusions as clinical information changes, and welcome further relevant information.
Each benefits plan defines which services are covered, excluded and subject to dollar caps or other limits. Members and their dentists will need to refer to the member's benefits plan to determine if any exclusions or other benefits limitations apply to this service or supply.
The conclusion that a particular service or supply is medically necessary does not guarantee that this service or supply is covered (that is, will be paid for by Aetna) for a particular member. The member's benefits plan determines coverage. Some plans exclude coverage for services or supplies that we consider 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.
Aetna considers the use of any screening aids, diagnostic tools and/or devices that assist in a diagnosis to be an adjunctive technique that is part of the oral evaluation or primary service.
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® technology (Zila, Inc.) is one such device. Other devices and/or techniques are VELscope® (LED Dental Inc.) and the OraRisk®HPV salivary test (Oral DNA® Labs).
Aetna considers the surgical biopsy the most definitive, accurate and reliable method for diagnosing oral mucosal lesions.* We do not offer a separate benefit for such oral cancer screening or prediagnostic tools.
Similarly, we do not offer a separate benefit for the use of diagnostic tools, devices or techniques used to evaluate oral structures. One example is pulp vitality tests.
*Regarding screening adjuncts, an ADA panel found insufficient evidence to support recommendations for or against the use of light-based technologies compared with conventional operatory lighting alone.1
D0431 – Adjunctive prediagnostic test that aids in detection of mucosal abnormalities including premalignant and malignant lesions, not to include cytology or biopsy procedures
D0460 – Pulp vitality tests
Original: 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
See Aetna Medical Policy Bulletin #0760 and #0443 Cervical Cancer Screening and Diagnosis.
The above policy is based on the following references:
1R Mehrotra, M Singh, S Thomas, P Nair, S Pandya, N Shakti Nigam, P Shukla. 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, 2014 at http://www.ncbi.nlm.nih.gov/pubmed/20123872.
2American Dental Association. CDT 2015 Dental Procedure Codes: 10.*
3The Oral Cancer Foundation website. Accessed July 23, 2014. http://www.oralcancerfoundation.org.
4Zila Pharmaceuticals website. Accessed July 23, 2014. http://www.denmat.com.
5Oh 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, 2014.
6Brocklehurst 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
7Rethman M. et al. Evidence-based clinical recommendations regarding screening for oral squamous cell carcinomas. J Am Dent Assoc 2010;141;509-520.
8Oral DNA®Labs website. Accessed July 23, 2014. http://www.oraldna.com/oral-hpv-testing.html.
*Copyright 2014 American Dental Association. All rights reserved.
Property of Aetna. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This 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 advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.