Adjunctive Prediagnostic Test (017)

Number: 017
(Update)

Subject: Adjunctive Prediagnostic Test

Date: September 10, 2012

Important Note

This Clinical Policy Bulletin expresses our determination of whether certain services or supplies are medically necessary. We have reached these conclusions 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 consult 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.

Policy

Aetna considers the use of any screening aid that assists in the operation, efficacy and/or function of an oral evaluation or screening of precancerous or cancerous oral lesions to be an adjunctive technique that is inclusive to the oral evaluation.

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 being marketed as a means for patients to benefit from improved identification of oral precancerous and early cancerous lesions, and possibly prevent the disease through early intervention. A 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 pre-diagnostic tools.

*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

Code2

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

Revision Dates

Original: November 22, 2005
Updated: November 28, 2007; October 4, 2010; July 11, 2011; September 10, 2012
Revised: November 20, 2006; October 13, 2008; August 24, 2009; February 28, 2011

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 February 28, 2011 at http://jada.ada.org/cgi/content/full/141/5/509.

2American Dental Association.Current dental terminology, CDT 2011-2012: 8.*

3The Oral Cancer Foundation website. Accessed October 4, 2010. http://www.oralcancerfoundation.org.

4Zila Pharmaceuticals website. Accessed October 04, 2000http://www.zila.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.

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 11, 2011. http://www.oraldna.com/oral-hpv-testing.html.

*Copyright 2010 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.

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