Subject: Adjunctive Prediagnostic Test
Date: September 10, 2012
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.
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.
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®
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
D0431 -- Adjunctive pre-diagnostic test that aids in detection of mucosal abnormalities including premalignant and malignant lesions, not to include cytology or biopsy procedures
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:
R 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
American Dental Association.Current dental terminology
, CDT 2011-2012: 8.*
The Oral Cancer Foundation website. Accessed October 4, 2010. http://www.oralcancerfoundation.org
Zila Pharmaceuticals website. Accessed October 04, 2000http://www.zila.com
Oh ES, Laskin DM. Efficacy of the ViziLite system in the identification of oral lesions
. Journal of Oral Maxillofacial Surgery 65:424-426, 2007.
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
Labs website. Accessed July 11, 2011. http://www.oraldna.com/oral-hpv-testing.html