Latest Review Date: December 2023

Category: Medical                                                    

POLICY:

Oral lesion identification systems (e.g. the Dentlight Oral Exam Light Kit, Microlux DL, Orascoptic DK, Sapphire Plus, TRIMIRA Identafi 3000, ViziLite-Blue, VELscopeViziLite™ or Velscope™) are considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Head and neck cancers account for 5 % of all tumors, and about 50 % of head and neck tumors occur specifically in the oral cavity.  In 2000, 300,000 of the 615,000 new cases of oral cavity tumors reported worldwide were primary oral cavity squamous cell carcinomas (SCC).  Recent data from the Surveillance, Epidemiology, and End Results Program suggested that 28,900 new cases of oral cancer will be identified and 7,400 deaths attributed to oral cancer each year in the United States.  The 6th leading cause of cancer-related mortality, oral cancer accounts for 1 death every hour in the United States (Kademani, 2007).  Since oral cancers are often detected in later stages, it is thought that early detection may lower the morbidity and mortality of oral cavity tumors.

ViziLite® (Zila Inc., Phoenix, AZ) is a chemiluminescent test, which has been proposed as an adjunct to visual examination to increase identification, evaluation, and monitoring of oral mucosal abnormalities in individuals at increased risk for oral cancer. ViziLite is a single-use product that consists of an acetic acid rinse, retractor, and light stick. The patient rinses with the acetic acid solution and expectorates. The ViziLite light stick is activated and inserted into the hollow end of the retractor. After dimming the lights, the provider examines the oral cavity using the ViziLite device. The light is purported to impart a blue hue to normal tissue, while lesions take on an “acetowhite” appearance, thus becoming clinically discernable.

VELscope™ received 510(k) market clearance in April 2006 and was deemed equivalent to Vizilite. VELscope is intended to be used by dentists or health-care providers as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or pre-malignant dysplasia. VELscope uses visible light in the 430 nm wavelength in order to cause fluorescent excitation of certain compounds in the tissues.

KEY POINTS:

Literature review performed through December 5, 2023.

Summary of Evidence:

For individuals who receive oral lesion identification using  technology, the evidence includes systematic reviews, prospective studies, and a case control study.  Relevant outcomes are test validity, overall survival, disease specific survival, and change in disease status. The studies report that the acid rinse may have accentuated some lesions, but the detection rate was not significantly improved.  Additionally, the oral tissues that were examined using ViziLite did not alter the preliminary diagnosis nor the biopsy site. Because the ability to differentiate benign vs. malignant lesions remains a concern, further research is needed to determine the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

The American Dental Association (ADA)’s evidence-based guideline on “Screening for oral squamous cell carcinomas” (Rethman et al, 2010) concluded that screening by means of visual and tactile examination to detect potentially malignant and malignant lesions may result in detection of oral cancers at earlier stages, but there is insufficient evidence to determine if screening alters disease-specific mortality in asymptomatic people seeking dental care.  The guideline evaluated adjunctive screening aids based on tissue reflectance (i.e., ViziLite Plus, MicroLux/DL, Orascoptic DK), autofluorescence (i.e., VELscope), and autofluorescence and tissue reflectance (i.e., TRIMIRA Identafi).  The ADA guideline concluded that there is insufficient evidence that use of commercial devices for lesion detection that are based on autofluorescence or tissue reflectance enhance visual detection of potentially malignant lesions beyond a conventional visual and tactile examination.  Moreover, the ADA guideline noted that additional research is needed for oral cancer screening and the use of adjuncts.

KEY WORDS:

Oral cancer screening, ViziLite™, VELscope system™, ViziLite Plus™, ViziLite Plus with TBlue630™, Zila Inc., ViziLite™ Blue Oral Lesion Identification and Marking System, chemiluminescent, Zila Technical, Inc., ViziLite Pro,Dentlight Oral Exam Light Kit, Microlux DL, Orascoptic DK, Sapphire Plus, TRIMIRA Identafi 3000, ViziLite-Blue and VELscope

APPROVED BY GOVERNING BODIES

The ViziLite® test kit is classified by the FDA as a dental operating light and regulated as a Class II (moderate risk) device. This test system received FDA 510(k) premarket approval on January 31, 2005 (K033033). According to 510(k) approval, a standard visual examination must always be performed before use of the ViziLite® test kit.

The Velscope™ functions similarly and is used for the same purpose as the Vizilite device. The 510 (k) number is K003995 and was FDA approved April 7, 2006.

The United States Food and Drug Administration (FDA) cleared ViziLite as an adjunct to visual examination of the oral cavity in November 2001.  This chemiluminescent light technology has been used since 1995 for the identification of abnormalities in stratified squamous epithelium.  The ViziLite-Blue oral examination kit, an oral lesion identification and marking system, is designed to be used as an adjunct to the conventional head and neck examination in patients at increased risk for oral cancer.  It is comprised of a chemiluminescent light source (ViziLite) to improve the identification of lesions and a blue phenothiazine dye to mark those lesions identified by ViziLite.  The ViziLite-Blue oral examination kit was cleared by the FDA through the 510(k) process in November 2004.

U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS

Oral Cancer: Screening

The primary screening test for oral cancer is a systematic clinical examination of the oral cavity. According to the World Health Organization and the National Institute of Dental and Craniofacial Research, an oral cancer screening examination should include a visual inspection of the face, neck, lips, labial mucosa, buccal mucosa, gingiva, floor of the mouth, tongue, and palate. Mouth mirrors can help visualize all surfaces. The examination also includes palpating the regional lymph nodes, tongue, and floor of the mouth. Any abnormality that lasts for more than 2 weeks should be reevaluated and considered for biopsy.

Oropharyngeal cancer is difficult to visualize and is usually located at the base of the tongue (the back third of the tongue), the soft palate (the back part of the roof of the mouth), the tonsils, and the side and back walls of the throat. A comprehensive examination of the oropharynx may require referral to a dental provider or specialist, which is outside the scope of this recommendation.

Additional tests proposed as adjuncts to the oral cancer screening examination include toluidine blue dye staining, chemiluminescent and autofluorescent lighting devices, and brush cytopathology. These screening and adjunct tests have not been adequately tested in primary care nondental settings. Although there is interest in screening for oral HPV infection, medical and dental organizations do not recommend it. Currently, no screening test for oral HPV infection has been approved by the U.S. Food and Drug Administration (FDA). Evaluating the accuracy of tests that detect oral HPV infection is a potentially promising area of research.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

CPT codes:

REFERENCES:

1. Awan K, et al. Utility of chemiluminescence (ViziLite™) in the detection of oral potentially malignant disorders and benign keratosis. J Oral Pathol Med 2011 Aug;40(7):541-4.
2. Awan K.,  et al Assessing the accuracy of autofluorescence, chemiluminescence and toluidine blue as diagnostic tools for oral potentially malignant disorders--a clinicopathological evaluation. Clin Oral Investig 2015 Dec;19(9):2267-72.
3. Downer MC, Moles DR, Palmer S and Speight PM. Database of abstracts of reviews of effects (DARE). A systematic review of test performance in screening for oral cancer and precancer. Centre for Reviews and Dissemination. www.crd.york.ac.uk/CRDWeb/ShowRecord.asp?View=Full&ID=12004000408. 
4. Downer MD. A systematic review of measures of effectiveness in screening for oral cancer and precancer. Oral Oncology, July 2006; 42(6): 551-560.
5. Epstein JB, Gorsky M, Cabay RJ, Day T and Gonsalves W. Screening for and diagnosis of oral premalignant lesions and oropharyngeal squamous cell carcinoma: Role of primary care physicians. Canadian Family Physician, June 2008; 54(8): 870-875.
6. Farah CS and McCullough MJ. A pilot case control study on the efficacy of acetic acid wash and chemiluminescent illumination (ViziLite) in the visualization of oral mucosal white lesions. Oral Oncol, September 2007; 43(8): 820-824.
7. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
8. Kademani D. Oral cancer. Mayo Clin Proc. 2007;82(7):878-887.
9. Kerr AR, Sirois DA, Epstein JB. Clinical evaluation of chemiluminescent lighting: An adjunct for oral mucosal examinations. J Clin Dent. 2006;17(3):59-63.
10. Kim DH, Lee J, Lee MH, et al. Efficacy of chemiluminescence in the diagnosis and screening of oral cancer and precancer: A systematic review and meta-analysis. Braz J Otorhinolaryngol. 2022;88(3):358-364.
11. Kim DH, Kim SW, Hwang SH, et al. Autofluorescence imaging to identify oral malignant or premalignant lesions: Systematic review and meta-analysis. Head Neck. 2020;42(12):3735-3743.
12. Lingen MW, Kalmar JR, Karrison T and Speight PM. Critical evaluation of diagnostic aids for the detection of oral cancer. Oral Oncology, January 2008; 44(1): 10-22.
13. Mascitti M, Orsini G, Tosco V, Monterubbianesi R, Balercia A, Putignano A, Procaccini M, Santarelli A. An Overview on Current Non-invasive Diagnostic Devices in Oral Oncology. Front Physiol. 2018 Oct 25;9:1510. doi: 10.3389/fphys.2018.01510.
14. McIntosh L, McCullough MJ, Farah CS. The assessment of diffused light illumination and acetic acid rinse (Microlux/DL) in the visualisation of oral mucosal lesions. Oral Oncol. 2009;45(12):e227-e231.
15. McNamara KK, Martin BD, Evans EW, Kalmar JR. The role of direct visual fluorescent examination (VELscope) in routine screening for potentially malignant oral mucosal lesions. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012;114(5):636-643.
16. National Cancer Institute. Oral cancer screening (PDQ®): Oral cancer screening. www.cancer.gov/cancertopics/pdq/screening/oral/Patient/page3.
17. National Cancer Institute. Oral cancer screening (PDQ®): Evidence of benefit. www.cancer.gov/cancertopics/pdq/screening/oral/HealthProfessional/page4.
18. Oh ES and Laskin DM. Efficacy of the ViziLite system in the identification of oral lesions. J Oral Maxillofac Surg, March 2007; 65(3): 424-426.
19. Patton LL, Epstein JB and Kerr AR. Adjunctive techniques for oral cancer examination and lesion diagnosis: A systematic review of the literature. J Am Dent Assoc 2008; 139: 896-905.
20. Rethman MP, Carpenter W, Cohen EE, et al; American Dental Association Council on Scientific Affairs Expert Panel on Screening for Oral Squamous Cell Carcinomas. Evidence-based clinical recommendations regarding screening for oral squamous cell carcinomas.  J Am Dent Assoc. 2010;141(5):509-520.
21. Robinson PN and Mickelson AR. Early diagnosis of oral cavity cancers. Otolaryngologic Clinics of North America, April 2006, Vol. 39, Issue 2.
22. Stenson KM. Diagnosis and staging of head and neck cancer. UpToDate.com. Accessed February 6, 2008.
23. Trullenque-Eriksson A, Munoz-Corcuera M, Campo-Trapero J, et al. Analysis of new diagnostic methods in suspicious lesions of the oral mucosa. Med Oral Patol Oral Cir Bucal, May 2009; 14(5): E210-216.
24. U.S. Preventive Services Task Force. Screening for oral cancer.  Agency for Healthcare Research and Quality, February 2004.  www.ahrq.gov/clinic/uspstf/uspsoral.htm.
25. U.S. Preventive Services Task Force. Screening for oral cancer.  Agency for Healthcare Research and Quality, November 2013. https://www.uspreventiveservicestaskforce.org/uspstf/document/RecommendationStatementFinal/oral-cancer-screening#bootstrap-panel--3
26. Yang G, Wei L, Thong BKS, et al. A systematic review of oral biopsies, sample types, and detection techniques applied in relation to oral cancer detection. BioTech (Basel). 2022;11(1):5.

POLICY HISTORY:

Medical Policy Group, October 2008 (4)

Medical Policy Administration Committee, November 2008

Available for comment November 20, 2008-January 5, 2009

Medical Policy Group, October 2009 (1)

Medical Policy Group, October 2010 (1) Update to Description, no policy change

Medical Policy Group, September 2012 (3): Effective September 14, 2012 this policy is no longer scheduled for regular literature reviews and updates.

Medical Policy Group, November 2019 (5): Updates to Key Points. No change to policy statement. Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, January 2021 (6): Updates to Key Points, Key Words (ViziLite Pro), Governing Bodies, Current Coding (removed coding D0431/D0502/D0999), USPSTF and References. Removed ViziLite™, Velscope™ from policy title.

Medical Policy Group, January 2022 (6): Reviewed by consensus. Policy statement updated to remove “not medically necessary,” no change to policy intent. Updates to Key Points and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, December 2022 (6): Updates to Policy Title: Oral Lesion Identification Systems, Description, Key Words, Key Points, Practice Guidelines and References.

Medical Policy Group, December 2023 (6): Updates to Key Points, Benefit Application and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.