Description of Procedure or Service

Oral cancer is defined as cancer occurring in the oral cavity between the vermilion border of the lips and the junction of the hard and soft palates or the posterior one third of the tongue. Squamous cell carcinoma is the most common(Gross, Lee, Okuno, & Rao, 2017).

Oral Screening and Lesion Identification Systems are adjunctive screening tests to identify malignancy in the lips, oral cavity or oropharynx (Fuller et al., 2015).

***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician.

Policy

Oral screening lesion identification systems and genetic screening is considered investigational. BCBSNC does not provide coverage for investigational services or procedures.

Benefits Application

This medical policy relates only to the services or supplies described herein. Please refer to the Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design; therefore member benefit language should be reviewed before applying the terms of this medical policy.

When Oral Screening Lesion Identification Systems and Genetic Screening is covered

Not applicable.

When Oral Screening Lesion Identification Systems and Genetic Screening is not covered

Oral screening, lesion identification systems and genetic testing are not covered for any use, including, but not limited to, the following:

• OraRisk^® HPV Salivary Diagnostic Test (OralDNA labs, Brentwood, TN)
• MOP^™ testing
• SaliMark OSCC^® (PeriRx)

Policy Guidelines

The American Cancer Society estimates the 2016 incidence of oral cancer to be 48,330 cases with approximately 9,570 deaths. OSCC is the most common form of oral cavity cancer (Scully & Porter, 2000). Many are preceded by potentially malignant disorders (PMD), a heterogeneous group of conditions including erythroplakia, non-homogeneous leukoplakia, erosive lichen planus, oral submucous fibrosis and actinic keratosis (Warnakulasuriya, Johnson, & van der Waal, 2007). The early detection and excision of PMD can prevent malignant transformation (Paul Brocklehurst, 2017; van der Waal, 2009; Warnakulasuriya et al., 2007).

Diagnosing and treating dermatologic lesions of the mouth and gums is challenging for most clinicians because of the wide variety of disease processes that can present with similar appearing lesions and the fact that most clinicians receive inadequate training in mouth diseases.(Goldstein & Goldstein, 2017) A number of index tests have been proposed as adjuncts to a conventional oral examination (COE) to improve diagnostic test accuracy (Fedele, 2009; Lingen, Kalmar, Karrison, & Speight, 2008; Patton, Epstein, & Kerr, 2008; Rethman et al., 2010; Seoane Leston & Diz Dios, 2010). Table from (Macey et al., 2015) – see Appendix.

None of the adjunctive tests can be recommended as a replacement for the currently used standard of COE followed by a scalpel biopsy and histological assessment (Fuller et al., 2015; Macey et al., 2015; Richards, 2015).

Clinical Validity and Utility

Patton et al (2008) conducted a systematic review to evaluate the effectiveness of adjunctive techniques including toluidine blue, ViziLite Plus with toluidine blue, ViziLite, VELscope, MicroLux/DL, Orascoptic DK and OralCDx brush biopsy. A total of 23 studies met the inclusion criteria. The authors concluded that there is insufficient evidence to support or refute the use of visually based examination adjuncts. The review concluded that, given the lack of effectiveness data in general dental practice settings, clinicians must rely on a thorough oral mucosal examination supported by specialty referral and/or tissue biopsy for oral premalignant and malignant lesions.

According to Huber (2012), several products like OralCDx Brush Test, ViziLite Plus with TBlue, Microlux, VELscope Vx, Sapphire Plus, Identafi, and the DOE Oral Exam System have been proposed as an adjunctive aid for identifying oral premalignant and malignant lesions (OPMLs). The author noted that studies evaluating the efficacy and utility of these products to screen for OPMLs are limited and conflicting.

Rashid and Warnakulasuriya (2015) studied the effectiveness of chemi-luminescence (CL) and tissue auto-fluorescence (AF) devices as adjuncts in the detection of oral cancer (OC) and oral potentially malignant disorders (OPMD). The authors performed a systematic review of the published literature to evaluate the effectiveness of the ViziLite and ViziLite Plus with TB, MicroLux/DL and the VELscope as aids in the detection of OC and OPMDs. Twenty-five primary studies published between 2004 and 2013 satisfied the criteria for selection – 13 utilized chemiluminescence and 12 tissue autofluorescence. The authors concluded that there is limited evidence for their use in primary care, and these tools are better suited to specialist clinics in which there is a higher prevalence of disease and where experienced clinicians may better discriminate between benign and malignant lesions.

Nagi et al (2016) conducted a systematic review to evaluate the effectiveness of adjunctive devices that utilize the principles of chemiluminescence and tissue autofluorescence in the detection of oral squamous cell carcinoma (OSCC) and oral potentially malignant disorders (OPMD). Twenty primary studies published satisfied the criteria for selection - 10 utilized chemiluminescence and 10 tissue autofluorescence. The authors concluded that more clinical trials in future should be conducted to establish optical imaging as an efficacious adjunct tool in early diagnosis of OSCC and OPMD.

Vila et al (2012) evaluated the accuracy of high-resolution microendoscopic (HRME) images to discriminate between cancerous and benign mucosa. The authors concluded that “with further refinement, HRME and other optical imaging methods have the potential to enhance the rational selection of initial margins, and decrease operative time and expense by limiting the use of frozen section analysis.” Although HRME is a promising tool, the authors caution that there are several limitations which highlight areas for further development.

Applicable Federal Regulations

This test is considered a laboratory developed test (LDT); developed, validated and performed by individual laboratories.

LDTs are regulated by the Centers for Medicare and Medicaid (CMS) as high-complexity tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88).

As an LDT, the U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use.

Guidelines and Recommendations

Practice Guidelines and Position Statements

American Dental Association (ADA)

In 2010, the ADA released evidence-based clinical recommendations for screening for oral squamous cell carcinomas and the use of adjunctive screening aids to visualize and detect potentially malignant and malignant oral lesions (Rethman et al, 2010). The guideline evaluated adjunctive screening aids based on tissue reflectance (i.e., ViziLite Plus, MicroLux/DL, Orascoptic DK), autofluorescence (i.e., VELscope) and combination of autofluorescence and tissue reflectance (i.e., TRIMIRA Identafi). The authors noted that “overall, visualization aids may affect a lesion's appearance in terms of brightness, texture and delineation of margins and in patients with previously detected lesions, but they have not been shown to enhance the practitioner's ability to identify potentially malignant lesions specifically or to identify lesions not visible under normal operatory lighting. Furthermore, there is insufficient evidence that these devices improve patient compliance or aid in patient education” The guidelines include the following conclusions:

• “There is insufficient evidence that commercial devices based on autofluorescence enhance visual detection of potentially malignant lesions beyond that achieved through a conventional visual and tactile examination.”
• “There is insufficient evidence that commercial devices based on tissue reflectance enhance visual detection of potentially malignant lesions beyond that achieved through a conventional visual and tactile examination.”

US Preventive Services Task Force (USPSTF)

In 2013, the USPSTF published final recommendations for screening of oral cancer. The recommendation stated that “the current evidence is insufficient to assess the balance of benefits and harms of screening for oral cancer in asymptomatic adults.” The USPSTF also noted that “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.”

National Comprehensive Cancer Network (NCCN)

NCCN’s 2017 clinical practice guidelines on head and neck cancers does not mention the use of adjunctive screening aids based on autofluorescence or tissue reflectance as a management tool.

Billing/Coding/Physician Documentation Information

This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed in the Category Search on the Medical Policy search page.

Applicable service codes: 82397, 87623, 87624, 87625

BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Scientific Background and Reference Sources

American Cancer Society. Oral Cavity and Oropharyngeal Cancer. American Cancer Society. Available

athttp://www.cancer.org/cancer/oralcavityandoropharyngealcancer/detailedguide/oralcavity-and-oropharyngeal-cancer-key-statistics. January 27, 2016; Accessed: February 18, 2016.

American Cancer Society. Survival rates for oral cavity and oropharyngeal cancer by stage.

American Cancer Society. Available athttp://www.cancer.org/cancer/oralcavityandoropharyngealcancer/detailedguide/oralcavity-and-oropharyngeal-cancer-survival-rates. January 27, 2016; Accessed: February 18, 2016.

Brocklehurst, P., O. K., Anne-Marie Glenny, Richard Oliver, Philip Sloan, Graham Ogden, Simon Shepherd. (2017). Screening programmes for the early detection and prevention of oral cancer. The Cochrane Library.

Epstein JB, Gorsky M, Lonky S, et al. The efficacy of oral lumenoscopy (ViziLite) in visualizing oral mucosal lesions. Spec Care Dentist. 2006;26(4):171-174.

Epstein JB, Silverman S Jr, Epstein JD, et al. Analysis of oral lesion biopsies identified and evaluated by visual examination, chemiluminescence and toluidine blue. Oral Oncol. 2008;44(6):538-544.

Fedele, S. (2009). Diagnostic aids in the screening of oral cancer. Head Neck Oncol, 1, 5. doi:10.1186/1758-3284-1-5

Fuller C, Camilon R, Nguyen S, et al. Adjunctive diagnostic techniques for oral lesions of unknown malignant potential: Systematic review with meta-analysis. Head Neck. 2015;37(5):755-762

Goldstein, B., & Goldstein, A. (2017). Oral lesions - UpToDate. In R. Corona (Ed.), UpToDate. Waltham. MA. Retrieved from https://www.uptodate.com/contents/oral-lesions?source=search_result&search=oral%20cancer&selectedTitle=3~150.

Gross, N., Lee, N., Okuno, S., & Rao, S. (2017). Treatment of stage I and II (early) head and neck cancer: The oral cavity - UpToDate. In M. Ross (Ed.), UpToDate. Waltham. MA. Retrieved from https://www.uptodate.com/contents/treatment-of-stage-i-and-ii-early-head-and-neck-cancer-the-oral-cavity?source=search_result&search=oral%20cancer&selectedTitle=1~150.

Huber, M.A. (2012). Adjunctive diagnostic aids in oral cancer screening: an update. Tex Dent J., 129(5):471-80.

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.

Lee YH, Wong DT. Saliva: An emerging biofluid for early detection of diseases. Am J Dent. 2009;22(4):241-248.

Lingen, M. W., Kalmar, J. R., Karrison, T., & Speight, P. M. (2008). Critical evaluation of diagnostic aids for the detection of oral cancer. Oral Oncol, 44(1), 10-22. doi:10.1016/j.oraloncology.2007.06.011

Macey, R., Walsh, T., Brocklehurst, P., Kerr, A. R., Liu, J. L., Lingen, M. W., . . . Scully, C. (2015). Diagnostic tests for oral cancer and potentially malignant disorders in patients presenting with clinically evident lesions. Cochrane Database Syst Rev(5), Cd010276. doi:10.1002/14651858.CD010276.pub2

Nagi, R., Reddy-Kantharaj, Y.B., Rakesh, N., et al (2016). Efficacy of light based detection systems for early detection of oral cancer and oral potentially malignant disorders: Systematic review. Med Oral Patol Oral Cir Bucal., 21(4):e447-e455.

Oh ES, Laskin DM. Efficacy of the ViziLite system in the identification of oral lesions. J Oral Maxillofac Surg. 2007;65(3):424-426.

OralDNA Labs. OralDNA[R] Labs introduces Orarisk (sm) HPV salivary diagnostic test to help dentists assess the risks of certain types of oral cancer. Available at: http://www.oraldna.com./. Accessed September 10, 2010.

Patton, L. L., Epstein, J. B., & Kerr, A. R. (2008). Adjunctive techniques for oral cancer examination and lesion diagnosis: a systematic review of the literature. J Am Dent Assoc, 139(7), 896-905; quiz 993-894.

Ram S, Siar CH. Chemiluminescence as a diagnostic aid in the detection of oral cancer and potentially malignant epithelial lesions. Int J Oral Maxillofac Surg. 2005;34(5):521-527.

Rashid, A. and Warnakulasuriya, S. (2015). The use of light-based (optical) detection systems as adjuncts in the detection of oral cancer and oral potentially malignant disorders: A systematic review. J Oral Pathol Med., 44(5):307-328.

Rethman, M. P., Carpenter, W., Cohen, E. E., Epstein, J., Evans, C. A., Flaitz, C. M., . . . Meyer, D. M. (2010). Evidence-based clinical recommendations regarding screening for oral squamous cell carcinomas. J Am Dent Assoc, 141(5), 509-520.

Richards, D. (2015). Adjunctive tests cannot replace scalpel biopsy for oral cancer diagnosis. Evid Based Dent, 16(2), 46-47. doi:10.1038/sj.ebd.6401093

Scully, C., & Porter, S. (2000). ABC of oral health. Oral cancer. Bmj, 321(7253), 97-100.

Seoane Leston, J., & Diz Dios, P. (2010). Diagnostic clinical aids in oral cancer. Oral Oncol, 46(6), 418-422. doi:10.1016/j.oraloncology.2010.03.006

van der Waal, I. (2009). Potentially malignant disorders of the oral and oropharyngeal mucosa; terminology, classification and present concepts of management. Oral Oncol, 45(4-5), 317-323. doi:10.1016/j.oraloncology.2008.05.016

Vila, P. M., Park, C. W., Pierce, M. C., Goldstein, G. H., Levy, L., Gurudutt, V. V., … Sikora, A. G. (2012). Discrimination of Benign and Neoplastic Mucosa with a High-Resolution Microendoscope (HRME) in Head and Neck Cancer. Annals of Surgical Oncology, 19(11), 3534–3539. http://doi.org/10.1245/s10434-012-2351-1

Warnakulasuriya, S., Johnson, N. W., & van der Waal, I. (2007). Nomenclature and classification of potentially malignant disorders of the oral mucosa. J Oral Pathol Med, 36(10), 575-580. doi:10.1111/j.1600-0714.2007.00582.x

Policy Implementation/Update Information

1/1/19 New policy developed. Oral screening lesion identification systems and genetic screening is considered investigational. BCBSNC does not provide coverage for investigational services or procedures. Medical Director review 1/1/2019. Policy noticed 1/1/2019 for effective date 4/1/2019. (an)

8/13/19 Reviewed by Avalon 2nd Quarter CAB. Added SaliMark OSCC^® (PeriRx) test to the Non Covered list. In the When Not Covered section, the investigational statement is revised to read “Oral screening, lesion identification systems and genetic testing are not covered for any use…” Code 81599 to Billing/Coding section. Medical Director review 8/2019. Policy noticed 8/13/2019 for effective date 10/15/2019. (an)