mp-332
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Oral Lesion Identification System (ViziLite™, Velscope™)

Policy Number: MP-332

Latest Review Date: November 2019

Category: Medical/Dental                                                      

Policy Grade: Active Policy but no longer scheduled for regular literature reviews and updates.

POLICY:

Oral lesion identification systems (such as ViziLite™ or Velscope™) are considered not medically necessary and investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Cancer is defined as the uncontrollable growth of cells that invade and cause damage to surrounding tissue. Oral cancer, which includes cancers of the lips, tongue, cheeks, floor of the mouth, hard and soft palate, sinuses, and pharynx (throat), can be life threatening if not diagnosed and treated early. The overall 1-year survival rate for patients with all stages of oral cavity and pharynx cancers is 81%. The 5- and 10-year survival rates are 56% and 41%, respectively. As part of a routine dental examination, the dentist will conduct an oral cancer screening exam. More specifically, the dentist will feel for any lumps or irregular tissue changes in the neck, head, face, and oral cavity. When examining the mouth, the dentist will look for any sores or discolored tissue as well as check for any signs and symptoms mentioned above. A dentist may perform an oral brush biopsy if he or she sees tissue in the mouth that looks suspicious. This test is painless and involves taking a small sample of the tissue and analyzing it for abnormal cells. Alternatively, if the tissue looks more suspicious, the dentist may recommend a scalpel biopsy. This procedure usually requires local anesthesia and may be performed by a dentist or a specialist. These tests are necessary to detect oral cancer early, before it has had a chance to progress and spread. The American Cancer Society recommends oral cancer screening exams every 3 years for persons over age 20 and annually for those over age 40. Risk factors include smoking, smokeless tobacco, excessive alcohol consumption, family history and/or excessive sun exposure.

ViziLite™, by Zila Pharmaceuticals, is a single-use product that is made up of a single acetic acid rinse, retractor and light stick. After rinsing with the acetic acid solution, the patient expectorates. The dentist then activates the ViziLite™ stick by bending until the inner capsule is broken. After shaking the light stick until it glows, it is inserted into the hollow end of the retractor and, with the lights dimmed; the oral cavity is examined with the ViziLite™ device. This light is reported to impart a blue hue to normal tissue, while lesions become clinically discernible by taking on an “acetowhite” appearance. The ViziLite™ test kit has been further updated by the addition of a three-component swab system, known as the ViziLite™ Blue Oral Lesion Identification and Marking System. The system contains two swabs of 1% acetic acid rinse and one swab with a metachromatic vital tissue dye, toluidine blue. The dye is applied to ViziLite™-identified white lesions to allow the examiner to visualize the lesions with incandescent light.

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. It is further intended to be used by surgeons to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for sugical excision. VELscope uses visible light in the 430 nm wavelength in order to cause fluorescent excitation of certain compounds in the tissues.

KEY POINTS:

No new peer reviewed literature was identified in a recent literature search. Therefore there is no change in the coverage statement of this policy.

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.

APPROVED BY GOVERNING BODIES

ViziLite™---510K FDA approved 2005

Velscope™---510K FDA approved 4/7/2006

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: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

CDT:

D0431        

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

D0502        

Other pathology procedures, by report 

D0999        

Unspecified diagnostic procedure, by report

CPT codes:

40899         

Unlisted procedure, vestibule of mouth

41599         

Unlisted procedure, tongue, floor of mouth

41899         

Unlisted procedure, dentoalveolar structures 

82397         

Chemiluminescent assay

REFERENCES:

  1. 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. Accessed October 22, 2008.
  2. Downer MD. A systematic review of measures of effectiveness in screening for oral cancer and precancer. Oral Oncology, July 2006; 42(6): 551-560.
  3. 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.
  4. 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): 820-82
  5. 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.
  6. National Cancer Institute. Oral cancer screening (PDQ®): Oral cancer screening. www.cancer.gov/cancertopics/pdq/screening/oral/Patient/page3. Accessed October 21, 2008.
  7. National Cancer Institute. Oral cancer screening (PDQ®): Evidence of benefit. www.cancer.gov/cancertopics/pdq/screening/oral/HealthProfessional/page4. Accessed October 21, 2008.
  8. 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.
  9. 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.
  10. Robinson PN and Mickelson AR. Early diagnosis of oral cavity cancers. Otolaryngologic Clinics of North America, April 2006, Vol. 39, Issue 2.
  11. Stenson KM. Diagnosis and staging of head and neck cancer. UpToDate.com. Accessed February 6, 2008.
  12. 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.
  13. 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.

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.

 

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.