The following case studies document how ViziLite® TBlue has been used to help dental professionals identify suspicious oral tissue and to identify these tissues earlier than using a conventional visual exam alone.
Mark Levin, D.M.D., F.A.G.D.
51-year old white male, a tobacco user, was found to have hyperparakeratosis with focal dyskeratosis after initial visualization using ViziLite® TBlue. This case report was submitted by Dr. Mark Levin and Nicole Nocille, R.D.H.
New York City Dental Clinic
New York, NY
35-year old white female was found to have a possible pre-malignant lesion using ViziLite® TBlue.
New York City Dental Clinic
New York, NY
62-year old male, a moderate tobacco user, was found to have a possible pre-malignant lesion using ViziLite® TBlue. In this case, the lesion was subsequently found to be oral cancer.
New York City Dental Clinic
New York, NY
47-year old male, a non-smoker, was found to have a pre-malignant lesion using ViziLite® TBlue.
Download Summaries of Oral Cancer Clinical Studies
ViziLite® TBlue is a clinically proven screening system that has been helping oral healthcare professionals identify and mark lesions for more than a decade. This system uses a chemiluminescent light source and a patented, GMP manufactured toluidine blue dye called TBlue. TBlue provides the deep blue staining that allows ViziLite® TBlue identified lesions to be seen clearly under normal light.
ViziLite® and ViziLite® TBlue have had numerous clinical studies published supporting its ability to help oral healthcare professionals identify, evaluate, monitor and mark abnormal oral lesions suspicious for pathology including precancerous and cancerous cells that may be difficult to see during a regular visual exam.
Mojsa I, Zaleska M, Stypulkowska J, et al. Value of the ViziLite Plus System as a Diagnostic Aid in the Early Detection of Oral Cancer/Premalignant Epithelial Lesions. J Craniofacial Surg. 2012;23(2):e162-164.
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.
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):615.
Kerr AR, Sirois DA, Epstein JB. Clinical evaluation of chemiluminescent lighting: an adjunct for oral mucosal examinations. New York University College of Dentistry. J Clin Dent. 2006;17(3):59-63.
Epstein JB, Gorsky M, Lonky S, et al. The efficacy of oral lumenoscopy (ViziLite) in visualizing oral mucosal lesions. College of Dentistry and Illinois Cancer Center. Spec Care Dentist. 2006;26(4):171-4.
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):521-7.
Zhang L, Williams M, Poh CF, et al. Toluidine blue staining identifies high-risk primary oral premalignant lesions with poor outcome. University of British Columbia. Cancer Res. 2005;65(17):8017-21.
Huber MA, Bsoul SA, Terezhalmy GT. Acetic acid wash and chemiluminescent illumination as an adjunct to conventional oral soft tissue examination for the detection of dysplasia: a pilot study. University of Texas Health Science Center of San Antonio. Quintessence Int. 2004;35(5):378-84.
Patient medical and dental insurance benefits should not dictate the standard of care that is provided. This is especially important for screening procedures, such as the ViziLite® TBlue examination. Practices that offer ViziLite TBlue exams to their patients want their patients to receive the highest quality standard of care available.
CDT Code: D0431
In 2005, the American Dental Association approved a CDT code for adjunctive tests intended to aid in oral mucosal examinations. The relevant passage reads: “Adjunctive pre-diagnostic test that aids in the detection of mucosal abnormalities including pre-malignant and malignant lesions not to include cytology or biopsy procedures.” The ViziLite® TBlue screening examination falls under this definition.
Increasing numbers of dental and medical insurance plans are covering CDT code D0431. While not all insurance companies are currently reimbursing for it, many insurance carriers are seeing the value and cost savings of early detection and diagnosis. Please check with your patient’s individual plan for policy coverage. We recommend that you submit every ViziLite® TBlue exam to the patient’s insurance company for payment. Even if the insurance company does not reimburse at this time, your submittal is what influences insurance companies to begin covering CDT code D0431.
Another resource for coverage is to include a reimbursement narrative letter with each D0431 claim. To download an Insurance Reimbursement Narrative template, click here.
Patient medical insurance may also cover the ViziLite® TBlue exam. Several medical insurance codes have been used to obtain insurance reimbursement for ViziLite® TBlue exam. These codes are as follows:
Dental professionals can provide necessary information to patients so that they can submit a medical claim to their medical insurance company, or dental professionals may submit a medical claim on behalf of their patient. Below are links to prepared, downloadable and printable medical claim forms containing the three code combinations listed above and a blank standard medical claim form.
Download the 82397/V76.42 form (Recommended)
Download the 99211/V76.42 form
Download the 99201/V76.42 form
Download a blank standard medical claim form
Patient medical insurance companies can also provide plan-specific forms.
Medical Spending Accounts (MSAs), if offered by patient employers, are an excellent option for patients to use for reimbursement of a ViziLite® TBlue examination. Healthcare Savings Accounts (HSAs), can also be an option for reimbursement of the annual ViziLite® TBlue exam. In any case, it is important to provide patients with documentation of the ViziLite® TBlue exam for submittal, along with payment receipt, for reimbursement.
What if a patient claim is denied?
Zila, Inc. has also prepared sample practice appeal letters for to be sent to insurance companies in the event that a submission for reimbursement has been denied. Simply download the letter here, fill in practice information, and mail to the insurance company.
Disclaimer – The reimbursement information contained here is provided to help you understand the reimbursement process. It is intended to assist providers in accurately obtaining reimbursement for dental health care services. It is not intended to increase or maximize reimbursement by any payer. We strongly suggest that you consult your payer organization with regard to local reimbursement policies. The information contained here is provided for information purposes only and represents no statement, promise or guarantee by DenMat, Inc., concerning reimbursement, payment or charge. Similarly, all CDT, CPT/HCPCS and ICD-9 codes are supplied for information purposes only and represent no statement, promise or guarantee by DenMat that these codes will be appropriate or that reimbursement will be made.
Oral Cancer Risk Factors
Q: Which patients should receive a ViziLite® TBlue examination?
Approximately 25% of oral cancers are discovered in patients once believed to have no lifestyle risk factors.5 Because the incidence of human papillomavirus 16/18 (HPV 16/18) related cancers are rising in young patients, it is recommended a practitioner perform ViziLite® TBlue exams on all adult patients ages 18 and older.6,7
Oral Cancer Relative Risk Profile1,3,4,5:
Patients age 40 and older (95% of all cases)
18-39 years of age combined with the following:
Chronic alcohol consumption
Oral HPV 16/18 infection
Patients age 65 and older with lifestyle risk factors
Patients with history of oral cancer
Q: Why shouldn’t I offer ViziLite® TBlue exams to tobacco users only?
The demographics for oral cancer are changing and 25% of oral cancers are discovered in patients once believed to have no lifestyle risk factors.5 Additionally, the incidence of human papillomavirus 16/18 (HPV 16/18) related cancers are rising in young patients. Therefore, it is recommended a practitioner perform ViziLite® TBlue exams on all adult patients.5,6
ViziLite TBlue Product Information
Q: What is ViziLite®?
ViziLite® is an FDA cleared medical device that emits a chemiluminescent light at the 430-580nm wavelengths.8 It is used for the identification, evaluation, and monitoring of oral mucosal abnormalities in populations at increased risk for oral cancer.9
Q: What is ViziLite® TBlue?
ViziLite® TBlue is an oral lesion identification and marking system that is used as an adjunct to conventional visual examination. It is comprised of a chemiluminescent light source (ViziLite®) to identify oral mucosal abnormalities and a blue metachromatic vital tissue dye (TBlue) to mark those lesions differentially identified by ViziLite® TBlue. ViziLite® TBlue is designed to be used as the standard of care adjunctive screening for the identification of oral mucosal abnormalities.8
Q: What is the purpose of the Acetic Acid rinse?
The Acetic Acid rinse prepares the mouth for the ViziLite® TBlue examination by desiccating the cells and changing the retractile properties of potential abnormalities.8
Q: How long does the ViziLite® TBlue light-stick glow?
Once activated, the examination must be completed within 5-10 minutes. While the light will continue to glow, it is maximally effective for up to 10 minutes.9
Q: Do I need a completely dark operatory to use ViziLite® TBlue?
Optimally, the field of view for chemiluminescent light would be as dark as possible. For offices that are unable to dim or turn out the lights, eyewear is supplied that eliminates ambient light and enables easier visualization of the wavelength range that ViziLite® TBlue uses: 430-580nm.8
How ViziLite® TBlue Works
Q: Who administers the ViziLite® TBlue exam?
The Food and Drug Administration cleared the ViziLite® TBlue device for use by “trained healthcare professionals.” This includes dentists, registered dental hygienists, physicians and nurses. Check with your state board for specific state requirements.
Q: What am I looking for?
During an examination, a practitioner will look for areas in the mouth that reflect white and become visually differentiated from the surrounding “normal” tissue. Normal tissue will absorb the chemiluminescent light and abnormal tissues will reflect the light. DenMat provides ViziLite® TBlue users with a Visual Guide containing photos of abnormalities identified using the chemiluminescent light.
Q: What should I do when I see a suspicious lesion or when a lesion retains TBlue?
Please refer to the following protocol:
Document the clinical appearance and location of the lesion on the ViziLite® TBlue mouth map. If possible, photograph the lesion.
If trauma or inflammation cannot be ruled out, have the patient return for re-evaluation in 7-14 days.
At re-evaluation, if the lesion persists, document recheck and note any deviations.
Proceed to apply TBlue oral lesion marking system. Document results on the mouth map. If possible, photograph the lesion.
If TBlue retention is present, biopsy the lesion or refer the patient to a specialist for further assessment.
Q: I’ve used ViziLite® TBlue 25 times, but I haven’t found anything abnormal. Is something wrong?
ViziLite® TBlue is a wellness exam. It is very likely that none of these patients presented with an abnormality. Each year, approximately 40,000 new people will be diagnosed with oral cancer, so not every patient you see will present with a suspicious lesion.10 Check for the following to ensure optimal screening results.
Patient should vigorously rinse with the solution for 30-60 seconds
Ambient light needs to be reduced
The ‘open’ side of the retractor is facing the tissues being examined
Q: My practice uses Oral CDx. Why should I use ViziLite® TBlue?
ViziLite® TBlue is used as an adjunct to the visual examination to identify oral lesions. Oral CDx is a pre-diagnostic test performed on clinically evident lesions. These are two different, yet complimentary, types of products. ViziLite® TBlue can guide you to a location to perform a brush biopsy or any other biopsy method of choice.
Q: Do I need to use another ViziLite® TBlue exam when I re-appoint the patient to re-evaluate the lesion?
If the lesion is visible and believed to be clinically suspicious, re-apply TBlue only. If the lesion is no longer visible under normal lighting, then repeat the ViziLite® exam prior to applying TBlue.
Q: When I see a suspicious lesion visually, is the ViziLite® TBlue exam still necessary?
Yes, you would still want to assess the entire mouth with a ViziLite® TBlue exam. Worldwide clinical studies have shown that the use of ViziLite® TBlue following your conventional examination can improve the net yield of suspicious lesions (suspicious lesions missed during visual examination).
Q: Is there a dental code I can use for reimbursement?
Yes, CDT D0431 can be used to submit insurance claims for reimbursement. There are also alternative codes, including medical insurance codes that have been successfully applied to receive reimbursement. Visit the “Insurance Coverage” tab for detailed coding information.
Q: Does my OS/H&N specialist need ViziLite® TBlue if I’m using it?
It is recommended that all dental practitioners utilize ViziLite® TBlue to identify any cell abnormalities and qualify the extent of the lesion with TBlue. It is important, however, for a copy of the ViziLite® TBlue mouth map to accompany the patient to the specialist appointment.
Q: What is TBlue?
TBlue is a patented, metachromatic vital tissue dye known as toluidine blue. It is used to differentially mark and qualify suspicious lesions identified during a ViziLite® TBlue exam.9,11
Q: Why should I use TBlue?
A lesion stained by TBlue allows the practitioner to clearly visualize the extent of the lesion after removal of the ViziLite® TBlue light source. The practitioner can now take an intraoral photograph for inclusion in the patient record, submission to the patient’s insurance carrier or as an invaluable tool for referral to a specialist. In one study, TBlue was shown to have an 80% predictive value of the transformation of benign to malignant lesions.12
Q: When should I use TBlue?
TBlue should be used after trauma, inflammation and benign ulcerative conditions have been eliminated as a cause of the abnormality. TBlue should be used to mark suspicious lesions identified during the ViziLite® TBlue exam. As such, you should perform a thorough visual examination followed by a ViziLite® examination prior to the application of TBlue.
Q: What types of lesions will TBlue mark (stain)?
Clinical studies have demonstrated that TBlue will stain nearly 100% of several dysplasia, carcinoma in situ and cancer. It will also stain approximately 60-70% of less serious pathology (mid and moderate dysplasia as well as traumatic, ulcerative and inflammatory lesions.
Q: Can I use TBlue to mark lesions I’ve identified visually, without ViziLite® TBlue?
Instructions for use require the use of TBlue in conjunction with a ViziLite® TBlue examination. This ensures the abnormality is differentially identified as compared to normal. TBlue was not investigated on lesions other than those that were identified by ViziLite® TBlue.
Q: Should I brush biopsy a lesion marked by TBlue?
Some practitioners feel as though this is an unnecessary step prior to scalpel biopsy. If a brush biopsy is performed after TBlue application, TBlue will not affect the results of the brush biopsy.
Q: What do I do when a lesion stains with TBlue?
The protocol for a suspicious lesion is as follows:
1. Rule out trauma (some providers will reassess the patient after 7 days).
2. If the lesion stains with TBlue, it is in the patient’s best interest for the practitioner to continue to the next step of their oral cancer diagnostic protocol, or refer to a specialist for further evaluation and treatment if required.
Q: Are there ViziLite® TBlue-identified lesions that TBlue won’t stain?
The package insert includes information on the step-by step procedure to ensure proper application of the stain. The insert also includes clinical data that shows what lesions could yield a TBlue negative result. However, it is best to follow the recommended procedure: When in doubt, send it out to a specialist for evaluation.
Q: What are the contraindications of TBlue9?
TBlue is not intended to be used without prior traditional oral visual examination using ambient projected light.
TBlue is contraindicated in patients with known history of hypersensitivity to any of the ingredients or their analogs
TBlue is contraindicated in patients who are pregnant or lactating
TBlue should not be used in children or patients with liver or renal insufficiency
TBlue should not be used in patients who are unable to control swallowing or follow directions
Q: Does TBlue stain anything other than soft tissue lesions? How long will the stain last?
TBlue may stain the dorsum of the tongue, around the margins of dental restorations, inflammatory and ulcerative lesions and dental plaque. TBlue stain will remain present for 2-6 hours after application.9
Q: If TBlue gets on my clothes, will it come out?
The type of fabric will dictate how much, if any, of the stain can be removed. A diluted solution of Acetic Acid (vinegar) should be applied immediately after the stain occurs for best removal.
Q: Are there other uses for TBlue?
DenMat’s patented TBlue is currently only cleared by the FDA for use within the oral cavity. Generic toluidine blue has been used for decades as a hemostatsis agent in the identification of gastrointestinal neoplasms on the female cervix for lesion identification. It has also been used to stain the parathyroid gland during thyroid surgery.13
Q: Do I charge a patient separately to use the TBlue Marking System?
This is a practice decision and every practice is different. Typically dentists don’t charge for TBlue itself, but may charge for an office visit.