ViziLite Plus Faqs

Frequently Asked Questions

Components

Incorporating Vizilite into the Practice

Q: What is ViziLite?

A: ViziLite is a simple device to improve the identification, evaluation and monitoring of oral mucosal abnormalities in populations at increased risk for oral cancer.  (v100405)

Q: What am I looking for?

A: A “ViziLite lesion” will become illuminated and appear distinctly white from the surrounding ‘normal’ tissue. Zila provides ViziLite users with a Visual Guide for Health Care Professionals and a training presentation is available on CD. To order materials contact ViziLite Customer Service, 1.866.ZilaPro (1.866.945.2776).  (v100405)

Q: Where should the ViziLite examination be performed?

A: At the present time the exam is best performed in an operatory that is as dark as possible.  Contact Zila Customer Service at 1.866.ZilaPro (1.866.945.2776) if your practice is unable to dim or turn off the lights in the operatories.   (v100405)

Q: What are the most common sites for Squamous Cell Carcinoma (SCC) within the oral cavity?

A: Lateral border of the tongue, lip, floor of the mouth, soft palate (including the tonsillar pillars) and the retromolar trigone. Lesions presenting on the lateral border of the tongue are often located just anterior to the foliate papilla.   (v100405)

Q: What do I do when I see a suspicious lesion?

A: If, in your professional opinion the lesion presents as suspicious, (you have ruled out trauma), and you are not 100% certain the lesion is benign, it is in the patient's best interests to perform an in-office biopsy or refer to a specialist for further assessment and possible biopsy.  As a general rule any erythroplakia, lesion detected visually and confirmed with ViziLite or detected with ViziLite alone, should be considered suspicious unless you can positively diagnose it as a benign condition.    (v101805)

Q: ViziLite has detected a white lesion, but I can’t see it under normal incandescent light. What do you recommend?

A: The lesion is below the epithelial surface and therefore, by definition, is not severe dysplasia, CIS or SCC. Clearly define the lesion on the supplied mouth map and have the patient return in for a follow-up ViziLite exam.  If the lesion is unchanged or smaller in size reappoint for a re-care appointment.  If the lesion is larger, refer to an expert for further evaluation.  It is important that you evaluate all that is presented.  What is the patient profile?  Is the lesion located in a high risk site?  This answer is only a guideline and not intended to replace your protocols for the management of oral lesions.   (v100405)

Q: What will a common finding like linea alba look like under ViziLite?

A: ViziLite will illuminate ‘hyperparakeratotic’ lesions. Therefore, linea alba will appear acetowhite.   (v100405)

Q: My practice uses Oral CDx. Why should I use ViziLite?

A: ViziLite is used as an adjunct to the visual examination to identify oral lesions.  Oral CDx is a diagnostic test performed on clinically evident lesions.  The two are very different, yet complementary, types of products.  ViziLite can guide you to a location to perform a brush biopsy or any other biopsy method of choice.    (v100405)

Q: I’ve used ViziLite 15 times, but I haven’t found anything abnormal. Is something wrong?

A: Remember this is a wellness exam. There is a good chance that your first 15 (or more) patients had no abnormalities.  Do not become discouraged.  Not every patient will present with a suspicious lesion.  Keep in mind that the best chance for early detection is a ViziLite screening combined with a conventional head and neck examination. Check for the following to ensure optimal ViziLite screening results:

  1. Patient must vigorously rinse with the solution a minimum of 30 seconds.
  2. Ambient light needs to be reduced.
  3. The ‘open’ side of the retractor is facing the tissues being examined.   (v100405)

Q: Does ViziLite give ‘false positive’ results?

A: ViziLite is a screening technology that can identify many types of lesions.  Included identifications will be many benign conditions (such as trauma, Linea alba, frictional keratosis) as well as some with pathology (such as dysplasia, CIS, or SCC).  Dental professionals using ViziLite in conjunction with a conventional oral screening be confident that their patients who screen negative for pathology have a less than 1% probability of having frank oral cancer* (Negative Predictive Value).   (v100405)   *Data available upon request

Q: What is the sensitivity and specificity of ViziLite?

A: ViziLite is a screening technology.  Lesions identified by ViziLite and biopsied during clinical trials have shown sensitivities approaching 100% for lesions with a white component such as linea alba, dysplasia, CIS, or SCC.  As with other screening technologies, as the sensitivity increases one would expect the specificity to be lower.  Contact the Director, Medical Affairs, 1.866.ZilaPro (1.866.945.2776) for answers to related questions.

Q: Who should I contact with questions about ViziLite?

A: Questions regarding the technical aspects of ViziLite will be answered by the Director, Medical Affairs.  All ViziLite inquiries should be directed to ViziLite Customer Service at 1.866.ZilaPro (1.866.945.2776).  (v100405)

Q: Where do I purchase ViziLite?

A: ViziLite can be purchased through most major distributors.  You can contact Zila Customer Service to place an order through a designated distributor.  The advantage to the practice of placing a ViziLite order through Zila is to ensure that all practice support materials are also ordered and shipped along with the product.  (v100405)

Q: What is the price of ViziLite?

A: Questions related to distributor pricing must be directed to the distributor.  Zila provides its distributors with MSRP’s for ViziLite. The MSRP of one ViziLite examination ranges from $19.95/unit to $29.95/unit depending upon the volume purchased and the distributor price to the dental practice.  You can contact Zila, 1.866.ZilaPro (1.866.945.2776) to get a list of ViziLite distributors.  (v100405)

Q: What should I charge for a ViziLite screening?

A: The fees for all services in your practice are dictated by the culture of your practice.  Typical factors involved in establishing the fee for a ViziLite screening are based on the unit cost and the amount of professional time allocated to the ViziLite exam.  (v100405)

Q: Are there any dental professionals I can contact if I have questions about ViziLite?

A: Yes.  Customer Service will provide you with a list of dental professionals who have agreed to be contacted regarding ViziLite; contact 1.866.ZilaPro (1.866.945.2776).  (v100405)

Q: Is there any clinical data to support the efficacy of ViziLite as compared with unaided vision?

A: Yes. Substantial clinical data supports the safety and efficacy of chemiluminescence as an adjunctive screening technology.  The clinical efficacy of the ViziLite technology has been demonstrated in over 13,000 patients and four FDA studies; this data has been evaluated by the ADA which subsequently assigned the new CDT-5 code (D0431) for the oral screening of abnormalities, including pre-cancerous and cancerous lesions.  In one recent multi-center trial of 134 patients, 2 lesions (one leukoplakia and one squamous cell cancer) were detected by ViziLite alone.  This abstract and other clinical data are available by contacting the Director,Medical Affairs at 1.866.ZilaPro (1.866.945.2776).  (v100405)

Q: Is there a dental code I can use for reimbursement?

A: Yes.  In June, 2004 the ADA approved a new dental reimbursement code for oral cancer screening products.  This new code, D0431, is effective as of January 1, 2005 in the CDT 5 manual.  There are also other alternative codes, including medical insurance codes, that have been successfully applied to receive reimbursement.  For additional reimbursement information,  contact Zila Customer Service at 1.866.ZilaPro (1.866.945.2776) for more detailed coding information and/or questions.   (v100405)

Q: What if reimbursement is denied on the new D0431 code?

A: As with almost all new codes, the insurance companies don't reimburse right away.  It may take multiple claim submissions to the payers before they begin paying on D0431.  The practices should collect those denials and send them to Zila Pharmaceuticals, Inc., ATTN: Customer Service (Insurance Denials), 5227 N. 7th Street, Phoenix, AZ, 85014, or fax them to Zila Customer Service at 602.234.2318.  Zila will use the reasons for denial in its ongoing discussions with the insurance companies.  Patients should be offered the benefits of the ViziLite screening for all the reasons that the dentist offers other procedures that require out-of-pocket expenditures and distinguish his/her practice from other practices.  This is an enhancement to the standard of care...insurance companies should not dictate a dentist's standard of care.  Today's dental plans are designed to assist patients with dental treatment.  It is important to remember that necessary services are not necessarily covered.  (v100405) 

Components

Q: Is any part of the ViziLite kit reusable?

A: No. ViziLite is a single use product. All components (acetic acid rinse, retractor, light- stick) are to be discarded after use. This is another advantage of ViziLite – it can be conveniently disposed per OSHA regulations immediately after use to eliminate the risk of cross-contamination.  (v100405)

Q: Are the ingredients in ViziLite safe?

A: Yes. The chemicals are non-toxic and biodegradable. The light-stick contains a peroxyoxalate solution.

Q: What is the purpose of the acetic acid rinse?

A: There are two functions of the acetic acid rinse. The solution removes the mucosal glycoprotein layer to reduce glare and increases the nuclear/cytoplasmic ratio.  (v100405)

Q: Will the rinse used in the ViziLite exam stain teeth or cause other problems?

A: The solution acts as both a cleanser and desiccant. It will not stain hard or soft tissues. It may "etch" hybrid acrylics. Make certain that any acrylic-based prosthetic is removed. If it is "fixed", as in the case of an implant- borne denture, have the patient rinse for a maximum of 30 seconds.

Q: How long does the ViziLite light-stick glow?

A: Once activated, the examination must be completed within 10 minutes.  While the light will continue to glow longer than 10 minutes, it is maximally effective for 10 minutes.  (v100405)

Q: What should I do if one of the components malfunctions, breaks or spills?

A: Replace that component with one from another kit and then contact 1.866.ZilaPro (1.866.945.2776) to receive a complimentary replacement component.

Incorporating Vizilite into the Practice

Q: Does Zila provide practice support materials?

A: Yes. Along with your ViziLite order Zila will provide your practice with ViziLite promotional materials and practice support information. The materials include:

  1. ViziLite patient brochures along with brochure holders
  2. Patient Consent/Waiver forms (with mouth map)
  3. Laminated procedure guides
  4. Pre-printed ViziLite postcards for patient mailings
  5. The Steps to Successfully Integrating ViziLite
  6. Coding/Reimbursement information
  7. In-office ViziLite script
  8. Wall posters
  9. Visual Guide for Healthcare Professionals
  10. Patient Video (VHS or DVD) 

Q: Which patients should receive a ViziLite examination?

A:ViziLite examinations should be performed on patients who are at increased risk for oral cancer.  Because over 25% of oral cancers are discovered in patients with no lifestyle risk factors, a practitioner may want to perform ViziLite exams on all adult patients (age 18 and older). The key step for the practice is to offer ViziLite screenings to the patients at highest risk for oral cancer.

Oral Cancer Risk by Patient Profile

Increased Risk:  patients age 18 - 39 with no lifestyle risk factors (annual ViziLite exam)

High Risk:  patients age 40 and older with no lifestyle risk factors OR patients 18 - 39 with lifestyle risk factors(annual ViziLite exam)

Lifestyle risk factors for oral cancer include:

  • Tobacco use (any type, any age, within 10 years)
  • Alcohol consumption of at least one drink per day
  • Autoimmune deficiencies such as HIV & AIDS
  • Viral infections, particularly HPV 16/18
  • Diabetes

Highest Risk:  patients 40 and older with lifestyle risk factors or patients with a history of oral cancer (at minimum, annual or semi-annual ViziLite exam)

Q: What is the profile for someone at highest risk for oral cancer?

A: Many factors contribute to oral cancer risk. For simplicity, we suggest the clinician focus on the most prominent risk factors (age 40 and older; tobacco use) as the definition of the "highest risk" patient. At minimum, a ViziLite examination should be offered to these patients annually; many professionals perform semi-annual/90-day ViziLite examinations on their patients at highest risk for oral cancer.  (v100405)

Q: How should potential ViziLite patients be identified for screening?

A:Because more than  25% of oral cancer victims have no lifestyle risk factors, many practices are now offering annual ViziLite exams to all adult patients (age 18 and older tobacco users of any age). Patients age 18 to 39 are at increased risk for oral cancer; Adults age 40 and older, and tobacco users of any age, are at high risk for oral cancer. Patients age 40 and older with lifestyle risk factors such as tobacco use, chronic alcohol use, diabetes, HIV an HPV 16/18 are at highest risk for oral cancer.   Practices assign responsibility to a staff member to flag those patients' charts for ViziLite examination, provide the patient with a ViziLite brochure and, once in the operatory, have the patient read the Patient Consent/Waiver Form.  Importantly, you must ensure that all ViziLite components are on the tray.  (v101005)

Q: Who should administer the ViziLite exam?

A: ViziLite exams can be performed by the doctor, dental hygienist or nurse; check state regulations. The doctor ultimately must discuss the results of the exam with the patient. This is another advantage of ViziLite.  In many offices, the dentist will perform the exam on the patient's initial visit; hygienists perform the exam annually on re-care patients.  (v100405)

Q: I’m concerned my patients will not want to pay for a ViziLite screening. What are the offices incorporating ViziLite doing to gain acceptance?

A: The offices that do the best in gaining acceptance have fully integrated ViziLite into their standard of care.  ViziLite is offered to all patients at increased risk for oral cancer (adults age 18 and older and tobacco users).  The primary tool used to gain patient acceptance is the Patient Consent/Waiver Form (with mouth map).  Practices are using the Patient Consent Waiver form as follows:

  1. Ensure that all patients at increased risk for oral cancer are given a ViziLite patient brochure. Once in the operatory the patient is then given the Patient Waiver form to read.
  2. Make certain all ViziLite components are on the tray.
  3. Ask the patient if he/she has any questions regarding the Patient Waiver form. Reiterate passionately the reasons the practice recommends the ViziLite screening for its patients in the increased risk, high risk and highest risk profiles.
  4. After the patient accepts the ViziLite screening, use the mouth map (back of the Patient Waiver form) to record findings for inclusion in the patients’ chart and submission to the insurance carrier.
  5. If the patient declines the ViziLite screening, have the patient sign and date the Patient Waiver form for inclusion into his/her dental record.  (v101805)